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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “display device 107” [¶0081], “sensor electronics module 204” [¶¶0037-0038].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 6 is/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.
Claim 6 recites the limitation “wherein comparing the analyte signal stream to the signal noise comprises…” [lines 1-2], which is considered indefinite, as the recited limitation is written as if further limiting a prior limitation of claims 1 or 6 [as opposed to being written such that an additional limitation is described], however the Examiner notes that there is no previously recited “comparing the analyte signal stream to the signal noise”, such that it is unclear whether the indefinite limitation is meant to define a new step/processor function of “comparing the analyte signal stream to the signal noise” or whether the indefinite limitation is meant to further limit the limitation of claim 1 of “the processor configured to:… determine a signal-to-noise ratio based on the analyte signal stream and the signal noise” [lines 4, 11-12], which the Examiner notes is not presently clearly linked to the indefinite limitation of claim 6 [as claim 1 merely states that the signal-to-noise ratio is based on the analyte signal stream and the signal noise, as opposed to claim 6 reciting “wherein comparing the analyte signal stream to the signal noise”]. For examination purposes, the Examiner has interpreted the indefinite limitation of claim 6 to further limit the limitation of claim 1 of “the processor configured to:… determine a signal-to-noise ratio based on the analyte signal stream and the signal noise”, similar to the limitation of lines 7-8 of claim 1 is further limited by claim 4. The Examiner further notes that the similar limitations of claims 10 [lines 9-10] and 11, as well as claims 16 [lines 4-5] and 18, are considered to be clearly linked.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Representative claim(s) 10 [representing all independent claims] recite(s):
An analyte sensor system, comprising:
a first sensor;
a second sensor;
a memory; and
a processor communicatively coupled to the memory, the processor configured to:
generate, using the first sensor, a first analyte signal stream indicating a level of a first analyte;
determine a first signal noise in the first analyte signal stream;
determine a first signal-to-noise ratio based on the first analyte signal stream and the first signal noise;
generate, using the second sensor, a second analyte signal stream indicating a level of a second analyte;
determine a second signal noise in the second analyte signal stream;
determine a second signal-to-noise ratio based on the second analyte signal stream and the second signal noise; and
in response to determining that the second signal-to-noise ratio exceeds the first signal-to-noise ratio, determine that the first sensor is defective.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) 10 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“determine a first signal noise in the first analyte signal stream” / “determine a second signal noise in the second analyte signal stream” – may be performed by merely observing known or collected data and drawing mental conclusions therefrom
“determine a first signal-to-noise ratio based on the first analyte signal stream and the first signal noise” / “determine a second signal-to-noise ratio based on the second analyte signal stream and the second signal noise” – may be performed by merely observing known or collected data and drawing mental conclusions therefrom [Applicant’s Specification ¶¶0064, 0068]
“in response to determining that the second signal-to-noise ratio exceeds the first signal-to-noise ratio, determine that the first sensor is defective” – may be performed by merely observing known or collected data and drawing mental conclusions therefrom
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extra-solutionary activity (and otherwise generic computer elements) then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Step 2A Prong 1 of the Mayo framework as set forth in the 2019 PEG.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) [i.e., “determine a first signal-to-noise ratio based on the first analyte signal stream and the first signal noise” / “determine a second signal-to-noise ratio based on the second analyte signal stream and the second signal noise”, “in response to determining that the second signal-to-noise ratio exceeds the first signal-to-noise ratio, determine that the first sensor is defective”] to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts [Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)]. The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
The dependent claims merely include limitations that either further define the abstract idea [e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process] and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data [Int. Ventures v. Cap One Financial], collecting information, analyzing it, and displaying certain results of the collection and analysis [Electric Power Group], collection, storage, and recognition of data [Smart Systems Innovations].
Step 2A Prong 2
The judicial exception is not integrated into a practical application.
Representative claim 10 only recites additional elements of extra-solutionary activity – in particular, extra-solution activity [generic computer function, data gathering] – without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 – the instant claim, for example does not tie into a particular machine, a sufficiently particular form of data or signal collection – via the claimed extra-solution activity, or a sufficiently particular form of display or computing architecture/structure).
