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 .
In light of the amendments to the claims filed 04/07/2026 in which claim 1 was amended, claim 5 was cancelled, and claim 16 was added, claims 1-4 and 6-16 are pending in the instant application and are examined on the merits herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submissions filed on 04/07/2026 and 05/06/2026 have been entered.
Priority
The instant application is a 371 of PCT/CN2022/080351 filed 03/11/2022 which claims priority to CN/2021/10269382.8 filed 03/12/2021 and CN/2021/10271604 filed on 03/12/2021.
Claims 1-4 and 6-16 receive priority to the prior-filed application, filed on 03/12/2021.
Response to Arguments
Claim Rejections under 35 U.S.C. 103
Applicant's arguments filed 04/07/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding amended claim 1, the applicant asserts on pg. 8-10 that the cited prior art to Hanaoka, Scherer, Pereira, and Total Water fail to disclose the newly added limitations: wherein the polymer resin is at least one selected from the group consisting of polyacrylic acid (PAA) and sodium polyacrylate (NaPA), and wherein the polymer hydrogel is formed by a presence of sodium polyacrylate in a crosslinked state within a hydrophilic matrix, the active ingredient is embedded in a resulting polymer skeleton of the polymer hydrogel, and a colloid of the polymer hydrogel is compounded with the ion inhibitor which is a nonionic aqueous ion inhibitor.
In response to the applicant’s argument, the examiner respectfully notes that Hanaoka was used in the previous Office Action filed 01/07/2026 to read on the limitation “wherein the polymer resin is at least one selected from the group consisting of polyacrylic acid (PAA) and sodium polyacrylate (NaPA)” and further notes that none of the prior art were used in the previous Office Action to read on the other newly added limitations. As discussed in the claim interpretation section below, the formation of the polymer hydrogel is considered a process of making such that the limitations are considered to be product-by-process and the claim can be interpreted to the extent that the product comprises the structure required from the process.
Regarding amended claim 1, the applicant asserts on pg. 10 that the cited references provide no indication that routine optimization would result in the claimed combination of ranges.
In response to the applicant’s argument, the examiner respectfully notes that Hanaoka discloses most of the claimed ranges and further discloses all of the required components of the polymer hydrogel. In the previous Office Action, the routine optimization rejections were added only for components which did not explicitly have disclosed ranges, but were contemplated by Hanaoka to be added to the polymer hydrogel. Each rejection, either based on Scherer or Pereira, discloses reasoning why one of ordinary skill would find it to be routine to optimize the mass percentage of either of the active ingredient or the preservative as explained below.
Regarding amended claim 1, the applicant asserts on pg. 10 that the instantly claimed invention recognizes a different technical problem from that of Hanaoka.
In response to the applicant’s argument, the examiner respectfully notes that the technical problem is not claimed and would be considered functional. Hanaoka discloses or makes obvious in view of Scherer, Pereira, and Total Water the structure of the claimed invention in at least the independent claim. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See MPEP 2145(II).
Regarding claim 16, the applicant asserts on pg. 11-12 that the cited prior art to Hanaoka, Scherer, Pereira, and Total Water fail to disclose the limitations of the newly added claim: wherein (i) the hydrogel elastic patch has a peeling strength that is greater than 1.0 N/2.5 cm after exposure to artificial sweat under pre-treatment, (ii) the ion inhibitor is in the 3-10 mass % range and is at least one selected from the group consisting of nonionic ion inhibitors of polyvinylpyrrolidone (PVP) and polyvinyl alcohol (PVA), (iii) aluminum glycinate is the crosslinking agent in 0.1-0.2 mass %, and (iv) the solvent comprises glycerol, propylene glycol, and polyoxyethylenesorbitan monooleate. The applicant further asserts on pg. 13-14 that the limitations of claim 16 would not be obvious in view of routine optimization. Further still, the applicant asserts on pg. 14-15 that the rejection of claim 16 would be based on improper hindsight in that the cited references don’t recognize the benefits of the features claimed or that the features could be obtained through routine optimization. Even further still, the applicant asserts on pg. 16-17 that the inventor identified a problem others did not such that it would not be obvious to increase the cost of implementing the features claimed without recognizing the problem identified by the inventors.
