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
`
`03/20/2012
`
`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. 2139 p. 1
`Mylan Pharms. Inc. V. Astrazeneca AB IPR2016-01316
`
`

`
`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 3 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.
`If 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 tor reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received bythe Office later than three months afterthe mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
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`1)IZl Responsive to communication(s) filed on 17January 2012.
`
`2a)I:I This action is FINAL.
`
`2b)IZ This action is non—final.
`
`3)I:l 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.
`
`4)I: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 O.G. 213.
`
`Disposition of Claims
`
`5)IZI Claim(s) 24 26 27 29 30 32 34-36 38 39 4142 44 46 47 and 54-57 is/are pending in the application.
`5a) Of the above claim(s) Z is/are withdrawn from consideration.
`
`6 I:| Claim s) j is/are allowed.
`
`IZI Claim s 24 26-27 29 30 32 34-36 38 39 41 42 44 46-47 and 54-57 is/are rejected.
`is/are objected to.
`
`are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`
`11)I:l The drawing(s) filed on j is/are: a)|:I accepted or b)I:l 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).
`
`12)I:l The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO—152.
`
`Priority under 35 U.S.C. § 119
`
`13)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)—(d) or (f).
`
`a)I:l All
`
`b)|:I Some * c)I:l None of:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.I:| Certified copies of the priority documents have been received in Application No. j
`
`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 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) El Notice of References Cited (PTO-892)
`2) D Notice of Draftspersons Patent Drawing Review (PTO-948)
`3) E Information Disclosure Statement(s) (PTO/SB/08)
`
`Paper No(s)/Mail Date 6/2011 1/17/12.
`US Patent and Trademark Office
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`4) D Interview Summary (PTO-413)
`Paper NOIS)/Mall Date j
`5) l:l NOTIC9 0f Informal Palenl Al3PIlCaTl0|"|
`6) D Other:
`.
`
`Part of Paper No./Mail Date 20120309
`
`Astrazeneca Ex. 2139 p. 2
`
`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 2
`
`DETAILED ACTION
`
`Continued Examination Under 37 CFR 1. 114
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
`
`application is eligible for continued examination under 37 CFR 1.114, and the fee set
`
`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
`
`1/17/2012 has been entered.
`
`Claims 24, 26-27, 29, 30, 32, 34-36, 38, 39, 41, 42, 44, 46-47, and 54-57 are
`
`pending.
`
`The outstanding rejection under 35 USC 103(a) is withdrawn in view of the
`
`arguments along with the declaration of Dr. Sawchuk filed 1/17/2012.
`
`However, in view of the decision dated 2/15/2012 with regard to the terminal
`
`disclaimer, the obviousness double patenting rejections are maintained with the new
`
`added claims are also rejected.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the “right to exclude” granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory
`
`obviousness-type double patenting rejection is appropriate where the conflicting claims
`
`Astrazeneca Ex. 2139 p. 3
`
`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 3
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`are not identical, but at least one examined application claim is not patentably distinct
`
`from the reference claim(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
`
`F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thoringfon, 418 F.2d 528, 163
`
`USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321(d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the conflicting application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
`
`activities undertaken within the scope of a joint research agreement.
`
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`
`37 CFR 3.73(b).
`
`Claims 24, 26-27, 29, 30, 32, 34-36, 38, 39, 41, 42, 44, 46-47, and 54-57 are
`
`rejected on the ground of nonstatutory obviousness—type 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
`
`Astrazeneca Ex. 2139 p. 4
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`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 4
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`the solvents and the excipients are within the range taught in '122. The optimization of
`
`result effect parameters (e.g., dosing regimen [single dosing or multiple divided dosing],
`
`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 “[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 Al/er, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA
`
`1955).
`
`Claims 24, 26-27, 29, 30, 32, 34-36, 38, 39, 41, 42, 44, 46-47, and 54-57 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 [single dosing or multiple divided dosing],
`
`weight ratio of the actives and the excipients) is obvious as being within the skill of the
`
`Astrazeneca Ex. 2139 p. 5
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`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 5
`
`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 AI/er, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA
`
`1955).
`
`No claims are allowed.
`
`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
`
`number for the organization where this application or proceeding is assigned is 571 —
`
`273-8300.
`
`Astrazeneca Ex. 2139 p. 6
`
`

`
`Application/Control Number: 12/285,887
`Art Unit: 1628
`
`Page 6
`
`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 (toll-free). If you would like assistance from a
`
`US PTO 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
`Primary Examiner
`Art Unit 1628
`
`/San-ming Hui/
`Primary Examiner, Art Unit 1628
`
`Astrazeneca Ex. 2139 p. 7
`
`

