DETAILED ACTION
This office action is in response to the communication received on 05/15/2026 concerning application no. 16/349,405 filed on 05/13/2019.
Claims 1, 14, 17, 19, 35, 37, 39, 41, 45, 48, and 50-54 are pending (Claims 53-54 are withdrawn from consideration).
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/15/2026 has been entered.
Claims 1, 14, 17, 19, 35, 37, 39, 41, 45, 48, and 50-54 are pending (Claims 53-54 are withdrawn from consideration).
Response to Arguments
Applicant's arguments filed 05/15/2026 have been fully considered but they are not persuasive.
Regarding the 103 rejection under Yodh et al. (PGPUB No. US 2016/0353997) in view of Mayer et al. (US Patent No. 8,320,98), Applicant argues that “Paragraph [0053] of the originally filed application provides the following: "In some cases, the DCS detectors can be used to combine DCS with different modalities, such as near-infrared spectroscopy. However, as described elsewhere herein, a surprising result of the present disclosure is the ability to accurately estimate fluid dynamics without the need for near-infrared spectroscopy to measure properties of a target medium" (emphasis added). Also see Paragraph [0087] of the originally filed application. For instance, Paragraph [0003]-[0004] of the originally filed application provides the following:…” With respect to Yodh et al. (PGPUB No. US 2016/0353997), Applicant alleges that “makes no mention of determining an absorption coefficient and a reduced scattering coefficient of the target medium from a DCS detector signal, as recited in amended Claim 1. Further, Yodh '997, including the cited portions thereof, makes no mention of determining dynamics of the target medium using the absorption coefficient and the reduced scattering coefficient in addition to the DCS detector signal and the one or more equations, as recited in amended Claim 1.”
Examiner disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the language of the specification paragraphs 0053, 0087, and 0003-04) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). With respect to Yodh et al. (PGPUB No. US 2016/0353997), Applicant’s allegations are without support and contrary to the very teachings of Yodh et al. (PGPUB No. US 2016/0353997). MPEP 2145 establishes “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc). Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” Applicant’s allegation that Yodh et al. (PGPUB No. US 2016/0353997) does not use DCS technology and not in the context of blood flow analysis is unsubstantiated and in direct opposition to the explicit language of the reference. Paragraph 0013 of Yodh et al. (PGPUB No. US 2016/0353997) establishes “Turning again to the non-limiting example of cerebral blood flow, one may use algorithms to isolate the cerebral blood flow contributions from the cortex from DCS (i.e., DCS and/or DOS) data using measurements at multiple pressures and optical source-detector separations. Pressure on the scalp may affect the blood flow in the extra-cerebral region.” (emphasis added). Paragraph 0015 establishes “Regarding the illustrative application to cerebral blood flow, the optical techniques of diffuse correlation spectroscopy (DCS) and diffuse optical spectroscopy are a noninvasive bedside, continuous, safe monitors of hemodynamics, e.g., cerebral blood flow (CBF) that improves individual patient management of stroke treatment as well as other brain diseases. (emphasis added). With respect to the blood flow index according to the DCS, Yodh et al. (PGPUB No. US 2016/0353997), paragraph 0047 acknowledges that the Fig. 13 is the assessment of the average BFI over time. Similarly, paragraph 0052 discloses acknowledges that the Fig. 18 is the assessment of the BFI over time. Contrary to Applicant’s allegation, the claimed invention is not novel for determination of BFI via DCS given that Yodh et al. (PGPUB No. US 2016/0353997), in paragraph 0162 discloses “The DCS blood flow index has been successfully validated against a plethora of ‘gold-standard’ techniques.” (emphasis added). With respect to the BFI being determined with respect to the scattering and absorption coefficients, Applicant’s allegations are also unpersuasive and contrary to Yodh et al. (PGPUB No. US 2016/0353997)’s explicit teachings. Paragraph 0163 discloses that DCS is being used to assess blood flow. Paragraphs 0170-71 disclose that “DCS Modified Beer-Lambert Law for Homogeneous Tissue One may begin by deriving a general expression for homogeneous tissue, characterized by a blood flow index, F, an absorption coefficient, μa, and a reduced scattering coefficient, μs′. The DCS Modified Beer-Lambert law is derived by truncating the Taylor series expansion of the DCS optical density to first order in F, μa, and μs′. The paragraphs 0168-206 teach the derivation and utilization of the Modified Beer-Lambert law. This requires consideration of the scattering and absorption coefficients with respect to BFI. Assuming, arguendo, Yodh et al. (PGPUB No. US 2016/0353997) was deficient, the determination of blood flow index according to scattering and absorption coefficients in spectroscopy and DCS is not novel. See at least Boas et al., ("Scattering and Imaging with Diffusing Temporal Field Correlations", 1995), Boas et al., ("Spatially varying dynamical properties of turbid media probed with diffusing temporal light correlation", 1997), Durduran et al., ("Diffuse optics for tissue monitoring and tomography", 2010), Mesquita et al., ("Direct measurement of tissue blood flow and metabolism with diffuse optics", 2011), He et al., ("Using few-mode fiber to improve the signal-to-noise ratio of DCS flow-oximeter measurements", 2012), Buckley et al., ("Validation of diffuse correlation spectroscopic measurement of cerebral blood flow using phase-encoded velocity mapping magnetic resonance imaging", 2012), Mesquita et al., ("Influence of probe pressure on the diffuse correlation spectroscopy blood flow signal: extra-cerebral contributions", 2013), Li et al., ("Simultaneous measurement of deep tissue blood flow and oxygenation using noncontact diffuse correlation spectroscopy flow-oximeter", 2013), Durduran et al., ("Diffuse correlation spectroscopy for non-invasive, micro-vascular cerebral blood flow measurement", 2014), Farzam et al. ("Multidistance diffuse correlation spectroscopy for simultaneous estimation of blood flow index and optical properties", May 2015), Li et al., ("Calibration of diffuse correlation spectroscopy blood flow index with venous-occlusion diffuse optical spectroscopy in skeletal muscle", 2015), Wang et al., ("Fast blood flow monitoring in deep tissues with real-time software correlators", February 2016), Busch et al. (PGPUB No. US 2016/0361017), Purdon et al. (PGPUB No. US 2014/0316218), and Bechtel et al. (PGPUB No. US 2014/0046152).
Examiner maintains the rejection.
Examiner also notes that Applicant’s own specification in paragraph 0095 discloses the performance of the BFI with respect to the scattering and absorption coefficients based on pertinent and available prior art in the form of Boas et al., ("Scattering and Imaging with Diffusing Temporal Field Correlations", 1995), Boas et al., ("Spatially varying dynamical properties of turbid media probed with diffusing temporal light correlation", 1997), Durduran et al., ("Diffuse optics for tissue monitoring and tomography", 2010), and Durduran et al., ("Diffuse correlation spectroscopy for non-invasive, micro-vascular cerebral blood flow measurement", 2014). Each of these references discloses the claimed language before the effective filing date of the instant application.
