DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding 1, the limitation “a first parameter value” is recited twice in the claim under both the sensor paragraph and the memory paragraph. It is unclear if these first parameter values are the same parameter values. For purposes of examination the indefinite limitation has been deemed to claim the same first parameter values.
Regarding Claims 1 and 19, the limitation “by index” renders the claim indefinite as it is unclear what the index is. For purposes of examination the indefinite limitation has been deemed to claim “indexing”.
Regarding Claim 7, the limitation “pair-data” and “the predetermined pair-data set” renders the claim indefinite. The claims previously set forth a first and second predetermined pair-data set, but not a single generic “pair-data” and “predetermined pair-data set”. For purposes of examination the indefinite limitation has been deemed to claim both first and second predetermined pair-data sets.
Regarding Claim 8, the limitation “based at least on a physical characteristics of a sensor partly” is grammatically broken and therefor renders the claim indefinite. For purposes of examination the indefinite limitation has been deemed to claim where adjustment is based at least somehow on the sensor.
Regarding Claim 19, the limitation “wherein the internal part is penetrated into a subcutaneous to obtain the first parameter value” is grammatically broken and therefor renders the claim indefinite. For purposes of examination the indefinite limitation has been deemed to claim “penetrated subcutaneously”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190320949 A1 to Bohm et al. (hereinafter, Bohm) in view of US 20140121477 A1 to Jin et al. (hereinafter, Jin).
Regarding Claims 1 and 19, Bohm discloses an analyte detection device, comprising inter alia:
a shell ([0265] “…the sensor extends through a housing…”);
a sensor ([0265] “…the sensor extends through a housing…”) comprising an internal part ([0263] “…the continuous analyte sensor system may be comprised of … transdermal device…”) and an external part ([0265] “…electrical connection of the sensor to sensor electronics.”), wherein the internal part is used to penetrate into a subcutaneous skin ([0263] “…the continuous analyte sensor system may be comprised of … transdermal device…”) to obtain a first parameter value ([0264] “…the continuous analyte sensor includes one or more working electrodes and one or more reference electrode, which operate together to measure a signal associated with a concentration of the analyte in the host. The output signal from the working electrode is typically a raw data stream…”);
a memory ([0033] “… the plurality of different sensitivity values are stored in a lookup table in computer memory.”) in which at least a first predetermined pair-data set and a second predetermined pair-data set ([0029] “…the a priori sensitivity information is stored in the sensor electronics prior to use of the sensor.”) composed of a first parameter value and a second parameter value are prestored ([0268] “…calibration of the sensor is obtained by solving the equation: y=mx+b wherein y represents the sensor signal (counts), x represents the estimated glucose concentration (mg/dL), m represents the sensor sensitivity to analyte concentration (counts/mg/dL)…” e.g., the sensor signal y (first parameter value, in counts) and the estimate glucose concentration x (second parameter value, in mg/dL) are related by y=mx+b, where m is the stored sensitivity value. The stored sensitivity value m defines the relationship between the first and second parameter values, and therefore is a pair-data set comprised of a first and second parameter value), wherein the first predetermined pair-data set has at least a time parameter difference relative to the second predetermined pair-data set ([0011] “… the a priori information is associated with at least one predetermined sensitivity value that is associated with a predetermined time after start of a sensor session.” e.g., Each predetermined sensitivity value stored in the lookup table is associated with a predetermined time after start of a sensor session. Therefore, the first stored sensitivity value (first pair-data set) is associated with a second, different predetermined time), and wherein the second parameter value is associated with an in vivo analyte parameter information ([0012] “… at least one predetermined sensitivity value is associated with a correlation between a sensitivity determined from in vitro analyte concentration measurements and a sensitivity determined from in vivo analyte concentration measurements at the predetermined time.” e.g., The predetermined sensitivity value is associated with a correlation between a sensitivity determined from in vitro analyte concentration measurements and a sensitivity determined from in vivo analyte concentration measurements at the predetermined time. Because applying the stored sensitivity to the sensor signal yields the second parameter value (glucose concentration), the second parameter value is associated with in vivo analyte parameter information.);
a processor programmed to call the first predetermined pair-data set from the memory in a first time period, calling the second predetermined pair-data set from the memory in a second time period, and obtaining the second parameter value by index based on the first parameter value ([0124] “…a first set of estimated analyte concentration values is generated using the determined sensitivity value and sensor data associated with a first time period, and wherein a second set of concentration values is generated using the second sensitivity value and sensor data associated with a second time period.”; [0054] “…forming a conversion function based at least in part on the sensitivity value; and determining an analyte output value by applying the conversion function to the at least one sensor data point.”);
a transmitter, which is used to transmit the first parameter value and/or the second parameter value to a remote equipment ([0314] “The transmitter may be used to transmit the first and second signals to a receiver, where additional data analysis and/or calibration of analyte concentration can be processed.”; [0429] “…a receiver, which can also be referred to as a display device, is in communication with the sensor electronics module…”);
(Claim 2) wherein the first parameter value is a current value or a voltage value ([0247] “…a raw data stream measured in counts is directly related to a voltage (for example, converted by an A/D converter), which is directly related to current from a working electrode.”);
(Claim 3) wherein the second parameter value comprises a blood glucose concentration value ([0268] “… x represents the estimated glucose concentration (mg/dL)…”);
