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)(4) because reference character ““115” is used to designate each of the processors of the at least partially implantable sensing device 110, external control device 120, and the cloud 130 [Applicant’s Fig. 1]; “140” is used to designate each of the controllers of the at least partially implantable sensing device 110, external control device 120, and the cloud 130 [Applicant’s Fig. 1].
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: “sensor system 100” [Applicant’s Specification ¶0054].
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 Objections
Claim(s) 22 and 30 is/are objected to because of the following informalities:
Claim 22 should read “or a [[ ]]fully implantable sensing device” [line 2] [Examiner notes that there appears to be a double space].
Claim 30 should read “[[A]] The method according to claim 29” [line 1].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
Claim(s) 16, 18, 20-22, 25, 30, 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 16 recites the limitation “the sensor system being programmed” [line 7], which is considered indefinite, as the sensor system is considered to comprise several elements [sensing device comprising a sensor and a temperature sensor], such that it is not specifically clear what element of the system is configured to be programmed, or whether the sensor system is meant to further comprise a processing device to be programmed to perform the claimed functions of the programming. For examination purposes, the Examiner has interpreted the sensor system to further comprise a processing device to be programmed to perform the claimed functions of the programming.
Claim 18 recites the limitation “wherein the sensor system is configured for performing an initial calibration based on said comparison” [lines 1-2], which is considered indefinite, as it is not clear whether the performed initial calibration of claim 18 is meant to further limit the previously recited initial calibration of claim 17 or define a new/separate initial calibration. For examination purposes, the Examiner has interpreted any of the identified interpretations to be applicable in light of any prior art applied under § 102 or § 103.
Claim 20 recites the limitation “the calibration” [line 1], which is considered to lack antecedent basis, as claims 16 and 20 fail to previously define any calibration, and is further considered to render claim 20 indefinite, as it is not clear whether claim 20 is meant to be dependent from either of claims 17-18, which do define a calibration to provide antecedent basis to the calibration as referenced in claim 20, or whether claim 20 is meant to define a new function of a calibration. For examination purposes, the Examiner has interpreted any of the identified interpretations to be applicable in light of any prior art applied under § 102 or § 103.
Claim 21 recites the limitation “the at least partially implantable sensing device” [line 4], which is considered to lack antecedent basis, as claims 16 and 21 fail to previously define any at least partially implantable sensing device or that the sensing device as defined in claim 16 is at least partially implantable, such that the recited limitation is further considered to render claim 21 unclear, as it is not clear whether the sensing device is meant to be further limited as being at least partially implantable or not. For examination purposes, the Examiner has interpreted any of the identified interpretations to be applicable in light of any prior art applied under § 102 or § 103.
Claim 22 recites the limitation “such as for example wherein the sensing device is fully implantable subcutaneous, the sensing device being suitable for sensing at least one compound in a living creature's analyte and/or wherein the temperature sensor is integrated on a substrate or positioned on or close to a substrate in contact with the analyte” [lines 2-6], wherein the phrase "such as for example" [lines 2-3] renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the Examiner has interpreted the recited limitation to be exemplary, wherein the exemplary language is not considered to be part of the claimed invention and are considered optional.
Claim 25 recites the limitation “such as for example a mobile phone, comprising software for controlling the at least partially implantable sensing device and for performing said comparison” [lines 2-4], wherein the phrase "such as for example" [lines 2-3] renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the Examiner has interpreted the recited limitation to be exemplary, wherein the exemplary language is not considered to be part of the claimed invention and are considered optional.
Claim 30 recites the limitation “wherein the method comprises comparing the temperature information derived from the spectroscopic information and the temperature information from the temperature sensor” [lines 1-3], which is considered indefinite, as it is not clear whether the comparison of claim 30 is meant to further limit the comparison of claim 29 or define a separate step of performing a comparison. For examination purposes, the Examiner has interpreted any of the identified interpretations to be applicable in light of any prior art applied under § 102 or § 103.
