UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`HYBRIGENICS SA
`Petitioner
`v.
`
`FORMA THERAPEUTICS, INC.
`Patent Owner
`
`Case PGR-2018-00098
`Patent 9,840,491
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`PETITIONER’S REPLY BRIEF
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`Page
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`b.
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`c.
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`d.
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`e.
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`f.
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`I.
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`II.
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`4.
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`2.
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`TABLE OF CONTENTS
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`ALL REAL PARTIES-IN-INTEREST WERE IDENTIFIED IN THE
`PETITION ...................................................................................................... 1
`1.
`Burden ........................................................................................ 1
`2.
`Real Party-in-Interest Factors .................................................... 3
`3.
`Servier Laboratories is not a real party-in-interest .................... 3
`a.
`Servier has never agreed to be bound by the
`determination of this proceeding ..................................... 3
`There is no pre-existing substantive legal
`relationship between Petitioner and Servier that
`justifies binding Servier to this proceeding ..................... 3
`Servier is not represented by Petitioner in this
`proceeding ........................................................................ 4
`Servier has never exercised control over this
`proceeding ........................................................................ 5
`Servier is not bound by a prior decision with
`respect to the ‘491 patent ................................................. 5
`No statutory scheme forecloses Servier from
`pursuing successive challenges to the ‘491 patent .......... 7
`Petitioner’s U.S. subsidiaries are not real parties-in-
`interest ........................................................................................ 7
`CLAIMS 1-17 SHOULD BE FOUND UNPATENTABLE ON
`STATUTORY GROUNDS OF WRITTEN DESCRIPTION,
`ENABLEMENT AND OBVIOUSNESS ..................................................... 10
`A.
`Claims 1-15 and 17 are invalid for filing to meet the written
`description requirement under 35 USC § 112 .................................... 11
`1.
`Prosecution amendments to “5- or 6- membered
`heteroaryl” are not supported by the specification as filed ...... 12
`Prosecution amendments to “3- to 7- membered
`heterocycloalkyl” are not supported by the specification
`as filed ...................................................................................... 14
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`B.
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`C.
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`TABLE OF CONTENTS
`(continued)
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`Page
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`3.
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`There is insufficient written description for dependent
`claims 2-15 and 17 ................................................................... 15
`Claims 1-17 are invalid for failing to meet the enablement
`requirement under 35 U.S.C. § 112 .................................................... 16
`1.
`The specification of the ‘491 patent fails to provide
`sufficient guidance to one skilled in the art to practice the
`claimed invention ..................................................................... 17
`a.
`Disclosure of four schemes for producing four
`similar compounds does not provide guidance to
`one skilled in the art to produce the remaining
`millions of compounds purportedly covered by the
`claims ............................................................................. 17
`Undue experimentation would be necessary in order to
`enable a person skilled in the art to practice the invention
`as claimed ................................................................................. 20
`“Methods known in the art of organic synthesis” alone
`does not provide a sufficient enablement for all millions
`of compounds purportedly claimed. ........................................ 21
`Application of the Wands factors all favor a lack of
`enablement ............................................................................... 21
`Claims 1-17 of the ‘491 patent are obvious in view of the
`disclosure in the ‘150 patent based on conventional medicinal
`chemistry protocol .............................................................................. 23
`1.
`Those skilled in the art would have used conventional
`medicinal chemistry techniques to try different branching
`configurations of the 14 example compounds in the ‘150
`patent ........................................................................................ 25
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`2.
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`3.
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`4.
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`TABLE OF AUTHORITIES
`
`Cases
`Amazon.com, Inc. and Amazon Web Services, Inc., v. Appistry, Inc, IPR 2015-
`
`00480 ...................................................................................................................... 8
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`Applications in Internet Time, LLC. V. RPX Corp., 897 F.3d 1336 ......................5, 6
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`Ariad Pharm., Inc v. Eli Lilly & Co.¸598 F.3d 1336, 1351 (Fed. Cir. 2010) ..........11
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`Atlantic Gas Light Co. v. Bennett Regulator, IPR2013-00453 ................................. 1
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`Cisco Systems, Inc. v Hewlett Packard Enterprise Company, IPR 2017-01933 . 8, 9,
`
`10
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`Fujikawa v. Wattanasin 93 F.3d 1559, 1571 (Fed. Cir. 1996) ................................13
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`Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) .......16
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`In re Ruschig, 379 F.2d 990, 994–95 (CCPA 1967) .................................. 13, 14, 15
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`In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) ....................................................16
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`Reiffin v. Microsoft Corp., 2014 F.3d 1342, 1345 (Fed. Cir. 2000) ........................11
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`Taylor v. Sturgell, 553 U.S. 880 (2008) ............................................................ 3, 4, 5
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`Union Oil Co. of California v. Atlantic Richfield Co., 208 F.3d 989, 1003 (Fed.
