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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/9/2025 has been entered.
Current status of 17/837,224
The rejections of record have been withdrawn below.
The Markush Search has not been extended. Claims 1-3, 5-6, 11-15, 17-18, and 21-22 read on the elected species.
Priority
This application claims priority to US. Provisional application 63/209,054, filed 06/10/2021.
The instant claims find support from the provisional application. Therefore, the effective filing date is 06/10/2021.
Response to Arguments
Applicants’ claim amendments and Remarks of 9/9/2025 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the 102 rejection, this rejection is withdrawn. Applicants amend claims 1-3 so that the OXTR chaperone is administered over 6 hours.
Response to Amendments
Claim interpretation
Examiner has further considered the instant claims. The instant compounds are known in the prior art (for example, L371,257 is known as a OXTR antagonist; KUCZYNSKI claim 6). The only active step in the instant base claims is administering the OXTR chaperone to a subject. Even though the methods of increasing the display of oxytocin receptor on a plasma member, increasing oxytocin sensitivity, or increasing the efficacy of oxytocin were not previously appreciated, the instant claims are not novel. Every time that someone administered, for example, L371,257 inherently anticipated the instant claims. See Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368 (Fed. Cir. 2001) which emphasized that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”
Claim Objections
Claim 21 is objected to because of the following informalities: Claim 21 has a comma instead of a period after the claim number. Appropriate correction is required.
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.
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 GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625