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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24 February 2026 has been entered.
Response to Amendment
The amendment filed 24 February 2026 has been entered. Claim(s) 5, 46-48, and 51-75 are pending in the application. Applicant’s amendments to the claims have overcome each and every rejection under 35 U.S.C. 112(b) and 35 U.S.C. 103 previously set forth in the Office Action mailed 28 January 2025.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Instant Application
18068704
18068860
16774835
18068072
51
51. (New) A transcutaneous electrochemical analyte sensor for detecting glucose and ketones in vivo, the sensor comprising:
Claim 1, line 1-2
Claim 1, lines 1-2
Claim 28, lines 1-2
Claim 1, lines 1-2
Feldman reference
a substrate;
a first working electrode and a second working electrode
Claim 1, line 3
Claim 1, line 3
Claim 28, line 3
Claim 1, lines 3-4
Feldman reference
disposed on opposite faces of the substrate;
a ketones-responsive active area for detecting ketones, the ketones-responsive active area disposed directly upon a surface of the first working electrode, the ketones-responsive active area comprising a first polymer and a cofactor;
Claim 1, lines 4-6
Claim 1, lines 4-7
Claim 28, line 4-7
Claim 1, lines 5-8
a glucose-responsive active area for detecting glucose, the glucose-responsive active area disposed upon a surface of the second working electrode, the glucose-responsive active area comprising a second polymer;
Claim 1, lines 7-9
Claim 1, lines 8-10
Claim 28, lines 8-11
Claim 1, lines 9-11
and a mass transport limiting membrane overcoating at least the ketones-responsive active area and the glucose-responsive active area
Claim 1, lines 10-14
Claim 1, lines 11-16
Claim 28, lines 12-16 and claim 75, lines 1-2
Claim 1, lines 12-17
the mass transport limiting membrane comprising a first membrane portion
Claim 1, line 11
Claim 1, lines 11-13
Claim 28, lines 12-16 and claim 73, lines 1-3
Claim 1, lines 12-14
and a second membrane portion,
Claim 1, line 13
Claim 1, lines 14-16
Claim 28, lines 12-16 and claim 74, lines 1-3
Claim 1, lines 15-17
wherein the sensor is configured to be partially inserted into a user's skin such that the sensor is transcutaneously positioned beneath the user's skin to detect glucose and ketones present within the user's interstitial fluid.
Claim 1, lines 21-23
Claim 1, lines 21-23
Claim 28, lines 17-19
Claim 1, lines 22-24
5
5. (Currently Amended) The analyte sensor of claim 51, wherein the ketones- responsive active area further comprises albumin.
Claim 3, lines 1-2
Claim 6, line 1-2
46
46. (Currently Amended) A sensor control device for detecting glucose and ketones in vivo, the device comprising:
(i) a processor; and
(ii) the analyte sensor of claim 51, wherein the sensor generates a first signal indicative of ketone concentration in the interstitial fluid and a second signal indicative of glucose concentration in the interstitial fluid and communicates the first and second signals to the processor.
47
47. (Currently Amended) A system for detecting glucose and ketones in vivo, the system comprising:
(i) the analyte sensor of claim 51; and
(ii) a processor configured to (a) correlate a first signal to a ketone concentration in the interstitial fluid, (b) correlate a second signal to a glucose concentration in the interstitial fluid, and (c) communicate the glucose and ketone concentrations to a reader device to be displayed.
48
48. (Currently Amended) A method for detecting glucose and ketones in vivo, the method comprising:
exposing the analyte sensor of claim 51 to interstitial fluid;
applying a potential to the first and second working electrodes;
obtaining a first signal at or above an oxidation-reduction potential of the ketones-responsive active area, the first signal being proportional to a ketones concentration in the interstitial fluid;
obtaining a second signal at or above an oxidation-reduction potential of the glucose-responsive active area, the second signal being proportional to a glucose concentration in the interstitial fluid;
correlating the first signal to a ketone concentration in the interstitial fluid; and correlating the second signal to a glucose concentration in the interstitial fluid.
Claim 20, lines 1-11
52
52. (New) The analyte sensor of claim 51, wherein the first membrane portion is suitable for limiting diffusion of ketones to the ketones-responsive active area.
Claim 1, lines 11-12
Claim 73, lines 1-3
53
53. (New) The analyte sensor of claim 52, wherein the second membrane portion is suitable for limiting diffusion of glucose to the glucose-responsive active area.
Claim 1, line 13
Claim 74, lines 1-3
54
54. (New) The analyte sensor of claim 53, wherein the second membrane portion is disposed over the first membrane portion.
Claim 1, lines 13-14
Claim 74, lines 1-3
55.
55. (New) The analyte sensor of claim 54, wherein the first membrane portion and the second membrane portion have differing permeability to ketones.
Claim 76, lines 1-2
56
56. (New) The analyte sensor of claim 55, wherein the first and second membrane portions have different compositions.
Claim 77, lines 1-2
57
57. (New) The analyte sensor of claim 56, wherein the first membrane portion comprises polyvinylpyridine.
Claim 78, lines 1-2
58
58. (New) The sensor of claim 57, wherein the second membrane portion comprises polyvinylpyridine-co-styrene.
Claim 79, lines 1-2
Claims 51-54 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/068,704 in view of Feldman (US 20090294306 A1--previously cited). See table above.
The copending application fails to explicitly disclose a substrate, wherein the a first working electrode and a second working electrode are disposed on opposite faces of the substrate.
