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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`SANDOZ INC.,
`Petitioner,
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`v.
`
`PHARMACYCLICS LLC,
`Patent Owner.
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`__________________
`
`Case IPR2019-00865
`U.S. Patent No. 9,795,604
`__________________
`
`PATENT OWNER’S MOTION TO STRIKE
`IMPROPER REPLY ARGUMENTS
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`
`
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`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-145
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`
`
`
`
`IPR2019-00865
`U.S. Patent No. 9,795,604
`Patent Owner respectfully moves to strike §§ III.B and III.C.1 of Petitioner’s
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`
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`Reply (Paper 17) as improper new arguments. Petitioner attempts to fill gaps in its
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`Petition by arguing for the first time in reply that the ’085 Publication explicitly
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`discloses (1) the patient subpopulations of claims 4, 13, and 15 (Reply at 9-10); and
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`(2) the efficacy limitations of claims 6-8, 29-31, 44-46, and 51-53 (id. at 10-11).
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`Petitioner’s improper new arguments are not only without merit, they also violate
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`Board rules and Federal Circuit precedent and would be unfairly prejudicial to Patent
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`Owner if considered.
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`I.
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`
`
`ARGUMENT
`Petitioner Improperly Raises a New Argument and Evidence
`A.
`Regarding Claims 4, 13, and 15 (§ III.B)
`Pre-institution, Petitioner’s sole anticipation theory for claims 4, 13, and 15
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`relied on what “a POSA would have known.” Pet., 38-39 (repeatedly referring to
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`the knowledge of the POSA). In finding no anticipation, the Board correctly
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`acknowledged in the Institution Decision that this knowledge has no place in an
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`anticipation analysis. Paper 8, 20-21.
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`
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`In Reply, Petitioner newly argues that the ’085 Publication explicitly discloses
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`the claimed subpopulations, without once referencing the knowledge of the POSA.
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`Reply, 9-10. Because this argument presents an entirely new rationale, it exceeds
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`the proper scope of reply and should be struck. Henny Penny Corp. v. Frymaster
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`LLC, 938 F.3d 1324, 1331 (Fed. Cir. 2019) (affirming Board’s rejection of a reply
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`1
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`
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`IPR2019-00865
`U.S. Patent No. 9,795,604
`argument presenting an “entirely new rationale” for why a claim was unpatentable).
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`To support its new argument, Petitioner relies on previously uncited ¶¶ [0121]
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`and [0124] of the ’085 Publication and unbidden, non-responsive testimony from its
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`expert, Dr. Ferrara—none of which can properly be considered. Id. (citing Ex. 2056,
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`212:1, 212:6-13). Petitioner did not refer to ¶¶[0121] or [0124] pre-institution. See
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`Pet., 38-39. A belated argument that a limitation is disclosed by “previously
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`unidentified” portions of the prior art “crosses the line from the responsive to the
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`new.” Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359, 1367 (Fed. Cir.
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`2015); see also In re NuVasive, Inc., 841 F.3d 966, 971 (Fed. Cir. 2016) (error to
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`rely on different portions of prior art from those presented in petition). Dr. Ferrara
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`likewise did not rely on these paragraphs in his pre-institution declaration. See
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`EX1006, ¶¶32, 85-86. Instead, he referenced one of them, ¶[0124], in a non-
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`responsive soliloquy during his post-institution deposition. See EX2056, 207:11-
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`213:22. Had Petitioner provided notice of this argument pre-institution, Patent
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`Owner could have cross-examined him on this point. Previous panels have rejected
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`such belated attempts to raise new arguments, especially with post-institution
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`testimony. Henny Penny Corp, 938 F.3d at 1331, n.1; Arista Networks, Inc., v. Cisco
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`Systems, Inc., IPR2016-00308, Paper 42 at 13 (PTAB, May 25, 2017). As in Arista,
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`the subject matter of Dr. Ferrara’s deposition testimony was not relied upon or
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`specifically argued in the Petition or his declaration. As a result, it would be
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`2
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`IPR2019-00865
`U.S. Patent No. 9,795,604
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`improper to permit this new argument into the record.
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`B.
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`Petitioner’s Reply Newly Argues Express Anticipation of the
`Clinical Efficacy Limitations (§ III.C.1)
`Initially, Petitioner relied solely on a theory of inherency to assert that the ’085
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`
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`Publication allegedly anticipates the efficacy limitations of claims 6-8, 29-31, 44-
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`46, and 51-53. Pet., 39-41 (“the patient outcomes recited in these dependent claims
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`are an inherent and necessary effect . . . .”) (emphasis added). In Reply, Petitioner
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`adds the new argument, with a dedicated heading, that such claims are “[e]xplicitly”
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`disclosed. Reply, 10-11. Tellingly, nowhere does Petitioner cite to Patent Owner’s
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`Response to support the inclusion of this new (and incorrect) argument. See id.
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`
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`Petitioner did not argue express anticipation in the Petition. Petitioner should
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`be held to its strategic choices. See Arista, IPR2016-00308, Paper 42 at 14 (“The
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`explanations in the Reply, therefore, are not responsive to Patent Owner’s arguments
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`that the limitation is not disclosed. Rather they are a new mapping of the claims to
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`the prior art in light of the gaps that Patent Owner pointed out in its Response.”).
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`II. CONCLUSION
`Patent Owner respectfully requests that the Board strike §§ III.B and III.C.1
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`from Petitioner’s Reply and not consider them in the Final Written Decision.
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`Date: June 4, 2020
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` Respectfully submitted,
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`By: / William B. Raich /
`William B. Raich, Reg. No. 54,386
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`
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`3
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`
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`IPR2019-00865
`U.S. Patent No. 9,795,604
`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Patent Owner’s
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`Motion to Strike Improper Reply Arguments was served electronically via
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`email on June 4, 2020 , in its entirety on the following:
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`Kirk T. Bradley
`Alston & Bird LLP
`101 South Tryon Street, Suite 4000
`Charlotte, NC 28280
`kirk.bradley@alston.com
`
`Siraj M. Abhyankar
`Alston & Bird LLP
`1201 W. Peachtree Street NE #4900
`Atlanta, GA 30309
`shri.abhyankar@alston.com
`
`Christopher L. McArdle
`Alston & Bird LLP
`90 Park Avenue, Suite 1200
`New York, NY 10016
`chris.mcardle@alston.com
`
`
`Petitioner has consented to service by email.
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`
`Date: June 4, 2020
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`
`
`By: / William Esper /
`William Esper
`Legal Assistant
`
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`
`
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