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) 16-21 and 23-30 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) 16 [representing all independent claims] recite(s):
A sensor system for sensing at least one compound, the sensor system comprising a sensing device comprising:
a sensor configured for capturing spectroscopic information regarding at least one compound in an analyte, and
a temperature sensor configured for capturing temperature information regarding the analyte,
the sensor system being programmed for deriving temperature information from the spectroscopic information and for controlling and/or adapting the sensor system based on a comparison of the temperature information derived from the spectroscopic information and the temperature information captured from the temperature sensor.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) 16 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“deriving temperature information from the spectroscopic information” – may be performed by merely observing at least a limited amount of previously collected or known data and drawing mental conclusions therefrom using known or previously derived relationships or known mathematical formulas/equations [Applicant’s Specification ¶¶0057-0058]
“a comparison of the temperature information derived from the spectroscopic information and the temperature information captured from the temperature sensor” – may be performed by merely observing at least a limited amount of previously collected or known data and drawing mental conclusions therefrom [Applicant’s Specification ¶0057]
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., “deriving temperature information from the spectroscopic information”] 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 16 only recites additional elements of extra-solutionary activity – in particular, extra-solution activity [generic computer function, pre-solution 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) 19, 21, 30 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) 23-26 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extra-solutionary activity [generic computer function, 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 16 and 29 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, pre-solution 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 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 [corresponding § 112(b) interpreted processor and generically recited 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 corresponding functions therein, 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 16 recites “the sensor system comprising a sensing device comprising: a sensor configured for capturing spectroscopic information regarding at least one compound in an analyte, and a temperature sensor configured for capturing temperature information regarding the analyte” and claim 29 recites “using a sensor system for sensing at least one compound in a living creature’s analyte, the method comprising: capturing spectroscopic information using a sensor of a sensing device… capturing temperature information regarding the analyte using a temperature sensor”, wherein claim 27 further limits the temperature as a “bandgap temperature sensor” and claim 28 further limits the sensor for capturing spectroscopic information as being “integrated in a silicon photonics integrated circuit and configured for performing spectral absorption, reflection or transmission measurements for detecting spectral information of the at least one compound”. Such a sensor system/sensing device is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding at least the particular structure of the generically claimed sensor and temperature sensor, and recites the temperature at a high level of generality [In embodiments wherein the sensor 112 is integrated, the substrate 111 may be or may be part of a semiconductor platform, e.g., an integrated circuit and/or a photonic integrated circuit, which may be made, for example, of silicon, silicon-oxide, silicon-carbide, or silicon-nitride or other typical materials of the semiconductor industry… According to embodiments of the present invention, the sensing device 110 furthermore comprises a temperature sensor 113 positioned on or near the substrate 111 for capturing temperature information regarding the substrate. One example of such a temperature sensor is a bandgap temperature sensor, e.g. a silicon bandgap temperature sensor. Such sensors are commonly known temperature sensors, such as the silicon bandgap temperature sensor, which often are integrated in substrates such as integrated circuits or photonics circuits. Nevertheless, it is to be noted that the temperature sensor may also be a different type of temperature sensor, such as for example a thermocouple. More generally any other temperature sensor providing temperature information in the relevant temperature range may be used (Applicant’s Specification ¶0054)]. 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 temperature sensing. 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].
