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 .
Abstract
The abstract of the disclosure is objected to because abstract will be read as “A method for calibrating an optical system that has a chamber for receiving an element of body fluid or tissue or environmental sample uses a light source for illuminating the chamber with light, and a spectrometer for measuring a spectrum of light originating from the chamber, wherein the brightness of the light source is controlled while measuring a spectrum for calibration with the spectrometer so that the brightness of the light source is a reduced brightness, a brightness reduced relative to a nominal brightness of the light source, and/or a brightness reduced relative to a brightness of the light source when measuring the spectrum of the element; and/or wherein a spectrometer of the optical system is monitored with regard to a changed measurement behavior, and upon detection of the changed measurement behavior of the spectrometer, a calibration is requested or performed.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Specification
The disclosure is objected to because of informalities indicated in an attached, marked-up copy of the specification showing tracking of changes, wherein each change indicates an informality.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: in Figures 4B-F, reference numeral 21 is missing; and none of the figures show reference numeral 32. 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.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Claim Objections
Claims 16, 21, 23-25 and 28-29 are objected to because of informalities indicated in an attached, marked-up copy of the claims showing tracking of changes, wherein each change indicates an informality.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim(s) 16-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carvalho Sousa et al. (US 2019/0323949 A1, hereinafter “Sousa”).
Regarding independent Claim 16, Sousa discloses a method for calibrating an optical system (Figure 1a: handheld and benchtop photonic system, with all the components; [0102]) comprising a chamber for receiving an element (Figure 12: capsule element 22 comprises a chamber for receiving the sample; [0120]) to be characterized by the optical system ([0004] “an optical system for parameter characterization of an element”), a light source (Figure 1a: element 5 is a light source; [0115]) for illuminating the chamber with light ([0005] “a light source for emitting light onto the element”, wherein “the element” is inside a chamber), and a spectrometer for measuring a spectrum of light originating from the chamber ([0006] “a spectrometer for recording the spectrum of light from the element”, wherein “the element” is inside a chamber), the method comprising:
controlling a brightness of the light source ([0073] “provide fine control on both light source and detector”) while measuring a spectrum for calibration with the spectrometer ([0010] “calibration was carried out against a spectrum reference previously measured by a reference spectrometer”), but does not specifically teach that the brightness of the light source is at least one of:
reduced relative to a nominal brightness of the light source,
reduced relative to a brightness of the light source when measuring the spectrum of the element received in the chamber,
feedback controlled.
However, Sousa teaches that the brightness of the light source is “optimized for … light intensity”; [0032], whereby it is understood in the art that optimized can mean reduced or increased, relative to “a nominal brightness of the light source”, which refers to a specified light output under ideal, standardized conditions provided by a manufacturer, and is implicit.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Sousa such that that the brightness of the light source is at least one of: reduced relative to a nominal brightness of the light source, reduced relative to a brightness of the light source when measuring the spectrum of the element received in the chamber, feedback controlled, because this ensures that the instrument's response is linear and all calibration data is accurate across the required spectral range.
Regarding Claim 17, modified Sousa discloses the method according to claim 16, wherein an empty chamber is illuminated with the light source (Figure 1a: element 5 is a light source; [0115]) while the spectrum is measured ([0159] “taking a measurement, without the body element to be characterized, in particular of the empty capsule”).
Regarding Claim 18, modified Sousa discloses the method according to claim 16, wherein the light source comprises at least one LED ([0056] “the light source is a bulb, led diode or laser diodes”), wherein the brightness of the at least one LED when measuring the element ([0039] “the element to be characterized is a sample of body fluid, in particular blood, blood serum, saliva, sweat, urine or tears, or a sample of body tissue, in particular adipose tissue”) is reduced (“optimized for … light intensity”; [0032], whereby it is understood in the art that optimized can mean reduced or increased) compared to its nominal brightness (refers to a specified light output under ideal, standardized conditions provided by a manufacturer, and is implicit) while a spectrum of the light originating from the element and/or the chamber is measured with a spectrometer ([0006] “a spectrometer for recording the spectrum of light from the element”).
