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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 03/09/2026 has been entered.
Priority
The instant application claims domestic benefit to US provisional application no. 63/158,338 filed on 03/08/2021.
Status of the Claims
The claim amendments and remarks filed on 03/09/2026 is acknowledged. Claims 17-18 are amended. Claims 1-16 are cancelled. Claims 21-25 are newly added.
Accordingly, claims 17-25 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
Applicant’s disclosure of nucleotide and/or amino acid sequences is now in compliance because the specification filed on 03/09/2026 now recites the size of the text file in bytes. Furthermore, after reconsideration, Applicant has disclosed SEQ ID NO: 273 in the sequence file as well as in the originally filed specification.
The 35 USC 112(a) rejection over claims 12-20 is withdrawn because independent claim 17 now recites “A” group as an antisense strand or sense strand of siRNA. Furthermore, claims 12-16 are now cancelled.
The cancellation of claims 12-16 renders the previous 35 USC 103 rejections over these claims moot.
The 35 USC 103 rejection over WO2020191183 in view of US20230113556 for claim 17 is withdrawn because claim 17 previously recited several conjugate species, however claim 17 now only recites one conjugate species, which has narrowed the scope of the claims and requires further search and consideration.
The 35 USC 103 rejection over US20160122761 in view of Lukhtanov and Sharma for claims 18-19 is withdrawn because this rejection relied on teaching a conjugate of claim 12, however claims 18-19 now recite a conjugate of claim 17.
The 35 USC 103 rejection over US20160122761 in view of Lukhtanov, Sharma, and Javanbakht for claim 20 is withdrawn because this rejection relied on teaching a conjugate of claim 12, however claims 18-19 now recite a conjugate of claim 17.
The nonstatutory double patenting rejections over US’927 is withdrawn in view of claims 12-16 being cancelled. Furthermore, in regards to claims 18-20, these rejections relied on teaching a conjugate of claim 12, however claims 18-20 now recite a conjugate of claim 17. Lastly, in regards to claim 17, claim 17 previously recited several conjugate species, however claim 17 now only recites one conjugate species, which has narrowed the scope of the claims and requires further search and consideration.
The following grounds of rejection are new as necessitated by Applicant’s amendments.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 17-19 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020191183 (in PTO-892 dated 03/19/2025) in view of US20230113556A1 (in PTO-892 dated 12/09/2025 and effective filing date of 03/26/2020).
WO’183 teaches the following GalNAc-oligonucleotide conjugate structure in claim 16 of ‘183 as shown below:
PNG
media_image1.png
775
1400
media_image1.png
Greyscale
wherein X and Y can be oxygen (O) (page 5 line 4). Here, the tri-GalNAc moiety group of WO’183 contains three GalNAc that are linked to a phenolic branching moiety through three linkerA spacer groups (page 2 lines 1-5) as well as a linkerB that functions as a spacer between the tri-GalNAc moiety and the phosphate / oligonucleotide (page 2 lines 4-5).
The recited linkerA and linkerB groups can be selected from several linking structures recited in claims 18-24 of WO‘183 such as an alkyl group (claims 18 and 20). WO’183 further discloses that the alkyl group can be 1-20 carbons (page 16 lines 5-10). WO’183 discloses pharmaceutical compositions comprising the conjugates and a pharmaceutically acceptable carrier (page 49 lines 8-15).
WO’183 further teaches that the multivalent GalNAc moiety has significantly higher binding affinity to asialoglycoprotein receptor (ASGPR) than individual GalNAc ligands and, thus, higher efficiency in delivering therapeutic oligonucleotides into liver (see page 1 lines 15-25). WO’183 discloses that the oligonucleotides can be single-stranded antisense oligonucleotides and others, and further discloses that the sequence of their oligonucleotide can be complementary to a coding sequence in an expressed target nucleic acid or target gene within a cell (page 14 lines 1-10). WO’183 discloses that their compositions can be administered to human subjects, and that their conjugate is capable of contacting a cell such as a liver cell expressing a target gene, and that the expression of the target gene in the cell and/or subject is associated with a disease or condition and reducing expression of the target gene treats the disease or condition (page 11 lines 15-25).
The difference between WO’183 and the claimed invention is that WO’183 does not disclose the recited tri-GalNAc phosphodiester branching moiety shown in instant claim 17.
