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 has PRO 63/531,020 (08/07/2023)
This application is a CIP of 16/134,723 (09/18/2018 ABN)
16/134,723 is a CON of 16/039,134 (07/18/2018 PAT 10561650)
16/134,723 is a CON of PCT/US2017/033234 (05/18/2017)
16/039,134 is a DIV of 15/241,308 (08/19/2016 ABN)
PCT/US2017/033234 has PRO 62/390,438 (03/29/2016)
PCT/US2017/033234 has PRO 62/390,081 (03/18/2016 ABN)
15/241,308 is a DIV of 13/815,664 (03/14/2013 ABN).
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, including Application Nos. 63/531020 62/390081, 62/390438, 13/815664, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. None of the prior filed applications support the current claim language of “composition for promoting NR4A2 (nurr1) activity”, for example. While NR4A2 is referred to in some of the documents, there is no clear teaching of a composition for promoting such activity. Thus, one of skill in the art would not recognize possession of the claimed invention from the prior-filed applications. Accordingly, claims 1-27 are not entitled to the benefit of the prior application.”). The priority date is that of the filing date of the instant application: 8/6/2024.
Drawings
The drawings filed 8/6/24 are objected to for not conforming to the requirements of 37 CFR 1.84(u)(1) (“View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.”). MPEP 608.02.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-27 rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 uses the term “derivatives” “metabolites” “analogs” and “isomers” which are not sufficiently defined in the claim or the specification and would be ambiguous and confusing to one of skill in the art due to the vague and unclear meaning. In addition, the claim uses “its” in a manner which adds ambiguity: “said composition comprises an aminopyridine, its derivatives, its metabolites, its analogs, and/or its isomers”.
Regarding the guidance in the specification, derivative has no definition, and only has exemplary language (p.3 “any of their analogs, any of their derivatives, any pro-drugs or active metabolite(s)-whether naturrally [sic] occurring or synthetically derived.”; p. 10; p. 68). “Analogs” has an unclear definition/meaning (p. 9: “By "analog" is meant a molecule that is not identical, but has analogous functional or structural features.”). “Metabolites” and “isomers” have no definition or examples. Based on the available definitions, one of skill in the art would not be apprised of the scope of what is and what is not a “derivative” or “analog” or “metabolite” or “isomer” in the claim. For example, isomer can mean positional isomer or structural isomer and one of skill the art would find the claim ambiguous as to which is included in the scope. Thus, the claims are rejected as indefinite.
For purposes of examination the claims language is interpreted broadly - derivate is interpreted as “any compound derived from”, isomer is interpreted as including both positional, structural, and constitutional isomers, analogs is interpreted as any non-identical compound with analogous features.
Claim 26 has “wherein the composition comprises one or more second agent, compound or drug selected from a drug class represented by one or more of the following exemplars: … ” “Mg” “Odt” “Osi” “T4” “Tts” “Wafer” “With” “Women” “Wound” “Xr”, etc., which are not defined in the specification or have a clear meaning as a drug class exemplar.
Claim 27 has “wherein the composition comprises one or more second agent, drug, compound or extract derived from an oil or extract in the classes represented by the following exemplars: … ” “Availability;” “Tamanu (Foraha Oil; Tangerine Murcott; Tansy, Blue; Tea Tree; Thyme ct Linalool;” etc., which are unclear, not defined in the specification and would be confusing to one of skill in the art.
Claim Rejections - 35 USC § 102
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.
Claims 1-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lesuisse et al. (Bioorganic & Medicinal Chemistry Letters 29 (2019) 929–932).
Lesuisse teaches aminopyridine derivative or isomer or analog compounds used as agonists of NURR1 (abstract, p. 930,932).
Regarding the product claim “wherein” clauses, these properties are considered inherent in the product and inseparable. MPEP 2112.01 (“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.). Regarding the claim “further comprises” a “natural compound” – Lesuisse teaches the same combination under a BRI of the term.
Regarding method claim 22 which “comprises treatment … with a composition comprising”, Lesuisse teaches treating cells and mice with the same product. Similarly with the product claims, the method “wherein” clauses use the same composition with properties that are considered inherent in the product and inseparable. MPEP 2112.01.
Regarding claim 26 “wherein the composition comprises one or more second agent, compound or drug selected from a drug class represented by one or more of the following exemplars: … ”, Leuisse teaches “With” as a composition administered to mice and cells which anticipates. Regarding claim 27 “wherein the composition comprises one or more second agent, drug, compound or extract derived from an oil or extract in the classes represented by the following exemplars: … ”, Leuisse teaches water as a compound derived from which anticipates.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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