Dependent claim(s) 4-7, 11-12, 14, and 18-19 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application/integration [the dependent claim(s) recite generic ‘units’ or ‘steps’ which encompass mere computer instructions to carry out an otherwise wholly abstract idea].
Dependent claim(s) 2-3, 8-9, 13, 15, 17, and 20 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extra-solutionary activity [generic data gathering] and/or generic computer elements [storage, memory per se].
Accordingly, the claim(s) are not integrated into a practical application under Step 2A Prong 2.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Independent claims 1, 10, and 16 as individual wholes fail to amount to significantly more than the judicial exception at Step 2B. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of extra-solutionary activity [i.e., generic computer function, data gathering] and generic computer elements cannot amount to significantly more than an abstract idea [MPEP § 2106.05(f)] and is further considered to merely implement an abstract idea on a generic computer [MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality].
For the independent claim portions and dependent claims which provide additional elements of extra-solutionary data gathering, MPEP § 2106.05(g) establishes that mere data gathering for determining a result does not amount to significantly more. The extra-solutionary activity of processor steps [acquiring, storing, generating signals, etc.] as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea.
For the independent claims as well as the dependent claims merely reciting generic computer elements and functions [processor and memory recited at a high level of generality and corresponding functions therein], MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality.
Accordingly, the generic computer elements and functions, as presently limited, cannot provide an inventive concept since they fall under a generic structure and/or function that does not add a meaningful additional feature to the judicial exception(s) of the claim(s).
Claim 1 recites “a sensor” as well as the processor steps to “generate, using the sensor, a reference analyte signal stream” and “generate, using the sensor, an analyte signal stream”; claim 2 recites “wherein the reference analyte signal stream indicates at least one of a lactate level, a ketone level, a creatinine level, a uric acid level, an ethanol level, a sodium level, a potassium level, or a calcium level”; claim 3 recites wherein “the sensor is positioned on a body of a user”; claim 10 recites “a first sensor; a second sensor” as well as processor steps to “generate, using the first sensor, a first analyte signal stream indicating a level of a first analyte” and “generate, using the second sensor, a second analyte signal stream indicating a level of a second analyte”; claim 13 recites wherein “the first sensor is positioned on a body of a user”; claim 15 recites “wherein the first analyte comprises lactate and the second analyte comprises glucose”; claim 16 recites “generating, using a sensor, a reference analyte signal stream” and “generating, using the sensor, an analyte signal stream”; claim 17 recites wherein “the sensor is positioned on a body of a user”; and claim 20 recites “wherein the reference analyte signal stream indicates a lactate level”. Such a “sensor” / “first sensor” / “second sensor” is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed “sensor”, “first sensor”, and “second sensor”, and recites the sensors at a high level of generality [A continuous analyte sensor 114 may include one or more analyte sensors for measuring analytes. A continuous analyte sensor 114 may include a multi-analyte sensor that continuously measures two or more analytes (e.g., glucose, lactate, uric acid, sodium, potassium, ketone, creatinine, etc.), and/or multiple single analyte sensors, each continuously measuring a single analyte (e.g., where one continuous analyte sensor 114 is used for measuring glucose and then a second continuous analyte sensor 114 used for measuring lactate, etc.). The continuous analyte sensor 114 may be a non-invasive device, a minimally-invasive device, a skin-adhered device, a subcutaneous device, a transcutaneous device, a subdermal device, an intradermal device, a transdermal device, or an intravascular device. The continuous analyte sensor 114 may continuously measure analyte levels of a user using one or more techniques, such as enzymatic techniques, ion-selective techniques, aptameric techniques, chemical techniques, physical techniques, electrochemical techniques, spectrophotometric techniques, polarimetric techniques, calorimetric techniques, iontophoretic techniques, radiometric techniques, immunochemical techniques, and the like. The continuous analyte sensor 114 may provide a signal stream indicative of a level (e.g., a concentration) of one or more analytes in the user over time. The signal stream may vary over time as the level of the one or more analytes changes over time. (Applicant’s Specification ¶0028)]. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of analyte monitoring. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications].
