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 .
Response to Amendment
In response to amendments, filed September 24, 2025, claims 1, 7, 14-15, and 17 have been amended. Claims 3, 12-13, 16, and 19 have been cancelled. No claims have been added. Claims 1-2, 4-11, 14-15, 17-18, and 20-23 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed September 24, 2025, with respect to 35 USC 112(b) rejection(s) have been fully considered and are persuasive. The rejection(s) under 35 USC 112(b) have been withdrawn.
Applicant’s arguments with respect to the prior art claims have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Yang (US 20210010865 A1)/Chu (US 20160238440 A1)/Yu (US 20060211926 A1)/Kondo (US 20210330222 A1)/Rava (US 20040186383 A1)/Ashrafi (US 10006859 B2)/Newberry (US 20170014056 A1). Any arguments still relevant based on the new grounds of rejection are addressed below.
In response to Applicant’s argument that Yang does not have a plurality of SiPM photodetectos in an internal cavity, each comprising a discrete channel configured to detect photons of Raman scatter light entering the cavity through a port immobilized against the skin of a user, and each counting single photons, Examiner respectfully disagrees. Yang [0029] describes the detector 280 to be configured in a one, two, or three-dimensional array and [0030] further describes the elements of the detector 280 array to single pixel time-gated detectors including silicon photomultipliers (SiPMs). Detector 280 is shown to be within the internal cavity per Fig. 2. Additionally, band 214 is shown in Fig. 2 to immobilize the internal cavity and port/opening 212 against the user’s skin, as described in [0047]. Figures 3A-3C and [0048] describe the filters used to ensure each SiPM photodetector in the array has a discrete channel for the detection of the Raman scatter light received through the port.
In response to Applicant’s argument that Yang/Yu could not be relied upon to deem features of the claims obvious due to having different approaches to Raman spectroscopy, Examiner respectfully disagrees. Regardless of whether the references teach different approaches to Raman spectroscopy, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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 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: “data acquisition electronics module” in claims 1 and 9 – Specification [0044] “The previously mentioned circuit board32 preferably includes a suitable data acquisition electronics module.”
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 § 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.
Claim(s) 1-2, 4-5, 9-14, 17-18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 20210010865 A1) in view of Chu (US 20160238440 A1) and Yu (US 20060211926 A1).
Regarding claim 1, Yang teaches a non-invasive, wearable, diagnostic spectrometer apparatus adapted for direct contact with a user's skin ([0006] “systems and methods for spectroscopy;” wearable spectroscopy system 200) comprising:
a housing having a sidewall surrounding an interior cavity, a cover disposed over said sidewall and said interior cavity, a base disposed under said sidewall at least partially enclosing said interior cavity, said base having a port therein configured to enable the transit of photons of light therethrough (Fig. 2, case 216, opening 212),
lashing extending from said housing and configured to immobilize said interior cavity of said housing directly against the skin of a user at a region of interest (Fig. 2; [0047] “analyte 240 is depicted as a cross-section of a human limb, such as a wrist, and includes blood vessel 242 and blood 244. Band 214 can be used secure spectrometer 210 to analyte 240 (e.g., the wrist). For example, spectrometer 210 is in contact with analyte 240 (e.g., spectrometer 210 is no more than 1 cm from analyte 240). Band 214 can be made from metal, plastic, and combinations thereof.”),
a light source configured to emit photons of light through said port that will probe molecular biomarkers of physiological interest in subcutaneous tissue and return photons of Rayleigh scattered light commingled with Raman scattered light through said port and into said interior cavity (Fig. 2, excitation light source 220, light 230, light 250; [0042] “Light 230 from excitation light source 120 can be said to be shone on analyte 240 and/or analyte 240 can be said to be illuminated by excitation light source 220 and/or light 230. When (incident) light from excitation light source 220 hits analyte 240, the (incident) light scatters. A majority (e.g., 99.999999%) of the scattered light is the same frequency as the light from excitation light source 220 (e.g., Rayleigh or elastic scattering).” [0043] “A small amount of the scattered light (e.g., on the order of 10.sup.−6 to 10.sup.−8 of the intensity of the (incident) light from excitation light source 220) is shifted in energy from the frequency of light 230 from excitation light source 220. The shift is due to interactions between (incident) light 230 from excitation light source 220 and the vibrational energy levels of molecules in analyte 240. (Incident) Light 230 interacts with molecular vibrations, phonons, or other excitations in analyte 240, causing the energy of the photons (of light 230 from excitation light source 220) to shift up or down (e.g., Raman or inelastic scattering). Light 250 can include, for example, at least one of Raman scatter, fluorescence, and Rayleigh scattering. The shift in energy of light 250 (e.g., Raman scatter from analyte 240) can be used to identify and quantify characteristics (e.g., molecules) of analyte 240.”).
