DETAILED ACTION
Applicant’s arguments, filed on 07/24/2026, 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.
Claims 1-20 are the current claims hereby under examination.
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 .
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.
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.
Claims 1, 5-8, 12-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kamath (US 20090242425) in view of Harley-Trochimczyk (US 20190223766).
Regarding independent claim 1, Kamath teaches a multi-analyte sensor system (Abstract: “Systems and methods of use for continuous analyte measurement of a host's vascular system are provided”) comprising:
a first analyte sensor arranged to produce a first analyte signal stream indicating a level of a first analyte ([0056]: “the analyte sensor is configured to generate a measurement signal associated with a measurement analyte concentration in vivo”. The measurement analyte is the first analyte, and the measurement signal is the first analyte signal stream.);
a second analyte sensor arranged to produce a second analyte signal stream indicating a level of a second analyte different from the first analyte ([0056]: “the analyte sensor is further configured to generate a reference signal associated with a reference analyte concentration in vivo”. The reference analyte is the second analyte that is different from the first analyte, and the reference signal is the second analyte signal stream.); and
a sensor electronics module (Abstract: “a continuous glucose measurement system includes … sensor electronics”; [0061]: “sensor electronics configured to process the signal”) configured to:
detect, based on the first analyte signal stream and the second analyte signal stream, an event ([0564]: “the signal related to a reference analyte can be used to calibrate the signals from a continuous analyte sensor, such as in the event of a drift in sensor sensitivity and/or baseline”).
However, Kamath does not teach that the event is at least one of a compression event or a dip and recover event.
Harley-Trochimczyk discloses systems and methods for analyte monitoring. Specifically, Harley-Trochimczyk teaches wherein the event is at least one of a compression event or a dip and recover event ([0130]: “the subject matter of any one or any combination of Examples 101-119 may be configured such that the glucose signal indicative of a condition is received from a continuous glucose sensor, and the condition is compression on a continuous glucose sensor”; [0405]: “rather than using the new gain and offset, a weighted average or probabilistic model may be used so that the gain and offset are not overly influenced by independent factors that may change the sensitivity, such as a period of inaccuracy after initial placement of a sensor (e.g., a “dip and recover” phenomenon where sensor signal generates low sensor signals (dip) during an initial “warm-up” period followed by more accurate (recovered) readings after warm-up)”). Kamath and Harley-Trochimczyk are analogous art as they are both related to analyte sensors.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the events being a compression event or a dip and recover event from Harley-Trochimczyk into the system from Kamath as it allows the system to determine and compensate for a compression event or dip and recover event, both of which can affect the readings of the first analyte, therefore ensuring the system can make an adjustment to provide the most accurate measurement.
The Kamath/Harley-Trochimczyk combination teaches in response to detecting at least one of the compression event or the dip and recover event, make an adjustment related to at least one of the first analyte sensor or the first analyte signal stream based on the event (Kamath, [0564]: “the signals related to the reference analyte, from the continuous analyte and reference sensors, can be processed to determine a calibration factor. The calibration factor can then be used to calibrate the continuous analyte sensor data”. The calibration factor is the adjustment related to the first signal stream. The compression event or dip and recover event can cause a drift in sensor sensitivity and/or baseline as it can change the measurements, therefore prompting the system to determine and apply the calibration factor.).
Regarding claim 5, the Kamath/Harley-Trochimczyk combination teaches the multi-analyte sensor system of Claim 1.
However, the Kamath/Harley-Trochimczyk combination is silent on how the dip and recover event is determined.
Harley-Trochimczyk teaches wherein detecting the dip and recover event is based on detecting drops in both the level of the first analyte and the level of the second analyte followed by a corresponding rise in both the level of the first analyte and the level of the second analyte ([0405]: “a “dip and recover” phenomenon where sensor signal generates low sensor signals (dip) during an initial “warm-up” period followed by more accurate (recovered) readings after warm-up”. Since the dip and recover event happens when there are low sensor signals, that includes low sensor signals from both the first and second analytes.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the detection steps of the dip and recover event from Harley-Trochimczyk into the Kamath/Harley-Trochimczyk combination as the combination is silent on how the dip and recover event is determined, and Harley-Trochimczyk discloses suitable steps in an analogous device.
