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 Amendment and Remarks filed June 17, 2026.
Claim 2, 3 and 5 have been canceled. New claim 18 is acknowledged. Claims 1, 4 and 17 have been amended.
Claims 1,4, 9-12 and 15-18 are pending in the instant application.
This application contains claims 9-12, 15 and 16 drawn to an invention nonelected without traverse in the reply filed February 23, 2026. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Accordingly, claims 1, 4, 17 and 18 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Nucleotide Sequence Disclosures
In the previous Office Action mailed March 17, 2026, it was noted that the present application failed to comply with the requirements of 37 C.F.R. §1.821-1.825. This notice is maintained because the Sequence Listing contains ERRORS for the reason(s) set forth on the attached Notice To Comply with Requirements for Patent Applications Containing Nucleotide Sequence Disclosures.
Applicant must fully comply with the sequence rules for any response to this action to be considered fully responsive.
Claim Rejections - 35 USC § 112
In the previous Office Action mailed March 17, 2026, claims 1-5 and 17 were 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 pre-AIA the applicant regards as the invention. This rejection is moot against claims 2, 3 and 5 in view of Applicant’s Amendment filed June 17, 2026 to cancel these claims. This rejection is maintained against the remaining claims for the reasons of record set forth in the previous Office Action mailed March 17, 2026. NOTE: New claim 18 is drawn to subject matter within the scope of the rejected claims and would have been rejected in the prior Office Action. Therefore, the instant rejection applies to new claim 18 as well.
Response to Arguments
In response to this rejection, Applicants submit that claim 1 has been amended to indicated that dormancy of quiescent neural stem cells (qNSCs) is inhibited by administering an activity inhibitor of histone lysine methyltransferase. Applicants also submit that the Office Action may be arguing that the administration site (route) must also be described in the claims in light of the description and knowledge in the art. In this regard, Applicants argue that the amended claims now clearly recite the allegedly essential features, namely the administration of a substance (an activity inhibitor of histone lysine methyltransferase) and the claims are clear in this regard.
Applicant’s arguments have been fully considered by the Examiner, however they are not found to be persuasive because as explained in the previous Office Action mailed March 17, 2026, the description and knowledge in the art make it very clear that inhibiting dormancy of qNSCs is accomplished by the specific injection of histone methyltransferase inhibitors into the subventricular zone (SVZ) and/or hippocampus SGZ (subgranular zone)/dentate gyrus (DG) of subjects. This specific mode of administration and site of administration is lacking in the present claims. The amendment to claim 1 does not cure this deficiency and therefore the claims remain rejected as being indefinite.
Claim Rejections - 35 USC § 112
In the previous Office Action mailed March 17, 2026, claims 1-5 and 17 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating autism spectrum disorder, the method comprising inhibiting dormancy of quiescent neural stem cells (qNSCs), does not reasonably provide enablement for a method of preventing autism spectrum disorder, the method comprising inhibiting dormancy of qNSCs. This rejection is moot against claims 2, 3 and 5 in view of Applicant’s Amendment filed June 17, 2026 to cancel these claims. This rejection is withdrawn against the remaining claims in view of Applicant’s Amendment to the claims filed March 17, 2026.
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In the previous Office Action mailed March 17, 2026, claims 1-5 and 17 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. This rejection is moot against claims 2, 3 and 5 in view of Applicant’s Amendment filed June 17, 2026 to cancel these claims. This rejection is maintained against the remaining claims for the reasons of record set forth in the previous Office Action mailed March 17, 2026. NOTE: New claim 18 is drawn to subject matter within the scope of the rejected claims and would have been rejected in the prior Office Action. Therefore, the instant rejection applies to new claim 18 as well.
