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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/16/2026 has been entered.
Status of Claims
Applicant's arguments, filed 06/16/2026, 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 left claims 1-14 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 § 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. [0062], para. [0094], para. [0100-0107], para. [0182] - element 51 is adhered to element 55 to form a permanently assembled object through the use of bonding and curing that is at least partially inserted in vivo); 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 an analogous 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, as taught by Say. This is because 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, as taught by Say. This is because 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 06/16/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 6-7 of Remarks, filed 06/16/2026, that “The Office relies on insulative layer 55 of Moein as the claimed second substrate. But Moein directly and explicitly contradicts the Office’s interpretation … Moein distinguishes insulative layer 55 … with what Moein actually regards as a substrate … There is an order of magnitude difference in thickness between Moein’s substrate and Moein’s insulative layers …”, “Moein discloses that the sensor of Fig. 5 has only one (1) substrate and three (3) insulative layers. One of ordinary skill in the art would understand that ‘insulative layers’ are not ‘substrates’ …”, and “substrates such as substrate 51 in Moein and the substrates taught by Applicant are specifically made to be cut …”.
The Examiner respectfully disagrees. First, Applicants arguments regarding the differences between the claimed second substrate and Moein’s insulative substrate layer and Moein’s insulative layers are not commensurate in scope. The claims do not limit the dimensions of “a second substrate”.
Second, the instant specification recites in para. [0032-0033], “’substrate’ refers to an arbitrary element having a substrate body which is designed to carry one or more other elements disposed thereon or therein … preferably, the substrate may have … a thickness of 10 µm to 100 μm … substrate may comprise at least partially, preferably completely, at least one electrically insulating material”. The broadest reasonably interpretation of “first substrate” and “second substrate”, in light of the specification, includes Moein’s “insulative layers” and “insulative substrate layers” as reiterated in the rejection above. In light of the specification, one of ordinary skill in the art would recognize “insulative layers”, “insulative substrate layers”, “first substrate”, and “second substrate” to be the same.
Third, in regards to Applicant’s arguments regarding “insulative layers”, “insulative substrate layers”, “first substrate”, and “second substrate”, "The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990)” (see MPEP 2131).
Fourth, Applicant’s arguments regarding the cutting process are not commensurate in scope with the claimed invention. The claims do not recite a specific order of layering different claim elements and do not recite specifics regarding singulation.
Applicant’s have argued on pages 7-8 of Remarks, filed 06/16/2026, that “in addition to there being no teaching in the prior art relied upon of Applicant’s step 1(d), the skilled artisan would not have attempted to produce the sensor depicted in Moein using lamination as recited in step 1(d) … Moein explicitly teaches that insulative layer 55 is not a substrate …”.
The Examiner respectfully disagrees. First, as recited above, Applicant’s arguments regarding the differences in “insulative layer 55” and “substrate” are not considered persuasive.
Second, Applicant’s arguments regarding Moein not teaching step 1(d) and the insulative layer not reliably withstanding the lamination process are not considered persuasive. 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, which may also be denoted as a ‘sandwich’, is generated as a result of this process … at least one of an adhesive, a pressure, or thermal energy may, especially, be applied … ‘adhesive’ or ‘glue’, may, specifically, be used …”. As reiterated in the rejection above, Moein discloses the first side of the first substrate with the second side of the second substrate are laminated, or permanently assembled, through the use of adhesives, pressure, or thermal energy.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights