American Regent, Inc.

Patent Trials and Appeals Board

Aug 14, 2020

PGR2020-00009 (P.T.A.B. Aug. 14, 2020)

Trials@uspto.gov Paper 17
Tel: 571-272-7822 Entered: August 14, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

PHARMACOSMOS A/S,
Petitioner,
v.
AMERICAN REGENT, INC.
Patent Owner.

PGR2020-00009
Patent 10,478,450 B2

Before ERICA A. FRANKLIN, JON B. TORNQUIST, and
JAMIE T. WISZ, Administrative Patent Judges.

WISZ, Administrative Patent Judge.
DECISION
Denying Institution of Post-Grant Review
35 U.S.C. § 325(d)

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I. INTRODUCTION
Pharmacosmos A/S (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
requesting a post-grant review of claims 1–22 of U.S. Patent No. 10,478,450
B2 (Ex. 1001, “the ’450 patent”). American Regent, Inc. (“Patent Owner”)
filed a Preliminary Response (Paper 12, “Prelim. Resp.”).1 With our
authorization, Petitioner filed a Reply (Paper 14, “Reply”), and Patent
Owner filed a Sur-Reply (Paper 16, “PO Sur-Reply”).
Under 35 U.S.C. § 324(a), a post-grant review may not be instituted
“unless . . . the information presented in the petition . . . , if such information
is not rebutted, would demonstrate that it is more likely than not that at least
1 of the claims challenged in the petition is unpatentable.” Upon
considering the arguments and evidence, we exercise our discretion to deny
institution of post-grant review under 35 U.S.C. §§ 324(a) and 325(d).
II. BACKGROUND
A. Real Parties-in-Interest
Petitioner identifies Pharmacosmos A/S and Pharmacosmos
Therapeutics Inc. as the real parties-in-interest. Pet. 4. Patent Owner
identifies American Regent, Inc., which is a subsidiary of Daiichi Sankyo
Inc., as the real party-in-interest. Paper 5, 1.
B. Related Proceedings
The parties indicate that Petitioner has filed four petitions for inter
partes review for related patents in the following proceedings, IPR2015-

1 Pursuant to the Notice of Waiver of Patent-Related Timing Deadlines
under the Coronavirus Aid, Relief, and Economic Security Act issued
March 31, 2020, Patent Owner requested, and we granted, a 30-day
extension of the deadline for Patent Owner to file its Preliminary Response.
Ex. 3001.
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01493 (U.S. Patent No. 8,431,549) (“the ’549 patent”) (claims 1–5, 9, 14,
16, and 19 held unpatentable); IPR2019-01142 (the ’549 patent) (not
instituted); IPR2015-01490 (U.S. Patent No. 7,754,702) (“the ’702 patent”)
(claims 1–3, 10–15, 23, 25, 27, 30, and 41–43 held unpatentable); IPR2015-
01495 (U.S. Patent No. 8,895,612) (“the ’612 patent”) (not instituted). See
Pet. 5; Paper 5, 2. The ’702 patent, which was the subject of IPR2015-
01490, and the ’549 patent, which was the subject of IPR2015-01493, were
also involved in appeals and cross appeals to the Federal Circuit. Paper 5, 2.
According to Patent Owner, both the ’612 and ’702 patents were
included in the following district court actions: Vifor (International) AG, et
al. v. Sandoz, Inc., 3-19-cv-16305 (D. N.J.); Vifor (International) AG, et al.
v. Mylan Laboratories Limited, 3-19-cv13955 (D. N.J.); and Vifor
(International) AG, et al. v. Mylan Laboratories Limited 1-19-cv-00126
(N.D. W.Va.). Paper 5, 2.
Patent Owner also indicates that the ’450 patent claims the benefit of
U.S. Provisional Application No. 60/757,119 filed January 6, 2006; U.S.
Patent Application No. 11/620,986, patented as the ’702 patent; U.S. Patent
Application No. 12/787,283, patented as the ’549 patent; and U.S. Patent
Application No. 13/847,254 (now abandoned). Paper 5, 1–2. U.S. Patent
Application No. 14/100,717, patented as the ’612 patent, also claims priority
to U.S. Provisional Application No. 60/757,119 (“the ’119 provisional”). Id.
In addition, the following applications claim the benefit of the ’450 patent:
16/192,681; 16/438,340; and 15/958,930. Id.
C. The ’450 Patent
The ’450 patent generally relates to the treatment of iron-related
conditions with iron carbohydrate complexes. Ex. 1001, code (57), 1:20–21.
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According to the Specification, parenteral iron therapy is known to be
effective in a variety of diseases and conditions including, inter alia, severe
iron deficiency and iron deficiency anemia. Id. at 1:25–27. However, iron
dextran, the first parenteral product available in the United States, has been
associated with an incidence of anaphylactoid-type reactions. Id. at 1:50–54.
The Specification further notes that pharmacokinetic studies suggested that
doses of iron complexes containing higher than 200 mg of iron are generally
unsuitable, and that the conventional therapy model prescribes repeated
applications of lower doses over several days. Id. at 2:14–18.
The Specification describes the administration of iron carbohydrate
complexes at a relatively high single unit dosage, i.e., containing at least 0.6
grams of elemental iron, “thereby providing a safe and efficient means for
delivery of a total dose of iron in fewer sessions over the course of
therapeutic treatment.” Ex. 1001, 2:28–42. According to the Specification,
the inventors discovered that certain characteristics of iron carbohydrate
complexes make them amenable to administration at dosages far higher than
contemplated by current administration protocols. Id. at 11:5–8. Among
these preferable characteristics are: a nearly neutral pH (e.g., about 5 to
about 7); physiological osmolarity; a stable carbohydrate component; an iron
core size no greater than about 9 nm; mean diameter particle size no greater
than about 35 nm, preferably about 25 nm to about 30 nm; slow and
competitive delivery of the complexed iron to endogenous iron binding sites;
serum half-life of over about 7 hours; low toxicity; a non-immunogenic
carbohydrate component; no cross reactivity with anti-dextran antibodies;
and/or low risk of anaphylactoid/hypersensitivity reactions. Id. at 11:8–21.
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D. Illustrative Claim
Petitioner challenges claims 1–22 of the ’450 patent. Claim 1, which
is the only independent claim of the ’450 patent, is illustrative of the
challenged claims, and is reproduced below:
1. A method of treating a disease, disorder, or condition
characterized by iron deficiency or dysfunctional iron
metabolism resulting in reduced bioavailability of dietary iron,
comprising administering to a subject in need thereof an iron
carbohydrate complex in a single dosage unit of at least 0.7
grams of elemental iron, wherein:
the iron carbohydrate complex is substantially non-
immunogenic, and has substantially no cross reactivity with
anti-dextran antibodies; and
the iron carbohydrate complex is an iron polyisomaltose
complex.
Ex. 1001, 27:7–17. Challenged claims 2–22 depend from claim 1,
either directly or indirectly.
E. The Asserted Grounds of Unpatentability
Petitioner contends claims 1–22 of the ’450 patent are unpatentable in
view of the following grounds. Pet. 8–9.
Ground Claims
Challenged
35 U.S.C. § References/Basis
1 1–22 112(a) Written Description
2 1–22 112(a) Enablement
3 1–22 112(b) Indefiniteness
4 1–4, 6, 7, 11,
12, 15, 19–22
102 Jahn2

