Board of Regents, The University of Texas System

Patent Trials and Appeals Board

Jun 10, 2020

IPR2019-00406 (P.T.A.B. Jun. 10, 2020)

Trials@uspto.gov Paper 27
571-272-7822 Date: June 10, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

ETHICON, INC.,
Petitioner,
v.
BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM,
Patent Owner.

IPR2019-00406
Patent 6,596,296 B1

Before SUSAN L. C. MITCHELL, AVELYN M. ROSS,
KRISTI L. R. SAWERT, Administrative Patent Judges.
ROSS, Administrative Patent Judge.
DECISION
Denying Institution of Inter Partes Review
35 U.S.C. § 314, 37 C.F.R. § 42.4

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I. INTRODUCTION
Ethicon, Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
inter partes review of claims 1, 4, 11, 16, 17, 20, and 26 of U.S. Patent No.
6,596,296 B1 (Ex. 1001, “the ’296 patent”). The Board of Regents,
The University of Texas System (“Patent Owner”) filed a Preliminary
Response to the Petition (Paper 26, “Prelim. Resp.”).
We have authority to determine whether to institute an inter partes
review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for instituting
an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that
an inter partes review may not be instituted “unless the Director
determines . . . there is a reasonable likelihood that the petitioner would
prevail with respect to at least [one] of the claims challenged in the petition.”
For the reasons set forth below, upon considering the Petition and
evidence of record, we determine that it is appropriate to exercise discretion
under § 314(a). Accordingly, we deny the Petition, and do not institute an
inter partes review.
A. Related Proceedings
Petitioner identifies the pending district court litigation styled Board
of Regents, The University of Texas System et al. v. Ethicon, Inc. et al., 1:17-
cv-01084 (W.D. Tex.) (“the Western District of Texas litigation” in the
“Western District of Texas”). Pet. 2, see also Patent Owner’s Mandatory
Notices, Paper 7, 1. Petitioner also identifies its co-pending petition, seeking
to institute inter partes review of U.S. Patent No. 7,033,603 (“the ’603
patent”) as a related proceeding, and states that the ’603 patent is a
continuation-in-part of the ’296 patent. Pet. 2–3; IPR2019-00407, Paper 2;
see also Patent Owner’s Mandatory Notices, Paper 7, 1.
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The ’296 patent is asserted against other defendants in the following
pending litigations:
Board of Regents, The University of Texas System et al. v. Boston
Scientific Corporation, 1:18-cv-00392 (D. Del.);
Board of Regents, The University of Texas System et al. v.
Medtronic, Inc. et al., No. 1:17-cv-00942 (W.D. Tex.)
(dismissed without prejudice on July 19, 2018).
Pet. 3–4; see also Patent Owner’s Mandatory Notices, Paper 7, 1. The ’296
patent is also the subject of a separate petition for inter partes review styled
Medtronic, Inc. et al. v. Board of Regents, the University of Texas System et
al., IPR2019-00037, Paper 2 (PTAB Oct. 9, 2018).
B. The ’296 Patent
The ’296 patent, titled “Drug Releasing Biodegradable Fiber
Implant,” issued on July 22, 2003.1 Ex. 1001, codes (45), (54). The ’296
patent is directed to tissue engineering compositions and, in particular to,
“biodegradable polymer fibers capable of the controlled delivery of
therapeutic agents.” Id. at 2:41–45.
According to the ’296 patent, “there are several primary avenues
investigators are using to engineer tissues” that include creating a scaffold in
the form of a three-dimensional polymer network. Id. at 1:20–26. “[T]he
scaffold may be biodegradable, meaning that over time it will break down
both chemically and mechanically.” Id. at 1:49–51. “[A] polymer
scaffolding provides not only the mechanical support, but also the three-
dimensional shape that is desired for the new tissue.” Id. at 2:15–18. The

