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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/935094, filed on 9/24/2022.
Response to Amendment
This Office Action has been issued in response to the amendment filed on 8/3/2026. Claims 1-10 are cancelled. Claims 11-19 are pending. Applicants’ arguments have been carefully and respectfully considered in light of the instant amendment and are persuasive, as they relate to the claim rejections under 35 U.S.C. 103. However, after further search and consideration, Examiner has found additional prior art, as will be discussed below. Accordingly, this action has been made FINAL.
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.
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Claims 11-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,147,332. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variant of each other.
Instant Application
U.S. Patent No. 12,147,332
Claim 11:
A method for storing measurement data detected by a sensor implanted in a patient and indicative of an analyte in a sample of a body fluid, comprising:
providing a first measurement data set comprising a first measurement value for an analyte in a sample of a body fluid measured by a sensor implanted in a patient;
providing second measurement data set comprising a second measurement value for the analyte in the sample of the body fluid measured by the sensor implanted in a patient;
wherein the first measurement data set and/or the second measurement data set further comprise a value selected from the group consisting of: orientation of the sensor implanted in a patient, a battery voltage, temperature of the device, and an event flag;
determining a relative measurement data set comprising a value difference between the measurement values in the first and second measurement data sets;
storing the first measurement data set in the memory;
storing the relative measurement data set in the memory in the memory, wherein the first measurement data set occupies a larger area in the memory than the relative measurement data set; and
storing an indicator assigned to the relative measurement data set in the memory and indicative of a characteristic of the relative measurement data set
Claim 1:
A method for storing measurement data detected by a sensor and indicative of an analyte in a sample of a body fluid, comprising, in a system having a processor and a memory:
dividing the memory into at least two pages, wherein a size of the at least two pages matches a page size of a flash or EEPROM memory;
providing first measurement data indicative of a first measurement value for an analyte in a sample of a body fluid measured by a sensor, wherein each of the at least two pages in the memory comprises a header having the first measurement data, whereby each of the at least two pages is configured to be decoded independently;
providing second measurement data indicative of a second measurement value for the analyte in the sample of the body fluid measured by the sensor;
determining a relative measurement value by the processor, the relative measurement value being indicative of a value difference between the first measurement value and the second measurement value;
providing first measurement storage data in the memory, comprising storing the first measurement value in a first storage area having a first storage size in the memory;
providing relative measurement storage data in the memory, comprising storing the relative measurement value in the memory, the relative measurement storage data stored in a second storage area having a second storage size in the memory which is smaller than the first storage size; and
storing an indicator in the memory, the indicator being assigned to the relative measurement storage data in the memory and indicative of a characteristic of the relative measurement storage data.
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are substantially similar in scope and they use the same limitations. It would have been obvious to a person of ordinary skill in the art at the time the invention was made to add “wherein the first measurement data set and/or the second measurement data set further comprise a value selected from the group consisting of: orientation of the sensor implanted in a patient, median of a current flowing into the sensor, a standard deviation, a sensor voltage median, a battery voltage, temperature of the device, and an event flag”, which is a common way within the art to design sensors with a medical monitoring device, and omit the additional elements "dividing the memory into at least two pages, wherein a size of the at least two pages matches a page size of a flash or EEPROM memory; wherein each of the at least two pages in the memory comprises a header having the first measurement data, whereby each of the at least two pages is configured to be decoded independently" of claims 1-12 of U.S. Patent No. 12,147,332 to arrive at the claims 11-19 of the instant application because the person would have realized that the remaining element would perform the same functions as before. "Omission of element and its function in combination is obvious expedient if the remaining elements perform same functions as before." See In re Karlson (CCPA) 136 USPQ 184, decide Jan 16, 1963, Appl. No. 6857, U. S. Court of Customs and Patent Appeals.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 11-13 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gupta et al (US 20190008461 A1).
As to claims 11 and 19, Gupta teaches a method for storing measurement data detected by a sensor implanted in a patient and indicative of an analyte in a sample of a body fluid, comprising:
(Gupta [0015]-[0039] discloses an implantable blood analyte sensor for accurately providing information relating to sensed analyte levels, including for example accounting or correcting for signal error due to one or more unmodeled variables within a living subject, for extended periods of time and without requiring explant of the sensor)
providing first measurement data indicative of a first measurement value for an analyte in a sample of a body fluid measured by the sensor implanted in a patient;
(Gupta [0018] discloses the implanted analyte sensor includes a glucose sensor (part of a so-called “continuous glucose monitor” or CGM), and the analyte signal data are blood glucose concentration data (i.e. first measurement data indicative of a first measurement value for an analyte in a sample of a body fluid measured by the sensor implanted in a patient). In one implementation, the glucose sensor is an oxygen-based glucose sensor. In another implementation, the glucose sensor is a hydrogen peroxide-based glucose sensor. In yet another implementation, the glucose sensor includes both a hydrogen peroxide-based sensor and oxygen-based glucose sensor. Gupta [0023] further discloses the data related to one or more other parameters includes data contemporaneously collected from one or more other sensors such as e.g., a pressure sensor and/or a temperature sensor. In another example, the one or more other sensors comprise at least a different blood analyte sensor, such as for detection of another blood analyte (i.e. second measurement data indicative of a second measurement value for the analyte in the sample of the body fluid measured by the sensor implanted in a patient).)
