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 .
Summary
This action is responsive to the application filed on 06/20/2024. Applicant has submitted Claims 1-14 for examination.
Examiner finds the following: 1) Claims 1-14 are rejected; 2) no claims objected to; and 3) no claims allowable.
Claim Interpretation
Generally: The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 4-6, 8-9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Jacques (US 5353790 A).
Regarding Claim 1, Jacques discloses:
A method for measuring carotenoid levels in tissue (Jacques, Background, C1, L9-12, “The invention relates to transcutaneous optical measurement of blood components and contaminants, particularly, transcutaneous measurement of hyperbilirubinemia in neonates”). Comprising:
determining a baseline for a melanin correction, the baseline being determined using absorbance values within a specified range (Jacques, FIG. 1, C4, L25-26, “FIG. 1 is a graph of the absorption spectra of bilirubin, oxygenated hemoglobin and dopa-melanin”);
removing the baseline from the absorbance values to determine corrected absorbance values (Jacques, C8, L56-59, “The correction factors were then derived by relating the measured reflectance and transmittance values to the true values predicted by adding-doubling”));
determining, based on the corrected absorbance values, a first optical density (OD) of carotenoids at a first wavelength (Jacques, C2, L49-54, “Various portions of the spectrum are analyzed to determine gestational maturity of the tissue, as well as melanin and blood content of the tissue, in addition to an uncorrected measurement of bilirubin content. Then, calculations are performed using these four quantities to provide a corrected concentration of bilirubin”);
determining, based on the corrected absorbance values, a second OD at a second wavelength that corresponds to a blood absorption peak (Jacques, FIG. 1, C4, L25-26, “FIG. 1 is a graph of the absorption spectra of bilirubin, oxygenated hemoglobin and dopa-melanin.” Examiner notes that FIG. 1 is over a range of wavelengths and that there is a distinct peak in blood absorption around 410 nm);
Jacques discloses the above but does not explicitly disclose:
converting, using extinction coefficients, the second OD from the first wavelength to the second wavelength to provide a blood OD; and
subtracting the blood OD from the first OD to obtain a carotenoid OD.
However, Jacques does disclose the use of extinction coefficients:
C50, L21-25: A.1. Optical Coefficients The rate at which energy is absorbed and scattered by a particle is the energy extinction rate, Wext, of the particle, expressed in watts.
Jacques also discloses subtracting an optical density of a component to arrive at the optical density of another component:
C24, L58-63: one can conclude that the absorbance from the epidermis has to be considered separately than diffuse absorbance present in the rest of the tissue. The optical density of the epidermal absorption can be subtracted linearly from the total optical density of the skin, since the effect on R is linear.
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify Jacques as claimed. PHOSITA would have known about the uses of extinction coefficients when calculating optical density and how to subtract an optical density of a component to arrive at the optical density of another component as disclosed by Jacques and how to use them to modify the system of Jacques. PHOSITA would have been motivated to do this as some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (See MPEP § 2143 (I)(G)), specifically applying a similar method as disclosed by the reference towards a different aspect of the system instead of those explicitly disclosed.
Regarding Claim 2, Jacques discloses Claim 1, and Jacques further discloses:
… removing the baseline from the absorbance values includes subtracting the tangent baseline to correct the absorbance values by removing an absorbance contribution due to melanin (Jacques, C43, L17-20, “The optical density after subtraction of the ODmelanin, at any particular wavelength of interest, is dependent on the scattering of the tissue, and the absorption due to the tissue, blood, and bilirubin at that wavelength”).
Jacques discloses the above but does not explicitly disclose:
… determining the baseline includes using the absorbance values at two wavelengths points within the specified spectral range to create a tangent baseline as the baseline; and …
However, Jacques does disclose:
C2, L49-54: Various portions of the spectrum are analyzed to determine gestational maturity of the tissue, as well as melanin and blood content of the tissue, in addition to an uncorrected measurement of bilirubin content. Then, calculations are performed using these four quantities to provide a corrected concentration of bilirubin.
As Examiner understands the limitation, Applicant is claiming generating a baseline across a range, which Jacques discloses. However, Jacques does not explicitly discuss creating a “tangent baseline.” Based on information and belief, Examiner understands Applicant to be claiming known standard mathematical methods.
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify Jacques as claimed. PHOSITA would have known about the uses of known standard mathematical methods and how to use them to modify the system of Jacques. PHOSITA would have been motivated to do this as some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (See MPEP § 2143 (I)(G)), specifically applying known standard mathematical methods to a system for analysis.
Regarding Claim 4, Jacques discloses Claim 1, and Jacques further discloses:
… comprising adjusting the optical density readings based on body size (Jacques, C37, L34-45, “The effect that the skin thickness has on the measured reflectance is diminished by the fact that the hypodermis, the layer underlying the dermis, is composed primarily of collagen and fat cells and is expected to have a high reflectance value. Furthermore, light that has penetrated deeply into the skin has a higher probability of being diffusely reflected outside. the optical patch collection area than shallow penetrating light. However, variation in skin thickness can still be a source of error in determinations of the skin maturity from the reflectance spectra. Appendix C treats this problem, and estimates the error”).
