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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/28/2026 has been entered.
Status of the Application
Claims 1-3 and 7-23 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 03/30/2026 are acknowledged. Claims 1-3, 7-8, and 19 remain withdrawn, as being drawn to an unelected invention or specie. Claims under consideration in the instant office action are claims 9-18 and 20-23.
Applicants' arguments, filed 03/30/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 9-18, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Boaz et al. (The effect of anti-inflammatory (aspirin and ⁄or statin) therapy on body weight in Type 2 diabetic individuals: EAT, a retrospective study, Diabetic medicine, 2009, 26(7), pp. 708-713) in view of Bucci et al. (Human obesity is characterized by defective fat storage and enhancedmuscle fatty acid oxidation, and trimetazidine gradually counteractsthese abnormalities, Am. J. Physiol. Endocrinology and Metabolism, 2011, 301, pp. E105-E112).
Boaz et al. teaches the effect of aspirin therapy on body weight in Type 2 diabetic individuals (see abstract). Boaz et al. teaches “An increase in circulating inflammatory factors in obese compared with normal-weight individuals and the identification of macrophage infiltration in white adipose tissue have established a role for the inflammatory process in the pathophysiology of obesity and pro-inflammatory biomarkers are positively associated with both visceral and subcutaneous fat mass. Such observations have prompted investigations into the role of anti-inflammatory therapies for obesity-associated pathologies. For example, high doses of salicylates (aspirin or salicylate) have been shown to improve insulin sensitivity in patients with Type 2 diabetes, most likely by inhibiting IjB kinase-b (IKK beta) activation. Animal models have demonstrated that aspirin and other nonprescription analgesic agents improve glucose tolerance and partially inhibit weight gain through their antioxidant, anti-inflammatory effects.” (pp. 711-712, bridging paragraph). Boaz et al. teaches oral administration of active agents (Table 1). Boaz et al. teaches aspirin dosages of 75 – 325 mg (pg. 710, left column, first paragraph).
Boaz does not teach a method of treating obesity wherein a second therapeutic agent B is administered.
Bucci et al. is drawn towards the effects of trimetazidine on human obesity (pg. E105). Bucci et al. teaches that “obesity is associated with an impairment in the esterification of FA in adipose tissue and skeletal muscle, which is accompanied by the upregulation in skeletal muscle FAO. The inability to store may initiate a cascade of events leading to FA oversupply to lean tissue, overload of the oxidative pathway, and accumulation of toxic lipid species and triglycerides, and it was paralleled by a proportional growth in insulin resistance. Trimetazidine increased the FA esterification and glucose phosphorylation rate constants in skeletal muscle, and the EMCL in one month, supporting the hypothesis of an indirect, albeit very gradual, diversion of FA from the oxidative to the nonoxidative pathway.” (pg. E111, left column, second paragraph). Bucci et al. teaches a dosage of 35 mg of trimetazidine (pg. E106, right column, second paragraph).
It would have been obvious to one of ordinary skill in the art to formulate a composition comprising aspirin and trimetazidine, as suggested by Bucci et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since it is prima facie obvious to combine components known for the same purpose for their combined additive effects, with a reasonable expectation of success absent evidence of criticality of the particular formulation. Additionally, “[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, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, it would have been prima facie obvious to combine aspirin and trimetazidine cojointly in a formulation to treat obesity.
With regards to the limitation claimed in instant claims 13-17, which claims simultaneous or separate administration, Boaz et al. and Bucci et al. do not specifically teach the sequence of administration claimed in instant claims 13-17. However, it would be within the skill of an ordinary artisan to be able to modify the sequence of administration in order to obtain the desired bioavailability of the agents. It is noted that "[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).
Even though the range for weight ratios as taught by Boaz et al. and Bucci et al. are not the same as the claimed weight ratios, Boaz et al. and Bucci et al. do teach or suggest an overlapping range of weight ratios, and it has been held that 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05(I). Furthermore, the determination of dosages is well within the purview of those skilled in the art through routine experimentation, and it has been held that “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). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the weight ratios in order to increase the efficacy of the formulation.
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
Response to Arguments
Applicant argues that “Applicant has amended independent claim 9 to recite indications with supporting data demonstrating unexpected therapeutic effects (see Table A below). Applicant appreciates the Examiner's acknowledgement that unexpected synergy has been demonstrated for NASH and PCOS. Accordingly, synergistic data supporting NASH and PCOS are not repeated in this response. Regarding treatment of obesity based on an obesity model, unlike alleged by the Examiner, the October 10, 2025 Response has presented such data showing unexpected synergy, such as Ng Declaration at 8, and page 8 second full paragraph of the October 10, 2025 Response. The obesity data is described here again for easier review.” The Examiner respectfully disagrees since although Applicant has demonstrated unexpected synergy of a combination of 30 mg/kg of aspirin and 5 mg/kg of trimetazidine daily in the treatment of overweight, obesity, NASH, non-alcoholic fatty liver, type 2 diabetes, dyslipidemia, hyperlipidemia, and PCOS, such results are not commensurate in scope with the claims. Applicant has not demonstrated unexpected synergy for other salicylates or for dosages outside of 30 mg/kg of aspirin and 5 mg/kg of trimetazidine daily.
Conclusion
Claims 9-18 and 20-23 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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