Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-5 and 8-27 are pending in a Response of 04/28/2026. Claims 22-27 have been withdrawn by way of applicant’s election of 12/22/2025.
Accordingly, claims 1-5 and 8-21 are now being examined on the merits to which the following grounds of rejections are applicable.
Allowable Subject Matter
Claims 11, 12, 15, 16, 21 and 22 are objected to as being dependent upon a rejected each base claims 1, 13 and 17, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It would be hindsight, after exhausting all the other rationales to combine, to select the components and their amounts, and arrange them as applicant has claimed.
Withdrawn objection/ rejections:
Applicant's amendments and arguments filed 04/28/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
Terminal Disclaimer
The terminal disclaimer filed on 04/28/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of copending application no. 18/381401; patent nos. 9422463; 9763833; 10434015; 10470936; 11147716; 11304854; 11304855; 11819389; 11826235 has been reviewed and is accepted. The terminal disclaimer has been recorded.
New Grounds of Rejection --- as necessitated by the amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-5, 8-10, 13-14 and 17-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rolf et al. (WO2003/063817A1) in view of Lykke (US2004/0065232A) and Ehrnsperger et al. (US2005/0003191A1); and Bracht (US6,689,379B1 – IDS of 01/16/2024).
Applicant claims the below claims 1, 13 and 17 filed on 04/28/2026:
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Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Rolf teaches an adhesive patch comprising a flexible backing which reads on the flexible outer layer, a cosmetic formulation containing cosmetic agent, skin absorption enhancer and solvent or skin protectant (e.g., topical moisturizer or skin conditioner (e.g., claim 1 of prior art) in which the cosmetic agent and skin absorption enhancer reads on the claimed optional ingredient such as skin protective agent, a pressure sensitive adhesive such as polyisobutylene, rubber, silicone based pressure sensitive adhesive, polystyrene-polybutadiene-polystyrene, polystyrene-polyisoprene-polystyrene, polystyrene-poly(ethylene-butylene)-polystyrene block polymers which reads on the claimed water insoluble adhesive, and a polymer such as polyacrylic acid (PAA) which reads on the claimed non-neutralized polymeric acid, and sodium polyacrylate which may read on the claimed partially-neutralized polymeric acid, and mixtures thereof (e.g., claims 1 and 44 of prior art) in which the mixture may consist of polymeric acid having –COOH acid and sodium polyacrylate having –COONa base, and when they are mixed together, buffering would arise, accordingly, the mixture of Rolf reads on the claimed buffered composition. Please note that as supported by the instant specification, “partial neutralization of PAA may be achieved with strong base (e.g., NaOH)” (see instant publication at [0034]), and therefore, Rolf teaches a composition comprising water insoluble adhesive, a buffered mixture and skin protective agent or active agent of instant claim 1. Although Rolf does not expressly disclose “wound dressing” of instant claim 17, Rolf disclose adhesive patch or an adhesive mask comprising the said composition and a flexible backing layer, which can be used for medical therapy (e.g., claim 106 of prior art) and thus, the patch/mask may read on the claimed wound dressing (instant claims 1, 13 and 17, in part, and instant clams 2, 3, 5, 10, 19 and 20); Rolf further teaches fibers such as polycellulose fibers, polyester fibers, polyurethane fibers, polyolefin fibers, polyamide fibers, cotton fibers, copolyester fibers, or any mixture thereof (claims 3 and 60 of prior art) which reads on the claimed fiber (instant claims 4, 14 and 18); Rolf further teaches the sodium polyacrylate is used in an amount of about 1.0%-about 20% (e.g., claim 47 of prior art), and although Roth teaches the amount of partially neutralized sodium polyacrylate, mixture of polyacrylic acid and its sodium polyacrylate would be used in that amount due to the same function and therefore, the amount would overlap the instant range of about 10 to about 32%, in the absence of criticality evidence to the contrary, and also the ratio of non-neutralized polyacrylic acid to partially neutralized polymeric acid of instant claim 8 would be optimized depending on the intended purpose and relationship with other ingredient, in the absence of criticality evidence to the contrary. In this context, MPEP 2144.05 (II)(A): 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 (instant claims 8-9).
However, Rolf remains silent about “the polymeric acids dispersed as particles” of instant claims 1, 13 and 17. The deficiencies are cured by Lykke.
