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 .
Response to Amendment
The amendment filed 01/20/2026 has been entered. Amendments to claims 1-3, 6, 8-11, and 14-20 are acknowledged. Claims 1-20 remain pending in the application.
Claim Rejections - 35 USC § 101
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “while a first sensor is inserted into the tissue of the subject, detect insertion of a second sensor into the tissue”, “initiate a cross-calibration procedure of the second sensor responsive to the detecting,”, “obtain a first current from the first sensor and a second current from the second sensor, and convert the first current into a first glucose value”, “in response to an indication that a predetermined condition is met for modeling a first non-glucose driven background current associated with the second sensor, predict the first non-glucose driven background current for the second sensor over a first time duration”, “during the first time duration, subtract the first non-glucose driven background current from the second current to obtain a subtracted second current for the second sensor”, “convert the subtracted second current to a second glucose value.”, “obtain an indication that the second glucose value is correlated with a predetermined threshold of the first glucose value”, and “in response to the indication that the second glucose value is correlated with the predetermined threshold of the first glucose value, provide an audible or visual alert that the first glucose sensor can be removed”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “computing device”, “processor”, “non-transitory memory”, and “sensor. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0002]: “generally uses an glucose sensor” of Feldman (US 20240081700 A1). Regarding claim 1, a generic computer structure such as “a computing device”, “processor”, etc. is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2-13 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 1-13 is/are rejected under 35 U.S.C. 101.
Claim 14 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 14 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “while a first sensor is inserted into the tissue of the subject, detect insertion of a second sensor into the tissue”, “responsive to the detecting, obtain a first current from the first sensor and a second current from the second sensor, and convert the first current into a first glucose value”, “in response to an indication that a predetermined condition is met for modeling a first non-glucose driven background current associated with the second sensor, predict the first non-glucose driven background current for the second sensor over a first time duration”, “during the first time duration, subtract the first non-glucose driven background current from the second current to obtain a subtracted second current for the second sensor”, “convert the subtracted second current to a second glucose value.” , “obtain an indication that the second glucose value is correlated with a predetermined threshold of the first glucose value”, and “in response to the indication that the second glucose value is correlated with the predetermined threshold of the first glucose value, provide an audible or visual alert that the first glucose sensor can be removed”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “processor”, “non-transitory memory”, and “sensor. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0002]: “generally uses an glucose sensor” of Feldman (US 20240081700 A1). Regarding claim 14, a generic computer structure such as “non-transitory memory” and “processor”, etc. is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 14 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 15-20 fail to cure the deficiencies of independent claim 14 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 14-20 is/are rejected under 35 U.S.C. 101.
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 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.
Claim(s) 1-5 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman (US 20240081700 A1, as cited by applicant’s IDS filed 05/23/2023) in view of Skyggebjerg et al. (US 20080312859 A1), hereinafter Skyggebjerg.
