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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 2, 2026, has been entered.
Response to Argument
Applicant’s amendments to the claims obviate the rejections of record. However, the remainder of Applicant’s arguments are moot in view the new prior art cited below. The prior art cited below is a directed response to the Amendment to the claims that the subject does not have pain in the hands or feet when menthol is administered.
The prior art below is directed to increasing cooling of brown adipose tissue by topically contacting an area of the body that has a high density of TRPM8 thermoreceptors with menthol, e.g.
Applicant’s unexpected results are also moot. It appears that the higher density of TRPM8 receptors in the hands feet, ankles, and wrist are not unexpected. See prior art cited below. Any unexpected result must be unexpected as compared to the closest prior art which is newly cited below in response to the Amendments to the claims. Full consideration has been given to Applicant’s arguments and allegations. A rejection is set forth below.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Tupone et al., “Autonomic regulation of brown adipose tissue thermogenesis in health and disease: potential clinical applications for altering BAT thermogenesis,” Frontiers in Science February 7, 2014, in view of Aronhalt et al., (US2015/0119849), and in view of Mueller et al., (US2018/0147163), and in view of Paschke et al., “Activation of the cold-receptor TRPM8 by low levels of menthol in tobacco products,” Toxicology Letters 271 (2017) 50-57.
Tupone teaches activating brown adipose tissue (BAT) cooling can facilitate the induction of therapeutic hypothermia for improving outcomes in stroke by lowering metabolic oxygen demand. See Abstract. TRPM8, activated by menthol and cooling is the primary candidate for cutaneous cold receptor TRP channel. See p2, 2nd par.
Aronhalt teaches methods for activating BAT with cooling in tissue having a high density of cold sensitive thermoreceptors to increase thermogenesis. See Abstract. In one method a cooling device is placed in contact with a area of high density cooling thermoreceptors, wherein those receptors are proximate to at least one wrist, ankle, hand, palm or foot. See prior art claim 2. The method further comprises delivering an agonist of at least one TRP channel, wherein the TRP channel is one of TRPV1, TRPM8, and TRPA1. See prior art claims 15 and 16. The TRP channels prevalent in the skin make them especially available to activation by agonists such as menthol. See par. 41. These channels are prevalent in the skin and can be imbedded in topical, cream, gel, and other delivery means to administer to an particular region of the skin. See par. 41.
Mueller teaches a composition comprising a TRPM8 agonist for treating disorders, including stroke. See par. 8 and 9. Menthol is referred to as one of the main TRPM8 agonist cooling agents in additional to iciclin and WS-12. See par. 78. Stroke is classified as ischemic and hemorrhagic. See par. 93. It is believed that TRPM8 agonists act on brown adipose tissue where they mimic cold exposure and increase cold thermogenesis. See par. 119. Administration includes topical application and administration among other forms of administration. See par. 181, 200, and others. Transdermal administration as a powder, spray, ointment, paste, cream, lotion, gel and others are contemplated. See par. 212.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed method in view of Tupone, Aronhalt, and Mueller. One would be motivated to do so because menthol is a known TRPM8 agonist that is recognized as increasing cooling thermogenesis by acting on brown adipose tissue. Further, Tupone suggests that it improves outcomes in stroke and Mueller independently teaches that it can be used to treat stroke. Moreover multiple references teach topical administration to the skin in the claimed forms and Aronhalt, which has matured into a patent, teaches contacting an area with a high density cooling thermoreceptors, wherein those receptors are proximate to at least one wrist, ankle, hand, palm or foot. As such, there is a reasonable and predictable expectation of success in mitigating harm caused by stroke by administering a known TRPM8, including menthol, because TRPM8 agonists and menthol in particular, are taught to activate BAT cooling to mitigate stroke and that a preferred therapeutic target is an area of the body having a high density of cooling thermoreceptors, such as the hands and feet as well as areas proximate thereto, including the wrist and ankle.
Paschke teaches that 50 micrograms of menthol can activate TRPM8 receptors. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In light of the known mechanism of action by which menthol is taught to treat stroke, a POSA would be able to optimize a dose to arrive at a percentage or amount to effectuate the desired mode of action through nothing more than routine experimentation.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JARED BARSKY/Primary Examiner, Art Unit 1628