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 .
Application Status
The amendment filed on 2/17/2026 in response to the Non-Final rejection of 9/15/2025 is acknowledged and has been entered. Claims 5, 90, 93, 98 and new claims 100-115 are currently pending.
Election/Restrictions
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 and 98 and new claims 100-104 and 114-115, read on the extended search, new claim 110 reads on the originally elected species. As such, claims 5, 90, 93, 98, 100-104, 110 and 114-115 are currently under consideration.
Claims 105-109 and 111-113 are withdrawn from consideration as being not included in the extended search.
Information Disclosure Statement
The information disclosure statement filed on 2/17/2026 has been considered except where lined through.
Claim Interpretation
Claim 5 has been amended to recite the limitation “…R2 is an optionally substituted heterocycle, optionally substituted C1 alkyl or optionally substituted C3-12 alkyl.” The specification defines “optionally substituted” as when a compound or chemical structural feature (such as alkyl or aryl) is referred to as being “optionally substituted”, it includes a feature that has no substituent (i.e. unsubstituted), or a feature that is “substituted”, meaning that the feature has one or more substituents. The term “substituent” has the broadest meaning known to one of ordinary skill in the art, and includes a moiety that occupies a position normally occupied by one or more hydrogen atoms attached to a parent compound or structural feature (see paragraph 0026 of the PGPUB). There does not appear to be a limiting definition of what is encompassed by a “substituent”. In view of this, it is reasonable to interpret an ethyl to be a substituted methyl since a methyl group is taking the place of a hydrogen on the parent methyl group. As such, optionally substituted will be interpreted broadly to encompass any substitution of a parent group.
Rejections Withdrawn:
The provisional rejection of claims 1-2, 4, 9, 18, 49, 54, 57-58, 60-61, 64, 81, 93, 98 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 8, 12-13, 15, 17, 48-53, 60-62, 65, 67 and 70 of copending Application No. 18/013,803 (reference application) is withdrawn in view of Applicants amendments.
The provisional rejection of claims 1-2, 54, 61 and 98 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, 12-13 of copending Application No. 18/725,739(reference application) is withdrawn in view of Applicants amendments.
Rejections Maintained, but amended in view of Applicants Amendments:
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.
Claim(s) 93 and 98 remain and amended claim 5 is rejected 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.
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 exemplary compounds having the structures , ,
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which read on the instantly claimed compound of claim 5 wherein: X is O and R2 is an optionally substituted C1 alkyl (see claim interpretation above). Moreover, the WO document teaches that the compounds are preferably administered as pharmaceutical compositions comprising a compound and a pharmaceutically acceptable carrier (page 25).
In response to this rejection, Applicants contend that claim 5, which was not rejected for allegedly lacking novelty, has been reformulated as an independent claim, and the remaining claims have been amended to depend from claim 5.
These arguments have been carefully considered, but are not found persuasive.
In response to Applicants arguments, the Examiner acknowledges that claim 5 was not originally rejected since original claim 5 was narrower limiting R2 to only a C3-C12 alkyl group. However, Applicants have broadened claim 5 to include optionally substituted C1 alkyl, which based on the claim interpretation is being interpreted encompass an ethyl functional group, e.g. a methyl group is taking the place of a hydrogen on the parent methyl group.
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) 90 remains rejected and new claims 100-104 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, as applied above to claims 5, 93 and 98 above.
As discussed above, 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 exemplary compounds having the structures
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,
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,
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and
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which read on the instantly claimed compound of formula I wherein: R3 is either a H, Cl or Br, R4 is H, n is 0, Z is a C1 hydrocarbon, R6 is a substituted C6 hydrocarbon, Q is -C(=O)-, X is O, R1 is either a bond or a C1-2 hydrocarbon, Y is a bond, R2 is either H or a C1alkyl. Moreover, the WO document teaches that the compounds are preferably administered as pharmaceutical compositions comprising a compound and a pharmaceutically acceptable carrier (page 25). In addition to the compounds described previously, California teaches exemplary compounds having the structures
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,
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,
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and
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.
The prior art 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, Applicants contend that the present application demonstrates that MPC inhibitor prodrugs wherein R2 is CH3 or C3-12 alkyl exhibit unexpectedly superior conversion kinetics from ester to free carboxylic acid (i.e., the active pharmaceutical ingredient) as compared to the ethyl homolog (e.g. JXL082), see Figure 1 (compared compounds PP20, PP29, PP24, PP21 and PP12, wherein R2 is C1 alkyl or C2-C12 alkyl with compound JXL082 wherein R2 is C2 alkyl) annotated below:
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Critically, Applicants contend that JXL082 (right box) shows little to no conversion vs. P20 and P29 which underwent complete hydrolysis. Thus, Applicants assert that the results described above are unexpected in view of the dramatic effects of ester shortening or elongation, as compared to the ethyl ester variant, and would not have been predicted from the teachings of California.