2 Jahn et al., A comparative study of the physicochemical properties of iron
isomaltoside 100 (Monofer®), a new intravenous iron preparation and its
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Ground Claims
Challenged
35 U.S.C. § References/Basis
5 5 103 Jahn, Helenek3
6 13 103 Jahn, Wikström4
7 14 103 Jahn, CKD Guidelines5
8 17 103 Jahn, ’668 patent6
Petitioner submits the Declarations of Lee Josephson, Ph.D. (Ex.
1102) and N. Franklin Adkinson, M.D. (Ex. 1103) in support of institution
of post-grant review. Patent Owner submits the Declarations of Dr. Todd
Lowary, Ph.D. (Ex. 2001) and Daniel Coyne, M.D. (Ex. 2003) in support of
its Preliminary Response.
III. DENIAL UNDER 35 U.S.C. § 325(d)
Patent Owner asserts that we should deny the Petition under 35 U.S.C.
§ 325(d) because “the Petitioner presents the same or substantially the same
arguments previously presented during prosecution and related post-grant
proceedings.” Prelim. Resp. 68. We have discretion to deny review when

clinical implications, 78 Eur. J. of Pharm. and Biopharm., 480–491 (2011)
(Ex. 1048, “Jahn”).
3 Helenek at al., U.S. Patent No. 6,960,571 B2, issued Nov. 1, 2005 (Ex.
1012, “Helenek”).
4 Wikström et al., Iron isomaltoside 1000: a new intravenous iron for
treating iron deficiency in chronic kidney disease, 24(5) J. Neprol., 589–596
(2011) (Ex. 1101, “Wikström”).
5 National Kidney Foundation – K/DOQI Clinical Practice Guidelines for
Anemia of Chronic Kidney Disease. Am. J. Kidney Dis. 37:S182–238, 2001
(Suppl. 1) (Ex. 1100, “CKD Guidelines”).
6 Lawrence et al., U.S. Patent No. 5,624,668, issued Apr. 29, 1997 (Ex.
1011, “’668 patent”).
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“the same or substantially the same prior art or arguments previously were
presented to the Office.” 35 U.S.C. § 325(d). In that respect, section 325(d)
provides that the Director may elect not to institute a proceeding if the
challenge to the patent is based on matters previously presented to the
Office.7 Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte
GmbH, IPR2019-01469, Paper 6 at 7 (PTAB Feb. 13, 2020) (precedential)
(“Advanced Bionics”).
In evaluating matters under § 325(d), the Board uses the following
two-part framework: (1) determining whether the same or substantially the
same art previously was presented to the Office or whether the same or
substantially the same arguments previously were presented to the Office;
and (2) if either condition of the first part of the framework is satisfied,
determining whether the petitioner has demonstrated that the Office erred in
a manner material to the patentability of challenged claims. Advanced
Bionics, Paper 6 at 8.
In applying the two-part framework, we consider several non-
exclusive factors, including:
(a) the similarities and material differences between the asserted
art and the prior art involved during examination;
(b) the cumulative nature of the asserted art and the prior art
evaluated during examination;
(c) the extent to which the asserted art was evaluated during
examination, including whether the prior art was the basis for
rejection;

