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 .
Information Disclosure Statement
The information disclosure statement filed 02/23/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Status of Claims
This Office Action is responsive to the claims filed on 12/18/2025. Claims 15-20 have been renumbered as claims 13-18 in response to objections to the claims filed 07/18/2025. Claims 1-3, 9, 12, 14-16, and 18 have been amended. Claims 1-18 are presently pending in this application.
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.
Claim 16 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation <1.5 x10^-15, and the claim also recites <7 x10^-16 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-12, 15-16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over League (US 20230184682) in view of Chen (US 20220034854), Bierewirtz (US 20250107725), Islam (US 20240130621) and Gambhir (US 10517964).
Regarding claims 1 and 18, League teaches a non-contact rapid diagnostic system and a method of non-contact rapid diagnosis of a human subject (Abstract; systems and methods of use thereof, and, in particular, hyperspectral fluorescence systems and methods for detecting aerosolized viral biologics and/or carcinogenic compounds); comprising:
at least one frequency-stabilized laser device (Paragraph [0079]; Hyperspectral camera/sensor 102… including an integrated laser excitation emitter; The integrated laser of hyperspectral fluorescent camera 201 emits a laser in excitation region 205) configured to generate electromagnetic radiation of a wavelength in the UV range or in the visible light range (Paragraph [0079]; the integrated laser excitation emitter is a 405 nm laser) and positionable so as to direct the electromagnetic radiation towards a human subject and toward an area external to the subject and surrounding a head, torso, and/or legs of the subject, the area containing a water mixture envelope comprising (ii) a low disperse water envelope (LDWE) emitted from the subject's body (Paragraph [0085]; arrangement shown in FIGS. 1A-1B and 2 can be used for measuring biological components, identifying presence or absence of components in samples within the area of its focal line. As an individual being tested in station 101 can breathe (i.e., aerosolized breadth) into sampling area 206, which is excited by integrated laser excitation emitter in excitation region 205, and the hyperspectral camera/sensor 102 can then gather date used for measuring);
at least one optical detector configured to receive the reflected electromagnetic radiation and generate an analog signal corresponding thereto (Paragraph [0079]; a hyperspectral fluorescent camera 201; Hyperspectral camera/sensors 102 further includes a hyperspectral lens 202, which measures the wavelengths and intensity of elements);
a processor (Paragraph [0033]; one or more processors) configured to:
using a signal analysis algorithm, generate (i) a spectrogram (Paragraph [0084]; measurement can be the fluorescence as a function of time) from the digitized reflected beam (Paragraph [0035]; one or more processors a spectral signature of one or more of the components in the aerosolized sample) or (ii) both the spectrogram and an image derived from the spectrogram (Paragraph [0074]; Hyperspectral Imaging (HSI) is a process to capture data across the electromagnetic spectrum and identify types of material for each pixel of the imaged scene),
store reference spectra of healthy subjects and ill subjects on a non-transitory computer readable storage medium (Paragraph [0088]; spectral image gathered using station 101 can be compared to library references for the presence (or non-presence) of infectious presence in the aerosolized exhalation of the individual via a laptop computer using spectral processing algorithms), and find a first pattern of frequencies in the reference spectra based on one or more of an amplitude, phase shift, frequency shift and a chemical shift of frequencies in the reference spectra (Paragraph [0079]; which measures the wavelengths and intensity of elements, their “signature,” aerosolized in the sampling area 206; Paragraph [0098]; information gathered is analyzed to determine the presence (or lack of presence of the targeted spectral signatures or signatures), wherein the reference spectra derive from one or more imaging techniques (Paragraph [0075]-[0076]; Amin 2017, an observable difference was observed between the Raman spectra of DENV-infects sera as compared with those of healthy individuals; There is a spectral signature to the severe acute respiratory syndrome coronavirus 2);
determine, after generating the spectrogram or both the spectrogram and the image, a second pattern of frequencies in the spectrogram derived from the digitized reflected beam, based on one or more of an amplitude, phase shift, frequency shift and a chemical shift in the spectrogram of the subject, and;
determine, based on the comparing of the first and second pattern of concentrations, at least a preliminary indication (Paragraph [0088]; spectral image gathered using station 101 can be compared to library references for the presence (or non-presence) of infectious presence in the aerosolized exhalation of the individual via a laptop computer using spectral processing algorithms); and
an output unit configured to receive data and output the determination (Paragraph [0084]; visualization software on the system computer, capable of visualizing and analyzing the resulting data; Paragraph [0078]; light panel… can be included in station 101 to provide visual indicators to… the results of the initial analysis),
wherein the system is configured to operate without requiring active participation by the subject (Paragraph [0077] and [0101]-[0107]; the hyperspectral fluorescence system includes a station or portal 101 that can be similar to the station or portal that is presently being used at TSA checkpoints in airport terminals; Paragraph [0110]; used in portals of movement… non-invasive procedures).
