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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 01 Dec 2025 has been entered.
Claims 1-21 remain pending in the application.
Claims 1, 6 7, and 9-13 are amended.
Claims 2 and 8-10 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 9 and 10 are now withdrawn as the amended claims require alternative species of preservative and solubilizing agent from the elected species.
Claims 1, 3-7 and 11-21 are under examination to the extent of the elected species, i.e. that the thickening agent is polyacrylate crosspolymer-6, the solubilizing agent is diethylene glycol monoethyl ether and the preservative is methylparaben.
Objections Withdrawn
Objections to the Specification
The specification objections set forth in the Non-Final Office Action mailed 21 Aug 2025 are hereby withdrawn in light of applicant’s amendments of the specification.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of claims 6, 7, and 10-13 pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 21 Aug 2025 are hereby withdrawn in light of applicant’s amendment of the claims.
Rejections Maintained
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 1, 3-7 and 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Scheiwe et al. (US 6,492,395, published 10 Dec 2002) in view of Vega et al. (GB 2447520A, published 17 Sep 2008), Kulkarni et al. (WO 2020/100096, published 22 May 2020) and Seth et al. (US 2006/0167064, published 27 Jul 2006).
Scheiwe teaches topical formulations for the treatment of skin ailments (abstract). Scheiwe teaches the topical formulation with an excipient which permits the dissolution or dispersion of a sufficient amount of pirfenidone (col 2 lines 1-6). Scheiwe teaches the formulation may be a gel (col 1 lines 6-7) rendering obvious the gel composition of claim 3. Scheiwe teaches that the invention is for the treatment of skin ailments of a fibrotic nature (col 2 lines 11-13), rendering obvious the treatment of skin disorders of the dermis of fibrous origin as in claim 17. Scheiwe teaches that the pirfenidone is preferably within the range of about 0.5 % to 9% by weight (col 2 lines 31-35), rendering obvious the amount of pirfenidone as in claims 4, 5, and 13. Scheiwe teaches that the excipient of the composition comprises one or more plasticizers, one or more antioxidants, one or more gel-forming agents and pH adjusting agent (col 2 lines 26-30). Scheiwe teaches that the compositions contain water (col 3 line 39), rendering obvious the water of instant claim 13. Scheiwe teaches the pH of the formulation is from 4 to 8 (col 2 lines 28-29), rendering obvious claim 15. Scheiwe teaches that the gel-forming agents can be present from 0.5% to 5% by weight (col 3 line 37) and may be included with emulsifying agents or gums such as xanthan gum (col 2 lines 64-65). Scheiwe teaches that the antimicrobial agent may be methylparaben (col 3 lines 11-15, 25) which may be present from 0% to 0.5% by weight (col 3 line 50, claim 17), rendering obvious the preservative of methylparaben and the amount of claims 9 and 13.
Scheiwe does not teach the inclusion of a thickening agent of polyacrylate crosspolymer-6 or a solubilizing agent such as diethylene glycol monoethyl ether (the elected species) or the viscosity between 0.5 and 9 poise as in claim 16. These deficiencies are made up for in the teachings of Vega and Seth.
Vega teaches topical compositions with antimicrobial benefit (title). Vega teaches that the compositions comprise a thickener system comprising a polyacrylate cross-polymer constituent with one or more polysaccharide polymers such as xanthan gum (page 2 lines 25-28). Vega teaches that the thickener system is present in an amount to provide a viscosity of at least about 500 cps (i.e. 5 poise) (page 3 lines 7-9, page 10 lines 26-28), rendering obvious a viscosity of at least 500 cps as suitable for topical compositions. Vega teaches that the thickener system may be present in different amounts in order to achieve a desired viscosity (page 11 lines 12-15) and that the polyacrylate cross-polymer thickener is present in an amount from about 0.1% to about 6% by weight (page 9 lines 24-26). Vega teaches preservatives for the composition such as methylparabens (page 23 lines 13-15). Vega teaches that suitable forms for the topical composition include a gel formulation (page 33 lines 21-22).
Kulkarni teaches topical compositions (page 1 line 7) for treating a skin disorder (page 9 lines 9 and 10) where the formulation may take the form of a gel (page 9 line 13). Kulkarni teaches that vehicles for solubilization of the active component and solvents for the composition include diethylene glycol monoethyl ether (page 6 lines 9-12, page 17 lines 5-8, page 18 lines 12-17) and the solvent may be present from about 0.1% to about 97% w/w . Kulkarni teaches that the compositions comprise a polymeric substance gelling agent (page 14 lines 15-22) such as polyacrylate crosspolymer-6 (page 15 line 7) present from about 0.05% to about 5% w/w (page 16 lines 19-20). Kulkarni teaches that the polymer substance may be a pH independent polymer meaning that the polymer does not require a neutralizer (page 15 lines 11-12), rendering obvious the limitation that the composition is free of neutralizing agents as in claim 14. Kulkarni teaches that the viscosity of the topical composition is from about 1 cps to about 10,000 cps (i.e. 0.01 to 100 poise) (page 22 lines 21-23). Kulkarni teaches that the composition may be applied at least once daily (page 36 lines 22-23) or twice daily (page 37 lines 26-27) or thrice daily (page 38 lines 5-6).