Lykke discloses adhesive composition for e.g., wound dressings or ostomy appliances comprising a polymeric matrix and absorbent particles that are microcolloid particles (abstract, [0009] and [0040]); the polymeric matrix for adhesive includes A-B-A block copolymer adhesives, amorphous poly alpha olefins, natural rubbers, polyisoprene, butyl rubber, polyisobutylene, silicones, polychloroprene, acrylic adhesives and acrylic dispersions and polyvinylethers, and any of these pressure sensitive adhesives, or blends thereof, may be used to form the polymeric matrix into which the microcolloid particles are dispersed ([0107]); the absorbent particles for incorporation into adhesives are often hydrocolloid particles which are water soluble or swellable material ([0004] and[0031]) such as polyacrylic acid, gums, pectin, alginate, cellulose derivatives, etc. ([0090], [0101] and the Examples). Such microcolloid type hydrocolloid particles dispersed in the adhesive improves absorbing and transporting moisture, having a good tack, being easy to separate and process ([0013]).
It would have been obvious to modify the teachings of Rolf with polyacrylic acids dispersed as particles of Lykke in order to improve the functional properties of the medical device as taught by Lykke because Rolf teaches/suggests the patches can be used for medical therapy and polyacrylic acids (e.g. mixture of PAA and sodium polyacrylate) can be present in the adhesive, and Lykke teaches medical device containing absorbent polyacrylic acid microcolloid particles having enhanced properties in the adhesive.
However, Rolf in view of Lykke does not expressly teach neutralization degree of instant claims 1, 13 and 17. The deficiency is cured by Ehrnsperger and/or Bracht.
Ehrnsperger discloses absorbent structure comprising coated superabsorbent polymer particles (title) in adhesive layer ([0074]); the superabsorbent polymer particles include polyacrylic acid, crosslinked polymers of polyacrylic acid, etc. ([0031]), and most preferred polymer materials used for making the super-absorbent polymers are e.g., polyacrylates/acrylic acid, and the polymers can be used in the form of a mixture of two or more different polymers the absorbent polymers comprise from about 50-95% neutralized, preferably about 75% neutralized, (slightly) network cross-linked, polyacrylic acid (i.e., poly(sodium acrylate/acrylic acid)) ([0032]-[0033]) which reads on the claimed combination of non-neutralized/partially neutralized PAA with 75% neutralization degree of partially neutralized PAA. Such absorbent structure absorbs bodily fluid ([0002]).
It would have been obvious to modify the teachings of Rolf in view of Lykke with combination of two different, non-neutralized polyacrylic acid and partially neutralized polyacrylate in order to improve body fluid uptake because Rolf teaches the patch/mask can be used for medical therapy and polyacrylic acid/sodium polyacrylate mixture in adhesive polymer; Lykke teaches medical device (e.g., wound dressing or ostomy appliances) containing absorbent polyacrylic acid particles in adhesive polymer; and Ehrnsperger discloses superabsorbent material for use in e.g., diaper and however, Ehrnsperger teaches superabsorbent polymer to absorb bodily fluid and therefore, it would be obvious to use known technique using superabsorbent combined material to improve body fluid uptake, e.g., wound exudate.
Even further, Bracht discloses a transdermal patch comprising high degree (70%-100%) of neutralized polyacrylic acid or its salt wherein the neutralization degree impacts on permeation rate of active substance and high neutralization degree of the acid or its salt leads to high permeation rate (see Fig. 5 and its explanation on col. 9), and the degree of neutralization 70-100% overlaps the instant range of about 75% of instant claim 1. MPEP 2144.05 states that [I]n 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).
Therefore it would have been obvious to further define the degree of neutralization of PAA in Rolf/Lykke/Ehrnsperger with high degree (e.g., 75%) in order to obtain high permeation rate of active ingredient, as taught by Bracht.
In light of the foregoing, instant claims 1-5, 8-10 and 17-20 are obvious over Rolf in view of Lykke and further in view of Ehrnsperger and/or Bracht.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are moot in view of new references. However, the Examiner would like to address the followings:
Applicant argues that Rolf does not teach wound dressing, and an adhesive that maintains pH of a wear’s skin, in the presence of physiological fluids, in the range of 4.0 to 5.5. with a combination of non-neutralized and partially neutralized PAAs.
The Examiner responds that Rolf discloses the patch or mask can be used for medical therapy, and suggests a combination of two different PAAs; and the claimed invention does not require pH. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057. First, in claim construction, one must not import limitations from the specification that are not part of the claim. Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1354 (Fed. Cir. 2012). SuperGuide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004); and the applied art of Rolf and Ehrnsperger discloses combination of the claimed buffer composition. Further it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
All examined claims 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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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