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 .
Applicant's response to the previous Office action, dated April 3, 2026, has been received. By way of this submission, Applicant has amended the specification and claims 1, 4-5, 11, and 14, and cancelled claims 6, 12, 23-24, and 26-28.
Claims 1-5, 7-11, 13-16, 18-22 and 25 are pending in the application. Claims 9, 11, 18, and 23-25 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed May 27, 2025.
Claims 1-5, 7-8, 10, 13-16, and 19-22 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated January 6, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 3, 2026 was filed after the mailing date of the first Office action on the merits on January 6, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure was previously objected to because it contains an embedded hyperlink and/or other form of browser-executable code.
Applicant's amendment to the specification has addressed this issue, and this objection is hereby withdrawn.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-5, 13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by June (US20150283178A1).
Applicant argues that June does not teach every aspect of the claims as amended; specifically, June does not teach a chimeric antigen receptor with a CD28 intracellular signaling region.
Applicant's arguments have been considered but are not found to be persuasive.
June teaches a CAR comprising the anti-CD19 FMC63 scFv (para. 0306).
June further teaches that the CAR may possess a CD3 zeta signaling domain (para. 0341).
June further teaches that the CAR may also possess a CD28 intracellular signaling domain (para. 0344).
This rejection is therefore maintained.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7-8, 10, 12, 14, 19, 20-22, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over June as applied to claim 1 above, and further in view of Gore (Blood Cancer J. 2018 Aug 22;8(9):80), Kasagra (Bone Marrow Transplant. 2019 Nov;54(11):1868-1880), Paul (Symposium on neoplastic hematology and medical oncology, Volume 91, Issue 11 p1645-1666 November 2016), and Better (US20150344844A1).
Applicant argues that the field of CAR design is known to be unpredictable, citing reference to Guedan, Dotti, and Shah (cited by Applicant in IDS). Applicant further argues that the prior art teaches away from the use of CD28 as a costimulatory domain over 4-1BB. Applicant further argues that the claimed method produces unexpected results in both efficacy and safety in treating mantle cell lymphoma as compared to Minson (cited by Applicant in IDS), which describes treatment with tisagenlecleucel, another anti-CD19 CAR.
Applicant's arguments have been considered fully but are not found to be persuasive.
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). MPEP 2123.
Guedan states that "CD28 and 4-1BB are the most widely used costimulatory endodomains in CARs. Clinical trials with CARs incorporating CD28 or 4-1BB intracellular domains showed similar response rates in patients with hematologic malignancies." (page 147, right column, last paragraph). While Guedan goes on to describe the functional differences between CD28 and 4-1BB, it was known that they performed a similar function, and both domains resulted in a functional CAR. This is not a lack of predictability in the field, the functions and differences were known according to Guedan. Guedan also suggests means by which the skilled artisan could choose which domain to use (page 148, left column, first paragraph: "The high effector function and self-limited expansion of CD28-based CARs may be ideal to transiently treat diseases with a rapid tumor elimination and short-term persistence of the CAR (i.e., as a bridge therapy for allogeneic hematopoietic stem cell transplantation). By contrast, 4-1BB-based CARs may be used to treat diseases in which complete responses require sustained T cell persistence."). Neither does Guedan discredit CD28 as an unworkable choice. Dotti and Sah concur with Guedan in that both CD28 and 4-1BB produced viable CARs.
With regards to Applicant's allegation of unexpected results, Minson states that tisagenlecleucel results in an overall response rate of 90% (page 1, last paragraph), which is comparable to Applicant's reported rate of 86% or 92%. Neelapu (The New England Journal of Medicine, December 28, 2017, pp. 2531-2544, Vol. 377, no. 26., cited in IDS), teaches that treatment with axicabtagene ciloleucel, an anti-CD19 CAR with a CD28 costimulatory region, results in 13% incidence of grade 3 or higher cytokine release syndrome (page 2531, "Results"), which is comparable with Applicant's reported 15% incidence of grade 3 or higher cytokine release syndrome.
"Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). MPEP 716.02(c). There is nothing to indicate that the components of the claimed combination are performing anything other than their known, usual functions. As Applicant's results are comparable to the teachings of the prior art, they cannot be said to be unexpected.
This rejection is therefore maintained.
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, 7-8, 10, 13-16, and 19-22, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 12,156,887 in view of June, Gore, Kansagra, Paul, and Better.
Applicant argues that the claims as amended are nonobvious in view of the cited references, for reasons described above. This is not found persuasive, for reasons described supra.
This rejection is therefore maintained.
Claims 1-5 and 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, and 10 of copending Application No. 17/091,039 (reference application).
Applicant has asked that this rejection be held in abeyance. This rejection is therefore maintained.
Conclusion
No claim is allowed.
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 PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/ Examiner, Art Unit 1644
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