Applicant’s arguments with respect to claim 1’s rejection Yodh et al. (PGPUB No. US 2006/0063995) in view of Verdeccchia et al. (“Multi-Distance Depth-Resolved Diffuse Correlation Spectroscopy", 2014, Biomedical Optics) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 14, 17, 19, 35, 37, 39, 41, 45, 48, and 50-52 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “determine, using the absorption coefficient and the reduced scattering coefficient, the dynamics of the target medium non-invasively using the plurality of optical properties, the DCS detector signal, and the one or more equations relating the correlation function to dynamics of scattering particles within the target medium, wherein the dynamics of the target medium are determined based at least in part on the first source-detector distance and the second source-detector distance, and wherein the dynamics of the target medium includes a blood flow index of the target medium”. While paragraph 0129 discusses the use of the coefficients and the determination of the BFI, the paragraph in particular and the specification as a whole fails do disclose the determination of dynamics of the target medium, being BFI, with respect to “the one or more equations relating the correlation function to dynamics of scattering particles within the target medium, wherein the dynamics of the target medium are determined based at least in part on the first source-detector distance and the second source-detector distance”. Paragraph 0098 discusses the consideration of BFI and the coefficients, however, as seen by the equations, the BFI is not determined using the coefficients and are rather used concurrently. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(a) are also rejected because they inherit the deficiencies of the claims they respectively depend upon.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 14, 17, 35, 37, 41, 45, 48, and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Yodh et al. (PGPUB No. US 2016/0353997) in view of Mayer et al. (US Patent No. 8,320,981).
Regarding claim 1, Yodh teaches a multi-distance, multi-wavelength diffuse correlation spectroscopy (MD-MW DCS) system comprising:
a set of DCS light sources (Paragraph 0027 teaches source detector pairs and differing distances and with two, three, or more separation distances. Paragraph 0116 teaches a user may use two, three, or even more source-detector pairs. Paragraph 0117 teaches application of diffuse correlation spectroscopy) including:
a first DCS light source associated with a first source location (Paragraph 0027 teaches source detector pairs and differing distances and with two, three, or more separation distances. Paragraph 0116 teaches a user may use two, three, or even more source-detector pairs. Paragraph 0117 teaches application of diffuse correlation spectroscopy) and configured to:
emit, from the first source location, a first light having a first wavelength (Paragraph 0112 teaches illumination may be light between 300 nm and 1500 nm in wavelength; one suitable typical wavelength range is between about 660 and about 930 nm. The illumination is conducted by the source detector pairs. Paragraph 0104 teaches operation at multiple wavelengths); and
transmit, from the first source location, the first light into a target medium at a single transmission location (Paragraph 0026 teaches the illumination of the cerebral tissue via the multiple source detector pairs. Fig. 1); and
a second DCS light source associated with a second source location and configured to:
emit, from the second source location, a second light having a second wavelength (Paragraph 0112 teaches illumination may be light between 300 nm and 1500 nm in wavelength; one suitable typical wavelength range is between about 660 and about 930 nm. The illumination is conducted by the source detector pairs. Paragraph 0104 teaches operation at multiple wavelengths); and
transmit, from the second source location, the second light into the target medium at the single transmission location (Paragraph 0026 teaches the illumination of the cerebral tissue via the multiple source detector pairs. Fig. 1);
a set of DCS detectors (Paragraph 0027 teaches source detector pairs and differing distances and with two, three, or more separation distances. Paragraph 0116 teaches a user may use two, three, or even more source-detector pairs. Paragraph 0117 teaches application of diffuse correlation spectroscopy) including:
a first DCS detector (Paragraph 0027 teaches source detector pairs and differing distances and with two, three, or more separation distances. Paragraph 0116 teaches a user may use two, three, or even more source-detector pairs. Paragraph 0117 teaches application of diffuse correlation spectroscopy) configured to:
receive, from the target medium, at least a portion of the first light (Paragraph 0026 teaches the collection of the illumination of the cerebral tissue via the multiple source detector pairs. Fig. 1);and
generate a first DCS detector signal in response to receiving the at least a portion of the first light (Paragraph 0020 teaches the collection of the DCS flow signals with respect to the anatomy. Paragraph 0026 teaches the collection of the signal that represents the hemodynamics); and
a second DCS detector (Paragraph 0027 teaches source detector pairs and differing distances and with two, three, or more separation distances. Paragraph 0116 teaches a user may use two, three, or even more source-detector pairs. Paragraph 0117 teaches application of diffuse correlation spectroscopy) configured to:
receive, from the target medium, at least a portion of the second light (Paragraph 0026 teaches the collection of the illumination of the cerebral tissue via the multiple source detector pairs. Fig. 1); and
generate a second DCS detector signal in response to receiving the at least a portion of the second light (Paragraph 0020 teaches the collection of the DCS flow signals with respect to the anatomy. Paragraph 0026 teaches the collection of the signal that represents the hemodynamics);
wherein the first DCS detector receives the at least a portion of the first light at a first detector location positioned at a first source-detector distance relative to the single transmission location, and the second DCS detector receives the at least a portion of the second light at a second detector location positioned at a second source-detector distance relative to the single transmission location, wherein the first source-detector distance is different than the second source-detector distance, wherein the first detector location and the second detector location are external to the target medium such that the first DCS detector receives the at least a portion of the first light non-invasively and the second DCS detect receives the at least a portion of the second light non-invasively (Paragraph 0027 teaches source detector pairs and differing distances and with two, three, or more separation distances. Paragraph 0116 teaches a user may use two, three, or even more source-detector pairs. Paragraph 0117 teaches application of diffuse correlation spectroscopy. Paragraph 0020 teaches the collection of the DCS flow signals with respect to the anatomy. Paragraph 0026 teaches the collection of the signal that represents the hemodynamics. Paragraph 0019 teaches noninvasively assessment of the head with short and long source-detector separations. The anatomy is assessed based on these pairs to get information of the parts of the anatomy. See Fig. 1);
a memory storing one or more equations relating a correlation function to dynamics of scattering particles within the target medium (Paragraph 0271 teaches a device configured to compute intensity correlation functions from photon counts. Such a device may be in electronic communication, optical communication, or both with at least one of the detectors of the first and second source-detector pairs. Suitable such devices include computers (stationary and portable), smartphones, tablet computers, microcontrollers and processors, field programmable gate arrays, electronic circuits and the like. It is inherent that a computational system will utilize a processor and memory for the performance of its computational functions); and
a processor coupled to the set of DCS detectors and the memory (Paragraph 0271 teaches a device configured to compute intensity correlation functions from photon counts. Such a device may be in electronic communication, optical communication, or both with at least one of the detectors of the first and second source-detector pairs. Suitable such devices include computers (stationary and portable), smartphones, tablet computers, microcontrollers and processors, field programmable gate arrays, electronic circuits and the like. It is inherent that a computational system will utilize a processor and memory for the performance of its computational functions.), the processor configured to:
