UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Oflice
`Address: COMMISSIONER FOR PATENTS
`P 0 Box 1450
`Alexandria Virginia 22313-1450
`WwW.uspt0.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/285,887
`
`10/15/2008
`
`John R. Evans
`
`11285.0056—00000
`
`1199
`
`FINNEGAN, HENDERSON, FARAB OW, GARRETT & DUNNER
`LLP
`901 NEW YORK AVENUE, NW
`WASHINGTON, DC 20001-4413
`
`HUI, SAN MING R
`
`1628
`
`MAIL DATE
`
`09/16/201 1
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—9OA (Rev. 04/07)
`
`Astrazeneca Ex. 2137 p. 1
`Mylan Pharms. Inc. V. Astrazeneca AB IPR2016-01324
`
`

`
`Office Action Summary
`
`Application No.
`
`12/285,887
`
`Examiner
`SAN—M|NG HUI
`
`App|icant(s)
`
`EVANS ET AL.
`
`Art Unit
`1628
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1.136(a).
`In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`lf NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`—
`— Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office laterthan three months after the mailing date ofthis communication, even iftimely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
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`1)|Zl Responsive to communication(s) filed on 20 June 2011.
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`2a)I:I This action is FINAL.
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`2b)IZ This action is non—final.
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`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
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`4)I:I 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 O.G. 213.
`
`Disposition of Claims
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`5)IZ| Claim(s) M’ is/are pending in the application.
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
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`6 I:| Claim s) j is/are allowed.
`R3 is/are rejected.
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`is/are objected to.
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`are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`
`11)|:| The drawing(s) filed on j is/are: a)|:| accepted or b)|:I objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`12)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO—152.
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`Priority under 35 U.S.C. § 119
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`13)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
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`a)I:I All
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`b)I:I Some * c)|:I None of:
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`1.|:I Certified copies of the priority documents have been received.
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`2.|:I Certified copies of the priority documents have been received in Application No. j
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`3.|:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`Notice of References Cited (PTO-892)
`1)
`2) D Notice of Draftsperson’s Patent Drawing Review (PTO-948)
`3) I:I Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date
`_
`US. Patent and Trademark Office
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`4) D Interview Summary (PTO-413)
`Paper N0(5)/Mail Date j
`5) I:l Notice of Informal Patent Application
`6) D Other:
`.
`
`Part of Paper No./Mail Date 20110906
`
`Astrazeneca Ex. 2137 p. 2
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`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 2
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`DETAILED ACTION
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`This is a continuation of US 10/872,784, filed 6/22/2004, now patent 7,456,160,
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`which is a continuation of US 09/756,291, filed 1/9/2001, now patent 6,774,122. The
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`instant application also claims the benefit of UNITED KINGDOM 0OO0313.7, filed
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`01/10/2000 and UNITED KINGDOM 0008837.7, filed 04/12/2000.
`
`AppIicant’s amendments filed 6/20/2011 have been entered. Claims 24-53 are
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`pending.
`
`The outstanding rejection under 35 USC 103(a) is withdrawn due to the
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`cancellation of the claims.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper timewise extension of the “right to exclude” granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory
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`obviousness—type double patenting rejection is appropriate where the conflicting claims
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`are not identical, but at least one examined application claim is not patentably distinct
`
`from the reference cIaim(s) because the examined application claim is either anticipated
`
`by, or would have been obvious over, the reference c|aim(s). See, e.g., In re Berg, 140
`
`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29
`
`USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
`
`1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422
`
`Astrazcncca Ex. 2137 p. 3
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`

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`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 3
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`F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
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`USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321(d)
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`may be used to overcome an actual or provisional rejection based on a nonstatutory
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`double patenting ground provided the conflicting application or patent either is shown to
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`be commonly owned with this application, or claims an invention made as a result of
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`activities undertaken within the scope of a joint research agreement.
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`Effective January 1, 1994, a registered attorney or agent of record may sign a
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`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
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`37 CFR 3.73(b).
`
`Claims 24-53 are rejected on the ground of nonstatutory obviousness-type
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`double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 6,774,122
`
`(‘122). Although the conflicting claims are not identical, they are not patentably distinct
`
`from each other because '122 teaches the method of treating hormonal dependent
`
`benign or malignant disease of reproductive tract by employing the herein claimed
`
`composition. The ratio of the solvents and the excipients are within the range taught in
`
`'122. The optimization of result effect parameters (e.g., dosing regimen, weight ratio of
`
`the actives and the excipients) is obvious as being within the skill of the artisan. The
`
`optimization of known effective amounts of known active agents to be administered, is
`
`considered well in the competence level of an ordinary skilled artisan in pharmaceutical
`
`science, involving merely routine skill in the art.
`
`It has been held that it is within the skill
`
`in the art to select optimal parameters, such as amounts of ingredients, in a composition
`
`Astrazeneca Ex. 2137 p. 4
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`

