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 .
Status of the Claims
Claim 2 is canceled and new claim 21 is presented, thus claims 1 and 3-21 are pending in the response filed 3/16/26.
Election/Restrictions
Applicant’s election of Group II and the species
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and Alzheimer’s in the reply filed on 3/16/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The search for the treatment of Alzheimer’s with the elected compound was found to be free of the art. The search was extended to the genus of compounds for Alzheimer’s, and did not result in art. The search was further extended to the species within claim 15, and was found to be free of the art.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/16/26.
It is noted that claim 20 is not subject to rejoinder should the claims be fully in condition for allowance.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-14, 18, 19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BOWEN (WO 2021/042178 A1, IDS 9/7/23). Additionally, Claim(s) 1, 3-14, 18, 19, and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by BOWEN (WO 2021/042178 A1).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The instant claims are drawn generally to a method of treating/preventing aggression, irritability, and/or anger in a subject comprising administration of a compound of formula I, such as
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.
Bowen teaches treatment of opioid withdrawal with the compounds of formula I (e.g. claim 1), where the compound is
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(e.g. claim 3), where the symptoms include, irritability, restlessness, anxiety, and others (e.g. claim 12) as well as the compound for use in treating opioid withdrawal and/or a symptom associated with withdrawal (e.g. claim 14). The doses administered are equivalent to those provided in the instant specification as effective doses (e.g. page 28 of Bowen). Administration is by any suitable means, including IV, parenteral, infusion, injection, and others (e.g. page 27). Opioid use is considered chemical injury to the brain, or causes injury to the brain, in that it causes physical dependence and results in abuse from both recreational and therapeutic use. And replacement opioids result in side effects when discontinued (page 2). Administration is concurrent with the last dose of opioid (e.g. claim 5), prior to cessation (claim 6), and thus administration would necessarily “prevent” the anger/aggression/irritation. It is noted that claims such as 11-14 limit the subset of conditions, but do not require selection of those conditions, thus the application of the compound in the context of opioid withdrawal is applicable.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-8, 17-19, and 21 is/are rejected under 35 U.S.C. 103 as being obvious over MCGREGOR (WO 2020/102857 A1, IDS 9/15/25).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The instant claims are drawn generally to a method of treating/preventing aggression, irritability, and/or anger in a subject comprising administration of a compound of formula I, such as
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where the aggression/agitation/irritation is associated with/caused by a condition such as Prader-Willi syndrome.
McGregor teaches treating obesity with the instantly claimed compounds, where the subject might be at risk of becoming overweight, or be obese, and the excess food consumption is from a disorder such as Prader-Willi syndrome (e.g. page 3, page 44). McGregor teaches the effective doses are the same as those instantly taught to be effective (e.g. page 39) and is formulated in conventional formulations for intravenous, infusion, implantation for parenteral, topical and other routes of administration (e.g. page 38).
It would have been obvious to have treated a patient with Prader-Willi syndrome with the compounds such as
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to treat obesity or the risk of becoming obese, as McGregor states the patient population is contemplated as one that would benefit. In treating these patients, one would necessarily be preventing any agitation/aggression/irritation associated with the Prader-Willi syndrome.
Allowable Subject Matter
Claims 15 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
While the art, as described above, teaches the compounds and uses for various methods of treatment, it does not teach the use for treating aggression, agitation, and/or anger associated with, or caused by, the conditions of claim 15. The claims amount to a new use of an old product, and the prior art does not contain a nexus between the conditions previously treated and those instantly claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew D Kosar whose telephone number is (571)272-0913. The examiner can normally be reached Monday-Friday, 7am-3:30pm.
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, Jennifer Michener can be reached at 571-272-1600. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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