DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on January 21, 2026.
Currently, claims 14 and 17-27 are pending and under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14 and 17-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 and all of dependent claims thereof recite “the antisense strand comprising a region of complementarity which comprises at least 21 contiguous nucleotides differing by no more than 1 nucleotide from the nucleotide sequence of” SEQ ID NO:562.
It is noted that a nucleotide sequence having a “complementarity” with at least a 21-mer sequence of SEQ ID NO:562 cannot qualify as an “antisense strand” sequence because SEQ ID NO:562 itself is an antisense strand sequence. That is, a nucleotide sequence that is complementary to SEQ ID NO:562 is a sense strand sequence. As such, the aforementioned limitation recites structurally conflicting limitations, thereby rendering the claimed double-stranded ribonucleic acid indefinite.
Solely in the interest of compact prosecution, “a region of complementarity which comprises” in the aforementioned limitation will not be taken into consideration.
Claim 14 recites the limitation "wherein the nucleotide modifications" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the region of complementary" in line 1. There is insufficient antecedent basis for this limitation in the claim. In addition, note that “a region of complementarity” recited in claim 14 is not taken into consideration as noted above. Hence, the limitation in claim 21 will be interpreted as the antisense strand sequence consists of SEQ ID NO:562.
Claims 14, 17-23, and 25 recite a method of making a dsRNA comprising at least a 21-mer antisense strand sequence of SEQ ID NO:562, wherein the antisense strand length is not claimed (e.g., see claim 14, 22-23, and 25) or “no more than 30 nucleotides in length” (e.g., claim 17), and the sense strand sequence/length is not claimed (e.g., claim 21). Hence, the clear metes and bounds pertaining to “(a) synthesizing a sense strand” and “(b) synthesizing an antisense strand” cannot be ascertained because the structures pertaining to the length and/or nucleotide sequence of the “sense strand” and the “antisense strand” are not particularly pointed out and distinctly claimed, thereby rendering the method step of “synthesizing” such indefinitely recited strands unclear.
Double Patenting
The text of the judicially created doctrine not included in this action can be found in a prior Office action.
Claims 14 and 17-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-62 of U.S. Patent No. 9,127,274 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by, encompassed by, and/or rendered obvious by the ‘274 patent claims that are drawn to and require a dsRNA comprising two separate chemically modified sense strand and antisense strand that are hybridized to from a duplex, wherein the antisense strand comprises SEQ ID NO:960 and the sense strand comprises SEQ ID NO:941. That is, in order to produce and use the dsRNA as claimed in the ‘274 patent claims, the method steps of synthesizing each of the chemically modified strands and annealing the two strands to from a dsRNA are necessary and required, which therefore indicates that the ‘274 patent claims inherently require the instantly claimed method of making the dsRNA comprising SEQ ID NOs:941 and 960.
Response to Arguments
Applicant's arguments filed on January 21, 2026 have been fully considered but they are not persuasive. Applicant argues that the conflicting claims are distinct because the ‘274 patent claims are drawn to a product, whereas the instant claims are drawn to a process. In response, applicant’s attention is directed to the fact that the process claims of the ‘274 patent do require making the dsRNA claimed in the ‘274 patent claims. That is, synthesis of the dsRNA is a prerequisite for practicing the process claims of the ‘274 patent claims. As such, the fact that the claims are different categories is not sufficient to show why the instant claims are not anticipated by, encompassed by, and/or rendered obvious by the ‘274 patent claims, which do require synthesis of the instantly claimed dsRNA.
Claims 14 and 17-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-55 of U.S. Patent No. 9,376,680 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by, encompassed by, and/or rendered obvious by the ‘680 patent claims that are drawn to and require a dsRNA comprising two separate chemically modified sense strand and antisense strand that are hybridized to from a duplex comprising SEQ ID NO:960 and SEQ ID NO:941 claimed in the instant case. That is, in order to produce and use the dsRNA as claimed in the ‘680 patent claims, the method steps of synthesizing each of the chemically modified strands and annealing the two strands to from a dsRNA are necessary and required, which therefore indicates that the ‘680 patent claims inherently require the instantly claimed method of making the dsRNA comprising SEQ ID NOs:941 and 960.
Response to Arguments
Applicant's arguments filed on January 21, 2026 have been fully considered but they are not persuasive. Applicant argues that the conflicting claims are distinct because the ‘680 patent claims are drawn to a product, whereas the instant claims are drawn to a process. In response, applicant’s attention is directed to the fact that the process claims of the ‘680 patent do require making the dsRNA claimed in the ‘680 patent claims. That is, synthesis of the dsRNA is a prerequisite for practicing the process claims of the ‘680 patent claims. As such, the fact that the claims are different categories is not sufficient to show why the instant claims are not anticipated by, encompassed by, and/or rendered obvious by the ‘680 patent claims, which do require synthesis of the instantly claimed dsRNA.
Claims 14 and 17-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 11,091,759 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by, encompassed by, and/or rendered obvious by the ‘759 patent claims that require a dsRNA molecule comprising two separate chemically modified sense strand and antisense strand that are hybridized to from a duplex comprising SEQ ID NO:13 as the sense strand and SEQ ID NO:14 as the antisense strand, wherein SEQ ID NO:13 of the ‘759 patent claims is 100% identical to SEQ ID NO:941 claimed in the instant case, and SEQ ID NO:14 of the ‘759 patent claims is 100% identical to SEQ ID NO:960 claimed in the instant case. That is, in order to use the dsRNA molecule as claimed in the ‘759 patent claims, the method steps of synthesizing each of the chemically modified strands and annealing the two strands to from a dsRNA are necessary and required, which therefore indicates that the ‘759 patent claims inherently require the instantly claimed method of making the dsRNA comprising SEQ ID NOs:941 and 960.
