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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 30, 2026 has been entered. By way of this reply, Applicant has amended claims 34, 41, 45, 47, 49-50, and 57, and cancelled claim 44.
Claims 34-42 and 45-59 are pending in the application. Claims 42, 51-53, 56 and 58 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed March 31, 2025.
Claims 34-41, 45-50, 54-55, 57, and 59 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated December 31, 2025.
Claim Objections
Claim 57 was previously objected to due to minor informalities.
Applicant's amendments to the claims have addressed this issue, and this objection is hereby withdrawn.
Claims 41, 44, 47, and 49-50 were previously objected to due to minor informalities.
Applicant's amendments to the claims have addressed this issue, and this objection is hereby withdrawn.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.
Claims 34-41, 45-50, 54-55, 57, and 59 are 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. This is a new grounds of rejection.
Claim 34 as amended recites that "the target of target cell recognized by the modified therapeutic immune cells and the target of the booster antigen are different" in the fifth clause, yet also recites that "the modified therapeutic immune cell expresses a chimeric antigen receptor (aBA-CAR) capable of specifically binding to the booster antigen" in the sixth clause. These two clauses appear to contradict one another, especially with the language of "target of target cell". It is not apparent if the aBA-CAR is meant to target the booster antigen or something else. Clarification is required.
For the purpose of claim construction, it is assumed that the aBA-CAR is meant to bind the booster antigen.
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 34-41, 44-50, 54-55, 57, and 59 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Dropulic (WO2016201394A1, cited in IDS) as evidenced by Wang (Exp Hematol Oncol. 2012 Nov 29;1(1):36). The following paragraph numbers refer to the corresponding US publication of Dropulic, US20190134091A1, which is identical to the WIPO document.
Dropulic teaches an immunotherapy composition comprising autologous antigen presentation cells expressing patient-derived tumor antigens, which are capable of promoting in
vivo expansion or persistence of patient-specific anti-tumor T-cells (para. 0014).
Dropulic further teaches that antigen presenting cells may prime or boost the activity of transduced T cells capable of recognizing the antigen (para. 0278).
Dropulic further teaches a chimeric antigen receptor (CAR), comprising an antibody that can bind to the antigen in question (para. 0030). Dropulic also teaches modifying the transduced T cells with said CAR (para. 0011).
Dropulic further teaches that the autologous antigen presentation cells are derived from B cells or peripheral blood derived lymphocytes (para. 0015), which is pertinent to claims 35 and 38-39.
Dropulic further teaches that the antigen may be CD19 (para. 0033), which is pertinent to claims 36-37.
Dropulic further teaches that the autologous antigen presentation cells may be immortalized B cells (para. 0019), which is pertinent to claim 40.
While Dropulic does not teach that CD19 comprises a transmembrane domain and a extracellular domain, Wang teaches that CD19 comprises a transmembrane domain and an extracellular N-terminus (i.e., an extracellular binding domain which can be recognized by the CAR-bearing therapeutic immune cell). Dropulic therefore inherently teaches these aspects of claim 41.
Dropulic further teaches that the CAR comprises a CD3 zeta domain and a costimulatory molecule (para. 0084), which is pertinent to claim 45.
Dropulic further teaches that the costimulatory domain may be CD28, 4-1BB, or ICOS (para. 0118), which is pertinent to claim 46.
Dropulic further teaches that the CAR may be expressed by a T cell, a tumor infiltrating cell, or an NK cell (para. 0218-220), which is pertinent to claims 47 and 48. Dropulic further teaches that the CAR may bind to viral antigens (para. 0094).
Dropulic further teaches that the autologous anti-tumor CAR-containing T cells may also be transduced with one or more patient-specific and tumor-specific TCRs (para. 0051), which is pertinent to claims 49 and 50.
Dropulic further teaches that the target cells may be cancer cells expressing Epstein Barr virus antigens or human papillomavirus (HPV) antigens (para. 0090), which is pertinent to claims 54-55, and 57.
Dropulic further teaches that the costimulatory domain may comprise CD28, 4-1BB, or ICOS (para. 0040), which is pertinent to claim 59.
Applicant argues that Dropulic does not teach every limitation of the claims as amended; specifically, Dropulic does not teach that the booster antigen is different from the target recognized by the modified therapeutic immune cells, or that the chimeric antigen receptors are used to recognize the booster antigen.
Applicant's arguments have been considered fully but are not found to be persuasive.
Dropulic teaches that the CAR augments the natural TCR response by providing the T cells with an additional signal to expand and survive in the body; and second, by targeting immunosuppressive cell antigens (para. 0078).
Applicant's arguments appear contradictory, in that Applicant argues that amended claim 34 recites that the modified therapeutic immune cell comprises a chimeric antigen receptor capable of recognizing the booster antigen, and that the teachings of Dropulic are limited to using an antigen identical to the immune cell's target as the booster antigen. But Applicant also argues that claim 34 "explicitly defines that the booster antigen is different from the target recognized by the modified therapeutic immune cells". Clarification is required.
Following the claim construction defined above that the aBA-CAR is meant to bind the booster antigen, Dropulic is explicit in teaching CARs capable of binding to the antigen in question (para. 0030).
This rejection is therefore maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tanaka (Clin Cancer Res. 2017 Jul 15;23(14):3499-3509) teaches T cells that bind VZV via their native TCR and GS2 via a chimeric antigen receptor, and that vaccination with VZV antigen improves in vivo expansion and persistence of said cells (page 3500, upper left box).
No claim is allowed.
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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/PETER JOHANSEN/Examiner, Art Unit 1644
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