Sanofi-Aventis Deutschland

Patent Trials and Appeals Board

Aug 11, 2020

IPR2019-00979 (P.T.A.B. Aug. 11, 2020)

Trials@uspto.gov Paper No. 38
571-272-7822 Date: August 11, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

PFIZER INC.,
Petitioner,
v.
SANOFI-AVENTIS DEUTSCHLAND GMBH,
Patent Owner.

IPR2019-00979
Patent 8,679,069 B2

Before HYUN J. JUNG, BART A. GERSTENBLITH, and
JAMES A. TARTAL, Administrative Patent Judges.
JUNG, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
Denying Petitioner’s Motion to Exclude
35 U.S.C. § 318(a)

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I. INTRODUCTION
We have jurisdiction under 35 U.S.C. § 6. This Final Written
Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
For the reasons that follow, we determine that Pfizer Inc. (“Petitioner”) has
shown by a preponderance of the evidence that claims 1–3 of
U.S. Patent No. 8,679,069 B2 (Ex. 1001, “the ’069 patent”) are
unpatentable. We also deny Petitioner’s Motion to Exclude.
A. Background and Summary
Petitioner filed a Petition (Paper 2, “Pet.”) requesting institution of an
inter partes review of claims 1–3 of the ’069 patent. Sanofi-Aventis
Deutschland GmbH (“Patent Owner”) waived filing a Preliminary Response.
Paper 9. Pursuant to 35 U.S.C. § 314, we instituted an inter partes review of
the ’069 patent. Paper 12 (“Dec. to Inst.”). In particular, we instituted
review of claims 1–3 on all presented challenges. Dec. to Inst. 2, 13, 22.
After institution, Patent Owner filed a Response (Paper 17, “PO
Resp.”), to which Petitioner filed a Reply (Paper 21, “Pet. Reply”), and
Patent Owner thereafter filed a Sur-reply (Paper 25, “PO Sur-reply”).
Petitioner also filed a motion to exclude (Paper 33, “Mot.”), and Patent
Owner filed an opposition to the motion to exclude (Paper 35, “Opp.”), to
which Petitioner filed a Reply (Paper 37, “Mot. Reply”). No oral hearing
was held in this proceeding. See Paper 28 (notice that Petitioner does not
seek oral argument); Paper 34 (order granting Patent Owner’s request to
withdraw its request for oral hearing); Ex. 3001.
B. Real Parties in Interest
Petitioner indicates that Pfizer Inc. and Hospira, Inc. are real parties in
interest. Pet. 1. Patent Owner indicates that Sanofi-Aventis Deutschland
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GmbH, Sanofi-Aventis U.S. LLC, and Sanofi Winthrop Industrie are real
parties in interest. Paper 6, 2.
C. Related Matters
The parties indicate that the ’069 patent has been asserted in Sanofi-
Aventis U.S. LLC v. Mylan GmbH, No. 2:17-cv-09105-SRC-CLW (D.N.J.)
(“Sanofi-9105”); Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.,
No. 1:16-cv-00812-RGA-MPT (D. Del.); and Sanofi-Aventis U.S. LLC v. Eli
Lilly and Co., No. 1:14-cv-00113-RGA-MPT (D. Del.). Pet. 1; Paper 6, 2;
Ex. 1029; Ex. 1030; Ex. 2016; Ex. 2165; Ex. 2166.
Mylan Pharmaceuticals Inc. (“Mylan”) challenged claim 1 of the ’069
patent in IPR2018-01670, which we discuss further below. Pet. 1; Paper 6,
3. Petitioner moved for joinder with IPR2018-01670, which we denied
because Petitioner additionally challenges claims 2 and 3 of the ’069 patent.
Paper 3; Dec. to Inst. 19–22.
Related patents are challenged in IPR2018-01675, IPR2018-01676,
IPR2018-01677, IPR2018-01678, IPR2018-01679, IPR2018-01680,
IPR2018-01682, IPR2018-01684, IPR2018-01696, IPR2019-00122,
IPR2019-00977, IPR2019-00978, IPR2019-00980, IPR2019-00981,
IPR2019-00982, IPR2019-00987, IPR2019-01022, and IPR2019-01023.
Pet. 1–2; Paper 6, 3–4.
D. The ’069 Patent (Ex. 1001)
The ’069 patent issued March 25, 2014, from an application filed
November 11, 2010, which is a continuation of an application filed on
July 11, 2006, which, in turn, is a continuation of an application filed on
March 2, 2004. Ex. 1001, codes (22), (45), (63), 1:6–12. The ’069 patent
also claims priority to a foreign application filed on March 3, 2003. Id. at
code (30), 1:10–11.
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The ’069 patent “relates to pen-type injectors . . . where a user may set
the dose.” Ex. 1001, 1:13–17. Figures 1 and 2 of the ’069 patent are
reproduced below.

Figure 1 “shows a sectional view of a pen-type injector . . . in a first,
cartridge full position,” and Figure 2 “shows a sectional view of the pen-type
injector . . . in a second, maximum first dose dialed, position.” Id. at 2:38–
42. The injector includes first cartridge retaining part 2 and second main
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housing part 4.1 Id. at 3:8–9. Insert 16 is at a first end of main housing 4
and is fixed rotationally and longitudinally to main housing 4. Id. at 3:29–
30. Insert 16 includes threaded circular opening 18, through which piston
rod 20 extends. Id. at 3:31–33, 3:37–39. Piston rod 20 includes first
thread 19 (id. at 3:36) and pressure foot 22 that abuts piston 10 of cartridge 8
(id. at 3:39–41).
Drive sleeve 30 extends about piston rod 20, and second thread 24 of
piston rod 20 engages internal helical groove 38 of drive sleeve 30. Id. at
3:41–42, 3:51, 3:58–60. Clutch 60 is disposed about drive sleeve 30
adjacent its second end. Id. at 4:12–14, 4:28–29. Clutch 60 is keyed to
drive sleeve 30 by splines to prevent relative rotation between clutch 60 and
drive sleeve 30. Id. at 4:39–41.
Dose-dial sleeve 70 is outside of clutch 60 but within main housing 4.
Id. at 4:49–51. Dose-dial sleeve 70 has helical groove 74 on its outer
surface. Id. at 4:51–52. Dose-dial grip 76 is disposed about the second end
of dose-dial sleeve 70 and secured to dose-dial sleeve 70 to prevent relative
motion. Id. at 5:3–4, 5:6–8.
A user rotates dose-dial grip 76 to set a dose and to cause dose-dial
sleeve 70 and drive sleeve 30 to rotate together out of main housing 4. Id. at
5:29–32, 5:42–44, Fig. 9. The dose can be reduced by turning dose-dial
grip 76 in the opposite direction. Id. at 5:65–66, Fig. 10. The user then
presses button 82, which causes clutch 60 to disengage from dose-dial
sleeve 70 so that clutch 60 moves axially and dose-dial sleeve 70 rotates
back into housing part 4. Id. at 6:6–9, 6:11–13, Fig. 11. Drive sleeve 30

1 The ’069 patent refers to “second main housing part 4” and “main
housing 4” interchangeably. Compare Ex. 1001, 3:9 (“second main housing
part 4”), with id. at 3:30 (“main housing 4”).
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also moves axially and causes piston rod 20 to rotate through threaded
opening 18 to dispense medicine from cartridge 8. Id. at 6:23–25.
E. Illustrative Claim
The ’069 patent has three claims, all of which Petitioner challenges.
Claim 1, the only independent claim, is reproduced below:
1. A housing part for a medication
dispensing apparatus, said housing part comprising:
a main housing, said main housing extending
from a distal end to a proximal end;
a dose dial sleeve positioned within said
housing, said dose dial sleeve comprising a helical
groove configured to engage a threading provided
by said main housing, said helical groove provided
along an outer surface of said dose dial sleeve;
a dose dial grip disposed near a proximal end
of said dose dial sleeve;
a piston rod provided within said housing,
said piston rod is non-rotatable during a dose setting
step relative to said main housing;
a drive sleeve extending along a portion of
said piston rod, said drive sleeve comprising an
internal threading near a distal portion of said drive
sleeve, said internal threading adapted to engage an
external thread of said piston rod; and,
a tubular clutch located adjacent a distal end
of said dose dial grip, said tubular clutch operatively
coupled to said dose dial grip,
wherein said dose dial sleeve extends
circumferentially around at least a portion of said
tubular clutch.

Ex. 1001, 6:37–60.
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F. Asserted Prior Art and Testimonial Evidence
Petitioner identifies the following references as prior art in the
asserted grounds of unpatentability:
U.S. Patent No. 6,221,046 B1, issued April 24, 2001 (Ex. 1013,
“Burroughs”);
U.S. Patent No. 6,235,004 B1, issued May 22, 2001 (Ex. 1014,
“Steenfeldt-Jensen”); and
U.S. Patent Application Publication No. US 2002/0052578 A1,
published May 2, 2002 (Ex. 1015, “Moller”).
Petitioner provides a Declaration (Ex. 1011) and a Reply Declaration
of Mr. Charles E. Clemens (Ex. 1095). Patent Owner provides a Declaration
of Alexander Slocum, Ph.D. Ex. 2107. A deposition transcript for
Mr. Clemens was filed. Ex. 2450. Deposition transcripts for Dr. Slocum
were also filed. Exs. 1053, 1054.
Primarily in support of objective indicia of nonobviousness, Patent
Owner provides declarations from Henry G. Grabowski, Ph.D. (Ex. 2109)
and Dr. Robin S. Goland (Ex. 2111). See Ex. 2109 ¶ 7 (stating that “I have
been retained by counsel for Sanofi to opine on the commercial success of
Lantus® SoloSTAR®”); Ex. 2111 ¶ 14 (stating in “Summary of Opinions”
that “it is my opinion that patients who require insulin or insulin analog
therapy need an easy-to-use injection pen device”).
In response, Petitioner provides declarations from Dr. William C.
Biggs (Ex. 1048) and DeForest McDuff, Ph.D. (Ex. 1060). See Ex. 1048
¶ 16 (stating that “[m]y opinions are directed principally to long-felt, unmet
need arguments”); Ex. 1060 ¶ 6 (stating that the scope of work is to review
and respond to the Grabowski declaration regarding commercial success).
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Deposition transcripts were filed for Prof. Grabowski (Ex. 1055),
Dr. Goland (Ex. 1056), Dr. Biggs (Ex. 2317), and Dr. McDuff (Ex. 2318).
G. Asserted Grounds
Petitioner asserts that claims 1–3 are unpatentable on the following
grounds:
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1–3 103(a)2 Burroughs
1 103(a) Steenfeldt-Jensen
1 103(a) Moller, Steenfeldt-Jensen
In IPR2018-01670, Mylan challenged claim 1 of the ’069 patent as
unpatentable over (1) Burroughs, (2) Steenfeldt-Jensen, and (3) Moller
combined with Steenfeldt-Jenson. Mylan Pharmaceuticals Inc. v. Sanofi-
Aventis Deutschland GmbH, IPR2018-01670, Paper 1 (September 10, 2018)
(Petition). Oral argument was held on January 15, 2020. Mylan, Paper 78.
We determined that Mylan showed by a preponderance of the evidence that
claim 1 is unpatentable over Burroughs and over Steenfeldt-Jensen. Mylan,
Paper 81 (PTAB April 2, 2020) (Final Written Decision).

II. ANALYSIS
A. Legal Standards
In an inter partes review, Petitioner bears the burden of proving
unpatentability of the challenged claims, and the burden of persuasion never
shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,

2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103, effective March 16,
2013. Because the challenged claims have an effective filing date before
this date, the pre-AIA version of § 103 applies.
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800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail in its challenges,
Petitioner must prove unpatentability by a preponderance of the evidence.
35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
The U.S. Supreme Court set forth the framework for applying the
statutory language of 35 U.S.C. § 103 in Graham v. John Deere Co. of
Kansas City, 383 U.S. 1, 17–18 (1966):
Under § 103, the scope and content of the prior art are to be
determined; differences between the prior art and the claims at
issue are to be ascertained; and the level of ordinary skill in the
pertinent art resolved. Against this background, the
obviousness or nonobviousness of the subject matter is
determined. Such secondary considerations as commercial
success, long felt but unsolved needs, failure of others, etc.,
might be utilized to give light to the circumstances surrounding
the origin of the subject matter sought to be patented.
As explained by the Supreme Court in KSR International Co. v. Teleflex
Inc.:
Often, it will be necessary for a court to look to interrelated
teachings of multiple patents; the effects of demands known to
the design community or present in the marketplace; and the
background knowledge possessed by a person having ordinary
skill in the art, all in order to determine whether there was an
apparent reason to combine the known elements in the fashion
claimed by the patent at issue. To facilitate review, this analysis
should be made explicit.
550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006) (“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.”)).
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“Whether an ordinarily skilled artisan would have been motivated to
modify the teachings of a reference is a question of fact.” WBIP, LLC v.
Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016). “[W]here a party argues
a skilled artisan would have been motivated to combine references, it must
show the artisan ‘would have had a reasonable expectation of success from
doing so.’” Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876
F.3d 1350, 1360–61 (Fed. Cir. 2017) (quoting In re Cyclobenzaprine
Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063,
1068–69 (Fed. Cir. 2012)).
As described below, the parties’ disputes are related to the scope and
content of the asserted prior art, differences between claim 1 and the asserted
prior art, and objective indicia of nonobviousness.
After reviewing the complete record, we conclude that Petitioner has
shown by a preponderance of the evidence that Burroughs teaches or
suggests the limitations of claims 1–3; that Steenfeldt-Jensen teaches or
suggests the limitations of claim 1; that a person of ordinary skill in the art
would have had a reason to modify Burroughs and Steenfeldt-Jensen with a
reasonable expectation of success; and that nexus has not been demonstrated
sufficiently for the asserted objective indicia of nonobviousness.
B. Level of Ordinary Skill in the Art
Petitioner asserts that one of ordinary skill in the art “would have had
at least a bachelor’s degree in mechanical engineering, or an equivalent
degree” and “would have understood the basics of medical-device design
and manufacturing, and the basic mechanical elements (e.g., gears, pistons)
involved in drug delivery devices.” Pet. 17 (citing Ex. 1011 ¶ 106). In our
Decision to Institute, we preliminarily adopted Petitioner’s unopposed
proposal. Dec. to Inst. 9.
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According to Patent Owner, one of ordinary skill would have
understood “the mechanical elements (e.g., lead screws, clutches, gears)
used in drug injection delivery devices as well as the principles governing
the interactions of such mechanical elements, and . . . the basics of device
design and manufacturing” and would have had “a bachelor’s degree in
mechanical engineering or an equivalent degree.” PO Resp. 4–5 (citing
Ex. 2107 ¶ 102). Patent Owner also states that its “level of ordinary skill is
similar to that proposed by Petitioner” and “any slight differences do not
affect the arguments made below.” Id. at 5.
In determining the level of ordinary skill in the art, various factors
may be considered, including the “type of problems encountered in the art;
prior art solutions to those problems; rapidity with which innovations are
made; sophistication of the technology; and educational level of active
workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)
(citation and internal quotation marks omitted).
Based on the full record before us, we see no reason to disturb our
preliminary finding regarding the level of ordinary skill in the art.
Accordingly, we maintain and reaffirm that one of ordinary skill in the art
“would have had at least a bachelor’s degree in mechanical engineering, or
an equivalent degree” and “would have understood the basics of medical-
device design and manufacturing, and the basic mechanical elements (e.g.,
gears, pistons) involved in drug-delivery devices.” Dec. to Inst. 9 (quoting
Pet. 17). This level of skill in the art is consistent with the disclosure of the
’069 patent and the prior art of record.
We agree with the parties that any differences in the parties’ proposals
do not affect their arguments and, thus, would not affect our analysis. PO
Resp. 5.
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C. Claim Construction
In an inter partes review based on a petition filed on or after
November 13, 2018, the claims are construed
using the same claim construction standard that would be used to
construe the claim in a civil action under 35 U.S.C. [§] 282(b),
including construing the claim in accordance with the ordinary
and customary meaning of such claim as understood by one of
ordinary skill in the art and the prosecution history pertaining to
the patent.
Changes to the Claim Construction Standard for Interpreting Claims in Trial
Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340
(Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b) effective November 13,
2018) (codified at 37 C.F.R. § 42.100(b) (2019)); see Phillips v. AWH Corp.,
415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). If the Specification
“reveal[s] a special definition given to a claim term by the patentee that
differs from the meaning it would otherwise possess[,] . . . the inventor’s
lexicography governs.” Phillips, 415 F.3d at 1316 (citing CCS Fitness, Inc.
v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)). Another
exception to the general rule that claims are given their ordinary and
customary meaning is “when the patentee disavows the full scope of a claim
term either in the specification or during prosecution.” Uship Intellectual
Props., LLC v. United States, 714 F.3d 1311, 1313 (Fed. Cir. 2013) (quoting
Thorner v. Sony Comput. Entm’t Am., LLC, 669 F.3d 1362, 1365 (Fed. Cir.
2012)).
Additionally, only terms that are in controversy need to be construed,
and these need be construed only to the extent necessary to resolve the
controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
803 (Fed. Cir. 1999) (holding that “only those terms need be construed that
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are in controversy, and only to the extent necessary to resolve the
controversy”); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.
Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the
context of an inter partes review).
Petitioner states that “claim terms should be given their ordinary and
customary meaning, consistent with the specification and how they would
have been understood by the [person of ordinary skill in the art].” Pet. 17.
Petitioner notes that Patent Owner proffered interpretations of “drive
sleeve,” “main housing,” “piston rod,” “thread/threaded/threading,” and
“tubular clutch” in related litigation. Id. at 17–18 (citing Ex. 1019, 19−24,
27–28, 30–31).
Petitioner also notes that, in related litigation, Mylan proffered a
means-plus-function interpretation for “tubular clutch.” Id. at 18 (citing
Ex. 1028 (Mylan’s Preliminary Claim Constructions in Sanofi-9105), 80–
85). To the extent the proper interpretation is a means-plus-function
construction, Petitioner proffers the same interpretation in this proceeding.
Id. at 19 (citing Ex. 1001, 2:5–7, 4:42–44, 6:14–22, 11:58–12:4, Figs. 1, 5–
11; Ex. 1028, 82).
In our Decision to Institute, we did not need to interpret expressly any
term at that stage of the proceeding. Dec. to Inst. 9. Patent Owner “believes
it is only necessary to address the construction of ‘tubular clutch.’” PO
Resp. 5.
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1. “tubular clutch”3
Petitioner contends “tubular clutch” is “[a] tubular structure that
couples and decouples a moveable component from another component.”
Pet. 18. Petitioner states that in related litigation, “Mylan proffered a
preliminary means-plus-function construction for the claim term ‘tubular
clutch,’” where the functions are “that during dose setting, it ‘clutch[es], i.e.,
coupling and decoupling a movable component from another component,’
or, during dose setting, it ‘operates to reversibly lock two components in
rotation.’” Id. at 18–19 (citing Ex. 1028, 80–85). Petitioner identifies the
structure that corresponds to those functions as “component 60” of the ’069
patent. Id. at 19 (citing Ex. 1001, 2:5–7, 4:42–44, 6:14–22, 11:58–12:4,
Figs. 1, 5–11).
Patent Owner contends that the plain and ordinary meaning of
“clutch” is “a tubular component that can operate to reversibly lock two
components in rotation.” PO Resp. 5, 6–7. Patent Owner asserts that this is
the construction adopted by the district court in Sanofi-9105. Id. at 6 (citing
Ex. 2165 (Opinion and Order (D.I. 319) construing claim terms in Sanofi-
9105, filed May 9, 2019), 13). Patent Owner contends that, in construing the
term, the district court disagreed with Petitioner’s proposed construction. Id.
(citing Ex. 2165, 10–11, 13).

3 “Tubular clutch” was construed by two different district courts. In Sanofi-
9105, the U.S. District Court for the District of New Jersey, construed the
term to mean “a component that can operate to reversibly lock two
components in rotation.” Ex. 2165, 13. Previously, in Sanofi-Aventis U.S.
LLC v. Eli Lilly & Co., 14-cv-113 (RGA) (D. Del.), the U.S. District Court
for the District of Delaware construed “tubular clutch” to mean “a structure
that couples and decouples a moveable component from another
component.” See Ex. 2165, 10 (referring to the Delaware court’s
construction).
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Petitioner replies that the courts’ constructions and Patent Owner’s
proffer are “evidence of the reasonable scope of the limitation” and that the
“limitation would at least encompass all these constructions absent a
showing that one construction is unreasonable,” which Patent Owner has not
shown according to Petitioner. Pet. Reply 2 (citing Pet. 18; PO Resp. 6–7;
Ex. 1019, 23–24; Ex. 1030, 12; Ex. 2165, 10–11).
Patent Owner also responds that “tubular clutch” is not a means-plus-
function term, the Petition does not present “any support to overcome the
presumption against applying means-plus-function,” the Petition presents no
analysis of whether sufficient structure is recited, and the District of New
Jersey has rejected the contention that “tubular clutch” is a means-plus-
function term. PO Resp. 6 (citing Ex. 2165, 12). Petitioner replies that
Patent Owner “has not addressed nonobviousness under this means-plus-
function construction, and any such argument is now waived.” Pet. Reply 1.
We are persuaded that “tubular clutch” does not invoke § 112, ¶ 6,4
and, for the reasons discussed below, we find that Petitioner sufficiently
establishes that the asserted references disclose a “tubular clutch,” under
either party’s construction—“a tubular structure that couples and decouples
a moveable component from another component” or “a component that can
operate to reversibly lock two components in rotation.”
Accordingly, we determine that no claim terms require express
construction beyond the discussion above. Vivid Techs., 200 F.3d at 803.

4 Petitioner fails to present any evidence or argument to overcome the
presumption that “tubular clutch,” which does not recite the word “means,”
is not a means-plus-function limitation. See Williamson v. Citrix Online,
LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015) (when a claim limitation does
not include the word “means,” there is a presumption that the term is not a
means-plus-function limitation and § 112, ¶ 6 does not apply).
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D. Scope and Content of the Asserted Prior Art
1. Burroughs (Ex. 1013)
Burroughs relates to “medical dispensing devices . . . that permit
selectively measured dosages of a liquid to be dispensed.” Ex. 1013, 1:13–
16; see also id. code (57) (describing a “multi-use medication dispensing
pen” that is “made of a minimal number of parts”). Figure 2 of Burroughs is
reproduced below.

