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`UN ITEIJ S'|‘A'I‘l:$ lJEP:\IiTEI1l'LN’1' DI-' COLIMERCE
`Unified States Patent nnd Trad:-marl: Omee
`Ad-drum COMMISSIONER OF‘ PATFJQTS AND TRA.DE.MILKK3
`Wnlhinumn, 11.6. 20231
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`APFLICATION N0.
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`FILING DATE
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`‘
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`FIRST NAMED IINYENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION N0.
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`09f7S6,19l
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`Dlf09l2'D0l
`
`John R. Evans
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`PM 275507 PHM'M}fi3SJ'US
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`5974
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`9629
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`7590
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`1210312002
`
`MORGAN LEWIS &B°C‘““S 1”’
`11 1 I PENNSYLVANIA AVENUE NW
`WASHINGTON, DC 20004
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`W" S‘’‘” MWG R
`ART UNIT
`PER NUMBER
`
`I6 I?
`7
`DATE MAIL!-ED: 12fO3J'20U2
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`Please find below and/‘or attached an Uffice communication concerning this application or proceeding.
`
`PTCLQGC (Rev. 07-01)
`
`Asti*aZeneca Ex. 2132 p. 1
`Mylan Pharms. Inc. V. AstraZeneca AB IPR2016-01324
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`

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`7 Applicant(s}
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`Application No.
`
`EVANS ET AL.
`
`
`
`7
`1611?
`San-ming Hui
`-« The MAILING DA TE of this communication appears on the cover sheet with the correspondence address —
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXF’lRE g MONTH(S) FROM
`THE MAlL|NG DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR r.-meta).
`after SIX (6) MONTHS from the mailing date of this communication.
`If the period for reply specified above is less than thirty (30) days. a repiy within the statutory minimum of thirty (30) days will be considered timely.
`-
`If NO period for repiy is specified above. the maximum statutory period will apply and will expire SIX (6) MDNTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period lor reply will, by statute. cause the application to become ABANDONED (35 U.S.C. § 133}.
`— Any reply received by the Office later than three months after the mailing date of this comrnuniration. own it timely filed. may reduce any
`earned patent term adjustment. See 3? CFR 1.T04(b).
`Status
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`In no event, however. may a reply be timely filed
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`1) Responsive to communicationts) filed on 13 September 2002 .
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`2a)l:I
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`This action is FINAL.
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`2o)® This action is non-final.
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`3)[:] Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 CD. 11, 453 0.63. 213.
`Disposition of Claims
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`4) Claim(s) giflislare pending in the application.
`islare withdrawn from consideration.
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`4a) Of the above claim(s) _:
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`5)|:l Clairn(s) _ islare allowed.
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`BJEI Ctaim(s) gi.5_o islare rejected.
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`7)|:l Claimt-3} j islare objected to.
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`8)I:I Ctaim(s) __
`Application Papers
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`are subject to restriction andior election requirement.
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`9)I:l The specification is objected to by the Examiner.
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`10)I:I The drawing(s) filed on j is/are: all] accepted or b)I:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawingts) be held in abeyance. See 37 CFR 1.85(a).
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`11)l:l The proposed drawing correction filed on :_ is: all] approved b)l:l disapproved by the Examiner.
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`If approved. corrected drawings are required in reply to this Office action.
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`12)C] The oath or declaration is objected to by the Examiner.
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`Priority under 35 U.S.C. §§ 119 and 120
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`M
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`13)E Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(3)-(cl) or (f).
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`£08] All b)l:] Some " c)I:l None of:
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`1. Certified copies of the priority documents have been received.
`
`2.E] Certified copies of the priority documents have been received in Application No.
`
`3.I:l Copies of the certified copies of the priority documents have been received in this National Stage
`appticalion from the international Bureau (PCT Rule ‘l7’.2(a)).
`“ See the attached detailed Office action for a list of the certified copies not received.
`
`14)l:l Acknowledgment is made of a claim for domestic priority under 35 U.S.C. § 119(9) {to a provisional application).
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`a) 1:] The translation of the foreign language provisional application has been received.
`’l5)I:I Acknowledgment is made of a claim for domestic priority under 35 U.S.C. §§ 120 andfor 121 .
`Attachmenttsi
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`
`
`
`
`1) [1 Notice of Ftelerenoes Cited iprosszj
`2) CI Notice of Draflspersolrs Patent Draining: Review {PTO-948)
`31$ |nfcln'nation Disclosure Statement[sl(PTO«144Q) Paper hints)
`U.S. Patent and Traderrnrlr Olfloe
`PTO-326 (Rev. 04-01)
`
`..-1'3 .
`
`4) El Interview Summary (PTO-413») Paper Noisl. __ .
`5) El Notice of Informal Patent Application (PTD~152l
`6} D Othen
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`Part of Paper No. 13
`
`Office Action Summary
`
`Astrazeneca Ex. 2132 p. 2
`
` U9fl'55,29'l
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`Examiner
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`Art Unit
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`
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`Office Action Summary
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`

