DETAILED ACTION
Status of the Claims
1. Claims 1-5, 8, 10-15 and 19-26 are pending.
Status of Claim Objections
2. Objection to claim 14 is being withdrawn in view of applicant’s amendment.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/06/2026 has been entered.
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, 8, 10-11, 20, 22-24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoss et al. (US 2017/0363564) in view of Hoss et al. (US 2017/0188908, hereinafter ‘908) and Abdolahad et al. (US 2022/0039737).
Claim 1. Hoss et al. teach an analyte sensor (electrochemical analyte sensor; abstract) comprising:
a substrate having an upper surface (non-conductive material; [0042];
an electrode layer disposed on the upper surface and having an elongate body comprising a proximal end and a distal end, the electrode layer including an active working electrode area having a surface area of between 0.15mm2 to 0.25mm2 (working electrode of conductive material disposed on non-conductive material and has length and width of different size range, thus reads on elongate body having proximal and distal end (see Fig 1 and [0042]), the working electrode having area in the range of 0.01 mm2 to 25.0 mm2; [0023];
at least one sensing spot disposed on the active working electrode area, wherein the at least one sensing spot includes at least one analyte responsive enzyme (sensing structures disposed on the working electrode and the sensing structures includes analyte responsive enzyme, [0030][0024][0047]).
Hoss et al. do not explicitly teach the active working electrode area is configured to reduce signals indicative of interferent species.
However, ‘098 teach a continuous analyte monitoring sensor comprised of working electrode disposed on a substrate wherein the working electrode is defined by a procedure such as laser ablation for modifying edges, e.g., removing excess material or otherwise shaping material [0075][0017] (Examiner notes applicant disclosure teach to reduce or remove interferent signals by planning of one or more edges of the carbon working electrode to remove carbon asperities, [0052]). 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 ‘098 teaching to modify edge of the working electrode to remove excess material to produce precise active of working electrode that would prevent CGM based calibration of the sensor.
Hoss et al. teach the sensor is configured to be inserted in vivo for continuous monitoring of analyte comprised of electrodes located at the insertion tip that is inserted into subcutaneous tissue [003][0091] but combined teachings of Hoss et al. and ‘098 do not explicitly teach at least a portion of the electrode layer has a beveled edge. However, Abdolahad et al. teach electrochemical sensor comprised of three electrodes having a bevel-shaped tip configured to facilitate a non-invasive insertion into the lymph nodes (LN) and surrounding tissues without causing rupture [0022][0060].
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 Abdolahad et al. teaching to shape the electrodes of Hoss et al. to have beveled edge because it would allow easy insertion of the electrodes for continuous monitoring without rupturing the surrounding tissue.
Limitation reciting “at least the electrode layer is laser planed…, wherein the laser planning comprises at least one initial cut made at an outermost location of a single carbon asperity and at least one cut made between the initial cut and a midline length of the electrode” is considered product-by-process limitation. The patentability of a product or apparatus does not depend on its method of production or formation (i.e. laser planning or laser cuts made to form beveled edge). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. (see MPEP § 2113).
Claim 2. Hoss et al. teach the active working electrode area has a surface area of 0.23mm2 (the working electrode has area in the range from 0.01 mm2 to 25 mm2 [0023], since the claimed surface area falls within the disclosed range then a prima facie case of obviousness exists (see MPEP 2144.05 I).
Claims 3 and 4. Hoss et al. teach the at least one sensing spot comprises a plurality of sensing spots (plurality of features such as 5 or more disposed along a longitudinal axis of the non-conductive layer; [00475 Fig 9).
Claim 5. Hoss et al. teach the sensing spots have a pitch ranging between approximately 200 µm and 250 µm (sensing structures are arranged at distance of 200 µm or more or 250 µm or more; [0046]).
Claim 10. Hoss et al. teach area of sensing feature is in the range of 0.1 to 0.5 mm2 [0027] and electrode area is in the range of 0.1 to 20 mm2 [0023]. Hoss et al. does not explicitly teach claimed ratio of 13:87, however one of ordinary skill in the art would have easily arrive at the claimed ratio based on the disclosed range.
Claim 11. Hoss et al. teach the at least one analyte responsive enzyme is responsive to an analyte including at least one of a glucose, ketone, or lactate (analyte is glucose; [0054].
Claim 20. Hoss et al. teach a method of using an analyte sensor (using an electrochemical analyte sensor; abstract) comprising:
providing an analyte sensor having a substrate having an upper surface (non-conductive material; [0042];
an electrode layer disposed on the upper surface and having an elongate body comprising a proximal end and a distal end, the electrode layer including an active working electrode area having a surface area of between 0.15mm2 to 0.25mm2 (working electrode of conductive material disposed on non-conductive material and has length and width of different size range, thus reads on elongate body having proximal and distal end (see Fig 1 and [0042]), the working electrode having area in the range of 0.01 mm2 to 25.0 mm2; [0023];
at least one sensing spot disposed on the active working electrode area, wherein the at least one sensing spot includes at least one analyte responsive enzyme (sensing structures disposed on the working electrode and the sensing structures includes analyte responsive enzyme, [0030][0024][0047]);
sensing glucose responsive to the analyte responsive enzyme with the at least one sensing spot [0047][0054].