Regarding Claim 19, modified Sousa discloses the method according to claim 18, wherein the light source comprises at least two LEDs ([0104] “uv-vis-nir bulbs or led diodes”) for generating light of different wavelengths ([0009] “said spectrum being contained within uv-vis-nir wavelengths, in particular 200-2500 nm wavelengths, further in particular 200-1200 nm wavelengths”), wherein the brightness of the LEDs is reduced (“optimized for … light intensity”; [0032], whereby it is understood in the art that optimized can mean reduced or increased) compared to the LED's nominal brightness (refers to a specified light output under ideal, standardized conditions provided by a manufacturer, and is implicit) when measuring the element ([0039] “the element to be characterized is a sample of body fluid, in particular blood, blood serum, saliva, sweat, urine or tears, or a sample of body tissue, in particular adipose tissue”), while a spectrum of the light originating from the element and/or chamber is measured with the spectrometer ([0006] “a spectrometer for recording the spectrum of light from the element”).
Regarding Claim 20, modified Sousa discloses the method according to claim 16, wherein the brightness is reduced ([0141] “optimizes … light intensity”, whereby it is understood in the art that optimizes can mean reduces or increases) to an extent that the spectrometer is driven at least substantially without overmodulation up to the limit of its dynamic range ([0141] “optimizes both integration time and light intensity, so that the recorded spectra in that window is always, substantially, or as much as possible, inside the optimum sensitivity and linear region of the detector”, wherein “substantially, or as much as possible, inside the optimum sensitivity … of the detector” is interpreted as being within the highest signal level the detector can handle, i.e., limit of its dynamic range, before it becomes saturated, i.e., before it becomes overloaded).
Regarding Claim 21, modified Sousa discloses the method according to claim 16, calibrating the optical system monitoring the spectrometer of the optical system ([0093] “a spectroscopy operating system comprising spectrometer basic operations of quality control, …, …, …, high-end calibration”) with regard to changed measurement behavior ([0133] “due to degradation of optical systems”, for example, or [0159] “for example every time a new disposable capsule is inserted”), and upon detection of changed measurement behavior ([0133] “due to degradation of optical systems”, for example, or [0159] “for example every time a new disposable capsule is inserted”) of the spectrometer ([0006] “a spectrometer for recording the spectrum of light”), performing or requesting calibration wherein spectra of preceding measurements are compared with each other ([0037] “linearly calibrating the spectrometer for each frequency such that the sample spectrum matches a previously obtained reference spectrum”; [0159] “calibrating against a previously obtained spectrum reference”) for monitoring functioning of the spectrometer ([0006] “a spectrometer for recording the spectrum of light”) in order to detect the changed measurement behavior ([0133] “due to degradation of optical systems”, for example, or [0159] “for example every time a new disposable capsule is inserted”).
Regarding Claim 22, modified Sousa discloses the method for according to claim 21, wherein the measured spectrum ([0040] “the spectrum of light from the element, said light from the element being of transmittance, reflectance or Raman scattering”) is compared with a reference spectrum ([0034] “multiple spectral measurements of the … spectrum reference” implies that a comparison is made with “spectrum reference”) and, on the basis of a difference between the measured spectrum and the reference spectrum, a correction variable is determined ([0007] “conversion matrix has been obtained by calibrating the optical system spectrum response against a spectrum reference”, wherein “conversion matrix” is interpreted as correction variable) for correcting spectra measured with the element in the chamber ([0007] “convert the recorded spectrum by a conversion matrix into a standardized spectrum”, wherein “convert the recorded spectrum” is interpreted as correcting spectra measured with the element in the chamber).