Regarding claim 1, Feldman discloses an apparatus for calibrating a biosensor (abstract) inserted into tissue of a subject ([0026]: “may be inserted through the skin of the patient using insertion devices”), comprising: a computing device including a processor ([0018]: “receiver/data processing unit 130”), the processor storing instructions in non-transitory memory that (claim 16), when executed, cause the processor to: while a first sensor is inserted into the tissue of the subject, detect insertion of a second sensor into the tissue ([0032]: “second glucose sensor 111B is positioned at a predetermined time prior to the scheduled removal of the first glucose sensor 111A. In one embodiment, the predetermined time overlap between the insertion of the second glucose sensor 111B and the removal of the first glucose sensor 111A”); initiate a cross-calibration procedure of the second sensor responsive to the detecting ([0028]: “the calibration of the first sensor in one embodiment is assigned or transferred to the second sensor.”), wherein in the cross-calibration procedure, the instructions, when executed, cause the processor to: obtain a first current from the first sensor and a second current from the second sensor ([0032]: “the output data or signals from the first sensor 111A received from transmitter unit 121A is correlated with the output data or signals from the second sensor 111B received from the transmitter unit 121B.”, [0047]: “converted to a current signal level by a multiplication factor of 11.5 picoamps/count.”), and convert the first current into a first glucose value ([0022]: “to detect glucose levels of a patient over a predetermined time period”); in response to an indication that a predetermined condition is met for modeling a first non-glucose driven background current associated with the second sensor, predict the first non-glucose driven background current for the second sensor over a first time duration ([0040-0041]: “determined whether the correlation level is above a predetermined threshold. As shown in the Figure, if it is determined at step 350 that the correlation level is not above the predetermined threshold level, then the receiver/data processing unit 130 returns the routine to step 340 to determine again the correlation level of the first sensor 111A and the second sensor 111B… once it is determined that the second sensor 111B is stable, then a sensitivity may be determined for the second sensor 111B based on the scaling factor determined at step 320 and the sensitivity of the first sensor 111A”); during the first time duration, subtract the first non-glucose driven background current from the second current to obtain a subtracted second current for the second sensor ([0037]: “to determine an average error between the data from the first sensor 111A and the data from the second sensor 111B.”, wherein determining an error involves calculating a difference); and convert the subtracted second current to a second glucose value ([0037]: “Based on the calculated average error, the scaling factor is determined as the one of the predetermined initial scaling factors which yields the smallest possible calculated average error.”, [0039]: “, the scaling factor is applied to the data from the second sensor 111B at step 330. More specifically, in one embodiment, the determined scaling factor at step 320 is multiplied to the data from the second sensor 111B at step 330.”, Fig 8); obtain an indication that the second glucose value is correlated with a predetermined threshold of the first glucose value ([0040]: “it is determined whether the correlation level is above a predetermined threshold”, Fig 3 step 340 and step 350).
While Feldman discloses that in response to the indication that the second glucose value is correlated with the predetermined threshold of the first glucose value, the first glucose sensor can be removed ([0075]: “the stability of the second sensor may be verified by correlation of its output with the output of the stabilized first sensor, prior to calibration of the second sensor based on data from the first sensor, and thereafter removing the first sensor while retaining the second sensor in fluid contact.”), they fail to disclose providing an audible or visual alert that the first glucose sensor can be removed.
Skyggebjerg discloses an in response to the indication that the second glucose value is correlated with the predetermined threshold of the first glucose value ([0023]: “introducing a second sensor subcutaneously, e) obtaining sensor data S.sub.2(t) provided by the second sensor, f) determining the rate of change over time .delta.R(t)/.delta.t, R(t) being a signal which correlates to sensor data S.sub.2(t) over time, and g) performing a calibration of the second sensor when .delta.R(t)/.delta.t is less than a predetermined value, said calibration of the second sensor being performed using sensor data S.sub.1(t) obtained by the first senso”), provide an audible or visual alert that the first glucose sensor can be removed ([0048]: “feature a display comprising an indication whether the new sensor is calibrated correctly… As soon as sensor 2 is calibrated, an indication to that effect will be made clearly available to the user who then removes sensor 1.”).
As Feldman discloses a display and audible indicator (Feldman [0031]), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the apparatus disclosed by Feldman to further include the audible or visual alert that the first glucose sensor can be removed disclosed by Skyggebjerg in order to allow for timely removal of the sensor (Skyggebjerg [0017]).
Regarding claim 2, Feldman discloses wherein the instructions, when executed, cause the processor to predict the first non-glucose driven background current based on the second current measured prior to the predetermined condition being met, and at least in part on one or more of the first current or the first glucose value obtained prior to the predetermined condition being met ([0040-0041]: “determined whether the correlation level is above a predetermined threshold. As shown in the Figure, if it is determined at step 350 that the correlation level is not above the predetermined threshold level, then the receiver/data processing unit 130 returns the routine to step 340 to determine again the correlation level of the first sensor 111A and the second sensor 111B… once it is determined that the second sensor 111B is stable, then a sensitivity may be determined for the second sensor 111B based on the scaling factor determined at step 320 and the sensitivity of the first sensor 111A”).
