DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 12/19/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Double Patenting (Maintained)
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 18-19 of U.S. Patent Application No. 17/769,198 (notice of allowance mailed 9/15/2025) in view of Kulke et al. (US 2015/0313820 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims recite all of the features instantly recited for the composition except for a solvent, such as lactic acid, a fragrance or flavor, and the composition being a liquid.
Kulke teaches cooling compounds for the skin or mucosa in combination with lactic acid and a fragrance [0001] [0192] [0198]. Kulke teaches lactic acid in an amount of 0.1 to 15 wt.% to optimize sensory properties of the composition and for moisture retention of the skin [0191]-[0192]. Kulke teaches fragrances are odor-masking agents which provide the composition with a pleasant scent [0198]. Kulke teaches the compositions of the disclosure are liquids [0228].
It would have been prima facie obvious to one of ordinary skill in the art to include lactic acid and a fragrance within the claims, and formulate the composition as a liquid. The ordinarily skilled artisan would have been motivated to include lactic acid to optimize sensory properties of the composition and for moisture retention of the skin [0191]-[0192], to include fragrances to provide a pleasant scent [0198], and to formulate the composition as a liquid, as taught by Kulke at [0228].
The amounts and weight ratios would be achieved by one of ordinary skill in the art through routine experimentation. See MPEP 2144.05(II)(A).
Response to Applicant’s Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Applicant argues that because Kulke does not teach the structure as recited in the claims that the double patenting rejection is improper because Kulke would never be considered in combination with application 17/769,198.
The Examiner disagrees. Both Kulke and application 17/769,198 are drawn to compounds with a cooling sensation (bringing the compound of formula Ia in contact with TRPM8 receptors inducing a cooling sensation - 17/769,198 specification), and therefore, are analogous art and would be considered in combination.
Applicant argues that Kulke’s mention of lactic acid is only properly considered in the context of Kulke’s compounds and there would be no motivation to select lactic acid in combination with the claimed compounds.
The Examiner disagrees. The ordinarily skilled artisan would have been motivated to include lactic acid to optimize sensory properties of the composition and for moisture retention of the skin as taught by Kulke [0191]-[0192].
Applicant also argues that the claims of 17/769,198 are distinguished as being method claims.
The Examiner disagrees that this feature makes the claims of 17/769,198 distinct from the claims of the instant application as the instant claims define the structure as a “cooling compound” and bringing the compound of formula Ia in contact with TRPM8 receptors, as claimed in 17/769,198 induces a cooling sensation (17/769,198 specification, for example at pg. 1).
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-19 of U.S. Patent Application No. 18/005,425.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (composition) recited in the claims of the copending application falls within the genus (composition) recited in the claims of the instant application, and thus read on the instant claims.
The amounts and weight ratios would be achieved by one of ordinary skill in the art through routine experimentation. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Response to Applicant’s Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Applicant argues that because Kulke does not teach the structure as recited in the claims that the double patenting rejection is improper because Kulke would never be considered in combination with application 18/005,425.
The Examiner disagrees because Kulke was not used to support the double patenting rejection over 18/005,425.
Applicant argues that the remarks concerning lactic acid are equally applicable in regards to the double patenting rejection over 18/005,425.
The Examiner disagrees because 18/005,425 recites lactic acid in claim 1.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-7 of U.S. Patent Application No. 18/275,055 in view of Kulke et al. (US 2015/0313820 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the composition except for lactic acid and the composition being a liquid.
Kulke teaches cooling compounds with improved flavor for the mucosa in combination with lactic acid [abstract] [0001] [0192]. Kulke teaches lactic acid in an amount of 0.1 to 15 wt.% to optimize sensory properties of the composition [0191]-[0192]. Kulke teaches the compositions of the disclosure are liquids [0228].
It would have been prima facie obvious to one of ordinary skill in the art to include lactic acid within the copending claims and to formulate the composition as a liquid. The ordinarily skilled artisan would have been motivated to include lactic acid to optimize sensory properties of the composition [0191]-[0192] and to formulate the composition as a liquid, as taught by Kulke at [0228].
The amounts and weight ratios would be achieved by one of ordinary skill in the art through routine experimentation. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Response to Applicant’s Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Applicant argues that because Kulke does not teach the structure as recited in the claims that the double patenting rejection is improper because Kulke would never be considered in combination with application 18/275,055.
The Examiner disagrees. Both Kulke and application 18/275,055 are drawn to flavor compositions, and therefore, are analogous art and would be considered in combination.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent Application No. 18/279,872 in view of Kulke et al. (US 2015/0313820 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the composition except for lactic acid and a fragrance or flavor.
Kulke teaches cooling compounds for mucosa in combination with lactic acid and a fragrance [0001] [0192] [0198]. Kulke teaches lactic acid in an amount of 0.1 to 15 wt.% to optimize sensory properties of the composition [0191]-[0192]. Kulke teaches fragrances are odor-masking agents which provide the composition with a pleasant scent [0198].
It would have been prima facie obvious to one of ordinary skill in the art to include lactic acid and a fragrance within the claims. The ordinarily skilled artisan would have been motivated to include lactic acid to optimize sensory properties of the composition [0191]-[0192] and to include fragrances to provide a pleasant scent [0198].