League does not explicitly teach water that has been treated electrochemically so as to remove impurities;
a mist or sprayed form of the electrochemically treated water;
at least one mist-generation device configured to spray the electrochemically treated water into open air surrounding the subject;
an analog to digital converter configured to receive the analog signal and generated a digitized reflected beam;
each of the ill subjects suffering from one of the following three medical conditions: brain hemorrhage, brain cancer, or cancer of the pancreas;
the reference spectra derive from one or more imaging techniques including PET CT, CT, MRI, and the frequency-stabilized laser scanning the brain or the pancreas;
derive a first pattern of concentrations of electrolytes and protein molecules in the stored reference spectra from the first pattern of frequencies using neural networks;
derive a second pattern of concentrations of electrolytes and protein molecules in the water mixture envelope of the subject from the second pattern of frequencies using the neural networks;
compare the first pattern of concentrations with the second pattern of concentrations; and
determine whether the subject suffers from one of: brain hemorrhage, brain cancer, and cancer of the pancreas by executing pattern recognition software.
Chen, however, teaches water that has been treated electrochemically so as to remove impurities (Paragraph [0040]; The rinse fluid is selected to ensure that the EBA and condensed EBA (exhaled breath condensate) samples and the components in sampling subsystem 101 remains in a generally sterile condition);
a mist or sprayed form of the electrochemically treated water (Paragraph [0039]; Further, the sheath fluid flow may be humidified; Paragraph [0040]; Nebulizer 110);
at least one mist-generation device configured to spray the electrochemically treated water into open air surrounding the subject (Paragraph [0039]; Further, the sheath fluid flow may be humidified to enable EBA particle size growth, thereby enabling a large fraction of the particles in the breath to be captured downstream in the aerosol capture device 108).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system and method of League to have included water that has been treated electrochemically so as to remove impurities, a mist or sprayed form of the electrochemically treated water, and at least one mist-generation device configured to spray the electrochemically treated water into open air surrounding the subject because it would have allowed the breath particles to grow in size (Paragraph [0039]) and further allowed the system to remove contaminants between uses of different patients, thereby reducing background noise and preventing erroneous diagnostics.
Together League and Chen do not explicitly teach an analog to digital converter configured to receive the analog signal and generated a digitized reflected beam;
each of the ill subjects suffering from one of the following three medical conditions: brain hemorrhage, brain cancer, or cancer of the pancreas;
the reference spectra derive from one or more imaging techniques including PET CT, CT, MRI, and the frequency-stabilized laser scanning the brain or the pancreas;
c of electrolytes and protein molecules in the stored reference spectra from the first pattern of frequencies using neural networks;
derive a second pattern of concentrations of electrolytes and protein molecules in the water mixture envelope of the subject from the second pattern of frequencies using the neural networks;
compare the first pattern of concentrations with the second pattern of concentrations; and
determine whether the subject suffers from one of: brain hemorrhage, brain cancer, and cancer of the pancreas by executing pattern recognition software.
