`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`
`PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`Case Nos. IPR2021-00880 & IPR2021-00881
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`
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`
`
`
`2.
`
`3.
`
`TABLE OF CONTENTS
`TABLE OF AUTHORITIES .................................................................................... ii
`I.
`INTRODUCTION. .......................................................................................... 1
`II.
`ARGUMENT. .................................................................................................. 3
`BACKGROUND: INTRINSIC RECORDS OF THE CHALLENGED
`PATENTS. ................................................................................................ 3
`DISCRETIONARY DENIAL UNDER § 325(d) IS NOT WARRANTED. .............. 6
`1.
`Petitioner’s asserted art and arguments are not the same
`or cumulative. (Becton, Dickinson (a), (b), and (d)). ................. 6
`Petitioner presents additional, new art and arguments.
`(Becton, Dickinson (a), (b), (d)). ................................................. 8
`If the Board concludes step one of Advanced Bionics is
`satisfied, the Office erred. (Becton, Dickinson (c), (e),
`(f)). .............................................................................................. 9
`The cases cited in the POPR are not relevant to the facts
`here. ............................................................................................. 9
`III. CONCLUSION. ............................................................................................. 10
`
`4.
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`
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`
`
`
`i
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`
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`
`TABLE OF AUTHORITIES
`Cases
`ABS Global, Inc. v. Cytonome/ST, LLC,
`IPR2021-00306, Paper 13 (P.T.A.B. Jun. 7, 2021) ............................................ 10
`Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH,
`IPR2019-01469, Paper 6 (P.T.A.B. Feb. 13, 2020) ................................... passim
`Amazon.com, Inc. v. M2M Solutions LLC,
`IPR2019-01205, Paper 14 (P.T.A.B. Jan. 27, 2020) ............................................ 1
`Amgen, Inc. v. Alexion Pharms., Inc.,
`IPR2019-00739, Paper 15 (P.T.A.B. Aug. 30, 2019) ........................................... 1
`Amneal Pharms. LLC v. Alkermes Pharma Ireland Ltd.,
`IPR2018-00943, Paper 8 (P.T.A.B. Nov. 7, 2018) ............................................... 1
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (P.T.A.B. Dec. 15, 2017) .................................. passim
`Boragen, Inc. v. Syngenta Participations AG,
`IPR2020-00124, Paper 16 (P.T.A.B. May 5, 2020) ........................................... 10
`Coolpad Techs., Inc. v. Bell N. Rsch., LLC,
`IPR2019-01319, Paper 19 (P.T.A.B. Jan. 29, 2020) ............................................ 4
`Dish Network L.L.C. v. Broadband iTV, Inc.,
`IPR2020-01332, Paper 14 (P.T.A.B. Jan. 17, 2021) ............................................ 7
`Gardner Denver, Inc. v. Utex Indus., Inc.,
`IPR2020-00333, Paper 12 (P.T.A.B. Aug. 5, 2020) ........................................... 10
`Guardian Indus. Corp. v. Pilkington Deutschland AG,
`IPR2016-01635, Paper 9 (P.T.A.B. Feb. 15, 2017) .............................................. 9
`Minerva Surgical, Inc. v. Hologic, Inc.,
`141 S. Ct. 2298 (2021) .......................................................................................... 2
`NXP USA, Inc. v. Impinj, Inc.,
`IPR2020-00519, Paper 7 (P.T.A.B. Aug. 17, 2020) ........................................... 10
`
`
`
`ii
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`
`
`Case Nos. IPR2021-00880 & IPR2021-00881
`
`
`Semiconductor Energy Laboratory Co. v. Samsung Electronics Co.,
`204 F.3d 1368 (Fed. Cir. 2000) ........................................................................4, 6
`Statutes
`35 U.S.C. §325(d) ...................................................................................................... 7
`Regulations
`37 C.F.R. § 1.56(a) ..................................................................................................... 2
`37 C.F.R. § 1.98(a)(2) ................................................................................................ 4
`
`
`
`
`
`
`iii
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`
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`As authorized by the Board (Paper 13), Petitioner submits this Reply.
