DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 17 July 2026. The Examiner acknowledges the amendments to claims 1, 4, 6, 10, 13-15. Claims 1-20 are pending.
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 Objections
Claim(s) 5 is/are objected to because of the following informalities:
Claim 5 should read “The analyte sensor of claim 1, wherein” [line 1].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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) 10 and those dependent therefrom 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 10 recites the limitation “a second signal noise in the second analyte signal stream” [line 14], which is considered to lack antecedent basis, as there is no “first” signal noise in the second analyte signal stream, such that claim 10 is rendered indefinite, as it is unclear how there may be a “second” signal noise in the second analyte signal stream. For examination purposes, the Examiner has interpreted claim 10 read “determine a in the second analyte signal stream” [lines 14-16] to clearly define a signal noise in the second analyte signal stream.
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 sensor;
a memory; and
at least one processor communicatively coupled to the memory, the processor configured to:
generate, using the sensor, a first analyte signal stream;
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 sensor, a second analyte signal stream;
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 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 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 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 sensor” as well as processor steps to “generate, using the sensor, a first analyte signal stream” and “generate, using the sensor, a second analyte signal stream”; claim 13 recites wherein “the sensor is positioned on a body of a user”; 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” 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, previously presented) [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, previously presented) [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, previously presented) [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, 15, 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.
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) 1-9 and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyser (US-20140005505-A1, cited by Applicant, previously presented).
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 elements of a sensor];
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];
determine a reference signal-to-noise ratio based on the reference analyte signal stream and the reference signal noise [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, 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 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 determining the signal-to-noise ratio 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 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].
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:
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) 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Peyser (US-20140005505-A1, cited by Applicant, previously presented) or, in the alternative, under 35 U.S.C. 103 as obvious over Peyser in view of Schmelzeisen-Redeker (US-20120249158-A1), hereinafter Schmelzeisen.
Regarding claim 10, 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); In some alternative dual-electrode or multi-electrode system embodiments, the analyte sensor can be configured to transmit signals obtained from each electrode separately (such as, for example, without subtraction of the baseline signal) (Peyser ¶0125); wherein as depicted in Peyser Fig. 1, the sensor elements of the sensor system as disclosed in ¶0116 may be considered to refer to elements of a sensor];
a memory [The sensor electronics may include a potentiostat, A/D converter, RAM, ROM, transceiver, processor, and/or the like (Peyser ¶0134)]; and
at least one 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 at least one processor configured to:
generate, using the sensor, a first 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 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 ¶0121];
generate, using the sensor, a second 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 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 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)].
However, for the sake of compact prosecution, the Examiner notes that while Peyser discloses that elements of the same sensor may be compared [Peyser ¶¶0116, 0120-0121, 0125], under a narrower interpretation of a “sensor” in which the sensor elements of Peyser are considered to refer to different and separate sensors, Peyser fails to explicitly disclose wherein the same sensor generates the first analyte signal stream and the second analyte signal stream.
The Examiner notes that Peyser does disclose that sensor data and derivatives thereof may be compared over time in the determination of sensor failure [Additionally, sensors may be responsive to baseline or sensitivity changes over time. In some embodiments, where the sensors are manufactured with the same specifications, sensor performance or failure can be identified by comparing the in vivo sensitivities, baseline, changes in sensitivity, or changes in baseline over time or at a certain time after implantation (Peyser ¶0127); In additional embodiments, the functionality of the sensors can be determined by comparing derivatives of sensor properties or parameters with respective to time or second order derivatives, or by comparing the measured parameters themselves. It is envisioned that any of the measured parameters (e.g., sensitivity, current density) described in this application, and derivatives thereof (e.g., the first order derivative of sensitivity with respect to time, that is, the rate of sensitivity change, the second order derivative of sensitivity with respect to time, etc.), can be used to evaluate the level of functionality of the sensors… In certain embodiments, comparison of the sensor properties or derivatives thereof, and/or the deviation between values can be used to determine a probability that one or more of the sensors is not functioning properly. For example, if the measured properties or derivatives thereof of one sensor vary by more than about 10% from the value of the second sensor, there may be an about 90% chance that one or more of the sensors is not functioning properly (Peyser ¶0129); In some embodiments, the processor can identify one data input, or alternatively can identify one or more of the measured parameters described herein. For example, the processor can be programmed to compare the sensitivity of each sensor a certain time or times after implantation (Peyser ¶0136)].
