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 .
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.
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: “path length control part” recited in Claim 1, “mechanical part” recited in Claim 19, “feedback device” recited in Claims 21-22 and 25, and “path length measurement device” recited in Claim 22.
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. No structure has been provided within the specification that would make it obvious to one of ordinary skill in the art at the time the invention was effectively filed to understand what comprises a “path length control part”, “mechanical part”, a “feedback device”, or a “path length measurement device”.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the limitation “wherein the spectral sensor is configured to:… produce the diffusely scattered light from which the spectrum is obtained by the detector” is indefinite. It is unclear what is the difference between a “spectral sensor” (that is in itself a detector) and a “detector”. Are these two different components? Is the “detector” part of the “spectral sensor”? Are these the same component? For this examination, the limitation is interpreted to mean that the “detector” is part of the “spectral sensor”.
Regarding Claim 2, the limitation “illumination optics coupled to receive” is indefinite. It is unclear what the “illumination optics” are “coupled to” given that no structure was recited after this phrase. For this examination, the limitation is interpreted to mean the “illumination optics” are “coupled to the apparatus disclosed in Claim 1”.
Claim limitations “path length control part” recited in Claim 1, “mechanical part” recited in Claim 19, “feedback device” recited in Claims 21-22 and 25, and “path length measurement device” recited in Claim 22 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure does not provide sufficient description as to what materials either of these claim limitations are made from, what form these claim limitations take on, etc. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
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.
Claims 1-14, 17-19, 24, 26-27, 32-39, and 42-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by White et. al.'759 (U.S. Patent Publication 20140171759).
Regarding Claim 1, White et. al.'759 discloses an apparatus configured for non-invasive optical spectroscopy (Paragraph [0105] - Spectroscopic measurements of analytes achieve sensitivity and selectivity to different degrees depending on the underlying form of spectroscopy used (absorption, emission, etc.), the wavelength region selected (visible, near-infrared, IR, etc.), and the specific embodiments of the measurement device (resolution, number of wavelengths, signal to noise ratio)), comprising:
a path length control part configured to control an effective optical path length of diffusely scattered light non-invasively transmitted through skin tissue of a subject to produce a target effective optical path length through the skin tissue (Paragraph [0132] - Second, the sampling system 200 is designed such that it provides control over where the light propagates while within the sample; Paragraph [0139] - The subsystem further includes an ergonomic apparatus 210, depicted in FIG. 15, which holds the sampling surface 204 and positions the tissue at the interface 206);
a spectral sensor (Paragraph [0140] - The optical input 202 of the tissue sampling subsystem 200 receives radiation from the illumination subsystem 100 (e.g., light exiting a light pipe) and transfers that radiation to the tissue interface 206);
a detector configured to obtain a spectrum of an analyte of the skin tissue under test based on the diffusely scattered light (Figure 1, spectrometer subsystem 300; Paragraph [0099] - For the purposes of these teachings the term "dispersive spectrometer" indicates a spectrometer based upon any device, component, or group of components that spatially separate one or more wavelengths of light from other wavelengths. Examples include, but are not limited to, spectrometers that use one or more diffraction gratings, prisms, holographic gratings); and
a light source configured to produce input light and to direct the input light towards the path length control part or the spectral sensor (Paragraph [0113] - In some cases, the light source can be a single element that emits many wavelengths simultaneously, a single element that emits only one wavelength, multiple individual elements that each emits a single wavelength, or a combination thereof); wherein
the spectral sensor (Paragraph [0140] - The optical input 202 of the tissue sampling subsystem 200 receives radiation from the illumination subsystem 100 (e.g., light exiting a light pipe) and transfers that radiation to the tissue interface 206) is configured to:
receive the input light, produce modulated light based on the input light, and direct the modulated light to the path length control part to produce the diffusely scattered light from which the spectrum is obtained by the detector (Paragraph [0140] - As an example, the optical input can comprise a bundle of optical fibers that are arranged in a geometric pattern that collects an appropriate amount of light from the illumination/modulation subsystem. FIG. 16 depicts one example arrangement), or
receive the diffusely scattered light from the path length control part and obtain the spectrum using the detector (Paragraph [0140] - Each cluster includes four central output fibers 212 that collect diffusely reflected light from the tissue).
Regarding Claim 2, White et. al.'759 discloses the apparatus disclosed in Claim 1 above as well as illumination optics coupled to receive incident light corresponding to the input light or the modulated light and to direct the incident light to the skin tissue in the path length control part (Paragraph [0146] - It can be important that the input optics of the tissue sampling subsystem collect sufficient light from the illumination subsystem 100 and from the sample in order to achieve an acceptable net attribute signal).
Regarding Claim 3, White et. al.'759 discloses the apparatus disclosed in Claim 2 above as well as wherein the illumination optics comprise a waveguide, a plurality of waveguides, a set of one or more lenses, or a reflector (Paragraph [0300] - It is recognized by one skilled in the art that the range of angles emitted by the light sources can be controlled within the light sources or by the use of additional optical components such as lenses, coatings, waveguides or homogenizers).
