ALKERMES EXHIBIT 2005
`Apotex Inc. v. Alkermes Pharma Ireland Limited
`IPR2025-00514
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`Page 1 of 20
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`Apotex Inc. v. Alkermes Pharma Ireland Limited
`IPR2025-00514
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`Page 1 of 20
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`DO NOT USE IN PALM PRINTER
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`(THIRD PARTY REQUESTER'S CORRESPONDENCE ADDRESS)
`
`Crowell & Moring LLP
`Intellectual Property Group
`PO Box 14300
`
`Washington DC 20044-4300
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`EX PARTE REEXAMINATION COMMUNICATION TRANSMITTAL FORM
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`REEXAMINATION CONTROL NO. 90/019,779 .
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`PATENT UNDER REEXAMINATION 7919499.
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`ART UNIT 3997 .
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`Enclosedis a copyof the latest communication from the United States Patent and Trademark
`Office in the above identified exparte reexamination proceeding (37 CFR 1.550(f)).
`
`Wherethis copy is supplied after the reply by requester, 37 CFR 1.535, or the timefor filing a
`reply has passed, no submission on behalf of the exoarfe reexamination requesterwill be
`acknowledged or considered (37 CFR 1.550(g)).
`
`PTOL-465 (Rev.07-04)
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`Page 2 of 20
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`Page 2 of 20
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`.
`Order Granting Request For
`Ex Parte Reexamination Art Unit|AIA (FITF) StatusExaminer
`
`
`LORA E DRISCOLL
`3091
`No
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`90/019,779
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`7919499
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`Control No.
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`Patent Under Reexamination
`
`
`
`--The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
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`The requestfor exgarfe reexamination filed 12/16/2024 has been considered and a determination has
`been made. Anidentification of the claims, the references relied upon, and the rationale supporting the
`determination are attached.
`
`Attachments: a)
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`PTO-892,
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`b)¥y)
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`PTO/SB/08,
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`c)Q Other:
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`1.
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`The requestfor exgarfe reexamination is GRANTED.
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`RESPONSE TIMES ARE SET AS FOLLOWS:
`
`For Patent Owner's Statement (Optional): TWO MONTHS from the mailing date of this communication
`(37 CFR 1.530 (b)). EXTENSIONS OF TIME ARE GOVERNED BY37 CFR 1.550(c).
`
`For Requester's Reply (optional): TWO MONTHS from the date of service of any timely filed
`Patent Owner's Statement (87 CFR 1.535). NO EXTENSION OF THIS TIME PERIOD IS PERMITTED.
`lf Patent Owner does notfile a timely statement under 37 CFR 1.530(b), then no reply by requester
`is permitted.
`
`Lora E Barnhart Driscoll/
`Patent Reexamination Specialist
`
`JOSEPH R KOSACK/
`Patent Reexam Spec., CRU 3991
`
`cc:Requester ( if third party requester }
`U.S. Patent and Trademark Office
`PTOL-471G(Rev. 01-13)
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`Office Action in Ex Parte Reexamination
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`Part of Paper No. 20241220
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`Page 3 of 20
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 2
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`Notice of Pre-AlA or AIA Status
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`The present application is being examined underthe pre-AlAfirst to invent
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`provisions.
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`Request for Reexamination
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`A request for ex parte reexamination of claims 1-13 of US Patent 7,919,499 was
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`filed by a third-party requester on 12/16/24.
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`Decision on Request
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`A substantial new question of patentability (SNQ) affecting claims 1-13 is raised
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`by the requestfor ex parte reexamination.
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`Scope of the Claims
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`The reexamination request is decided on the basis of the claims in effect at the
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`time of the request. See MPEP 2221. In reexamination, patent claims are construed
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`broadly. See In re Yamamoto, 740 F.2d 1569, 1571, 222 U.S.P.Q. 934, 936 (Fed. Cir.
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`1984) (claims given “their broadest reasonable interpretation consistent with the
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`specification’).