7 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a);
Advanced Bionics, Paper 6 at 7 n.7.
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(d) the extent of the overlap between the arguments made
during examination and the manner in which petitioner relies on
the prior art or patent owner distinguishes the prior art;
(e) whether petitioner has pointed out sufficiently how the
examiner erred in its evaluation of the asserted prior art; and
(f) the extent to which additional evidence and facts presented
in the petition warrant reconsideration of the prior art or
arguments.
Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper
8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first
paragraph) (“Becton, Dickinson”).
Factors (a), (b), and (d) of the Becton, Dickinson factors relate to
whether the art or arguments presented in the Petition are the same or
substantially the same as those previously presented to the Office. Advanced
Bionics, Paper 6 at 10. Factors (c), (e), and (f) “relate to whether the
petitioner has demonstrated a material error by the Office” in its prior
consideration of that art or arguments. Id. Only if the same or substantially
the same art or arguments were previously presented to the Office do we
then consider whether petitioner has demonstrated a material error by the
Office. Id. “At bottom, this framework reflects a commitment to defer to
previous Office evaluations of the evidence of record unless material error is
shown.” Id. at 9.
F. Relevant Prosecution History
The ’450 patent claims the benefit of: U.S. Provisional Application
No. 60/757,119 filed January 6, 2006 (“the ’119 provisional”); U.S. Patent
Application No. 11/620,986 filed January 8, 2007, patented as the ’702
patent; U.S. Patent Application No. 12/787,283 filed May 25, 2010, patented
as the ’549 patent; and U.S. Patent Application No. 13/847,254 filed March
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19, 2013 (now abandoned). Ex. 1001, codes (21), (60), (63). We discuss the
prosecution of both the ’549 patent and the ’450 patent below.
1. The ’549 Patent Prosecution History
During prosecution of the ’549 patent, the Examiner rejected the
claims for lack of enablement “because the specification does not reasonably
provide enablement for [an] iron polyisomaltose complex having [a]
substantially non-immunogenic carbohydrate complex and substantially no
cross reactivity with anti-dextran antibodies.” Ex. 1007, 81.8 In discussing
the factors from In re Wands, 858 F.2d 731, 736–737 (Fed. Cir. 1988) (“the
Wands factors”), the Examiner asserted that “[o]ne of skill in the art would
expect anti-dextran antibodies to cross react with polyisomaltose, which is a
linear α(1-6) chain of dextran.” Id. at 82. The Examiner also asserted that
“the specification does not provide specific guidance as to what structural
features” give rise to the claimed characteristics and further contended that:
In order to practice the invention with the full range of all
possible methods of administration beyond those known in the
art, (such as those causing significant adverse reaction or cross
reactivity with anti-dextran antibodies) one skilled in the art
would undertake a novel and extensive research program into
what specific structural features are recognized by each
anti-dextran antibody and how to remove such structural
recognition from iron polyisomaltose complex.
Id. at 83.
In response, Patent Owner argued that “an iron polyisomaltose is a
type of iron carbohydrate complex that includes isomaltose units in the
carbohydrate component” and that “[o]ne example of an iron polyisomaltose

8 The cited page numbers in Ex. 1007 refer to the page numbers added by
Petitioner in the bottom-right corner of the page.
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complex is an iron isomaltoside (e.g., Monofer®), where the carbohydrate
component is a pure linear chemical structure of repeating α1-6 linked
glucose units.” Ex. 1007, 99. Patent Owner further argued:
It was understood at the time of filing that isomaltose
oligomers prevent or block anaphylaxis to dextrans (Coulson
and Stevens 1961 J Immun 86, 241; evidenced by Jahn et al.
2011 Eur J Pharma and Biopharma 78, 480-491, at 489, col. 1,
ln. 53-58; see Lawrence Declaration, ¶5). It was also
understood at the time of filing that isomaltose oligomers acted
as haptens against circulating anti-dextran antibodies
(retrospective summary in Jahn et al. 2011 Eur J Pharma and
Biopharma 78, 480-491, at 489, col. 1, ln. 58-60; see Lawrence
Declaration, ¶5). A hapten can bind an antibody without
inducing anaphylaxis or an immune response (see term
definition in retrospective summary of Jahn et al. 2011 Eur J
Pharma and Biopharma 78, 480-491, at 489, col. 2, ln. 3-5; see
Lawrence Declaration, ¶5).
Id. at 99–100.
Patent Owner also submitted the Declaration of Richard P. Lawrence
(“the Lawrence Declaration”), one of the named inventors, who made
similar statements. Ex. 1007, 110–113. For example, the Declaration stated,
“[b]ased on my experience, an iron polyisomaltose is a type of iron
carbohydrate complex that includes isomaltose units in the carbohydrate
component.” Id. at 111. The Declaration also stated, “Jahn et al. evidences
that even in the 1960s it was known that isomaltose oligomers prevent or
block anaphylaxis and that later research in the 1970s and 1980s showed that
isomaltose oligomers acted as haptens against circulating anti-dextran
antibodies.” Id. at 112 (citing Ex. 1048, 489).
Following submission of the response and the Lawrence Declaration,
the Examiner withdrew the enablement rejection and allowed the claims.
See Ex. 1007, 137–146. In the Reasons for Allowance, the Examiner stated:
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Applicant’s Remarks and declaration of Richard P. Lawrence
regarding the state of the art at the time of the instant invention
as presented in post art Jahn et al. are [persuasive] that one of
ordinary skill in the art at the time of the instant invention
would have been able to practice the invention for iron
polyisomaltose complex having substantially non-immunogenic
carbohydrate complex and substantially no cross reactivity with
anti-dextran antibodies. Post art Jahn et al. at page 489, left
column, paragraph 5 provides evidence that at the time of the
instant invention one of ordinary skill in the art would have
been able to select isomaltose oligomers to block anaphlaxis to
dextrans and that selection of isomaltose oligomers that were
nonanaphylactogenic and desensitizing in animals sensitized
against dextran.
Id. at 142.
2. The ’450 Patent Prosecution History
During the prosecution of the ’450 patent, the Examiner issued an
indefiniteness rejection and asserted that the specification does not define
the structure of “an iron polyisomaltose complex” and it is unclear if the
term includes dextran. Ex. 1002, 187–189.9 In response, Patent Owner
amended the claims to recite that the iron polyisomaltose carbohydrate
complex “is substantially non-immunogenic, and has substantially no cross
reactivity with anti-dextran antibodies,” and argued that, in view of this
amendment, “a person of skill in the art would understand ‘polyisomaltose’
does not refer to dextrans, which are distinguished in the application from
the iron carbohydrate complexes used in the methods, disclosed and
claimed.” Id. at 201, 206. Patent Owner further stated:
Hence, “polyisomaltose” is not the same as dextran, which is a
branched glucan polysaccharide. Thus, the skilled person