Figure 2 shows an exploded view of injection medication device 20.
Ex. 1013, 6:42–43, 7:15–16. “[I]njection medication device 20 ha[s] the
general appearance of a pen” and “comprises a mechanism housing 22
having a first part 24 and a second part 26.” Id. at 7:15–20.
“Dial mechanism 34 comprises proximal portion 78, intermediate
portion 80, and distal portion 82.” Id. at 8:2–4. The “term ‘proximal’ shall
designate a relative axial position toward the button end of the delivery pen,
and the term ‘distal’ shall designate a relative axial position toward the
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delivery needle end of the delivery pen.” Id. at 7:9–13. “Proximal portion
78 comprises enlarged diameter portion 84, tapered portion 86, and ring 90
extending about the circumference of proximal portion 78.” Id. at 8:4–6.
“[P]roximal ends of flexible sections 92 and 95 each include fingers 94 . . .
adapted for engagement with enlarged diameter portion 54 of button 32” and
“[w]hen button 32 is depressed, enlarged diameter portion 54 is also
depressed and . . . forces fingers 94 outward” so that “[d]ial mechanism 34 is
then able to travel axially towards cartridge 40 during injection of the
medical product.” Id. at 8:11–20; see also id. at 8:9–11 (stating that
“[g]enerally U-shaped grooves 91 and 93 (FIGS. 6, 8) are formed in
intermediate portion 80 to form a flexible sections 92 and 95,
respectively.”). Dial mechanism 34 also includes outwardly extending
threads 110, 112 that “enter helical groove 158 during commencement of the
dosing process.” Id. at 8:9–11, 8:33–36, 8:62–9:1, Figs. 3, 5.
Dial mechanism 34 engages button 32, and “button 32 comprises a
hollow cylindrical portion 48 having a proximal end 50.” Id. at 7:46–47,
8:9–14, Figs. 6, 8. “Cylindrical portion 48 . . . includes an enlarged diameter
ring 54.” Id. at 7:49–51. When button 32 is depressed, dial mechanism 34
travels axially towards cartridge 40. Id. at 8:15–20. Splines 144 on the
interior of dial mechanism 34 engage teeth 192 of nut 36 when the clutch is
engaged to set a dosage. Id. at 8:42–48, Fig. 9.
“Housing parts 24 and 26 include bulkhead ledges 178, 180,
respectively” that include “flexible tangs 182, 184, respectively.” Id. at 9:8–
11. “[L]eadscrew 38 is shown having a ratchet teeth 204 located on two
opposing sides of leadscrew 38 and axially extending along the length of
leadscrew 38 from proximal end 200 to plunger engagement portion 206.”
Id. at 9:26–30. “Helical threads 208 extend along the axial length of
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leadscrew 36.” Id. at 9:30–31. “[P]lunger engagement portion 206 of
leadscrew 38 is in engagement with piston 210 of cartridge 40.” Id. at 9:32–
34.
Device 20 includes nut 36 that “is generally cylindrical in shape.” Id.
at 9:12–14. “The interior surface of the distal end of nut 36 includes a
helical thread 198,” and “[t]hread 198 extends 350° about the inner surface
of nut 36.” Id. at 9:22–25. “Helical threads 208 extend along the axial
length of leadscrew 36,” and “[l]eadscrew 38 fits within the cylindrical
opening of nut 36.” Id. at 9:30–32.
Rotating dial mechanism 34 causes nut 36 to rotate and move relative
to housing 20, but rotation of leadscrew 38 is prevented. Id. at 10:25–27.
“Rotation of leadscrew 38 is prevented by a key-keyway type of engagement
between the anti-backup tangs 182 and 184 and leadscrew 38,” and
“tangs 182, 184 form a key, and leadscrew 38 forms a keyway which comes
into contact with the sides of the key.” Id. at 10:26–30. “Upon rotation of
dial 34, . . . dial mechanism 34 retracts from housing 22.” Id. at 10:34–42.
“Rotation of dial mechanism 34 causes rotation of nut 36 so that internal
helical raised groove 198 of nut 36 rotates along external threads 208 of
leadscrew 38 to cause nut 36 to axially retract a corresponding axial
distance.” Id. at 10:38–42.
A series of numerals are printed on dial mechanism 34 to indicate a
desired dosage. Id. at 10:5–9. “As a dosage is being set, outwardly
extending threads 110 and 112 of dial mechanism 34 ride in helical
groove 158 of housing parts 24 and 26.” Id. at 10:60–63.
Once a desired dosage has been set, button 32 is pushed to move dial
mechanism 34, nut 36, and leadscrew 38 forward to deliver the set dosage.
Id. at 11:13–19, 11:31–34. “Movement of leadscrew 38 is prevented in the
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proximal direction due to anti-backup tangs 182, 184 being in engagement
with ratchet teeth 204” so that “head 206 of leadscrew 38 remains in
constant engagement with piston 210 at all times.” Id. at 11:52–56.
2. Steenfeldt-Jensen (Ex. 1014)
Steenfeldt-Jensen “relates to injection syringes of the kind
apportioning set doses of a medicine from a cartridge containing an amount
of medicine sufficient for the preparation of a number of therapeutic doses”
Ex. 1014, 1:12–15. Figures 15–17 of Steenfeldt-Jensen are reproduced
below.

Figures 15 and 16 show side sectional views of a syringe, and
Figure 17 shows an exploded view of the syringe of Figures 15 and 16. Id.
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at 5:23–28. The syringe of Steenfeldt-Jensen includes tubular housing 1 that
is partitioned so that a first division has ampoule holder 2. Id. at 5:38–40;
see also id. at 14:11(reciting in claim 11 “a housing having proximal and
distal ends”).
“The end of the ampoule holder 2 inserted in the housing 1 is closed
by a wall 4 having a central bore with an internal thread 5” and “piston rod 6
having an external thread 7 mating the thread 5 of said bore extends through
said bore.” Id. at 5:55–58. Driver tube 85 is disposed about piston rod 6.
See id. at Figs. 15–17. “[E]nd wall 4 with the internal thread 5 is provided in
a separate member 40 which is mounted in an end of the housing.” Id. at
8:35–38.
“To maintain a clockwise rotation of a dose setting button for
increasing the set dose the pawl mechanism working between the driver tube
and the housing . . . bars clockwise rotation . . . of the driver tube.” Id. at
11:6–11. The “thread of the piston rod and the thread in the end wall of the
housing is so designed that an anticlockwise rotation of the piston will screw
the piston rod through said end wall and into the cartridge holder
compartment,” and “[t]he piston rod has a not round cross-section and fits
through the driver tube bore which has a corresponding not round cross-
section” so that “rotation is transmitted” and “the piston rod is allowed to
move longitudinally through the driver tube.” Id. at 11:11–19.
Within housing 1 is scale drum 80, and “scale drum 80 is in its outer
wall provided with a helical track which is engaged by a helical rib 16 along
the inner wall of the housing 1.” Id. at 11:20–22. “At its proximal end the
scale drum 80 has a diameter exceeding the inner diameter of the housing to
form a dose setting button 81 which on its cylindrical outer wall is knurled
to ensure a good finger grip,” Id. at 11:22–25.
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Bushing 82 fits within scale drum 80 and over driver tube 85.
Ex. 1014, 11:26–29. Bushing 82 is coupled to driver tube 85 so that both
can rotate but not longitudinally move. Id. at 11:30–33. Injection button 88
is rotatably mounted at an end of bushing 82. Id. at 11:49–51.
“When a dose is set by rotating the dose setting button 81 in a
clockwise direction, the scale drum is screwed out of the housing and the
dose setting button is lifted away from the proximal end of the housing.” Id.
at 11:52–55. “[I]f a set dose is reduced by rotating the dose setting
button 81 in an anticlockwise direction the pawl mechanism working
between the driver tube and the housing . . . prevent[s] the bushing 82 from
following this anticlockwise rotation.” Id. at 11:57–62.
“When the injection button 88 is pressed to inject the set dose,” “the
thread engagement between the helical track of the scale drum 80 and the
rib 16 in the housing when the scale drum 80 is pressed back into said
housing” induces “anticlockwise rotation of the dose setting button 81,” and
bushing 82 follows that rotation. Id. at 12:4–10. “The bushing will rotate
the driver tube 85 in an anticlockwise direction which the pawl mechanism
reluctantly allows,” and “the piston rod is thereby screwed further into an
ampoule 89 in the ampoule holder 2.” Id. at 12:10–13.
3. Moller (Ex. 1015)
Moller “relates to syringes by which a dose can be set by rotating a
dose setting member and by which an injection button elevates from an end
of the syringe a distance proportional to the set dose.” Ex. 1015 ¶ 1.
Figure 1 of Moller is reproduced below.
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Figure 1 shows a sectional view of an injection device. Ex. 1015 ¶ 17.
The device includes housing 1 with partitioning wall 2 that divides
housing 1 into two compartments, one with a dose setting mechanism and
the other for accommodating an ampoule. Id. ¶ 22. Threaded piston rod 4
extends through an opening in wall 2 so that it can move longitudinally but
not rotationally because threaded piston rod 4 has a non-circular cross
section. Id. Tubular element 5 extends from the opening around threaded
piston rod 4 and engages gearbox 9 so that gearbox 9 can rotate within
housing 1. Id. ¶ 23.
Nut 13 engages the threads of the threaded piston rod 4 and connects
to gearbox 9 via connection bars 12. Id. ¶ 24. Dose setting drum 17
engages thread 6 of tubular element 5 at one end and at the opposite end has
an enlarged diameter forming dose setting button 18. Id. ¶ 25. Dose setting
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drum 17 can be screwed into or out of housing 1 and includes a scale on its
outer surface. Id. ¶ 25.
A cup shaped element that fits over gearbox 9 and into dose setting
drum 17 forms an injection button. Id. ¶ 26. The cup shaped element is
coupled to dose setting drum 17 so that the cup shaped element, dose setting
drum 17, and gearbox 9 rotate together. Id.
Dose setting button 18 is rotated to set a dose, which causes dose
setting drum 17 to screw out with the cup shaped element. Id. ¶ 29.
Bottom 19 of the cup shaped element is pressed to inject the set dose. Id.
¶ 32.
E. Alleged Obviousness over Burroughs
Petitioner contends that Burroughs’s medication dispensing pen
includes the same components as recited by claim 1, except that the asserted
dose dial sleeve of Burroughs has threads on its outer surface that form a
helical rib to engage with a helical groove of a main housing. Pet. 27.
Petitioner asserts that it would have been obvious to interchange these
features to provide a dial mechanism with a helical groove on its outer
surface that engages with a thread on the main housing. Id.
Patent Owner responds that Petitioner’s proposed modification to
Burroughs significantly complicates dose dispensing. PO Resp. 1. Patent
Owner contends that Burroughs does not teach a “helical groove provided
along an outer surface of said dose dial sleeve” and that Petitioner does not
show that Burroughs would have rendered obvious such a helical sleeve. Id.
at 16.
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1. Analysis of Claim 1
a) A housing part for a medication dispensing apparatus, said
housing part comprising:
Petitioner argues that Burroughs teaches the preamble of claim 1.
Pet. 28–29 (citing Ex. 1011 ¶ 126; Ex. 1013, code (57), 7:15–19, Figs. 1, 2).
To the extent that the preamble is limiting, we find that the relied-
upon portions of Burroughs teach a “multi-use medication dispensing pen”
that is “made of a minimal number of parts, which include a housing”
(Ex. 1013, code (57)) and “an injection medication device 20 having the
general appearance of a pen” that “comprises a mechanism housing 22” (id.
at 7:15–19). We also find that Figures 1 and 2 of Burroughs show injection
medication device 20 with housing 22. We further credit Mr. Clemens’s
testimony because Burroughs supports it. Ex. 1011 ¶ 126 (citing Ex. 1013,
1:13–16, 7:15–20, 8:2–8, 9:12–25, 9:26–34, 10:38–42, 11:13–34, Figs. 1, 2).
Patent Owner does not present an argument regarding the preamble of
claim 1. See PO Resp. 16–28. Because Burroughs teaches housing 22 for
injection medication device 20, Petitioner persuades us that Burroughs
teaches a “housing part for a medication dispensing apparatus.”
b) a main housing, said main housing extending from a distal end
to a proximal end;
Petitioner argues that Burroughs teaches the required main housing of
claim 1. Pet. 29–30 (citing Ex. 1011 ¶¶ 158–160; Ex. 1013, 7:9–13, 7:17–
20, Figs. 1–3, 5).
We find that the relied-upon portions of Burroughs state that “the term
‘proximal’ shall designate a relative axial position toward the button end of
the delivery pen, and the term ‘distal’ shall designate a relative axial position
toward the delivery needle end of the delivery pen” (Ex. 1013, 7:9–13) and
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teach that a “device comprises a mechanism housing 22 having a first
part 24 and a second part 26 (FIG. 2)” (id. at 7:17–20). We also find that
Figures 1–3 and 5 show housing 22 with first part 24 and second part 26 that
extend between ends. We further credit Mr. Clemens’s testimony because
Burroughs supports it. Ex. 1011 ¶¶ 158–160 (citing Ex. 1013, 7:17–20,
Figs. 1–3, 5).
Patent Owner does not present an argument regarding the main
housing of claim 1. See PO Resp. 16–28. Because Burroughs teaches a
housing that extends between ends, Petitioner persuades us that Burroughs
teaches “a main housing, said main housing extending from a distal end to a
proximal end.”
c) a dose dial sleeve positioned within said housing, said dose
dial sleeve comprising a helical groove configured to engage a
threading provided by said main housing, said helical groove
provided along an outer surface of said dose dial sleeve;
Petitioner contends Burroughs teaches a dose dial sleeve, except that
Burroughs’s sleeve includes helical threads along its outer surface as
opposed to a helical groove, as recited above. Pet. 30–33. In particular,
Petitioner asserts dial mechanism 34 of Burroughs teaches the recited dose
dial sleeve. Id. at 32 (citing Ex. 1011 ¶ 166; Ex. 1013, 7:31–32, Fig. 2).
Petitioner argues that Burroughs’s dial mechanism 34 “is positioned within
housing 22, and includes on its outer surface threads 110, 112.” Id. (citing
Ex. 1011 ¶¶ 161–163; Ex. 1013, 7:65–67, 8:33–36, Figs. 1, 2, 6–9).
Petitioner contends threads 110, 112 of dial mechanism 34 “are configured
to releasably engage with helical spiral groove 158 provided on an inner
surface of housing 22.” Id. (citing Ex. 1011 ¶ 164; Ex. 1013, 8:62–9:1,
Figs. 1, 3, 5–9).
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Petitioner asserts “[t]hreads 110, 112 are shown to be rib-like
structures that fit into and move within helical spiral groove 158 of housing
parts 24, 26 to allow the dial mechanism to rotate and move axially away
from the needle-end of the housing during the dose-setting phase.” Pet. 33
(citing Ex. 1011 ¶ 167; Ex. 1013, Figs. 6–9). Relying upon Mr. Clemens’s
testimony, Petitioner contends “in order to properly engage with helical
spiral groove 158 for rotation, threads 110, 112 also must be positioned
helically relative to one another, forming a discontinuous helical rib
corresponding to the housing’s helical groove.” Id. (citing Ex. 1011 ¶ 165;
cf. Ex. 1001, 3:62–64) (also relying on Ex. 1013, Figs. 1, 7).
Thus, Petitioner argues “Burroughs discloses that dial mechanism 34
includes a ‘helical rib,’ in the form of threads 110, 112, along its outer
surface that engages with threading on housing 22.” Id. (citing Ex. 1011
¶ 165). Petitioner also argues that one of ordinary skill in the art “would
have considered it obvious to implement the helical rib as a helical groove
corresponding to helical threading on the housing.” Id.
Patent Owner responds that “Burroughs does not disclose a ‘helical
groove provided along an outer surface of said dose dial sleeve’” (PO
Resp. 16); “Petitioner admits that Burroughs does not disclose a helical
groove on the outer surface of the dose dial sleeve” (id. at 19 (citing
Pet. 33)); and “there is no dispute that Burroughs fails to disclose this
limitation” (id.).
As discussed above, Petitioner acknowledges that Burroughs does not
disclose this limitation of claim 1, and we agree with the parties that
Burroughs does not. Our determination that Burroughs fails to teach this
limitation does not end our inquiry because Petitioner proposes modifying
Burroughs as set forth below.
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(1) Petitioner’s Reason to Modify
Petitioner asserts one of ordinary skill in the art “would have known
the alternative to reverse the features and configure threads 110, 112 as a
‘helical groove.’” Pet. 46 (citing Ex. 1011 ¶¶ 166–169). In particular,
Mr. Clemens testifies that one of ordinary skill in the art “would have found
it obvious to add another helical rib next to the existing one, such that
threads 110, 112 form a ‘helical groove’ that engages a threading provided
by the housing.” Ex. 1011 ¶ 166. Petitioner contends “[t]he use of a rib-to-
groove threaded connection is a common and well-known mechanism used
for the purpose of providing relative rotational movement between
components.” Pet. 47 (citing Ex. 1011 ¶ 168). Petitioner argues
“determining whether to place a helical rib on one component and a
complementary helical groove on another engaging component would have
been considered a routine task,” and “would have been viewed as no more
than ‘the predictable use of prior art elements according to their established
functions.’” Id. (quoting KSR, 550 U.S. at 417). Thus, Petitioner asserts
that one of ordinary skill in the art “would have considered the placement of
a rib-to-groove connection to be largely interchangeable between its
engaging parts.” Id. (citing Ex. 1011 ¶ 169).
Additionally, Petitioner contends that one of ordinary skill in the art
“would have understood that the rotational operability between dial
mechanism 34 and housing 22 would not change if helical threads 110, 112
were provided as two, parallel ribs that formed a helical groove for engaging
a helical rib on the housing.” Id. (citing Ex. 1011 ¶ 170). Petitioner asserts
one of ordinary skill in the art “would have reasonably expected that the
releasable connection between dial mechanism 34 and housing 22 would
remain substantially the same.” Id. (citing Ex. 1011 ¶ 170).
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Petitioner also contends that one of ordinary skill in the art “would
have considered the choice as to whether the dial mechanism contained the
groove and the housing contained the corresponding rib, or vice versa, to
have been the use of well-known and familiar elements” and “would have
reasonably expected that use of the elements in that configuration would
have resulted in the elements performing their same, predictable functions
(e.g., rotational engagement).” Pet. 48 (citing Ex. 1011 ¶ 170; KSR, 550
U.S. at 417).
Patent Owner understands Petitioner and Mr. Clemens to be proposing
“add[ing] another helical rib next to the existing one, such that threads 110,
112 [along with the added thread] form a ‘helical groove’ that engages with
a threading provided by the housing.” PO Resp. 16 (citing Pet. 48; Ex. 1011
¶ 166; Ex. 2107 ¶ 171). Patent Owner states that Petitioner’s proposal is
“plac[ing] an additional thread behind Burroughs’ existing threads 110, 112,
such that the space between the threads forms a helical groove.” Id. at 16–
17 (citing Ex. 2107 ¶ 171).
Patent Owner argues that “[a]lthough the Petition refers to this
proposed modification as ‘revers[ing] the features’ of Burroughs, it is plainly
not a reversal” and that “[r]eversing the features would result in a spiral
groove across the outer surface of dial mechanism 34 and two discrete,
protruding threads 110, 112 at the inner surface of Burroughs’ housing.” Id.
at 18–19 (citing Ex. 2107 ¶ 172). According to Patent Owner, Mylan’s
declarant in IPR2018-01670 agreed that the threads are not being swapped
around. Id. at 19 (citing Ex. 2163, 194:15–20); see also id. at 17 n.2
(indicating that Mr. Clemens agreed with the cited testimony) (citing
Ex. 2450, 23:15–22).
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Patent Owner argues that one of ordinary skill in the art “would not
have been motivated to try Petitioner’s proposed modification, which
increases the likelihood that the injection pen as modified would not
properly function and subjects the internal components of the pen to
undesirable increased stress during use.” PO Resp. 19. In particular,
because the Petition and Mr. Clemens argue that (1) “rib-to-groove threaded
connections were known in the art,” (2) “the relative placement of the ribs
and grooves was ‘largely interchangeable’ and ‘routine variations,’” and
(3) a person of ordinary skill in the art “would have understood that
positioning the threads 110, 112 as proposed by Petitioner to form two
parallel ribs would have preserved the rotational operability of the
components in Burroughs’ injector pen,” Patent Owner argues that Petitioner
only establishes that a person of ordinary skill in the art could have made the
proposed modification, not that such a person would have made the
proposed modification. Id. at 19–20 (citing Ex. 1011 ¶¶ 168–171). Patent
Owner contends that these assertions do no more than establish that a person
of ordinary skill in the art “could have performed the proposed modification,
not that a [person of ordinary skill in the art] would have done so.” Id. at 20.
In its Reply, Petitioner contends that “[w]hen known interchangeable
solutions exist, [precedent supports swapping] one for another as obvious.”
Pet. Reply 3 (citing Pet. 47–48 (citing KSR, 550 U.S. at 417); PO Resp. 19–
20; Ex. 1095 ¶ 22). In its Sur-reply, Patent Owner contends that “[m]erely
asserting a ‘design choice’ does not make it obvious” and that “Petitioner’s
alleged ‘interchangeability’ at best goes to expectation of success, not
whether a [person of ordinary skill in the art] would have had a motivation to
make the change – a legally distinct concept from reasonable expectation of
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success.” PO Sur-reply 5 (citing Intelligent Bio-Systems, Inc. v. Illumina
Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016)).
In KSR, the Supreme Court stated that “when a patent ‘simply
arranges old elements with each performing the same function it had been
known to perform’ and yields no more than one would expect from such an
arrangement, the combination is obvious.” KSR, 550 U.S. at 417 (citing
Sakraida v. Ag Pro, Inc., 425 U.S. 273 (1976)). The Court stated that
applying the principles from its previous cases “may be more difficult in
other cases than it is here because the claimed subject matter may involve
more than the simple substitution of one known element for another or the
mere application of a known technique to a piece of prior art ready for the
improvement.” Id.
In the circumstances presented here, Petitioner establishes sufficiently
that the addition of a thread to form a groove (where there was a thread) and
the addition of a thread (where there was a groove) simply rearranges old
elements (a thread-groove connection) with each performing the same
function, yielding no more than one of ordinary skill in the art would have
expected. As Petitioner explains, this is a question of known
interchangeability. Pet. 46–47; Ex. 1011 ¶¶ 166–169. In such circumstance,
and on the facts presented here, we find that Petitioner sufficiently sets forth
a basis as to why one of ordinary skill in the art would have modified
Burroughs—because thread-groove arrangements and groove-thread
arrangements were known to be interchangeable—and one of ordinary skill
in the art would have had a reasonable expectation of success in producing
the same predictable result. Ex. 1011 ¶¶ 166–170. That finding does not
end our inquiry, however, because Patent Owner additionally contends that
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one of ordinary skill in the art would have been deterred from making the
modifications proposed by Petitioner, which we now address.
(2) Patent Owner’s Asserted Reasons Not to Make the
Proposed Modification
Patent Owner also argues that a person of ordinary skill in the art
would have had reasons not to make Petitioner’s modification. PO Resp. 21.
Patent Owner asserts that Petitioner’s modification to add an additional
thread to threads 110 and 112 would have (1) required that legs 102 and 104
pivot far enough inward to disengage from two threads (instead of one),
(2) required an increase of 30% to 40% in force and stress during the
injection process, and (3) resulted in the legs wearing out faster, thus
decreasing the lifespan of Burroughs’s multi-use injector. Id. at 21–22
(citing Ex. 2107 ¶¶ 181, 184–188).
Patent Owner also contends that although additional modifications to
Burroughs’s device could be made to reduce the negative consequences of
Petitioner’s proposed change, Petitioner does not propose any additional
modifications. Id. at 22 (citing Ex. 2163, 195:14–25). As an example of an
additional modification, Patent Owner asserts that the stress exerted on the
legs could be reduced by changing their dimensions. Id. According to
Patent Owner, that change, however, would have also necessitated
increasing the internal diameter of the injector “by at least 10 percent to
accommodate the modified legs when they pivot inward during injection.”
Id. at 22–23 (citing Ex. 2107 ¶¶ 190–191). Patent Owner argues that
increasing the diameter is undesirable because it is more difficult to grasp
and manipulate, especially for diabetic patients who may suffer from hand
and wrist conditions that decrease their grip strength and dexterity. Id. at 23
(citing Ex. 2107 ¶¶ 190–191). Patent Owner asserts that increasing the
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diameter of the device would also require more material for manufacturing
and would make the device heavier and less portable. Id.
Further, Patent Owner contends that with or without the modifications
to Burroughs’s legs, the injection force required for a user to dispense a dose
would be increased by 15% because the legs must pivot further in order for
the added threads to clear helical groove 158 during dose injection. PO
Resp. 23 (citing Ex. 2107 ¶ 192). Increasing injection force also is
considered a detriment because of the device’s use by diabetic patients who
have decreased hand and wrist strength as discussed above without any
benefit asserted by Petitioner or its declarant. Id. at 22–24 (citing Ex. 2107
¶ 193).
In its Reply, Petitioner does not dispute Patent Owner’s argument that
adding threads would result in an increase in stress and wear on Burroughs’s
legs. See Pet. Reply 3–4 (citing PO Resp. 21–22). Rather, Petitioner
contends that Patent Owner identifies a viable solution to such detriment—
modifying the dimensions of the legs. Id. at 3 (citing PO Resp. 22–23).
Petitioner asserts that one of ordinary skill in the art would have used routine
skill to implement the proposed change (i.e., adding threads) presumably
contending that one of ordinary skill would have also considered modifying
the dimensions of the legs.5 Id.
Additionally, Petitioner contends that making the device wider is not
necessarily a disadvantage, relying on the testimony of Dr. Biggs that “width
. . . can aid patients with grip or agility problems.” Id. (quoting Ex. 1048