Schmelzeisen discloses systems for determining a malfunction of a sensor for measuring an analyte concentration in vivo, wherein Schmelzeisen discloses comparing a signal-to-noise ratio of a first analyte signal stream measured at a first time by the sensor to a signal-to-noise ratio of a second analyte signal stream measured at a second [later] time by the same sensor [The noise parameter used according to the invention can be a unit-less parameter and indicate the noise in relation to the intensity of a useful signal. Proceeding as mentioned, the noise parameter corresponds to the signal-to-noise ratio that is in use in many technical fields (Schmelzeisen ¶0021); The noise portion n shown in FIG. 2 can be used to calculate a noise parameter that indicates how strongly the measurement is impaired by interference signals… In general, it is preferably to calculate the noise parameter for sliding time windows of at least 5 minutes, for example for time windows of 5 to 30 minutes, in particular 10 to 20 minutes (Schmelzeisen ¶0034); FIG. 5 evidences an increase in the rate of change .DELTA.SD of the noise as a peak that is clearly distinct from the background. The end of the increased noise is indicated likewise by a peak pointing downwards. Accordingly, analysis of the rate of change .DELTA.SD allows increased noise to be detected early and reliably and allows one to conclude that a malfunction is present. For this purpose, the rate of change of the noise can be compared, for example, to a pre-determined threshold value. The rate of change of the noise exceeding a pre-determined threshold value of, for example, half of a standard deviation of the noise per minute triggers the generation of a warning signal (Schmelzeisen ¶0038), wherein determining a rate of change of a noise parameter (signal-to-noise ratio) over time is considered to read on comparing a signal-to-noise ratio at a first point in time to a signal-to-noise ratio at a second (later) point in time].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyte sensor system of Peyser to employ wherein the same sensor generates the first analyte signal stream and the second signal stream, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [enable determination of whether a sensor is non-responsive or malfunctioning based on measured data comparison] [MPEP § 2143(I)(D)]. Under the present modification of Peyser in view of Schmelzeisen, the combination is considered to teach wherein the first and second analyte signal streams, as generated by the same sensor, are respectively used to determine first and second signal noises and first and second signal-to-noise ratios for comparison.
Regarding claim 11, Peyser, or in the alternative, Peyser in view of Schmelzeisen 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, or in the alternative, Peyser in view of Schmelzeisen 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, or in the alternative, Peyser in view of Schmelzeisen teaches
The analyte sensor system of claim 10, wherein generating the first analyte signal stream and the second 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 first/second analyte signal streams is/are understood to be generated after implantation].
Regarding claim 14, Peyser, or in the alternative, Peyser in view of Schmelzeisen teaches
The analyte sensor system of claim 10, wherein the at least one 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 [Peyser ¶¶0090, 0145].
Regarding claim 15, Peyser, or in the alternative, Peyser in view of Schmelzeisen teaches
The analyte sensor system of claim 14, wherein the at least one processor is further configured to request a user action in response to determining that the sensor is defective [Peyser ¶¶0090, 0145].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8, filed 17 July 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The objections for reference characters not mentioned in the description have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-9, with respect to the previously applied rejection(s) under § 112(b) have been fully considered and are persuasive. The rejection of claim 6 under § 112(b) has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 9-11, with respect to the previously applied rejections under § 101 have been fully considered but they are not persuasive.
Regarding the analysis at Step 2A Prong 1, the Applicant asserts that the identification of limitations as reciting mental processes and mathematical concepts oversimplifies the claims under their broadest reasonable interpretation, wherein the Applicant notes that each of claims 1, 10, and 16 comprise limitations that are not merely “observing known or collected data and drawing mental conclusions”, as the claimed operations begin with real analyte signal streams generated by physical sensors and require determining noise in those signal streams. The Applicant further asserts that the specification explains that the problem solved by the invention [¶0022] and that the sensor-stream generation and signal-noise-determination operations cannot be practically be performed in the human mind. The Examiner acknowledges that the claims recite real analyte signal streams generated by physical sensors, and that the positively recited sensors and use of the sensors to generate signal streams were not identified at Step 2A Prong 1 as being directed towards a judicial exception of an abstract idea, and are further analyzed at Step 2A Prong 2 and Step 2B. However, the Examiner notes that the argued limitations directed towards determining noise in the signal streams are considered to be directed towards an abstract idea that may be performed in the mind or by hand and alternatively/in addition to mathematical concepts, and the Applicant argument that the identified limitations would not be able to be performed in the mind or by hand amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the Step 2A Prong 1 analysis.