9 The cited page numbers in Ex. 1002 refer to the page numbers added by
Petitioner in the bottom-right corner of the page.
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would understand polyisomaltose refers to a linear chemical
structure of repeating α-1,6 linked glucose units that optionally
is reduced.
Id. at 207. Patent Owner also cited to prior art references to support its
position that the skilled person would not understand polyisomaltose to
include or be synonymous with dextran. See id. at 210.
Following the response, the Examiner withdrew the indefiniteness
rejection and allowed the claims. See Ex. 1002, 233–241. In the Reasons
for Allowance, the Examiner stated:
Applicant’s remarks are persuasive that language of the claim
drawn to the method wherein the iron carbohydrate complex is
an iron polyisomaltose complex having the properties as
recited, when read in view of the instant specification makes
reasonably clear that polyisomaltose as described in the instant
application does not mean dextran and instead the term is given
its regular meaning in the art which the cited Muller et al.
acknowledges is different from dextran in that polyisomaltose
is the degradation product of dextran consisting of polymerized
glucose residues joined predominantly by 1,6 linkages . . . .
Id. at 237.
G. Same or Substantially the Same Art or Arguments Previously
Presented to the Office
We first consider whether Petitioner asserts the same or substantially
the same art or arguments that previously were presented to the Office.
Advanced Bionics, Paper 6 at 8. As discussed below, we conclude that
Petitioner asserts the same or substantially the same art and arguments that
previously were before the Office.
According to Patent Owner, “the Petition is premised on (1) claim
construction arguments regarding the term ‘iron polyisomaltose’ that the
[Office has] repeatedly rejected, and (2) § 112 arguments that the examiner
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squarely addressed during prosecution.” Prelim. Resp. 68. Patent Owner
argues that Petitioner relies on its erroneous claim construction to argue that
the ’450 patent lacks written description and fails to enable the full scope of
the claims. Id. at 46, 58. Patent Owner also asserts that Petitioner’s claim
construction arguments were previously addressed in the context of an
indefiniteness rejection during prosecution of the ’450 patent. Id. at 21. We
first address the parties’ arguments regarding claim construction in order to
determine the impact of claim construction as previously considered with
respect to the unpatentability challenges under § 112.10
1. Claim Construction
Petitioner asserts that the claim term “iron polyisomaltose complex”
should be construed to mean “iron complexed to a carbohydrate that is a
polysaccharide consisting of many (at least 20) glucose units joined
predominantly by α-1, 6 linkages.” Pet. 31 (citing Ex. 1102 ¶¶ 92–96).
Patent Owner proposes to construe this term to mean “iron complexed to a
linear chemical structure of repeating α-1, 6 linked glucose units that
optionally is reduced.” Prelim. Resp. 19. In contrast to Petitioner’s
proposed construction, Patent Owner’s proposed construction requires that
the iron polyisomaltose complex be linear and has no lower limitation on the
number of glucose units that are joined; in other words, it includes
oligoisomaltoses, while Petitioner’s construction does not.
Patent Owner asserts that the Office has “already addressed whether
‘polyisomaltose’ is linear and includes oligoisomaltoses and agreed with

10 This Decision does not address claim construction as a stand-alone
argument under 35 U.S.C. § 325(d) but, rather, addresses the impact of claim
construction on the Petitioner’s challenges under § 112.
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Patent Owner on both points.” PO Sur-Reply 1 (citing Prelim. Resp. 20–26,
30–31, 55–57). According to Patent Owner, “[d]uring prosecution of the
’450 patent and its parent ’549 patent, the Examiner questioned the meaning
of ‘polyisomaltose,’ and Patent Owner conclusively defined ‘iron
polyisomaltose’ as linear.” Id. (citing Ex. 1002, 188, 206–207, 209–212;
Ex. 1007, 99–101, 111). Patent Owner further asserts that the “Examiner
then applied this definition and eventually allowed the claims.” Id. at 2
(citing Ex. 1002, 237).
Patent Owner also contends that, during prosecution of the ’549
patent, Patent Owner cited to Monofer, an iron oligosaccharide complex, as
“[o]ne example of an iron polyisomaltose complex…where the carbohydrate
component is a pure linear chemical structure of repeating α1-6 linked
glucose units.” PO Sur-Reply, 2 (citing Ex. 1007, 99–101, 111). The
Examiner found Patent Owner’s arguments “persuasive” and further equated
“polyisomaltose” and “isomaltose oligomers,” finding that “one of ordinary
skill in the art … would have been able to practice the invention for iron
polyisomaltose complex … [because] one of ordinary skill in the art would
have been able to select isomaltose oligomers to block anaphylaxis to
dextrans.” Id. (citing Ex. 1007, 142).
Petitioner asserts that “[t]he Examiner never formally construed
‘polyisomaltose’ or assessed whether, given the intrinsic and extrinsic
evidence, it could cover oligomers (Becton, Dickinson factors (a)-(d)).”
Reply 1.11 Specifically, Petitioner contends that the Examiner’s

11 While Petitioner challenges that the Examiner construed “polyisomaltose”
to cover oligomers, Petitioner appears to accept that the Examiner found that
“polyisomaltose” is linear in arguing that “‘linearity’ as a trait of
polyisomaltose arose when the Examiner volunteered it, without support.”
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“acceptance” of Patent Owner’s incorrect assertions regarding claim
construction “at face value, leading him to erroneously withdraw an
enablement rejection, does not establish that he considered and decided the
matter such that the Board need not hear it.” Id. at 2.
We agree with Patent Owner that Petitioner’s arguments regarding
construction of the claim term “polyisomaltose” are substantially the same
as arguments previously before the Office. We are not persuaded by
Petitioner’s assertion that the Examiner never “formally construed
‘polyisomaltose’” or assessed whether it could cover oligomers. In the
Reasons for Allowance of the ’549 patent, the Examiner contemplated that
the term “polyisomaltose” includes oligomers in stating that “one of
ordinary skill in the art . . . would have been able to practice the invention
for iron polyisomaltose complex . . . [because] one of ordinary skill in the art
would have been able to select isomaltose oligomers to block anaphylaxis to
dextrans.” Ex. 1007, 142 (emphasis added). Furthermore, as discussed
above, the Examiner also considered the meaning of the term
“polyisomaltose” in the prosecution of the ’450 patent and found the Patent
Owner’s arguments “persuasive.” Ex. 1002, 188, 206–207, 209–21, 237.
We are, thus, persuaded by Patent Owner that Petitioner’s arguments
regarding claim construction of “polyisomaltose” are substantially the same
as issues previously before the Office.