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`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 4
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`in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
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`It is also noted that “[VV]here the general conditions of a claim are disclosed in the prior
`
`art, it is not inventive to discover the optimum or workable ranges by routine
`
`experimentation.” In re Al/er, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
`
`Claims 24-53 are rejected on the ground of nonstatutory obviousness—type
`
`double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 7,456,160
`
`(‘160). Although the conflicting claims are not identical, they are not patentably distinct
`
`from each other because '160 teaches the method of treating hormonal dependent
`
`benign or malignant disease of reproductive tract by employing the herein claimed
`
`composition. The ratio of the solvents and the excipients are within the range taught in
`
`'160. The optimization of result effect parameters (e.g., dosing regimen, weight ratio of
`
`the actives and the excipients) is obvious as being within the skill of the artisan. The
`
`optimization of known effective amounts of known active agents to be administered, is
`
`considered well in the competence level of an ordinary skilled artisan in pharmaceutical
`
`science, involving merely routine skill in the art.
`
`It has been held that it is within the skill
`
`in the art to select optimal parameters, such as amounts of ingredients, in a composition
`
`in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
`
`It is also noted that “[VV]here the general conditions of a claim are disclosed in the prior
`
`art, it is not inventive to discover the optimum or workable ranges by routine
`
`experimentation." In re Al/er, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
`
`Astrazeneca Ex. 2137 p. 5
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`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 5
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`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be 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 skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`Claims 24-53 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`McKeskey et al., from IDS filed 6/20/2011 in view of Dukes (EP 0 346 014), Osborne et
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`al., Journal of National Cancer Institute, 1995;87(20):746—750, and the abstract of
`
`Wakeling et al., The Journal of Steroid Biochemistry and Molecular Biology, 1992;43(1—
`
`3):173-177.
`
`McKeskey et al. teaches a studies employing subcutaneous injection of
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`fulvestrant to nude mice. The fulvestrant formulation contains 50mg/ml in a vehicle of
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`10% ethanol, 15% benzyl benzoate, 10% benzyl alcohol brought to volume with Castor
`
`oil (see page 698, col. 2, Drugs section).
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`McKeskey et al. does not expressly teach the use of fulvestrant in treating
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`hormonal dependent diseases of breast.
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`It does not expressly teach the dosing
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`regimen to be once a month, intramuscular administration, or the volume administered.
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`McKeskey et al. does not expressly teach the herein claimed serum concentration of
`
`fulvestrant.
`
`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
`
`Astrazeneca Ex. 2137 p. 6
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`

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`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 6
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`agent, including fulvestrant, via intramuscular route of administration may be used in a
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`dosage of 50mg to 5g in vehicle comprising castor oil and benzyl alcohol (See page 7,
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`line 20-24).
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`Osborne et al. teaches fulvestrant as useful in treating human breast cancer (See
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`pages 747- 748, Result Section).
`
`Wakeling et al. teaches the administration of fulvestrant (ICI 182780)
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`demonstrating the antiestrogenic effect for over a 1 month period (see the abstract).
`
`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 fulvestrant in McKeskey's, in the herein claimed dosing
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`regimen and dosage, for treating hormonal dependent diseases such as breast cancer
`
`and postmenopausal symptoms.
`
`One of ordinary skill in the art would have been motivated to employ fulvestrant
`
`in McKeskey's, in the herein claimed dosing regimen and dosage, for treating hormonal
`
`dependent diseases such as breast cancer and postmenopausal symptoms.
`
`It is known
`
`in the art that fulvestrant as being useful in treating hormonal dependent disease.
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`It is
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`also known in the art that fulvestrant can be administered intramuscularly and its
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`antitumor effect can last for more than 1 month. Employing McKeskey’s formulation of
`
`fulvestrant for intramuscular administration would be seen as obvious since
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`administering a relative large volume of fulvestrant (5ml) would not be appropriate for
`
`subcutaneous administration. The examiner notes that in McKeskey’s study, only 0.1 ml
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`was injected via subcutaneous administration. Furthermore, the optimization of result
`
`effect parameters (e.g., dosing regimen, weight ratio of the actives and the excipients) is
`
`Astrazeneca Ex. 2137 p. 7
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`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 7
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`obvious as being within the skill of the artisan. The optimization of known effective
`
`amounts of known active agents to be administered, is considered well in the
`
`competence level of an ordinary skilled artisan in pharmaceutical science, involving
`
`merely routine skill in the art.
`
`It has been held that it is within the skill in the art to select
`
`optimal parameters, such as amounts of ingredients, in a composition in order to
`
`achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also
`
`noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is
`
`not inventive to discover the optimum or workable ranges by routine experimentation.”
`
`In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
`
`The examiner notes that the herein claimed serum concentration is considered to
`
`be an inherent effect of the formulation of fulvestrant.
`
`Response to Arguments
`
`Applicant's arguments with respect to claims 24-53 have been considered but are
`
`moot in view of the new ground(s) of rejection.
`
`Applicant's amendment necessitated the new ground(s) of rejection presented in
`
`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
`
`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
`
`CFR1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action.
`
`In the event a first reply is filed within
`
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`
`Astrazeneca Ex. 2137 p. 8
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`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 8
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SAN-MING HUI whose telephone number is (571)272-
`
`0626. The examiner can normally be reached on Mon — Fri from 9:00 to 5:00.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Brandon Fetterolf can be reached on (571) 272-2919. The fax phone
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`number for the organization where this application or proceeding is assigned is 571 -
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`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair—direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toII—free).
`
`If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, Call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`San—ming Hui
`
`Astrazeneca Ex. 2137 p. 9
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`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 9
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`Primary Examiner
`Art Unit 1628
`
`/San-ming Hui/
`Primary Examiner, Art Unit 1628
`
`Astrazeneca EX. 2137 p. 10
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`

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`Page 1 of 1
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`Application/Control No.
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`12/285387
`Examiner
`
`App|icant(s)/Patent Under
`Reexamination
`EVANS ET AL.
`Art Unit
`
`SAN-MING HUI
`
`1628
`
`U.S. PATENT DOCUMENTS
`
`Notice of References Cited
`
`*
`
`Document Number
`Date
`.
`_
`_
`Country COde_NUmber_Kmd Code
`MM_YYYY
`Country
`Name
`Classification
`I—2-
`
`FOREIGN PATENT DOCUMENTS
`
`
`I—2-
`
`
`I—2-
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`*A copy of this reference is not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US or foreign.
`U.S. Patent and Trademark Office
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20110906
`
`Astrazeneca EX. 2137 p. 11