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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 of PCT/US2020/012903 filed January 9, 2020, which claims the benefit of US Provisional Application No. 62/791,368 filed January 11, 2019 and US Provisional Application No. 62/913,945 filed October 11, 2019. Amended Claims 1, 6, 10-11, 16-17, 49, and 55-60 do not have support in US Provisional Application No. 62/791,368 because it does not teach the administration of an anti-CD3 antibody. US Provisional Application No. 62/913,945 does teach the administration of an anti-CD3 antibody. Therefore, Claims 1, 6, 10-11, 16-17, 49, and 55-60 receive an effective filing date of October 11, 2019, and Claims 50-54 receive an effective filing date of January 11, 2019.
Claim Status
Claim listing filed on October 27, 2025 is pending. Claims 2-5, 7-9, 12-15, 18-48 are canceled. Claims 1, 6, 10-11, and 16-17 are amended. Claims 49-60 are new. Claims 1, 6, 10-11, 16-17, and 49-60 are examined upon their merits.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claims 2-5, 8-9, 13, and 20 have rendered all previous rejections directed to these claims moot.
Applicant’s amendments have overcome the specification objections of record, and the specification objections are withdrawn.
The rejection of claims 1, 6, 10-11, and 16-17 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments. In particular, Claim 17 is no longer indefinite because the increase in level or activity of IL-17 receptor is compared to a patient with the neurodevelopmental disorder that has not been administered the treatment of Claim 1. Note, the specification defines “increases” as any increase between 10-100% as compared to a reference level (paragraph [0065]), and activity and level of IL-17a or IL-17a receptor can be measured by a variety of methods known in the art (paragraphs [0097]-[0098]). Claim 17 is interpreted as an inherent functional property of the methodological steps of Claim 1 (MPEP § 2112).
The rejection of Claims 1, 6, 10-11, and 16-17 under 35 U.S.C. 102(a)(1) as being anticipated by Huh et al. US 2017/0326356 is withdrawn in view of Applicant’s amendments. Huh does not teach administering an anti-CD3 antibody to treat neurodevelopmental disorders.
The provisional rejection of Claims 1 and 17 on the ground of nonstatutory double patenting as being unpatentable over copending U.S. App. No. 18/853,224 is withdrawn in view of Applicant’s amendments. The copending claims do not teach the administration of IL-25 or an anti-CD3 antibody to treat neurodevelopmental disorders.
Claim Rejections - 35 USC § 112 (Maintained)
Claims 1, 6, 10-11, 16-17, and 49-55 are 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Note, the rejection of record applied to Claims 1-6, 8-11, 13, 16-17, and 20, and now applies to Claims 1, 6, 10-11, 16-17, and 49-55 due to Applicant’s amendments.
The claims are directed to a method of treating a neurodevelopmental disorder by administering IL17a, IL-25, an anti-CD3 antibody, IFNγ, or combinations thereof wherein the neurodevelopmental disorder is selected from autism spectrum disorder (ASD), Asperger’s syndrome, and fragile X syndrome.
The specification teaches examples of treating mouse models of autism and fragile X syndrome with IL17a and IFNγ (Example 1 starting at paragraph [00195] and Example 3 starting at paragraph [00230]). The specification further teaches treating mouse models of autism and fragile X syndrome with an anti-CD3 antibody (Example 5 starting at paragraph [00263]). The specification fails to teach any examples wherein IL-25 was administered to treat any disease.
Applicant's arguments filed October 27, 2025 have been fully considered but they are not persuasive. Applicant argues that the amended claims satisfy the written description requirement. Examiner maintains that no guidance is provided for a method of treating neurological disorders by administering IL-25. The therapeutic properties of IL-25 in neurological diseases are not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time of filing.
Claims 1, 6, 10-11, 16-17, and 49-55 are 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 treating ASD, Asperger’s syndrome, and fragile X syndrome by administering IL17a, IFNγ, anti-CD3, or combinations thereof, does not reasonably provide enablement for treating these diseases by administering IL-25. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Note, the rejection of record applied to Claims 1-6, 8-11, 13, 16-17, and 20, and now applies to Claims 1, 6, 10-11, 16-17, and 49-55 due to Applicant’s amendments.
