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 .
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 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.
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 1-2, 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sato (US20140296418, herein Sato).
Regarding Claims 1, 2, Sato teaches composition for hydrogel, comprising: “a polymer matrix of a copolymer of a monofunctional monomer and a crosslinking monomer (a)” [0014]; comprising acrylamide and N,N’methylene bisacrylamide [0105], which indicate the claimed acrylic monomer and a crosslinkable monomer; “polyvinylpyrrolidone” [0054] which matches claimed water-soluble polymer; crosslinking monomer (a): methylenebis(meth)acrylamide, ethylenebis(meth)acrylamide [0023] which reads on the crosslinkable monomer includes polyfunctional (meth)acrylamide.
Sato further teaches “homopolymer of N-vinyl-2-pyrrolidone, that is, polyvinylpyrrolidone, or a copolymer of N-vinyl-2-pyrrolidone.” [0054], which indicates the selection of polyvinylpyrrolidone can be the solo water soluble polymer between homopolymer and copolymer of polyvinylpyrrolidone.
“water” [0020]; and “polyhydric alcohol” [0020]
Sato teaches “polymer matrix is a matrix of a copolymer of a monofunctional monomer and a crosslinking monomer (a).” [0021] wherein the “crosslinking monomer (a) 0.01 wt %, and preferably less than or equal to 0.5 wt %.” [0027] overlaps the claimed range, wherein, the crosslinking monomer (a): methylenebis(meth)acrylamide, ethylenebis(meth)acrylamide [0023]; since the “The monofunctional monomer preferably contains the (meth)acrylamide and/or (meth)acrylamide derivative (d)” [0048] reads on the acrylamide based monomer, therefore the range of the (meth)acrylamide is 99.5% to 99.99%, overlaps the claimed range. In 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). See MPEP § 2144.05.
Regarding the tensile strength, the Office realizes that all of the claimed effects or physical properties are not positively stated by the reference(s). However, the reference(s) teaches all of the claimed ingredients in the claimed amounts, and teaches the composition as being made by a substantially similar process. The original specification does not provide any disclosure on how to obtain the claimed properties outside the components of the composition itself. Therefore, the claimed effects and physical properties, i.e. tensile strength, would necessarily arise from a composition with all the claimed ingredients in the claimed amounts. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching enabling a person of ordinary skill in the art to obtain the claimed properties with only the claimed ingredients, absent undue experimentation.
Regarding Claim 4, Sato teaches the crosslinking monomer is present in an amount greater than or equal to 0.03 wt %, and more preferably less than or equal to 0.1 wt %. [0027] which lies in the claimed range.
Regarding Claim 5, Sato teaches “The content rate of structural units derived from N-vinyl-2-pyrrolidone (e) in the adhesive hydrogel in accordance with the present invention, although by no means limited in any particular manner, is preferably greater than or equal to 0.1 wt % and preferably less than or equal to 20 wt %.” [0056] which encompasses the claimed range.
In 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). See MPEP § 2144.05.
Regarding Claims 6, 7, Sato teaches that “The strip is backed with nonwoven fabric to prepare a test piece which is then attached to a Bakelite plate” [0084] matches the claimed intermediate substrate is embedded along an in-plane direction, which further applied to “then attached to the skin on the inner side of the left arm” [0086], which further indicates the hydrogel composition applied to nonwoven fabric then attached to human skin, therefore the layers of hydrogel and nonwoven fabric are attached in plane direction.
Regarding Claim 8, Sato teaches “thickness of 0.01 mm to 2.0 mm” [0090] which encompasses the claimed range.
In 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). See MPEP § 2144.05.
Regarding Claim 9, The Office realizes that all of the claimed effects or physical properties are not positively stated by the reference(s). However, Sato teaches all of the claimed ingredients in the claimed amounts, and teaches the composition as being made by a substantially similar process as of “a composition for adhesive hydrogel containing a monofunctional monomer, a crosslinking monomer (a), another polymer component, water, and a polyhydric alcohol may be heated or subjected to ultraviolet light radiation for polymerization” [0082] as taught by Sato. The original specification does not provide any disclosure on how to obtain the claimed properties outside the components of the composition itself. Therefore, the claimed effects and physical properties, i.e. storage modulus, would necessarily arise from a composition with all the claimed ingredients in the claimed amounts. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching enabling a person of ordinary skill in the art to obtain the claimed properties with only the claimed ingredients, absent undue experimentation.
