DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
The previous restriction requirement on 1/16/2016 is withdrawn in view of the current amendment filed on February 13, 2026. Therefore, claims 2-21 are considered on the merits. See below for more detail.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed applications (17/163083 filed on 1/29/21; 14/567293 filed on 12/11/14; 13/747746 filed on 1/23/13; and 61/666618 filed on 6/29/12) are acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27 February 2024, 23 August 2024, and 20 October 2025 have been considered by the examiner.
Claim Rejections - 35 USC § 102B
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2-21 are rejected under pre-AIA 35 U.S.C. 102(B) as being anticipated by Hayter et al. (US PG Pub. No. 2013/0158376 A1) (hereinafter “Hayter”).
With respect to claims 2 and 13, Hayter teaches a system/method for measurement of an analyte in a host (abstract “Methods, devices and systems…providing accurate glucose levels”), comprising: a sensor configured to be inserted under a skin of the host (par.0275 “sensor 400 may include… a second portion positioned below the surface of the skin”), the sensor comprising: at least one electrode configured to generate a signal representative of a concentration of glucose in the host (par.0175 “glucose sensor having a glucose sensing area 1401 including three electrodes”); and at least one membrane located over at least a portion of the at least one electrode (par.0161 “electrodes may be covered by a thin layer of membrane to restrict the glucose flux as well as to protect the electrode components”), wherein the at least one membrane is configured to be in contact with a biological fluid when inserted under the skin of the host (Fig. 4), wherein the at least one membrane comprises an enzyme that reacts with glucose (par.0161 “thin layer of membrane to restrict the glucose flux”; see also par.0222 “sensor having different enzymes”; par.0223 “diffusion controlling membrane”), wherein reaction kinetics of the enzyme is affected by temperature changes (abstract “temperatures that may adversely affect glucose value”; see also par.0048, 0055); a temperature sensor configured to measure a temperature value (par.0059 “temperature sensor disposed near the in vivo analyte sensor to estimate the sensor temperature”); and a processor configured to receive the signal from the sensor (processor 204 receives anal signal from electrodes 210-213, as depicted in Fig. 2), the processor configured to: determine an in vivo temperature value based on the measured temperature value and a previous temperature value measured by the temperature sensor (par.0328 “rate-of-change of the temperature measurement exceeds the threshold requirement” equates to multiple temperature measurements that are not simultaneous, thereby taking into consideration a previous temperature value; see also par.0331 “monitoring changes during a period of time”; see also Fig. 9, which depicts comparison of multiple temperature values from first/second temperature sensors, which further teaches previous temperature measurements when taking into consideration broadest reasonable interpretation of “previous”); determine a sensitivity of the sensor to glucose based on the in vivo temperature value (“Determine Temperature-Compensated Sensor Signal 1035”, which occurs after, i.e. is based on, signals obtained from temperature sensors 1010, as depicted in Fig. 2); and determine a glucose concentration value based at least in part on the sensitivity (“Determine Analyte Level 1040”, which occurs after, i.e. is based on, the sensitivity step 1035, as depicted in Fig. 2).
With respect to claim 3, Hayter teaches wherein the at least one electrode comprises a first electrode and a second electrode (par.0175).
With respect to claim 4, Hayter teaches wherein the first electrode is a working electrode and the second electrode is a reference electrode (par.0175).
With respect to claim 5, Hayter teachers further comprising a third electrode, wherein the first electrode and the second electrode are each working electrodes and the third electrode is a reference electrode (par.0175).
With respect to claim 6, Hayter teaches further comprising a connector configured to connect the first electrode and the second electrode, wherein the connector comprises a thermistor (par.0100, 0163-164).
With respect to claim 7, Hayter teaches wherein the connector comprises a thermistor (par.0100, 0163-164).
With respect to claim 8, Hayter teaches wherein the connector comprises a diode (par.0214).
With respect to claim 9, Hayter teaches wherein the connector comprises a capacitor (par.0270, 0289).
With respect to claim 10, Hayter teaches further comprising sensor electronics configured to apply at least one potential to the at least one electrode (par.0171).
With respect to claim 11, Hayter teaches wherein the at least one potential includes a first potential that is applied to a first electrode of the at least one electrodes and a second potential that is applied to a second electrode of the at least one electrodes (par.0171).
With respect to claim 12, Hayter teaches wherein the first potential is different from the second potential (par.0171).
With respect to claim 14, Hayter teaches wherein the at least one processor is a processor as part of sensor electronics that are adhered to the skin of the host (par.0163).
With respect to claim 15, Hayter teaches wherein the at least one processor is a processor located in a reader device in wireless communication with the sensor (par.0265).
With respect to claim 16, Hayter teaches wherein the at least one processor is a first processor as part of sensor electronics configured to be adhered to the skin of the host and a second processor located in a reader device that is not adhered to the skin of the host (par.0163, 0265).
With respect to claim 17, Hayter teaches wherein the at least one electrode comprises a first electrode and a second electrode, wherein the first electrode is a working electrode and the second electrode is a reference electrode (par.0175).
With respect to claim 18, Hayter teaches further comprising storing a priori sensitivity information in a memory, wherein the determining the sensitivity of the sensor to glucose is based on the in vivo temperature value and the a priori sensitivity information (par.0336).
With respect to claim 19, Hayter teaches further comprising sensor electronics configured to apply at least one potential to the at least one electrode (par.0171).
With respect to claim 20, Hayter teaches wherein the at least one potential includes a first potential that is applied to a first electrode of the at least one electrodes and a second potential that is applied to a second electrode of the at least one electrodes (par.0171).
With respect to claim 21, Hayter teaches wherein the first potential is different from the second potential (par.0171).
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.
Claims 2-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,598,627 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791