`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`PHARMACOSMOS A/S,
`Petitioner,
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`v.
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`AMERICAN REGENT, INC.,
`Patent Owner.
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`Case PGR2020-00009
`Patent No. 10,478,450
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`PATENT OWNER’S SUR-REPLY ON THE ISSUE OF
`DISCRETIONARY DENIAL UNDER 35 U.S.C. § 325(d)
`(AUTHORIZED BY THE BOARD’S JUNE 2, 2020 ORDER, PAPER NO. 13)
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`I.
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`TABLE OF CONTENTS
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`PGR2020-00009
`Patent No. 10,478,450
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`Advanced Bionics Warrants Denial of Institution Under § 325(d) ................. 1
`A.
`Claim Construction ............................................................................... 1
`B.
`Indefiniteness ......................................................................................... 4
`C.
`Enablement ............................................................................................ 5
`D. Written Description ............................................................................... 7
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`TABLE OF AUTHORITIES
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`PGR2020-00009
`Patent No. 10,478,450
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` Page(s)
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`Cases
`Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH
`IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) .......................................... 1, 3, 5
`Honeywell Int’l, Inc. v. Universal Avionics Sys. Corp.,
`493 F.3d 1358 (Fed. Cir. 2007) ............................................................................ 3
`R.J. Reynolds Vapor Co. v. Fontem Holdings 1 B.V.,
`IPR2017-01180, Paper 10 (PTAB Oct. 23, 2017) ................................................ 6
`Statutes
`35 U.S.C. § 112 .......................................................................................................... 1
`35 U.S.C. § 325(d) ............................................................................................. 1, 4, 6
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`ii
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`PGR2020-00009
`Patent No. 10,478,450
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`The Examiner and Board have repeatedly rejected Petitioner’s incorrect claim
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`construction of “iron polyisomaltose” and its meritless § 112 challenges. Petitioner
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`fails to identify any error in the Office’s previous determinations; in fact, neither the
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`Petition nor Reply provides any substantive analysis of the Office’s previous
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`findings. In Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH,
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`the Board exercised its discretion to deny institution because, even though the
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`petitioner raised new art and arguments, it failed to identify error in the Examiner’s
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`previous consideration of similar art and arguments. IPR2019-01469, Paper 6, at
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`21-22 (PTAB Feb. 13, 2020). “At bottom, this framework reflects a commitment to
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`defer to previous Office evaluations of the evidence of record unless material error
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`is shown.” Id. at 9. Similar to Advanced Bionics, the Board should defer to the
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`Office’s previous evaluations as Petitioner fails to establish any error by the Office.
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`I.
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`Advanced Bionics Warrants Denial of Institution Under § 325(d)
`A. Claim Construction
`Advanced Bionics Prong 1 (Becton Dickinson factors a-d): The Examiner
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`and the Board have already addressed whether “polyisomaltose” is linear and
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`includes oligoisomaltoses and agreed with Patent Owner on both points. POPR, 20-
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`26, 30-31, 55-57. During prosecution of the ’450 patent and its parent ’549 patent,
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`the Examiner questioned the meaning of “polyisomaltose,” and Patent Owner
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`conclusively defined “iron polyisomaltose” as linear. Ex. 1002, 188, 206-207, 209-
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`1
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`PGR2020-00009
`Patent No. 10,478,450
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`212; Ex. 1007, 99-101, 111. The Examiner then applied this definition and
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`eventually allowed the claims. Ex. 1002, 237. Patent Owner also cited Monofer®,
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`an iron oligosaccharide complex, stating that “[o]ne example of an iron
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`polyisomaltose complex is an iron isomaltoside (e.g., Monofer®), where the
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`carbohydrate component is a pure linear chemical structure of repeating α1-6 linked
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`glucose units.” Ex. 1007, 99-101, 111. Petitioner concedes that Monofer® is an
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`oligoisomaltose. Pet., 3, 18 (citing Ex. 1048). The Examiner found Patent Owner’s
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`arguments “persuasive” and further equated “polyisomaltose” and “isomaltose
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`oligomers,” finding that “one of ordinary skill in the art … would have been able to
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`practice the invention for iron polyisomaltose complex … [because] one of ordinary
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`skill in the art would have been able to select isomaltose oligomers to block
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`anaphylaxis to dextrans.” Ex. 1007, 142. Petitioner’s contention that the Examiner
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`never “formally” considered the linearity and oligomer issues or gave it “cursory”
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`treatment (Reply, 1-2) is belied by the record. Becton Dickinson factor (d) favors
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`denial.
