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 without transverse of Group I, claims 1-7, in the reply filed on 5/30/2025 is acknowledged.
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 5-7 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 5 recites “wherein the side surface of the reference layer is exposed to the analyte" in lines 1-2, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claim 6 is rejected by virtue of its dependence from claim 5.
Claim 6 recites “wherein the side surface of the reference layer is covered with a protective film through which the analyte is transmitted” in lines 1-2, which contradicts that the side surface is exposed in claim 1, lines 7-8. This contradiction renders claim 6 indefinite.
Regarding claim 7, the phrase "as the reference layer, a paste-form material ejected from a nozzle is applied to the electrode to cross over a cut line" renders the claim indefinite because it is unclear what the claim language is referring to by stating “as the reference layer”. Also, it is unclear what the reference layer is doing. Further, it is unclear what “cross over a cut line” is referring to. That is, what element has this cut line? Finally, the recitation reads as an action step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claim Rejections - 35 USC § 103In 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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hoss et al. (US20100230285A1, hereinafter known as “Hoss”) in view of Gottlieb et al. (US20110319734A1; hereinafter known as “Gottlieb”). Regarding claim 1, Hoss teaches a sensor that measures an analyte (See Hoss abstract continuous analyte monitoring device), comprising: a probe that is to be inserted into a living body (See Hoss [0068], distal section used for position within the skin), wherein the probe includes a substrate (See Hoss [0074], substate 102), an electrode that is formed on or above the substrate (See Hoss [0074-0076] and Figure 3A and 3B, electrode 121a is on the substrate, also see [0074], the working electrode 121a can be any electrode, the sensing material can be applied to one or more electrodes), and a reference layer that is formed (See Hoss [0076], layer 116), and the reference layer has an upper surface covered with a film and has a side surface exposed (See Hoss Figure 3B and [0077]-[0079], film 112 and coverlay material 118 are on the working electrode or can be disposed on one or more electrodes, therefore the side surface would be exposed if the coverlay material is not implemented since Hoss says that the coverlay material is optional ([0077]: “a coverlay material 118 may be applied…”)). Hoss is silent with respect to the reference layer being formed on or above the electrode. Gottlieb teaches a reference layer formed on or above the electrode (See Gottlieb Figure 2A, [0075], the electrodes are coated with layers, 104 is the conductive layer which is equivalent to the reference layer and the base plate is a metal substrate which is equivalent to the electrode, the conductive layer is located above the base plate). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to form the reference layer of Hoss on or above the electrode, as taught by Gottlieb, to modulate the material properties of the electrodes (See Gottlieb [0075]). Regarding claim 2, Hoss teaches the reference layer has a shape narrowed in a direction from the side surface toward inside of the reference layer when seen from the upper surface (See Hoss Figure 1, 3A, and 3B the reference layer 116 is on top of 121a which narrows [0075]).
Regarding claim 3, Hoss teaches a shape of the reference layer in a direction from the side surface toward inside of the reference layer is an arc shape, an elliptical arc shape, or a triangular shape (See Hoss Figure 3A, the reference layer would be above the electrode which is represented by 121a therefore would arc like shape due to the rounded edges). Regarding claim 4, Hoss teaches the reference layer has a plurality of the arc shapes, a plurality of the elliptical arc shapes, or a plurality of the triangular shapes(See Hoss Figure 3A, the reference layer would be above the electrode which is represented by 121a therefore would arc like shape due to the rounded edges ). Regarding claim 5, Hoss teaches the side surface of the reference layer is exposed to the analyte (See Hoss Figure 3B and [0079], overlay material 118 are on the working electrode or can be disposed on one or more electrodes, therefore the side surface would be exposed if the coverlay material is not implemented since Hoss says that the coverlay material is optional ([0077]: “a coverlay material 118 may be applied…”), the reference layer is disposed on the electrode [0074-0076] which measures the analyte). Regarding claim 6, Hoss teaches the side surface of the reference layer is covered with a protective film through which the analyte is transmitted (See Hoss [0074], biocompatible membrane 114). Regarding claim 7, Hoss teaches a sensor that measures an analyte ((See Hoss abstract continuous analyte monitoring device), comprising: a probe that is to be inserted into a living body (See Hoss [0068], distal section used for position within the skin), wherein, in the probe, an electrode is formed on or above a sheet-shaped substrate (See Hoss [0074-0076] and Figure 3A and 3B, electrode 121C is on the substrate 102), a reference layer is formed (See Hoss [0076], layer 116), a film is disposed on or above the reference layer (See Hoss Figure 3B and [0079], film 112 and coverlay material 118 are on the working electrode or can be disposed on one or more electrodes, therefore the side surface would be exposed if the coverlay material is not implemented since Hoss says that the coverlay material is optional ([0077]: “a coverlay material 118 may be applied…”)), the substrate is formed by being cut into a probe shape (See Hoss Figure 1), and as the reference layer, a paste-form material ejected from a nozzle is applied to the electrode to cross over a cut line (See Hoss [0075], using a sputtering processes layers the electrodes with various materials. Hoss is silent with respect to the reference layer being formed on or above the electrode. Gottlieb teaches the reference layer that is formed on or above the electrode (See Gottlieb Figure 2A, [0075], the electrodes are coated with layers, 104 is the conductive layer which is equivalent to the reference layer and the base plate is a metal substrate which is equivalent to the electrode, the conductive layer is located above the base plate). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to form the reference layer of Hoss on or above the electrode, as taught by Gottlieb, to modulate the material properties of the electrodes (See Gottlieb [0075]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meghan R Kumar whose telephone number is (571)272-7125. The examiner can normally be reached Monday-Friday, 8a.m - 5p.m.
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/M.R.K./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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