Seth teaches a pharmaceutical composition containing pirfenidone in very high concentration of more or less 25% by weight which is obtained by dissolving the pirfenidone in diethylene glycol monoethyl ether (abstract). Seth teaches that after storage the of a long time the pirfenidone has good chemical and physical stability and does not recrystallize (abstract). Seth teaches the diethylene glycol monoethyl ether as present form 70-80 % by weight ([0016]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used polyacrylate crosspolymer-6 and diethylene glycol monoethyl ether in the pirfenidone composition of Scheiwe and to have the composition with a viscosity greater than 5 poise. Topical formulations such as gel formulations comprising pirfenidone from 0.5-9% by weight and methylparaben from 0-0.5% by weight are known from the teachings of Scheiwe. A thickener system comprising about 0.1% to about 6% by weight of a polyacrylate cross-polymer is known as suitable for topical formulations such as get formulations from the teachings of Vega. The specific polyacrylate of polyacrylate crosspolymer-6 is known as a gelling agent for topical compositions from the teachings of Kulkarni. Thus, it would have been obvious to include 0.5%-5% by weight polyacrylate crosspolymer-6 as a thickening gelling agent in the pirfenidone composition of Scheiwe as 0.5%-5% by weight of a gel forming agent is suitable for the composition, as taught by Scheiwe, and polyacrylate crosspolymer-6 is a known thickening component suitable for topical compositions. Thus, there is a reasonable expectation of successfully forming a gel composition with polyacrylate crosspolymer-6 as the gel compositions of Scheiwe include a gelling agent and polyacrylate crosspolymer-6 merely represents the inclusion of a known gelling agent for topical compositions for use in a topical gel composition. Further, Kulkarni indicates that the polymers may be used without a neutralizer, as described above, rendering it obvious to form topical compositions with components as described without neutralizers. The use of diethylene glycol monoethyl ether is similarly known for use as a solvent in pharmaceutical compositions from the teachings of Kulkami and Seth. Diethylene glycol monoethyl ether is specifically known as an excellent solvent for pirfenidone from the teachings of Seth, where it is taught that large amounts of pirfenidone may be dissolved in diethylene glycol monoethyl ether with good stability, further rendering it obvious and providing an expectation of success for using this solvent with pirfenidone compositions. The amount of solvent for a composition is variable and may range from 0.1% to about 97% w/w in topical compositions, as taught by Kulkarni, rendering obvious the amount of diethylene glycol, monoethyl ether of the instant claims. It is further obvious that suitable viscosities for topical compositions may be more than 500 cps (i.e. 5 poise) from the teachings of Vega and viscosities of 1 cps to 10,000 cps (i.e. 0.01 to 100 poise) are known for topical compositions from Kulkarni. One of ordinary skill would thus have a reasonable expectation of success in forming the topical composition with a viscosity of at least 500 cps (5 poise) as this is known to be suitable for topical formulations. Regarding the overlap of the ranges taught in the prior art with the claimed ranges, the examiner notes that 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).
Regarding claims 18-20, the application of topical pharmaceutical formulations once, twice or three times daily is known from the teachings of Kulkarni, rendering these application rates as obvious for topical formulations. However, the examiner additionally notes that the application rates of once, twice and three times daily (claims 18-20) and at nighttime (claim 21) as well as the limitation in claim 17 that the composition is for use in treatment of skin disorders, are all intended uses of the compositions and do not distinguish the composition from the prior art. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the claims are drawn to a composition comprising pirfenidone, polyacrylate crosspolymer-6, a solubilizing agent such as diethylene glycol monoethyl ether and a preservative such as methylparaben and this composition is obvious over the teachings of Scheiwe, Vega, Kulkami and Seth as described above.
Response to Arguments
Applicant's arguments filed 01 Dec 2025 have been fully considered but they are not persuasive. Applicant argues that one would not refer to the teachings of Vega and Kulkarni as they do not mention pirfenidone (pages 16-17 of remarks). The examiner does not find this persuasive. Vega and Kulkarni are not relied upon for the pirfenidone and it is not necessary for Vega and Kulkarni to teach pirfenidone for their other teachings to be understood as related and obvious. Vega and Kulkarni both teach topical compositions, such as gels, which is similar to the topical compositions of Scheiwe which may be in forms such as a gel. Thus, Vega, Kulkarni and Scheiwe teach similar compositional forms for the same manner of topical application, providing a connection between the teachings of the Scheiwe, Kulkarni and Vega. Gel forming agents such as gums are known form Scheiwe and viscosity considerations and gelling agents or thickening systems including polyacrylate copolymers and gums are known from Vega and Kulkarni for such topical compositions. Vega indicates polyacrylate cross-polymer are part of a thickening system for such compositions and Kulkarni specifically identifies polyacrylate crosspolymer-6. Taken together, the prior art relied upon is in the same field of endeavor of topical compositions that may be gels and gelling agents and thickeners as known to be included in such compositions. Polyacrylate crosspolymers and specifically polyacrylate crosspolymer-6 is a known gelling agent suitable for such topical compositions and thus the inclusion of polyacrylate crosspolymer-6 in the topical compositions of Scheiwe merely represents a known prior art element, namely a gelling agent suitable for topical compositions, in use for its known purpose as a gelling agent in topical compositions. The lack of pirfenidone in Vega and Kulkarni does not serve as evidence that one of ordinary skill in the art would identify polyacrylate crosspolymer-6 as incompatible with the topical compositions of Scheiwe, but rather, the similar compositions for topical use and that may be in gel forms provides support that one of ordinary skill in the art would have a reasonable expectation of success in including polyacrylate crosspolymer-6 in the compositions of Scheiwe.