5 Petitioner does not state expressly that modifying the dimensions of the
legs is within the “routine skill” that one of ordinary skill in the art would
have used when adding the additional threads, but Petitioner’s Reply
suggests that is what Petitioner meant. Pet. Reply 7.
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¶ 50). Thus, Petitioner asserts that what Dr. Slocum considers a
disadvantage (i.e., increased width), Dr. Biggs considers an advantage. Id.
at 3–4 (citing Ex. 1053, 13:2–6). With respect to Patent Owner’s argument
of a 15% increase in injection force, Petitioner contends Dr. Slocum “pulls
this percentage out of thin air.” Pet. Reply 4 (citing PO Resp. 23; Ex. 1095
¶ 24; Ex. 2107 ¶ 192). Petitioner asserts that Dr. Slocum’s testimony is
conclusory and entitled to no weight, but that, even if injection force were
increased, that may only disadvantage some, not all, patients. Id. (citing In
re Kao, 639 F.3d 1057, 1067 (Fed. Cir. 2011); Ex. 1048 ¶¶ 29–30).6
In its Sur-reply, Patent Owner contends that the Petition does not
propose the further modifications Petitioner sets forth in the Reply to
mitigate the additional stress resulting from the addition of threads to
Burroughs’s device. PO Sur-reply 5 (citing Pet. Reply 3–4 n.2; Ex. 2163,
195:14–21). Patent Owner also asserts that the size and position of the
additional threads are necessarily fixed by the size of the existing
threads 110, 112 and the pitch of the existing helical groove, neither of
which Petitioner originally proposed to modify. Id. at 5–6 (citing Ex. 1054,
277:19–279:2, 281:5–18; Ex. 1095 ¶ 22). Thus, Patent Owner argues that
we should “give no weight to Petitioner’s assertion that a [person of ordinary

6 Petitioner further contends, in a footnote, that Patent Owner does not
address routine options one of ordinary skill in the art would employ to
counter an increase in injection force, such as employing different thread
heights and shifting the threading. Pet. Reply 4 n.3 (citing Ex. 1095 ¶¶ 20–
23, 26). We do not fault Patent Owner for its lack of prescience or ability to
predict Petitioner’s argument. Thus, we disagree with Petitioner’s
suggestion that Patent Owner should have addressed these issues in its
Response.
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skill in the art] could have accommodated the modification by changing the
dimensions of the added thread.” Id. at 6.
Additionally, Patent Owner encourages us to reject Petitioner’s “new
contention that the modification could have been accommodated through
application of ‘routine skill.’” PO Sur-reply 6 (quoting Pet. Reply 3).
Patent Owner relies upon Dr. Slocum’s testimony that Petitioner’s
modification would require additional substantial changes to Burroughs’s
device, such as lengthening legs 102, 104 and increasing the thickness of the
injector. Id. Patent Owner also contends that Petitioner “makes no showing
that the proposed modification would result in ease-of-grip.” Id. (citing Pet.
Reply 3–4). Patent Owner asserts that the additional changes required,
including redesigning the internal components of the device that are sized
for Burroughs’s existing design, “calls into question whether this is an
‘interchangeable solution[].’” Id. at 6–7 (alteration by Patent Owner).
Further, Patent Owner argues that Petitioner does not contest that
injection force would increase even if Petitioner disputes the precise amount
of that increase. Id. at 7 (citing Pet. Reply 4). Patent Owner also points to
the testimony of Dr. Goland, that injection force is one of the reasons she
has switched patients to certain devices over others. Id. (citing Ex. 1056,
66:9–15).
We find the evidence weighs in Petitioner’s favor as to the question of
whether it would have been obvious to modify Burroughs’s dose dial sleeve.
The evidence reflects, on the facts presented here, that a groove-thread
connection and a thread-groove connection are interchangeable. Ex. 1011
¶¶ 166–170. Patent Owner’s evidence does not support the finding that
Burroughs’s device would be inoperable if modified as Petitioner proposes.
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Ex. 2107 ¶¶ 181, 184–188, 190–193. And, we expressly find, and agree
with Petitioner, that Burroughs would be operable.
Patent Owner’s evidence, at best, suggests that Burroughs’s device
might not operate as well for every user. Petitioner’s evidence, however,
suggests that is not necessarily the case for everyone. See Ex. 1048 ¶¶ 29,
30, 50. Specifically, the evidence discussed above reflects that increased
size of the device may be an advantage to some users of the device while
also a disadvantage to others. See id.
Further, we find that Patent Owner establishes that additional stress
and force would likely be experienced by the addition of threads, but
Petitioner (and Dr. Slocum’s testimony7) establishes that one of ordinary
skill in the art would understand how to accommodate that stress and that
additional modifications could be made to alleviate that stress if desired. We
do not, however, find that additional modifications are required because,
although added stress is a potential detriment of the modification, we do not
find that it would deter one of ordinary skill in the art from adding the
additional threads and do not find that it would render Burroughs inoperable
for its intended purpose.
Finally, even though we find that injection force may increase, we
again are not persuaded that it is of the order that would render Burroughs
inoperable for all users such that one of ordinary skill in the art would not
undertake the modification. In short, we determine that Petitioner has

7 Even though Dr. Slocum proposes modifications not originally presented
by Petitioner, the modifications proposed are well within the level of
ordinary skill in the art and we find that one of ordinary skill in the art would
have understood them and undertaken them if increased stress were a
concern. See KSR, 550 U.S. at 421 (one of ordinary skill in the art “is also a
person of ordinary creativity, not an automaton”).
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established that modifying Burroughs’s thread-groove connection to a
groove-thread connection would have been obvious to one of ordinary skill
in the art at the time of the invention. We weigh the evidence of record as to
the full scope of claim 1 after addressing each limitation.
d) a dose dial grip disposed near a proximal end of said dose dial
sleeve;
Petitioner argues that Burroughs teaches the recited dose dial grip.
Pet. 33–35 (citing Ex. 1011 ¶¶ 173–175; Ex. 1013, 8:2–6, 10:34–42, Figs. 1,
2, 6–9). In particular, Petitioner argues that “Burroughs discloses a ‘dose
dial grip’ in the form of proximal portion 78 of dial mechanism 34, located
near a proximal end (i.e., button-end) of the dial.” Id. at 35 (citing Ex. 1011
¶ 175; Ex. 1013, 8:2–6, Figs. 1, 6–9).
We find that the relied-upon portions of Burroughs teach that “[d]ial
mechanism 34 comprises proximal portion 78, intermediate portion 80, and
distal portion 82,” “[p]roximal portion 78 comprises enlarged diameter
portion 84, tapered portion 86, and ring 90 extending about the
circumference of proximal portion 78,” and “[u]pon rotation of dial 34, . . .
dial mechanism 34 retracts from housing 22.” Ex. 1013, 8:2–6, 10:34–42;
see also id. at 7:9–13 (stating that “the term ‘proximal’ shall designate a
relative axial position toward the button end of the delivery pen”). We also
credit Mr. Clemens’s testimony because Burroughs supports it. Ex. 1011
¶¶ 173–175 (citing Ex. 1013, 8:2–6, 10:34–42, Figs. 1, 2, 6–9).
Patent Owner does not present an argument regarding the dose dial
grip of claim 1. See PO Resp. 16–28. Because Burroughs teaches proximal
portion 78 of dial mechanism 34 is towards the proximal end, Petitioner
persuades us that Burroughs teaches “a dose dial grip disposed near a
proximal end of said dose dial sleeve.”
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e) a piston rod provided within said housing, said piston rod is
non-rotatable during a dose setting step relative to said main
housing;
Petitioner argues that Burroughs teaches the recited piston rod.
Pet. 35–39 (citing Ex. 1011 ¶¶ 176–178; Ex. 1013, 9:8–11, 9:26–34, 10:26–
42, 11:52–56, Figs. 1–3, 5, 12, 13). In particular, Petitioner argues that
“Burroughs further discloses a ‘piston rod’ in the form of leadscrew 38.” Id.
at 38.
We find that the relied-upon portions of Burroughs teach that
“[h]ousing parts 24 and 26 include bulkhead ledges 178, 180, respectively”
that include “flexible tangs 182, 184, respectively,” “leadscrew 38 is shown
having a ratchet teeth 204 located on two opposing sides of leadscrew 38
and axially extending along the length of leadscrew 38 from proximal
end 200 to plunger engagement portion 206,” “[h]elical threads 208 extend
along the axial length of leadscrew 36,” and “plunger engagement
portion 206 of leadscrew 38 is in engagement with piston 210 of
cartridge 40.” Ex. 1013, 9:8–11, 9:26–34.
We also find that the relied-upon portions of Burroughs teach that
“[r]otation of leadscrew 38 is prevented by a key-keyway type of
engagement between the anti-backup tangs 182 and 184 and leadscrew 38,”
“tangs 182, 184 form a key, and leadscrew 38 forms a keyway which comes
into contact with the sides of the key,” “[r]otation of dial mechanism 34
causes rotation of nut 36 so that internal helical raised groove 198 of nut 36
rotates along external threads 208 of leadscrew 38 to cause nut 36 to axially
retract a corresponding axial distance,” and “[m]ovement of leadscrew 38 is
prevented in the proximal direction due to anti-backup tangs 182, 184 being
in engagement with ratchet teeth 204” so that “head 206 of leadscrew 38
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remains in constant engagement with piston 210 at all times.” Id. at 10:26–
30, 10:38–42, 11:52–56. We further credit Mr. Clemens’s testimony
because Burroughs supports it. Ex. 1011 ¶¶ 176–178 (citing Ex. 1013, 9:8–
11, 9:26–34, 10:26–42, 11:52–56, Figs. 1–3, 5, 12).
Patent Owner does not present an argument regarding the piston rod
of claim 1. See PO Resp. 16–28. Because Burroughs teaches leadscrew 38
is within housing parts 24, 26 and prevented from moving during rotation of
dial mechanism 34 by tangs 182, 184, Petitioner persuades us that Burroughs
teaches “a piston rod provided within said housing, said piston rod is non-
rotatable during a dose setting step relative to said main housing.”
f) a drive sleeve extending along a portion of said piston rod,
said drive sleeve comprising an internal threading near a
distal portion of said drive sleeve, said internal threading
adapted to engage an external thread of said piston rod; and,
Petitioner argues that Burroughs teaches the recited drive sleeve.
Pet. 39–41 (citing Ex. 1011 ¶¶ 179–181; Ex. 1013, 9:12–25, 9:30–32,
10:38–42, Figs. 1, 2, 10, 11). In particular, Petitioner argues that
“Burroughs discloses a ‘drive sleeve’ in the form of nut 36.” Id. at 41 (citing
Ex. 1011 ¶¶ 179–181; Ex. 1013, 9:12–13, Figs. 1, 2, 10, 11).
We find that the relied-upon portions of Burroughs teach that
“[n]ut 36 is generally cylindrical in shape,” “[t]he interior surface of the
distal end of nut 36 includes a helical thread 198,” and “[t]hread 198 extends
350° about the inner surface of nut 36.” Ex. 1013, 9:12–13, 9:22–25. We
also find that the relied-upon portions of Burroughs teach that “[h]elical
threads 208 extend along the axial length of leadscrew 36,” “[l]eadscrew 38
fits within the cylindrical opening of nut 36,” and “[r]otation of dial
mechanism 34 causes rotation of nut 36 so that internal helical raised
groove 198 of nut 36 rotates along external threads 208 of leadscrew 38 to
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cause nut 36 to axially retract a corresponding axial distance.” Id. at 9:30–
32, 10:38–42. We further credit Mr. Clemens’s testimony because
Burroughs supports it. Ex. 1011 ¶¶ 179–181 (citing Ex. 1013, 8:42–48,
9:12–25, 9:30–32, 10:21–26, 10:38–42, 11:27–34, Figs. 1, 2, 9–11).
Patent Owner does not present an argument regarding the drive sleeve
of claim 1. See PO Resp. 16–28. Because Burroughs teaches that
leadscrew 38 fits within nut 36 and nut 36 includes internally thread 198 that
engages external thread 208 of leadscrew 38, Petitioner persuades us that
Burroughs teaches “a drive sleeve extending along a portion of said piston
rod, said drive sleeve comprising an internal threading near a distal portion
of said drive sleeve, said internal threading adapted to engage an external
thread of said piston rod.”
g) a tubular clutch located adjacent a distal end of said dose dial
grip, said tubular clutch operatively coupled to said dose dial
grip,
Petitioner argues that Burroughs teaches the recited tubular clutch.
Pet. 41–45 (citing Ex. 1011 ¶¶ 182–187; Ex. 1013, 7:46–55, 8:11–20, 8:42–
48, 9:16–18, 11:5–20, 11:27–30, Figs. 1, 2, 6–11, 14, 15). In particular,
Petitioner argues that “Burroughs discloses a ‘tubular clutch’ in the form of
button 32.” Id. at 44 (citing Ex. 1011 ¶ 187).
We find that the relied-upon portions of Burroughs teach that
“button 32 comprises a hollow cylindrical portion 48 having a proximal
end 50” and that “[c]ylindrical portion 48 . . . includes an enlarged diameter
ring 54.” Ex. 1013, 7:46–51. We also find that the relied-upon portions of
Burroughs teach, in relation to dial mechanism 34, that “proximal ends of
flexible sections 92 and 95 each include fingers 94 . . . adapted for
engagement with enlarged diameter portion 54 of button 32” and “[w]hen
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button 32 is depressed, enlarged diameter portion 54 is also depressed and
. . . forces fingers 94 outward” so that “[d]ial mechanism 34 is then able to
travel axially towards cartridge 40 during injection of the medical product.”
Id. at 8:11–20; see also id. at 8:2–3 (stating that “[d]ial mechanism 34
comprises . . . intermediate portion 80”), 8:9–11 (stating that “[g]enerally
U-shaped grooves 91 and 93 (FIGS. 6, 8) are formed in intermediate
portion 80 to form a flexible sections 92 and 95, respectively”). We also
credit Mr. Clemens’s testimony because Burroughs supports it. Ex. 1011
¶¶ 182–187 (citing Ex. 1013, 7:46–58, 8:11–20, 10:21–26, 10:34–38, 11:5–
12, 11:20–23, 11:27–34, Figs. 1, 2, 9, 11, 14, 15).
Patent Owner responds that Burroughs does not disclose or render
obvious the recited tubular clutch. PO Resp. 1, 24–28. First, Patent Owner
asserts that the proper construction for tubular clutch is “a tubular
component that can operate to reversibly lock two components in rotation.”
Id. at 24; see also id. at 25 (citing Ex. 2165, 10–11). Patent Owner contends
that Petitioner’s proposed construction of the term as a means-plus-function
limitation included this operation as one of the functions, yet Petitioner fails
to address this function in the Petition. Id. at 24–25 (citing Pet. 18, 41–45).
Thus, Patent Owner argues that “[i]n view of the construction advocated by
the Petitioner in the Petition, the Petitioner should not be given a ‘do-over’
in its forthcoming reply.” Id. at 25.
Second, Patent Owner contends that merely rotationally decoupling
dial mechanism 34 from nut 36 and housing 22 does not establish the
capability to reversibly lock those components in rotation. Id. at 25. Patent
Owner addresses each of the functions identified by Petitioner.
With respect to the engagement between dial mechanism 34 and
housing 22, Patent Owner asserts that dial mechanism 34 “is coupled to the
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housing by threads 110, 112, which engage with the housing’s helical
groove 158.” Id. at 25–26. Patent Owner provides the following:
As Burroughs explains, “[u]pon rotation of dial 34, threads 110,
112 move within housing groove 158 in the proximal direction
as dial mechanism 34 retracts from housing 22 . . . .” Ex. 1013,
10:34–37. As Professor Slocum explains, this means that the dial
mechanism 34 rotates relative to housing 22, and therefore dial
mechanism 34 and housing 22 are not “reversibly locked in
rotation.” Ex. 2107 ¶ 207. Thus, Petitioner’s first theory does
not invalidate the claims.
PO Resp. 26.
With respect to the engagement between dial mechanism 34 and
nut 36, Patent Owner contends button 32 “never locks the dial to the nut;”
rather, “splines 144 and 192 engage to couple the dial to the nut when the
user retracts the dial mechanism from the zero-dose position during dose
setting.” Id. (citing Ex. 2107 ¶ 208; Ex. 1013, 8:42–48, 10:15–26). Thus,
Patent Owner asserts “button 32 does not reversibly lock two components in
rotation.” Id. at 26–27.
Third, Patent Owner contends that Burroughs discloses a “clutch”
consisting of splines 144 and teeth 192, which “reversibly lock two
components in rotation – dial mechanism 34 and nut 36.” Id. at 27. Patent
Owner quotes Burroughs’s description of its “clutching device” as follows:
The clutching device comprises a series of splines on the inner
cylindrical surface of the dial mechanism which axially engage
corresponding splines on the outer surface of the nut. The splines
are engaged with one another by retracting the dial mechanism
with respect to the nut after the dial mechanism has been rotated
to its zero-dose position.
Id. (quoting Ex. 1013, 2:59–65) (citing Ex. 2107 ¶ 209) (emphasis added by
Patent Owner). Patent Owner asserts that Petitioner cannot rely upon
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splines 144 and teeth 192 as teaching the claimed “tubular clutch” because
(1) splines 144 and teeth 192 are not tubular and (2) they are not located
adjacent to a distal end of the proximal portion 78 of the dial mechanism 34,
as required by claim 1. Id.
In its Reply, Petitioner first addresses Patent Owner’s argument
regarding claim construction, asserting that Patent Owner has waived any
argument directed to Petitioner’s non-means-plus-function construction of
“tubular clutch”—“a tubular structure that couples and decouples a
moveable component from another component.” Pet. Reply 2 (citing Pet.
18; Ex. 1019, 23–24; Ex. 1030, 12). Petitioner also asserts that “Petitioner’s
proposed construction is reasonable, as [Patent Owner] conceded in
proposing the same construction in litigation” and Patent Owner “offers no
basis to find that the same construction it proposed in district court is now
unreasonable.” Id. at 5.
Second, Petitioner asserts that button 32 operates to reversibly lock
two components in rotation because it operates to engage and disengage dial
mechanism 34 from the housing’s helical groove. Id. (citing Pet. 41–45; PO
Resp. 24–27; Ex. 1095 ¶ 31). Petitioner contends that “[w]hen the user
injects a dose, button 32 disengages splines connecting dial mechanism 34
and nut 36, reversing rotational locking of those components.” Id. at 5–6
(citing Ex. 1095 ¶¶ 31–32; Ex. 1013, 8:42–48, 10:21–26, 10:38–42, 11:27–
30, Figs. 9, 11; Ex. 1011 ¶¶ 180, 182–183). Thus, Petitioner contends
button 32 teaches a tubular clutch under Patent Owner’s new construction.
Id.
Third, Petitioner contends that Patent Owner “adopts an even
narrower interpretation of its construction, requiring the clutch to act directly
on the locked components to ‘operate to reversibly lock two components in
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rotation.’” Id. at 6. Petitioner asserts that “[w]hen engaged, splines 144 and
teeth 192 define a tubular (‘360°’) structure (clutching device) within dial
mechanism 34’s intermediate portion 80” that “lies between the proximal
portion 78 and distal portion 82, together comprising the dial
mechanism 34.” Pet. Reply 6–7 (citing Ex. 1013, 8:2–4, Fig. 8). Petitioner
argues that “‘adjacent’ means simply ‘next to.’” Id. at 7. Therefore,
because “[i]ntermediate portion 80 in which the clutching device is located
is on the distal end of the proximal portion 78,” Petitioner contends it is next
to the distal end of the proximal portion. Id. Thus, Petitioner asserts that
button 32 teaches the recited “tubular clutch” of claim 1 under either
construction. Id.
In its Sur-reply, Patent Owner contends Petitioner’s interpretation of
“tubular clutch” “unreasonably broadens the claim by permitting any
structure to be a clutch as long as it directly or indirectly triggers a locking
of two components.” PO Sur-reply 2 (responding to Pet. Reply 5–6). Patent
Owner asserts that such interpretation would permit a “user’s hand” to be a
“clutch” because “the user operates button 32 using her hand, causing
splines 144 and teeth 192 to lock the dial mechanism and nut in rotation.”
Id. at 2–3. Patent Owner contends that Petitioner’s construction is not
reasonable. Id. at 3. Even if considering an indirect action, Patent Owner
asserts “splines 144 and teeth 192 lock due to axial retraction of dial
mechanism 34, not button 32,” and, therefore, “button 32 still is not a
‘tubular clutch.’” Id. (citing Ex. 1013, 10:15–26).
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Additionally, Patent Owner contends that we should disregard
Petitioner’s new argument8 that splines 144 and teeth 192 teach the recited
“tubular clutch.” PO Sur-reply 3 (citing Pet. Reply 6–7). Even if
considered, however, Patent Owner asserts these structures do not teach the
“tubular clutch” because (1) they are not tubular and (2) they are not
adjacent to a distal end of a dose dial grip. Id.
Patent Owner contends the distal end of Burroughs’s dose dial grip is
not next to splines 144 or teeth 192 because they are separated by the
intervening portion of dial 34. Id. at 3–4 (citing Pet. Reply 7; Ex. 1013,
Fig. 9). Patent Owner also contends that splines 144 and teeth 192 are not
tubular because the parties’ construction requires a singular component or
structure, which the splines and teeth are not. Id. at 4 (citing Pet. Reply 6).
To begin, we reiterate that under either construction—the broader, “a
tubular structure that couples and decouples a moveable component from
another component” or, the narrower, “a component that can operate to
reversibly lock two components in rotation”—we find that Burroughs’s
button 32 teaches the recited “tubular clutch” of claim 1. Therefore, we

