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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/10/26 has been entered.
Response to amendment and Argument
Claims 1-7 and 11-12 are pending and under examination in this office action.
Claims 8-10 remain withdrawn per Applicant’s election.
Maintained Claim Rejections - 35 USC § 103 necessitated by amendment
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.
Claim(s) 1-7 and 11-12 stand rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2018/0236215) in view of in view of Ronca et al. (Materials (Basel) 2018 ii(12):2454) and further in view of Tsanaktsidou et al. (European Polymer J. 114, 2019; 47-56) and Choi et al. (Biotechniques 66; 40-53 (2019) from IDS
With regards to instant claims 1 and 10, Liu teaches a composition comprising a modified hyaluronic acid (see 0016), comprising poly(ethylene glycol) (see 0072), wherein the average molecular weight of hyaluronic acid is from 10- 6000 kDa (see 0060 and 0072 as required by instant claims 1 and 4).es
However Liu fails to teach that the poly(ethylene)glycol is a poly(ethylene glycol) diacrylate) and also fails to teach that the hyaluronic acid is modified using methacrylic anhydride..
Ronca teaches a double network hydrogel comprising hyaluronic acid, wherein the hyaluronic acid is a modified hyaluronic acid) and poly(ethylene glycol)diacrylate (see heading and abstract) and water (see para. above sec. 2.2 and 2.3) having a weight percent from 1 to 10 wt % (see para. above sec. 2.3, last line) and the poly(ethylene glycol is 1 kDa (see sec 2.3) and comprises a photo-initiator (see para 2.2, as required by instant claims 5-7). Additionally, Ronca teaches that the ratios of the metaacrylic acid /and hyaluronic acid varies (see sec 2.1)
With regards to claim 11, wherein the Young’s module, will be based or controlled by the starting by the molecular weight of the hyaluronic acid and the poly(ethylene glycol). Therefore It is reasonable that the Young’s modulus will of the hydrogel material will have the same modulus based on the molecular weight of the starting material.
Tsanaktsidou teaches methacrylated hyaluronic acid wherein the hyaluronic acid can be easily modified via the incorporation of functional groups (e.g., methacrylates and acrylates, via its reaction with methacrylic anhydride (see intro rt col. and sec. 2.2).
Choi teaches poly(ethylene )diacrylate are derivatives through substitution of hydroxyl groups of PEG and has varying molecular weight ranging from 1-50 kDa (see rt. Col. pg. 34, last para)
It would have been obvious to one of ordinary skill in the art to have expanded the teachings of Liu, substitute the polymer used in modification of the hyaluronic acid (see 0017) with the poly(ethylene )diacrylate of Ronca obtained from the teaching of Tsanaktsidou and Choi to result in the instant claimed invention with a reasonable expectation of success that the modified hyaluronic acid and the poly(ethylene glycol)diacrylate and water would yield success. Additionally, both Ronca and Choi, teaches that PEG-DA based on the molar ratio of the hyaluronic acid and methyl acrylic acid , one would reasonable expect the molecular weight of the poly(ethylene )diacrylate to vary. Therefore it is within the purview of the skilled artisan to decide the appropriate molecular weight for the poly(ethylene )diacrylate to be used in the hydrogel.
One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a).
Applicant’s argues in summary that claim 1 of the referenced application claims a hydrogel composition comprising 1 wt% to 7 wt% of the modified hyaluronic acid obtained by modifying hyaluronic acid with methacrylic anhydride (hereinafter referred to as MeHA), 43 wt% to 49 wt% of 4 kDa to 10 kDa poly(ethylene glycol) diacrylate (hereinafter referred to as PEGDA) and water. Applicant argues that the 35 USC as a whole prevents evaluation of the invention in parts.
In response, after careful consideration, Applicant’s argument is found unpersuasive because 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 (Fed. Cir. 1986). Applicant should note that The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). Specifically, Ronca teaches a double network hydrogel comprising hyaluronic acid, wherein the hyaluronic acid is a modified hyaluronic acid) and poly(ethylene glycol)diacrylate (see heading and abstract) and water (see para. above sec. 2.2 and 2.3) having a weight percent from 1 to 10 wt % (see para. above sec. 2.3, last line) and the poly(ethylene glycol is 1 kDa (see sec 2.3) and comprises a photo-initiator (see para 2.2, as required by instant claims 5-7). Additionally, Ronca teaches that the ratios of the metaacrylic acid /and hyaluronic acid varies (see sec 2.1). Therefore it would have been obvious to one of ordinary skill in the art to have arrived at the instant claimed invention with the combination of the references.
Additionally, the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95,217 USPQ 1, 5-6 (Fed. Cir. 1983). In the instant case, the prior art teaches that carboplatin being used in combination with other chemotherapeutic agents for the treatment of neoplasms wherein the combination therapy is more effective than either agent used alone hydrogel comprising hyaluronic acid, wherein the hyaluronic acid is a modified hyaluronic acid) and poly(ethylene glycol)diacrylate (see heading and abstract) and water (see para. above sec. 2.2 and 2.3) having a weight percent from 1 to 10 wt % (see para. above sec. 2.3, last line) and the poly(ethylene glycol is 1 kDa (see sec 2.3) and comprises a photo-initiator (see para 2.2, as required by instant claims 5-7). Accordingly, the skilled artisan would expect a superior beneficial result from a combination.
Further, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to optimize determination of weight percent amounts having the optimum therapeutic index while minimizing adverse and/or unwanted side effects is well within the level of the skilled artisan. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of Applicant's invention. Thus, the weight percent amounts that would have actually been employed would have been expected to vary widely and, in the absence of evidence to the contrary, would not have been inconsistent with that which is presently claimed.
No Claims are allowed.
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 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 7/29/26
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