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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 and 13-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,502,079 hereinafter Olvera ‘079. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant invention would be an obvious modification of the reference patent.
Regarding claim 1, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
An optical measurement system (Olvera ‘079, claim 1) comprising:
a module (Olvera ‘079, claim 1) comprising:
a light source configured to emit light directed at a target (Olvera ‘079, claim 1),
a plurality of detectors configured to detect target photon arrival times of target photons of the light after the light is scattered by the target (Olvera ‘079, claim 1),
a reference detector configured to detect reference photon arrival times of reference photons of the light after the light is reflected within the module (Olvera ‘079, claim 1), and
a waveguide configured to direct the light reflected within the module through a plurality of channels of the waveguide to the reference detector (Olvera ‘079, claims 8-10); and
a controller configured to determine, based on an output from the reference detector, an instrument response function (IRF) of the module (Olvera ‘079, claim 1).
Regarding claim 2, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the controller is further configured to:
generate, based on the target photon arrival times and the reference photon arrival times, histogram data associated with the target (Olvera ‘079, claim 2); and
determine, based on the histogram data, a property of the target (Olvera ‘079, claim 2).
Regarding claim 3, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the reference detector is substantially identical to the plurality of detectors and shielded from the target photons (Olvera ‘079, claim 3).
Regarding claim 4, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein:
the module comprises an additional light source configured to emit light directed at the target (Olvera ‘079, claim 4); and
the light source and the additional light source are positioned equidistant from the reference detector (Olvera ‘079, claim 4).
Regarding claim 5, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein:
the module comprises a lower layer of components and an upper layer of components stacked above the lower layer of components within the module (Olvera ‘079, claim 1);
the plurality of detectors is positioned on the upper layer (Olvera ‘079, claim 1);
the reference detector is positioned on the lower layer (Olvera ‘079, claim 1); and
the light reflected within the module comprises light reflected off of an underside of the upper layer (Olvera ‘079, claim 1).
Regarding claim 6, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
further comprising:
an enclosure configured for the reference detector (Olvera ‘079, claim 6); and
an aperture in a wall of the enclosure configured to allow the light reflected within the module to reach the reference detector (Olvera ‘079, claim 6).
Regarding claim 7, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the aperture is configured to be adjustable to control an amount of the light reflected within the module to reach the reference detector (Olvera ‘079, claim 7).
Regarding claim 8, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein a portion of the waveguide is positioned inside an optical assembly of the light source (Olvera ‘079, claim 9).
Regarding claim 9, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the portion of the waveguide positioned inside the light source comprises an optical element configured to direct photons of the light through the channels of the waveguide (Olvera ‘079, claim 10).
Regarding claim 10, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the optical element comprises a facet configured to reflect the light (Olvera ‘079, claim 11).
Regarding claim 11, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the optical element comprises a beam splitter configured to partially reflect the light (Olvera ‘079, claim 12).
Regarding claim 13, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
A wearable device comprising:
a wearable (Olvera ‘079, claim 13) assembly;
a plurality of modules each configured to be selectively inserted into the wearable assembly (Olvera ‘079, claim 13), each module included in the plurality of modules comprising:
a light source configured to emit light directed at a target (Olvera ‘079, claim 13),
a plurality of detectors configured to detect target photon arrival times of target photons of the light after the light is scattered by the target (Olvera ‘079, claim 13),
a reference detector configured to detect reference photon arrival times of reference photons of the light after the light is reflected within the module (Olvera ‘079, claim 13),
a waveguide configured to direct the light reflected within the module through a plurality of channels of the waveguide to the reference detector (Olvera ‘079, claims 20-22); and
a controller configured to determine, based on an output from the reference detector, an instrument response function (IRF) of the module (Olvera ‘079, claim 13).
Regarding claim 14, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the controller is further configured to:
generate, based on the target photon arrival times and the reference photon arrival times, histogram data associated with the target (Olvera ‘079, claim 14); and
determine, based on the histogram data, a property of the target (Olvera ‘079, claim 14).
Regarding claim 15, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the reference detector is substantially identical to the plurality of detectors and shielded from the target photons (Olvera ‘079, claim 15).