Hoss et al. do not explicitly teach the active working electrode area is configured to reduce signals indicative of interferent species.
However, ‘098 teach a continuous analyte monitoring sensor comprised of working electrode disposed on a substrate wherein the working electrode is defined by a procedure such as laser ablation for modifying edges, e.g., removing excess material or otherwise shaping material [0075][0017] (Examiner notes applicant disclosure teach to reduce or remove interferent signals by planning of one or more edges of the carbon working electrode to remove carbon asperities, [0052]). 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 ‘098 teaching to modify edge of the working electrode to remove excess material to produce precise active of working electrode that would prevent CGM based calibration of the sensor.
Hoss et al. teach the sensor is configured to be inserted in vivo for continuous monitoring of analyte comprised of electrodes located at the insertion tip that is inserted into subcutaneous tissue [003][0091] but combined teachings of Hoss et al. and ‘098 do not explicitly teach at least a portion of the electrode layer has a beveled edge. However, Abdolahad et al. teach electrochemical sensor comprised of three electrodes having a bevel-shaped tip configured to facilitate a non-invasive insertion into the lymph nodes (LN) and surrounding tissues without causing rupture [0022][0060].
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 Abdolahad et al. teaching to shape the electrodes of Hoss et al. to have beveled edge because it would allow easy insertion of the electrodes for continuous monitoring without rupturing the surrounding tissue.
Limitation reciting “at least the electrode layer is laser planed…, wherein the laser planning comprises at least one initial cut made at an outermost location of a single carbon asperity and at least one cut made between the initial cut and a midline length of the electrode” is considered product-by-process limitation. The patentability of a product or apparatus does not depend on its method of production or formation (i.e. laser planning or laser cuts made to form beveled edge). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. (see MPEP § 2113).
Claim 22. Hoss et al. teach an analyte sensor (electrochemical analyte sensor; abstract) comprising:
a substrate having an upper surface (non-conductive material; [0042];
an electrode layer disposed on the upper surface and having an elongate body comprising a proximal end and a distal end, the electrode layer including an active working electrode area having a surface area of between 0.15mm2 to 0.25mm2 (working electrode of conductive material disposed on non-conductive material and has length and width of different size range, thus reads on elongate body having proximal and distal end (see Fig 1 and [0042]), the working electrode having area in the range of 0.01 mm2 to 25.0 mm2; [0023];
at least one sensing spot disposed on the active working electrode area, wherein the at least one sensing spot includes at least one analyte responsive enzyme (sensing structures disposed on the working electrode and the sensing structures includes analyte responsive enzyme, [0030][0024][0047]).
Hoss et al. do not explicitly teach the active working electrode area is configured to reduce signals indicative of interferent species.
However, ‘098 teach a continuous analyte monitoring sensor comprised of working electrode disposed on a substrate wherein the working electrode is defined by a procedure such as laser ablation for modifying edges, e.g., removing excess material or otherwise shaping material [0075][0017] (Examiner notes applicant disclosure teach to reduce or remove interferent signals by planning of one or more edges of the carbon working electrode to remove carbon asperities, [0052]). 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 ‘098 teaching to modify edge of the working electrode to remove excess material to produce precise active of working electrode that would prevent CGM based calibration of the sensor.
Hoss et al. teach the sensor is configured to be inserted in vivo for continuous monitoring of analyte comprised of electrodes located at the insertion tip that is inserted into subcutaneous tissue [003][0091] but combined teachings of Hoss et al. and ‘098 do not explicitly teach at least a portion of the electrode layer has a beveled edge. However, Abdolahad et al. teach electrochemical sensor comprised of three electrodes having a bevel-shaped tip configured to facilitate a non-invasive insertion into the lymph nodes (LN) and surrounding tissues without causing rupture [0022][0060].
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 Abdolahad et al. teaching to shape the electrodes of Hoss et al. to have beveled edge because it would allow easy insertion of the electrodes for continuous monitoring without rupturing the surrounding tissue.
Limitation reciting “at least the electrode layer is laser planed…, wherein the laser planning comprises making a plurality of single-planing cuts, wherein the plurality of single-pass planning cuts are spaced apart by distance in a range of 1 microns to 100 microns” is considered product-by-process limitation. The patentability of a product or apparatus does not depend on its method of production or formation (i.e. laser planning or laser cuts made to form beveled edge). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. (see MPEP § 2113).
