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 .
Current Status of 17/837,224
The rejections of record have been maintained below.
The Markush search has not been extended.
Claims 1-3, 5-6, 11-15, 17-18, and 21-22 of 6/25/2026 are examined on the merits. Claims 7-10 and 19-20 are still withdrawn as they are drawn to nonelected species.
Response to Arguments
Applicants’ claim amendments and Remarks of 6/25/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
Claims 1, 2, and 3 are amended.
In regard to the claim interpretation in paragraph 8 of the Nonfinal of 2/25/2026, Applicants assert that a single acute injection does not inherently results in the pharmacological chaperone effect that requires a long-term treatment. Additionally, Applicants assert that the claims require a specific sequential method.
With the current claim amendments, Examiner agrees that the instant claims 1-3 have active sequential steps of administering an OXTR chaperone for a period of more than 6 hours and later also administering oxytocin.
In regard to the 103 rejection, this rejection is maintained. Applicants Remark’s with Examiner’s reply are summarized below:
Penagarikano teaches using L371,257 not as an OXTR chaperone, but as an oxytocin receptor antagonist.
From the instant claim construction, L371,257 is a OXTR chaperone. Additionally, Examiner has looked for and points out that there is no complete (or even partial) list of compounds that act as OXTR chaperones.
Applicants submit that Penagarikano’s methods are different from the claim methods, because the instant claims require administering an OXTR chaperone to increase trafficking of OXTR from intracellular stores to the cell surface, and then administering oxytocin.
Where Examiner disagrees is that Penagarikano discloses the active steps of administering the elected species of an OXTR chaperone (L371,257) followed by administering oxytocin (page 3 and figure 1D, also on page 5 of the Non-Final of 2/25/2026). Penagarikano does not teach administering over a period of more than 6 hours, and Penagarikano does not disclose the desired effects of instant claims 1-3.
Applicants submit that Office’s reliance on Kucynski for the timing limitation is misplaced.
Examiner disagrees. Since Penagarikano teach a method of administering the elected species of an OXTR chaperone (L371,257) followed by administering oxytocin (page 3 and figure 1D of Penagarikano, also on page 5 of the Non-Final of 2/25/2026) and since Kuczynski teaches L371,257 is administered over 24 hours (page 2 and claim 6), then it would necessarily increase trafficking of OXTR from intracellular stores to the cell surface.
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144.IV.
The current obviousness rejection is focused on modifying the dosing regimen (i.e scheduling). See page 6 of the Nonfinal rejection of 2/25/2026. Examiner also includes Loftsson as a generic teaching that optimizing dosage regimens are well known in the art.
Additionally, Examiner points out that the Instant claims are not directed to a patient population; anyone could be a subject of the instant claims. Also, there is no dosage amount required by the claims. The claims, as currently written, only require administering over a certain amount of time.
Examiner also recommends showing surprising/unexpected results for the whole scope of claim 1 to expedite prosecution.
Response to Amendments
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.
Claim(s) 1-3, 5-6, 11-15, 17-18 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Peñagarikano (Peñagarikano et al., “Exogenous and evoked oxytocin restores social behavior in the Cntnap2 mouse model of autism”, Science Translational Medicine, January 21, 2015, previously cited) as evidenced by Stavropoulos (Stavropoulos et al., “Research Review: Social motivation and oxytocin in autism – implications for joint attention development and intervention”, J Chil Psychol Psychiatry, June 1, 2014, previously cited) in view of KUCZYNSKI (WO 2006121362, previously cited) and in view of LOFTSSON (Thorsteinn Loftsson, “Chapter 5- Pharmacologic response and Drug Dosage Adjustments”, A Primer for Pharmaceutical Scientists”, 2015).
Peñagarikano teaches administering L371,257 and oxytocin (OXT) to a subject (Cntnap2 mouse model of autism) (page 3 and Figure 1D).
Stavropoulos is relied upon for the beneficial teaching that children with autism had lower oxytocin levels than controls (neurotypical peers) as well as children with ASD with higher oxytocin levels were more impaired in social and linguistic development which is in line with social motivation hypothesis (Evidence for deficient/different oxytocin levels in ASD).
The Cntnap2 mouse model of autism is a subject which has oxytocin insensitivity (subject of instant claim 1 and 3, and suspected of having autism of claim 18). Peñagarikano (page 3 and Figure 1D) inherently teaches the methods of 1-3, 5-6, and 11-15, and 21-22.
Peñagarikano teaches administering L371,257 and oxytocin (OXT) to a subject (Cntnap2 mouse model of autism) (page 3 and Figure 1D). This teaches the subpopulations of claims 17-18.
While Peñagarikano teaches methods of administering L371,257 and oxytocin, Peñagarikano does not teach administering over any amount of time.
KUCZYNSKI teaches antagonists of oxytocin are administered enterally or parenterally in the 24h dose ranging from about 0,01 mg up to about 10g (page 2).
KUCZYNSKI teaches the elected species of OXTR chaperone of claim 6, L371,257 (claim 6 on page 15). This teaches claim 5 (OXTR antagonist) and claim 6 (L371,257).
KUCZYNSKI teaches administering this compound to humans (page 2).
KUCZYNSKI does not teach administering oxytocin.
LOFTSSON teaches that dosage regimens are based on average pharmacokinetic parameters (page 120). LOFTSSON also teaches that these parameters may vary with patients’ gender, age, weight, and disease state (page 120). Furthermore, dosage adjustment is known (examples 5.1-5.4 on pages 120-124).
The artisan would have been motivated and expected to use the known dosage of L371,257. While Peñagarikano does not teach administering L371,257 over an amount of time, KUCZYNSKI teaches antagonists of oxytocin (including L371,257 (claim 6 on page 15) are administered enterally or parenterally in the 24h dose ranging from about 0.01 mg up to about 10g (page 2). This teaches the time of the doses (over more than 6 hours) for claims 1-3.
Additionally, the artisan would have been motivated to optimize the times of the dosages (i.e. scheduling). It would be obvious to optimize the dosing regimen to maintain a therapeutic window and adjust for the impacts of disease state, age, weight, etc. (LOFTSSON pages 120-124). One would be motivated to adjust the regimen to maintain the therapeutic window, and would have a reasonable expectation for success in doing so, because this is something that is routinely practiced in the pharmaceutical arts. See MPEP 2144.05(II)A. Nothing in the specification or record appears to indicate the dosing regimen claimed is critical. Thus, the artisan would be motivated and expected to optimize the scheduling of the OXTR chaperone and oxytocin.
This teaches claims 1-3.
Conclusion
No claims are allowed as written.
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.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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