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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-16 and new claim 20, in the reply filed on 04/23/2026 is acknowledged. The traversal is on the ground(s) that there is no undue burden to examine both groups together. This is not found persuasive because the groups have different classifications and also it is reiterated that all claims of Group II are indefinite, because it is not clear if they are drawn to a product or a process.
The requirement is still deemed proper and is therefore made FINAL.
Upon further consideration election of species is withdrawn.
Claims 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/23/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 depends on claim 1 and adda a limitation that viral vector – based RNA delivery system is for use in a mammal. Such limitation is of intended use and does not affect the structure of the system of claim 1. Therefore claim 16 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 4-7, 9-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (CN 109971756, July 2019, cited from machine translation of 20 pages).
Concerning claims 1, 4, 12-13 and 15-16 Zhang disclose viral vector-based siRNA delivery systems (see page 3), wherein siRNA targets EGFR (see page 2), such system includes targeting tag of RVG peptide to target malignant tumors (see pages 3, 10). Zhang teach that such systems use liver as a biogenerator to generate and envelope small RNAs in exosomes for delivery by circulatory system to target tissues (see page 10).
Concerning claim 5 such system can comprise promoter and a targeting tag (see pages 3 and 9).
Concerning claims 6, 9, 10 such system comprises promoter and siRNA (see page 3). Claims 9 and 10 depend on claim 6 and add limitations to one of the options recited in claim 6. Rejection of claim 6 is made based on the other option in the claim, therefore claims 9 and 10 are rejected by it as well.
Concerning claim 7 such system can comprise 5’promoter-flanking sequence-siRNA with loop sequence-3’ flanking sequence, wherein siRNA forms stem-loop structure with a compensatory strand complementary to the other strand of siRNA and a loop in between strands, such loop comprising SEQ ID NO: 2 identical to instant SEQ ID NO: 2 (see pages 3, 7).
Concerning claim 11 Zhang disclose that the system can be delivered to liver forming an exosome (see page 10).
Concerning claim 14 Zhang disclose siRNA targeting EGFR of SEQ ID NO: 1, 20 nucleotides long (see page 6, sequence listing).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang, above, as applied to claims 1, 4-7, 9-16 and in further view of Konstantinova et al (WO 2016/102664, June 2016) and Gong et al (US 2018/0140557, May 2018).
Teachings of Zhang are discussed above. It is further noted that Zhang teach 5’ flanking sequence of SEQ ID NO: 12 on page 3, which is 70% identical to instant SEQ ID NO: 1, and 3’ flanking sequence of SEQ ID NO: 15 on page 4, which is 70% identical to instant SEQ ID NO: 3.
Zhang do not teach flanking sequences at least 80% identical to instant SEQ ID NOs: 1 and 3 or expression in adeno-associated virus type 5 or targeting peptide of GE11.
Konstantinova teach siRNA delivery expression cassettes such as of SEQ ID NO: 20 (see Figure 2F, description on pages 3-4), which comprises 5’ flanking sequence at least 90% identical to instant SEQ ID NO: 1 (highlighted first below) and 3’ flanking sequence at least 90% identical to instant SEQ ID NO: 3 (highlighted second below):
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Further Konstantinova teach expression of siRNAs in adeno-associated vectors (AAV) such as AAV serotype 5 (see lines 5-20 on page 18).
Gong teach targeting peptide GE11 as a ligand binding to cancer cells (see paragraph [0034]).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to introduce elements taught by Konstantinova into systems taught by Zhang or to replace RVG targeting peptide with GE11 one taught by Gong, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so, because Zhang suggest viral vectors for expression of siRNAs and Konstantinova teach using AAV for expression of siRNAs. Further, Konstantinova provide example of flanking sequences, which are 70% similar to ones taught by Zhang and therefore can be used in the systems taught by Zhang. One would be motivated to replace RVG targeting peptide of Zhang by GE11 peptide taught by Gong, because Gong teach that such peptide can target cancer cells similar to RVG peptide of Zhang, therefore providi8ng targeted delivery of siRNAs to such cells.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,533,173 in view of Zhang, Konstantinova and Gong, above. Claims from ‘173 recite expression vectors comprising siRNAs targeting the same genes as in instant invention. Teachings of Zhang, Konstantinova and Gong are discussed above. It would have been obvious to further modify vectors from ‘173 with teachings of Zhang, Konstantinova and Gong, arriving at instant invention.
Claims 1-16 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,982,213 in view of Zhang, Konstantinova and Gong, above. Claims from ‘213 recite expression vectors comprising siRNAs targeting the same genes as in instant invention. Teachings of Zhang, Konstantinova and Gong are discussed above. It would have been obvious to further modify vectors from ‘213 with teachings of Zhang, Konstantinova and Gong, arriving at instant invention.
Claims 1-16 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,304,970 in view of Zhang, Konstantinova and Gong, above. Claims from ‘970 recite expression vectors comprising siRNAs targeting the same genes as in instant invention. Teachings of Zhang, Konstantinova and Gong are discussed above. It would have been obvious to further modify vectors from ‘970 with teachings of Zhang, Konstantinova and Gong, arriving at instant invention.
Claims 1-16 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,553,048 in view of Zhang, Konstantinova and Gong, above. Claims from ‘048 recite expression vectors comprising siRNAs targeting the same genes as in instant invention. Teachings of Zhang, Konstantinova and Gong are discussed above. It would have been obvious to further modify vectors from ‘048 with teachings of Zhang, Konstantinova and Gong, arriving at instant invention.
Claims 1-16 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/373,605 in view of Konstantinova, above. Claims from ‘605 recite the same constructs as in instant claims. Teachings of Konstantinova are discussed above. It would have been obvious to modify constructs from ‘605 with teachings of Konstantinova, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
Claims 1-16 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/374,236 in view of Konstantinova, above. Claims from ‘236 recite the same constructs as in instant claims. Teachings of Konstantinova are discussed above. It would have been obvious to modify constructs from ‘236 with teachings of Konstantinova, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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