DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/28/2025 has been entered.
AIA Status of the Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, filed 7/28/2025, have been fully considered.
The previous objections and rejections are WITHDRAWN in view of Applicant’s amendments to the claims.
The following rejection is newly applied and constitutes 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.
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.
Claims 1, 3 and 29 are rejected under 35 U.S.C. 103(a) as being unpatentable over Haque et al (Toxicol Mech Methods 24:116-123, 2014) in view of Cho et al (J Nutritional Biochem 23:192-201, 2012).
As amended, claim 1 is drawn to a method of treating/preventing/managing cellular malfunction, genome damage, or a disease or condition associated with altered mitochondrial function or reduced mitochondrial density (more specifically, wherein the disease or condition is obesity (claim 3)), the method comprising:
administering a composition comprising a combination of thymol and carvacrol to an individual in need thereof;
wherein the composition is administered in a daily dosage comprising the combination in a range of 0.05 mg to 1.0 g per kg body weight.
As taught by Haque et al, “thymol prevents high fat diet induced obesity in murine model” (Title). Specifically, Haque et al teach that “[m]ale Wistar rats were fed HFD [high fat diet] for 6 weeks” and, following the second week, “[t]hymol (14 mg/kg) [was] administered twice per day… for 4 weeks” (Abstract). As demonstrated by Haque et al, whereas untreated “rats fed with HFD exhibited significantly (p < 0.001) enhanced body weight gain, visceral pad weight, lipids, alanine aminotransferase (ALT), aspartate aminotransaminase (AST), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), glucose, insulin and leptin levels… [t]hymol treatment showed significantly (p < 0.001) decreased body weight gain, visceral pad weight, lipids, ALT, AST, LDH, BUN, glucose, insulin and leptin levels in HFD-induced obese rats” (Abstract). As such, Haque et al suggest that “thymol could be valuable in the development of new drug therapies to prevent obesity and its complications with no obvious toxicity” (Page 122, Column 1).
Similarly, as taught by Cho et al, “[c]arvacrol prevents diet-induced obesity… in mice fed with high-fat diet” (Title). Specifically, Cho et al teach that “C57BL/6N mice” were fed high fat diet which “contained 0.1% carvacrol… for 10 weeks” (Page 193, Columns 1-2), “equivalent to 100 mg/kg body weight” (Page 199, Column 1).
Accordingly, based on Haque et al and Cho et al, it would have been prima facie obvious to administer a composition comprising a combination of thymol and carvacrol, wherein the composition is administered in a daily dosage comprising the combination in a range of 0.05 mg to 1.0 g per kg body weight, for the treatment/prevention/management of obesity in a patient in need thereof, with a reasonable expectation of success. As stated in MPEP 2144.06, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846 (CCPA 1980).
As such, claims 1 and 3 are rejected as prima facie obvious.
Claim 29 is drawn to the method of claim 1, wherein the individual is not an ageing individual (see Specification, Paragraph 0061), suffering from or at risk of developing sarcopenia, suffering from or at risk of developing frailty, or critically ill.
At the outset, nowhere do Haque et al or Cho et al identify the subjects treated therein as suffering from or at risk of any of the conditions identified in claim 29. Moreover, in carrying out the method based on Haque et al and Cho et al – comprising administering a composition comprising a combination of thymol and carvacrol, wherein the composition is administered in a daily dosage comprising the combination in a range of 0.05 mg to 1.0 g per kg body weight, for the treatment/prevention/management of obesity in a patient in need thereof, with a reasonable expectation of success – it would have been obvious to apply the method to any patient in need thereof, not only patients suffering from or at risk of any of the conditions identified in claim 29.
Accordingly, claim 29 is also rejected as prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. 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.
/CRAIG D RICCI/Primary Examiner, Art Unit 1611