Claim 23. Hoss et al. teach a method of using an analyte sensor (using an electrochemical analyte sensor; abstract) comprising:
providing an analyte sensor having a substrate having an upper surface (non-conductive material; [0042];
an electrode layer disposed on the upper surface and having an elongate body comprising a proximal end and a distal end, the electrode layer including an active working electrode area having a surface area of between 0.15mm2 to 0.25mm2 (working electrode of conductive material disposed on non-conductive material and has length and width of different size range, thus reads on elongate body having proximal and distal end (see Fig 1 and [0042]), the working electrode having area in the range of 0.01 mm2 to 25.0 mm2; [0023];
at least one sensing spot disposed on the active working electrode area, wherein the at least one sensing spot includes at least one analyte responsive enzyme (sensing structures disposed on the working electrode and the sensing structures includes analyte responsive enzyme, [0030][0024][0047]);
sensing glucose responsive to the analyte responsive enzyme with the at least one sensing spot [0047][0054].
Hoss et al. do not explicitly teach the active working electrode area is configured to reduce signals indicative of interferent species.
However, ‘098 teach a continuous analyte monitoring sensor comprised of working electrode disposed on a substrate wherein the working electrode is defined by a procedure such as laser ablation for modifying edges, e.g., removing excess material or otherwise shaping material [0075][0017] (Examiner notes applicant disclosure teach to reduce or remove interferent signals by planning of one or more edges of the carbon working electrode to remove carbon asperities, [0052]). 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 ‘098 teaching to modify edge of the working electrode to remove excess material to produce precise active of working electrode that would prevent CGM based calibration of the sensor.
Hoss et al. teach the sensor is configured to be inserted in vivo for continuous monitoring of analyte comprised of electrodes located at the insertion tip that is inserted into subcutaneous tissue [003][0091] but combined teachings of Hoss et al. and ‘098 do not explicitly teach at least a portion of the electrode layer has a beveled edge. However, Abdolahad et al. teach electrochemical sensor comprised of three electrodes having a bevel-shaped tip configured to facilitate a non-invasive insertion into the lymph nodes (LN) and surrounding tissues without causing rupture [0022][0060].
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 Abdolahad et al. teaching to shape the electrodes of Hoss et al. to have beveled edge because it would allow easy insertion of the electrodes for continuous monitoring without rupturing the surrounding tissue.
Limitation reciting “at least the electrode layer is laser planed…, wherein the laser planning comprises making a plurality of single-planing cuts, wherein the plurality of single-pass planning cuts are spaced apart by distance in a range of 1 microns to 100 microns” is considered product-by-process limitation. The patentability of a product or apparatus does not depend on its method of production or formation (i.e. laser planning or laser cuts made to form beveled edge). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. (see MPEP § 2113).
Claims 24 and 26. Hoss et al. teach the analyte responsive enzyme is lactate [0075].
Allowable Subject Matter
Claims 12-15, 19, 21 and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the cited prior art, Hoss et al. teach working electrode of conductive material disposed on a non-conductive material and the working electrode having area in the range of 0.01 mm2 to 25.0 mm2; [0023] but does not teach steps of making plurality of single-pass planing cuts by a distance in a range of 1 to 100 microns and planing comprises at least initial cut made at an outermost location and at least one cut made between the initial cut and midline length of the electrode as recited in claim 12.
Response to Arguments
Applicant's arguments filed 4/06/2026 have been fully considered but they are not persuasive.
Applicant argues on page 9 of remarks that cited reference Abdolahad teaching of a bevel-shaped tip at the distal end of the needle electrode is not at beveled edge of the electrode layer as recited in claim 1.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In making the rejection, combination of references was used (Hoss et al. in view of Abdolahad et al.). Abdolahad et al. teaching of bevel-shaped tip (one of the edges of the needle electrode) configured to facilitate a non-invasive insertion into the lymph nodes (LN) and surrounding tissues without causing rupture [0022][0060] was used to modify shape of Hoss et al. electrode (electrode layer disposed on substrate; [0042]) to have beveled edge (front edge) to promote easy insertion of the electrode for continuous monitoring without rupturing the surrounding tissue and thus modification of Hoss et al. electrode layer in view of Abdolahad et al. would yield electrode layer with beveled edge/tip.
Applicant argues on page 10 of remarks that Abdolahad is silent with respect to any cuts made into the electrode layer including portion of the electrode layer is laser planed to form a beveled edge. In response, limitation reciting “at least the electrode layer is laser planed…, wherein the laser planning comprises at least one initial cut made at an outermost location of a single carbon asperity and at least one cut made between the initial cut and a midline length of the electrode” is considered product-by-process limitation. The patentability of a product or apparatus does not depend on its method of production or formation (i.e. laser planning or laser cuts made to form beveled edge). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. (see MPEP § 2113).
Conclusion
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759