US’556 teaches an oligonucleotide conjugate in which the antisense oligomer is bound with a molecule capable of binding to an asialoglycoprotein (ASGP) receptor (see Abstract).
US’556 teaches the ASGP receptor binding molecule can be GalNAc (paragraph 0084) and teaches the following compound B1 tri-GalNAc-oligonucleotide conjugate structure shown below (paragraph 0088):
PNG
media_image2.png
886
1875
media_image2.png
Greyscale
Here, compound B1 contains the same tri-GalNAc phosphodiester branching moiety shown in instant claim 17.
US’556 further teaches that APOC3 protein is a protein expressed primarily in hepatocytes, and efficient antisense delivery to the liver permits still lower doses, and further teaches that the activity of the antisense nucleic acid in the liver can be enhanced 10-fold or more by conjugating GalNAc to an antisense nucleic acid as a ligand for the ASGP receptor, which is a receptor specifically expressed in hepatocytes (paragraph 0085).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the GalNAc conjugate of WO’183 by selecting 1-20 carbon alkyl group for the linkerA and linkerB group and further substitute the phenolic branching moiety group) of WO’183 with the phosphodiester branching moiety of US’556 to arrive at the claimed invention.
One of ordinary skill in the art would have chosen from a finite number of identified, predictable solutions of a 1-20 carbon alkyl group for linkerA linkerB with a reasonable expectation of success because WO’183 discloses that linkerA and linkerB can be selected from several linking structures including an alkyl group that can be 1-20 carbons. Furthermore, the 1-20 carbon alkyl group of WO’183 overlaps in the number of carbons with the shown alkyl linking groups for the tri-GalNAc in instant claims 21-22 as well the C6 spacer group of the instant claims, rendering them obvious. See MPEP 2144.05 I.
One of ordinary skill in the art would have substituted one known element (the phenolic moiety branching group of WO’183) for another (the phosphodiester branching moiety of US’556) to obtain predictable results because both tri-branching moieties have the same known use in tri-GalNAc oligonucleotide conjugates to enhance the delivery of therapeutic oligonucleotides to the hepatocytes of the liver, and both branching moieties are attaching the same tri-GalNAc compounds through an oxygen group on the moiety.
Claims 20 and 25 are rejected under 35 U.S.C. 103 as being unpatentable WO 2020191183 (in PTO-892 dated 03/19/2025) in view of US20230113556A1 (in PTO-892 dated 12/09/2025 and effective filing date of 03/26/2020), as applied to claims 17-19 and 22-24 above, and further in view of Meike et al. (The Lancet, 2017 in PTO-892).
The combined teachings of WO’183 and US’556 are as described above and teach the method of instant claims 19 and 24 as discussed above.
The combined references, however, do not teach wherein the disease is an RNA dependent viral infection.
Meike discloses the use of RG-101, a hepatocyte targeted N-acetylgalactosamine conjugated oligonucleotide that antagonises miR-122, in patients with chronic hepatitis C virus (HCV) infection (Abstract). Meike discloses that HCV is an enveloped, single-stranded RNA virus of the Flaviviridae family (first paragraph left column page 709), which meets the limitation of an RNA-dependent viral infection. Meike discloses that RG-101 is a mixed chemistry phosphorothioate oligonucleotide inhibitor of miR-122 that is linked to a multivalent N-acetylgalactosamine carbohydrate structure designed to enhance uptake of the oligonucleotide by hepatocytes through binding to the asialoglycoprotein receptor on hepatocytes and further discloses that conjugation to the N-acetylgalactosamine structure increases the potency of RG-101 by up to 10–20 times compared with the non-conjugated oligonucleotide )last paragraph left column page 710). Meike discloses that one administration of 2 mg/kg or 4 mg/kg RG-101 was well tolerated and resulted in substantial viral load reduction in all treated patients within 4 weeks, and sustained virological response in three patients for 76 weeks (Abstract).
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the oligonucleotide in the modified conjugate as disclosed by the combined teachings of WO’183 and US’556 described above with the anti-miR-122 oligonucleotide of Meike to treat chronic hepatitis C infection as disclosed in Meike.
One of ordinary skill in the would have substituted one known element (oligonucleotide) with another (anti-miR-122 oligonucleotide) to obtain predictable results because both the combined references described above and Javanbakht et al. disclose GalNAc conjugates that has the same mechanism (enhanced uptake of antisense strands into hepatocytes), and Meike provides further guidance to use these types of conjugates for the treatment of chronic hepatitis C infection.