In response to the applicant’s argument, the examiner respectfully notes that the cited prior art to Hanaoka, Scherer, Pereira, Total Water, Lin, and Locke were not used in the previous Office Action to read on the specific limitations of the newly added claim. As explained below, Hanaoka alone discloses or makes obvious the limitations of the ion inhibitor in the 3-10 mass % range and is at least one selected from the group consisting of nonionic ion inhibitors of polyvinylpyrrolidone (PVP) and polyvinyl alcohol (PVA), (iii) aluminum glycinate is the crosslinking agent in 0.1-0.2 mass %, and (iv) the solvent comprises glycerol, propylene glycol, and polyoxyethylenesorbitan monooleate. As further explained below, it flows naturally from the disclosures of the cited prior art that the hydrogel elastic patch can have a peeling strength that is greater than 1.0 N/2.5 cm after exposure to artificial sweat under pre-treatment.
In response to the applicant’s arguments against routine optimization, the examiner respectfully notes that Hanaoka discloses most of the claimed ranges and further discloses all of the required components of the polymer hydrogel. In the previous Office Action, the routine optimization rejections were added only for components which did not explicitly have disclosed ranges, but were contemplated by Hanaoka to be added to the polymer hydrogel. Each rejection, either based on Scherer or Pereira, discloses reasoning why one of ordinary skill would find it to be routine to optimize the mass percentage of either of the active ingredient or the preservative as explained below.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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 MPEP 2145. In the previous Office Action, only knowledge known in the art was used to read on the claims.
In response to the applicant’s argument that the inventor identified a problem others did not, the examiner respectfully notes that the technical problem is not claimed and would be considered functional. Hanaoka discloses or makes obvious in view of Scherer, Pereira, and Total Water the structure of the claimed invention in at least the independent claim. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See MPEP 2145(II).
The amendments to the claims have necessitated new grounds of rejection.
It should be noted that the rejection in view of Hanaoka has been modified from being based on the Chinese application to the U.S. application; however, the newly cited paragraphs correspond to the previously cited paragraphs.
Claim Interpretation
The Examiner recognizes claims 1, 9-10, 13, and 15 as "product-by-process" claims. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claim 1 to require the polymer hydrogel to comprise the following structural elements: a mixture of the elements to form the polymer hydrogel.
As a product claim, Examiner has determined claims 9-10 to require the polymer hydrogel to comprise the following structural elements in addition to those in the claims from which they depend: paste-like formulation. In the prior art rejection in this Office action, Examiner considers claims 9-10 to be met when a reference teaches these structural limitations.
As a product claim, Examiner has determined claims 13 and 15 to require the elastic material layer to comprise the following structural elements in addition to those in the claims from which they depend: elastic material forming the elastic material layer compounded with a hydrophobic additive. In the prior art rejection in this Office action, Examiner considers claims 13 and 15 to be met when a reference teaches these structural limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 16 recites the limitation “the hydrogel elastic patch has a peeling strength that is greater than 1.0 N/2.5 cm after exposure to artificial sweat under pre-treatment” in ln. 2-3. The instant specification discloses multiple compositions of the polymer hydrogel which have peeling strength less than 1.0 N/2.5 cm comprising contents within the claimed mass % ranges (pg. 21-31).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the mass % range of ion inhibitor and crosslinking agent in ln. 4 and 6. This limitation is indefinite in that it is unclear if this mass % is meant to the be the mass % of ion inhibitor in the entire hydrogel elastic patch or in the polymer hydrogel as recited in claim 1, which claim 16 is dependent upon. For the sake of compact prosecution, the examiner is treating the claim as though the mass % claimed are in reference to the polymer hydrogel as recited in claim 1.
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 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 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 1-4 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over US/2003/0165560 A1 to Hanaoka in view of US/2009/0022780 A1 to Scherer, NPL V to Pereira, and NPL U to Total Water.