Regarding claim 16, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein a portion of the waveguide is positioned inside an optical assembly of the light source (Olvera ‘079, claim 21).
Regarding claim 17, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the portion of the waveguide positioned inside the light source comprises an optical element configured to direct photons of the light through the waveguide (Olvera ‘079, claim 22).
Regarding claim 18, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the optical element comprises a facet configured to reflect the light (Olvera ‘079, claim 23).
Regarding claim 19, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) teaches:
wherein the optical element comprises a beam splitter configured to partially reflect the light (Olvera ‘079, claim 24).
Claims 12 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,502,079 hereinafter Olvera ‘079, in view of Ogasawara et al. (U.S. Pat. No. 7,894,702) hereinafter Ogasawara. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant invention would be an obvious modification of the reference patent.
Regarding claim 12, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) further fails to teach:
wherein the waveguide further comprises an additional optical element at a center of the waveguide configured to deflect the photons of the light directed through the channels of the waveguide to the reference detector
However, the analogous art of Ogasawara of a optical waveguide directivity method (abstract) teaches:
wherein the waveguide further comprises an additional optical element at a center of the waveguide configured to deflect the photons of the light directed through the channels of the waveguide to the reference detector (Ogasawara, claim 1, diffuse reflection members at a center portion of the optical waveguide).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical measurement system with light source, detector and waveguide of Olvera ‘079 to incorporate the additional optical element at a waveguide center as taught by Ogasawara because it provides for directivity in an optical waveguide which obtains relationship between the shape and incident position of the light (Ogasawara, col 1, lines 45-50). This provides additional light output data, and additional measurable information.
Regarding claim 20, reference patent Olvera ‘079 (U.S. Pat. No. 12,502,079) further fails to teach:
wherein the waveguide further comprises an additional optical element at a center of the waveguide configured to deflect the photons of the light directed through the channels of the waveguide to the reference detector
However, the analogous art of Ogasawara of a optical waveguide directivity method (abstract) teaches:
wherein the waveguide further comprises an additional optical element at a center of the waveguide configured to deflect the photons of the light directed through the channels of the waveguide to the reference detector (Ogasawara, claim 1, diffuse reflection members at a center portion of the optical waveguide).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical measurement system with light source, detector and waveguide of Olvera ‘079 to incorporate the additional optical element at a waveguide center as taught by Ogasawara because it provides for directivity in an optical waveguide which obtains relationship between the shape and incident position of the light (Ogasawara, col 1, lines 45-50). This provides additional light output data, and additional measurable information.
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 1-2, 8-9, 12-14, 16-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Katnani et al. (U.S. Pub. No. 20210259597) hereinafter Katnani, in view of Nahman et al. (U.S. Pub. No. 20150099980) hereinafter Nahman.
Regarding claim 1, primary reference Katnani teaches:
An optical measurement system (abstract) comprising:
a module ([0072]-[0078], module 600 in figures 6A through 7B) comprising:
a light source configured to emit light directed at a target ([0072]-[0078], figures 6A through 7B include the light-emitting member 604 which forms a light source configured to emit light to a target; [0081]-[0088], light source; [0116]-[0120], light source 1204 forms light source configured to direct light to the body 1216 of figure 12; [0130]-[0131]; [0136]-[0145], light source 1204; [0148]-[0154]),
a plurality of detectors configured to detect target photon arrival times of target photons of the light after the light is scattered by the target ([0073], plurality of detector assemblies; [0077], “a photodetector (e.g., photodetector 106)”; [0095]-[0097], plurality of detector assemblies; [0098]-[0100], detector assembly 1002 includes photodetectors; [0109]-[0113], detector 1006, includes a plurality of detectors across the overall module; [0116]-[0120], detector 1210 of figure 12; [0130]-[0131]; [0136]-[0145], detector 1210; [0146], arrival times; [0147]-[0154], arrival time of photons),
