DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election without traverse of Group I (claims 1-14) in the reply filed on 02 June 2026 is acknowledged. Claim(s) 1-20 is/are pending, with claim(s) 15-20 withdrawn from consideration for being drawn to a non-elected invention and/or species.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation ("BRI") using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The BRI of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked.
As explained in MPEP § 2181(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action.
Claim Objections
Claim(s) 2 is/are objected to because of the following informalities: "instantenous" should be corrected to "instantaneous."
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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) 1-3, 5, 8-9 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0339221 A1 (Bhavaraju) in view of US 2022/0192552 A1 (Feldman).
Regarding claim 1, Bhavaraju discloses and/or suggests an analyte monitoring system, comprising:
a body worn device (Fig. 1, sensor system 101; Fig. 3, on-skin sensor assembly 600; etc.) including a housing (Fig. 3; ¶ [0210]; etc.) that contains a processor (Fig. 2, processor module), a memory (Fig. 2, program memory 216, RAM 218 and/or data storage memory 220), a power supply (Fig. 2, battery 234) and a sensor interface (Fig. 2, first input port 211; ¶ [0219] sensor interposer that mechanically and electrically interfaces the analyte sensor 138 with the sensor electronics; etc.); and
an analyte sensor being coupled to the sensor interface (Fig. 1, continuous analyte sensor 138; ¶ [0219]; etc.), the analyte sensor having a proximal portion contained within the housing being interfaced with the sensor interface, the analyte sensor further having a distal portion configured to be inserted into a host when positioned outside the housing (¶¶ [0252]-[0253]; Figs. 3-4; etc.),
wherein the processor generates calibrated sensor values based on selected calibration coefficients and time-varying inputs from the analyte sensor (¶ [0124] a combination calibration factor is configured to provide a conversion between a detected signal from the sensor wire and an analyte concentration in the user; etc.).
Bhavaraju discloses the system, such as the processor (214) located within the body worn device (e.g., Figs. 1-2) thereof, is configured to select calibration coefficients based on a current state of the analyte monitoring system (e.g., ¶ [0207] life phase; ¶ [0124] upon sensor insertion; etc.), an instantaneous input (e.g., ¶ [0207] initial calibration factor obtained during sensor manufacture, ¶ [0214] some of the parameters involve information, obtained prior to the sensor session, which can be accounted for in a calibration code that is associated with a particular sensor lot), and time-varying inputs received from the analyte sensor (e.g., ¶ [0207] time t since the sensor was manufactured and various parameters pi, such as environmental conditions; ¶ [0214] time of a sensor session, etc.) (e.g., Fig. 20, different calibration factors within each phase for determining sensitivity of the sensor and/or its baseline value). As one apparent example, Bhavaraju discloses sensitivity and baseline (i.e., calibration coefficients used to convert a sensor signal to an analyte concentration, e.g., ¶ [0267]) of a sensor may change or drift as a function of at least one time-varying input, such as time since insertion and/or time within a sensor session, wherein said changes/drifts over a sensor session are consistent among sensors manufactured in the same way under the same conditions (¶¶ [0267]-[0278]; Figs. 7, 20; etc.). Accordingly, Bhavaraju discloses/suggests for a sensor of a particular lot, different calibration coefficients (sensitivity and/or baseline values) should be applied to sensor data at different intervals within the sensor session (e.g., Fig. 7, t1, t2, t3) to accurately/reliably estimate analyte concentration. Bhavaraju does not expressly describe the means of the system for said selection as a finite state machine. However, Bhavaraju does disclose the system may comprise a library of stored calibration functions associated with one or more calibration codes, wherein each calibration function results in calibrating the system for a different set of conditions (i.e., each calibration function is associated with a state determined by the calibration code and condition(s)). Accordingly, Bhavaraju discloses/suggests the system may select one of a plurality of possible calibration coefficients based on instantaneous and time-varying inputs, such that one of ordinary skill in the art would readily appreciate the system, or processor thereof, functions as a finite state machine.
