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 .
Priority
Foreign priority to application EP22159101.9 filed 02/28/2022 is acknowledged. Further, it is acknowledged that the present application is a 371 of international application PCTEP2023053444 filed 02/13/2023.
Information Disclosure Statement
The information disclosure statements (IDS) filed 08/15/2024 and 04/24/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the referenced included have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group III (claims 6-9 and 13-14) in the reply filed 07/10/2026 is acknowledged.
Claims 1-5 and 10-12 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/10/2026.
Claims 6-9 and 13-14 are pending and under current examination.
Claim Objections
Claim 6 is objected to because of the following informalities: it is dependent on claim 1, which has been withdrawn from consideration as being drawn to a nonelected invention. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claim(s) 6-9 and 13-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or joint inventor regards as the invention.
Claim 6 recites the limitation "active agent according to claim 1" in the third line of the claim There is insufficient antecedent basis for this limitation in the claim, since claim 1 has been withdrawn from further consideration as above. The claim should read on pending claims only.
Claims 7-9 and 13-14 are rejected by virtue of their dependency on claim 6.
Claim Interpretation
Claim 6 recites an active agent for the use of treatment in skin aging, dependent on withdrawn claim 1 where the active agent actives, enhances, or positively modulates a cellular response of a transient receptor potential ion channel TRPM5 for use in the treatment of skin aging. For the purpose of examination, the examiner understands that the claim requires that the active agent be capable of anti-aging benefits. The active agent is understood to be one of dimethylpyrazine, dimethylethylpyrazine, tetramethylpyrazine, 2-heptanone, eugenol, SID2848719 (CAS number 702636-90-6), rutamarin, bergapten, xanthotoxin, isopimpinellin, carbachol, 3-deoxyglucosone, glucagon-like peptide 1, (E)-N- (3,4dimethoxybenzylidene)-2-naphthalene-1-yl)acetohydrazide, or a combination thereof, as defined in instant specification as agonists for TRPM5 (para. [0025]). Prior art which teaches the required active agent being used for a different purpose than that indicated above is understood to meet the claimed requirements. This is because something which is old does not become patentable upon the discovery of a new property, and this feature need not have been recognized at the time of filing. Further as these are composition claims they are not limited by ‘future intended use’. See MPEP § 2112(I & II), MPEP § 2112.01(I & II) and MPEP § 2114(II).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 6-9, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (US 20210401682 A1) as evidenced by Mohiuddin et. al (International Journal of Clinical Dermatology & Research, 2019, 7, 209-223), hereinafter Mohiuddin.
Regarding claims 6 and 7, Hernandez teaches a topical composition for the skin that delivers anti-aging benefits (see abstract). The composition comprises eugenol (para. [0101]), which as above, is taught in instant specification to function as a TRPM5 agonist (see instant specification, para. [0025]). While Hernandez is silent as to the active agent enhancing or activating the cellular response of the transient receptor potential ion channel TRPM5, the discovery of a scientific explanation for the prior art’s function does not render the composition of the prior art patentable to the discoverer. See MPEP § 2112(I). Hernandez further teaches that the composition comprises auxiliary agents such as mineral oil and petrolatum (para. [0087]) and emulsifiers such as polyethylene glycol (para. [0089]), and glycerin (para. [0099]).
Regarding claims 8 and 13, Hernandez teaches that the composition can further comprise active ingredients such as retinol and Vitamin C (para. [0079]). Mohiuddin describes that both retinol and Vitamin C are used for their benefits in anti-aging. Mohiuddin teaches forms of Vitamin A, such as retinol, that are capable of diminishing the signs of aging by decreasing fine lines and wrinkles (pg. 221, col. 1 line 7). Mohiuddin also teaches that Vitamin C is an antioxidant that protects and rejuvenates aged skin (pg. 223, col. 1 line 38).
Regarding claims 9 and 14, Hernandez teaches that the topical composition may be formulated in any dermatological acceptable vehicle such as an ointment, lotion, cream, or gel (para. [0078]).
Hernandez does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Hernandez with a reasonable expectation of success to obtain the formulation of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is…a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the method of the instant claims with predictable results.
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(s) 6, 7, and 14 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 7, 8, and 10 of U.S. co-pending Application No. 18/836,992 (hereafter App. ‘992).
Regarding claim 6 of instant invention, App. ‘992 claims a cosmetic or medical composition comprising at least one active agent that activates, inactivates, or blocks the cellular response of the transient receptor potential ion channel TRPM5 (see claims 1 and 7). App. ‘992 further comprises an auxiliary agent selected from the group consisting of carriers, excipients, adjuvants, diluents, and disintegrants (see claim 7).
Regarding claim 7 of instant invention, App. ‘992 claims that the auxiliary agent is selected from group consisting of liposomes, nanoparticles, carboxymethyl cellulose, hydroxyethyl cellulose, mineral oil, petrolatum, glycerin, polysorbate 80, hydroxyethyl starch, dextran, and polyethylene glycol (see claim 8).
Regarding claim 14 of instant invention, App. ‘992 claims that the composition is in the form of an ointment, a lotion, a cream, a gel, a solution, a spray, a plaster or a sustained release plaster (see claim 10).
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not yet been patented.
Claim(s) 6, 7, and 14 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 16, 22, and 24 of U.S. co-pending Application No. 18/043,263 (hereafter App. ‘263).
Regarding claims 6 and 7 of instant invention, App. ‘263 claims a cosmetic or medical composition comprising at least one active agent that activates, inactivates, or blocks the cellular response of the transient receptor potential ion channel TRPM5 (see claim 16). App. ‘263 further describes that the composition comprises an auxiliary agent selected from group consisting of liposomes, nanoparticles, carboxymethyl cellulose, hydroxyethyl cellulose, mineral oil, petrolatum, glycerin, polysorbate 80, hydroxyethyl starch, dextran, and polyethylene glycol (see claim 22).
Regarding claim 14 of instant invention, App. ‘263 claims that the composition is in the form of an ointment, lotion, cream, a gel, a solution, a spray, a plaster, or a sustained release plaster (see claim 24).
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not yet been patented.
Conclusion
Claims 6-9 and 13-14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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