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`Claims 1-13 of the 499 patent are under reexamination. Claims 1 and 14 are the
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`independentclaims. Claim 1 reads:
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`1. A methodfor treating an individual in need of naltrexone comprising the step of
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`parenterally administering a long acting formulation comprising about 310 mg to
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`about 480 mg of naltrexone and a biocompatible polymerto the individual
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`wherein the serum AUCof naltrexone is aboutthree times greater than that
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`achieved by 50 mg/day oral administration and wherein the biocompatible
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`polymer is a polylactide-co-glycolide polymer.
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Claim 14 reads:
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`Page 3
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`14. A methodfor treating an individual in need of naltrexone comprising the step
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`of parenterally administering a long acting formulation comprising about 190 mg
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`to about 240 mg of naltrexone and a biocompatible polymerto the individual
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`wherein the serum AUCof naltrexone is about two times greater than that
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`achieved by 50 mg/day oral administration and wherein the biocompatible
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`polymer is a polylactide-co-glycolide polymer.
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`Priority
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`Application 11/083,167 wasfiled on 3/17/05 and claims benefit of US provisional
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`application 60/564,542, which wasfiled on 4/22/04. The ’499 patent issued from the
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`"167 application on 4/5/11. The ’499 patentlists no other domestic-benefit or foreign-
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`priority claims.
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`Documents Submitted by Requester
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`Comeret al., 2002, “Depot Naltrexone: Long-Lasting Antagonism of the Effects
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`of Heroin in Humans,” Psychopharmacology 159(4): 351-360 (“Comer’; Ex. E)
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`US Patent No. 7,157,102 (“Nuwayser”: Ex. F)
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`Johnson et al., 2004, “A Pilot Evaluation of the Safety and Tolerability of Repeat
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`Dose Administration of Long-Acting Injectable Naltrexone (Vivitrex®) in Patients with
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`Alcohol Dependence,” Alcoholism:Clinical and Experimental Research 28(9): 1356-
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`1361 (“Vivitrex Pilot Study”; Ex. G)
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`Rubio et al., 2001, “Naltrexone Versus Acamprosate: One Year Follow-Up of
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`Alcohol Dependence Treatment,” A/cohol & Alcoholism 36(5): 419-425 (“Rubio”’; Ex. W)
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`US Patent 6,264,987 (“Wright’; Ex. N)
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 4
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`The Vivitrex Pilot Study, Nuwayser, and Rubio did not appearon an information
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`disclosure statement(IDS) and were notcited by the examiner as relevant evidencein
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`the original prosecution, so they represent new art not previously submitted.
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`Comer and Wright were cited on IDSesin the 167 application but were notrelied
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`upon or discussed by the examinerin the original prosecution. (167 application, IDS of
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`5/26/10, nonpatent reference 1 (Comer): ’167 application, IDS of 8/29/05, US Patent
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`reference AB (Wright); see also request at page 14, discussing Exhibits E and N;
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`request at pages 33 and 37.)
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`A substantial new question of patentability may be based solely on old art where
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`the old art is being presented/viewed in a newlight, or in a different way, as compared
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`with its use in the earlier examination(s), in view of a material new argumentor
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`interpretation presented in the request. Such material new argumentor interpretation
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`may be basedsolely on claim scope of the patent being reexamined. MPEP 2242(II)(A).
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`A proposed SNQ (ground 1; request at page 15) is therefore based solely on
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`patents and/or printed publications already cited/considered in an earlier concluded
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`examination or review of the patent being reexamined, or has been raised to or by the
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`Office in a pending reexamination or supplemental examination of the patent. On
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`November 2, 2002, Public Law 107-273 was enacted. Title III, Subtitle A, Section
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`13105, part (a) of the Act revised the reexamination statute by adding the following new
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`last sentence to 35 U.S.C. 303(a) and 312(a):
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`The existence of a substantial new question of patentability is not precluded by
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`the fact that a patent or printed publication was previously cited by or to the
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`Office or considered by the Office.
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 5
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`For any reexamination ordered on or after November2, 2002, the effective date
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`of the statutory revision, reliance on previously cited/consideredart, i.e., “old art,” does
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`not necessarily preclude the existence of a substantial new question of patentability
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`(SNQ)that is based exclusively on that old art. Rather, determinations on whether a
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`SNQ exists in such an instance shall be based upona fact-specific inquiry done ona
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`case-by-casebasis. In the present instance, there exists a SNQ based solely on Comer.