Regarding Claim 10, Sato teaches “an adhesive hydrogel is formed on one face of a conductive layer” [0098] which indicates the layer by layer structure, which can be “safely adheres to, for example, the skin” [0097] as of “used as an electrode pad or other like adhesive conductive sites” [0097].
Claims 11, 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sato (US20140296418, herein Sato), as applied in the claim 1 above, in the further view of Cinelli (US20030187115, herein Cinelli).
Regarding Claim 11, Sato teaches composition for preparation of the hydrogel, comprising: “a polymer matrix of a copolymer of a monofunctional monomer and a crosslinking monomer (a)” [0014] ; comprising acrylamide and N,N’methylene bisacrylamide [0105], which indicate the claimed acrylic monomer and a crosslinkable monomer; “polyvinylpyrrolidone” [0054] which matches claimed water-soluble polymer; “water” [0020]; and “polyhydric alcohol” [0020], wherein the “crosslinking monomer (a) 0.01 wt %, and preferably less than or equal to 0.5 wt %.” [0027], encompasses the claimed range.
In 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). See MPEP § 2144.05.
Sato teaches the adhesive hydrogel in accordance with the present invention is to be manufactured by ultraviolet light radiation [0082], but is silent on irradiating a polymerizable solution with ultraviolet light having a peak intensity of 70 to 150 mW/cm2, however, Cinelli teaches “sufficient intensity and exposure duration (e.g. 10-3000 mW/cm 2) to complete the polymerization” [0050], overlaps the claimed range.
Sato and Cinelli are considered analogous art because they are in the same field of endeavor, that of acrylamide-based hydrogel composition development via UV irradiation polymerization. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have optimized Sato to add the teachings of Cinelli and provide wherein the specificized reaction condition of the “sufficient intensity and exposure duration (e.g. 10-3000 mW/cm 2) to complete the polymerization” [0050] and apply them into composition development. Doing so would further fulfill the suitability of the polymerization process as of “to complete the polymerization in a reasonable time.” [0050].
Regarding Claim 13, Sato teaches composition for hydrogel, comprising: “a polymer matrix of a copolymer of a monofunctional monomer and a crosslinking monomer (a)” [0014]; comprising acrylamide and N,N’methylene bisacrylamide [0105], which indicate the claimed acrylic monomer and a crosslinkable monomer;
“polyvinylpyrrolidone” [0054] which matches claimed water-soluble polymer; “water” [0020]; and “polyhydric alcohol” [0020]
Sato teaches “polymer matrix is a matrix of a copolymer of a monofunctional monomer and a crosslinking monomer (a).” [0021] wherein the “crosslinking monomer (a) 0.01 wt %, and preferably less than or equal to 0.5 wt %.” [0027], since the “The monofunctional monomer preferably contains the (meth)acrylamide and/or (meth)acrylamide derivative (d)” [0048], therefore the range of the (meth)acrylamide is 99.5% to 99.99%, overlaps the claimed range.
In 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). See MPEP § 2144.05.
Regarding Claim 14, Sato teaches the crosslinking monomer is present in an amount greater than or equal to 0.03 wt %, and more preferably less than or equal to 0.1 wt %. [0027] which lies in the claimed range.
Regarding Claim 15, Sato teaches “The content rate of structural units derived from N-vinyl-2-pyrrolidone (e) in the adhesive hydrogel in accordance with the present invention, although by no means limited in any particular manner, is preferably greater than or equal to 0.1 wt % and preferably less than or equal to 20 wt %.” [0056] which encompasses the claimed range.
In 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). See MPEP § 2144.05.