Regarding claim 1, Hanaoka discloses a polymer hydrogel (para. 0005; para. 0010; para. 0012), comprising the following components in mass percentage contents:
an active ingredient (para. 0031-0042),
0.05% to 50% of an ion inhibitor (para. 0015, polyvinyl alcohol or polyvinylpyrrolidone may be used alone or in combination),
0.001% to 10% of a crosslinking agent (para. 0017, aluminum hydroxide or aluminum glycinate may be used alone or in combination),
0.05% to 50% of a polymer resin (para. 0015, polyacrylic acid or sodium polyacrylate may be used alone or in combination),
0.001% to 30% or 1% to 95% of a solvent (para. 0024, polysorbate 80 may be used alone or in combination; para. 0028, glycerin and propylene glycol may be used alone or in combination; para. 0046, formation of the paste includes mixing the above-described components),
0.01% to 30% of a skin-touch regulator (para. 0022, kaolin may be used alone or in combination),
0% to 80% of water (para. 0030),
0.01% to 30% of an appearance modifier (para. 0022, titanium dioxide may be used alone or in combination),
0.001% to 10% of a crosslinking regulator (para. 0019, lactic acid, citric acid, or tartaric acid may be used alone or in combination),
a preservative (para. 0032, drugs may be used alone or in combination; para. 0034, benzalkonium chloride may be used), and
0.01% to 30% of a transdermal absorption enhancer (para. 0026, isopropyl myristate may be used alone or in combination),
wherein the polymer resin is at least one selected from the group consisting of polyacrylic acid (PAA) and sodium polyacrylate (NaPA) (para. 0015, polyacrylic acid or sodium polyacrylate may be used alone or in combination), and
wherein the polymer hydrogel is formed by a presence of sodium polyacrylate in a crosslinked state within a hydrophilic matrix (para. 0012; para. 0015; para. 0017; para. 0046, paste is prepared by mixing the above-described ingredients), the active ingredient is embedded in a resulting polymer skeleton of the polymer hydrogel (para. 0012; para. 0015; para. 0017; para. 0046, paste is prepared by mixing the above-described ingredients), and a colloid of the polymer hydrogel is compounded with the ion inhibitor which is a nonionic aqueous ion inhibitor (para. 0012; para. 0015; para. 0017; para. 0046, paste is prepared by mixing the above-described ingredients).
Hanaoka differs from the instantly claimed invention in that Hanaoka fails to disclose the specific ranges as disclosed in the claim as written.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the weight percentages of the ion inhibitor, the crosslinking agent, the polymer resin, the solvent, the skin-touch regulator, the water, the appearance modifier, the crosslinking regulator, and the transdermal absorption enhancer in Hanaoka from 0.05-50% to 0.01-15%, 0.001-10% to 0.01-1%, 0.05-50% to 0.1-10%, 0.001-30 % or 1-95% to 10-35%, 0.01-30% to 0.1-15%, 0-80% to 46.2-53.95%, 0.01-30% to 0.1-3%, 0.001-10% to 0.01-1%, and 0.01-30% to 0.01-5% respectively, since it has been held 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.” See MPEP 2144.05. Further, applicant appears to have placed no criticality on the claimed range (see pg. 17-18, indicating simply that the chemical compositions are provided within the claimed ranges and providing further preferred ranges).
Further, Hanaoka differs from the instantly claimed invention in that Hanaoka fails to disclose any range for the active ingredient.
Scherer teaches a hydrogel (para. 0001) comprising an active ingredient (para. 0024) and further teaches that it may be advantageous to include active ingredients at lower contents when the liquid level adjustment and control performance of the inventive preparation are more important than anti-infective aspects (para. 0066).
Further, Scherer teaches that optimization of liquid content in the wound is optimized by the balance/ liquid level adjustment between the liquid absorption and the liquid release properties of the hydrogel (para. 0008; para. 0030). As such, the weight percentage of the active ingredient in the hydrogel is disclosed to be a result effective variable in that changing the weight percentage of the active ingredient changes the amount of liquid content in the wound which affects wound healing.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hanaoka device to have an active ingredient within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hanaoka by making the weight percentage of the active ingredient be between 4-5% as a matter of routine optimization since it has been held that “where 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." See MPEP 2144.05(II).
