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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-13, drawn to a solid-state reference electrode.
Group II, claim(s) 14-17, drawn to a method of making a solid-state reference electrode.
Group III, claim(s) 18-20, drawn to a method of making the hydrogel polymeric membrane.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because even though the inventions of these groups require the technical features of a hydrogel polymeric membrane comprising a chloride salt and a supporting electrolyte disposed on a metal-metal salt layer of a solid-state reference electrode, these technical features are not special technical features as they do not make a contribution over the prior art in view of Cha et al. (US 2001/0032785 A1). Cha teaches a hydrogel polymeric membrane comprising a chloride salt and a supporting electrolyte disposed on a metal-metal salt layer of a solid-state reference electrode (a hydrogel polymer layer 5 comprising KCl and CaCl2 electrolyte disposed on an Ag/AgCl electrode 3 of a planar reference electrode, Figs. 2a-2e, para. [0106]-[0111], [0142]-[0145], Table 1, Example 8).
During a telephone conversation with Jonathan Raymond on February 3, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statement filed February 26, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statement filed February 26, 2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 9, “electrically-conducting” should read “electrically-conductive”.
In lines 14-15, “the insulating substrate layer” should read “the insulating support substrate”.
Appropriate correction is required.
Claim 5 is objected to because of the following informalities: in line 3, “sodium or” should read “sodium, or”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: in line 6, “polysacharrides” should read “polysaccharides”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: in line 3, “filing” should read “filling”. Appropriate correction is required.
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.
Claims 9-13 are 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 9 recites the limitation “wherein the hydrogel polymeric membrane is selected from the group consisting of polyacrylates, polymethacrylates, polyvinyl compounds, polyurethanes, polycarbamoyl sulfonates, polyureas, polyethers, crosslinkable PVA-SBQ, crosslinked protein matrix like gelatin, silk fibroin, BSA, crosslinked polysacharrides like cellulose, dextrans, cyclodextrans, alginates, chitosan, Agar, and any combination of thereof”. Claim 9 depends from claim 1 which recites “the hydrogel polymeric membrane being a polymeric hydrogel network containing (i) a chloride salt from inorganic salts of chlorides or organic salts of chlorides and (ii) a supporting electrolyte from salts of an anionic species” in lines 26-29 of claim 1. Claim 9 recites “wherein the hydrogel polymeric membrane is selected from the group”, so it is unclear whether the listed materials in claim 9 are in addition to the materials recited in claim 1. Does the hydrogel polymeric membrane further include at least one of the listed materials of claim 9? Or are the materials in claim 9 for the polymeric hydrogel network recited in claim 1? For the purpose of examination, Examiner interprets claim 9 to mean that the hydrogel polymeric membrane further includes at least one of the listed materials in claim 9.
Regarding claims 9 and 12, the phrase "like" 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).
The term “high molecular weight” in claims 10 and 12 is a relative term which renders the claims indefinite. The term “high molecular weight” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the instant specification discloses examples of high molecular weight polymers at para. [0030] of the instant US PGPub, this does not provide a standard for ascertaining the requisite degree. Claim 11 is also rejected as dependent thereon.
Claim 13 recites the limitation "the hydrophilic plasticizer" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the high molecular weight polymer" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-7, and 9 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Cha et al. (US 2001/0032785 A1), as evidenced by Applicant’s specification with respect to claims 2 and 6.
