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
This application, filed October 5, 2022, claims the benefit of U.S. provisional application 63/229628, filed October 5, 2021.
Status of the Application
Applicant’s communication, received September 17, 2025, wherein claims 4 and 38-41` are amended, claims 2, 9-11, 16, 17, and 35 are canceled, and new claims 44-49 are added, is acknowledged.
Claims 4, 12-15, 18-21, 38-41, and 44-49 are pending and examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, received September 17, 2025, with respect to the rejection of claim 41 under 35 USC § 112(a) for lacking enablement for a method of treating or preventing a disease in a subject in need thereof has been fully considered and found to be persuasive to remove the rejection because claim 41 is amended to require remove this limitation. Therefore the rejection is withdrawn.
Applicant’s amendment, received September 17, 2025, with respect to the rejection of claims 2, 4, 9, 12, 17-21, and 39-41 under 35 USC § 103 as being unpatentable over Huang in view of Rajeev has been fully considered and found to be persuasive to remove the rejection because claims 2, 9, and 17 are canceled and independent claim 4 is amended to require the specific structures shown in the claim, which the combination of Huang and Rajeev does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received September 17, 2025, with respect to the rejection of claims Claim 4, 9, 12, 17-21, and 39-41 under 35 USC § 103 as being unpatentable over Heyes in view of Rajeev has been fully considered and found to be persuasive to remove the rejection because claims 9 and 17 are canceled and independent claim 4 is amended to require the specific structures shown in the claim, which the combination of Heyes and Rajeev does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received September 17, 2025, with respect to the rejection of claims 4, 9, and 12-18 under 35 USC § 103 as being unpatentable over Huang in view of Rajeev and Damha has been fully considered and found to be persuasive to remove the rejection because claims 9 and 17 are canceled and independent claim 4 is amended to require the specific structures shown in the claim, which the combination of Huang in view of Rajeev and Damha does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received September 17, 2025, with respect to the rejection of claims 11 and 35 under 35 USC § 103 as being unpatentable over Huang in view of Rajeev and Rydzik has been fully considered and found to be persuasive to remove the rejection because claims 11 and 35 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received September 17, 2025, with respect to the rejection of claim 10 under 35 USC § 103 as being unpatentable over Huang in view of Rajeev, Rydzik, and Manoharan has been fully considered and found to be persuasive to remove the rejection because claim 10 is canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received September 17, 2025, with respect to the rejection of claim 38 under 35 USC § 103 as being unpatentable over Huang in view Rajeev and Wolfrum has been fully considered and found to be persuasive to remove the rejection because independent claim 4 is amended to require the specific structures shown in the claim, which the combination of Huang, Rajeev, and Wolfrum does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received September 17, 2025, with respect to the rejection of claim 38 under 35 USC § 103 as being unpatentable over Huang in view Rajeev and Ashley has been fully considered and found to be persuasive to remove the rejection because independent claim 4 is amended to require the specific structures shown in the claim, which the combination of Huang, Rajeev, and Ashley does not teach. Therefore the rejection is withdrawn.
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 4, 12-15, 18-21, and 38-41, and 44-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 12-19, 31, and 34-37 of co-pending U.S. patent application 17/881935 (reference patent, herein referred to as ‘935) in view of Huang.
The present application and ‘935 are each assigned to Sanegene Bio USA Inc.
The amended claims for ‘935 received May 27, 2025 are cited in this non-statutory double patenting rejection.
The present claim 4 claims a conjugate or a pharmaceutically acceptable salt thereof, wherein the conjugate comprises:
(i) one or more Nucleic Acid Agents; and
ii) one or more moieties selected from the structures shown in the claim.
These structures include:
PNG
media_image1.png
168
358
media_image1.png
Greyscale
(p. 1, first structure)
PNG
media_image2.png
166
359
media_image2.png
Greyscale
(p. 1, second structure)
PNG
media_image3.png
178
339
media_image3.png
Greyscale
(p. 1, third structure)
PNG
media_image4.png
182
344
media_image4.png
Greyscale
(p. 2, first structure)
PNG
media_image5.png
141
356
media_image5.png
Greyscale
(p. 2, second structure)
PNG
media_image6.png
138
358
media_image6.png
Greyscale
(p. 2, third structure)
These conjugates of present claim 4 are also recited in present claims 44-49.
Claim 4 of ‘935 recites a conjugate or a pharmaceutically acceptable salt thereof, wherein the conjugate comprises (i) one or more nucleic acid agents, (ii) one or more ligand, and (iii) one or more linker units with the structures as show. Claim 31 of ‘935 claims specific structures of conjugate 4, wherein the conjugate comprises a linker unit-ligand moiety selected from the structures therein, including the structures shown below. These structures are analogous to the structures from present claims 4 and 44-49 described above, except that they include a ribose group in place of the cyclopropyl group, and they include a 3-carbon linker between the ribose and amide.