Regarding claim 6, the Kamath/Harley-Trochimczyk combination teaches the multi-analyte sensor system of Claim 1, wherein the adjustment comprises at least one of (i) powering down the first analyte sensor, (ii) applying a correction to the first analyte signal stream, or (iii) ignoring or purging the first analyte signal stream (Kamath, [0564]: “the signals related to the reference analyte, from the continuous analyte and reference sensors, can be processed to determine a calibration factor. The calibration factor can then be used to calibrate the continuous analyte sensor data”. The calibration factor is the correction applied to the first analyte signal stream.).
Regarding claim 7, the Kamath/Harley-Trochimczyk combination teaches the multi-analyte sensor system of Claim 1, wherein the first analyte is glucose (Kamath, [0004]: “A variety of sensors are known that use an electrochemical cell to provide output signals by which the presence or absence of an analyte, such as glucose”) and wherein the second analyte is lactate (Kamath, [0555]: “a "reference analyte" can be any analyte that can be measured by both the analyte sensor and the reference sensor, such those analytes listed under the definition of "analyte" in the section entitled "Definitions."”; [0268]: “The term "analyte" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include … lactate”).
Regarding independent claim 8, Kamath teaches a method (Abstract: “Systems and methods of use for continuous analyte measurement of a host's vascular system are provided” ) comprising:
producing, by a first analyte sensor, a first analyte signal stream indicating a level of a first analyte ([0056]: “the analyte sensor is configured to generate a measurement signal associated with a measurement analyte concentration in vivo”. The measurement analyte is the first analyte, and the measurement signal is the first analyte signal stream.);
producing, by a second analyte sensor, a second analyte signal stream indicating a level of a second analyte different from the first analyte ([0056]: “the analyte sensor is further configured to generate a reference signal associated with a reference analyte concentration in vivo”. The reference analyte is the second analyte that is different from the first analyte, and the reference signal is the second analyte signal stream.);
detecting, by a sensor electronic module (Abstract: “a continuous glucose measurement system includes … sensor electronics”; [0061]: “sensor electronics configured to process the signal”) and based on the first analyte signal stream and the second analyte signal stream, an event ([0564]: “the signal related to a reference analyte can be used to calibrate the signals from a continuous analyte sensor, such as in the event of a drift in sensor sensitivity and/or baseline”).
However, Kamath does not teach that the event is at least one of a compression event or a dip and recover event.
Harley-Trochimczyk discloses systems and methods for analyte monitoring. Specifically, Harley-Trochimczyk teaches wherein the event is at least one of a compression event or a dip and recover event ([0130]: “the subject matter of any one or any combination of Examples 101-119 may be configured such that the glucose signal indicative of a condition is received from a continuous glucose sensor, and the condition is compression on a continuous glucose sensor”; [0405]: “rather than using the new gain and offset, a weighted average or probabilistic model may be used so that the gain and offset are not overly influenced by independent factors that may change the sensitivity, such as a period of inaccuracy after initial placement of a sensor (e.g., a “dip and recover” phenomenon where sensor signal generates low sensor signals (dip) during an initial “warm-up” period followed by more accurate (recovered) readings after warm-up)”). Kamath and Harley-Trochimczyk are analogous art as they are both related to analyte sensors.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the events being a compression event or a dip and recover event from Harley-Trochimczyk into the method from Kamath as it allows the system to determine and compensate for a compression event or dip and recover event, both of which can affect the readings of the first analyte, therefore ensuring the method can make an adjustment to provide the most accurate measurement.
The Kamath/Harley-Trochimczyk combination teaches in response to detecting at least one of the compression event or the dip and recover event, making, by the sensor electronics module, an adjustment related to at least one of the first analyte sensor or the first analyte signal stream based on the event (Kamath, [0564]: “the signals related to the reference analyte, from the continuous analyte and reference sensors, can be processed to determine a calibration factor. The calibration factor can then be used to calibrate the continuous analyte sensor data”. The calibration factor is the adjustment related to the first signal stream. The compression event or dip and recover event can cause a drift in sensor sensitivity and/or baseline as it can change the measurements, therefore prompting the method to determine and apply the calibration factor.).
Regarding claim 12, the Kamath/Harley-Trochimczyk combination teaches the method of Claim 8.
However, the Kamath/Harley-Trochimczyk combination is silent on how the dip and recover event is determined.