However, Yang fails to disclose the light source comprising a plurality of LEDs. Chu teaches an optical sensor module comprising a light source, photodetector, and substrate for the evaluation of biological tissue.
The combination of Yang/Chu discloses said light source comprising a plurality of discrete light emitting diodes (LEDs) (Chu: discrete light source 110; [0099] “the optical sensor module 10 may employ one or more light emitting diodes (LED), organic light emitting diodes (OLED), laser diodes (LD), or the like as light source 110. For example, the light source 110 of the optical sensor module 10 may comprise one or more LEDs, each configured to emit light in the specific spectrum of wavelengths.) each configured to produce monochromatic light having a frequency in the spectral band of 200nm - 1500nm (Yang: [0022] “According to some embodiments, excitation light source 220 is a monochromatic light source … excitation light source 220 can provide light (electromagnetic waves) in a range between ultra-violet (UV) light (e.g., electromagnetic radiation with a wavelength from 10 nm to 400 nm) and shortwave near-infrared (NIR) (1.4 μm to 3 μm), including portions of the electromagnetic spectrum in-between, such as visible light (e.g., 380 nm-760 nm) and NIR light (e.g., 0.75 μm to 1.4 μm).”) which sequentially or simultaneously excite distinct quantized modes of excitation of interest (Chu: [0099] “It is contemplated that the light sources 110 may further emit light in different spectrum of wavelengths synchronously or asynchronously depending on various applications.”).
Therefore, 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 Yang to include a plurality of discrete light emitting diodes as disclosed in Chu for each to be configured to emit light in a specific spectrum of wavelengths in a coordinated manner to enhance the spectroscopy (Chu [0099]).
The combination of Yang/Chu discloses further discloses:
an array of photodetectors disposed in said interior cavity of said housing, each photodetector comprising a discrete channel ([Symbol font/0x6C]n) configured to detect photons of Raman scattered light entering said interior cavity through said port, wherein said photodetectors are silicon photomultipliers [SiPM] (Yang: [0030] “detector 280 is a single pixel time-gated detector such as single-photon avalanche diode (SPAD), micro-channel plate (MCP), photomultiplier tube (PMT), silicon photomultiplier (SiPM), …” [0034] “Silicon photomultipliers (SiPM) are solid-state single-photon-sensitive devices based on Single-photon avalanche diode (SPAD) implemented on a common silicon substrate. Each SPAD in an SiPM can be coupled with the others by a metal or polysilicon quenching resistor.” [0038] “A spectral resolution of a spectrum measured by detector 280 can depend on the number of pixels (e.g., discrete photodetectors) in detector 280. A greater number of pixels can provide a higher spectral and spatial resolutions. Detector 280 can comprise a one-dimensional, two-, or three-dimensional array of pixels.” Fig. 2, filter 270, detector 280; Figs. 3A-3C),
at least one optical filter in said interior cavity and associated with each said SiPM photodetector, said optical filter operatively disposed between the associated said SiPM photodetector and said port, each said optical filter limiting the transit of light reaching the associated said SiPM photodetector to a specific wavelength (Yang: [0048] “FIGS. 3A-3C illustrate configurations of filter 270 and sensor 280 (FIG. 2) according to some embodiments… FIG. 3C shows filters 270C.sub.1,1-270C.sub.x,y disposed on sensor 280C (e.g., an xxy array). Filters 270C.sub.1,1-270C.sub.x,y transmit light (in a wavelength range) centered around wavelengths λ.sub.1,1-λ.sub.x,y, respectively.” [0027] “By way of further non-limiting example, beam splitter can transmit light 250 (e.g., Raman scatter) to detector 280 through filter 270.” [0028] “Filter 270 transmits a particular wavelength (or range of wavelengths) of light to detector 280 (and blocks the rest)”).
While the combination of Yang/Chu discloses allowing specific wavelengths through to the photodetectors, the combination of Yang/Chu doesn’t explicitly teach eliminating Raleigh scattered light. Yu teaches a method and apparatus in relation to non-invasive measurement of human blood analytes such as glucose using Raman Spectroscopy. Yu discloses and eliminating Rayleigh scattered light ([0024] “The notch filter 135 allows Raman-shifted components to pass, but blocks the Rayleigh scattering at pump wavelength .lamda..sub.0.” filter 235).