8 To the extent Petitioner relies upon splines 144 and teeth 192 as an
alternative teaching of a “tubular clutch,” see Pet. Reply 6–7 (discussing the
shape and location of splines 144 and teeth 192), we agree with Patent
Owner that the identification of a different structure in Burroughs (i.e.,
splines 144 and teeth 192 as opposed to button 32) would be an improper
new argument. However, we do not find improper Petitioner’s argument
that the tubular clutch is not required to act directly to operate to reversibly
lock two components in rotation. See id. at 6 (first full paragraph). That
argument maintains Petitioner’s reliance upon button 32 as teaching the
“tubular clutch” and is responsive to Patent Owner’s argument directed to
the action of button 32 in the Patent Owner Response. Our discussion is
focused on Petitioner’s identification of button 32.
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need not decide which construction to adopt to decide the specific issue
before us.
First, Patent Owner does not dispute that button 32 satisfies the first
construction of tubular clutch. Patent Owner’s arguments are instead
directed to the second construction. For the reasons explained by Petitioner
and detailed below, we find that Burroughs’s button 32 is a tubular structure
that couples and decouples a moveable component from another component.
Second, we do not agree with Patent Owner’s more restrictive
interpretation, requiring that the identified structure operate directly to
reversibly lock two components in rotation. In particular, Patent Owner has
identified no intrinsic evidence that justifies such limitation.9 Based on the
full record before us, we determine that an identified structure may teach a
tubular clutch even if it operates to indirectly reversibly lock two
components in rotation. In particular, the phrase “a component that can
operate to” does not limit how that component operates to accomplish the
remainder of the construction—“reversibly lock two components in
rotation.”
Turning to Burroughs, Burroughs teaches that after a desired dosage is
set, a user inserts the needle of the device and pushes button 32 to inject the
dosage. Ex. 1013, 11:13–16. This is accomplished by the button moving
out of engagement with legs 102 and 104, which then allows dial

9 By this statement, we do not imply that Patent Owner has any specific
burden in this context; rather our statement is directed to the unremarkable
concept that a party seeking to read a construction more narrowly should
identify some reason why such narrowing is appropriate. Patent Owner’s
hypothetical example of finding a user’s hand is a clutch is inapposite as a
user’s hand is clearly not part of “[a] housing part for a medication
dispensing apparatus” as stated in the preamble of claim 1.
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mechanism 34 to move forward because threads 110, 112 are no longer in
engagement with groove 158. Id. at 11:16–20. Burroughs explains that
“[a]s dial mechanism 34 is initially moved forward, splines 144 move out of
engagement with splines 192 of nut 36 to disengage the clutch by
rotationally decoupling dial mechanism 34 from nut 36 prior to any axial
movement of nut 36.” Id. at 11:27–30 (emphasis added).
With respect to the first construction, as the above description
indicates, button 32 couples and decouples a moveable component—dial
mechanism 34—from another component—nut 36. With respect to the
second construction, the above description also indicates that button 32
operates to rotationally decouple dial mechanism 34 from nut 36, which
reverses the rotational locking of those two components. See Pet. 39
(identifying dial mechanism 34’s rotational connection with nut 36);
Ex. 1095 ¶ 29 (discussing, inter alia, the releasable engagement between
dial mechanism 34 and nut 36).
Additionally, with respect to the remaining limitations of the tubular
clutch clause of claim 1 recited in the heading above, Patent Owner does not
dispute that button 32 is tubular and located adjacent a distal end of said
dose dial grip (i.e., Burroughs’s proximal portion 78 of dial mechanism 34).
Figure 14 of Burroughs, reproduced below, illustrates the tubular structure
of button 32.
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Figure 14 “is a perspective view of the button.” Ex. 1013, 6:66. Figure 1 of
Burroughs, reproduced below, illustrates that button 32 is adjacent (i.e., next
to) proximal portion 78 (unlabeled, but it is located at the leftmost area
identified by numeral 34) of dial mechanism 34.

Figure 1 “is a sectional assembly view” of Burroughs’s device. Id. at 6:40–
41.
Accordingly, for the reasons discussed above, we find that Petitioner
has shown that Burroughs’s button 32 teaches “a tubular clutch located
adjacent a distal end of said dose dial grip, said tubular clutch operatively
coupled to said dose dial grip.”
h) wherein said dose dial sleeve extends circumferentially around
at least a portion of said tubular clutch.
Petitioner argues that Burroughs teaches the wherein clause of
claim 1. Pet. 45–46 (citing Ex. 1011 ¶ 188; Ex. 1013, Fig. 1). We find that
Figure 1 of Burroughs shows that dial mechanism 34 extends
circumferentially around at least a portion of button 32. We also credit
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Mr. Clemens’s testimony because Burroughs supports it. Ex. 1011 ¶ 188
(discussing Ex. 1013, Fig. 1).
Patent Owner does not present an argument regarding this wherein
clause of claim 1. See PO Resp. 16–28. Because Burroughs shows dial
mechanism 34 extending circumferentially around at least a portion of
button 32, Petitioner persuades us that Burroughs teaches “wherein said dose
dial sleeve extends circumferentially around at least a portion of said tubular
clutch.”
2. Analysis of Claim 2
Claim 2 depends from claim 1 and further requires:
a cartridge retaining part operatively coupled to said main
housing, said cartridge retaining part comprising a fluid
container,
wherein said fluid container defines a medicament filled
reservoir with a movable plunger at a proximal end and an outlet
at a distal end,
said cartridge piston movable by said piston rod to be
advanced toward an outlet of said fluid container when said
piston rod is moved distally, wherein during a dose setting step,
said dose dial grip, is rotated and moves away from said proximal
end of said main housing so that a dose of a medicament
contained within said medicament filled reservoir can be
selected.
Ex. 1001, 6:61–7:7.
Petitioner argues that cartridge retainer part 42 secured and coupled
through leadscrew 38 and piston 210 to housing 22 of Burroughs teaches the
“cartridge retaining part.” Pet. 48 (citing Ex. 1011 ¶¶ 858–859; Ex. 1013,
9:32–41, Fig. 1). Petitioner also argues that cartridge 40 teaches the “fluid
container.” Id. (citing Ex. 1011 ¶¶ 858–859; Ex. 1013, 9:32–41, Fig. 1).
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For the wherein clause, Petitioner contends that chamber 212,
piston 210, and neck 214 teach the “fluid container,” “movable plunger,”
and “outlet,” respectively. Id. at 48–49 (citing Ex. 1011 ¶¶ 858–859;
Ex. 1013, 2:42–44, 9:32–40, Fig. 1). Petitioner also contends that
piston 210, leadscrew 38, and plunger engagement portion 206 provide the
required movability between the cartridge piston and piston rod. Id. at 49
(citing Ex. 1011 ¶ 859; Ex. 1013, 9:32–40, Fig. 1). Petitioner further
contends that Burroughs teaches the rotation and movement of the dose dial
grip. Id. (citing Ex. 1011 ¶ 860; Ex. 1013, 8:24–29, 10:34–52).
We find that the relied-upon portions of Burroughs teach that
“[c]artridge 40 is housed within cartridge retainer 42, which is permanently
secured to housing parts 24 and 26” (Ex. 1013, 9:34–36), “[a] liquid
medication product is housed in a variable volume cartridge within the
housing of the device” (id. at 2:42–44), and “plunger engagement
portion 206 of leadscrew 38 is in engagement with piston 210 of
cartridge 40” (id. at 9:32–34). See also id. Fig. 1 (showing plunger
engagement portion 206 of leadscrew 38 abutting piston 210). We also find
that the relied-upon portions of Burroughs teach that “[c]artridge 40 . . .
comprises a tube defining an inner chamber 212 which openly terminates at
its distal end in a neck 214 having a cap 216.” Id. at 9:36–39.
We further find that the relied-upon portions of Burroughs teach that
“[p]roximal portion 78 of dial mechanism 34 further includes a first U-
shaped groove 100 (FIG. 6) and a second U-shaped groove 101 (FIG. 8)
which form flexible legs 102, 104” that respectively include “outwardly
extending thread 110, 112.” Id. at 8:24–29. We additionally find that the
relied-upon portions of Burroughs teach that “[u]pon rotation of dial 34,
threads 110, 112 move within housing groove 158 in the proximal direction
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as dial mechanism 34 retracts from housing 22,” rotation of dial mechanism
34 causes “causes a ‘click’ to occur, thereby providing an audible indication
of each unit of dosage dialed up,” “a single numeral appears in lens 25 after
each unit rotation indicating the current dose selected,” and “[o]nce a dosage
has been selected, that dosage may be made larger or smaller by rotating the
dial assembly in either the clockwise or counterclockwise direction.” Id. at
10:34–52. We credit the testimony of Mr. Clemens regarding claim 2
because Burroughs supports it. Ex. 1011 ¶¶ 858–860 (citing Ex. 1013,
code (57), 2:42–48, 9:32–41, 9:47–49, 9:59–61, 10:15–18, 10:34–42, 10:48–
49, Figs. 1, 2).
Patent Owner does not provide an argument specifically for claim 2.
See PO Resp. 16–28; see also Pet. Reply 7–8 (arguing that Patent Owner
“has not addressed these claims or otherwise asserted that they are
independently patentable over claim 1” and “has waived any such
argument”).
Because Burroughs teaches (1) cartridge retainer part 42 permanently
secured to housing parts 24, 26, (2) cartridge retainer part 42 houses
cartridge 40, and (3) cartridge 40 houses a liquid medication product and
comprises piston 210, inner chamber 212, and neck 240 with cap 216,
Petitioner persuades us that Burroughs teaches “a cartridge retaining part
operatively coupled to said main housing, said cartridge retaining part
comprising a fluid container, wherein said fluid container defines a
medicament filled reservoir with a movable plunger at a proximal end and
an outlet at a distal end,” as recited by claim 2.
Also, because Burroughs shows plunger engagement portion 206 of
leadscrew 38 abutting piston 210 inside cartridge 40 and piston 210 is
opposite neck 40, Petitioner persuades us that Burroughs teaches “said
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cartridge piston movable by said piston rod to be advanced toward an outlet
of said fluid container when said piston rod is moved distally.”
Further, because Burroughs teaches rotating proximal portion 78 of
dial mechanism 34 causes dial mechanism 34 to retract from the housing and
set a dose indicated by a click and a number in lens 25, Petitioner persuades
us that Burroughs teaches “wherein during a dose setting step, said dose dial
grip, is rotated and moves away from said proximal end of said main
housing so that a dose of a medicament contained within said medicament
filled reservoir can be selected.”
3. Analysis of Claim 3
Claim 3 depends from claim 2 and recites “wherein said dose dial grip
is operatively configured to said tubular clutch so that, during said dose
setting step, said tubular clutch, said dose dial sleeve, and said dose dial grip
rotate and move in a proximal direction in relation to said main housing.”
Ex. 1001, 7:8–12.
Petitioner refers to its arguments regarding the recited clutch, dose
dial sleeve, and dose dial grip and argues that, “[s]ince the proximal portion
of the dial mechanism abuts and surrounds the end 68 of the button, turning
the dial mechanism causes the button to rotate and move in a proximal
direction in relation to the main housing 22.” Pet. 49 (citing Ex. 1011
¶¶ 862–863; Ex. 1013, 7:46–64, 10:34–44, Figs. 1, 6–9, 14, 15).
We find that the relied-upon portions of Burroughs teach that
“button 32 comprises a hollow cylindrical portion 48” with components “to
keep button 32 centered within dial mechanism 34 and also prevent
button 32 from inadvertently falling or being removed from dial 34” and so
that “end 68 protrudes 1.5 millimeters beyond the end of dial mechanism 34
to enable the user to easily depress the button during injection.” Ex. 1013,
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7:46–64, Figs. 14, 15. We also find that the relied-upon portions of
Burroughs teach that “[i]n its zero-dose position, dial mechanism 34 may be
axially retracted a predetermined distance, e.g. 3 to 5 mm, to engage the
clutch mechanism” and “[u]pon rotation of dial 34, . . . dial mechanism 34
retracts from housing 22.” Id. at 10:34–44, Figs. 1, 4. We further credit
Mr. Clemens’s testimony regarding claim 3 because Burroughs supports it.
Ex. 1011 ¶¶ 862–863 (citing Ex. 1013, 7:47–58, 8:2–8, 8:63–91, 9:47–54,
10:31–42, 11:3–12, Figs. 1, 2).
Patent Owner does not provide an argument specifically for claim 3.
See PO Resp. 16–28; see also Pet. Reply 7–8 (arguing that Patent Owner
“has not addressed these claims or otherwise asserted that they are
independently patentable over claim 1” and “has waived any such
argument”).
As discussed above for claim 1, because Burroughs teaches proximal
portion 78 of dial mechanism 34 is towards the proximal end, Petitioner
persuades us that Burroughs teaches “a dose dial grip disposed near a
proximal end of said dose dial sleeve;” Petitioner persuades us that one of
ordinary skill in the art would have modified dial mechanism 34 of
Burroughs to arrive at the recited dose dial sleeve; and Petitioner has shown
that Burroughs’s button 32 teaches “a tubular clutch located adjacent a distal
end of said dose dial grip, said tubular clutch operatively coupled to said
dose dial grip.”
Because Burroughs teaches button 32 fixed to dial mechanism 34, and
thus proximal portion 78, that is rotated out of housing 22, Petitioner
persuades us that Burroughs teaches “wherein said dose dial grip is
operatively configured to said tubular clutch so that, during said dose setting
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step, said tubular clutch, said dose dial sleeve, and said dose dial grip rotate
and move in a proximal direction in relation to said main housing.”
F. Alleged Obviousness over Steenfeldt-Jensen
Petitioner argues that “Steenfeldt-Jensen disclosed a single device
comprising all of the components, including the same structural limitations,
recited by claim 1.” Pet. 50. Petitioner also argues that “[t]o the extent that
Steenfeldt-Jensen may not disclose a ‘drive sleeve’ as required by
challenged claim 1, it would have been obvious to modify Steenfeldt-
Jensen’s device to include such a drive sleeve.” Id.
Patent Owner responds that “Petitioner concedes that Steenfeldt-
Jensen fails to disclose a drive sleeve that engages with a piston rod via a
threaded connection” and further argues that one of ordinary skill in the art
“would not have been motivated to make Petitioner’s proposed modification
because it renders Steenfeldt-Jensen’s device inoperable for its intended
purpose.” PO Resp. 1.
For the reasons below, we determine that Steenfeldt-Jensen teaches or
suggests the limitations of claim 1 and that one of ordinary skill in the art
would have had a reason to make Petitioner’s proposed modification with a
reasonable expectation of success.
1. Analysis of Claim 1
a) A housing part for a medication dispensing apparatus, said
housing part comprising:
Petitioner argues that Steenfeldt-Jensen teaches the preamble of
claim 1. Pet. 50–51 (citing Ex. 1011 ¶¶ 261, 262; Ex. 1014, 1:12–15, 5:38–
44, Figs. 15–17).
To the extent that the preamble is limiting, we find that the relied-
upon portions of Steenfeldt-Jensen teach “injection syringes of the kind
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apportioning set doses of a medicine from a cartridge containing an amount
of medicine sufficient for the preparation of a number of therapeutic doses”
(Ex. 1014, 1:12–15) and the “injection syringe comprises a housing” (id.,
code (57)). See id. at 5:38–44 (describing that the “syringe comprise[s] a
tubular housing 1”), Figs. 15–17. We also credit Mr. Clemens’s testimony
because Steenfeldt-Jensen supports it. Ex. 1011 ¶¶ 261, 262 (citing
Ex. 1014, code (57), 1:12–15, 5:38–44, Figs. 15–17).
Patent Owner does not present an argument regarding the preamble of
claim 1. See PO Resp. 28–44. Because Steenfeldt-Jensen teaches an
injection syringe with a cartridge with medicine and a housing, Petitioner
persuades us that Steenfeldt-Jensen teaches a “housing part for a medication
dispensing apparatus.”
b) a main housing, said main housing extending from a distal end
to a proximal end;
Petitioner argues that Steenfeldt-Jensen teaches the main housing
recited by claim 1. Pet. 51–53 (citing Ex. 1011 ¶ 263; Ex. 1014, 5:38–44,
Figs. 15–17, claim 11).
We find that the relied-upon portions of Steenfeldt-Jensen teach the
syringe comprises housing 1 (Ex. 1014, 5:38–44) and has proximal and
distal ends (id., claim 11). See also id. at Figs. 15–7 (showing housing 1).
We also credit Mr. Clemens’s testimony because Steenfeldt-Jensen supports
it. Ex. 1011 ¶ 263 (citing Ex. 1014, 5:38–44, Figs. 15–17, claim 11).
Patent Owner does not present an argument regarding the main
housing of claim 1. See PO Resp. 28–44. Because Steenfeldt-Jensen
teaches an injection syringe with a housing having proximal and distal ends,
Petitioner persuades us that Steenfeldt-Jensen teaches “a main housing, said
main housing extending from a distal end to a proximal end.”
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c) a dose dial sleeve positioned within said housing, said dose
dial sleeve comprising a helical groove configured to engage a
threading provided by said main housing, said helical groove
provided along an outer surface of said dose dial sleeve;
Petitioner argues that Steenfeldt-Jensen teaches the required dose dial
sleeve of claim 1. Pet. 53–55 (citing Ex. 1011 ¶¶ 264, 265; Ex. 1014,
11:20–22, 11:52–54, 12:4–9, Figs. 15–17). Specifically, Petitioner argues
that “Steenfeldt-Jensen discloses that the syringe includes a ‘dose dial
sleeve’ in the form of scale drum 80.” Id. at 54 (citing Ex. 1014, 11:20–22).
We find that the relied-upon portions of Steenfeldt-Jensen teach that
“scale drum 80 is in its outer wall provided with a helical track which is
engaged by a helical rib 16 along the inner wall of the housing 1,” “[w]hen a
dose is set by rotating the dose setting button 81 in a clockwise direction, the
scale drum is screwed out of the housing and the dose setting button is lifted
away from the proximal end of the housing,” and
[w]hen the injection button 88 is pressed to inject the set dose the
said rosettes are pressed into engagement so that the bushing 82
will follow the anticlockwise rotation of the dose setting button
81 which is induced by the thread engagement between the
helical track of the scale drum 80 and the rib 16 in the housing
when the scale drum 80 is pressed back into said housing.
Ex. 1014, 11:20–22, 11:52–54, 12:4–9. We also find that Figures 15 and 16
of Steenfeldt-Jensen show scale drum 80 within housing 1. We further
credit Mr. Clemens’s testimony because Steenfeldt-Jensen supports it.
Ex. 1011 ¶¶ 264, 265 (citing Ex. 1014, 11:20–22, 11:52–54, 12:4–9,
Figs. 15–17).
Patent Owner does not present an argument regarding the dose dial
sleeve of claim 1. See PO Resp. 28–44. Because Steenfeldt-Jensen teaches
that scale drum 80 is within housing 1 and has a helical track on its outer
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surface that engages helical rib 16 of housing 1, Petitioner persuades us that
Steenfeldt-Jensen teaches “a dose dial sleeve positioned within said housing,
said dose dial sleeve comprising a helical groove configured to engage a
threading provided by said main housing, said helical groove provided along
an outer surface of said dose dial sleeve.”
d) a dose dial grip disposed near a proximal end of said dose dial
sleeve;
Petitioner argues that Steenfeldt-Jensen teaches the dose dial grip of
claim 1. Pet. 55–56 (citing Ex. 1011 ¶¶ 266, 267; Ex. 1014, 11:22–25,
11:52–62, Figs. 15–17). In particular, Petitioner argues that “Steenfeldt-
Jensen discloses a ‘dose dial grip’ in the form of dose setting button 81,
which the user rotates to set a dose.” Id. at 56 (citing Ex. 1011 ¶ 266;
Ex. 1014, 11:22–25, Figs. 15–17).
We find that the relied-upon portions of Steenfeldt-Jensen teach that
“[a]t its proximal end the scale drum 80 has a diameter exceeding the inner
diameter of the housing to form a dose setting button 81 which on its
cylindrical outer wall is knurled to ensure a good finger grip,” “[w]hen a
dose is set by rotating the dose setting button 81 in a clockwise direction, the
scale drum is screwed out of the housing and the dose setting button is lifted
away from the proximal end of the housing,” and “a set dose is reduced by
rotating the dose setting button 81 in an anticlockwise direction.” Ex. 1014,
11:22–25, 11:52–54, 11:57–58. We also find that Figures 15–17 of
Steenfeldt-Jensen show dose setting button 81 at the button-end of scale
drum 80. We further credit Mr. Clemens’s testimony because Steenfeldt-
Jensen supports it. Ex. 1011 ¶¶ 266, 267 (citing Ex. 1014, 11:22–25, 11:52–
62, Figs. 15–17).
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Patent Owner does not present an argument regarding the dose dial
grip of claim 1. See PO Resp. 28–44. Because Steenfeldt-Jensen teaches
dose setting button 81 at the proximal end of scale drum 80, Petitioner
persuades us that Steenfeldt-Jensen teaches “a dose dial grip disposed near a
proximal end of said dose dial sleeve.”
e) a piston rod provided within said housing, said piston rod is
non-rotatable during a dose setting step relative to said main
housing;
Petitioner argues that Steenfeldt-Jensen teaches the piston rod of
claim 1. Pet. 56–60 (citing Ex. 1011 ¶¶ 268, 270–272; Ex. 1014, 5:55–58,
8:35–38, 11:6–19, 11:52–62, Figs. 15–17). In particular, Petitioner argues
that Steenfeldt-Jensen teaches piston rod 6 that “is non-rotatable during a
dose setting step relative to housing 1 due to a pawl mechanism that works
between driver tube 85 and member 40” and the pawl mechanism “bars
clockwise rotation of driver tube 85 relative to housing 1.” Id. at 59–60
(citing Ex. 1011 ¶ 271; Ex. 1014, 11:6–19, 11:52–62).
We find that the relied-upon portions of Steenfeldt-Jensen teach
“piston rod 6 having an external thread 7 mating the thread 5 of said bore,”
piston rod 6 “extends through said bore,” and “end wall 4 with the internal
thread 5 is provided in a separate member 40 which is mounted in an end of
the housing.” Ex. 1014, 5:55–58, 8:35–38. We also find that Figure 16 of
Steenfeldt-Jensen shows piston rod 6 in housing 1.
We further find that the relied-upon portions of Steenfeldt-Jensen
teach that “the thread of the piston rod and the thread in the end wall of the
housing is so designed that an anticlockwise rotation of the piston will screw
the piston rod through said end wall and into the cartridge holder
compartment,” and “[t]he piston rod has a not round cross-section and fits
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through the driver tube bore which has a corresponding not round cross-
section” so that “rotation is transmitted” and “the piston rod is allowed to
move longitudinally through the driver tube.” Id. at 11:11–19.
Regarding piston rod 6 being non-rotatable relative to housing 1
during dose setting, we find that Steenfeldt-Jensen teaches a pawl
mechanism between the driver tube that rotates piston rod 6 and housing 1
and that the pawl mechanism prevents the driver tube from rotating during
dose setting. In particular, Steenfeldt-Jensen teaches that “[t]o maintain a
clockwise rotation of a dose setting button for increasing the set dose the
pawl mechanism working between the driver tube and the housing . . . bars
clockwise rotation . . . of the driver tube.” Id. at 11:6–11. Steenfeldt-Jensen
also teaches that “[w]hen a dose is set by rotating the dose setting button 81
in a clockwise direction, the scale drum is screwed out of the housing and
the dose setting button is lifted away from the proximal end of the housing”
and “[t]he bushing is kept non rotated due to its coupling to the driver tube
which is locked against clockwise rotation.” Id. at 11:52–57. “[I]f a set
dose is reduced by rotating the dose setting button 81 in an anticlockwise
direction,” Steenfeldt-Jensen teaches that “the pawl mechanism working
between the driver tube and the housing . . . prevent[s] the bushing 82 from
following this anticlockwise rotation.” Id. at 11:57–62. We additionally
credit Mr. Clemens’s testimony because Steenfeldt-Jensen supports it.
Ex. 1011 ¶¶ 268, 270–272 (citing Ex. 1014, 5:55–58, 8:34–35, 8:49–53,
11:6–15, 11:52–62, Figs. 15–17).
Patent Owner does not present an argument regarding the piston rod
of claim 1. See PO Resp. 28–44. Because Steenfeldt-Jensen teaches piston
rod 6 in housing 1 and a pawl mechanism bars rotation of the driver tube that
would rotate piston rod 6 during dose setting, Petitioner persuades us that
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Steenfeldt-Jensen teaches “a piston rod provided within said housing, said
piston rod is non-rotatable during a dose setting step relative to said main
housing.”
f) a drive sleeve extending along a portion of said piston rod,
said drive sleeve comprising an internal threading near a
distal portion of said drive sleeve, said internal threading
adapted to engage an external thread of said piston rod; and,
Petitioner argues that Steenfeldt-Jensen teaches the drive sleeve of
claim 1. Pet. 60–64 (citing Ex. 1011 ¶¶ 273–274; Ex. 1014, 11:6–19, 11:52–
62, 12:4–12, Figs. 15–17). In particular, Petitioner argues that “Steenfeldt-
Jensen discloses a ‘drive sleeve’ in the form of driver tube 85.” Id. at 63
(citing Ex. 1011 ¶¶ 273–274).
We find that Figure 16 of Steenfeldt-Jensen shows driver tube 85
around a portion of piston rod 6. Also, as discussed above for the recited
piston rod, Steenfeldt-Jensen teaches that “the thread of the piston rod and
the thread in the end wall of the housing is so designed that an anticlockwise
rotation of the piston will screw the piston rod through said end wall and
into the cartridge holder compartment,” and “[t]he piston rod has a not round
cross-section and fits through the driver tube bore which has a corresponding
not round cross-section” so that “rotation is transmitted” and “the piston rod
is allowed to move longitudinally through the driver tube.” Ex. 1014,
11:11–19.
We also find that the relied-upon portions of Steenfeldt-Jensen teach
that pressing injection button 88 injects a set dose, “the thread engagement
between the helical track of the scale drum 80 and the rib 16 in the housing
when the scale drum 80 is pressed back into said housing” induces
“anticlockwise rotation of the dose setting button 81,” bushing 82 follows
that rotation, “[t]he bushing will rotate the driver tube 85 in an anticlockwise
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direction which the pawl mechanism reluctantly allows,” and “the piston rod
is thereby screwed further into an ampoule 89 in the ampoule holder 2.” Id.
at 12:4–12; see also id. at 11:6–11 (describing the pawl mechanism), 11:52–
62 (describing dose setting). We also credit Mr. Clemens’s testimony
regarding what Steenfeldt-Jensen teaches in connection with this limitation
because Steenfeldt-Jensen supports it. Ex. 1011 ¶¶ 273–274 (citing
Ex. 1014, 11:6–19, Figs. 16, 17).
Patent Owner responds that Petitioner concedes that driver tube 85 of
Steenfeldt-Jensen does not engage a piston rod with an internal threading
near a distal portion. PO Resp. 28 (citing Pet. 63–64). Patent Owner also
responds that “[n]one of the four passages in Steenfeldt-Jensen that
Petitioner relies on discloses an internally threaded driver tube,” and that
“[i]nstead, these passages disclose an internally threaded ‘nut member’ or
‘nut element’, which is rotated by a driver tube – the driver tube itself is not
threaded.” Id.; see also id. at 29–30 (arguing what the passages would teach
to one of ordinary skill in the art).
We agree with Patent Owner that Petitioner argues that Steenfeldt-
Jensen teaches piston rod 6 “rotationally engages with the rod through the
non-circular bore, rather than ‘an internal threading near a distal portion.’”
Pet. 63–64 (citing Ex. 1011 ¶ 274). Petitioner, however, further argues that
one of ordinary skill in the art “would have considered it obvious to modify
driver tube 85 to provide the ‘drive sleeve’ of claim 1,” which we analyze
below. Id. at 64 (citing Ex. 1011 ¶¶ 275–279).
For the reasons above, because Steenfeldt-Jensen teaches driver
tube 85 around a portion of piston rod 6, Petitioner persuades us that
Steenfeldt-Jensen teaches “a drive sleeve extending along a portion of said
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piston rod” that rotates the piston rod via a non-circular bore so that piston
rod screws through internal threading of end wall 4.
(1) Reason to Modify
Regarding “said drive sleeve comprising an internal threading near a
distal portion of said drive sleeve, said internal threading adapted to engage
an external thread of said piston rod,” Petitioner contends that, although
Steenfeldt-Jensen teaches that driver tube 85 rotationally engages piston
rod 6 via a non-circular bore, it would have been obvious to modify driver
tube 85 with an internal threading near a distal portion. Pet. 69 (citing
Ex. 1011 ¶ 274); see also id. at 64 (citing Ex. 1011 ¶¶ 275–279). Petitioner
argues that “the modified device would have been understood to contain a
‘drive sleeve’ of claim 1 having the claimed structural elements.” Pet. 69
(citing Ex. 1011 ¶ 274).
According to Petitioner, Steenfeldt-Jensen expressly states at
column 7, lines 44–47, that “[e]mbodiments may be imagined wherein the
piston rod guide is provided in the wall 4 and a nut element is rotated by the
driver tube and such embodiment will not be beyond the scope of the
invention” and therefore, Steenfeldt-Jensen contemplates a driver tube with
an internal threading to engage a piston rod’s external threading. Id. at 69–
70 (citing Ex. 1011 ¶ 275; Ex. 1014, 3:15–20, 3:44–47, 7:44–47).
Petitioner also argues that one of ordinary skill in the art would have
understood driver tube 85, shown in Figures 15–17, includes a “piston rod
guide” because “it allows relative axial movement of the piston rod, while
preventing relative rotational movement due to its non-circular bore.” Id.
at 70 (citing Ex. 1011 ¶ 276; Ex. 1014, 2:46–53, 3:15–20). Petitioner further
argues that a person of ordinary skill in the art would have understood
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member 40 includes a “nut element” because member 40 has internal
threading on end wall 4. Id. (citing Ex. 1011 ¶ 276).
Petitioner, thus, contends that Steenfeldt-Jensen suggests a “nut
element” on a driver tube and a “piston rod guide” on a member and one of
ordinary skill in the art “would have reason to modify (1) driver tube 85 to
include an internal threading for engaging the piston rod’s external
threading, and (2) member 40 to include a non-circular cross-section for
axially guiding the piston rod.” Id. (citing Ex. 1011 ¶ 277). Petitioner also
contends that one of ordinary skill in the art would have reasonably expected
the modified parts to perform the same function as before. Id. at 71 (citing
Ex. 1011 ¶ 278).
Patent Owner responds that one of ordinary skill in the art would have
understood that column 7, lines 44–47, of Steenfeldt-Jensen does not apply
to the fifth embodiment of Steenfeldt-Jensen. PO Resp. 30–31 (citing
Ex. 1014, 7:41–47; Ex. 2107 ¶¶ 223–226). Patent Owner argues that the
phrase “shown embodiment” in that part of Steenfeldt-Jensen refers to the
first embodiment shown in Figures 1–5, the description of the fifth
embodiment does not include a statement similar to “[e]mbodiments may be
imagined wherein the piston rod guide is provided in the wall 4 and a nut
element is rotated by the driver tube,” and the provisional application
included the statement at lines 41–47 of column 7 and description for the
first embodiment, but not the fifth embodiment. PO Resp. 31–32 (citing
Ex. 1014, 5:33–7:47, 11:6–12:16; Ex. 2127, 11:2–5).
Patent Owner also argues that one of ordinary skill in the art would
not have understood that lines 41–47 of column 7 are applicable to each
embodiment of Steenfeldt-Jensen because, for example, applying it to
Steenfeldt-Jensen’s second embodiment results in a non-functioning pen
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injector. Id. at 32 (citing Ex. 2107 ¶ 226). Patent Owner further argues that,
even if applied to the fifth embodiment, lines 41–47 of column 7 do not
teach or suggest Petitioner’s proposed modification. Id. at 32–33 (citing
Pet. 69–71; Ex. 2107 ¶ 227; Ex. 2164, 219:18–220:11). According to Patent
Owner, “it teaches putting a piston rod guide in end wall 4 of ampoule
holder 2 (of the first embodiment), and having driver tube 26 (of the first
embodiment) rotate a nut element.” Id. at 33 (citing Ex. 2107 ¶ 215).
Petitioner replies that “a driver with a nut member is an internally-
threaded driver” and that one of ordinary skill in the art would have
understood “that when Steenfeldt-Jensen refers to a driver rotating a nut
member, it describes an internally-threaded driver tube.” Pet. Reply 8–9
(citing Pet. 69–71; PO Resp. 29–30; Ex. 1014, 3:41–47; Ex. 1095 ¶¶ 37–38;
Ex. 2107 ¶¶ 29–30, 215–222). Petitioner contends that one of ordinary skill
in the art would have understood Steenfeldt-Jensen teaches an internally-
threaded driver tube when referring to a driver rotating a nut member,
because Steenfeldt-Jensen describes the well-known alternative of a driver
rotating a nut member or nut element, and that, because no meaningful
distinction exists between an integral piston-rod guide and rectangular bore,
no meaningful distinction exists between an integral nut member and
threads. Pet. Reply 8–9 (citing Pet. 69–71; Ex. 1014, 3:41–47, 6:35–36,
11:15–19; Ex. 1095 ¶¶ 37–40; Ex. 2107 ¶ 30). Petitioner further contends
that “Steenfeldt-Jensen states that ‘end wall 4 with its threaded bore forms a
nut member’” and one of ordinary skill in the art would have understood that
“a driver tube with a threaded bore operates as a nut member.” Id. at 9
(citing Ex. 1014, 7:41–43; Ex. 1095 ¶¶ 39–40).
Petitioner also replies that one of ordinary skill in the art would have
been able to apply relevant teachings from one embodiment to another. Id.
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at 9–10 (responding to PO Resp. 30–33). Petitioner argues that Steenfeldt-
Jensen teaches alternative driver mechanisms before describing other
embodiments and Patent Owner ignores the broader context. Id. at 10
(citing Pet. 69–71; PO Resp. 29–30; Ex. 1014, 2:40–53, 3:15–20, 3:44–47;
Ex. 1095 ¶¶ 41–42). Because Steenfeldt-Jensen teaches alternative driver
mechanisms before describing other embodiments, Petitioner contends that
one of ordinary skill in the art would have known such alternatives would
also apply to the fifth embodiment and “Steenfeldt-Jensen provides a broad
discussion of drive mechanisms using rotating piston-rod guides or nut
members.” Id. at 10–11 (citing Ex. 1014, 2:40–53, 3:10–20, 3:41–47;
Ex. 1095 ¶¶ 43–45).
Petitioner further replies that the first and fifth embodiments have
analogous features so that one of ordinary skill in the art would have
understood that the alternative configuration for the first embodiment applies
to the fifth embodiment and the alternative would have been the same with
the same effect. Pet. Reply 11–12 (citing Ex. 1095 ¶¶ 44, 45). According to
Petitioner, for the first and fifth embodiments, “Dr. Slocum agreed these
driver tubes have ‘the same engagement method’ with the piston rod and
apply torque in the same way” and “agreed that the drive mechanisms’
‘force chain’ was similar.” Id. at 12 (citing Ex. 1054, 306:23–308:9, 342:3–
343:18). Petitioner further contends that whether the alternative
configuration could be applied to the second embodiment is irrelevant
because of the second embodiment’s different drive mechanism. Id. (citing
Ex. 1014, 7:51–54; Ex. 1054, 344:7–346:25).
Patent Owner replies that “Steenfeldt-Jensen nowhere discloses a
threaded driver tube,” and thus, “the parties’ arguments about whether 7:41–
47 applies to the fifth embodiment are moot.” PO Sur-reply 7 (citing PO
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Resp. 28–30). Patent Owner also replies that it addressed other parts of
Steenfeldt-Jensen that Petitioner cites. Id. (citing Pet. Reply 10). Patent
Owner argues that Petitioner concedes the disclosure at lines 41–47 of
column 7 “is not a blanket statement,” and that Mr. Clemens acknowledges
the differences between embodiments but focuses on the first and fifth
embodiments’ driver tubes and nut members without regard to their overall
structure and operation. Id. at 8 (citing Pet. Reply 11; Ex. 1095 ¶ 44).
Patent Owner also argues that the “embodiments are not analogous”
and one of ordinary skill in the art “would not apply a teaching specific to
the first embodiment to the fifth embodiment” because their differences
“mandate different dialing and dose dispensing methods.” Id. at 8–9 (citing
PO Resp. 30–33; Pet. Reply 9–10; Ex. 1014, 5:38–46, 6:42–59). Patent
Owner further contends that Dr. Slocum opined that Petitioner’s
modification “would impair the first embodiment” and lines 41–7 of
column 7 does not disclose Petitioner’s modification. Id. at 9 (citing Pet.
Reply 13).
Patent Owner also replies that “the claims specifically require a
threaded driver tube,” Steenfeldt-Jensen’s nut member is separate from the
driver tube, and Petitioner misreads lines 41–47 of column 3. Id. at 14.
Patent Owner contends that the first, third, fourth, and fifth embodiments
have a nut member distinct from a driver tube and lines 41–47 of column 3
do not mention an integrally formed nut member. PO Sur-reply 15–17
(citing Ex. 1014, 3:41–47, Figs. 2, 12, 14, 16).
Patent Owner also contends that Petitioner incorrectly asserts that a
driver tube with integral piston rod guide suggests a driver tube with integral
nut member because Steenfeldt-Jensen does not equate the piston rod guide
and the nut member. Id. at 17 (citing Pet. Reply 8, 9; Ex. 1014, 3:41–47).
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According to Patent Owner, lines 41–47 of column 3 “at best, draw[] a
parallel between a piston rod (not a piston rod guide) and nut member, but in
no way suggest[] an integrally formed nut member.” Id. at 18. Patent
Owner further contends that another relied-upon portion of Steenfeldt-
Jensen does not suggest a nut member integrally formed with a driver tube.
Id. (citing Pet. Reply 9; Ex. 1014, 7:41–43).
We agree with Patent Owner that the phrase, “[i]n the shown
embodiment,” refers to Steenfeldt-Jensen’s first embodiment because of the
references to end wall 4, piston rod guide 14, and driver tube 26 that are
described and shown as components of the first embodiment. Ex. 1014,
7:41–43.10 We also find that the language that follows expressly teaches
other embodiments “wherein the piston rod guide is provided in the wall 4
and a nut element is rotated by the driver tube.” Id. at 7:44–46. Because
this teaching comes after describing the first embodiment, we determine that
this express teaching applies directly to the first embodiment.
Even though the teaching at column 7, lines 44–47, applies directly to
the first embodiment, we agree with Petitioner that this express teaching
would have, at least, suggested to one of ordinary skill in the art to consider
a similar alternative for other embodiments as well, even though the same
statement is not repeated after the discussion of each embodiment. See
Pet. 69–70; Pet. Reply 8–12. We credit Mr. Clemens’s testimony regarding
Steenfeldt-Jensen’s suggestion because, for the reasons discussed below, the
full record before us supports it. Ex. 1011 ¶ 277.

