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 .
This office action is in response to applicants’ submission of 10/15/2025. Applicants’ request for consideration after non-final rejection is entered and considered. No claims were amended.
Claim 1-10 are pending and under consideration.
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 1-10 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10792299, for reasons of record set forth in the office action of 4/16/2025. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11390871, for reasons of record set forth in the office action of 4/16/2025. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 12-21 of U.S. Patent No. 11045488, for reasons of record set forth in the office action of 4/16/2025. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 12-21 of U.S. Patent No. 11045488 as applied to claims 1-9 above and further in view of Zetter et al., (US 20130028885), for reasons of record set forth in the office action of 4/16/2025.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 15, and 17 of U.S. Patent No. 11708575, for reasons of record set forth in the office action of 4/16/2025. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 15, and 17 of U.S. Patent No. 11708575 as applied to claims 1-8 above and further in view of Zetter et al., (US 20130028885), for reasons of record set forth in the office action of 4/16/2025.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10358647, for reasons of record set forth in the office action of 4/16/2025. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10358647 as applied to claims 1-8 above and further in view of Zetter et al., (US 20130028885), for reasons of record set forth in the office action of 4/16/2025.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 87, 88, and 89 of copending Application No. 18/298900 (reference application), for reasons of record set forth in the office action of 4/16/2025. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 9 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 87, 88, and 89 of copending Application No. 18/298900 as applied to claims 1-8 above and further in view of Zetter et al., (US 20130028885), for reasons of record set forth in the office action of 4/16/2025.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive. The only argument presented by the applicants is that none of the cited U.S. patents and applications (US 10,792,299, 11,390,871, 11,045,488 and 11,708,575, and U.S. Application No. 18/298,900) include the limitation of claim 1 that the antisense strand contains deoxynucleotides in a plurality of positions, the plurality of positions being one of the following:
each of positions 4, 6 and 8, from the 5’ end of the antisense strand;
each of positions 3, 5 and 7, from the 5’ end of the antisense strand;
each of positions 1, 3, 5 and 7, from the 5’ end of the antisense strand;
each of positions 3-8, from the 5’ end of the antisense strand; or
each of positions 5-8, from the 5’ end of the antisense strand. Furthermore, the applicants argue that as to U.S. Pat. No. 10,358,647, none of the cited claims of the ‘647 Patent include GST-2 as recited in pending Claim 1.
Applicants are advised to review each of the rejections (in the FAOM of 4/16/2025, page 4) in entirety. For example, rejection of claims over claims of US Patent 10792299 (page 4) states:
The ‘299 patent claimed RNAi molecules directed against GST-pi, and methods of using the RNAi molecules to treat sarcoma or carcinoma, wherein the RNAi molecule strands were 21 nucleotides in length with 19 contiguous nucleotides of duplexed strands, the antisense strand comprised 19 contiguous nucleotides of complementarity to GST-pi mRNA, and the antisense strand comprised 3 deoxynucleotides at position 4, 6, and 8 from the 5’-end. The antisense strand further comprised 2’-F and 2’-OMe modifications within the duplexed region. See e.g. claims 2, 6, 7, 17, and 19. The RNAi molecules were comprised in pharmaceutical compositions comprising excipients such as lipid compounds or lipid nanoparticles (claims 4, 5). Thus the ‘299 claims account for all of the instant claims.
It is reiterated that claims 2, 6, 7, 17 and 19 of US Patent 10792299 teach the claimed limitation.
Similarly, dependent claims of each of the cited patents and patent application(s) recite the limitations of the instant applications as was discussed in each rejection in the office action of 4/16/2025.
Accordingly, all the double patenting rejections are maintained for reasons of record set forth in the office action of 4/16/2025.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAM R SHUKLA whose telephone number is (571)272-0735. The examiner can normally be reached Mon-Fri 9 AM - 6 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Sullivan can be reached at 571-272-09000. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAM R. SHUKLA
Supervisory Patent Examiner
Art Unit 1635
/RAM R SHUKLA/Supervisory Patent Examiner, Art Unit 1635