`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
` CONFIRMATION NO.
`
`14/608,644
`
`01/29/2015
`
`Peter Wayne Marks
`
`PAT034678-US-CNT
`
`8815
`
`
`NOVARTIS PHARMACEUTICAL CORPORATION [Lavine7]
`NO CALCPCEXAMINERTAR
`
`
`INTELLECTUAL PROPERTY DEPARTMENT
`JEAN-LOUIS, SAMIRA JM
`ONE HEALTH PLAZA 433/2
`EAST HANOVER,NIJ 07936-1080
`
`PAPER NUMBER
`
`1627
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`12/18/2015
`
`ELECTRONIC
`
`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.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date” to the
`following e-mail address(es):
`phip.patents @novartis.com
`
`PTOT.-90A (Rev. 04/07)
`
`West-Ward Pharm.
`Exhibit 1057
`Page 001
`
`West-Ward Pharm.
`Exhibit 1057
`Page 001
`
`

`

`
`Applicant(s)
`MARKSETAL.
`14/608,644
`Office Action Summary
`Art Unit
`AIA (FirstInventor to File)
`Examiner
`
`
`1627SAMIRA JEAN-LOUIS ca
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondenceaddress--
`Period for Reply
`
` Application No.
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 GFA 1.136(a).
`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 trom 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).
`Anyreply received by the Office later than three months after the mailing date of this communication, evenif timely filed. may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, maya reply betimelyfiled
`
`Status
`1) Responsive to communication(s)filed on 12/01/15.
`L] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon
`2a)0 This action is FINAL.
`2b) This action is non-final.
`3)L An election was madeby the applicant in responsetoarestriction requirementset forth during the interview on
`___; the restriction requirement and election have been incorporated into this action.
`4)L] Sincethis 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) Claim(s) 1-9 is/are pending in the application.
`5a) Of the above claim(s) 5-7 is/are withdrawn from consideration.
`6)L] Claim(s)__ is/are allowed.
`7)K] Claim(s) 1-4,8 and 9 is/are rejected.
`8) Claim(s)__ is/are objected to.
`
`9)1) Claim(s)
`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may beeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`g
`Jin.usote.dov/
`
`
`
`nit
`atenis/init events/peh/index.isp or send an inquiry to PPHieedback@uspto.qoy.
`
`Application Papers
`10)L] The specification is objected to by the Examiner.
`
`11)L] The drawing(s)filed on
`is/are: a)__] accepted or b)[_] 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).
`
`Priority under 35 U.S.C. § 119
`12)_] Acknowledgmentis made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or(f).
`Certified copies:
`a) All 6) Some** c)] None of the:
`1.1] Certified copies of the priority documents have been received.
`210 Certified copies of the priority documents have been received in Application No.
`3.1] Copies ofthe certified copies of the priority documents have been receivedin 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) | Notice of References Cited (PTO-892)
`.
`;
`;
`2) xX Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 01/29/15, 02/04/15, 04/01/15.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`3) | Interview Summary (PTO-413)
`Paper No(s)/Mail Date.
`4 oO Other:
`
`Part of Paper No./Mail Date 20151211
`
`West-Ward Pharm.
`Exhibit 1057
`Page 002
`
`West-Ward Pharm.
`Exhibit 1057
`Page 002
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Page 2
`
`The present application is being examined underthe pre-AlA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`Election/Restrictions
`
`Claims 1-9 are currently pending in the application.
`
`Applicant’s election of Group | (i.e. claims 1-4 and 8-12) in the reply filed on
`
`12/01/15 and election of everolimus as the m-TOR inhibitor is acknowledged. Because
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`applicant did not distinctly and specifically point out the supposederrors in the
`
`restriction requirement, the election has been treated as an election without traverse
`
`(MPEP § 818.03(a)).
`
`Thus, the requirement is deemed proper and is therefore made FINAL.
`
`Claims 5-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b)
`
`as being drawn to a nonelected group and species, there being no allowable generic or
`
`linking claim. Claims 1-4 and 8-9 are examined on the merits herein.