Therefore, 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 Yang to include eliminating Rayleigh scatted light as disclosed in Yu to precisely acquire Raman signal spectra (Yu [0027]).
The combination of Yang/Chu/Yu discloses and a data acquisition electronics module fixed relative to said housing and operatively associated with said array of SiPM photodetectors, said data acquisition electronics module configured to count single photons of Raman scattered light reaching each said SiPM photodetector over a predetermined sampling time (Yang: Fig. 2, Electronics 290; [0040] “A predetermined amount of time after light 230 is provided, electronics 290 can provide a signal directing detector 280 to (effectively) stop detecting and provide measurements (e.g., report a photon count at that time). For example, the predetermined amount of time can be selected using the duration of light 230 (e.g., a laser pulse), characteristics of analyte 240 (e.g., duration/lifetime of fluorescence), and the like.” [0043] “The shift in energy of light 250 (e.g., Raman scatter from analyte 240) can be used to identify and quantify characteristics (e.g., molecules) of analyte 240.” [0066] “The detected spectrum (e.g., data, graphical representation, and the like) can be stored by in spectrometer 210 and 210A, and/or computing system 295.”).
Regarding claim 2, the combination of Yang/Chu/Yu discloses the apparatus of Claim 1, wherein said array of SiPM photodetectors comprises at least one SiPM photodetector generating a reference signal (Yu: [0029] “Since the intensity of the light emitted from the broadband source [or one or more light emitting diodes (LED) per Chu] is not constant over the selected wavelength range, it is desirable to normalize the reflectance measurement with a measurement of the light incident on the sample.” [0034] “In one preferred embodiment, the skin/tissue function is measured using procedures illustrated in FIG. 3. It involves the following steps: [0035] 1. Measure the incident spectrum P.sub.0(.lamda.). It is used as a reference at each wavelength. [0036] 2. Illuminate the laser-tissue interaction region with the light P.sub.0(.lamda.). This will generate a reflectance spectrum from skin and tissue.” [0037] “3. Measure the reflectance spectrum P(.lamda.). [0038] 4. Calculate the skin/tissue function f(.lamda.) according to Equation (1). [0039] The skin tissue function f(.lamda.) is then used to correct the measured Raman spectral response, using for example, equation (2). In the preferred embodiment, when broadband light is used to generate the skin/tissue function f(.lamda.), the correction is performed for all wavelength components over the whole selected wavelength range.”) and a plurality of SiPM photodetectors detecting a plurality of discrete Raman lines (Yang: [0063] “cover a range of Raman shift from 300 cm.sup.−1 to 1800 cm.sup.−1 wavenumber;” [0058] “FIGS. 6A and 6B are graphical representations (e.g., plot, graph, and the like) 600A and 600B of received light intensity (in milliwatts (mW), other units can be a.u. (arbitrary units of intensity) and photon count) (along axis 620) over received light (Raman shift) wavelength (in nanometers (nm), other units can be wavenumber in cm.sup.−1) (along axis 610)”).
Regarding claim 4, the combination of Yang/Chu/Yu discloses the apparatus of Claim 1, further including a light shield disposed in said interior cavity between said light source and said plurality of SiPM photodetectors (Yang: Fig. 2, beam splitter 260, light source 220, detector 280; [0027] “Beam splitter 260 can be an optical device which reflects some light and passes other light (e.g., based upon the light's angle of incidence). For example, beam splitter 260 can reflect light 230 from excitation light source 220 through opening 212 and onto analyte 240.”).
Regarding claim 5, the combination of Yang/Chu/Yu discloses the apparatus of Claim 4, wherein said light shield extends substantially from said light source toward a terminal end adjacent said port (Yang: Fig. 2, beam splitter 260, light source 220, detector 280, opening 2121).