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`Comer wascited on an IDS in the 167 application but was not relied upon or discussed
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`by the examinerin the original prosecution. Comer has therefore been presented and
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`viewedin a new light and a different way than in the original prosecution.
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`Requester presented additional exhibits including patent and nonpatent
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`references, documents from USPTO proceeding IPR2018-00943 (“the IPR
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`proceeding”), declarations from the original prosecution and from the IPR proceeding,
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`and Office actions and responses from the original prosecution. These are notrelied
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`uponin the proposed SNQs.
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`Requester’s Proposed SNQs
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`Ground 1: Comer
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`The request presents a substantial new question of patentability of claims 1, 3-5,
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`and 12 of the ’499 patent based on Comer. The requestrelies on Nuwayserin this SNQ
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`solely for the definition of the art-recognized trademark DEPOTREX. (Request at pages
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`39-40.)
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`Comerdiscloses treating addicts and alcoholics with depot formulations of
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`naltrexone. (Request at pages 38-39.) Comer administers DEPOTREX®, a known
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`depot formulation, to administer 384 mg of naltrexone. (Request at pages 39-41.)
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 6
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`Comer’s DEPOTREX®contains polylactide-co-glycolide (PLGA) as a biocompatible
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`polymer. (Request at pages 39-41.)
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`Regarding claims 3 and 4, Comer teaches release for “a month.” (Request at
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`page 44; see ’499 patent, column 4, line 56, identifying “every four weeks” as one
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`example of “monthly” administration.)
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`Regarding claim 5, Comer administers the same formulation as that recited in
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`claim 5. (Requestat page 44.)
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`Regarding claim 12, Comer teachesinjection of the depot formulation through an
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`18-gauge needle. (Request at page 44.)
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`For "a substantial new question of patentability" to be present, it is only
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`necessarythat: (A) the prior art patents and/or printed publications raise a substantial
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`question of patentability regarding at least one claim, i.e., the teaching of the (prior art)
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`patents and printed publications is such that a reasonable examiner would consider the
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`teaching to be important in deciding whether or not the claim is patentable; and (B) the
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`same question of patentability as to the claim has not been decided by the Office in an
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`earlier concluded examination or review of the patent, raised to or by the Office in a
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`pending reexamination or supplemental examination of the patent, or decidedinafinal
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`holding of invalidity (after all appeals) by a federal court in a decision on the merits
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`involving the claim. MPEP 2242.
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`Regarding (A), an examiner would have found Comer’s teachings importantin
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`assessing patentability. Regarding (B), the same question of patentability has not been
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`decided by the Office in an earlier concluded review because IPR2018-00943 was
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`terminated before the PTAB could issue a final written decision.
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 7
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`Ground 2: The Vivitrex Pilot Study
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`The request presents a substantial new question of patentability of claims 1, 3-5,
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`and 10-12 of the 499 patent based on the Vivitrex Pilot Study. The request discusses
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`whetherthe ’499 patentis entitled to the benefit of its "542 provisional application’s filing
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`date and discusses the teachings of the Vivitrex Pilot Study. The request establishes a
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`substantial likelihood that a reasonable examiner would consider the Vivitrex Pilot Study
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`to be important in deciding whether or not the claims are patentable.
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`The request contends that the 542 provisional application does not provide
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`support under 35 U.S.C. 112,first paragraph, for the claimed increase in naltrexone
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`serum AUC comparedto that yielded by oral administration. (Request at pages 45-48.)
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`The underlying 167 application adds material beyond the disclosure of the 542
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`provisional application (specifically, examples 3-5 at columns 18-20), so it is analogous
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`to a continuation-in-part of that provisional application. See MPEP 2152.01 (analysis of
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`effective filing date not changed by AIA and referencing MPEP 2133.01). “[A]ny claim
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`that contains a limitation that is only supported as required by pre-AlA 35 U.S.C. 112,
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`first paragraph, by the disclosure of the CIP application will have the effectivefiling date
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`of the CIP application.” MPEP 2133.01. See also MPEP 2218:
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`[W]here the patent for which reexamination is requested is a continuation-in-part
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`of a parent application, the requester would notify the Office of the application
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`numberof the parent application andits status if the asserted substantial new
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`question of patentability relates to a proposed rejection based on anintervening
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`art and the question of whether the claimed subject matter in the patent has
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`support in the parent application is relevant.