`
`Cir. 2000) ..............................................................................................................13
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`Vas-Cath Inc. v. Mahurkar, 935, F.2d 1555, 1563, USPQ2d 1111, 1116 (Fed. Cir.
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`1991) .....................................................................................................................12
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`Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1384 (Fed. Cir. 2013) ......16
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`Statutes
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`35 U.S.C. § 112(a) ...................................................................................................16
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`35 U.S.C. §321(c) ...................................................................................................... 7
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`Regulations
`Practice Guide, 77 Fed. Reg at 48759 ....................................................................... 3
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`Exhibit 1029
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`EXHIBIT LIST
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`Second Declaration of Rémi Delansorne, Ph.D. (“Delansorne
`Dec. 2”)
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`I.
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`ALL REAL PARTIES-IN-INTEREST WERE IDENTIFIED IN THE
`PETITION
`Burden
`1.
`In both the original Petition and the Corrected Petition, Hybrigenics SA was
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`identified as the real party-in-interest (RPI). Patent Owner asserts that three parties not
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`identified at the time the petition was filed should have been included as RPIs: Servier
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`Laboratories (“Servier”), Hybrigenics Corp., and Hybrigenics Pharma Inc. However,
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`Patent Owner’s position is incorrect.
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`A petitioner’s identification of the RPI at the time the petition is filed is typically
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`accepted. However, when “a patent owner provides sufficient rebuttal evidence that
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`reasonably brings into question the accuracy of a petitioner’s identification of the real
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`parties in interest, the burden remains with the petitioner to establish that it has complied
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`with the statutory requirement to identify all the real parties in interest.” Atlantic Gas
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`Light Co. v. Bennett Regulator, IPR2013-00453, Paper 88, sip op. at 8.
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`Not only has Patent Owner failed to establish sufficient rebuttal evidence to
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`question the accuracy of the Petitioner’s identification of the RPI, but Hybrigenics SA is
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`the only real party in interest in this proceeding as shown below.
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`When Patent Owner filed its Preliminary Response, it only provided certain public
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`documents showing a research collaboration between Petitioner and Servier and that
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`Hybrigenics Corp., and Hybrigenics Pharma Inc. are subsidiaries of Petitioner. See Ex.
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`1
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`2001- Ex. 2009. These same documents were resubmitted with the Patent Owner’s
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`Response. See Ex. 2012-2020. The Board already concluded in the Decision to Institute
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`the PGR that these documents were “insufficient to establish that Servier should have
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`been named as a real party in interest.” PGR2018-00098 (Paper 10) at pages 14-15.
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`The only additional evidence provided with Patent Owner’s Response was three
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`patent applications filed by Servier. See Ex. 2023-2025. Each of these patents claim
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`priority to French Applications which were filed before issuance of the ‘491 patent. See
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`Ex. 2023, US Publication No. 2019/0144448 A1 (ꞌ449 publication) claiming priority to
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`FR 1655392 filed June 10, 2016; Ex. 2024, US Publication No. 2019/0144449 A1 (ꞌ449
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`publication) claiming priority to FR 1655387 filed on June 10, 2016; Ex. 2025, PCT
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`Publication No. 2019/015963 A1 (ꞌ963 publication) claiming priority to FR 1761338 filed
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`on November 29, 2017. Servier’s decisions to file these patent applications was clearly
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`made independently of the current proceedings.
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`Patent Owner’s evidence therefore still “amounts to little more than an assertion
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`that Servier had a preexisting, established relationship with Petitioner and is a beneficiary
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`of the Petition.” PGR2018-00098 (Paper 10) at page 15. This is clearly insufficient to
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`establish that Servier should have been named as a real party in interest.
