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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/18/2026 has been entered.
Status of Claims
Applicant's arguments, filed 05/18/2026, 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 amended their claims, filed 05/18/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 4, 5, 8, 11-13, 16, and 17.
Applicants have left claims 6, 18, and 20 as originally filed/previously presented.
Applicants have introduced new claims 21-24.
Applicants have canceled/previously canceled claims 2, 3, 7, 9, 10, 14, 15, and 19.
Claims 1, 4-6, 8, 11-13, 16-18, and 20-24 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/25/2026 is being considered by the examiner.
Claim Objections - Newly Applied Necessitated by Applicant’s Amendments
Claims 1, 5, and 13 are objected to because of the following informalities:
Regarding claim 1, line 15 recites “the monitored analyte level”, however it appears it should read --the monitored lactate level-- (emphasis added).
Regarding claim 5, line 2 recites “a user”, however it appears it should read --the user-- (emphasis added).
Regarding claim 13, line 12 recites “the monitored analyte level”, however it appears it should read --the monitored lactate level-- (emphasis added).
Claim Rejections - 35 USC § 112(d) - Withdrawn
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed 05/18/2026, with respect to claim 8 have been fully considered and are persuasive. Applicants have amended claim 8, rendering the rejection moot. The 112(d) rejection of claim 8 has been withdrawn.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
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, 4-6, 8, 11-13, 16-18, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al. (US 20130178727 A1) (previously cited), hereinafter referred to as Hayter, in view of Shah et al. (US 20190246962 A1), hereinafter referred to as Shah.
The claims are generally directed to an analyte monitoring device comprising: one or more processors; an analyte sensor configured to measure a lactate level; a communication module; and one or more hardware storage devices that store instructions that are executable by the one or more processors to cause the analyte monitoring device to: generate first analyte data indicative of a monitored lactate level measured by the analyte sensor corresponding to a first time; generate second analyte data indicative of the monitored lactate level measured by the analyte sensor corresponding to a second time; calculate a correction parameter based on the first analyte data corresponding to the first time and the second analyte data corresponding to the second time, wherein the correction parameter includes a lag time calculated based on the first time and the second time; and perform a lag correction to obtain the monitored analyte level using at least the calculated correction parameter, wherein the lag correction is performed during an exercise period of a user.
Regarding claim 1, Hayter discloses an analyte monitoring device (Abstract, Fig. 1) comprising:
one or more processors (Fig. 1, element 104, element 106, Fig. 3, element 307, para. [0093]);
an analyte sensor configured to measure an analyte level (Fig. 1, element 101, para. [0017], para. [0021], para. [0029]);
a communication module (Fig. 1, element 102, para. [0022]); and
one or more hardware storage devices that store instructions that are executable by the one or more processors to cause the analyte monitoring device to (Fig. 3, element 307, para. [0102-0103]):
generate first analyte data indicative of a monitored analyte level measured by the analyte sensor corresponding to a first time (Fig. 5, element 520, para. [0044], “monitored sensor data at time T=T-1, at time T=T+1, or any other suitable time period …”, para. [0051], “monitored analyte value at the calibration time is retrieved …”);
generate second analyte data indicative of the monitored analyte level measured by the analyte sensor corresponding to a second time (Fig. 4, Fig. 5, Fig. 6, para. [0044], para. [0047], para. [0057]);
calculate a correction parameter based on the first analyte data corresponding to the first time and the second analyte data corresponding to the second time (para. [0047], “determining the calibration parameter and updating the monitored data at the calibration time (T=0), the counter is incremented by one, and dynamic, real-time update of the calibration parameter is performed …”, para. [0057-0058], “updated based on the monitored data value at the subsequent incremented time …” - the calibration parameter is updated based on analyte data at a second time), wherein the correction parameter includes a lag time calculated based on the first time and the second time (para. [0071]); and
perform a lag correction to obtain the monitored analyte level using at least the calculated correction parameter (Fig. 5, element 540, Fig. 6, element 640, para. [0058], “lag corrected monitored data at the calibration time is updated or determined …”, para. [0065-0071], para. [0089-0091]).
Hayter suggests, but does not explicitly disclose, the analyte sensor is configured to measure a lactate level, the first and second analyte data is indicative of a monitored lactate level, and the lag correction is performed during an exercise period of a user. Hayter suggests this by teaching the system may be configured to monitor lactate (para. [0017]).