Response to Arguments
Applicant’s arguments filed on 03/09/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that neither WO’183 nor US’556 teach or suggest the claimed conjugates. However, the new rejection over WO’183 in view of US’556 addresses and makes obvious the recited conjugates as described above.
Furthermore, it is noted that the instant specification has been considered for unexpected results. Here, Applicant has demonstrated in Example 7 (page 49) of the instant specification that GalNAc-oligonucleotide conjugates with the C6 spacer shown in instant claim 17 had superior activity over GalNAc-oligonucleotide conjugates without the C6 spacer. Here, as demonstrated in FIG. 1A, Applicant provides data that the B003 conjugate that contained a C6 spacer reduced ApoB levels in mice greater than a B001 conjugate that did not contain the C6 spacer. Applicant provides the structure of B003 in FIG. 1C, and provides further comparisons of the B003 conjugate to other conjugates with the additional spacer. Here, Applicant demonstrates in FIG. 1B that the B003 conjugate was comparable to a positive control B005 (another conjugate with a spacer, structure provided in Example 10 page 54), and further demonstrates in FIG. 2D that B009 (the recited compound in instant claim 17, see Table on page 45) also had comparable activity to the positive control B005.
While Applicant has provided evidence that the C6 spacer feature in the conjugate has superior activity over a conjugate without the C6 spacer, Applicant has not provided a sufficient comparison to the closest prior arts to rebut a prima facie case of obviousness as stated in MPEP 716.02(e).
Here, the closest prior arts are WO’183 and US’556. As stated in MPEP 716.02(e) II, “Showing unexpected results over one of two equally close prior art references will not rebut prima facie obviousness unless the teachings of the prior art references are sufficiently similar to each other that the testing of one showing unexpected results would provide the same information as to the other.” Here, WO’183discloses GalNAc conjugates that have a tri-GalNAc phenolic branching moiety as well as an additional spacer (linkerB) as described above, and US’556 discloses GalNAc conjugates that have the recited phosphodiester branching moiety but does not disclose an additional spacer group. Therefore, the showing of unexpected results must be provided over both prior arts as WO’183 and US’556 disclose different structural features that are not similar to one another in the GalNAc conjugate.
In regards to the showing of unexpected results over WO’183, while Applicant has provided several conjugate comparisons including the positive control B005 conjugate, Applicant has not provided comparisons to conjugate structures that are representative to the conjugates disclosed in WO’183. Here, it is also noted that Applicant discloses two phenolic moiety-based conjugates on page 48 (first and third conjugate) of the instant specification. These two conjugates appear to be representative of the conjugate structures disclosed in WO’183, however Applicant has not provided these comparisons to the claimed B009 conjugate.
In regards to the showing of unexpected results over US’556, while Applicant has provided a comparison to a B001 conjugate that did not have the recited C6 spacer, Applicant has not provided the structure of the B001 conjugate, making it difficult to ascertain if the B001 conjugate is representative of the phosphodiester branching moiety disclosed in US’556.
Therefore, Applicant has not provided sufficient evidence to rebut the prima facie obviousness over the closest prior arts (WO’183 and US’556).
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 17-19 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 7-12 of U.S. Patent No. 11,597,927 (referred to as ‘927) in view of WO 2020191183 (in PTO-892 dated 03/19/2025) and US20230113556A1 (in PTO-892 dated 12/09/2025 and effective filing date of 03/26/2020).
Claim 11 of ‘927 recites the following GalNAc compound:
PNG
media_image3.png
789
1827
media_image3.png
Greyscale
Furthermore, claim 7 of ’927 recites “oligonucleotides of the plurality each independently comprise a target moiety (RCD)”, and claim 9 of ‘927 recites “wherein RCD is connected to the oligonucleotide or oligonucleotides through a linker.” Claim 12 of ‘927 recites a method for treating various listed liver disease by administering a therapeutically effective amount of their composition.
The claims of ‘927 differ from that of the instantly claimed invention in that ‘927 does not recite the conjugate shown in instant claim 17.
