UNITED STA (cid:9)1ES PA (cid:9)PENT 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
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`APPLICATION NO. (cid:9)
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO. (cid:9)
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`CONFIRMATION NO.
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`13/893,537
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`05/14/2013
`
`Heidi Lane
`
`01/19/2016
`7590 (cid:9)
`28249 (cid:9)
`DILWORTH & BARRESE, LLP
`Dilworth & Barrese, LLP
`1000 WOODBURY ROAD
`SUI IL 405
`WOODBURY, NY 11797
`
`031671-US-CNTO5 167-62
`C5
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`6198
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`EXAMINER
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`KLINKEL, KORTNEY L
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`ART UNIT
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`PAPER NUMBER
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`1611
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`MAIL DATE
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`DELIVERY MODE
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`01/19/2016
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL-90A (Rev. 04/07)
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`NOVARTIS EXHIBIT 2017
`Breckenridge v. Novartis, IPR 2017-01592
`Page 1 of 8
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`Application No.
`13/893,537
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`Applicant(s)
`LANE ET AL.
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`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`Examiner
`Kortney L. Klinkel
`
`Art Unit
`1611
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(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.
`- (cid:9) 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).
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`Status
`1)Z Responsive to communication(s) filed on 10/13/2015.
`q A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on (cid:9)
`2a)1=1 This action is FINAL. (cid:9)
`2b)Z This action is non-final.
`3)0 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)0 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.
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`
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`Disposition of Claims*
`5)Z Claim(s) 1-9 is/are pending in the application.
`5a) Of the above claim(s) 8 and 9 is/are withdrawn from consideration.
`6)0 Claim(s) (cid:9)
`is/are allowed.
`7)Z Claim(s) 1-7 is/are rejected.
`8)0 Claim(s) (cid:9)
`is/are objected to.
`9)0 Claim(s) (cid:9)
`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
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`participating intellectual property office for the corresponding application. For more information, please see
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`httpliwwwusptagovipatents/nit eventsipphlindex.jsp or send an inquiry to PRF-Ifeedback@usptaaov.
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`Application Papers
`10)0 The specification is objected to by the Examiner.
`11)0 The drawing(s) filed on (cid:9)
`is/are: a)1=1 accepted or b)1=1 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).
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`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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`Priority under 35 U.S.C. § 119
`12)Z Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)Z All b)E1Some** c)EINone of the:
`1.0 (cid:9) Certified copies of the priority documents have been received.
`2.Z (cid:9) Certified copies of the priority documents have been received in Application No. 10/468,520.
`3.0 (cid:9) 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)
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`1) q Notice of References Cited (PTO-892)
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`2) Z Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date (cid:9)
`
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`3) q Interview Summary (PTO-413)
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`Paper No(s)/Mail Date.
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`
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`4) q Other:
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`
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`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mail Date 20160107
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`Application/Control Number: *** (cid:9)
`Art Unit: 1611
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`Page 2
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`DETAILED ACTION
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`Claims 1-9 are pending in the instant Office action. The present application is
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`being examined under the pre-AIA first to invent provisions.
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`In the event the determination of the status of the application as subject to AIA 35
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`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
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`correction of the statutory basis for the rejection will not be considered a new ground of
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`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
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`the same under either status.
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`Election/Restriction
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`Applicant's election without traverse of the species of method directed to the
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`administration of everolimus and lymphatic cancer which is non-Hodgkin's lymphoma in
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`the response 10/13/2015 is acknowledged. The requirement is still deemed proper and
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`is therefore made FINAL. Claims 1-7 encompass the elected species.
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`Claims 8 and 9 are withdrawn from further consideration pursuant to 37 CFR
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`1.142(b) as being drawn to a nonelected subject matter, there being no allowable
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`generic or linking claim. Election was made without traverse in the reply filed on
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`10/13/2015.
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`Information Disclosure Statement
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`Acknowledgement is made of applicant's submitting information disclosure
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`statements on 5/14/2013, 9/11/2014, and 7/2/2015. The submissions are in compliance
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`with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements
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`have been considered by the examiner.
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`Application/Control Number: *** (cid:9)
`Art Unit: 1611
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`Page 3
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`Priority
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`Acknowledgement is made of applicant's priority claim that the instant application is a
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`CON of 13/546686 filed 7/11/2012 which is a CON of 10/468520 filed 1/27/2004 which
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`is a 371 of PCT/EP02/01714 filed 2/18/2002 which claims priority to foreign applications
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`UK 0104072.4 filed 2/19/2001 and UK 0124957.2 filed 10/17/2001.
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C.
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`102 that form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(a) the invention was known or used by others in this country, or patented or described in a
`printed publication in this or a foreign country, before the invention thereof by the applicant for
`a patent.
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`(e) the invention was described in (1) an application for patent, published under section
`122(b), by another filed in the United States before the invention by the applicant for patent or
`(2) a patent granted on an application for patent by another filed in the United States before
`the invention by the applicant for patent, except that an international application filed under
`the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an
`application filed in the United States only if the international application designated the United
`States and was published under Article 21(2) of such treaty in the English language.