Regarding Claim 4, White et. al.'759 discloses the apparatus disclosed in Claim 3 above as well as wherein the reflector comprises a metallized molded part having a shape forming a compound parabolic concentrator or a compound elliptic concentrator (Paragraph [0121] - A parabolic mirror is an example of a reflective collimating optic; Paragraph [0364] - The material can be metal, including but not limited to stainless steel or aluminum, plastic, glass, or other suitable material. The primary objectives of the sample interface are to hold the illumination and collection portions of the optical probe in place).
Regarding Claim 5, White et. al.'759 discloses the apparatus disclosed in Claim 2 above as well as collection optics configured to receive the diffusely scattered light and to direct the diffusely scattered light to the spectral sensor or the detector (Paragraph [0119] - The elements that make up the transfer optics can include collimating and/or condensing optics, optical filters, optical diffusers, a reflective integrating chamber, a diffuse integrating chamber, a homogenizer or light pipe for scrambling and the corresponding mechanical components to hold the optics and light source).
Regarding Claim 6, White et. al.'759 discloses the apparatus disclosed in Claim 5 above as well as the collection optics comprise a waveguide, a plurality of waveguides, a set of one or more lenses, or a reflector (Paragraph [0134] - An orientation is comprised of the angle of the illumination fiber or fibers, the angle of the collection fiber or fibers).
Regarding Claim 7, White et. al.'759 discloses the apparatus disclosed in Claim 6 above as well as the reflector comprises a metallized molded part having a shape producing a compound parabolic concentrator or a compound elliptic concentrator (Paragraph [0121] - A parabolic mirror is an example of a reflective collimating optic; Paragraph [0364] - The material can be metal, including but not limited to stainless steel or aluminum, plastic, glass, or other suitable material. The primary objectives of the sample interface are to hold the illumination and collection portions of the optical probe in place).
Regarding Claim 8, White et. al.'759 discloses the apparatus disclosed in Claim 7 above as well as the detector comprises a set of two or more detectors and the reflector comprises a set of two or more reflectors, each configured to direct the diffusely scattered light to a respective detector of the two or more detectors (Paragraph [0156] - Alternatively, a multi-element detector such as a CCD or photodiode array can be used to detect multiple wavelengths simultaneously; Paragraph [0158] - The interferogram is formed by modulating the wavelengths of light collected by the sampling subsystem 200 or the illumination subsystem 100, depending on the system's orientation, to different frequencies. FIG. 24 schematically depicts one embodiment of a spectrometer 230, called a Fourier Transform interferometer (FTIR), which includes a beamsplitter 234 and compensator optics 236, a fixed retro-reflector 238 and a moving retro-reflector 240)
Regarding Claim 9, White et. al.'759 discloses the apparatus disclosed in Claim 5 above as well as the illumination optics comprises a plurality of waveguides, and wherein each of the plurality of waveguides is tilted in a horizontal plane by respective angles towards an optical axis of the collection optics and each of the plurality of waveguides comprises an angle-cleaved optical fiber configured to maintain contact with the skin tissue (Paragraph [0098] - The terms "solid state light source" or "semiconductor light source" refer to all sources of light, whether spectrally narrow (e.g. a laser) or broad (e.g. an LED) that are based upon semiconductors which include, but are not limited to, light emitting diodes (LED's), vertical cavity surface emitting lasers (VCSEL's), horizontal cavity surface emitting lasers (HCSEL's)).
Regarding Claim 10, White et. al.'759 discloses the apparatus disclosed in Claim 5 above as well as the illumination optics comprises a plurality of waveguides, and wherein the plurality of waveguides are tilted in a vertical plane perpendicular to an optical axis of the diffusely scattered tight transmitted through the skin tissue by a first angle and the collection optics are tilted in the vertical plane by a second angle (Paragraph [0098] - The terms "solid state light source" or "semiconductor light source" refer to all sources of light, whether spectrally narrow (e.g. a laser) or broad (e.g. an LED) that are based upon semiconductors which include, but are not limited to, light emitting diodes (LED's), vertical cavity surface emitting lasers (VCSEL's), horizontal cavity surface emitting lasers (HCSEL's))
Regarding Claim 11, White et. al.'759 discloses the apparatus disclosed in Claim 5 above as well as the illumination optics comprises a plurality of waveguides (Paragraph [0300] - It is recognized by one skilled in the art that the range of angles emitted by the light sources can be controlled within the light sources or by the use of additional optical components such as lenses, coatings, waveguides or homogenizers), and further comprising:
a substrate, wherein the plurality of waveguides are integrated on the substrate (Paragraph [0127] - The light emitted by the multiple sources can be optically combined, for example using a light pipe or other homogenizer, introduced and collected from the sample of interest, and then measured by a single detector; Paragraph [0251] - The light pipe is generally fabricated from a metallic, glass (amorphous), crystalline, polymeric, or other similar material, or any combination thereof)
Regarding Claim 12, White et. al.'759 discloses the apparatus disclosed in Claim 5 above as well as at least one of the illumination optics or the collection optics comprises a waveguide, wherein the waveguide comprises a dielectric slab or a silicon slab (Paragraph [0129] - narrow light sources using optical filters such as, but not limited to, linearly variable filters (LVF's), dielectric stacks, distributed Bragg gratings, photonic crystal lattice filters, polymer films)
Regarding Claim 13, White et. al.'759 discloses the apparatus disclosed in Claim 5 above as well as at least one of the illumination optics or the collection optics comprises a waveguide (Paragraph [0300] - It is recognized by one skilled in the art that the range of angles emitted by the light sources can be controlled within the light sources or by the use of additional optical components such as lenses, coatings, waveguides or homogenizers), and further comprising:
one or more optical windows coupled to the waveguide (Paragraph [0296] - An optically transparent material such as a fused silica window, microlens array, or other suitable material is then placed over the laser diodes and detector. This material serves as the sample interface and prevents damage to the laser diodes and detector).
