DETAILED ACTION
Applicants’ arguments, filed 1 October 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1-5 and 7-10 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 1 has been amended to recite the following, wherein relevant text is reproduced below and is annotated by the examiner.
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Because of the use of the word “or”, it is unclear if the claim requires that all of the above-recited active agents are excluded, or if the claim requires exclusion of at least one of the above-recited active agents but not all of the above-recited agents. As such, it is unclear if a hypothetical composition comprising miconazole but lacking chlorpromazine and lacking isopimpinellin meets the claimed requirements. This is because such a hypothetical composition lacks both chlorpromazine, and lacks isopimpinellin, which would therefore appear to indicate that such a composition meets the claimed requirements.
Claim Interpretation in view of Indefiniteness Issues: For the purposes of examination under prior art, the examiner will examine claim 1 with the understanding that the ingredient recited by claim 1 must not be any of miconazole, chlorpromazine, and isopimpinellin.
With that being said, the examiner will examine claim 9 with the understanding that the further active agent recited by claim 9 may be miconazole, chlorpromazine, or isopimpinellin.
The examiner further notes that the amendment to claim 1 excluding miconazole, chlorpromazine, and/or isopimpinellin does not appear to be new matter. Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See MPEP 2173.05(i), last paragraph in section.
Claim Interpretation
The instant claims recite the abbreviation “TRPM5.” This refers to “transient receptor potential cation channel subfamily M member 5.” See the instant specification as of the paragraph bridging pages 3-4.
Claim 1 recites a cosmetic or medical skin pigmentation composition. For the purposes of examination under prior art, the examiner will examine the prior art with the understanding that a prior art composition that teaches all of the claimed requirements but does not teach that the composition is a cosmetic or medical skin pigmentation composition is understood to meet the claimed requirements. According to MPEP 2114(II), apparatus claims cover what a device is, not what a device does. The examiner understands this rationale to apply to composition claims; as such, composition claims cover what a composition is, i.e. what chemicals are in the composition, not what the composition does. See also MPEP 2112.
Claim 1, last line, recites the phrase “the ion channel.” As best understood by the examiner, it is clear from the context that the ion channel being referred to here is the TRPM5 ion channel.
Claim 5 recites “pigmented nevi (moles)” and “post-birth hypopigmented stretch marks [striae distensae]”. As best understood by the examiner, “pigmented nevi” and “moles” have the same meaning. Also, as best understood by the examiner, “post-birth hypopigmented stretch marks” and “striae distensae” have the same meaning. As such, the claim appears to recite synonyms. This is not understood to render the claim indefinite because it appears that the recited synonyms have the same meaning.
Note Regarding CAS Numbers in Claims
Claim 5 specifies the CAS number of a particular recited ingredient. The examiner notes that CAS numbers refer to numbers assigned by Chemical Abstracts Services to all chemicals to identify said chemicals. As such, CAS numbers can be used to identify particular chemicals.
The examiner notes that according to MPEP 2173.05(u), trade names and trademarks in claims can render claims indefinite. However, the examiner notes that CAS numbers are not trademarks or trade names. As such, the provisions of MPEP 2173.05(u) are not understood to render claim 5 to be indefinite.
Claim Rejections - 35 USC § 102 – Anticipation
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) 1, 3-5, 7-8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Firooz et al. (International Journal of Pharmaceutics 495, 2015, pages 599–607) as evidenced by Barilli et al. (Journal of Medicinal Chemistry, Vol. 64, 2021, pages 5931-5955).
Note Regarding Multiple References in an Anticipation Rejection: Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to… (C) Show that a characteristic not disclosed in the reference is inherent. See MPEP 2131.01, especially MPEP 2131.01(III). In this case, the examiner takes the position that the Barilli reference is cited to show that a characteristic not disclosed by Firooz is inherent in Firooz.
Firooz et al. (hereafter referred to as Firooz) is drawn to econazole topical cream and gel preparations, as of Firooz, page 599, title and abstract. Said preparations comprise econazole as the active ingredient and are intended for topical application (e.g. to skin).