1 The ’296 patent claims priority to U.S. provisional application No.
60/147,827, which was filed on August 6, 1999. Ex. 1001, code (60). The
specific priority date of the challenged claims currently is not at issue in this
proceeding, and we need not make any determination in this regard.
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’296 patent purports that “[m]ost current methodologies provide no specific
means of actively assisting the incorporation of blood vessels into and
throughout the polymer matrix.” Id. at 2:21–23. In contrast, “[t]he present
invention provides compositions and methods that promote the directed
migration of appropriate cell types into the engineered extracellular matrix.”
Id. at 2:27–30.
The ’296 patent describes creating heterogeneous scaffolds by
encapsulating therapeutic agents into individual fibers of a three-
dimensional fiber matrix. Id. at 8:32–35. “The therapeutic agents are
released from each individual fiber slowly, and in a controlled manner.” Id.
at 8:36–37.
The ’296 patent describes processes for fabricating polymer fibers
containing therapeutic agents. Id. at 17:36–19:36 (Example 1). “First, a
biodegradable polymer . . . [is] dissolved in some appropriate solvent (A) at
concentrations ranging from 5 to 30 wt % . . . In this embodiment, solvent
(A) has low miscibility with water, and is very miscible with the coagulation
bath solvent (B).” Id. at 17:42–50. The biodegradable polymer may include
“poly(L-lactic acid) (PLLA), poly(DL-lactic acid), polycaprolactone,
poly(glycolic acid), polyanhydride, or copolymers or blends of these or other
biodegradable polymers.” Id. at 17:43–46. “Once the polymer is dissolved,
an aqueous solution containing both the biomolecules(s) of interest and a
surfactant, is added to the polymer solution.” Id. at 17:52–54. “Using some
form of mechanical energy such as sonication, vortexing, or shear forces
generated by forcing the liquid through a small orifice, a water-in-oil type
emulsion is formed between the aqueous and organic phases.” Id. at 18:1–4.
The ’296 patent further describes extruding the formed emulsion into
a coagulation bath containing solvent (B). Id. at 18:12–13. “Solvent (B)
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must be highly miscible with solvent (A), and must be a non-solvent for the
polymer.” Id. at 18:14–16. The ’296 patent explains that:
Because solvent (A) is highly miscible with coagulating bath
solvent (B), it freely diffuses from the polymer solution stream,
into the coagulating bath. The polymer, however, is not soluble
in solvent (B), and therefore begins to precipitate upon itself,
forming the outer sheath of a fiber and trapping virtually all of
the dispersed aqueous phase of the emulsion within the forming
fiber. In this way, the fiber is loaded with the drug or protein of
interest.
Id. at 18:22–30. “Preferred choices of solvent (A) include chloroform and
methylene chloride.” Id. at 17:51–52. Examples of solvent (B) include
isopropyl alcohol and hexane. Id. at 18:15–22.
C. Illustrative Claims
Petitioner challenges claims 1, 4, 11, 16, 17, 20, and 26 of the ’296
patent. Independent claim 1 is the only independent claim challenged and is
reproduced below.
1. A composition comprising at least one biodegradable
polymer fiber wherein said fiber is composed of a first phase and
a second phase, the first and second phases being immiscible,
and wherein the second phase comprises one or more therapeutic
agents.
Ex. 1001, 27:54–58.
D. The Asserted Unpatentability Challenges
Petitioner asserts that claims 1, 4, 11, 16, 17, 20, and 26 would have
been unpatentable on the following grounds:
Claim(s) Challenged 35 U.S.C. Reference(s)/Basis
1, 11, 16, 17, 26 §§ 102 and 103 Song2
4, 20 § 103 Song

2 Song, US 5,364,627, issued November 15, 1994 (Ex. 1005, “Song”).
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Claim(s) Challenged 35 U.S.C. Reference(s)/Basis
4 § 103 Song, Billmeyer,3 Curatolo4
20 § 103 Song, Sidman5
1, 4, 11, 16, 17, 20,
26 §§ 102 and 103 Choi
6