Regarding claim 1, Cha teaches a solid-state reference electrode (a planar reference electrode, Figs. 2a-2e, para. [0082]), the solid-state reference electrode comprising:
an insulating support substrate (a plate 4 formed of alumina, glass, plastic, polyester, or polycarbonate, Figs. 2a-2e, para. [0091]);
an electrically-conductive material disposed on the insulating support substrate, wherein a first portion of the electrically-conductive material is an electrode portion and a second portion of the electrically-conductive material is an electrical contact portion (Ag/AgCl is disposed on the alumina plate 4 to form an electrode 3 and an electrode connection part 1, Figs. 2a-2e, para. [0094], [0107]-[0108]), the electrically-conducting material comprising one of a conductive noble metal, an electrically conductive ink, or a metal-metal salt selected from the group consisting of silver-silver chloride and mercury-mercurous chloride (Ag/AgCl, Figs. 2a-2e, para. [0094]);
an electrode-forming insulating layer having an opening, the electrode-forming insulating layer disposed on the insulating substrate layer, wherein the opening forms a well having predefined dimensions and exposing the electrode portion of the electrically-conductive material (an insulating membrane 2 is formed on the alumina plate 4 excluding the electrode 3 such that the insulating membrane 2 has an opening forming a well that exposes the electrode 3, Figs. 2a-2c, para. [0095], [0109]);
a metal-metal salt layer disposed in the well over the electrode portion of the electrically-conductive material when the electrically-conductive material is not the metal-metal salt (the electrode 3 is Ag/AgCl, Figs. 2a-2e, para. [0094]); and
a hydrogel polymeric membrane disposed (a) on the metal-metal salt layer forming the solid-state reference electrode when the electrically-conductive material is not the metal-metal salt, or (b) directly on the electrically-conductive material when the electrically-conductive material is the metal-metal salt (a hydrogel polymer layer 5 is disposed on the Ag/AgCl electrode 3, Figs. 2b-2d, para. [0111]), the hydrogel polymeric membrane being a polymeric hydrogel network containing (i) a chloride salt from inorganic salts of chlorides or organic salts of chlorides and (ii) a supporting electrolyte from salts of an anionic species (the hydrogel polymer layer 5 includes KCl and CaCl2 electrolyte in Example 8, Figs. 2b-2d, para. [0087]-[0090], [0111], [0145], [0147], Table 1).
The limitation “for use in whole blood, serum, plasma, other biological fluids, and/or aqueous solutions” is interpreted as intended use language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The planar reference electrode disclosed by Cha teaches all of the structural limitations of the claim and thus is configured for and capable of being for use in whole blood, serum, plasma, other biological fluids, and/or aqueous solutions.
Regarding claim 2, Cha teaches a second polymeric membrane disposed onto the hydrogel polymeric membrane (a porous protection membrane 9 is disposed on the hydrogel polymer layer 5, Figs. 2a-2d, para. [0112]-[0113]), the second polymeric membrane selected from hydrophilic silicon compounds or from lipophilic polymers (the porous protection membrane 9 is formed of cellulose nitrate in Example 8, Figs. 2a-2d, para. [0092], [0146]-[0147], Table 1). As evidenced by Applicant’s instant specification, cellulose nitrate (nitrocellulose) is a lipophilic polymer (see para. [0025], [0058] of the instant US PGPub).
Regarding claim 3, claim 1 recites “the electrically-conducting material comprising one of a conductive noble metal, an electrically conductive ink, or a metal-metal salt selected from the group consisting of silver-silver chloride and mercury-mercurous chloride,” and therefore, the limitation “wherein the conductive noble metal is selected from the group consisting of gold, platinum, palladium, copper, indium, and tin oxide” of claim 3 is further limiting an optional component of claim 1 and is not further limiting the electrically-conducting material when the electrically-conducting material comprises a metal-metal salt selected from the group consisting of silver-silver chloride and mercury-mercurous chloride (Cha teaches that the electrode 3 is Ag/AgCl, Figs. 2a-2e, para. [0094]).
Regarding claim 4, Cha teaches wherein the chloride salt in the hydrogel polymeric membrane is selected from the group consisting of sodium chloride, potassium chloride, lithium chloride, choline chloride, 1-butyl-3-methylimidazolium chloride, 1-butyl-2,3- dimethylimidazolium chloride, 1-butyl-1-methylpyrrolidium chloride, 1,2-dimethyl-3- propylimidazolium chloride, and 1,3-dimethylimidazolium chloride (the hydrogel polymer layer 5 includes KCl in Example 8, Figs. 2b-2d, para. [0090], [0145], Table 1).
Regarding claim 6, claim 2 recites “the second polymeric membrane selected from hydrophilic silicon compounds or from lipophilic polymers,” and therefore, the limitation “wherein the silicone compounds are selected from the group consisting of diluted silicon tetrachloride, aminopropyltriethoxysilane, n-[3-(trimethoxysilyl)propyl]ethylenediamine, methyltrimethoxy silane, and phenyltrimethoxysilane” of claim 6 is further limiting an optional component of claim 2 and is not further limiting the second polymeric membrane when the second polymeric membrane comprises lipophilic polymers (Cha teaches that the porous protection membrane 9 is formed of cellulose nitrate in Example 8, Figs. 2a-2d, para. [0092], [0146]-[0147], Table 1; as evidenced by Applicant’s instant specification, cellulose nitrate or nitrocellulose is a lipophilic polymer, see para. [0025], [0058] of the instant US PGPub).