Firooz is silent as to the effect of econazole on TRPM5. Nevertheless, Barilli et al. (hereafter referred to as Barilli) is drawn to high throughput screening of various azole compounds, as of Barilli, page 5931, title and abstract. Barilli teaches the following on page 5932, left column, relevant text reproduced below.
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As such, the skilled artisan would have expected that the econazole of Firooz would have inherently inhibited TRPM5 even if this property was not recognized by Firooz. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning (e.g. that the composition of Firooz functions by inhibiting TRPM5), does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Additionally, when the structure taught by the reference is substantially identical to that recited by the claims, the claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I). In this case, the chemical structure of econazole in Firooz is substantially identical to that in instant claim 4(b); as such, the skilled artisan would have expected the properties and functions of econazole to have been inherent.
As to claim 1, the claim requires a cosmetic or medical composition. The skilled artisan would have understood the composition of Firooz to have met this requirement because it is applied topically, and topical administration is a known route of administration for cosmetic and medical compositions.
As to claim 1, the claim requires that the composition is a skin pigmentation composition. This does not appear to have been explicitly taught by Firooz. Nevertheless, the discovery of a previously unappreciated property of a prior art composition (e.g. that a composition comprising econazole can be used to affect skin pigmentation), or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer, and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, when the structure taught by the reference is substantially identical to that recited by the claims, the claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I). In this case, the chemical structure of econazole in Firooz is substantially identical to that in instant claim 4(b); as such, the skilled artisan would have expected the properties and functions of econazole to have been inherent.
As to claim 3, the skilled artisan would have expected the econazole of Firooz to have blocked TRPM5 and hence to have acted as an antagonist, as of the evidence provided by Barilli.
As to claim 4, the teachings of Firooz read on the econazole required by part (b) of claim 4.
As to claim 5, the econazole of Firooz is the same compound as recited by the instant claims, and the composition of Firooz is formulated for topical administration. As such, the skilled artisan would have expected that the composition of Firooz would have been useful for treating the recited conditions even though Firooz does not recognize its composition for this purpose. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer, and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II), also see MPEP 2112.01(I & II).
As to claim 7, Firooz teaches the following on page 601, Table 1, reproduced in part below.
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The examiner notes that various of the above formulations include compounds such as lipids, Tween 80 (which is an emulsifying agent), fatty alcohols, and other agents that read on the required carriers, excipients, adjuvants, diluents, or disintegrants.
As to claim 8, Firooz teaches nanoparticles, as of page 599, title and page 601, relevant text reproduced above.
As to claim 10, the composition of Firooz is a cream or gel, as of Firooz, page 599, abstract.
Claim Rejections - 35 USC § 103 – Obviousness
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) 1, 3-5, and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Firooz et al. (International Journal of Pharmaceutics 495, 2015, pages 599–607) as evidenced by or in view of Barilli et al. (Journal of Medicinal Chemistry, Vol. 64, 2021, pages 5931-5955).
Firooz et al. (hereafter referred to as Firooz) is drawn to econazole topical cream and gel preparations, as of Firooz, page 599, title and abstract. Said preparations comprise econazole as the active ingredient, and are intended for topical application (e.g. to skin).
Firooz is silent as to the effect of econazole on TRPM5. Nevertheless, Barilli et al. (hereafter referred to as Barilli) is drawn to high throughput screening of various azole compounds, as of Barilli, page 5931, title and abstract. Barilli teaches the following on page 5932, left column, relevant text reproduced below.
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As such, the skilled artisan would have expected that the econazole of Firooz would have inherently inhibited TRPM5 even if this property was not recognized by Firooz. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning (e.g. that the composition of Firooz functions by inhibiting TRPM5), does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Additionally, when the structure taught by the reference is substantially identical to that recited by the claims, the claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I). In this case, the chemical structure of econazole in Firooz is substantially identical to that in instant claim 4(b); as such, the skilled artisan would have expected the properties and functions of econazole to have been inherent.