a reference detector configured to detect reference photon arrival times of reference photons of the light after the light is reflected within the module ([0026]-[0027], reference photon detection by the at least one photodetector, wherein the photodetector of a plurality of detectors forms a teaching to a reference detector as claimed; [0118]-[0124], reference photons received by detector 1210 of figure 12 forms a teaching to the detector being a reference detector as claimed, with arrival times of reference photons incorporated into the measured histogram; [0126]-[0131], reference photons detected by detector 1210, teaches to the reference detector; [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S; [0145]; [0146], arrival times; [0147]-[0154], arrival time of photons; [0159]), and
a waveguide configured to direct the light reflected within the module to the reference detector ([0116]; figure 12, light guide 1206 directs reference light to the reference detector (detector 1210 serves as reference detector); [0117]-[0118]; [0119], “light guide 1206 may be implemented by any suitable light guide described herein (e.g., optical conduit 114, light guide 606, light guide 808, etc.)” which teaches to the citations of a waveguide in [0040], optical conduit 114 as a waveguide, light guide 808 as a rigid elongate waveguide; [0120]-[0131]); and
a controller configured to determine, based on an output from the reference detector, an instrument response function (IRF) of the module ([0143], “system noise can be removed and the signal-to-noise ratio increased by using the instrument response function of detector 1210 to deconvolve histogram 1702 before histogram 1702 is analyzed to determine the absolute measures of the reduced scattering coefficient μ.sub.s′ and absorption coefficient μ.sub.a of the target and the absolute optical pathlength”, Detector 1210 acquires both reference and target photons and therefore the generated instrument response function for system noise removal is based upon the output of the detector; see also [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S).
Primary reference Katnani fails to teach:
a waveguide configured to direct the light reflected within the module through a plurality of channels
However, the analogous art of Nahman of a device for measuring reflected optical signals from a patient region of interest (abstract) teaches:
a waveguide configured to direct the light reflected within the module through a plurality of channels ([0021], plurality of channels; [0024]; [0063]; [0066]-[0069], figure 5, waveguide assembly 550 includes a plurality of optical channels; [0101]; [0114], optical channels of the waveguide assembly as in figures 5-7)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical measurement system with light source, detector and waveguide of Katnani to incorporate the waveguide with particularly a plurality of channels as taught by Nahman because the use of a plurality of measured channels enables localization of signals from a target region of interest (Nahman, [0021]). This leads to higher quality diagnostics and improved clinical outcomes.
Regarding claim 2, the combined references of Katnani and Nahman teach all of the limitations of claim 1. Primary reference Katnani further teaches:
wherein the controller is further configured to:
generate, based on the target photon arrival times and the reference photon arrival times, histogram data associated with the target ([0026]-[0027], histogram data associated with target; [0044], histogram representing light pulse in the target; [0051]-[0053]; [0055]; [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S; [0145], histogram provides for “absolute optical properties of the target” which forms a property of the target; [0146], arrival times; [0147]-[0154], arrival time of photons; [0159], property of the target from histogram 1702 such as oxidation state); and
determine, based on the histogram data, a property of the target ([0026]-[0027], histogram data associated with target; [0044], histogram representing light pulse in the target; [0051]-[0053]; [0055]; [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S; [0145], histogram provides for “absolute optical properties of the target” which forms a property of the target; [0146]-[0154]; [0159], property of the target from histogram 1702 such as oxidation state).
Regarding claim 8, the combined references of Katnani and Nahman teach all of the limitations of claim 1. Primary reference Katnani further teaches:
wherein a portion of the waveguide is positioned inside an optical assembly of the light source ([0116]; figure 12, light guide 1206; [0117]-[0118]; [0119], “light guide 1206 may be implemented by any suitable light guide described herein (e.g., optical conduit 114, light guide 606, light guide 808, etc.)” which teaches to the citations of a waveguide in [0040], optical conduit 114 as a waveguide, light guide 808 as a rigid elongate waveguide; [0120]-[0124]; [0125]-[0126], optical elements of figures 13 and 14 form elements of an overall optical assembly of the light source 1204 as connected to the target tissue region of interest, and therefore a portion of the waveguide is positioned within this overall assembly; [0127]-[0131]).
