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`UNITED STATES PATENT AND TIRADEMARK OFFICE
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`b
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`UNl'l'.ED S'1'a\'I"l‘L‘.'.I D.EP.r\fl'I‘l\1EN'l' DI-' CDIVIMEBCE
`United States Patent nnd "E'nad-nmark Omen
`Addreu-: COMMISSIONER OF PATENTAI AND TRADEMARKS
`Wnnhinglan, ILG.
`2B‘.‘..\!.'l
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`“’PL'°*"°“ “*1
`09/756,29]
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`F“-‘"0 °*"=‘
`Dll09l2'DCIl
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`9629
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`7590
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`12!03i'2l)O2
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`MORGAN LEWIS &. BOCKIUS 1.1.?
`[III PENNSYLVANIA AVENUE NW
`WASHINGTON, DC 20004
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`John R. Evans
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`PM 275507 PHM70fi35fIJS
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`CON FIILMATJON NO.
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`5974
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`EXAMINER
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`HUI, SAN MING R
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`ART UNIT
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`[6 |‘}'
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`PAPER. NUMBER
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`DATE MAILED‘: 12f03l2002
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`PTO-90C (Rev. 07-01)
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`Asttazeneca Ex. 2132 p. 1
`Mylan Pharms. Inc. V. Astrazeneca AB IPR2016-01325
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`

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`‘ Applicantts}
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`Application No.
` U9I?56,291
`EVANS ET AL.
`Office Action Summary
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`Art Unit
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`1
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`Examiner
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`161?
`San-rning 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 EXPTIRE Q MONTH(S) FROM
`THE MAILING DATE OF THlS COMMUNICATION.
`- Extensions of time may be avaitable under the provisions of 3? CFR 1.136(a).
`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 reply within the statutory minimum of thirty (30) days will be considered timely.
`-
`If NO period for reply is specified above. the maximum statutory period wiil apply and will expire SIX (6) MONTHS ircm the mailing date of this communication.
`-
`- Failure to reply within the set or extended period tor reply will. by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`- Any repiy received by the Orfice later than three months after the mailing date of this communication. even it timely filed, may reduce any
`earned patent temi adjustment. See 37 CFR 1.7lJ«t(b).
`Status
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`In no event, however. may a reply be tlmety llled
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`1) Responsive to cornrnunicationis) filed on 13 September 2002 .
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`2a)l:I This action is FINAL.
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`2b)E This action is non-final.
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`3)[:l 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 C.D. 11. 453 0.G. 213.
`Disposition of Claims
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`4) Claim(s) g§_-_5QisIare pending in the application.
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`4a) Of the above ctaim(s) _ islare withdrawn from consideration.
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`5)EI Claim(s) j isiare allowed.
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`6)® Claimis) fig‘ isiare rejected.
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`?)l] Claimis) j islare objected to.
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`8)[:_l Claims)
`Application Papers
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`are subject to restriction andior election requirement.
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`9)D The specification is objected to by the Examiner.
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`10)Ij The drawings) filed on ? isiare: a)l:I 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:] The proposed drawing correction filed on __ is: a)l:I 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)l:] 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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`13)E Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)K All b)l:] Some * c)El None of:
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`1.E Certified copies of the priority documents have been received.
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`2.Ij Certified copies of the priority documents have been received in Application No.
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`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 172(3)).
`" See the attached detailed Office action for a list of the certified copies not received.
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`14)l:] Acknowiedgment is made of a claim for domestic priority under 35 U.S.C. § 119(e) (to a provisional application).
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`a) CI The translation of the foreign language provisional application has been received.
`15)I:I Acknowledgment is made of a claim for domestic priority under 35 U.S.C. §§ 120 andior 121.
`Attachmenttsl
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`4) I3 interview Summary (PTO-413) Paper No(s).
`5) El Notice of Informal Patent Application (PTO~152)
`6) D Other:
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`.
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`.a,.-12 .