receive the first DCS detector signal and the second DCS detector signal, thereby generating a DCS detector signal including photon arrival time information, wavelength information, source-detector distance information, and light intensity information for each of the first source-detector distance and the second source-detector distance; (Paragraphs 0020-21 teaches the extension of Modified Beer Lambert to the DCS measurement where the monitoring time, delay time, and the source detector separation are considered in the functions. Paragraph 0112 teaches illumination may be light between 300 nm and 1500 nm in wavelength; one suitable typical wavelength range is between about 660 and about 930 nm. The illumination is conducted by the source detector pairs. Paragraph 0104 teaches operation at multiple wavelengths. Paragraph 0104 teaches that the cerebral absorption monitoring at multiple light wavelengths in turn enables the computation of cerebral oxy-hemoglobin, deoxy-hemoglobin, and blood oxygen saturation. Paragraph 0019 establishes that the noninvasive probes have short and long source detector separations. Fig. 1 shows that each of the source detector separations have their respective normalized intensity autocorrelation functions with respect to the time, tau. Paragraph 0042 teaches that these intensity fluctuations are being characterized by the normalized intensity autocorrelation functions. Paragraph 0097 establishes that the intensity autocorrelation function accounts for the source detector separation and the detected light intensity);
determine, from the DCS detector signal, a plurality of optical properties of the target medium, wherein the plurality of optical properties includes an absorption coefficient and a reduced scattering coefficient (Paragraph 0165 teaches the utilization of the scatting and absorption coefficients for the correlation diffusion equation. Paragraph 0171 teaches the derivation of the DCS Modified Beer-Lambert law according to the coefficients); and
determine, using the absorption coefficient and the reduced scattering coefficient, the dynamics of the target medium non-invasively using the plurality of optical properties, the DCS detector signal, and the one or more equations relating the correlation function to dynamics of scattering particles within the target medium, wherein the dynamics of the target medium are determined based at least in part on the first source-detector distance and the second source-detector distance, and wherein the dynamics of the target medium includes a blood flow index of the target medium (Paragraphs 0020-21 teaches the extension of Modified Beer Lambert to the DCS measurement where the monitoring time, delay time, and the source detector separation are considered in the functions. Paragraph 0112 teaches illumination may be light between 300 nm and 1500 nm in wavelength; one suitable typical wavelength range is between about 660 and about 930 nm. The illumination is conducted by the source detector pairs. Paragraph 0104 teaches operation at multiple wavelengths. Paragraph 0047 discloses the assessment of the BFI. See Fig. 13. Paragraph 0052 discloses the assessment and extraction of the BFI according to the correlation diffusion approach of the BFI. See Fig. 18. Paragraph 00162 teaches that DCS blood flow index has been successfully validated. Paragraph 0163-167 teach the determination of the BFI with consideration of the coefficients. Paragraph 0172 teaches that the BFI has baseline coefficient properties and is used in the Modified Beer Lambert equation. Paragraphs 0184-87 teach the BFI with respect to the coefficients and that the equations can be rearranged).
However, Yodh is silent regarding a system,
wherein the plurality of sources are emitting such that their respective light enters the target medium at the single transmission location.
In an analogous imaging field of endeavor, regarding spectroscopy for blood parameters with multiple light sources and detectors, Mayer teaches a system,
emit, from the first source location, a first light having a first wavelength (Abstract taches that the light sources are to transmit toward vascularized tissue, in a time multiplexed manner, light having a first wavelength of approximately 660 nm, light having a second wavelength of approximately 810 nm, light having a third wavelength of approximately 910 nm, and light having a fourth wavelength of approximately 980 nm); and
transmit, from the first source location, the first light into a target medium at a single transmission location such that the first light enters the target medium at the single transmission location (Fig. 1 shows the plurality of sources located at differing locations. Fig. 3 shows transmission at a single target location for analysis of the blood. Abstract taches that the light sources are to transmit toward vascularized tissue, in a time multiplexed manner, light having a first wavelength of approximately 660 nm, light having a second wavelength of approximately 810 nm, light having a third wavelength of approximately 910 nm, and light having a fourth wavelength of approximately 980 nm);
emit, from the second source location, a second light having a second wavelength (Abstract taches that the light sources are to transmit toward vascularized tissue, in a time multiplexed manner, light having a first wavelength of approximately 660 nm, light having a second wavelength of approximately 810 nm, light having a third wavelength of approximately 910 nm, and light having a fourth wavelength of approximately 980 nm); and
transmit, from the second source location, the second light into the target medium at the single transmission location such that the second light enters the target medium at the single transmission location (Fig. 1 shows the plurality of sources located at differing locations. Fig. 3 shows transmission at a single target location for analysis of the blood. Abstract taches that the light sources are to transmit toward vascularized tissue, in a time multiplexed manner, light having a first wavelength of approximately 660 nm, light having a second wavelength of approximately 810 nm, light having a third wavelength of approximately 910 nm, and light having a fourth wavelength of approximately 980 nm).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Yodh with Mayer’s teaching of targeting a common single transmission location with varying wavelength transmitting sources. This modified apparatus would allow the user to measure blood oxygen saturation, tissue oxygen saturation, hemoglobin concentration, and/or tissue hydration (Abstract of Mayer). Furthermore, the modification would be beneficial to increase the accuracy of such sensors (Col. 1, lines 47-51 of Mayer).
Regarding claim 14, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the set of DCS detectors includes a third DCS detector configured to receive at least a portion of the third light from the target medium, wherein the third DCS detector is configured to generate a third DCS detector signal in response to receiving the at least a portion of the third light, wherein the third DCS detector receives the at least a portion of the third light at a third detector location positioned a third source-detector distance relative to the single transmission location, wherein the first source-detector distance, the second source-detector distance, and the third source-detector distance are different (Paragraph 0027 teaches source detector pairs and differing distances and with two, three, or more separation distances. Paragraph 0116 teaches a user may use two, three, or even more source-detector pairs. Paragraph 0117 teaches application of diffuse correlation spectroscopy. Paragraph 0112 teaches illumination may be light between 300 nm and 1500 nm in wavelength; one suitable typical wavelength range is between about 660 and about 930 nm. The illumination is conducted by the source detector pairs. Paragraph 0104 teaches operation at multiple wavelengths).
However, Yodh is silent regarding a system, wherein the set of DCS light sources includes a third DCS light source associated with a third source location and configured to emit a third light having a third wavelength, the third DCS light source configured to transmit, from the third source location, the third light into the target medium at the single transmission location such that the third light enters the target medium at the single transmission location, wherein the first wavelength, the second wavelength, and the third wavelength are different.