Regarding Claim 14, White et. al.'759 discloses the apparatus disclosed in claim 13 above as well as coupling optics configured to couple an output of the collection optics to the spectral sensor (Paragraph [0250] - The output of the light pipe can directly couple to the input of the tissue sampler or can be used in conjunction with additional transfer optics before the light is sent to the tissue sampler).
Regarding Claim 17, White et. al.'759 discloses the apparatus disclosed in Claim 5 above as well as the illumination optics and the collection optics are on a same axis on either side of the path length control part (Paragraph [0139] - Referring to FIG. 14, the tissue sampling subsystem 200 has an optical input 202, a sampling surface 204 which forms a tissue interface 206 that interrogates the tissue and an optical output 207. The subsystem further includes an ergonomic apparatus 210, depicted in FIG. 15, which holds the sampling surface 204 and positions the tissue at the interface 206; Paragraph [0145] - The clustered input and output fibers are mounted into a cluster ferrule that is mounted into a sampling head 216).
Regarding Claim 18, White et. al.'759 discloses the apparatus disclosed in Claim 5 above as well as wherein the path length control part comprises the illumination optics and the collection optics and is formed by a groove between the illumination optics and the collection optics to measure through a dermis layer of the skin tissue (Paragraph [0149] - The tissue sampling subsystem can employ an ergonomic apparatus or cradle 210 that positions the tissue over the sampling interface 206 in a reproducible manner… The ergonomic cradle 210 includes a base 221 having an opening 223 there through. The opening is sized for receiving the sample head 216 therein to position the sampling surface 204 generally coplanar with an upper surface 225 of the base 221. The ergonomic cradle 210 generally references a part of the sample such that it accurately positions the sample on the sampling interface).
Regarding Claim 19, White et. al.'759 discloses the apparatus disclosed in Claim 1 above as well as the path length control part comprises a mechanical part configured to compress and hold the skin tissue to produce the target effective optical path length (Paragraph [0150] - entire paragraph - The example ergonomic cradle 210…The adjustable hand rest 224…a lifting mechanism is included which raises and lowers the cradle periodically).
Regarding Claim 24, White et. al.'759 discloses the apparatus disclosed in Claim 19 above as well as the target effective optical path length is a fixed optical path length repeatable across respective measurements of the skin tissue (Paragraph [0123] - Uniform radiance can be utilized in the present teachings for achieving accurate and precise measurements; Paragraph [0213] - An inflated outlier metric value (a value beyond a fixed threshold, for example) can be used to trigger a fixed response such as a repeat of the measurement, application of an alternative calibration model, or a sampling site cleaning procedure. This is represented in FIG. 30 as the "Spectral Check OK" decision point).
Regarding Claim 26, White et. al.'759 discloses the apparatus disclosed in Claim 19 above as well as the mechanical part further comprises at least one of illumination optics or collection optics integrated therewith (Paragraph [0145] - The output ends of the output fibers are clustered into a ferrule 220 for interface with the data acquisition subsystem 300).
Regarding Claim 27, White et. al.'759 discloses the apparatus disclosed in Claim 19 above as well as the mechanical part comprises an opening configured to receive the skin tissue, wherein a distance between walls of the opening is configured to control the effective optical path length, and wherein pressure is applied against the mechanical part by the subject to insert the skin tissue (Figure 15; Paragraph [0150] - entire paragraph - The example ergonomic cradle 210…The adjustable hand rest 224…a lifting mechanism is included which raises and lowers the cradle periodically).
Regarding Claim 32, White et. al.’759 discloses the apparatus disclosed in Claim 19 above as well as wherein the mechanical part is configured to apply at least one of mechanical pressure or suction pressure to the skin tissue (Paragraph [0076] - The blood constituent concentration detector measures the blood constituent concentration based on measurement of the pulse wave under a condition that the load to the operation element 20d is controlled to be in a predetermined range), and further comprising:
illumination optics configured to direct the input light towards the skin tissue for diffused transmission of the input light through the skin tissue to produce the diffusely scattered light (Paragraph [0112] - subsystems provide reproducible and preferably spatially uniform radiance of the tissue); and
collection optics configured to receive the diffusely scattered light from the skin tissue (Paragraph [0112] - efficient collection of diffuse reflectance spectra from the tissue).
Regarding Claim 33, White et. al.’759 discloses the apparatus disclosed in Claim 32 above. White et. al.’759 further discloses wherein the illumination optics are configured to direct the input light towards the skin tissue at an oblique angle (Paragraph [0134] - An orientation is comprised of the angle of the illumination fiber or fibers, the angle of the collection fiber or fibers, the numerical aperture of the illumination fiber or fibers, the numerical aperture of the collection fiber or fibers, and the separation distance between the illumination and collection fiber or fibers).