Regarding claim 7, Cha teaches wherein the lipophilic polymers are selected from the group consisting of polyvinylpyrrolidone, polyvinyl alcohol, PVC, poly(methyl methacrylate), agar, gelatin, poly(urethane), cellulose acetate butyrate, cellulose acetate, and nitro cellulose (the porous protection membrane 9 is formed of cellulose nitrate in Example 8, Figs. 2a-2d, para. [0092], [0146]-[0147], Table 1; Examiner notes that cellulose nitrate is another name for nitrocellulose and they are equivalent).
Regarding claim 9, Cha teaches wherein the hydrogel polymeric membrane is selected from the group consisting of polyacrylates, polymethacrylates, polyvinyl compounds, polyurethanes, polycarbamoyl sulfonates, polyureas, polyethers, crosslinkable PVA-SBQ, crosslinked protein matrix like gelatin, silk fibroin, BSA, crosslinked polysacharrides like cellulose, dextrans, cyclodextrans, alginates, chitosan, Agar, and any combination of thereof (the hydrogel polymer layer 5 further includes poly(vinyl pyrrolidone), Figs. 2a-2d, para. [0089], [0145], [0147], Table 1, Example 8).
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.
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 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Cha as applied to claims 1-2 above, and further in view of Mohd Rais et al. (WO 2010/021536 A2) (provided in Applicant’s IDS filed on February 26, 2025).
Regarding claim 5, Cha teaches that the supporting electrolyte in the hydrogel polymer layer 5 is CaCl2 in Example 8 (Cha, Figs. 2b-2d, para. [0088], [0111], [0145], [0147], Table 1). Cha fails to teach wherein the supporting electrolyte is selected from the group consisting of lithium, sodium or potassium salts of citrates, acetates, sulfonates, or triflates.
Mohd Rais teaches a planar reference electrode 10 comprising a substrate 20, an electrode connecting part 24, an electrode 22, an internal reference layer 23, and a micro porous polymer membrane 38 (Mohd Rais, abstract, Fig. 1). Mohd Rais teaches that the internal reference layer 23 comprises a bulk hydrogel layer 26 containing organic internal electrolytes, a photo hydrophilic layer 28 conditioned with internal electrolyte, a hybrid solgel 30, a bulk hydrogel 32 containing bridge salts, a photo hydrophilic layer 34 conditioned with the bridge salts, and a hybrid solgel 36 (Mohd Rais, abstract, Fig. 1). Mohd Rais teaches that the external hydrogel layer 32 contains lithium acetate or potassium chloride, and the photo hydrophilic layer 34 is conditioned with lithium acetate (Mohd Rais, Fig. 1, pg. 4, lns. 21-24, pg. 7, lns. 2-8).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the CaCl2 electrolyte of Cha with lithium acetate as taught by Mohd Rais in order to yield the predictable result of a hydrogel polymer layer with another electrolyte (lithium acetate) that is compatible with KCl. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Regarding claim 8, Cha teaches wherein the metal-metal salt layer is silver-silver chloride (the electrode 3 is Ag/AgCl, Cha, Figs. 2a-2e, para. [0094]), the chloride salt in the hydrogel polymeric membrane is potassium chloride (the hydrogel polymer layer 5 includes KCl in Example 8, Figs. 2b-2d, para. [0090], [0111], [0145], [0147], Table 1), and the supporting electrolyte is CaCl2 (Cha, Figs. 2b-2d, para. [0088], [0111], [0145], [0147], Table 1, Example 8). Cha fails to teach wherein the supporting electrolyte is lithium acetate.
Mohd Rais teaches a planar reference electrode 10 comprising a substrate 20, an electrode connecting part 24, an electrode 22, an internal reference layer 23, and a micro porous polymer membrane 38 (Mohd Rais, abstract, Fig. 1). Mohd Rais teaches that the internal reference layer 23 comprises a bulk hydrogel layer 26 containing organic internal electrolytes, a photo hydrophilic layer 28 conditioned with internal electrolyte, a hybrid solgel 30, a bulk hydrogel 32 containing bridge salts, a photo hydrophilic layer 34 conditioned with the bridge salts, and a hybrid solgel 36 (Mohd Rais, abstract, Fig. 1). Mohd Rais teaches that the external hydrogel layer 32 contains lithium acetate or potassium chloride, and the photo hydrophilic layer 34 is conditioned with lithium acetate (Mohd Rais, Fig. 1, pg. 4, lns. 21-24, pg. 7, lns. 2-8).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the CaCl2 electrolyte of Cha with lithium acetate as taught by Mohd Rais in order to yield the predictable result of a hydrogel polymer layer with another electrolyte (lithium acetate) that is compatible with KCl. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cha as applied to claim 1 above, and further in view of Choi et al. (US 2002/0065332 A1), as evidenced by Applicant’s specification with respect to claim 10.
Regarding claim 10, Cha teaches wherein the hydrogel polymeric membrane further includes (b) a high molecular weight polymer (the hydrogel polymer layer 5 further includes poly(vinyl pyrrolidone), Cha, Figs. 2a-2d, para. [0089], [0145], [0147], Table 1, Example 8). As evidenced by Applicant’s instant specification, polyvinylpyrrolidone is a high molecular weight polymer (see para. [0030] of the instant US PGPub).
Example 8 of Cha fails to teach wherein the hydrogel polymeric membrane further includes (a) a hydrophilic plasticizer.
Choi teaches a mono-layered solid-state reference electrode comprising a substrate 10, an insulating film layer 9 formed on the substrate 10, a reference electrode material 11 insulated by the insulating film layer 9, and a mono-layered polymeric reference electrode membrane 13 for protecting the reference electrode material 11 (Choi, Fig. 3b, para. [0099]). Choi teaches that the reference electrode material 11 is silver/silver chloride (Choi, Fig. 3b, para. [0104]). Choi teaches that the mono-layered polymeric reference electrode membrane 13 includes a hydrophilic plasticizer saturated with a KCl salt and a lipophilic polymer (Choi, Fig. 3b, para. [0100]). Choi teaches that the hydrophilic plasticizer is selected from the group consisting of glycerol, polyethylene glycol, ethylene glycol monomethyl ether, ethylene glycol, and formamide (Choi, Fig. 3b, para. [0080]). Choi teaches that the hydrophilic plasticizer plays a role in the reference electrode by solidifying the lipophilic polymer, absorbing water from air to dissolve salts, and slowly releasing the electrolyte, and thus can shorten the preconditioning time required (Choi, Fig. 3b, para. [0081], [0101]). As evidenced by Applicant’s instant specification, polyvinylpyrrolidone is a lipophilic polymer (see para. [0025], [0058] of the instant US PGPub).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrogel polymer layer 5 (which includes polyvinylpyrrolidone) of Cha to further include a hydrophilic plasticizer selected from the group consisting of glycerol, polyethylene glycol, ethylene glycol monomethyl ether, ethylene glycol, and formamide as taught by Choi because the hydrophilic plasticizer can solidify the lipophilic polymer (polyvinylpyrrolidone), absorb water from air to dissolve salts, and slowly release the electrolyte, and thus can shorten the preconditioning time required (Choi, Fig. 3b, para. [0080]-[0081], [0101]). Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
The limitations “capable of filing the polymeric hydrogel network and solidifying and plasticizing the hydrogel polymeric membrane” and “capable of reinforcing the polymeric hydrogel network” are interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The hydrophilic plasticizer in the hydrogel polymer layer 5 disclosed by Modified Cha teaches all of the structural limitations of the claim and thus is configured for and capable of filling the polymeric hydrogel network and solidifying and plasticizing the hydrogel polymeric membrane. The polyvinylpyrrolidone in the hydrogel polymer layer 5 disclosed by Modified Cha teaches all of the structural limitations of the claim and thus is configured for and capable of reinforcing the polymeric hydrogel network.
Regarding claim 11, Modified Cha teaches wherein the hydrophilic plasticizer is selected from at least one of glycerol, polyethylene glycol, ethylene glycol monomethyl ester, ethylene glycol, and formamide (the hydrophilic plasticizer is selected from the group consisting of glycerol, polyethylene glycol, ethylene glycol monomethyl ether, ethylene glycol, and formamide, Choi, Fig. 3b, para. [0080], see modification supra).
Regarding claim 12, Modified Cha teaches wherein the high molecular weight polymer is one of polyethylene glycol, polyvinyl alcohol, polyvinylpyrrolidone, poly(2-hydroxyethyl methacrylate), and particulates like pyrogenic silica or latex (polyvinylpyrrolidone, Cha, Figs. 2a-2d, para. [0089], [0145], [0147], Table 1, Example 8).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Cha as applied to claim 1 above, and further in view of Mohd Rais et al. (WO 2010/021536 A2) (provided in Applicant’s IDS filed on February 26, 2025) and Choi et al. (US 2002/0065332 A1), as evidenced by Applicant’s instant specification.