As to claim 1, the claim requires a cosmetic or medical composition. The skilled artisan would have understood the composition of Firooz to have met this requirement because it is applied topically, and topical administration is a known route of administration for cosmetic and medical compositions.
As to claim 1, the claim requires that the composition is a skin pigmentation composition. This does not appear to have been explicitly taught by Firooz. Nevertheless, the discovery of a previously unappreciated property of a prior art composition (e.g. that a composition comprising econazole can be used to affect skin pigmentation), or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer, and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, when the structure taught by the reference is substantially identical to that recited by the claims, the claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I). In this case, the chemical structure of econazole in Firooz is substantially identical to that in instant claim 4(b); as such, the skilled artisan would have expected the properties and functions of econazole to have been inherent.
As to claim 1, purely en arguendo and for the purposes of this ground of rejection only, the examiner understands that Firooz teaches all of the required elements, but not in the same embodiment. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 3, the skilled artisan would have expected the econazole of Firooz to have blocked TRPM5 and hence to have acted as an antagonist, as of the evidence provided by Barilli.
As to claim 4, the teachings of Firooz read on the econazole required by part (b) of claim 4.
As to claim 5, the econazole of Firooz is the same compound as recited by the instant claims, and the composition of Firooz is formulated for topical administration. As such, the skilled artisan would have expected that the composition of Firooz would have been useful for treating the recited conditions even though Firooz does not recognize its composition for this purpose. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer, and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II), also see MPEP 2112.01(I & II).
As to claim 7, Firooz teaches the following on page 601, Table 1, reproduced in in the anticipation rejection above. The examiner notes that various of the above formulations include compounds such as lipids, Tween 80 (which is an emulsifying agent), fatty alcohols, and other agents that read on the required carriers, excipients, adjuvants, diluents, or disintegrants.
As to claim 8, Firooz teaches nanoparticles, as of page 599, title and page 601, relevant text reproduced above.
As to claim 9, Barilli teaches the following on page 5932, left column, relevant text reproduced below.
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The skilled artisan would have been motivated to have combined the miconazole of Barilli with the econazole of Firooz in order to have predictably achieved an antifungal effect with a reasonable expectation of success. Combining prior art elements (e.g. econazole, as of Firooz, and miconazole, as of Barilli) according to known methods to yield predictable results (an antifungal effect) is prima facie obvious. See MPEP 2143, Exemplary Rationale A and MPEP 2144.06(I). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem (in this case, the purpose of the prior art is an antifungal purpose, which differs from the claimed purpose of affecting skin pigmentation). It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144(IV).
As to claim 10, the composition of Firooz is a cream or gel, as of Firooz, page 599, abstract.
Claim(s) 1-2, 4-5, 7 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saguchi et al. (US 2014/0308328 A1) in view of or as evidenced by Mardaryev et al. (Journal of Investigative Dermatology, Vol. 141, 2021, pages 2300-2303 and 9 pages of supplemental information).
Saguchi et al. (hereafter referred to as Saguchi) is drawn to a gel composition, as of Saguchi, title and abstract. Said gel composition may comprise 2,5-dimethylpyrazine, as of paragraph 0029.
As to claim 1, the claim recites that the active agent activates, enhances, inactivates, blocks or dampens the cellular response of the transient receptor potential ion channel TRPM5 or interferes with the expression of the TRPM5 ion channel. This is not explicitly taught by Saguchi.
Mardaryev et al. (hereafter referred to as Mardaryev) is drawn to TRPM5 signaling, as of Mardaryev, page 2300, title and first paragraph. Mardaryev teaches the following, as of page 2302, left column, relevant text reproduced below.
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As such, Mardaryev teaches that 2,5-dimethylpyrazine is a TRPM5 activator. Mardaryev also teaches growing of hair follicles, as of the reference title. Mardaryev also teaches hair growth, as of page 2302, right column.
