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 .
Election/Restrictions
Claims 9-11 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected process for making the electrically and/or ionically conducting hydrogel, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/03/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/29/2024 and 07/29/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Regarding claims 2, 3, and 4, the phrase “about” renders the scope of the claim unclear because the specification fails to provide a standard for the boundaries of the term. See MPEP § 2173.05(d).
Regarding claims 2, 3, 4, and 12, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
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.
Claims 1, 6-8 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Guo Yan (CN113943428A) herein referred to as “Guo” in view of Souza et al (“Polysaccharide-Based Materials Created by Physical Processes: From Preparation to Biomedical Applications” (See attached)) herein referred to as “Souza”.
Regarding claim 1, Guo discloses: A thermoreversible (As defined by google, “thermoreversible hydrogel” is ‘a type of hydrogel that can reversibly transition between a liquid (sol) and solid (gel) state in response to changes in temperature’; [page 10: line 8] the solution which is seen as the liquid (sol) state cools and forms the conductive gel which is seen as the solid (gel) state, hence the hydrogel disclosed in Guo is thermoreversible) electrically and/or ionically conducting hydrogel ([Abstract] a conductive gel which is seen as the electrically and/or ionically conducting hydrogel) comprising: a mixture of glycerol, ([page 7: paragraph 2] can contain glycerol) chitosan ([page 7: paragraph 3] can contain chitosan) and gelatin, ([page 7: paragraph 2] can contain gelatin) a given amount of an electrically conducting material, ([page 7: paragraph 3] contains salt electrolyte which is seen as the electrically conducting agent) and an aqueous solvent ([page 7: paragraph 3] contains water which is seen as the aqueous solvent). However, Guo does not explicitly disclose: wherein the conducting hydrogel is free of crosslinking agent
Souza discloses: wherein the conducting hydrogel is free of crosslinking agent ([Page 33: Paragraph 3] See attached; the hydrogels are engineered without the use of crosslinking agents)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the conducting hydrogel of Guo to make it free of crosslinking agent as disclosed in Souza. The motivation being that crosslinking agents reduce biodegradability and cytocompatibility which prevents the use of this hydrogels in biomedical applications (Souza [Page 33: Paragraph 3] See attached).
Regarding claim 6, Guo in view of Souza discloses: The hydrogel of claim 1, for use for the manufacturing of a medical electrode, a standalone transmitter for various signals, and/or wearable electronics for recording /stimulation (Guo [page 3: paragraph 1] the conductive gel can be used in the field of medical electrodes).
Regarding claim 7, Guo in view of Souza discloses: The hydrogel of claim 6, however Guo in view of Souza does not explicitly disclose: wherein the medical electrode or standalone transmitter is manufactured using 3D printing, casting or molding techniques.
The end result of the product taught in Guo in view of Souza possesses the same properties as the claimed invention, that is, the medical electrode or standalone transmitter. (“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).
Regarding claim 8, Guo in view of Souza discloses: The hydrogel of claim 6 wherein the medical electrode is used for electrophysiological signal comprising electrocardiography (ECG), electromyography (EMG), electroencephalography (EEG), electrogastrography (EGG) or electrooculography (EOG) (Guo [page 3: line 1] the conductive gel which is seen as the hydrogel for use with the electrode is for electrocardiographic detection).
Regarding claim 13, Guo in view of Souza discloses: The medical electrode of claim 12, wherein the shape of the hydrogel is obtained by molding said hydrogel in its sol state at a given temperature, (Guo [page 10: lines 1-8] the hydrogel undergoes injection molding while being heated 55-65 degrees Celsius) the hydrogel being then cooled until jellification/stretchable (Gel state) (Guo [page 10: lines 1-8] the hydrogel is then cooled to obtain the conductive gel).
Regarding claim 14, Guo in view of Souza discloses: The medical electrode of claim 12, however, Guo in view of Souza does not explicitly disclose: wherein the shape of the hydrogel is obtained by 3D printing said hydrogel in its sol state at a given temperature.
The end result of the product taught in Guo in view of Souza possesses the same properties as the claimed invention, that is, the shape of the hydrogel. (“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).
