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
This application claims priority to U.S. provisional applications 63/322,868, filed on 27
April 2022. The effective filing date is 27 April 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 31 October 2025, 28 May 2025, 02 January 2025, 31 October 2024, 29 August 2024, 09 July 2024, 07 June 2024, 16 January 2024, 27 September 2023, and 28 August 2026 are being considered by the examiner.
Status of Application, Amendments, and/or Claims
Claims 1-24 are the original claims filed on 27 April 2024. In response to the office action filed on 04 March 2026, claims 2, 3, 5, 17, 18, and 21 were cancelled, claims 1, 4, 6-8, 19, and 22-24 were amended, and claims 25 and 26 were added. Claims 1, 4, 6-16, 19, 20, and 22-26 are pending and the subject of this office action.
Withdrawn Objections/Rejections
In the office action of 11 February 2026, the examiner noted that the application did not meet the requirements of 37 CFR 1.821 - 1.825, regarding nucleotide and/or amino acid sequence disclosure. The applicant has amended the application to meet these requirements.
Claims 1, 9, and 12-15 were rejected 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US20190169264 A1 (herein Sternson). As a result of the amendments, in which additional limitations were added to the independent claim, these rejections have been withdrawn.
Claims 1, 9-16, and 20 were rejected under 35 U.S.C. 103 as being unpatentable over US20190169264 A1 (herein Sternson) in view of WO2021035179 A1 (herein Lau), and Rössger K, et al. (2013) A closed-loop synthetic gene circuit for the treatment of diet-induced obesity in mice. Nat Commun. 2013;4:2825 (herein Rössger) with Kern KA, et al. (2020) Distributed amylin receptor signaling and its influence on motivated behavior. Physiol Behav. 2020 Aug 1;222:112958 (herein Kern) providing additional evidentiary value. The applicant has amended these claims to recite specific ingested substances. Considering the amendments made, the applicant’s arguments that the cited prior art failed to explicitly teach chemogenetic receptors that bind ligands associated with any of the ingested substances listed in the relevant claims, were found to be compelling, and as a result the prior rejections have been removed.
Claims 2-8, 17-19, and 21-24 were rejected under 35 U.S.C. 103 as being unpatentable over US20190169264 A1 (herein Sternson) in view of WO2021035179 A1 (herein Lau), and Rössger K, et al. (2013) A closed-loop synthetic gene circuit for the treatment of diet-induced obesity in mice. Nat Commun. 2013;4:2825 (herein Rössger) with Kern KA, et al. (2020) Distributed amylin receptor signaling and its influence on motivated behavior. Physiol Behav. 2020 Aug 1;222:112958 (herein Kern), Magnus CJ, et al. (2019) Ultrapotent chemogenetics for research and potential clinical applications. Science. 2019 Apr 12;364(6436) (herein Magnus (2019)), Magnus CJ, et al. (2011) Chemical and genetic engineering of selective ion channel-ligand interactions. Science. 2011 Sep 2;333(6047):1292-6 (herein Magnus (2011)), and Volkow ND, et al. (2019) The Neuroscience of Drug Reward and Addiction. Physiol Rev. 2019 Oct 1;99(4):2115-2140 (herein Volkow) providing additional evidentiary value. Claims 2, 3, 5, 17, 18, and 21 were cancelled, rendering the rejections moot. The applicant has amended these claims to recite specific ingested substances. Considering the amendments made, the applicant’s arguments that the cited prior art failed to explicitly teach chemogenetic receptors that bind ligands associated with any of the ingested substances listed in the relevant claims, were found to be compelling, and as a result the prior rejections have been removed.
Claims 1-24 were rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 130-138, 161, and 164-172 of U.S. Patent No. 10961296 in view of in view of WO2021035179 A1 (herein Lau), and Rössger K, et al. (2013) A closed-loop synthetic gene circuit for the treatment of diet-induced obesity in mice. Nat Commun. 2013;4:2825 (herein Rössger) with Kern KA, et al. (2020) Distributed amylin receptor signaling and its influence on motivated behavior. Physiol Behav. 2020 Aug 1;222:112958 (herein Kern) providing additional evidentiary value. However, after considering the applicant’s arguments, regarding the 35 U.S.C. 103 rejections, it has been decided that these rejections should also be withdrawn, as they relied on a similar application of prior art teachings, which the applicant has compelling argued against.