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`With respect to the two U.S. subsidiaries, Patent Owner has provided no additional
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`evidence, and thus the current record still fails to bring into question the accuracy of the
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`RPIs, and as shown below, these parties are not RPIs to the present proceeding.
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`2
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`Real Party-in-Interest Factors
`2.
`Assuming arguendo that Petitioner’s identification of the RPI is under question,
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`there are still no facts presented which would overcome Petitioner’s assertion of the RPI.
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`When determining an RPI, “common-law principles” are to be applied, with the Practice
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`Guide referring to those six factors identified in Taylor v. Sturgell, 553 U.S. 880 (2008)
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`for guidance (Practice Guide, 77 Fed. Reg at 48759) discussed below.
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`3.
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`Servier Laboratories is not a real party-in-interest
`Servier has never agreed to be bound by the determination
`a.
`of this proceeding
`With respect to the first Taylor factor, Patent Owner has not alleged that any
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`binding agreement exists, and Petitioner confirms that no such agreement exists.
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`b.
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`There is no pre-existing substantive legal relationship
`between Petitioner and Servier that justifies binding Servier
`to this proceeding
`The second Taylor factor includes legal relationships such as “preceding and
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`succeeding owners of property, bailee and bailor, and assignee and assignor. See 2
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`Restatement §§ 43-44, 52, 55.” Taylor at 894.
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`However, none of the above legal relationships exists between Petition and Servier.
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`While an agreement did exist between Petition and Servier in which Petitioner
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`screened and profiled Servier’s compounds as potential USP7 inhibitors, this agreement
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`terminated in 2016. See Delansorne Dec. 2 (Ex. 1029) paragraph 2. Furthermore, this
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`agreement did not relate to the ‘491 patent or any third party’s patents. See id.,
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`paragraphs 3-5.
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`Servier is not represented by Petitioner in this proceeding
`c.
`The third Taylor factor includes “limited circumstances” in which representation is
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`considered adequate including situations such as “properly conducted class
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`actions…trustees, guardians, and other fiduciaries.” See Taylor at 894.
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`None of these circumstances exist in in the present case. In particular, Petitioner is
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`not a fiduciary of Servier. Petitioner has only ever worked with Servier as an independent
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`contractor. See Delansorne Dec. 2 (Ex. 1029) paragraph 6.
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`Furthermore, “[a] party’s representation of a nonparty is ‘adequate’ for preclusion
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`purposes only if, at a minimum: (1) The interests of the nonparty and her representative
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`are aligned; and (2) either the party understood herself to be acting in a representative
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`capacity or the original court took care to the protect the interests of the nonparty.”
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`Taylor at 900 (internal quotations omitted).
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`Petitioner was not acting in a representative capacity for Servier. There was no
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`agreement between Petitioner and Servier regarding the ‘491 patent, nor any third parties’
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`patents generally. See Delansorne Dec. 2 (Ex. 1029) paragraphs 3-5. No instructions were
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`provided by Servier regarding the ‘491 patent before or after implementation of the PGR.
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`See id., paragraphs 8-9.
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`Servier has never exercised control over this proceeding
`d.
`With respect to the fourth Taylor factor, Servier never exercised control of this
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`PGR. See id. Petitioner has only ever worked with Servier as an independent contractor.
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`See id., paragraph 6. Furthermore, there is no overlap between the managements of
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`Petitioner and Servier. See id., paragraph 7. Servier has not asserted any control over
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`Petitioner, nor could it assert any control over Petitioner with respect to this proceeding.
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`e.
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`Servier is not bound by a prior decision with respect to the
`‘491 patent
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`With respect to the fifth Taylor factor, “a party bound by a judgment may not
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`avoid its preclusive force by relitigating through a proxy.” Taylor at 895.