Regarding claim 9, the combination of Yang/Chu/Yu discloses the apparatus of Claim 1, wherein said data acquisition electronics module includes a scaler to digitally measure the integrated intensity of the Raman scattered light resulting from the excitation of specific quantized normal modes of vibration, said quantized normal modes of vibration including at least one of electronic modes, optical vibrational modes, acoustic vibrational modes, ultrasonic modes and vibronic modes (Yang: electronics 290; [0030] “According to various embodiments, each pixel in some SPAD arrays can count a single photon and the SPAD array can provide a digital output (e.g., a 1 or 0 to denote the presence or absence of a photon for each pixel).” [0040] “A predetermined amount of time after light 230 is provided, electronics 290 can provide a signal directing detector 280 to (effectively) stop detecting and provide measurements (e.g., report a photon count at that time).” [0043] “(Incident) Light 230 interacts with molecular vibrations, phonons, or other excitations in analyte 240, causing the energy of the photons (of light 230 from excitation light source 220) to shift up or down (e.g., Raman or inelastic scattering). Light 250 can include, for example, at least one of Raman scatter, fluorescence, and Rayleigh scattering. The shift in energy of light 250 (e.g., Raman scatter from analyte 240) can be used to identify and quantify characteristics (e.g., molecules) of analyte 240.” [0044] “Computing system 295 can receive intensity measurements from spectrometer 210, produces at least one Raman spectrum using data (e.g., intensity measurements) from spectrometer 210, and identifies and/or quantifies molecules in analyte 240 using the at least one Raman spectrum and a database of Raman spectra associated with known molecules.”).
Regarding claim 10, the combination of Yang/Chu/Yu discloses the apparatus of Claim 1, wherein said optical filters are selected from the group consisting essentially of: bandpass, notch (Yu: [0024] “In FIG. 1, the bandpass filter 110 generates a narrow band light at a single wavelength .lamda..sub.0. The notch filter 135 allows Raman-shifted components to pass, but blocks the Rayleigh scattering at pump wavelength .lamda..sub.0.” filter 210, filter 235, element 270).
Regarding claim 11, the combination of Yang/Chu/Yu discloses the apparatus of Claim 1, wherein each said optical filter comprises a first filter configured to reject Rayleigh scattered light and a second filter configured to limit the transit of light reaching the associated said SiPM photodetector to a specific wavelength (Yang: [0028] “Filter 270 transmits a particular wavelength (or range of wavelengths) of light to detector 280 (and blocks the rest). As illustrated in FIGS. 3A-3C, filter 270 can be a one-dimensional, two-dimensional, or three-dimensional array of separate filters, each filter transmitting light centered around a different (or same) wavelength (A) to detector 280.” Yu: [0024] “In FIG. 1, the bandpass filter 110 generates a narrow band light at a single wavelength .lamda..sub.0. The notch filter 135 allows Raman-shifted components to pass, but blocks the Rayleigh scattering at pump wavelength .lamda..sub.0.” filter 210, filter 235, element 270”).
Regarding claim 14, the combination of Yang/Chu/Yu discloses the apparatus of Claim 1, wherein said light source is configured to produce light capable of activating fluorescence or phosphorescence responses from biological tissue being probed (Yang: [0022] “By way of further non-limiting example, excitation light source 220 can provide light (electromagnetic waves) in a range between ultra-violet (UV) light (e.g., electromagnetic radiation with a wavelength from 10 nm to 400 nm) and shortwave near-infrared (NIR) (1.4 μm to 3 μm), including portions of the electromagnetic spectrum in-between, such as visible light (e.g., 380 nm-760 nm) and NIR light (e.g., 0.75 μm to 1.4 μm).” [0043] “Light 250 can include, for example, at least one of Raman scatter, fluorescence, and Rayleigh scattering.”).