For the purposes of this rejection, the examiner takes the position, purely en arguendo and in regard to this ground of rejection only, that while Mardaryev teaches 2,5-dimethylpyrazine, Mardaryev does not teach that said 2,5-dimethylpyrazine is in a form that can be considered to be a cosmetic or medical skin pigmentation composition.
It would have been prima facie obvious for one of ordinary skill in the art to have used the gel comprising 2,5-dimethylpyrazine, as of Saguchi, for growing hair follicles. Mardaryev teaches that 2,5-dimethylpyrazine is useful for growing hair follicles because 2,5-dimethylpyrazine is a TRPM5 activator and TRPM5 activators are useful for hair growth. As such, the skilled artisan would have been motivated to have used the gel of Saguchi in order to have predictably promoted hair growth with a reasonable expectation of success.
In the alternative, the skilled artisan would have expected that a gel comprising 2,5-dimethylpyrazine, which would have been prima facie obvious based upon the teachings of Saguchi, would have been useful to have activated TRPM5 even if this property was not recognized by Saguchi. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning (e.g. that the 2,5-dimethylpyrazine of Saguchi would have activated TRPM5), does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Additionally, when the structure in the reference is substantially identical to that of the claims, claimed properties and/or functions are presumed to be inherent. See MPEP 2112.01(I). In this case, the 2,5-dimethylpyrazine of Saguchi appears to be substantially identical to the 2,5-dimethylpyrazine disclosed on page 12 of the instant specification. As such, the property of activating TRPM5 would have been presumed to have been inherent. As such, there would have been a reasonable expectation that the composition of Saguchi would have been a skin pigmentation composition even though this property was not recognized by Saguchi.
As to claim 1, the claim recites that the composition is a cosmetic or medical composition. Saguchi teaches a gel form of the composition. The skilled artisan would have understood that a gel is a cosmetic composition because it can be administered to the skin or hair. As such, even though Saguchi does not teach the composition for cosmetic purposes, the skilled artisan would have understood that the composition of Saguchi would have been a cosmetic or medical composition.
As to claim 2, the skilled artisan would have expected that the composition of Saguchi, by itself or in view of Mardaryev, would have been useful for the treatment of hypopigmentation even if this property was not recognized by Saguchi.
As to claim 4, the 2,5-dimethylpyrazine of Saguchi reads on the required dimethylpyrazine of part (a) of claim 4.
As to claim 5, the 2,5-dimethylpyrazine of Saguchi is the same compound as recited by the instant claims. As such, the skilled artisan would have expected the 2,5-dimethylpyrazine of Saguchi to have had the same properties in treating the same diseases as that recited by the instant claims. Products of identical chemical composition can not have mutually exclusive properties; this is relevant because the 2,5-dimehtylpyrazine of Saguchi is the same as that recited by instant claim 4. See MPEP 2112.01(II).
As to claim 7, Saguchi teaches polysaccharides and waxes in paragraphs 0038-0039; these appear to be excipients.
As to claim 9, Saguchi teaches 2-heptanone in paragraph 0031; these reads on the additional agent.
As to claim 10, Saguchi teaches a gel, as of the reference title.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saguchi et al. (US 2014/0308328 A1) in view of or as evidenced by Mardaryev et al. (Journal of Investigative Dermatology, Vol. 141, 2021, pages 2300-2303 and 9 pages of supplemental information), the combination further in view of Tanaka et al. (JP 2012067027 A).
As an initial matter, the examiner notes that Tanaka et al. (JP 2012067027 A) was written in Japanese rather than in English. The examiner has provided an English translation as of Google Patents (https://patents.google.com/patent/JP2012067027A/en?oq=JP+2012067027+A accessed 13 October 2026). All page and line citations are to the English translation; however, the material cited therein is understood to have been present in the original Japanese document.
Saguchi is drawn to a gel composition comprising 2,5-dimethylpyrazine. The composition of Saguchi appears to be intended for insecticidal purposes.
Saguchi does not teach glycerin.