Further still, Hanaoka differs from the instantly claimed invention in that Hanaoka fails to disclose a range for the preservative.
Pereira teaches that the recommended or allowed concentration of benzalkonium chloride as a preservative is 0.10% and as an antiseptic is 0.13% (“Widespread Use in a Multi-Billion Dollar Market”; Table 1).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the concentration of benzalkonium chloride in Hanaoka to be 0.10% or 0.13% as taught by Pereira, because Pereira teaches that benzalkonium chloride is a known skin irritant (“Toxicity to Humans”).
Even further still, Hanaoka differs from the instantly claimed invention in that Hanaoka fails to disclose the water being deionized.
Total Water teaches the advantages of using deionized water in medical and chemical applications (“The Importance of Deionized Water”).
Total Water is considered to be analogous to the instantly claimed invention in that Total Water discusses chemicals for use in medical applications. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the water of Hanaoka to be deionized water as taught by Total Water, because Total Water teaches that in order to create a chemically sound product, the water can’t contain any impurities that could potentially change the product’s chemical composition (“The Importance of Deionized Water”).
Regarding the limitation “the hydrogel for slow-release function”, the cited prior art does not explicitly disclose this limitation, but it follows naturally that the structure recited in the cited prior art can have a slow-release function as the hydrogel can be made from the same materials within similar ranges as those of the instant application (Instant Application: pg. 17-19). As supported in MPEP section 2112.01(II), “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”.
Regarding claim 2, the cited prior art suggests the invention of claim 1. Hanaoka further discloses: wherein the active ingredient comprises any one or more selected from the group consisting of a pharmaceutical ingredient, a traditional Chinese medicine (TCM) powder or an extract of the TCM powder, an amino acid, and a plant extract (para. 0031-0042, pharmaceutical ingredients and amino acid).
Regarding claim 3, the cited prior art suggests the invention of claim 1. Hanaoka further discloses: wherein the ion inhibitor comprises at least one selected from the group consisting of nonionic ion inhibitors of polyvinylpyrrolidone (PVP) and polyvinyl alcohol (PVA) (para. 0015, polyvinyl alcohol or polyvinylpyrrolidone may be used alone or in combination).
Regarding claim 4, the cited prior art suggests the invention of claim 1. Hanaoka further discloses: wherein the crosslinking agent is aluminum glycinate or aluminum hydroxide (para. 0017, aluminum hydroxide or aluminum glycinate may be used alone or in combination).
Regarding claim 6, the cited prior art suggests the invention of claim 1. Hanaoka further discloses: wherein the solvent comprises at least one selected from the group consisting of glycerol, propylene glycol (PG), mineral oil, and polyoxyethylenesorbitan monooleate (para. 0024, polysorbate 80 may be used alone or in combination; para. 0028, glycerin and propylene glycol may be used alone or in combination; para. 0046, formation of the paste includes mixing the above-described components).
Regarding claim 7, the cited prior art suggests the invention of claim 1. Hanaoka further discloses: wherein the skin-touch regulator is at least one selected from the group consisting of kaolin and sodium carboxymethyl cellulose (CMC-Na) (para. 0022, kaolin may be used alone or in combination); and the appearance modifier is titanium dioxide (para. 0022, titanium dioxide may be used alone or in combination).
Regarding claim 8, the cited prior art suggests the invention of claim 1. Hanaoka further discloses: wherein the crosslinking regulator is at least one selected from the group consisting of tartaric acid, citric acid, ethylenediaminetetraacetic acid disodium (EDTA-2Na), ethylenediaminetetraacetic acid tetrasodium (EDTA-4Na), malic acid, and lactic acid (para. 0019, lactic acid, citric acid, or tartaric acid may be used alone or in combination); the preservative is at least one selected from the group consisting of benzalkonium chloride, methylparaben, propylparaben, and phenoxyethanol (para. 0032, drugs may be used alone or in combination; para. 0034, benzalkonium chloride may be used); and the transdermal absorption enhancer is at least one selected from the group consisting of isopropyl myristate, dimethylsulfoxide (DMSO), and azone (para. 0026, isopropyl myristate may be used alone or in combination).