Regarding claim 3, Feldman discloses herein the instructions, when executed, cause the processor to predict the first non-glucose driven background current based on previously generated pattern of background current changes learned over time from a plurality of other glucose sensors inserted into the subject at earlier times ([0027]: “deploying and calibrating a first sensor (e.g., glucose sensor 111A) at predetermined time intervals using fingerstick calibrations,”).
Regarding claim 4, Feldman discloses the indication that predetermined condition is met for modeling the first non- glucose driven background current occurs between one minute and sixty minutes after initiation of the cross-calibration procedure ([0032]: “the predetermined time overlap between the insertion of the second glucose sensor 111B and the removal of the first glucose sensor 111A from the patient may be a two to ten hour period. Alternatively, the time overlap may be longer or shorter depending upon the sensor configuration”, wherein the overlap may be shorter than two hours).
Regarding claim 5, Feldman discloses wherein the first time duration in which the first non-glucose driven background current is subtracted from the second current is at least two hours and up to sixty-four hours. ([0032]: “the predetermined time overlap between the insertion of the second glucose sensor 111B and the removal of the first glucose sensor 111A from the patient may be a two to ten hour period. Alternatively, the time overlap may be longer or shorter depending upon the sensor configuration”).
Regarding claim 14, Feldman discloses an apparatus for calibrating a biosensor (abstract) inserted into tissue of a subject ([0026]: “may be inserted through the skin of the patient using insertion devices”), comprising: a non-transitory memory storing instructions (claim 16) and a processor to execute the instructions ([0018]: “receiver/data processing unit 130”) to: while a first sensor is inserted into the tissue of the subject, detect insertion of a second sensor into the tissue ([0032]: “second glucose sensor 111B is positioned at a predetermined time prior to the scheduled removal of the first glucose sensor 111A. In one embodiment, the predetermined time overlap between the insertion of the second glucose sensor 111B and the removal of the first glucose sensor 111A”); initiate a cross-calibration procedure of the second sensor responsive to the detecting ([0028]: “the calibration of the first sensor in one embodiment is assigned or transferred to the second sensor.”), wherein in the cross-calibration procedure, the instructions, when executed, cause the processor to: obtain a first current from the first sensor and a second current from the second sensor ([0032]: “the output data or signals from the first sensor 111A received from transmitter unit 121A is correlated with the output data or signals from the second sensor 111B received from the transmitter unit 121B.”, [0047]: “converted to a current signal level by a multiplication factor of 11.5 picoamps/count.”), and convert the first current into a first glucose value ([0022]: “to detect glucose levels of a patient over a predetermined time period”); in response to an indication that a predetermined condition is met for modeling a first non-glucose driven background current associated with the second sensor, predict the first non-glucose driven background current for the second sensor over a first time duration ([0040-0041]: “determined whether the correlation level is above a predetermined threshold. As shown in the Figure, if it is determined at step 350 that the correlation level is not above the predetermined threshold level, then the receiver/data processing unit 130 returns the routine to step 340 to determine again the correlation level of the first sensor 111A and the second sensor 111B… once it is determined that the second sensor 111B is stable, then a sensitivity may be determined for the second sensor 111B based on the scaling factor determined at step 320 and the sensitivity of the first sensor 111A”); during the first time duration, subtract the first non-glucose driven background current from the second current to obtain a subtracted second current for the second sensor ([0037]: “to determine an average error between the data from the first sensor 111A and the data from the second sensor 111B.”, wherein determining an error involves calculating a difference); and convert the subtracted second current to a second glucose value ([0037]: “Based on the calculated average error, the scaling factor is determined as the one of the predetermined initial scaling factors which yields the smallest possible calculated average error.”, [0039]: “, the scaling factor is applied to the data from the second sensor 111B at step 330. More specifically, in one embodiment, the determined scaling factor at step 320 is multiplied to the data from the second sensor 111B at step 330.”, Fig 8).