PNG
media_image7.png
136
376
media_image7.png
Greyscale
PNG
media_image8.png
137
375
media_image8.png
Greyscale
PNG
media_image9.png
142
352
media_image9.png
Greyscale
PNG
media_image10.png
137
366
media_image10.png
Greyscale
PNG
media_image11.png
106
379
media_image11.png
Greyscale
The claims of ‘935 do not claim the exact structures of the moieties of present claim 4, specifically with respect to the cyclopropyl group of the presently claimed compounds and the specific linker structure of the presently claimed compounds that lack the 3 carbon linker between the cyclopentyl group and the amide group.
Huang teaches the cyclopropyl structures below that are used to anchor saccharides to nucleic acid groups for the purposes of enhancing nucleic acid delivery. As one example, Huang teaches the structure shown below (p. 40, third structure shown):
PNG
media_image12.png
170
432
media_image12.png
Greyscale
Huang also teaches a similar structure that has the cyclopentyl group substituted with a ribose group and also includes a 1 carbon linker between the ribose and amino groups (p. 40, fifth structure shown):
PNG
media_image13.png
159
429
media_image13.png
Greyscale
It would therefore have been prima facie obvious to one of ordinary skill in the art to substitute the ribose group for a cyclopentyl group in view of Huang teaching structurally similar, cyclopropyl-based groups used to link GalNAc ligands to the 3′ terminus of a nucleic acid. Moreover, it would have been obvious to one of ordinary skill in the art to substitute the 3 carbon linker between the recited in the claims of ‘935 with a bond, such that the amino group is directly attached to the cyclopentyl group, given the structures above disclosed by Huang that include both 1 carbon linkers and linkers attached directly to a core cyclopropyl group, because in view of Huang’s disclosure, these compounds are each effective for conjugating GalNAc ligands to a nucleic acid.
Regarding the sixth structure recited in present claim 4, this appears to be a broader recitation of the first structure shown in the claim. The sixth structure does not require the phosphate group, but attachment to the one or more nucleic acid agents via a phosphate group would reasonably fall within the scope of this conjugate. Accordingly, the sixth structure of claim 4 is also obvious over the claims of ‘935 in view of Huang.
The present claim 12 requires Y as H, claim 13 requires Y as C1-C6 alkyl optionally substituted with one or more halogen, claim 14 requires Y as one of the phosphate-containing groups listed, and claim 15 requires Y as a hydroxy protecting group.
Claim 12 of ‘935 depends from claim 4 and requires Y as H, claim 13 requires Y as C1-C6 alkyl optionally substituted with one or more halogen, claim 14 requires Y as one of the phosphate-containing groups listed, and claim 15 requires Y as a hydroxy protecting group.
The present claim 18 depends from claim 4 and requires Z as H, claim 19 requires Z as C1-C6 alkyl optionally substituted with one or more halogen, claim 20 requires Z one of the phosphate-containing groups listed, and claim 21 requires Z as a hydroxy protecting group.
Claim 16 of ‘935 requires Z as H, claim 17 requires Z as C1-C6 alkyl optionally substituted with one or more halogen, claim 18 requires Z one of the phosphate-containing groups listed, and claim 19 requires Z as a hydroxy protecting group.
The present claim 38 requires the ligand comprises a lipid, a peptide moiety, or an antibody moiety, claim 39 requires the Nucleic Acid Agent independently comprises an oligonucleotide, claim 40 claims a pharmaceutical composition comprising the conjugate of claim 4 and at least one pharmaceutically acceptable excipient or carrier, and claim 41 claims a method of reducing the expression of a target gene in a subject or delivering a Nucleic Acid Agent to a subject, comprising administering to the subject the conjugate of claim 4.
Claim 34 of ‘935 claims the ligand comprises a lipid, a peptide moiety, or an antibody moiety, claim 35 requires the Nucleic Acid Agent comprises an oligonucleotide, claim 36 claims a pharmaceutical composition comprising the conjugate of claim 4, and claim 37 claims a method of modulating the expression of a target gene in a subject, delivering a Nucleic Acid Agent to a subject, or treating or preventing a disease in a subject in need thereof, comprising administering to the subject the conjugate of claim 4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented. However, a Notice of Allowance has been mailed in ‘935, and upon issue of the corresponding patent, this provisional nonstatutory double patenting rejection will become a become a nonstatutory double patenting rejection.
Response to Applicant’s arguments: Applicant requests that the rejection of claims 4, 12-15, 18-21, and 38-41 be held in abeyance until otherwise allowable patentable subject matter has been identified in the instant application.
The above non-statutory double patenting rejection is updated to reflect amendments to the claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN BRANDSEN whose telephone number is (703)756-4780. The examiner can normally be reached Monday - Friday from 9:00 am to 5:00 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, Scarlett Goon can be reached at (571)270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.M.B./Examiner, Art Unit 1693
/ERIC OLSON/Primary Examiner, Art Unit 1693