DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 10-31-25.
Claims 21-45 are pending in the instant application.
Election/Restrictions
Claims 37-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10-31-25.
Applicant’s election without traverse of Group I, a single LPEI:PEG ratio of 1:1, a single LPEI linker bond comprising NH-CO-, the diconjugate of claim 33(i), claims 21-36, in the reply filed on 10-31-25 is acknowledged.
Claim Objections
Claim 26 is objected to because of the following informalities: in claim 26, line 8, “of of” appears to be a grammatical error. Replacing “of of” with – or of – would perhaps be remedial. Appropriate correction is required.
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) 21-31, 36 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Levitski et al (US 2012/0021006).
Levitski et al (US 2012/0021006) teach pharmaceutical compositions comprising polyplexes comprising dsRNA of polyinosinic polycytidylic (poly I:C) acid double stranded RNA non-covalently associated with a polyethylene glycol (PEG) moiety, which PEG is conjugated via a linker to a targeting moiety capable of binding to a cancer antigen, which PEG moiety optionally forms an NH-CO bond with a linear polyethyleneimine (PEI), which linker optionally forms an S-S, NH-CO-, CO-NH-, -S-C-, O-CO-, or CO-O- bond with a targeting moiety, or which linker optionally comprises -CO-R2-Rx-R3 or a peptide moiety consisting of 3-7 amino acid residues, which R2 optionally comprises an alkylene, alkenylene, alkynylene or a heterarylenediyl (see esp. the abstract, pages 3-8, claims 1-14).
Claim(s) 21-31, 36 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Shir et al (WO 2004/045491).
Shir et al (WO 2004/045491) teach pharmaceutical compositions comprising polyplexes comprising dsRNA of polyinosinic polycytidylic (poly I:C) acid double stranded RNA non-covalently associated with a polyethylene glycol (PEG) moiety, which PEG is conjugated via a linker to a targeting moiety capable of binding to a cancer antigen, which PEG moiety optionally forms an NH-CO bond with a linear polyethyleneimine (PEI), which linker optionally forms an S-S, NH-CO-, CO-NH-, -S-C-, O-CO-, or CO-O- bond with a targeting moiety, or which linker optionally comprises -CO-R2-Rx-R3 or a peptide moiety consisting of 3-7 amino acid residues, which R2 optionally comprises an alkylene, alkenylene, alkynylene or a heterarylenediyl (see esp. the Abstract, pages 1-7, Table 2, pages 9, 10, 26-28, 34-36, 53-54).
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 21-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,278,991. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to pharmaceutical compositions comprising polyplexes comprising dsRNA of polyinosinic polycytidylic (poly I:C) acid double stranded RNA non-covalently associated with a polyethylene glycol (PEG) moiety, which PEG is conjugated via a linker to a targeting moiety capable of binding to a cancer antigen, which PEG moiety optionally forms an NH-CO bond with a linear polyethyleneimine (PEI), which linker optionally forms an S-S, NH-CO-, CO-NH-, -S-C-, O-CO-, or CO-O- bond with a targeting moiety, or which linker optionally comprises -CO-R2-Rx-R3 or a peptide moiety consisting of 3-7 amino acid residues, which R2 optionally comprises an alkylene, alkenylene, alkynylene or a heterarylenediyl, and which polyplex comprises a deconjugate comprising formula (i)-(viii).
. Claims 21-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,543,232. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to pharmaceutical compositions comprising polyplexes comprising dsRNA of polyinosinic polycytidylic (poly I:C) acid double stranded RNA non-covalently associated with a polyethylene glycol (PEG) moiety, which PEG is conjugated via a linker to a targeting moiety capable of binding to a cancer antigen, which PEG moiety optionally forms an NH-CO bond with a linear polyethyleneimine (PEI), which linker optionally forms an S-S, NH-CO-, CO-NH-, -S-C-, O-CO-, or CO-O- bond with a targeting moiety, or which linker optionally comprises -CO-R2-Rx-R3 or a peptide moiety consisting of 3-7 amino acid residues, which R2 optionally comprises an alkylene, alkenylene, alkynylene or a heterarylenediyl, and which polyplex comprises a deconjugate comprising formula (i)-(viii).
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
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Jane Zara
1-8-26
/JANE J ZARA/Primary Examiner, Art Unit 1637