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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 10, 2026, has been entered. By way of this submission, Applicant has amended claims 18, 19, 21, 24, and 27-29, cancelled claims 22, 23, and 31-33, and introduced new claim 37.
Claims 14, 18-19, 21, 24-30, and 34-37 are pending in the application. Claims 14 and 34 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed July 11, 2024.
Claims 14, 18-19, 21, 24-30, and 35-37 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated February 11, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 10, 2026 was filed after the mailing date of the first Office action on the merits on November 13, 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 24 is objected to because of the following informalities: the word “personalized” is spelled two different ways in the claim. Appropriate correction is required.
Response to Amendment
Applicant argues that Kadiyala and Shulka do not teach every aspect of the claims as amended; specifically Kadiyala and Shulka do not teach that a particle is used to perform both adoptive immunotherapy and active immunotherapy in conjunction with each other treating the same subject in such a way that APCs harvested from the subject after a first particle was administered to the subject would then be contacted with a second particle and then be used to activate and expand anticancer T-cells harvested from the subject.
Applicant further argues that Kadiyala does not teach a particle with a largest dimension of about 1 micrometer, and nothing in the teaching of Kadiyala would have led a skilled person to choose that particular size for particles to be used in the claimed method. Applicant further argues that Kadiyala does not provide motivation for the skilled artisan to select the claimed particle, neoantigenic construct, and method steps without further guidance.
In view of Applicant's amendments to the claims only, the rejections under 35 U.S.C. 103 to Kadiyala and Kadiyala in view of Shulka, and the nonstatutory double patenting rejection over claims 51, 59-64, 69-71, and 73-76 of copending Application No. 18/999,139 in view of Kadiyala and Shukla are withdrawn.
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 14, 18-19, 21, 24-30 and 35-37 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. The is a new ground of rejection, necessitated by Applicant’s amendments to the claims. This is a new matter rejection.
Applicant’s amendment, filed August 10, 2026, contains new matter in claim 18 because the specification as-filed does not provide sufficient written description for the recitation of a second phagocytosable particle for use in activating and expanding anticancer T-cells harvested from the subject in vitro.
Applicant's specification describes steps i) and ii) of using a phagocytosable particle comprising personalized neoantigenic constructs covalently attached to a core, followed by contacting anticancer T-cells with antigen presenting cells (APCs) that have phagocytosed the above particle. However, the specification does not describe that this particle can be used to perform both adoptive immunotherapy and active immunotherapy in conjunction with each other to treat the same subject. Applicant's arguments in the reply dated August 10, 2026, on page 7 emphasize that this combination is essential to the invention as claimed and that "[s]tating that a substance has two different uses does not suggest combining the two different uses together in a single therapeutic method."
The specification does not the steps of administering to a subject a first phagocytosable particle and using a second phagocytosable particle to perform in vitro T cell activation in the same embodiment. Applicant's examples and described embodiments only describe separate uses of the particle, not their use in conjunction with one another, which Applicant asserts is essential to the claimed method.
As such, the claims now recite a limitation which was not clearly disclosed in the specification as-filed and now change the scope of the instant disclosure as-filed. Such a limitation recited in the present claims, which did not appear in the specification, as-filed, introduces a new concept and violates the description requirement of the first paragraph of 35 U.S.C. 112.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schneck (US20170246277A1) teaches that paramagnetic particles comprising between three and ten neoantigens are useful to both enrich for and expand antigen-specific T cells (para. 0066). Schneck also teaches administration of said particles bearing neoantigens identified in vitro through genetic analysis of the patient's tumor (para. 0098).
No claim is allowed.
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/PETER JOHANSEN/Primary Examiner, Art Unit 1642
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