`
`Case Nos. IPR2021-00880 & IPR2021-00881
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`
`I.
`
`INTRODUCTION.
`Discretionary denial is not warranted here. “The Board has consistently
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`declined exercising its discretion under Section 325(d) when the only fact a Patent
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`Owner can point to is that a reference was disclosed to the Examiner during the
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`prosecution.” Amgen Inc. v. Alexion Pharms., Inc., IPR2019-00739, Paper 15 at 62
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`(P.T.A.B. Aug. 30, 2019) (citing Amneal Pharms. LLC v. Alkermes Pharma Ireland
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`Ltd., IPR2018-00943, Paper 8 at 40 (P.T.A.B. Nov. 7, 2018); Amazon.com, Inc. v.
`
`M2M Solutions LLC, IPR2019-01205, Paper 14 at 16 (P.T.A.B. Jan. 27, 2020) (“[A]
`
`reference that ‘was neither applied against the claims nor discussed by the Examiner’
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`does not weigh in favor of exercising the Board’s discretion under § 325(d) to deny
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`a petition.”). In neither prosecution did the Examiner consider art or arguments the
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`same or substantially the same as Petitioner’s. Thus, there was no need for Petitioner
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`to address Becton, Dickinson factors or allege Examiner error.1
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`[IPR2021-00880] The ’069 Patent File History Does Not Pass Advanced
`
`Bionics’ Threshold Inquiry. Neither “the same [nor] substantially the same” art or
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`arguments were “previously . . . presented to the Office” for U.S. 9,669,069 (“the
`
`
`1 PO raised the Chengdu PGR2021-00035, which is inapposite. The ’345 patent
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`contains eight pages of “References Cited.” PGR2021-00035, Ex.1001, 1-8.
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`
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`1
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`’069 patent”). Petitioner asserts, among several other references, Dixon (Ex.1006),
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`as anticipatory art. Patent Owner (“PO”) argues that “Dixon was submitted to the
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`Office . . . and was marked ‘considered’ by the Examiner.” The intrinsic record
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`confirms otherwise. First, like in Amazon, Dixon was “neither applied against the
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`claims nor discussed by the Examiner.” (See also Petition, 32 (“Dixon was not cited
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`by the Examiner.”)). Second, while a “Dixon” citation appears in an IDS submitted
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`at the end of prosecution, Dixon—in the form asserted by Petitioner (Ex.1006)—
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`was in fact neither presented nor considered. Instead, PO intentionally submitted
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`only the first page of Dixon to the Examiner, misdirecting him from the critical
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`disclosures that anticipate and invalidate the claims. PO never “‘disclose[d]’ to the
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`PTO all information [it] kn[ew] ‘to be material to patentability.’” Minerva Surgical,
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`Inc. v. Hologic, Inc., 141 S. Ct. 2298, 2309 n.3 (2021) (quoting 37 C.F.R. § 1.56(a)).
`
`The Examiner therefore never considered Dixon—in its entirety, as Petitioner
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`asserts—or the dosing regimens disclosed therein.
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`[IPR2021-00881] The ’338 Patent File History Does Not Pass Advanced
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`Bionics’ Threshold Inquiry. Similarly, neither “the same [nor] substantially the
`
`same” art or arguments were “previously . . . presented to the Office” for U.S.
`
`9,254,338 (“the ’338 patent”). PO distorts the intrinsic record, misrepresenting a
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`2012 (post-art) paper as a 2008 publication to argue cumulativeness. That argument
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`fails for its deliberate contradiction of the facts, which confirm the Examiner never
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`
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`2
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`
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`considered Petitioner’s asserted art or any other VIEW prior art.