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 8
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`The request states that the ’542 provisional application nowhere provides data
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`demonstrating possession of the claimed increased serum AUC from the claimed range
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`of naltrexone dose. (Request at page 48.) The request further states that the person of
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`ordinary skill in the art would have understood that serum AUC dependson several
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`factors and would therefore not have concluded that the ’542 provisional application
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`teachesthe claimed increase. (Request at pages 47-48.)
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`Based on the request’s analysis of the ’499 patent’s benefit claim, a reasonable
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`examiner could reasonably conclude that the ’499 patent’s effectivefiling date is its
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`actualfiling date, 3/17/05. In that case, then, the examiner wouldfind that the Vivitrex
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`Pilot Study of September 2004is important in assessing patentability. (See request at
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`pages 45-46.)
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`Regarding claim 1, the Vivitrex Pilot Study administers 400 mg naltrexone
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`intramuscularly in a formulation comprising PLGA. (Request at pages 48-49.) An
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`examiner would have found these teachings important in assessing patentability.
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`Regarding claims 3 and 4, the Study teaches multiple “1-month treatment
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`cycles.” (Request at pages 49-50; see 499 patent, column 4, line 56, identifying “every
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`four weeks” as one example of “monthly” administration.)
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`Regarding claim 5, the Study administers the same formulation as that recited in
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`claim 5. (Request at page 50.)
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`Regarding claim 10, the Study’s patients were alcohol-dependent. (Request at
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`page 50.)
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`Regarding claim 11, the Study’s patients received thefirst dose of naltrexone on
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`day 0 of the pilot. (Request at page 50.)
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`Page 10 of 20
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 9
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`Regarding claim 12, the Study teachesintramuscularinjection of the depot
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`formulation. (Request at page 50.)
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`For "a substantial new question of patentability" to be present, it is only
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`necessarythat: (A) the prior art patents and/or printed publications raise a substantial
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`question of patentability regarding at least one claim, i.e., the teaching of the (prior art)
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`patents and printed publications is such that a reasonable examiner would consider the
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`teaching to be important in deciding whetheror not the claim is patentable; and (B) the
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`same question of patentability as to the claim has not been decided by the Office in an
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`earlier concluded examination or review of the patent, raised to or by the Office in a
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`pending reexamination or supplemental examination of the patent, or decidedin a final
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`holding of invalidity (after all appeals) by a federal court in a decision on the merits
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`involving the claim. MPEP 2242.
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`Regarding (A), an examiner would have foundthe Vivitrex Pilot Study’s teachings
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`important in assessing patentability becausethey are relevant to the claim limitations.
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`Regarding (B), the same question of patentability has not been decided by the Office in
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`an earlier concluded review becausethe Vivitrex Pilot Study was not before the PTABin
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`IPR2018-00943.
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`Ground 3: Comer in view of Nuwayser, Rubio, and Wright
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`The request presents a substantial new question of patentability of claims 1-13 of
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`the 499 patent based on Comerin view of Nuwayser, Rubio, and Wright. Comer
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`discloses treating addicts and alcoholics with depot formulations of naltrexone.
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`(Request at pages 38-39.) Comer administers DEPOTREX®, a known depot
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`formulation, to administer 384 mg of naltrexone. (Request at pages 39-41.) Comer’s
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 10
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`DEPOTREX® contains polylactide-co-glycolide (PLGA) as a biocompatible polymer.
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`(Request at pages 39-41.) Nuwayser teaches a formulation that achieves acceptable
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`delivery of naltrexone via a depot formulation. (Request at pages 51-52.) An examiner
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`would have found these teachings important in assessing patentability.
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`Regarding claims 3-5 and 12, see the discussion of Comer provided under
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`Ground 1. (Request at pages 56 and 58.)
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`Regarding claim 2, Comer teaches administering over a year, and Rubio teaches
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`of 12-month treatment protocols in alcoholics. (Request at pages 56-57.)