Harley-Trochimczyk teaches wherein detecting the dip and recover event is based on detecting drops in both the level of the first analyte and the level of the second analyte followed by a corresponding rise in both the level of the first analyte and the level of the second analyte ([0405]: “a “dip and recover” phenomenon where sensor signal generates low sensor signals (dip) during an initial “warm-up” period followed by more accurate (recovered) readings after warm-up”. Since the dip and recover event happens when there are low sensor signals, that includes low sensor signals from both the first and second analytes.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the detection steps of the dip and recover event from Harley-Trochimczyk into the Kamath/Harley-Trochimczyk combination as the combination is silent on how the dip and recover event is determined, and Harley-Trochimczyk discloses suitable steps in an analogous device.
Regarding claim 13, the Kamath/Harley-Trochimczyk combination teaches the method of Claim 8, wherein the adjustment comprises at least one of (i) powering down the first analyte sensor, (ii) applying a correction to the first analyte signal stream, or (iii) ignoring or purging the first analyte signal stream (Kamath, [0564]: “the signals related to the reference analyte, from the continuous analyte and reference sensors, can be processed to determine a calibration factor. The calibration factor can then be used to calibrate the continuous analyte sensor data”. The calibration factor is the correction applied to the first analyte signal stream.).
Regarding claim 14, the Kamath/Harley-Trochimczyk combination teaches the method of Claim 8, wherein the first analyte is glucose (Kamath, [0004]: “A variety of sensors are known that use an electrochemical cell to provide output signals by which the presence or absence of an analyte, such as glucose”) and wherein the second analyte is lactate (Kamath, [0555]: “a "reference analyte" can be any analyte that can be measured by both the analyte sensor and the reference sensor, such those analytes listed under the definition of "analyte" in the section entitled "Definitions."”; [0268]: “The term "analyte" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include … lactate”).
Regarding independent claim 15, Kamath teaches a system (Abstract: “Systems and methods of use for continuous analyte measurement of a host's vascular system are provided”) comprising:
a glucose sensor arranged to produce a first signal stream indicating a level of glucose in a user ([0056]: “the analyte sensor is configured to generate a measurement signal associated with a measurement analyte concentration in vivo”; [0004]: “A variety of sensors are known that use an electrochemical cell to provide output signals by which the presence or absence of an analyte, such as glucose”);
a lactate sensor arranged to produce a second signal stream indicating a level of lactate in the user ([0056]: “the analyte sensor is further configured to generate a reference signal associated with a reference analyte concentration in vivo”; [0555]: “a "reference analyte" can be any analyte that can be measured by both the analyte sensor and the reference sensor, such those analytes listed under the definition of "analyte" in the section entitled "Definitions."”; [0268]: “The term "analyte" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include … lactate”); and
a sensor electronics module (Abstract: “a continuous glucose measurement system includes … sensor electronics”; [0061]: “sensor electronics configured to process the signal”) configured to:
detect, based on the first signal stream and the second signal stream, an event ([0564]: “the signal related to a reference analyte can be used to calibrate the signals from a continuous analyte sensor, such as in the event of a drift in sensor sensitivity and/or baseline”).
However, Kamath does not teach that the event is at least one of a compression event or a dip and recover event.
Harley-Trochimczyk discloses systems and methods for analyte monitoring. Specifically, Harley-Trochimczyk teaches wherein the event is at least one of a compression event or a dip and recover event ([0130]: “the subject matter of any one or any combination of Examples 101-119 may be configured such that the glucose signal indicative of a condition is received from a continuous glucose sensor, and the condition is compression on a continuous glucose sensor”; [0405]: “rather than using the new gain and offset, a weighted average or probabilistic model may be used so that the gain and offset are not overly influenced by independent factors that may change the sensitivity, such as a period of inaccuracy after initial placement of a sensor (e.g., a “dip and recover” phenomenon where sensor signal generates low sensor signals (dip) during an initial “warm-up” period followed by more accurate (recovered) readings after warm-up)”). Kamath and Harley-Trochimczyk are analogous art as they are both related to analyte sensors.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the events being a compression event or a dip and recover event from Harley-Trochimczyk into the system from Kamath as it allows the system to determine and compensate for a compression event or dip and recover event, both of which can affect the readings of the first analyte, therefore ensuring the system can make an adjustment to provide the most accurate measurement.
The Kamath/Harley-Trochimczyk combination teaches in response to detecting at least one of the compression event or the dip and recover event, make an adjustment related to at least one of the glucose sensor or the first signal stream based on the event (Kamath, [0564]: “the signals related to the reference analyte, from the continuous analyte and reference sensors, can be processed to determine a calibration factor. The calibration factor can then be used to calibrate the continuous analyte sensor data”. The calibration factor is the adjustment related to the first signal stream. The compression event or dip and recover event can cause a drift in sensor sensitivity and/or baseline as it can change the measurements, therefore prompting the system to determine and apply the calibration factor.).