Regarding claim 17, Yang teaches a method for non-invasively diagnosing a condition of subcutaneous biological tissue using Raman spectroscopy ([0006] “systems and methods for spectroscopy;” wearable spectroscopy system 200), said method comprising the steps of:
stationing a plurality of photodetectors in an internal cavity having a port (Fig. 2, case 216, opening 212, detector 280 in an array per [0038]),
the photodetectors comprising silicon photomultipliers (SiPM) ([0030] “detector 280 is a single pixel time-gated detector such as single-photon avalanche diode (SPAD), micro-channel plate (MCP), photomultiplier tube (PMT), silicon photomultiplier (SiPM), …” [0034] “Silicon photomultipliers (SiPM) are solid-state single-photon-sensitive devices based on Single-photon avalanche diode (SPAD) implemented on a common silicon substrate. Each SPAD in an SiPM can be coupled with the others by a metal or polysilicon quenching resistor.”), each SiPM photodetector comprising a discrete channel ([Symbol font/0x6C]n) configured to detect photons of Raman scattered light entering the internal cavity through the port ([0038] “A spectral resolution of a spectrum measured by detector 280 can depend on the number of pixels (e.g., discrete photodetectors) in detector 280. A greater number of pixels can provide a higher spectral and spatial resolutions. Detector 280 can comprise a one-dimensional, two-, or three-dimensional array of pixels.” [0048] “FIGS. 3A-3C illustrate configurations of filter 270 and sensor 280 (FIG. 2) according to some embodiments… FIG. 3C shows filters 270C.sub.1,1-270C.sub.x,y disposed on sensor 280C (e.g., an xxy array). Filters 270C.sub.1,1-270C.sub.x,y transmit light (in a wavelength range) centered around wavelengths λ.sub.1,1-λ.sub.x,y, respectively.” [0027] “By way of further non-limiting example, beam splitter can transmit light 250 (e.g., Raman scatter) to detector 280 through filter 270.” [0028] “Filter 270 transmits a particular wavelength (or range of wavelengths) of light to detector 280 (and blocks the rest);” Fig. 2),
immobilizing the port of the interior cavity directly against the skin of a user ([0047] “Band 214 can be used secure spectrometer 210 to analyte 240 (e.g., the wrist) For example, spectrometer 210 is in contact with analyte 240 (e.g., spectrometer 210 is no more than 1 cm from analyte 240)”; Fig. 2, opening 212),
emitting light from a light source in the interior cavity through the port and directly onto the skin of the user (Fig. 2, excitation light source 220, light 230, opening 212, analyte 240 being the user’s wrist per [0047]), wherein said step of emitting light includes producing monochromatic light having a frequency in the spectral band of 200nm - 1500nm ([0022] “According to some embodiments, excitation light source 220 is a monochromatic light source … excitation light source 220 can provide light (electromagnetic waves) in a range between ultra-violet (UV) light (e.g., electromagnetic radiation with a wavelength from 10 nm to 400 nm) and shortwave near-infrared (NIR) (1.4 μm to 3 μm), including portions of the electromagnetic spectrum in-between, such as visible light (e.g., 380 nm-760 nm) and NIR light (e.g., 0.75 μm to 1.4 μm).
However, Yang fails to disclose the light source comprising a plurality of LEDs.
The Chu discloses from a plurality of discrete light emitting diodes (LEDs) (discrete light source 110; [0099] “the optical sensor module 10 may employ one or more light emitting diodes (LED), organic light emitting diodes (OLED), laser diodes (LD), or the like as light source 110. For example, the light source 110 of the optical sensor module 10 may comprise one or more LEDs, each configured to emit light in the specific spectrum of wavelengths.) and wherein the LEDs sequentially or simultaneously excite distinct quantized modes ([0099] “It is contemplated that the light sources 110 may further emit light in different spectrum of wavelengths synchronously or asynchronously depending on various applications.”).
Therefore, 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 Yang to include a plurality of discrete light emitting diodes as disclosed in Chu for each to be configured to emit light in a specific spectrum of wavelengths in a coordinated manner to enhance the spectroscopy (Chu [0099]).
The combination of Yang/Chu discloses:
interrogating with the light at least one subcutaneous molecule below the skin of the user, said interrogating step producing optical photons of Rayleigh scattered light commingled with Raman scattered light that re-enter the internal cavity through the port (Yang: Fig. 2, excitation light source 220, light 230, light 250, opening 212; [0042] “Light 230 from excitation light source 120 can be said to be shone on analyte 240 and/or analyte 240 can be said to be illuminated by excitation light source 220 and/or light 230. When (incident) light from excitation light source 220 hits analyte 240, the (incident) light scatters. A majority (e.g., 99.999999%) of the scattered light is the same frequency as the light from excitation light source 220 (e.g., Rayleigh or elastic scattering). [0043] A small amount of the scattered light (e.g., on the order of 10.sup.−6 to 10.sup.−8 of the intensity of the (incident) light from excitation light source 220) is shifted in energy from the frequency of light 230 from excitation light source 220. The shift is due to interactions between (incident) light 230 from excitation light source 220 and the vibrational energy levels of molecules in analyte 240. (Incident) Light 230 interacts with molecular vibrations, phonons, or other excitations in analyte 240, causing the energy of the photons (of light 230 from excitation light source 220) to shift up or down (e.g., Raman or inelastic scattering). Light 250 can include, for example, at least one of Raman scatter, fluorescence, and Rayleigh scattering. The shift in energy of light 250 (e.g., Raman scatter from analyte 240) can be used to identify and quantify characteristics (e.g., molecules) of analyte 240.”).