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`In sum, the answer to Advanced Bionics’ first inquiry—whether the same or
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`substantially the same art or arguments were previously presented to the Office—
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`for both challenged patents is a definitive “no.” Petitioner thus had no reason to
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`allege Examiner error or provide Becton, Dickinson analysis.
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`II. ARGUMENT.
` BACKGROUND: INTRINSIC RECORDS OF THE CHALLENGED PATENTS.
` [IPR2021-00880] The ’069 Patent Prosecution. First, Dixon (Ex.1006)
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`was “neither applied against the claims nor discussed by the [E]xaminer.”
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`Amazon.com, Paper 14 at 16; (see also Petition, 32).2 The Examiner issued one
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`office action, asserting OTDP over several prior PO patents, none of which disclosed
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`CLEAR-IT-23 (Ex.1017, 105-09), and further stating that while the OTDP patents
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`“do[] not disclose the [claimed] dosing schedules,” the element was “routine
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`experimentation.” The Examiner did not apply any prior art disclosing the dosing
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`2 PO alleges Regeneron (30-April-2009) is cumulative of Regeneron (20-December-
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`2010). Not so. The 2010 document is 102(a) art; Regeneron (30-April-2009) is
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`102(b) art, and, like Dixon, was never asserted or discussed by the Examiner.
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`Further, Mitchell (ranibizumab) is not cumulative of one-page Dixon (aflibercept).
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`3 PO notably does not allege Dixon is cumulative of the art or arguments the
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`Examiner actually asserted (i.e., the OTDP patents) during prosecution.
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`3
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`regimens in Dixon. In response, PO asserted so-called “improved unexpected
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`results,” presenting Heier-2012 as support. (Id., 136). PO never directed the
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`Examiner to Dixon or any other prior art disclosing the dosing regimens in Dixon.
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`Second, Dixon was, in fact, not presented to the Examiner. The EFS
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`Acknowledgment Receipt clearly states that the Examiner received only one page:
`
`*
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`*
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`*
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`
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`(Ex.1017, 126 (emphasis added)).4 The certified file history confirms PO only
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`submitted a one-page copy. (Ex.1087 [-880 IPR]). Under 37 C.F.R. § 1.98(a)(2),
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`PO thus informed the Examiner that its one-page copy represented the “portion
`
`which caused [Dixon] to be listed,” affirmatively excluding the rest. The submitted
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`page, however, does not disclose (or even mention) the prior art regimens described
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`4 PO argues the Examiner’s initials signify he “considered” Dixon. (POPR, 10-11).
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`The initialed IDS shows, at best, that he “considered” the single page—no more.
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`Coolpad Techs., Inc. v. Bell N. Rsch., LLC, IPR2019-01319, Paper 19 at 9-12
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`(P.T.A.B. Jan. 29, 2020) (citing Semiconductor Energy Lab’y Co. v. Samsung
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`Electronics Co., 204 F.3d 1368, 1377-78 (Fed. Cir. 2000) (initials “extend[] only to
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`the examiner’s consideration of the brief translated portion”)).
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`4
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`extensively in the complete Dixon (Ex.1006). (Compare id., with Petition, 32-34).
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`[IPR2021-00881] The ’338 Patent Prosecution. Petitioner’s anticipatory art
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`was not considered by the Examiner. (Petition, 27-36). PO contends that art is
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`cumulative of an IDS-listed document which PO presents to the Board as a
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`“September 28, 2008, Regeneron Press Release” (hereinafter, the “9/28/08 PR”).
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`(POPR, 9). This is false and misleading. The paper on which PO hinges its argument
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`is a 2012 (i.e., post-art)5 printout of a “Thomson Reuters” website (“Reuters-
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`2012”)—i.e., not the 9/28/08 PR.6 (Ex.2007). The actual 9/28/08 PR (accessible to
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`PO but withheld from the Examiner7) contains information absent in Reuters-2012.