Regarding claim 9, the combined references of Katnani and Nahman teach all of the limitations of claim 8. Primary reference Katnani further teaches:
wherein the portion of the waveguide positioned inside the light source comprises an optical element configured to direct photons of the light through the channels of the waveguide ([0116]; figure 12, light guide 1206; [0117]-[0118]; [0119], “light guide 1206 may be implemented by any suitable light guide described herein (e.g., optical conduit 114, light guide 606, light guide 808, etc.)” which teaches to the citations of a waveguide in [0040], optical conduit 114 as a waveguide, light guide 808 as a rigid elongate waveguide; [0120]-[0124]; [0125]-[0126], optical elements of figures 13 and 14 form elements of an overall optical assembly of the light source 1204 as connected to the target tissue region of interest, and therefore a portion of the waveguide is positioned within this overall assembly; [0127]-[0131]; note that Nahman teaches to a plurality of channels in the combined prior art invention).
Regarding claim 12, the combined references of Katnani and Nahman teach all of the limitations of claim 9. Primary reference Katnani further fails to teach:
wherein the waveguide further comprises an additional optical element at a center of the waveguide configured to deflect the photons of the light directed through the channels of the waveguide to the reference detector
However, the analogous art of Nahman of a device for measuring reflected optical signals from a patient region of interest (abstract) teaches:
wherein the waveguide further comprises an additional optical element at a center of the waveguide configured to deflect the photons of the light directed through the channels of the waveguide to the reference detector ([0021], plurality of channels; [0024]; [0063]; [0066]-[0069], figure 5, waveguide assembly 550 includes a plurality of optical channels with mirrors 552a,b,c and the central mirror 552b forms an optical element at the center of waveguide assembly 550 that deflects photons of the light and back to the detector; [0101]; [0114], optical channels of the waveguide assembly as in figures 5-7)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical measurement system with light source, detector and waveguide of Katnani and Nahman to incorporate the waveguide with multiple channels including a central reflector as taught by Nahman because the use of a plurality of measured channels enables localization of signals from a target region of interest (Nahman, [0021]). This leads to higher quality diagnostics and improved clinical outcomes.
Regarding claim 13, primary reference Katnani teaches:
A wearable device (abstract) comprising:
a wearable assembly ([0059]-[0060], wearable device; [0062], wearable brain interface system 500; [0071], wearable module 600; [0075], wearable module assemblies; [0096]; [0115]; [0132]; [0134]-[0135]; [0147]-[0153], wearable assembly; [0160], figures 20-25);
a plurality of modules each configured to be selectively inserted into the wearable assembly ([0071]-[0073], plurality of assemblies; [0075], “allows a plurality of modules to be flexibly interconnected adjacent one another in a wearable module assembly”; [0148], plurality of wearable assemblies; [0160], “include a plurality of modules 2002, similar to wearable module 600 shown in FIGS. 6A-7B, described herein. For example, each module 2002 includes a source (e.g., light-emitting member 604) and a plurality of detectors (e.g., light-receiving members 606-1 through 606-6).”; figures 20-25), each module included in the plurality of modules comprising:
a light source configured to emit light directed at a target ([0072]-[0078], figures 6A through 7B include the light-emitting member 604 which forms a light source configured to emit light to a target; [0081]-[0088], light source; [0116]-[0120], light source 1204 forms light source configured to direct light to the body 1216 of figure 12; [0130]-[0131]; [0136]-[0145], light source 1204; [0148]-[0154]),
a plurality of detectors configured to detect target photon arrival times of target photons of the light after the light is scattered by the target ([0073], plurality of detector assemblies; [0077], “a photodetector (e.g., photodetector 106)”; [0095]-[0097], plurality of detector assemblies; [0098]-[0100], detector assembly 1002 includes photodetectors; [0109]-[0113], detector 1006, includes a plurality of detectors across the overall module; [0116]-[0120], detector 1210 of figure 12; [0130]-[0131]; [0136]-[0145], detector 1210; [0146], arrival times; [0147]-[0154], arrival time of photons),
a reference detector configured to detect reference photon arrival times of reference photons of the light after the light is reflected within the module ([0026]-[0027], reference photon detection by the at least one photodetector, wherein the photodetector of a plurality of detectors forms a teaching to a reference detector as claimed; [0118]-[0124], reference photons received by detector 1210 of figure 12 forms a teaching to the detector being a reference detector as claimed, with arrival times of reference photons incorporated into the measured histogram; [0126]-[0131], reference photons detected by detector 1210, teaches to the reference detector; [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S; [0145]; [0146], arrival times; [0147]-[0154], arrival time of photons; [0159]),
a waveguide configured to direct the light reflected within the module to the reference detector ([0116]; figure 12, light guide 1206 directs reference light to the reference detector (detector 1210 serves as reference detector); [0117]-[0118]; [0119], “light guide 1206 may be implemented by any suitable light guide described herein (e.g., optical conduit 114, light guide 606, light guide 808, etc.)” which teaches to the citations of a waveguide in [0040], optical conduit 114 as a waveguide, light guide 808 as a rigid elongate waveguide; [0120]-[0131]); and
a controller configured to determine, based on an output from the reference detector, an instrument response function (IRF) of the module ([0143], “system noise can be removed and the signal-to-noise ratio increased by using the instrument response function of detector 1210 to deconvolve histogram 1702 before histogram 1702 is analyzed to determine the absolute measures of the reduced scattering coefficient μ.sub.s′ and absorption coefficient μ.sub.a of the target and the absolute optical pathlength”, Detector 1210 acquires both reference and target photons and therefore the generated instrument response function for system noise removal is based upon the output of the detector; see also [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S).
