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 .
Status of Claims
Applicant's arguments, filed 12/23/2025, 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 12/23/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 3, 5, 8, 13, 15, 17, and 20.
Applicants have left claims 4, 6, 11-12, 16, and 18 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 2, 7, 9-10, 14, and 19.
Claims 1, 3-6, 8, 11-13, 15-18, and 20 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/05/2026 is being considered by the examiner.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed 12/23/2025, with respect to claim 9 have been fully considered and are persuasive. Applicants have canceled the claim, rendering the object moot. The objection of claim 9 has been withdrawn.
Claim Rejections - 35 USC § 112(b) - Withdrawn
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed 12/23/2025, with respect to claims 2 and 14 have been fully considered and are persuasive. Applicants have canceled claims 2 and 14, rendering the rejections moot. The rejections of claims 2 and 14 have been withdrawn.
Claim Rejections - 35 USC § 112(d) - Newly Applied Necessitated by Applicant’s Amendments
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.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 8, the claim fails to depend from a claim. For the purposes of examination, claim 8 is being interpreted as being dependent from claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101 - Withdrawn
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed 12/23/2025, with respect to the rejection of claims 5-6 have been fully considered and are persuasive. Applicants have amended the claims, rendering the rejections moot. The rejection of claims 5-6 have been withdrawn.
Claim Rejections - 35 USC § 102 - Withdrawn
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Response to Arguments
Applicant’s arguments, see pages 6-8 of Remarks, filed 12/23/2025, with respect to claims 1-20 have been fully considered and are persuasive. Applicants have amended the claims, rendering the rejection moot. The 102(a)(1) rejection of claims 1-20 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, 3-6, 8, 11-13, 15-18, and 20 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 Schmelzeisen-Redeker et al. (US 20170319112 A1), hereinafter referred to as Schmelzeisen-Redeker.
The claims are generally directed to an analyte monitoring device comprising: one or more processors; an analyte sensor; 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 analyte level measured by the analyte sensor corresponding to a first time; generate second analyte data indicative of the monitored analyte 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 equal to an added combination of a noise amount and 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.
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 (Fig. 1, element 101, 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]), 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, Hayter does not explicitly disclose wherein 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 disclosed by 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 3, modified Hayter discloses the analyte monitoring device of claim 1, wherein performing the lag correction to obtain the monitored analyte level is performed during an exercise period of a user (para. [0054]).
Regarding claim 4, modified Hayter discloses the analyte monitoring device of claim 3, wherein the exercise period comprises a period of high-intensity exercise (para. [0054]).
Further, 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 (para. [0054]), 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 in to 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 …”).
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 analyte level in interstitial fluid and the monitored analyte level in blood (para. [0004], para. [0065]).
Regarding claim 12, modified Hayter discloses the analyte monitoring device of claim 1, further comprising a display configured to receive and display the monitored analyte level (para. [0041]).
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, 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 …”), 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, Hayter does not explicitly disclose wherein the lag correction includes an added combination of a noise amount.
Schmelzeisen-Redeker teaches an analogous analyte monitoring device and method 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 disclosed by 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 15, modified Hayter discloses the computer-readable medium of claim 13, wherein performing the lag correction to obtain the monitored analyte level is performed during an exercise period of a user (para. [0054]).
Regarding claim 16, modified Hayter discloses the computer-readable medium of claim 15, wherein the exercise period comprises a period of high-intensity exercise (para. [0054]).
Further, 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 (para. [0054]), 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 in to 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 …”).
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]).
Conclusion
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 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.
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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.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791