Regarding Claim 23, modified Sousa discloses the method according to claim 22, comprising an additional step of determining a parameter ([0001] “point-of-care, real-time, non-invasive determination of parameters”), representing a property of the element ([0004] “parameter characterization of an element of body fluid or tissue”) received in the chamber (Figure 12: capsule element 22 comprises a chamber for receiving the sample; [0120]), with the spectrometer ([0006] “a spectrometer”), after said calibration is first performed ([0037] “linearly calibrating the spectrometer for each frequency such that the sample spectrum matches a previously obtained reference spectrum”; [0159] “calibrating against a previously obtained spectrum reference”), and wherein said parameter is determined ([0001] “point-of-care, real-time, non-invasive determination of parameters”) with the spectrometer ([0006] “a spectrometer”) by illuminating the element with the light source ([0005] “a light source for emitting light onto the element”), measuring with the spectrometer a spectrum of light originating from the element ([0006] “a spectrometer for recording the spectrum of light from the element”), and forming a corrected spectrum by correcting the measured spectrum with the correction variable ([0007] “convert the recorded spectrum by a conversion matrix into a standardized spectrum”, wherein “standardized spectrum” is interpreted as corrected spectrum, “convert the recorded spectrum” is interpreted as correcting the measured spectrum, and “conversion matrix” is interpreted as correction variable) before determining the parameter ([0001] “point-of-care, real-time, non-invasive determination of parameters”) by correlating the corrected spectrum with one or more reference spectra ([Claim 1] “correlate, for parameter quantification, the converted pre-processed spectrum with pre-obtained spectral bands … measured by the reference spectrometer”, wherein “the converted pre-processed spectrum” is interpreted as the corrected spectrum, and “pre-obtained spectral bands … measured by the reference spectrometer” are interpreted as one or more reference spectra).
Regarding Claim 24, modified Sousa discloses the method according to claim 23, wherein the parameter representing a property of different reference elements is determined with a reference method, wherein reference spectra of the respective elements are measured with a reference spectrometer ([0011] “pre-obtained spectral bands for each parameter were previously measured by the reference spectrometer”), and the parameter of the element in the chamber is determined ([0004] “parameter characterization of an element of body fluid or tissue”; Figure 12: capsule element 22 comprises a chamber for receiving the sample; [0120]) by correlating the corrected spectrum with the reference spectra ([Claim 1] “correlate, for parameter quantification, the converted pre-processed spectrum with pre-obtained spectral bands … measured by the reference spectrometer”, wherein “the converted pre-processed spectrum” is interpreted as the corrected spectrum, and “pre-obtained spectral bands … measured by the reference spectrometer” are interpreted as the reference spectra) by means of a self-learning method ([0017] “the spectral bands for each parameter were pre-obtained, explicitly or implicitly, by correlation through multivariate regression, latent variable model, PLS, two-step PLS, S-PLS, canonical correlation, or artificial neural network, or support vector machines”).
Regarding Claim 25, modified Sousa disclose the method according to claim 23, wherein a spectrum determined during a measurement with the spectrometer ([0006] “a spectrometer for recording the spectrum of light from the element”) is examined for plausibility and/or proper functioning of the spectrometer ([0130] “system diagnosis initialization, such as checking and managing the temperature of the light source and spectral recording conditions”; [0130] “diagnosis of the operating system in real time”, wherein “diagnosis” is interpreted as checking for proper functioning) by comparison with spectra previously determined with the spectrometer ([0130] “using a reference for performing the diagnostic of the optical properties of the spectrophotometric system”, wherein “using a reference” is interpreted as comparison) whereupon a quality indicator is assigned to the measurement ([0079] “performs pattern recognition to the spectra fingerprint to check its quality and integrity at each measurement”).
Regarding Claim 26, modified Sousa discloses the method according to claim 25, wherein the quality indicator is output with the measured spectrum ([0079] “performs pattern recognition to the spectra fingerprint to check its quality and integrity at each measurement”, which is interpreted as “quality” of “spectra fingerprint” being indicated) or with the parameter determined using the spectrum (moot).
Regarding Claim 27, modified Sousa discloses the method according to claim 16, wherein the light source ([0104] “uv-vis-nir bulbs or led diodes”) emits a spectral maximum in the UV range and at least one further spectral maximum in the spectral range visible to the human eye and/or in the near infrared range ([0009] “uv-vis-nir wavelengths, in particular 200-2500 nm wavelengths, further in particular 200-1200 nm wavelengths”).
