DETAILED ACTION
Status of the Claims
1. Claims 1-5, 8 and 9 are pending.
Status of the Rejections
2. Rejection of claims is being modified in view of applicant’s amendments.
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.
3. Claim(s) 1-5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Yokoyama et al. (US 2012/0325658) in view of Wilson et al. (US 2020/0064296).
Claim 1. Yokoyama et al. teach a biosensor (detection device for detecting sample; see abstract) comprising:
a first substrate having a hydrophobic surface on one side (substrate 11 made up of PET [0091][0092] which is hydrophobic, thus the substrate has surface that is hydrophobic);
a second substrate disposed on the first substrate and having a hydrophilic surface on one surface (same receptable portion 34 disposed over the substrate 11 and face the substrate 11 has a hydrophilic face; [0107] and Fig 1B);
a support layer having a predetermined height to provide a space between the hydrophobic surface of the first substrate and the hydrophilic surface of the second substrate (spacer 31a having height to provide space between the substrate 11 and sample receptable portion 32 to form a space P2; see Fig 1B and [0110]);
one or more electrode layers formed within the space on the first substrate; and an enzyme reaction layer formed on the electrode layer (electrode system 20 formed in P2 and measurement reagent formed on the electrode system; [0098]);
wherein the electrode layer comprises a working electrode layer and a reference electrode layer (electrode system comprised of working and reference electrodes; [0098]).
Yokoyama et al. teach the enzyme reaction layer is formed on the working electrode layer but do not teach it has an area that is 60% to 330% times the area of the working electrode layer. However, Wilson et al. teach enzyme electrode comprising of enzyme layer on electrode at any percentage of surface area that allows the biosensor to perform and allow for sufficient capture of the target analyte, the surface area of enzyme layer is greater than surface area of electrode wherein the enzyme layer is present about 60% to 120% and above [0043].
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 Wilson et al. teaching to construct reagent layer of Yokoyama et al. at any percentage of surface area that allows the biosensor to perform effectively to achieve adequate results.
Claim 2. Yokoyama et al. teach the height of the support layer is larger than 25 µm and smaller than 300 µm (the spacer has height of 0.11 mm or 110 um, [0273] which is within claimed range).
Claim 3. Yokoyama et al. teach the support layer is made of a polymer resin (spacer is made up of plastic film such as two-sided adhesive tape i.e. pressure adhesive; [0273]).
Claims 4 and 5. Yokoyama et al. teach the enzyme reaction layer comprises at least one selected from the group consisting of oxidases and dehydrogenases (glucose oxidase; [0122].
Claim 8. Yokoyama et al. teach the electrode layer comprises at least one selected from the group consisting of a carbon electrode layer [0305].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama et al. and Wilson et al. as applied to claim 8 above, and further in view of Boock et al. (US 2019/0310222).
Claim 9. Yokoyama et al. teach electrode layer is made up of metal layer [0305] but do not teach the metal electrode layer comprises a metal protective layer formed on the metal layer. However, Boock et al. teach biological sensor comprised of working electrode composed of metal such as carbon or platinum (abstract and [0058]) and catalyst or material is added such metal oxide for reducing resistivity thereby enabling working electrode with higher signal to noise ratio [0087].
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 Boock et al. teaching to modified Yokoyama et al. electrode layer by adding layer of metal oxide because it would reduce resistivity thereby enabling working electrode with higher signal to noise ratio
Response to Arguments
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
Applicant argues on page 8 of remarks that cited reference, Yokoyama does not disclose any content to the area of the enzyme layer and cited reference, Wilson et al. discloses enzyme layer having an arbitrary percentage of surface area relative to the electrode without disclosing any effect of improving resolution depending on a specific ratio of the enzyme layer.
In response, examiner respectfully disagrees with applicant’s assertion. Yokoyama et al. teach the measurement reagent i.e. enzyme layer is provided in the overlap position P2 (area) that encompass working, counter and reference electrodes [0098]. Wilson et al. further teaches enzyme layer 14 is disposed on the electrode 12 such that enzyme layer has surface area greater than the surface area of the electrode 12 and percent surface area that falls within range of about 1% to 120% and above to allow for sufficient capture of the target analyte [0043], thus it is obvious from teachings of Wilson, the enzyme layer having surface area having range 1% to 120% is not arbitrary but a range that allow for sufficient capture of the targe analyte and in turn allow biosensor to perform. Furthermore, applicant’s argument of Wilson does not disclose “any effect of improving resolution depending on a specific ratio of the enzyme layer” is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, in an apparatus claim such feature is consider a property/function of an apparatus and such feature is presumed to be inherent in an apparatus claim. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary (see MPEP § 2112.01, I.).
Applicant further argues on page 9 that Wilson et al. describes area ratio of the enzyme layer in a very wide range without any special limitation and there is no recognition of restricting it within a specific range and thus one would not recognize the effect of improving resolution depending on a specific ratio of the enzyme layer of the present invention.
In response, Wilson teaching of enzyme layer percent surface area falls within range of about 1% to 120% and above overlaps claimed range of 60% to 330% and is not consider a very wide range as applicant alleges. Applicant’s argument of Wilson does not disclose “any effect of improving resolution depending on a specific ratio of the enzyme layer” is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, in an apparatus claim such feature is consider a property/function of an apparatus and such feature is presumed to be inherent in an apparatus claim. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary (see MPEP § 2112.01, I.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
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