10 Steenfeldt-Jensen does not use reference numbers for the end wall, piston
rod guide, and driver tube of the fifth embodiment. See Ex. 1001, 11:11–19.
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In so doing, however, we recognize, as Patent Owner points out, that
one of ordinary skill in the art may not have applied the taught or suggested
alternative arrangement to the second embodiment because of differences in
the structure of the second embodiment as compared to the first. See PO
Resp. 32. That the alternative arrangement may not have applied to the
second embodiment, however, does not lead to the conclusion that one of
ordinary skill in the art would not have or could not have applied the
suggestion to Steenfeldt-Jensen’s other embodiments. See Ex. 1095 ¶ 45.
We agree with Petitioner that (1) the various embodiments of
Steenfeldt-Jensen have either analogous or the same components,
and (2) Steenfeldt-Jensen does not repeat descriptions for those components
in the discussion of each latter embodiment. See Pet. Reply 10–12. For
example, the first embodiment includes “wall 4 having a central bore with an
internal thread 5” and “piston rod 6 having an external thread 7 mating the
thread 5 of said bore” (Ex. 1014, 5:56–58); the second embodiment has a
piston rod (id. at 7:64); the third embodiment includes “piston rod 6 [that]
engages by its external thread 7 the internal thread of the end wall 4” (id. at
8:45–46); the fourth embodiment also has an internally threaded wall 4 that
is not described but shown in Figure 14; and for the fifth embodiment, “the
thread of the piston rod and the thread in the end wall of the housing is so
designed that an anticlockwise rotation of the piston will screw the piston
rod through said end wall” (id. at 11:11–14). See also id. at Figs. 2
(showing, for the first embodiment, externally threaded piston rod 6
engaging internally threaded wall 4), 7 (showing, for the second
embodiment, externally threaded piston rod 6 engaging internally threaded
wall 4), 11–12 (showing, for the third embodiment, externally threaded
piston rod 6 engaging internally threaded wall 4), 14 (showing, for the fourth
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embodiment, internally threaded wall 4), 15–16 (showing, for the fifth
embodiment, externally threaded piston rod 6 engaging internally threaded
wall 4).
Based on the portions of Steenfeldt-Jensen discussed above, we find
that Steenfeldt-Jensen does not repeat certain descriptions for components
that are analogous or the same in each embodiment, including end wall 4.
See Ex. 1014, 8:45–46, 11:11–14, Fig. 14. We find that one of ordinary skill
in the art would have understood that Steenfeldt-Jensen employed this
method of description and would have applied lines 44–47 of column 7 to
embodiments with the same or analogous components—the first, third,
fourth, and fifth embodiments—because lines 44–47 of column 7 relate to, at
least, end wall 4, which is included in each of those embodiments. Ex. 1011
¶ 277; Ex. 1095 ¶ 44. We also find that the first and fifth embodiments have
substantially similar arrangements of piston rods, piston rod guides, and nut
members. Compare id. at Fig. 3, with id. at Fig. 17; see also Ex. 1054,
306:23–308:9 (Dr. Slocum testifying that driver tubes and piston rods shown
in Figs. 3 and 17 work similarly), 342:3–343:19 (Dr. Slocum testifying that
driver tubes of the first and fifth embodiments work similarly).
Additionally, we find that the fact that Steenfeldt-Jensen does not repeat the
description of the piston rod guide or nut element, also discussed at lines 44–
47 of column 7, means that these components are not so different from the
first embodiment that further description of those components is warranted
for the other embodiments.
Regarding whether Steenfeldt-Jensen would have taught or suggested
a driver tube with an integral nut element, Petitioner provides evidence that
one of ordinary skill would have understood lines 41–47 of column 3 to
suggest such a driver tube. See Pet. Reply 8–9 (citing Pet. 69–71; PO
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Resp. 29–30; Ex. 1014, 3:41–47, 6:35–36, 11:15–19; Ex. 1095 ¶¶ 37–40;
Ex. 2107 ¶¶ 30, 215–222). Patent Owner provides a refuting argument with
support from what Steenfeldt-Jensen expressly teaches. See PO Sur-reply
14–18 (citing Pet. Reply 8–9; Ex. 1014, 3:41–47, 7:41–43, Figs. 2, 12, 14,
16). Patent Owner points to portions of the record that do not indicate that
one of ordinary skill in the art would have been limited to only the express
teachings in the manner argued by Patent Owner. Petitioner, on the other
hand, sufficiently shows with support from Steenfeldt-Jensen’s teachings
and declarant testimony that, even if Steenfeldt-Jensen does not teach
expressly a driver tube with an integral nut element, Steenfeldt-Jensen, at
lines 41–47 of column 3, suggests such a driver tube, and the understanding
of one of ordinary skill in the art would not have been limited to only the
express teachings. See Pet. 69–71; Pet. Reply 8–9; Ex. 1011 ¶¶ 275–277;
Ex. 1014, 2:46–53, 3:15–20, 3:41–47, 7:41–47, 6:35–36, 11:15–19;
Ex. 1095 ¶¶ 37–40; Ex. 2107 ¶ 30.
For the reasons above, Petitioner persuades us that one of ordinary
skill in the art, reading that an alternative arrangement can include a “piston
rod guide [that] is provided in the wall 4 and a nut element [that] is rotated
by the driver tube” (Ex. 1014, 7:44–46), “would have reason to
modify (1) driver tube 85 to include an internal threading for engaging the
piston rod’s external threading, and (2) member 40 to include a non-circular
cross-section for axially guiding the piston rod” in Steenfeldt-Jensen’s fifth
embodiment. Pet. 69–70; Ex. 1011 ¶¶ 275–277; Ex. 1095 ¶¶ 37–40. We
also agree with Petitioner that one of ordinary skill in the art would have
reasonably expected the modified parts to perform the same function as
before, and thus, one of ordinary skill in the art would have had a reasonable
expectation of success in making Petitioner’s proposed modification. See
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Pet. 71 (citing Ex. 1011 ¶ 278). We further credit Mr. Clemens’s testimony
regarding Petitioner’s proposed modification because it finds support in
Steenfeldt-Jensen. Ex. 1011 ¶¶ 275–278 (citing Ex. 1014, 2:46–53, 3:15–20,
3:44–47, 7:44–47, 8:48–53, Figs. 15–17).
For the reasons above, we determine that Petitioner’s modified driver
tube 85 rotating a nut member with internal threading engaging externally
threaded piston rod 6 would result in “said drive sleeve comprising an
internal threading near a distal portion of said drive sleeve, said internal
threading adapted to engage an external thread of said piston rod,” as
required by claim 1.
(a) Patent Owner’s Models and Asserted Higher Friction
Patent Owner also responds that Petitioner’s proposed modification to
switch the non-circular opening and threaded opening of Steenfeldt-Jensen’s
fifth embodiment would result in an inferior pen and thus, one of ordinary
skill in the art would not have been motivated to make Petitioner’s proposed
modification. PO Resp. 33–44; see also id. at 1 (arguing that Petitioner’s
proposed modification would have rendered Steenfeldt-Jensen inoperable for
its intended purpose). In particular, Patent Owner argues that moving
threads to the driver tube and moving the non-circular bore to member 40
would cause “a major new source of friction to Steenfeldt-Jensen’s fifth
embodiment.” Id. at 33 (citing Ex. 2107 ¶¶ 232–238).
Patent Owner contends that higher friction would increase injection
force, which is a benchmark. Id. at 34 (citing Ex. 1015 ¶¶ 4–6; Ex. 2107
¶¶ 37–39, 44–45, 54, 56–57; Ex. 2163, 80:17–81:5). In support of its
argument, Patent Owner points us to “an analytical model presented in a
spreadsheet” and a “Collar Friction Model.” Id. at 34–35 (citing Ex. 2107
¶¶ 242–255; Ex. 2211; Ex. 2215; Ex. 2216; Ex. 2217); see also id. at 35–36
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(explaining the analytical model and contending that it shows “Petitioner’s
proposed modification increases the amount of force required from the user
to inject a dose by 51%”) (citing Ex. 2107, App’x A ¶¶ 242–244), 36–39
(explaining the Collar Friction Model and contending that “manually
rotating the Collar with the Threaded Insert requires 50% more force on
average to advance the piston rod than rotating the Collar with Guide”)
(citing Ex. 2107 ¶¶ 245–255; Ex. 2215; Ex. 2216; Ex. 2217), 39–42
(explaining why Petitioner’s modification results in higher friction) (citing
Ex. 1004, 1:36–40; Ex. 1014, 12:10–13, Fig. 16; Ex. 1015 ¶¶ 4–6; Ex. 2107
¶¶ 54–57, 229–231, 233–238, 242–244; Ex. 2152).
Petitioner replies that Patent Owner’s models are based on Patent
Owner’s declarant ignoring Steenfeldt-Jensen’s suggested alternative for the
fifth embodiment but that Patent Owner’s declarant agreed that the
suggestion expressly applied to the first embodiment. Pet. Reply 12–13
(citing PO Resp. 33–44; Ex. 1054, 306:23–313:6). Petitioner also argues
that Patent Owner assumes incorrectly that one of ordinary skill in the art
would focus on designing only insulin pens. Id. at 13 (citing PO Resp. 33–
34). According to Petitioner, the claim and asserted references are not
limited to such pens. Id. (citing Ex. 1053, 62:13–71:2, 72:3–11, 75:22–76:3;
Ex. 2107 ¶¶ 44–61). Petitioner agrees that injection force is a factor, but
argues that it is not the only factor one of ordinary skill in the art would
consider when designing pen injectors. Id. at 13–14 (citing Ex. 1048 ¶¶ 28–
30, 32; Ex. 1095 ¶ 47).
Petitioner also replies that Patent Owner’s models are flawed
because (1) a named inventor provided most of the inputs for the analytical
model spreadsheet (id. at 14–16 (citing PO Resp. 35–36; Ex. 1053, 12:22–
13:5, 28:18–29:2, 30:5–33:13; Ex. 1054, 313:10–325:12; Ex. 1095 ¶¶ 48,
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49; Ex. 2107 ¶¶ 242–243)), (2) the models focus on friction at one point but
ignore reductions in friction at other points (id. at 16 (citing Ex. 1095 ¶ 50;
Ex. 2107 ¶ 58)), and (3) the models exaggerate friction losses by not
considering the changes, within the ordinary level of creativity, that one of
ordinary skill in the art could also make to minimize friction (id. at 16–17
(citing Ex. 1053, 33:5–13, 41:3–42:13; Ex. 1054, 325:22–327:6; Ex. 1095
¶¶ 48–50)).
Patent Owner replies that Dr. Slocum’s analytical and physical models
show a 51% higher injection force that would dissuade one of ordinary skill
in the art from making Petitioner’s modification. PO Sur-reply 9 (citing PO
Resp. 33–44). According to Patent Owner, “Petitioner presents no rebuttal
models or calculations,” only argument, and “identifies no other application
where higher injection force would be acceptable.” Id. at 9–10 (citing Pet.
Reply 12–14; Ex. 1014, 1:16–18); see also id. at 11 (arguing that “injection
force would increase—a fact not disputed (only the magnitude)”).
According to Patent Owner, when considering whether to combine teachings
of embodiments, one of ordinary skill in the art “would consider Steenfeldt-
Jensen’s context, e.g., diabetic injection pens.” Id. at 10 (citing Ex. 1014,
1:16–18). Patent Owner argues that Dr. Slocum “verified the models,
conducted his own experiments, and gathered his own data” and the named
inventor is not an employee and has no financial stake in the outcome of this
proceeding. Id. at 12 (citing Pet. Reply 14–16; Ex. 2107 ¶¶ 242–255).
Patent Owner also argues that the “51% increase in injection force is derived
from a comparison between the fifth embodiment and the modified fifth
embodiment.” Id. at 13 (citing Pet. Reply 16). Patent Owner further argues
that any friction mitigation applied to the modified fifth embodiment would
also be “applied to the unmodified fifth embodiment and thus would be a
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wash.” Id. (citing Pet. Reply 16). Patent Owner lastly replies that Petitioner
did not inspect Patent Owner’s models and presents no refuting evidence.
Id. at 12, 13, 14.
We find that the first and fifth embodiments have substantially similar
arrangements of piston rods, piston rod guides, and nut members. Compare
Ex. 1014, Fig. 3, with id. at Fig. 17. Patent Owner presents persuasive
evidence that Petitioner’s proposed modification would increase friction to
some extent. Nonetheless, Steenfeldt-Jensen expressly teaches an
alternative configuration wherein a piston rod guide is in wall 4 and a driver
tube rotates a nut element instead of a piston rod guide. See id. at 7:41–47.
Petitioner provides persuasive evidence that at least some of the friction
increase could be offset by making routine changes well within the level of
ordinary skill in the art and that the increase would not have dissuaded one
of ordinary skill in the art from applying the alternative disclosed in
Steenfeldt-Jensen to the fifth embodiment. Ex. 1095 ¶¶ 48–50.
Additionally, even if we assume, as Patent Owner contends, that
Steenfeldt-Jensen’s alternative arrangement were limited to the first
embodiment, Patent Owner’s models indicate that, by implementing that
alternative in the first embodiment, friction would also increase. Despite
this result, Steenfeldt-Jensen does not indicate that the alternative
configuration for the first embodiment has higher friction or that any
resulting increase in friction is a cause for concern. See Ex. 1014, 7:41–47.
Therefore, Steenfeld-Jensen’s disclosure further supports our finding that an
increase in friction would not have dissuaded one of ordinary skill in the art
from making Petitioner’s proposed modification to Steenfeldt-Jensen’s fifth
embodiment.
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(b) Issues with the Flexible Arms
Patent Owner also contends that there are other potential failures in
Petitioner’s proposed modification. PO Resp. 43–44. Specifically, Patent
Owner argues that flexible arms of driver tube 85, which act as a ratchet
with member 40, can break, get stuck, or become jammed in an opening in a
ring-shaped wall. Id. (citing Ex. 1014, 11:55–62, Figs. 15, 16; Ex. 2107
¶¶ 239–241).
Petitioner replies that Patent Owner offers no evidence that the
flexible arms would be affected and that one of ordinary skill in the art could
address the asserted potential failures as a “routine issue without difficulty.”
Pet. Reply 17–18 (citing PO Resp. 43–44; Ex. 1095 ¶ 51; Ex. 2107 ¶¶ 239–
241). Patent Owner replies that Petitioner proposes further modifications
that would lead to other problems and difficulties. PO Sur-reply 11 (citing
PO Resp. 43–44; Pet. Reply 17).
As discussed above, Steenfeldt-Jensen expressly describes an
alternative configuration wherein a piston rod guide is in wall 4 and a driver
tube rotates a nut element instead of a piston rod guide. See Ex. 1014, 7:41–
47. Steenfeldt-Jensen does not address whether the alternative configuration
results in potential failures in the flexible arms of the alternative driver tube.
See id. Patent Owner’s declarant opines that there may be potential issues
with these flexible arms in Petitioner’s proposed modification, but that
testimony does not cite sufficient supporting evidence. See Ex. 2107
¶¶ 239–241. Thus, because Steenfeldt-Jensen proposes a similar
modification and does not address potential failures in the flexible arms of
the alternative driver tube, and because Patent Owner’s declarant, as one of
ordinary skill in the art, recognizes these potential failures, the full record
persuades us that such potential failures are matters that would have been
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recognized by ordinarily skilled artisans and would have been addressed by
those artisans. Ex. 1095 ¶ 51. Therefore, based on the full record before us,
Patent Owner’s asserted potential failures in the flexible arms of the
alternative driver tube do not show that one of ordinary skill in the art would
have been dissuaded from making Petitioner’s proposed modification.
(c) Determination as to the Reason to Modify
For the reasons above, based on the full record before us, Petitioner
persuades us that Steenfeldt-Jensen suggests Petitioner’s proposed
modifications. Petitioner persuades us that the expressly taught modification
for Steenfeldt-Jensen’s first embodiment would have suggested to one of
ordinary skill in the art to modify Steenfeldt-Jensen’s fifth embodiment.
Petitioner also presents arguments based on Exhibit 1016.11 Pet.
Reply 17–18 (citing Ex. 1016, 3:1–26, Figs. 2, 3, 5–7; Ex. 1054, 308:10–
310:22; Ex. 1095 ¶ 52). Patent Owner argues that Petitioner presents a new
argument based on Exhibit 1016. PO Sur-reply 18–19 (citing Pet. Reply 17–
18). We do not need to address Exhibit 1016 because, for the reasons above,
Petitioner persuades us that one of ordinary skill in the art would have made
Petitioner’s proposed modification based on arguments made in the Petition.
g) a tubular clutch located adjacent a distal end of said dose dial
grip, said tubular clutch operatively coupled to said dose dial
grip,
Petitioner argues that Steenfeldt-Jensen teaches the required tubular
clutch of claim 1. Pet. 64–67 (citing Ex. 1011 ¶¶ 280–283; Ex. 1014, 11:26–
42, 11:52–62, 12:1–13, Figs. 15–17). Specifically, Petitioner argues that
bushing 82 teaches the tubular clutch because rosette 93 of teeth engage
teeth on dose setting button 81 during injection and disengage during dose

