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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 for Continued Examination (RCE) Transmittal filed on 13 November 2025 has been entered.
Claim status
In the reply filed 13 November 2025, Applicant has amended claims 1, 9, 13, 23, 24; claims 2-7, 10-11, 15, 19, 21-22, 25-28 are cancelled and claims 13, 14, 16, 23, 24 are withdrawn. Therefore, claims 1,8-9,12-14,16,18, 20 and 23-24 are herein pending.
Election/Restrictions
Applicant’s election of Group 1, claims 1, 8-9, 12, 18 drawn to a cell which comprises a chimeric antigen receptor (CAR) or a transgenic T-cell receptor (TCR) and at least one polypeptide capable of co-localizing an MHC class I polypeptide in the reply filed on 05 November 2024 is acknowledged. Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement with an election that mailed on 09/06/2024. Therefore, the election response filed on 05 November 2024 will be treated without traverse (MPEP § 818.01(a)).
Claims 13-14, and 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant elected, MHC class II polypeptide, CD3zeta endodomain and Gln40Tyr substitution mutation of CD4 with SEQ ID NO: 47. Group 1 claims 1, 8-9, 12, 18 encompass the three elected species.
Upon further consideration (and due to a finding in the prior art, see rejections below), the species election requirement for substitution mutation of CD4 is hereby withdrawn.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Therefore, claims 1, 8-9, 12, 18 and 20 are herein under examination.
Priority
This application was filed 10/05/2021 and is a 371 application of PCT/GB2020/050908 filed on 04/07/2020, which claims benefit to the foreign priority to 1904971.7 filed on 04/08/2019. Thus, the earliest possible priority for the instant application is 04/08/2019.
Withdrawn Claim Objections
The prior objections to Claims 13-14, and 23-24 have been withdrawn due to applicant’s amendment and included claim status identifier (withdrawn) or (withdrawn – currently amended) and the text of the non-elected claims have been presented with markings to indicate the changes.
Withdrawn Title Objections
In the reply filed 13 November 2025, applicant amended the SPEC and replaced the title to clearly indicated the invention to which the claims are directed according to MPEP 606.01. Therefore, the title to objection is withdrawn.
Amended title: “CAR T-Cell to Activate the Cellular-Mediated Immune Response through Recognition of Peptide/MHC Complexes.”
New objection to Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See SPEC filed on 10/05/2021; page 16, line 25 and page 25, line 16. Applicant is required to amend or delete the embedded hyperlink (i.e., http://) and/or other form of browser-executable code. Similarly, “www” can be replaced with “world wide web” as the URL code. See MPEP § 608.01.
Withdrawn Rejections
The Applicant has amended the claims 1, 13, 23-24 and exclusively included the wherein the engineered or bispecific polypeptide activates cytotoxic-mediated cell killing by the cell. In the remark, applicant argues that the engineered/bispecific polypeptides of the present invention cause the claimed cells to only deplete recipient T cells which express a TCR that specifically recognizes an MHC or peptide/MHC complex on the claimed cell. This targeted T cell ablation is custom to the claimed cells and will not cause generalized nonspecific elimination of activated T and NK cells, which may be detrimental to the patient.
In the prior art Mo et al. (Biol Blood Marrow Transplant (2019), 25 (3), S100-S289) discloses off-the-shelf CD19 CART cells co-expressing a so-called alloimmune defense receptor (ADR) directed against 4-1 BB (Abstract). The ADR protects allogeneic CAR T cells against rejection by alloreactive lymphocytes. The subject-matter of the instant claim is contrary from the disclosure of Mo in that the cell expresses a polypeptide capable of co-localizing an MHC class I or II with an intracellular signaling domain. Therefore, Applicant argument found persuasive and therefore, the prior rejection of claims 1, 8, and 12 under 35 U.S.C. 103 as being unpatentable over Mo et al. (Biol Blood Marrow Transplant (2019), 25 (3), S100-S289) in view of Zhang et al., (Journal of Autoimmunity 96 (2019) 50–58) and Wang et al. (PNAS, 108(38), pp.15960-15965; 2011) and evidentiary reference Bauer et al. (science, 285(5428), pp.727-729;) is hereby withdrawn.
