Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 17
`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)
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Paper 17
`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)
`
`
`
`
`
`
`
`
`
`PGR2020-00009
`Patent 10,478,450 B2
`
`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.
`
`2
`
`
`
`PGR2020-00009
`Patent 10,478,450 B2
`
`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.
`
`3
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`
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`PGR2020-00009
`Patent 10,478,450 B2
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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.
`
`4
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`PGR2020-00009
`Patent 10,478,450 B2
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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
`1–22
`
`1
`
`35 U.S.C. § References/Basis
`
`112(a)
`
`Written Description
`
`2
`
`3
`
`4
`
`1–22
`
`1–22
`
`112(a)
`
`112(b)
`
`Enablement
`
`Indefiniteness
`
`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
`
`5
`
`
`
`PGR2020-00009
`Patent 10,478,450 B2
`
`Ground Claims
`Challenged
`5
`
`5
`
`6
`
`7
`
`8
`
`13
`
`14
`
`17
`
`35 U.S.C. § References/Basis
`
`103
`
`103
`
`103
`
`103
`
`Jahn, Helenek3
`
`Jahn, Wikström4
`
`Jahn, CKD Guidelines5
`
`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”).
`
`6
`
`
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`PGR2020-00009
`Patent 10,478,450 B2
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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.
`
`7
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`PGR2020-00009
`Patent 10,478,450 B2
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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
`
`8
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`
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`PGR2020-00009
`Patent 10,478,450 B2
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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(cid:173)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(cid:173)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.
`
`9
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`PGR2020-00009
`Patent 10,478,450 B2
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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:
`
`10
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`PGR2020-00009
`Patent 10,478,450 B2
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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.
`
`11
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`Patent 10,478,450 B2
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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
`
`12
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`Patent 10,478,450 B2
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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.
`
`13
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`PGR2020-00009
`Patent 10,478,450 B2
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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.”
`
`14
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`PGR2020-00009
`Patent 10,478,450 B2
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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).
`
`15
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`PGR2020-00009
`Patent 10,478,450 B2
`
`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
`
`16
`
`
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`PGR2020-00009
`Patent 10,478,450 B2
`
`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(cid:173)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(cid:173)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
`
`17
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`PGR2020-00009
`Patent 10,478,450 B2
`
`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
`
`18
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`
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`PGR2020-00009
`Patent 10,478,450 B2
`
`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 an
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