Peyser (US-20140005505-A1, cited by Applicant) [In some embodiments, the analyte for measurement by the sensor heads, devices, and methods disclosed herein is glucose. However, other analytes are contemplated as well, including but not limited to… creatine kinase; creatine kinase MM isoenzyme;… lactate… Salts, sugar, protein, fat, vitamins and hormones naturally occurring in blood or interstitial fluids may also constitute analytes in certain embodiments… the analyte may be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to… ethanol… Analytes such as neurochemicals and other chemicals generated within the body may also be analyzed, such as, for example,… uric acid (Peyser ¶0042); The terms "continuous analyte sensor," and "continuous glucose sensor," as used herein, are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a device that continuously or continually measures a concentration of an analyte/glucose (Peyser ¶0049); the sensors can be configured and arranged for transcutaneous implantation (Peyser ¶0092)]
Hoss (US-20100230285-A1) [Embodiments of the present disclosure relate to methods and devices for detecting at least one analyte, such as glucose, in body fluid. Embodiments relate to the continuous and/or automatic in vivo monitoring of the level of one or more analytes using an analyte monitoring system that includes an analyte sensor for the in vivo detection of an analyte, such as glucose, ketones, lactate, and the like, in a body fluid. Embodiments include wholly implantable analyte sensors and transcutaneous analyte sensors in which only a portion of the sensor is positioned under the skin and a portion of the sensor resides above the skin, e.g., for contact to a control unit, transmitter, receiver, transceiver, processor, etc. (Hoss ¶0057)]
Rebec (US-20130217983-A1) [For the purposes of this description, an "implantable sensor" is a sensor that is in planted into the skin with the main body of the sensor, or a portion thereof, residing in the dermis of the skin (Rebec ¶0021); The optical data acquired by the optical sensor may be converted to an analyte concentration, such as a blood glucose value (Rebec ¶0026); Alternatively, a control region may detect another analyte, such as an analyte that is typically present at relatively constant levels within the dermis. Examples of such analytes include, but are not limited to, sodium, potassium, pH, creatinine, uric acid, chloride, and cholesterol (Rebec ¶0031); As illustrated, an implantable sensor 100 may have a base 103 coupled to a body 105. Analysis regions 113 may be arranged along base 103 and surrounded by body 105. Some of the analysis regions may be provided with an analyte reagent system, including one or more sensor reagents, for analyzing the target analyte(s). One or more of the other analysis regions may be configured to serve as a control for calibration and/or to confirm correct positioning, functionality, and/or accessibility of implantable sensor 100 to the target analyte(s) or control analyte(s) (Rebec ¶0035)]
Examiner’s Note Regarding Particular Treatment or Prophylaxis: Claim(s) 9 and 19 recite subject matter regarding “request a user action in response to determining that the sensor is defective”, which the Examiner notes is not considered to be a particular treatment or prophylaxis, as none of the identified claims positively recite or include language that is considered to be a particular treatment or prophylaxis as an additional element to integrate the judicial exception into a practical application or allow the identified claims to amount to significantly more than the judicial exception [MPEP § 2106.04(d)(2)].
Accordingly, the claim(s) as whole(s) fail amount to significantly more than the judicial exception under Step 2B.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 3 recites the limitation “wherein generating the reference analyte signal stream occurs after the sensor is positioned on a body of a user” [lines 1-2, emphasis applied], wherein the emphasized portion of claim 3 is considered to positively recite the human body. The Examiner suggests amending claim 3 to read “wherein the sensor is configured to be positioned on a body of a user, wherein generating the reference analyte signal stream occurs after the sensor is positioned on [[a]] the body of [[a]] the user”.
