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
`
`APPLICATION NO. (cid:9)
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO. (cid:9)
`
`CONFIRMATION NO.
`
`13/893,589
`
`05/14/2013
`
`Heidi Lane
`
`01/27/2016
`7590 (cid:9)
`28249 (cid:9)
`DILWORTH & BARRESE, LLP
`Dilworth & Barrese, LLP
`1000 WOODBURY ROAD
`SUI IL 405
`WOODBURY, NY 11797
`
`031671-US-CNTO6 167-62
`C6
`
`7529
`
`EXAMINER
`
`KLINKEL, KORTNEY L
`
`ART UNIT
`
`PAPER NUMBER
`
`1611
`
`MAIL DATE
`
`DELIVERY MODE
`
`01/27/2016
`
`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-90A (Rev. 04/07)
`
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`Application No.
`13/893,589
`
`Applicant(s)
`LANE ET AL.
`
`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
`
`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).
`
`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.
`
`
`
`Disposition of Claims*
`5)Z Claim(s) /40 is/are pending in the application.
`5a) Of the above claim(s) 9 and 10 is/are withdrawn from consideration.
`6)0 Claim(s) (cid:9)
`is/are allowed.
`7)Z Claim(s) 1-8 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
`
`participating intellectual property office for the corresponding application. For more information, please see
`
`httpliwwwusptagovipatents/nit eventsipphlindex.jsp or send an inquiry to PRF-Ifeedback@usptaaov.
`
`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).
`
`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)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)
`
`1) Z Notice of References Cited (PTO-892)
`
`2) Z Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date (cid:9)
`
`
`3) q Interview Summary (PTO-413)
`
`Paper No(s)/Mail Date.
`
`
`
`4) q Other:
`
`
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20160107
`
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`Application/Control Number: 13/893,537 (cid:9)
`Art Unit: 1611
`
`Page 2
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`DETAILED ACTION
`
`Claims 1-10 are pending in the instant Office action. The present application is
`
`being examined under the pre-AIA first to invent provisions. In the event the
`
`determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103
`
`(or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
`
`statutory basis for the rejection will not be considered a new ground of rejection if the
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`prior art relied upon, and the rationale supporting the rejection, would be the same
`
`under either status.
`
`Election/Restriction
`
`Applicant's election without traverse of the species of method directed to the
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`administration of everolimus with the histone deacetylase inhibitor SAHA and lymphatic
`
`cancer which is non-Hodgkin's lymphoma in the response 10/13/2015 is acknowledged.
`
`The requirement is still deemed proper and is therefore made FINAL. Claims 1-8
`
`encompass the elected species.
`
`Claims 9 and 10 are withdrawn from further consideration pursuant to 37 CFR
`
`1.142(b) as being drawn to a nonelected subject matter, there being no allowable
`
`generic or linking claim. Election was made without traverse in the reply filed on
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`10/13/2015.
`
`Claim Objections
`
`Claim 1 is objected to because of the following informalities:
`
`(1) Claim 1 currently has two periods. The period following X is =0 should be deleted.
`
`(2) Deacetylase is misspelled is claim 1. Appropriate correction is required.
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`Application/Control Number: 13/893,537 (cid:9)
`Art Unit: 1611
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`Page 3
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`Information Disclosure Statement
`
`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
`
`with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements
`
`have been considered by the examiner.
`
`Priority
`
`Acknowledgement is made of applicant's priority claim that the instant application
`
`is a CON of 13/546686 filed 7/11/2012 which is a CON of 10/468520 filed 1/27/2004
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`which is a 371 of PCT/EP02/01714 filed 2/18/2002 which claims priority to foreign
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`applications UK 0104072.4 filed 2/19/2001 and UK 0124957.2 filed 10/17/2001.
`
`It is noted that UK application 0104072.4 fails to provide adequate support or
`
`enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first
`
`paragraph for one or more claims of this application. US 0104072.4 does not discuss or
`
`disclose any combination therapies and thus fails to provide support for a combination
`
`of a rapamycin derivative such as everolimus with a histone deacetylase inhibitor.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all 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
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`Application/Control Number: 13/893,537 (cid:9)
`Art Unit: 1611
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`Page 4
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`said subject matter pertains. Patentability shall not be negatived by the manner in which the
`invention was made.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
`
`obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
`
`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.