Bierewirtz, however, teaches derive a first pattern of concentrations of electrolytes and protein molecules in the stored reference spectra from the first pattern of frequencies (Paragraph [0178]; For example, the reference data may be obtained by performing appropriate calibration experiments that measure the relationship between the change in optical properties and amount and/or type of antigens);
derive a second pattern of concentrations of electrolytes and protein molecules in the water mixture envelope of the subject from the second pattern of frequencies (Paragraph [0069]; a spectral sensor, wherein preferably channels of the spectral sensor are configured to detect raman shifted light scattered by the pathogen-nanoparticle-agglomerates excited by the laser or light source; Paragraphs [0059] and [0131]-[0137]; the computing unit is configured to calculate a concentration of an antigen based on the change of optical properties of the solvent; Paragraph [0186]; In the spectrum of the light scattered by the sample on the solvent by agglomeration of the nanoparticles (in the case of antigens matching the antibodies), other frequencies are observed in addition to the irradiated frequency (Rayleigh scattering));
compare the first pattern of concentrations with the second pattern of concentrations (Claim 14; the first parameter is compared to a second parameter by the computing unit… when the first parameter is greater than or identical to the second parameter, wherein the second parameter is a pre-set value; Paragraph [0142]; preset value is a second parameter used for comparison with a first parameter. In terms of the present invention, this change includes a change in optical properties. The preset value is associated with the minimum value for detecting a change in optical properties, such as light emission, that must be achieved to define a detection as a positive detection in the sense of a detected antigen.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League in view of Chen to have further included deriving a first pattern of concentrations of electrolytes and protein molecules in the stored reference spectra from the first pattern of frequencies; deriving a second pattern of concentrations of electrolytes and protein molecules in the water mixture envelope of the subject from the second pattern of frequencies; and comparing the first pattern of concentrations with the second pattern of concentrations as taught by Bierewirtz because it would have been known methods of analyzing the spectra for specific analytes and further would have ensured detection of the concentrations of analytes, thereby improving diagnosis by allowing one to determine whether the analytes exceeded a certain threshold for a diagnosis.
Together League, Chen, and Bierewirtz do not explicitly teach an analog to digital converter configured to receive the analog signal and generated a digitized reflected beam;
each of the ill subjects suffering from one of the following three medical conditions: brain hemorrhage, brain cancer, or cancer of the pancreas;
the reference spectra derive from one or more imaging techniques including PET CT, CT, MRI, and the frequency-stabilized laser scanning the brain or the pancreas;
deriving patterns of concentrations of electrolytes and protein molecules using neural networks;
and determine whether the subject suffers from one of: brain hemorrhage, brain cancer, and cancer of the pancreas by executing pattern recognition software.
Islam, however, teaches a diagnostic system (Paragraph [0031]; a measurement system… system is configured to receive at least a portion of laser light from the one or more laser diodes reflected from the tissue comprising skin, and the second detection system) comprising an analog to digital converter configured to receive the analog signal and generated a digitized reflected beam (Paragraph [0203]; the signal may be received at a receiver… The receiver may also be coupled to analog to digital converters, particularly if the signal is to be fed to a digital device);
each of the ill subjects suffering from one of the following three medical conditions: brain hemorrhage, brain cancer, or cancer of the pancreas (Paragraph [0025]; the same techniques may also be applied to other cancer types, including brain, pancreatic, cancer);
the reference spectra derive from one or more imaging techniques including PET CT, CT, MRI, and the frequency-stabilized laser scanning the brain or the pancreas; and
deriving patterns of concentrations of electrolytes and protein molecules using neural networks (Paragraph [0441]; a person's characteristics over a period of time and using artificial intelligence or machine learning algorithms, as well as taking training sets and validation sets over numerous individuals, it may be possible to detect glucose level or HbA1c); and
and determine whether the subject suffers from one of: brain hemorrhage, brain cancer, and cancer of the pancreas (Paragraph [0025]; the same techniques may also be applied to other cancer types, including brain, pancreatic, cancer) by executing pattern recognition software (Paragraph [0516]; Deep learning refers to typically large neural networks, such as pattern recognition and the passage of the input through various layers of simulated neural connections).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system and method of League in view of Chen and Bierewirtz to have included digital to analog converter configured to receive the reflected beam and generated a digitized reflected beam; the medical conditions comprise brain cancer and cancer of the pancreas the subject's body; and deriving patterns of concentrations of electrolytes and protein molecules using neural networks as taught by Islam because they would have been known elements and methods for spectral analysis that further would ensure the digital components of the system could analyze the reflected beam (Islam, Paragraph [0203]), and further improve the ability measuring specific proteins with spectral data (Islam Paragraph [0441]).
Together League, Chen, Bierewirtz, and Islam do not explicitly teach the reference spectra derive from one or more imaging techniques including PET CT, CT, MRI, and the frequency-stabilized laser scanning the brain or the pancreas.
