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 .
Detailed Action
This office action is a response to applicant’s communication submitted March 13, 2026, wherein claim 159 is amended and new claims 172-174 are introduced. This application is a continuation of US application 16/092685, now US patent 11896672, filed October 10, 2018, which is a national stage application of PCT/CA2017/050447, which claims benefit of provisional applications 62/438310, filed December 22, 2016, 62/417156, filed November 3, 3016, and 62/321034, filed April 11, 2016.
Claims 159-174 are pending in this application.
Claims 159-174 as amended are examined on the merits herein.
Withdrawn rejections
The rejection of claims 159-171 under 35 USC 112(a) for reciting the indefinite variable “saccharide,” has been fully considered and found to be persuasive to remove the rejection as base claim 159 has been amended to specifically define the saccharide. Therefore the rejection nis withdrawn.
The provisional rejection of claims 159-167, and 169-171 on the ground of nonstatutory double patenting as being unpatentable over claims 24, 29, 30, and 33-35 of copending Application No. 17/782901 is withdrawn in view of the letter of express abandonment of record in ‘901.
The provisional rejection of claims 159-167, and 169-171 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, and 14-18 of copending Application No. 17/770504 is withdrawn in view of the abandonment of ‘504.
Applicant’s amendment, submitted March 13, 2026, with respect to the rejection of Claims 159-161, 164-167, and 169-171 for claiming the same invention as claims 49, 57, 58, 60, and 61 of copending Application No. 18/851013, has been fully considered and found to be persuasive to remove the rejection as the claims have been amended to require that the saccharide be some form of aminosugar. Therefore the rejection is withdrawn.
The following rejections of record in the previous action are maintained:
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 159-161, 165-167, and 169-174 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, and 5 of U.S. Patent No. 11896672. (Cited in 3/25/2024 PTO-1449, herein referred to as ‘672) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘672 anticipate the present claims. Specifically, claim 1 of ‘672 claims a compound having the same structure
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recited in present claim 159. Furthermore Q is defined as -L1R1 wherein L1 is selected from a number of options falling within the generic definition of L1 in present claim 1. R1 is furthermore defined as having the same tetravalent structure
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recited in present claim 159, wherein B1 is further defined as CH as recited in present claims 160 and 161, and B2 as one of a number of structures falling within present claims 169. Two of these structures also have a phenyl ring at the branch point and therefore would fall within claims 165-167. For these reasons claim 1 of ‘672 anticipates present claims 169-161, 165-167, and 169. Furthermore claims 4 and 5 of ‘672 claim pharmaceutical compositions and methods of delivering siRNA to the liver utilizing these compounds, thereby anticipating present claims 170 and 171. Regarding present clams 172-174, these claims are anticipated by the N-acetylgalactosamine embodiment recited in claim 3 of ‘672
Claims 159-161, 164-167, 169-170, and 172-174 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 11427823. (Cited in 3/25/2024 PTO-1449, herein referred to as ‘823) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘823 anticipate the present claims. Specifically, claim 1 of ‘823 claims a compound having the structure
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. This compound falls within the scope of the structural formulae in present claim 159, as well as containing branch points corresponding to B1, B2, and B3 which meet the requirements of dependent claims 164 and 169. Furthermore the specific branch point corresponding to B1 can be interpreted as being simply the CH portion of the structure, with the rest of the atoms between this CH being part of the linking groups T1 and T2, thereby anticipating present claims 160-161. Claim 9 claims a pharmaceutical composition comprising this compound. Therefore the claims of ‘823 anticipate the present claims. Regarding present clams 172-174, these claims are anticipated by the N-acetylgalactosamine structure appearing in claim 1 of ‘823
Claims 159-161, 164-167, and 169-174 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 4 of U.S. Patent No. 12043833. (Cited in PTO-892, herein referred to as ‘833) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘833 anticipate the present claims. Specifically, claim 1 of ‘833 claims a compound having the structure
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. This compound falls within the scope of the structural formulae in present claim 159, as well as containing branch points corresponding to B1, B2, and B3 which meet the requirements of dependent claims 164 and 169. Furthermore the specific branch point corresponding to B1 can be interpreted as being simply the CH portion of the structure, with the rest of the atoms between this CH being part of the linking groups T1 and T2, thereby anticipating present claims 160-161. Claim 3 claims a pharmaceutical composition comprising this compound, anticipating present claim 170. Furthermore claim 4 of ‘833 claims a method of delivering siRNA to the liver utilizing this compounds, thereby anticipating present claim 171. Therefore the claims of ‘933 anticipate the present claims. Regarding present clams 172-174, these claims are anticipated by the N-acetylgalactosamine structure appearing in claim 1 of ‘833.
