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 .
Response to Amendments
Applicant’s amendments to the claims of August 20, 2026, in response to the Office Action of May 20, 2026, are acknowledged.
Response to Arguments
The provisional double patenting rejection is withdrawn in view of the amendments to the claims.
The non-provisional DP rejection is maintained. The ‘575 patent is direct to the claimed BTK inhibitor and in view of Hamdy would be obvious to combine with immunotherapy, including anti-PD-1 antibody.
The anticipation rejection is withdrawn in view of the amendments to the claims.
With respect to the traversal of the § 103 rejection, Applicant argues that Hamdy discloses an irreversible BTK inhibitor rather than a reversible BTK inhibitor.
The examiner notes that the combination of prior art teaches a POSA that a compound that inhibits BTK can be combined with an anti-PD-1 antibody to treat cancers. The claims as well as the abstract disclose combination therapy with a BTK inhibitor and a PD-1 antibody. “In certain embodiments, the invention includes therapeutic methods of using a PD-1 monoclonal antibody and a BTK inhibitor.” Abstract. Further independent claim 60 is shown below:
Claims
1-59. (canceled)
60. A method of treating a cancer, comprising the steps of co-administering, to a human in need thereof, a therapeutically effective amount of (1) a programmed death 1 (PD-1) inhibitor or a programmed death ligand 1 (PD-L1) inhibitor, or an antigen-binding fragment, variant, conjugate, or biosimilar thereof, and (2) a Bruton's tyrosine kinase (BTK) inhibitor or a pharmaceutically acceptable salt thereof.
The Abstract, Claims, and teachings of Hamdy do not teach away from the use of any BTK inhibitor. It is the BTK inhibition that treats subjects and a POSA would not interpret Hamdy as limited to only reversible BTK inhibitors. As such, a prima facie showing is established. Applicant has not provided nor shown unexpected results as compared to the closest prior art.
Claim of Foreign Priority
Applicant’s claim of foreign priority, Certified Copy of foreign priority documents, and English translation of foreign priority documents have been received by the Office.
Status of the Claims
Claims 1 and 15 are pending. Claim 1 is examined. Claim 15 is withdrawn.
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.
Claim 1 is 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:
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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 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 Monday through Friday from 8:30 to 5:30. 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.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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