DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 9 and 11-18 are pending and examined.
Claim of Foreign Priority
Applicant’s claim of foreign priority and Certified Copy of Foreign Priority Application GB 2020843.5 are acknowledged.
Request for Information
The examiner did not apply duplicative references. The Double Patenting Rejections include those applications and patents assigned to Avexxin Oncology AS, which appears to be a subsidiary of Coegin Pharma AB. If this is not the case, or if there is a relationship between these two entities, the examiner requests Applicant provide such information for the record.
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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 9 and 11-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Johansen et al., (WO2015/181135 A1) (cited in ISR).
Johansen teaches compounds for treating skin cancer, including squamous cell carcinoma and related conditions. See p6, line 16. The generic formula includes R-L-CO-X, wherein L is an S substituted with a C1-C6 alkyl. See p8, lines 10, 22-24. R is a C10-C24 unsaturated hydrocarbon with 5 to 7 double bonds, and most preferred 17 to 19 carbons. See p7, line 18. Further, in some embodiments all are in the cis configuration or a majority are in the cis configuration, except the one closest to the carbonyl. Double bonds can be in any configuration. See p7, lines 21-25. Administration can be oral or topically for skin cancer. See p15, lines 13-14. Further, the following compounds were used in experiments.
PNG
media_image1.png
276
525
media_image1.png
Greyscale
PNG
media_image2.png
135
713
media_image2.png
Greyscale
The above cPLAα inhibitors inhibited EGF induced keratinocyte AA release. See p21, lines 19-22. The subject can be a human or mammal. See prior art claim 17.
Claims 9 and 11-18 are anticipated by the prior art.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9 and 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,085,953. The claims of the ‘953 patent are directed to treating skin cancer by administering compounds, including those claimed (see prior art claim 10), wherein said subject is a mammal and a human. Administration can be orally and topically. See claim 15. Claim 13 allows for the cancer to be squamous cell carcinoma. As such, the claims of ‘953 patent are directed to administration of the same compounds by the same routes of administration to a same subject population. It would be obvious to arrive at the claimed methods in view of those taught by the ‘953 patent.
Claims 9 and 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,953,004, in view of Johansen et al., (WO2015/181135 A1).
The claims of the ‘004 patent are directed to the claimed compounds in a pharmaceutical formulation. See claims 1 and 2. The instant claims are broader because they do not require compound B of the claimed combination in the ‘004 patent. The compound is described for topical and oral administration to treat and prevent cancers, generally. Johansen et al., (WO2015/181135 A1) teaches the same compounds for use in treating the claimed forms of cancers. It would be obvious to arrive at the claimed methods in view of those products taught by the ‘004 patent, in view of the additionally and more specific cancers taught by Johansen et al.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571-272-1310. 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 automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JARED BARSKY/Primary Examiner, Art Unit 1628