Gambhir, however, further teaches the reference spectra derive (Col. 34, ln. 13-43; Overall, the spectral study demonstrates that radiation luminescent could be used to excite QDs to produce detectable fluorescent lights for optical imaging purpose, and the QDs preserve their fluorescence emission properties under the mouse serum incubation as well as high energy radioactive irradiation for the time frame investigated in this study) from one or more imaging techniques including PET CT (Col. 14, ln. 4-43; radioactive agents have traditionally been studied by PET, SPECT or γcameras; however, these scanners and detectors are expensive, hard to maintain and not widely available to many researchers; Col. 10, ln. 41-52; optical imaging instrument with a charge-coupled device (CCD) camera (IVIS Spectrum); mice bearing C6-fluc glioma and imaged sequentially with IVIS Spectrum), CT, MRI, and the frequency-stabilized laser scanning the brain or the pancreas (Col. 14, ln. 44-63; present disclosure may be useful for radioactive optical imaging in cancer imaging and in imaging of other diseases. Radioactive optical imaging can be used in the detection, characterization and/or determination of the localization of a disease ranging from early to late stage disease… pancreas cancer, colorectal cancer, prostate cancer, lung cancer, brain tumor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of League in view of Chen, Bierewirtz, and Islam to have derived reference spectra from one or more imaging techniques including PET CT, CT, MRI, and the frequency-stabilized laser scanning the brain or the pancreas because it would have been known methods of imaging patients and detecting spectra and correlating the features of diseases between multiple modes of imaging, thereby allowing one to confirm a spectral feature results from a disease and thus evaluate and monitor the disease (Col. 9, ln. 66-Col. 10, ln. 11).
Regarding claim 2, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
League does not explicitly teach the second pattern of frequencies of the subject indicates a resonance density of at least seven, wherein the resonance density is a total number of resonance frequency peaks in the spectrogram.
Islam however teaches the second pattern of frequencies of the subject indicates a resonance density of at least seven, wherein the resonance density is a total number of resonance frequency peaks in the spectrogram (Paragraph [0380]; collagen seems to be related to cancer development, because high mammographic density may be recognized as a risk factor for breast cancer. Moreover, collagen type in high-risk dense breasts may appear to be different from collagen in low-density breast; Paragraph [0385]; in the data of FIG. 75 is seen that a new peak appeared as the cancer grew around 1690 nm; Paragraph [0389]-[0392]; Absorption peaks in the standard samples occur at the following exemplary wavelengths…; at least 7 peak wavelengths are listed which relate to the cancer detection which is considered to read on the claimed limitation as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir such that the one or more of a variety of medical conditions comprises cancer and wherein the second pattern of frequencies of the subject indicates a resonance density of at least seven because it would have allowed recognition of other cancers and determined areas of density in the tissue to treat disease.
Regarding claim 3, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
League does not explicitly teach the processor creates an unsupervised training set from the references spectra of the healthy and ill subjects.
Islam, however, teaches the digital processing unit creates an unsupervised training set from the references spectra of the healthy and ill subjects (Paragraph [0510]; Unsupervised learning may be described as let the computer learn how to do something, and use this to determine structure and patterns in the data.; Paragraph [0547]; unsupervised learning may be typically used when there are a large number of positive and negative examples).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of League in view of Chen, Bierewirtz, Islam and Gambhir such that the digital processing unit creates an unsupervised training set from the references spectra of the healthy and ill subjects because it is a well understood technique for training neural networks which is typically used when there are a large number of positive and negative examples, for example healthy and ill spectra, which better improves anomaly detection (Islam, Paragraph [0547]).