Claims 159-167, and 169-174 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 30, 64, 90, 105, 120, and 168 of copending Application No. 17/290549 (reference application, US pre-grant publication 2022/0051847, of record in previous action, herein referred to as ‘504) in view of Manoharan et al. (US pre-grant publication 2009/0239814, cited in PTO-1449)
Claim 1 of ‘549 claims a method for delivering a nucleic caid to a cell utilizing a nucleic acid conjugate. Claim 30 further defines the conjugate as having a structure
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wherein R2 is a nucleic acid molecule. Claim 64 of ‘549 defines the group R1 as
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similar to present claim 159. Claims 90, 105, 120, and 168 further define the branch points in a manner consistent with present claims 160-167 and 169. In particular the specific branch point corresponding to B1 in many of these structures such as
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can be interpreted as being simply the CH portion of the structure, with the rest of the atoms between this CH being part of the linking groups T1 and T2, thereby anticipating present claims 160-161.
While the claims of ‘549 do not specifically define the nucleic acid as an siRNA or the target as the liver, Manoharan et al. describes conjugates of an iRNA molecule, which is a double stranded RNA equivalent to a siRNA, to one or more targeting agents. (p. 3 paragraph 16) These conjugates are used to target cells (e.g. the liver) similarly to the conjugates claimed by ‘549. (p. 2 paragraph 17) It would have been obvious to one of ordinary skill in the art at the time of the invention to use the conjugates described by ‘549 for delivering double stranded inhibitory siRNAs to liver cells, in view of the disclosure by Manoharan et al. suggesting using similar conjugates for this specific purpose.
Regarding present claim 170, while none of the claims of ‘549 do not refer specifically to a pharmaceutically acceptable carrier, the recitation of methods of delivering these compounds to a cell would have motivated one of ordinary skill in the art to prepare the claimed compounds as pharmaceutical compositions comprising a carrier, in order to carry out said methods, thereby rendering claim 170 obvious. Regarding present clams 172-174, these claims are anticipated by the N-acetylgalactosamine structure appearing in claim 168 of ‘549.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 159-167, and 169-174 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 196, 197, 199, and 209-211 of copending Application No. 18/734444. (reference application, US pre-grant publication 2025/0179496, of record in previous action, herein referred to as ‘444). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘444 anticipate the present claims.
Claims 196 and 197 of ‘444 claim a compound
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wherein R2 is a siRNA molecule similar to present claim 159. Claim 199 further defines this compound as one of a number of tetravalent conjugates having branch points as recited in present claims 160-167 and 169. In particular the specific branch point corresponding to B1 in many of these structures such as
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can be interpreted as being simply the CH portion of the structure, with the rest of the atoms between this CH being part of the linking groups T1 and T2, thereby anticipating present claims 160-161. Still further dependent claim 209 of ‘444 claims a pharmaceutical composition comprising this compound and a pharmaceutical carrier, and claim 211 of ’444 claims a method of delivering siRNA to the liver using this compound. Regarding present clams 172-174, these claims are anticipated by the N-acetylgalactosamine structure appearing in claim 199 of ‘144.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 159-161, 164-167, and 169-174 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 56 of copending Application No. 17/440480. (reference application, US pre-grant publication 2022/0168430, of record in previous action, herein referred to as ‘480). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘480 anticipate the present claims.
Claim 56 of ‘480 claims a method of treating a subject using a conjugate
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. This structure falls within the scope of structures recited in present claim 159 and has branch points as recited in present claims 160-16, 164-167 and 169. In particular the specific branch point corresponding to B1 in this structure can be interpreted as being simply the CH portion of the structure, with the rest of the atoms between this CH being part of the linking groups T1 and T2, thereby anticipating present claims 160-161. Still further the method claimed by claim 56 of ‘480 is a method of treating a liver disease which would necessitate delivering siRNA to the liver using this compound as recited in present claim 171.
