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 .
Response to Amendment
The amendment filed 10/22/2025 has been entered. Amendments to claims 1, 12, 13, 19, 21, 24, 26, 28, and 29, cancellation of claims 2-5, 9-10, 16, and 20, and new claims 128-135 are acknowledged, Claims 1, 12, 13, 18-19, 21, 23-26, 28-29, and 128-135 remain pending in the application.
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.
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.
Claim(s) 1, 12, 13, 18, 19, 21, 23-26, 28, 29, 128, 129 , 132, and 13 -135 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adler (US 20250064359 A1) in view of Simpson et al. (US 20220322977 A1).
Regarding claim 1, Adler discloses a continuous analyte sensor (title) comprising: a substrate (Fig 3 element 311) having a first side and a second side opposite the first side (Fig 3 element 311 left and right sides respectively), wherein the substrate is planar (Fig 3 element 311, [0206]: “where the non-conductive substrate may be in a wafer (planar) form”), and wherein the substrate has a distal tip (Fig 3 element 311 distal edge at top of substrate); a first working electrode positioned on the first side of the substrate (Fig 3 element 313W-1), wherein the first working electrode is configured for sensing a first analyte ([0226]: “designed for analyte specificity directed to the target analyte, e.g., glucose, oxygen, a ketone, or other.”), and wherein the first working electrode has a length extending in a proximal-distal direction and a width extending in a lateral direction perpendicular to the proximal-distal direction (Fig 3 element 313W-1); a first reference electrode positioned on the first side of the substrate and co-planar with the first working electrode (Fig 3 element 313R-1), wherein the first reference electrode has a length extending in the proximal- distal direction and a width extending in the lateral direction (Fig 3 element 313R-1), wherein the width of the first reference electrode is greater than the width of the first working electrode ([0207]: “the reference electrode has a greater width than the working electrode”); and wherein the first reference electrode is positioned farther away from the distal tip of the substrate than the first working electrode (Fig 3, wherein element 313R-1 is further away from the distal edge than 313W-1); a second working electrode positioned on the second side of the substrate (Fig 3 element 313W-2), wherein the second working electrode is configured for sensing a second analyte different from the first analyte ([0223-0224]: “the working electrode 213W of the second electrochemical sensor electrode contingent 214 may be modified with a different chemical layer 119 than the chemical layer 119 on the working electrode 213W of the electrochemical sensor electrode contingent 212 to sense a different target analyte when the sensor 210C is deployed and operated in vivo…. the working electrodes 313W and the reference electrodes 313R can include the materials as described for… electrodes 213W and 213R”); a second reference electrode positioned on the second side of the substrate and co-planar with the second working electrode (Fig 3 element 313R-2), wherein the second reference electrode is positioned farther away from the distal tip of the substrate than the second working electrode (Fig 3 element 313R-2), and wherein the first working electrode, the second working electrode, the first reference electrode, and the second reference electrode are each planar electrodes (Fig 3, wherein the electrodes are planar on the planar substrate); and an interconnect extending through the substrate between the first side and the second side of the substrate, the interconnect in electrical communication with at least the first reference electrode ([0279]: “comprising electrical interconnection wires and electrical interfacing contact sites disposed on the substrate, wherein the electrical interconnection wires are coupled between the electrochemical sensor electrode contingent and the electrical interfacing contact sites”).
Adler fails to disclose wherein the length of the first reference electrode is greater than the length of the first working electrode.
Simpson discloses wherein the length of the first reference electrode is greater than the length of the first working electrode (Fig 7M E1 as compared to the length of R1).
As Adler discloses that the relative sizes of the working and reference electrodes are variable, ([0215]: “the working electrode(s) and reference electrode(s) can be configured to have an area shown in Table 1. It is noted that the size, shape, and surface area configurations of the electrodes are not limited to those shown in Table 1.” [0216] and Table 1, wherein the size of the working electrode to reference electrode is variable), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the size of the working and reference electrode to have length of the first reference electrode be greater than the length of the first working electrode in order to optimize electrode configurations for different purposes (Simpson [0291]: “the electrodes can be of various sizes, depending upon their purpose”).
Regarding claim 12, Adler further discloses a third working electrode (Fig 3 element 318), wherein the third working electrode is co-planar with at least one of the first working electrode or the second working electrode (Fig 3, wherein the electrodes are on the same planar substrate).
Regarding claim 13, Adler further discloses wherein the first working electrode and the third working electrode are on the first side of the substrate (Fig 3 wherein 313 and 318 are on the same side).
Regarding claim 14, Adler further discloses a first counter electrode, wherein the first counter electrode is a planar electrode. ([0232]: “the electrodes of the electrical conductivity sensor 316 can additionally or alternatively be used as additional electrochemical sensor electrodes for the electrochemical sensor electrode contingent 313, e.g., such as a counter electrode or as additional working or reference electrodes”, Fig 3 element 316A wherein the elements are planar).
Regarding claim 19, Adler further discloses wherein the first counter electrode is co-planar with at least one of the first working electrode or the second working electrode, or the reference electrode (Fig 3).
Regarding claim 21, Adler further discloses, wherein the counter electrode is spaced distally from the first reference electrode on the substrate (Fig 3 elements 313R-1 and 316A).
Regarding claim 23, Adler further discloses a second counter electrode (Fig 3 element 316B), the first counter electrode and the second counter electrode each being planar electrodes (Fig 3).
Regarding claim 24, Adler further discloses wherein the first working electrode, the second working electrode, the first reference electrode, and the second reference electrode are centrally aligned longitudinally along the substrate (Fig 3).
