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
Applicant's election with traverse of Group I (claims 1-18) in the reply filed on January 27, 2026 is acknowledged. The traversal is on the ground(s) that “there would not be a serious burden on the Examiner if restriction is not required. Further, it would be more efficient to examine all claims at once (see “Remarks” 3rd paragraph of page 5). This is not found persuasive because claim 1 does not require all the structural elements of claim 19 (i.e., working electrode) and Claim 19 does not require the processing steps of claim 1. Therefore, it would be a serious burden on the examiner to examine both distinct and independent Inventions I and II.
The requirement is still deemed proper and is therefore made FINAL.
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 1-18 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.
“obtaining the electrode of the analyte sensor on the first side of the substrate” (claim 1, last line) is vague and confusing because it is uncertain as what is “obtaining” meant? How to obtain the electrode (i.e., pick it up, receive it)? After steps a-c are performed the electrode are formed on the substrate or other processing step is needed to obtain the electrode. Please clarify.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 6,299,757 to Feldman et al in view of Article “The electrochemical formation and reduction of a thick AgCl deposition layer on silver substrate” by Jin et al.
Regarding claim 1, Feldman et al disclose a method for manufacturing an electrode (22/24) of an analyte sensor (see Figs. 1-2), the method comprising: a) providing a substrate (30/38) having a first side and a second side and a conductive material (see Col. 8, lines 1-16) positioned on the first side; and b) applying a layer of an AgCl-containing composition onto the conductive material, wherein the layer of the AgCl-containing composition comprises an outer surface that faces away from the conductive material and an inner surface that contacts the conductive material (see Col. 24, lines 45-52); except for at least partially reducing AgCl on the outer surface and thereby forming elemental Ag on the outer surface to obtain the electrode of the analyte sensor on the first side of the substrate. Jin et al teach the process of reducing AgCl on a conductive layer (carbon, see Section 3.2) for obtaining a porous silver layer (see Fig. 13). 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 invention Feldman et al by utilizing the process of reducing AgCl layer as taught by Jin et al for obtaining a porous silver layer on the conductive layer.
Regarding claims 2-5, Feldman et al disclose the AgCl-containing composition applied in step b) further comprises at least one binder and/or elemental Ag,
a non-conductive polymer of one or more of a PVC-based polymer and a polyurethane-based polymer or the binder is a hydrophobic polyurethane-based polymer (see Col. 59, lines 15-32).
Regarding claims 6-8, Feldman et al disclose the conductive material is selected from the group consisting of gold, carbon, carbon paste and combinations thereof and comprises at least two different layers of gold layer and a carbon layer (see Col. 8, lines 8-11).
Regarding claims 9-10 Jin et al disclose the AgCl is reduced by a chemical
treatment and/or by an electrochemical treatment and an amount of about 0.2 µg/mm² to about 10 µg/mm² AgCl on the outer surface is reduced (see Section 3. Results and discussion).
Regarding claims 11-12, Jin et al disclose a layer of Ag having a thickness
from about 0.1 µm to about 5 µm is formed on the outer surface of the AgCl-containing
composition (see “2. Experimental” section) and about 90 mol-% to about 99 mol-% of the AgCl in the layer of Ag is reduced to elemental Ag (see “3.1.2. Conductivity of the AgCl deposit layer”.
Regarding claims 13-18, Feldman et al disclose the electrode (22/24) is used as a reference electrode, a counter electrode and/or a combined counter/reference electrode of an analyte sensor (see Figs. 1-2) and providing the working electrode comprises applying a sensing material to the substrate and obtaining a working electrode of the analyte sensor on the substrate; the sensing material comprises at least one enzyme; a cross-linker and/or a polymeric metal complex and the enzyme is a glucose dehydrogenase (GOD) or a glucose oxidase (GOX, see Col. 23, lines 50-53).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prior art references cited for their general teachings of making a biosensor device.
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/DN/ /DONGHAI D NGUYEN/March 7, 2026 Primary Examiner, Art Unit 3729