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`The concept of a “proxy” as related to IPRs was recently addressed by the CAFC
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`in Applications in Internet Time, LLC. V. RPX Corp., 897 F.3d 1336, in which RPX
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`Corporation (“RPX”) filed three petitions for IPRs against patents owned by Applicants
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`in Internet Time, LLC (“AIT”). Previously, AIT filed complaints alleging infringement
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`by a third party, Salesforce.com Inc. (“Salesforce”). RPX was “a for-profit company
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`whose clients pay for its portfolio of ‘patent risk solutions.’ These solutions help paying
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`members ‘extricate themselves from NPE lawsuits.’ The company’s SEC filings reveal
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`that one of its ‘strategies’ for transforming the patent market is ‘the facilitation of
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`challenges to patent validity,’ one intent of which is to ‘reduce expenses for [RPX’s]
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`client.’” Application in Internet Time at 1351 (internal quotations omitted). Salesforce
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`was a client of RPX, but was not identified as a RPI in any of the three petitions.
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`Petitioner does not provide any services for Servier akin to the relationship between RPX
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`and Salesforce.
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`As indicated above, while an agreement did exist wherein Petitioner screened and
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`profiled Servier’s compounds as potential USP7 inhibitors, this agreement terminated in
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`2016. See Delansorne Dec. 2 (Ex. 1029) paragraph 2. Petitioner still remains entitled to
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`development milestones in recognition of its contribution to the screening and profiling
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`of compounds, but not to any royalties. See id., paragraph 3. This agreement does not
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`relate to any patents owned by Petitioner, Servier, Hybrigenics, the ‘491 patent, or any
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`third party’s patents. See id., paragraphs 3-5.
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`The Board has already explained that “‘[t]he RPI analysis set out in AIT and the
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`common law require more than simply confining the analysis to determining whether a
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`party benefits generally from the filing of this Petition and also has a relationship with the
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`Petitioner.’). If the sole requirement for being named a real party in interest were that a
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`party might benefit from the filing of a petition, as suggested by Patent Owner, it would
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`ensnare third parties, such as suppliers and contract research organizations, with no
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`connection to the Petition.” PGR2018-00098 (Paper 10) at page 15.
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`Petitioner was not acting in a representative capacity for Servier, nor was there any
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`agreement between Petitioner and Servier regarding the ‘491 patent, or any third parties’
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`patents generally. See Delansorne Dec. 2 (Ex. 1029) paragraphs 3-5. No instructions were
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`provided by Servier regarding the ‘491 patent before or after implementation of the PGR.
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`See id., paragraphs 8-9.
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`Petitioner was thus not acting as a proxy for Servier with respect to the present
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`PGR.
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`f.
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`No statutory scheme forecloses Servier from pursuing
`successive challenges to the ‘491 patent
`With respect to the sixth Taylor factor, no such statutory scheme exists in the
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`present case. Admittedly, Servier is unable to file a PGR at this point, due to the 9 month
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`filing deadline set out in 35 U.S.C. §321(c). However, at the time Petitioner filed the
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`petition, Servier was not statutorily precluded from filing its own PGR, but failed to do
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`so.
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`Petitioner’s U.S. subsidiaries are not real parties-in-interest
`4.
`Hybrigenics Corp. is 100% owned by Hybrigenics Services SAS which is a
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`subsidiary of Petitioner. However, Petitioner only retains 19.99% ownership of
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`Hybrigenics Services SAS. See Delansorne Dec. 2 (Ex. 1029) paragraphs 10-16.
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`Petitioner therefore lacks control of Hybrigenics Corp., and this company has no control
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`over Petitioner.
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`Hybrigenics Pharma Inc. was exclusively set up to manage clinical studies of
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`inecalcitol in the U.S. See id., paragraph 16. Hybrigenics Pharma Inc. is 100% owned by
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`Hybrigenics SA. See id., paragraph 17. Petitioner therefore controls Hybrigenics Pharma
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`Inc. Hybrigenics Pharma Inc. has no control over Petitioner.
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`The first, second, third, and sixth Taylor factors clearly are not applicable to either
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`of the U.S. subsidiaries.
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`While the Board in rare circumstances has denied the institution of a PGR when an
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`unnamed subsidiary should have been listed as an RPI (see e.g., Amazon.com, Inc. and
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`Amazon Web Services, Inc., v. Appistry, Inc, IPR 2015-00480; Cisco Systems, Inc. v
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`Hewlett Packard Enterprise Company, IPR 2017-01933 ), the circumstances surrounding
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`those proceedings are unlike the present circumstances.