Regarding claim 4, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz further teaches the treated water is configured to act as a contrast material vis a vis the LDWE (Paragraph [0058]; flushes the filter of the first container and now the solvent is guided into the first container and is present in contact with the aerosols. If antigens are present on the aerosols that match the antibodies of the nanoparticles, agglomeration of the nanoparticles occurs as antibodies and antigens combine with each other, causing a change in optical properties, which is detectable by a light sensor and a light source irradiating the solvent.) so as to increase a signal to noise ratio (Paragraph [0072]; better signal-to-noise-ratio is obtained by such filter.) and thereby facilitate processing of the one or both of the spectrogram and the image of the reflected beam reflected from the laser device (Paragraph [0165]; the measuring unit preferably designates in volume in which the light source irradiates the solvent and optical properties can be detected by the light sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir such that the treated water is configured to act as a contrast material vis a vis the LDWE so as to increase a signal to noise ratio and thereby facilitate processing of the one or both of the spectrogram and the image of the reflected beam reflected from the laser device because it would improve scatter of the light from the breath toward the sensor and the fluid might possibly contain, a better signal-to-noise-ratio is obtained by such filter (Paragraph [0072]).
Regarding claim 5, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 4 as noted above.
Bierewirtz further teaches the reflected beam (Paragraph [0067]; light signal detected by the light sensor is a light signal that has been reflected) has an electromagnetic frequency of the reflected laser (Paragraph [0186]; in the spectrum of the light scattered by the sample on the solvent by agglomeration of the nanoparticles… other frequencies are observed in addition to the irradiated frequency (Rayleigh scattering)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir such that the reflected beam has an electromagnetic frequency of the reflected laser as further taught by Bierewirtz because it would allow spectral measurement of the mixture by determining the absorption of the laser light through the mixture.
Regarding claim 6, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz further teaches the water mixture envelope comprises particles of 1-60 microns in diameter (Paragraph [0160]; the aerosol particle travels in exhaled air bound to a liquid component, the aerosol, and/or as an aerosol particle in a crystal structure. The diameter of aerosol particles is between preferably 0.01 μm to 500 μm, more preferably 0.1 μm to 100 μm, most preferably 0.1 μm to 50 μm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir as taught by Bierewirtz because it is known diameter of droplets that carries the pathogen or analytes that further allows spectroscopic measurement of the analytes.
Regarding claim 7, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz further teaches the electromagnetic radiation comprises a laser beam having a range of wavelengths from 600 nm to 685 nm (Paragraph [0061]; said wavelengths preferably can be between 600 nm and 700 nm, preferably between 610 nm and 690 nm, more preferably between 620 nm and 680 nm) and wherein the laser device is configured to direct the laser beam (Paragraph [0166]; Furthermore, it is preferred that further optical components, such as lenses, mirrors, prisms and/or gratings, are positioned in a beam path between the light source and the light sensor, for example, in order to adapt and/or adjust the beam path).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir such that the electromagnetic radiation comprises a laser beam having a range of wavelengths from 600 nm to 685 nm and wherein the laser device is configured to direct the laser beam because these are wavelengths known to excite pathogen-nanoparticle-agglomerates (Paragraph [0061]) and provide a sensitive and precise measurement (Paragraph [0063]).
Regarding claim 8, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz further teaches an infrared emitter configured to emit electromagnetic radiation (Paragraph [0169]; a light source in a wavelength range within the infrared spectrum).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir to include an infrared device configured to emit electromagnetic radiation because it would allow measuring the presence of a specific target analyte in the sample which absorbs in the infrared region.
Bierewirtz does not explicitly teach a wavelength from 1050 nm to 2900 nm.
Islam, however, teaches a wavelength from 1050 nm to 2900 nm (Paragraph [0030]; it may be advantageous to use optical wavelengths in the range of about 1000-1400 nm. In another embodiment, it may be advantageous to use optical wavelengths in the range of about 1600-1800 nm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of League in view of Chen, Bierewirtz, Islam and Gambhir such that the wavelength is from 1050 nm to 2900 nm because it would have been more advantageous for detecting the spectral features and thus concentrations of certain molecules for cancer detection, and further been beneficial for preventing pain or damage to the skin and outer layer surrounding the tissue (Islam, Paragraph [0030]).
Regarding claim 9, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz further teaches comprising an infrared emitter (Paragraph [0169]; a light source in a wavelength range within the infrared spectrum).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir to include an infrared device configured to emit electromagnetic radiation because it would allow measuring the presence of a specific target analyte in the sample which absorbs in the infrared region.
