DETAILED ACTION
A non-final Office action was mailed 3 November 2025 (“Office Action”).
Applicant’s reply to the Office Action was received 3 February 2026 (“Reply”).
Information Disclosure Statement
The information disclosure statement (IDS) submitted 3 February 2026 is acknowledged and has been considered.
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1, 3, 4, 10–12, 21–23, and 30–41 are pending.
Claims 2, 5–9, 13–20, and 24–29 are canceled.
Claims 1, 3, 4, 10, 12, 21, 23, and 30–33 are amended.
Claims 34–41 are new.
Claims 3, 4, 34, 36, 38, and 39 are withdrawn.
Examiner has updated the prior art search in view of the claim amendments, and any claim rejections or objections are set forth below. The updated status of the withdrawn claims is:
Claims 3 and 4 remain withdrawn.
Claims 34, 36, 38, and 39 are rejoined and have been examined herein.
Status of Rejections and Objections
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
In the Office Action, claims were rejected as anticipated and/or obvious based on Rosen compound RN 2668959-08-6, having the structure:
PNG
media_image1.png
295
475
media_image1.png
Greyscale
. The Office Action referred to compound RN 2668959-08-6 in the citation as compound 10; however, the citation should have referred to compound 14. While Applicant’s remarks focus on compound 10, the claims have been amended to include a proviso that excludes compound 14 (when B is unsubstituted 4-pyridinyl, then A is not 3-(3-tolyl)-pyrazol-1-yl).
Response to Arguments
Applicant’s arguments submitted with the Reply have been fully considered. Because the new grounds of rejections herein do not rely on the same basis or theory that was applied in a rejection in the Office Action, the arguments are considered moot.
Claim Rejections - 35 U.S.C. § 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.
Claim 11 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 11 depends on claim 10 and recites “said heteroaryl.” Amended claim 10 does not recite “a heteroaryl.” Accordingly, there is insufficient antecedent basis for using definite article “the” because there is no preceding recitation of indefinite article “a” or “an.”
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(ii) Claim 21 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 21 depends on claim 1, which states: “A is pyrazole substituted with an optionally substituted phenyl.”
Claim 21 includes a compound without a phenyl-substituted pyrazole,
PNG
media_image2.png
294
271
media_image2.png
Greyscale
.
Claim 21 is an improper dependent claim because it fails to incorporate all the limitations of the claim it depends from and then impose a further structural requirement.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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)(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, 10, 12, 22, 23, 30, 32, 33, and 40 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by WO2021/146192 (claiming the benefit of U.S. Prov. Pat. App. Serial Nos. 63/960,412, filed 13 January 2020, and 63/074,388, filed 3 September 2020) (“Rosen”) [IDS].
Rosen discloses Compound 13 having the structure:
PNG
media_image3.png
277
710
media_image3.png
Greyscale
(Rosen, ¶75).
Unlike Compound 14, which is excluded from the claim via proviso, Compound 13 does not have a 3-(3-toyl)-pyrazol-1-yl moiety and therefore reads on instant Formula I when:
A = 3-substituted-1-pyrazolyl and B = 4-pyridinyl.
Rosen discloses additional compounds that anticipate instant Formula I:
PNG
media_image4.png
119
599
media_image4.png
Greyscale
PNG
media_image5.png
59
599
media_image5.png
Greyscale
PNG
media_image5.png
59
599
media_image5.png
Greyscale
PNG
media_image6.png
116
598
media_image6.png
Greyscale
PNG
media_image7.png
124
599
media_image7.png
Greyscale
(Id.).
Rosen discloses pharmaceutical compositions comprising the compound. (Id., ¶¶76–102).
Rosen discloses methods of treating a disease or disorder, such as a neurological disease, comprising administering a compound or composition in the disclosure. (Id.).
Claim Rejections - 35 U.S.C. § 103
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.
Claims 1, 10–12, 21–23, 30–33, 36, and 40 are rejected under 35 U.S.C. § 103 as being unpatentable over Rosen.
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Rosen discloses Compound 14 (shown in rejection above).
Rosen also discloses Compounds 1, 3, 4, 8, and 10:
PNG
media_image8.png
62
602
media_image8.png
Greyscale
PNG
media_image8.png
62
602
media_image8.png
Greyscale
PNG
media_image9.png
33
599
media_image9.png
Greyscale
PNG
media_image9.png
33
599
media_image9.png
Greyscale
(Rosen, ¶75).
Each of Compounds 1, 3, 4, 8, and 10 have a phenyl moiety that is substituted with a methyl. The methyl substituent is either ortho, meta, or para to the pyrazole moiety.
Rosen discloses pharmaceutical compositions comprising the compound. (Id., ¶¶76–102).
Rosen discloses methods of treating a disease or disorder, such as a neurological disease, comprising administering a compound or composition in the disclosure. (Id.).
Ascertaining the differences between the prior art and the claims at issue
Claim 21 includes the compound
PNG
media_image10.png
192
161
media_image10.png
Greyscale
.
Rosen Compound 14 is a positional isomer of the claimed compound in which the methyl substituents on the respective phenyl moieties are meta and ortho to the pyrazole moiety.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include evidence showing an unexpected result for the claimed compound compared to Rosen Compound RN 2668959-08-6.
The question of obviousness
Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Rosen to arrive at the above-identified compound in claim 21 because Rosen discloses Compound 14, which is identical to that compound but for their respective methyl substituents being positional isomers on the phenyl moiety. One of ordinary skill in the art would have been motivated to modify Compound 14 to obtain positional isomers thereof, and would have had a reasonable expectation of success in doing so, because Rosen discloses Compounds 1, 3, 4, 8, and 10—each having a methyl substituent on the phenyl moiety positioned on the ortho, meta, or para positions of the phenyl. The compounds are disclosed as having the same utility (i.e., the treatment of one or more diseases or disorders). Considered as a whole, Rosen discloses and suggests positional isomers with respect to the methyl substituted on the phenyl group.
The examples and data in the specification has been considered, but there is no evidence of an unexpected property for the claimed isomer compared to Rosen Compound 14.
Allowable Subject Matter
Claims 34, 35, 37–39, and 41 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.
The compounds of Formula I when A = 1-substituted-3-pyrazole are not disclosed or suggested in Rosen or other prior art.
Summary
Claims 1, 10–12, 21–23, and 30–33, 36, and 40 are rejected.
Claims 34, 35, 37–39, and 41 are objected.
Claims 3 and 4 are withdrawn.
Conclusion
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 C.F.R. § 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 nonprovisional extension fee (37 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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 mailing date of this final action.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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 submit an Automated Interview Request: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
Prosecution Insights