Regarding claim 13, Cha teaches wherein the hydrogel polymeric membrane includes polyvinylpyrrolidone as the high molecular weight polymer (the hydrogel polymer layer 5 includes poly(vinyl pyrrolidone), Cha, Figs. 2a-2d, para. [0089], [0145], [0147], Table 1, Example 8). Example 8 of Cha fails to teach wherein the hydrogel polymeric membrane further includes poly-2-hydroxyethyl methacrylate, and ethylene glycol as the hydrophilic plasticizer.
Mohd Rais teaches a planar reference electrode 10 comprising a substrate 20, an electrode connecting part 24, an electrode 22, an internal reference layer 23, and a micro porous polymer membrane 38 (Mohd Rais, abstract, Fig. 1). Mohd Rais teaches that the internal reference layer 23 comprises a bulk hydrogel layer 26 containing organic internal electrolytes, a photo hydrophilic layer 28 conditioned with internal electrolyte, a hybrid solgel 30, a bulk hydrogel 32 containing bridge salts, a photo hydrophilic layer 34 conditioned with the bridge salts, and a hybrid solgel 36 (Mohd Rais, abstract, Fig. 1). Mohd Rais teaches that hydrophilic gels such as poly hydroxyethyl methacrylate (polyHEMA) and polyvinyl pyrrolidone containing hydrophilic organic chloride and/or potassium chloride are coated onto the silver-silver chloride reference electrode (Mohd Rais, Fig. 1, pg. 4, lns. 20-24, pg. 6, lns. 29-34, pg. 7, lns. 2-7). Mohd Rais teaches that the planar reference electrode with the moisture-retaining hydrogels is durable with good stability and prolonged lifetime (Mohd Rais, pg. 2, lns. 28-33, pg. 3, lns. 1-2).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrogel polymer layer 5 (which includes polyvinylpyrrolidone and KCl) of Cha to further include poly hydroxyethyl methacrylate (polyHEMA) as taught by Mohd Rais in order to yield the predictable result of a planar reference electrode having a durable hydrogel polymer layer with good stability and prolonged lifetime. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Choi teaches a mono-layered solid-state reference electrode comprising a substrate 10, an insulating film layer 9 formed on the substrate 10, a reference electrode material 11 insulated by the insulating film layer 9, and a mono-layered polymeric reference electrode membrane 13 for protecting the reference electrode material 11 (Choi, Fig. 3b, para. [0099]). Choi teaches that the reference electrode material 11 is silver/silver chloride (Choi, Fig. 3b, para. [0104]). Choi teaches that the mono-layered polymeric reference electrode membrane 13 includes a hydrophilic plasticizer saturated with a KCl salt and a lipophilic polymer (Choi, Fig. 3b, para. [0100]). Choi teaches that the hydrophilic plasticizer is selected from the group consisting of glycerol, polyethylene glycol, ethylene glycol monomethyl ether, ethylene glycol, and formamide (Choi, Fig. 3b, para. [0080]). Choi teaches that the hydrophilic plasticizer plays a role in the reference electrode by solidifying the lipophilic polymer, absorbing water from air to dissolve salts, and slowly releasing the electrolyte, and thus can shorten the preconditioning time required (Choi, Fig. 3b, para. [0081], [0101]). As evidenced by Applicant’s instant specification, polyvinylpyrrolidone is a lipophilic polymer (see para. [0025], [0058] of the instant US PGPub).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrogel polymer layer 5 (which includes polyvinylpyrrolidone) of Modified Cha to further include a hydrophilic plasticizer such as ethylene glycol as taught by Choi because the ethylene glycol can solidify the lipophilic polymer (polyvinylpyrrolidone), absorb water from air to dissolve salts, and slowly release the electrolyte, and thus can shorten the preconditioning time required (Choi, Fig. 3b, para. [0080]-[0081], [0101]). Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Therefore, Modified Cha teaches wherein the hydrogel polymer layer 5 includes poly hydroxyethyl methacrylate, ethylene glycol as the hydrophilic plasticizer, and polyvinylpyrrolidone as the high molecular weight polymer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIVIAN A TRAN whose telephone number is (571)272-3232. The examiner can normally be reached Mon - Fri 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794