Regarding Claim 34, White et. al.'759 discloses the apparatus disclosed in Claim 1 above as well as the spectral sensor comprises a spectrometer configured to receive the diffusely scattered light and to obtain the spectrum of the analyte (Paragraph [0099] - For the purposes of these teachings the term "dispersive spectrometer" indicates a spectrometer based upon any device, component, or group of components that spatially separate one or more wavelengths of light from other wavelengths; Paragraph [0105] - This is done by measuring a spectrum comprised of multiple wavelengths and subsequently determining the portion of the spectrum that is unique to the analyte of interest (e.g. related to the molecular fingerprint of the analyte)).
Regarding Claim 35, White et. al.'759 discloses the apparatus disclosed in Claim 34 above as well as a non-dispersive infrared system comprising at least one narrowband light source configured to emit additional light towards the skin tissue and at least one detector configured to receive reflected light or transmitted light from the skin tissue (Paragraph [0098] - The terms "solid state light source" or "semiconductor light source" refer to all sources of light, whether spectrally narrow (e.g. a laser) or broad (e.g. an LED) that are based upon semiconductors; Paragraph [0234] - The narrow profiles exhibited by the LED's could allow better fine tuning of the relative intensities of the wavelengths as compared to blackbody light sources; Paragraph [0160] - a typical interferogram created by an FTIR spectrometer. At the point of zero path difference between the transmitted and reflected beams, there will be maximum constructive interference, and the centerburst of the interferogram is created. The interferogram is then focused onto a detector (part of the data acquisition subsystem), as shown in FIG. 1. The detector converts the optical interferogram into an electrical representation of the interferogram for subsequent digitizing by the data acquisition subsystem 400).
Regarding Claim 36, White et. al.'759 discloses the apparatus disclosed in Claim 34 above as well as a laser source configured to illuminate the skin tissue at a wavelength outside an operating range of the spectrometer and corresponding to an absorption peak of the analyte (Paragraph [0240] - Furthermore, the change in optical properties caused by thermal state and electrical conditions can be leveraged to allow a single light source to be tuned to multiple peak wavelength locations. This can result in analyte property measurement systems that can measure more wavelength locations than the number of discrete light sources that can reduce system cost and complexity).
Regarding Claim 37, White et. al.'759 discloses the apparatus disclosed in claim 1 above as well as the spectral sensor comprises an interferometer configured to receive the input light and produce the modulated light for transmission through the skin tissue to the detector (Paragraph [0099] - For the purposes of these teachings the term "interferometric/modulating spectrometer" indicates a class of spectrometers based upon the optical modulation of different wavelengths of light to different frequencies in time or selectively transmits or reflects certain wavelengths of light based upon the properties of light interference).
Regarding Claim 38, White et. al.'759 discloses the apparatus disclosed in Claim 1 above as well as the spectral sensor comprises a Fourier Transform infrared (FTIR) spectrometer (Paragraph [0099] - For the purposes of these teachings the term "interferometric/modulating spectrometer" indicates a class of spectrometers based upon the optical modulation of different wavelengths of light to different frequencies in time or selectively transmits or reflects certain wavelengths of light based upon the properties of light interference. Examples include, but are not limited to, Hadamard transform spectrometers, Fourier transform interferometers).
Regarding Claim 39, White et. al.'759 discloses the apparatus disclosed in Claim 1 above as well as the skin tissue comprises a tip of a finger, a bottom of a fingertip, an interdigital web of a hand, an earlobe, a wrist, a nose, or a portion of a neck of the subject (Paragraph [0133] - Some suitable locations for the purposes of the present teachings are the finger, arm, forearm, upper arm, shoulder, lip, ear, ear lobe, leg, face, or any location on the body that is accessible or useful to determining the water concentration, total body water, and/or hydration state of the person being tested).
Regarding Claim 42, White et. al.'759 discloses the apparatus disclosed in Claim 1 above as well as one or more ultrasonic transducers configured to excite a standing acoustic wave inside of the skin tissue to modify a refractive index of the skin tissue to reduce scattering loss inside the skin tissue (Paragraph [0383] - Another possible technology is the use of an ultrasonic detection device. This device, an ultrasonic emitter and receiver, can be tuned to measure the water content in the deeper tissue).
Regarding Claim 43, White et. al.'759 discloses the apparatus disclosed in Claim 1 above as well as an enclosure housing the light source, the enclosure comprising an optical window for direct illumination on the skin tissue (Paragraph [0296] - An optically transparent material such as a fused silica window, microlens array, or other suitable material is then placed over the laser diodes and detector. This material serves as the sample interface and prevents damage to the laser diodes and detector); and
free space optics configured to couple the input light to the skin tissue (Paragraph [0301] - In some embodiments, the window provides a protective layer that prevents contamination or failure of the light sources or photodetector due to the presence of materials such as interferences or sweat on the tissue surface. The window can be any material (glass, quartz, fused silica, sapphire, plastic, etc.) that sufficiently transmits the wavelengths of light used by the embodiment).
Regarding Claim 44, White et. al.'759 discloses the apparatus disclosed in Claim 43 above as well as the optical window is coated with a material configured to filter a portion of the input light (Paragraph [0301] - In some embodiments, the window provides a protective layer that prevents contamination or failure of the light sources or photodetector due to the presence of materials such as interferences or sweat on the tissue surface. The window can be any material (glass, quartz, fused silica, sapphire, plastic, etc.) that sufficiently transmits the wavelengths of light used by the embodiment).