Reply 4 (citing Ex. 1007, 82). Therefore, we address Petitioner’s arguments
regarding whether “polyisomaltose” should properly be construed as a linear
chain in the second part of the Advanced Bionics framework (i.e., whether
the Office erred in a manner material to the patentability of challenged
claims).
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2. Enablement
Petitioner argues that the claims are unpatentable for lack of
enablement given the breadth of the term “polyisomaltose” and the lack of
guidance in obtaining a substantially non-immunogenic iron polyisomaltose
complex. Pet. 55–67.
Patent Owner contends that the Examiner has already considered, and
rejected, the enablement argument raised by Petitioner that the ’450 patent
does not describe or enable the claimed substantially non-immunogenic iron
polyisomaltose complex. PO Sur-Reply 5 (citing Pet. 39–67). Patent Owner
points to the enablement rejection of the ’549 patent claims and the
Examiner’s assertion that the specification did not identify or provide
guidance as to the properties of the claimed iron polyisomaltose that
rendered it substantially non-immunogenic with no cross reactivity with
antidextran antibodies. Id. (citing Ex. 1007, 80–84). Patent Owner argues
that it overcame the rejection by arguing the Wands factors and the claims
were allowed. Id. at 5–6 (citing Ex. 1007, 97–104, 110–113).
In response, Petitioner argues that “the ’450 patent claims a
substantially non-immunogenic iron carbohydrate complex, while the ’549
[patent] requires only that the individual carbohydrate component—prior to
complexation with iron—be non-immunogenic.” Reply 7. Therefore,
according to Petitioner, the enablement rejection from the ’549 patent’s
prosecution is irrelevant. Id.
We agree with Patent Owner that Petitioner’s enablement arguments
are substantially the same as arguments previously before the Office.
Although the enablement rejection in the ’549 patent was directed to claims
reciting a “substantially non-immunogenic carbohydrate component,” the
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Examiner stated in the rejection that “the specification does not reasonably
provide enablement for [an] iron polyisomaltose complex having [a]
substantially non-immunogenic carbohydrate complex and substantially no
cross reactivity with anti-dextran antibodies.” Ex. 1007, 48, 81 (emphasis
added).
Furthermore, the Examiner’s discussion of the Wands factors include
many of the same or substantially the same arguments advanced by
Petitioner. For example, similar to arguments made in the Petition, the
Examiner argued that the specification does not provide specific guidance as
to what structural features are necessary for a non-immunogenic
carbohydrate component and no cross reactivity with anti-dextran
antibodies. Compare Pet. 58–61, with Ex. 1007, 82–83. Similarly, as
asserted in the Petition, the Examiner argued that there were no working
examples of “an iron polyisomaltose complex having [a] substantially non-
immunogenic carbohydrate complex and substantially no cross reactivity
with anti-dextran antibodies.” Compare Pet. 61–62, with Ex. 1007, 83.
Furthermore, as argued in the Petition, the Examiner asserted:
In order to practice the invention with the full range of all
possible methods of administration beyond those known in the
art, (such as those causing significant adverse reaction or cross
reactivity with anti-dextran antibodies) one skilled in the art
would undertake a novel and extensive research program into
what specific structural features are recognized by each
anti-dextran antibody and how to remove such structural
recognition from iron polyisomaltose complex.
Compare Pet. 63–64, with Ex. 1007, 83.
As discussed supra, Patent Owner responded to the enablement
rejection by providing an analysis of the Wands factors and by submitting
the Lawrence Declaration. See Ex. 1007, 97–104, 110–113. The Examiner
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found Patent Owner’s arguments and the Lawrence Declaration to be
“persuasive” and further stated that:
one of ordinary skill in the art at the time of the instant
invention would have been able to practice the invention for
iron polyisomaltose complex having substantially non-
immunogenic carbohydrate complex and substantially no cross
reactivity with anti-dextran antibodies. . . . [A]t the time of the
instant invention one of ordinary skill in the art would have
been able to select isomaltose oligomers to block anaphylaxis to
dextrans and that selection of isomaltose oligomers were
nonanaphylactogenic and desensitizing in animals sensitized
against dextran.
Ex. 1007, 142.
Based on the above, we are persuaded by Patent Owner that
Petitioner’s enablement arguments are substantially the same as issues
previously before the Office.
3. Indefiniteness
Petitioner argues that the term “iron polyisomaltose complex” is
indefinite because it is not defined in the ’450 patent and it is unclear
whether this term encompasses dextran. Pet. 67–69. Petitioner also argues
that the term “substantially non-immunogenic” is indefinite because “it is
impossible to ascertain the claims’ scope” and the patent lacks “any
guidance on how (if at all) the claimed iron polyisomaltose complex differs
from prior art iron dextran or other iron polyisomaltoses that were known to
be immunogenic.” Id. at 71.
Patent Owner asserts that the indefiniteness challenges raised in the
Petition were previously before the Office. PO Sur-Reply 4. Specifically,
Patent Owner contends that, “Petitioner’s challenge—that the relationship
between ‘iron polyisomaltose’ and ‘dextran’ is unclear and that a skilled
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artisan could not identify the claimed substantially non-immunogenic
polyisomaltose (Pet., 67–71)—has been conclusively decided by the Office.”
Id. Petitioner does not address indefiniteness in its Reply brief regarding 35
U.S.C. 325(d). See generally Reply.
We agree with Patent Owner that Petitioner’s indefiniteness
arguments are substantially the same as arguments previously before the
Office. As discussed supra, during prosecution of the ’450 patent, the
Examiner issued an indefiniteness rejection and stated, “it is unclear if the
meaning of the term ‘polyisomaltose’ encompasses the meaning loosely
‘dextran’ as used in the prior art.” Ex. 1002, 188. In response, Patent