Shah teaches an analogous analyte monitoring system (Abstract, para. [0017-0019]). Shah further teaches the analyte sensor is configured to measure a lactate level and analyte data is indicative of a monitored lactate level (para. [0017-0019], para. [0026], “produce signals related to the analyte each transducer is configured to measure or detect (e.g., … lactate …)”, para. [0029]). Shah further teaches the analyte monitoring device is configured to perform operations during an exercise period of a user (para. [0029]). 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 analyte monitoring device disclosed by Hayter to explicitly be configured to measure a lactate level, and perform the lag correction during an exercise period of a user, as taught by Shah. This is because Shah teaches monitoring lactate levels during exercise of a user allows for differences between anaerobic and aerobic activities to be determined (para. [0029], para. [0053]), and further substituting a glucose specific sensor for a lactate specific sensor would have been obvious to one of ordinary skill in the art for obtaining the predictable result of obtaining lactate levels for performing analyte lag correction calculations.
Regarding claim 4, modified Hayter discloses the analyte monitoring device of claim 1.
However, modified Hayter does not explicitly disclose wherein the exercise period comprises a period of high-intensity exercise.
Shah further teaches the exercise period comprising a period of high-intensity exercise (para. [0029], para. [0053]). 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 analyte monitoring device taught by modified Hayter to additionally perform operations during a period of high-intensity exercise, as taught by Shah. This is because Shah teaches monitoring lactate levels during exercise of a user allows for differences between anaerobic and aerobic activities to be determined (para. [0029], para. [0053]).
Alternatively and/or additionally, in regard to the limitation of “a period of high-intensity exercise”, it is considered an intended use of the claimed device. Such a limitation does not further limit the structure of the claimed device. There is no recitation in the claim what structural limitation causes the exercise period to be a period of high-intensity exercise. As modified Hayter teaches a period can be based on physical activities by the patient such as exercise (see the rejection of claim 1 above), the processor, and the memory, it is considered reading on the limitation of a period of high-intensity exercise. For the above consideration, see MPEP § 2114.II: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 5, modified Hayter discloses the analyte monitoring device of claim 1, wherein the analyte sensor is configured to be subcutaneously inserted into a bodily fluid of a user (para. [0016], para. [0021]).
Regarding claim 6, modified Hayter discloses the analyte monitoring device of claim 5, wherein the bodily fluid comprises blood or interstitial fluid (para. [0021], para. [0065], “continuous stream of interstitial glucose …” - further, see the rejection of claim 1 above).
Regarding claim 8, modified Hayter discloses the analyte monitoring device of claim 1, wherein the lag correction is performed using a linear correction model (para. [0089-0091]).
Regarding claim 11, modified Hayter discloses the analyte monitoring device of claim 1, wherein the lag correction comprises correcting a lag between a change in the monitored lactate level in interstitial fluid and the monitored lactate level in blood (para. [0004], para. [0017], para. [0065] - further, see the rejection of claim 1 above).
Regarding claim 12, modified Hayter discloses the analyte monitoring device of claim 1, further comprising a display configured to receive and display the monitored lactate level (para. [0017], para. [0041] - further, see the rejection of claim 1 above).
Regarding claim 13, Hayter discloses a non-transitory computer-readable medium comprising instructions that, when executed by one or more processors of an analyte monitoring system configured to measure an analyte level, cause the analyte monitoring system to (Fig. 1, Fig. 3, para. [0093], para. [0102-0103]):
generate first analyte data indicative of a monitored analyte level measured by an analyte sensor corresponding to a first time (Fig. 5, element 520, para. [0044], “monitored sensor data at time T=T-1, at time T=T+1, or any other suitable time period …”, para. [0051], “monitored analyte value at the calibration time is retrieved …”);
generate second analyte data indicative of the monitored analyte level measured by the analyte sensor corresponding to a second time (Fig. 4, Fig. 5, Fig. 6, para. [0044], para. [0047], para. [0057]);
calculate a correction parameter based on the first analyte data corresponding to the first time and the second analyte data corresponding to the second time (para. [0047], “determining the calibration parameter and updating the monitored data at the calibration time (T=0), the counter is incremented by one, and dynamic, real-time update of the calibration parameter is performed …”, para. [0057-0058], “updated based on the monitored data value at the subsequent incremented time …” - the calibration parameter is updated based on analyte data at a second time), wherein the correction parameter includes a lag time calculated based on the first time and the second time (para. [0071]); and
perform a lag correction to obtain the monitored analyte level using at least the calculated correction parameter (Fig. 5, element 540, Fig. 6, element 640, para. [0058], “lag corrected monitored data at the calibration time is updated or determined …”).