The independent teachings of WO’183 and US’556 are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the GalNAc conjugate recited in ‘927 by substituting the alkyl linker - oligonucleotide (to the right of the GalNac branching moiety) with the 1-20 carbon alkyl linker – phosphate – oligonucleotide structure disclosed in WO’183 and further substitute the branching moiety group of ‘927 with the phosphodiester branching moiety of US’556 as well as further substitute the alkyl amide linking groups in ‘927 with the 1-20 carbon alkyl linking group disclosed in WO’183 to arrive at the claimed invention.
One of ordinary skill in the art would have substituted one known element (the alkyl linker - oligonucleotide of ‘927) for another (the 1-20 carbon alkyl linker – phosphate – oligonucleotide structure of WO’183) to obtain predictable results because WO’183 discloses a linkerB, which is in the same position as the alkyl linker in the ‘927 conjugate, that can be selected from several linking structures including an alkyl group that can be 1-20 carbons, and further discloses the oligonucleotide can be linked to the alkyl linker with a phosphate end. Furthermore, the 1-20 carbon alkyl group of WO’183 overlaps in the number of carbons with the shown C6 spacer group of the instant claims, rendering the C6 spacer group obvious. See MPEP 2144.05 I.
One of ordinary skill in the art would have substituted one known element (the branchingmoiety group of ‘927) for another (the phosphodiester branching moiety of US’556) to obtain predictable results because both tri-GalNAc moieties have the same known use in tri-GalNAc oligonucleotide conjugates to enhance the delivery of therapeutic oligonucleotides to the hepatocytes of the liver, and both branching moieties are attaching the same tri-GalNAc compounds through an oxygen group on the moiety.
One of ordinary skill in the would have substituted one known element (alkyl amide linking groups disclosed in ‘927) with another (1-20 carbon alkyl linking group disclosed in WO’183) to obtain predictable results because both linking groups have the same known use of linking the tri-GalNAc to a branching moiety. Furthermore, the 1-20 carbon alkyl linking group of WO’183 overlaps in the number of carbons with the shown alkyl groups of instant claims 21-22, rendering these alkyl linking groups obvious. See MPEP 2144.05 I.
In regards to instant claims 18 and 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have formulated the modified conjugate described above into a pharmaceutical composition with a pharmaceutically acceptable carrier as disclosed in WO’183. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because WO’183 provides guidance that these GalNAc-oligonucleotide conjugate can be formed in the pharmaceutical compositions with pharmaceutically acceptable carriers.
Claims 17-20 and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 7-12 of U.S. Patent No. 11,597,927 (referred to as ‘927) (in PTO-892 dated 03/19/2025) in view of WO 2020191183 (in PTO-892 dated 03/19/2025), US20230113556A1 (in PTO-892 dated 12/09/2025 and effective filing date of 03/26/2020), and Meike et al. (The Lancet, 2017 in PTO-892).
The combination of the claims of ‘927 and the teachings of WO’183 and US’556 are as described above and teach methods of instant claims 19 and 24 as discussed above.
The combinations, however, do not recite wherein the disease is an RNA-dependent viral infection.
The teachings of Meike are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the oligonucleotide in the modified conjugate as disclosed by the combination of the claims of ‘823 and the teachings of WO’183 and US’556 described above with the anti-miR-122 oligonucleotide of Meike to treat chronic hepatitis C infection as disclosed in Meike.
One of ordinary skill in the would have substituted one known element (oligonucleotide) with another (anti-miR-122 oligonucleotide) to obtain predictable results because both the combined references described above and Javanbakht et al. disclose GalNAc conjugates that has the same mechanism (enhanced uptake of antisense strands into hepatocytes), and Meike provides further guidance to use these types of conjugates for the treatment of chronic hepatitis C infection.
Claims 17-19 and 21-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 86-104 of copending Application No. 18/178,470 (‘470) in view of WO 2020191183 (in PTO-892 dated 03/19/2025) and US20230113556A1 (in PTO-892 dated 12/09/2025 and effective filing date of 03/26/2020).
Claim 86 of ‘470 recites a composition comprising oligonucleotides and further recites in claim 96 of ‘470 that composition has the following linked GalNAc structure to the oligonucleotide below:
PNG
media_image4.png
250
615
media_image4.png
Greyscale
Claims 102-104 of ‘470 recite a method of treating several liver diseases as well as reducing expression from a mutant PNPLA3 allele by administering their compositions
The claims of ‘470 differ from that of the instantly claimed invention in that ‘470 does not recite the conjugate shown in instant claim 17.
