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 .
Priority
The instant application, filed 12/09/2022 is a national stage entry under 35 USC 371 of
PCT/CN2021/098870 (filed 06/08/2021). Also, acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCTCN2020095211, filed on 06/09/2020. Therefore, the earliest possible priority for the instant Application is 06/09/2020.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1, 3, 6, 9, 20, 23-24, 30, 32, 35), drawn to a modified immune cell, which has attenuated expression and/or activity, relative to an unmodified immune cell, of YTH N6-Methyladenosine RNA Binding Protein 2 (YTHDF2); and enhanced anti-tumor activity, and a composition, comprising the modified cell, in the reply filed on 04/06/2026 is acknowledged. The traversal is on the ground(s) that a search and examination of the entire application would not place a serious burden on the examiner, whereas it would be a serious burden on Applicant to maintain separate applications and it is believed that the claims of the present application would be part of an overlapping search area.
This is not found persuasive because the different groups of invention lack unity of invention because even though the inventions of these groups require the technical feature of a modified immune cell, which has attenuated expression and/or activity, relative to an unmodified immune cell of YTHDF2, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kennedy et al. (Kennedy et al., “Post-transcriptional m6A Editing of HIV- 1 mRNAs Enhances Viral Gene Expression”. Cell Host Microbe. 2016 May 11;19 (5):675-85). Kennedy et al. teaches a CEM-SS CD4+T cell, which the endogenous YTHDF2 gene was mutationally inactivated using CRISPR/Cas (page 7, paragraph 3, lines 1-3). Therefore, Kennedy et al. teaches a modified immune cell, which has attenuated expression and/or activity, relative to an unmodified immune cell of YTHDF2.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 3, 6, 9, 20, /23-24, 30, 32, 35, 38, 42, 45, 53, 57, 76, 79, 81, 84, and 87 are pending in the instant application. Claims 38, 42, 45, 53, 57, 76, 79, 81, 84, and 87 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 timely traversed the restriction (election) requirement in the reply filed on 04/06/2026. Therefore, claims 1, 3, 6, 9, 20, 23-24, 30, 32, and 35 are under examination in the instant application.
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 32, 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Both claims 32 and 35 recite “second active ingredient”. There’s insufficient antecedent basis for this recitation in the claim. Claim 24, from which claims 32 and 35 depends, recites “an agent” and there is no recitation of “first active ingredient” or even “first” alone in the claim. See MPEP 2173.05(e).
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 3, 6, 9, 20, 23-24, and 30 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Li et al. (WO2019074980A1, filed on 10/09/2018, and published on 04/18/2019) as evidenced by Sui et al. (Sui et al., "The anticancer immune response of anti-PD-1/PD-L1 and the genetic determinants of response to anti-PD-1/PD-L1 antibodies in cancer patients". Oncotarget. 2015 Aug 14;6(23):19393-404) (for claim 9).
Regarding claim 1, Li et al. teaches a modified immune cell, which has attenuated expression and/or activity, relative to an unmodified immune cell, of YTH N6-Methyladenosine RNA Binding Protein 2 (YTHDF2); and enhanced anti-tumor activity (claims 1-7, paragraph 00108, 00110, and 00159).
Regarding claim 3: Following discussion of claim 1 above, Li et al. teaches that the immune cell is a T cell (paragraphs 0056-0067).
Regarding claim 6: Following discussion of claim 1 above, Li et al. teaches that the immune cell is a CAR-T cell (paragraphs 0056-0067).
Regarding claim 9: Following discussion of claim 1 above, although Li et al. does not specifically mention that the unmodified corresponding immune cell is PD-1+, Sui et al. (Sui et al., "The anticancer immune response of anti-PD-1/PD-L1 and the genetic determinants of response to anti-PD-1/PD-L1 antibodies in cancer patients". Oncotarget. 2015 Aug 14;6(23):19393-404) provides evidence that PD-1 is a coinhibitory receptor expressed on activated T cells and B cells, and is demonstrated to induce an immune-mediated response and play a critical role in tumor initiation and development (Abstract). Therefore, expressing PD-1 by the unmodified immune cell (T-cell) is inherently and necessarily present in Li et al. Accordingly, the mere recitation of its presence in the instant claims is not sufficient to distinguish the instant claims from prior art. “When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent.” See MPEP 2112.01 or In re Best, 195 USPQ 430, 433 (CCPA 1997).
Regarding claim 20: Following discussion of claim 1 above, Li et al. teaches that the immune cell has been modified with an agent capable of attenuating the expression and/or activity of YTHDF and wherein the agent capable of attenuating the expression and/or activity of YTHDF2 comprises small interfering RNA (siRNA) (claim 2, 31, 114, and paragraphs 0110, 0143).
Regarding claim 23: Following discussion of claim 1 above, Li et al. teaches a composition comprising the modified immune cell and a pharmaceutically acceptable excipient (paragraphs 0210-0214).
Regarding claim 24: Following discussion of claim 1 above, Li et al. teaches a composition comprising the modified immune cell, an agent capable of attenuating the expression and/or activity of YTHDF2, and a pharmaceutically acceptable excipient (paragraphs 0210-0214).
Regarding claim 30: Following discussion of claim 24 above, Li et al. teaches that the agent capable of attenuating the expression and/or activity of YTHDF2 comprises small interfering RNA (siRNA) (claim 2, 31, 114, and paragraphs 0110, 0143).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1, 24, 32, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO2019074980A1, filed on 10/09/2018, and published on 04/18/2019), in view of Sui et al. (Sui et al., "The anticancer immune response of anti-PD-1/PD-L1 and the genetic determinants of response to anti-PD-1/PD-L1 antibodies in cancer patients". Oncotarget. 2015 Aug 14;6(23):19393-404).
Regarding claims 1 and 24, the teachings of Li et al. are set forth in detail above.
Regarding claims 32 and 35: Following discussion of claim 24 above, Li et al. fails to teach that the composition further comprises a second active ingredient, wherein the second active ingredient is an anti-cancer agent.
However, Sui et al. teaches that immune checkpoint modulation as a therapeutic strategy is attracting more and more attention in cancer therapy. Anti-PD-1/PD-L1 antibodies have antitumor potential and improve cancer
patients’ survival (page 19399, column 1, last paragraph).
Therefore, it would have been prima facie obvious to have to one of the ordinary skills in the art before the
effective filing date of the claimed invention to have combined the first agent capable of attenuating the expression and/or activity of YTHDF2 in the composition of Li et al. with a second anti-cancer agent, such as an anti-PD-1 antibody. One would have expected the combined therapy to provide persistent positive therapeutic results in terms of enhancing anti-tumor activity and improving cancer patients’ survival as taught by Li et al. and Sui et al. As discussed in In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), and then upheld in KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (U.S. 2007), the combination of multiple elements (in this case therapies), each taught in the prior art as effective for the same purpose, to yield a combination with predictable results (e.g. the combined effect of each individual element) is prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANAN ISAM ABUZEINEH whose telephone number is (571)272-9596. The examiner can normally be reached Mon- Fri 8:30-5:00.
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Hanan Isam Abuzeineh
/H.I.A./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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