In an analogous imaging field of endeavor, regarding spectroscopy for blood parameters with multiple light sources and detectors, Mayer teaches a system, wherein the set of DCS light sources includes a third DCS light source associated with a third source location and configured to emit a third light having a third wavelength, the third DCS light source configured to transmit, from the third source location, the third light into the target medium at the single transmission location such that the third light enters the target medium at the single transmission location, wherein the first wavelength, the second wavelength, and the third wavelength are different (Fig. 1 shows the plurality of sources located at differing locations. Fig. 3 shows transmission at a single target location for analysis of the blood. Abstract taches that the light sources are to transmit toward vascularized tissue, in a time multiplexed manner, light having a first wavelength of approximately 660 nm, light having a second wavelength of approximately 810 nm, light having a third wavelength of approximately 910 nm, and light having a fourth wavelength of approximately 980 nm).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Yodh with Mayer’s teaching of a third source with a different location and varying wavelengths. This modified apparatus would allow the user to measure blood oxygen saturation, tissue oxygen saturation, hemoglobin concentration, and/or tissue hydration (Abstract of Mayer). Furthermore, the modification would be beneficial to increase the accuracy of such sensors (Col. 1, lines 47-51 of Mayer).
Regarding claim 17, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the first source-detector distance is between 0.1 cm and 2.0 cm and the second source-detector distance is between 1.0 cm and 3.0 cm, wherein the second source-detector distance is greater than the first source-detector distance (Paragraph 0027 teaches source detector pairs and differing distances and with two, three, or more separation distances. Paragraph 0019 teaches that the source detector pairs can be 0.5 cm and 2.5 cm).
Regarding claim 35, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the set of DCS light sources includes at least one of a diode laser, a solid-state laser, a fiber laser, a vertical cavity surface- emitting laser (VCSEL), a DBR laser, a Fabry-Perot laser, a ridge laser, or a tapered laser (Paragraph 0119 teaches that the target is illuminated with coherent laser light using fiber optics).
Regarding claim 37, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the set of DCS light sources are configured to emit light at a wavelength of between 400 nm and 1800 nm or an average power of between 10 pW and 10W (Paragraph 0112 teaches illumination may be light between 300 nm and 1500 nm in wavelength; one suitable typical wavelength range is between about 660 and about 930 nm).
Regarding claim 41, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, the system further comprising a near infrared spectroscopy light source separate from the set of DCS light sources and a near infrared spectroscopy detector separate from the set of DCS light detectors, wherein the near infrared spectroscopy light source is configured to emit light having at least one property different from the first light and the second light (Paragraph 0010. Teaches that a combination of DCS and NIRs can be applied. Paragraph 0237 teaches in the DCS measurement, a continuous wave, long coherence length 785 nm laser and in the NIRS measurement, three lasers with operation of 690 nm, 785 nm, and 830 nm are used at 70 MHz with sequential cycling).
Regarding claim 45, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the set of DCS detectors includes a detector selected from the group consisting of a single-photon avalanche photodiode detector, a photomultiplier tube, a Si, Ge, InGaAs, PbS, PbSe or HgCdTe photodiode or PIN photodiode, phototransistors, MSM photodetectors, CCD and CMOS detector arrays, LCD, silicon photomultipliers, multi-pixel-photon-counters, and combinations thereof (Paragraph 0144 teaches that the detector can be a photon counting avalanche diode, a photomultiplier tube (PMT), a photo diodes (PD), an avalanche photodiode (APD), a charge coupled device (CCD), a complementary metal oxide semiconductor (CMOS), or any combination thereof).
Regarding claim 48, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, the system further comprising at least one of: a plurality of waveguides or a plurality of lenses, wherein the at least one of the plurality of waveguides or the plurality of lenses is configured to couple the set of DCS light sources to the target medium (Paragraph 0147 teaches a fiber optic, a prism or mirror, a short optical component, and a lens or other optical component that interfaces with the skin. Paragraphs 0154-55 teaches the use of a lens and fiber optic).
Regarding claim 51, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the set of DCS detectors are configured to collect light from one speckle (Paragraph 0163 teaches that DCS detects tissue blood flow using speckle correlation techniques).
Regarding claim 52, modified Yodh teaches the system in claim 1, as discussed above.
However, Yodh is silent regarding a system, wherein the first wavelength and the second wavelength are separated from one another by between 20 nm and 500 nm.
In an analogous imaging field of endeavor, regarding spectroscopy for blood parameters with multiple light sources and detectors, Mayer teaches a system, wherein the first wavelength and the second wavelength are separated from one another by between 20 nm and 500 nm (Abstract taches that the light sources are to transmit toward vascularized tissue, in a time multiplexed manner, light having a first wavelength of approximately 660 nm, light having a second wavelength of approximately 810 nm, light having a third wavelength of approximately 910 nm, and light having a fourth wavelength of approximately 980 nm).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Yodh with Mayer’s teaching of varying wavelengths that are close to each other with respect to a specified range. This modified apparatus would allow the user to measure blood oxygen saturation, tissue oxygen saturation, hemoglobin concentration, and/or tissue hydration (Abstract of Mayer). Furthermore, the modification would be beneficial to increase the accuracy of such sensors (Col. 1, lines 47-51 of Mayer).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Yodh et al. (PGPUB No. US 2016/0353997) in view of Mayer et al. (US Patent No. 8,320,981) further in view of Tachtsidis et al. ("A Hybrid Multi-Distance Phase and Broadband Spatially Resolved Spectrometer and Algorithm for Resolving Absolute Concentrations of Chromophores in the Near-Infrared Light", 2010).
Regarding claim 19, modified Yodh teaches the system in claim 14, as discussed above.
However, the combination of Yodh and Mayer is silent regarding a system, wherein the first source-detector distance is between 0.1 cm and 2.0 cm, the second source-detector distance is between 1.0 cm and 3.0 cm, and the third source-detector distance is between 1.0 cm and 5.0 cm, wherein the second source- detector distance is greater than the first source-detector distance and the third source-detector distance is greater than the second source-detector distance.
In an analogous imaging field of endeavor, regarding multiple sources and detectors for spectroscopy, Tachtsidis teaches a system, wherein the first source-detector distance is between 0.1 cm and 2.0 cm, the second source-detector distance is between 1.0 cm and 3.0 cm, and the third source-detector distance is between 1.0 cm and 5.0 cm, wherein the second source- detector distance is greater than the first source-detector distance and the third source-detector distance is greater than the second source-detector distance (Fig. 1 shows the distance between the lower source to the bottom left detector to be 2 cm and the upper right source to the upper detector to be 3 cm. The upper left source is 3.5 cm to the upper detector).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Yodh and Mayer with Tachtsidis’s teaching of varying distances of the detector to sources. This modified apparatus would allow the user to acquire data with better resolution and better signal-to-noise ratio (SNR) (Introduction of Tachtsidis). Furthermore, the modification will allow a more accurate quantification of chromophores (Discussion of Tachtsidis).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Yodh et al. (PGPUB No. US 2016/0353997) in view of Mayer et al. (US Patent No. 8,320,981) further in view of Fantini et al. ("Frequency--domain multichannel optical detector for noninvasive tissue spectroscopy and oximetry", January 1995, Optical Engineering).