Regarding claim 15, Guo in view of Souza discloses: The medical electrode of claim 12 for use for electrophysiological signal comprising electrocardiography (ECG), electromyography (EMG), electroencephalography (EEG), electrogastrography (EGG) or electrooculography (EOG) (Guo [page 3: line 1] the conductive gel which is seen as the hydrogel is for electrocardiographic detection).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Souza in further view of Santos et al (US20210138071A1) herein referred to as “Santos”
Regarding claim 2, Guo in view of Souza discloses: The hydrogel of claim 1, However, Guo in view of Souza does not explicitly disclose: wherein for 12 mL of said aqueous solvent, such as water, the hydrogel comprises: about 12.5 to 30 v/v% of glycerol; about 12.5 to 50 v/v% of a chitosan solution, wherein said chitosan solution comprises about 0.5 to 5 wt/Vol. % of chitosan in water with preferably 1 to 3 v/v of 99% acetic acid; and about 14.5 to 58 wt.vol% of gelatin; and about 10 v/v% of said conducting material
Santos discloses: wherein for 12 mL of said aqueous solvent, such as water, ([0072] the product can be prepared in an aqueous solution) the hydrogel comprises: about 12.5 to 30 v/v% of glycerol; ([166] glycerol can be included as gelling agent) about 12.5 to 50 v/v% of a chitosan solution, wherein said chitosan solution comprises about 0.5 to 5 wt/Vol. % of chitosan in water ([0139] chitosan may be used to form scaffolding networks) with preferably 1 to 3 v/v of 99% acetic acid; (See Table 1 excipients can include acetic acid) and about 14.5 to 58 wt.vol% of gelatin; ([166] gelatin can be included as gelling agent) and about 10 v/v% of said conducting material ([0161] excipients such as transition metal salts can be used); ([0181] and [0182] the above excipients and cargos from Table 1 which include glycerol, chitosan, acetic acid, gelatin and conducting material can be included in such products at concentrations ranging from 0.01% to 99.9% w/v or at concentrations ranging from 0.01% to 99.9% v/v)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of the hydrogel as disclosed in Guo in view of Souza in further view of Santos to include wherein for 12 mL of said aqueous solvent, such as water, the hydrogel comprises: about 12.5 to 30 v/v% of glycerol; about 12.5 to 50 v/v% of a chitosan solution, wherein said chitosan solution comprises about 0.5 to 5 wt/Vol. % of chitosan in water with preferably 1 to 3 v/v of 99% acetic acid; and about 14.5 to 58 wt.vol% of gelatin; and about 10 v/v% of said conducting material 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). There is no criticality on the ratios claimed in Applicant specification.
Regarding claim 3, Guo in view of Souza discloses: The hydrogel of claim 1, However, Guo in view of Souza does not explicitly disclose: wherein for 12 mL of said aqueous solvent, such as water, the hydrogel comprises: about 1.5 to 3mL of glycerol; about 1.5 to 3mL of a chitosan solution, wherein said chitosan solution comprises about 0.5 to 5 wt/Vol. % of chitosan in water with preferably 1 to 3 v/v of 99% acetic acid; and about 1.75 to 3.75g of gelatin; and about 10 v/v% of said conducting material
Santos discloses: wherein for 12 mL of said aqueous solvent, such as water, ([0072] the product can be prepared in an aqueous solution) the hydrogel comprises: about 1.5 to 3mL of glycerol; ([166] glycerol can be included as gelling agent) about 1.5 to 3mL of a chitosan solution, wherein said chitosan solution comprises about 0.5 to 5 wt/Vol. % of chitosan in water ([0139] chitosan may be used to form scaffolding networks) with preferably 1 to 3 v/v of 99% acetic acid; ; (See Table 1 excipients can include acetic acid) and about 1.75 to 3.75g of gelatin; ([166] gelatin can be included as gelling agent) and about 10 v/v% of said conducting material ([0161] excipients such as transition metal salts can be used); ([0181] and [0182] the above excipients and cargos from Table 1 which include glycerol, chitosan, acetic acid, gelatin and conducting material can be included in such products at concentrations ranging from 0.01% to 99.9% w/v or at concentrations ranging from 0.01% to 99.9% v/v)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of the hydrogel as disclosed in Guo in view of Souza in further view of Santos to include wherein for 12 mL of said aqueous solvent, such as water, the hydrogel comprises: about 1.5 to 3mL of glycerol; about 1.5 to 3mL of a chitosan solution, wherein said chitosan solution comprises about 0.5 to 5 wt/Vol. % of chitosan in water with preferably 1 to 3 v/v of 99% acetic acid; and about 1.75 to 3.75g of gelatin; and about 10 v/v% of said conducting material 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). There is no criticality on the ratios claimed in Applicant specification.
