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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: skin measurement unit in claim 1, light-emitting unit in claim 1, light detection unit in claim 1. The proceeding claim limitations are being modified by sufficient structure, material, or acts for performing the claim function.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: skin component amount calculation unit in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 2 & 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richards et al. (U.S. Patent Application 2021/0330207 A1).
Claim 1: Richards teaches –
A component amount measurement device [PPG device] (Figure 1, Element 100) for measuring skin component amount information about a user [(SpO2) can be obtained. SpO2 refers to a fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood] (Para 0004),
Examiner’s Note: In Para 54 of the Specification as originally filed discloses components of the skin as water, hemoglobin, melanin, fat, etc.
the device comprising:
a skin measurement unit for measuring the skin of the user [PPG sensor interacts with the skin surface] (Para 0032 and Figure 1B, Element 116, 102, 106 & 122); and
a skin component amount calculation unit [processors] (Figure 1B, Element 110) for calculating a component amount for a target component in the skin of the user [the processor 110 generates a physiological metric…Various techniques for generating…SpO2] (Para 0070),
wherein the skin measurement unit comprises:
a light-emitting unit that comprises at least one light source [light sources] (Figure 1G, Element 102); and
a light detection unit that comprises at least one light detector [light detectors] (Figure 1G, Element 106),
wherein the light-emitting unit [light sources] (Figure 1G, Element 102) comprises
a first light source for irradiating a surface of the skin with a first light having a plurality of wavelengths [a light source 102 described herein may include two or more co-located light emitters that are each configured to emit light having a different center wavelength (e.g., a green light emitter, a red light emitter, and an infrared light emitter, or any combination thereof, may be packaged in a single light source 102)] (Para 0048); and
the light detection unit [light detectors] (Figure 1G, Element 106) comprises
a first light detector for detecting the first light emitted from the first light source [a light detector 106 described herein may be configured to detect light of multiple ranges of wavelengths (e.g., green light, red light, and infrared light, or any combination thereof)] (Para 0048),
wherein the skin component amount calculation unit [processor] (Figure 1B, Element 110) measures [electrical digital microprocessor coupled to detectors] (Para 0062) the component amount [determining an SpO2 value] (Para 0033) for the target component on the basis of a light signal of the first light absorbed and scattered within the skin [the first PPG signals may correspond to green light previously emitted by a light source (or light sources) after the emitted light has interacted with a user's skin, when the PPG device 100 is worn. The first PPG signals may include a motion component and a cardiac component. In another example, the first PPG signals may include a motion component and another physiological component] (Para 0068).
Examiner’s Note: While the disclosure does not specifically mention the light absorbed and scattered within the skin, it is understood that is what is happening when light is emitted into skin. Also, the claim limitation, “on the basis of”, is broad and including the direct and indirect use or relationship with a light signal of the light absorbed and scattered within the skin.
Claim 2/1: Richards teaches –
wherein light emitted from the at least one light source is LED white light [the light source(s) may be configured to emit one or more of green, red, and/or infrared light] (Para 0028) [light sources 102 comprise electronic semiconductor light sources, such as LEDs] (Para 0058),
Examiner’s Note: The Specification as originally filed in Para 57 states, “the LED white light may include a combination of red LED light, blue LED light, and/or green LED light”. This disclosure gives a special definition to the term “LED white light”. Thus, LED white light is interpreted as a combination of red and green light.
the first light detector [light detectors] (Figure 1G, Element 106) comprises
a plurality of bandpass filters [One or more of the detectors may comprise a bandpass filter circuit] (Para 0061) arranged in a grid arrangement [box shape (e.g., in a two-dimensional layout)] (Para 0051), and
obtains a light signal for each of the plurality of wavelengths [one or more detectors configured to detect a specific wavelength or wavelength range different from one or more other detectors] (Para 0028) comprised in the first light through the plurality of bandpass filters [One or more of the detectors may comprise a bandpass filter circuit] (Para 0061), and
the skin component amount calculation unit (Figure 1B, Element 110) calculates the component amount [determining an SpO2 value] (Para 0033) for the target component on the basis of the light signal for each of the plurality of wavelengths [the first PPG signals may correspond to green light previously emitted by a light source (or light sources) after the emitted light has interacted with a user's skin, when the PPG device 100 is worn] (Para 0068) [one or more detectors configured to detect a specific wavelength or wavelength range different from one or more other detectors] (Para 0028).