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`Application/Control Number O9/756.291
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`Page 2
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`Art Unit: 1617
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`DETAILED ACTION
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`The amendments filed September 13, 2002 have been entered. The cancellation
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`of claims 1-23 in the amendments filed September 13, 2002 is acknowledged. The
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`addition of claims 24-50 in the amendments filed September 13, 2002 is acknowledged.
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`Claims 24 — 50 are drawn to a method of treating benign or malignant disease of
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`the breast or reproductive tract.
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`The outstanding objection is withdrawn in view of the cancellation of the claims.
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`The IDS received September 13, 2002 ahs been considered.
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`Claim Objections
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`Claim 32 is objected to because of the following informalities: no period at the
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`end of the claim. Appropriate correction is required.
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`Claim Rejections - 35 USC § 112
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`The following is a quotation of the first paragraph of 35 U.S.C. 112:
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`The specification shall contain a written description of the invention, and of 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, or with which it is most nearly connected. to make and use the same and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
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`Claims 24-50 are rejected under 35 U.S.C. 112, first paragraph, because the
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`specification, while being enabling for cancer and certain hormonal-dependent benign
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`diseases of the breast and endometrial lining, does not reasonably provide enablement
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`for other non-hormonal dependent conditions of the breast and the reproductive tract.
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`The specification does not enable any person skilled in the art to which it pertains. or
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`Astrazeneca Ex. 2132 p. 3
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`

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`
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`Appiicatianicantrai Mumeer; i39l755,2Q1
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`Page 3
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`Art Unit: 151?‘
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`with which it is most neariy connected, to uae the invention commensurate in scope with
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`these ctaima.
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`in the irtetantcaae, the epecitieatirm fails to provide infermatier: that would aiiew
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`the skirted artisan ta practice the instant invention without undue experimentation,
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`Attention is —directed to In re Wanda, 8 USPQ2d 1400 (CAFC H388) at 1404 where the
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`ceurt set forth the eight factors to censider when assessing it a disclosure weuid have
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`required undue experimentation. Citing Ex parre Forman, 23:3 USPQ 548 {Bd/Apia
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`198$) at 54‘? the ceurt retzited eight factere:
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`1} the quantity of experimentation necessary,
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`2) the amount of direetian er guidance provided,
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`3} the presence of absence of werkirrg exampiee,
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`4) the nature of the invention,
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`5) the state of the prior art,
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`6) the reiative eisziil efthese in the art
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`7) the preeictahiiity at the art, and
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`3) the breadth of the ciaima.
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`Appiicant fails to set ferth the criteria that define "benign disease at the breast
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`and reproductive tract".
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`in the instant case, eniy a iimiteci number at “disease of the
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`breast and reproductive tract" exampiee are set ferth, thereby failing to premiere sufficient
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`working exampiea.
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`it is hated that these examples are neither exhaustive. nor define
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`the type or kind of disease treated. The pharmaceutical art is unpredictable, requiring
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`each embodiment ta be individualiy assessed for physiatogieat activity. The instant
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`Astrazeneca Ex. 2132 p. 4
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`

