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 .
Applicants' arguments, filed 12/30/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 103--Previous
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.
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.
1) Claim(s) 1-2, 10, 13, 19 remain rejected under 35 U.S.C. 103 as being unpatentable over Noncovich et al., (Bioorganic & Medicinal Chemistry Letters, 2017) and Patron et al., (US 2017/0087199).
Noncovich et al. teaches “a novel series of phenoxyacetyl amides as human TRPM8 receptor agonists” as “cooling agents”, wherein an example of phenoxyacetyl amide is “N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide” (Abstract), recited in claims 1 and 10.
Noncovich et al. does not teach lactic acid.
Patron et al. teaches “compositions comprising combinations of one or more cooling agents with additional cooling agents, inactive drug ingredients, food additives, antimicrobials . . . to be used in the production of home, personal care, and pet care products, and smokable materials” (Abstract).
In regard to the use of “lactic acid” Patron et al. teaches, “It is sometimes advantageous to include an agent causing a cooling sensation in the delivery of a pharmaceutical compound, whether to improve the flavor of oral liquid or powder forms, to improve the sensation of taking tablet or capsule forms, to modulate sensation in the sinus or lung for inhalable forms, or for other reasons known in the art” (p. 37, para. [0024}, where examples of known pharmaceutical excipients “for combination with cooling compounds” include, but are not limited to: “Lactic acid” (see para. [0024] at p. 41, bottom left column).
Since Patron et al. teaches “the cooling compound is in a concentration ranging from about 0.0001 ppm to 100,000 ppm” (p. 59, para. [0037]), it would have been obvious to provide at least 1% of the at least one non-natural cooling compound, as per claim 2.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to combine the cooling agent of Noncovich et al. with lactic acid for the advantage of improving the flavor of oral liquid or powder forms, improving the sensation of taking tablet or capsule forms, and/or modulating sensation in the sinus or lung for inhalable forms, as taught by Patron et al.
Patron et al. also includes “(2s,5r)-N-[4-(2-Amino-2-Oxoethyl)Phenyl]-5-Methyl-2-(propan-2-yl)Cyclohexanecarboxamide” (para. [0122] at p. 85, bottom right column), as per claims 13 and 19. Accordingly, it would have been obvious to add it or combine it with lactic acid, for the same advantage given above.
2) Claim(s) 12 and 18 remain rejected under 35 U.S.C. 103 as being unpatentable over Noncovich et al., (Bioorganic & Medicinal Chemistry Letters, 2017) and Patron et al., (US 2017/0087199) as applied to claim 1 above, and further in view of Kolbe et al., (US 2009/0306152).
The combination of Noncovich et al. and Paton et al., which is taught above, differs from claim 12 and 18 insofar as it does not teach 2-isopropyl-5-methyl-N-(2-(pyridin-2-yl)ethyl)cyclohexane-1- carboxamide.
Kolbe et al. teaches “(1R,2S,5R)-2-isopropyl-5-methyl-N-(2-(pyridin-2-yl)ethyl)cyclohexane carboxamide”, as per claim 12 and 18, as a cooling agent for topical applications in cosmetic or dermatological preparations (see Title and Abstract).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to combine the cooling agent of Kolbe et al. with the lactic acid of Patron et al. for the advantage of improving the flavor of oral liquid or powder forms, improving the sensation of taking tablet or capsule forms, and/or modulating sensation in the sinus or lung for inhalable forms, as taught by Patron et al.
Allowable Subject Matter
Claims 11 and 17 are 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.
Nonstatutory Obvious-type 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3, 10-13, 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/005,404 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions comprising a non-natural cooling agent, e.g., 2-methyl-1-(2-(5-(p-tolyl)-1H-imidazol-2yl)piperidin-1-yl)butan-1-one, and lactic acid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
i) Applicant does not agree that the claims are obvious in view of the combination of references insofar as “Examiner’s reliance on Patron to supply the ‘lactic acid’ to overcome the identified deficiency in Noncovich is improper as being impermissible ‘hindsight reconstruction’ of the presently claimed invention” (p. 7-8). Applicant further argues that Patron “discloses thousands of compound materials . . . but provides no impetus to narrow down and identify ‘lactic acid’ to be considered in providing a liquid composition for the same technical benefits disclosed only in the present application” (p. 14-15).
The Examiner disagrees.
Initially, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the notion that lactic acid can be used as a cooling agent and combined with other cooling agents was gleaned from the prior art.
Further, it is well settled that it is obvious for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as the prior art teaches that the selection will result in the disclosed effect. See Merck & Co., v. Biocrafi Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("That the '813 patent discloses a multitude of effective combinations does not render any particular formulation less obvious."); See also In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985) (affirming obviousness rejection of claims in light of prior art teaching that "hydrated zeolites will work" in detergent formulations, even though "the inventors selected the zeolites of the claims from among 'thousands' of compounds").
In this case, the fact that Patron et al. lists lactic acid, as a cooling agent, in a group of known cooling agents does not make its selection less obvious.
ii) Applicant argues that the obvious-type double patenting rejection should be withdrawn insofar as U.S. application 18/005404 has a international filing date of July 28, 2021, whereas the instant application has a PCT filing date December 16, 2020.
The Examiner disagrees.
It is noted that MPEP 804 was superseded by MPEP 1490, and it is MPEP 1490 that is controlling here. MPEP 1490V(D) states, “If both applications are filed on the same day, the provisional ODP rejection made in each of the applications should be maintained until applicant overcomes the rejections by either filing a reply showing that the claims subject to the provisional ODP rejections are patentably distinct or filing a terminal disclaimer in each of the pending applications.”
According to PTO records, the instant 18/005,424 and the 18/005,404 application have the same filing date of 01/13/2023.
Since the copending application 18/005,404 and the instant 18/005,424 application have the same effective filing date, 01/13/2023, the provisional ODP rejection made will be maintained until applicant overcomes the rejections by either filing a reply showing that the claims subject to the provisional ODP rejections are patentably distinct or filing a terminal disclaimer in each of the pending applications.
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/ Primary Examiner, Art Unit 1612