Regarding claim 4, Guo in view of Souza discloses: The hydrogel of claim 3, however, Guo in view of Souza does not explicitly disclose: wherein for 12 mL of said aqueous solvent, such as water, the hydrogel comprises: about 3mL of glycerol; ([166] glycerol can be included as gelling agent) about 3mL of a chitosan solution, wherein said chitosan solution comprises about 0.5 to 5 wt/Vol. % of chitosan in water with preferably 1 to 3 v/v of 99% acetic acid; ; (See Table 1 excipients can include acetic acid) and about 3.75g of gelatin; and about 10 v/v% of said conducting material
Santos discloses: wherein for 12 mL of said aqueous solvent, such as water, ([0072] the product can be prepared in an aqueous solution) the hydrogel comprises: about 3mL of glycerol; ([166] glycerol can be included as gelling agent) about 3mL of a chitosan solution, wherein said chitosan solution comprises about 0.5 to 5 wt/Vol. % of chitosan in water ([0139] chitosan may be used to form scaffolding networks) with preferably 1 to 3 v/v of 99% acetic acid; and about 3.75g of gelatin; ([166] gelatin can be included as gelling agent) and about 10 v/v% of said conducting material ([0161] excipients such as transition metal salts can be used); ([0181] and [0182] the above excipients and cargos from Table 1 which include glycerol, chitosan, acetic acid, gelatin and conducting material can be included in such products at concentrations ranging from 0.01% to 99.9% w/v or at concentrations ranging from 0.01% to 99.9% v/v)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of the hydrogel as disclosed in Guo in view of Souza in further view of Santos to include : wherein for 12 mL of said aqueous solvent, such as water, the hydrogel comprises: about 3mL of glycerol; about 3mL of a chitosan solution, wherein said chitosan solution comprises about 0.5 to 5 wt/Vol. % of chitosan in water with preferably 1 to 3 v/v of 99% acetic acid; and about 3.75g of gelatin; and about 10 v/v% of said conducting material 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). There is no criticality on the ratios claimed in Applicant specification.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Souza in further view of Vitale et al (US20230397870A1) herein referred to as “Vitale
Regarding claim 5, Guo in view of Souza discloses: The hydrogel of claim 1. However, Guo in view of Souza does not explicitly disclose: wherein said conducting material comprises poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT: PSS), thermally reduced graphene (TRG), or Ti3C2Tx ( MXene)
Vitale discloses: wherein said conducting material comprises poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT: PSS), thermally reduced graphene (TRG), or Ti3C2Tx ( MXene) ([0024] conductive fillers can be PEDOT:PSS and MXene)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrogel as disclosed in Guo in view of Souza to include a conducting material such as poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT: PSS), thermally reduced graphene (TRG), or Ti3C2Tx ( MXene) as disclosed in Vitale. The motivation being these fillers have highly advantageous properties for wearable health monitoring (Vitale [0025]).
Regarding claim 12, Guo in view of Souza discloses: A medical electrode comprising: the electrically and/or ionically conducting hydrogel as claimed in claim 1, (Guo [page 3: paragraph 1] the medical electrode can be used with the conductive gel). However, Guo in view of Souza does not explicitly disclose: the conducting hydrogel being in its gel state and having a shape configured for being applied to a patient’s skin; and an electrical connector, preferably comprising a metal or an intermediate flexible substrate, operatively connected to the electrically and/or ionically conducting hydrogel.
Vitale discloses: the conducting hydrogel being in its gel state and having a shape configured for being applied to a patient’s skin; (See FIG 3B where the hydrogel is in gel state with a geometric shape for applying to the patient’s skin) and an electrical connector, preferably comprising a metal or an intermediate flexible substrate, ([0027] and [0028] electrical connectors made from conductive fillers such as MXene which is a metal) operatively connected to the electrically and/or ionically conducting hydrogel ([0028] the electrical wires made from the conductive fillers are used to connect the hydrogel).
It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the hydrogel as disclosed in Guo in view of Souza to include having a shape configured for being applied to a patient’s skin, and an electrical connector to connect to the hydrogel as disclosed in Vitale. The motivation being a hydrogel in a gel state possesses structural integrity to prevent it from running, and an electrical connector is required to connect the hydrogel to electronic instruments to take readings. (Vitale [0028]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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