Regarding present claim 170, while none of the claims of ‘480 do not refer specifically to a pharmaceutically acceptable carrier, the recitation of methods of using these compounds to treat disease would have motivated one of ordinary skill in the art to prepare the claimed compounds as pharmaceutical compositions comprising a carrier, in order to carry out said methods, thereby rendering claim 170 obvious. Regarding present clams 172-174, these claims are anticipated by the N-acetylgalactosamine structure appearing in claim 56 of ‘480.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 159-161, 164-167, and 169-174 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35, 50, and 52 of copending Application No. 17/787089. (reference application, US pre-grant publication 2023/0113948, of record in previous action, herein referred to as ‘089). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘089 anticipate the present claims.
Claims 35 and 50 of ‘089 claim a method of making a conjugate
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. This structure falls within the scope of structures recited in present claim 159 and has branch points as recited in present claims 160-16, 164-167 and 169. In particular the specific branch point corresponding to B1 in this structure can be interpreted as being simply the CH portion of the structure, with the rest of the atoms between this CH being part of the linking groups T1 and T2, thereby anticipating present claims 160-161. Still claim 52 of ‘089 claims a method of treating a liver disease which would necessitate delivering siRNA to the liver using this compound as recited in present claim 171.
Regarding present claim 170, while none of the claims of ‘089 do not refer specifically to a pharmaceutically acceptable carrier, the recitation of methods of using these compounds to treat disease would have motivated one of ordinary skill in the art to prepare the claimed compounds as pharmaceutical compositions comprising a carrier, in order to carry out said methods, thereby rendering claim 170 obvious. Regarding present clams 172-174, these claims are anticipated by the N-acetylgalactosamine structure appearing in claim 50 of ‘089.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 159-161, 164-167, and 169-171 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 160, 164, 167, and 168 of copending Application No. 18/035695. (reference application, US pre-grant publication 2024/0052349, of record in previous action, herein referred to as ‘695). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘695 anticipate the present claims.
Claim 160 of ‘695 claims a conjugate of the structure
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This is a conjugate structure as recited in present claim 159, having branch points as recited in present claims 160-167 and 169. In particular the specific branch point corresponding to B1 in this structure can be interpreted as being simply the CH portion of the structure, with the rest of the atoms between this CH being part of the linking groups T1 and T2, thereby anticipating present claims 160-161. Still further dependent claim 167 of ‘695 claims a pharmaceutical composition comprising this compound and a pharmaceutical carrier, and claim 169 of ‘695 claims a method of delivering siRNA to the liver using this compound. Regarding present clams 172-174, these claims are anticipated by the N-acetylgalactosamine structure appearing in claim 164 of ‘695.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 159-161, 164-167, and 169-171 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 56 of copending Application No. 19/370211. (reference application, unpublished, of record in previous action, herein referred to as ‘211). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘211 anticipate the present claims.
Claim 56 of ‘480 claims a method of treating HBV infection in a subject using a conjugate
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. This structure falls within the scope of structures recited in present claim 159 and has branch points as recited in present claims 160-16, 164-167 and 169. In particular the specific branch point corresponding to B1 in this structure can be interpreted as being simply the CH portion of the structure, with the rest of the atoms between this CH being part of the linking groups T1 and T2, thereby anticipating present claims 160-161. Still further the method claimed by claim 56 of ‘211 is a method of treating a liver disease which would necessitate delivering siRNA to the liver using this compound as recited in present claim 171.
Regarding present claim 170, while none of the claims of ‘211 do not refer specifically to a pharmaceutically acceptable carrier, the recitation of methods of using these compounds to treat disease would have motivated one of ordinary skill in the art to prepare the claimed compounds as pharmaceutical compositions comprising a carrier, in order to carry out said methods, thereby rendering claim 170 obvious. Regarding present clams 172-174, these claims are anticipated by the N-acetylgalactosamine structure appearing in claim 56 of ‘211.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 159-167 and 169-174 are rejected. Claim 168 is objected to for depending from a rejected base claim but would be allowable if rewritten in independent form incorporating all the limitations of the rejected base claim and any intervening claims. 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 ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y 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.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 5/6/2026
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