Owner amended the claims to affirmatively recite that the iron
polyisomaltose carbohydrate complex “is substantially non-immunogenic
and has substantially no cross reactivity with anti-dextran antibodies” and
argued that, in view of the amendments, “a person of skill in the art would
understand ‘polyisomaltose’ does not refer to dextrans.” Ex. 1002, 201,
206–207.
In response, the Examiner withdrew the indefiniteness rejection and
stated that Patent Owner’s remarks were “persuasive.” Ex. 1002, 236–237.
The Examiner further stated that “the instant specification makes reasonably
clear that polyisomaltose as described in the instant application does not
mean dextran and instead the term is given its regular meaning in the art.”
Id. at 237. Therefore, during prosecution of the ’450 patent, the Examiner
addressed the issue of whether the term “polyisomaltose” was indefinite and
also specifically addressed whether dextran was encompassed by the term.
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We are, thus, persuaded by Patent Owner that Petitioner’s
indefiniteness arguments are substantially the same as issues previously
before the Office.
4. Written Description
Petitioner argues that the claims are unpatentable for lack of written
description because “[t]he ’450 patent does not describe or exemplify any
iron polyisomaltose complex, let alone the claimed substantially non-
immunogenic iron polyisomaltose complex that does not cross-react with
anti-dextran antibodies.” Pet. 39–55. Petitioner also argues that a
“substantially non-immunogenic complex” is not described in the ’450
patent specification. Id. at 43–44.
Patent Owner asserts that, “[a]lthough the Office has not expressly
addressed written description of the ’450 patent claims, Petitioner’s written
description arguments substantially overlap [with] its incorrect claim
construction and enablement positions . . . .” PO Sur-Reply 7 (citing Pet.
39–55). Petitioner asserts that “written description was never raised before,
much less decided (Becton, Dickinson factors (a), (b), (d)).” Reply 5.
We agree with Petitioner that the Examiner never issued a written
description rejection during prosecution of the ’450 or ’549 patents.
However, we also agree with Patent Owner that many of the issues involved
in Petitioner’s claim construction and enablement arguments (which were
previously before the Office), overlap with issues Petitioner raises in
connection with written description. For example, Petitioner argues that the
’450 patent does not describe or exemplify any iron polyisomaltose
complex, nor such a complex that is substantially non-immunogenic and
does not cross react with anti-dextran antibodies. Pet. 39. As discussed
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supra, a similar argument was made by the Examiner in the enablement
rejection of the ’549 patent. See Ex. 1007, 83. Petitioner also argues that
“[t]he ’450 patent provides no structural information, physicochemical
characteristics, or study data for any iron polyisomaltose complex, let alone
a ‘substantially non-immunogenic’ and ‘substantially non-cross-reactive’
one,” similar to arguments made by the Examiner. Compare Pet. 40, with
Ex. 1007, 82–83. Petitioner also discusses the ’450 patent’s failure to
provide details on how the claimed iron polyisomaltose differs from iron
dextran, which was discussed by the Examiner in relation to the
indefiniteness rejection during prosecution of the ’450 patent. Compare Pet.
40–41, with Ex. 1002, 187–189, 206–213, 236–237.
Based on the above, we find that there is substantial overlap between
the arguments made in Petitioner’s written description analysis and those
previously presented to the Office. We address how this finding impacts our
overall section 325(d) analysis below.
5. Jahn
Ground 4 of the Petition asserts that most of the challenged claims are
anticipated by Jahn. Pet. 73–86. In grounds 5–8, Petitioner asserts that
dependent claims 5, 13, 14, and 17, respectively, are rendered obvious by
Jahn in combination with one additional reference. Id. at 86–94. Although
neither party discusses the Jahn reference in their section § 325(d) briefing,
we note that Jahn was before the Examiner during prosecution of the ’549
and ’450 patents.
As discussed supra, Jahn was discussed by Patent Owner in response
to an enablement rejection in the ’549 patent prosecution and the Examiner
also discussed Jahn in the Reasons for Allowance. See Ex. 1007, 99–103,
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142. Jahn was also submitted on an Information Disclosure Statement
(“IDS”) during prosecution of the ’450 patent, which was considered by the
Examiner, and is listed under “References Cited” on the ’450 patent. See
Ex. 1001, code (56); Ex. 3002; Ex. 3003. Thus, Jahn previously was
presented to the Office.
H. Whether the Office Erred in a Manner Material to Patentability
Because we find that the same or substantially the same art and
arguments previously were presented to the Office, we turn to whether
Petitioner demonstrates that the Office erred in a manner material to the
patentability of the challenged claims. Advanced Bionics, Paper 6 at 8, 10;
see Becton, Dickinson, Paper 8 at 24. As discussed below, we conclude that
Petitioner does not demonstrate such an error material to patentability.
1. Claim Construction
Petitioner argues that “even if the Examiner did ‘accept’” Patent
Owner’s “lexicographic [re]definition,” of the term “polyisomaltose” to
include iron oligoisomaltose, that was an error. Reply 3. Petitioner cites to
ten pages of the Petition as evidence of the Examiner’s alleged error. Id. at 2
(citing Pet., 31–36, 46–50). The Petition asserts that the Examiner
“apparently never considered the key distinction between oligoisomaltoses
and polyisomaltoses” and contends that the claims and specification of the
’450 patent distinguish the two. Pet. 35. Specifically, Petitioner asserts that
the claims require the use of polyisomaltose rather than oligoisomaltose
wherein “poly means ‘many’ and oligo means ‘few.’” Id. at 32 (citing Ex.
1102 ¶ 93; Ex. 1015, 3–4)
Petitioner also contends that the specification classifies
polysaccharides and oligosaccharides separately, listing “iron
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monosaccharide complexes, iron disaccharide complexes, iron
oligosaccharide complexes, and iron polysaccharide complexes” as
