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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/29/2026 has been entered.
Claims 5, 90, 93, 98, 100-101, 103 and 105-117 are currently pending.
Applicant’s election without traverse of the following species:
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which reads on a compound of formula (I) in claim 1, wherein: R3 is H, n is 0, R6 is substituted C6 hydrocarbon, Z is a C1 hydrocarbon, Q is -C(=O)-, X is O, R1 is -, Y is – and R2 is an unsubstituted heterocycle in the reply filed on 8/25/2025 has been acknowledged. The species had been searched and was found to be free of the prior art. Consistent with election of species practice for Markush claims, the examination of the Markush group will be extended. As set forth below, prior art has been found that anticipate or render obvious the Markush claim with respect to non-elected species.
Claims 5, 90, 93, 98, 101, 103, 110 and 114-115, read on the elected species and extended search, and are under consideration.
Claims 100, 105-109, 111-113 and 116-117 are withdrawn from consideration as being not included in the extended search.
Information Disclosure Statement
The information disclosure statement filed on 7/29/2026 is acknowledged and has been considered except where lined through.
Rejections Withdrawn:
The rejection of Claim(s) 5, 93 and 98 under 35 U.S.C. 102a(1) as being anticipated by The Reagents of the University of California (WO2019/006359A1, 2019-01-03, IDS) referred to herein as California is withdrawn in view of Applicants amendment.
The provisional rejection of Claims 5, 93 and 98 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 20, 23-24 of copending Application No. 18/725,732 (reference application) is withdrawn in view of Applicants amendments.
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Rejections Maintained, but amended in view of Applicants amendments:
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 5, 90, 93, 98, 101, 103 and 114-115 are rejected under 35 U.S.C. 103 as being unpatentable over The Reagents of the University of California (WO2019/006359A1, 2019-01-03, IDS) referred to herein as California.
California discloses compounds that are capable of inhibiting the mitochondrial pyruvate carrier and promoting hair growth, as well as, methods of promoting hair growth or treating conditions or disorders affecting hair growth, such as baldness or alopecia (abstract). With regards to the compounds, the WO document teaches that the compounds can have the general formula
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or
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, wherein 1 is an alkyl (see clims 41 and 42 of the WO document). Specifically, the WO document teaches exemplary compounds having the structures including, but not limited to, , ,
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,
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,
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and
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(see claim 53). Moreover, the WO document teaches that the compounds are preferably administered as pharmaceutical compositions comprising a compound and a pharmaceutically acceptable carrier (page 25).
The WO document differs from the instant claims by either shortening or elongation of the Et (ethyl) or substitution of the fused benzene ring for a fused pyridine ring.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the compounds taught by California by either shortening or elongating the Et or substituting the fused benzene ring for a fused pyridine ring. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-California teaches that both the fused benzene ring and fused pyridine ring are useful compounds for promoting hair growth.
-Moreover, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
In response to this rejection and the Examiners previous allegation that Applicant’s previously submitted evidence of secondary considerations is unpersuasive, Applicants contend that the concentration difference between the compound in Figure 1 is due to differences in recover efficiency from the skin homogenates, not the concentration of API or prodrug doses in the homogenates. Nevertheless, it is the ratio of prodrug (i.e., unhydrolyzed compound) to API (i./e., hydrolyzed compound) that is indicative of hydrolysis kinetics and concentration has no bearing on this ratio.
In response to Applicants remarks, the Examiner appreciates Applicants for clarifying the results of Figure 1, specifically regarding the concentration.
Moreover, Applicants contend that the scope of the claims has been amended to recite compounds wherein the position corresponding to R2 is optionally substituted heterocycle, ester-or carbonate-substituted C1 alkyl, ester-substituted C2 alkyl or branched 3-12 alkly which is a reasonable generalization of the compounda in figure 1(e.g. ester-carbonate-substituted C1 alkyl corresponds to PP20, PP24 and PP29, optionally substituted heterocycle corresponds to PP21, ester-substituted C2 alkyl corresponds to PP30 and branched alkyl corresponds to PP12).
These arguments have been carefully considered, but are not found persuasive.
In response to these arguments, the Examiner would like to point out that the majority of Applicants arguments appear to be regarding unexamined species. As noted in the previous office action, the instant rejection is based on an obviousness analysis to modify the compounds taught by California by shortening or elongating the Et or substituting the fused benzene ring for a fused pyridine ring. It is noted that the following compounds from the specification appear to correspond to the modifications addressed in the obviousness rejection: PP5 (CH3), PP9 (propyl), PP11 (butyl), and PP15(octyl). All other specific compounds taught in the specification are not within the scope of the obviousness rejection other than
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which would be a substitution of the fused benzene for a fused pyridine and would read on wherein R2 is a branched alkyl, e.g. t-butyl, but is not an example within the specification. Thus, while the examiner acknowledges Applicants alleged unexpected results for these structurally different compounds, it does not appear that Applicants have provided any explanation of how these results would also extend to elongation or shortening of the alkyl chain of California or substitution of the fused benyl ring for a fused pyridine ring (in the case of the R2 is a branched alkyl). Regarding the branched alkyl, Applicants have not provided any evidence that a fused benzene would act any differently than a fused pyridine as claimed. Moreover, Applicants are reminded that position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
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 5, 90, 93, 98, 101, 103 and 114-115 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,213,513 to Lowry et al. (2022-01-04) in view of The Reagents of the University of California (WO2019/006359A1, 2019-01-03, IDS).