Alternatively/Additionally, Feldman more expressly discloses use of a finite state machine (e.g., Fig. 15) located within the body worn device (e.g., sensor 110, e.g., ¶ [0070]) to identify sensor state based on a current state of the analyte monitoring system (e.g., active paired), an instantaneous input (e.g., threshold time of operation), and time-varying inputs received from the analyte sensor (e.g., time of operation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bhavaraju with a finite state machine located within the body worn device configured to select from possible sensor calibration coefficients based on a current state of the analyte monitoring system, an instantaneous input, and time-varying inputs received from the analyte sensor as disclosed and/or suggested by Feldman (e.g., finite state machine for identifying state of sensor, wherein each state is associated with calibration factors/coefficients) in order to facilitate achieving high level of accuracy during a sensor session without (or with reduced) reliance on reference data from a reference analyte monitor (Bhavaraju, ¶ [0206]).
Regarding claim 2, Bhavaraju as modified discloses/suggests the instantaneous input includes a number of analytes being monitored, an analyte or analytes being monitored, and manufacturing information of the analyte sensor (e.g., ¶ [0214] parameters associated with sensor fabrication and/or information which can be accounted for in a calibration code that is associated with a particular sensor lot; ¶ [0273] sensitivity profile or curve of each sensor or sensor lot; ¶¶ [0279]-[0280]; etc.).
Regarding claims 3 and 5, Bhavaraju as modified discloses/suggests the time-varying inputs include an age of the analyte sensor (¶ [0193], ¶ [0214], ¶ [0268], etc., time since implantation of the sensor, e.g., time of a sensor session), wherein a combination of a current state, the instantaneous input and the age of the analyte sensor transition the finite state machine to a new state that selects a different sensor calibration coefficient (¶ [0214]; ¶ [0268]; Fig. 20, different calibration factors CSSn obtained over time in sensor session phase; etc.).
Regarding claim 8, Bhavaraju as modified discloses and/or suggests the manufacturing information enables transition to different states based on expected sensor measurement values (Bhavaraju, ¶ [0314]; Feldman, ¶ [0155], ¶ [0173]; etc.).
Regarding claims 9 and 11, Bhavaraju as modified discloses/suggests the limitations of claim 2, and the finite state machine is located within the body worn device, as discussed above, and further discloses/suggests, when the sensor age exceeds a maximum duration, the finite state machine transitions to an end-of-life state (e.g., ¶ [0389]). Alternatively/Additionally, Feldman discloses/suggests, when the sensor age exceeds a maximum duration, the finite state machine transitions to an end-of-life state (e.g., Fig. 15, while in active paired state 6055, sensor 110 increments the time of operation; once sensor 110 reaches a predetermined threshold time of operation (e.g., once the time of operation reaches a predetermined threshold), sensor 110 transitions to active expired state 6065). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bhavaraju with, when the sensor age exceeds a maximum duration, the finite state machine transitioning to an end-of-life state as disclosed/suggested by Feldman in order to facilitate shutting down the sensor (Feldman, ¶ [0175]); preventing accidental reuse of the sensor (Bhavaraju, ¶ [0389]); etc.
Regarding claim 12, Bhavaraju as modified discloses/suggests the limitations of claim 1, as discussed above, but does not disclose the analyte sensor is configured to monitor a plurality of analytes using a corresponding plurality of channels. Feldman discloses/suggests a comparable system comprising an analyte sensor configured to monitor a plurality of analytes using a corresponding plurality of channels (e.g., ¶ [0207] sensor 110 can include one working electrode capable of detecting alcohol and/or another working electrode capable of detecting glucose, ketone, lactate, and/or any other analyte levels; sensor 110 can include two or more sensing elements configured to detect two or more analyte levels in a bodily fluid; etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bhavaraju with the analyte sensor being configured to monitor a plurality of analytes using a corresponding plurality of channels as disclosed/suggested by Feldman in order to enable simultaneously sensing multiple analytes to monitor multiple physiological conditions (Feldman, ¶ [0003]).
Regarding claim 13, Bhavaraju as modified discloses/suggests the limitations of claim 12, as discussed above, but does not expressly disclose each of the corresponding plurality of channels includes a finite state machine to select from possible sensor calibration coefficients. However, each of Bhavaraju and Feldman disclose/suggest the state of the sensor, as calibration coefficients associated therewith, are sensor-specific (e.g., manufacturing information, such as lot, membrane application and/or thickness, sensitivity profile, etc.). Feldman further discloses embodiment features may be combined (e.g., ¶ [0254]) and/or the system may incorporate multiple of each component interacting throughout the system (e.g., ¶ [0072]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bhavaraju with each of the corresponding plurality of channels including a finite state machine to select from possible sensor calibration coefficients in order to apply different calibration coefficients to sensor data from each sensor/channel within the sensor session to accurately/reliably estimate concentrations of each analyte.