Regarding claim 19, the Kamath/Harley-Trochimczyk combination teaches the system of Claim 17.
However, the Kamath/Harley-Trochimczyk combination is silent on how the dip and recover event is determined.
Harley-Trochimczyk teaches wherein detecting the dip and recover event is based on detecting drops in both the level of glucose and the level of lactate followed by a corresponding rise in both the level of glucose and the level of lactate ([0405]: “a “dip and recover” phenomenon where sensor signal generates low sensor signals (dip) during an initial “warm-up” period followed by more accurate (recovered) readings after warm-up”. Since the dip and recover event happens when there are low sensor signals, that includes low sensor signals from both the first and second analytes.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the detection steps of the dip and recover event from Harley-Trochimczyk into the Kamath/Harley-Trochimczyk combination as the combination is silent on how the dip and recover event is determined, and Harley-Trochimczyk discloses suitable steps in an analogous device.
Regarding claim 20, the Kamath/Harley-Trochimczyk combination teaches the system of Claim 15, wherein the adjustment comprises at least one of (i) powering down the glucose sensor, (ii) applying a correction to the first signal stream, or (iii) ignoring or purging the first signal stream (Kamath, [0564]: “the signals related to the reference analyte, from the continuous analyte and reference sensors, can be processed to determine a calibration factor. The calibration factor can then be used to calibrate the continuous analyte sensor data”. The calibration factor is the correction applied to the first analyte signal stream.).
Claims 2-4, 9-11, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over the Kamath/Harley-Trochimczyk combination as applied to claims 1, 8, and 15 above, and further in view of Huang (“Effects of Mechanical Compression on Metabolism and Distribution of Oxygen and Lactate in Intervertebral Disc”).
Regarding claim 2, the Kamath/Harley-Trochimczyk combination teaches the multi-analyte sensor system of Claim 1.
However, the Kamath/Harley-Trochimczyk combination is silent on how the compression event is detected.
Harley-Trochimczyk discloses wherein detecting the compression event is based on detecting a drop in the level of the first analyte ([0131]: “the compression is detected based at least in part upon a rapid drop in the glucose signal”. Kamath also discloses that the first analyte is glucose ([0004]: “A variety of sensors are known that use an electrochemical cell to provide output signals by which the presence or absence of an analyte, such as glucose”)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the compression event being detected based on a drop in glucose from Harley-Trochimczyk into the Kamath/Harley-Trochimczyk combination as the combination is silent on how the compression event is determined based on the first analyte, and Harley-Trochimczyk discloses a suitable relation between the compression event and glucose level in an analogous device.
However, the Kamath/Harley-Trochimczyk combination is silent on how the second analyte is used in determining the compression event.
Huang discloses the effects of compression on lactate levels. Specifically, Huang teaches wherein detecting the compression event is based on a corresponding rise in the level of the second analyte (“Dynamic compression … promoted oxygen consumption and lactate production”. Kamath also discloses that the second analyte is lactate ([0555]: “a "reference analyte" can be any analyte that can be measured by both the analyte sensor and the reference sensor, such those analytes listed under the definition of "analyte" in the section entitled "Definitions."”; [0268]: “The term "analyte" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include … lactate”)). Harley-Trochimczyk and Huang are analogous arts as they are both related to determining compression from physiological parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include using lactate levels to determine a compression event from Huang into the Kamath/Harley-Trochimczyk combination as the combination is silent on the effect of the second analyte on the compression event, and Huang discloses a suitable correlation between the second analyte (lactate) and a compression event, which allows for additional measurements used to confirm the compression event.
Regarding claim 3, the Kamath/Harley-Trochimczyk/Huang combination teaches the multi-analyte sensor system of Claim 2.
However, the Kamath/Harley-Trochimczyk/Huang combination does not teach wherein detecting the compression event comprises detecting a physiological state of a user.
Harley-Trochimczyk teaches wherein detecting the compression event comprises detecting a physiological state of a user ([0132]: “the subject matter of Example 120 or 121 may be configured such that the condition is compression during sleep”. Sleep is the physiological state.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the compression being detected during sleep from Harley-Trochimczyk as Harley-Trochimczyk further defines the specific type of compression event, which allows for a more specific analysis and determination of the compression event.