These arguments have been carefully considered, but are not found persuasive.
Regarding Applicants unexpected results argument, the Examiner recognizes that 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. In contrast to Applicants contention that wherein R2 is CH3 or C3-12 alkyl exhibit unexpectedly superior conversion kinetics from ester to free carboxylic acid, only one of the compounds PP12 which could be considered a C4-branched alkyl falls within the definition Applicants set forth above. However, a C4-branched alkyl was not included in the species expansion and not intended to be part of the rejection. Instead, 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 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. 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. A couple notes regarding the figures presented in the specification, e.g. Figures 1, Figure 2 and Figure 3. First, the specification and figures specifically call out that 10 mM of the tested compounds were used for the esterase activity measurements. Thus, when looking at the figures, one would assume that each of the bars would max at around 10 mM concentration of drug. However, this does not appear to be the case. For example, looking at figure 1 PP29A only appears to be at around 7 mM vs. JXL082 which is close to around 10 mM. This is concerning because it would seem that one would expect more conversion with less concentration, e.g. there is less so more would be converted. Secondly, it appears that the compounds were tested in a number of homogenates from mouse (figure 1), minipig (figure 2) and human (figure 3) each of which provided different conversion rates/amounts. For example, PP12 has slightly more conversion in mouse and minipig as compared to JXL082, but the conversion was almost identical to JXL082 in human (note: the concentration of PP12 was less vs. JXL082). As such, while the examiner has reviewed the figures, it is unclear how to interpret these figures based on the obviousness rejection set forth above.
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.
Claim 98 remains, amended claim 5 and 90 are and new claims 100-104 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.
As discussed above, 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 exemplary compounds having the structures
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and
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which read on the instantly claimed compound of formula I wherein: R3 is either a H, Cl or Br, R4 is H, n is 0, Z is a C1 hydrocarbon, R6 is a substituted C6 hydrocarbon, Q is -C(=O)-, X is O, R1 is either a bond or a C1-2 hydrocarbon, Y is a bond, R2 is either H or a C1alkyl. Moreover, the WO document teaches that the compounds are preferably administered as pharmaceutical compositions comprising a compound and a pharmaceutically acceptable carrier (page 25). In addition to the compounds described previously, California teaches exemplary compounds having the structures
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and
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.
The prior art 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 compound claimed by the US Patent by 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.
In response to this rejection, Applicants contend that claim 5, which was not rejected, has been reformulated as an independent claim, and the remaining claims have been amended to depend from claim 5.
These arguments have been carefully considered, but are not found persuasive.
In response to Applicants arguments, the Examiner acknowledges that claim 5 was not originally rejected since original claim 5 was narrower limiting R2 to only a C3-C12 alkyl group. However, Applicants have broadened claim 5 to include optionally substituted C1 alkyl, which based on the claim interpretation is being interpreted encompass an ethyl functional group, e.g. a methyl group is taking the place of a hydrogen on the parent methyl group.
Claims 93 and 98 remain, amended claim 5 and 90 are and new claims 100-104 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) Although the claims at issue are not identical, they are not patentably distinct from each other because the compound claimed in the US Patent anticipates the instantly claimed compound of formula 1. 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).
In response to this rejection, Applicants contend that claim 5, which was not rejected, has been reformulated as an independent claim, and the remaining claims have been amended to depend from claim 5.
These arguments have been carefully considered, but are not found persuasive.
In response to Applicants arguments, the Examiner acknowledges that claim 5 was not originally rejected since original claim 5 was narrower limiting R2 to only a C3-C12 alkyl group. However, Applicants have broadened claim 5 to include optionally substituted C1 alkyl, which based on the claim interpretation is being interpreted encompass an ethyl functional group, e.g. a methyl group is taking the place of a hydrogen on the parent methyl group.
Claims 5, 93 and 98 remain provisionally rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds claimed and method of using said compound for use in promoting hair growth as claimed in the copending application overlaps in scope with the compounds of formula I and method of their use as claimed in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In response to this rejection, Applicants request that the rejection be held in abeyance until allowable subject matter has been found in the instant application at which point the provisional rejection should be withdrawn since the instant application is entitled to an early filing date.
These arguments have been considered and the rejection is maintained.
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.
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 CFR 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 CFR 1.17(a)) pursuant to 37 CFR 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.
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