Regarding Claim 5, Jacques discloses Claim 1, and Jacques further discloses:
… comprising standardizing a sampling area in optical measurements used to generate absorbance spectra that include an absorbance spectrum comprising the absorbance values (Jacques, C8, L56-59, “The correction factors were then derived by relating the measured reflectance and transmittance values to the true values predicted by adding-doubling, and C14, L26-29, “The term Rtissue, or simply R, denotes the true total reflectance of the material measured (tissue or standard)”).
Regarding Claim 6, Jacques discloses Claim 1, but does not explicitly disclose
… comprising correcting the carotenoid OD using one or more machine learning models trained on datasets that include at least one of melanin levels, hemoglobin concentration, biometric data, or known carotenoid levels.
Examiner takes Official Notice on the use of machine learning models as machine learning models are well known in the art. It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify Jacques with machine learning models. PHOSITA would have known about the uses of machine learning models and how to use them to modify Jacques. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of machine learning models when sorting through and analyzing data sets.
Regarding Claim 8, Jacques discloses Claim 1, and Jacques further discloses:
… acquiring the absorbance values using an optical device (Jacques, C40, L7-9, “transcutaneous reflectance spectra are often measured with an optical device, such as an optical patch, in which not all the reflected light is collected”); and
regularly calibrating the optical device with standard references comprising standard reference materials with known optical properties (Jacques, C14, L13-16, “The reflected light measured with an optical patch is usually calibrated relative to a standard reference, such as Teflon”).
Regarding Claim 9, Jacques discloses Claim 1, and Jacques further discloses:
… wherein the absorbance values within the specified range are acquired by measuring absorbance across a range of wavelengths spanning at least 400 nm to generate spectral data (Jacques, FIG. 1, C4, L25-26, “FIG. 1 is a graph of the absorption spectra of bilirubin, oxygenated hemoglobin and dopa-melanin”) and analyzing the spectral data to differentiate carotenoids from other compounds (Jacques, C14, L13-16, “The reflected light measured with an optical patch is usually calibrated relative to a standard reference, such as Teflon”).
Regarding Claim 12, Jacques discloses Claim 4, and Jacques further discloses:
… wherein adjusting the optical density readings based on the size of a subject includes using a correction factor derived from at least one of a body mass index (BMI) of a subject, a weight of the subject, or relevant biometric data (Jacques, C37, L34-45, “The effect that the skin thickness has on the measured reflectance is diminished by the fact that the hypodermis, the layer underlying the dermis, is composed primarily of collagen and fat cells and is expected to have a high reflectance value. Furthermore, light that has penetrated deeply into the skin has a higher probability of being diffusely reflected outside. the optical patch collection area than shallow penetrating light. However, variation in skin thickness can still be a source of error in determinations of the skin maturity from the reflectance spectra. Appendix C treats this problem, and estimates the error”).
Regarding Claim 13, Jacques discloses Claim 5, and Jacques further discloses:
… wherein standardizing the sampling area in optical measurements includes using a standardized device or protocol to maintain uniformity across all subjects (Jacques, C14, L26-29, “The term Rtissue, or simply R, denotes the true total reflectance of the material measured (tissue or standard)”).
Regarding Claim 14, Jacques discloses Claim 6, and Jacques further discloses:
… wherein standardizing the sampling area in optical measurements includes using a standardized device or protocol to maintain uniformity across all subjects (Jacques, C14, L26-29, “The term Rtissue, or simply R, denotes the true total reflectance of the material measured (tissue or standard)”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Jacques (US 5353790 A) in view of Pinter (US 20210299879 A1).
Regarding Claim 7, Jacques discloses Claim 1, but does not explicitly disclose:
… comprising compensating for environmental variations in optical measurements by measuring environmental factors during an optical measurement to acquire the absorbance values and applying to the carotenoid OD correction factors that are based on the measured environmental factors.
However, Pinter, in a similar field of endeavor (MACHINE VISION SYSTEMS, ILLUMINATION SOURCES FOR USE IN MACHINE VISION SYSTEMS, AND COMPONENTS FOR USE IN THE ILLUMINATION SOURCES), discloses:
… comprising compensating for environmental variations in optical measurements by measuring environmental factors during an optical measurement to acquire the absorbance values and applying to the carotenoid OD correction factors that are based on the measured environmental factors (NAME, [0068], “An infrared light may be used to eliminate reflections (e.g., inspecting shiny objects such as chrome parts). Machine vision systems may rely on transitions of gray levels in a digital image. In many machine vision applications, ambient light sources (i.e., overhead room lighting) may contribute unwanted bright reflections that make it difficult or impossible for the vision system to detect the features of interest”).
