DETAILED ACTION
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 .
Claim Status
In the reply filed 27 July 2026, Applicant has cancelled claims 2-7, 10-11, 15, 17, 19, 21-22, 25-28 and claims 13, 14, 23-24 stand withdrawn.
Therefore, 1,8-9,12-14,16,18, 20 and 23-24 are pending.
Election/Restrictions
Applicants previously elected 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.
Applicants 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Claims 13-14, 16 and 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 and 20 encompass the three elected species.
Upon further consideration (and due to a finding in the prior art, see prior office action mailed 07/14/2025), the species election requirement for substitution mutation of CD4 is hereby withdrawn.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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, applicants 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 on 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Withdrawn Objections
Applicant has submitted amended specification on 07/27/2026 that contains embedded hyperlinks at page 16, line 25, and page 25, line 16. Therefore, amended specification is compliant with MPEP §608.01. Accordingly, the objection to specification is withdrawn.
Maintained 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. This rejection is maintained for reasons of record and further explained below.
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 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 this additional evidence, 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
Applicants’ arguments filed on 27 July 2026 are acknowledged.
Applicant argues that the invention of the claims lies in the bispecific polypeptide that co-localizes MHC polypeptide with an intracellular signaling domain to prevent rejection by alloreactive T cells. Applicant further Mo does not use colocalization of an MHC molecule with an intracellular signaling domain to prevent rejection by alloreactive T cells, therefore Mo is not relevant to the written description of the presently claimed invention. See remark p. 7 last ¶.
Applicants’ arguments regarding written description rejection have been fully considered but they are not persuasive
MPEP 2163 states “To satisfy the written description requirement, a patent 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. 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. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.”
Instant specification 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.
Under the broadest reasonable interpretation of the instant claim, a bispecific polypeptide is not positively recited as a required claim limitation. 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 ¶).
Accordingly, with the prior evidence (e.., Mo et al.), 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.
Conclusion
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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 extension fee 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 date of this final action.
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).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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