Examiner’s Note: While the disclosure does not specifically mention for each of the plurality of wavelengths, it is understood that is what is happening when light is detected and processed. Also, the claim limitation, “on the basis of”, is broad and including the direct and indirect use or relationship with each of the plurality of wavelengths.
Claim 4/2/1: Richards teaches –
wherein the at least one light source comprises the first light source and a second light source [light sources] (Figure 1G, Element 102) arranged to be adjacent to the first light source [the light sources are adjacent only to the light detectors along the horizontal direction and only to other light sources along the vertical direction] (Para 0051 and Figure 1G), and
the at least one light detector comprises the first light detector and a second light detector [light detectors] (Figure 1G, Element 106) arranged to be adjacent to the first light detector [the light detectors are adjacent only to the light sources along the horizontal direction and only to other light detectors along the vertical direction] (Para 0051 and Figure 1G),
the skin component amount calculation unit [processor] (Figure 1B, Element 110) calculates a first component amount for the target component within a first skin region between the first light source and the first light detector through the first light source and the first light detector (Figure 9, Element 1; disclosed as a similar embodiment to Figure 1G in Para 0115),
calculates a second component amount for the target component within a second skin region between the first light source and the second light detector through the first light source and the second light detector (Figure 9, Element 2),
calculates a third component amount for the target component within a third skin region between the second light source and the first light detector through the second light source and the first light detector (Figure 9, Element 4), and
calculates a fourth component amount for the target component within a fourth skin region between the second light source and the second light detector through the second light source and the second light detector (Figure 9, Element 3)
[Accordingly, as shown, the PPG device 100 includes a total of four channels as indicated by reference numbers 1, 2, 3, and 4 (i.e., which refers to a single, distinct light path from a particular light source to a particular light detector)] (Para 0115)
[each PPG signal of the multiple PPG signals may represent a unique source-detector pair (e.g., light source A to light detector X)] (Para 0105) [some or all of the PPG signals (e.g., two or more PPG signals with the highest confidence values, or two or more estimates with the highest confidence values) may be averaged or weighted for the purpose of determining the final value] (Para 0106)
Examiner’s Note: Richards teaches calculating multiple values to average into a final value. It is understood that those values are calculated from light paths 1-4 and would be interpreted as the first, second, third and fourth component amount respectively and then used to average into a final value.
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richards et al. (U.S. Patent Application 2021/0330207 A1) and further in view of Aikawa (W/O 2021/166471 A1; enclosed herein and English translation referenced).
Claim 3/2/1: Richards teaches wherein the skin component amount calculation unit [processor] (Figure 1B, Element 110) calculates the component amount [determining an SpO2 value] (Para 0033) for the target component on the basis of at least concentration of each component in the skin [the first PPG signals may include a motion component and another physiological component] (Para 0068) and a distance between the first light source and the first light detector [information associated with a first distance between the first light source and the light detector] (Para 0128).
Richards fails to teach the extinction coefficient of each component in the skin. However, Aikawa teaches the extinction coefficient of each component in the skin [the absorption coefficient of oxidized hemoglobin corresponds to about 10% of the absorption coefficient of total hemoglobin] (Page 12, 3rd paragraph from the bottom) in order to more accurately estimate the absorbance derived from the color component to be measured for obtaining a more accurate result (Page 12, 3rd paragraph from the bottom).