Bierewirtz does not explicitly teaches the processor is configured to obtain (i) an external water fingerprint from a spectroscopic analysis of the one or both of the spectrogram and image from the reflected beam that was reflected from the electromagnetic radiation emitted by the laser device and (ii) a general water fingerprint of both the water mixture envelope external to the subject and of water internal to the body of the subject derived from signal from the reflected beam that was reflected from the electromagnetic radiation emitted by the infrared emitter, and to compare each of the external and general water spectra with the stored spectra.
Islam, however, teaches the digital processing unit is configured to obtain (i) an external water fingerprint from a spectroscopic analysis of the one or both of the spectrogram and image from the reflected beam that was reflected from the electromagnetic radiation emitted by the laser device (Paragraph [0198]; absorption or extinction ratio for light transmission has been studied. FIG. 16A illustrates the attenuation coefficient 1600 for dental enamel 1601 (filled circles) and the absorption coefficient of water 1602 (open circles) versus wavelength.) and (ii) a general water fingerprint of both the water mixture envelope external to the subject and of water internal to the body of the subject derived from signal from the reflected beam that was reflected from the electromagnetic radiation emitted by the infrared device (Paragraph [0187]; For example, FIG. 10 illustrates 1000 the absorption coefficients for water (including scattering) 1001, adipose 1002, collagen 1003 and elastin 1004. Note that the absorption curves for water 1001 and adipose 1002 are calibrated), and to compare each of the external and general water spectra with the stored spectra (Paragraph [0187]-[0188]; For tissue that contains adipose, collagen and elastin, such as the dermis of the skin, the total absorption can exceed the light energy lost to water absorption and light scattering at 1720 nm. On the other hand, at 1210 nm the adipose absorption 1002 can be considerably lower than the water plus scattering loss 1001, particularly since the scattering loss can be dominant at these shorter wavelengths).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League in view of Chen, Bierewirtz, Islam and Gambhir such that the digital processing unit is configured to obtain (i) an external water fingerprint from a spectroscopic analysis of the one or both of the spectrogram and image from the reflected beam that was reflected from the electromagnetic radiation emitted by the laser device and (ii) a general water fingerprint of both the water mixture envelope external to the subject and of water internal to the body of the subject derived from signal from the reflected beam that was reflected from the electromagnetic radiation emitted by the infrared device, and to compare each of the external and general water spectra with the stored spectra because it would be useful for determining the material in which light of a certain infrared wavelength will be absorbed, to determine the penetration depth of the light of a certain wavelength may also require the addition of scattering loss to the curves, due to water scattering in the spectrum, thereby improving the accuracy of determining protein concentrations (Paragraphs [0187]-[0188]).
Regarding claim 10, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz further teaches a terahertz device wherein the electromagnetic radiation that is emitted by the terahertz device has a frequency of 1.0x10^5 MHz to 1.0x10^7 MHz (Paragraph [0195]; a communication unit preferably means a transmitting unit for transmitting a signal… can vary from a few hertz (low frequency) to several hundred terahertz (visible light)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir to include a terahertz device wherein the electromagnetic radiation that is emitted by the terahertz device has a frequency of 1.0x10^5 MHz to 1.0x10^7 MHz because it would have allowed communicating information and data about the optical properties and antigens to other devices or networks (Paragraph [0195]).
Regarding claim 11, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz further teaches the electromagnetic radiation emitted by the at least one laser device is non-ionizing UV radiation (Paragraph [0169]; conjugate to a light source in a wavelength range within the ultraviolet spectrum).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League, Chen, Bierewirtz, Islam, and Gambhir such that the electromagnetic radiation emitted by the at least one laser device is non-ionizing UV radiation because it would allow measuring the presence of a specific target analyte in the sample which absorbs in the UV region.
Bierewirtz does not explicitly teach a wavelength of 320 nm to 385 nm.
Gambhir, however, further teaches a wavelength of 320 nm to 385 nm (Col. 8, ln. 22-43; exemplary embodiments of the present disclosure provide methods and systems of medical imaging in the low energy window of light (<0.005 keV, at wavelengths >300 nm); about 350-750 nm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the modified the system of League, Chen, Bierewirtz, Islam and Gambhir such to have used a wavelength of 320 nm to 385 nm because it is known to be highly suited for medical molecular imaging and achieve high sensitivity and spatial resolution (Col. 8, ln. 22-43).