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`Regarding claims 7-9, Comer and Nuwayserboth teach weekly administration.
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`(Requestat page 57.)
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`Regarding claim 10, Comer discusses the use of depot naltrexone in alcoholics,
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`as does Rubio. (Request at pages 57-58.)
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`Regarding claim 11, Comer specifically states that oral naltrexone is not
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`necessary prior to depotinjection. (Request at page 58.)
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`Regarding claim 13, Nuwayser’s formulation exemplifies 54.4% naltrexone by
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`weight and Wright teaches that drug loading maybein the range of 30-75%by weight.
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`(Request at page 58, citing Ex. N (Wright).)
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`For "a substantial new question of patentability" to be present, it is only
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`necessarythat: (A) the prior art patents and/or printed publications raise a substantial
`
`question of patentability regarding at least one claim, i.e., the teaching of the (prior art)
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`patents and printed publications is such that a reasonable examiner would consider the
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`teaching to be important in deciding whether or not the claim is patentable; and (B) the
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`same question of patentability as to the claim has not been decided by the Office in an
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 11
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`earlier concluded examination or review of the patent, raised to or by the Office in a
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`pending reexamination or supplemental examination of the patent, or decidedin a final
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`holding of invalidity (after all appeals) by a federal court in a decision on the merits
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`involving the claim. MPEP 2242.
`
`Regarding (A), an examiner would have found the teachings of Comer,
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`Nuwayser, Rubio, and Wright important in assessing patentability because they are
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`relevant to the claim limitations. Regarding (B), the same question of patentability has
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`not been decided by the Office in an earlier concluded review because IPR2018-00943
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`was terminated before the PTAB could issue a final written decision.
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`Ground 4: The Vivitrex Pilot Study in view of Nuwayser, Rubio, and Wright
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`The request presents a substantial new question of patentability of claims 1-13 of
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`the 499 patent based on the Vivitrex Pilot Study in view of Nuwayser, Rubio, and
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`Wright.
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`Regarding claim 1, the Vivitrex Pilot Study administers 400 mg naltrexone
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`intramuscularly in a formulation comprising PLGA. (Request at pages 59-60.) An
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`examiner would have found that teaching important in assessing patentability.
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`Regarding claims 3-5 and 10-12, a reasonable examiner would have found the
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`Study important in assessing patentability for the reasons provided under Ground2.
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`(Request at pages 61-63.)
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`Regarding claims 2 and 6, the Study treated patients every 4 weeksfor 16
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`weeks, while both Rubio teaches administration for a year or more. (Request at pages
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 12
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`60-61.) An examiner would have found these teachings important in assessing
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`patentability.
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`Regarding claims 7-9, the Study teaches weekly administration. (Request at
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`page 62.) An examiner would have found these teachings important in assessing
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`patentability.
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`Regarding claim 10, the Study discusses the use of depot naltrexone in
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`alcoholics, as does Rubio. (Request at pages 62-63.) An examiner would have found
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`these teachings important in assessing patentability.
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`Regarding claim 11, the Study does not teach providing aninitial oral dose of
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`naltrexone. (Request at page 63.) An examiner would have found that teaching
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`important in assessing patentability.
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`Regarding claim 13, Wright's formulation may bein the range of 30-75% by
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`weight. (Request at page 63.) An examiner would have found that teaching importantin
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`assessing patentability.
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`For "a substantial new question of patentability" to be present, it is only
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`necessarythat: (A) the prior art patents and/or printed publications raise a substantial
`
`question of patentability regarding at least one claim, i.e., the teaching of the (prior art)
`
`patents and printed publications is such that a reasonable examiner would consider the
`
`teaching to be important in deciding whether or not the claim is patentable; and (B) the
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`same question of patentability as to the claim has not been decided by the Office in an
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`earlier concluded examination or review of the patent, raised to or by the Office ina
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`pending reexamination or supplemental examination of the patent, or decidedinafinal
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 13
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`holding of invalidity (after all appeals) by a federal court in a decision on the merits
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`involving the claim. MPEP 2242.