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`Appiicatianlcontml Number: OQ!?56,29‘l
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`Page 4
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`Art Unit: 1617’
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`claims read cin g; "disease of the breast and reproductive tract“ which including nrmn
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`hcirmonal-dependent meciicai condiiicms, such as yeast vaginiiis, bacterial vaginitis,
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`geniiiai herpes, viral vaginiiis, and sexual iransmittad diseases, necessitating an
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`exhaustive Search for the embodiments suitable to practice the claimed invention.
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`Applicants fall to provide information sufficieni to practice the claimed invention, absent
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`undue experimentation.
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`The feilowing is a qucriaiion of the seccind paragraph of 35 11.8.6. 112:
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`The s :ies:;ificatiori shall czonciude with me ctr more claims particulariy painting nut and distinctly
`ciaiming ihe subject matter which the appiinzani regards as his invention.
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`1
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`’\...—»r»
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`Claim 32 is rejected under 35 U.S.C. 112, semnd paragraph, as being indefinite
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`far faliing to particuliariy paint out and distinctly claim the subject matter which applicant
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`regards as the invention.
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`Claim 32 is net understood b&£3ElUSB it is an incomplete claim.
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`Ciaim Rejections - 35 USC § 1'03
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`The follciwing is a quotation cf 35 U.S.C. 103(3) which iczrrns the ibasis for ali
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`obviousness rejeciicms set fczrlzh in this Qfiirse aciirm:
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`{3} A patent rrzay not be obtained though the invention is natlidantically disclesed um described as set
`forth in section 102 {if this title, if the differences between the subject matter smighi to be patented and
`the prior art are such that the subject matier as a whole wauld have been obvious at the time the
`invention was made to a person having crciinary ski): in the art to which said subject matter periaina
`Paieniabiiity shall not be riegaiived by the manner in which the invention was made.
`
`Astrazeneca Ex. 2132 p. 5
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`

`
`Applicationlcontrol Nu mber: 091756291
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`Page 5
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`Art Unit: 161?
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`The factual inquiries set forth in Graham v. John Deere Co., 383 US. 1, 148
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`USPQ 459 (1986), that are applied for establishing a background for detemiining
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`obviousness under 35 U.S.C. 103(3) are summarized as follows:
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`1.
`2.
`3.
`4.
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`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating
`obviousness or nonobviousness.
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`Claims 24-50 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Dukes (EP 0 346 014 from the IDS received February 1, 2002) in view of Lehmann et
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`al. (US Patent Re. 28.690), GB 1 569 286 from the IDS received February 1. 2002
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`(herein after referred as ‘286), and Remington (Remington's Pharmaceutical Sciences,
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`18”‘ ed., 1990. page 219).
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`Dukes teaches antiestrogen agents, including fulvestrant. are useful in treating
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`postmenopausal symptoms such as urogenital atrophy affecting the vagina (See page
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`3, lines 56-page 4, line 1; also page 7, line 28-29). Dukes teaches that antiestrogen
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`agent. including fulvestrant, may be used in a dosage of 50mg to 5g in vehicle
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`comprising castor oil and benzyl alcohol (See page 7, line 20-24).
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`Dukes does not expressly teach the dosage of fulvestrant to be 45mg. Dukes
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`does not expressly teach the employment of benzyl benzoate, in the percent amount of
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`60% wiv or less, or 50% wiv or less. or 45% wfv or less, 40% wiv or less. or 35% wlv or
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`less. or 30% wlv or less, 25% wiv or less. or 10-25% w/v, or 12-18% w/v, as part of the
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`vehicle herein. Dukes does not expressly teach the total amount of the fuIvestrant-
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`containing composition administered. Dukes does not expressly teach weight amount
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`Astrazeneca Ex. 2132 p. 6
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`