While Feldman discloses that in response to the indication that the second glucose value is correlated with the predetermined threshold of the first glucose value, the first glucose sensor can be removed ([0075]: “the stability of the second sensor may be verified by correlation of its output with the output of the stabilized first sensor, prior to calibration of the second sensor based on data from the first sensor, and thereafter removing the first sensor while retaining the second sensor in fluid contact.”), they fail to disclose providing an audible or visual alert that the first glucose sensor can be removed.
Skyggebjerg discloses an in response to the indication that the second glucose value is correlated with the predetermined threshold of the first glucose value ([0023]: “introducing a second sensor subcutaneously, e) obtaining sensor data S.sub.2(t) provided by the second sensor, f) determining the rate of change over time .delta.R(t)/.delta.t, R(t) being a signal which correlates to sensor data S.sub.2(t) over time, and g) performing a calibration of the second sensor when .delta.R(t)/.delta.t is less than a predetermined value, said calibration of the second sensor being performed using sensor data S.sub.1(t) obtained by the first senso”), provide an audible or visual alert that the first glucose sensor can be removed ([0048]: “feature a display comprising an indication whether the new sensor is calibrated correctly… As soon as sensor 2 is calibrated, an indication to that effect will be made clearly available to the user who then removes sensor 1.”).
As Feldman discloses a display and audible indicator (Feldman [0031]), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the apparatus disclosed by Feldman to further include the audible or visual alert that the first glucose sensor can be removed disclosed by Skyggebjerg in order to allow for timely removal of the sensor (Skyggebjerg [0017]).
Regarding claim 15, Feldman discloses wherein the instructions, when executed, cause the processor to predict the first non-glucose driven background current based on the second current measured prior to the predetermined condition being met, and at least in part on one or more of the first current or the first glucose value obtained prior to the predetermined condition being met ([0040-0041]: “determined whether the correlation level is above a predetermined threshold. As shown in the Figure, if it is determined at step 350 that the correlation level is not above the predetermined threshold level, then the receiver/data processing unit 130 returns the routine to step 340 to determine again the correlation level of the first sensor 111A and the second sensor 111B… once it is determined that the second sensor 111B is stable, then a sensitivity may be determined for the second sensor 111B based on the scaling factor determined at step 320 and the sensitivity of the first sensor 111A”).
Regarding claim 16, Feldman discloses herein the instructions, when executed, cause the processor to predict the first non-glucose driven background current based on previously generated pattern of background current changes learned over time from a plurality of other glucose sensors inserted into the subject at earlier times ([0027]: “deploying and calibrating a first sensor (e.g., glucose sensor 111A) at predetermined time intervals using fingerstick calibrations,”).
Claim(s) 6-13 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman in view of Skyggebjerg in view of Gross et al. (US6275717B1), hereinafter Gross.
Regarding claim 6, Feldman as modified by Skyggebjerg discloses the apparatus of claim 1, but fails to disclose wherein the instructions, when executed, cause the processor to: model a second non-glucose driven background current associated with the second sensor over a second time duration that extends past the first time duration; continue to obtain the second current from the second sensor over the second time duration; subtract the second non-glucose driven background current from the second current measured over the second time duration to obtain the subtracted second current for the second sensor; and convert the subtracted second current to the second glucose value.