Regarding claim 39, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, the system further comprising a light source driver coupled to a computer and the set of DCS light sources (Paragraph 0271 teaches a device configured to compute intensity correlation functions from photon counts. Such a device may be in electronic communication, optical communication, or both with at least one of the detectors of the first and second source-detector pairs. Suitable such devices include computers (stationary and portable), smartphones, tablet computers, microcontrollers and processors, field programmable gate arrays, electronic circuits and the like. See Fig. 3).
However, the combination of Yodh and Mayer is silent regarding a system, wherein the light source driver is configured to control the first DCS light source and the second DCS light source to multiplex the first light and the second light.
In an analogous imaging field of endeavor, regarding noninvasive tissue spectroscopy with multiple light sources, Fantini teaches a system, wherein the light source driver is configured to control the first DCS light source and the second DCS light source to multiplex the first light and the second light (Paragraph 1 of the “Feature 3” section teaches that the 8 light sources are controlled with a multiplexer).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Yodh and Mayer with Fantini’s teaching of multiplexing of light sources. This modified system would allow the user to real-time monitoring of measured parameters that include hemoglobin values with a cost-effective, reliable, and safe device (Abstract and Description of the Instrument of Fantini). Furthermore, the modification a compact portable unit (Abstract of Fantini).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Yodh et al. (PGPUB No. US 2016/0353997) in view of Mayer et al. (US Patent No. 8,320,981) further in view of Baker et al. (PGPUB No. US 2008/0146906).
Regarding claim 50, modified Yodh teaches the system in claim 1, as discussed above.
However, the combination of Yodh and Mayer is silent regarding a system, wherein the system is contained in one or more handheld units.
In an analogous imaging field of endeavor, regarding spectroscopy for blood parameters with multiple sources and detectors, Baker teaches a system, wherein the system is contained in one or more handheld units (Paragraph 0044 teaches that the device is held in the user hand).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Yodh and Mayer with Baker’s teaching of a handheld system. This allows for a compact and easy-to-hold means for the sensor (Paragraph 0044 of Baker). This modified apparatus would allow the user to facilitate early diagnosis of skin wounds and compartment syndromes (Abstract of Baker). Furthermore, the modification allows for the assessment and indication of a patient’s condition status (Paragraphs 0015-16 of Baker).
Claims 1, 17, 35, 37, 39, 45, 48, and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Yodh et al. (PGPUB No. US 2006/0063995) in view of Irwin et al., ("Influences of tissue absorption and scattering on diffuse correlation spectroscopy blood flow measurements", 2011).
Regarding claim 1, Yodh teaches a multi-distance, multi-wavelength diffuse correlation spectroscopy (MD-MW DCS) system comprising:
a set of DCS light sources (Fig. 9 shows two laser sources and the common location of emission. Paragraph 0072 teaches that the second laser source is added and used with the plurality of detectors. The lasers operate at 735 and 690 nm) including:
a first DCS light source associated with a first source location and (Fig. 9 shows two laser sources and the common location of emission. Paragraph 0072 teaches that the second laser source is added and used with the plurality of detectors. The lasers operate at 735 and 690 nm) configured to:
emit, from the first source location, a first light having a first wavelength (Fig. 9 shows two laser sources and the common location of emission. Paragraph 0072 teaches that the second laser source is added and used with the plurality of detectors. The lasers operate at 735 and 690 nm); and
transmit, from the first source location, the first light into a target medium at a single transmission location such that the first light enters the target medium at the single transmission location (Fig. 9 shows two laser sources and the common location of emission. Paragraph 0072 teaches that the second laser source is added and used with the plurality of detectors. The lasers operate at 735 and 690 nm): and
a second DCS light source associated with a second source location and (Fig. 9 shows two laser sources and the common location of emission. Paragraph 0072 teaches that the second laser source is added and used with the plurality of detectors. The lasers operate at 735 and 690 nm) configured to:
emit, from the second source location, a second light having a second wavelength (Fig. 9 shows two laser sources and the common location of emission. Paragraph 0072 teaches that the second laser source is added and used with the plurality of detectors. The lasers operate at 735 and 690 nm); and
transmit, from the second source location, the second light into the target medium at the single transmission location such that the second light enters the target medium at the single transmission location (Fig. 9 shows two laser sources and the common location of emission. Paragraph 0072 teaches that the second laser source is added and used with the plurality of detectors. The lasers operate at 735 and 690 nm);
a set of DCS detectors (Fig. 9 shows the two detectors situated and differing distances from the source to which the lasers are connected and the use of APD detection modules. Paragraphs 0067-68 teach the light detection and outputting of measurements. Paragraphs 0072-73 teaches the use of detectors with respect to the lasers. The device can use CCD camera, photomultiplier, photodiode, avalanche diode, photomultiplier tubes, etc. Paragraph 0029 teaches that varying light wavelengths are used and the detectors are used in receiving the light. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. Paragraph 0030 teaches Source-detector separation may range, for example, from 0.5-3 cm for DCS) including:
a first DCS detector (Fig. 9 shows the two detectors situated and differing distances from the source to which the lasers are connected and the use of APD detection modules. Paragraphs 0067-68 teach the light detection and outputting of measurements. Paragraphs 0072-73 teaches the use of detectors with respect to the lasers. The device can use CCD camera, photomultiplier, photodiode, avalanche diode, photomultiplier tubes, etc. Paragraph 0029 teaches that varying light wavelengths are used and the detectors are used in receiving the light. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. Paragraph 0030 teaches Source-detector separation may range, for example, from 0.5-3 cm for DCS) configured to:
receive, from the target medium, at least a portion of the first light (Fig. 9 shows the two detectors situated and differing distances from the source to which the lasers are connected and the use of APD detection modules. Paragraphs 0067-68 teach the light detection and outputting of measurements. Paragraphs 0072-73 teaches the use of detectors with respect to the lasers. The device can use CCD camera, photomultiplier, photodiode, avalanche diode, photomultiplier tubes, etc. Paragraph 0029 teaches that varying light wavelengths are used and the detectors are used in receiving the light. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. Paragraph 0030 teaches Source-detector separation may range, for example, from 0.5-3 cm for DCS); and
generate a first DCS detector signal in response to receiving the at least a portion of the first light (Fig. 9 shows the two detectors situated and differing distances from the source to which the lasers are connected and the use of APD detection modules. Paragraphs 0067-68 teach the light detection and outputting of measurements. Paragraphs 0072-73 teaches the use of detectors with respect to the lasers. The device can use CCD camera, photomultiplier, photodiode, avalanche diode, photomultiplier tubes, etc. Paragraph 0029 teaches that varying light wavelengths are used and the detectors are used in receiving the light. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. Paragraph 0030 teaches Source-detector separation may range, for example, from 0.5-3 cm for DCS):and
a second DCS detector (Fig. 9 shows the two detectors situated and differing distances from the source to which the lasers are connected and the use of APD detection modules. Paragraphs 0067-68 teach the light detection and outputting of measurements. Paragraphs 0072-73 teaches the use of detectors with respect to the lasers. The device can use CCD camera, photomultiplier, photodiode, avalanche diode, photomultiplier tubes, etc. Paragraph 0029 teaches that varying light wavelengths are used and the detectors are used in receiving the light. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. Paragraph 0030 teaches Source-detector separation may range, for example, from 0.5-3 cm for DCS) configured to:
