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 . Claims included in the prosecution are claims 1-3, 7-12 and 14.
Applicants' arguments, filed 02/03/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 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.
1. Claims 1, 2, 7-10, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Patron et al. (US 2017/0087199, Mar. 30, 2017) (hereinafter Patron) in view of Maekawa (JP 2019110896 A, Jul. 11, 2019) (of record).
Patron discloses compositions for providing a cooling effect (¶ [0005]). The composition may be incorporated into a personal care product (¶ [0006]). Personal care products include oral care compositions (¶ [0052]). The composition may comprise a combination of one or more cooling compounds with one or more flavorants (¶ [0124]). Suitable flavorants include 2-methyl-2-butenal (page 93), 2-isopropyl-5-methyl-2-hexenal (page 93), 4-amino-5,6-dimethylthieno[2,3-D]Pyrimidin-2(1h)One (page 97), and peppermint oil (i.e., mint flavoring) (page 91). Suitable cooling agents include (-)-menthol (¶ [0023]). The cooling compounds and combinations thereof are further combined with a pharmaceutical excipient (¶ [0024]). Suitable excipients include saccharin sodium (i.e., high-intensity sweetener) (page 47).
Patron differs from the instant claims insofar as not disclosing wherein the composition comprises E-2-methyl-2-butenal.
However, Maekawa discloses a composition that enhances a spice-like favor (abstract). The composition comprises a flavor component such as (E)-2-methyl-2-butenal (page 6, first paragraph).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Patron discloses wherein the composition comprises 2-methyl-2-butenal as a flavorant. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated (E)-2-methyl-2-butenal into the composition of Patron since it is a known and effective type of 2-methyl-2-butenal used as a flavorant as taught by Maekawa.
2. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Patron et al. (US 2017/0087199, Mar. 30, 2017) (hereinafter Patron) in view of HMDB (2-Isopropyl-5-methyl-2-hexenal, Sep. 17, 2018).
The teachings of Patron are discussed above. Patron does not teach wherein the composition comprises E-2-isopropyl-5-methyl-2-hexenal.
However, HMDB discloses wherein 2-isopropyl-5-methyl-2-hexenal is a flavoring ingredient and wherein (2E)-2-isopropyl-5-methyl-2-hexenal is synonymous with 2-isopropyl-5-methyl-2-hexenal.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Patron discloses wherein the composition comprises 2-isopropyl-5-methyl-2-hexenal as a flavorant. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated (2E)-2-isopropyl-5-methyl-2-hexenal into the composition of Patron since it is a known and effective type of 2-isopropyl-5-methyl-2-hexenal used as a flavorant as taught by HMDB.
3. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Patron et al. (US 2017/0087199, Mar. 30, 2017) (hereinafter Patron) in view of Maekawa (JP 2019110896 A, Jul. 11, 2019) (of record) or HMDB (2-Isopropyl-5-methyl-2-hexenal, Sep. 17, 2018), and further in view of Huboux et al. (WO 2019/012071 A1, Jan. 17, 2019) (hereinafter Huboux).
The teachings of Patron and, Maekawa or HMBD are discussed above. Patron and, Maekawa or HMBD do not teach wherein the composition comprises N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide.
However, Huboux discloses a composition as part of a flavoring or perfuming product (abstract). Examples of flavoring product include oral care products (page 14, line 24). There is a need to solubilize compounds imparting a cold or cooling impression in a consumer product in a diluted form. The solution is by using alkyl lactates (page 2, lines 4-6). Compounds of formula (I) could be easily solubilized in C1-6 linear or branched alkyl lactate (page 4, lines 21-22). The compound of formula (I) may be N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide (page 6, lines 15-16).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Patron discloses wherein the composition comprises one or more cooling agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide into the composition of Patron since it is a known and effective cooling agent as taught by Huboux.
Response to Arguments
Applicant argues that while Patron recites flavorants, these flavorants are found within a very large list of ingredients which spans several pages and which also includes menthol as a flavorant. With respect to cooling agents, menthol is mentioned within a large list of cooling agents as well. Patron does not provide any rationale for specifically selecting (-)-menthol and combining with a compound recited in the claim.
The Examiner does not find Applicant’s argument to be persuasive. Because Patron discloses wherein the composition may comprise a combination of one or more cooling compounds with one or more flavorants, it would have been obvious to one of ordinary skill in the art to have selected one or more cooling compound and one or more flavorant disclosed by Patron and combine the two. Although Patron lists many cooling compounds and flavorants, multiple effective combinations does not make any one combination less obvious. A reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). As such, Applicant’s argument is unpersuasive.
Applicant argues that they have shown that 2-methyl-2-butenal or 2-isopropyl-5-methyl-2-hexenal have the effect of enhancing the cooling effect provided by menthol.
The Examiner does not find Applicant’s argument to be persuasive. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. See MPEP 716.02.
In Example 2, Control 2 (menthol only) has a cooling value of 3, 2.75 and 2.20 while brushing, post brushing 1 min, and post brushing 2 min, respectively. Sample 1 (inventive example) has a cooling value of 3.98, 3.85, 3.50 while brushing, post brushing 1 min, and post brushing 2 min, respectively. Since Control 2 and Sample 1 are different compositions, one would expect for the cooling value to be different while brushing, post brushing 1 min, and post brushing 2 min. In Example 6, Sample 7 (cubebol only) has a cooling value of 0.3 and 0.5 while brushing and 3 min after brushing, respectively. Sample 8 (inventive example) has a cooling value of 0.5 and 1.2 while brushing and 3 min after brushing. Since Sample 7 and Sample 8 are different compositions, one would expect for the cooling value to be different while brushing and 3 min after brushing. In Example 8, Example 7A (menthol only) have cooling values of 5.14, 4.72, 2.59, 1.04, and 0.12, while Example 7B (inventive example) have cooling values of 4.82, 4.83, 2.72, 1.13, and 0.50, respectively. Since Example 7A and Example 7B are different compositions, one would expect for the cooling values to be different. In Example 10, Example 9A (menthol only) have cooling values of 4.1, 3.6, 2.65, 2.15, 1.80, while Example 9B (inventive example) have cooling values of 44.25, 3.8, 2.95, 2.2, and 1.85, respectively. Since Example 9A and Example 9B are different compositions, one would expect for the cooling values to be different.
Applicant has not explained how the differences in result are in fact unexpected and unobvious and of both statistical and practical significance, which is required according to MPEP 761.02(b). The differences in result do not appear to be drastically different. As such, Applicant’s argument is unpersuasive.
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 1-3, 7-12 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-14 of copending Application No. 18/562,250 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional ingredients) and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Since the double patenting rejection is not the only remaining rejection, the double patenting rejection is maintained.
Conclusion
Claims 1-3, 7-12 and 14 are rejected.
Claims 13 and 15-17 have been withdrawn.
No claims are allowed.
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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/TRACY LIU/Primary Examiner, Art Unit 1614