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`(Ex.1098 [-881 IPR] (comparison, with text missing from Reuters-2012 in blue)).
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`Reuters-2012 was also never “applied against the claims []or discussed by the
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`[E]xaminer”—nor was any VIEW dosing regimen prior art. Amazon.com, Paper 14
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`at 16. Instead, the Examiner made one round of OTDP rejections (based upon
`
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`5 The ’338 patent purports a Jan. 2011 priority date. Nothing in the record supports
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`finding the Examiner accepted Reuters-2012 as prior art or a printed publication.
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`6 In its POPR, PO short-cites Reuters-2012 (Ex.2007) as “9/28/2008 Press Release,”
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`repeatedly mispresenting it as a 2008 disclosure. (POPR, 9, 12-14, 58-59).
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`7 Actual, complete press releases, e.g., 9/28/08 PR, were accessible to PO. (Ex.1012;
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`Ex.1013; Ex.1028; Ex.1041; Ex.1053; Ex.1054; Ex.1056). None were presented.
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`5
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`Regeneron’s earlier sequence patents) before allowing the claims. No § 102 or § 103
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`rejections were lodged by the Examiner. (Ex.1017, 259-69).
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` DISCRETIONARY DENIAL UNDER § 325(d) IS NOT WARRANTED.
`In light of Advanced Bionics, incorporating the Becton, Dickinson factors, the
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`Board should not exercise its discretionary denial authority.
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`1.
`
`Petitioner’s asserted art and arguments are not the same or
`cumulative. (Becton, Dickinson (a), (b), and (d)).
`[IPR2021-00880]. PO classifies Petitioner’s primary references (Exs.1006,
`
`1012, 1020) as cumulative of the one-page “Dixon” the Examiner received at the
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`end of prosecution.8 As set forth above, neither Dixon (Ex.1006) nor any cumulative
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`art or substantially the same arguments were presented to or considered by the
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`Examiner. Indeed, PO’s one-page “Dixon” excludes every invalidating disclosure
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`of the prior art dosing regimens—all of which are expressly included in Petitioner’s
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`art. Accordingly, the first Advanced Bionics factor is not, and cannot be, satisfied.9
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`8 As stated above (see n.2 supra), Regeneron (30-April-2009) (Ex.1028) is also not
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`the same or substantially the same art as Regeneron (20-Dec-2010).
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`9 Petitioner further submits that the one-page “Dixon” fails to comply with PO’s
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`Rule 56 duties of candor, good faith, and disclosure. Instead, PO’s “misleadingly
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`incomplete” one-page copy “misdirect[ed] the examiner’s attention from [Dixon’s]
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`relevant teaching.” See Semiconductor, 204 F.3d at 1377-78.
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`6
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`[IPR2021-00881]. It is undisputed that Petitioner’s anticipatory references
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`were never presented, considered, or asserted during prosecution. Petitioner’s art—
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`all predating the ’338 patent—also is not substantially the same as Reuters-2012.
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`First, Reuters-2012 is post-art and thus is not, and cannot be, the “same or
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`substantially the same prior art.” 35 U.S.C. § 325(d) (emphasis added); Dish
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`Network L.L.C. v. Broadband iTV, Inc., IPR2020-01332, Paper 14 at 15 (P.T.A.B.
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`Jan. 27, 2021) (the cited reference “was not ‘prior art,’ as provided in §
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`325(d) . . . [thus] does not present ‘the same or substantially the same prior art’”)).10
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`Second, Petitioner’s art contains additional disclosures not in Reuters-2012.
