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 .
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1-13, in the reply filed on May 5, 2026, is acknowledged. Applicant also elected compounds I-A and anti-PD-1 antibody.
Claims 1-5, 9, and 10 read on both compound I-A and anti-PD-1 antibody.
Claim of Foreign Priority
Applicant’s claim of foreign priority and Certified Copy of foreign priority documents have been received by the Office. Priority has not yet been perfected as an English language translation has not been provided.
Status of the Claims
Claims 1-13 and 15 are pending. Claim 15 is withdrawn for being directed to a non-elected group. Claims 6-8 and 11-13 are withdrawn for being directed to a non-elected species (i.e., not compound I-A or a PD-1 inhibitor).
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.
Claim 1, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hamdy et al., (US2017/0239351).
Hamdy teaches therapeutic combinations include a BTK inhibitor and an anti-PD-1 or PDL-2 compound. See Abstract and par. 2. The combination is for the treatment of many cancers, including leukemia, lymphoma, and solid tumors. See par. 15. Further, the combination of a BTK inhibitor and a PD-1 inhibitor (including an anti-PD-1 antibody) provides a surprising and synergistic effect. See par. 12.
As such, claims 1, 9 and 10 are anticipated by the prior art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kawahata et al., (WO2018/097234A1), in view of Hamdy et al., (US2017/0239351).
Kawahata teaches BTK inhibitors compounds or a salt thereof for treating many types of cancers. The compound includes Examples 23, which is the elected species and is shown below:
PNG
media_image1.png
501
1385
media_image1.png
Greyscale
Kawahata does not teach combination therapy with an anti-PD-1 immunotherapy.
Hamdy teaches therapeutic compositions including both a BTK inhibitor and an anti-PD-1 compound. See Abstract. The combination is for the treatment of many cancers, including leukemia, lymphoma, and solid tumors. See par. 15. Further, the combination of a BTK inhibitor and a PD-1 inhibitor (including an anti-PD-1 antibody) provides a surprising and synergistic effect. See par. 12.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed products in view of the cited prior art. One would have been motivated to do so because each of the claimed agents are known and taught for a same use. Moreover, a combination of a Btk inhibitor and an anti-PD-1 antibody are taught to provide a synergistic benefit in the treatment of cancer. As such, there is a reasonable and predictable expectation of success in arriving at the claimed product in view of the cited 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 1-5, 9, and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 9-11, 13, 14, and 20-22 of copending Application No. 17/796,814, in view of Hamdy et al., (US2017/0239351).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘814 application are directed to products and methods of treating cancer using compound I-A Btk inhibitor. Hamdy teaches therapeutic combinations include a BTK inhibitor and an anti-PD-1 or PDL-2 compound. See Abstract and par. 2. The combination is for the treatment of many cancers, including leukemia, lymphoma, and solid tumors. See par. 15. Further, the combination of a BTK inhibitor and a PD-1 inhibitor (including an anti-PD-1 antibody) provides a surprising and synergistic effect. See par. 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,793,575, in view of Hamdy et al., (US2017/0239351).
Although the claims at issue are not identical, they are not patentably distinct from each other because Hamdy teaches therapeutic compositions including both a BTK inhibitor and an anti-PD-1 or PDL-2 compound. See Abstract and par. 2. The combination is for the treatment of many cancers, including leukemia, lymphoma, and solid tumors. See par. 15. Further, the combination of a BTK inhibitor and a PD-1 inhibitor provides a surprising and synergistic effect. See par. 12. As such, there is a reasonable and predictable expectation of success in arriving at the claimed products as applied above, and in view of Hamdy.
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 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
Prosecution Insights