As stated in the written description rejection above, the claims are directed to a method of treating ASD, Asperger’s syndrome, or Fragile X syndrome by administering IL-25. However, the specification provides no examples or guidance that teach the therapeutic activity of IL-25 in any of these disease settings. Given that the nature of the claims is in vivo treatment, a person having ordinary skill in the art would have to perform multiple further experiments, in human clinical trials or in animal models, that are predictive of treatment in a representative number of the neurodevelopmental disorders by administering IL-25 in order to demonstrate the invention could be used with a reasonable expectation of success.
Applicant's arguments filed October 27, 2025 have been fully considered but they are not persuasive. Applicant argues that the amended claims are enabled by the disclosure. Examiner maintains that no guidance is provided for a method of treating neurological disorders by administering IL-25. Undue experimentation would be required by one of ordinary skill to test the therapeutic activity of IL-25 in a representative number of neurodevelopmental disorder models. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim Rejections - 35 USC § 103 (New, necessitated by amendment)
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.
Claims 1, 6, 10-11, 16-17, 49, and 56-60 are rejected under 35 U.S.C. 103 as being unpatentable over Huh et al. US PGPub 2017/0326356 (of record) in view of Hofstetter et al. Cytokine 2006; Gupta et al. J Clin Immunol 2010; and Magid-Bernstein et al. Journal of Child Neurology 2015.
Huh teaches a method for treating a subject afflicted with ASD by administering agents that modulate (promote or inhibit) IL-17 activity wherein agents that promote IL-17 activity include recombinant IL-17a (paragraph [0006]). The recombinant IL-17a can be administered alone or in conjunction with agents that modulate (promote or inhibit) IFNγ activity wherein agents that promote IFNγ activity include recombinant IFNγ (paragraph [0006]). The agents can be administered by subcutaneous injection (paragraph [0087]).
Huh fails to teach wherein the IL17a and IFNγ can be administered in combination with an anti-CD3 antibody to treat ASD (Claims 1, 6, 10-11, 16-17, 49, and 56-60).
Hofstetter teaches that administration of an anti-CD3 antibody in vitro non-disease immune cells significantly stimulated the production of IL-17 (Fig. 1A, Fig. 1C, and results sections 3.1-3.2). The anti-CD3 administration also stimulated the production of IFNγ, just to a lesser extent (Fig. 1A and results section 3.1). Gupta teaches that administration of anti-CD3 plus anti-CD28 antibodies stimulated production of IL-17 in autism peripheral blood mononuclear cell as compared to control cells (Figure 1A). Gupta teaches that with the same experimental design, IFNγ increased slightly in the autism groups but did not show a statistically significant change (Figure 1B). Magid-Bernstein teaches the administration of anti-CD3 and anti-CD28 antibodies to peripheral blood mononuclear cells from ASD patients significantly increased the production of IFNγ as compared to a control patient, and the levels of IL-17 did not change significantly (Table I – Twin B, results paragraph 1). Together, the art teaches that anti-CD3 antibodies are known to stimulate production of IL-17 and IFNγ both in non-disease settings and in ASD.
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of treating ASD taught by Huh to further include the administration of an anti-CD3 antibody as taught by Hofstetter, Gupta, and Magid-Bernstein. Huh teaches that agents that promote IL-17a can be used in combination with agents that promote IFNγ to treat ASD. Hofstetter, Gupta, and Magid-Bernstein teach that anti-CD3 antibodies are known to promote IL-17 and IFNγ in ASD settings. One of ordinary skill could have combined the administration of IL-17a, IFNγ, and anti-CD3, and in combination, each agent merely performs the same function as it does separately (promoting IL-17 and IFNγ to induce an ASD therapeutic effect). Because Huh specifically teaches the combination of multiple agents to treat ASD, the results of the combination would be predictable. The motivation to add an anti-CD3 antibody to the method of treatment is to further stimulate IL-17 and IFNγ to effectively treat patients with ASD.
Conclusion
No claim is allowed.
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 SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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, Jeffrey Stucker can be reached on (571) 272-0911. 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.
/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675