`
`This application currently names joint inventors. In considering patentability of the
`
`claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter
`
`of the various 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 the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
`
`consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C.
`
`102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
`
`Claims 1-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable
`
`over Wasik et al. (WO 01/51049 published July 19, 2001 and having an international
`
`filing date of January 12, 2001 (which is after November 29, 2001) and claiming priority
`
`to US provisional application 60/176086 filed January 14, 2000) in view of Grant et al.
`
`(WO 02/22133 having an international filing date of September 7, 2001 and claiming
`
`priority to US provisional application 60/231885 filed September 12, 2000). Thus the
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`Application/Control Number: 13/893,537 (cid:9)
`Art Unit: 1611
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`Page 5
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`102(a) date of Wasik et al. is July 19, 2001 and the 102(e) date is January 14, 2000,
`
`see MPEP 706.02(f)(1)(1)(C) and the 102(e) date of Grant et al. is September 12, 2000.
`
`Wasik et al. teach a method for treating lymphatic cancer, including non-
`
`Hodgkin's lymphoma, comprising administering to a subject a therapeutically effective
`
`amount of everolimus (referred to throughout the document as SDZ RAD) (p. 2 final
`
`paragraph, p. 8 lines 1-2, Fig. 7, p. 12 first full paragraph, claims 1, 5 and 16). The SDZ
`
`RAD (everolimus) can be administered orally (p. 14 line 4). The preferred daily dose is
`
`1 to 10 mg which falls within the ranges of claims 3 through 5 and overlaps with and
`
`shares an endpoint with the claimed unit dosage of 10 mg of claim 6 (p. 16 lines 18-24).
`
`Also Wasik et al. teach a preferred unit dose ranging from about 0.5 to 10 mg (p. 14
`
`lines 23-24). In the case where the claimed ranges "overlap or lie inside ranges
`
`disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541
`
`F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d
`
`1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-
`
`5%" while the claim was limited to "more than 5%." The court held that "about 1-5%"
`
`allowed for concentrations slightly above 5% thus the ranges overlapped.). Generally,
`
`differences in concentration or temperature will not support the patentability of subject
`
`matter encompassed by the prior art unless there is evidence indicating such
`
`concentration or temperature is critical. "[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 Alter, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA
`
`1955).
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`Application/Control Number: 13/893,537 (cid:9)
`Art Unit: 1611
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`Page 6
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`Wasik et al. teach that the SDZ RAD (everolimus) can be admixed with one or
`
`more other active agents, including anticancer agents such as cisplatin inter alia (p. 12,
`
`line 29-p.13 line 2 and p. 14 line 27 to p. 15 line 2). Wasik et al. fails to suggest a
`
`combination of everolimus with a histone deacetylase inhibitor for the treatment of
`
`lymphoma.
`
`Grant et al. teach the administration of a cyclin dependent kinase inhibitor and a
`
`histone deacetylase inhibitor for the treatment of cancer, including lymphoma (p. 4, line
`
`15 to p. 5 line 9, p. 11 lines 29-31). The preferred histone deacetylase inhibitors include
`
`sodium butyrate, phenylbutyrate, suberoylanilide hydroxamic acid (SAHA, the elected
`
`histone deacetylase inhibitor), depsipeptide, tricostatin A, MS-275 (which is MS-27-275)
`
`and CI-994 (p. 4, lines 19-20, p. 5 lines 14-15). A preferred and exemplified
`
`combination is Flavopiridol with SAHA (see examples).