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`
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`Notice of Reierenoes Cited {PTO-B92)
`1}
`2} El Notice of Draftspersorfs Patent Drawing Review {PTO-948}
`3} E Information Disclosure Statement(sl {PTO-1449) Paper No{s)
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`u.s. Patent and fiaaermrlt omce
`PTO-326 (Rev. 04-01}
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`
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`Office Action Summary
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`'
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`'
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`Part of Paper No. 13
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`Astrazcneca Ex. 2132 p. 2
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`

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`Applicationltlontrol Number: 09I756,291
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`Page 2
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`Art Unit: 1617
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`’--.4...,_,.,.‘,,___“.,,'
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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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`Ciaim Objections
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`Claim 32 is objected to because of the following informalitiesz no period at the
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`end of the claim. Appropriate correction is required.
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`Claim Rejections - 35 USC § 1 1‘ 2
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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 hormona|—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—hormona| 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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`Aopiicationicontrol Number: t'.i9i‘755,29t
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`Page 3
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`Art Unit: 161 i‘
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`with which it is most neariy connected, to use the invention commensurate in scope with
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`these ciaimsi
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`in the instant case, the specification fails to provide information that would allow
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`the skiiied artisan to practice the instant invention without undue experimentation.
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`Attention is directed to in re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the
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`court set forth the eight factors to consider when assessing if a disciosure wouid have
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`required undue experimentation. Citing Ex parte Forman. 238 USPQ 548 (BdApis
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`i985) at 54?‘ the court recited eight factors:
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`1) the quantity of experimentation necessary,
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`2) the amount of direction or guidance provided,
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`3) the presence of absence of working exampies,
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`At) the nature of the invention,
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`5) the state of the prior art.
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`6) the relative skiil of those in the art
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`7) the oredictaoiiity of the art, and
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`8} the breadth of the ciairns.
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`Appiicant fails to set forth the criteria that define "benign disease of the breast
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`and reproductive tract".
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`in the instant case. only a iimited number of "disease of the
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`breast and reproductive tract" exampies are set forth, thereby failing to provide sufficient
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`working exarnpies.
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`it is noted that these exampies are neither exhaustive. nor define
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`the type or kind of disease treated. The pharmaceutical art is unpredictabie, requiring
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`each embodiment to be individually assessed for physioiogicai activity. The instant
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`Astrazeneca Ex. 2132 p. 4
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`’"=“-""*"*"""wP'&—flV'.»”""'P!|O'Q
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`Apollcationlcontrol Number: 09!?‘58,29'l
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`Page 4
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`Art Unit: 1617'
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`claims read on all “disease of the breast and reproductive tract“ which including non«
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`hormonal-dependent medical conditions, such as yeast traginitis, bacterial vaginitis,
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`genitial herpes, viral vaginitis, and sexuai transmitted diseases, necessitating an
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`exhaustive search for the embodiments suitable to practice the claimed invention.
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`Applicants tail to provide information sufficient to practice the claimed invention, absent
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`undue experimentation.
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`The following is a quotation of the second paragraph of 35 1.1.8.0. 112:
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`The specification shall conclude with one or more claims particolariy pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
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`,_
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`'~ ‘~«»"“-1-
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`Claim 32 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite
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`for failing to particularly point out and distinctly olairn the subject matter which aooiicant
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`regards as the invention,
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`Claim 32 is not understood because it is an incomplete claim.
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`Ciaim Rejections - 35 USC § 103
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`The following is a quotation of 35 U,S.C. i€.l3(a) which forms the basis for all
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`ohiriousness rejections set forth in this Office action:
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`{a} is patent may not he obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skili in the art to which said subject matter pertains,
`Patentahllity shall not be negatived by the manner in which the invention was made.
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`Astrazeneca Ex. 2132 p. 5
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`

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`Application/Control Number: 091756291
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`Page 5
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`Art Unit: 1617
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`The factual inquiries set forth in Graham v. John Deere Co.. 383 U.S. 1, 148
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`USPQ 459 (1966), that are applied for establishing a background for determining
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`obviousness under 35 U.S.C. 103(a) 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 skiil 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% wfv or less, or 50% w/v or less. or 45% w/v or less, 40% wlv or less, or 35% wlv or
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`less. or 30% wlv or less, 25% wlv or less. or 10-25% wlv, or 12-18% wiv, as part of the
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`vehicle herein. Dukes does not expressly teach the total amount of the fu|vestrant—
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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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`v'h'v--—-_'7
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`Appiioationicontroi Number: 09!i'56,291
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`Page 6
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`Art Unit: 1617
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`of oastor oil and benzyl alcohol. Dukes does not expressly teach the employment of
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`ethanol as part of the vehicle herein. Dukes does not expressiy teach the dosage of
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`fulvestrant to be 250mg. Dukes does not expressly teach the plasma oonoentratlon of
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`fuhxestrant herein.