While the combination of Yang/Chu discloses allowing specific wavelengths through to the photodetectors, the combination of Yang/Chu doesn’t explicitly teach eliminating Raleigh scattered light.
Yu discloses eliminating Rayleigh scattered light from the photons re-entering the internal cavity through the port ([0024] “The notch filter 135 allows Raman-shifted components to pass, but blocks the Rayleigh scattering at pump wavelength .lamda..sub.0.” filter 235).
Therefore, 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 Yang to include eliminating Rayleigh scatted light as disclosed in Yu to precisely acquire Raman signal spectra (Yu [0027]).
The combination Yang/Chu/Yu further discloses limiting the Raman scattered light reaching each SiPM photodetector to a specific wavelength associated with a Raman active line (Yang: [0028] “Filter 270 transmits a particular wavelength (or range of wavelengths) of light to detector 280 (and blocks the rest);” Fig. 6A, Fig. 6B), and counting single photons received in each SiPM photodetector over a predetermined sampling time to measure the integrated intensity of the selected Raman active line (Yang: [0040] “A predetermined amount of time after light 230 is provided, electronics 290 can provide a signal directing detector 280 to (effectively) stop detecting and provide measurements (e.g., report a photon count at that time). For example, the predetermined amount of time can be selected using the duration of light 230 (e.g., a laser pulse), characteristics of analyte 240 (e.g., duration/lifetime of fluorescence), and the like.” [0043] “The shift in energy of light 250 (e.g., Raman scatter from analyte 240) can be used to identify and quantify characteristics (e.g., molecules) of analyte 240.” [0058] “FIGS. 6A and 6B are graphical representations (e.g., plot, graph, and the like) 600A and 600B of received light intensity (in milliwatts (mW), other units can be a.u. (arbitrary units of intensity) and photon count) (along axis 620) over received light (Raman shift) wavelength (in nanometers (nm), other units can be wavenumber in cm.sup.−1) (along axis 610)”).
Regarding claim 18, the combination Yang/Chu/Yu discloses the method of Claim 17 wherein the interrogated subcutaneous molecule below the skin of the user is selected from the group consisting essentially of: hemoglobin and glucose (Yang: [0073] “Non-limiting examples of molecules that can be detected at step 990 are provided in Table 2.” Table 2, Molecule… Glucose… HbA1c), and the selected Raman active line is selected from the group consisting essentially of about: 436 cm-1, 456 cm-1, 527 cm-1, 572 cm-1, 796 cm-1, 855 cm-1, 912 cm-1, 1060 cm-1,1125 cm-1,1360 cm-1,1366 cm-1,1456 cm-1, and 1549 cm-1 (Yang: [0063] “cover a range of Raman shift from 300 cm.sup.−1 to 1800 cm.sup.−1 wavenumber.” [0058] “FIGS. 6A and 6B are graphical representations (e.g., plot, graph, and the like) 600A and 600B of received light intensity (in milliwatts (mW), other units can be a.u. (arbitrary units of intensity) and photon count) (along axis 620) over received light (Raman shift) wavelength (in nanometers (nm), other units can be wavenumber in cm.sup.−1) (along axis 610);” Fig. 8).
Regarding claim 21, the combination of Yang/Chu/Yu discloses the method of Claim 17 further including the step of transmitting data informed by the measured integrated intensity of the selected Raman active line to a remote computing device via a secure communication connection (Yang: [0044] “System 200 can include computing system 295. According to various embodiments, computing system 295 can be communicatively coupled to spectrometer 210 using various combinations and permutations of wired and wireless communications (e.g., networks) described below in relation to FIG. 8. In some embodiments, computing system 295 can include a database of Raman spectra associated with known molecules and/or remotely access the database over a communications network (not shown in FIG. 2). Computing system 295 can receive intensity measurements from spectrometer 210, produces at least one Raman spectrum using data (e.g., intensity measurements) from spectrometer 210, and identifies and/or quantifies molecules in analyte 240 using the at least one Raman spectrum and a database of Raman spectra associated with known molecules.” [0045] “computing system 295 is a desktop or notebook computer communicatively coupled to Spectrometer 210 through a Universal Serial Bus (USB) connection, a WiFi connection, and the like”).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 20210010865 A1) in view of Chu (US 20160238440 A1) and Yu (US 20060211926 A1), and in further view of Kondo (US 20210330222 A1).