Primary reference Katnani fails to teach:
a waveguide configured to direct the light reflected within the module through a plurality of channels of the waveguide
However, the analogous art of Nahman of a device for measuring reflected optical signals from a patient region of interest (abstract) teaches:
a waveguide configured to direct the light reflected within the module through a plurality of channels of the waveguide ([0021], plurality of channels; [0024]; [0063]; [0066]-[0069], figure 5, waveguide assembly 550 includes a plurality of optical channels; [0101]; [0114], optical channels of the waveguide assembly as in figures 5-7)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical measurement system with light source, detector and waveguide of Katnani to incorporate the waveguide with particularly a plurality of channels as taught by Nahman because the use of a plurality of measured channels enables localization of signals from a target region of interest (Nahman, [0021]). This leads to higher quality diagnostics and improved clinical outcomes.
Regarding claim 14, the combined references of Katnani and Nahman teach all of the limitations of claim 13. Primary reference Katnani further teaches:
wherein the controller is further configured to:
generate, based on the target photon arrival times and the reference photon arrival times, histogram data associated with the target ([0026]-[0027], histogram data associated with target; [0044], histogram representing light pulse in the target; [0051]-[0053]; [0055]; [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S; [0145], histogram provides for “absolute optical properties of the target” which forms a property of the target; [0146], arrival times; [0147]-[0154], arrival time of photons; [0159], property of the target from histogram 1702 such as oxidation state); and
determine, based on the histogram data, a property of the target ([0026]-[0027], histogram data associated with target; [0044], histogram representing light pulse in the target; [0051]-[0053]; [0055]; [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S; [0145], histogram provides for “absolute optical properties of the target” which forms a property of the target; [0146]-[0154]; [0159], property of the target from histogram 1702 such as oxidation state).
Regarding claim 16, the combined references of Katnani and Nahman teach all of the limitations of claim 13. Primary reference Katnani further teaches:
wherein a portion of the waveguide is positioned inside an optical assembly of the light source ([0116]; figure 12, light guide 1206; [0117]-[0118]; [0119], “light guide 1206 may be implemented by any suitable light guide described herein (e.g., optical conduit 114, light guide 606, light guide 808, etc.)” which teaches to the citations of a waveguide in [0040], optical conduit 114 as a waveguide, light guide 808 as a rigid elongate waveguide; [0120]-[0124]; [0125]-[0126], optical elements of figures 13 and 14 form elements of an overall optical assembly of the light source 1204 as connected to the target tissue region of interest, and therefore a portion of the waveguide is positioned within this overall assembly; [0127]-[0131]).