Regarding the analysis at Step 2A Prong 2, the Applicant asserts that even if aspects of the signal-to-noise-ratio processing were considered mathematical, the claims integrate the aspects into a practical application, as the processing is applied to diagnose whether an analyte sensor has become defective [Applicant’s Specification ¶0023], such that the ordered combination provides a technology-rooted sensor-diagnostics solution in the continuous analyte monitoring field as an improvement to analyte-sensor monitoring by using signal-noise and signal-to-noise-ratio processing to detect a non-responsive or defective physical sensor. However, the Examiner disagrees that the argued improvement integrates the abstract idea(s) into a practical application, as the argued improvement of signal-noise and signal-to-noise-ratio processing to detect a non-responsive or defective physical sensor has been identified as an abstract idea, such that the argued improvement is not considered to be an additional element. As such, under MPEP 2106.05(a), "an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology". Specifically, the "improvements" analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity [MPEP § 2106.04(d)(1)]. It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception [MPEP § 2106.05(a)]. It is important to note that in order for a method claim to improve computer functionality, the broadest reasonable interpretation of the claim must be limited to computer implementation. That is, a claim whose entire scope can be performed mentally, cannot be said to improve computer technology. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit into a hardware component description of a logic circuit was found to be ineligible because the method did not employ a computer and a skilled artisan could perform all the steps mentally) [MPEP § 2106.05(a)(I)]. As such, the claims do not recite additional elements that may integrate the abstract ideas into a practical application of the abstract ideas, and thus the claimed invention is not considered to improve other technology or technical field.
Regarding the analysis at Step 2B, the Applicant asserts that the claimed ordered combination has not been established as well-understood, routine, and conventional, as the cited discussion of sensors, memory, and processors addresses individual components at a high level of generality, but the claims recite an ordered sensor-diagnostic combination as a solution to sensor defectiveness and signal-to-noise erosion [Applicant’s Specification ¶0022] and to allow determination of when an analyte sensor has become defective [¶0023]. However, the Examiner notes that the claimed elements of a sensor(s), memory, and processor are each recited at a high level of generality, such that the analysis of each as being well-understood, routine, and conventional is considered to be applicable. Furthermore, the Examiner directs attention to the response to the arguments regarding the Step 2A Prong 2 analysis regarding the claimed improvement as not being sufficient to integrate the abstract idea(s) into a practical application at Step 2A Prong 2 or allow the claims as a whole to amount to significantly more at Step 2B.
Applicant’s arguments, see Applicant’s Remarks p. 11-12, with respect to the previously presented rejections under § 101 have been fully considered and are persuasive. The rejections of claims 3 and 13 with respect to the positive recitation of the human body under § 101 have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 12-13, with respect to the previously applied rejections under § 102 have been fully considered but they are not persuasive. In the alternative, Applicant’s arguments with respect to claim(s) 10 have been considered but are moot because the new alternative ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the previously applied rejection of claims 1 and 16 under § 102, the Applicant asserts that Peyser’s comparison of values from different sensors is not a disclosure of generating a reference stream and a later analyte stream using the same sensor and then identifying that same sensor as defective. However, the Examiner disagrees with the Applicant’s argument, as claims 1 and 16 refer to the “sensor” at a high level of generality, such that the sensor system of Peyser comprising sensor elements is considered to read on the sensor system of Peyser being configured to perform both functions of generating a reference analyte signal [Peyser ¶¶0120, 0134] and generating an analyte signal stream [Peyser ¶¶0120, 0134]. The Examiner further notes that Peyser additionally refers to sensor elements of a sensor as capable of detecting different analyte signals [Peyser ¶0125]. The Examiner further notes that in response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a “later” analyte stream [there is no claim language directed towards when the reference stream and the analyte stream are generated]) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the previously applied rejection of claim 10 under § 102, the Applicant asserts Peyser does not disclose the claimed arrangement, similar to claims 1 and 16 as discussed above. The Applicant further asserts that claim 10 requires generating both a first analyte signal stream and a second analyte signal stream using the same sensor, determining corresponding signal noises and signal-to-noise ratios, and determining that the sensor is defective based on the recited comparison, wherein the Applicant notes that Peyser does not describe a same-sensor disclosure of defect detection. However, the Examiner disagrees with the Applicant’s arguments for the same reasons as discussed above in the Examiner’s response to the Applicant’s arguments with respect to the § 102 rejections of claims 1 and 16 above mutatis mutandis. However, for the sake of compact prosecution, the Examiner notes that the Applicant’s arguments with respect to claim(s) 10 have been considered but may be considered moot because the new ground of rejection in the alternative does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claim 10 is presently alternatively rejected as obvious over Peyser (US-20140005505-A1, cited by Applicant, previously presented) in view of Schmelzeisen (US-20120249158-A1), wherein the Examiner further notes that Peyser also discloses that sensor data and derivatives thereof may be compared over time in the determination of sensor failure [Peyser ¶¶0127, 0129, 0136] and Schmelzeisen discloses comparing a signal-to-noise ratio of a first analyte signal stream measured at a first time by the sensor to a signal-to-noise ratio of a second analyte signal stream measured at a second [later] time by the same sensor [Schmelzeisen ¶¶0021, 0034, 0038], such that under a narrower interpretation of a “sensor”, the same sensor of Peyser may be modified to generate the first analyte signal stream and the second analyte signal stream at a later point in time for comparison of the first signal-to-noise ratio to the second signal-to-noise ratio.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
