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 .
DETAILED ACTION
Status of the Claims
Applicant’s cancellation of claims 1-18 and introduction of new claims 21-35 in the response filed on March 25th 2026 is acknowledged. Claims 19-35 are pending and are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed on March 25th 2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 112(b) Rejections Moot
Applicant has canceled claims 1-18, thereby rendering all 112(b) rejections moot. Said rejections are thereby withdrawn.
Statutory Double Patenting Rejections Moot
Applicant has canceled claims 1-18, thereby rendering all statutory double patenting rejections moot. Said rejections are thereby withdrawn.
35 U.S.C. § 112(b) Rejections Necessitated by Amendment
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22, 23, and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 is indefinite for the phrase, “wherein the selectivity of the compound of Formula 1 or a pharmaceutically acceptable salt thereof for melanocortin-4 receptor is 2 or more in a ratio to melanocortin-1 receptor,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the compound of claim 19. This functional-descriptive language appears to limit the active compounds of claim 19, but does not impose particular structural limitations to the compound, and only limits its functional activity. The specification recites the importance of this particular activity (specification, pg. 2, 7), but does not explicitly state how the structure of the compound must be further limited in order to achieve said activity.
Claims 23 is indefinite for the phrase, “wherein the selectivity of the compound of Formula 1 or a pharmaceutically acceptable salt thereof for melanocortin-4 receptor is 5 or more in a ratio to melanocortin-1 receptor,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the compound of claim 19. This functional-descriptive language appears to limit the active compounds of claim 1, but does not impose particular structural limitations to the compound, and only limits its functional activity. The specification recites the importance of this particular activity (specification, pg. 2, 7), but does not explicitly state how the structure of the compound must be further limited in order to achieve said activity.
Claims 29 is indefinite for the phrase, “comprising reducing pigmentation in the subject pigmentation” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 19. This functional-descriptive language appears to limit the results of administration of the compound, but provides no limitation to the compound administered, amount administered, method of administration, or patient population receiving such administration. This activity is described in the specification in identical language (Specification, pg. 8, 19-20), but at no point in the specification is it described how the method must be limited in order to achieve said activity.
35 U.S.C. § 103 Rejections Maintained
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 rejection of claims 19-20 under 35 U.S.C. 103 as being unpatentable over Choi (U.S. Patent No. 7,879,852) in view of Lima (Lima et al., Homologation: A Versatile Molecular Modification Strategy to Drug Discovery. Curr Top Med Chem. 2019;19(19):1734-1750) is maintained.
Applicant’s arguments in the response filed on March 25th 2026 are acknowledged. Applicant argues that:
Choi’s compound genus differs from applicant’s compound genus in several locations and thus applicant’s compound genus would not be predictable from Choi’s compound genus.
Choi’s compound A96 differs from applicant’s compound genus in a 2nd location, namely a 2nd methyl on the cyclohexyl group.
One of ordinary skill in the art would not reasonably select Choi’s compound A96, used in the previous 103 rejection, as a reasonable starting point.
Regarding argument 1, the previous 103 rejections did not allege an obviousness argument over Choi’s entire compound genus, as the argument on pg. 7 of applicant’s response appears to indicate, but instead that Choi teaches specific compounds that render applicant’s genus prima facie obvious. For example, compound A-96:
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As applicant has stated, this compound does indeed differ from applicant’s two locations:
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(Choi)
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(Applicant).
However, in each case, such differences are mere additions/removals of carbons. As the technique of homologation has been demonstrated to be a common bioisosteric substitution in the field of drug discovery (see the below 103 rejection), applicant’s 1st and 2nd arguments are found not persuasive.
Regarding the selection of Choi’s compound A-96, applicant is correct in stating that Choi provides many active compounds, including several that exhibit higher MC4R activity than compound A-96:
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However, these compounds serve as only a small sample of the compounds developed by Choi, of which over 500 compounds are presented. As these 33 compounds have already been selected from such a vastly larger array of compounds and demonstrated to have significant activity as MC4R agonists, one of ordinary skill in the art would recognize any of the 33 compounds as a reasonable starting point.
Absent unexpected results, of which applicant does not claim, such a bioisosteric transformation on Choi’s compounds to develop compounds of similar MC4R activity is prima facie obvious.
Previous 103 Rejections
The claims are directed towards a medicament comprising a compound of Formula 1:
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One such compound is
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Choi teaches the compound,
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(Choi, col. 142, claim 14),
as well as its activity as a melanocortin receptor agonist (Choi, col. 147, claim 15), and the treatment of obesity, diabetes, inflammation, and erectile dysfunction with the compound (Choi, col. 148, claims 16-19).
Choi’s compound differs from applicant’s compounds only in the length of the carbon chain in the R1 location. One of ordinary skill in the art would have a reasonable expectation of success in developing applicant’s compounds, and particularly,
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because the necessary replacement of the methyl endcap with a branched propane is predictable from the art. Notably, Lima teaches homologues as a standard bioisosteric replacement in the art of drug discovery and notes the development of branched homologues as being commonplace (Lima, pg. 1735, Figure 3). A medicament comprising such a compound, and consequently claims 1-2, would therefore be prima facie obvious.1
Claim 3 is directed to the medicament of claim 1 wherein the salt is selected from hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, hydrobromic acid, and hydroioidic acid. Each of these acid salts are taught by Choi (Choi, col. 5), and claim 3 is therefore prima facie obvious.