Regarding claim 12, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz does not explicitly teach the processor is configured to perform a spectral analysis of an external water spectra and of a general water spectra to distinguish between healthy and ill subjects based on a magnitude of a resonance density, wherein the resonance density is a total number of resonance frequency peaks in the spectrogram.
Islam, however, teaches the digital processing unit is configured to perform a spectral analysis of an external water spectra and of a general water spectra (Paragraph [0187]-[0188]; For tissue that contains adipose, collagen and elastin, such as the dermis of the skin, the total absorption can exceed the light energy lost to water absorption and light scattering at 1720 nm. On the other hand, at 1210 nm the adipose absorption 1002 can be considerably lower than the water plus scattering loss 1001, particularly since the scattering loss can be dominant at these shorter wavelengths) to distinguish between healthy and ill subjects based on a magnitude of a resonance density (Paragraph [0380]; collagen seems to be related to cancer development, because high mammographic density may be recognized as a risk factor for breast cancer. Moreover, collagen type in high-risk dense breasts may appear to be different from collagen in low-density breast), wherein the resonance density is a total number of resonance frequency peaks in the spectrogram (Paragraph [0389]-[0392]; Absorption peaks in the standard samples occur at the following exemplary wavelengths…; at least 7 peak wavelengths are listed which relate to the cancer detection which is considered to read on the claimed limitation as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Bierewirtz in view of Islam and Gambhir such that the one or more of a variety of medical conditions comprises cancer and wherein the digital processing unit is configured to perform a spectral analysis of an external water spectra and of a general water spectra to distinguish between healthy and ill subjects based on a magnitude of a resonance density because it would have allowed recognition of other cancers and determined areas of density in the tissue to treat disease and it would be useful for determining the material in which light of a certain infrared wavelength will be absorbed, to determine the penetration depth of the light of a certain wavelength may also require the addition of scattering loss to the curves, due to water scattering in the spectrum, thereby improving the accuracy of determining protein concentrations (Paragraphs [0187]-[0188]).
Regarding claim 13, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz further teaches mirrors configured to mechanically adjust a beam of the laser device via an alignment of the mirrors (Paragraph [0166]; Furthermore, it is preferred that further optical components, such as lenses, mirrors, prisms and/or gratings, are positioned in a beam path between the light source and the light sensor, for example, in order to adapt and/or adjust the beam path).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir to include mirrors configured to mechanically adjust a beam of the laser device via an alignment of the mirrors because it would have been a well-understood method of controlling the laser beam, thereby ensuring the light passes through the sample and returns to the light detector.
Bierewirtz does not explicitly teach the laser device configured to be adjusted electrically by adjusting one or more of a frequency and a power of the laser device so as to select a depth of penetration of a laser beam into the water mixture envelope in order to scan different layers of the water mixture envelope.
Islam, however, teaches laser device configured to be adjusted electrically by adjusting one or more of a frequency and a power of the laser device so as to select a depth of penetration of a laser beam (Paragraph [0400]; To permit higher signal-to-noise levels and higher penetration depths, higher intensity or brightness of light sources may be used) into the water mixture envelope in order to scan different layers of the water mixture envelope (Paragraph [0389]; longer wavelengths lead to less scattering in tissue and water, again permitting deeper penetration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League, Chen, Bierewirtz, Islam and Gambhir to have the laser device configured to be adjusted electrically by adjusting one or more of a frequency and a power of the laser device so as to select a depth of penetration of a laser beam into the water mixture envelope in order to scan different layers of the water mixture envelope because it would allow to less scattering in water and more accurately measure characteristic bands of proteins at specific wavelengths (Paragraph [0389]).
Regarding claim 14, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz does not explicitly teach an infrared device positioned 2 to 5 meters from the subject.
Islam, however, teaches an infrared emitter positioned 2 to 5 meters from the subject (Paragraph [0539]; The IR camera may provide a two-dimensional image of the surroundings. The time-of-flight sensor may provide 3D imaging capabilities at distances up to 4 or 5 meters, perhaps even up to 10 meters or more).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Bierewirtz in view of Islam and Gambhir to have an infrared emitter positioned 2 to 5 meters from the subject because it would have allowed different capabilities and operation over different distances.
Regarding claim 16, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
Bierewirtz does not explicitly teach a stability of the frequency-stabilized laser device is <7 x 10^-16 or is <1.5 x 10^-15.