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`-v«WV;..
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`Apeiicatienfilentrei Number: i}9i756,29’l
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`Page 8
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`Art Unit: 1617
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`ef caster :22! end benzyl eieehel. Dukes cieee net expressly teach the employment ef
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`ethane! as part of the vehicle herein. Dukes dues not expreesiy teach the desage of
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`fulvestrant to be 250mg. (Dukes does not expressly teach the plasma cencentratien of
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`fulvestrant herein.
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`Lehmann et ai. teaches that benzyi benzeate and caster eil are weil~imown
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`solvent useful as conventional carriers fer steroids (See cot. 1, line 21-25).
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`‘286 teaches an intramuscular injection of testeeierene derivative containing
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`caster eilihenzoate in a retie of 6:4 (See page 1, line 17}.
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`Fiemingten teaches that ethanol is me :3!’ the meat eemmenly used eelvente in
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`pharmaceutical industry (See page 219).
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`it weulci have been obvious to one ef erdinary skill in the art at the time the
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`lmentien was made to empioy benzyl henzeate, ethanoi, caster oil, and benzyi eleehei,
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`in the herein claimed weight percent, with fulvestrant in the deeage herein, in 3 methed
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`of treating pestrnenepaueai sympteme such as uregenital atrephy in the vagina.
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`One of ordinary skill in the art would have been motivated to employ benzyi
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`benzeate, ethanei, caster oil, and benzyl aieehel, in the herein claimed weight pereent,
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`with fulvestrent, in the dosage herein, in a method of treating postmenopausal
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`symptoms such as urogenital atrephy because fulveeirant is known te be useful in
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`treating uregenitel atrophy, a benign disease of the female reproductive tract in the
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`vagina. Castor eii and henzyl aleehel are known he be effective as vehicle fer
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`fulvestrant. Ethanol is a cemmenly used pharmaceutical solvent. Benzyi henozate is
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`knewn to be effective as seivent for etereiclai eempounds. Since fulveetrant is a
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`Astrazeneca Ex. 2132 p. 7
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`

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`Appiicatienlcerrtrei Number; t3§:‘7’56,29‘l
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`»
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`Page 1?
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`Art Unit: 1617
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`v‘V..»~;.rv,,
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`eetregen‘derive1tive, benzyt benzoate weuld be reasenabiy expected to be useful as a
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`eelvent for ftrlveetrant. Therefore, eernbining ene or more agents, which are imewn to
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`be ueefut as commonly used eclvente, each as benzyl benzeate, ethanei, caster eil, and
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`benzyl alcbhel, together and ineerperated such cembinatien with an eetregen
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`derivatives, tulvestrent, weuid be reasonably expected it: be useful in formulating a
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`pharmaceutical cemeeeition. Fir rthermere, employing such fulveetrant-containing
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`composition to treat uregenital atrephy in vagina would be reasbnabiy expected to be
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`effective. Mereever, the eptimization of reeutt effect parameters (eg., amount of
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`excipiente, acreage renge, and deeing regimens} ie ebtrieue as being within the skin at
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`the artisan.
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`One of ordinary skiil in the art would have been metivated ta maintain the ptaema
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`cencentratien at fulveetrant herein because maintaining the therapeutic plasma level at
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`the active eempeunde would be eensiderett obvious as being within the purview of the
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`skitled artisan.
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`Any inquiry concerning this communicatien or earlier communications from the
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`‘examiner ehouid be directed to San-ming Hui whose telephone number is (H13) 3tJ5«~
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`10132. The examiner can nermatly be reached on Mon *:~3:t}C1te t:OO, Tu - Fri tram 9:00 te
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`6:00.
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`it attempts te reach the examiner by tetephone are uneuccesstui; the ezvtaminefe
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`supervieer, Sreeni Padmanebhan, Phil, can be reached on (7:33) 305-'i8?'7i The fax
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`phone numbers fer the organizaticin where this application or proceeding is assigned
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`Astrazeneca Ex. 2132 p. 8
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`

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`
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`Application/Control Number: 091756.291
`Art Unit: 161?
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`Page 8
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`are (703) 308-4556 for regular communications and (703) 308-4556 for After Final
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`communications.
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`Any inquiry of a general nature or relating to the status of this application or
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`proceeding should be directed to the receptionist whose telephone number is (703) 308-
`
`1235.
`
`San-ming Hui
`December 2. 2002
`
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`Astrazeneca Ex. 2132 p. 9