`
`|NFoRMAT|0N D|ScLosURE
`STATEMENT BY APPLICANT
`(Use as many Sheets as necessary)
`
`Application Number
`
`dl
`
`Filing Date
`t
`F‘
`tN
`""e"°’
`A’,’fUm.j""‘*
`Examiner Name
`Attorney Docket Number
`
`Complete if Known
`12/285,887
`
`October 15,2008
`J h R.EVANS
`122';
`HUI, San Ming R.
`1 12850056-00000
`
`U.S. PATENTS AND PUBLISHED U.S. PATENT APPLICATIONS
`
`Examiner
`Initials
`
`Cite
`No.‘
`
`Document Number
`_
`2
`Number-Kind Code (ifknown)
`
`Issue or
`Publication Date
`_
`_
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines. Where
`Relevant Passages or Relevant
`Figures Appear
`
`Foreign Patent Document
`
`Country Code3 Number‘ Kind Code5 (ifknawn)
`
`Publication Date
`MM-DD-YYYY
`
`
`
` NONPATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LE1'|'ERS), title of the article (when appropriate), title of the item
`Translation“
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`
`The Merck Index, 12th Ed., Merck 8. Co., |nc., pgs. xiv, 189-190, 641-642 and 1715
`(1996).
`Guerrini, et al., “Pharmacokinetics of probenecid in sheep”, J Vet Pharmacol Ther.,
`128-135 (1985).
`
`intramuscularly and subcutaneously to dogs”, J Vet Pharmacol Ther., 22(4):261-265
`(1999).
`
`subcutaneous administration in calves”, Vet Res Commun., 31(4):467-476 (2007).
`
`Lavy, etal., “Pharmacokinetics ofclindamycin HCI administered intravenously, -
`- Ismail, “Disposition kinetics of difloxacin after intravenous, intramuscular and _
`138) from August 27, 2009 to December 15, 2011.CH
`- Documents from the prosecution of European Application No. 10180667.? (EP 2 266
`573) from November 23, 2010 to December 19, 2011.
`
`
`Documents from the prosecution of European Application No. 10180661.0 (EP 2 286
`818) from January 19, 2011 to December 19, 2011.
`
`Declaration Under 35 U.S.C §1.132 of Dr. Paul Gellert filed in August 2008 in U.S.
`Application No. 10/872,784.
`I
`_
`‘
`I
`/San Mil’) HLll/
`
`
`
`
`
`
`Date
`Considered
`
`
`
`Examiner
`Signature
`
`
`
`03/09/'20‘i 2
`
`
`
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through
`EXAMINER:
`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE I_i|\iED THRQUGH.
`
`/S.|-I./’
`
`Astrazeneca Ex. 2139 p. 8
`
`
`
`
`
`
`
`
`

`
`Application Number
`
`Complete if Known
`12/285,887
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`jjlijj Attorney Docket Number
`
`Filing Date
`M W
`
`October 15, 2008
`John R. EVANS
`
`San Ming H, Hui
`112ss.oos6-ooooo
`
`U.S. PATENTS AND PUBLISHED U.S. PATENT APPLICATIONS
`
`—
`
`Examln_er
`Initials
`
`Cite
`No.‘
`
`Pages, Columns, Lines, Where
`Issue or
`Document Number
`Relevant Passages or Relevant
`Publication Date
`_
`2
`Figures Appear
`MM_DD_yyyy
`Number-Kind Code (ifknown)
`jjfl
`-
`
`Name of Patentee or
`Applicant of Cited Document
`
`Note: Submission of copies of U.S. Patents and published U.S. Patent Applications is not required.
`
`Examiner
`
`'
`
`Foreign Patent Document
`
`Country Code3 Number‘ Kind Code5 (ifknown)
`
`Publication Date
`—
`
`Pages, Columns, Lines,
`Name of Patentee or
`Applicant of Cited Document Where Relevant Passages
`or Relevant Figures
`App°a'
`
`Translations
`
`FOREIGN PATENT DOCUMENTS
`
`NONPATENT LITERATURE DOCUMENTS
`
`Cite
`No.‘
`
`Examiner
`Initials
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`McLeskey et al., ‘Tamoxifen-resistant fibroblast growth factor-transfected MCF-7 cells are cross-resistant in
`vivo to the antiestrogen lCl 182,780 and two aromatase inhibitors,” Clin. Cancer Res., 4:697-711 (1998).
`JRF Robertson, et al., "Fulvestrant: phannacokinetics and phannacology,” British Journal of Cancer,
`90(1):S7-S10 (2004).
`John F. R. Robertson, “Fulvestrant (Faslodex® )--how to make a good drug better,” The Oncologist, 12:774-
`784 (2007).-
`- Search Report for European Patent Application No. 1018o667.7 dated November23, 2010.
`‘E Search Report for European Patent Application No. 10180661.0 dated January 19, 2011.
`Documents from the Opposition against European Patent Application No 01900186 6 from Apnl 21 2009 to
`September 7, 2009.
`
`Examiner
`
`Date
`
`,, ,
`,
`,I
`ct-we/2<»2
`
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through
`EXAMINER:
`citation it not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LiNED THROUGH. /em
`
`Astrazeneca Ex. 2139 p. 9