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6 Preliminary Response: Patent Owner Preliminary Response

Document IPR2021-01132, No. 6 Preliminary Response - Patent Owner Preliminary Response (P.T.A.B. Oct. 12, 2021)

Paper No. 6 Filed: October 12, 2021 Introduction The Board should deny institution under 35 U.S.C. § 325(d) because the Petition recycles the same prior art and arguments considered by the Examiner during prosecution of the ’927 patent.

Paper No. 6 Filed: October 12, 2021 (“Compounds that bind to neuronal nicotinic receptor sites, including [varenicline], and its hydrochloride salt, are referred to in WO 99/35131 [i.e., Coe], published Jul.

Despite Petitioner’s assertions to the contrary, a plain reading of the prosecution history leaves no doubt that the Examiner evaluated the precise arguments that Petitioner Paper No. 6 Filed: October 12, 2021 now raises.

As discussed above, this type of broad overview does not “add significantly to the information considered by the Examiner during prosecution,” Canon Inc., IPR2016-01202, Paper 15 at 13, and does not shift factor (c) in favor of institution.

Nor does Pfizer demonstrate the Examiner erred in allowing the challenged claims here, as there is no evidence (either in the file history or cited in the Petition) that would have led a POSA to the tartrate salt of varenicline.

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3 Mandatory Notice: Patent Owners Mandatory Notices

Document IPR2021-01132, No. 3 Mandatory Notice - Patent Owners Mandatory Notices (P.T.A.B. Jul. 7, 2021)

A Power of Attorney appointing lead and back-up counsel to transact business in this proceeding on behalf of Pfizer Inc. will be submitted concurrently with this Mandatory Notice.

Related Matters Patent Owner is not aware of any judicial or administrative matters that would affect, or be affected by, a decision in this proceeding.

The ’927 patent has been the subject of the following terminated judicial proceedings: • Pfizer Inc. et al. v. Viwit Pharmaceutical Co., Ltd., C.A.

Lead and Backup Counsel Pursuant to 37 C.F.R. § 42.8(b)(3), Patent Owner designates the following lead and backup counsel:

Paper No. 3 Filed: July 7, 2021 _/Michael Liu/___________ Andrew V. Trask (Reg. No. 59,239) Michael Xun Liu (Reg. No: 68,815) Williams & Connolly LLP 725 Twelfth Street NW Washington, D.C. 20005

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