Petitioner also relies on declaration testimony of David J. Mooney,
Ph.D. (Ex. 1002, “the Mooney Declaration”).
II. ANALYSIS
A. Discretion Under 35 U.S.C. § 314(a)
Patent Owner does not address the substance of Petitioner’s
challenges. See generally Prelim. Resp. Rather, Patent Owner argues the
Board should exercise its discretion and deny the Petition under 35 U.S.C.
§ 314(a). Id. at 3. Patent Owner explains that the co-pending district court
litigation between Patent Owner and Petitioner “has now progressed
significantly and a trial is scheduled to begin in approximately three months,
on June 22, 2020.” Id. at 4 (citing Ex. 2004, 2); but see Ex. 3004 (providing
notice to the Board that the trial date has been suspended). Patent Owner
contends that “[g]iven the advanced stage of the district court litigation, a
trial here will not serve as a ‘timely, cost-effective alternative to litigation’
(77 Fed. Reg. 48,680 (Aug. 14, 2012)), but rather as a duplicative
proceeding that unnecessarily taxes the Board’s resources.” Id. at 5.

3 Fred W. Billmeyer, Jr., Textbook of Polymer Science 513–532 (2nd ed.,
John Wiley & Sons, Inc.) (1971) (Ex. 1008, “Billmeyer”).
4 Curatolo, EP 0253554 A2, published January 20, 1988 (Ex. 1009,
“Curatolo”).
5 Sidman, US 4,351,337, issued September 28, 1982 (Ex. 1006, “Sidman”).
6 Choi et al., US 4,093,709, issued June 6, 1978 (Ex. 1007, “Choi”).
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We have discretion to deny a petition for inter partes review under
§ 314(a). See 35 U.S.C. § 314(a) (stating “[t]he Director may not authorize
an inter partes review to be instituted unless . . . .”); Cuozzo Speed Techs.,
LLC v. Lee, 136 S. Ct. 2131, 2140 (“[T]he agency’s decision to deny a
petition is a matter committed to the Patent Office’s discretion.”); Harmonic
Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“First of all,
the PTO is permitted, but never compelled, to institute an IPR proceeding.”
(citing 35 U.S.C. § 314(a))). “[E]vents in other proceedings related to the
same patent, either at the Office, in district courts, or the ITC,” may favor
“denying a petition even though some claims meet the threshold standards
for institution under 35 U.S.C. §§ 314(a).” Consolidated Trial Practice
Guide (“Practice Guide”)7 at 58 (citing NHK Spring Co., Ltd. v. Intri-Plex
Techs., Inc., IPR2018-00752, Paper 8, 11–21 (PTAB Sept. 12, 2018)
(precedential). In weighing whether to exercise discretion we balance, inter
alia, the following factors:
1. whether the court granted a stay or evidence exists that one
may be granted if a proceeding is instituted;
2. proximity of the court’s trial date to the Board’s projected
statutory deadline for a final written decision;
3. investment in the parallel proceeding by the court and the
parties;
4. overlap between issues raised in the petition and in the
parallel proceeding;
5. whether the petitioner and the defendant in the parallel
proceeding are the same party; and
6. other circumstances that impact the Board’s exercise of
discretion, including the merits.

7 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11, 6 (PTAB Mar. 20,
2020) (precedential). We address the application of the Fintiv factors below.
1. whether the court granted a stay or evidence exists that one may
be granted if a proceeding is instituted
The first Fintiv factor requires consideration of whether the district
court has stayed or will stay the proceeding pending inter partes review. “A
district court stay of the litigation pending resolution of the PTAB trial
allays concerns about inefficiency and duplication efforts.” See Fintiv,
IPR2020-00019, Paper 11, 6. Where a stay has been entered, we weigh this
factor strongly against exercising discretion to deny instituting review. Id.
Patent Owner argues that the Western District of Texas temporarily
stayed merits discovery but that stay was lifted on February 28, 2019—more
than a year ago. Prelim. Resp. 2. Further, Patent Owner asserts that “[a]t no
point did Ethicon request a stay of the district court case pending resolution
of this IPR proceeding.” Id. at 3, 12 (“Ethicon never asked the district court
to stay its proceeding.”).
We find that this factor does not weigh for or against discretionary
denial in this case. Although the Western District of Texas did institute a
stay for a discrete period of time, that stay was lifted more than a year ago
and the case was allowed to proceed to near completion.8 Prelim. Resp. 2.
Further, there is no evidence to suggest that the Western District of Texas
would entertain granting a stay at this late stage even if inter partes review
were instituted. And, as Patent Owner notes, Petitioner did not seek a stay

