DETAILED ACTION
Status of the Claims
1. Claims 1-20 are pending.
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.
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.
2. Claim(s) 1, 2, 5, 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cai et al. (US 2007/0131549).
Claim 1. Cai et al. teach an electrochemical sensor (glucose biosensor; Fig 6), comprising:
a first conductive substrate being coupled to, and electrically isolated from, a second conductive substrate (base layer 20 with conductive layer 21 electrically isolated from base layer 320 with conductive layer [0075][0063] and Fig 6);
a first electrode trace being formed from the first conductive substrate, the first electrode trace having at least one first electrode opening (trace formed corresponding to opening 32; [0075]);
a second electrode trace being formed from the first conductive substrate, the second electrode trace having at least one second electrode opening (trace corresponding to opening 34; [0075] and Fig 6);
a third electrode trace being formed from the second conductive substrate, the third electrode trace including at least one third electrode opening (trace corresponding to opening 3222; [0075] and Fig 6);
a first transport material disposed as a barrier between any of the first, second or third electrode openings (polymer is disposed as part of the reagent in openings; [0065][0101]),
Cai do not explicitly teach the first transport material (polymer) is impervious to any byproduct of a reaction at any of the first, second or third electrode openings. However, Cai teach the polymer stabilize and bind chemicals in the reagent; [0102].
Thus, it would be obvious if not apparent, the polymer which is capable of stabilizing the chemicals in the reagent would be unaffected by byproduct i.e. hydrogen peroxide of a reaction at the openings.
Claim 2. Cai et al. teach a first working electrode being defined by having a first reactive chemistry responsive to a first analyte within the at least first electrode opening (WE 1 comprised of GOD reagent which is responsive to glucose; [0075][0065]).
Claim 5. Cai et al. teach a second working electrode being defined by disposing a second reactive chemistry responsive to a second analyte within the at least second electrode opening (second working electrode W2 is loaded with GDH-based reagent in second opening; [0075][0065]).
Claim 8. Cai et al. teach a counter-reference electrode being disposed within the at least third electrode opening (counter/reference electrode located in third opening 322’ [0075][0017]).
Claim 10. Cai et al. teach the second electrode trace is a counter electrode and the third electrode trace is a reference electrode (Fig 6 shows four openings defining electrode areas of W1, W2, R and B; [0085], thus trace R reads on third electrode trace and B trace reads on counter electrode).
3. Claim(s) 3, 4, 6, 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cai et al. as applied to claim 1 above, and further in view of Shah et al. (US 2017/0328857).
Claims 3 and 6. Cai do not teach the first reactive chemistry overfills the at least first electrode opening or the second reactive chemistry overfills the at least second electrode opening.
However, Shah et al. teach analyte sensor comprised of aperture electrode wherein the aperture is either fill with reactive chemistry or overfilled with reactive chemistry 202 and further overlayed with transport material transmissive to glucose (see Fig 5C and 5E and [0108]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Shah et al. teaching to try overfilling the openings of Cai with reactive chemistry because overfilling the opening with reactive chemistry was known in the art and one would achieve same results of detecting the analyte with an overfill opening.
Claims 4, 7 and 9. Cai et al. teach the polymer is mixed with reactive chemistry and the reactive chemistry is filled in first, second and third electrode openings [0102] but do not teach the transport material being applied directly over the reactive chemistry openings.
However, Shah et al. teach an analyte sensor comprised of aperture electrode wherein the aperture is comprised of reactive chemistry 202 and transport material transmissive to glucose is disposed thereon to enable flux of the analyte to the electrode (see Fig 5C, abstract and [0108]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Shah et al. teaching to try placing the polymer over the reaction chemistry in the openings of Cai because placing the polymer over the reactive chemistry was known in the art and one would achieve same results of enabling fluxing of the analyte and any byproduct of the reactive chemistry to the electrode surface.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 11-20 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-10 of prior U.S. Patent No.12,350,046 (hereinafter ‘046). This is a statutory double patenting rejection.
Conclusion
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