examples of “commercially available” complexes. Pet. 32–33 (citing Ex.
1001, 10:63–65). According to Petitioner, “when the patent lists the
‘various embodiments’ of the alleged invention, it specifically omits
oligosaccharides, mentioning only ‘an iron monosaccharide complex, and
iron disaccharide complex, or an iron polysaccharide complex.’” Id. at 32–
33 (citing Ex. 1001, 3:39–41). Petitioner also cites to extrinsic evidence that
purportedly shows that polysaccharides and oligosaccharides are distinct and
do not encompass each other. See id. at 33–34.
We are not persuaded by Petitioner’s arguments that the Examiner
materially erred. There is no indication in the prosecution history that the
Examiner misapprehended or overlooked the potential differences between
oligoisomaltoses and polyisomaltoses. As discussed supra, in responding to
an enablement rejection in the ’549 patent prosecution, Patent Owner stated
that “[o]ne example of an iron polyisomaltose complex is an iron
isomaltoside (e.g., Monofer®), where the carbohydrate component is a pure
linear chemical structure of repeating α1-6 linked glucose units.” Ex. 1007,
99 (emphasis added). The Lawrence Declaration submitted by Patent Owner
during the ’549 patent prosecution similarly stated that “[b]ased on my
experience, an iron polyisomaltose is a type of iron carbohydrate complex
that includes isomaltose units in the carbohydrate component.” Ex. 1007,
111 (emphasis added). Patent Owner further argued that “[i]t was also
understood at the time of filing that isomaltose oligomers acted as haptens
against circulating anti-dextran antibodies,” which was also supported by the
Lawrence Declaration. Ex. 1007, 99, 11–113 (emphasis added). In response
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to these arguments, the Examiner withdrew the enablement rejection and
stated the following in the Reasons for Allowance:
[Jahn] provides evidence that at the time of the instant
invention one of ordinary skill in the art would have been able
to select isomaltose oligomers to block anaphlaxis to dextrans
and that selection of isomaltose oligomers that were
nonanaphylactogenic and desensitizing in animals sensitized
against dextran.
Id. at 142 (italicized emphasis added).
These excerpts from the prosecution history indicate that the
Examiner viewed isomaltose oligomers as being encompassed by
polyisomaltose, as argued by Patent Owner during prosecution and in the
Preliminary Response. See Ex. 1007, 99–101, 111–113; Prelim. Resp. 27–
34. Petitioner does not present persuasive evidence that there was material
error in this interpretation.
Petitioner also argues that the Examiner erred by interpreting
“polyisomaltose” to be linear and dextran to be branched and that the
Examiner “incorrectly assumed linearity was key, without truly considering
it.” Reply 4. As discussed supra, the distinction between dextran as being
branched and iron polyisomaltose as being linear was discussed by Patent
Owner and the Examiner during prosecution. Ex. 1002, 207–213; Ex. 1007,
82, 99–100, 119–113. Therefore, based on the art and arguments presented
during prosecution distinguishing dextran from polyisomaltose, the
Examiner found “iron polyisomaltose” to be linear. See, e.g., Ex. 1002,
207–213; Ex. 1007, 82, 99–100, 119–113. Petitioner has not persuaded us
that there was a material error in the Examiner’s finding.
Petitioner further asserts that the Examiner “never addressed the
arguments and evidence” that Petitioner offers here and that “[t]hese errors
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support institution.” Reply 4. Petitioner fails to provide a sufficient
explanation as to why the additional arguments and evidence warrant
reconsideration of this claim construction. Thus, this argument also fails to
persuade us that the Office erred in a manner material to patentability.
2. Enablement
Petitioner argues that the Examiner was wrong to withdraw the
enablement rejection and cites to thirteen pages of its Petition as
“explain[ing] this in detail.” Reply 7 (citing Pet., 55–67). The cited pages
refer to the enablement rejection in the ’549 patent prosecution in a few
places. First, in assessing the second Wands factor, Petitioner states that, in
response to the enablement rejection, Patent Owner identified two references
cited in the specification that could be used to assess hypersensitivity, safety,
efficacy, and toxicity. See Pet. 59 (citing Ex. 1007, 101; Ex. 1001, 11:40–
45). According to Petitioner, these references illustrate that “determining
whether a given complex falls within the claims would require the post-hoc
review of years of testing.” Id. at 59–60 (citing Ex. 1102 ¶ 123; Ex. 1103
¶¶ 97–98, 100). However, Petitioner provides no discussion of how the
Examiner analyzed these references or why the Examiner materially erred in
such consideration.
Similarly, Petitioner references Patent Owner’s identification of
Examples 4 and 5 in the specification as relevant working examples in
response to the Examiner’s enablement rejection. Pet. 62 (citing Ex. 1007,
102–103). Petitioner contends that these examples, which describe eleven
clinical trials in thousands of patients, are evidence of “undue
experimentation.” Id. Petitioner also contests Patent Owner’s statement that
there was an “increased level of predictability in the art” in response to the
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enablement rejection. Id. at 64. However, again, Petitioner fails to provide
any analysis of how the Examiner viewed these arguments or materially
erred in such analysis.
Lastly, Petitioner argues that Patent Owner incorrectly relied on post-
filing art, Jahn, in responding to the enablement rejection. Pet. 65–67.
However, Petitioner fails to show that Patent Owner and the Examiner
incorrectly relied on Jahn to show what was known at the time of filing
based on Jahn’s retrospective teachings. Specifically, Patent Owner
discussed Jahn’s teachings of the ability of isomaltose oligomers to prevent
or block anaphylaxis to dextrans and act as haptens against circulating anti-
dextran antibodies as described in references from the 1960’s, 1970’s, and
1980’s. See Ex. 1007, 99–101, 112 (citing Ex. 1048; Ex. 1034). In response
to these arguments, the Examiner withdrew the enablement rejection and
cited to Jahn in the Reasons for Allowance as providing evidence that “at the