8 We understand that trial was previously set to begin on June 22, 2020 and
that recently the Western District of Texas indefinitely continued the current
trial date because of the current pandemic. Ex. 3004, 2.
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from the Western District of Texas pending resolution of this proceeding.
Id. at 3.
2. proximity of the court’s trial date to the Board’s projected
statutory deadline for a final written decision
Under the second Fintiv factor, “[i]f the [district] court’s trial date is
earlier than the projected statutory deadline, the Board generally has
weighed this fact in favor of exercising authority to deny institution.” See
Fintiv, IPR2020-00019, Paper 11, 9.
Patent Owner contends that because trial before the Western District
of Texas is presently set for June 22, 2020, “[i]f the Board elects to institute
a trial in this matter, that trial is unlikely to conclude before June 2021—
nearly a full year after the district court will have resolved the parties’
dispute.” Prelim. Resp. 4–5.
Until recently, trial was set to begin on June 22, 2020. This trial date
“has been adjourned [and] [t]he trial date has not yet been reset.” Ex. 3004,
2; see Ex. 3005 (continuing the trial date); see also Supplemental Order
Regarding Court Operations Under the Exigent Circumstances Created by
the COVID-19 PANDEMIC, May 8, 2020 (W.D. Tex.) (continuing all trials
“scheduled to begin on any date from [May 8, 2020] through June 30,
2020”). Though the Western District of Texas has continued the trial date
indefinitely, the Court explained that
[t]his should be the number one case on all of your minds because
it has been set for June 22nd for a long time. The mere fact that
we have this pandemic and we may have to put it off only affects
the trial date. It does not affect anything else in this case. . . . I
expect you to quit working on anything else you might have and
treat this case as if it were going to trial on June 22nd, because
that’s where it has been set.
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Ex. 3005, 9:23–10:6. The Court further explained that should the parties
waive a jury demand, a trial “will happen sooner if it is scheduled as a bench
trial than it will as a jury trial.” Id. at 14:20–24. According to the Court, the
parties should expect trial to occur within a year. See id. at 17:21–23
(“What I’m telling you is that you will get reached in sooner than a year, in
all likelihood.”). Both parties withdrew their request for a jury demand. See
Ex. 3006. Were we to institute inter partes review, a final written decision
in this proceeding would issue in June 2021—leaving a year before
resolution of this proceeding. Given the Western District of Texas’
emphasis that the parallel litigation should proceed as if still set for June 22,
2020, and its expectation of holding a bench trial within a year, this factor
weighs strongly in favor of discretionary denial in this case.
3. investment in the parallel proceeding by the court and the parties
The third Fintiv factor considers “the amount and type of work
already completed in the parallel litigation by the [district] court and the
parties at the time of the institution decision. Specifically, if at the time of
the institution decision, the district court has issued substantive orders
related to the patent at issue in the petition, this fact favors denial.” See
Fintiv, IPR2020-00019, Paper 11, 9–10. Thus, the more advanced the
parallel proceeding, the less likely we are to institute an inter partes review.
Id. at 10.
Patent Owner argues that “[g]iven the advanced stage of the district
court litigation, a trial here will not serve as a ‘timely, cost-effective
alternative to litigation,’ but rather as a duplicative proceeding that
unnecessarily taxes the Board’s resources.” Prelim. Resp. 5; see also id. at 2
(“[T]he district [court] case has moved forward significantly.”); 4 (“The
litigation has now progressed significantly.”). By way of example, Patent
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Owner contends that “the parties ha[ve] already completed claim
construction discovery and the district court ha[s] issued its Markman order,
(id. at 2)” and “both fact and expert discovery, and all dispositive motions
have been filed (id.).” Therefore, Patent Owner reasons that a discretionary