The applicant argues that Vega and Kulkarni would lead to the inclusion of xanthan gum and that this goes against the claimed invention which does not recites xanthan gum (pages 16-17 of remarks). The examiner dose not concede that the inclusion of xanthan gum would be required based on the prior art teachings, but notes that even if it was required that the argument presented by the applicant is not persuasive as the claims are open ended with “comprising” language. There is nothing in the claims that would prevent the inclusion of xanthan gum as “comprising” allows for the inclusion of unrecited elements. The applicant may amend the claims to “a topical composition consisting of” if the desire is to exclude components such as xanthan gum.
The applicant argues that while the teachings of Seth disclose diethylene glycol monoethyl ether, that there is nothing to suggest pirfenidone, diethylene glycol monoethyl ether and polyacrylate crosspolymer-6 as required per the claims (page 17 of remarks). The applicant notes that Seth and Scheiwe teach thickening agents such as bentonite, calcium magnesium silicate and the like but not polyacrylate crosspolymer-6 and that one would employ bentonite or a magnesium silicate. The examiner does not find this persuasive and notes that the combination of the components is obvious when the prior art is examined together, as described in the rejection. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Each of these components are known for topical compositions and would be obvious to include in light of Scheiwe, Vega, Kulkarni and Seth for the reasons provided above. Further, as noted above with xanthan gum, the claims do not exclude additional agents such as bentonite and calcium magnesium silicate do to the open ended comprising language.
The applicant argues that there is no teaching that one would achieve the advantageous viscosity that comes from their invention (page 17 of remarks). The examiner is not persuaded by this as the art renders obvious compositions comprising the same components of the instant claims and renders obvious a viscosity greater than 5 poise rendering obvious the claimed viscosities as in claim 16. The applicant argues that there is no motivation without hindsight bias to include polyacrylate crosspolymer-6 and diethylene glycol monoethyl ether to the disclosure of Scheiwe (page 18 of remarks). The examiner does not find this persuasive and notes that it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The combination of polyacrylate crosspolymer-6 and diethylene glycol monoethyl ether with the compositions of Scheiwe is obvious for the reasons described above and in the applied rejection.
The applicant argues for surprising results for the claimed compositions (page 18) by noting higher viscosity over the range of shear rates compared to xanthan gum and high shear viscosity drop for compositions with xanthan gum compared to polyacrylate crosspolymer-6 and points to pages 14-15 of the filed specification (pages 15-16 of remarks). The examiner is not persuaded by this argument. As a first matter, the data pointed to is not commensurate in scope with the claims. One example with pirfenidone, diethylene glycol monoethyl ether, methylparaben, and polyacrylate cosspolymer-6 is demonstrated and each of the components are in a specific amount not require by the claims (Table on pages 14-15). Base claim 1 is very broad as it only requires pirfenidone, polyacrylate crosspolymer-6 and diethylene glycol monoethyl ether to be present and doesn’t specify any amounts for the components. Second, it is not clear that the results are surprising or unexpected, as asserted. Three solutions were tested where the thickening agent was varied between a taurate, polyacrylate crosspolymer-6 and xanthan gum. Viscosities are presented in the table on page 15 but it is not clear why one would understand the data as unexpected. Three thickeners prepared at three different amounts (4.0% for the taurate copolymer, 3.0% for polyacrylate crosspolymer-6 and 2.85% for xanthan gum) providing three different viscosities does not seem unexpected but rather expected based on the different components being used in the system. The viscosity of the solution with polyacrylate crosspolymer-6 is 5.26 which is in the middle of the taurate copolymer (viscosity 6.41) and the xanthan gum (viscosity 1.06) so it is not clear what is unexpected about this. Even the xanthan gum, which is presented as the comparative composition, provides a viscosity (1.06 poise) which falls within the claimed viscosity range of claim 16. Shear thinning data is presented in the table spanning pages 15-16, but it is not clear why the results with polyacrylate crosspolymer-6 are to be understood as unexpected when compared to the results of the other two compositions. Further, the art does not require the presence of xanthan gum in the compositions and the difference in viscosity comparison to xanthan gum with the compositions presented is insufficient to establish unexpected results to overcome the prima facie case of obviousness in the rejection.
Conclusion
No claims are allowed.
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 EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner Art Unit 1600