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 .
Status of Claims
Applicant's arguments, filed 01/23/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 01/23/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claim 3.
Applicants have left claims 1-2 and 4-14 as originally filed/previously presented.
Claims 1-14 are the current claims hereby under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see page 4 of Remarks, filed 01/23/2026, with respect to the rejection of claim 3 have been fully considered and are persuasive. Applicants have amended the claim, rendering the rejection moot. The 112(b) rejection of claim 3 has been withdrawn.
Claim Rejections - 35 USC § 103 - Maintained
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Moein et al. (US 20180263537 A1) (previously cited), hereinafter referred to as Moein, in view of Say et al. (US 20100298681 A1) (previously cited), hereinafter referred to as Say.
The claims are generally directed towards a method for producing an analyte sensor, comprising: a) providing a first substrate having a first side and a second side, wherein the second side has a first layer comprising a first conductive material; b) providing a second substrate having a first side and a second side, wherein the first side has a second layer comprising a second conductive material and the second side has a third layer comprising a third conductive material; c) applying a conductive preparation onto at least one of the first side of the first substrate and the third layer or a portion thereof to form a conductive preparation layer, wherein the conductive preparation comprises a plurality of conductive particles and a polymeric binder; d) laminating the first side of the first substrate with the second side of the second substrate; and e) obtaining the analyte sensor.
Regarding claim 1, Moein discloses a method for producing an analyte sensor (Abstract, para. [0008], “methods of making and using the analyte monitoring systems …”), comprising:
a) providing a first substrate having a first side and a second side (Fig. 5, element 51, “base substrate”, para. [0094], - element 51 has at least a first side and a second side), wherein the second side has a first layer comprising a first conductive material (Fig. 5, element 52, “first conductive layer”, para. [0094], - element 52 is provided on the second side of element 51);
b) providing a second substrate having a first side and a second side (Fig. 5, element 55, “second insulative layer”, para. [0097-0098], - element 55 has at least a first side and a second side), wherein the first side has a second layer comprising a second conductive material (Fig. 5, element 56, “conductive layer”, para. [0096-0098], - element 56 is provided on a first side of element 55) and the second side has a third layer comprising a third conductive material (Fig. 5, element 53, “second conductive layer”, para. [0094-0098], - element 53 is provided on a second side of element 55);
d) laminating the first side of the first substrate with the second side of the second substrate (Fig. 5, para. [0094], para. [0182] - element 51 is adhered to element 55 to form the analyte sensor); and
e) obtaining the analyte sensor (Fig. 5, element 50, para. [0094], “double-sided analyte sensor”).
However, Moein does not explicitly disclose c) applying a conductive preparation onto at least one of the first side of the first substrate and the third layer or a portion thereof to form a conductive preparation layer, wherein the conductive preparation comprises a plurality of conductive particles and a polymeric binder.
Say teaches a sensor for an analyte monitoring device (Abstract, Fig. 2, para. [0071]). Say teaches the sensor comprises a first substrate (Fig. 3A, element 50, para. [0071]). Say further teaches applying a conductive preparation onto at least one of the first side of the first substrate and the third layer or a portion thereof to form a conductive preparation layer, wherein the conductive preparation comprises a plurality of conductive particles and a polymeric binder (para. [0090-0092], “conductive material is a part of a precursor material, such as a conductive ink … conductive ink … contains particles of the carbon, metal, alloy, or metallic compound … in addition to the particles … conductive ink may also contain a binder … polyurethane resins …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Moein to additionally include applying a conductive preparation onto at least one of the first side of the first substrate and the third layer or a portion thereof to form a conductive preparation layer, wherein the conductive preparation comprises a plurality of conductive particles and a polymeric binder. Say teaches a conductive preparation material comprising a plurality of conductive particles and a polymeric binder increases the conductivity of the sensor while also adhering better to the sensor, improving the sensor design and output (para. [0091-0092]).
Regarding claim 2, modified Moein discloses the method according to claim 1, wherein the conductive particles comprise carbon, Ag, AgCl or Ag/AgCl (Say, para. [0091], “particles of carbon, metal, alloy, or metallic compound …” - further, see the rejection of claim 1).
Regarding claim 3, modified Moein discloses the method according to claim 1, wherein the polymeric binder is selected from at least one of a thermoplastic polyurethane and an acrylate (Say, para. [0091], “binders include, for example, polyurethane resins …” - further, see the rejection of claim 1).
Regarding claim 4, modified Moein discloses the method according to claim 1.
However, modified Moein does not explicitly disclose wherein the conductive preparation is applied until the layer of the conductive preparation has a thickness of 5 μm to 20 μm.
Say further teaches the conductive preparation is applied until the layer of the conductive preparation has a thickness of 5 μm to 20 μm (para. [0088], “filling … with a conductive material … depths in the range of about 12.5 μm to 75 μm”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the conductive preparation layer taught by modified Moein to additionally have a thickness of 5 μm to 20 μm. Say teaches a thickness within the range of 5 μm to 20 μm is suitable for achieving the purpose of forming a conductive material (para. [0088]).
Regarding claim 5, modified Moein discloses the method according to claim 1, wherein a first electrode is formed on the first layer or the first layer is the first electrode (para. [0097], “conductive layer 52 is configured to include a counter electrode”).
Regarding claim 6, modified Moein discloses the method according to claim 5.
However, modified Moein does not explicitly disclose wherein the first electrode is a first working electrode.