receive, from the target medium, at least a portion of the second light (Fig. 9 shows the two detectors situated and differing distances from the source to which the lasers are connected and the use of APD detection modules. Paragraphs 0067-68 teach the light detection and outputting of measurements. Paragraphs 0072-73 teaches the use of detectors with respect to the lasers. The device can use CCD camera, photomultiplier, photodiode, avalanche diode, photomultiplier tubes, etc. Paragraph 0029 teaches that varying light wavelengths are used and the detectors are used in receiving the light. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. Paragraph 0030 teaches Source-detector separation may range, for example, from 0.5-3 cm for DCS); and
generate a second DCS detector signal in response to receiving the at least a portion of the second light (Fig. 9 shows the two detectors situated and differing distances from the source to which the lasers are connected and the use of APD detection modules. Paragraphs 0067-68 teach the light detection and outputting of measurements. Paragraphs 0072-73 teaches the use of detectors with respect to the lasers. The device can use CCD camera, photomultiplier, photodiode, avalanche diode, photomultiplier tubes, etc. Paragraph 0029 teaches that varying light wavelengths are used and the detectors are used in receiving the light. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. Paragraph 0030 teaches Source-detector separation may range, for example, from 0.5-3 cm for DCS):
wherein the first DCS detector receives the at least a portion of the first light at a first detector location positioned at a first source-detector distance relative to the single transmission location, and the second DCS detector receives the at least a portion of the second light at a second detector location positioned at a second source-detector distance relative to the single transmission location, wherein the first source-detector distance is different than the second source-detector distance, wherein the first detector location and the second detector location are external to the target medium such that the first DCS detector receives the at least a portion of the first light non-invasively and the second DCS detect receives the at least a portion of the second light non-invasively (Fig. 9 shows the two detectors situated and differing distances from the source to which the lasers are connected and the use of APD detection modules. Paragraphs 0067-68 teach the light detection and outputting of measurements. Paragraphs 0072-73 teaches the use of detectors with respect to the lasers. The device can use CCD camera, photomultiplier, photodiode, avalanche diode, photomultiplier tubes, etc. Paragraph 0029 teaches that varying light wavelengths are used and the detectors are used in receiving the light. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. Paragraph 0030 teaches source-detector separation may range, for example, from 0.5-3 cm for DCS. Paragraphs 0065-67 teach the implementation for non-invasive measurements. See Figs. 9-10);
a memory storing one or more equations relating a correlation function to dynamics of scattering particles within the target medium (Paragraphs 0034-35 teaches the DCS measurement of relative blood flow and assessment of tracking via autocorrelation and consideration of correlation time and equations. Paragraph 0027 teaches the use of a computer. It is inherent that a computational system will utilize a processor and memory for the performance of its computational functions); and
a processor coupled to the set of DCS detectors and the memory (Paragraph 0027 teaches computer processor with the appropriate software that implements the correlation diffusion theory described below determines the scattering, absorption and dynamic characteristics of the medium from the diffusion correlation wave and thereby reconstructs an image of the dynamically heterogeneous medium. Also, the computer may include software that allows a calculation of a correlation function. The computer can be any known, standard processor which can utilize the correlation information output by the autocorrelator. In this manner, a reconstructed image of the medium having the object therein can be produced as a function of the scattering and absorption of the diffuse correlation wave as it propagates diffusing through the medium. It is inherent that a computational system will utilize a processor and memory for the performance of its computational functions), the processor configured to:
receive the first DCS detector signal and the second DCS detector signal, thereby generating a DCS detector signal including photon arrival time information, wavelength information, source-detector distance information, and light intensity information for each of the first source-detector distance and the second source-detector distance (Paragraph 0068 teaches the detector is a fast, photon counting avalanche photodiode (APD) with low dark current, for example a model SPCM-AQR-14, manufactured by Perkin-Elmer of Canada. The APD may include an amplifier-discriminator unit that outputs a standard TTL signal corresponding to the number of photons counted. See Fig. 9. Paragraph 0033 teaches multi-distance and multi-wavelength DRS measurements of diffusive waves on the tissue surface provide information about tissue absorption. Paragraph 0072 teaches that the light intensity and wavelengths are recorded at each detector position. Paragraph 0074 teaches that the intensity data at both the both wavelengths will be fit to a multi-distance, two-layer diffusion model, yielding the oxy- and deoxyhemoglobin concentrations. Paragraph 0052 teaches that the source detector separations are the basis for assessment of the blood flow measure where the light is quantified and with respect to the optical properties and thickness are considered. See Fig. 4 that shows the biological assessment according to the source detector separations);
determine, from the DCS detector signal, a plurality of optical properties of the target medium, wherein the plurality of optical properties includes an absorption coefficient and a reduced scattering coefficient (Paragraph 0028 teaches the generation of the data according to the absorption and scattering coefficients according to the diffuse light. Paragraphs 0032-33 teach the consideration of the multiple distances and wavelengths for the absorption and scattering coefficients. Paragraph 0037 teaches that scatting coefficient baseline is used in the calculation of the blood flow. Paragraph 0066 teaches that the changes of the index are observed. Paragraph 0065 teaches observation of blood flow according to DCS); and
determine, using the absorption coefficient and the reduced scattering coefficient, the dynamics of the target medium non-invasively using the plurality of optical properties, the DCS detector signal, and the one or more equations relating the correlation function to dynamics of scattering particles within the target medium, wherein the dynamics of the target medium are determined based at least in part on the first source-detector distance and the second source-detector distance, and wherein the dynamics of the target medium includes a blood flow index of the target medium (Paragraph 0033 teaches multi-distance and multi-wavelength DRS measurements of diffusive waves on the tissue surface provide information about tissue absorption. Paragraphs 0034-35 teaches the DCS measurement of relative blood flow and assessment of tracking via autocorrelation and consideration of correlation time and equations. Paragraph 0036 teaches that images can be generation based on the diffusion equation analysis. Paragraphs 0065-67 teach the implementation for non-invasive measurements. See Figs. 9-10. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. See Figs. 4-5. Paragraph 0030 teaches source-detector separation may range, for example, from 0.5-3 cm for DCS. Paragraph 0027 teaches the use of a computer. It is inherent that a computational system will utilize a processor and memory for the performance of its computational functions. Paragraph 0028 teaches the generation of the data according to the absorption and scattering coefficients according to the diffuse light. Paragraphs 0032-33 teach the consideration of the multiple distances and wavelengths for the absorption and scattering coefficients. Paragraph 0037 teaches that scatting coefficient baseline is used in the calculation of the blood flow. Paragraph 0066 teaches that the changes of the index are observed. Paragraph 0065 teaches observation of blood flow according to DCS).