Regarding Claim 45, White et. al.'759 discloses the apparatus disclosed in Claim 1 above as well as an optical filter configured to filter the input light or the modulated light (Paragraph [0129] - In these embodiments, the broad blackbody source is converted to multiple, narrow light sources using optical filters such as, but not limited to, linearly variable filters (LVF's), dielectric stacks, distributed Bragg gratings, photonic crystal lattice filters, polymer films, absorption filters, reflection filters, etelons, dispersive elements such as prisms and gratings, and quantum dot filters).
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759) as applied to Claim 5 above, and further in view of Kurani et. al.'472 (U.S. Patent Publication 20230404472).
Regarding Claim 15, White et. al.’759 discloses the apparatus disclosed in Claim 5 above as well as interferometers and a silicon detector (Paragraph [0099]; Paragraph [0167] - a silicon detector can be suitable if the wavelength range of interest were within the 300-1100 nm range). White et. al.’759 fails to disclose at least one of the illumination optics or the collection optics comprises at least one waveguide, wherein the spectral sensor comprises a micro-electro-mechanical system (MEMS) interferometer, and further comprising: a silicon chip, wherein the at least one waveguide and the MEMS interferometer are integrated into the silicon chip. Kurani et. al.'472 teaches utilizing MEMS devices that combine small mechanical and electronic components on a silicon surface (Paragraph [0128] - They are fabricated using integrated circuit (IC) batch processing techniques and can range in size from a few micrometers to millimeters. MEMS devices combine small mechanical and electronic components on a silicon chip. The fabrication techniques used for creating transistors, interconnects, and other components on an integrated circuit (IC) can also be used to construct mechanical components such as springs, deformable membranes, vibrating structures, valves, gears, and levers. This technology can be used to make a variety of sensors such as microbial biosensors, particulate matter sensors, enviro sensor comprising RIFD tag sensors, location, temperature, humidity, pressure, air quality, smoke, gas, ambient light, and so on. MEMS enables the combination of accurate sensors, powerful processing, and wireless communication (for example, Wi-Fi or Bluetooth) on a single integrated circuit). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.’759 to include a MEMS setup in order to combine sensors, processors, wiring, and other essential components into a singularly integrated circuit as seen in Kurani et. al.’472.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759), as applied to Claim 5 above, and further in view of Connor'513 (U.S. Patent Publication 20180042513).
Regarding Claim 16, White et. al.’759 discloses the apparatus disclosed in Claim 5 above as well as rotating optics (Paragraph [0156] - The intensities can be measured sequentially using a single element detector and rotating the dispersing element to place the desired wavelength on the detector), but fails to disclose wherein the illumination optics and the collection optics are fixed onto a moveable tilting component configured to tilt the illumination optics and the collection optics between a first position at an angle from an optical axis of the apparatus and a second position in-plane with the optical axis of the apparatus in response to a force applied by the subject to the illumination optics and the collection optics, and wherein the path length control part comprises a latch configured to fix the illumination optics and the collection optics in the second position to obtain the spectrum. Connor’513 teaches a device with optics that are tilted and locked in place (Paragraph [0279] - a light emitter can be automatically tilted, rotated, raised, or lowered in order to maintain a selected distance (or distance range) from the surface of a person's body. In an example, a light emitter can be automatically tilted, rotated, raised, or lowered in order to maintain a selected angle (or angle range) with respect to the surface of a person's body; Paragraph [0486] - a locking mechanism which locks a light emitter and/or light receiver in place once it has been slid to an optimal location). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.’759 to include optics that tilt and lock (latch) into place in order to achieve optimal locations that can send and receive signals as seen in Connor’513.
Claims 20-21 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759) as applied to Claim 5 above, and further in view of Osaki et. al.'187 (U.S. Patent Publication 20100125187).
Regarding Claim 20, White et. al.’759 discloses the apparatus disclosed in Claim 5 above but fails to disclose wherein the mechanical part comprises a pressure sensor to measure a pressure applied to the mechanical part by the subject or by the mechanical part to the skin tissue to produce pressure sensor data. Osaki et. al.’187 teaches a pressure sensor configured to record pressure applied to a device from a subject (Paragraph [0099] - the detector may include a sensor for detecting the load to the detection portion, and based on a signal from the sensor, the detector may determine whether the load to the detection portion is equal to or larger than the first threshold, and smaller than the second threshold). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.’759 to include a pressure sensor in order to determine whether proper contact has been made by the user with the measurement device and obtain measurement readings as seen in Osaki et. al.’187.
