DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s arguments filed in the reply on June 16, 2026 were received and fully considered. Claims 1 and 13 were amended. The current action is FINAL. Please see corresponding rejections and response to arguments section below for more detail.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 17, 2026 has been considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hayter et al. (US PG Pub. No. 2013/0158376 A1) (hereinafter “Hayter”).
Hayter was applied in the previous office action.
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)… 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).
Although Hayter does not explicitly teach 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; wherein the previous temperature value was previously measured by the temperature sensor, and wherein the in vivo temperature value accounts for a change in temperature of an environment of the temperature sensor from the previous temperature value, further modification to incorporate this feature would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons.
Mainly, Hayter discloses, in other embodiments, the following:
[0078] “In certain embodiments, changes in skin temperature are used to detect and correct for ambient temperature influences. For example, an ambient correction factor may be applied after a change in skin temperature is detected. It should be appreciated that the magnitude of the change may vary in different implementations as desired. For example, in some instances, a "normal" temperature could be detected at the start of a sensor wear, and when the temperature deviates by some predetermined amount (or, for example, by an amount detected by monitoring the changes during a period at the start of a sensor wear), then the ambient temperature compensation can be performed, such as described above”)
As such, Hayter’s other embodiments suggest determining in vivo temperature values that take into consideration when a change in temperature is detected, while also compensating for ambient temperature, i.e. a temperature of an environment of the temperature sensor.
Therefore, PHOSITA would have had predictable success modifying Hayter when the invention was filed to determine an in vivo temperature value and accounting for a change in temperature of an environment, as set forth in the current amendment, for the purpose of correcting for ambient temperature influences, as suggested by Hayter’s other embodiments (par.78).
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).
Response to Arguments
Applicant's arguments filed with respect to the prior art rejections raised in the previous office action were fully considered. While the previous anticipation rejections are withdrawn, Examiner raises new obviousness rejections in view of other embodiments from the Hayter reference that were necessitated by amendment. Please see prior art section above for more detail, updated citations, and updated obviousness rationale.
Applicant’s arguments filed with respect to the double patenting rejections raised in the previous office action were persuasive in view of the approved terminal disclaimer on June 23, 2026. Therefore, these rejections are withdrawn.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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