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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4,6-12,14-17, and 19-26, 28-30 in the reply filed on 5/15/2026 is acknowledged.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: photodetection system in claims 1-4, 6-12, 14-17, 19-20, 23-26, and 28-30; and illumination system in claims 24-26 and 28-30. Note that claims 21-22 have sufficient structure (e.g. an array of single photon detectors) so that they don’t invoke 112f.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-12, 14-17, and 19-26, 28-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 reads, “the body” in line 4, where there hasn’t been a body previously mentioned. It’s unclear whether this refers to any body or to the body of the person wearing the device. This lack of clarity causes the scope of the claim to be indefinite. For the sake of examination, it will be interpreted as referring to the body of the person wearing the device.
Claim 1 reads, “wherein the optical measurement system comprises a first reference optical path between the light source and photodetection system to couple at least a portion of the beam to the photodetection system to provide a first reference signal.” However, there is no mention of any other path, therefore it’s not clear whether this is an implicit, different path, corresponding to a sample path, or whether it only requires a single path, the reference path (e.g. the illumination of the target area and the detection of scattered light from the target light can be according to the same path). This lack of clarity causes the scope of the claim to be indefinite.
Regarding claims 2-4, 6, 8, 10, 11-12, 14-17, 21, 26, and 30 the phrase "optionally or preferably," renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For the sake of examination, the limitations following the phrase are not considered part of the claimed invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ban (Kernel Flow: A high channel count scalable TD-fNIRS system; cited by Applicant).
Regarding claim 24¸Ban teaches a method of performing standardised time domain diffuse optical spectroscopy (section 2.1.3 and 2.2) in a wearable device (page 13 and figure 1) comprising an optical measurement system configured to perform time domain diffuse optical spectroscopy, the optical measurement system comprising an illumination system (section 2.1.2) and a photodetection system (section 2.1.3 and 2.2; page 13 and figure 1), the method comprising:
measuring a time of flight (ToF) distribution for photons detected in response to a pulsed or modulated beam of light being directed towards a target region of the body (section 1, paragraph 1; section 2.1.3; page 12);
measuring the IRF in response to a pulsed or modulated beam of light being directed towards a photodetection system along a reference optical path without interacting with the target region (page 12; section 2.2; it interacts with the phantom not the body; for pulses also, see page 4; for modulated, see pencil laser beam).
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Claim Rejections - 35 USC § 102/103
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25-26 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Ban or, in the alternative, under 35 U.S.C. 103 as obvious over Ban, as applied to claim 24, above further in view of Wabnitz (Performance assessment of time-domain optical brain imagers).
Regarding claim 25, Ban teaches the method comprises
measuring a ToF distribution for photons detected in response to a pulsed or modulated beam of light being directed towards a tissue mimicking phantom located in the same or a different reference optical path (figure 11; for more details see Section 2 of Wabnitz, which Ban describes [see Ban, page 7] as providing more details of the experimental setup; for distribution, also see both histogram of flight times and distribution of flight times);
extracting one or more optical properties of the phantom from the shape of the measured ToF distribution by comparison to a model ToF curve derived from a theoretical diffusive media model convolved with the measured IRF (page 9); and
determining, based on a comparison of the extracted one or more optical properties with known optical properties of the phantom, a calibration factor to apply to the one or more optical properties extracted from the shape of the ToF distribution measured from the target region (pages 7 and 9-10).
For the reasons given above, the examiner considers Ban as anticipating the claim. Alternatively, if one were to consider measuring a ToF distribution for photons to be a different embodiment from the extracting and determining based on the phantom, then Wabnitz is also directed to time domain optical spectroscopy and teaches measuring a ToF distribution for photons detected in response to a pulsed or modulated beam of light being directed towards a tissue mimicking phantom located in the same or a different reference optical path (Section 2 of Wabnitz; for distribution, also see both histogram of flight times and distribution of flight time). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ban such that it comprises measuring a ToF distribution for photons detected in response to a pulsed or modulated beam of light being directed towards a tissue mimicking phantom located in the same or a different reference optical path (see the teaching of Wabiin order to have the most accurate possible data based on calibrating and correcting the measurements using the same experimental conditions (such as a pulsed light source) when using the calibrating phantom.
Regarding claim 26, the above combination comprises (citations are to Ban):
extracting a CW measurement signal from the measured ToF distribution from the target region by summing all or a part of the measured ToF distribution from the target region, the CW measurement signal representing an amount of scattered light detected (page 16);
measuring a series of ToF distributions over a period of time and extracting a timecourse of the CW measurement signal in response to a pulsed or modulated beam of light being directed to the target region (pages 16-17);
determining one or more optical biomarker values based, at least in part, on an optical property of the target region extracted from the measured timecourse (pages 17-18; for optical property, also see table 1 and first paragraph of page 10); and
applying a correction factor to the measured timecourse and/or the one or more optical biomarker values based, at least in part, on one or more static and/or dynamic optical properties extracted from the ToF measurements (implicit in page 11 and averaging on pages 18-18).