As it is unclear how claims 4-5 further limit the medicament of claim 1 (see the above 112(b) rejections for claims 4 and 5), They too are prima facie obvious.
Claim 6-7 are directed towards the medicament of claim 1, wherein the disease is obesity. As Choi teaches the treatment of obesity (Choi, col. 147, claims 16), claims 6 and 7 are prima facie obvious.
As it is unclear how claim 8 further limits the medicament of claim 1 (see the above 112(b) rejections for claim 8), it too is prima facie obvious.
Claim 9 requires that the medicament of claim 1 is in an oral formulation. Choi teaches oral administration (Choi, col. 8), and claim 9 is prima facie obvious.
Claims 10-18 are substantially equivalent to claims 1-10, with the additional requirement that the composition comprises a pharmaceutically acceptable carrier. Choi teaches the composition with pharmaceutically acceptable carriers (Choi, col. 147, claim 15), and claims 10-18 are therefore prima facie obvious.
Claims 19-20 are directed towards a method for the prevention or treatment of a disease associated with melanocortin receptor by selective agonist effect for melanocortin-4 receptor comprising administration of the compound,
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One example of such a disease is found in the specification to be obesity (specification, pg. 7). As the treatment of obesity with the above compound is obvious (see the above 103 rejection for claim 6, claims 19-20 are prima facie obvious.
35 U.S.C. § 103 Rejections Necessitated by Amendment
Claims 21-35 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (U.S. Patent No. 7,879,852) in view of Lima (Lima et al., Homologation: A Versatile Molecular Modification Strategy to Drug Discovery. Curr Top Med Chem. 2019;19(19):1734-1750).
Claim 21 is directed towards the method of claim 19 wherein the wherein the salt is selected from hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, hydrobromic acid, and hydroioidic acid. For the teachings of Choi and Lima as they are relevant to claim 19, see the above 103 rejection for claim 19. Each of these acid salts are taught by Choi (Choi, col. 5), and claim 21 is therefore prima facie obvious.
As it is unclear how claims 22-23 further limit the method of claim 19 (see the above 112(b) rejections for claims 22-23), they too are prima facie obvious.
Claims 24-25 are directed towards the method of claim 19, wherein the disease is obesity. As Choi teaches the treatment of obesity (Choi, col. 147, claim 16), claims 24-25 are prima facie obvious.
Claim 26 is directed towards the method of claim 19, wherein the disease is diabetes. As Choi teaches the treatment of diabetes (Choi, col. 148, claim 17), claim 26 is prima facie obvious.
Claim 27 is directed towards the method of claim 19, wherein the disease is inflammation. As Choi teaches the treatment of inflammation (Choi, col. 148, claim 18), claim 27 is prima facie obvious.
Claim 28 is directed towards the method of claim 19, wherein the disease is erectile dysfunction. As Choi teaches the treatment of erectile dysfunction (Choi, col. 148, claim 19), claim 28 is prima facie obvious.
As it is unclear how claim 29 further limits the method of claim 19 (see the above 112(b) rejections for claim 29), it too is prima facie obvious.
Claim 30 is directed towards the method of claim 19 wherein the compound is formulated in a pharmaceutical composition with a pharmaceutically acceptable carrier. As Choi teaches such pharmaceutical compositions (Choi, col. 147, claim 15), claim 30 is prima facie obvious.
Claim 31 is directed towards the method of claim 30 wherein the formulation is an oral formulation. Choi teaches oral administration (Choi, col. 8), and claim 31 is prima facie obvious.
Claims 32 and 33 limit the compound administered in the method of claim 19 to wherein R1 is C2 and C3 alkyl, respectively. As these modifications are the mere extension of a carbon chain, they fall under the category of homologation, as described by Lima (Lima, pg. 1735), and claims 32-33 are prima facie obvious.
Claims 34-35 limit the compound administered in the method of claim 31 to wherein R1 is C4 and C5 alkyl, respectively. As these modifications are the mere extension of a carbon chain, they fall under the category of homologation, as described by Lima (Lima, pg. 1735), and claims 34-35 are prima facie obvious.
Nonstatutory Double Patenting Rejections Maintained
Applicant has requested that the remaining nonstatutory double patenting rejections be held in abeyance. Said rejections are thereby maintained.