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`Claims 1-7 are rejected under both pre-AIA 35 U.S.C. 102(a) and 102(e) as
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`being anticipated by Wasik et al. (WO 01/51049 published July 19, 2001 and having an
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`international filing date of January 12, 2001 (which is after November 29, 2001) and
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`claiming priority to US provisional application 60/176086 filed January 14, 2000). Thus
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`the 102(a) date of Wasik et al. is July 19, 2001 and the 102(e) date is January 14, 2000,
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`see MPEP 706.02(f)(1)(I)(C).
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`Wasik et al. teach a method for treating lymphatic cancer, including non-
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`Hodgkin's lymphoma, comprising administering to a subject a therapeutically effective
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`Application/Control Number: *** (cid:9)
`Art Unit: 1611
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`Page 4
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`amount of everolimus (referred to throughout the document as SDZ RAD) (p. 2 final
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`paragraph, p. 8 lines 1-2, Fig. 7, p. 12 first full paragraph, claims 1, 5 and 16). The
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`preferred daily dose is 1 to 10 mg which falls within and thereby anticipates the ranges
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`of claims 3 through 5 (p. 16 lines 18-24). Also Wasik et al. teach a preferred unit dose
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`ranging from about 0.5 to 10 mg (p. 14 lines 23-24). The SDZ RAD (everolimus) can be
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`administered orally (p. 14 line 4).
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
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`for all obviousness rejections set forth in this Office action:
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`(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.
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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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
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`1.
`2.
`3.
`4.
`
`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 skill in the pertinent art.
`Considering objective evidence present in the application indicating
`obviousness or nonobviousness.
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`This application currently names joint inventors. In considering patentability of the
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`claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter
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`of the various claims was commonly owned at the time any inventions covered therein
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`were made absent any evidence to the contrary. Applicant is advised of the obligation
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`Application/Control Number: *** (cid:9)
`Art Unit: 1611
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`Page 5
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`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
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`not commonly owned at the time a later invention was made in order for the examiner to
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`consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C.
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`102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
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`Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
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`Wasik et al. (WO 01/51049 published July 19, 2001 and having an international filing
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`date of January 12, 2001 (which is after November 29, 2001) and claiming priority to US
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`provisional application 60/176086 filed January 14, 2000).
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`The teachings of Wasik et al. are set forth above. Wasik et al. teaches a
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`preferred daily dosage of everolimus (SDZ RAD) of 1 to 10 mg and a unit dose from
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`about 0.5 to 10 mg, both of which overlap with and share an endpoint with the claimed
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`unit dosage of claim 6. In the case where the claimed ranges overlap or lie inside
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`ranges disclosed by the prior art" a prima facie case of obviousness exists. in re
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`Wertheim, 541 F.2d 257, 191 USPO 90 (CCPA 1976); in re Woodruff, 919 F.2d 1575,
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`16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations
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`of "about 1 -5%" while the claim was limited to "more than 5%." The court held that
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`"about 1-5%" allowed for concentrations slightly above 5% thus the ranges
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`overlapped.). Generally, differences in concentration or temperature will not support the
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`patentability of subject matter encompassed by the prior art unless there is evidence
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`indicating such concentration or temperature is critical. "[W]here the general conditions
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`of a claim are disclosed in the prior art, it is not inventive to discover the optimum or
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`Application/Control Number: *** (cid:9)
`Art Unit: 1611
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`Page 6
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`workable ranges by routine experimentation," In re Ailer, 220 F,2d 454, 456, 105 USPQ
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`233, 235 (CCPA 1955).
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`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 double
`patenting rejection is appropriate where the claims at issue 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 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 actual or 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. See MPEP §
`717.02 for applications subject to examination under the first inventor to file provisions
`of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(1)(1) - 706.02(1)(3) for
`applications not subject to examination under the first inventor to file provisions of the
`AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
`The USPTO Internet website contains terminal disclaimer forms which may be
`used. Please visit www.uspto.gov/forms/. The filing date of the application in which the
`form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or
`PTO/AIA/26) 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
`eTerminal (cid:9)
`refer (cid:9)
`information (cid:9)
`Disclaimers, (cid:9)
`about (cid:9)
`to
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
`
`Claims 1-7 are provisionally rejected on the ground of nonstatutory double
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`patenting as being unpatentable over claims 1-10 of copending Application No.
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`13/893589 (reference application). Although the claims at issue are not identical, they
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`Application/Control Number: *** (cid:9)
`Art Unit: 1611
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`Page 7
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`are not patentably distinct from each other because the copending claims are directed
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`to a method for treating lymphatic cancer comprising administering to a subject a
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`therapeutically effective amount of everolimus concomitantly or sequentially with a
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`histone deacytelase inhibitor. Dependent claims 2-6 and 8-10 mirror instant claims 2-9.
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`Copending claim 7 acts to narrow the scope of the histone deacetylase inhibitor. The
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`copending claims anticipate the instant claims.
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`This is a provisional nonstatutory double patenting rejection because the
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`patentably indistinct claims have not in fact been patented.
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`Conclusion
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`Claims 1-7 are rejected. No claim is allowed.
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`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Kortney Klinkel whose telephone number is (571)270-
`5239. The examiner can normally be reached on Monday-Friday 10 am to 7 pm.
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`supervisor, Bethany Barham can be reached on (571)272-6175. 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. (cid:9)
`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.
`
`/Kortney L. Klinkel/
`Primary Examiner, Art Unit 1611
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