DETAILED ACTION
This Action is in response to the communication filed on 05/01/2026.
Claims 1, 7, 8, 16, 17, 20, 22, 24, 27-29, 34, 38, 43-45, 49, 54, 56, 57 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I and species (b) (SEQ ID Nos: 13-14) in the reply filed on 05/01/2026 is acknowledged.
Claims 8, 16, 17, 20, 22, 24, 27-29, 34, 38, 45, 49, 54, 56, 57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), wherein claims 8, 16, 17, 20, 22, 24, 27-29, 34, 38 are withdrawn as being drawn to a nonelected species, and claims 45, 49, 54, 56, 57 are withdrawn as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/01/2026.
Claims 1, 7, 43-44 are under consideration as they are drawn to the elected invention and species.
Improper Markush Rejection
Claims 1, 7, 43-44 are rejected on the basis that claim 1 contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). Claims 7, 43-44 are included in the rejection as they are dependent claims that incorporate the improper Markush group. A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of dsRNA agents is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: although each dsRNA agent is comprised of sense and antisense nucleotide strands wherein each dsRNA targets and inhibits expression of SOD1, the dsRNA agents do not share a structural similarity because the sequences of each dsRNA agent is different from the others and they do not have any common nucleotide sequence that is shared among the claimed members of the Markush group. Furthermore, since each dsRNA agent has a different nucleotide sequence, there is a reasonable expectation that no two dsRNAs would have the exact same effect (i.e., each would be expected to have some difference in target gene inhibition).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 43-44 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. 20250283071.
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
U.S. 20250283071 has an effective filing date of January 22, 2021 and lists 21 different inventors. The instant application has an effective filing date of February 12, 2021and lists 6 different inventors wherein all 6 of the inventors of the instant application are listed as co-inventors of U.S. 20250283071. Accordingly, the U.S. 20250283071 reference is applicable as prior art under 35 USC 102(a)(2).
Regarding claim 1, U.S. 20250283071 teaches a dsRNA wherein the sense strand is csasggu(Chd)cuCfAfCfuuuaauccsusa (instant SEQ ID NO: 13), and the antisense strand is VPusdAsggdAudTaaagdTgAfggaccugscsg (instant SEQ ID NO: 14).
Regarding claim 43, U.S. 20250283071 teaches that the dsRNA can be administered to a cell in vitro to inhibit expression of the target gene in the cell, thereby creating an isolated cell comprising the dsRNA (e.g., see paragraph [0327]).
Regarding claim 44, U.S. 20250283071 teaches a pharmaceutical composition comprising the dsRNA agent and a pharmaceutically acceptable diluent (e.g., see paragraph [0297]).
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 20250283071, as applied in the rejection above, in view of U.S. 20080015162.
U.S. 20250283071 teaches a dsRNA that targets SOD1 wherein the sense strand is csasggu(Chd)cuCfAfCfuuuaauccsusa (instant SEQ ID NO: 13), and the antisense strand is VPusdAsggdAudTaaagdTgAfggaccugscsg (instant SEQ ID NO: 14), as indicated above.
U.S. 20250283071 does not teach a sodium salt of the dsRNA.
However, sodium salts of dsRNAs were well known in the prior art. For instance, U.S. 20080015162 teaches sodium salts of dsRNA compounds that target SOD1 (e.g., see paragraph [0864]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the day the claimed invention was filed to modify the dsRNA taught by U.S. 20250283071 as indicated above, to make a sodium salt of the dsRNA, with a reasonable expectation of success. One of ordinary skill in the art would readily understand that a sodium salt form of the dsRNA would improve stability and enhance solubility of the dsRNA, thus providing sufficient reason to make a sodium salt form of the dsRNA.
Examiner’s Comment
It is noted that no other prior art that teaches a dsRNA having sense strand that differs by no more than 4 bases from the nucleotide sequence 5'-csasggu(Chd)cuCfAfCfuuuaauccsusa-3' (SEQ ID NO: 13) and an antisense strand differs by no more than 4 bases from the nucleotide sequence 5'-VPusdAsggdAudTaaagdTgAfggaccugscsg-3' (SEQ ID NO: 14) was identified.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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, Jennifer Dunston can be reached at (571) 272-2916. 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.
J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637
Prosecution Insights