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`Regarding (A), an examiner would have found the teachings of the Vivitrex Pilot
`
`Study, Nuwayser, Rubio, and Wright important in assessing patentability because they
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`are relevantto the claim limitations. Regarding (B), the same question of patentability
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`has not been decided by the Office in an earlier concluded review becausethe Vivitrex
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`Pilot Study was not before the PTABin IPR2018-00943.
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`35 U.S.C. 325(d)
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`35 USC 325(d) states in part, “...[i]n determining whether to institute or order a
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`proceeding under this chapter, chapter 30, or chapter 31, the Director may take into
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`account whether, and reject the petition or request because, the same or substantially
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`the same prior art or arguments previously were presented to the Office.” Thus in order
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`for the Director to exercise discretion as to whether to Order a reexamination under
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`chapter 30, the request mustfirst be determined to be based on the same or
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`substantially the same prior art or arguments that previously were presented to the
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`Office.
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`A review of the post grant history of the ’499 patentindicates that the patent was
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`the subject of a single prior Office post grant challengefiled before the filing of this
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`Request (90/019,779).
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`IPR2018-00943
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`On 4/20/18, Petitioner Amneal Pharmaceuticals LLC, being different from the
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`Requesterin this application’s Request,filed a petition for inter partes review of claims
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`Application/Control Number: 90/019,779
`Art Unit: 3991
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`Page 14
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`1-13 of the ’499 patent (IPR2018-00943) which asserted the following grounds as
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`raising a reasonablelikelihood of prevailing (RLP):
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`
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`Nuwayser, Kranzler, Rubio, and Wright
`#6 § 103(a)|Alkermes 10-K, Vivitrex Specimen, Wright,3
`and Rubio
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`
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`On 11/7/18, the Patent Trial and Appeal Board (PTAB) mailed a Decision
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`instituting inter partes review holding that the Petitioner showed a reasonable likelihood
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`of prevailing on all grounds. See Decision Granting Institution, page 41.
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`On 7/31/19, prior to the issuance of anyfinal written decision, the PTAB issued a
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`decision terminating the proceeding in view of a joint settlement agreement between the
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`parties. The PTAB noted that on August 16, 2024, Petitioner and Patent Ownerfiled a
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`Joint Motion to Terminate and thus, the proceeding was terminated under 35 USC §
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`317(a). See Termination Decision entered 7/31/19.
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`A comparison between the prior art and arguments presentedin the instant
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`request and the earlier IPR petition, indicates that ground 3 presented in the instant
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`reexamination request is based on the same art and arguments as presented in RLPs 3
`
`and 4 of IPR2018-00943.
`
`As indicated above, the current request asserts the following groundsasraising
`
`a substation new question of patentability (SNQ) of the ‘499 patent.
`
`Page 16 of 20
`
`Page 16 of 20
`
`
`
`Application/Control Number: 90/019,779
`Art Unit: 3991
`
`90/019.779
`
`Page 15
`
`
`
`|1|1,3-5,12 |35 U.S.C. 102(b)|Comer as evidenced by Nuwayser
`
`|2 fd, 3-5, 10-12|35 U.S.C. 12aa)|Vivitrex Pilot Stud
`iene esey
`PLRHee[aeveraBBeSWright
`
`
`
`Rubio, and Wright
`
`Becauseat least one ground in the instant Request e.g., ground #8, is based on
`
`the same prior art previously presented to the Office in the prior IPR petition, the
`
`statutory threshold under 325(d) is met for the Director to exercise discretion in deciding
`
`whetherto reject the 90/019,779 request.
`
`However, in view of the fact that the prior instituted IPR petition was terminated
`
`after institution based on a joint settlement agreement and the PTABdid notfully
`
`evaluate the prior art presented in the petition, the Examiner as delegated by the
`
`Director declines to exercise such discretion to reject the reexamination request,
`
`Accordingly, ex parte reexamination is ordered for the ’499 patent, in view of the
`
`determination above that a substantial new question of patentability has been raised in
`
`the instant Request for Reexamination.
`
`Conclusion
`
`In view of the analysis above, the request for reexamination is GRANTED.
`
`Claims 1-13 of US Patent 7,919,499 will be reexamined.
