DETAILED ACTION
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 .
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on October 29, 2025.
Currently, claims 1-14, 17-20, 22, and 25-44 are pending in the instant application. Claims 1-12, 17-19, and 26-44 are withdrawn from further consideration as being drawn to nonelected inventions/species. Accordingly, claims 13-14, 20, and 25 are 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Objections/Rejections
Drawings
The color drawings filed on June 22, 2023 remain objected to for the reasons as set forth in the Office action mailed on July 29, 2025 and for the reasons set forth below.
Applicant's arguments filed on October 29, 2025 have been fully considered but they are not persuasive. Applicant argues that a petition and the fee concurrently filed with the remarks are sufficient to render the objections moot. Contrary to applicant’s argument, the examiner is unable to locate the petition to accept color drawings and the necessary fee accompanied with the response filed on October 29, 2025. Accordingly, this objection is maintained.
Priority
Priority benefit denial is maintained for the reasons as set forth in the Office action mailed on July 29, 2025 because applicant did not address the priority issues raised in the last Office action.
Claim Rejections - 35 USC § 112
Claims 13-14, 20, and 25 remain rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement for the reasons as set forth in the Office action mailed on July 29, 2025 and for the reasons set forth below.
Applicant's arguments filed on October 29, 2025 have been fully considered but they are not persuasive. Applicant argues that the claims as amended fully comply with the written description requirement. In particular, applicant points out Table 3, which “demonstrates” that “TRIM17 reduces insoluble Ataxin1 82Q by more than 25%” although not colocalized with ataxin 82Q aggregates thus one skilled in the art would “readily envision” that compounds that increase TRIM17 would have utility in treating a disease associated with ataxin aggregates. In response, it is noted that Table 3 at best lists results pertaining to “Atxn1 82Q”, wherein Atxn1 is not representative of all Ataxin isoforms (e.g., Atxn2, Atxn 3, Atxn7) and aggregates thereof. For instance, Atxn3 polyQ aggregation was known to be associated with Machado-Joseph disease as evidenced by Koch et al. (Nature, 2011, 480:543-546), and Atxn7 polyQ aggregation was known to be associated with spinocerebellar ataxia type 7 (SCA7) as evidenced by Furrer et al. (Human Molecular Genetics, 2013, 22:890-903). As such, the reduction in the single ataxin polyQ species, Ataxin 1 82Q, is far from representing the reduction in all ataxin polyQ species known in the art, especially in view of the fact that there is no relevant prior art whatsoever pertaining to the claimed nexus between TRIM17 activator and the resultant effect of treating any disease associated with any and all ataxin aggregates in a subject in need of the disease treatment as broadly claimed. In addition, the instant specification expressly teaches that TRIM protein’s colocalization with polyQ protein aggregates is indicative or reflective of the protein’s function in degrading the polyQ protein aggregates via the “overexpression” of the TRIM protein. See page 81 disclosing the TRIM19 “colocalizes with aggregates formed by polyQ proteins associated with SCAs” and “upon overexpression, promotes degradation of at least one of them”. Similarly, the instant co-inventors purposefully pursued TRIM27 and TRIM32, which “co-localized with Atxn1 82Q-GFP inclusion in the nucleus” (see page 115), which when overexpressed “showed stronger activity than PML in reducing the levels of soluble Atxn1 82Q”, wherein “the activity of TRIM32 in reducing aggregated Atxn1 82Q was comparable to that of PML” (see page 116). Moreover, the instant co-inventors also pursued overexpressing TRIM11 by a recombinant TRIM11 construct to degrade Atxn1 82Q, wherein “treatment of HeLa cells with TRIM11 led as strong reduction in the levels of Atxn1 82Q” (see page 129) as TRIM11 is also colocalized with Atxn 1 82Q. Now, unlike TRIM19, TRIM11, TRIM27, and TRIM32 that were experimentally tested based on the fact that the proteins are colocalized with the aggregates, the instantly claimed protein TRIM17 is not colocalized with Atxn1 82Q aggregates, nor is overexpression of the protein tested by the instant co-inventors for its function of promoting degradation of the aggregates of any and all Ataxin proteins.
Now, applicant’s attention is directed to the fact that the instant specification expressly discloses unreliability of the assay used to formulate Table 3 because “TRIM27 and TRIM32, which were shown above to be able to reduce Atxn1 82Q, did not display an effect in this assay.” (emphasis added). See page 119. Hence, it is unclear how the teachings of the instant specification as a whole can possibly be deemed to adequately describe the instantly claimed disease treatment method in vivo when there is not even an adequate in vitro support disclosed in the specification for the claimed protein TRIM17 that was tested in an unreliable assay, let alone the treatment of the entire genus of Ataxin aggregates associated with diseases including but not limited to “SCA2, SCA3, SCA6, SCA7, and SCA17”, even if the results of Table 3 pertaining to TRIM17 only in relation to Atxn1 associated with SCA1 should be deemed reliable.
In view of the foregoing, this rejection is maintained.
Potential Double Patenting
Applicant is advised of the fact that the claims of Application No. 19/486,240 filed on November 20, 2025 after the mailing date of the last Office action of this application overlap in scope with the instant claims.
Conclusion
No claim is allowed.
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 DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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, 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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