Regarding Claim 21, White et. al.’759 in view of Osaki et. al.’187 discloses the apparatus disclosed in Claim 20 above but fails to disclose a feedback device configured to adjust the mechanical part or notify a user to apply additional pressure based on at least one of the pressure sensor data or the spectrum. Osaki et. al.’187 teaches providing feedback pertaining to pressure applied by a subject (Paragraph [0051] - Here, when the load to the concavities 20a, 20b is small so that the load is smaller than the first threshold, or when the load to the concavities 20a, 20b is large so that the load is larger than the second threshold, the determination in Step S100 is "NO." In this case, Step S100 is repeated; Paragraph [0053] - When the user puts the finger in the concavities 20a, 20b with appropriate force so that the switch 28 turns on and the switch 29 turns off, the determination in Step S100 is "YES." Then, in Step S102, the pulse wave is measured). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.’759 to include providing feedback to a user based on adequate pressure loads applied by the user onto the device in order to assist the user in proper positioning of their finger to obtain measurement readings as seen in Osaki et. al.’187.
Regarding Claim 31, White et. al.’759 discloses the apparatus disclosed in Claim 27 above but fails to disclose the opening comprises a spring-loaded moveable diffuser in a light path of the apparatus to obtain a background spectrum, wherein the pressure is applied to the spring-loaded moveable diffuser to move the skin tissue into the light path to obtain the spectrum. Osaki et. al.’187 teaches a spring-loaded mechanical system to move skin of a subject closer to optics of the system (Paragraph [0075] - Specifically, the spring 27 between the casing 20 and the stay 25 applies elastic force to the switch 28 such that the switch 28 turns on when load of the finger 50 to the concavities 20a, 20b is equal to or larger than a first threshold). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.’759 to include a spring-loaded element that helps control positioning the skin tissue in an appropriate position at a proper load in order to obtain accurate measurement readings only once in the appropriate positioning as seen in Osaki et. al.’187.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759) in view of Osaki et. al.'187 (U.S. Patent Publication 20100125187), as applied to Claim 20 above, further in view of Reichl'600 (U.S. Patent Publication 20220287600), and further in view of Vo et. al.'877 (U.S. Patent Publication 20200196877 – cited by applicant).
Regarding Claim 22, White et. al.’759 in view of Osaki et. al.’187 discloses the apparatus disclosed in Claim 20 above, but fails to disclose wherein the mechanical part comprises a path length measurement device configured to measure a thickness of the skin tissue corresponding to the effective optical path length, wherein the mechanical part is further configured to adjust the effective optical path length based on the thickness to produce the target effective optical path length; and a feedback device configured to receive the thickness and adjust the effective optical path length based on the thickness. Reichl'600 teaches adjusting optical path length based on various skin thicknesses (Paragraph [0041] - The use of a multi-wavelength radiation source allows adjusting a predetermined penetration depth of electromagnetic radiation into the tissue of the irradiated body part depending on specific characteristics of the body part, e.g. pigmentation, skin thickness, presence or absence of horny skin. As shown in FIG. 1, supra, the penetration depth into body tissue varies with the wavelength and the use of VIS/NIR radiation with different wavelengths or with combinations of different wavelengths can be adapted for each subject and/or each body part individually, if desired). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.'759 in view of Osaki et. al.'187 to include adjusting an optical path length based on measured tissue thickness in order to obtain desired depths across various locations of a user’s body or between various users as seen in Reichl'600.
Vo et. al.'877 teaches mechanically adjusting an optical path length based on tissue thickness (Paragraph [0090] - The one or more probes (such as fibers 105, 107) can be moved toward one another such that, when they compress the tissue of the user, the compressed tissue has a thickness 1/12 inch (0.21 cm) and ¼ inch (0.64 cm), for example. The one or more probes (such as fibers 105, 107) can be moved toward one another such that, when they compress the tissue of the user, the compressed tissue has a thickness less than or equal to 1/12 inch (0.21 cm), 1/11 inch (0.23 cm), 1/10 inch (0.25 cm), 1/9 inch (0.28 cm), ⅛ inch (0.32 cm), 1/7 inch (0.36 cm), ⅙ inch (0.42 cm), ⅕ inch (0.51 cm), ¼ of inch (0.64 cm), or any value therebetween, or any range bounded by any combination of these values, although values outside these are possible. Interrogating a short path length of tissue allows measurements to be taken through highly absorbing media which enables detection of signals that may normally fall below detectable limits). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.'759 in view of Osaki et. al.'187, and further in view of Reichl'600 to include mechanically adjusting an optical path length based on measured tissue thickness in order to obtain more accurate measurements at depths wherein signals may fall below detectable thresholds as seen in Vo et. al.'877.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759) in view of Osaki et. al.'187 (U.S. Patent Publication 20100125187), further in view of Reichl'600 (U.S. Patent Publication 20220287600), further in view of Vo et. al.'877 (U.S. Patent Publication 20200196877 – cited by applicant), as applied to Claim 22, and further in view of Newberry'431 (U.S. Patent Publication 20180125431).