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`In Amazon.com, the patent owner provided sufficient evidence to show that
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`“Petitioner AWS is a wholly-owned subsidiary of AWSHC, which in turn is a wholly-
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`owned subsidiary of ADS, and ADS is a wholly-owned subsidiary of Petitioner
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`Amazon.com” as illustrated in the diagram from page 4 of patent owner’s Preliminary
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`Response, reproduced below. See IPR 2015-00480 (Paper 18) at page 5. The
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`identification of only Amazon.com, Inc. and Amazon Web Services, Inc. as the real
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`parties-in-interest was thus found to be deficient. The Board’s decision relied on the
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`control that the unnamed parents, ADS and AWSHC, had over the named subsidiary,
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`AWS. The decision was not related to the control the named parent, Amazon.com, had
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`over the unnamed parties, ADS and AWSHS. See generally id. at page 5.
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`Unlike the situation in Amazon.com, Petitioner has no parent corporations
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`whatsoever. Neither Hybrigenics Corp. nor Hybrigenics Pharma Inc. have control over
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`Petitioner and, therefore, are not real parties-in-interest.
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`Petitioner agrees with the Board’s conclusion in the Decision to Institute the PGR
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`that “the current record does not suggest that Hybrigenics’ unnamed subsidiaries were
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`intermediaries through which a parent that had been identified as a real party in interest
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`exercised control over a subsidiary that was also named as a real party in interest.”
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`PGR2018-00098 (Paper 10) at page 18.
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`Other circumstances do not exist for holding a failure to identify RPI. For example,
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`in Cisco, the patent owner previously served Springpath, Inc. (“Springpath”) with a
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`complaint asserting infringement of the patent at issue. See IPR 2017-01933 (Paper 9) at
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`page 10. Subsequently, the petitioner, Cisco Systems, Inc., acquired Springpath as a
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`wholly-owned subsidiary of petitioner. Importantly, the subsidiary, Springpath, had
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`already filed petitions requesting IPRs related to the patent at issue the day before the one
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`year statutory deadline. The petition at issue in Cisco, however, was filed almost a year
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`later. See id. In other words, petitioner’s failure to list Springpath as an PRI was clearly a
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`means of attempting to avoid the one year statutory limit for filing IPRs. See id. at page
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`15, concluding that “Petitioner brought the Petition as a proxy for Springpath, who
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`otherwise would be barred from challenging the ‘799 parent.”
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`Unlike Cisco, neither of Petitioner’s subsidiaries would have been barred from
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`filing their own petitions. In no way is Petitioner acting as a proxy for subsidiaries who
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`otherwise would have been barred from challenging the ‘491 patent.
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`In short, neither of the U.S. subsidiaries are real parties-in-interest.
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`For the reasons set forth above, Petitioner agrees with the Board’s conclusion that
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`“the current record does not include evidence suggesting that Petitioner lacks an
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`independent interest in these proceedings or that Petitioner was acting as a proxy for its
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`U.S. subsidiaries.” PGR2018-00098 (Paper 10) at page 17.
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`II. CLAIMS 1-17 SHOULD BE FOUND UNPATENTABLE ON STATUTORY
`GROUNDS OF WRITTEN DESCRIPTION, ENABLEMENT AND
`OBVIOUSNESS
`Petitioner submits that claims 1-17 are unpatentable in view of the three grounds
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`previously asserted, namely written description, enablement and obviousness. Upon full
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`consideration of the record in this case, Petitioner asserts that claims 1-17 will be found
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`to be unpatentable based on these grounds.
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`A. Claims 1-15 and 17 are invalid for filing to meet the written description
`requirement under 35 USC § 112
`To satisfy the written description requirement, the specification must fully support
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`the claimed subject matter and must describe an invention so as to “reasonably convey[]
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`to those skilled in the art that the inventor had possession of the claimed subject matter as
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`of the filing date.” Ariad Pharm., Inc v. Eli Lilly & Co.¸598 F.3d 1336, 1351 (Fed. Cir.
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`2010). The purpose of this requirement is to ensure that a patent’s claims “[do] not
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`overreach the scope of the inventor’s contribution to the field of art as described in the
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`patent specification.” Reiffin v. Microsoft Corp., 2014 F.3d 1342, 1345 (Fed. Cir. 2000).