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify Jacques with the ambient accounting of Pinter. PHOSITA would have known about the uses of ambient accounting as disclosed by Pinter and how to use them to modify Jacques. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of ambient reduction techniques to clean up optical data.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jacques (US 5353790 A) in view of Gellermann (US 6205354 B1).
Regarding Claim 10, Jacques discloses Claim 1, but does not explicitly disclose:
… comprising acquiring optical measurements and applying one or more noise reduction techniques to the optical measurements to provide the absorbance values.
However, Gellermann, in a similar field of endeavor (Method And Apparatus For Noninvasive Measurement Of Carotenoids And Related Chemical Substances In Biological Tissue), discloses:
… comprising acquiring optical measurements and applying one or more noise reduction techniques to the optical measurements to provide the absorbance values (Gellermann, C10, L34-44, The spectrum was measured using resonance Raman techniques for further enhancement of the inherently weak Raman signal. Raman peaks characteristic of carotenoid molecules appear in the graph of FIG. 3, which are superimposed on a broad fluorescence background. Nevertheless, the Raman peaks are clearly resolved, and, using the high dynamic sensitivity range of the CCD detector, can be displayed with good sensitivity resolution and high signal-to-noise ratio. This is shown for example in FIG. 4, where the fluorescence background has been fitted with a higher order polynomial and subtracted from the spectrum).
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify Jacques with the noise reduction of Gellermann. PHOSITA would have known about the uses of noise reduction as disclosed by Gellermann and how to use them to modify Jacques. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of noise reduction techniques to clean up optical data.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jacques (US 5353790 A) in view of Sharifzadeh (US 20140058224 A1).
Regarding Claim 11, Jacques discloses Claim 1, and Jacques further discloses:
… acquiring optical measurements and generating the absorbance values based on the optical measurements (Jacques, FIG. 1, C4, L25-26, “FIG. 1 is a graph of the absorption spectra of bilirubin, oxygenated hemoglobin and dopa-melanin”);
Jacques discloses the above but does not explicitly disclose:
… adjusting the optical measurements based on determining one or more indicia of a tissue hydration status during the optical measurement; and
applying a correction factor to adjust the absorbance values in accordance with the one or more indicia of the tissue hydration status.
However, Jacques does disclose an awareness of the effects of hydration:
C7, L48-51: A separate study of the water content of the skin samples indicated that typical hydration was 65.4% (meanicS.D., n = 10), based on the difference in mass between fresh and oven-dried samples.
Additionally:
C48, L23-29: The difference between the final values of optical properties arrived at here, and the in vitro measurements may be contributed to due to differences in hydration between in vitro skin samples and in vitro skin. The difference between the initial and final values of the scattering coefficient at 585 nm was also less than 10%.
However, Sharifzadeh, in a similar field of endeavor (Method And Apparatus For Noninvasive Measurement Of Carotenoids And Related Chemical Substances In Biological Tissue), discloses:
… adjusting the optical measurements based on determining one or more indicia of a tissue hydration status during the optical measurement (Sharifzadeh, FIG. 4, [0082], “the spectral selection module 440 may filter out collected light outside of the 400 nm-600 nm wavelength. As another example, the spectral selection module 440 may filter out collected light outside of the band of hydrated tissues. In other words, the spectral selection module 440 may filter out signals from irrelevant or unwanted wavelengths,” and FIG. 4, [0083], “a spectrograph may be required to measure the carotenoid, hydration and/or hemoglobin levels in the sample 422”); and
applying a correction factor to adjust the absorbance values in accordance with the one or more indicia of the tissue hydration status (Sharifzadeh, FIG. 4, [0082], “the spectral selection module 440 may filter out collected light outside of the 400 nm-600 nm wavelength. As another example, the spectral selection module 440 may filter out collected light outside of the band of hydrated tissues. In other words, the spectral selection module 440 may filter out signals from irrelevant or unwanted wavelengths,” and FIG. 4, [0083], “a spectrograph may be required to measure the carotenoid, hydration and/or hemoglobin levels in the sample 422”).
It would have been obvious to PHOSITA before the effective filing date of the claimed invention to modify Jacques with the hydration detection of Sharifzadeh. PHOSITA would have known about the uses of hydration detection as disclosed by Sharifzadeh and how to use them to modify Jacques. PHOSITA would have been motivated to do this as a combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 (I)(A)), specifically the use of hydration detection techniques when analyzing skin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAD A REVERMAN whose telephone number is (571)270-0079. The examiner can normally be reached Mon-Fri 9-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kara Geisel can be reached at (571) 272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAD ANDREW REVERMAN/Examiner, Art Unit 2877
/Kara E. Geisel/Supervisory Patent Examiner, Art Unit 2877
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