Claim 13 recites the limitation “wherein generating the first analyte signal stream and the second analyte signal stream occurs after the first sensor is positioned on a body of a user” [lines 1-3, emphasis applied], wherein the emphasized portion of claim 13 is considered to positively recite the human body. The Examiner suggests amending claim 13 to read “wherein the first sensor is configured to be positioned on a body of a user, wherein generating the first analyte signal stream and the second analyte signal stream occurs after the first sensor is positioned on a body of a user”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyser (US-20140005505-A1, cited by Applicant).
Regarding claim 1, Peyser teaches
An analyte sensor system comprising:
a sensor [Although the examples provided above describe a sensor system having two or three sensor elements, it is also contemplated that the sensor system can include any number of sensor elements (Peyser ¶0116); Two or more sensors fabricated with substantially similar characteristics or specifications can be used to take various measurements related to sensor function. In some embodiments, each sensor substantially continuously measures an analyte concentration in the host (Peyser ¶0120), wherein as depicted in Peyser Fig. 1, the sensor elements of the sensor system as disclosed in ¶0116 may be considered to refer to sensor 1 and sensor 2];
a memory [The sensor electronics may include a potentiostat, A/D converter, RAM, ROM, transceiver, processor, and/or the like (Peyser ¶0134)]; and
a processor communicatively coupled to the memory [the measurement data can be processed by electronic circuitry or a processor module in order to identify a sensor failure and/or produce a quality score (Peyser ¶0090)], the processor configured to:
generate, using the sensor, a reference analyte signal stream [Peyser ¶0120; The sensor electronics may include a potentiostat, A/D converter, RAM, ROM, transceiver, processor, and/or the like. The potentiostat may be used to provide a bias to the electrodes and to convert the raw data (e.g., raw counts) collected from a sensor to an analyte concentration value (such as, for example, a glucose concentration value expressed in units of mg/dL) (Peyser ¶0134), wherein any analyte measured by sensor 1 (a sensor element of the sensor system) is considered to be a “reference” analyte signal stream];
determine a reference signal noise in the reference analyte signal stream [the sensors measure other in vivo parameters or sensor properties (such as, for example,… signal to noise ratio,… etc.) (Peyser ¶0121); the sensor electronics may perform additional operations, such as, for example, data filtering and noise analysis (Peyser ¶0134), wherein determining a signal to noise ratio is considered to read on determining a signal noise in order to determine the signal to noise ratio];
compare the reference analyte signal stream to the reference signal noise to determine a reference signal-to-noise ratio [Peyser ¶0121];
generate, using the sensor, an analyte signal stream [Peyser ¶¶0120, 0134, wherein any analyte measured by sensor 2 (a second sensor element of the sensor system) is considered to be the analyte signal stream];
determine a signal noise in the analyte signal stream [Peyser ¶¶0121, 0134, wherein determining a signal to noise ratio is considered to read on determining a signal noise in order to determine the signal to noise ratio];
determine a signal-to-noise ratio based on the analyte signal stream and the signal noise [Peyser ¶0121]; and
in response to determining that the signal-to-noise ratio is less than the reference signal-to-noise ratio, determine that the sensor is defective [The values obtained by each substantially similar sensor can then be compared for consistency. Divergence or variation in values between sensors can indicate that one or more of the sensors may not be working properly… In some embodiments, the sensors measure other in vivo parameters or sensor properties (such as, for example,… signal to noise ratio,… etc.). In such embodiments, sensor failure can be indicated if the measured values by the sensors of such properties vary by more than about, e.g., 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, or 10% or more (Peyser ¶121)].
Regarding claim 2, Peyser teaches
The analyte sensor system of claim 1, wherein the reference analyte signal stream indicates at least one of a lactate level, a ketone level, a creatinine level, a uric acid level, an ethanol level, a sodium level, a potassium level, or a calcium level [In some embodiments, the analyte for measurement by the sensor heads, devices, and methods disclosed herein is glucose. However, other analytes are contemplated as well, including but not limited to… creatine kinase; creatine kinase MM isoenzyme;… lactate… Salts, sugar, protein, fat, vitamins and hormones naturally occurring in blood or interstitial fluids may also constitute analytes in certain embodiments… the analyte may be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to… ethanol… Analytes such as neurochemicals and other chemicals generated within the body may also be analyzed, such as, for example,… uric acid (Peyser ¶0042)].
