UNITED STATES PATENT AND TRADEMARK OEEICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Oflice
`Address: COMJVIISS IONER FOR PATENTS
`P O. Box 1450
`Alexandria, Vi
`‘nia 22313-1450
`WWW.l]Spi.O go
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAIVIED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF MATION NO.
`
`14/608,644
`
`01/29/2015
`
`Peter VVayne Marks
`
`PATO34678—US—CNT
`
`8815
`
`12/18/2015
`7590
`1095
`NOVARTIS PHARMACEUTICAL CORPORATION
`INTELLECTUAL PROPERTY DEPARTMENT
`ONE HEALTH PLAZA 433/2
`EAST HANOVER, NJ 07936-1080
`
`EXAIVIINER
`
`JEAN'L0U15- SAMIRAJM
`
`PAPER NLTVIBER
`
`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 @n0Vartis.c0m
`
`PTOI 4—90A (Rev. 04/07)
`
`West-Ward Pharm.
`Exhibit 1057
`Page 001
`
`West-Ward Pharm.
`Exhibit 1057
`Page 001
`
`

`

`Application No.
`14/608,644
`
`App|icant(s)
`MARKS ET AL.
`
`Office Action Summary
`
`AIA (First lnventorto File)
`An unit
`Examiner
`:l*;‘"5
`1627
`SAMI RA J EAN-LOU is
`-- 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 Q MONTHS FROM THE MAILING DATE OF
`TH IS COMMUNICATION.
`— Extensions of time may be available under the provisions of 37 CFR1.186(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 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 later than three months after the mailing date of this communication, even if timely filed. may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`—
`—
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`Status
`
`1)|Z Responsive to communication(s) filed on 12/01/15.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)IXl This action is non-final.
`2a)I:I This action is FINAL.
`3)I:| An election was made by the applicant in response to a restriction requirement set forth during the interview on
`j; the restriction requirement and election have been incorporated into this action.
`
`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 parfe Quayle, 1935 C.D. 11,453 O.G. 213.
`
`Disposition of Claims*
`
`5)|Z Claim(s) gals/are pending in the application.
`5a) Of the above Claim(s) 5;7is/are withdrawn from consideration.
`Z is/are allowed.
`
`is/are objected to.
`j are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://www.usUto. ov/ atents/init events/' . ih/index.'s . or send an inquiry to I-“I-’Hleedback-’,c':>usg)to.<:iov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:| The drawing(s) filed on j is/are: a)|:I accepted or b)I: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( ).
`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)|:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119( )—(d) or (f).
`Certified copies:
`a)|:I All
`b)I:l Some” c)I:l None of the:
`1.I:I Certified copies of the priority documents have been received.
`2.I:l Certified copies of the priority documents have been received in Application No.
`3.|:l 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.
`
`Attach ment(s)
`
`1) El Notice of References Cited (PTO-892)
`
`2) E 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.
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`3) D jmervjew summary (PTO.413)
`Paper No(s)/Mail Date.
`4 D O h
`_
`I
`I er" j‘
`
`Pan 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
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`Election/Restrictions
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`Claims 1-9 are currently pending in the application.
`
`App|icant’s election of Group I (i.e. claims 1-4 and 8-12) in the reply filed on
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`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 supposed errors in the
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`restriction requirement, the election has been treated as an election without traverse
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`(MPEP § 818.03( )).
`
`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)
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`as being drawn to a nonelected group and species, there being no allowable generic or
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`linking claim. Claims 1-4 and 8-9 are examined on the merits herein.
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`The information disclosure statements (IDS) submitted on 01/29/15, 02/04/15, and
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`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
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`have been considered by the examiner.
`
`West-Ward Pha
`
`West-Ward Pharm.
`Exhibit 1057
`Page 003
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`Provisional Non-Statutory 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 double
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`patenting rejection is appropriate where the claims at issue are not identical, but at least
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`one examined application claim is not patentably distinct from the reference c|aim(s)
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`because the examined application claim is either anticipated by, or would have been
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`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)
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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 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
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`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http://www.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 be filled
`
`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://www.uspto.gov/patents/process/file/efs/guidance/eTD—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
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`claims are not completely identical, they are not patentably distinct from each other
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`because both applications are directed to a method of treating endocrine tumors
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`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
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`for all obviousness rejections set forth in this Office action:
`
`West-Ward Pharm.
`Exhibit 1057
`Page 005
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`(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 1-4 and 8-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over Gibbons et al. (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,
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`cited by applicant and filed on an IDS 1449).
`
`This application currently names joint inventors. In considering patentability of the claims
`
`under pre-A IA 35 U. S. C. 103(a), the examiner presumes that the subject matter of the various
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`claims was commonly owned at 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
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`the inventor and invention dates of each claim that was not commonly owned at the time a later
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`invention was made in order for the examiner to consider the applicability of pre-A IA 35 U. S. C.
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`103(0) and potential pre—AlA 35 U.S.C. 102(9), (f) or (g) prior art under pre-A/A 35 U. S. C.
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`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 cancers including treatment of
`
`neuroendocrine tumor of the lung (see paragraph 00100 and claim 5). By treatment,
`
`West-Ward Phar
`Exhibit 10
`
`West-Ward Pharm.
`Exhibit 1057
`Page 006
`
`

