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 is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.1
Status of Claims
Claims 1-21 are pending. Claims 1, 5, 7-13 and 21 are under examination. As detailed previously, Applicant’s election of species without traverse was acknowledged.
The species elected are those psychiatric disorders of claim 5, autistic spectrum disorder, a social anxiety disorder, a depressive disorder (major depressive disorder), and schizophrenia and compound species:
PNG
media_image1.png
114
102
media_image1.png
Greyscale
Compound (xliv):.
Claims 2-4, 6 and 14-20 are withdrawn
Response to Arguments
Applicant’s arguments, filed 4/3/2026, with respect to Claims 5, 10 and 11 rejected under 35 U.S.C. 112(b) have been fully considered and are persuasive.
Specifically, claim 5 was amended to delete reference to the narrower statement of “including major depressive disorder” in reference to the broader recitation of “depressive disorder.” Further, Applicant successfully argued a person skilled in the art would not consider schizophrenia is a narrower embodiment of the broader recitation of “depressive disorder.”
Further, Applicant’s amendment of claims 10 and 11 to properly define the substituents of the cyclic structure are “at X” overcomes the previous rejection.
The rejection of Claims 5, 10 and 11 has been withdrawn.
Applicant’s arguments, filed 4/3/2026, with respect to Claims 1, 5, 7 and 9-13 rejected under 35 U.S.C. 102(a)(1) as by WO 2006/021213 have been fully considered and are persuasive.
The Attorney argument that compound 150 is not within the scope of claim 1, formula I is not convincing. For the record, claimed formula I discloses
PNG
media_image2.png
314
274
media_image2.png
Greyscale
where R1, R2 and R3 are H,
X is a cyclic structure, such as unfused cycloalkyl (cyclohexyl), where X is substituted with X1;
X1 is substituted C1-C4 alkyl, such as methyl substituted with NH2, in a pharmaceutically acceptable form (i.e., a salt). This embodiment of claim 1 is compound 150 of WO 213 and therefore within the scope of the claimed compounds.
Additionally, claimed formula I discloses
where R1 and R3 are H,
R2 is alkyl (methyl),
X is a cyclic structure, such as unfused cycloalkyl (cyclohexyl), where X is substituted with X1;
X1 is substituted C1-C4 alkyl, such as methyl substituted with NH2, in a pharmaceutically acceptable form (i.e., a salt). This embodiment of claim 1 is compound 149 of WO 213 and therefore within the scope of the claimed compounds. See below.
PNG
media_image3.png
376
410
media_image3.png
Greyscale
While both prior art compounds 149 and 150 are within the scope of claimed formula I, this disclosure of the two compounds is NOT anticipatory as follows.
The Attorney persuasively argues that compounds 150 and an additional compound, E75, are intermediate compounds for synthesis of final product therapeutic compounds, and therefore not anticipatory of the claimed therapeutic method. See page 206, scheme where Example E75 teaches compound E75 as an intermediate. See also Example E16.1 on page 47, where compound 150 is used as a synthesis intermediate. Therefore, compounds 150 and E75 are not anticipatory for the claimed therapeutic use.
With regard compound 149, the Attorney response states it is outside the claimed scope. This is not the case, however, similar to compounds 150 and E75, compound 149 is used as a synthesis intermediate and therefore not anticipatory for the claimed therapeutic use, see Examples E13 (page 45), E18 (page 48) and E24 (page 41).
The Attorney arguments that compounds 30, 31 and 151-156 of WO 2013 are no longer in scope of the examined compounds of amended claim 1 are persuasive and overcome the novelty rejection. The rejection of Claims 1, 5, 7 and 9-13 has been withdrawn.
Applicant’s arguments, filed 4/3/2026, with respect to Claims 1, 5, 7, and 10-12 rejected under 35 U.S.C. 102(a)(1) as by Frantz have been fully considered and are persuasive. As argued by the Attorney response, claim1 is amended to recite that X may only be substituted by X1, and further that the substituents of each alkyl, alkenyl, alkynyl, alkaryl, or alkyl-heterocyclyl is a closed group, recited therein. Thus, the compounds of Frantz are not encompassed by formula I.
The rejection of Claims 1, 5, 7, and 10-12 has been withdrawn.
Terminal Disclaimer
The terminal disclaimer filed on 4/3/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 11,491,165 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 7-13 and 21 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.
Claims , 5, 7-13 and 21 are directed to treating or preventing a broad scope of disorders and conditions with a broad scope of non-peptide oxytocin receptor agonists of formula I. The specification does not enable any person having ordinary skilled in the art (PHOSITA) to which it pertains, or with which it is most nearly connected, to practice the invention.
Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set eight forth factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The predictability or unpredictability of the art:
The instant claimed invention is highly unpredictable since a PHOSITA recognizes the unpredictability in the treatment and prevention of the claimed psychiatric disorders of the scope of claim 1, as recited by claim 5.