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`The ‘491 patent specification does not support all of the claim language added
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`during patent prosecution. Specifically, amendments to the definitions of substituents
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`(“R” groups) of Formula (I) Claims 1-15 and 17 are not supported by the specification as
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`filed and thus fail to meet the written description requirement.
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`During prosecution, the pending claims were amended to remove reference to
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`hydrate, solvate and prodrug, to amend the definition of the substituent R2 narrowing the
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`definition of the heteroaryl, the heterocycloalkyl, and to amend the definition of R3 to
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`narrow the definition of the heteroaryl and heterocycloalkyl. See ‘491 File history (Ex.
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`1009) at pages 177-178. In addition, the definitions of R6-R11, R13, R14, R17, R19, R21-R24,
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`R26 and R27 were also amended. See id. at pages 177-178). Specifically R2, R3, R6-R11,
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`R13, R14, R17, R19, R21-R24, R26 and R27 were narrowed by limiting the heteroaryl and
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`heterocycloalkyl to “5- or 6- membered heteroaryl comprising 1 to 3 heteroatoms
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`selected from O, N, and S, or “3- to 7- membered heterocycloalkyl comprising 1 to 3
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`heteroatoms selected from O, N, and S” See id. at pages 311-312, and 314 (emphasis
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`added)).
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`1.
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`Prosecution amendments to “5- or 6- membered heteroaryl” are
`not supported by the specification as filed
`In order to satisfy the written description requirement, “the applicant must…
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`convey with reasonable clarity to those skilled in the art that, as of the filing date sought,
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`he or she was in possession of the invention. The invention is, for purposes of the ‘written
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`description’ inquiry, whatever is now claimed.” See e.g., Vas-Cath Inc. v. Mahurkar, 935,
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`F.2d 1555, 1563, USPQ2d 1111, 1116 (Fed. Cir. 1991) (emphasis original).
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`Patent Owner argues that paragraph [0033] of the specification provides support
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`for the amended language “5- or 6- membered heteroaryl comprising 1 to 3 heteroatoms
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`selected from O, N, and S.” In particular, Patent Owner states that paragraph [0033] lists
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`88 unique heteroaryls, of which 18 are 5- or 6- membered rings. See Patent Owner’s
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`Response, PGR2018-00098 (Paper 16) at pages 8-11. However, Patent Owner fails to
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`identify any portion of the specification of the ‘491 patent which indicates that these 18
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`specific examples were considered any more important than the remaining 70 examples.
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`In other words, one skilled in the art would not have had any understanding that
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`the inventor was in possession of knowledge that these 18 specific examples are of any
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`particular importance over any of the other examples, i.e., that the inventor was in
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`possession of the broad amended claim limitation of “5- or 6- membered heteroaryl.”
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`Specifically, only upon receiving a prior art rejection did applicant amend the
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`claims to specify the particular subgenus of “5- or 6- membered heteroaryl.” At the time
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`of filing, applicant provided no indication that this subgenus was part of the invention. To
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`support a claim directed to a species or subgenus within a broad generic disclosure, there
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`must be “specific direction,” expressed in “‘full, clear, concise, and exact’ language,” to
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`the narrower subject matter within the genus. Union Oil Co. of California v. Atlantic
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`Richfield Co., 208 F.3d 989, 1003 (Fed. Cir. 2000). This requirement has been analogized
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`to “‘blaze marks’ on specific trees that mark a trail through a forest.” Id. (citing In re
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`Ruschig, 379 F.2d 990, 994–95 (CCPA 1967); see also Fujikawa v. Wattanasin 93 F.3d
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`1559, 1571 (Fed. Cir. 1996) (“In the absence of . . . blazemarks, simply describing a large
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`genus of compounds is not sufficient to satisfy the written description requirement as to
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`particular species or sub-genuses.”).
`
`To extend the arboreal metaphor, these 18 examples were certainly among the
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`forest of trees initially disclosed. However, nothing in the specification provides the
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`necessary “blaze marks” to identify any importance of these particular 18 trees. Patent
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`Owner is “pointing to trees. We are looking for blaze marks which single out particular
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`trees.” See Ruschig at 995.