Regarding claims 9-10, the cited prior art suggests the invention of claim 1. Hanaoka further discloses: a method of preparing the polymer hydrogel of claim 1 (as explained in the rejection of claim 1), the method comprising mixing NaPA, the crosslinking agent, the crosslinking regulator, the appearance modifier, the solvent, the active ingredient, the ion inhibitor, the skin-touch regulator, the transdermal absorption enhancer, the preservative, and the water to create a paste-like hydrogel (para. 0005; para. 0010; para. 0012; para. 0015, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid, or sodium polyacrylate may be used alone or in combination; para. 0017, aluminum hydroxide or aluminum glycinate may be used alone or in combination; para. 0019, lactic acid, citric acid, or tartaric acid may be used alone or in combination; para. 0022, kaolin or titanium dioxide may be used alone or in combination; para. 0026, isopropyl myristate may be used alone or in combination; para. 0024, polysorbate 80 may be used alone or in combination; para. 0028, glycerin and propylene glycol may be used alone or in combination; para. 0030; para. 0032, drugs may be used alone or in combination; para. 0034, benzalkonium chloride may be used; para. 0031-0042; para. 0045-0046).
The cited prior art fail to disclose the specific preparation method steps of claims 9-10; however, as explained under the claim interpretation section, the specific method steps are not required as the patentability of a product does not depend on its method of production.
Claim 11-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over the cited prior art as applied above, and further in view of WO/2017/117761 A1 to Lin and US/2021/0290444 A1 to Locke.
Regarding claims 11 and 13-15, the cited prior art suggests the invention of claim 1. Hanaoka further discloses: (Claim 11) a hydrogel elastic patch (para. 0043-0044), comprising a flexible material layer (para. 0044, base material having flexibility that is stretchable in every direction), a polymer hydrogel layer with the slow-release function (para. 0044, paste spread on base material; as explained in the rejection of claim 1), and a release overlay layer (para. 0026, film may be a release film; para. 0046, protective film for covering the surface of the paste spread on the base material), wherein the flexible material layer, the polymer hydrogel layer with the slow-release function, and the release overlay layer are arranged sequentially (para. 0046); and the polymer hydrogel layer comprises the polymer hydrogel according to claim 1 (as explained in the rejection of claim 1).
The combination of the prior art differs from the instantly claimed invention in that the prior art fail to disclose
(Claim 11) wherein the elastic material layer is selected from the group consisting of an elastic material layer compounded with a hydrophobic additive, a material layer formed by compounding an elastic material and a waterproof material, and an elastic material layer with an air layer structure;
(Claim 12) wherein the hydrophobic additive is at least one selected from the group consisting of a polyfluoroalkyl acrylate copolymer, a silicone, a fluorocarbon polymer, a long-chain alkane ester, and a copolymer of the long-chain alkane ester or the waterproof material is a thermoplastic elastomer or a rubber; and
(Claims 13 and 15) elastic material forming the elastic material layer compounded with a hydrophobic additive.
Lin teaches (Claims 11, 13, 15) an elastic, hydrophobic backing material for a hydrogel dressing to avoid breakage of the tape (pg. 3; pg. 4, hydrophobicity of the support layer; pg. 6, meltblown nonwoven fabric layer composed of thermoplastic polyurethane; pg. 7, meltblown nonwoven fabric layer having multidirectional elastic tension; Fig. 1, meltblown nonwoven fabric layer 101).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the base material of the prior art to be formed from the material of Lin, because Lin teaches that the traditional materials for hydrogels are nonelastic, which can easily cause the adhesive tape structure to break and makes the structure unable to conform to the user’s body (pg. 3).
Locke teaches (Claims 11-13 and 15) a polymer backing film for a dressing that is hydrophobic and coated by silicones and fluorocarbons to increase the hydrophobicity of the material (para. 0056 ln. 28-32).
Locke is considered to be analogous to the instantly claimed invention in that Locke teaches a dressing. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the base hydrophilic material layer of the cited prior art to further be coated by silicones and fluorocarbons as taught by Locke, because Locke teaches that coating with silicones or fluorocarbons increases hydrophobicity of an already hydrophobic material (para. 0056 ln. 28-32), which ensures that moisture stays on the wound-side of the hydrogel.