The amounts and weight ratios would be achieved by one of ordinary skill in the art through routine experimentation. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Response to Applicant’s Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Applicant argues that because Kulke does not teach the structure as recited in the claims that the double patenting rejection is improper because Kulke would never be considered in combination with application 18/279,872.
The Examiner disagrees. Both Kulke and application 18/279,872 are drawn to compounds with a cooling sensation, and therefore, are analogous art and would be considered in combination.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-12 of U.S. Patent Application No. 18/286,525 in view of Kulke et al. (US 2015/0313820 A1).
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-16 of U.S. Patent Application No. 18/276,412 in view of Kulke et al. (US 2015/0313820 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the composition except for a solvent, such as lactic acid, a fragrance or flavor, and the composition being a liquid.
Kulke teaches cooling compounds for the skin or mucosa in combination with lactic acid and a fragrance [0001] [0192] [0198]. Kulke teaches lactic acid in an amount of 0.1 to 15 wt.% to optimize sensory properties of the composition and for moisture retention of the skin [0191]-[0192]. Kulke teaches fragrances are odor-masking agents which provide the composition with a pleasant scent [0198]. Kulke teaches the compositions of the disclosure are liquids [0228].
It would have been prima facie obvious to one of ordinary skill in the art to include lactic acid and a fragrance within the copending claims, and formulate the composition as a liquid. The ordinarily skilled artisan would have been motivated to include lactic acid to optimize sensory properties of the composition and for moisture retention of the skin [0191]-[0192], to include fragrances to provide a pleasant scent [0198], and to formulate the composition as a liquid, as taught by Kulke at [0228].
The amounts and weight ratios would be achieved by one of ordinary skill in the art through routine experimentation. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Response to Applicant’s Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Applicant argues that because Kulke does not teach the structure as recited in the claims that the double patenting rejections are improper because Kulke would never be considered in combination with application 18/286,525 or 18/276,412.
The Examiner disagrees. Kulke and 18/286,525 or Kulke and 18/276,412 are both drawn to compounds with a cooling sensation, and therefore, are analogous art and would be considered in combination.
Applicant also argues that the claims of 18/286,525 are distinguished as being method claims.
The Examiner disagrees that this feature makes the claims of 18/286,525 distinct from the claims of the instant application as the instant claims define the structure as a “cooling compound” and bringing the compound of formula I in contact with TRPM8 receptors, as claimed in 18/286,525 induces a cooling sensation (18/286,525 specification, for example at pg. 1).
Potentially Allowable Subject Matter
Claims 1-17 are free of prior art but are currently rejected under non-provisional double patenting.
The closest prior art to the instant claims is Gal et al. (WO 2007/039781 A2), Kulke et al. (US 2015/0313820 A1), and Kawamoto et al. (US 2007/0191389 A1).
The instant claim 1 and all dependent claims are drawn to:
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Gal discloses compounds of formula (I), which are similar in structure to those instantly claimed as Q is a -CH- group, Y1 and Y2 are selected from the group consisting of hydrogen, a halogen atom, or a C1-4 alkyl, Z is -(CH2)n- group where n is 2, and R is a C1-7 alkyl (abstract).
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However, the structure differs from that instantly claimed as X1 and X2 are different and are independently selected from N and O (i.e., cannot be an imidazole group as instantly claimed) (abstract). Specific examples are provided in tables 1 (pg. 26-28) and 2 (pg. 42-53), all of which show that X1 and X2 are different and are independently selected from N and O.
Gal discloses that the compounds of the disclosure can be used in a formulation to treat mGluR5 receptor-mediated disorders with 0.01-15 wt.% active agent, 0.1-5 wt.% ethanol and a flavoring agent (pg. 38, lines 24-28) (abstract), but does not provide any indication that the compounds or compositions of the disclosure provide a cooling effect.
Therefore, the instant claims are not anticipated nor obvious over Gal because Gal does not teach the structure of the instant claim 1 and there is no indication that the compounds of Gal would provide a cooling effect or be used in compositions that provide a cooling sensation.
Kulke discloses preparations which provide a cooling effect that contain menthol compounds such as WS-12 [0001] [0122]:
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The compositions include a suitable carrier such as ethanol [0248] in a weight ratio of active agent to ethanol of 0.01:99.9 to 2:98 [0250]. The compositions also include lactic acid [0192] [0194] and fragrances [0198] [0211].
However, the instant claims are not anticipated nor obvious over Kulke because Kulke does not teach the structure of the instant claim 1.
Kawamoto discloses compounds of the following structure which have mGluR1 inhibiting action [abstract],
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which are similar in structure to those instantly claimed as R1 is a branched lower alkyl group, such as an isobutyl group [abstract] [0069] Q1 and Q2 are carbon connected by a single bond [0025]-[0026], A is an imidazole group [Abstract] [0019] and R2 is a phenyl group [0089].
However, Kawamoto teaches the “A” substituent is necessarily in the para – position relative to the nitrogen (Examples 1-90) and in applicant’s compound, as claimed, an ortho - position is defined. There is also no indication that the compounds of Kawamoto would provide a cooling effect or be used in compositions that provide a cooling sensation.
Therefore, the instant claims are not anticipated nor obvious over Kawamoto because Kawamoto does not teach the structure of the instant claim 1, and there is no indication that the compounds of Kawamoto would provide a cooling effect or be used in compositions that provide a cooling sensation.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612