11 Giambattista, U.S. Patent No. 6,932,794 B2, issued August 23, 2005.
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setting. Id. at 66–67 (citing Ex. 1011 ¶¶ 280–281, 283; Ex. 1014, 11:26–42,
11:52–62, 12:1–12, Figs. 15–16).
We find that the relied-upon portions of Steenfeldt-Jensen teach that
“bushing 82 ha[s] a flange 83 at its proximal end” (Ex. 1014, 11:26), “[i]n
the dose setting button a compartment is . . . provided with . . . a bottom with
a rosette of teeth having a triangular cross-section” (id. at 11:34–37),
“flange 83 of the bushing 82 is adopted in said compartment” (id. at 11:37–
38), and “[a]t its distal side the flange 83 has a rosette 93 of teeth which can
be brought into engagement with the rosette at the bottom of the
compartment” (id. at 11:40–42).
We also find that the relied-upon portions of Steenfeldt-Jensen teach
that “[d]uring the setting the rosette in the dose setting button forces the
rosette 93 on the flange 83 of the bushing 82 out of engagement” (id.
at 12:1–3) and “[w]hen the injection button 88 is pressed to inject the set
dose the said rosettes are pressed into engagement so that the bushing 82
will follow the anticlockwise rotation of the dose setting button 81” (id. at
12:4–7). As discussed above for the recited “dose dial grip,” Petitioner
argues that “Steenfeldt-Jensen discloses a ‘dose dial grip’ in the form of
dose setting button 81, which the user rotates to set a dose.” Pet. 56 (citing
Ex. 1011 ¶ 266; Ex. 1014, 11:22–25, Figs. 15–17). We additionally find that
Figures 15–17 show bushing 82 is tubular and located near dose setting
button 81. We further credit Mr. Clemens’s testimony because Steenfeldt-
Jensen supports it. Ex. 1011 ¶¶ 280–283 (citing Ex. 1014, 11:26–49, 11:52–
62, 12:1–13, Figs. 15–17).
Patent Owner does not present an argument regarding the tubular
clutch of claim 1. See PO Resp. 28–44. Because Steenfeldt-Jensen teaches
bushing 82 is tubular, located near dose setting button 81, and can engage or
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disengage with dose setting button 81, Petitioner persuades us that
Steenfeldt-Jensen teaches “a tubular clutch located adjacent a distal end of
said dose dial grip, said tubular clutch operatively coupled to said dose dial
grip.”
h) wherein said dose dial sleeve extends circumferentially around
at least a portion of said tubular clutch.
Petitioner argues that Steenfeldt-Jensen teaches this wherein clause of
claim 1. Pet. 68–69 (citing Ex. 1011 ¶ 285; Ex. 1014, 11:26–28, Figs. 15–
16). As discussed above for the recited dose dial sleeve, Petitioner contends
that “Steenfeldt-Jensen discloses that the syringe includes a ‘dose dial
sleeve’ in the form of scale drum 80.” Id. at 54 (citing Ex. 1014, 11:20–22).
We find that the relied-upon portion of Steenfeldt-Jensen teaches that
“bushing 82 . . . fits into the scale drum 80.” Ex. 1014, 11:26–28. We also
find that Figures 15 and 16 of Steenfeldt-Jensen show scale drum 80
circumferentially around a portion of bushing 82. We further credit
Mr. Clemens’s testimony because Steenfeldt-Jensen supports it. Ex. 1011
¶ 285 (citing Ex. 1014, 11:28–30, Figs. 15–16).
Patent Owner does not present an argument regarding this wherein
clause of claim 1. See PO Resp. 28–44. Because Steenfeldt-Jensen teaches
scale drum 80 circumferentially around a portion of bushing 82, Petitioner
persuades us that Steenfeldt-Jensen teaches “wherein said dose dial sleeve
extends circumferentially around at least a portion of said tubular clutch.”
G. Objective Indicia of Nonobviousness
Patent Owner argues that “the [’]069 Patent addressed a long-felt, but
unmet need in the insulin pen injector industry – the need for an injection
pen with reduced injection force” and the “commercial embodiment of the
[’]069 Patent, Sanofi’s LANTUS® SoloSTAR®1, achieved critical acclaim
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and overwhelming commercial success that is directly attributable to the
[’]069 Patent.” PO Resp. 2; see also Ex. 2109 ¶ 6 (stating that Patent Owner
“sells Lantus®, insulin glargine (of rDNA origin), both in vial form
(‘Lantus® vial’) and in pen form (‘Lantus® SoloSTAR®’)”).
1. Nexus
Objective indicia of nonobviousness are “only relevant to the
obviousness inquiry ‘if there is a nexus between the claimed invention and
the [objective indicia of nonobviousness].’” In re Affinity Labs of Tex., LLC,
856 F.3d 883, 901 (Fed. Cir. 2017) (quoting Ormco Corp. v. Align Tech.,
Inc., 463 F.3d 1299, 1312 (Fed. Cir. 2006)). For objective indicia of
nonobviousness to be accorded substantial weight, their proponent must
establish a nexus between the evidence and the merits of the claimed
invention. ClassCo, Inc., v. Apple, Inc., 838 F.3d 1214, 1220 (Fed. Cir.
2016). “[T]here is no nexus unless the evidence presented is ‘reasonably
commensurate with the scope of the claims.’” Id. (quoting Rambus Inc. v.
Rea, 731 F.3d 1248, 1257 (Fed. Cir. 2013)).
A patentee is entitled to a presumption of nexus “when the patentee
shows that the asserted objective evidence is tied to a specific product and
that product ‘embodies the claimed features, and is coextensive with them.’”
Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019)
(quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed.
Cir. 2018) (quoting Brown & Williamson Tobacco Corp. v. Philip Morris
Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000))); Lectrosonics, Inc. v. Zaxcom,
Inc., IPR2018-01129, Paper 33, 32 (PTAB January 24, 2020) (precedential,
designated April 14, 2020). On the other hand, the patentee is not entitled to
a presumption of nexus if the patented invention is only a component of a
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commercially successful machine or process. Id. (reaffirming the
importance of the “coextensiveness” requirement).
“[T]he purpose of the coextensiveness requirement is to ensure that
nexus is only presumed when the product tied to the evidence of secondary
considerations ‘is the invention disclosed and claimed.’” Id. at 1374
(quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387,
1392 (Fed. Cir. 1988)). “[T]he degree of correspondence between a product
and a patent claim falls along a spectrum. At one end of the spectrum lies
perfect or near perfect correspondence. At the other end lies no or very little
correspondence.” Id. “A patent claim is not coextensive with a product that
includes a ‘critical’ unclaimed feature that is claimed by a different patent
and that materially impacts the product’s functionality.” Id. at 1375.
However, “[a] finding that a presumption of nexus is inappropriate
does not end the inquiry into secondary considerations.” Fox Factory, 944
F.3d at 1375. “To the contrary, the patent owner is still afforded an
opportunity to prove nexus by showing that the evidence of secondary
considerations is the ‘direct result of the unique characteristics of the
claimed invention.’” Id. at 1373–74 (quoting In re Huang, 100 F.3d 135,
140 (Fed. Cir. 1996)). “Where the offered secondary consideration actually
results from something other than what is both claimed and novel in the
claim, there is no nexus to the merits of the claimed invention,” meaning that
“there must be a nexus to some aspect of the claim not already in the prior
art.” In re Kao, 639 F.3d 1057, 1068–69 (Fed. Cir. 2011) (emphasis in
original). On the other hand, there is no requirement that “objective
evidence must be tied exclusively to claim elements that are not disclosed in
a particular prior art reference in order for that evidence to carry substantial
weight.” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1331 (Fed. Cir. 2016).
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A patent owner may show, for example, “that it is the claimed combination
as a whole that serves as a nexus for the objective evidence; proof of nexus
is not limited to only when objective evidence is tied to the supposedly
‘new’ feature(s).” Id.
Ultimately, the fact finder must weigh the secondary considerations
evidence presented in the context of whether the claimed invention as a
whole would have been obvious to a skilled artisan. Id. at 1331–32. Once
the patentee has presented a prima facie case of nexus, the burden of coming
forward with evidence in rebuttal shifts to the challenger “to adduce
evidence to show that the commercial success was due to extraneous factors
other than the patented invention.” Demaco, 851 F.2d at 1393.
Patent Owner argues that “Sanofi’s LANTUS® SoloSTAR® product
practices the challenged claim” and Dr. Slocum “confirms that the claimed
components and interfaces, such as the threaded engagements, piston rod,
drive sleeve, and tubular clutch, are reflected in the LANTUS®
SoloSTAR®.” PO Resp. 59 (internal footnote omitted) (citing Ex. 2107
¶¶ 472–512). According to Patent Owner,
As explained by Prof. Slocum, the inventions in the challenged
claim describe a set of components that elegantly work together
to provide the user a mechanical device that is easy to use and
includes a combination of desirable features and properties, such
as (i) low injection force, (ii) short injection stroke length or
higher maximum dose per injection, and (iii) a relatively small
number of components that decrease the complexity of the
device.
Id. (citing Ex. 2107 ¶¶ 472–512) (emphasis added).
Petitioner replies that “Lantus[®] SoloStar[®] is not ‘the invention’”
because Patent Owner “relies on unclaimed features . . . , including the
Lantus[®] drug product, its 80-unit cartridge, its stroke length or its injection
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force.” Pet. Reply 23–24 (citing Ex. 1095 ¶¶ 68–70). Petitioner also argues
that the “‘overwhelming consideration’ in insulin-prescription decisions is
‘the insulin itself,’” that the “the claimed injection pen for delivering the
insulin is not an important factor driving the market,” and “[i]nsulin pens are
‘largely fungible.’” Id. at 24 (citing Ex. 1048 ¶¶ 25, 27–28; Ex. 1055,
28:14–29:22, 30:2–6; Ex. 1060 ¶¶ 37–39; Ex. 2145, 8, 15, 22; Ex. 2146, 13,
36, 77–78). According to Petitioner, Lantus® drove SoloStar® sales, and
Patent Owner pushed SoloStar® over OptiClik®, another pen with long-
acting insulin from Sanofi. Id. at 24–25 (citing Ex. 1055, 86:20–87:6,
88:14–19, 96:13–20, 103:18–104:6, 104:14–105:5, 125:16–127:6; Ex. 1056,
69:9–70:10; Ex. 1060 ¶¶ 20–21, 25–27, 30–35, 40–41, 46–51, 64,
Attachments B-2–B-9; Ex. 2145, 8, 10, 99). Petitioner contends that
“Lantus[®]’ blocking patents” show no nexus and “[t]here is no connection
between any alleged awards or industry praise and the claims-at-issue.” Id.
at 25 (citing Ex. 1060 ¶¶ 30–35, 57–60, 63–67).
Patent Owner replies that Petitioner provides no rebuttal evidence and
does not analyze the challenged claim to determine whether SoloSTAR®
embodies the claim. PO Sur-reply 25 (citing Pet. Reply 23–24; Ex. 1060
¶¶ 25, 27–30, 52–56; Ex. 2107 ¶¶ 472–512). Patent Owner also argues that
Mr. Leinsing opines that the claim covers prior art pens instead of analyzing
whether unclaimed features are responsible for low injection force and other
attributes. Id. (citing Ex. 1095 ¶ 70; Ex. 2107 ¶ 650).
Patent Owner also replies that “Petitioner provides no credible
evidence rebutting these facts, or the fact that the challenged claims enable
SoloSTAR®’s low injection force and other features identified in the
Response” and “provides no analysis of the challenged claims, whether they
enable commercially-successful features, or whether SoloSTAR® embodies
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them.” PO Sur-Reply 25 (citing Pet. Reply 23–24; Ex. 1060 ¶¶ 25, 27–30,
52–56). Patent Owner also replies that Mr. Leinsing “argues against nexus
because he believes the claims cover the prior art pens” and “provides no
analysis of any unclaimed features of SoloSTAR® purportedly responsible
for its low injection force and other attributes.” Id. (citing Ex. 1095 ¶ 70;
Ex. 2107 ¶ 650).
The challenged claims do not require expressly any particular
injection force, injection stroke, or dose per injection. See Ex. 1001, 6:37–
7:12. The challenged claims also recite a housing part comprising a main
housing, dose dial sleeve, dose dial grip, piston rod, and drive sleeve, but it
does not require any particular number of parts for the medication
dispensing apparatus, much less a relatively small number of components.
See id. The word “comprising” also indicates that additional components
could be added to the ones expressly recited. See id. at 6:38. The
challenged claim further requires the recited components to be in particular
relative positions, such as “positioned within said housing,” “disposed near,”
“provided within said housing,” “extending along a portion of said piston
rod,” and “located adjacent a distal end of said does dial grip,” but, other
than threaded engagements between certain components, the challenged
claim does not recite expressly how the components work together during
injection. See id. at 6:37–60. As discussed above, the required threaded
engagements were known in the art.
Patent Owner’s declarant opines that the challenged claim describes
components that provide desirable features and properties, such as low
injection force, short injection stroke or higher dose per injection, and a
relatively small number of components. Ex. 2107 ¶¶ 472–512. Patent
Owner, however, does not explain sufficiently how the recitation of
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limitations in the claims corresponding to those components necessarily
result in the asserted desirable features and properties. See PO Resp. 58–68;
see also PO Sur-reply 23–29. With this understanding of the scope of the
challenged claims, we analyze Patent Owner’s proffered evidence of
objection indicia of nonobviousness.
Patent Owner “bears the burden of showing that a nexus exists.”
WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed.
Cir. 1999). “To determine whether the patentee has met that burden, we
consider the correspondence between the objective evidence and the scope
of the claim.” Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332
(Fed. Cir. 2019) (quoting Demaco, 851 F.2d at 1392). Patent Owner asserts
the indicia of nonobviousness support a showing of long-felt need, industry
praise, and commercial success. We discuss Patent Owner’s showing with
respect to nexus and the asserted long-felt need, industry praise, and
commercial success in turn below.
2. Long-Felt, Unmet Need
Patent Owner contends that, according to Dr. Goland’s testimony,
there was a “need an easy-to-use injection device with a low injection force
to reduce the burden on the patient and increase the likelihood of the patient
adhering to their prescribed therapy.” PO Resp. 59–60 (citing Ex. 2111
¶¶ 22–26). Patent Owner also contends that available injection pens “had
numerous shortcomings and design flaws that resulted in significant
injection force” higher than SoloSTAR®, and that “made the devices
difficult to use and thus increased the risk of patients not adhering to their
insulin and insulin-analog therapy.” Id. at 60–61 (citing Ex. 2107 ¶ 646;
Ex. 2109 ¶¶ 52–55; Ex. 2111 ¶¶ 23–25, 33–35; Ex. 2143; Ex. 2144).
According to Patent Owner, SoloSTAR® “revolutionized the injection pen
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market” because it was easier to use, as confirmed by literature at the time.
Id. at 61 (citing Ex. 2111 ¶ 33; Ex. 2116, 7; Ex. 2142). Patent Owner asserts
that the ’069 patent addressed reducing overall force required for use, as
reflected in a related patent; that industry recognized SoloSTAR® solved the
“problem of needing to deliver high doses with a short dial extension and
with low injection force”; and that patients preferred SoloSTAR®. Id. at 61–
62 (citing Ex. 1001, 3:44–47; Ex. 1005, 1:66–2:3; Ex. 2117; Ex. 2121, 2, 9;
Ex. 2123, 6; Ex. 2128; Ex. 2143; Ex. 2144; Ex. 2184, 2; Ex. 2185, 1).
Patent Owner, thus, asserts that SoloSTAR® “satisfied a long-felt but unmet
need for an easy-to-use pen that was particularly well suited to administer
medication with a low injection force.” Id. at 62.
Petitioner replies that, according to the testimony of Dr. Biggs, other
insulin pens were available, fungible with SoloSTAR®, and easy to use.
Pet. Reply 25 (citing Ex. 1048 ¶¶ 27, 29, 32–44, 52). Petitioner also argues
that “SoloStar[®] was not an unusually good pen.” Id. (citing Ex. 1048 ¶¶ 43,
49). Petitioner additionally argues that “Dr. Goland never heard a patient
wish they had a pen with lower injection force, never saw syringe use
prevent a patient from taking Lantus[®], and never prescribed an insulin
solely based on its pen.” Id. at 25 (citing Ex. 1056, 52:6–9, 71:4–16).
According to Petitioner, injection force was not a concern, and SoloSTAR®
does not have a lower injection force. Id. at 25–26 (citing Ex. 1048 ¶¶ 29–
30, 58; Ex. 1060 ¶ 53; Ex. 2145, 15, 20–21). Petitioner further replies that
Patent Owner presents marketing that does not show industry recognition of
an unmet need. Id. at 26 (citing PO Resp. 62; Ex. 2123, 7; Ex. 2128, 9; Ex.
2184, 1, 3; Ex. 2185).
Patent Owner replies that, according to Dr. Goland, SoloSTAR® was
preferred over OptiClik®, earlier FlexPens® were hard to push, and some
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patients did not take their insulin because prior art devices were problematic.
PO Sur-reply 27–28 (citing Pet. Reply 25; Ex. 1056, 34:3–17, 35:7–36:12;
Ex. 2100; Ex. 2111 ¶¶ 31–43; Ex. 2113; Ex. 2116; Ex. 2121; Ex. 2123;
Ex. 2126; Ex. 2128; Ex. 2140; Ex. 2143; Ex. 2144; Ex. 2184; Ex. 2185).
Patent Owner also replies that Dr. Goland transitioned patients to
SoloSTAR® because of its lower injection force. Id. at 28 (citing Ex. 1056,
66:9–15).
According to Patent Owner, Mylan’s declarant in IPR2018-01670
acknowledges a focus on reducing injection force. Id. (citing Ex. 2316,
80:24–81:1). Patent Owner also argues that Dr. Biggs suggests “any long-
felt need was satisfied by the Lantus® vial and syringe, that patients
complaining of injection force could have caregivers . . . administer their
treatments, and that patients could carry around . . . preloaded syringes,” but
Dr. Goland disagrees, opining that those suggestions would be disliked by
patients. Id. (citing Ex. 1048 ¶¶ 31–32; Ex. 1056, 52:23–53:25, 58:18–
59:24; Ex. 2317, 70:10–19, 84:24–85:14). Patent Owner further argues that
Dr. Biggs’s testimony is undermined by his admission that his suggestions
may not be covered under Medicare or insurance and that the majority of his
patients switched from Lantus® vial to Lantus® SoloSTAR®, which most
patients preferred. Id. at 28–29 (citing Ex. 2317, 38:7–39:3, 115:23–116:6,
118:19–22).
We agree with Petitioner that Patent Owner fails to establish a nexus
between the purported evidence of alleged long-felt need for a pen with a
reduced injection force and the claims at issue in this proceeding. Although,
Patent Owner has provided evidence supporting its position that the asserted
objective evidence of long-felt need is tied to a specific product (i.e. Lantus®
SoloSTAR®), Patent Owner has not demonstrated that this product
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“embodies the claimed features, and is coextensive with them.” Fox
Factory, 944 F.3d at 1373 (citing Polaris Indus., Inc. v. Arctic Cat, Inc., 882
F.3d 1056, 1072 (Fed. Cir. 2018)). Specifically, Patent Owner has not
explained sufficiently how the limitations set forth in the claims at issue
satisfy the alleged long-felt need by identifying where the claim requires low
injection force as compared to other pens. As discussed above, the
challenged claims do not require expressly any particular injection force,
injection stroke, or dose per injection, and does not expressly recite how the
claimed components work together during injection. See Ex. 1003, 6:37–
7:12. For this reason, Patent Owner is not entitled to the presumption of
nexus, and Patent Owner has not otherwise demonstrated nexus for the
asserted long-felt need.
Moreover, even if we assume nexus, Patent Owner fails to sufficiently
demonstrate a long-felt need for a pen with a low injection force. The
Federal Circuit has explained that “[l]ong-felt need is closely related to the
failure of others,” and that “[e]vidence] is particularly probative of
obviousness when it demonstrates both that a demand existed for the
patented invention, and that others tried but failed to satisfy that demand.”
Eurand, Inc. v. Mylan Pharms., Inc. (In re Cyclobenzaprine Hydrochloride
Extended-Release Capsule Patent Litig.), 676 F.3d 1063, 1082 (Fed. Cir.
2012). Establishing a long-felt need requires objective evidence that the
invention has provided a long-awaited, widely accepted, and promptly
adopted solution to a problem existent in the art, or that others had tried but
failed to solve that problem. See In re Mixon, 470 F.2d 1374, 1377 (CCPA
1973). Furthermore, one must demonstrate that “widespread efforts of
skilled workers having knowledge of the prior art had failed to find a
solution to the problem.” In re Allen, 324 F.2d 993, 997 (CCPA 1963).
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We find that Patent Owner’s evidence demonstrates acceptance of the
Lantus® SoloStar® pen. See, e.g., Ex. 2184, 1; Ex. 2185, 1; Ex. 2121, 6.
But, we also find that the evidence does not demonstrate a long awaited need
for such a pen. Rather, Patent Owner’s evidence demonstrates that “[p]rior
to the launch of LANTUS® SoloSTAR®, there were multiple injection pens
on the market for administering insulin or an insulin analog – e.g., Levemir®
FlexPen® and LANTUS® OptiClik® in the long-acting category, and the
Humalog KwikPen® in the rapid-and intermediate-acting categories, among
many others.” PO Resp. 60. Patent Owner’s evidence does not show that
others tried and failed to make such a pen. Rather, as noted above, the ’069
patent attributes the reduction in force to its clutch means — a feature that
was already present in other pens such as Moller’s pen. See, e.g., Ex. 1015
¶¶ 26–27. Although Patent Owner’s evidence may demonstrate that the
Lantus® SoloStar® pen is an improvement over prior art pens, such evidence
is insufficient to establish a long-felt need for this particular pen.
3. Industry Praise
Patent Owner contends that it received a “high level of praise and
industry recognition” for designs in the SoloSTAR® device. PO Resp. 62–
63. Specifically, Patent Owner directs our attention to evidence indicating
that “SoloSTAR[®] won the Gold, International Export, and Grand Prix
awards at the Design Business Association (DBA) Design Effectiveness
Awards” in 2009. Id. at 63 (citing Ex. 2121). According to Patent Owner,
“[t]he DBA is a design organization based in the UK that is interested in
how a design commercially impacts a company’s business.” Id. Patent
Owner asserts that “[t]he case study of SoloSTAR[®] for the DBA Awards
describes the SoloSTAR[®]’s inventiveness as ‘suitably ambitious’ and
explains that ‘SoloSTAR® is the first disposable insulin pen to combine very
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low injection force (which provides a smooth injection experience for
patients) with 80 units maximum dose capability, an important
breakthrough.’” Id. at (citing Ex. 2121, 3).
Patent Owner submits further that “SoloSTAR® won the Good Design
Award by the Chicago Athenaeum Museum of Architecture and Design.”
PO Resp. 63 (citing Ex. 2109 ¶ 73; Ex. 2201; Ex. 2223). According to
Patent Owner, “[i]n connection with this award, the LANTUS® and Apidra®
SoloSTAR® devices were put into the permanent Design Collection of the
Chicago Athenaeum Museum of Architecture and Design.” Id. (citing
Ex. 2223, 2); see also Ex. 2109 ¶ 56 (testifying that Apidra® SoloSTAR® is
another product practicing the patent at issue). Patent Owner also submits
that “at the Prix Galien USA 2009 Award, which ‘recognize[s] innovative
biopharmaceutical drugs and medical technologies’ and ‘is considered the
industry’s highest accolade for pharmaceutical research and development —
equivalent to the Nobel Prize,’ Sanofi and DCA were both finalists.” PO
Resp. 64 (citing Ex. 2109 ¶ 74); see also id. at 62 (identifying DCA as “the
design firm with whom Sanofi partnered in creating SoloSTAR®”).
Petitioner replies that Patent Owner’s evidence is either self-praise or
is praise directed to features, such as low injection force, that are not
required by the challenged claim. Pet. Reply 26 (citing Ex. 1055, 79:6–
81:19; Ex. 1060 ¶¶ 57–58; Ex. 1075; Ex. 2201; Ex. 2223). Patent Owner
replies that it did not make up or give itself industry praise. PO Sur-reply
29. Patent Owner argues that the awards cannot be denied. Id. (citing
Ex. 1060 ¶¶ 57–60). Patent Owner also argues that articles concerning
SoloSTAR® were peer reviewed, are not diminished by Patent Owner’s
involvement, and refer to low injection force. Id. (citing Ex. 2116;
Ex. 2224; Ex. 2318, 72:11–73:18, 76:2–77:4; Ex. 2223).
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Again, we agree with Petitioner. As with the proffered evidence of
long-felt need discussed above, Patent Owner fails to demonstrate nexus
between the purported evidence of industry praise and the claims at issue in
this proceeding. The evidence provided indicates that Lantus® SoloStar®
received industry praise based on its visual design and its combination of
low injection force and large maximum dose capability. See, e.g., Ex. 2121,
2–3, 5. But, these features are not coextensive with the challenged claim
because the claim does not require low injection force in combination with
high maximum dose capability.
Moreover, even if we assume Patent Owner has demonstrated nexus
between the alleged industry praise and the claim at issue, much of the
praise was generated by DCA, Sanofi’s affiliate. See, e.g., Ex. 1055 ¶¶ 57–
60. Such self-generated praise is not persuasive industry praise. Further,
evidence independent of DCA, such as consideration of Lantus® SoloStar®
for the Prix Galien USA 2009 award, only generally specifies the criteria
used to judge the nominees. Ex. 2042, 2. It does not evidence industry
praise of any specific feature of the claimed invention. Id.
4. Commercial Success
Patent Owner contends that SoloSTAR® contributed to “the growth of
the LANTUS® franchise overall” and performed well “compared to other
long-acting insulin and insulin analog pens.” PO Resp. 64. Relying on the
testimony of Dr. Grabowski, Patent Owner argues that (1) “LANTUS®
SoloSTAR® has enjoyed fast and long-sustained growth in terms of dollar
sales, new prescriptions, and total prescriptions”; (2) “the overall levels and
shares of dollar sales, new prescriptions, and total prescriptions, as well as
the profitability and formulary placement achieved by LANTUS®
SoloSTAR®” demonstrate commercial success; (3) “sales and prescriptions
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for LANTUS® SoloSTAR® remained strong despite the entry of several
competing long-acting insulin and insulin analog drugs (all in pen form)
starting in 2015”; and (4) “the LANTUS® SoloSTAR® achieved the highest
level of sales among long-acting insulin and insulin analog pens even though
it launched after several other long-acting insulin and insulin analog pens,
including the Levemir® FlexPen® (the commercial embodiment of
Steenfeldt-Jensen), which was the first long-acting insulin or insulin analog
product available in a disposable pen.” Id. at 64–65 (citing Ex. 2109 ¶ 12).
Patent Owner also contends that LANTUS® SoloSTAR® grew faster
than LANTUS® OptiClik®, specifically in number of new prescriptions. Id.
at 65 (citing Ex. 2109 ¶¶ 12, 37). Patent Owner further contends that “the
features of the device disclosed and claimed in the 069 Patent and used in
LANTUS® SoloSTAR® contributed to its commercial success.” Id. at 65–66
(citing Ex. 2107 ¶¶ 472–512; Ex. 2109 ¶ 53). According to Patent Owner,
factors beyond claimed features, such as marketing, did not drive
SoloSTAR®’s commercial success because “total marketing expenditures for
LANTUS® SoloSTAR® were in line with, or were lower than, many other
long-acting insulin products.” Id. at 66 (citing Ex. 2109 ¶¶ 16, 64–69).
Regarding “alleged ‘blocking patents’ covering the glargine molecule
that is used in the production of the active ingredient in LANTUS®,” Patent
Owner argues that “the law does not mandate across-the-board-discounting
of commercial success simply because other patents cover components of
the product,” and that the Board should “weigh the evidence on a case-by-
case basis, in light of the specific commercial success argument being
made.” Id. at 67. Patent Owner also argues that “the success of LANTUS®
SoloSTAR® cannot be attributed solely to the insulin glargine molecule
because LANTUS® OptiClik® used the exact same LANTUS® formulation”
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and did not achieve SoloSTAR®’s success, thus the design of SoloSTAR®
must have attributed at least in part to the success. Id. Patent Owner further
argues that “Sanofi’s earlier patents on the insulin glargine molecule did not
prevent others from entering the market for non-glargine, long-acting insulin
products and competing with LANTUS® SoloSTAR®.” Id. Patent Owner
identifies Levemir® FlexPen® with its long-acting insulin as an example of a
disposable pen device with long-acting insulin. Id.
Petitioner replies that Dr. Grabowski did not evaluate profitability and
Patent Owner “provides no benchmarks for evaluating success, applies a
faulty pens-only market definition, and overstates the importance of
formulary status to demonstrate commercial success.” Pet. Reply 26–27
(citing Ex. 1060 ¶¶ 23–24). Petitioner argues that OptiClik® did as well in
its first three years and certain versions of SoloSTAR® fell below Lantus®
OptiClik® sales. Id. (citing Ex. 1060 ¶¶ 20, 70–71). Petitioner also argues
that Patent Owner excludes other insulin injectable products from its market
share analysis and thus, presents commercial success “out of context.” Id.
(citing Ex. 1060 ¶¶ 25–27).
Responding to Patent Owner’s contention that “Lantus[®] SoloStar[®]
lost market share after 2015,” Petitioner asserts that “Basaglar and Tresiba
long-acting insulin products completely changed trajectory for both
Lantus[®] and Toujeo SoloStar[®] products without practicing the claims.”
Pet. Reply 27 (citing Ex. 1055, 96:13–20; Ex. 1060 ¶¶ 30–35, 64).
According to Petitioner, “[g]eneric entry of biologics is not expected to
replace existing biologics as much or as fast as for small molecules” and
“[d]iabetes patients are particularly reluctant to switch to a different insulin
product.” Id. (citing Ex. 1055, 143:10–144:10; Ex. 1056, 71:17–22). As a
result, Petitioner asserts that “[t]he downturn for Lantus[®] and Toujeo
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SoloStar[®] after 2015 provides strong evidence that SoloStar[®] itself is not a
commercial success.” Id.
Petitioner also replies that “Lantus[®] SoloStar[®] benefited from a
Lantus[®] franchise that predated the Levemir[®] franchise by five years and
inherited the foundation of earlier Lantus[®] pen (OptiClik[®])” and
“OptiClik[®] had twice as many prescriptions in 2007 as Levemir[®]
FlexPen[®].” Pet. Reply 27–28 (citing Ex. 2186, 2; Ex. 2198). Petitioner
contends that “Lantus[®] SoloStar[®] overtook Levemir[®] FlexPen[®] not
because of any unique SoloStar[®] attributes but because, like OptiClik[®],
[Patent Owner] selected it as the exclusive U.S. Lantus[®] pen.” Id. at 28
(citing Ex. 1060 ¶¶ 20–22, 30–35).
Patent Owner replies that Petitioner’s data shows SoloSTAR® has
been commercially successful. PO Sur-reply 23 (citing Ex. 2318,
Attachment B-10, 31:14–17, 31:25–32:8). Patent Owner argues that the
diabetes community has widely adopted SoloSTAR®. Id. at 23–24 (citing
Pet. Reply 26–28). Patent Owner contends that Dr. McDuff acknowledged
the large SoloSTAR® sales and admitted that profitability analysis is not
required. Id. at 24 (citing Ex. 2318, 15:10–13, 28:7–19, 29:20–30). Patent
Owner also contends that SoloSTAR® has the largest market share in
Petitioner’s asserted broader market. Id. (citing Ex. 1060, Attachment B-10;
Ex. 2318, 31:14–17, 31:25–32:8). Patent Owner further contends that
SoloSTAR® prescriptions more than quadrupled OptiClik®’s in the first four
years of launch and that SoloSTAR® grew the Lantus® market and remains
number one. Id. (citing Ex. 1060, Attachment B-10; Ex. 2318, 18:23–19:20,
21:22–22:8). Patent Owner asserts that “SoloSTAR® enjoys favorable
placement in health,” due, in part as admitted by Dr. McDuff, to its
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“mechanical features and attributes.” Id. at 24–25 (citing Pet. Reply 27;
Ex. 2318, 33:7–36:3).
Central to Patent Owner’s allegations regarding commercial success is
its assertion that the Lantus® SoloStar® pen is coextensive with, and thus,
embodies the claimed invention. See PO Resp. 64–68. We, however, for
reasons similar to those discussed above, are not convinced that this is the
case. Patent Owner contends that “[t]he tremendous success of LANTUS®
SoloSTAR®, as compared to pens with long-acting insulins that failed to
address the long-felt but unfilled need for a low injection force device”
demonstrates “a strong nexus with the claimed invention.” PO Resp. 68.
Patent Owner, however, has not sufficiently demonstrated that this
“tremendous success” can fairly be attributed to the claimed invention,
which does not require low injection force or insulin, let alone Lantus®’s
long-acting insulin formulation. For the reasons above, we determine that
there is no nexus to the asserted commercial success.
Even if we assume nexus, Patent Owner has not sufficiently
demonstrated commercial success. Attachment B-10 to the Declaration of
Deforest McDuff, Ph.D. presents total prescription data by year for 40
insulin delivery products for the 20-year period 1999–2019. Ex. 1060,
Attachment B-10. It also provides corresponding market share data for that
same time period. Id. The data presented in this table is the most pertinent
evidence regarding commercial success provided in this proceeding. We
find the evidence, at best, to be inconclusive.
Attachment B-10 shows that from the introduction of Lantus® Vial
in 2002, until 2019, Lantus® delivery products (i.e., Lantus® Vial, Lantus®
OptiClik®, and Lantus® SoloStar®) were by far the most proscribed insulin
delivery devices. Ex. 1060, Attachment B-10. As shown, from 2002 to
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2011 prescriptions of Lantus® Vial grew from roughly 1.3 to 11 million
prescriptions, while the most successful competing products (Humulin and
Novolog) each grew to prescription levels of roughly 5 million prescriptions.
Id. Thus, Attachment B-10 clearly demonstrates the commercial success of
Lantus® Vial during that time period. Attachment B-10 also demonstrates
that once Lantus® OptiClik® was introduced, prescriptions of Lantus® Vial
decreased as prescriptions of Lantus® OptiClik® increased, with the overall
number of Lantus® OptiClik® prescriptions slowly, but steadily climbing.
Id. We note that during the time period that Lantus OptiClik® was the only
alternative to Lantus® Vial, the number of Lantus® Vial prescriptions
essentially stayed the same.
In 2008, Lantus® SoloStar® was introduced. Ex. 1060, Attachment B-
10. From 2008–2011, prescriptions of Lantus® SoloStar® steadily rose while
prescriptions of Lantus® OptiClik® declined. Id. During this time period,
prescriptions of Lantus® Vial continued to remain steady. Id. Then in 2012,
things changed. Id. First, prescriptions of Lantus® OptiClik® dropped off
significantly. Id. By 2014, prescriptions of Lantus® OptiClik® dropped to a
mere 382 prescriptions. Id. During the time period from 2011–2016 (when
prescriptions of Lantus® SoloStar® hit their peak), prescriptions of Lantus®
Vial began to decrease at a rate of about 500,000 prescriptions per year. It is
unknown why prescriptions of Lantus® Vial began to decline starting in
2012, but it appears that they declined as the prescriptions of Lantus®
Solostar® increased. Patent Owner submits that this is because of the
superior features of the Lantus® SoloStar® pen. See PO Sur-reply 24.
Whereas, Petitioner suggests that it was because of the introduction of
competing products. Pet. Reply 27 (citing Ex 1048 ¶¶ 30–35, 64).
Regardless, the evidence clearly shows that the number of Lantus®
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SoloStar® prescriptions peaked in 2016 and that most of the increase in
prescriptions for Lantus® SoloStar® merely offset the decline in prescriptions
for Lantus® Vial. Thus, the evidence does not support a showing of
commercial success for Lantus® SoloStar®. Rather, it appears to show a
fairly stable number of prescriptions for Lantus® products from 2009–2016,
with a decline in those prescriptions from 2017–2019.
5. Determination as to Indicia of Nonobviousness
Having considered all the indicia of nonobviousness submitted by
Patent Owner, we do not find sufficient evidence of nexus to long-felt need,
industry praise, or commercial success.
H. Weighing the Graham Factors
“Once all relevant facts are found, the ultimate legal determination [of
obviousness] involves weighing of the fact findings to conclude whether the
claimed combination would have been obvious to an ordinary artisan.”
Arctic Cat, 876 F.3d at 1361. Above, based on full record before us, we
provide our factual findings regarding (1) the level of ordinary skill in the
art, (2) the scope and content of the prior art, (3) any differences between the
claimed subject matter and the prior art, and (4) objective evidence of
nonobviousness.
In particular, we find that (1) Petitioner’s proposed level of ordinary
skill in the art is consistent with the prior art of record, (2) Burroughs
teaches or suggests each of the limitations of claims 1–3, (3) one of ordinary
skill in the art would have had a reason to modify Burroughs with a
reasonable expectation of success, and (4) there is insufficient demonstration
of nexus to objective evidence of nonobviousness in the record. Also, we
find that Steenfeldt-Jensen teaches or suggests each of the limitations of
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claim 1 and one of ordinary skill in the art would have had a reason to
modify Steenfeldt-Jensen with a reasonable expectation of success.
Weighing these findings with our determinations of level of ordinary
skill and objective evidence of nonobviousness in the record, a
preponderance of the evidence persuades us that (1) claims 1–3 of the ’069
patent are unpatentable over Burroughs, and (2) claim 1 is unpatentable over
Steenfeldt-Jensen. Further, even if nexus to objective evidence of
nonobviousness were established and we reweighed the evidence presented
by the parties, including Patent Owner’s evidence directed to alleged long-
felt need, industry praise, and commercial success, we would come to the
same determination for the reasons provided above—that claims 1–3 of the
’069 patent would have been obvious to one of ordinary skill in the art at the
time of the invention over the asserted prior art in this proceeding.
I. Alleged Obviousness Over Moller and Steenfeldt-Jensen
Petitioner also challenges claim 1 as unpatentable over Moller and
Steenfeldt-Jensen. Pet. 71–96. Because we determine that claim 1 is
unpatentable over Burroughs alone and over Steenfeldt-Jensen alone, we do
not reach this additional challenge to claim 1. See SAS Inst. Inc. v. Iancu,
138 S. Ct. 1348, 1359 (2018) (holding a petitioner “is entitled to a final
written decision addressing all of the claims it has challenged”).

