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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/27/2025 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/27/2025 and 08/07/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant’s arguments, see pp. 5-6, filed 06/27/2025, with respect to the objection to claim 43 and the rejection of claims 43-44, 50-51, 67-75 and 78 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Amendments moot the objection/rejection. The objection/rejection of 03/27/2025 has been withdrawn.
Applicant's arguments filed 06/27/2025 have been fully considered but they are not persuasive. Applicant asserts that the claimed group of dispersion polymers (unpredictably) lead to a significantly improved solubility. A certain degree of improved solubility is expected for reasons presented previously in the obviousness rejection. Only a particularly high degree of improvement can be considered unexpected, i.e. the first group examples of Table 5 wherein the Increase in AUC over API AUC is >2.0 which is significantly greater than the improvement imparted by the other dispersion polymers. Applicant asserts that a certain class of cellulosic polymers modified with hydroxylated alkyl groups exhibit unexpected results. However, only HPMCAS-M and HPMCAS-H appear at certain ratios appear to exhibit unexpected results. It is unclear based upon the evidence of record that the claims which encompass HPMC, HPC, etc. and different ratios can be considered commensurate in scope with these results. It is not readily apparent that those unexpected results can be extrapolated to the additional claimed species. Applicant is reminded that the burden is on applicant to establish that results are unexpected and significant. See MPEP 716.02(b). No claim is commensurate in scope with the 4 highlighted examples. Accordingly, the rejection under 35 U.S.C. 103 is maintained. A modified rejection under 35 U.S.C. 103 is presented below in order to address amendments.
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.
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 43-44, 50-51, 67-75 and 78 are rejected under 35 U.S.C. 103 as being unpatentable over U.S.2018/0354957A1 to Petrukhin et al. in view of Paudel et al. "Manufacturing of solid dispersions of poorly water soluble drugs by spray drying: Formulation and process considerations" International Journal of Pharmaceutics 453 (2013) 253–284.
Petrukhin et al. teaches Compound 81 (Table 1, p. 79, bottom right) which is a compound of instant formula (I) as well as the compound of instant claim 66 and applicant’s elected species. Compound 81 lowers serum RBP4 levels (Figure 9). Petrukhin et al. also discusses oral administration (Para. [0222]) and the use of carriers (fillers) such as starch (Para. [0218]).
Petrukhin et al. does not teach the method as instantly claimed wherein a composition comprising a solid dispersion comprising (i) a compound of Formula (I) and (ii) a dispersion polymer selected from those claimed is used to lower the serum concentration of RBP4 in a subject.
Paudel et al. teaches the preparation of solid dispersions using a dispersion polymer such as HPMC-AS or HPC to improve solubility of poorly soluble drugs (see p. 60-62; whole document) as common general knowledge; note that Paudel is a review article. The skilled artisan would have found it prima facie obvious to use a dispersion polymer such as HPMC-AS or HPC with Compound 81 taught by Petrukhin et al. to improve solubility of the API for a method of lowering serum RBP4 concentration in a subject. While there is no specific teaching of poor solubility of Compound 81, a PHOSITA would understand that the teachings of Paudel could be applied to any API for which improved solubility is desired. Accordingly, it would have been obvious to apply the teachings of Paudel et al. to improve the solubility of Compound 81 as taught by Petrukhin et al. With respect to claims drawn to specific percentages of ratios of components, a PHOSITA would have arrived at the claimed amounts under the process of routine optimization. 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). There is no readily apparent criticality of any ranges or showing of unexpected results commensurate with the scope of any claims. Accordingly, the claims are prima facie obvious.
Conclusion
Claims 43-44, 50-51, 67-75 and 78 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623