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 09/01/2025 in which claims 1, 6, and 12 were amended, claims 1-15 are pending in the instant application and are examined on the merits herein.
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 1-15 receive priority to the prior-filed application, filed on 03/12/2021.
Response to Arguments
Claim Objections
The objections to the claims are withdrawn in view of the amendments to the claims.
Claim Rejections under 35 U.S.C. 112(b)
The rejections of the claims under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims.
Claim Rejections under 35 U.S.C. 103
Applicant's arguments filed 09/01/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Applicant’s arguments on pg. 9-10 and 12 with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant asserts that Hanaoka fails to disclose a range for the active ingredient or the preservative and that the examiner has made no showing of obviousness of these ranges. The new grounds of rejection are not dependent upon the case law to Gardner V. TEC which the applicant is arguing against here. Further, applicant asserts that Hanaoka as not disclosing the composition of all of the ingredients claimed does not teach the identical chemical structure to the claimed invention. The new grounds of rejection further suggest the composition of all of the ingredients claimed.
Regarding claim 1, the applicant asserts on pg. 10-11 that the ranges of the elements claimed is critical to the slow-release function of the hydrogel.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully disagrees with the applicant’s general determination of criticality. According to MPEP 716.02(d), criticality of a claimed range can be demonstrated with unexpected results and to establish unexpected results, applicant’s should compare a sufficient number of tests both inside and outside the claimed range. As such, the applicant has not demonstrated criticality of the ranges claimed.
Applicant’s arguments, see pg. 11, filed 09/01/2025, with respect to the rejection(s) of claim(s) 11-13 and 15 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of WO/2017/117761 A1 to Lin.
Regarding claims 11-13 and 15 under U.S.C. 103, the applicant asserts that the liquid coating of Locke would inherently reduce the substrate’s elasticity and that the combination of Locke with Hanaoka would decrease the elasticity of the invention so that Hanaoka would no longer be able to stretch and cover a wound.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully disagrees. Applicant cites Locke (para. 0056) to disclose that the coatings of Locke would inherently reduce the substrate’s elasticity. There is no disclosure in Locke that the coatings of their invention would reduce a substrate’s elasticity, and further, Locke discloses liquid coating which is similar to the coating method claimed in the instant invention (Claim 13). Therefore, as the instant invention maintains elasticity with a liquid hydrophobic coating, this seems to provide evidence that the combination of the prior art would not make Hanaoka inoperable for its intended purpose.
Regarding claim 1, the applicant asserts on pg. 15-16 that the examiner has relied on hindsight reasoning to reject the independent claim.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully disagrees. 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). Further, MPEP 2144.04 states, “an examiner may utilize legal precedent as a source of supporting rationale when warranted and appropriately supported. In formulating any rejection invoking legal precedent, the examiner must take care to ensure that the rationale is explained and shown to apply to the facts at hand.” In the previous Office Action, the examiner relied upon case law to read on the ranges of the components in the hydrogel, and appropriately supported said case law with the disclosure of Hanaoka that there is no particular limitation to the composition and the instant specification’s failure to provide criticality for the ranges claimed.
Claim Interpretation
The Examiner recognizes claims 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 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 § 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over CN/1458848 A 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. 0008; para. 0015; para. 0017), comprising the following components in mass percentage contents:
an active ingredient (para. 0036-0047),
0.05% to 50% of an ion inhibitor (para. 0020, polyvinyl alcohol or polyvinylpyrrolidone may be used alone or in combination),
0.001% to 10% of a crosslinking agent (para. 0022, aluminum hydroxide may be used alone or in combination),
0.05% to 50% of a polymer resin (para. 0020, polyacrylic acid or sodium polyacrylate may be used alone or in combination),
1% to 95% of a solvent (para. 0033, propylene glycol may be used alone or in combination),
0.01% to 30% of a skin-touch regulator (para. 0027, kaolin may be used alone or in combination),
0% to 80% of water (para. 0035),
0.01% to 30% of an appearance modifier (para. 0027, titanium dioxide may be used alone or in combination),
0.001% to 10% of a crosslinking regulator (para. 0024, lactic acid, citric acid, or tartaric acid may be used alone or in combination),
a preservative (para. 0037, drugs may be used alone or in combination; para. 0039, benzalkonium chloride may be used), and
0.01% to 30% of a transdermal absorption enhancer (para. 0031, isopropyl myristate may be used alone or in combination).
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%, 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.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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”, it would have been considered inherent that the hydrogel of the cited prior art may have a slow-release function, because the hydrogel of the combined invention may 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”. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
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. 0036-0047, 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. 0020, 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. 0022, aluminum hydroxide may be used alone or in combination).
Regarding claim 5, the cited prior art suggests the invention of claim 1. Hanaoka further discloses: wherein the polymer resin is at least one selected from the group consisting of polyacrylic acid (PAA) and sodium polyacrylate (NaPA) (para. 0020, polyacrylic acid or sodium polyacrylate 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. 0033, propylene glycol may be used alone or in combination).
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. 0027, kaolin may be used alone or in combination); and the appearance modifier is titanium dioxide (para. 0027, 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. 0024, 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. 0037, drugs may be used alone or in combination; para. 0039, 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. 0031, 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. 0008; para. 0015; para. 0017; para. 0020, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid, or sodium polyacrylate may be used alone or in combination; para. 0022, aluminum hydroxide may be used alone or in combination; para. 0024, lactic acid, citric acid, or tartaric acid may be used alone or in combination; para. 0027, kaolin or titanium dioxide may be used alone or in combination; para. 0031, isopropyl myristate may be used alone or in combination; para. 0033, propylene glycol may be used alone or in combination; para. 0035; para. 0037, drugs may be used alone or in combination; para. 0039, benzalkonium chloride may be used; para. 0036-0047; para. 0050-0051).
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 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. 0048-0049), comprising a flexible material layer (para. 0049, base material having flexibility that is stretchable in every direction), a polymer hydrogel layer with the slow-release function (para. 0049, paste spread on base material; as explained in the rejection of claim 1), and a release overlay layer (para. 0031, film may be a release film; para. 0051, 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. 0051); and the polymer hydrogel layer comprises the polymer hydrogel according to claim 1 (as explained in the rejection of claim 1).
However, 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 (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 (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.
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. 0031, film may be a release film; para. 0051, coating polymer hydrogel paste on base material layer and covering the paste surface with a protective film); however, 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 (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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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