Islam, however, teaches a stability of the frequency-stabilized laser device is <7 x 10^-16 or is <1.5 x 10^-15 (Paragraph [0268]; Using a lock-in type technique (e.g., detecting at the same frequency as the pulsed light source and also possibly phase locked to the same signal), the detection system may be able to reject background or spurious signals and increase the signal-to-noise ratio of the measurement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League, Chen, Bierewirtz in view of Islam and Gambhir such that a stability of the frequency-stabilized laser device is <7 x 10^-16 or is <1.5 x 10^-15 because the detection system may be able to reject background or spurious signals and increase the signal-to-noise ratio of the measurement.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over League, in view of Chen, Bierewirtz, Islam, and Gambhir as applied to claim 1 above, and further in view of Ashrafi (US 20170138851).
Regarding claim 15, together League, Chen, Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
League does not explicitly teach at least one frequency-stabilized laser device is a helium-neon laser device.
Ashrafi, however, teaches at least one frequency-stabilized laser device comprises is a helium-neon laser device (Paragraph [0351]; three laser wavelengths 488, 514.5 and 632.8 nm from argon-ion and helium neon laser sources; Paragraph [0360]; the output of a HeNe laser is chopped around 1 kHz and sent into a single mode fiber).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League, in view of Chen, Bierewirtz, Islam and Gambhir such that at least one frequency-stabilized laser device comprises is a helium-neon laser device because it is well understood component in spectroscopic systems that further allow measuring biological molecules with various spectroscopic techniques (Paragraph [0351]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over League in view of Chen, Bierewirtz, Islam, and Gambhir as applied to claim 1 above, and further in view of Krylov (US 20050189216).
Regarding claim 19, together Bierewirtz, Islam, and Gambhir teach all of the limitations of claim 1 as noted above.
League does not explicitly teach the water that has been treated electrochemically is water that has been treated by electrocoagulation and has been prepared by an electrochemical process that utilized an oxidative reduction potential (ORP) of between -800 mV and -400 mV.
Krylov, however, teaches water that has been treated electrochemically is water that has been treated by electrocoagulation (Paragraph [0006]; electrocoagulating systems; Paragraph [0008]; providing disinfecting or therapeutic fluids; Paragraph [0010]; provides conditions to disinfect waste or drinking water) and has been prepared by an electrochemical process that utilized an oxidative reduction potential (ORP) of between -800 mV and -400 mV (Paragraph [0099]; produce a catholyte fluid that has a oxygen reduction potential (redox) between -500 to -800 mV and no Chlorine).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of League in view of Chen, Bierewirtz, Islam, and Gambhir to use water that has been treated electrochemically is water that has been treated by electrocoagulation and has been prepared by an electrochemical process that utilized an oxidative reduction potential (ORP) of between -800 mV and -400 mV because it a known method for providing a disinfecting or therapeutic fluid and a system for using these fluids.
Response to Arguments
Information Disclosure Statement
Copies of each foreign patent and each non-literature publication have not been provided regarding the information disclosure statement filed 02/03/2025 and thus continues to fail to comply with 37 CFR 1.98(a)(2) as noted above.
Specification
Examiner acknowledges the amendments to the specification and withdraws all objections to the specification.
Claim Objections
Examiner acknowledges the amendments to the claims and withdraws all objections to the claims.
Claim Interpretation under – 35 U.S.C. § 112(f)
Examiner acknowledges the amendments to the claims and withdraws all claim interpretations under 35 U.S.C. § 112(f).
Claim Rejections under – 35 U.S.C. § 112
Examiner acknowledges the amendments and remarks to claims 1 and 18 and withdraws previous rejections under 35 USC 112(a) and 35 USC 112(b) over claims 1-15 and 17-18.
Amendments and remarks fail to respond to rejections of current claim 16 under 35 USC 112(b). Rejections of claims 16 under 35 USC 112(b) are maintained for being indefinite as to the metes and bounds of the frequency stability being <7 x10^-16 or <1.5 x10^-15
Claim Rejections under – 35 U.S.C. § 101
Examiner acknowledges the amendments and remarks to claims 1-18 and withdraws all previous rejections under 35 USC 101.
Claim Rejections under – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
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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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/22/26