Regarding Claim 23, White et. al.’759 in view of Osaki et. al.’187, further in view of Reichl'600, and further in view of Vo et. al.'877 discloses the apparatus disclosed in Claim 22 above, but fails to disclose a processor configured to calculate a concentration of the analyte based on the pressure sensor data, the effective optical path length, and the spectrum. Newberry'431 teaches determining a concentration of an analyte based on pressure sensor data, optical path length, and spectrometer readings (Paragraph [0082] - The biosensor 100 may also include a touch pad or touch point with a proximity indicator 114 and pressure sensor 112. The proximity indicator 114 includes one or more LEDs, e.g. in the IR range, that emit pulses of light. When a finger or other body part is positioned near the touch point, a photodiode may then detect a reflectance of the IR light. The biosensor 100 may then activate the PPG circuit 110. A pressure sensor 112 may detect a pressure on the touch point by a finger or other body part and provide a feedback indicator. The feedback indicator provides a visible, audible or tactile indication that the pressure applied by the finger is within tolerance levels or needs to increase or decrease for proper detection of spectral data by the biosensor 100; Paragraph [0097] - First, the spectral response of a substance or substances in the arterial blood flow is determined in a controlled environment, so that an absorption coefficient α.sub.g1 can be obtained at a first light wavelength λ1 and at a second wavelength λ2. According to the Beer-Lambert law, light intensity will decrease logarithmically with path length l (such as through an artery of length l). Assuming then an initial intensity I.sub.in of light is passed through a path length l, a concentration C.sub.g of a substance may be determined). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.'759 in view of Osaki et. al.'187, further in view of Reichl'600, and further in view of Vo et. al.'877 to include calculating a concentration of an analyte based on pressure sensor data, pathlength, and spectral data in order to obtain measurements only once appropriate contact has been made between a user and the measurement apparatus as well as use a known method of calculation such as Beer-Lambert law that accounts for pathlength and spectral data to observe analyte presence as seen in Newberry’431 (Paragraph [0018] - current non-invasive method is known…spectrophotometry to determine spectral absorbencies and determining concentration levels of oxygen based on Beer-Lambert law principles; Paragraph [0028] - the patient vital includes at least one of: oxygen saturation SpO2, a concentration level of nitric oxide (NO), a concentration level of a liver enzyme, a concentration level of glucose, a concentration level of an electrolyte, a concentration of one or more species of hemoglobin, or a concentration level of another substance in a blood stream of the user).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759) as applied to Claim 19 above, and further in view of Akbari et. al.'092 (U.S. Patent Publication 20210338092).
Regarding Claim 25, White et. al.’759 discloses the apparatus disclosed in Claim 19 above, but fails to disclose the mechanical part is further configured to adjust the effective optical path length based on the spectrum to produce the target effective optical path length, wherein the mechanical part further comprises a feedback device configured to receive the spectrum and adjust the effective optical path length based on the spectrum. Akbari et. al.'092 teaches adjusting a path length based on received biological signals (Paragraph [0108] - the mean penetration depth may be changed by adjusting one or more source-detector separation distances, modulation frequencies, or wavelengths of the coherent or incoherent light signals, or a combination thereof. In some embodiments, the device may be configured to calculate absolute value of CMRO.sub.2 at a selected depth, and may be programmed with instructions for iteratively determining the mean penetration depth and adjusting one or more parameters effecting mean penetration depth until the selected depth is reached). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.'759 to include an adjustable pathlength based on a measured analyte concentration in order to account for analyte concentrations most appropriately measured across various pathlengths as seen in Akbari et. al.’092.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759), as applied to Claim 27 above, and further in view of Newberry'431 (U.S. Patent Publication 20180125431).
Regarding Claim 28, White et. al.’759 discloses the apparatus disclosed in Claim 27 above, but fails to disclose wherein the mechanical part further comprises: a pressure sensor configured to measure the pressure applied by the subject to the mechanical part, wherein the effective optical path length is calculated based on at least one of the pressure or the spectrum. Newberry'431 teaches determining an optical path length based on pressure sensor data and spectrometer readings (Paragraph [0082] - The biosensor 100 may also include a touch pad or touch point with a proximity indicator 114 and pressure sensor 112. The proximity indicator 114 includes one or more LEDs, e.g. in the IR range, that emit pulses of light. When a finger or other body part is positioned near the touch point, a photodiode may then detect a reflectance of the IR light. The biosensor 100 may then activate the PPG circuit 110. A pressure sensor 112 may detect a pressure on the touch point by a finger or other body part and provide a feedback indicator. The feedback indicator provides a visible, audible or tactile indication that the pressure applied by the finger is within tolerance levels or needs to increase or decrease for proper detection of spectral data by the biosensor 100; Paragraph [0097] - First, the spectral response of a substance or substances in the arterial blood flow is determined in a controlled environment, so that an absorption coefficient α.sub.g1 can be obtained at a first light wavelength λ1 and at a second wavelength λ2. According to the Beer-Lambert law, light intensity will decrease logarithmically with path length l (such as through an artery of length l). Assuming then an initial intensity I.sub.in of light is passed through a path length l, a concentration C.sub.g of a substance may be determined). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.'759 to include calculating an optical path length based on pressure sensor data and spectral data in order to obtain measurements only once appropriate contact has been made between a user and the measurement apparatus as well as use a known method of calculation such as Beer-Lambert law that accounts for pathlength and spectral data to observe analyte presence as seen in Newberry’431 (Paragraph [0018] - current non-invasive method is known…spectrophotometry to determine spectral absorbencies and determining concentration levels of oxygen based on Beer-Lambert law principles; Paragraph [0028] - the patient vital includes at least one of: oxygen saturation SpO2, a concentration level of nitric oxide (NO), a concentration level of a liver enzyme, a concentration level of glucose, a concentration level of an electrolyte, a concentration of one or more species of hemoglobin, or a concentration level of another substance in a blood stream of the user).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759), in view of Newberry'431 (U.S. Patent Publication 20180125431), as applied to Claim 28 above, and further in view of Osaki et. al.'187 (U.S. Patent Publication 20100125187).