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`In an IPR challenging the parent ’549 patent, the Board likewise equated “iron
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`polyisomaltose” and oligosaccharides by finding the limitation was met by prior art
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`disclosing “isomaltoseoligosacccharides.” Ex. 1098, 21. Petitioner argues that
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`Patent Owner “omits critical details”—that this finding was based only on an
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`“alternative” construction offered by Petitioner. Reply, 3-4. But the Board applied
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`PGR2020-00009
`Patent No. 10,478,450
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`this construction to agree with Petitioner that certain claims of the ’549 patent were
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`unpatentable. Ex. 1098, 21. Petitioner should not have it both ways: it should not
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`be able to argue unpatentability under Patent Owner’s construction in one case and
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`then later in another case argue that the construction is incorrect.
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`Advanced Bionics Prong 2 (Becton Dickinson factors e-f): Petitioner
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`identifies no error or evidence warranting reconsideration. As to prosecution,
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`Petitioner suggests that Patent Owner’s lexicography does not “bind[] the Board in
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`this PGR.” Reply, 2. But “[w]hen a patentee defines a claim term, the patentee’s
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`definition governs.” Honeywell Int’l, Inc. v. Universal Avionics Sys. Corp., 493 F.3d
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`1358, 1361 (Fed. Cir. 2007). And Petitioner does not explain how Patent Owner’s
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`lexicography purportedly “enlarge[d]” the limitation (Reply, 2-3), given that
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`oligoisomaltoses have always been within the scope of the claims. Petitioner’s only
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`other arguments are that the Office did not “truly consider” or “conclusively rule”
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`on the question, or if it did, that the Petition “debunks” and “prevails” over those
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`determinations—block-citing to the Petition but providing no additional argument.
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`Reply, 4-5. These arguments fail, as the Office did consider the issue (explained
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`above), and Petitioner’s merits arguments do not change the result. POPR, 19-34;
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`Advanced Bionics, at 9 (“If reasonable minds can disagree regarding the purported
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`treatment of the art or arguments, it cannot be said that the Office erred in a manner
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`material to patentability.”).
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`PGR2020-00009
`Patent No. 10,478,450
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`Indefiniteness
`B.
`Petitioner’s Reply omits mention of § 325(d) applied to its indefiniteness
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`challenge. That is because Petitioner’s challenge—that the relationship between
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`“iron polyisomaltose” and “dextran” is unclear and that a skilled artisan could not
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`identify the claimed substantially non-immunogenic polyisomaltose (Pet., 67-71)—
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`has been conclusively decided by the Office. POPR, 24-26, 35-38.
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`Advanced Bionics Prong 1 (Becton Dickinson factors a-d): During
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`prosecution, the Examiner initially rejected the claims as indefinite on grounds that
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`it was “unclear if the meaning of term ‘polyisomaltose’ encompasses the meaning
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`loosely ‘dextran’ as used in the prior art.” Ex. 1002, 188. Patent Owner explained:
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`“[A] person of skill in the art would understand ‘polyisomaltose’ does not refer to
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`dextrans, which are distinguished in the application from the iron carbohydrate
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`complexes used in the methods, disclosed and claimed. Hence, ‘polyisomaltose’ is
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`not the same as dextran, which is a branched glucan polysaccharide.” Ex. 1002,
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`206-207. In view of Patent Owner’s response, the Examiner withdrew the rejection
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`and allowed the claims: “the instant specification makes reasonably clear that
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`polyisomaltose [] in the instant application does not mean dextran.” Ex. 1002,
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`237. Similarly, in denying institution of the IPR of related U.S. Patent No.
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`8,895,612, which derives from the same priority application, the Board held that
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`Pharmacosmos “ha[d] not established adequately that the claim term ‘iron
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`Patent No. 10,478,450
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`polyisomaltose’ would be understood … to encompass Marchasin’s ‘iron-
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`dextran.’” Ex. 2009, 14. Becton Dickinson factor (d) favors denial.
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`Advanced Bionics Prong 2 (Becton Dickinson factors e-f): Petitioner’s
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`Reply nowhere addresses indefiniteness and therefore does not demonstrate error in
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`the Office’s determination. To the extent Petitioner addresses this issue in the
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`context of claim construction (Reply, 4-5), those arguments fail as explained above:
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`Petitioner merely argues its position is correct without directly addressing the
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`Examiner’s specific findings or demonstrating error. Advanced Bionics, at 21
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`(“Petitioner must demonstrate … that the Examiner misapprehended or overlooked
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`specific teachings in the relevant prior art.”); Becton Dickinson factors (e)-(f).