providing second measurement data indicative of a second measurement value for the analyte in the sample of the body fluid measured by the sensor implanted in a patient;
(Gupta [0018] discloses the implanted analyte sensor includes a glucose sensor (part of a so-called “continuous glucose monitor” or CGM), and the analyte signal data are blood glucose concentration data (i.e. first measurement data indicative of a first measurement value for an analyte in a sample of a body fluid measured by the sensor implanted in a patient). In one implementation, the glucose sensor is an oxygen-based glucose sensor. In another implementation, the glucose sensor is a hydrogen peroxide-based glucose sensor. In yet another implementation, the glucose sensor includes both a hydrogen peroxide-based sensor and oxygen-based glucose sensor. Gupta [0023] further discloses the data related to one or more other parameters includes data contemporaneously collected from one or more other sensors such as e.g., a pressure sensor and/or a temperature sensor. In another example, the one or more other sensors comprise at least a different blood analyte sensor, such as for detection of another blood analyte (i.e. second measurement data indicative of a second measurement value for the analyte in the sample of the body fluid measured by the sensor implanted in a patient).)
wherein the first measurement data set and/or the second measurement data set further comprise a value selected from the group consisting of: orientation of the sensor, median of a current flowing into the sensor, a standard deviation, a sensor voltage median, a battery voltage, temperature of the device, and an event flag;
(Gupta [0153]-[0155] discloses the system can collect data (hereinafter “OS.sub.cal” data) received from one or more other sensors (such as e.g., internal sensors 232 on the implanted sensor 200, external sensors 432 such as on the receiver or parent platform, or other additional sensors associated with the blood analyte detection system). For example, the one or more internal sensors 232 associated with the implanted sensor 200 (or similar sensors implanted proximate to the sensor 200) can collect/calculate internal OS.sub.cal data such as e.g., internal body temperature in the region of the implanted sensor, pulse rate of the user, motion and/or orientation data, pressure, pH, local blood flow/tissue perfusion, electrical impedance of the sensor/tissue interface, blood analyte concentration of other non-target analytes (e.g., oxygen), and/or other internal data. In another example, the one or more external sensors 432 associated with the receiver 400, 450 can collect external OS.sub.cal data such as e.g., external body temperature, pulse rate of the user, blood pressure, motion and/or orientation data, and/or other external data, or even pre-processed “state” or other context data; e.g., as to what activity or state the user is currently engaged in (such as ambulatory, sleeping, exercising, eating, etc., so in effect the computerized modeling logic does not have to deduce or derive this information from raw sensor data alone).)
determining a relative measurement value by the processor, the relative measurement value being indicative of a value difference between the first measurement value and the second measurement value;
(Gupta [0009] [0065] [0169] discloses mean absolute relative difference (MARD) between the sensor output and a set of comparison measurements (i.e., a reference measurement), or by the frequency of outliers in the comparison. In one example, the relationship between a measured blood analyte level and a reference blood analyte level (taken at a corresponding point in time).)
storing the first measurement value in the memory;
(Gupta [0158] discloses storing data from sensors in local storage and then offloading large amounts of data, based on a threshold to a cloud-based storage.)
storing the relative measurement value in the memory, wherein the first measurement data set occupies a larger area in the memory than the relative measurement data set; and
(Gupta [0158] discloses storing data from sensors in local storage and then offloading large amounts of data, based on a threshold to a cloud-based storage. Gupta [0009] [0065] [0169] discloses the mean absolute relative difference (MARD) appears to be a point in time measurement instead of a constant/continuous calculation and thus would take up less memory to store.)
storing an indicator assigned to the relative measurement data set in the memory and indicative of a characteristic of the relative measurement data set.
(Gupta [0009] [0065] [0169]-[0171] discloses errors/ouliers are identified (i.e. assigned indicator providing a characteristic) based on the MARD calculations (i.e. relative measurement data) and stored as references for which a machine learning model can be trained.)
As to claim 12, Gupta teaches storing an additional indicator assigned to the first measurement data set in the memory and indicative of a characteristic of the first measurement data set (Gupta [0009] [0065] [0169]-[0171] discloses errors/ouliers are identified (i.e. assigned indicator providing a characteristic) based on the MARD calculations (i.e. relative measurement data) and stored as references for which a machine learning model can be trained.).
As to claim 13, Muhlenberg teaches the first measurement value is stored as an absolute value of the first measurement value (Gupta [0009] [0065] [0169]-[0171] discloses mean absolute relative difference (MARD) between the sensor output and a set of comparison measurements (i.e., a reference measurement), or by the frequency of outliers in the comparison. In one example, the relationship between a measured blood analyte level and a reference blood analyte level (taken at a corresponding point in time).).
Allowable Subject Matter
Claims 14-18 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.
Specifically, claims 14-18 recite various limitations which speak to how the measurements (i.e. relative measurement value) are stored as bits in memory and the order with which they are stored.
The cited prior art fails to disclose this level of storing measurement data detected by a sensor implanted in a patient and indicative of an analyte in a sample of a body fluid.
Response to Arguments
Applicant’s arguments with respect to claim(s) 11-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pages 4-5, filed 8/3/2026, with respect to the rejection(s) of claim(s) 11-19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gupta et al (US 20190008461 A1).
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED M BIBBEE whose telephone number is (571)270-1054. The examiner can normally be reached Monday-Thursday 8AM-6PM.
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/JARED M BIBBEE/Primary Examiner, Art Unit 2161
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