Regarding claim 3, Peyser teaches
The analyte sensor system of claim 1, wherein generating the reference analyte signal stream occurs after the sensor is positioned on a body of a user [the sensors can be configured and arranged for transcutaneous implantation (Peyser ¶0092), wherein as the sensor is transcutaneous, the reference analyte signal stream is understood to be generated after implantation].
Regarding claim 4, Peyser teaches
The analyte sensor system of claim 1, wherein comparing the reference analyte signal stream to the reference signal noise comprises comparing a peak of the reference analyte signal stream to the reference signal noise [wherein the Examiner notes that a ratio by definition is considered to refer to the relationship in quantity, amount, or size between two or more things (https://www.merriam-webster.com/dictionary/ratio), such that Peyser ¶0121 is considered to anticipate comparing any peak of the reference analyte signal stream (which is understood to be defined as a value over time, see Peyser ¶¶0120, 0134) to the reference signal noise].
Regarding claim 5, Peyser teaches
The analyte sensor system of claim 1 wherein determining the reference signal noise occurs while generating the reference analyte signal stream [Peyser ¶¶0120-0121, wherein the as the sensor continuously measures, the reference signal noise is considered to be generated while the reference analyte signal stream is generated].
Regarding claim 6, Peyser teaches
The analyte sensor system of claim 1, wherein comparing the analyte signal stream to the signal noise comprises comparing a peak of the analyte signal stream to the signal noise [wherein the Examiner notes that a ratio by definition is considered to refer to the relationship in quantity, amount, or size between two or more things (https://www.merriam-webster.com/dictionary/ratio), such that Peyser ¶0121 is considered to anticipate comparing any peak of the analyte signal stream (which is understood to be defined as a value over time, see Peyser ¶¶0120, 0134) to the signal noise].
Regarding claim 7, Peyser teaches
The analyte sensor system of claim 1, wherein determining the signal noise occurs while generating the analyte signal stream [Peyser ¶¶0120-0121, wherein the as the sensor continuously measures, the signal noise is considered to be generated while the analyte signal stream is generated].
Regarding claim 8, Peyser teaches
The analyte sensor system of claim 1, wherein the processor is further configured to communicate at least one of an alert, a notification, or an alarm in response to determining that the sensor is defective [the system can prompt a user, such as, for example, a patient or doctor, to respond to the sensor failure in any of a variety of ways (Peyser ¶0090); After certain sensor failures are identified, such as biofouling or encapsulation, the sensor may no longer be reliable, providing inaccurate sensor data. To prevent further use of the unreliable sensor, in some embodiments a user is notified to change the sensor after it has been determined that the sensor should no longer be used (Peyser ¶0145)].
Regarding claim 9, Peyser teaches
The analyte sensor system of claim 1, wherein the processor is further configured to request a user action in response to determining that the sensor is defective [Peyser ¶0090, 0145].