Gross discloses wherein the instructions, when executed, cause the processor to: model a second non-glucose driven background current associated with the second sensor (col 4 lines 49-54: “electronic circuitry associated with the sensor for receiving the signal and providing a calibrated output based on the signal, wherein the electronic circuitry includes means for determining a calibration function for the sensor based on the first measured sensor signal resulting from the predetermined stimulus.”, col 5 lines 22-25: “means are provided for generating a base line signal corresponding to the signal obtained when substantially no glucose is present in the vicinity of the needle, and the base line signal is used to calibrate the sensor.” ), over a second time duration that extends past the first time duration (col 5 lines 64-67: “the method of testing the sensor needle are repeated periodically. This allows the sensor to be repeatedly tested while in use, thereby monitoring the sensor for deviations from the expected performance”, wherein subsequent calibration extends for a duration following the first); continue to obtain the second current from the second sensor over the second time duration (col 6 lines 30 -50 “applying a potential to the electrode and varying the electrode potential so as to cause the electrode current to undergo at least part of a cycle which exhibits hysteresis; (b) measuring and recording a plurality of current values on the hysteresis cycle; (c) calculating a characteristic point on the hysteresis curve from the plurality of current values; and (e) comparing the characteristic point with a stored value and determining from this comparison whether the sensor meets a predetermined condition.”); subtract the second non-glucose driven background current from the second current measured over the second time duration to obtain the subtracted second current for the second sensor (col 14 lines 43-47: “concentration-dependent calibration function in which the amount added to (or subtracted from) the measured signal 42 c, when mapping this signal to point 40 c, varies in accordance with the position of this point along curve 42”); and convert the subtracted second current to the second glucose value (col 15 lines 11-12: “then be correlated to a value of 0.41 mA on the reference curve, which in turn corresponds to a glucose concentration of 4 mM (72 mg/dlit).”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the apparatus disclosed by Feldman to take further measurements for calibration as disclosed by Gross in order to allow for changes in the performance over the duration of its use (Gross col 1 lines 42-43).
Regarding claim 7, Feldman discloses wherein the second time duration in which the second non-glucose driven background current is subtracted from the second current is at least 15 days and as long as 32 days ([0027]).
Regarding claim 8, Feldman discloses wherein the instructions, when executed, cause the processor to model the second non-glucose driven background current based on data retrieved from one or more glucose sensors of a same type as each of the first sensor and the second sensor, previously worn by the subject ([0026] “the glucose sensors 111A, 111B”).
Regarding claim 9, Feldman further discloses wherein to obtain the subtracted second current and convert the subtracted second current to the second glucose value, the instructions, when executed, cause the processor to: recall one or more previously learned glucose sensitivity values from prior use by the subject of other glucose sensors ([0041]: " then a sensitivity may be determined for the second sensor 111B based on the scaling factor determined at step 320 and the sensitivity of the first sensor 111A. This determination may be expressed as follows."); and apply a correction procedure to obtain an accurate glucose sensitivity for the second sensor ([0033]: " the second sensor is calibrated based on one or more scaling factors associated with the two sensors.").
Regarding claim 10, Feldman further discloses the instructions, when executed, cause the processor to generate a conversion operation that includes one or more conversion parameters and which is used to convert the subtracted second current to the second glucose value for each of the first time duration and the second time duration ([0047], Fig 8).
Regarding claim 11, Feldman further discloses each of the first time duration and the second time duration are variable ([0063]: “the time period may be variable”) and terminate responsive to an indication that the conversion operation is accurately converting the subtracted current to the second glucose current during each of the first time duration and the second time duration (Fig 3 elements 350 to 360).
Regarding claim 12, Feldman further discloses wherein the one or more conversion parameters for the conversion operation are the same between the first time duration and the second time duration ([0037]: “is configured to determine a scaling factor for the second sensor 111B based on the data or signals from the first sensor 111A.”).
Regarding claim 13, Feldman further discloses wherein the one or more conversion parameters for the conversion operation are different between the first time duration and the second time duration ([0040]: “whether the correlation level is above a predetermined threshold. As shown in the Figure, if it is determined at step 350 that the correlation level is not above the predetermined threshold level.”).