`
`It would have been prima facie obvious to one of ordinary skill in the art at the
`
`time of the instant invention to have administered everolimus with a cyclin dependent
`
`kinase inhibitor and a histone deacetylase inhibitor, specifically the preferred histone
`
`deacetylase inhibitor SAHA to a subject having lymphatic cancer with a reasonable
`
`expectation that the lymphatic cancer, including non-Hodgkin's lymphoma, would be
`
`treated. One would have been motivated to do so as both everolimus and the
`
`combination of a cyclin dependent kinase inhibitor and a histone deacetylase inhibitor,
`
`specifically the preferred histone deacetylase inhibitor SAHA are known to treat
`
`lymphoma. "It is prima facie obvious to combine two compositions each of which is
`
`taught by the prior art to be useful for the same purpose, in order to form a third
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`Application/Control Number: 13/893,537 (cid:9)
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`Page 7
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`composition to be used for the very same purpose.... [T]he idea of combining them
`
`flows logically from their having been individually taught in the prior art." In re
`
`Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
`
`Accordingly, to establish obviousness in such fact situations it is NOT necessary
`
`that the motivation come explicitly from the reference itself. The natural presumption
`
`that two individually known compositions effective at treating lymphoma would, when
`
`combined, provide a third composition also useful for treating lymphoma flows logically
`
`from each having been individually taught in the prior art. Applicant has presented no
`
`evidence (e.g. unexpected results) to rebut this natural presumption.
`
`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
`
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`Application/Control Number: 13/893,537 (cid:9)
`Art Unit: 1611
`
`Page 8
`
`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 1-8 are provisionally rejected on the ground of nonstatutory double
`
`patenting as being unpatentable over claims 1-9 of copending Application No.
`
`13/893537 (reference application) in view of Grant et al. (WO 02/22133 having an
`
`international filing date of September 7, 2001 and claiming priority to US provisional
`
`application 60/231885 filed September 12, 2000). Although the claims at issue are not
`
`identical, they are not patentably distinct from each other because the copending claims
`
`are directed to a method for treating lymphatic cancer comprising administering to a
`
`subject a therapeutically effective amount of everolimus. Dependent claims 2-9 mirror
`
`instant claims 2-6 and 8. The copending claims differ from the instant claims in that the
`
`everolimus is not administered with a histone deacetylase inhibitor. However, this
`
`difference is obvious in light of the teachings of Grant et al.
`
`Grant et al. teach the administration of a cyclin dependent kinase inhibitor and a
`
`histone deacetylase inhibitor for the treatment of cancer, including lymphoma (p. 4, line
`
`15 to p. 5 line 9, p. 11 lines 29-31). The preferred histone deacetylase inhibitors include
`
`sodium butyrate, phenylbutyrate, suberoylanilide hydroxamic acid (SAHA, the elected
`
`histone deacetylase inhibitor), depsipeptide, tricostatin A, MS-275 (which is MS-27-275)
`
`and CI-994 (p. 4, lines 19-20, p. 5 lines 14-15). A preferred and exemplified
`
`combination is Flavopiridol with SAHA (see examples).
`
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`Application/Control Number: 13/893,537 (cid:9)
`Art Unit: 1611
`
`Page 9
`
`It would have been prima facie obvious to one of ordinary skill in the art at the
`
`time of the instant invention to have administered everolimus with a cyclin dependent
`
`kinase inhibitor and a histone deacetylase inhibitor, specifically the preferred histone
`
`deacetylase inhibitor SAHA to a subject having lymphatic cancer with a reasonable
`
`expectation that the lymphatic cancer, including non-Hodgkin's lymphoma, would be
`
`treated. One would have been motivated to do so as both everolimus and the
`
`combination of a cyclin dependent kinase inhibitor and a histone deacetylase inhibitor,
`
`specifically the preferred histone deacetylase inhibitor SAHA are known to treat
`
`lymphoma. "It is prima facie obvious to combine two compositions each of which is
`
`taught by the prior art to be useful for the same purpose, in order to form a third
`
`composition to be used for the very same purpose.... [T]he idea of combining them
`
`flows logically from their having been individually taught in the prior art." In re
`
`Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
`
`Accordingly, to establish obviousness in such fact situations it is NOT necessary
`
`that the motivation come explicitly from the reference itself. The natural presumption
`
`that two individually known compositions effective at treating lymphoma would, when
`
`combined, provide a third composition also useful for treating lymphoma flows logically
`
`from each having been individually taught in the prior art. Applicant has presented no
`
`evidence (e.g. unexpected results) to rebut this natural presumption.
`
`This is a provisional nonstatutory double patenting rejection because the
`
`patentably indistinct claims have not in fact been patented.
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`Application/Control Number: 13/893,537 (cid:9)
`Art Unit: 1611
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`Page 10
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`Conclusion
`
`Claims 1-8 are rejected. No claim is allowed.
`
`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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