Regarding claim 17, the combined references of Katnani and Nahman teach all of the limitations of claim 16. Primary reference Katnani further teaches:
wherein the portion of the waveguide positioned inside the light source comprises an optical element configured to direct photons of the light through the waveguide ([0116]; figure 12, light guide 1206; [0117]-[0118]; [0119], “light guide 1206 may be implemented by any suitable light guide described herein (e.g., optical conduit 114, light guide 606, light guide 808, etc.)” which teaches to the citations of a waveguide in [0040], optical conduit 114 as a waveguide, light guide 808 as a rigid elongate waveguide; [0120]-[0124]; [0125]-[0126], optical elements of figures 13 and 14 form elements of an overall optical assembly of the light source 1204 as connected to the target tissue region of interest, and therefore a portion of the waveguide is positioned within this overall assembly; [0127]-[0131]; note that Nahman teaches to a plurality of channels in the combined prior art invention).
Regarding claim 20, the combined references of Katnani and Nahman teach all of the limitations of claim 16. Primary reference Katnani further fails to teach:
wherein the waveguide further comprises an additional optical element at a center of the waveguide configured to deflect the photons of the light directed through the channels of the waveguide to the reference detector
However, the analogous art of Nahman of a device for measuring reflected optical signals from a patient region of interest (abstract) teaches:
wherein the waveguide further comprises an additional optical element at a center of the waveguide configured to deflect the photons of the light directed through the channels of the waveguide to the reference detector ([0021], plurality of channels; [0024]; [0063]; [0066]-[0069], figure 5, waveguide assembly 550 includes a plurality of optical channels with mirrors 552a,b,c and the central mirror 552b forms an optical element at the center of waveguide assembly 550 that deflects photons of the light and back to the detector; [0101]; [0114], optical channels of the waveguide assembly as in figures 5-7)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical measurement system with light source, detector and waveguide of Katnani and Nahman to incorporate the waveguide with multiple channels including a central reflector as taught by Nahman because the use of a plurality of measured channels enables localization of signals from a target region of interest (Nahman, [0021]). This leads to higher quality diagnostics and improved clinical outcomes.
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Katnani, in view of Nahman as applied to claims 1 or 13 above, and further in view of Kappel et al. (U.S. Pub. No. 20190187254) hereinafter Kappel.
Regarding claim 3, the combined references of Katnani and Nahman teach all of the limitations of claim 1. Primary reference Katnani further teaches:
wherein the reference detector is substantially identical to the plurality of detectors ([0026]-[0027], reference photon detection by the at least one photodetector, wherein the photodetector of a plurality of detectors forms a teaching to a reference detector as claimed; [0118]-[0124], reference photons received by detector 1210 of figure 12 forms a teaching to the detector being a reference detector as claimed, with arrival times of reference photons incorporated into the measured histogram; [0126]-[0131], reference photons detected by detector 1210, teaches to the reference detector; [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S; [0145]; [0146], arrival times; [0147]-[0154], arrival time of photons; [0159])
Primary reference Katnani further fails to teach:
and shielded from the target photons
However, the analogous art of Kappel of an optical sensor module for time-of-flight measurements (abstract) teaches:
and shielded from the target photons ([0029], “The reference path and the reference detector may thus be located outside the first chamber and shielded from stray light due to the encircling material” the stray light forms a teaching to all non-reference light which would include the target photons in the combined prior art invention).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source and detector photon measurement system of Katnani and Nahman to incorporate the shielded reference detector as taught by Kappel because shielding a detector from stray light reduces the noise received by the detector and increases the output measurement quality, leading to improved diagnostic data (see Kappel, [0029]).
Regarding claim 15, the combined references of Katnani and Nahman teach all of the limitations of claim 13. Primary reference Katnani further teaches:
wherein the reference detector is substantially identical to the plurality of detectors ([0026]-[0027], reference photon detection by the at least one photodetector, wherein the photodetector of a plurality of detectors forms a teaching to a reference detector as claimed; [0118]-[0124], reference photons received by detector 1210 of figure 12 forms a teaching to the detector being a reference detector as claimed, with arrival times of reference photons incorporated into the measured histogram; [0126]-[0131], reference photons detected by detector 1210, teaches to the reference detector; [0136]-[0144] and histogram 1702, with temporal distribution of reference photons 1212-R and signal photons 1212-S; [0145]; [0146], arrival times; [0147]-[0154], arrival time of photons; [0159])
Primary reference Katnani further fails to teach:
and shielded from the target photons
However, the analogous art of Kappel of an optical sensor module for time-of-flight measurements (abstract) teaches:
and shielded from the target photons ([0029], “The reference path and the reference detector may thus be located outside the first chamber and shielded from stray light due to the encircling material” the stray light forms a teaching to all non-reference light which would include the target photons in the combined prior art invention).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source and detector photon measurement system of Katnani and Nahman to incorporate the shielded reference detector as taught by Kappel because shielding a detector from stray light reduces the noise received by the detector and increases the output measurement quality, leading to improved diagnostic data (see Kappel, [0029]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Katnani, in view of Nahman as applied to claim 1 above, and further in view of Lee et al. (U.S. Pub. No. 20190083010) hereinafter Lee.