Regarding Claims 16, 17, Sato teaches that “The strip is backed with nonwoven fabric to prepare a test piece which is then attached to a Bakelite plate” [0084] matches the claimed intermediate substrate is embedded along an in-plane direction, which further applied to “then attached to the skin on the inner side of the left arm” [0086], which further indicates the hydrogel composition applied to nonwoven fabric then attached to human skin, therefore the layers of hydrogel and nonwoven fabric are attached in plane direction.
Regarding Claim 18, Sato teaches “thickness of 0.01 mm to 2.0 mm” [0090] which encompasses the claimed range.
In 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). See MPEP § 2144.05.
Regarding Claim 19, The Office realizes that all of the claimed effects or physical properties are not positively stated by the reference(s). However, Sato teaches all of the claimed ingredients in the claimed amounts, and teaches the composition as being made by a substantially similar process as of “a composition for adhesive hydrogel containing a monofunctional monomer, a crosslinking monomer (a), another polymer component, water, and a polyhydric alcohol may be heated or subjected to ultraviolet light radiation for polymerization” [0082] as taught by Sato. The original specification does not provide any disclosure on how to obtain the claimed properties outside the components of the composition itself. Therefore, the claimed effects and physical properties, i.e. storage modulus, would necessarily arise from a composition with all the claimed ingredients in the claimed amounts. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching enabling a person of ordinary skill in the art to obtain the claimed properties with only the claimed ingredients, absent undue experimentation.
Regarding Claim 20, Sato teaches “an adhesive hydrogel is formed on one face of a conductive layer” [0098] which indicates the layer by layer structure, which can be “safely adheres to, for example, the skin” [0097] as of “used as an electrode pad or other like adhesive conductive sites” [0097].
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered but they are not persuasive.
In response to the applicant’s argument of the “claim 1 is currently amended to recite that the crosslinkable monomer includes polyfunctional (meth)acrylamide, which Applicant submits is not disclosed or suggested in Sato, such that amended claim 1 is patentable over Sato”, the argument is not persuasive.
In fact, Sato explicitly teaches crosslinking monomer (a): methylenebis(meth)acrylamide, ethylenebis(meth)acrylamide [0023] which reads on the crosslinkable monomer includes polyfunctional (meth)acrylamide as set forth above.
In response to the applicant’s argument of the “Applicant submits that as seen in Sato (e.g., Table 2), Sato's Examples 4 to 10 include polyvinylpyrrolidone as well as a large amount of acrylic acid. The compositions of Sato apparently do not satisfy the recitation in claim 1 that "the content of the structural unit derived from the acrylamide-based monomer in the polymer matrix is within the range of 98.5 mass% to 99.97 mass%”, the argument is not persuasive.
In fact, first, Sato teaches “polymer matrix is a matrix of a copolymer of a monofunctional monomer and a crosslinking monomer (a).” [0021] wherein the “crosslinking monomer (a) 0.01 wt %, and preferably less than or equal to 0.5 wt %.” [0027] overlaps the claimed range, wherein, the crosslinking monomer (a) are methylenebis(meth)acrylamide, ethylenebis(meth)acrylamide [0023]; since the “the monofunctional monomer preferably contains the (meth)acrylamide and/or (meth)acrylamide derivative (d)” [0048] reads on the acrylamide based monomer, therefore the range of the (meth)acrylamide is 99.5% to 99.99%, overlaps the claimed range. Hence, the composition as taught Sato satisfies the claim 1 as set forth in the rejection above.
Second, Sato not only teaches the examples 4-10, which included the acrylic acid; but also teaches the examples 1-3 which all excluded the acrylic acid [P11; Table 1], collectively match the hydrogel may or may not contain acrylic acid as an acrylic monomer [Instant App. US20220340719; 0022], hence, Sato does not teach away the instant application.
Conclusion
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 mailing date of this final action.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zhen Liu whose telephone number is (703)756-4782. The examiner can normally be reached Monday-Friday 9:00 am - 5:00 pm.
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/Z.L./
Examiner, Art Unit 1767
/MARK EASHOO/Supervisory Patent Examiner, Art Unit 1767
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