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`C. Enablement
`Advanced Bionics Prong 1 (Becton Dickinson factors a-d): Petitioner
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`argues the ’450 patent does not describe or enable the claimed substantially non-
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`immunogenic iron polyisomaltose complex. Pet., 39-67. But the Examiner has
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`already rejected that contention, finding similar claims of the ’549 patent enabled.
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`POPR, 58-65. Namely, the Examiner initially rejected the ’549 patent claims for
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`lack of enablement out of concern (as Petitioner argues here, Pet., 39-67) that the
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`specification did not identify or provide guidance as to the properties of the claimed
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`iron polyisomaltose that rendered it substantially non-immunogenic with no cross
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`reactivity with antidextran antibodies. Ex. 1007, 80-84. Patent Owner overcame
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`5
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`PGR2020-00009
`Patent No. 10,478,450
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`that rejection, explaining through a detailed Wands analysis that the specification’s
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`disclosure, including description of the characteristics of the claimed complexes and
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`the known methods of testing, combined with the state of the art at the time, would
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`have enabled a person of ordinary skill in the art to make and use the claimed non-
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`immunogenic and non-cross-reactive iron polyisomaltose complex. Ex. 1007, 97-
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`104, 110-113. The Examiner found these arguments “persuasive” and allowed the
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`claims: “Applicant’s remarks and declaration of Richard P. Lawrence … are
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`persuasive that one of ordinary skill in the art at the time of the instant invention
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`would have been able to practice the invention for iron polyisomaltose complex
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`having substantially non-immunogenic carbohydrate complex and substantially no
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`cross reactivity with anti-dextran antibodies.” Ex. 1007, 142.
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`Petitioner argues the Examiner’s enablement finding is “irrelevant” because
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`the claims of the ’450 and ’549 patents are not identical, insofar as one recites a
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`carbohydrate “complex” and the other a carbohydrate “component.” Reply, 7. But
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`the Board has discretion to deny institution under § 325(d) based on similar
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`arguments raised in proceedings involving related patents. R.J. Reynolds Vapor Co.
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`v. Fontem Holdings 1 B.V., IPR2017-01180, Paper 10, 11-14 (PTAB Oct. 23, 2017).
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`And here, Petitioner fails to distinguish the arguments and simply ignores the
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`Board’s prior, dispositive factual finding that “the carbohydrate component
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`PGR2020-00009
`Patent No. 10,478,450
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`determines the immunological properties of the iron carbohydrate complex as a
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`whole.” Ex. 1098, 17; POPR, 54.
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`Advanced Bionics Prong 2 (Becton Dickinson factors e-f): Petitioner argues
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`the Petition explains “in detail” why the Examiner was wrong to withdraw his
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`enablement rejection. Reply, 7 (citing Pet., 55-67). But the cited pages hardly
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`mention the Examiner’s determination, much less explain “how the Examiner erred
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`in its evaluation.” Becton Dickinson factor (e).
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`D. Written Description
`Although the Office has not expressly addressed written description of the
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`’450 patent claims, Petitioner’s written description arguments substantially overlap
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`its incorrect claim construction and enablement positions (Pet., 39-55) and fail for
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`the reasons already described. Moreover, the Examiner observed that the ’450 patent
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`claims are supported by the ’549 pre-AIA patent when issuing a double patenting
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`rejection, and that the ’450 patent is subject to pre-AIA law. POPR, 11-14.
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`Petitioner only speculates that the Examiner’s finding was based on “a simple
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`‘control+F’ search” and that the claims “might not be subject to pre-AIA law,” but
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`fails to identify any substantive error by the Office. Reply, 6-7. Accordingly,
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`discretionary denial is appropriate. Becton Dickinson factor (e).
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`Dated: June 16, 2020
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`PGR2020-00009
`Patent No. 10,478,450
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`Respectfully submitted,
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`By: /Barbara R. Rudolph/
`Barbara R. Rudolph
`Lead Counsel for American Regent Inc.
`Registration No. 77,737
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`CERTIFICATE OF SERVICE
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`PGR2020-00009
`Patent No. 10,478,450
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Sur-Reply on the Issue of Discretionary Denial Under 35 U.S.C. §
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`325(d) was served on June 16, 2020 via email directed to counsel of record for the
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`Petitioner at the following:
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`Jeffrey J. Oelke
`Ryan P. Johnson
`Vanessa Park-Thompson
`So Yeon Choe
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`joelke@fenwick.com
`ryan.johnson@fenwick.com
`vpark-thompson@fenwick.com
`schoe@fenwick.com
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`Dated: June 16, 2020
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`By: /William Esper/
`William Esper, Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P
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