`
`IDS
`
`The information disclosure statements (IDS) submitted on 01/29/15, 02/04/15, and
`
`04/01/15 are acknowledged and have been entered. The submission is in compliance
`
`with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements
`
`have been considered by the examiner.
`
`West-Ward Pharm.
`Exhibit 1057
`Page 003
`
`West-Ward Pharm.
`Exhibit 1057
`Page 003
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Page 3
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`Provisional Non-Statutory Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine groundedin 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 double
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`patenting rejection is appropriate wherethe claims at issue are notidentical, 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 claim(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 Thorington, 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 actualor provisional rejection based on a nonstatutory
`
`double patenting ground provided the reference 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. A terminal
`
`disclaimer must be signed in compliance with 37 CFR 1.321(b).
`
`The USPTOinternet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http:/Awww.uspto.gov/forms/. The filing date of the application will
`
`West-Ward Pharm.
`Exhibit 1057
`Page 004
`
`West-Ward Pharm.
`Exhibit 1057
`Page 004
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Page 4
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`determine what form should be used. A web-based eTerminal Disclaimer may befilled
`
`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`requirements is auto-processed and approved immediately upon submission. For more
`
`information about eTerminal Disclaimers, refer to
`
`http:/Avww.uspto.gov/patents/process/file/efs/guidance/eT D-info-l.jsp.
`
`Claims 1-4 are provisionally rejected on the ground of nonstatutory obviousness-
`
`type double patenting as being unpatentable over claims 1 and 3 of U.S. patent No.
`
`9,006,224 (hereinafter Marks US Patent Application No. ‘224). Although the conflicting
`
`claims are not completely identical, they are not patentably distinct from each other
`
`becauseboth applications are directed to a methodof treating endocrine tumors
`
`comprising administering an mTOR inhibitor. The claimed invention and U.S. patent
`
`Marks ‘224 are rendered obvious over another as the claimed invention teaches a broad
`
`genus of a method for treating endocrine tumors by administering a broad genus of
`
`mTOR inhibitors whereas Marks ‘224 teaches a subgenus of treatment of pancreatic
`
`neuroendocrine tumors by administering everolimus. Thus, the aforementioned claims
`
`of the instant application are substantially overlapping in scope as discussed
`
`hereinabove and are prima facie obvious over the cited claims of U.S. Patent No.
`
`9,006,224.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre-AlA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousnessrejections set forth in this Office action:
`
`West-Ward Pharm.
`Exhibit 1057
`Page 005
`
`West-Ward Pharm.
`Exhibit 1057
`Page 005
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Page 5
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`(a) A patent may not be obtained though the invention is not identically disclosed
`or described assetforth in section 102 ofthis 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 mannerin which the invention was
`made.
`
`Claims 1-4 and 8-9 are rejected under pre-AlA 35 U.S.C. 103(a) as being
`
`unpatentable over Gibbonsetal. (U.S. 2002/0183239, cited by applicant and filed
`
`on an IDS 1449)in view of Oberg (Oncologia, Vol. 27, No. 4, 2004, pgs. 185-189,
`
`cited by applicant and filed on an IDS 1449).
`
`This application currently namesjoint inventors. In considering patentability of the claims
`
`under pre-AlA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various
`
`claims was commonly ownedat the time any inventions covered therein were made absent any
`
`evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out
`
`the inventor and invention dates of each claim that was not commonly ownedatthe time a later
`
`invention was madein order for the examiner to consider the applicability of pre-AlA 35 U.S.C.
`
`103(c) and potential pre-AlA 35 U.S.C. 102(e), (f) er (g) prior art under pre-AlA 35 U.S.C.
`
`103(a).
`
`Gibbons Jr. et al. teach the use of a combination of an mTOR inhibitor and an
`
`antimetabolite antineoplastic agent in the treatment of neoplasms (see abstract and
`
`paragraph 0010 and claim 1). Specifically, Gibbons Jr. et al. teach that the combination
`
`is especially useful in the treatment of various cancersincluding treatmentof
`
`neuroendocrine tumor of the lung (See paragraph 00100 and claim 5). By treatment,
`
`West-Ward Pharm.
`Exhibit 1057
`Page 006
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`West-Ward Pharm.
`Exhibit 1057
`Page 006
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Page 6
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`Gibbons Jr. et al. teach that it is meant that administration of such combination can
`
`inhibit, eradicate or alleviate the neoplasm (See paragraph 0011). Additionally, Gibbons
`
`Jr. et al. teach that a rapamycin derivative is administered as an MTOR inhibitor
`
`wherein preferred rapamycins include: 42-0-(2-hydroxy)ethyl-rapamycin or everolimus
`
`(see paragraphs 0032, 0034, and 0063).
`
`Gibbons Jr. et al. do not specifically teach addition of a somatostatin or
`
`somatostatin analogues.
`
`Oberg teaches that neuroendocrine (NE) tumors constitute about 2%ofall
`
`malignant tumors (see pg. 57). Additionally, Oberg teaches that somatostatin receptors
`
`are found in 80%to 90%of NE tumors(see pg. 59, right col.). Additionally, Oberg
`
`teachesthat treatment with somatostatin analogues have led to some complete tumor
`
`regression, and mostly partial regression and/or disease stabilization (see pg. 59, right
`
`col.)
`
`Thus, to one of ordinary skill in the art at the time of the invention would have
`
`found it obvious to combine the method of Gibbons Jr. et al. with somatostatin
`
`analogues since Gibbons Jr. et al. teach that everolimus is a preferred mTOR inhibitor
`
`that can be used to treat neuroendocrine tumors and in view of Oberg who teachesthe
`
`use of somatostatin analoguesaseffective in inducing NE tumor regression. Given the
`
`teachings of Gibbons Jr. and Oberg, one of ordinary skill would have been motivated to
`
`combine the mTOR inhibitor, Everolimus, and a somatostatin analogue to treat
`
`West-Ward Pharm.
`Exhibit 1057
`Page 007
`
`West-Ward Pharm.
`Exhibit 1057
`Page 007
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Page 7
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`neuroendocrine tumor of the lung with the reasonable expectation of providing a method
`
`that is effective in inhibiting neuroendocrine tumor growth.
`
`Claims 1-4 are rejected under 35 U.S.C. 103 (a) as being unpatentable over
`
`by Weckbecker (WO 97/47317, cited by applicant andfiled on an IDS 1449) as
`
`evidenced by Novartis Data Sheet (Novartis, GEP NE tumors, Published online on
`
`04/2005, pgs. 1-2, cited by applicant and filed on an IDS 1449).
`
`Weckbeckerteaches a combination of a somatostatin analogue and a rapamycin
`
`for the prevention and treatmentof cell hyperproliferation (see abstract and pg. 1,
`
`paragraph 1). Additionally, Weckbecker teaches that rapamycin or derivatives thereof
`
`are desired given that such compounds are immunosuppressive and knownto inhibit
`
`cancer (see pg. 10, last paragraph and pg. 12, last paragraph). A preferred rapamycin
`
`compoundis 40-O-(2-hydroxy)ethyl-rapamycin (i.e. elected species; see pg. 12,
`
`paragraph 3). According to Weckbecker, such combination can be used for preventing
`
`or treating cell hyperproliferation including GEP tumors(i.e. Gastroentero-pancreatic
`
`neuroendocrine tumors: slow growing tumorsof the pancreas and Gl tract) and pituitary
`
`adenomas(anothertype of endocrine tumor; see pg. 13 and pg. 14, paragraph 2).
`
`Weckbeckerdoes notspecifically teach that GEP tumors are endocrine tumors.
`
`Novartis Data Sheetis provided to demonstrate that GEP, a.k.a
`
`gastroenteropancreatic neuroendocrine tumors are slow growing tumors that occur in
`
`West-Ward Pharm.
`Exhibit 1057
`Page 008
`
`West-Ward Pharm.
`Exhibit 1057
`Page 008
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Page 8
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`the pancreas and gastrointestinal tract and are thought to arise from neuroendocrine
`
`cells (see pg. 1, paragraphs 1-2).