Response to Arguments
In response to this rejection, Applicants argue that to advance prosecution, claim 1 has been amended to define that the activity inhibitor of histone lysine methyltransferase is one or more selected from OICR-9429, Kmt2a inhibitor, and Kmt2c inhibitor, and the Kmt2a inhibitor or the Kmt2c inhibitor is an interfering RNA, a ribozyme, a DNAzyme, a PNA (peptide nucleic acids), an antisense oligonucleotide, a peptide, an antibody, or an aptamer which is specific to KMT2A gene or KMT2C gene. Applicants submit that OICR-9429, Kmt2a shRNA, and Kmt2c shRNA are used in the Examples, and the Kmt2a shRNA and Kmt2c shRNA are presented as representative examples of the Kmt2a inhibitor or Kmt2c inhibitor described in amended Claim 1. In view of these amendments, Applicants request reconsideration and withdrawal of the rejection.
Applicant’s arguments have been fully considered by the Examiner, however they are not found to be persuasive because as explained in the previous Office Action mailed March 17, 2026, according to the MPEP, the Specification must provide sufficient distinguishing identifying characteristics of the genus. In the present case, the instant invention demonstrates that only the limited species of Kmt2a and Kmt2c specific shRNA or OICR-9429 functions as claimed. However, the breadth of the claims include histone lysine methyltransferase inhibitors selected from one or more of OICR-9429, Kmt2a inhibitor, and Kmt2c inhibitor, and the Kmt2a inhibitor or the Kmt2c inhibitor is an interfering RNA, a ribozyme, a DNAzyme, a PNA (peptide nucleic acids), an antisense oligonucleotide, a peptide, an antibody, or an aptamer which is specific to KMT2A gene or KMT2C gene. Given only three species of a broad genus of activity inhibitor of histone lysine methyltransferase, the Examiner maintains that one of skill in the art would not recognize Applicant as having possession of the genus of inhibitors encompassed by the claims.
Applicant is reminded that sufficient blaze marks within the Specification allow a genus to be "sufficiently disclosed by 'either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can visualize or recognize the members of the genus.'" (citing Ariad, 598 F.3d at 1350). Accordingly, blaze marks have been described within the Specification as descriptions that "single out particular trees in a forest, rather than simply 'pointing to trees.'" (quoting Fujikawa, 93 F.3d at 1570).
There is no record or description which would demonstrate conception of those activity inhibitors of histone lysine methyltransferase which treat autism spectrum disorder, comprising inhibiting dormancy of qNSCs, other than Kmt2a and Kmt2c shRNA and OICR-9429. The Specification as filed does not provide sufficient descriptive support for the myriad of activity inhibitors of histone lysine methyltransferase that function as claimed. For the reasons discussed above, the 35 USC § 112 rejection for written description is maintained.
Applicant’s Amendment filed March 17, 2026 necessitated a new grounds of rejection as presented below:
Improper Markush Groups
Claims 1, 4 and 17 are rejected on the basis that it 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). 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 claims are 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: The claims include histone lysine methyltransferase inhibitors selected from OICR-9429, Kmt2a inhibitor, and Kmt2c inhibitor, and the Kmt2a inhibitor or the Kmt2c inhibitor is an interfering RNA, a ribozyme, a DNAzyme, a PNA (peptide nucleic acids), an antisense oligonucleotide, a peptide, an antibody, or an aptamer which is specific to KMT2A gene or KMT2C gene. Between these different histone lysine methyltransferase inhibitors, they do not share a single structural similarity as they are chemically different compounds (e.g. nucleic acid vs. protein vs. peptide vs. small molecule, etc.). Further, the claims do not share a common use as the histone lysine methyltransferase activity is inhibited by different means (e.g. at the protein level vs. the gene level).
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.
Claims Free of the Prior Art
Claims drawn to a method of treating autism spectrum disorder, the method comprising inhibiting dormancy of quiescent neural stem cells (qNSCs) by administering an activity inhibitor of histone lysine methyltransferase, wherein the activity inhibitor of histone lysine methyltransferase is OICR-9429, Kmt2a interfering RNA, or Kmt2c interfering RNA, and wherein the activity inhibitor of histone lysine methyltransferase is administered to the subventricular zone (SVZ) or hippocampus subgranular zone (SGZ) of the brain are free of the art.
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 Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 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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/TERRA C GIBBS/Primary Examiner, Art Unit 1635
Prosecution Insights