Regarding claim 25, Adler further discloses at least one analyte-sensing membrane extending over one or more of the first working electrode and the second working electrode ([0226]: “the working electrode 313W includes a membrane”).
Regarding claim 26, Adler further discloses the at least one analyte-sensing membrane comprises an enzymatic layer configured to sense glucose or lactate ([0226]: “designed for analyte specificity directed to the target analyte, e.g., glucose, oxygen, a ketone, or other.”).
Regarding claim 28, Adler further discloses wherein the at least one analyte-sensing membrane is configured to sense more than one analyte. ([0226] “, among other things, can confirm that the sensor is detecting fluid containing oxygen and/or glucose or ketones”).
Regarding claim 29, Adler further discloses wherein each of the first working electrode, the second working electrode, and the first reference electrode has a border on the substrate (Fig 3, wherein the electrodes have edges) .
Regarding claim 128, Adler discloses least one analyte- sensing membrane extending over both of the first working electrode and the second working electrode (Fig 4 element 419, [0226]: “the working electrode 313W includes a membrane (e.g., such as membrane 419, discussed later in FIG. 4”).
Regarding claim 129, Adler discloses the continuous analyte sensor of claim 128, and further discloses and a common membrane layer disposed over both the first working electrode and the second working electrode ([0226]: “a membrane (e.g., such as membrane 419, discussed later in FIG. 4”, Fig 4 element 419 covering the electrodes 413 W-1 and 413 W-2). However, Adler fails to disclose a first membrane layer disposed over the first working electrode to allow for detection of the first analyte; a second membrane layer disposed over the second working electrode to allow for detection of the second analyte.
Simpson discloses a first membrane layer disposed over a first working electrode to allow for detection of the first analyte ([0083]: “the first working electrode comprises a first electroactive surface and a first membrane portion disposed thereon, the first membrane portion comprising an active enzymatic enzyme domain and the first resistance domain”); a second membrane layer disposed over the second working electrode to allow for detection of the second analyte ([0083]: “the second working electrode comprises a second electroactive surface and a second membrane portion disposed thereon, the second membrane portion comprising at least one of an inactive enzymatic portion or a non-enzymatic portion and the second resistance domain”);
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the sensor disclosed by Adler include the first and second membrane disclosed by Simpson in order to improve sensor sensitivity (Simpson [0401]).
Regarding claim 132, Simpson discloses wherein the at least one analyte-sensing membrane comprises a first enzymatic layer configured to sense glucose ([0289]: “active enzyme is applied to the electroactive surface of at least one working electrode (e.g., E1). In some embodiments, no enzyme (or inactivated enzyme) is applied to the electroactive surface of a second working electrode (e.g., E2).”); and a second enzymatic layer configured to sense ketones ([0289]: “second enzyme is applied to the second working electrode (e.g., E2) such that the sensor can measure the signals of two different analytes (e.g., glucose and aureate or oxygen)”, [0143]: “other analytes are contemplated as well, including but not limited to… succinylacetone”).
Regarding claim 133, Simpson discloses wherein the at least one analyte-sensing membrane comprises a first enzymatic layer configured to sense glucose ([0289]: “active enzyme is applied to the electroactive surface of at least one working electrode (e.g., E1). In some embodiments, no enzyme (or inactivated enzyme) is applied to the electroactive surface of a second working electrode (e.g., E2).”); and a second enzymatic layer configured to sense lactate ([0289]: “second enzyme is applied to the second working electrode (e.g., E2) such that the sensor can measure the signals of two different analytes (e.g., glucose and aureate or oxygen)”, [0143]: “other analytes are contemplated as well, including but not limited to… lactate”).
Regarding claim 134, Adler discloses at least two contact pads, wherein each of the at least two contact pads is in electrical communication with one of the first working electrode, the second working electrode, the first reference electrode, or the second reference electrode, and wherein the at least two contact pads are longitudinally aligned with the first working electrode and the first reference electrode.
Regarding claim 135, Adler discloses wherein the second working electrode is has the same dimensions as the first working electrode (Fig 3 elements 313W-1 and 313W-2).
Claim(s) 130 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adler in view of Simpson in further in view of Wang et al (US 20250295337 A1).
Adler as modified by Simpson fails to disclose wherein at least a portion of the at least one analyte-sensing membrane is formed using a slot-die coating process.
Wang discloses at least a portion of the at least one analyte-sensing membrane is formed using a slot-die coating process ([00130]: “Suitable techniques for depositing a mass transport limiting membrane upon the active area(s) may include… slot die coating”).
As Adler does not specify how the membrane is formed, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the membrane disclosed by Adler to be formed using a slot-die coating process as disclosed by Wang in order to clarify the construction process of the membrane.
Claim(s) 131 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adler in view of Simpson in further view of Koelker et al. (US 20140251826 A1), hereinafter Koelker.
Adler as modified by Simpson fails to disclose wherein at least a portion of the at least one analyte-sensing membrane is formed using jet valve dispensing.
Koelker discloses at least a portion of the at least one analyte-sensing membrane is formed using a slot-die coating process ([0121]: “the first electrode material can be applied as a liquid phase and/or as another form of a deformable material, such as a paste… ink-jet printing through an opening (e.g., a nozzle or valve)”).
As Adler does not specify how the membrane is formed, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the membrane disclosed by Adler to be formed using a jet valve dispensing process as disclosed by Koelker in order to clarify the construction process of the membrane.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/22/2025, with respect to the rejection(s) of claim(s) 1-5, 9-10, 18-21, 23-26, and 28-29 under USC § 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of USC § 102 (see rejection above).
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.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791