`
`In fact Novartis Data Sheet teaches that pancreatic
`
`endocrine tumors are one subtype of such tumors and entail various subtypesincluding
`
`insulinomas, gastrinomas, VIPomas, PPomas, and glucgonomas(seepg. 1, last
`
`paragraph).
`
`Thus, to one of ordinary skill in the art at the time of the invention would have
`
`found it obvious to treat neuroendocrine tumors and other endocrine tumors such as
`
`pituitary tumors since Weckbeckerteachesthat the combination of somatostatin
`
`analogue and a rapamycin derivative such as 40-O-(2-hydroxy)ethyl-rapamycin is
`
`effective in the treatmentof pituitary tumors and GEP tumors and given that Novartis
`
`data Sheet teaches that GEP tumors encompass neuroendocrine tumors. Given the
`
`teachings of Weckbecker and Novartis Data Sheet, one of ordinary skill would have
`
`been motivated to administer the somatostatin and Everolimus as the rapamycin
`
`derivative of Weckbecker to treat neuroendocrine tumors with the reasonable
`
`expectation of providing a methodthatis effective in treating and inhibiting various
`
`endocrine tumors.
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section madein this Office action:
`
`A perseon shall be entitled to a patent unless —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in public
`use or on sale in this country, more than one year prior to the date of application for patent in the United
`States.
`
`West-Ward Pharm.
`Exhibit 1057
`Page 009
`
`West-Ward Pharm.
`Exhibit 1057
`Page 009
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Page 9
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`Claims 1-4 are rejected under 35 U.S.C. 102(b) as being anticipated by
`
`O’Reilly et al. (Proceedings of the American Association for Cancer Research
`
`Annual Meeting, 03/2002, Vol. 43, pg. 71, cited by applicant and filed on an IDS
`
`1449) as evidenced by Merck Manuals (Merck Manuals, Pancreatic endocrine
`
`tumors, 2009, pgs. 1-4, cited by applicant and filed on an IDS 1449).
`
`O'Reilly et al. teach the use of RADOO1 (i.e. 40-O-(2-hydroxyethyl)-rapamycin;
`
`elected species) as a bioavailable hydroxyethyl ether derivative of rapamycin that has
`
`demonstratedin vitro anti-proliferative activity against a panel of human tumors(see pg.
`
`71, #359).
`
`Importantly, O’Reilly et al. teach that RADOO1 wasfound to be a potent
`
`inhibitor of tumor growth in 10 different cell lines and in vivo against pancreatic tumors
`
`(see pg. 71, #359). Persistent tumor regressions were observed and O'Reilly etal.
`
`suggest that RADOO1 maynot only be effective against tumor cells, it may also affect
`
`angiogenesis (see pg. 71, #359). Additionally, O’Reilly et al. teach that doses ranging
`
`from 0.5-5.0 mg per day was administered and found to be potent in xenograft and cell
`
`line tumor models (see pg. 71, #359).
`
`Merck Manual was provided to demonstrate that pancreatic tumors are
`
`characterized by endocrine tumorsthat tend to produce hormonesthat lead to aberrant
`
`functions and thus pancreatic tumors are classified as endocrine tumors(seepg. 1).
`
`Accordingly, the teachings of O’Reilly et al. anticipate claims 1-4.
`
`West-Ward Pharm.
`Exhibit 1057
`Page 010
`
`West-Ward Pharm.
`Exhibit 1057
`Page 010
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Conclusion
`
`No claims are allowed.
`
`Page 10
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`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Samira Jean-Louis whose telephone numberis 571-
`
`270-3503. The examiner can normally be reached on 7:30-6 PM EST M-Th.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Sreeni Padmanabhan can be reached on 571-272-0629. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571 -
`
`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(toll-free). If you would like assistance from a USPTO
`
`Customer Service Representative or access to the automatedinformation system, call
`
`800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/SAMIRA JEAN-LOUIS/
`
`Primary Examiner, Art Unit 1627
`
`12/11/2015
`
`West-Ward Pharm.
`Exhibit 1057
`Page 011
`
`West-Ward Pharm.
`Exhibit 1057
`Page 011
`
`