Regarding claim 17, Feldman as modified by Skyggebjerg discloses the apparatus of claim 1, but fails to disclose wherein the instructions, when executed, cause the processor to: model a second non-glucose driven background current associated with the second sensor over a second time duration that extends past the first time duration; continue to obtain the second current from the second sensor over the second time duration; subtract the second non-glucose driven background current from the second current measured over the second time duration to obtain the subtracted second current for the second sensor; and convert the subtracted second current to the second glucose value.
Gross discloses wherein the instructions, when executed, cause the processor to: model a second non-glucose driven background current associated with the second sensor (col 4 lines 49-54: “electronic circuitry associated with the sensor for receiving the signal and providing a calibrated output based on the signal, wherein the electronic circuitry includes means for determining a calibration function for the sensor based on the first measured sensor signal resulting from the predetermined stimulus.”, col 5 lines 22-25: “means are provided for generating a base line signal corresponding to the signal obtained when substantially no glucose is present in the vicinity of the needle, and the base line signal is used to calibrate the sensor.” ), over a second time duration that extends past the first time duration (col 5 lines 64-67: “the method of testing the sensor needle are repeated periodically. This allows the sensor to be repeatedly tested while in use, thereby monitoring the sensor for deviations from the expected performance”, wherein subsequent calibration extends for a duration following the first); continue to obtain the second current from the second sensor over the second time duration (col 6 lines 30 -50 “applying a potential to the electrode and varying the electrode potential so as to cause the electrode current to undergo at least part of a cycle which exhibits hysteresis; (b) measuring and recording a plurality of current values on the hysteresis cycle; (c) calculating a characteristic point on the hysteresis curve from the plurality of current values; and (e) comparing the characteristic point with a stored value and determining from this comparison whether the sensor meets a predetermined condition.”); subtract the second non-glucose driven background current from the second current measured over the second time duration to obtain the subtracted second current for the second sensor (col 14 lines 43-47: “concentration-dependent calibration function in which the amount added to (or subtracted from) the measured signal 42 c, when mapping this signal to point 40 c, varies in accordance with the position of this point along curve 42”); and convert the subtracted second current to the second glucose value (col 15 lines 11-12: “then be correlated to a value of 0.41 mA on the reference curve, which in turn corresponds to a glucose concentration of 4 mM (72 mg/dlit).”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the apparatus disclosed by Feldman to take further measurements for calibration as disclosed by Gross in order to allow for changes in the performance over the duration of its use (Gross col 1 lines 42-43).
Regarding claim 18, Feldman further discloses wherein to obtain the subtracted second current and convert the subtracted second current to the second glucose value, the instructions, when executed, cause the processor to: recall one or more previously learned glucose sensitivity values from prior use by the subject of other glucose sensors ([0041]: " then a sensitivity may be determined for the second sensor 111B based on the scaling factor determined at step 320 and the sensitivity of the first sensor 111A. This determination may be expressed as follows."); and apply a correction procedure to obtain an accurate glucose sensitivity for the second sensor ([0033]: " the second sensor is calibrated based on one or more scaling factors associated with the two sensors.").
Regarding claim 19, Feldman further discloses the instructions, when executed, cause the processor to generate a conversion operation that includes one or more conversion parameters and which is used to convert the subtracted second current to the second glucose value for each of the first time duration and the second time duration ([0047], Fig 8).
Regarding claim 20, Feldman further discloses each of the first time duration and the second time duration are variable ([0063]: “the time period may be variable”) and terminate responsive to an indication that the conversion operation is accurately converting the subtracted current to the second glucose value during each of the first time duration and the second time duration (Fig 3 elements 350 to 360).
Response to Arguments
Applicant's arguments filed 01/20/2026 with respect to the rejection of claims 1-20 under 35 U.S.C. § 101 have been fully considered but they are not persuasive. Providing an audible or visual alert in response to an indication that a second glucose value of a second glucose sensor is correlated with a predetermined threshold of a first glucose value is a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). As such, the rejection is maintained.
Applicant’s arguments, see pages 2 and 3 of Remarks, filed 01/20/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. § 102/103 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 35 U.S.C. § 103 (see above).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791