The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Applicant’s reply dated 7/27/2026 has been received. Claims 21, 31-46 and 48-55 are pending and under consideration.
Claim Objections
Claim 49 is objected to because of the following informalities: Claim 49 depends from canceled claim 22. Claim 49 is interpreted as depending from claim 21. Appropriate correction is required.
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.
The rejection of claims 21-22,45-46,49 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of the amendments to claim 21, limiting the administered cells to T cells.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claims 47 and 48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn.
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 said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The rejection of claims 21,22, and 31-55 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jena (2010, Blood, 116:1035-1044; IDS) in view of Finney (2004, J Immunol, 172:104-113; IDS) and Hutloff (1999, Nature, 397:283-266; IDS) is withdrawn in light of Applicant’s arguments. Applicant argues the teachings of Jena regarding Th17/Tc17 and the ICOS signaling domain are too general to lead one to reasonably expect the recited persistence upon combining the ICOS signaling domain in a CAR in Th17 or Tc17 cells. This argument is supported by the post-filing reference Guedan (BLOOD, 14 AUGUST 2014 | VOLUME 124, NUMBER 7, pages 1070-1080; IDS).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21, 31-46 and 48-55 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-9 of U.S. Patent No. 10,577,407.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical but an examined application is not patentably distinct from the reference claims because the examined claim is either anticipate by, or would have been obvious over, the reference claims. See, e.e., 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).
The instant claims are drawn to methods comprising administering cells to a mammal wherein the cells are genetically modified to express a CAR comprising an antigen binding domain, a transmembrane domain and an ICOS intracellular domain comprising the sequence set forth by SEQ ID NO:13. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 21,31 and 38 are generic to all that is recited in claim 1 of US 10,577,407. That is, claim 4 ‘407 falls entirely within the scope of claim 21 of the instant application. Specifically, claim 4 of ‘407 is drawn to a method of providing anti-tumor immunity comprising the same method steps as the instant invention, which is to administer a CAR T-cell to the individual where the CAR comprises an antigen binding domain, that binds a tumor antigen (species to the instant claims), an ICOS transmembrane domain, and an ICOS intracellular signaling domain having the sequence set forth by Seq Id No:13. Claim 6 of the patent limits the cells to Th17 or Tc17 which is recited in pending claims 31d,37,38c,44,47. The CD3z domain recited in pending claims 22,32 and 39 is claimed in patent claim 7. Other dependent claims recite inherent effects to the method or alternative limitations.
Applicant references their arguments for the rejection under 35 USC 103 and that the Examiner has asserted certain elements are inherent to the claimed methods without providing any objective evidence. This argument is not persuasive in this case because the rejection is not an obviousness-type rejection. The claimed methods are the same as those patented and therefore, any and all effects of carrying out the method are inherent. Patented and claimed methods treat a subject with Th17 or Tc17 cells with a CAR that comprises a specific ICOS intracellular signaling domain, that set forth by SEQ ID NO:13.
The rejection of claims 21,22, and 31-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-18 of U.S. Patent No. 9,714,278 in view of Jena (2010, Blood, 116:1035-1044; IDS) is withdrawn.
The rejection of claims 21,22, and 31-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7 of U.S. Patent No. 11,958,892 in view of Jena (2010, Blood, 116:1035-1044; IDS) is withdrawn.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached on M-F 6AM-2:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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