Regarding claim 10, Peyser teaches
An analyte sensor system, comprising:
a first sensor [Two or more sensors fabricated with substantially similar characteristics or specifications can be used to take various measurements related to sensor function. In some embodiments, each sensor substantially continuously measures an analyte concentration in the host (Peyser ¶0120); sensor 1 in Peyser Fig. 1];
a second sensor [Peyser ¶0120, sensor 2 in Peyser Fig. 1];
a memory [The sensor electronics may include a potentiostat, A/D converter, RAM, ROM, transceiver, processor, and/or the like (Peyser ¶0134)]; and
a processor communicatively coupled to the memory [the measurement data can be processed by electronic circuitry or a processor module in order to identify a sensor failure and/or produce a quality score (Peyser ¶0090)], the processor configured to:
generate, using the first sensor, a first analyte signal stream indicating a level of a first analyte [Peyser ¶0120; The sensor electronics may include a potentiostat, A/D converter, RAM, ROM, transceiver, processor, and/or the like. The potentiostat may be used to provide a bias to the electrodes and to convert the raw data (e.g., raw counts) collected from a sensor to an analyte concentration value (such as, for example, a glucose concentration value expressed in units of mg/dL) (Peyser ¶0134)];
determine a first signal noise in the first analyte signal stream [the sensors measure other in vivo parameters or sensor properties (such as, for example,… signal to noise ratio,… etc.) (Peyser ¶0121); the sensor electronics may perform additional operations, such as, for example, data filtering and noise analysis (Peyser ¶0134), wherein determining a signal to noise ratio is considered to read on determining a signal noise in order to determine the signal to noise ratio];
determine a first signal-to-noise ratio based on the first analyte signal stream and the first signal noise [Peyser ¶0120];
generate, using the second sensor, a second analyte signal stream indicating a level of a second analyte [Peyser ¶¶0120, 0134];
determine a second signal noise in the second analyte signal stream [Peyser ¶¶0121, 0134, wherein determining a signal to noise ratio is considered to read on determining a signal noise in order to determine the signal to noise ratio];
determine a second signal-to-noise ratio based on the second analyte signal stream and the second signal noise [Peyser ¶0121]; and
in response to determining that the second signal-to-noise ratio exceeds the first signal-to-noise ratio, determine that the first sensor is defective [The values obtained by each substantially similar sensor can then be compared for consistency. Divergence or variation in values between sensors can indicate that one or more of the sensors may not be working properly… In some embodiments, the sensors measure other in vivo parameters or sensor properties (such as, for example,… signal to noise ratio,… etc.). In such embodiments, sensor failure can be indicated if the measured values by the sensors of such properties vary by more than about, e.g., 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, or 10% or more (Peyser ¶121)].
Regarding claim 11, Peyser teaches
The analyte sensor system of claim 10, wherein determining the first signal-to-noise ratio comprises comparing a peak of the first analyte signal stream to the first signal noise [wherein the Examiner notes that a ratio by definition is considered to refer to the relationship in quantity, amount, or size between two or more things (https://www.merriam-webster.com/dictionary/ratio), such that Peyser ¶0121 is considered to anticipate comparing any peak of the first analyte signal stream (which is understood to be defined as a value over time, see Peyser ¶¶0120, 0134) to the first signal noise].
Regarding claim 12, Peyser teaches
The analyte sensor system of claim 10, wherein determining the first signal noise occurs while generating the first analyte signal stream [Peyser ¶¶0120-0121, wherein the as the sensors continuously measure, the first signal noise is considered to be generated while the first analyte signal stream is generated].
Regarding claim 13, Peyser teaches
The analyte sensor system of claim 10, wherein generating the first analyte signal stream and the second analyte signal stream occurs after the first sensor is positioned on a body of a user [Peyser ¶0092, wherein as the sensors are transcutaneous, the first analyte signal stream and the second analyte signal stream are understood to be generated after implantation].
Regarding claim 14, Peyser teaches
The analyte sensor system of claim 10, wherein generating the first analyte signal stream occurs while generating the second analyte signal stream [Peyser ¶¶0120-0121, wherein the as the sensors continuously measure, the first analyte signal stream is considered to be generated while the second analyte signal stream is generated].
Regarding claim 15, Peyser teaches
The analyte sensor system of claim 10, wherein the first analyte comprises lactate and the second analyte comprises glucose [In some embodiments, the analyte for measurement by the sensor heads, devices, and methods disclosed herein is glucose. However, other analytes are contemplated as well, including but not limited to… lactate (Peyser ¶0042)].