III. PETITIONER’S MOTION TO EXCLUDE
Petitioner moves to exclude Exhibits 2100–2107, 2109, 2113–2126,
2128–2153, 2158–2164, 2166–2201, 2203–2212, 2214–2218, 2223, and
2224. Mot. 1. Petitioner notes that objections were filed. Id. (citing
Papers 18, 26). Petitioner also requests that “[t]o the extent that any exhibit
or portion of an exhibit is not excluded, use of the exhibit should be
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restricted to the use for which it was originally submitted.” Id. at 5.
Petitioner, as the “moving party,” “has the burden of proof to establish that it
is entitled to the requested relief.” 37 C.F.R. § 42.20(c).
A. Exhibits 2100–2102, 2104–2106, 2113–2115, 2118–2120, 2122,
2124, 2125, 2129–2135, 2138–2141, 2145, 2146, 2151, 2153, 2158–
2162, 2166–2174, 2176–2183, 2186–2200, 2203–2210, 2212, 2214,
and 2218
Petitioner contends the above-listed exhibits should be excluded
pursuant to Federal Rules of Evidence (“FRE”) 402 and 403 “because they
were not discussed in Sanofi’s Response, cannot be relevant to it, and
consequently serve only to confuse and create prejudice through belated
surprise.” Mot. 1.
Patent Owner contends that Exhibits 2100–2102 and 2104–2106 are
exhibits to the deposition of Mr. Leinsing, declarant for Mylan in IPR2018-
01670, and are relevant because they “provide necessary context for
Mr. Leinsing’s cross-examination.” Opp. 1. Patent Owner also contends
that Mr. Leinsing’s cross-examination is relevant to the present proceeding.
Additionally, Patent Owner asserts that “each of these exhibits was among
the materials that Dr. Slocum considered and reasonably relied upon in
forming his opinions regarding the validity of the challenged patent and thus
should be admitted under FRE703.” Id. Patent Owner contends that “at
least EX2100-2102, 2113, 2120, 2131, 2134-2135, 2138, 2153, 2158-2161,
2166-2171, 2173-2174, 2176-2183, 2206-2207, 2214, and 2218 were
expressly cited by Dr. Slocum in his declaration testimony.” Id. (citing
Ex. 2107 ¶¶ 26, 27, 29, 33, 36, 41, 44–46, 48–53, 56, 95–97, 114, 127, 149,
150, 428, 432, 462, 474). Patent Owner also contends that “EX2124, 2145,
2146, 2186–2199, 2203–2205, and 2208–2210 were also considered and
expressly cited by Dr. Grabowski in forming his opinions” and “EX2125,
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2140-2141, and 2200 were also considered and expressly cited by
Dr. Goland in forming her opinions.” Id. at 2 (citing Ex. 2109 ¶¶ 32–34, 39–
45, 51, 53–55, 66–68; Ex. 2111 ¶¶ 23, 25, 43).
Petitioner replies that the facts and data relied upon by an expert must
still be relevant to be admissible, and Patent Owner has not shown
relevance. Mot. Reply 1. Petitioner also replies that Dr. Slocum’s
declaration responds to five inter partes reviews, and thus, significant
portions are not relevant to this proceeding. Id. (citing Ex. 2107 ¶ 1). Id.
Petitioner contends that the portions cited by Patent Owner are not in the
part of Dr. Slocum’s declaration that addresses the ’069 patent. Id.
Petitioner also argues that the Board has found in a related proceeding that
the ’069 patent lacks sufficient nexus to the alleged benefits supported by
testimonies of Drs. Grabowski and Goland, and thus, the exhibits relied
upon by them are irrelevant. Id. at 1–2.
We cite these exhibits to indicate where Patent Owner believes
support can be found for its asserted objective indicia of nonobviousness.
We do not, however, rely on these exhibits in our analysis. Additionally, the
sole basis argued in Petitioner’s Motion for Exclusion—that the exhibits
were not cited in Patent Owner’s Response—is not, in and of itself,
dispositive as to whether an exhibit should be excluded. Accordingly,
Petitioner has not satisfied its burden to show that these exhibits should be
excluded.
B. Exhibit 2103
Exhibit 2103 consists of hand-drawn annotations made by Mylan’s
declarant, Mr. Leinsing, during his deposition in IPR2018-01670 and in
response to questions pertaining to Petitioner’s proposed modifications to
Burroughs’s device. Mot. 1; Opp. 3. Petitioner contends that Patent
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Owner’s use of Exhibit 2103 “lacks relevance, risks confusing the issues, is
misleading, and is prejudicial.” Mot. 2. Petitioner complains that the
exhibit “is offered to establish an actual modification purported to be
embodied by the annotations.” Id. at 1–2. Patent Owner contends that the
exhibit is relevant to Mr. Leinsing’s opinions regarding modifying
Burroughs, which was adopted by Mr. Clemens and is one of the central
issues in this proceeding. Opp. 3 (citing Paper 3, 5; Ex. 2163, 189:3–15).
Petitioner replies that Mr. Clemens submitted his declaration before
Mr. Leinsing’s deposition and thus, could not have adopted Mr. Leinsing’s
testimony. Mot. Reply 2. Petitioner also argues that Patent Owner had the
opportunity to depose Mr. Clemens about this exhibit but did not. Id. (citing
Ex. 2450).
We agree with Patent Owner that Exhibit 2103 is relevant to the
proceeding for the reason explained by Patent Owner. Additionally,
Petitioner’s argument does not provide any explanation as to why the exhibit
risks confusing the issues, is misleading, or is prejudicial. Accordingly,
Petitioner’s Motion is denied with respect to Exhibit 2103.
C. Exhibits 2100–2106, 2163, and 2164
Petitioner moves to exclude Exhibits 2100–2106, 2163, and 2164
(deposition exhibits and transcripts of Mylan’s declarant in IPR2018-01670)
under FRE 402 and 403 because they “lack relevance, risk confusing the
issues, are misleading, and are prejudicial” and under FRE 801–804 “as
hearsay offered for the truth of their contents without satisfying any hearsay
exception.” Mot. 2. Patent Owner argues that Mr. Clemens adopted the
opinions of Mylan’s declarant and are therefore relevant to this proceeding.
Opp. 4 (citing Paper 3, 5; Paper 17, 15–16). Patent Owner also argues that
the parties have not misrepresented the exhibits so there can be no risk of
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confusing the issues and Petitioner offered to be bound by Mylan’s declarant
testimony so there can be no prejudice to Petitioner. Id. at 4–5 (citing
Paper 10, 2).
Regarding hearsay, Patent Owner argues that experts can “rely upon
hearsay if reasonable to do so in the expert’s field,” and Dr. Slocum relied
on Exhibits 2100, 2101, 2103, 2163, and 2164 to understand the state of the
art and to understand Petitioner’s declarant testimony. Id. at 5 (citing
Ex. 2017 ¶¶ 29, 36, 44–61, 171, 172, 179, 227, 230, 377). Petitioner
provides the same reply arguments we summarize above for Exhibit 2103.
Mot. Reply 2.
For Exhibits 2100–2102, 2104–2106, 2163, and 2164, we cite these
exhibits only to indicate where Patent Owner believes support can be found
for its arguments. For the reasons above, we deny Petitioner’s Motion with
respect to Exhibit 2103. We also do not rely on these exhibits in our
analysis. Thus, Petitioner’s Motion is denied with respect to Exhibits 2100–
2106, 2163, and 2164.
D. Exhibit 2107
Petitioner seeks to exclude Dr. Slocum’s entire declaration (Ex. 2107)
pursuant to FRE 702, 703, and 705. Mot. 2–3. Petitioner argues that certain
portions of the declaration refer to Appendices A through F which were not
submitted with the declaration in this proceeding and thus, “Dr. Slocum’s
declaration does not set forth the principles used in forming his opinion.” Id.
at 2. Petitioner also argues that Dr. Slocum without justification relied upon
Mr. Veasey, one of the named inventors of the ’069 patent, for certain data
about a third-party pen and a model used for various calculations in the
declaration. Id. at 3 (citing Ex. 1053, 12:22–13:5, 28:18–29:2, 30:5–33:13;
Ex. 1054, 313:10–325:12).
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Patent Owner responds that Petitioner’s criticism of Dr. Slocum’s
reliance upon the information and model obtained from Mr. Veasey are
unfounded. Opp. 6–9. In particular, Patent Owner asserts that Dr. Slocum
performed his own investigation and research into design considerations and
the state of the art, as documented in his declaration. Id. at 6–7 (citing
Ex. 2107 ¶¶ 25–61), 9 (citing Ex. 1053, 30:5–33:13). Patent Owner raises
additional arguments regarding the specific discussions between Dr. Slocum
and Mr. Veasey. Id. at 7–8 (discussing measurements of the FlexPen® and
embodiments in Steenfeldt-Jensen). Patent Owner notes that Petitioner does
not assert that any of the design considerations noted by Dr. Slocum are
incorrect. Id. at 8–9.
Patent Owner further contends that Petitioner ignores that Patent
Owner “served as supplemental evidence the native spreadsheets that specify
[the] principles and calculations” set forth in Appendices A through F. Id. at
10 (citing Ex. 2453). Patent Owner further asserts that “the measurements
provided by Mr. Veasey are corroborated, unrebutted, and reliable.” Id.
Patent Owner lastly compares Dr. Slocum’s declaration with Mr. Clemens’s
declaration. Id. at 10–11.
Petitioner replies that the record does not support Patent Owner’s
contentions because it shows Dr. Slocum accepted data and a test rig from
Mr. Veasey and an opinion from Dr. Goland to make up for an absence of
relevant experience in the field. Mot. Reply 3 (citing Ex. 1053, 7:23–8:4,
28:9–29:20, 30:23–33:13, 37:21–38:3, 40:20–42:13, 46:23–47:2, 47:25–
51:13, 54:2–22, 75:8–21, 203:2–5, 209:13–213:5; Ex. 1054, 316:22–323:18,
329:13–331:11, 332:23–333:25; Ex. 1056, 52:6–9, 71:4–16). Petitioner
argues that Dr. Slocum’s testimony cannot be a product of reliable principles
and methods or has reliably applied those principles and methods. Id. at 3–
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4. Petitioner also reiterates that Appendices A through F were not submitted
with Dr. Slocum’s declaration. Id. at 4. Petitioner lastly argues that Patent
Owner’s comparison to Mr. Clemens’s declaration should be disregarded.
Id.
Dr. Slocum is undisputedly an expert in mechanical engineering with
knowledge and experience beyond the level of ordinary skill in the art as the
parties have proposed and we have adopted. See Sundance, Inc. v. DeMonte
Fabricating Ltd., 550 F.3d 1356, 1363 (Fed. Cir. 2008) (noting that “[a]
witness possessing merely ordinary skill will often be qualified to present
expert testimony both in patent trials and more generally”). Additionally,
there is no requirement that an expert have personal knowledge of the
technology during the specific relevant time period in order to qualify as an
expert. In this regard, we find that Patent Owner and Dr. Slocum have
established sufficient support, as detailed by Patent Owner, as to how he
acquired knowledge of the specific technology at issue—the mechanical
operation and design of injection pens. Opp. 6–9.
Further, Dr. Slocum’s reliance upon other individuals, including
Mr. Veasey, to provide information upon which he based his opinions does
not render him unqualified to offer an expert opinion. To the extent the
credibility of any of the individuals upon which Dr. Slocum relied may be in
doubt, e.g., Mr. Veasey’s potential bias as a named inventor, those issues are
the proper subject of cross-examination, go to the weight accorded the
evidence, and do not justify excluding Dr. Slocum’s testimony on the facts
presented here. And, to the extent Petitioner questions the data or model
provided by Mr. Veasey, the proper recourse is to probe the bases for such
during cross-examination.
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Therefore, Petitioner has not shown that Dr. Slocum should be
disqualified as an expert in this proceeding. Accordingly, Petitioner’s
Motion with respect to Dr. Slocum’s declaration (Ex. 2107) is denied.
E. Exhibit 2109
Petitioner contends that paragraphs 19, 20, 31, 35, 45, 49, 50, 52, 53,
56, 71, and 72 of Exhibit 2109, the Declaration of Henry G. Grabowski,
Ph.D., should be excluded under FRE 801–804 “because they constitute
hearsay to the extent they repeat and rely on statements made in an
interview.” Mot. 3. Petitioner also contends that Exhibit 2109 should be
excluded under FRE 702, 703, and 705 “because it does not provide
sufficient facts or data, is not the product of reliable principles and methods,
and has not applied the proper principles to the facts of this proceeding.” Id.
Patent Owner argues that “FRE703 permits experts to rely upon
hearsay if reasonable to do so in the expert’s field” and Dr. Grabowski, a
pharmaceutical economist, reasonably relied on “a device expert
(Dr. Slocum) and an endocrinologist (Dr. Goland), both of whom are
reliable sources and were subject to cross-examination.” Opp. 11. Patent
Owner also argues that “Dr. Grabowski does not introduce the hearsay
statements of the two experts; instead, he provides his own opinions of the
facts based on his interviews.” Id. Patent Owner further argues that
“Petitioner cites no authority that a party must file every single document
that an expert considers in forming his opinions” and that Patent Owner has
disclosed “Dr. Grabowski’s reliance on IMS Health data,” and “the
underlying IMS Health data is voluminous.” Id. at 11–12. Petitioner replies
that Patent Owner’s position is contrary to 37 C.F.R. § 42.65(a). Mot.
Reply 4.
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Whether every supporting document for Exhibit 2109 has been filed
in addition to being identified in Dr. Grabowski’s declaration, goes to the
weight we should give to that testimony. As for the paragraphs at issue from
Exhibit 2019, Petitioner deposed Dr. Grabowski (Ex. 1055), Dr. Slocum
(Exs. 1053, 1054), and Dr. Goland (Ex. 1056), and we agree with Patent
Owner that Dr. Grabowski “provides his own opinions . . . based on his
interviews,” which we can appropriately weigh. Opp. 11.
Thus, Petitioner’s motion with respect to Exhibit 2109 is denied.
F. Exhibits 2117, 2147–2152, 2162, 2167, 2168, 2206, 2207, 2211, and
2215–221812
Petitioner contends the above-listed exhibits are animations “offered
to show animated operations of prior art and non-prior art and non-prior art
injection pens” and should be excluded pursuant to FRE 801–804 “because
they are offered for the truth of their contents without satisfying any of the
hearsay exceptions.” Mot. 4. Patent Owner provides the same response here
as it did with respect to Petitioner’s challenge to Exhibit 2109. Opp. 12–13.
Namely, Dr. Slocum relied upon each in formulating his opinions. Id.
Petitioner does not provide a reply argument. Mot. Reply 4.
For the reasons explained in our discussion of Exhibit 2109, we do not
exclude these exhibits. We, however, agree with Petitioner that the use of
these exhibits should be limited. Mot. 5.