Deck (US-20190336050-A1, cited by Applicant) [an implantable sensor element 110 (Deck ¶0126, Fig. 1); The sensor element 110 comprises at least one optical detector 132 designed to detect at least one property of the reflection light beam 130 and to generate at least one sensor signal dependent on the presence of the analyte… The optical detector 132 may comprise at least one spectrometric setting, for example at least one Fabry-Pérot interferometer (Deck ¶0134, Fig. 1); The evaluation device 134 may be adapted to perform a temperature correction. The sensor signal may be influenced due to temperature changes such that drifts in signal may occur. The evaluation device 134 may be adapted to distinguish signal drift due to temperature change from signal drift due to changes in analyte concentration by using spectral information. The temperature influence may be corrected using calibration data from a prior temperature calibration measurement. Additionally or alternatively, the sensor element 110 may comprise at least one temperature sensor as for example a platinum resistance thermometer. The temperature sensor may be arranged in close proximity to the measurement chamber plate 114. The temperature influence may be corrected using calibration data from a prior temperature calibration measurement and the measured temperature of the temperature sensor (Deck ¶0138)]
Nakamura (US-20210177310-A1) [The component concentration measuring apparatus shown in the figure includes a measurement probe 1 that is arranged near a measurement subject (not shown) or in contact with the measurement subject, a dielectric spectroscopy portion 2, a temperature measurement portion 3, a signal processing portion 4 (correcting portion) (Nakamura ¶0028, Fig. 1); With the correction of this embodiment, it is possible to suppress a change in the output of the dielectric spectroscopy portion 2 due to a change in the temperature, and to measure the amount of change in the component concentration (Nakamura ¶0064)]
Van Gogh (US-20080214913-A1) [In step 208 radiation returning to the spectroscopic apparatus via objective lens 110 is coupled to a respective radiation detector, whose output is finally processed by means of the spectroscopic system 116. This spectral analysis of the return radiation is performed in step 210 and based on this analysis, in the final step 212 a determination of the concentration of the analyte can be performed (Van Gogh ¶0045, Fig. 1)]
Claim 17 recites “performing, based on said comparison, an initial calibration of the sensor system after implantation or for performing a recalibration of the sensor system when in use”, claim 18 recites “performing an initial calibration based on said comparison”, claim 20 recites “wherein the calibration is a personalized calibration of the sensor system fit to the individual user, based on said comparison”. Such a function/step of calibrating a sensor is considered well-understood, routine, and conventional, as known by at least:
Deck ¶0138
Nakamura [a dielectric spectroscopy spectrum of a measurement subject such as a living body is acquired using the dielectric spectroscopy portion 2 that can measure the complex permittivity in MHz to GHz bands and the temperature measurement portion 3 that can measure the temperature in a state in which the dielectric spectroscopy sensor 20 and the temperature sensor 30 are located close to each other, and a change in the dielectric spectroscopy spectrum due to a temperature change is suppressed using the temperature information. Thus, it is possible to measure the component concentration of a measurement subject at a high level of precision even in the case of a measurement subject, such as a living body, in which the temperature changes in a relatively short period of time (Nakamura ¶0067)]
Newberry (US-20170014056-A1) [The above described embodiment of a glucose biosensor 100 still requires calibration using a glucose meter 1200. For example, frequent, even daily calibration with a glucose meter 1200 is sometimes required, and thereby compounds the potential for errors and possible infections. This problem of daily calibration has been difficult to overcome due to various factors including blood emissivity types, tissue color variances, temperature, and even manufactured insulin induced bio-chemical reaction (Newberry ¶0116); In an embodiment, an analytic biosensor is configured to perform monitoring of biometric analytical markers, including glucose levels, using a combination of two or more non-invasive techniques that analyze light reflected from an ear canal. For example, the techniques may include: near infrared spectroscopy, Raman spectroscopy, flourophoresence, thermal emissions, photoacoustic and polarimetry (Newberry ¶0117)]
Examiner’s Note Regarding Particular Treatment or Prophylaxis: No claims are considered to recite subject matter regarding 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.
Examiner’s Note Regarding § 101 Analysis: The Examiner notes that claim(s) 22 recites a judicial exception [see incorporated subject matter of claim 16 identified as being directed towards abstract ideas above] at Step 2A Prong 1, which is considered to be an abstract idea [see Step 2A Prong 1 analysis above]. However, the Examiner further notes that claim(s) 22 recites limitations directed towards additional elements [wherein the sensing device as structurally recited in claim 16 being an at least partially implantable or a fully implantable sensing device] that is considered to integrate the judicial exception into a practical application at Step 2A Prong 2 and allow the invention to amount to significantly more than the judicial exception at 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) 16-25 and 28-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deck (US-20190336050-A1, cited by Applicant).