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`For example, Dixon discusses Lucentis extended dosing regimens and the problems
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`with monthly intravitreal injections. (Ex.1006, 1574, 1577; Petition, 28-29). Adis
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`and Dixon disclose that VEGF Trap-Eye is aflibercept. (Ex.1006, 1573; Ex.1007,
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`261; Petition, 23-24). Regeneron (8-May-2008) includes efficacy endpoints for the
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`VIEW trials and PO/inventor statements about the claimed regimens. (Ex.1013).11
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`[Both IPRs] PO concedes Petitioner’s secondary references (’758 patent and
`
`Dix) were not presented to the Examiner. Instead, PO argues the ’234 application is
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`substantially the same, but, in doing so, PO ignores the additional, non-cumulative
`
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`10 Reuters-2012 is the only dosing reference PO bases its § 325(d) arguments on.
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`11 Such disclosures will rebut PO’s efficacy and expectation of success arguments.
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`7
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`disclosures in Petitioner’s art. For example, the ’758 patent contains Fig. 24, the
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`aflibercept sequence and domain annotations not found in the ’234 application or the
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`OTDP references. (Ex.1010, Fig.24A-C; Petition, 36, 63). Dix incorporates Holash,
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`the original publication detailing the creation and structure of aflibercept. (Ex.1033,
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`[0005]; Petition, 37, 63). The ’758 patent file history contains an EYLEA® PTE
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`application with PO admissions confirming Fig. 24A-C is the aflibercept sequence
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`and tying aflibercept to Holash. (Ex.1024, 2, 6-7; Petition, 36).12
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`2.
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`Petitioner presents additional, new art and arguments.
`(Becton, Dickinson (a), (b), (d)).
`[IPR2021-00880]. Beyond the complete version of Dixon and other § 102(b)
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`references, Petitioner relies on new art and arguments. For example, the Examiner
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`never rejected claims under §§ 102/103, whereas Petitioner asserts four anticipation
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`and two obviousness grounds—all involving art the Examiner never considered.
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`[IPR2021-00881]. As discussed above, Petitioner’s asserted art was neither
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`presented to the Examiner, nor is it “substantially the same” as Reuters-2012. In
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`addition, Petitioner presents arguments never considered by the Examiner, who
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`never rejected claims under §§ 102/103. Plus, there is no evidence the Examiner
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`considered, evaluated, or asserted prior art based on the VIEW dosing regimen.
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`12 US2005/0163798, not raised in the POPR, also does not include the incorporation
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`by reference to Holash, or the EYLEA® PTE application disclosures.
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`8
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`In both IPRs, Petitioner also presents Dr. Albini’s opinions and analyses,
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`further weighing against § 325(d) denial. See Guardian Indus. Corp. v. Pilkington
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`Deutschland AG, IPR2016-01635, Paper 9 at 9-10 (P.T.A.B. Feb. 15, 2017).
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`3.
`
`If the Board concludes step one of Advanced Bionics is
`satisfied, the Office erred. (Becton, Dickinson (c), (e), (f)).
`As explained, the records do not reflect that Petitioner’s art or arguments were
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`presented to, or considered by, the Examiner. Petitioner submits that PO’s
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`documents (the one-page Dixon; Regeneron (20-December-2010); and Reuters-
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`2012) are not Rule 56 disclosures of “the same or substantially the same art.” Plus,
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`the Examiner issued no analogous rejections. Accordingly, Advanced Bionics’ first
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`factor is not satisfied and Petitioner should not have been required to allege error.
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`[IPR2021-00880]. In the event the Board disagrees, Petitioner respectfully
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`submits that the Examiner materially erred in (i) accepting PO’s one-page
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`submission, (ii) not obtaining a complete copy of Dixon, and (iii) not rejecting the
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`claims over Dixon and/or any other § 102(b) reference disclosing the PRN regimens
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`set forth therein. (See Petition, 1 (“These claims should have never issued.”)).
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`[IPR2021-00881]. Likewise, Petitioner respectfully submits that the
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`Examiner materially erred in not evaluating whether Reuters-2012 could be tied to
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`earlier publications, and further erred in not locating and asserting any of the art that
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`reads directly on the claims, including the VIEW prior art, during prosecution.