Regarding claim 6, the combination of Yang/Chu/Yu discloses the apparatus of Claim 4. However, the combination of Yang/Chu/Yu fails to disclose the light shield being tubular and surrounding the light source. Kondo teaches a pulse oximeter that measures blood oxygen saturation level using infrared light. Kondo discloses wherein said light shield is generally tubular and surrounds said light source (Fig. 2; [0022] “The emitter light shield wall 91 has a distal end located further inward from the end of the light emitter 60 located toward the inner side of the curved flexible substrate 50. As a result, the emitter light shield wall 91 surrounds the outer perimeter of the light emitter 60”).
Therefore, 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 combination of Yang/Yu to include a tubular light shield surrounding the light source as disclosed in Kondo to ensure only light that has interacted with the target tissue is received by the photodetectors (Kondo [0039, 0056]).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 20210010865 A1) in view of Chu (US 20160238440 A1) and Yu (US 20060211926 A1), and in further view of Rava (US 20040186383 A1).
Regarding claim 7, the combination of Yang/Chu/Yu discloses the apparatus of Claim 1, wherein said predetermined sampling time (Yang: [0040] “A predetermined amount of time after light 230 is provided, electronics 290 can provide a signal directing detector 280 to (effectively) stop detecting and provide measurements (e.g., report a photon count at that time). For example, the predetermined amount of time can be selected using the duration of light 230 (e.g., a laser pulse), characteristics of analyte 240 (e.g., duration/lifetime of fluorescence), and the like.”). However, the combination of Yang/Chu/Yu fails to disclose a range for the sampling time.
Rava teaches systems and methods for Raman spectroscopic diagnosis of tissues. Rava discloses wherein said predetermined sampling time is less than or equal to 1000 ms (Claim 17 “the system collects returning light for 8 seconds or less to generate spectral data for a region of interest.”).
Therefore, 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 combination of Yang/Yu to include a range for the sampling time as disclosed in Rava to control the signal-to-noise ratio for more accurate readings (Rava [0127]).
Regarding claim 8, the combination of Yang/Chu/Yu discloses the apparatus of Claim 1, wherein said predetermined sampling time (Yang: [0040] “A predetermined amount of time after light 230 is provided, electronics 290 can provide a signal directing detector 280 to (effectively) stop detecting and provide measurements (e.g., report a photon count at that time). For example, the predetermined amount of time can be selected using the duration of light 230 (e.g., a laser pulse), characteristics of analyte 240 (e.g., duration/lifetime of fluorescence), and the like.”). However, the combination of Yang/Chu/Yu fails to disclose a range for the sampling time.
Rava discloses wherein said predetermined sampling time is in the range of 1-10 seconds (Claim 17 “the system collects returning light for 8 seconds or less to generate spectral data for a region of interest.”).
Therefore, 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 combination of Yang/Chu/Yu to include a range for the sampling time as disclosed in Rava to control the signal-to-noise ratio for more accurate readings (Rava [0127]).
Claim(s) 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 20210010865 A1) in view of Chu (US 20160238440 A1) and Yu (US 20060211926 A1), and in further view of Ashrafi (US 10006859 B2).
Regarding claim 15, the combination of Yang/Chu/Yu discloses the apparatus of Claim 1, wherein said light source is configured to produce tunable monochromatic light ([0022] “According to some embodiments, excitation light source 220 is a monochromatic light source, such as a laser.” [0023] “Excitation light source 220 can be tunable”). While the combination of Yang/Yu fails to disclose a resonant mode, a capability statement is non-limiting. Still, Ashrafi teaches an apparatus for detecting a material within a sample includes a light emitting unit for directing at least one light beam through the sample and discloses capable of performing measurements in resonant mode (Col 41, lines 30-50, “The Raman effect in classical Raman spectroscopy depends only on the frequency of incident light with scattered intensity dependence on ν_0 ^4 as discussed earlier. If the vibrational mode of a molecular absorption transition precisely matches the energy of incident light, the observed scattered intensity may be as intense as ˜ν_0 ^6. T;” Col 62, lines 20-29, “any number of spectroscopic techniques such as optical spectroscopy, infrared spectroscopy, Ramen spectroscopy, spontaneous Ramen spectroscopy, simulated Ramen spectroscopy, resonance Ramen spectroscopy, … may be used in any number of various combinations in order to provide better detection of sample types in concentrations.”).