denial is appropriate. Id. at 5.
Here, the both the Western District of Texas and parties have engaged
in considerable effort to advance the stage of the parallel litigation. All fact
and expert discovery is complete (Prelim. Resp. 2), the parties fully briefed
and the Western District of Texas issued a claim construction order (id.;
Ex. 1018 (Markman Order), and dispositive motions have been filed (Prelim.
Resp. 2; Ex. 2006 (Motion for Summary Judgment of Invalidity). We
further observe that both motions to exclude and motions in limine have
been fully briefed. See Board of Regents, The University of Texas System et
al. v. Ethicon, Inc. et al., 1:17-cv-01084 (LY), (W.D. Tex. May 8, 2020),
Dkt. Nos. 119, 120 (motions to exclude), 156, 161 (motions in limine).
Also, the parties are to file proposed findings of fact and conclusions of law
no later than July 20, 2020. Ex. 3006 (Order Granting Motion to Continue).
Therefore, because of the advanced stage of the Western District of Texas
litigation—particularly at a time prior to institution of inter partes review—
this factor weighs heavily in favor of exercising discretion to deny institution
under § 314 (a).
4. overlap between issues raised in the petition and in the parallel
proceeding
The fourth Fintiv factor requires consideration of “inefficiency and
the possibility of conflicting decisions.” See Fintiv, IPR2020-00019, Paper
11, 12. Therefore, “if the petition includes the same or substantially the
same claims, grounds, arguments, and evidence, as presented in the parallel
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proceeding, this fact has favored denial.” Id. The Fintiv panel
acknowledged that “the degree of overlap is highly fact dependent” and
encouraged the parties “to indicate whether all or some of the claims
challenged in the petition are also at issue in the district court.” Id. at 13.
Patent Owner argues that there is also significant overlap in the issues
before the Board and that before the Western District of Texas. Prelim.
Resp. 5–9. In particular, asserts “[t]he invalidity issues that the district court
will consider and decide overlap completely with the invalidity issues that
the Board is being asked to consider.” Id. at 6. According to Patent Owner,
“Ethicon even offers the same expert—Prof. David J. Mooney—to address
invalidity in both proceedings.” Id. at 8.
We determine that this factor weighs heavily in favor of exercising
discretion under § 314(a). The claims challenged here are completely
subsumed by those Petitioner seeks to invalidate in the Western District of
Texas. Compare Pet. 8 (identifying claims 1, 4, 11, 16–17, 20, and 26 as
challenged claims) with Ex. 2006, 12–28 (requesting summary judgment of
invalidity for claims 1, 2, 4, 11, 16–17, 20, and 26). Furthermore, Ethicon
relies on the same prior art combinations and the same expert in both its
Petition and the parallel district court litigation. Id. Though Petitioner in the
parallel litigation did not rely on the Curatolo reference (presented as an
alternative reference to Billmeyer in the Petition (see Pet. 8)) in its summary
judgment motion, Petitioner does include Curatolo in the invalidity
contentions accompanying its Answer to the Amended Complaint. See Ex.
2007, Exhibit A. Accordingly, the posture and scope of the Western District
of Texas litigation weighs strongly in favor of exercising discretion to deny
institution under § 314 (a).
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5. whether the petitioner and the defendant in the parallel
proceeding are the same party
According to the fifth Fintiv factor, “[i]f a petitioner is unrelated to a
defendant in an earlier [district] court proceeding, the Board has weighed
this fact against exercising discretion to deny institution.” See Fintiv,
IPR2020-00019, Paper 11, 13–14. “Even when a petitioner is unrelated to a
defendant, however, if the issues are the same as, or substantially similar to,
those already or about to be litigated, or other circumstances weigh against
redoing the work of another tribunal, the Board may, nevertheless, exercise
the authority to deny institution.” Id. at 14.
Patent Owner asserts that both “Ethicon and [The University of
Texas] are parties to the underlying district court litigation.” Prelim. Resp. 5.
Petitioner and Patent Owner are the defendant and plaintiff, respectively, in