Nonstatutory Double Patenting Rejections Reiterated
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 19-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-17 of copending Application No. 18/262,256 (US20240148743). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of a rare genetic obesity associated with impaired MCR-4 pathway via administration of a compound of formula 1 or 2, while the instant claims are directed towards the treatment of a disease associated with MCR via administration of a compound of formula 1 or 2.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-12 of copending Application No. 18/837,125 (US20250134898). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of a rare genetic obesity associated POMC deficiency via administration of a compound of formula 1 or 2, while the instant claims are directed towards the treatment of obesity via administration of a compound of formula 1 or 2.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 7,879,852) in view of Lima (Lima et al., Homologation: A Versatile Molecular Modification Strategy to Drug Discovery. Curr Top Med Chem. 2019;19(19):1734-1750). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons stated in the above 103 rejections.
Claims 19-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-14 of copending Application No. 18/547,800 (US20240190856). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of inflammation, diabetes, obesity, erectile dysfunction, with a compound genus that encompasses the instant compounds. Furthermore, the compounds would necessarily be administrated in the form of a medicament/pharmaceutical composition.
Claims 1-7 and 16-26 of copending Application No. 17/619,893 (US20220289731). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of inflammation, diabetes, obesity, erectile dysfunction, with an equivalent compound genus. Furthermore, the compounds would necessarily be administrated in the form of a medicament/pharmaceutical composition.
Claims 1-13 of copending Application No. 18/251,129 (US20230382895). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of inflammation, diabetes, obesity, erectile dysfunction, with crystal forms of an equivalent compound genus. Furthermore, the compounds would necessarily be administrated in the form of a medicament/pharmaceutical composition.
Claims 1-13 of copending Application No. 18/251,101 (US20230399321). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of inflammation, diabetes, obesity, erectile dysfunction, with crystal forms of an equivalent compound genus. Furthermore, the compounds would necessarily be administrated in the form of a medicament/pharmaceutical composition.
Claims 1-13 of copending Application No. 18/251,111 (US20240010633). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of inflammation, diabetes, obesity, erectile dysfunction, with crystal forms of an equivalent compound genus. Furthermore, the compounds would necessarily be administrated in the form of a medicament/pharmaceutical composition.
Claims 1-12 of copending Application No. 18/251,074 (US20250179016). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches pharmaceutical compositions comprising an amorphous form of the compound for the treatment of obesity, diabetes, inflammation, or erectile dysfunction.
Claims 1-13 of copending Application No. 18/251,084 (US20230373984). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of inflammation, diabetes, obesity, erectile dysfunction, with crystal forms of an equivalent compound genus. Furthermore, the compounds would necessarily be administrated in the form of a medicament/pharmaceutical composition.
Claims 1-19 of copending Application No. 18/258,730 (US20240051919). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of inflammation, diabetes, obesity, erectile dysfunction, with crystal forms of an equivalent compound genus. Furthermore, the compounds would necessarily be administrated in the form of a medicament/pharmaceutical composition.
Claims 1-13 of copending Application No. 18/258,705 (US20240059652). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches pharmaceutical compositions comprising an amorphous form of the compound for the treatment of obesity, diabetes, inflammation, or erectile dysfunction.
Claims 1-16 of copending Application No. 18/258,717 (US20240051944). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of inflammation, diabetes, obesity, erectile dysfunction, with crystal forms of an equivalent compound genus. Furthermore, the compounds would necessarily be administrated in the form of a medicament/pharmaceutical composition.
Claims 1-13 of copending Application No. 18/258,711 (US20240043407). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches pharmaceutical compositions comprising a crystalline form of the compound for the treatment of obesity, diabetes, inflammation, or erectile dysfunction.
Claims 1-14 of copending Application No. 18/558,351 (US20240217954). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches pharmaceutical compositions comprising a crystalline form of the compound for the treatment of obesity, diabetes, inflammation, or erectile dysfunction.
Claims 1-18 and 20-21 of copending Application No. 18/557,866 (US20240228473). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches a method of agonizing MCR4 with crystal forms of an equivalent compound genus. Furthermore, the compounds would necessarily be administrated in the form of a medicament/pharmaceutical composition.
Claims 1-11 of copending Application No. 18/558,142 (US20240239782). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches pharmaceutical compositions comprising a crystalline form of the compound for the treatment of obesity, diabetes, inflammation, or erectile dysfunction.
Claims 1-11 of copending Application No. 18/558,812 (US20240239769). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches pharmaceutical compositions comprising a crystalline form of the compound for the treatment of obesity, diabetes, inflammation, or erectile dysfunction.
Claims 1-14 of copending Application No. 18/558,148 (US20240239783). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches pharmaceutical compositions comprising a crystalline form of the compound for the treatment of obesity, diabetes, inflammation, or erectile dysfunction.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Nonstatutory Double Patenting Rejections Necessitated by New Application
Claims 21-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/410,552 (US 20260092056). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of all of obesity, diabetes, inflammation, and erectile dysfunction with pharmaceutical compositions comprising compounds identical to applicant’s compounds.
Conclusion
THIS ACTION IS MADE FINAL. 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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey 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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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Examiner notes that the limitation “for the prevention or treatment of a disease associated with melanocortin receptor having a selective agonistic effect for melanocortin-4 receptor” is equivalent to an intended use of the medicament of claim 1 and is therefore not further limiting to the medicament itself.
Prosecution Insights