Regarding claim 4, the Kamath/Harley-Trochimczyk/Huang combination teaches the multi-analyte sensor system of Claim 3, wherein the physiological state is whether the user is sleeping (Harley-Trochimczyk, [0132]: “the subject matter of Example 120 or 121 may be configured such that the condition is compression during sleep”).
Regarding claim 9, the Kamath/Harley-Trochimczyk combination teaches the method of Claim 8.
However, the Kamath/Harley-Trochimczyk combination is silent on how the compression event is detected.
Harley-Trochimczyk discloses wherein detecting the compression event is based on detecting a drop in the level of the first analyte ([0131]: “the compression is detected based at least in part upon a rapid drop in the glucose signal”. Kamath also discloses that the first analyte is glucose ([0004]: “A variety of sensors are known that use an electrochemical cell to provide output signals by which the presence or absence of an analyte, such as glucose”)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the compression event being detected based on a drop in glucose from Harley-Trochimczyk into the Kamath/Harley-Trochimczyk combination as the combination is silent on how the compression event is determined based on the first analyte, and Harley-Trochimczyk discloses a suitable relation between the compression event and glucose level in an analogous device.
However, the Kamath/Harley-Trochimczyk combination is silent on how the second analyte is used in determining the compression event.
Huang discloses the effects of compression on lactate levels. Specifically, Huang teaches wherein detecting the compression event is based on a corresponding rise in the level of the second analyte (“Dynamic compression … promoted oxygen consumption and lactate production”. Kamath also discloses that the second analyte is lactate ([0555]: “a "reference analyte" can be any analyte that can be measured by both the analyte sensor and the reference sensor, such those analytes listed under the definition of "analyte" in the section entitled "Definitions."”; [0268]: “The term "analyte" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include … lactate”)). Harley-Trochimczyk and Huang are analogous arts as they are both related to determining compression from physiological parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include using lactate levels to determine a compression event from Huang into the Kamath/Harley-Trochimczyk combination as the combination is silent on the effect of the second analyte on the compression event, and Huang discloses a suitable correlation between the second analyte (lactate) and a compression event, which allows for additional measurements used to confirm the compression event.
Regarding claim 10, the Kamath/Harley-Trochimczyk/Huang combination teaches the method of Claim 9.
However, the Kamath/Harley-Trochimczyk/Huang combination does not teach wherein detecting the compression event comprises detecting a physiological state of a user.
Harley-Trochimczyk teaches wherein detecting the compression event comprises detecting a physiological state of a user ([0132]: “the subject matter of Example 120 or 121 may be configured such that the condition is compression during sleep”. Sleep is the physiological state.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the compression being detected during sleep from Harley-Trochimczyk as Harley-Trochimczyk further defines the specific type of compression event, which allows for a more specific analysis and determination of the compression event.
Regarding claim 11, the Kamath/Harley-Trochimczyk/Huang combination teaches the method of Claim 10, wherein the physiological state is whether the user is sleeping (Harley-Trochimczyk , [0132]: “the subject matter of Example 120 or 121 may be configured such that the condition is compression during sleep”).
Regarding claim 16, the Kamath/Harley-Trochimczyk combination teaches the system of Claim 15.
However, the Kamath/Harley-Trochimczyk combination is silent on how the compression event is detected.
Harley-Trochimczyk discloses wherein detecting the compression event is based on detecting a drop in the level of the first analyte ([0131]: “the compression is detected based at least in part upon a rapid drop in the glucose signal”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the compression event being detected based on a drop in glucose from Harley-Trochimczyk into the Kamath/Harley-Trochimczyk combination as the combination is silent on how the compression event is determined based on the first analyte, and Harley-Trochimczyk discloses a suitable relation between the compression event and glucose level in an analogous device.
However, the Kamath/Harley-Trochimczyk combination is silent on how the second analyte is used in determining the compression event.
Huang discloses the effects of compression on lactate levels. Specifically, Huang teaches wherein detecting the compression event is based on a corresponding rise in the level of the second analyte (“Dynamic compression … promoted oxygen consumption and lactate production”). Harley-Trochimczyk and Huang are analogous arts as they are both related to determining compression from physiological parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include using lactate levels to determine a compression event from Huang into the Kamath/Harley-Trochimczyk combination as the combination is silent on the effect of the second analyte on the compression event, and Huang discloses a suitable correlation between the second analyte (lactate) and a compression event.
Regarding claim 17, the Kamath/Harley-Trochimczyk/Huang combination teaches the system of Claim 16.