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`4.
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`The cases cited in the POPR are not relevant to the facts here.
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`9
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`None of PO’s cases support its attempt to shield the challenged claims from
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`substantive review. NXP USA, Inc. v. Impinj, Inc. involved a reference that was
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`prior art; cited as the lone reference in an IDS; with the same authors as the IPR-
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`asserted art; involving numerous § 103 rejections wherein the Examiner extensively
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`evaluated and compared the pending claims against art disclosing the same features
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`as the IDS reference. IPR2020-00519, Paper 7 (P.T.A.B. Aug. 17, 2020); (see, e.g.,
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`Ex.1088 [-880 IPR], 1, 4-18, 22-36, 44-46; Ex.1099 [-881 IPR] (same)).
`
`In ABS Global, Inc. v. Cytonome/ST, LLC, an IDS listed three of the IPR-
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`asserted references; one was evaluated and asserted by the Examiner during
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`prosecution; and the petitioner had “multiple failed attempts” asserting the art in
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`related IPRs and district court. IPR2021-00306, Paper 13 (P.T.A.B. June 7, 2021).
`
`In Gardner Denver, Inc. v. Utex Indus., Inc., “nearly identical” disclosures were
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`“thoroughly considered” “multiple times” in the Examiner’s §§ 102/103 rejections.
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`IPR2020-00333, Paper 12 (P.T.A.B. Aug. 5, 2020). Boragen, Inc. v. Syngenta
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`Participations AG, involved IPR art “asserted by the Examiner in five separate office
`
`actions.” IPR2020-00124, Paper 16 (P.T.A.B. May 5, 2020).
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`
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`In short, PO cites no cases that deny institution based upon merely an IDS
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`listing, where, as here, the claims were never subject to any §§102/103 challenges.
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`III. CONCLUSION.
`Petitioner respectfully asks the Board reject PO’s request for § 325(d) denial.
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`10
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`Dated: September 29, 2021
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`Case Nos. IPR2021-00880 & IPR2021-00881
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`
`Respectfully Submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/Paul J. Molino/
`Paul J. Molino (Reg. No. 45,350)
`6 West Hubbard Street
`Suite 500
`Chicago, IL 60654
`Telephone:
`(312) 222-6300
`Facsimile:
`(312) 222-6320
`paul@rmmslegal.com
`
`Counsel for Petitioner
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`11
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a true and correct copy of the foregoing
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`PETITIONER’S REPLY TO PATENT OWNER’S PRELIMINARY RESPONSE
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`was served on September 29, 2021, via electronic mail by agreement of the parties,
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`to the following counsel for record of Patent Owners:
`
`Deborah E. Fishman (Reg. No. 48,621)
`ARNOLD & PORTER KAYE SCHOLER LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306-3807
`Telephone: 650.319.4519
`Facsimile: 650.319.4573
`Deborah.Fishman@arnoldporter.com
`regeneroneyleaiprs@arnoldporter.com
`
`Matthew M. Wilk
`ARNOLD & PORTER KAYE SCHOLER LLP
`250 West 55th Street
`New York, New York 10019-9710
`Telephone: 212.836.8000
`Facsimile: 212.836.8689
`Matthew.Wilk@arnoldporter.com
`
`
`Dated: September 29, 2021
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`
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`Alice S. Ho (Lim. Rec. No. L1162)
`Victoria Reines
`Rebecca Neubauer
`ARNOLD & PORTER KAYE SCHOLER LLP
`601 Massachusetts Ave., N.W.
`Washington D.C. 20001
`Tel: 202.942.5000
`Fax: 202.942.5999
`Alice.Ho@arnoldporter.com
`Victoria.Reines@arnoldporter.com
`Rebecca.Neubauer@arnoldporter.com
`
`
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`Respectfully Submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/Paul J. Molino/
`Paul J. Molino (Reg. No. 45,350)
`
`
`
`