Prior rejection of claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Mo et al. (Biol Blood Marrow Transplant 25 (2019) S100-S289, vol. 25, no. 3, 1 March 2019) in view of Zhang et al., (Journal of Autoimmunity 96 (2019) 50–58) as applied to claims 1, 8 and 12 above, and further in view of Chen et al. (US20180362975A1) is hereby withdrawn.
New Claim Rejections - 35 USC § 112 (a)
(Written description)
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 1, 8-9, 12, 18 and 20 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 contains subject matter that 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 pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
Under the written description guidelines (see MPEP 2163), the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
Claims 1 and 9 encompasses a genus of any chimeric antigen receptor (CAR) or any transgenic T-cell receptor (TCR). However, the specification doesn't have adequate support in the disclosure for the any CAR or any TCR. The specification discloses that the CAR-encoding nucleic acids may be transferred to T cells using, for example, retroviral vectors. In this way, a large number of antigen-specific T cells can be generated for adoptive cell transfer. When the CAR binds the target-antigen, this results in the transmission of an activating signal to the T-cell it is expressed on. Thus, the CAR directs the specificity and cytotoxicity of the T cell towards cells expressing the targeted antigen (see SPEC [0435] ¶ of US20220211830A1). Furthermore, SPEC discloses a various tumor associated antigens (TAA) are known, as shown in the Table 3. The antigen-binding domain used in the present invention may be a domain which is capable of binding a TAA as indicated therein (SPEC [0439-0440] ¶). More specifically, SPEC has established actual reduction to practice for only CD19 CAR T cell in Examples 3-4 ([0538-0539] ¶). However, specification does not disclose that the cell comprises any CAR or any TCR can be activated the cytotoxic-mediated cell killing by engineered polypeptide. Therefore, the specification fails to identify a cell which comprises any CAR or any TCR.
In the prior art Mo et al. (Biol Blood Marrow Transplant 25 (2019) S100-S289, vol. 25, no. 3, 1 March 2019; cited in IDS dated 01/10/2022; hereinafter “Mo”) disclose CD19 CART cells co-expressing engineered polypeptide (i.e., alloimmune defense receptor (ADR)) directed against 4-1BB and OX40 costimulatory molecules transiently upregulated on activated T- and NK-cells enabled specific elimination of activated T cells (p. S168 Abstract and method ¶). The engineered ADR protects allogeneic CAR T cells against rejection by alloreactive lymphocytes. 4-1BB ADR T cells preferentially targeted activated CD8+ T cells while OX40 ADR T cells were more selective against CD4+ T cells (p. S168 Methods ¶) and eradicated the tumor (Fig.1). Accordingly, the engineered polypeptide activates cytotoxic-mediated cell killing by the cell. Therefore, it is obvious that prior art does not support to identify the cell comprises any CAR or any TCR can be activated the cytotoxic-mediated cell killing by engineered polypeptide.
With these additional evidences, the cell comprises any CAR or any TCR and engineered polypeptide is not well established at the time of filling and the ordinary artisan cannot predictably identify any CAR or any TCR in a subject. Therefore, one of skill in the art would neither expect nor predict the appropriate method of developing the instantly claimed the cell comprises any CAR or any TCR can be activated the cytotoxic-mediated cell killing by engineered polypeptide.
Therefore, it concludes that the claimed genus of any CAR or any TCR in a subject doesn't have an adequate written description. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed in claims 1, 9 and dependent claims 8, 12, 18 and 20.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 13 November 2025 are acknowledged.
Applicant’s arguments with respect to the obviousness rejection of claims 1, 8-9, 12, 18 and 20 withdrawn in view of the amendments and remarks have been considered and withdrawn. Therefore, applicant' s arguments are moot.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684