the Western District of Texas litigation. Id.; see Exs. 2001, 2003, 2007.
Therefore, we find that this factor weighs in favor of exercising discretion to
deny instituting inter partes review.
6. other circumstances that impact the Board’s exercise of
discretion, including the merits
Lastly, “all relevant circumstances,” including the merits, are
considered in assessing whether to exercise discretion to deny institution of
inter partes review. Fintiv, IPR2020-00019, Paper 11, 14.
Patent Owner asserts that Ethicon’s “lack of diligence” and “strategic
choices” favor denial of inter partes review. Prelim. Resp. 11–13. In
particular, Patent Owner explains that “Ethicon waited until four days
before the one-year bar in 35 U.S.C. § 315(b) to file its Petition” and that it
filed its Petition at a time when it “knew (or should have known) that the
Board had suspended IPR proceedings involving State universities pending
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resolution of the UMN Appeal.” Id. at 11. Patent Owner explains that even
if the Board had not stayed this proceeding, “a final written decision in this
proceeding would be due (coincidentally) on the same day that the district
court trial would commence. Thus, the Board would still be considering the
same issues that the district court was actively considering in parallel.” Id.
at 12.
Without more, we do not view mere delay, until shortly before the
statutory deadline to file a petition, as exhibiting lack of diligence or a
strategic choice such that denial of inter partes review is appropriate. Thus,
this factor does not weigh in favor of or against discretionary denial in this
case.
7. summary
Therefore, after considering all of the evidence and arguments
presented, we determine that the factors weigh in favor of exercising
discretion to deny institution. In weighing the factors, we determine that the
advanced stage of the Western District of Texas litigation and the likelihood
the parallel litigation will be concluded prior to any final written decision in
this case, the identity of the parties in this and the parallel litigation, the near
identity of the unpatentability grounds advanced by Petitioner in both the
parallel proceeding and this proceeding, and the significant investment by
the Western District of Texas, as well as the parties, in the parallel litigation
to be particularly persuasive. Accordingly, we exercise discretion to deny
institution of inter partes review.
B. Sovereign Immunity
Patent Owner also argues, that “[The University of Texas] is an arm
of the state of Texas, and as such is immune from this administrative
adjudicatory proceeding under Supreme Court precedent.” Prelim. Resp. 13.
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Patent Owner “acknowledges that the Federal Circuit has ruled that states
are not immune from IPR proceedings” and that “the Federal Circuit’s ruling
is binding on this Board.” Id. (citing Regents of the Univ. of Minn. v. LSI
Corp., 926 F.3d 1327 (Fed. Cir. 2019), cert. denied, 140 S.Ct. 908 (U.S. Jan.
13, 2020)). Therefore, Patent Owner “will not expand on its sovereign
immunity argument further here, but reserves its right to do so on appeal
and/or in a cert. petition following any final written decision” and “[b]y
defending itself on the merits of this proceeding, UT does not waive its right
to be immune from this proceeding and from any decision this Board may
render impacting UT’s ‘296 Patent.” Id. at 13–14.
Because we exercise discretion to deny institution of inter partes
review under 35 U.S.C. § 314 (a), we need not reach Patent Owner’s
sovereign immunity argument.
III. CONCLUSION
For the foregoing reasons, we exercise discretion and deny the
Petition. Accordingly, we do not institute inter partes review of the ’296
patent.
IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that, the Petition (Paper 2) is denied as to the challenged
claims of the ’296 patent; and
FURTHER ORDERED that no inter partes review is instituted.
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FOR PETITIONER:
Jeffrey S. Ginsberg
Andrew D. Cohen
PATTERSON BELKNAP WEBB & TYLER LLP
jginsberg@pbwt.com
acohen@pbwt.com

FOR PATENT OWNER:
Gerald B. Hrycyszyn
Richard F. Giunta
WOLF, GREENFIELD & SACKS, P.C.
ghrycyszyn-ptab@wolfgreenfield.com
rgiunta-ptab@wolfgreenfield.com