However, the Kamath/Harley-Trochimczyk/Huang combination does not teach wherein detecting the compression event comprises detecting a physiological state of a user.
Harley-Trochimczyk teaches further comprising a non-analyte sensor arranged to detect a physiological state of the user, wherein detecting the compression event is further based on the physiological state ([0134]: “sleep is detected using one or more of temperature, posture, activity, and heart rate”; [0402]: “In some systems, devices, or methods, a subcutaneous temperature may be determined (e.g., estimated) using a temperature signal from a non-subcutaneous temperature sensor”; [0132]: “the subject matter of Example 120 or 121 may be configured such that the condition is compression during sleep”. Sleep is the physiological state.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the compression being detected during sleep from Harley-Trochimczyk as Harley-Trochimczyk further defines the specific type of compression event, which allows for a more specific analysis and determination of the compression event.
Regarding claim 18, the Kamath/Harley-Trochimczyk/Huang combination teaches the system of Claim 17, wherein the physiological state is whether the user is sleeping (Harley-Trochimczyk, [0132]: “the subject matter of Example 120 or 121 may be configured such that the condition is compression during sleep”).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant's arguments with regards to claims 1-20 have been fully considered but they are not persuasive. Applicant argues that Kamath does not teach detecting an event based on signal streams indicating levels of two different analytes. This argument is not persuasive, however, since the events that are detected in Kamath are based on the relationship between the analyte and a reference analyte, which are two different analytes. Therefore, the event detection is based on signal streams indicating levels of two different analytes and teaches on this limitation (Kamath, [0564]: “the signal related to a reference analyte can be used to calibrate the signals from a continuous analyte sensor, such as in the event of a drift in sensor sensitivity and/or baseline”; [0289]: “calibration can be updated or recalibrated over time if changes in the relationship between the sensor data and reference data occur, for example, due to changes in sensitivity, baseline”. The reference data is data from the reference analyte.). Applicant also argues that Kamath does not teach identifying either a compression event or a dip and recover event, however Kamath is not relied upon to teach this limitation, therefore this argument is not persuasive.
Applicant also argues that Harley-Trochimczyk does not teach detecting a compression based on both a first analyte signal and a second analyte signal. However, Harley-Trochimczyk is not relied on entirely to teach this limitation. Harley-Trochimczyk is relied upon to teach detecting an event such as compression or dip and recover readings in a signal from an analyte sensor. Events such as these can cause drifts in sensor sensitivity and baseline, which are the events detected in Kamath; therefore, this limitation is merely reciting a specific type of event that is already described in Kamath. Kamath teaches monitoring both the analyte signal and the reference signal to detect events, and therefore teaches the limitation of monitoring two different analytes to detect events. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant also argues that there is no motivation to combine the references. However, as stated above, Kamath teaches monitoring the signal streams to detect events that cause shifts in sensitivity and baseline, and Harley-Trochimczyk is simply providing specific examples of what some of these events are in an analogous analyte sensor, therefore one of ordinary skill in the art would easily look to Harley-Trochimczyk to identify specific types of events that fall under the broad types of events disclosed in Kamath.
Applicant also argues that Harley-Trochimczyk does not disclose drops in the levels of two different analytes followed by corresponding rises in both analytes, such as founds in claims 5, 12, and 19. This argument is again not found persuasive for similar reasons as described above. Harley-Trochimczyk discloses what a dip and recover event is (i.e., low sensor readings initially (the drop in the measured analyte signal) followed by more accurate readings (the corresponding rise in the measured analyte signal)), and Kamath discloses monitoring both an analyte signal and a reference analyte signal, therefore the combination teaches on this limitation. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant also argues that Huang does not teach a rise in lactate levels in a compression event. This argument is not persuasive, since Huang states that compression leads to an increase in lactate production, which directly correlates to a rise in lactate level (i.e., the second analyte). Applicant cites Fig. 7 of Huang showing a decrease in lactate concentration, however Fig. 7 is not used to teach any limitation nor combined with the references and also shows an increase in lactate concentration. Additionally, as stated in the abstract, it was concluded that the compression promoted lactate production, therefore teaches on this limitation. Applicant also argues that there is no motivation to combine Huang, however, as stated in the 103 rejection above, the Kamath/Harley-Trochimczyk combination is silent on the specific effect of the second analyte based on the compression event, therefore it would be obvious for one of ordinary skill in the art to look to another reference such as Huang to identify how a compression event would affect a second analyte such as lactate.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