Therefore, 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 combination of Yang/Chu/Yu to include a resonant mode as disclosed in Ashrafi because the resonance Raman effect permits highly sensitive spectroscopic discrimination of a molecular species within a complex material medium such as chromophores within proteins embedded in a biological membrane (Ashrafi, Col 41, lines 30-50).
Regarding claim 20, the combination Yang/Chu/Yu discloses the method of Claim 17 wherein said step of emitting light from a light source includes simultaneously exciting distinct quantized modes of excitation of interest selected from the group consisting essentially of: vibrational (Yang: [0043] “The shift is due to interactions between (incident) light 230 from excitation light source 220 and the vibrational energy levels of molecules in analyte 240. (Incident) Light 230 interacts with molecular vibrations, phonons, or other excitations in analyte 240, causing the energy of the photons (of light 230 from excitation light source 220) to shift up or down (e.g., Raman or inelastic scattering).”). However, the combination Yang/Chu/Yu fails to disclose resonance.
Ashrafi discloses resonantly vibronic (Col 41, lines 30-50, “The Raman effect in classical Raman spectroscopy depends only on the frequency of incident light with scattered intensity dependence on ν_0 ^4 as discussed earlier. If the vibrational mode of a molecular absorption transition precisely matches the energy of incident light, the observed scattered intensity may be as intense as ˜ν_0 ^6. T;”).
Therefore, 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 combination of Yang/Chu/Yu to include a resonant mode as disclosed in Ashrafi because the resonance Raman effect permits highly sensitive spectroscopic discrimination of a molecular species within a complex material medium such as chromophores within proteins embedded in a biological membrane (Ashrafi, Col 41, lines 30-50).
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 20210010865 A1) in view of Chu (US 20160238440 A1) and Yu (US 20060211926 A1), and in further view of Newberry (US 20170014056 A1).
Regarding claim 22, the combination of Yang/Chu/Yu discloses the method of Claim 17. However, the combination of Yang/Chu/Yu fails to disclose transmitting the Raman spectroscopy data to a remedial device.
Newberry teaches a glucose biosensor that processes light from each photodetector to determine a glucose level measurement. Newberry discloses further including the step of transmitting data informed by the measured integrated intensity of the selected Raman active line to a remote controller of a remedial device ([0143] “The analytic biosensor 2000 is thus configured to obtain glucose level measurements using a plurality of measurement techniques, including infrared absorption spectroscopy, Raman spectroscopy … The analytic biosensor 2000 may then wirelessly transfer the glucose level measurement to a gateway or glucose meter or user device. In another embodiment, the analytic biosensor 2000 may include a wired network interface card that is operable to communicate with a user device or gateway over a wired connection.” [0068] “The glucose level measurement and alert with request are wireless transmitted to a gateway or glucose meter or user device 808. For example, when the glucose measurement is lower than 70 mg/Dl or greater than 150 mg/Dl, the alert message may include a request for an alternate glucose monitoring method be performed to confirm the glucose levels, such as a finger prick method. The alert may also trigger warnings to inject insulin or perform other corrective health measures. In addition, the glucose biosensor 100 may transmit immediate health alerts when a dangerous level of glucose is detected, such as lower than 40 mg/Dl or over 240 mg/Dl, with a message advising that the patient perform certain corrective measures, such as injection of insulin. The immediate health alert may be transmitted to a gateway, glucose meter, a user device, doctor's office, or other contact person as well.”).
Therefore, 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 combination of Yang/Chu/Yu to include transmitting Raman spectroscopy data to a remedial device as disclosed in Newberry to inject insulin or perform other corrective health measures when appropriate (Newberry [0068]).
Regarding claim 23, the combination of Yang/Chu/Yu discloses the method of Claim 17. However, the combination of Yang/Chu/Yu fails to disclose an alarm. Newberry discloses further including the step of generating an alarm signal in response to the measured integrated intensity of the selected Raman active line ([0143] “The analytic biosensor 2000 is thus configured to obtain glucose level measurements using a plurality of measurement techniques, including infrared absorption spectroscopy, Raman spectroscopy;” [0068] “When the glucose level measurements are not within the predetermined thresholds, an alert is generated”).
Therefore, 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 combination of Yang/Chu/Yu to include an alarm in response to the Raman spectroscopy as disclosed in Newberry to notify a caregiver of abnormal glucose levels and advise that the patient perform certain corrective measures (Newberry [0068]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791