Regarding claim 16, Deck teaches
A sensor system for sensing at least one compound, the sensor system comprising a sensing device [an implantable sensor element 110 (Deck ¶0126, Fig. 1)] comprising:
a sensor configured for capturing spectroscopic information regarding at least one compound in an analyte [The sensor element 110 comprises at least one optical detector 132 designed to detect at least one property of the reflection light beam 130 and to generate at least one sensor signal dependent on the presence of the analyte… The optical detector 132 may comprise at least one spectrometric setting, for example at least one Fabry-Pérot interferometer (Deck ¶0134, Fig. 1)], and
a temperature sensor configured for capturing temperature information regarding the analyte [Additionally or alternatively, the sensor element 110 may comprise at least one temperature sensor as for example a platinum resistance thermometer (Deck ¶0138)],
the sensor system being programmed for deriving temperature information from the spectroscopic information and for controlling and/or adapting the sensor system based on a comparison of the temperature information derived from the spectroscopic information and the temperature information captured from the temperature sensor [The evaluation device 134 may be adapted to determine the analyte concentration by evaluating the spectral information… The evaluation device 134 may be adapted to identify and/or determine a relevant signal or signal component, for example a signal referring to glucose, and to distinguish the relevant signal from signals of interfering molecules. The evaluation device 134 may be adapted to distinguish the relevant signal from other signal influences such as from signal influences due to system changes such as temperature (Deck ¶0136); The evaluation device 134 may be adapted to perform a temperature correction. The sensor signal may be influenced due to temperature changes such that drifts in signal may occur. The evaluation device 134 may be adapted to distinguish signal drift due to temperature change from signal drift due to changes in analyte concentration by using spectral information. The temperature influence may be corrected using calibration data from a prior temperature calibration measurement. Additionally or alternatively, the sensor element 110 may comprise at least one temperature sensor as for example a platinum resistance thermometer. The temperature sensor may be arranged in close proximity to the measurement chamber plate 114. The temperature influence may be corrected using calibration data from a prior temperature calibration measurement and the measured temperature of the temperature sensor (Deck ¶0138)].
Regarding claim 17, Deck teaches
The sensor system according to claim 16, wherein the sensor system is configured for performing, based on said comparison, an initial calibration of the sensor system after implantation or for performing a recalibration of the sensor system when in use [Deck ¶0138, wherein any calibration after the sensor element 110 is implanted (Deck ¶0126) may be considered to define the initial calibration or recalibration].
Regarding claim 18, Deck teaches
The sensor system according to claim 17, wherein the sensor system is configured for performing an initial calibration based on said comparison and taking into account a modelling of the sensor system behavior after implantation [Deck ¶0138, wherein the temperature influence being corrected following calibration is considered to read on modelling of the sensor system behavior after implantation].
Regarding claim 19, Deck teaches
The sensor system according to claim 16, wherein deriving temperature information from the spectroscopic information comprises deriving temperature information from chemometrics on the spectroscopic information [The evaluation device 134 may be adapted to determine from the spectral information the at least one information on the analyte by using uni- or multivariate data analysis, e.g., principle component regression (PCR) and partial least square regression (PLS). The evaluation device 134 may be adapted to detect and potentially quantify a variety of biomolecules using uni- or multivariate data analysis… The evaluation device 134 may be adapted to distinguish the relevant signal from other signal influences such as from signal influences due to system changes such as temperature (Deck ¶0136); wherein the application of uni/multivariate data analysis to spectral information is considered to read on the broadest reasonable interpretation of chemometrics based on the plain definition of chemometrics referring to “the application of statistics to the field of chemical analysis” (https://www.merriam-webster.com/dictionary/chemometrics)].
Regarding claim 20, Deck teaches
The sensor system according to claim 16, wherein the calibration is a personalized calibration of the sensor system fit to the individual user, based on said comparison [Deck ¶0138, wherein the calibration being based on user data is considered to read on being personalized].