Regarding claim 4, the combined references of Katnani and Nahman teach all of the limitations of claim 1. Primary reference Katnani further teaches:
wherein: the module comprises an additional light source configured to emit light directed at the target ([0082], second light source 804-2; [0085]-[0088]); and
Primary reference Katnani further fails to teach:
the light source and the additional light source are positioned equidistant from the reference detector
However, the analogous art of Lee of a bio-signal detecting apparatus using light sources and detectors (abstract) teaches:
the light source and the additional light source are positioned equidistant from the reference detector ([0094]-[0095],” sequentially activate the light sources positioned at equal distances from any one detector, and may generate the reference signal for each reference distance based on the detected optical signal”, these multiple light sources form equidistant positions from the determined detector serving as the reference detector; see also [0052]-[0053], which teach to the plurality of light sources 121 and 122, which include equidistant positioning to a particular detection module; [0111]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source and detector photon measurement system of Katnani and Nahman to incorporate the equidistant positioning of a light source from the detector position as taught by Lee because the equal spacing of light sources from a detector provide for a controllable variable of light transmission between each source, which enables comparable data at the detector module. This enables higher quality signal processing compared to randomly positioned components, leading to improved clinical diagnostic outcomes (see Lee, [0005]; [0094]-[0095]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Katnani, in view of Nahman as applied to claim 1 above, and further in view of Gable et al. (U.S. Pub. No. 20120232362) hereinafter Gable.
Regarding claim 6, the combined references of Katnani and Nahman teach all of the limitations of claim 1. Primary reference Katnani further fails to teach:
further comprising:
an enclosure configured for the reference detector
an aperture in a wall of the enclosure configured to allow the light reflected within the module to reach the reference detector
However, the analogous art of Gable of an optical bodily fluid measurement apparatus (abstract) teaches:
further comprising:
an enclosure configured for the reference detector ([0232]-[0233], detector housing 172 forms an enclosure for the reference detector); and
an aperture in a wall of the enclosure configured to allow the light reflected within the module to reach the reference detector ([0232]-[0233], aperture 172c allows the reference beam to advance into the chamber and to the reference detector).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source and detector photon measurement system of Katnani and Nahman to incorporate the reference detector housing with aperture for beam transmission as taught by Gable because it reduces the potential stray light noise added to the reference detection, leading to higher quality signal processing and detection output (see also Gable, [0232]-[0233]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Katnani, in view of Nahman, in further view of Gable as applied to claim 6 above, and further in view of Baltz et al. (U.S. Pub. No. 20160139046) hereinafter Baltz.
Regarding claim 7, the combined references of Katnani, Nahman and Gable teach all of the limitations of claim 6. Primary reference Katnani further fails to teach:
wherein the aperture is configured to be adjustable to control an amount of the light reflected within the module to reach the reference detector
However, the analogous art of Baltz of an optical sensing system for measuring the optical qualities of a medium (abstract) teaches:
wherein the aperture is configured to be adjustable to control an amount of the light reflected within the module to reach the reference detector ([0017]-[0018], “The aperture in front of the reference photodiode is another variable that can be adjusted to either increase or decrease the amount of light that comes to the reference detector”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source and detector photon measurement system of Katnani, Nahman and Gable to incorporate the adjustable aperture as taught by Baltz because it avoids use of another loose component and the aperture can be adjusted so that the trans-impedance gains of each amplifier are made the same (Baltz, [0018]). This increases signal quality and leads to improved accuracy of outputs.
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Katnani, in view of Nahman as applied to claims 9 or 17 above, and further in view of Parsa et al. (U.S. Pub. No. 20220413143) hereinafter Parsa.