The combination of the cited prior art fail to disclose the specific preparation method steps of claims 13 and 15; however, as explained under the claim interpretation section, the specific method steps are not required as the patentability of a product does not depend on its method of production.
Regarding claim 16, the cited prior art suggests the invention of claim 11. Hanaoka further discloses:
(ii) wherein the ion inhibitor is in the 0.05-50 mass % range and is at least one selected from the group consisting of nonionic ion inhibitors of polyvinylpyrrolidone (PVP) and polyvinyl alcohol (PVA) (para. 0015, polyvinyl alcohol or polyvinylpyrrolidone may be used alone or in combination),
(iii) aluminum glycinate is the crosslinking agent in 0.001-10 mass % (para. 0017, aluminum hydroxide or aluminum glycinate may be used alone or in combination), and
(iv) the solvent comprises glycerol, propylene glycol, and polyoxyethylenesorbitan monooleate (para. 0024, polysorbate 80 may be used alone or in combination; para. 0028, glycerin and propylene glycol may be used alone or in combination; para. 0046, formation of the paste includes mixing the above-described components).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose the specific ranges as disclosed in the claim as written.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the weight percentages of the ion inhibitor and the crosslinking agent in Hanaoka from 0.05-50% to 3-10% and 0.001-10% to 0.01-0.2% respectively, since it has been held 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.” See MPEP 2144.05. Further, applicant appears to have placed no criticality on the claimed range (see pg. 17-18, indicating simply that the chemical compositions are provided within the claimed ranges and providing further preferred ranges).
Further, while the cited prior art suggests all aspects of the claimed invention, the cited prior art fails to explicitly disclose wherein the hydrogel elastic patch has a peeling strength that is greater than 1.0 N/ 2.5 cm after exposure to artificial sweat under pre-treatment.
Regarding the limitation “wherein the hydrogel elastic patch has a peeling strength that is greater than 1.0 N/ 2.5 cm after exposure to artificial sweat under pre-treatment”, the cited prior art does not explicitly disclose this limitation, but it follows naturally that the structure recited in the cited prior art can have the required peeling strength as the hydrogel can be made from the same materials within similar ranges as those of the instant application (Instant Application: pg. 17-19). As supported in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” The applicant’s specification seems to connect increased peeling strength with the inclusion of an ion inhibitor, the specific ion inhibitor used, and the weight percent of water in the polymer hydrogel (instant: pg. 21-31). As explained above, Hanaoka discloses a polymer hydrogel that can comprise either of PVP or PVA and water in overlapping ranges to those of the instant application. Hanaoka further discloses that easy release of the polymer hydrogel without sticking to the wound surface is desired such that it is preferred to have the adhesive force of the paste have a sufficient adhesive force necessary for adhesion to the skin without adversely affecting the skin upon change of the preparation (para. 0011), such that Hanaoka would be interested in maintaining adhesion to the skin.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over the prior art as applied above, and further in view of WO/2022/157198 A1 to Anthis.
Regarding claim 14, the cited prior art suggests the invention of claim 11. Hanaoka further discloses: coating the polymer hydrogel layer with the slow-release function on the elastic material layer, covering the polymer hydrogel layer with the release overlay layer (para. 0026, film may be a release film; para. 0046, coating polymer hydrogel paste on base material layer and covering the paste surface with a protective film).
The combination of prior art differs from the instantly claimed invention in that the prior art fails to disclose cutting, curing, and packaging to obtain the hydrogel elastic patch.
Anthis teaches cutting, curing, and packaging the dressing to obtain a hydrogel patch and prepare the patch for transport or sale (pg. 47 para. 2).
Anthis is considered to be analogous to the instantly claimed invention in that Anthis discloses a hydrogel dressing. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the preparation method of the cited prior art to comprise further processing steps as taught by Anthis, because Anthis teaches that these steps prepare a hydrogel patch for transport or sale (pg. 47 para. 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
17 June 2026
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