time of the instant invention one of ordinary skill in the art would have been
able to select isomaltose oligomers to block anaphlaxis to dextrans.” Ex.
1007, 142. Petitioner does not discuss these statements by Patent Owner or
the Examiner and fails to show how the Examiner materially erred in
considering this retrospective art.
Petitioner further asserts that they have never before presented their
arguments and evidence on enablement (Reply 7); however, this general
statement is not enough to show that the Examiner erred in a manner that is
material to patentability.
3. Indefiniteness
As mentioned supra, Petitioner did not make any arguments regarding
indefiniteness in its Reply regarding section 325(d). Thus, on this record,
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we determine that Petitioner does not demonstrate that the Office erred in a
manner material to the patentability of the challenged claims with regard to
indefiniteness.
4. Written Description
Petitioner does not present specific arguments as to why the Office
materially erred with respect to written description because it argues that
written description was never addressed by the Office. Reply 5. As stated
above, many of the issues involved in Petitioner’s claim construction,
enablement, and indefiniteness arguments (which were previously before the
Office), overlap with issues raised with respect to written description. For
the reasons discussed above, to the extent the issues overlap, we find no
material error in the Examiner’s analysis.
5. Jahn
As discussed supra, Jahn was before the Examiner during prosecution
of the ’549 and ’450 patents. The Examiner clearly considered this
reference by discussing it in the Reasons for Allowance of the ’549 patent
and indicating consideration of it when it was submitted on an IDS during
prosecution of the ’450 patent. See Ex. 1007, 99–103, 142; Ex. 3003.
Despite this consideration, the Examiner did not apply Jahn in any rejections
against the claims of the ’549 or ’450 patents. Ex. 1007, 142.
We note that Petitioner’s assertion that Jahn is prior art depends
primarily on its arguments that the ’450 patent claims lack section 112
support. Pet. 73 (referencing discussion at Pet. 29–31). Petitioner has not
persuaded us that the Examiner erred in deciding not to reject the challenged
claims over Jahn.
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6. Conclusion as to § 325(d)
For the reasons set forth above, we do not institute review of claims
1‒22 under grounds 2–8 because, under 35 U.S.C. § 325(d), the same or
substantially the same prior art and arguments previously were presented to
the Office, and Petitioner has not shown that the Office erred in a manner
material to patentability.
IV. U.S.C. § 324(a)
Pursuant to 35 U.S.C. § 324(a), a post-grant review may not be
instituted “unless . . . the information presented in the petition . . . if such
information is not rebutted, would demonstrate that it is more likely than not
that at least 1 of the claims challenged in the petition is unpatentable.” But
even when a petitioner demonstrates a reasonable likelihood of prevailing
with respect to one or more claims, institution of review remains
discretionary. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018)
(“[Section] 314(a) invests the Director with discretion on the question
whether to institute review . . . .” (emphasis omitted)); Harmonic Inc. v. Avid
Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is permitted,
but never compelled, to institute an IPR proceeding.”).
In exercising that discretion, we are guided by the statutory
requirement, in promulgating regulations for post-grant review, to consider
the effect of any regulations on “the efficient administration of the Office
[and] the ability of the Office to timely complete proceedings,” 35 U.S.C.
§ 326(b), as well as the requirement to construe our rules to “secure the just,
speedy, and inexpensive resolution of every proceeding,” 37 C.F.R.
§ 42.1(b). Office guidance, issued June 5, 2018, also explains that the Board
“will evaluate the challenges and determine whether § 325(d) is sufficiently
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implicated that its statutory purpose would be undermined by instituting on
all challenges” and, if so, “evaluate whether the entire petition should be
denied.” SAS Q&A’s, Part D, Effect of SAS on Future Challenges that
Could Be Denied for Statutory Reasons (June 5, 2018), available at
https://www.uspto.gov/sites/default/files/documents/sas_qas_20180605.pdf
(answer to Question D1).
Here, as discussed above, we determine that § 325(d) is sufficiently
implicated to deny institution of grounds 2–8. The remaining ground,
ground 1, asserts that claims 1–22 are unpatentable for lack of written
description. As discussed above, many of the issues raised by Petitioner
with respect to written description overlap with arguments previously before
the Office regarding claim construction, enablement, and indefiniteness.
On this record, and based on the particular facts of this proceeding,
instituting a trial with respect to all grounds based on evidence and
arguments directed to only one ground, with overlapping issues to those
already considered by the Office, would not be an efficient use of the
Board’s time and resources. See, e.g., Deeper, UAB v. Vexilar, Inc.,
IPR2018-01310, Paper 7 at 41–43 (PTAB Jan. 24, 2019) (informative);
Chevron Oronite Co. v. Infineum USA L.P., IPR2018-00923, Paper 9 at 10–
11 (PTAB Nov. 7, 2018) (informative). Further, we find that § 325(d) is
sufficiently implicated by grounds 2–8 that its statutory purpose would be
undermined by instituting on all challenges. Thus, we do not institute a
post-grant review.
V. CONCLUSION
For the foregoing reasons, we exercise our discretion not to institute
post-grant review.
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VI. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that the Petition is denied and no post-grant review is
instituted.

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PETITIONER:
Jeffrey Oelke
Ryan P. Johnson
Vanessa Park-Thompson
So Yeon Choe
FENWICK & WEST LLP
joelke@fenwick.com
ryan.johnson@fenwick.com
vpark-thompson@fenwick.com
schoe@fenwick.com

PATENT OWNER:
Barbara Rudolph
Trenton Ward
Cora Holt
FINNEGAN, HENDERSON, FARABOW,
GARRETT & DUNNER, LLP
barbara.rudolph@finnegan.com
trenton.ward@finnegan.com
cora.holt@finnegan.com