Regarding claim 10, the combined references of Katnani and Nahman teach all of the limitations of claim 9. Primary reference Katnani further fails to teach:
wherein the optical element comprises a facet configured to reflect the light
However, the analogous art of Parsa of a light detection sensor for sampling tissue (abstract) teaches:
wherein the optical element comprises a facet configured to reflect the light ([0179], launch facet; [0190], “for example a facet” with the receive waveguide).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source and detector photon measurement system of Katnani and Nahman to incorporate the facet configured to reflect the light in combination with a waveguide as taught by Parsa because using the launch facet to receive the received backscattered light may have the advantage of increasing the extent to which the illuminated volume coincides with the sampled volume and simplifies the emission and collection optics (Parsa, [0179]).
Regarding claim 18, the combined references of Katnani and Nahman teach all of the limitations of claim 17. Primary reference Katnani further fails to teach:
wherein the optical element comprises a facet configured to reflect the light
However, the analogous art of Parsa of a light detection sensor for sampling tissue (abstract) teaches:
wherein the optical element comprises a facet configured to reflect the light ([0179], launch facet; [0190], “for example a facet” with the receive waveguide).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source and detector photon measurement system of Katnani and Nahman to incorporate the facet configured to reflect the light in combination with a waveguide as taught by Parsa because using the launch facet to receive the received backscattered light may have the advantage of increasing the extent to which the illuminated volume coincides with the sampled volume and simplifies the emission and collection optics (Parsa, [0179]).
Claims 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Katnani, in view of Nahman as applied to claims 9 or 17 above, and further in view of Swanson et al. (U.S. Pub. No. 20190212761) hereinafter Swanson.
Regarding claim 11, the combined references of Katnani and Nahman teach all of the limitations of claim 9. Primary reference Katnani further fails to teach:
wherein the optical element comprises a beam splitter configured to partially reflect the light
However, the analogous art of Swanson of an optical probe for measuring light reflections within tissue regions of interest (abstract) teaches:
wherein the optical element comprises a beam splitter configured to partially reflect the light ([0059], figure 4, beam splitter 426, partially reflects x polarized and y polarized light towards the detector arrays from the reference path 408).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source and detector photon measurement system of Katnani and Nahman to incorporate the beam splitter as taught by Swanson because it provides for differentiation between polarizations of the light, which enable an additional signal feature of the reflected light to provide for processing of detected data (Swanson [0058]-[0059]). This increases the overall signal detection quality.
Regarding claim 19, the combined references of Katnani and Nahman teach all of the limitations of claim 17. Primary reference Katnani further fails to teach:
wherein the optical element comprises a beam splitter configured to partially reflect the light
However, the analogous art of Swanson of an optical probe for measuring light reflections within tissue regions of interest (abstract) teaches:
wherein the optical element comprises a beam splitter configured to partially reflect the light ([0059], figure 4, beam splitter 426, partially reflects x polarized and y polarized light towards the detector arrays from the reference path 408).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light source and detector photon measurement system of Katnani and Nahman to incorporate the beam splitter as taught by Swanson because it provides for differentiation between polarizations of the light, which enable an additional signal feature of the reflected light to provide for processing of detected data (Swanson [0058]-[0059]). This increases the overall signal detection quality.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The claims are currently rejected as indicated above, and thus are not currently in condition for allowance.
Claim 5 contains subject matter similar to the parent case, issued patent U.S. Pat. No. 12,502,079, independent claims. The claims are otherwise similar in scope and contain the subject matter found allowable in the parent application, in that they include features such as detecting an instrument response function with a module including stacked components on multiple layers. The claims as a whole form a nonobvious combination of features that differentiate from the closest prior art references, in light of the similar features to the parent case.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zilkie et al. (U.S. Pub. No. 20220370010) teaches to an optical sensing module for wearable devices that includes the use of reflected light beams off of sampled regions of interest to an array of detectors.
Chung et al. (U.S. Pub. No. 20190246963) teaches to an optical sensor module for medical diagnostic measurements that includes a reference receiver (see receiver 222 configured to measure reference light 320, in figure 3A-3E).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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