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`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
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`inhibit, eradicate or alleviate the neoplasm (see paragraph 0011). Additionally, Gibbons
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`Jr. et al. teach that a rapamyoin derivative is administered as an mTOR inhibitor
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`wherein preferred rapamycins include: 42-o-(2-hydroxy)ethy|-rapamycin or everolimus
`
`(see paragraphs 0032, 0034, and 0063).
`
`Gibbons Jr. et al. do not specifically teach addition of a somatostatin or
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`somatostatin analogues.
`
`Oberg teaches that neuroendocrine (NE) tumors constitute about 2% of all
`
`malignant tumors (see pg. 57). Additionally, Oberg teaches that somatostatin receptors
`
`are found in 80°/o to 90% of NE tumors (see pg. 59, right col.). Additionally, Oberg
`
`teaches that treatment with somatostatin analogues have led to some complete tumor
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`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 teaches the
`
`use of somatostatin analogues as effective 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 Pha
`
`West-Ward Pharm.
`Exhibit 1057
`Page 007
`
`

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`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
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`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 and filed on an IDS 1449) as
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`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).
`
`Weckbecker teaches a combination of a somatostatin analogue and a rapamycin
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`for the prevention and treatment of 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 known to inhibit
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`cancer (see pg. 10, last paragraph and pg. 12, last paragraph). A preferred rapamycin
`
`compound is 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 tumors of the pancreas and GI tract) and pituitary
`
`adenomas (another type of endocrine tumor; see pg. 13 and pg. 14, paragraph 2).
`
`Weckbecker does not specifically teach that GEP tumors are endocrine tumors.
`
`Novartis Data Sheet is 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
`
`

`

`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 subtypes including
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`insulinomas, gastrinomas, VlPomas, PPomas, and glucgonomas (see pg. 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 Weckbecker teaches that the combination of somatostatin
`
`analogue and a rapamycin derivative such as 40—O—(2—hydroxy)ethyl-rapamycin is
`
`effective in the treatment of 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 method that is 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 made in this Office action:
`
`A person 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 Phar
`Exhibit 10
`
`West-Ward Pharm.
`Exhibit 1057
`Page 009
`
`

`

`Application/Control Number: 14/608,644
`Art Unit: 1627
`
`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 RAD001 (i.e. 40-O-(2-hydroxyethyl)-rapamycin;
`
`elected species) as a bioavailable hydroxyethyl ether derivative of rapamycin that has
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`demonstrated in vitro anti—proliferative activity against a panel of human tumors (see pg.
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`71, #359).
`
`importantly, O’Rei||y et al. teach that RAD001 was found to be a potent
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`inhibitor of tumor growth in 10 different cell lines and in vivo against pancreatic tumors
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`(see pg. 71, #359). Persistent tumor regressions were observed and O’Rei||y et al.
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`suggest that RAD001 may not 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
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`line tumor models (see pg. 71, #359).
`
`Merck Manual was provided to demonstrate that pancreatic tumors are
`
`characterized by endocrine tumors that tend to produce hormones that lead to aberrant
`
`functions and thus pancreatic tumors are classified as endocrine tumors (see pg. 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
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`No claims are allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Samira Jean-Louis whose telephone number is 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
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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 (toll-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.
`
`/SAMIRA .JEAN-LOUIS/
`
`Primary Examiner, Art Unit 1627
`
`12/11/2015
`
`West-Ward Pharm.
`Exhibit 1057
`Page 011
`
`