12 Petitioner’s challenge to the admissibility of these exhibits pursuant to
FRE 402 and 403 is discussed above. This section is directed to Petitioner’s
challenge based on FRE 801–804, which Petitioner discusses separately.
Compare Mot. 1 (addressing FRE 402 and 403), with id. at 4 (addressing
FRE 801–804).
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G. Exhibits 2116, 2117, 2121, 2123, 2126, 2128, 2136, 2137, 2142–
2144, 2175, 2184, 2185, 2201, and 2223
Petitioner moves to exclude the above-listed exhibits under FRE 402
and 403 “because the properties for which they are cited (e.g., injection force
and ease of use) are not required by the challenged claims so these exhibits
serve only to confuse the issues and create prejudice through needless
multiplication of issues” and under FRE 801–804 “as hearsay offered for the
truth of their contents without satisfying any hearsay exception.” Mot. 4.
Petitioner also argues that Exhibits 2121, 2142, 2184, 2185, and 2201
“should be excluded under FRE 901 for lack of support to show that they are
what Sanofi purports them to be” and that Exhibit 2223 “is just self-serving
advertisement by an interested entity.” Id. at 4–5.
Patent Owner responds that Dr. Slocum relied upon each of these
exhibits in formulating his opinions. Opp. 13–14. Petitioner replies that the
asserted low injection force and ease of use are not claimed features and
thus, do not show sufficient nexus to the challenged claims. Mot. Reply 5.
Petitioner also argues that “the exhibits should be limited to the purpose for
which they were submitted (showing the benefits of unclaimed features).”
Id.
For the reasons explained in our discussion of Exhibit 2109, we do not
exclude these exhibits. We, however, agree with Petitioner that the use of
these exhibits should be limited. Mot. 5; Mot. Reply 5.
H. Exhibit 2224
Petitioner contends that Exhibit 2224 are offered to show objective
indicia of nonobviousness, but “[i]t is hearsay without exception, lack
authentication, and are unreasonably prejudicial because they are cited for a
new purpose.” Mot. 5. Patent Owner responds that the exhibit was
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presented without objection during deposition of Dr. McDuff and confirms
that Exhibit 2116, which is cited in Dr. McDuff’s and Dr. Grabowski’s
declarations, was peer-reviewed and a reliable source of information.
Opp. 15 (citing Ex. 1060 n.127; Ex. 2109 n.53; Ex. 2318, 73:3–18, 88:7–
89:20. Petitioner replies that Patent Owner does not contest the
Exhibit 2224 is hearsay and an expert’s reliance on Exhibit 2224 does not
make it admissible. Mot. Reply 5.
We agree that Patent Owner does not dispute that Exhibit 2224
constitutes hearsay, and Petitioner does not dispute that Dr. McDuff and
Dr. Grabowski were permitted to rely upon an exhibit that pertains to
Exhibit 2116 in formulating their opinions. Accordingly, Petitioner’s
Motion is denied as to Exhibit 2224, but its use is limited to showing the
basis for Dr. McDuff’s and Dr. Grabowski’s testimonies.

IV. PETITIONER’S SUBMISSION OF CORRECTED EXHIBIT
With the Board’s permission and Patent Owner’s agreement,
Petitioner submitted a corrected copy of Exhibit 1088. Paper 22, 1.
Petitioner requested that the originally filed Exhibit 1088 be expunged. Id.
The request is granted.

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V. CONCLUSION13
In summary:

VI. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–3 of U.S. Patent No. 8,679,069 B2 have
been shown, by a preponderance of the evidence, to be unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude is denied;
FURTHER ORDERED that Exhibit 1088 is expunged; and

13 Should Patent Owner wish to pursue amendment of the challenged claim
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
14 As explained above in Section II.I., we do not reach the challenge to
claim 1 based on Moller and Steenfeldt-Jensen because the same claim is
determined to be unpatentable over Burroughs and unpatentable over
Steenfeldt-Jensen.
Claim(s)

35
U.S.C. §
Reference(s)/Basis Claim(s)
Shown
Unpatentable
Claim(s)
Not Shown
Unpatentable
1–3 103 Burroughs 1–3
1 103 Steenfeldt-Jensen 1
1 103 Moller, Steenfeldt-
Jensen14

Overall
Outcome
1–3
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FURTHER ORDERED that, because this is a Final Written Decision,
the parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

For PETITIONER:

Jovial Wong
WINSTON & STRAWN LLP
jwong@winston.com

For PATENT OWNER:

Elizabeth Weiswasser
Anish Desai
Adrian Percer
Brian Chang
William Ansley
Matthew Sieger
WEIL, GOTSHAL & MANGES LLP
elizabeth.weiswasser@weil.com
anish.desai@weil.com
adrian.percer@weil.com
brian.chang@weil.com
sutton.ansley@weil.com
matthew.sieger@weil.com