US Patent No 11,213,513 claim a method of accelerating, promoting, or restoring hair growth, comprising administering to a subject in need thereof an effective amount of a compound of formula (I):
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or a pharmaceutically acceptable salt thereof.
The US Patent differs from the instant application is that the fused benzene is substituted with a fused pyridine.
California discloses compounds that are capable of inhibiting the mitochondrial pyruvate carrier and promoting hair growth, as well as, methods of promoting hair growth or treating conditions or disorders affecting hair growth, such as baldness or alopecia (abstract). With regards to the compounds, the WO document teaches that the compounds can have the general formula
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or
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, wherein 1 is an alkyl (see clims 41 and 42 of the WO document). Specifically, the WO document teaches exemplary compounds having the structures including, but not limited to, , ,
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and
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(see claim 53). Moreover, the WO document teaches that the compounds are preferably administered as pharmaceutical compositions comprising a compound and a pharmaceutically acceptable carrier (page 25).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the compound claimed by the US Patent by either shortening or elongation of the Et (ethyl) or substituting the fused benzene ring for a fused pyridine ring in view of the teachings of California. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-California teaches that both the fused benzene ring and fused pyridine ring are useful compounds for promoting hair growth.
-Moreover, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
In response to this rejection, Applications reiterate that one of ordinary skill in the art would not have predicted the unexpected results associated with the compounds recited in the instant claims in view of the teachings of California.
These arguments have been carefully and not found persuasive for the reasons set forth above and incorporated herein.
Claims 5, 90, 93, 98, 101, 103 and 114-115 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US11,472,804B2 to Lowry et al. (2022-10-18) in view of The Reagents of the University of California (WO2019/006359A1, 2019-01-03, IDS).
The US Patent claims
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. Moreover, as taught in the US Patent, teaches a method of promoting hair growth or treating conditions or disorders affecting hair growth with the compounds (abstract).
California discloses compounds that are capable of inhibiting the mitochondrial pyruvate carrier and promoting hair growth, as well as, methods of promoting hair growth or treating conditions or disorders affecting hair growth, such as baldness or alopecia (abstract). With regards to the compounds, the WO document teaches that the compounds can have the general formula
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or
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, wherein 1 is an alkyl (see clims 41 and 42 of the WO document). Specifically, the WO document teaches exemplary compounds having the structures including, but not limited to, , ,
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and
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(see claim 53). Moreover, the WO document teaches that the compounds are preferably administered as pharmaceutical compositions comprising a compound and a pharmaceutically acceptable carrier (page 25).
The WO document differs from the instant claims by either shortening or elongation of the Et (ethyl) or substitution of the fused benzene ring for a fused pyridine ring.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the compounds claimed by US Patent by either shortening or elongating the Et or substituting the fused benzene ring for a fused pyridine ring. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-California teaches that both the fused benzene ring and fused pyridine ring are useful compounds for promoting hair growth.
-Moreover, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
In response to this rejection, Applicants contend that the ‘804 patent does not teach or suggest ester prodrugs, let alone ester prodrugs recited in the instant claims.
These arguments have been carefully considered, but are not found persuasive for the reasons set forth above and incorporated herein.
New Rejections:
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.
Claim 5 is 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. THIS IS A NEW MATTER REJECTION.
Note: While claims 100 and 117 have been withdrawn from consideration, with compact prosecution in mind, the rejection could be applied to these claims as well.
In the instant case, claim 5 has been amended to include the limitation ester-or carbonate-substituted C1 alkyl or ester-substituted C2 alkyl when defining R2. A careful review of the specification, as originally filed, does not appear to lend support for such claim limitations and Applicants have specifically pointed to any section of the specification where support can be found. Applicants, in their response, assert that the genera recited in the now-amended claims are a reasonable generalization of the compounds tested in Figure 1 (see page 15 of response, 1st paragraph). However, it is unclear how this generic teaching is supported to is full scope by a few species of compounds tested in Figure 1. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Se also, in Tronzo v. Biomet, 156 F.3d 1154, 1159, 47 USPQ2d 1829, 1833 (Fed. Cir. 1998), the disclosure of a species in the parent application did not suffice to provide written description support for the genus in the child application where the specification taught against other species. Accordingly, this is a NEW MATTER REJECTION.
Conclusion
Claim 110 is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626
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