Hayter suggests, but does not explicitly disclose, the analyte monitoring system is configured to measure a lactate level, the first and second analyte data is indicative of a monitored lactate level, and the lag correction is performed during an exercise period of a user. Hayter suggests this by teaching the system may be configured to monitor lactate (para. [0017]).
Shah teaches an analogous analyte monitoring system (Abstract, para. [0017-0019]). Shah further teaches the analyte monitoring system is configured to measure a lactate level and analyte data is indicative of a monitored lactate level (para. [0017-0019], para. [0026], “produce signals related to the analyte each transducer is configured to measure or detect (e.g., … lactate …)”, para. [0029]). Shah further teaches the analyte monitoring system is configured to perform operations during an exercise period of a user (para. [0029]). 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 analyte monitoring system disclosed by Hayter to explicitly be configured to measure a lactate level, and perform the lag correction during an exercise period of a user, as taught by Shah. This is because Shah teaches monitoring lactate levels during exercise of a user allows for differences between anaerobic and aerobic activities to be determined (para. [0029], para. [0053]), and further substituting a glucose specific sensor for a lactate specific sensor would have been obvious to one of ordinary skill in the art for obtaining the predictable result of obtaining lactate levels for performing analyte lag correction calculations.
Regarding claim 16, modified Hayter discloses the computer-readable medium of claim 13.
However, modified Hayter does not explicitly disclose wherein the exercise period comprises a period of high-intensity exercise.
Shah further teaches the exercise period comprising a period of high-intensity exercise (para. [0029], para. [0053]). 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 analyte monitoring system taught by modified Hayter to additionally perform operations during a period of high-intensity exercise, as taught by Shah. This is because Shah teaches monitoring lactate levels during exercise of a user allows for differences between anaerobic and aerobic activities to be determined (para. [0029], para. [0053]).
Alternatively and/or additionally, in regard to the limitation of “a period of high-intensity exercise”, it is considered an intended use of the claimed device. Such a limitation does not further limit the structure of the claimed device. There is no recitation in the claim what structural limitation causes the exercise period to be a period of high-intensity exercise. As modified Hayter teaches a period can be based on physical activities by the patient such as exercise (see the rejection of claim 13 above), the processor, and the memory, it is considered reading on the limitation of a period of high-intensity exercise. For the above consideration, see MPEP § 2114.II: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 17, modified Hayter discloses the computer-readable medium of claim 13, wherein the analyte sensor is configured to be subcutaneously inserted into a bodily fluid of a user (para. [0016], para. [0021]).
Regarding claim 18, modified Hayter discloses the computer-readable medium of claim 17, wherein the bodily fluid comprises blood or interstitial fluid (para. [0021], para. [0065], “continuous stream of interstitial glucose …” - further, see the rejection of claim 13 above).
Regarding claim 20, modified Hayter discloses the computer-readable medium of claim 13, wherein the lag correction is performed using a linear correction model (para. [0089-0091]).
Regarding claim 21, modified Hayter discloses the computer-readable medium of claim 13, wherein the correction parameter is calculated automatically without requiring a manual input from the user corresponding to any monitored analyte level (para. [0044], para. [0049], “dynamically … real-time obtaining reference data, … receiving measured data … updating calibration parameter …”, para. [0051], para. [0057-0058], “lag correction and dynamically updating calibration routine … updated based on the monitored data value at the subsequent incremented time …” - the monitoring system continuously detects the monitored analyte levels at a plurality of times to dynamically and continuously calculate the correction parameter, and the user is not required for a manual input).
