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 Claims
Claims 1-2, 5-7, and 9-17 are currently pending. Claims 1-2, 5-7, and 9-10 are under examination and claims 11-17 stand withdrawn pursuant to 37 C.F.R. 1.142(b).
WITHDRAWN OBJECTIONS and/or REJECTIONS
Applicant’s amendments and/or arguments filed October 15, 2025, with respect to:
Rejection of claims 1-10 under 35 U.S.C. 112(a) (see Remarks on pg. 6 spanning pg. 7),
Rejection of claims 1-10 under 35 U.S.C. § 102 over Sampson or NCI (see pg. 7 through the first ¶ on pg. 9), and
Rejection of claims 1-7 on the grounds of nonstatutory double patenting over U.S. Patent No. 11,147,862 (see pg. 9).
have been fully considered and are persuasive. The aforementioned grounds of rejection have been withdrawn.
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.
Claim 5 stands rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant's arguments filed October 15, 2025 have been fully considered but they are not persuasive. Applicant argues that amendments to claim 1 and 5 overcome the indefinite rejection (see Remarks on pg. 6 in the first full ¶).
However, new issues of indefinite arise. Claim 5 now recites “the tumor-specific or tumor-associated antigen” and claim 1 now recites a “the tumor-specific or tumor-associated antigen” in relation to both the immunogenic agent and the therapeutic agent. It is unclear which “tumor-specific or tumor-associated antigen” to which claim 5 refers. Some skilled artisan would argue that since claim 5 distinguished the “tumor-specific or tumor-associated antigen” as different form the antigen of the immunogenic agent, the referenced “tumor-specific or tumor-associated antigen” is the one to which the therapeutic agent binds. Other skilled artisan would argue that claim 5 encompasses the scope of referring to either the immunogenic agents or therapeutic agent, e.g. claim 5 is interpreted as further limiting the immunogenic agent to further comprising an additional tumor-specific or tumor-associated antigen that is different from the first.
For the purpose of applying art, claim 5 is interpreted with the scope of “wherein the tumor-specific or tumor-associated antigen bound by the antibody or antigen binding fragment of the therapeutic agent is different from the tumor-specific or tumor-associated antigen of the immunogenic agent.”
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 1, 2, 5, 6, 7, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slaney et al. Clin Cancer Res. May 15, 2017. 23(10):2478-2490, cited herewith; as evidenced by Yong et al. PLoS One. 2015. 10(10):e0140543, cited herewith and Marincola et al. J Immunother Emphasis Tumor Immunol: Abstract. 1996 19(3):192-205, cited herewith.
Slaney teaches treating a liver tumor by administering an anti-HER2 CAR T cells expressing a pMEL TCR specific for gp100 (CARaMEL T cells), i.e. a therapeutic agent comprising an antibody fragment that specifically binds to a tumor-associated antigen, in combination with a vaccine comprising a vaccinia virus comprising gp100, i.e. an immunogenic agent comprising a tumor-associated antigen (see pg. 2479 in the last ¶ of the second col. through pg. 2480 in the penultimate ¶ of the first col.).
Slaney does not expressly recite that the anti-HER2 CAR comprises an antibody fragment targeting HER2, but cites Yong as providing the structure of the CAR (see pg. 2479 in the last ¶ of the second col.). Yong, in Fig. 1 on pg. 4, evidences that the anti-HER2 CAR comprises an anti-HER2 scFv, thus the “antibody fragment” limitation as recited in instant claim 1 is inherent to the structure of the anti-HER2 CAR taught by Slaney. Additionally, while Slaney does not explicitly state that gp100 is a tumor-associated antigen, gp100 is inherently a melanoma associated antigen (see Abstract of Marincola).
The gp100-bearing vaccinia virus elicits an immune response by activating CARaMEL T cell expansion, cytokine secretion, and tumor cell lysis (see pg. 2481 in the second ¶ of the first col.). Following proliferation in the periphery, CARaMEL T cells were able to infiltrate tumors (see pg. 2482 in the first full ¶ of the second col.), demonstrating that access to the respective tumor results from the immune response of the CARaMEL T cells to the gp100 vaccinia virus vaccine. Therefore, Slaney’s administration of the combined CAR T cells and vaccine to a subject with a liver tumor teaches all elements of instant claims 1, 2, 5, 7, and 9.
Regarding instant claim 6, Slaney teaches that the CARaMEL cells were splenocytes which comprises both CD8 and CD4 T cells, (see pg. 2481 in the last ¶ of the first col. spanning the second col.), and that persistent CARaMEL T cells expressed a memory T-cell phenotype (see pg. 2484 in the first full ¶ of the first col.). Thus, Slaney teaches that immune response of the CAR T cells to the vaccine produces CD4 memory T cells.
Regarding instant claim 10, brain metastasis of HER2 positive cancer falls under the broadest reasonable interpretation of “a neurological disorder,” and therefore HER2 is an antigen associated with a neurological disorder. Thus, the anti-HER2 CAR T cells taught by Slaney teaches that the antibody fragment of the therapeutic agents binds an antigen associated with a neurological disorder.
Double Patenting
9. 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.
10. Claims 1, 6-7, and 9-10 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/782,338 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant's arguments filed October 15, 2025 have been fully considered but they are not persuasive. On pg. 10 in the first full ¶, Applicant requests that the double patenting rejections be held in abeyance.
Applicant’s request that the provisional double patenting rejection over Application No. 17/782,338, be held in abeyance until allowable subject matter is indicated is acknowledged, but cannot be granted. Obviousness type double patenting rejections, whether provisional or not, cannot be held in abeyance. A double patenting rejection can be overcome, e.g., by a convincing rebuttal of the merits of the rejection, by amending the claims such that they are no longer anticipated and/or rendered obvious by the reference claims or by filing a proper terminal disclaimer.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/B.K.S./Examiner, Art Unit 1644
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683