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, 50-57 and 59-90 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of species a. wherein X = CH2 in the reply filed on 02/17/2026 is acknowledged.
The claims are drawn to multiple inventions for reasons set forth in the restriction requirement. The claims are examined only to the extent that they read on the elected invention. Cancellation of the non-elected subject matter (i.e. X = O) is recommended in response to this Office Action.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 46, 50-57 and 59-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 and 22-30 of U.S. Patent No. 8,952,030. Although the claims at issue are not identical, they are not patentably distinct from each other because the genus compound of formula(I) in the instant claim 46 is the same as the genus compound of formula (I) of patent ‘030. The instant claims are drawn to the treatment/prevention of stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression. The claims in patent ‘030 are drawn to compounds of formula (I), pharmaceutical composition and method of treating or preventing pain. Since there is overlap with the compounds and the fact that the instant claims are broad and include the treatment recited in patent ‘030, the nonstatutory double patenting rejection is proper.
Claims 46, 50-57 and 59-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-83 of U.S. Patent No. 10,442,802. Although the claims at issue are not identical, they are not patentably distinct from each other because the genus compound of formula(I) in the instant claim 46 is the same as the genus compound of formula (I) of patent ‘802. The species recited in claim 60 of patent ‘802 are the same species recited in instant claim 89. The instant claims are drawn to the treatment/prevention of stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression. The claims in patent ‘802 are drawn to compounds, antidepressants, anxiolytic agents, therapeutic agents, pharmaceutical composition and method of treating or preventing pain. Since there is overlap with the compounds and the fact that the instant claims are broad and include the treatment recited in patent ‘802, the nonstatutory double patenting rejection is proper.
Claims 46, 50-57 and 59-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,633,392. Although the claims at issue are not identical, they are not patentably distinct from each other because the species used in patent ‘392 are the same in the instant claims. The six species recited in claim 1 of patent ‘392 are the same species recited in instant claim 89. The instant claims are drawn to the treatment/prevention of stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression. The claims in patent ‘392 are drawn to the treatment of fibromyalgia-associated anxiety or depression that comprises administering six species that are part of formula (I) of instant claim 46. Since there is overlap with the compounds and the fact that the instant claims are broad and include the treatment recited in patent ‘392, the nonstatutory double patenting rejection is proper.
Claims 46, 50-57 and 59-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,109,209. Although the claims at issue are not identical, they are not patentably distinct from each other because the species used in patent ‘209 are the same in the instant claims. The species recited in claim 1 of patent ‘209 are the same species recited in instant claim 89. The instant claims are drawn to the treatment/prevention of stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression. The claims in patent ‘209 are drawn to the treatment of pain-associated anxiety or depression that comprises administering six species that are part of formula (I) of instant claim 46. Since there is overlap with the compounds and the fact that the instant claims are broad and include the treatment recited in patent ‘209, the nonstatutory double patenting rejection is proper.
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 46, 50-57 and 59-90 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 stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression, does not reasonably provide enablement for the prevention of said 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 stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression, 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 stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression 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 stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression. Dosage is generic to the disorders - same dosage for all disorders. There is no working example that proves the prevention of stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression.
(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 stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression.
(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 stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression.
(5). Nature of the Invention and Predictability: The invention is directed to treating or preventing of stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression. 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 stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression are especially unpredictable due to their complex nature of the disorders. Note that to this day, the only means available is the treatment of stress-related disorders, stress-induced anxiety disorders, or stress-related disorders or anxiety disorders associated with depression.
(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 getting said disorders in the first place.
(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 “preventing” as it was done in related case 16/33.373.
Claim Objections
Claims 46, and 59-90 are objected to because of the following informalities: The phrase “general formula (I)” is not specific. A formula has to be specific e.g. formula (A), formula I, formula (1), etc. and not general. It is recommended that applicants delete “general”.
Appropriate correction is required.
Information Disclosure Statement
12. Applicant’s Information Disclosure Statement, filed on 12/06/2024 and 11/22/2023 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
13. 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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/Kahsay Habte/
Primary Examiner, Art Unit 1624