DETAILED ACTION
Notice of 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 .
Status of the Claims
The amendments filed 3/16/2026 have been entered.
Response to Arguments
The rejection of claims has been modified based on Applicant’s amendments to the claims. To the extent that Applicant’s arguments are applicable to the current basis of rejection, the following response is provided:
Applicant first argues that “Haque is directed to the treatment of high-fat diet-induced obesity... [but] does not disclose or suggest treating, preventing, or managing cellular malfunction, genome damage, or diseases or conditions associated with altered mitochondrial function or reduced mitochondrial density” (Applicant Arguments, Page 6). Similarly, Applicant argues that “Cho reports that carvacrol may prevent diet-induced obesity... however... does not disclose or suggest treatment of mitochondrial dysfunction, reduced mitochondrial density, or genome damage” (Applicant Arguments, Page 6). And, as argued by Applicant, “[t]he presently claimed invention is not directed to treating obesity per se, but rather to treating cellular malfunction and diseases or conditions associated with altered mitochondrial function or reduced mitochondrial density” (Applicant Arguments, Page 6).
The argument is not found persuasive. Claim 1 recites “[a] method of treating, preventing or managing... a disease or condition associated with altered mitochondrial function or reduced mitochondrial density” wherein, as recited by claim 3, “[t]he disease or condition associated with altered mitochondrial function or reduced mitochondrial density is... obesity”.
Applicant next argues that, “even assuming arguendo that a person of ordinary skill in the art would contemplate combining thymol and carvacrol for obesity-related reasons, there is no teaching or suggestion in the cited art that such a combination would be administered in a manner that achieves the claimed plasma levels, daily serving amounts, or compositional concentrations” (Applicant Arguments, Page 6).
The argument is not found persuasive. As discussed in the basis of the rejection, Haque et al teach that “[t]hymol (14 mg/kg) [was] administered twice per day… for 4 weeks” to “[m]ale Wistar rats” (Abstract) which were “8-12 weeks old, 150-200 body weight” (Page 117, Column 1) – which is calculated as 2.1-2.8 mg thymol twice per day. And Cho et al teach that “C57BL/6N mice” – which, as evidenced by the Centre for Comparative Medicine Research, mature C57BL/6N mice weigh about 20-30 grams – were fed high fat diet which “contained 0.1% carvacrol” (Page 193, Columns 1-2), “equivalent to 100 mg/kg body weight” (Page 199, Column 1) – which is calculated as 2.0-3.0 mg carvacrol.
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; of record) in view of Cho et al (J Nutritional Biochem 23:192-201, 2012; of record) as evidenced by Centre for Comparative Medicine Research (available online at https://ccmr.hku.hk/en/Animals/Animals/Animal-Strains/Mouse/C57BL_6N, accessed 4/10/2026).
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 serving comprising 50 µg to 10 g of the combination in one or more portions.
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 [“8-12 weeks old, 150-200 body weight” (Page 117, Column 1)] 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) – which is calculated as 2.1-2.8 mg thymol twice per day. 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” – which, as evidenced by the Centre for Comparative Medicine Research, mature C57BL/6N mice weigh about 20-30 grams – 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) – which is calculated as 2.0-3.0 mg carvacrol.
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 serving comprising 50 µg to 10 g of the combination in one or more portions, 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 serving comprising 50 µg to 10 g of the combination in one or more portions, 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
The new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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