DETAILED ACTION
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/09/2026 has been entered.
Previous Rejections
Applicants' arguments, filed 07/09/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent Application No. 12,528,801 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 as a humectant 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 as an odor-masking agent and 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 07/09/2026 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 U.S patent 12,528,801.
The Examiner disagrees. U.S patent 12,528,801 claims the structure recited in the instant claims. Both Kulke and U.S patent 12,528,801 are drawn to compounds with a cooling sensation (bringing the compound of formula Ia in contact with TRPM8 receptors inducing a cooling sensation - U.S patent 12,528,801 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. Applicant further argues that the mere recitation of “lactic acid” in Kulke makes no mention of any specific reason why it should be selected.
The Examiner disagrees. The ordinarily skilled artisan would have been motivated to include lactic acid as a humectant to optimize sensory properties of the composition and for moisture retention of the skin as taught by Kulke [0191]-[0192].
Applicant further argues that any consideration of Kulke is improper as the Examiner’s characterization of Kulke relies on a “hindsight reconstruction” using the applicant’s specification describing their invention as a template.
The Examiner disagrees. 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 MPEP 2145 X.A. In the instant case, the knowledge was not gleaned from the applicant’s disclosure and 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 as an odor-masking agent and to provide a pleasant scent [0198], and to formulate the composition as a liquid [0228], as taught by Kulke.
Applicant also argues that the claims of U.S patent 12,528,801 are distinguished as being method claims.
The Examiner disagrees that this feature makes the claims of U.S patent 12,528,801 distinct from the claims of the instant application. The method claims of 12,528,801 include the instantly claimed compound. 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 12,528,801 induces a cooling sensation (12,528,801 specification, for example at pg. 1).
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent Application No. 18/279,872 (notice of allowance mailed 07/07/26) 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 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 as a humectant 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 as a humectant to optimize sensory properties of the composition [0191]-[0192] and to include fragrances as odor-masking agents and 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).
Response to Applicant’s Arguments
Applicant's arguments filed 07/09/2026 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. Application 18/279,872 claims the structure recited in the instant claims. 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.
Applicant further argues that application 18/279,872 is to a different teaching, namely of enhancing taste perception in alcohol product.
The Examiner disagrees that this feature makes the claims of 18/279,872 distinct from the claims of the instant application. Application 18/279,872 claims the compound recited in the instant claims and in both cases it is defined as a “cooling compound”. The claims of application 18/279,872 are drawn to enhancing taste perception in alcohol product by adding the cooling compound, and therefore, are not patentably distinct.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10, 12-13, and 18-19 of U.S. Patent Application No. 18/005,425 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 fragrance or flavor.
Kulke teaches cooling compounds in combination with a fragrance [0001] [0192] [0198]. 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 a fragrance within the copending claims. The ordinarily skilled artisan would have been motivated to include fragrances as odor-masking agents and 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 07/09/2026 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. The copending claims recite all of the features instantly claimed (including the claimed compound, lactic acid, and the composition being a liquid) expect for the composition including a fragrance. Both Kulke and application 18/005,425 are drawn to compounds with a cooling sensation, and therefore, are analogous art and would be considered in combination. The ordinarily skilled artisan would be motivated to include fragrances as odor-masking agents and to provide a pleasant scent [0198].
Applicant further argues that the same remarks above concerning Kulke’s teaching of “lactic acid” are equally applicable here.
The Examiner disagrees because copending application 18/005,425 claims lactic acid (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 a humectant, such as lactic acid [abstract] [0001] [0192]. Kulke teaches the humectant 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 07/09/2026 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. Application 18/275,055 claims the structure recited in the instant claims. 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 1-4 and 6-12 of U.S. Patent Application No. 18/286,525 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 as a humectant 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 as a humectant to optimize sensory properties of the composition and for moisture retention of the skin [0191]-[0192], to include fragrances as odor-masking agents and 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 07/09/2026 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 18/286,525.
The Examiner disagrees. Application 18/286,525 claims the structure recited in the instant claims. Kulke and 18/286,525 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 18/286,525 claims “a composition for inducing a cooling sensation” (claim 7) with the claimed compound(s).
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:
PNG
media_image1.png
402
513
media_image1.png
Greyscale
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).
PNG
media_image2.png
174
437
media_image2.png
Greyscale
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]:
PNG
media_image3.png
177
290
media_image3.png
Greyscale
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],
PNG
media_image4.png
100
432
media_image4.png
Greyscale
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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights