DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-13) in the reply filed on 12 February 2025 is acknowledged.
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.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,135,414. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate the instant claims as detailed below:
Instant
Patent
1. A method for delivering an siRNA construct across a dermal barrier, the method comprising:
penetrating the stratum corneum with a microneedle having a surface on which
a plurality of nanostructures and/or a plurality of microstructures
are arranged in a pattern that comprises a fractal and/or fractal-like geometry,
wherein the nanostructures and/or microstructures project outward from the surface of the microneedle, and
wherein the microneedle further contains a channel;
transporting an siRNA construct through the channel of the microneedle and across the stratum corneum.
18. A method for delivering an siRNA construct across a dermal barrier, the method comprising:
penetrating the stratum corneum with a microneedle having a surface on which
a plurality of nanostructures
are arranged in a pattern that comprises a fractal and/or fractal-like geometry,
wherein the nanostructures project outward from the surface of the microneedle, and
wherein the microneedle further contains a channel;
transporting an siRNA construct from a reservoir through the channel of the microneedle and across the stratum corneum.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,135,414 in view of Binks et al (US 2008/0312610).
Regarding claim 2, the patent discloses the method of claim 1 but is silent regarding “wherein the siRNA construct is transported across the stratum corneum at a steady concentration over a period of time.” Binks teaches a transdermal microneedle delivery device, thus being in the same field of endeavor, that transports the drug at a steady state rate of delivery (¶0007) in order to have controlled delivery of the drug with predictable results. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have delivered the drug of the patent at a steady concentration over a period of time as taught by Binks in order to have controlled delivery of the drug with predictable results.
Claims 3, 5-7, and 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,135,414 in view of Wen et al (US 2008/0305989).
Regarding claim 3, the patent discloses the method of claim 1 but is silent regarding “wherein the siRNA construct includes a duplexed region of between about 20 and about 30 pairs.” Wen teaches using siRNA for transdermal delivery (¶0079), thus being in the same field of endeavor, using an siRNA agent with a duplexed region of between 20-30 pairs (¶0079 – “e.g., 21-23 nucleotides”). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the siRNA construct of the patent to be a construct with a duplexed region of about 20 and about 30 pairs as taught by Wen as such a modification would be the result of a simple substitution of one known element (the siRNA construct of the patent) for another known patent (the siRNA construct of Wen with the duplexed region) to obtain predictable results (providing an effective therapy using siRNA).
Regarding claim 5, the patent discloses the method of claim 1 but is silent regarding “wherein the siRNA construct comprises additional nucleotides or nucleotide analogues.” Wen teaches using siRNA for transdermal delivery (¶0079), thus being in the same field of endeavor, using an siRNA agent with additional nucleotides or nucleotide analogues (¶0045). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the siRNA construct of the patent to be a construct with additional nucleotides or nucleotide analogues as taught by Wen as such a modification would be the result of a simple substitution of one known element (the siRNA construct of the patent) for another known patent (the siRNA construct of Wen with the nucleotides/analogues) to obtain predictable results (providing an effective therapy using siRNA).
Regarding claim 6, the patent discloses the method of claim 1 but is silent regarding “wherein the siRNA construct includes insertions, deletions, or single point mutations compared to a portion of a targeted gene.” Wen teaches using siRNA for transdermal delivery (¶0079), thus being in the same field of endeavor, using an siRNA agent with insertions, deletions, or single point mutations compared to a portion of a targeted gene (¶0049). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the siRNA construct of the patent to be a construct with insertions, deletions, or single point mutations as taught by Wen as such a modification would be the result of a simple substitution of one known element (the siRNA construct of the patent) for another known patent (the siRNA construct of Wen with insertions, deletions, or single point mutations) to obtain predictable results (providing an effective therapy using siRNA).
Regarding claim 7, the patent discloses the method of claim 1 but is silent regarding “wherein the siRNA construct is a single strand siRNA.” Wen teaches using siRNA for transdermal delivery (¶0079), thus being in the same field of endeavor, using an siRNA agent in the form of a single strand (¶0058). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the siRNA construct of the patent to be a construct in the form of a single strand of siRNA as taught by Wen as such a modification would be the result of a simple substitution of one known element (the siRNA construct of the patent) for another known patent (the single strand siRNA construct of Wen) to obtain predictable results (providing an effective therapy using siRNA).
Regarding claim 10, the patent discloses the method of claim 1 but is silent regarding “wherein the siRNA construct is incorporated into a delivery vehicle.” Wen teaches using siRNA for transdermal delivery (¶0079), thus being in the same field of endeavor, using an siRNA agent incorporated into a delivery vehicle such as a liposome (¶0094). Doing so allows delivery of an siRNA agent while preventing anything toxic or deleterious to interact with the siRNA agent (¶0097). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the siRNA construct of the patent to be incorporated into a delivery vehicle as taught by Wen in order to allow delivery of an siRNA agent while preventing anything toxic or deleterious to interact with the siRNA agent, as recognized by Wen.
Regarding claim 11, the patent in view of Wen discloses the method of claim 10, wherein the delivery vehicle being a liposome (Wen; ¶0094).
Regarding claim 12, the patent discloses the method of claim 1 but is silent regarding “wherein the siRNA construct comprises a vector.” Wen teaches using siRNA for transdermal delivery (¶0079), thus being in the same field of endeavor, using an siRNA agent comprising a vector (¶0079). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the siRNA construct of the patent to be a construct comprising a vector as taught by Wen as such a modification would be the result of a simple substitution of one known element (the siRNA construct of the patent) for another known patent (the siRNA construct of Wen with a vector) to obtain predictable results (providing an effective therapy using siRNA).
Regarding claim 13, the patent in view of Wen discloses the method of claim 12, wherein the vector is a viral vector (Wen; ¶0080).
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,135,414 in view of Sung et al (US 8137697).
Regarding claim 4, the patent discloses the method of claim 1 but is silent regarding “wherein at least one strand of the siRNA construct includes a 3' overhang of two or three nucleotides.” Sung teaches an siRNA structure, thus being in the same field of endeavor, has a well-defined structure of a short double strand of RNA with 2 nucleotide 3’ overhangs on either end (Col. 34:37-39). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the siRNA construct of the patent to incorporate a 3’ overhang of two nucleotides as taught by Sung in order to provide sufficient structure for a functional siRNA construct.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,135,414 in view of Nabel et al (US 5328470).
Regarding claim 8, the patent discloses the method of claim 1 but is silent regarding “wherein the siRNA comprises a ligand tethered to the siRNA.” Nabel teaches a method of targeted delivery of RNA, thus being in the same field of endeavor, that uses targeting ligands (Col. 11:7-29) in order to improve targeted delivery of the siRNA (Col. 13:55-58). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the siRNA of the patent to comprise a ligand tethered to the siRNA as taught by Nabel in order to improve targeted delivery, as recognized by Nabel.
Regarding claim 9, the patent in view of Nabel discloses the method of claim 8, wherein the ligand is selected from the group consisting of a therapeutic modifier and a diagnostic compound (Nabel; Abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783