Regarding claim 16, Peyser teaches
A method, comprising:
generating, using a sensor, a reference analyte signal stream [Although the examples provided above describe a sensor system having two or three sensor elements, it is also contemplated that the sensor system can include any number of sensor elements (Peyser ¶0116); Two or more sensors fabricated with substantially similar characteristics or specifications can be used to take various measurements related to sensor function. In some embodiments, each sensor substantially continuously measures an analyte concentration in the host (Peyser ¶0120); The sensor electronics may include a potentiostat, A/D converter, RAM, ROM, transceiver, processor, and/or the like. The potentiostat may be used to provide a bias to the electrodes and to convert the raw data (e.g., raw counts) collected from a sensor to an analyte concentration value (such as, for example, a glucose concentration value expressed in units of mg/dL) (Peyser ¶0134), wherein as depicted in Peyser Fig. 1, the sensor elements of the sensor system as disclosed in ¶0116 may be considered to refer to sensor 1 and sensor 2, and wherein any analyte measured by sensor 1 (a sensor element of the sensor system) is considered to be a “reference” analyte signal stream];
determining a reference signal noise in the reference analyte signal stream [the sensors measure other in vivo parameters or sensor properties (such as, for example,… signal to noise ratio,… etc.) (Peyser ¶0121); the sensor electronics may perform additional operations, such as, for example, data filtering and noise analysis (Peyser ¶0134), wherein determining a signal to noise ratio is considered to read on determining a signal noise in order to determine the signal to noise ratio];
comparing the reference analyte signal stream to the reference signal noise to determine a reference signal-to-noise ratio [Peyser ¶0121];
generating, using the sensor, an analyte signal stream [Peyser ¶¶0120, 0134, wherein any analyte measured by sensor 2 (a second sensor element of the sensor system) is considered to be the analyte signal stream];
determining a signal noise in the analyte signal stream [Peyser ¶¶0121, 0134, wherein determining a signal to noise ratio is considered to read on determining a signal noise in order to determine the signal to noise ratio];
determining a signal-to-noise ratio based on the analyte signal stream and the signal noise [Peyser ¶0121]; and
in response to determining that the reference signal-to-noise ratio exceeds the signal-to-noise ratio, determining that the sensor is defective [The values obtained by each substantially similar sensor can then be compared for consistency. Divergence or variation in values between sensors can indicate that one or more of the sensors may not be working properly… In some embodiments, the sensors measure other in vivo parameters or sensor properties (such as, for example,… signal to noise ratio,… etc.). In such embodiments, sensor failure can be indicated if the measured values by the sensors of such properties vary by more than about, e.g., 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, or 10% or more (Peyser ¶121)].
Regarding claim 17, Peyser teaches
The method of claim 16, wherein generating the reference analyte signal stream occurs after the sensor is positioned on a body of a user [Peyser ¶0092, wherein as the sensor is transcutaneous, the reference analyte signal stream is understood to be generated after implantation].
Regarding claim 18, Peyser teaches
The method of claim 16, wherein determining the reference signal-to-noise ratio comprises comparing a peak of the reference analyte signal stream to the reference signal noise [wherein the Examiner notes that a ratio by definition is considered to refer to the relationship in quantity, amount, or size between two or more things (https://www.merriam-webster.com/dictionary/ratio), such that Peyser ¶0121 is considered to anticipate comparing any peak of the reference analyte signal stream (which is understood to be defined as a value over time, see Peyser ¶¶0120, 0134) to the reference signal noise].
Regarding claim 19, Peyser teaches
The method of claim 16, further comprising requesting a user action in response to determining that the sensor is defective [Peyser ¶0090, 0145].
Regarding claim 20, Peyser teaches
The method of claim 16, wherein the reference analyte signal stream indicates a lactate level [Peyser ¶0042].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kuban (“Fundamental aspects of contactless conductivity detection for capillary electrophoresis. Part II: Signal-to-noise ratio and stray capacitance”, NPL attached) discloses methods for determining a signal-to-noise ratio, wherein the determination comprises comparing a peak of a signal stream to a signal noise by determining a ratio of the power of the signal stream at its peak amplitude to the power of the signal noise [The signal-to-noise ratios were calculated as the peak height divided by the background noise value. The peak-to-peak background noise was measured for a 15 s section of the baseline where no analyte peak occurred and the baseline was stable (typically 30–60 s after injection) (Kuban p. 3399)]
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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