Claims 1-24 were provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-17 of co-pending Application No. 18/834135 in view of in view of WO2021035179 A1 (herein Lau), and Rössger K, et al. (2013) A closed-loop synthetic gene circuit for the treatment of diet-induced obesity in mice. Nat Commun. 2013;4:2825 (herein Rössger) with Kern KA, et al. (2020) Distributed amylin receptor signaling and its influence on motivated behavior. Physiol Behav. 2020 Aug 1;222:112958 (herein Kern) providing additional evidentiary value. However, after considering the applicant’s arguments, regarding the 35 U.S.C. 103 rejections, it has been decided that these rejections should also be withdrawn, as they relied on a similar application of prior art teachings, which the applicant has compelling argued against.
The following rejections remain.
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.
WRITTEN DESCRIPTION
Claims 1, 4, 7, 9-16, 19, 20, and 23, and 25-26 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 1, 4, 7, 12-16, 19, 20, and 23, and 25-26 refer to chemogenetic receptors, cells comprising said chemogenetic receptors, or methods comprising the administration of said cells, in which the chemogenetic receptor comprises a ligand binding domain, wherein “the LBD has been engineered to bind a ligand associated with an ingested substance whose ingestion results in reinforcing behavior, wherein the ingested substance is a nutrient substance or a substance selected from cocaine or a cocaine metabolite, methylphenidate, an amphetamine, a cathinone, and an opioid.” These claims encompass a broad genus of receptors, but the applicant has only provided examples of such receptors, capable of binding cocaine, amphetamines, and opioids, which represent only a fraction of the claimed subject matter (Tables 3, 4, and 6). These receptors were obtained through high-throughput screening of mutated receptors against a library or addictive drugs, metabolites, and endogenous agonists (Examples 2 and 3). It is not evident from the prior art or the current application that a structure-function relationship is known, that would allow the design of receptors, capable of performing the claimed function (i.e. binding cathinones, methylphenidates, or nutrient substances), without the implementation of extensive screens for mutants possessing the desired properties. The closest prior art, Magnus CJ, et al. (2019) Ultrapotent chemogenetics for research and potential clinical applications. Science. 2019 Apr 12;364(6436):eaav5282 (herein Magnus), US20190169264 A1 (herein Sternson 2019) and US 2018/0009862 A1 (herein Sternson), also teach similar screening strategies and do not provide the necessary structure-function relationship (Sternson-Examples 1 and 2 pages 15 and 16, Magnus-Engineering channel sensitivity to clinically used drugs). Thus, it is not clear from the specification that the applicant was in possession of receptors capable of binding cathinones, methylphenidates, or nutrient substances (claims 1, 4, 7), or cells and methods comprising said receptors (claims 12-16, 19, 20, and 23), nor was it clear that the applicant was in possession of such receptors that also satisfy the structural/functional/efficacy limitations established in claims 9-11, 25 and 26. It should be noted that the applicant does provide an example of neuromodulation of neurons by fatty acids (Figure 12 and [0087]). However, this example is simply a wild-type receptor (GPR40 or FFA1) that was expressed as a trans-gene in hippocampal neurons and does not align with the claim limitations defining the current invention. Critically, instant claim 1 defines that the receptor is engineered, but the provided example is simply the wild-type receptor, and as such fails to meet a limitation shared between all claims of the current application. Thus, this example does not satisfy the written description requirement, as it is simply a wild-type receptor being expressed as a transgene and binding its native ligands, which does not align the claimed limitations that define the current invention.
Allowable Subject Matter
Claims 6, 8, 22, and 24 are objected to as being dependent upon rejected base claims, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW CURRAN METCALF whose telephone number is (571)272-5520. The examiner can normally be reached 7:30AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at (571)272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW CURRAN METCALF/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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