The independent teachings of WO’183 and US’556 are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the GalNAc conjugate recited in ‘470 by substituting the alkyl linker - oligonucleotide (to the right of the GalNac branching moiety) with the 1-20 carbon alkyl linker – phosphate – oligonucleotide structure disclosed in WO’183 and further substitute the branching moiety group of ‘470 with the phosphodiester branching moiety of US’556 as well as further substitute the alkyl amide linking groups in ‘470 with the 1-20 carbon alkyl linking group disclosed in WO’183 to arrive at the claimed invention.
One of ordinary skill in the art would have substituted one known element (the alkyl linker - oligonucleotide of ‘470) for another (the 1-20 carbon alkyl linker – phosphate – oligonucleotide structure of WO’183) to obtain predictable results because WO’183 discloses a linkerB, which is in the same position as the alkyl linker in the ‘470 conjugate, that can be selected from several linking structures including an alkyl group that can be 1-20 carbons, and further discloses the oligonucleotide can be linked to the alkyl linker with a phosphate end. Furthermore, the 1-20 carbon alkyl group of WO’183 overlaps in the number of carbons with the shown C6 spacer group of the instant claims, rendering the C6 spacer group obvious. See MPEP 2144.05 I.
One of ordinary skill in the art would have substituted one known element (the branching moiety group of ‘470) for another (the phosphodiester branching moiety of US’556) to obtain predictable results because both tri-GalNAc moieties have the same known use in tri-GalNAc oligonucleotide conjugates to enhance the delivery of therapeutic oligonucleotides to the hepatocytes of the liver, and both branching moieties are attaching the same tri-GalNAc compounds through an oxygen group on the moiety.
One of ordinary skill in the would have substituted one known element (alkyl amide linking groups disclosed in ‘470) with another (1-20 carbon alkyl linking group disclosed in WO’183) to obtain predictable results because both linking groups have the same known use of linking the tri-GalNAc to a branching moiety. Furthermore, the 1-20 carbon alkyl linking group of WO’183 overlaps in the number of carbons with the shown alkyl groups of instant claims 21-22, rendering these alkyl linking groups obvious. See MPEP 2144.05 I.
In regards to instant claims 18 and 23, it would have been prima facie obvious before the effective filing date of the claimed invention to have formulated the modified conjugate described above into a pharmaceutical composition with a pharmaceutically acceptable carrier as disclosed in WO’183. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because WO’183 provides guidance that these GalNAc-oligonucleotide conjugate can be formed in the pharmaceutical compositions with pharmaceutically acceptable carriers.
This is a provisional nonstatutory double patenting rejection.
Claims 17-19 and 21-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 86-104 of copending Application No. 18/178,470 (‘470) in view of WO 2020191183 (in PTO-892 dated 03/19/2025), US20230113556A1 (in PTO-892 dated 12/09/2025 and effective filing date of 03/26/2020), and Meike et al. (The Lancet, 2017 in PTO-892).
The combination of the claims of ‘470 and the teachings of WO’183 and US’556 are as described above and teach methods of instant claims 19 and 24 as discussed above.
The combinations, however, do not recite wherein the disease is an RNA-dependent viral infection.
The teachings of Meike are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the oligonucleotide in the modified conjugate as disclosed by the combination of the claims of ‘470 and the teachings of WO’183 and US’556 described above with the anti-miR-122 oligonucleotide of Meike to treat chronic hepatitis C infection as disclosed in Meike.
One of ordinary skill in the would have substituted one known element (oligonucleotide) with another (anti-miR-122 oligonucleotide) to obtain predictable results because both the combined references described above and Javanbakht et al. disclose GalNAc conjugates that has the same mechanism (enhanced uptake of antisense strands into hepatocytes), and Meike provides further guidance to use these types of conjugates for the treatment of chronic hepatitis C infection.
Response to Arguments
Applicant’s arguments filed on 03/09/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states the nonstatutory double patenting rejections should be withdrawn in view of the same reasons discussed above for the prior art rejections.
Because the reasons to withdraw the prior art rejections were not found persuasive as discussed above, the nonstatutory double patenting rejections are maintained.
Conclusion
No claim is found allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H CHO whose telephone number is (571)270-0691. The examiner can normally be reached M-F 8AM-5PM.
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.
/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
Prosecution Insights