Feldman, in the same field of endeavor of an analyte sensor including a first and second working electrode, wherein the electrodes may be disposed on opposite faces of a substrate (Paragraph 0075--in certain embodiments one or more of the electrodes 501, 502, 503 may be disposed on opposing sides of the substrate 504).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of the copending application to utilize a substrate including a first and second working electrode on opposite sides of the substrate as disclosed by Feldman in order to predictably ensure that there is suitable spacing between the electrodes while minimizing the size of the substrate by not requiring that the spacing between electrodes be within the same plane (see Feldman, paragraph 0075--suitable spacing there between and/or include dielectric material or insulation material disposed between the conducting layers/electrodes).
This is a provisional nonstatutory double patenting rejection.
Claim 51 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/068,860 in view of Feldman (US 20090294306 A1--previously cited). See table above.
The copending application fails to explicitly disclose a substrate, wherein the a first working electrode and a second working electrode are disposed on opposite faces of the substrate.
Feldman, in the same field of endeavor of an analyte sensor including a first and second working electrode, wherein the electrodes may be disposed on opposite faces of a substrate (Paragraph 0075--in certain embodiments one or more of the electrodes 501, 502, 503 may be disposed on opposing sides of the substrate 504).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of the copending application to utilize a substrate including a first and second working electrode on opposite sides of the substrate as disclosed by Feldman in order to predictably ensure that there is suitable spacing between the electrodes while minimizing the size of the substrate by not requiring that the spacing between electrodes be within the same plane (see Feldman, paragraph 0075--suitable spacing there between and/or include dielectric material or insulation material disposed between the conducting layers/electrodes).
This is a provisional nonstatutory double patenting rejection.
Claims 51-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 79 of copending Application No. 16/774,835 in view of Feldman (US 20090294306 A1--previously cited). See table above.
The copending application fails to explicitly disclose a substrate, wherein the a first working electrode and a second working electrode are disposed on opposite faces of the substrate.
Feldman, in the same field of endeavor of an analyte sensor including a first and second working electrode, wherein the electrodes may be disposed on opposite faces of a substrate (Paragraph 0075--in certain embodiments one or more of the electrodes 501, 502, 503 may be disposed on opposing sides of the substrate 504).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of the copending application to utilize a substrate including a first and second working electrode on opposite sides of the substrate as disclosed by Feldman in order to predictably ensure that there is suitable spacing between the electrodes while minimizing the size of the substrate by not requiring that the spacing between electrodes be within the same plane (see Feldman, paragraph 0075--suitable spacing there between and/or include dielectric material or insulation material disposed between the conducting layers/electrodes).
This is a provisional nonstatutory double patenting rejection.
Claims 5 and 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 18/068,072 in view of Feldman (US 20090294306 A1--previously cited). See table above.
The copending application fails to explicitly disclose a substrate, wherein the a first working electrode and a second working electrode are disposed on opposite faces of the substrate.
Feldman, in the same field of endeavor of an analyte sensor including a first and second working electrode, wherein the electrodes may be disposed on opposite faces of a substrate (Paragraph 0075--in certain embodiments one or more of the electrodes 501, 502, 503 may be disposed on opposing sides of the substrate 504).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of the copending application to utilize a substrate including a first and second working electrode on opposite sides of the substrate as disclosed by Feldman in order to predictably ensure that there is suitable spacing between the electrodes while minimizing the size of the substrate by not requiring that the spacing between electrodes be within the same plane (see Feldman, paragraph 0075--suitable spacing there between and/or include dielectric material or insulation material disposed between the conducting layers/electrodes).
This is a provisional nonstatutory double patenting rejection.
Claims 48 and 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of copending Application No. 18/068,072 in view of Feldman (US 20090294306 A1--previously cited). See table above.
The copending application fails to explicitly disclose a substrate, wherein the a first working electrode and a second working electrode are disposed on opposite faces of the substrate.
Feldman, in the same field of endeavor of an analyte sensor including a first and second working electrode, wherein the electrodes may be disposed on opposite faces of a substrate (Paragraph 0075--in certain embodiments one or more of the electrodes 501, 502, 503 may be disposed on opposing sides of the substrate 504).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of the copending application to utilize a substrate including a first and second working electrode on opposite sides of the substrate as disclosed by Feldman in order to predictably ensure that there is suitable spacing between the electrodes while minimizing the size of the substrate by not requiring that the spacing between electrodes be within the same plane (see Feldman, paragraph 0075--suitable spacing there between and/or include dielectric material or insulation material disposed between the conducting layers/electrodes).
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 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 prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, “a ketones-responsive active area for detecting ketones, the ketones-responsive active area disposed directly upon a surface of the first working electrode, the ketones-responsive active area comprising a first polymer and a cofactor” of claim 51.
The most pertinent prior art of the record, McColl (WO 2011030093—previously cited) fails to teach the above limitation, wherein the ketones-responsive active area has been clarified to be disposed directly upon the surface of the first working electrode, as argued by the applicant in page 12 of the remarks dated 06 August 2025 as an interpretation of McColl which includes the cofactor in the ketones-responsive active area would not be disposed directly upon the surface of the first working electrode, nor does McColl adequately suggest making this modification.
Response to Arguments
Applicant’s arguments, see applicant's remarks, filed 24 February 2026, with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered and are persuasive. The rejection of the claims under 35 U.S.C. 103 has been withdrawn.
However, the claims remain rejected for double patenting over the co-pending applications 16/774,835, 18/086,060, 18/068,072, and 18/068,704 which have the same patent term date; the double patenting rejections have been updated above to reflect the new limitations of the claims.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791