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
Applicant states that instant application is a continuation application of the prior-filed PCT application PCT/CN2017/082989 (filed 05/04/2017). A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: instant application discloses small interfering RNA (siRNA) sequences (SEQ ID NO: 3-12) capable of silencing the FATS of SEQ ID NO: 1, which are not disclosed in prior-filed PCT application.
In addition, Acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) based upon an application filed in PEOPLE’S REPUBLIC OF CHINA on 05/12/2016. The claim for priority cannot be based on said application because the subsequent nonprovisional or international application designating the United States was filed more than twelve months thereafter and no petition under 37 CFR 1.55 or request under PCT Rule 26bis.3 to restore the right of priority has been granted.
Furthermore, this application is a continuation-in-part (CIP) of U.S. Patent Application No. 16/134,983, which was filed 09/19/2018. MPEP 211.05 states: “[A]ny claim in a continuation-in-part application which is directed solely to subject matter adequately disclosed under 35 U.S.C. 112 in the parent nonprovisional application is entitled to the benefit of the filing date of the parent nonprovisional application. However, if a claim in a continuation-in-part application recites a feature which was not disclosed or adequately supported by a proper disclosure under 35 U.S.C. 112 in the parent nonprovisional application, but which was first introduced or adequately supported in the continuation-in-part application, such a claim is entitled only to the filing date of the continuation-in-part application. See, e.g., In re Chu, 66 F.3d 292, 36 USPQ2d 1089 (Fed. Cir. 1995); Transco Products, Inc. v. Performance Contracting Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994); In re Van Lagenhoven, 458 F.2d 132, 136, 173 USPQ 426, 429 (CCPA 1972)”. In instant application, claims 1-16 contain the following matter which was not disclosed or adequately supported by a proper disclosure under 35 U.S.C. 112 in the parent nonprovisional application 16/134,983: claims 1-16 disclose small interfering RNA (siRNA) sequences (SEQ ID NO: 3-12) capable of silencing the FATS of SEQ ID NO: 1, which are not disclosed in prior-filed application 16/134,983, therefore claims 1-16 has an effective filing date of the filing date of the continuation-in-part application, which is 04/21/2023; and claims 17-20 are directed to a subject matter adequately disclosed under 35 U.S.C. 112 in the parent nonprovisional application, therefore is entitled to the benefit of the filing date of the parent nonprovisional application 16/134,983, which is 09/19/2018.
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-6, drawn to a composition comprising modified macrophages, as well as siRNA SEQ ID NO:2, in the reply filed on 01/21/2026 is acknowledged. Accordingly, claims 1-6 with a species of siRNA SEQ ID NO:2 have been considered on the merits. Claims 7-20 are withdrawn from consideration pursuant 37 CFR 1.142(b).
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.
Claims 1-6 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Zhang et al. (Nat Commun. 2021 Jul 14;12(1):4300), as evidenced by NCBI Reference Sequence: NM_001199941.1 (available 2010).
Zhang et al. teach a function of FATS (fragile site-associated tumor suppressor) in tumor development via regulation of tumor immunity (Abstract).
Regarding claim 1, Zhang et al. teach utilizing Fats−/− mice to explore the role of FATS in tumor immunity. FATS deficiency reduces tumor growth in vivo and increases the survival of mice (p2, left column). Zhang et al. teach Fats−/− bone marrow-derived macrophage (BMDMs, see i.e., figure 4). This teaching reads on “a composition comprising modified macrophages have a deletion of fragile-site associated tumor suppressor (FATS)” as recited in instant claim. Zhang et al.’s FATS gene has a sequence 100% identical to SEQ ID NO:1, which is evidence by NCBI Reference Sequence: NM_001199941.1 (sequenced is provided). NCBI Reference Sequence: NM_001199941.1 is Mus musculus DNA segment, Chr 7, ERATO Doi 443, expressed (D7Ertd443e), transcript variant 1, mRNA. Zhang et al.’s teaching is listed in the GenBank for this gene as a reference (see p1, reference 2). In addition, Zhang et al. teach siRNAs targeting mouse Fats (5′- GCAACATGTACCAGTAGCA) and human FATS (5′-GAGATCAAATTGCCCTTAA) (p14, right column-p15, left column), wherein siRNA targeting mouse Fats is 100% identical to SEQ ID NO:2 as recited in instant claim (sequence alignment is provided as follows). This teaching reads “a composition comprising modified macrophages modified macrophages comprise a small interfering RNA (siRNA) capable of silencing the FATS of SEQ ID NO: 1, wherein the siRNA is SEQ ID NO: 2” as recited in instant claim. Therefore Zhang et al.’s teaching anticipates instant claim.
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162
813
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Regarding claim 2, as discussed above, Zhang et al. teach Fats−/− bone marrow-derived macrophage (BMDMs, see i.e., figure 4).
Regarding claim 3, Zhang et al. teach FATS deficiency increases M1 polarization under tumor conditions (p5, left column), reads on the macrophages are M1 macrophages.
Regarding claim 4, Zhang et al. teach using FATS knockout C57BL/6 mice (Fats−/−) (p12, right column), and bone marrow-derived cells aseptically harvested from 6–8-week-old female mice (p13, right column). This teaching reads on the macrophages are derived from a rodent.
Regarding claims 5 and 6, as discussed above, Zhang et al. teach siRNA targeting mouse Fats (5′- GCAACATGTACCAGTAGCA) (p14, right column-p15, left column), wherein the siRNA is 100% identical to SEQ ID NO:2 as recited in instant claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QINHUA GU whose telephone number is (703)756-1176. The examiner can normally be reached M-F: 9:00 - 5:00.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
Sequence alignment
SEQ ID NO:1 v.s. NM_001199941.1
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1016
906
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962
683
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306
713
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