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 the Application
Claims 1-7, 15-20, and 24-27 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 12/03/2025 are acknowledged. Claims 15-20 and 24-27 remain withdrawn, as being drawn to an unelected invention or specie. Claims under consideration in the instant office action are claims 1-7.
Applicants' arguments, filed 12/03/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Janakiraman et al. (TAF1-gene editing alters the morphology and function of the cerebellum and cerebral cortex, Neurobiology of Disease, 2019, 132, pp. 1-13) in view of Fukunaga (US 2015/0045385).
Janakiraman et al. teaches “TAF1-edited rats exhibited behavioral deficits at both the neonatal and juvenile stages of development. Deletion of TAF1 lead to a hypoplasia and loss of the Purkinje cells. We also observed a decreased in GFAP positive astrocytes and an increase in Iba1 positive microglia within the granular layer of the cerebellum in TAF1-edited animals. Immunostaining revealed a reduction in the expression of the CaV3.1 T-type calcium channel. Abnormal motor symptoms in TAF1-edited rats were associated with irregular cerebellar output caused by changes in the intrinsic activity of the Purkinje cells due to loss of pre-synaptic CaV3.1. This animal model provides a powerful new tool for studies of neuronal dysfunction in conditions associated with TAF1 abnormalities and should prove useful for developing therapeutic strategies to treat TAF1 ID syndrome.” (see abstract). Regarding claims 4-6, Janakiraman et al. teaches “We continued our behavioral assessment past the weanling stage. We performed the beam walking test and open field test. The beam walking test can evaluate motor coordination and balance (Rajasankar et al., 2009). The beam crossing time (Fig. 4A) and number of foot slips errors were higher in the TAF1-edited animals at PD35 compared to controls (Fig. 4B).” (pg. 6, left column, second paragraph).
Janakiraman et al. does not teach administering SAK3 for the treatment or improvement of motor deficits associated with TAF1 ID.
Fukunaga is drawn towards methods of improving brain function using compounds of formula (I) (see abstract). Fukunaga teaches that “nerve cell whose calcium ion level shows a significant increase by the addition of a compound represented by the following formula (SAK3)” (paragraphs 0072-0073, 0154; see Fig. 8).
It would have been obvious to one of ordinary skill in the art to administer SAK3 for the treatment or improvement of motor deficits associated with TAF1 ID, as suggested by Fukunaga, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since Fukunaga teaches SAK3 as an effective CaV3.1 T-type calcium channel activator (paragraph 0154; Fig. 8), which would ameliorate the motor deficits associated with TAF1 ID as taught by Janakiraman (see abstract; Fig. 4A, 4B), with a reasonable expectation of success absent evidence of criticality of the particular steps.
Response to Arguments
Applicant argues that “there is no teaching or suggestion in the art that SAK3-tested only in a depression-based OBX mouse model-would be effective in treating motor dysfunction resulting from TAF1 deficiency. Accordingly, neither the Janakiraman prior art nor the Fukunaga prior art OBX model provides a sufficient rationale or reasonable expectation of success for applying SAK3 to treat motor deficits associated with TAF1 ID. The prior arts do not bridge the substantial biological and mechanistic gap between depression-based OBX models and a disease-specific TAF1 deficiency model, and therefore cannot render the claimed methods obvious.” The Examiner respectfully disagrees since although Fukunaga does not teach an animal model that model for TAF1 deficiency or motor deficits, Fukunaga does teach that compound SAK3 can active calcium channels that are dysregulated by TAF1 deficiency (paragraphs 0072-0073, 0154; see Fig. 8). Given that Janakiraman teaches such abnormalities can be a therapeutic target for treating TAF1 ID Syndrome and its attendant symptoms, one of ordinary skill in the art would have been motivated to administer compound SAK3 in the treatment of TAF1 ID Syndrome, with a reasonable expectation of success absent evidence of criticality of the particular steps.
Conclusion
Claims 1-7 are rejected.
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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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