Regarding Claim 28, modified Sousa discloses the method according to claim 16, wherein noise suppression ([0012] “noise rejection”) is performed by at least one of:
reducing power loss of the spectrometer by temporary deactivation,
averaging spectra of the same element from several measurements with the spectrometer,
calibrating the spectrometer ([0010] “the calibration was carried out against a spectrum reference previously measured by a reference spectrometer”) such that the signal-to-noise ratio is increased ([0012] “the reference spectrometer has improved or equal optical resolution”, wherein “improved or equal optical resolution” is interpreted as increased signal-to-noise ratio),
driving the spectrometer at least substantially overload-free up to the limit of its dynamic range ([0141] “optimizes both integration time and light intensity, so that the recorded spectra in that window is always, substantially, or as much as possible, inside the optimum sensitivity and linear region of the detector”, wherein “substantially, or as much as possible, inside the optimum sensitivity … of the detector” is interpreted as being within the highest signal level the detector can handle, i.e., limit of its dynamic range, before it becomes saturated, i.e., before it becomes overloaded) so that the signal-to-noise ratio is increased (as known in the art, signal-to-noise ratio is high when if signal is high and detector is not saturated), and/or
reducing a temperature of the spectrometer ([0139] “The CCD detector has, in an embodiment, an internal thermocouple to measure its temperature, and if this is above the threshold, a mini-fan is used to cool it”), a temperature increase and/or a temperature drift of the spectrometer (moot) by performing a waiting time with the light source deactivated ([0138] “the system holds and waits until the condition is satisfied”) before the calibration is started (moot), before the measurement is started ([0138] “temperature is critical for a stable spectrum emission, either from a led diode, light-bulb or laser diode. If the temperature is inside the optimum interval, the system proceeds”), and/or between the calibration and the measurement (moot).
Regarding independent Claim 29, Sousa discloses an optical system, comprising:
a chamber for receiving an element (Figure 12: capsule element 22 comprises a chamber for receiving the sample; [0120]) to be characterized by the optical system ([0004] “an optical system for parameter characterization of an element”),
a light source (Figure 1a: element 5 is a light source; [0115]) for illuminating the chamber with light ([0005] “a light source for emitting light onto the element”, wherein “the element” is inside a chamber),
a spectrometer for measuring a spectrum of light originating from the chamber ([0006] “a spectrometer for recording the spectrum of light from the element”, wherein “the element” is inside a chamber), and
means for controlling a brightness of the light source ([0073] “provide fine control on both light source and detector”) while measuring a spectrum for calibration with the spectrometer ([0010] “calibration was carried out against a spectrum reference previously measured by a reference spectrometer”), but does not specifically teach that the brightness of the light source is at least one of:
reduced relative to a nominal brightness of the light source,
reduced relative to a brightness of the light source when measuring the spectrum of the element received in the chamber,
feedback controlled.
However, Sousa teaches that the brightness of the light source is “optimized for … light intensity”; [0032], whereby it is understood in the art that optimized can mean reduced or increased, relative to “a nominal brightness of the light source”, which refers to a specified light output under ideal, standardized conditions provided by a manufacturer, and is implicit.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Sousa such that that the brightness of the light source is at least one of: reduced relative to a nominal brightness of the light source, reduced relative to a brightness of the light source when measuring the spectrum of the element received in the chamber, feedback controlled, because this ensures that the instrument's response is linear and all calibration data is accurate across the required spectral range.
Regarding Claim 30, modified Sousa discloses the optical system according to claim 29, wherein the light source comprises at least two LEDs ([0104] “uv-vis-nir bulbs or led diodes”) of different light color ([0009] “said spectrum being contained within uv-vis-nir wavelengths, in particular 200-2500 nm wavelengths, further in particular 200-1200 nm wavelengths”) and at least three fiber optics, wherein light from the two LEDs ([0104] “uv-vis-nir bulbs or led diodes”; Figure 3c: element 36 is a light source; [0129]) is guided to the chamber (Figure 3c: element 32 is a fast plug-in/out system comprising a chamber; [0129]) via two of the three fiber optics (Figure 3c: element 33 is fibre optics that conducts light from the light source, [0129]; two fibre optics are implicit for conducting light from two LED diodes) and light from the chamber (Figure 3c: element 32 is a fast plug-in/out system comprising a chamber; [0129]) is guided to the spectrometer (Figure 3c: element 35 is a spectrometer; [0129]) via a third of the three fiber optics (Figure 3c: element 34 is fibre that conducts light into the spectrometer; [0129]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Akbar H. Rizvi whose telephone number is (571) 272-5085. The examiner can normally be reached Monday - Friday, 9:30 am - 6:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur R. Chowdhury can be reached at (571) 272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AKBAR H. RIZVI/
Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877