However, Yodh is silent regarding a system, wherein the dynamics of the target medium are determined based at least in part on the first source-detector distance and the second source-detector distance.
In an analogous imaging field of endeavor, regarding spectroscopy for blood parameters with multiple sources and detectors, Irwin teaches a system, a processor coupled to the set of DCS detectors and the memory (Pages 5-6 teach the use of a DCS system. See Fig. 1. It is inherent that a computational system will utilize a processor and memory for the performance of its computational functions),
determine, from the DCS detector signal, a plurality of optical properties of the target medium, wherein the plurality of optical properties includes an absorption coefficient and a reduced scattering coefficient (Page 5, paragraph 2, teaches that the iamgent system is able to measure the scattering and absorption coefficients. Page 9 teaches the determination of the scattering and absorption coefficients),
determine, using the absorption coefficient and the reduced scattering coefficient, the dynamics of the target medium non-invasively using the plurality of optical properties, the DCS detector signal, and the one or more equations relating the correlation function to dynamics of scattering particles within the target medium, wherein the dynamics of the target medium are determined based at least in part on the first source-detector distance and the second source-detector distance, and wherein the dynamics of the target medium includes a blood flow index of the target medium (Page 5, paragraph 2, teaches that the iamgent system is able to measure the scattering and absorption coefficients. Page 9 teaches the determination of the scattering and absorption coefficients. Page 10 teaches that the scattering and absorption coefficients are used in calculating the first DCS blood flow index. This is considered to be the true flow index. The coefficients are then used in the determination of the remaining three DCS blood flow indices. See Fig. 3);
receive the first DCS detector signal and the second DCS detector signal, thereby generating a DCS detector signal including source-detector distance information, and light intensity information for each of the first source-detector distance and the second source-detector distance (Pages 5-6 teach the use of multiple sources and detectors. See Fig. 1. Page 7 teaches that the absorption and scattering coefficients are obtained via multi-distance spatially resolved spectroscopy in the form of the imagent system at varying distances. Page 6 teaches the consideration the source detector separation and light intensity. See Equation 3).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Yodh with Irwin’s teaching of dynamics that are determined based on varying distances between the sources and detectors. This modified apparatus would allow the user to concurrently measure flow index and optical properties for accurate extraction of blood flow information. (Abstract of Irwin). Furthermore, the modification provides a safe and quick alternative for measurement of blood flow in deep tissue (Conclusion of Irwin).
Regarding claim 17, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the first source-detector distance is between 0.1 cm and 2.0 cm and the second source-detector distance is between 1.0 cm and 3.0 cm, wherein the second source-detector distance is greater than the first source-detector distance (Fig. 9 shows the two detectors situated and differing distances from the source to which the lasers are connected and the use of APD detection modules. Paragraph 0042 teaches the use of source detector pairings for DCS measurement and 0.5, 1, 2, and 3 cm. Paragraph 0030 teaches source-detector separation may range, for example, from 0.5-3 cm for DCS. Fig. 9 shows an upper limit of 3 cm).
Regarding claim 35, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the set of DCS light sources includes at least one of a diode laser, a solid-state laser, a fiber laser, a vertical cavity surface-emitting laser (VCSEL), a DBR laser, a Fabry-Perot laser, a ridge laser, or a tapered laser (Paragraph 0071 teaches the use of a diode pumped laser diode).
Regarding claim 37, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the set of DCS light sources are configured to emit light at a wavelength of between 400 nm and 1800 nm or an average power of between 10 pW and 10W (Fig. 9 shows two laser sources and the common location of emission. Paragraph 0072 teaches that the second laser source is added and used with the plurality of detectors. The lasers operate at 735 and 690 nm).
Regarding claim 39, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, the system further comprising a light source driver coupled to a computer and the set of DCS light sources, wherein the light source driver is configured to control the first DCS light source and the second DCS light source to multiplex the first light and the second light (Paragraph 0072 teaches that the laser sources can be switched via the computer system. Fig. 9 shows the use of the system that has two laser sources operating at differing wavelengths).
Regarding claim 45, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the set of DCS detectors includes a detector selected from the group consisting of a single-photon avalanche photodiode detector, a photomultiplier tube, a Si, Ge, InGaAs, PbS, PbSe or HgCdTe photodiode or PIN photodiode, phototransistors, MSM photodetectors, CCD and CMOS detector arrays, LCD, silicon photomultipliers, multi-pixel-photon-counters, and combinations thereof (Paragraphs 0072-73 teaches the use of detectors with respect to the lasers. The device can use CCD camera, photomultiplier, photodiode, avalanche diode, photomultiplier tubes, etc.).
Regarding claim 48, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, the system further comprising at least one of: a plurality of
waveguides or a plurality of lenses, wherein the at least one of the plurality of waveguides or the plurality of lenses is configured to couple the set of DCS light sources to the target medium (Paragraph 0037 teaches that multiple source fibers can be used. Paragraph 0072 teaches the use of source fibers for emission).
Regarding claim 51, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the set of DCS detectors are configured to collect light from one speckle (Paragraph 0026 teaches that the intensity fluctuations of the signal speckle is observed as it is collected by the photomultiplier tube).
Regarding claim 52, modified Yodh teaches the system in claim 1, as discussed above.
Yodh further teaches a system, wherein the first wavelength and the second wavelength are separated from one another by between 20 nm and 500 nm (Fig. 9 shows two laser sources and the common location of emission. Paragraph 0072 teaches that the second laser source is added and used with the plurality of detectors. The lasers operate at 735 and 690 nm. This is within the 20-500 nm separation range).
Claims 14, 19, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Yodh et al. (PGPUB No. US 2006/0063995) in view of Irwin et al., ("Influences of tissue absorption and scattering on diffuse correlation spectroscopy blood flow measurements", 2011) further in view of Baker et al. (PGPUB No. US 2008/0146906).
Regarding claim 14, modified Yodh teaches the system in claim 1, as discussed above.
However, the combination of Yodh and Irwin is silent regarding a system, wherein the set of DCS light sources includes a third DCS light source associated with a third source location and configured to emit a third light having a third wavelength, the third DCS light source configured to transmit, from the third source location, the third light into the target medium at the single transmission location such that the third light enters the target medium at the single transmission location, wherein the first wavelength, the second wavelength, and the third wavelength are different, wherein the set of DCS detectors includes a third DCS detector configured to receive at least a portion of the third light from the target medium, wherein the third DCS detector is configured to generate a third DCS detector signal in response to receiving the at least a portion of the third light, wherein the third DCS detector receives the at least a portion of the third light at a third detector location positioned a third source-detector distance relative to the single transmission location, wherein the first source-detector distance, the second source-detector distance, and the third source-detector distance are different.