As to location(s) of the working electrode(s), the counter electrode, and the combined counter/reference electrode, or the reference electrode, Say teaches in a layered sensor configuration the positioning of the layers of the working, reference, and counter electrodes can be modified (para. [0092]). The location(s) of working electrode(s), the counter electrode, and the combined counter/reference electrode, or the reference electrode will depend upon the desired resulting configuration and what material is additionally applied to the electrodes. As such, the location(s) of working electrode(s), the counter electrode, and the combined counter/reference electrode, or the reference electrode are results-effective variables that would have been optimized through routine experimentation based on the desired sensor design. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location(s) of the working electrode so as to be the first electrode.
Regarding claim 7, modified Moein discloses the method according to claim 1, wherein a second electrode is formed on the second layer or the second layer is the second electrode (para. [0096-0098], “conductive layer 56 is configured to include a reference electrode …”).
Regarding claim 8, modified Moein discloses the method according to claim 7.
However, modified Moein does not explicitly disclose wherein the second electrode is a second working electrode or a counter electrode.
As to location(s) of the working electrode(s), the counter electrode, and the combined counter/reference electrode, or the reference electrode, Say teaches in a layered sensor configuration the positioning of the layers of the working, reference, and counter electrodes can be modified (para. [0092]). The location(s) of working electrode(s), the counter electrode, and the combined counter/reference electrode, or the reference electrode will depend upon the desired resulting configuration and what material is additionally applied to the electrodes. As such, the location(s) of working electrode(s), the counter electrode, and the combined counter/reference electrode, or the reference electrode are results-effective variables that would have been optimized through routine experimentation based on the desired sensor design. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location(s) of the second working electrode or the counter electrode so as to be the second electrode.
Regarding claim 9, modified Moein discloses the method according to claim 1, wherein an interlayer is formed by the third layer and the conductive preparation layer (Fig. 5, element 53, “second conductive layer” - element 53, including the addition of the conductive preparation layer taught above forms an interlayer)-.
Regarding claim 10, modified Moein discloses the method according to claim 9, wherein the interlayer comprises a third electrode (para. [0094-0098], “conductive layer … configured to include a working electrode …”).
Regarding claim 11, modified Moein discloses the method according to claim 10.
However, modified Moein does not explicitly disclose wherein the third electrode is a combined counter/reference electrode or a reference electrode.
As to location(s) of the working electrode(s), the counter electrode, and the combined counter/reference electrode, or the reference electrode, Say teaches in a layered sensor configuration the positioning of the layers of the working, reference, and counter electrodes can be modified (para. [0092]). The location(s) of working electrode(s), the counter electrode, and the combined counter/reference electrode, or the reference electrode will depend upon the desired resulting configuration and what material is additionally applied to the electrodes. As such, the location(s) of working electrode(s), the counter electrode, and the combined counter/reference electrode, or the reference electrode are results-effective variables that would have been optimized through routine experimentation based on the desired sensor design. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location(s) of the combined counter/reference electrode or the reference electrode so as to be the third electrode.
Regarding claim 12, modified Moein discloses the method according to claim 1, wherein a laminated substrate is obtained by step d), wherein the laminated substrate is cut after step d) and prior to step e) (para. [0098], “during singulation … accomplished by cutting through two or more conductive layers …”, para. [0101], “positioned in an analyte sensor sheet containing a plurality of analyte sensors prior to singulation …”).
Regarding claim 13, modified Moein discloses the method according to claim 12, wherein the laminated substrate is cut by laser cutting or dye cutting (para. [0098], “singulation is accomplished by cutting …”, para. [0108], para. [0113]).
Regarding claim 14, modified Moein discloses an analyte sensor made by the method of claim 1 (Fig. 27, element 913, para. [0182]).
Response to Arguments
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 4-6 of Remarks, filed 01/23/2026, that “Applicant’s step d) requires laminating the first side of the first substrate with the second side of the second substrate … none of the prior art, alone or in combination, teaches these method steps”.
The Examiner respectfully disagrees. The instant specification recites in para. [0041], “laminating … relates to a process of joining at least two adjacent sides of at least two individual bodies in a planar fashion, whereby a permanently assembled object”. That is, “laminating” refers to joining two objects to be permanently assembled.
The following is provided to expand upon the previous rejection. As recited above, Moein teaches an assembled double-sided analyte sensor with multiple layers. Moein clearly teaches the multiple layers are joined into a permanently assembled analyte sensor as the entire structure is configured to be implanted (para. [0062]). In addition, Moein further discloses the construction of the double-side analyte sensor, including the multiple layers, are applied, bonded, and cured (para. [0101-0107]). That is, Moein clearly teaches the multiple layers are joined to form a permanently assembled object. Alternatively and/or additionally, US 2010/0230285, incorporated by reference in Moein (para. [0100]) additionally teaches adhering layers to form a permanently assembled object.
Applicants have argued on page 6 of Remarks, filed 01/23/2026, that “step d) of Applicant’s claim 1 requires laminating the first side of the first substrate with the second side of the second substrate. If this were done with the exposed enzyme layer of Say, or with the sensor layers disclosed in Moein, the enzyme would be sealed off and not able to reach with body fluid. This would render the resulting sensor inoperable …”.
The Examiner respectfully disagrees. First, the claim recites “applying a conductive preparation onto at least one of the first side of the first substrate and the third layer or a portion thereof …”. That is, only a portion of the first side of the first substrate or the third layer are required to have a conductive preparation. The enzyme layers would not be seal off. Further, in the recited rejection above, the modification is applying a conductive preparation in onto element 51 or 53, such that the conductive preparation layer is between elements 51 and 53 of Moein when completed as a uniform double-sided analyte sensor. As recited above, Moein clearly discloses the multiple layers are layered and adjoined to form a permanently assembled object.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791