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 .
DETAILED ACTION
This office action is in response to a request for continued examination received February 6th, 2026.
Status of Claims
Claims 1, 6-9, and 14-17 are pending in the instant application.
Claims 2-5 and 10-13 have been canceled.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the rejection of Claim 7 under 35 U.S.C. 112(b). This rejection is hereby withdrawn.
Applicant has canceled Claims 10-13, rendering the rejection thereof under 35 U.S.C. 112(a) moot. This rejection is hereby withdrawn.
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.
The rejection of Claim 9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained, because the specification, while being enabling for treating depression, does not reasonably provide enablement for prevention of depression or the prevention and treatment of anxiety disorders, obsessive-compulsive and behavioral disorders. 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.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a method for prevention and/or treatment of depression, anxiety disorders, obsessive-compulsive, and behavioral disorders.
Breadth of the invention:
The scope of the claimed invention is broad, as it is drawn to the prevention and/or treatment of any anxiety and behavioral disorder. This would be inclusive of anxiety and behavioral disorders presently known, or disorders discovered years from now, or known disorders classified later as anxiety and/or behavioral disorders. Can the Applicant simply “reach through” and gain patent protection for either disorders not presently known, or those disorders that are known presently, but are later classified under the umbrella of anxiety and/or behavioral disorders?
State of the prior art and predictability in the art:
Applicant points to the forced swim test (FST) and tail suspension test (TST) as evidence for the efficacy of the disclosed compounds in preventing and/or treating depression, anxiety disorders, obsessive-compulsive and behavioral disorders.
With regard to the FST, Della Valle et. al. (“Machine learning-based model for behavioural analysis in rodents applied to the forced swim test”, Scientific Reports, 2025; hereinafter referred to as Della Valle) represents the state of the art.
At the Abstract, Della Valle teaches the FST is widely used as a preclinical model for assessing antidepressant efficacy, studying stress response, and evaluating depressive-like behaviors in rodents.
At Page 2, second paragraph, Della Valle states “Over the years it has been amply demonstrated that the FST is sensitive to all major classes of antidepressant drugs which consistently reduce the amount of immobility time in the test by increasing active escape behavior.”
With regard to the TST, Can et. al. (“The Tail Suspension Test”, Journal of Visualized Experiments, 2012; hereinafter referred to as Can) represents the state of the prior art.
At the Abstract, Can teaches the TST is useful in the screening of antidepressant drugs, and that it is a valuable tool in drug discovery for high-throughput screening of prospective antidepressant compounds. Further, at Page 4, under Discussion, Can teaches that the TST is best validated for the evaluation of antidepressant efficacy of drugs.
Taken together, Della Valle and Can establish in the art the effectiveness of the FST and TST in evaluating the efficacy of compounds in treating depression. There is no suggestion in view of Della Valle and Can that these tests are suitable for evaluating the efficacy of compounds in preventing depression or treating and/or preventing anxiety disorders and obsessive compulsive and other behavioral disorders.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Beginning at Page 51 of the instant specification, Example 1 discloses the activity of the instantly claimed compounds in a 5-HTT reuptake activity assay. This assay demonstrates the efficacy of the instantly claimed compounds in inhibiting serotonin reuptake.
Beginning at Page 53 of the instant specification, Example 2 discloses the activity of the instantly claimed compounds as inhibitors of the 5-HT3 receptor.
Beginning at Page 55 of the instant specification, Example 3 discloses the activity of the instantly claimed compounds in a forced swimming test and tail suspension test in a mouse forced swimming model The results from these tests demonstrate the instantly claimed compounds can reduce immobility time of mice in these tests, demonstrating these compounds are effective after oral administration.
At Page 54 of the instant specification, first paragraph, Applicant states “antagonizing 5-HT3 receptors may cause de-inhibition, thereby increasing the release of neurotransmitters.” Further, at the first Paragraph of Page 55, Applicant states “it is expected that antidepressant drugs with 5-HT3R antagonism can alleviate the pain condition of patients with depression.” As noted in the office action mailed November 7th, 2025, these statements are speculative, and are not enabling for the treatment of disorders beyond depression.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As referenced above, a person having ordinary skill in the art would not readily ascertain from the instant disclosure the efficacy of the instantly disclosed compounds in treating disorders beyond depression. Therefore, a person having ordinary skill in the art would need not only to identify and/or develop metrics to determine the efficacy of the instantly claimed method of prevention and/or treatment of disorders beyond depression, but then to employ these methods with no assurance of success in the prevention and/or treatment thereof.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
Genentech Inc. v Novo Nordisk A/S (CAAFC) 42 USPQ2d 1001 states “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person having ordinary skill in the art would have to engage in undue experimentation to determine the efficacy of the instantly claimed method of prevention and/or treatment of a central nervous system disease, with no assurance of success.
Allowable Subject Matter
Claims 1, 6-8, and 14-17 are allowed.
Conclusion
Claim 9 is rejected.
Claims 1, 6-8, and 14-17 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624