In an analogous imaging field of endeavor, regarding spectroscopy for blood parameters with multiple sources and detectors, Baker teaches a system, wherein the set of DCS light sources includes a third DCS light source associated with a third source location and configured to emit a third light having a third wavelength, the third DCS light source configured to transmit, from the third source location, the third light into the target medium at the single transmission location such that the third light enters the target medium at the single transmission location, wherein the first wavelength, the second wavelength, and the third wavelength are different, wherein the set of DCS detectors includes a third DCS detector configured to receive at least a portion of the third light from the target medium, wherein the third DCS detector is configured to generate a third DCS detector signal in response to receiving the at least a portion of the third light, wherein the third DCS detector receives the at least a portion of the third light at a third detector location positioned a third source-detector distance relative to the single transmission location, wherein the first source-detector distance, the second source-detector distance, and the third source-detector distance are different (Fig. 7 shows the emitter at a common location situated with respect to four detectors. Each at a different distance from the other 3. Paragraph 0033 teaches the implementation of the three wavelengths. Paragraphs 0014-15 teaches that the detector receives the emitted light that passes through the medium).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Yodh and Irwin with Baker’s teaching of three detector source relationships with three wavelengths. This modified apparatus would allow the user to facilitate early diagnosis of skin wounds and compartment syndromes (Abstract of Baker). Furthermore, the modification allows for the assessment and indication of a patient’s condition status (Paragraphs 0015-16 of Baker).
Regarding claim 19, modified Yodh teaches the system in claim 14, as discussed above.
However, Yodh is silent regarding a system, wherein the first source-detector distance is between 0.1 cm and 2.0 cm, the second source-detector distance is between 1.0 cm and 3.0 cm, and the third source-detector distance is between 1.0 cm and 5.0 cm, wherein the second source- detector distance is greater than the first source-detector distance and the third source-detector distance is greater than the second source-detector distance.
In an analogous imaging field of endeavor, regarding spectroscopy for blood parameters with multiple sources and detectors, Irwin teaches a system, wherein the first source-detector distance is between 0.1 cm and 2.0 cm, the second source-detector distance is between 1.0 cm and 3.0 cm, and the third source-detector distance is between 1.0 cm and 5.0 cm, wherein the second source- detector distance is greater than the first source-detector distance and the third source-detector distance is greater than the second source-detector distance (Page 7 teaches the use of varying distances between the sources and the detectors. The predetermined distances are 2, 2.5, 3, and 3.5 cm).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Yodh with Irwin’s teaching of dynamics that are determined based on varying distances between the sources and detectors. This modified apparatus would allow the user to concurrently measure flow index and optical properties for accurate extraction of blood flow information. (Abstract of Irwin). Furthermore, the modification provides a safe and quick alternative for measurement of blood flow in deep tissue (Conclusion of Irwin).
Regarding claim 50, modified Yodh teaches the system in claim 1, as discussed above.
However, the combination of Yodh and Irwin is silent regarding a system, wherein the system is contained in one or more handheld units.
In an analogous imaging field of endeavor, regarding spectroscopy for blood parameters with multiple sources and detectors, Baker teaches a system, wherein the system is contained in one or more handheld units (Paragraph 0044 teaches that the device is held in the user hand).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Yodh and Irwin with Baker’s teaching of a handheld system. This allows for a compact and easy-to-hold means for the sensor (Paragraph 0044 of Baker). This modified apparatus would allow the user to facilitate early diagnosis of skin wounds and compartment syndromes (Abstract of Baker). Furthermore, the modification allows for the assessment and indication of a patient’s condition status (Paragraphs 0015-16 of Baker).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Yodh et al. (PGPUB No. US 2006/0063995) in view of Irwin et al., ("Influences of tissue absorption and scattering on diffuse correlation spectroscopy blood flow measurements", 2011) further in view of Zubkov et al. (PGPUB No. US 2017/0007132).
Regarding claim 41, modified Yodh teaches the system in claim 1, as discussed above.
However, the combination of Yodh and Irwin is silent regarding a system, the system further comprising a near infrared spectroscopy light source separate from the set of DCS light sources and a near infrared spectroscopy detector separate from the set of DCS light detectors, wherein the near infrared spectroscopy light source is configured to emit light having at least one property different from the first light and the second light.
In an analogous imaging field of endeavor, regarding multiple sources and detectors for spectroscopy, Zubkov teaches a system, the system further comprising a near infrared spectroscopy light source separate from the set of DCS light sources and a near infrared spectroscopy detector separate from the set of DCS light detectors, wherein the near infrared spectroscopy light source is configured to emit light having at least one property different from the first light and the second light (Paragraph 0041 teaches that the DCS and DNIRS can be used. Paragraph 0043 teaches that the DCS is used in assessing the movement of the particles and paragraph 0043 teaches that the NIRS is used in assessing concentrations in a near infrared window of 650 and 850 nm. Paragraph 0044 teaches the DCS operates in 785 nm. Paragraph 0053 teaches the use of different source and detectors. Paragraph 0048 teaches separations for the source and detector).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Yodh and Irwin with Zubkov’s teaching of NIRS along with DCS. This modified apparatus would allow the user to determine the skin's optical scattering and absorption coefficients (Paragraph 0014 of Zubkov). Furthermore, the modification useful for detecting and/or assessing the severity of Peripheral Arterial Disease (PAD) and/or vascular effects of smoking in adults (Paragraph 0041 of Zubkov).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Nakaji et al. (WO2015109005): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Boas et al., ("Scattering and Imaging with Diffusing Temporal Field Correlations", 1995): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Boas et al., ("Spatially varying dynamical properties of turbid media probed with diffusing temporal light correlation", 1997): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Durduran et al., ("Diffuse optics for tissue monitoring and tomography", 2010): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Mesquita et al., ("Direct measurement of tissue blood flow and metabolism with diffuse optics", 2011): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
He et al., ("Using few-mode fiber to improve the signal-to-noise ratio of DCS flow-oximeter measurements", 2012): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Buckley et al., ("Validation of diffuse correlation spectroscopic measurement of cerebral blood flow using phase-encoded velocity mapping magnetic resonance imaging", 2012): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Mesquita et al., ("Influence of probe pressure on the diffuse correlation spectroscopy blood flow signal: extra-cerebral contributions", 2013): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Li et al., ("Simultaneous measurement of deep tissue blood flow and oxygenation using noncontact diffuse correlation spectroscopy flow-oximeter", 2013): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Durduran et al., ("Diffuse correlation spectroscopy for non-invasive, micro-vascular cerebral blood flow measurement", 2014): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Farzam et al. ("Multidistance diffuse correlation spectroscopy for simultaneous estimation of blood flow index and optical properties", May 2015): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Li et al., ("Calibration of diffuse correlation spectroscopy blood flow index with venous-occlusion diffuse optical spectroscopy in skeletal muscle", 2015): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Wang et al., ("Fast blood flow monitoring in deep tissues with real-time software correlators", February 2016): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Nakaji et al. (PGPUB No. US 2016/0345880): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Busch et al. (PGPUB No. US 2016/0361017): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Purdon et al. (PGPUB No. US 2014/0316218): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
Bechtel et al. (PGPUB No. US 2014/0046152): Teaches determination of blood flow index according to scattering and absorption coefficients with respect to spectroscopy.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
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