Regarding claim 21, Deck teaches
The sensor system according to claim 16, wherein the sensor system is programmed for, based on said comparison, identifying a drift including caused by drift of one or more components of the sensor system [Deck ¶0138] or drift of the sensor system caused by external causes such as encapsulation of the at least partially implantable sensing device.
Regarding claim 22, Deck teaches
The sensor system according to claim 16, wherein the sensing device is an at least partially implantable sensing device or a fully implantable sensing device [Deck ¶0126], such as for example wherein the sensing device is fully implantable subcutaneous, the sensing device being suitable for sensing at least one compound in a living creature's analyte [As used herein, the term “implantable” refers to the fact that the sensor element is adapted to have appropriate dimensions to be inserted into the body tissue of the user, such as into subcutaneous tissue, and, further, that the sensor element is biocompatible in order to remain in the body tissue for an elongated time period, such as for several days or even several weeks or several months (Deck ¶0020); Deck ¶0126] and/or wherein the temperature sensor is integrated on a substrate or positioned on or close to a substrate in contact with the analyte.
Regarding claim 23, Deck teaches
The sensor system according to claim 16, wherein the sensing device comprises a processor for performing said comparison [As an example, the evaluation device 134 may be or may comprise one or more integrated circuits, such as one or more application-specific integrated circuits (ASICs), and/or one or more data processing devices, such as one or more computers, preferably one or more microcomputers and/or microcontrollers (Deck ¶0135)].
Regarding claim 24, Deck teaches
The sensor system according to claim 16, wherein the sensor system comprises an external control device for controlling the at least partially implantable sensing device, the external control device comprising a processor for performing said comparison [Additionally or alternatively, one or more of these components may be provided in a further device situated outside the body of the user. The sensor element can be adapted to transfer data, such as the raw sensor signal and/or the evaluated sensor signal, automatically and/or upon request to the further device for evaluation and data storing. The control unit can be designed to receive instructions and/or data, for example from the further device, contactless, for example via the inductive connection. The sensor element and the further device may be adapted to communicate, i.e., transfer data and instructions, wirelessly such as by an inductive connection (Deck ¶0046)].
Regarding claim 25, Deck teaches
The sensor system according to claim 24, wherein the external control device is any of a dedicated external control device or a mobile apparatus, such as for example a mobile phone, comprising software for controlling the at least partially implantable sensing device and for performing said comparison [Deck ¶0046].
Regarding claim 28, Deck teaches
The sensor system according to claim 16, wherein the sensor for capturing spectroscopic information is integrated in a silicon photonics integrated circuit and configured for performing spectral absorption, reflection or transmission measurements for detecting spectral information of the at least one compound [the optical detector may comprise an integrated amplifier circuit and/or one or more signal filters (Deck ¶0046); The optical detector 132 may be adapted to determine one or more of intensity, absorbance, attenuation, transmission, reflection, wavelength and frequency of the reflection light beam 130 (Deck ¶0134); The first chamber wall 148 may consist fully of biocompatible material, for example a biocompatible material comprising at least one synthetic diamond or silicon. The first chamber wall 148 may comprise at least one anti-reflective coating adapted to minimize reflections from a surface of the first chamber wall 148 to the optical detector 132 and/or reflections of the reflected beam back into the measurement chamber plate 114, for example in order to minimize interference effects on the signal (Deck ¶0140, Fig. 1); The second infrared window 158 may be or may comprise a silicon plate having a plurality of holes. Such a design can ensure proper rigidity. The silicon plate may be sputtered with a gold layer in order to enhance reflectivity (Deck ¶0144, Fig. 1)].