Tanaka et al. (hereafter referred to as Tanaka) is drawn to an insecticidal gel, as of Tanaka, page 1, title. Said gel comprises glycerin and a gelling agent, along with an insecticidal component, as of Tanaka, page 1, abstract and claims.
Tanaka does not appear to teach 2,5-dimethylpyrazine.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the glycerin of Tanaka with the composition of Saguchi. Saguchi is drawn to a gel for administration of an insecticide, which may be 2,5-dimethylpyrazine. Tanaka is drawn to an insecticidal gel formulation, which may comprise glycerin as an excipient. As such, the skilled artisan would have been motivated to have combined the glycerin of Tanaka with the insecticide active agent of 2,5-dimethylpyrazine of Saguchi for predictable delivery of the insecticide active agent of Saguchi in a manner that it can predictably protect plants from insect pests with a reasonable expectation of success.
Non-Statutory 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 1-5 and 7-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/838,817 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to an active agent for use in treating skin pigmentation and a composition comprising said active agent. Said active agent may be one of various agents including dimethylpyrazine, as of instant claim 4. The instant claims recite various drug formulations such as a gel or cream in claim 10, and various excipient such as glycerin in claim 8.
The copending claims are drawn to an active agent for use in treating skin anti-aging and a composition comprising said active agent. Said active agent may be one of various agents including dimethylpyrazine, as of copending claim 3. The instant claims recite various drug formulations such as a gel or cream in copending claim 9, and various excipient such as glycerin in copending claim 7.
The instant and copending claims differ because the instant claims are drawn to a composition for the treatment of skin pigmentation, whereas the copending claims are drawn to an anti-aging composition. Nevertheless, the active agents in the copending claims appear to be the same as those in the instant claims. As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 7-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-34 of copending Application No. 18/043,263 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to an active agent for use in treating skin pigmentation and a composition comprising said active agent. Said active agent may be one of various agents including dimethylpyrazine, as of instant claim 4. The instant claims recite various drug formulations such as a gel or cream in claim 10, and various excipient such as glycerin in claim 8.
The copending claims are drawn to a composition comprising an active agent for regulating hair growth, along with an auxiliary agent. Said active agent may be one of various agents including dimethylpyrazine, as of copending claim 18. The instant claims recite various drug formulations such as a gel or cream in copending claim 24, and various excipient such as glycerin in copending claim 22.
The instant and copending claims differ because the instant claims are drawn to a composition for the treatment of skin pigmentation, whereas the copending claims are drawn to a composition for regulating hair growth. Nevertheless, the active agents in the copending claims appear to be the same as those in the instant claims; e.g. dimethylpyrazine is recited by copending claim 18 as well as instant claim 4. As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant has presented arguments in applicant’s response on 1 October 2026. These arguments are addressed below.
In applicant’s response, pages 1-2, applicant argues that the applied rejections have been overcome in view of the claim amendments. The examiner does not disagree with this position. Newly applied rejections have been set forth by the examiner; these newly applied rejections are understood to have been necessitated by amendment.
Regarding the previously applied double patenting rejections, applicant requests that these be held in abeyance, as of applicant’s response on page 2. As such, the previously applied double patenting rejections have been maintained.
Additional Cited Prior Art
As another additional relevant reference, the examiner cites Maeda et al. (Oncotarget, 2017, Vol. 8, (No. 45), pp: 78312-78326). Maeda et al. (hereafter referred to as Maeda) is drawn to TRPM5 siRNA, as of Maeda, page 78312, abstract. With that being said, Maeda does not teach treating skin pigmentation.
In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03. As best understood by the examiner, Maeda is just as good as Lee et al. (US 2005/0137185 A1), over which the claims have been rejected above, but no better than this reference. This is because Maeda, like Firooz, is drawn to a composition comprising a compound explicitly recited by instant claim 4, but not intended for use in the treatment of skin pigmentation. As such, the teachings of Maeda are similar to those of Firooz. As such, the examiner has not written an additional rejection over Maeda in view of the provisions of MPEP 904.03.
Conclusion
No claim is allowed.
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.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
