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 . Claims 46, 51-57, 59-72 and 74-90 are pending in this application.
Response to Amendment
2. Applicant’s amendment filed 06/18/2026 in response to the previous Office Action (03/23/2026) is acknowledged. The nonstatutory double patenting rejection (items 5-8) has been obviated. Applicants have amended the claims to overcome the enablement rejection (item 10), but said amendment raises new issue that needs further rejection.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 46, 51-57, 59-72 and 74-90 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 the treatment of post-traumatic stress disorders, does not reasonably provide enablement for the prevention of post-traumatic stress 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 use the invention commensurate in scope with these claims. In claim 46, it is recited a method of preventing post-traumatic stress disorders, but the specification is not enabled for such a scope.
A number of factors are relevant to whether undue experimentation would be required to practice the claimed invention, including “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
(1). Breadth of Claims: Claims 46, 50-57 and 59-90 are directed to a method of treatment or prevention of post-traumatic stress disorders by administering a therapeutically effective amount of a selective δ-opioid receptor agonist to a subject in need thereof. The scope of use that applicants intend to treat let alone to prevent may well be very broad. The scope of the compounds is also broad. It is apparent that hundreds of millions of combinations of compounds can be created from the definitions, owing especially to broad scope of R1-R5, R6a, R6b, R8-R10 and Y.
(2). Direction of Guidance: The amount of direction or guidance is minimal. There is no guidance for the prevention of post-traumatic stress disorders. Dosage is generic to the disorders - same dosage for all disorders. There is no working example that proves the prevention of post-traumatic stress disorders.
(3). State of Prior Art: There is no evidence of record that compounds structurally similar to these δ-opioid receptor compounds of formula (I) are in use for the prevention of post-traumatic stress disorders.
(4). Working Examples: The opioid receptor function test (Evaluation of Agonist Activity) and data are disclosed at pages 116-123, but there is no way to convert this data into specific useful knowledge, especially in view of preventing post-traumatic stress disorders stress-related disorders.
(5). Nature of the Invention and Predictability: The invention is directed to treating or preventing of post-traumatic stress disorders. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Prevention of post-traumatic stress disorders stress-related disorders are especially unpredictable due to their complex nature of the disorders. Note that to this day, the only means available is the treatment of post-traumatic stress disorders and not the prevention of a healthy patient from having post-traumatic disorders in the first place.
(6). The Relative Skill of Those in the Art: The relative skill is extremely very low. To this day, there is no magic bullet that can prevent a healthy patient from said disorder.
(7). The Quantity of Experimentation Necessary: Immense, because of points (1), (2) and (6).
MPEP 2164.01(a) states, “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. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
It is recommended that applicants delete “prevention” as it was done in related case 16/333,373.
Information Disclosure Statement
5. Applicant’s Information Disclosure Statement, filed on 06/29/2026 and 11/22/2023 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
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 extension fee 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 date of this final action.
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624
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