Response to Arguments
Applicant's arguments filed on January 21, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant rejection is improper because “the instant application has an earlier patent term filing date and an accordingly earlier expiration date than the ‘759 patent.” In so arguing, applicant points to the Allergan caselaw (Fed. Cir. 2024) and the PTAB decision rendered in Application No. 17/135,529. In response, applicant’s attention is directed to the fact that the ‘759 patent is not “the first patent ever to be filed covering a particular drug compound”, nor were the ‘759 patent claims issued on August 17, 2021 were determined “not obvious” over the instant claims drawn to a method of making a dsRNA targeting Serpinc1, which were initially filed on July 9, 2025 and now amended as filed on January 21, 2026. Note that the instantly claimed subject matter was not even claimed in the original claims filed on January 17, 2023. As such, the fact pattern of the instant rejection is not whatsoever analogous to that in Allergan or the aforementioned PTAB decision. Hence, applicant’s arguments are found irrelevant and unpersuasive.
Claims 14 and 17-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-63 of U.S. Patent issued in Application No. 17/396,331 (issue fee paid).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by, encompassed by, and/or rendered obvious by the ‘331 claims that are drawn to and require a dsRNA comprising two separate chemically modified sense strand and antisense strand that are hybridized to from a duplex comprising SEQ ID NO:960 and SEQ ID NO:941. That is, in order to produce and use the dsRNA of the ‘331 claims, the method steps of synthesizing each of the chemically modified strands and annealing the two strands to from a dsRNA are necessary and required, which therefore indicates that the ‘331 claims inherently require the instantly claimed method of making the dsRNA comprising SEQ ID NOs:941 and 960.
Response to Arguments
Applicant's arguments filed on January 21, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant “provisional” rejection should be withdrawn pursuant to MPEP §804. In response, it is noted that the instant rejection is not provisional as an issue fee has already been paid in the ‘331 application. Further, even if this rejection should be deemed “provisional”, this rejection is not the only outstanding rejection in the instant application.
Claims 14 and 17-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42-44, 48, and 62-65 of copending Application No. 17/375,785.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by, encompassed by, and/or rendered obvious by the ‘785 claims that are drawn to a dsRNA molecule comprising two separate chemically modified sense strand and antisense strand that are hybridized to from a duplex comprising SEQ ID NO:13 as the sense strand and SEQ ID NO:14 as the antisense strand, wherein SEQ ID NO:13 is 100% identical to SEQ ID NO:941 claimed in the instant case, and SEQ ID NO:14 is 100% identical to SEQ ID NO:960 claimed in the instant case. That is, in order to produce the dsRNA molecule included in the kit of the ‘785 claims, the method steps of synthesizing each of the chemically modified strands and annealing the two strands to from a dsRNA are necessary and required, which therefore indicates that the ‘785 claims inherently require the instantly claimed method of making the dsRNA comprising SEQ ID NOs:941 and 960.
Response to Arguments
Applicant's arguments filed on January 21, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant rejection should be withdrawn pursuant to MPEP §804. In response, it is noted that this rejection is not the only outstanding rejection in the instant application.
Claims 14 and 17-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 71 and 78-103 of copending Application No. 17/878,884.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by, encompassed by, and/or rendered obvious by the ‘884 claims require a dsRNA comprising two separate chemically modified sense strand and antisense strand that are hybridized to from a duplex comprising SEQ ID NO:13 as the sense strand and SEQ ID NO:14 as the antisense strand, wherein SEQ ID NO:13 is 100% identical to SEQ ID NO:941 claimed in the instant case, and SEQ ID NO:14 is 100% identical to SEQ ID NO:960 claimed in the instant case. That is, in order to use the dsRNA of the ‘884 claims, the method steps of synthesizing each of the chemically modified strands and annealing the two strands to from a dsRNA are necessary and required, which therefore indicates that the ‘884 claims inherently require the instantly claimed method of making the dsRNA comprising SEQ ID NOs:941 and 960.
Response to Arguments
Applicant's arguments filed on January 21, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant rejection should be withdrawn pursuant to MPEP §804. In response, it is noted that this rejection is not the only outstanding rejection in the instant application.
Claims 14 and 17-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-10, 13-14, 20, 23, 26-30, 32, and 55-62 of copending Application No. 19/231,316.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by, encompassed by, and/or rendered obvious by the ‘316 claims that are drawn to a dsRNA comprising two separate chemically modified sense strand and antisense strand that are hybridized to from a duplex consisting of SEQ ID NO:13 as the sense strand and SEQ ID NO:14 as the antisense strand, wherein SEQ ID NO:13 is 100% identical to SEQ ID NO:941 claimed in the instant case, and SEQ ID NO:14 is 100% identical to SEQ ID NO:960 claimed in the instant case. That is, in order to produce the dsRNA of the ‘316 claims, the method steps of synthesizing each of the chemically modified strands and annealing the two strands to from a dsRNA are necessary and required, which therefore indicates that the ‘316 claims inherently require the instantly claimed method of making the dsRNA comprising SEQ ID NOs:941 and 960.
Response to Arguments
Applicant's arguments filed on January 21, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant rejection should be withdrawn pursuant to MPEP §804. In response, it is noted that this rejection is not the only outstanding rejection in the instant application.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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