The claimed method broadly claims to prevent any psychiatric disorders. However, even with preventing a single specific subject in need suffering from autism spectrum disorder, the art notes the unpredictability to do so., See Mayo clinic website, Autism Spectrum Disorder, Section Prevention. “There's no known way to prevent autism spectrum disorder.”2
Similarly, the Mayo Clinic website notes there is no way to prevent schizophrenia3 (Section Prevention) or depression (Major Depressive Disorder, section Prevention)4.
Further, the claimed compounds are oxytocin agonists where their use to treat the disorders of claim 5 is unpredictable.
With regard to autism, Sikich et al.5 reports on a “placebo-controlled trial of intranasal oxytocin therapy in children and adolescents with autism spectrum disorder [that] showed no significant between-group differences in the least-squares mean change from baseline on measures of social or cognitive functioning over a period of 24 weeks.” See abstract, Section Conclusions.
With regard to social anxiety disorder (SAD), Voncken et al.6 notes the unpredictability of oxytocin treatment, where it states “improvement [of oxytocin-induced improvement of observer-rated social behavior in SAD patients compared to placebo] seemed context-dependent (i.e., only present in the getting-acquainted task) and ‘not perceived by the patient.” See abstract.
Slattery and Neumann7 teaches despite the therapeutic potential of oxytocin (OXT) in at least some subsets of major depressive disorder (MDD) patients, “the studies to date are not conclusive with regard to the role of OXT in the aetiology and potential treatment of MDD.” See Section Conclusions, page 714.
Sabe et al.8 teaches with regard to treating schizophrenia with intranasal oxytocin, “[t]he present results show no consistent beneficial effect of intranasal oxytocin for the treatment of negative and positive symptoms.” See abstract
Accordingly, the unpredictability in the art is a Wands factor against enablement of the claims.
The breadth of the claims:
The instant claims are deemed broad since these claims read on treatment of any social dysfunction (unelected), substance abuse disorder (unelected) and a psychiatric disorder (elected) with the broad scope of compounds of Formula I.
The broad scope is a Wands factors weighing against enablement of the claims.
The amount of direction or guidance presented, and the presence or absence of working examples:
It has been established that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970).
It is pointed out that there is no working example, either in vivo or in vitro to enable the treatment any of the psychiatric disorders claimed by Applicant.
Starting at paragraph 223, the specification details a method of testing the selectivity of compounds of Formula I in vitro with Human Embryonic Kidney (HEK) Cells. At paragraphs 228-229, the specification notes the testing of a single compound WJ0679 on mice test subjects for social interaction. The single compound cannot enable either the full scope of formula I, or the claimed invention’s disorders to be treated.
The lack of working examples is Wands factor against the enablement of claimed invention.
PNG
media_image4.png
292
198
media_image4.png
Greyscale
Therefore, in view of the Wands factors as discussed above, Applicant fails to provide information sufficient to practice the claimed invention as claimed.
Conclusion and Correspondence
In summary no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. 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.
/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 The present application is a continuation of parent application, 16439570, which in turn is a continuation of International Application PCT/AU2017/051371. Priority to the earlier filed foreign patent (AU 2016905126, filed 12.12.2016) was perfected in International Application PCT/AU2017/051371.
2 See Mayo Clinic website, Autism Spectrum Disorder, accessed June 2, 2026. https://www.mayoclinic.org/diseases-conditions/autism-spectrum-disorder/symptoms-causes/syc-20352928
3 See Mayo Clinic website, Schizophrenia, accessed June 2, 2026. https://www.mayoclinic.org/diseases-conditions/schizophrenia/symptoms-causes/syc-20354443
4 See Mayo Clinic website, Depression (major depressive disorder) - Symptoms and causes - Mayo Clinic https://www.mayoclinic.org/diseases-conditions/depression/symptoms-causes/syc-20356007
5 Sikich et al. Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder Published October 13, 2021 N Engl J Med 2021;385:1462-1473 DOI: 10.1056/NEJMoa2103583 VOL. 385 NO. 16 (Funded by the National Institute of Child Health and Human Development; SOARS-B ClinicalTrials.gov number, NCT01944046.)
6 Voncken et al. The effect of intranasally administered oxytocin on observed social behavior in social anxiety disorder European Neuropsychopharmacology Volume 53, December 2021, Pages 25-33
7 Slattery and Neumann Oxytocin and Major Depressive Disorder: Experimental and Clinical Evidence for Links to Aetiology and Possible Treatment Pharmaceuticals (Basel). 2010 Mar 16;3(3):702–724. doi: 10.3390/ph3030702
8 Sabe et al. Intranasal Oxytocin for Negative Symptoms of Schizophrenia: Systematic Review, Meta-Analysis, and Dose-Response Meta-Analysis of Randomized Controlled Trials International Journal of Neuropsychopharmacology, Volume 24, Issue 8, August 2021, Pages 601–614, https://doi.org/10.1093/ijnp/pyab020
Prosecution Insights