Examiner’s Note: The extinction coefficient is disclosed as also being the absorption coefficient in Para 0058 of the Specification of the Applicant as originally filed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the calculation of Richards to include the absorption/extinction coefficient as taught by Aikawa in order to more accurately estimate the absorbance derived from the color component to be measured for obtaining a more accurate result (Page 12, 3rd paragraph from the bottom).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richards et al. (U.S. Patent Application 2021/0330207 A1) and further in view of Aikawa (W/O 2021/166471 A1; enclosed herein and English translation referenced) and Rowe et al. (U.S. Patent 7,147,153 B2).
Claim 5/4/2/1: Richards fails to teach the fifth skin region. However, Aikawa teaches wherein the skin component amount calculation unit determines a fifth skin region (Figure 8, Element SL1) excluding the first skin region to the fourth skin region (Figure 8, Element SL2- SL4)
Examiner’s Note: Figure 5 of the Drawings of the Applicant as originally filed is analogous to Figure 8 of Aikawa. Element 330 overlaps similarly to Element SL1 of Aikawa and parts of the regions are excluded in the regions of SL2-SL4 in SL1.
Aikawa teaches calculates a fifth component amount for the target component within the fifth skin region on the basis of the first component amount to the fourth component amount [the control unit 50 corrects the first actual measurement value D1 by using the second actual measurement value D2 to the fifth actual measurement value D5] (Page 16 of third paragraph from the top) in order to improve accuracy by making corrections (Page 16 of third paragraph from the top).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the measuring regions of Richards to include a fifth measurement region as taught by Aikawa in order to improve accuracy by making corrections (Page 16 of third paragraph from the top).
Richards and Aikawa fail to teach generating a two-dimensional image map for the target component to generate spatial information for the target component. However, Rowe teaches generating a two-dimensional image map [a full two-dimensional image from a resulting series of image slices] (Col. 12, Line 33-34) for the target component to generate spatial information for the target component [collect multispectral image data that represent spatio-spectral information from multiple skin features at various depths and positions within an image volume] (Col. 3, Line 14-17) [multispectral image data may also be used to ascertain information about the presence and amount of particular physiological analytes that may be present in the tissue at the image location] (Col. 3, Line 22-25) in order to achieve improved methods and systems for analyte estimation using multispectral imaging systems and methods (Col. 3, Line 6-8)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Richards and Aikawa to include the two-dimensional map as taught by Rowe in order to achieve improved methods and systems for analyte estimation using multispectral imaging systems and methods (Col. 3, Line 6-8).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Darty et al. (U.S. Patent Application 2020/0088580 A1) – Darty teaches hyperspectral/multiple spectral imaging methods and devices. A method obtains first and second spectral image datasets of a region of interest (ROI). The first spectral image dataset is characterized by a first spectral range and the second spectral image dataset is characterized by a second spectral range. The method then performs a first spectral analysis on the first spectral image dataset and a second spectral analysis on the second spectral image dataset. Afterwards, the method determines one or more spectral signature(s) at a deeper layer of the ROI.
Hattery et al. (U.S. Patent Application 2014/0092288 A1) – Hattery teaches controlling illumination of an image scene, by passing bands of wavelengths to an imager. The sensitivity of the pixels comprised with the imager is identified and quantified. Multiple images are acquired. The pixels identified and quantified are corrected. The informational contrast is extracted from light intensities. The imager is a CCD sensor or a CMOS sensor. The illumination of an optically dense sample is controlled, by passing specific wavelengths of light to the pixels of a chip comprised with the imager.
Patwardhan (U.S. Patent Application 2009/0137908 A1) – Patwardhan teaches multi-spectral imaging of tissue to obtain information about the distribution of fluorophores and chromophores in the tissue. Using specific spectral bands for illumination and specific spectral bands for detection, the signal-to-noise ratio and information related to the distribution of specific fluorophores is enhanced as compared to UV photography, which uses a single RGB image. Furthermore, the chromophore distribution information derived from the multi-spectral absorption images can be used to correct the fluorescence measurements. The combined fluorescence, absorption, and broadband reflectance data can be analyzed for disease diagnosis and skin feature detection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
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/Helene Bor/ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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