Regarding claim 14, Bhavaraju as modified discloses/suggests the limitations of claim 13, as discussed above, but does not a state of a first finite state machine is used as an input for a second finite state machine. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Bhavaraju with a state of a first finite state machine is used as an input for a second finite state machine because Applicant has not disclosed that the above-noted configuration provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant merely states, "In some embodiments, the state of one channel may also serve as an input into the state of another channel" (¶ [0045]), without providing any indication as to why, for what purpose, etc. this arrangement may be used. Applicant has provided no disclosure as to how the state of one analyte channel affects or relates to the state of another analyte channel, etc. Accordingly, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with each channel comprising an independent finite state machine as discussed with respect to claim 13 because either arrangement enables applying different calibration coefficients associated with different sensor states to sensor data from each sensor/channel within a session to accurately/reliably estimate concentrations of each analyte.
Claim(s) 4 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhavaraju in view of Feldman as applied to claim(s) 3 above, and further in view of US 2018/0242891 A1 (Bernstein).
Regarding claims 4 and 6-7, Bhavaraju as modified discloses/suggests the limitations of claim 3, as discussed above, and further discloses/suggests calibration factors/coefficients may be determined based on additional parameters, including patient-specific data (e.g., ¶ [0207]) and/or parameters that affect sensor sensitivity or provide additional information about sensor sensitivity during the sensor session (e.g., ¶¶ [0214]-[0215]). Bhavaraju as modified does not disclose the time-varying inputs further include sensor measurement values.
Bernstein discloses/suggests sensor measurement values, particularly whether said sensor measurement values are in a low, medium or high range affects sensor sensitivity, disclosing and/or suggesting a correlation (e.g., function or a lookup table) between sensitivity of each sensor with the median BG value allows a sensor calibration factor to be further optimized to each patient's current state of glucose control (e.g., ¶¶ [0213]-[0215]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bhavaraju with the time-varying inputs further including sensor measurement values, wherein a combination of a current state, the instantaneous input and the sensor measurement values transition the finite state machine to a different state based on the sensor measurement values being in a low, medium or high range, as disclosed and/or suggested by Bernstein in order to further optimize the calibration coefficients applied to generate calibrated sensor values, thereby providing more accurate calibrated sensor values (Bernstein, ¶¶ [0213]-[0215]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhavaraju in view of Feldman as applied to claim(s) 1 above, and further in view of US 2019/0336053 A1 (Halac).
Regarding claim 10, Bhavaraju as modified discloses/suggests the limitations of claim 1, as discussed above, but does not disclose the finite state machine is implemented in hardware that includes single write semiconductors. Halac discloses a system comprising a finite state machine implemented in hardware (e.g., ¶ [0269]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bhavaraju with the finite state machine being implemented in hardware as taught/suggested by Halac in order to offload the function(s) performed thereby from a processor-based controller (Halac, ¶ [0269]).
Bhavaraju as modified does not disclose the finite state machine hardware includes single write semiconductors. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Bhavaraju with the finite state machine hardware including single write semiconductors because Applicant has not disclosed that the above-noted configuration provides an advantage, is used for a particular purpose, or solves a stated problem. The examiner cannot locate any portion of the specification as filed that describes the hardware including single write semiconductors, let alone describing a benefit thereof. Accordingly, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the hardware finite state machine as disclosed/suggested by Bhavaraju as modified above because either arrangement enables offloading identifying sensor state and/or selecting calibration coefficients associated therewith from a processor-based controller.
Alternatively/Additionally, Feldman discloses hardware components (e.g., memory) may be rewriteable or one-time programmable (e.g., ¶ [0084]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bhavaraju with the finite state machine hardware including single write semiconductors as disclosed/suggested by Feldman to provide the hardware finite state machine with the inherent advantages of single-write components, e.g., enhanced reliability, security, etc.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791