Regarding Claim 29, White et. al.’759 in view of Newberry'431 discloses the apparatus disclosed in Claim 28 above, but fails to disclose wherein the pressure sensor comprises a spring-loaded part. Osaki et. al.'187 teaches a pressure sensor comprising a spring (Paragraph [0072] - Multiple springs 27 are formed between the operation element 20d and the bottom of the casing 20 such that the springs 27 are supported by the spring guides 26). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.'759 in view of Newberry'431 to include a pressure sensor as a spring-loaded element in order to deform upon a user’s contact force and allow the apparatus to perform measurements as seen in Osaki et. al.’187 (Paragraph [0073] - When the driver puts the finger 50 on the operation element 20d, each spring 27 is deformed so that the operation element 20d is displaced downward; Paragraph [0075] - The spring 27 between the stay 25 and the bottom element 20c applies elastic force to the switch 29 such that the switch 29 turns on when load of the finger 50 to the concavities 20a, 20b is equal to or larger than a second threshold).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759), in view of Newberry'431 (U.S. Patent Publication 20180125431), further in view of Osaki et. al.'187 (U.S. Patent Publication 20100125187), as applied to Claim 29 above, and further in view of Rosenthal et. al.’455 (U.S. Patent 5436455).
Regarding Claim 30, White et. al.’759 in view of Newberry'431 and further in view of Osaki et. al.'187 discloses the apparatus disclosed in Claim 29 above, but fails to disclose wherein the spring-loaded part is configured to lock into place in response to the pressure reaching a desired amount. Rosenthal et. al.’455 teaches a spring configured to lock in place under proper pressure (Column 8 Lines 23-28 - the springs 42 may be omitted and replaced by another mechanism such as a small pressure sensitive motor or the like, or the sliding baffle 40 may be provided with external locking means to lock it in position after finger insertion so that a standard reading may be taken with the aperture 54 in a constant position). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.'759 in view of Newberry'431 and further in view of Osaki et. al.’187 to include a spring-loaded element capable of locking into place upon response to a pressure reaching a desired amount in order to allow the apparatus to perform measurements at a constant position as seen in Rosenthal et. al.’455.
Claims 40 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over White et. al.'759 (U.S. Patent Publication 20140171759) as applied to Claim 1 above, and further in view of Osaki et. al.'187 (U.S. Patent Publication 20100125187) as evidenced by Determann et. al.’664 (U.S. Patent Publication 20190392664).
Regarding Claim 40, White et. al.’759 discloses the apparatus disclosed in Claim 1 above as well as providing power for a car key (Paragraph [0344] - Some embodiments for remotely storing enrollment data are comprised of a means for storing data, a means for providing power, a means for communication and data transfer…These components can be combined in many possible form factors. Some examples include car key, plastic transponder, credit card style smart card, employee id badge, lapel pin, etc.), but fails to disclose wherein the apparatus is integrated into a steering wheel of a vehicle, an ignition press button of the vehicle, a console of the vehicle, a dashboard of the vehicle, or a seatbelt of the vehicle or the apparatus is a wearable device connected to the vehicle. Osaki et. al.’187 teaches integrating a power source into a start control of a vehicle (Paragraph [0081] - Thus, the starter switches a power source position and controls to start an engine of the vehicle with using a combination of a starter switch operation and a brake operation). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of White et. al.’759 to include a car key as an ignition press button as seen in Osaki et. al.’187 as evidenced by Determann et. al.’664 that teaches vehicles have experienced a growing popularity of ignition press buttons being incorporated (Paragraph [0010] - car keys began incorporating “passive” functionality into RKE systems…push a button to start the vehicle engine).
Regarding Claim 41, White et. al.’759 in view of Osaki et. al.’187 as evidence by Determann et. al.’664 discloses the apparatus disclosed in Claim 40 above. White et. al.’759 further discloses wherein the analyte of the skin tissue under test includes a blood alcohol concentration or a glucose level and wherein the apparatus controls operation of the vehicle based on the blood alcohol concentration or the glucose level (Paragraph [0024] -Therefore, given the relative abundance of water in a typical skin sample, it should be significantly more feasible to spectroscopically measure either the absolute level of hydration, or at a minimum, a relative level of hydration in the skin relative to measurements of less concentrated analytes such as alcohol or glucose; Paragraph [0238] - Likewise, a different set could be activated when measuring a different analyte such as cholesterol or glucose; Paragraph [0344] - Some embodiments for remotely storing enrollment data are comprised of a means for storing data, a means for providing power, a means for communication and data transfer…These components can be combined in many possible form factors. Some examples include car key, plastic transponder, credit card style smart card, employee id badge, lapel pin, etc.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Diab’581 (U.S. Patent 7801581) discloses an optical spectroscopy device comprising a tilting mechanism as well as surrounding a tissue of interest with optical sensors. Steinberg’349 (U.S. Patent 5743349) discloses an optical device configured to act as a vehicle ignition interlock system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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/SARAH ANN WESTFALL/ Examiner, Art Unit 3791
/ETSUB D BERHANU/ Primary Examiner, Art Unit 3791
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