(Claim 4) wherein the first predetermined pair-data set is at least partially derived from in vivo tests ([0012] “… least one predetermined sensitivity value is associated with a correlation between a sensitivity determined from in vitro analyte concentration measurements and a sensitivity determined from in vivo analyte concentration measurements at the predetermined time.”), and wherein the second predetermined pair-data set is at least partially derived from in vivo tests ([0033] “…the plurality of different sensitivity values are stored in a lookup table in computer memory.”);
(Claim 5) wherein the first predetermined pair-data set is at least partially derived from in vitro tests ([0012] “… least one predetermined sensitivity value is associated with a correlation between a sensitivity determined from in vitro analyte concentration measurements and a sensitivity determined from in vivo analyte concentration measurements at the predetermined time.”), and wherein the second predetermined pair-data set is at least partially derived from in vitro tests ([0033] “…the plurality of different sensitivity values are stored in a lookup table in computer memory.”) ([0279] “…a sensor may undergo an in vitro sensor sensitivity drift test, in which the sensor is exposed to changing conditions (e.g., step changes of glucose concentrations in a solution), and an in vitro sensitivity profile of the sensor is generated over a certain time period.”);
(Claim 6) wherein a test time difference between the first predetermined pair-data set and the second predetermined pair-data set is equal to a difference between the first time period and the second time period ([0012] “… least one predetermined sensitivity value is associated with a correlation between a sensitivity determined from in vitro analyte concentration measurements and a sensitivity determined from in vivo analyte concentration measurements at the predetermined time.” e.g., Each predetermined sensitivity is tied to a specific predetermined time after start of sensor session, the same time it was testing and the same time it is applied during use. Both pair-data sets follow this rule – the difference in test time automatically equals the difference in application times.);
(Claim 7) wherein at least some of pair-data in the predetermined pair-data set are adjustable ([0298] “…the sensor sensitivity profile may be adjusted during sensor use to account for, in real-time, certain parameters that may affect sensor sensitivity or provide additional information about sensor sensitivity.”);
(Claim 8) wherein an adjustment of the pair-data is based at least on a physical characteristics of a sensor partly ([0298] “These parameters may include, but are not limited to, parameters associated with sensor properties, such as, for example, sensor membrane permeability or the level of sensor hydration…”);
(Claim 9) wherein the physical characteristics of the sensor comprise at least one of a membrane thickness, an active enzyme area, an active enzyme volume or a resistance of an electrode [0298] “These parameters may include, but are not limited to, parameters associated with sensor properties, such as, for example, sensor membrane permeability or the level of sensor hydration…”);
(Claim 10) wherein an adjustment of the pair-data is fixed ([0286] “…although the in vivo to in vitro sensitivity relationship was not equal, the relationship nonetheless involved a consistently fixed ratio.”);
(Claim 11) wherein an adjustment of the pair-data is linear ([0469] “… the sensor sensitivity drift could be compensated using either linear or non-linear sensor sensitivity-impedance correlation.”);
(Claim 12) wherein the first parameter value or the second parameter value is set with at least one threshold, when the first parameter value or the second parameter value exceeds the threshold, the remote equipment sends an alert indication ([0365] “If the impedance magnitude and phase values exceed one or both of the respective predefined levels, then process 1900 initiates an error routine at step 1910. The error routine can include one or more of triggering an audible alarm and/or visual alarm on a display screen to alert a user that the sensor system may not be functioning properly.”);
(Claim 13) wherein the threshold is set by a user or a non-user ([0365] “…predefined levels…”);
(Claim 14) wherein the second parameter value is obtained by interpolating the first parameter value (([0268] “…calibration of the sensor is obtained by solving the equation: y=mx+b…” e.g., applying the linear equation to a measured first parameter reads on interpolating to obtain the second parameter value.);
(Claim 15) wherein the first parameter value in the first predetermined pair-data set or the second predetermined pair-data set is a continuous range interval, and the second parameter value is obtained by judging the range interval in which the first parameter value falls with indexing ([0268] “…calibration of the sensor is obtained by solving the equation: y=mx+b wherein y represents the sensor signal (counts), x represents the estimated glucose concentration (mg/dL), m represents the sensor sensitivity to analyte concentration (counts/mg/dL)…” e.g., the equation operates over a continuous range of current values (first parameter values) and applying it to measured current value “judges” where on that continuous range the value falls, and indexes via the function to yield the glucose value (second parameter)); and
(Claim 18) wherein at least two of the transmitter, the processor and the memory are integrated (all elements of the device are “integrated” because they are part of the same device).
Bohm discloses that electric energy is provided to the device ([0244]), but does not expressly disclose (Claim 1) where a battery specifically provides electric energy and further discloses where part of the sensor is located in the shell ([0265] “… the sensor extends through a housing …”) but does not expressly disclose (Claims 16 and 17) wherein the transmitter, the battery are also located in the shell, and the memory and/or the processor are located in the remote equipment.
However, Jin teaches a transmitter that is in a housing ([0013]), the transmitter including a sensor, a power supply and memory components ([0014], [0039], [0042]) and a processor located in remote equipment ([0038]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to include the aforementioned components in the housing of Jin, as Jin teaches at [0043] that this would have protected those components from water.
Conclusion
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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