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`2.
`
`Prosecution amendments to “3- to 7- membered heterocycloalkyl”
`are not supported by the specification as filed
`Patent Owner argues that paragraphs [0040]-[0041] of the specification provide
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`support for the amended language “3- to 7- membered heterocycloalkyl comprising 1 to 3
`
`heteroatoms selected from O, N, and S.” With respect to 4- to 7- membered
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`heterocycloalkyl, Patent Owner states that paragraph [0041] lists 24 unique
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`heterocycloalkyls, of which 22 are 4-, 5-, 6-, or 7- membered rings. See PGR2018-00098
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`(Paper 16) at pages 14-17. However, with respect to 3- membered heterocycloalkyl,
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`Patent Owner merely relies on paragraph [0040] stating that “cycloalkyl” groups contain
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`3-18 carbon atoms or that a “C3-C8 cycloalkyl” group contains between 3 and 8 carbon
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`atoms. See PGR2018-00098 (Paper 16) at pages 14-15. Once again, Patent Owner fails to
`
`identify any portion of the specification of the ‘491 patent which serves to identify that 3-
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`, 4-, 5-, 6-, or 7- membered heterocycloalkyls were of any particular importance, let alone
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`that the entire range of 3- to 7- membered heterocycloalkyls was more important than the
`
`other examples provided, such as 8-18 carbon atoms.
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`Given similar facts, the predecessor to the CAFC commented that:
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`“Working backward…by hindsight, it is all very clear what
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`route one would travel through the forest of the specification to
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`arrive at [the claim]. But looking at the problem, as we must,
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`from the standpoint of one with no foreknowledge of the
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`specific compound, it is our considered opinion that…[n]ot
`
`having been specifically named or mentioned in any manner,
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`one is left to selection from the myriads of possibilities
`
`encompassed by the broad disclosure, with no guide indicating
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`or directing that this particular selection should be made rather
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`than any of the many others which could also be made.”
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`Ruschig at 995.
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`The claims were amended to recite a narrower but still broad subgenus. While
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`species of this subgenus were included in the specification, the subgenus itself was
`
`unidentified prior to the narrowing amendments. Accordingly, the disclosure of the
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`application fails to reasonably convey to one skilled in the art that the inventor had
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`possession of this subgenus as of the filing date.
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`3.
`
`There is insufficient written description for dependent claims 2-15
`and 17
`Claims 2-15 and 17 depend from claim 1 and include at least one or more of the
`
`definitions of the amended heteroaryl or heterocycloalkyl introduced in amended claim 1.
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`Accordingly, claims 2-15 and 17 fail the written description requirement for the
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`reasons provided with respect to claim 1.
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`Petitioner’s Reply Brief
`U.S. Patent No. 9,840,491
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`B. Claims 1-17 are invalid for failing to meet the enablement requirement
`under 35 U.S.C. § 112
`To satisfy the enablement requirement under 35 U.S.C. § 112, first paragraph “[a]
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`patent's specification must describe the invention and ‘the manner and process of making
`
`and using it, in such full, clear, concise, and exact terms as to enable any person skilled in
`
`the art to which it pertains... to make and use the same.’ ” Wyeth & Cordis Corp. v.
`
`Abbott Labs., 720 F.3d 1380, 1384 (Fed. Cir. 2013) (quoting 35 U.S.C. § 112(a) (2012)).
`
`Further, the patent specification must teach those skilled in the art how to make and use
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`the full scope of the claimed invention without ‘undue experimentation.’ Genentech, Inc.
`
`v. Novo Nordisk, A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999
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`F.2d 1557, 1561 (Fed. Cir. 1993)). Whether undue experimentation is needed is not a
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`single, simple factual determination, but rather is a conclusion reached by weighing many
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`factual considerations known as the “Wands factors.” See In re Wands, 858 F.2d 731,
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`737 (Fed. Cir. 1988)1.
`
`
`1 In re Wands established that factors for determining whether undue experimentation is
`required include “(1) the quantity of experimentation necessary, (2) the amount of
`direction or guidance presented, (3) the presence or absence of working examples, (4) the
`nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the
`art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
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