`
`Duty to Disclose
`
`The patent owneris remindedof the continuing responsibility under 37 CFR
`
`1.565(a) to apprise the Office of anylitigation activity, or other prior or concurrent
`
`Page 17 of 20
`
`Page 17 of 20
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`
`
`Application/Control Number: 90/019,779
`Art Unit: 3991
`
`Page 16
`
`proceeding, involving US Patent 7,919,499 throughout the course of this reexamination
`
`proceeding. See MPEP 2207, 2282, and 2286.
`
`Amendment in Reexamination Proceedings
`
`Any proposed amendmentto the specification and/or claims in the reexamination
`
`made by the patent owner must comply with 37 CFR 1.530(d)-(j), must be formally
`
`presented as directed by 37 CFR 1.52(a) and (b), and must be accompanied by any
`
`fees required by 37 CFR 1.20(c).
`
`Waiver of Right to File Patent Owner Statement
`
`In a reexamination proceeding, patent owner may waive the right under 37 CFR
`
`1.530 to file a Patent Owner Statement. The document must contain a statement that
`
`patent owner waives the right under 37 CFR 1.530 to file a Patent Owner Statement
`
`and proof of service in the manner provided by 37 CFR 1.248 because the requestfor
`
`reexamination was madebya third party. See 37 CFR 1.550(f).
`
`Service of Papers
`
`After the filing of a request for reexamination by a third-party requester, any
`
`documentfiled by either the patent owneror the third-party requester must be served on
`
`the other party (or parties, where two or morethird-party requester proceedings are
`
`merged) in the reexamination proceeding in the manner provided by 37 CFR 1.228. See
`
`37 CFR 1.550(f).
`
`Extension of Time
`
`Extensions of time under 37 CFR 1.136(a) will not be permitted in these
`
`proceedings becausethe provisions of 37 CFR 1.136(a) apply only to “an applicant” and
`
`not to parties in a reexamination proceeding. Additionally, 35 U.S.C. 305 requires that
`
`Page 18 of 20
`
`Page 18 of 20
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`
`
`Application/Control Number: 90/019,779
`Art Unit: 3991
`
`Page 17
`
`ex parte reexamination proceedings “will be conducted with special dispatch.” See 37
`
`CFR 1.550(a). Extensions of time in ex parte reexamination proceedings are provided
`
`for in 37 CFR 1.550(c).
`
`Correspondence
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to LORA E BARNHART DRISCOLL, whosetelephone
`
`number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m.
`
`ET.
`
`Examiner interviews are available via telephone, in-person, and video
`
`conferencing using a USPTO supplied web-basedcollaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http:/Avwww.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Jean Witz, can be reached on 571-272-0927.
`
`All correspondencerelating to this ex parte reexamination proceeding may be
`
`submitted:
`
`Electronically:
`
`Registered users may submit via Patent Center
`
`By Mail to:
`
`https://patentcenter.uspto.gov/.
`
`Mail Stop Ex Parte Reexam
`Central Reexamination Unit
`Commissioner for Patents
`United States Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Page 19 of 20
`
`Page 19 of 20
`
`
`
`Application/Control Number: 90/019,779
`Art Unit: 3991
`
`Page 18
`
`By FAX to
`
`By hand:
`
`(571) 273-9900
`Central Reexamination Unit
`
`Customer Service Window
`Knox Building
`501 Dulany Street
`Alexandria, VA 22314
`
`For Patent Center transmissions, 37 CFR 1.8(a)(1)(i)(C) and(ii) state that
`
`correspondence (except for a request for reexamination and a corrected or replacement
`
`requestfor reexamination) will be considered timely filed if (a) it is transmitted via the
`
`Office's electronicfiling system in accordance with 37 CFR 1.6(a)(4) , and (b) includes a
`
`certificate of transmission for each piece of correspondencestating the date of
`
`transmission, whichis prior to the expiration of the set period of time in the Office action.
`
`/Lora E Barnhart Driscoll/
`Patent Reexamination Specialist, Art Unit 3991
`
`Conferees:
`
`/JOSEPH R KOSACK/
`Patent Reexamination Specialist, Art Unit 3991
`
`/T.M.S/
`Supervisory Patent Examiner, Art Unit 3991
`
`Page 20 of 20
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`Page 20 of 20
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`
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