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`Lehmann et ai. teaches that oenzyl benzoate and Castor oil are well-ltnown
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`solvent useful as conventional oarriers for steroids (See col. 1, line 21-26).
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`‘286 teaches an intramuscular injeotion of testosterone derivative containing
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`oastor oillhenzoate in a ratio of 6:4 (See page 1, line 17).
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`Remington teaches that ethanol is one of the most oomrnonly used solvents in
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`pharrnaoeutioal industry (See page 219).
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`it would have been obvious to one of ordinary skill in the art at the time the
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`invention was made to employ oenzyl iaenzoate, ethanol, oastor oil, and benzyl alcohol,
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`in the herein olalmeo weight peroent, with tulvestrant in the dosage herein. in a method
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`of treating postmenopausai symptoms such as urogenital atrophy 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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`oensoate, ethanol, Castor oil, and benayl aioohoi, in the herein olaimeo weight percent.
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`with fulvestrant, in the dosage herein, in a method of treating postmenopausal
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`symptoms such as urogenital atrophy beoause fuivestrant is known to be useful in
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`treating urogenital atrophy, a benign disease of the female reproductive tract in the
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`vagina. Castor oil and henayl alcohol are known to be effective as vehicle for
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`fulvestrant. Ethanol is a oommonly used pharmaceutical solvent. Benzyl oenosate is
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`known to be effective as solvent for steroidal compounds. Since fulvestrant is a
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`Astrazeneca Ex. 2132 p. 7
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`

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`Application/Controt Number: G§!?5b,291
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`-
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`Page ?
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`Art Unit: tear
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`estrogenoerivetive, benzyl benzoate would be reasonably expected to be useful as a
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`solvent for fulvestrant. Therefore, oornbining one or more agents, which are known to
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`be useful as commonly used solvents. such as benzyl benzoate, ethanol, oastor oil, and
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`benzyl alcohol. together and incorporated such combination with an estrogen
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`derivatives, tuhrestrant, would be reasonably expected to be useful in formulating a
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`pharmaceutical oornposition. Furthermore, employing suoh fultrestrant-containing
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`composition to treat urogenital atrophy in vagina would be reasonably expected to be
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`effective. Moreover, the optimization of result effeot parameters (eg., amount of
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`exoioients, dosage range, anti dosing regimens) is obvious as being within the skill of
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`the artisan.
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`One of ordinary skill in the art would have been motivated to maintain the plasma
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`concentration of fulvestrant herein because maintaining the therapeutic plasma level of
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`the active oompounds would be considered obvious as being within the purview of the
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`skilled artisan.
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`Any inquiry oonoerning this communication or earlier communications from the
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`‘examiner should be directed to San-ming Hui whose telephone number is (‘i’O3) 305«
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`‘$002. The examiner nan normally be reached on Mon 9:00 to 1:00, To - Fri from 910G to
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`6:06.
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`if attempts to reach the examiner by teiephone are unsuccessful‘ the examiner's
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`supervisor, Sreeni Padrnanabhan, Phil, oan be reached on (T03) 305-487?. The fax
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`phone numbers for the organization where this application or proceeding is assigned
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`Astrazeneca Ex. 2132 p. 8
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`Application/Control Number: 09/756,291
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`Page 8
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`Alt Unit: 1617
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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-
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`1235.
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`San-ming Hui
`December 2. 2002
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`PHlMARYEXAM1i-IER
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`PP.ilii1AFl‘l’ EXAMINER
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`\,1’,\ ~;,\ fl/"’
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`Astrazeneca Ex. 2132 p. 9