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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive.
First, applicant argues that the claims are commensurate in scope with the examples provided. However, the genus of “cellulosic polymers modified with hydroxylated alkyl groups” argued to exhibit unexpected results cannot be considered as a whole to exhibit said results. For example, the
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formulation exhibits a decrease in AUC.
Furthermore, applicant argues that the selection of the AUC enhancement used by the Examiner as showing unexpected results is arbitrary. While these arguments are well-taken, it has been established that some degree of improved dissolution parameters can be expected when dispersion polymers are used. Accordingly, a mere improvement cannot be considered unexpected. No baseline for an expected improvement is established, and accordingly only the data provided can be assessed. In view of the totality of the data, the >2.0 increase in AUC examples are significantly greater than those showing ≤ 1.7 increase in AUC. Applicant is reminded that the burden is on applicant to establish results are unexpected and significant and applicant have burden of explaining proffered data. See MPEP 716.02(b).
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, 67-74 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, 67-74 and 78 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 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 JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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