DETAILED ACTION
Claims 13-18, submitted on 13 February 2025, are pending in the application and subject to examination in the instant Office 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 with traverse of the species of tumor, melanoma, and the species of HDAC inhibitor, ACY-1215, and the species of PD1 inhibitor, lambrolizumab, in the reply filed on 09 October 2025 is acknowledged. The traversal is on the ground(s) that the present genus of 3 tumors, 7 HDAC inhibitors, and 3 PD-1 inhibitors represents a finite number of species and thus the Applicant should not be required in the present application to elect a species. This is not found persuasive because, as presented in the previous restriction requirement, the species are independent and distinct due to the species not being obvious variants of each other based on the current record.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement filed 03 September 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “A method for treating a tumor in a subject, comprising administering to the subject a therapeutically effective amount of a histone deacetylase (HDAC) inhibitor and a therapeutically effective amount of a Programmed Death 1 receptor (PD1) inhibitor”, for which the specification does not provide an adequate written description to convey that the inventors were in possession of the scope of the claimed invention. The functional property of the genus of compounds does not permit one to envisage which compounds would have the desired biological function.
Claim 17 recites “an antibody that specifically binds to PD1”, for which the specification does not provide an adequate written description to convey that the inventors were in possession of the scope of the claimed invention. The instant claim is generic to antibodies that bind to PD1 which encompasses all synthetic and natural PD1 antibodies and does not permit one to envisage which compounds would have the desired effect in regards to the treatment of a tumor in combination with an HDAC inhibitor.
In Example 4, found on pages 27-28 of the instant specification, the Applicant teaches the combinatory treatment of the pan HDAC inhibitor, LBH589, and an anti-PDL1 antibody. It’s also taught that this combination increased the survival advantage of melanoma bearing mice compared to monotherapy of the PDL1 blocking antibodies or HDAC inhibitor alone. Applicant, however, fails to teach the combination of an HDAC6 inhibitor in combination with a PD1 inhibitor. It’s known in the art that different PD1 inhibitors can have a wide range of structures, however, it is unclear if all PD1 inhibitors would successfully produce the same or substantially similar results. It’s widely known that the pharmaceutical arts are unpredictable, and as such, there would be uncertainty in the combination of pharmaceutical agents without adequate experimentation or description of a structure function activity and/or consensus sequence(s) that would permit the ordinary skilled artisan to readily be able to identify HDAC6 inhibitors and PD1 inhibitors.
Additionally, the Applicant appears to be making a prophetic example of the combinatory treatment of the HDAC inhibitor, ACY1215 with the PD1 inhibitor, lambrolizumab by stating “these results provide strong rationale for the evaluation of combination therapies utilizing PDL1 or PD1 blocking antibodies in combination with HDACi”. As the Applicant has provided no experimental data with the aforementioned combination, and in view of the prophetic exemplification, the instantly claimed invention is not described in such a way as to reasonably convey to one skilled in the art that the inventor, at the time the application was filed, had possession of the instantly claimed invention.
Regarding the requirement for adequate written description, the Applicant is
directed to MPEP 2163 which states “An applicant shows that the inventor was in
possession of the claimed invention by describing the claimed invention with all of its
limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107
F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997)”. Based on the language of
the specification and absence of supporting material, the Examiner concludes that the
Applicant does not have possession of the claimed invention.
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 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9,987,258. Although the claims at issue are not identical, they are not patentably distinct from each other because the independent claim 1 of USPN ‘258 is drawn to a method that renders obvious the instantly rejected claims. Independent claim 1 of USPN ‘258 is drawn to combinatory treatment of a therapeutically amount of an HDAC inhibitor and a therapeutically amount of a PDL1 inhibitor, a PD1 inhibitor, or a combination thereof for the treatment of melanoma. When compared to instant claim 13, the aforementioned claim of USPN ‘258 reads on the similar administration of an HDAC inhibitor and a PD1 inhibitor. Additionally, as evidenced by dependent claim 16 of the instant application and the election of the specifically disclosed species of melanoma, the instant application is also drawn to the treatment of melanoma. As such, claim 1 of USPN ‘258 teaches an identical utility, thus obviating that of the instant application which necessitates the instant rejection.
Additionally, claim 4 of USPN ‘258 recites an identical limitation to that of instant claim 14 wherein the limitation reads “wherein the HDAC inhibitor is a selective HDAC6 inhibitor”.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622