Regarding claim 23, modified Hayter discloses the analyte monitoring device of claim 1, wherein the correction parameter is calculated automatically without requiring a manual input from the user corresponding to any monitored analyte level (para. [0044], para. [0049], “dynamically … real-time obtaining reference data, … receiving measured data … updating calibration parameter …”, para. [0051], para. [0057-0058], “lag correction and dynamically updating calibration routine … updated based on the monitored data value at the subsequent incremented time …” - the monitoring system continuously detects the monitored analyte levels at a plurality of times to dynamically and continuously calculate the correction parameter, and the user is not required for a manual input).
Claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al. (US 20130178727 A1) (previously cited), hereinafter referred to as Hayter, in view of Shah et al. (US 20190246962 A1), hereinafter referred to as Shah as applied to claims 1 and 13 above, and further in view of Schmelzeisen-Redeker et al. (US 20170319112 A1) (previously cited), hereinafter referred to as Schmelzeisen-Redeker.
Regarding claim 22, modified Hayter discloses the computer-readable medium of claim 13, wherein the lag correction is equal to a product of the lag time multiplied by a rate of change of the monitored analyte level (para. [0065-0070]), where the rate of change is based on the first or second analyte data (para. [0052], “rate of change of the monitored data at the calibration time is determined …”, para. [0057], para. [0061], “calculating the rate of change of the monitored data at the subsequent incremented time …”).
However, modified Hayter does not explicitly disclose the lag correction includes an added combination of a noise amount.
Schmelzeisen-Redeker teaches an analogous analyte monitoring system for performing lag correction (Abstract, para. [0010], para. [0079-0080]). Schmelzeisen-Redeker further teaches the lag correction includes an added combination of a noise amount (para. [0016], para. [0022-0026]). 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 lag correction equation taught by modified Hayter to additionally include correcting a noise amount, as taught by Schmelzeisen-Redeker. This is because Schmelzeisen-Redeker teaches accounting for noise, such as sensor offset, allows for a more accurate blood glucose level reading (para. [0016], para. [0022-0026]).
Regarding claim 24, modified Hayter discloses the analyte monitoring device of claim 1, wherein the lag correction is equal to a product of the lag time multiplied by a rate of change of the monitored analyte level, where the rate of change is based on the first or second analyte data (para. [0065-0070]), where the rate of change is based on the first or second analyte data (para. [0052], “rate of change of the monitored data at the calibration time is determined …”, para. [0057], para. [0061], “calculating the rate of change of the monitored data at the subsequent incremented time …”).
However, modified Hayter does not explicitly disclose the lag correction includes an added combination of a noise amount.
Schmelzeisen-Redeker teaches an analogous analyte monitoring device for performing lag correction (Abstract, para. [0010], para. [0079-0080]). Schmelzeisen-Redeker further teaches the lag correction includes an added combination of a noise amount (para. [0016], para. [0022-0026]). 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 lag correction equation taught by modified Hayter to additionally include correcting a noise amount, as taught by Schmelzeisen-Redeker. This is because Schmelzeisen-Redeker teaches accounting for noise, such as sensor offset, allows for a more accurate blood glucose level reading (para. [0016], para. [0022-0026]).
Response to Arguments
First, applicant’s arguments, see pages 6-7 of Remarks, filed 05/18/2026, with respect to the rejection(s) of claim(s) 1, 3-6, 8, 11-13, 15-18, and 20 under 35 USC 103 have been fully considered and are persuasive, in regards to a system configured for measuring lactate levels. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shah et al. (US 20190246962 A1), hereinafter referred to as Shah.
Further, Applicant's arguments filed 05/18/2026 in regards to the lag correction being performed automatically, without requiring manual user input corresponding to any measured analyte level, see page 7 of Remarks, have been fully considered but they are not persuasive.
As recited above, modified Hayter teaches the correction parameter is calculated automatically without requiring a manual input from the user corresponding to any monitored analyte level. Specifically, the system continuously obtains and/or retrieves measured data and continuously updates the calibration routine (para. [0044], para. [0049], para. [0051], para. [0057-0058]). That is, the system performs the correction parameter calculation automatically and without user intervention/input. Further, Applicants arguments regarding a reference blood reference value is not commensurate in scope with the claimed invention. Modified Hayter teaches the system continuously updates the calibration routine utilizing data from the continuous analyte sensor, as cited above.
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
/RENE T TOWA/Primary Examiner, Art Unit 3791
Prosecution Insights