Regarding claim 29, Deck teaches
A method for using a sensor system for sensing at least one compound in a living creature's analyte [an implantable sensor element 110 (Deck ¶0126, Fig. 1)], the method comprising:
capturing spectroscopic information using a sensor of a sensing device [The sensor element 110 comprises at least one optical detector 132 designed to detect at least one property of the reflection light beam 130 and to generate at least one sensor signal dependent on the presence of the analyte… The optical detector 132 may comprise at least one spectrometric setting, for example at least one Fabry-Pérot interferometer (Deck ¶0134, Fig. 1)] and deriving temperature information from said spectroscopic information [The evaluation device 134 may be adapted to determine the analyte concentration by evaluating the spectral information… The evaluation device 134 may be adapted to identify and/or determine a relevant signal or signal component, for example a signal referring to glucose, and to distinguish the relevant signal from signals of interfering molecules. The evaluation device 134 may be adapted to distinguish the relevant signal from other signal influences such as from signal influences due to system changes such as temperature (Deck ¶0136)],
capturing temperature information regarding the analyte using a temperature sensor [Additionally or alternatively, the sensor element 110 may comprise at least one temperature sensor as for example a platinum resistance thermometer (Deck ¶0138)], and
controlling and/or adapting the sensor system based on a comparison of the temperature information derived from the spectroscopic information and the temperature information captured from the temperature sensor [The evaluation device 134 may be adapted to perform a temperature correction. The sensor signal may be influenced due to temperature changes such that drifts in signal may occur. The evaluation device 134 may be adapted to distinguish signal drift due to temperature change from signal drift due to changes in analyte concentration by using spectral information. The temperature influence may be corrected using calibration data from a prior temperature calibration measurement. Additionally or alternatively, the sensor element 110 may comprise at least one temperature sensor as for example a platinum resistance thermometer. The temperature sensor may be arranged in close proximity to the measurement chamber plate 114. The temperature influence may be corrected using calibration data from a prior temperature calibration measurement and the measured temperature of the temperature sensor (Deck ¶0138)].
Regarding claim 30, Deck teaches
A method according to claim 29, wherein the method comprises comparing the temperature information derived from the spectroscopic information and the temperature information from the temperature sensor and deriving based thereon calibration or recalibration information for the sensor system [Deck ¶0138].
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.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deck, as applied to claim 16 above, in view of Harley-Trochimczyk (US-20190227022-A1).
Regarding claim 26, Deck teaches
The sensor system according to claim 16.
However, Deck fails to explicitly disclose wherein the sensor system is configured to communicate with a cloud-based processor for performing said comparison.
Harley-Trochimczyk discloses sensor systems for sensing at least one compound, wherein Harley-Trochimczyk discloses wherein the sensor system comprises an implantable sensor device that is configured to communicate with a cloud-based processor for performing data analysis [In some example implementations, the system 100 may include a cloud-based analyte processor 490 configured to analyze analyte data (and/or other patient-related data) provided via network 406 (e.g., via wired, wireless, or a combination thereof) from sensor system 8 and other devices, such as display devices 14-20 and the like, associated with the host (also referred to as a subject or patient) and generate reports providing high-level information, such as statistics, regarding the measured analyte over a certain time frame (Harley-Trochimczyk ¶0342, Fig. 1)].
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 system of Deck to employ wherein the sensor system is configured to communicate with a cloud-based processor for performing said comparison, 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 wireless and remote data analysis] [MPEP § 2143(I)(D)].
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deck, as applied to claim 16 above, in view of Sayani (US-10244985-B1).
Regarding claim 27, Deck teaches
The sensor system according to claim 16.
However, Deck fails to explicitly disclose wherein the temperature sensor is a bandgap temperature sensor.
Sayani discloses sensor systems for sensing at least one compound, wherein Sayani discloses wherein the sensor system comprises a sensor device that comprises a bandgap temperature sensor [A temperature sensor 108 may be used to measure the body temperature of the user. The temperature sensor 108 may be implemented in various suitable ways. For example, the temperature sensor 108 may be a thermocouple, a silicon bandgap sensor, a thermometer, or a thermistor comprising one or more sensing resistors (Sayani Col 6:32-37)].
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 system of Deck to employ wherein the temperature sensor is a bandgap temperature sensor, as this modification would amount to mere simple substitution of one known element for another with similar expected results [provide temperature information] [MPEP § 2143(I)(B)].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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