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ban as applied to claim 24 above, and further in view of Re (Effect of a thin superficial layer on the estimate of hemodynamic changes in a two-layer medium by time domain NIRS).
Regarding claim 28, Ban doesn’t explicitly teach detecting the presence of and/or determining one or more optical properties of a superficial layer of the target region based on the attenuation and/or shape of the measured ToF distribution.
Like Ban (and like the instant application), Re is directed to time domain spectroscopy and teaches detecting the presence of and/or determining one or more optical properties of a superficial layer of the target region based on the attenuation and/or shape of the measured ToF distribution (abstract and pages 1-4).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ban such that the method comprises detecting the presence of and/or determining one or more optical properties of a superficial layer of the target region based on the attenuation and/or shape of the measured ToF distribution in order to obtain more accurate results by distinguishing the effects of the superficial layer from the effects of the deeper layers.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Ban and Re as applied to claim 28 above, and further in view of Lacerenza (A wearable time domain near infrared spectroscopy system).
Regarding claim 29, the above combination comprises measuring a series of ToF distributions over a period of time (see citations above).
The above combination doesn’t explicitly teach detecting a motion artefact in at least one of the ToF distributions based on dynamic changes in the determined one or more optical properties of the superficial layer.
Like the above combination (and like the instant application), Lacerenza is directed to a time domain spectroscopy system and teaches measuring a series of ToF distributions over a period of time; detecting a motion artefact in at least one of the ToF distributions based on dynamic changes in the determined one or more optical properties of the superficial layer (page 4 and figure 4; as explained on page 4, the determination of the degree of artefacts is based on a property of the change in hemoglobin over a series of times).
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Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Ban as applied to claim 24 above, and further in view Cochran (Hybrid time-domain and continuous wave diffuse optical tomography instrument with…).
Regarding clam 30, Ban teaches the optical measurement system is further configured to perform diffuse optical spectroscopy in a hardware mode, the method comprising: operating the optical measurement system in a mode; measuring a timecourse of the amount of scattered light detected from the target region in response to a beam of light being directed to the target region (pages 16-17); determining one or more optical biomarker values based, at least in part, on an optical property of the target region extracted from the measured timecourse (pages 17-18; for optical property, also see table 1 and first paragraph of page 10); and applying a correction factor to the one or more optical biomarker values based, at least in part, on one or more static and/or dynamic optical properties determined in the ToF measurement mode (implicit in page 11 and averaging on pages 18-18).
Ban doesn’t explicitly teach the above embodiment also features continuous wave mode
Like Ban (and like the instant application), Cochran is directed to a time domain spectroscopy on the human body and teaches the optical measurement system is further configured to perform continuous wave (CW) diffuse optical spectroscopy in a hardware CW mode, the method comprising: operating the optical measurement system in a CW mode in the same device that also operates the time domain mode (page 1; section 3) ; measuring a timecourse of the amount of scattered light detected from the target region in response to a continuous beam of light being directed to the target region (page 2); determining one or more optical biomarker values based, at least in part, on an optical property of the target region extracted from the measured timecourse (page 2). Additionally, Cochran teaches this provides the benefit of permitting both absolute assignment of tissue optical properties and rapid measurements (page 1).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such it combines TD and CW modes, or in other words, such that the optical measurement system is further configured to perform continuous wave (CW) diffuse optical spectroscopy in a hardware CW mode, the method comprising: operating the optical measurement system in a CW mode in the same device that also operates the time domain mode; measuring a timecourse of the amount of scattered light detected from the target region in response to a continuous beam of light being directed to the target region; determining one or more optical biomarker values based, at least in part, on an optical property of the target region extracted from the measured timecourse – in order to permit both absolute assignment of tissue optical properties and rapid measurements.
Claims 1-4, 6-8, 17, 20-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ban in view of Lacerenza.
Regarding claim 1¸Ban teaches a wearable device (page 13 and figure 1) configured to perform standardised time domain diffuse optical spectroscopy (section 2.1.3 and 2.2), comprising:
an optical measurement system including an illumination system with a light source (section 2.1.2) configured to illuminate a target region of the body, at an injection point, with a pulsed or modulated beam of light thereby producing scattered light from the interaction of the light beam with the target region (section 1, paragraph 1; section 2.1.3; page 12), a photodetection system configured to detect scattered light exiting the target region at a distance from the injection point and provide a measurement signal (section 2.1.3 and 2.2; page 13 and figure 1), and a processing circuit in communication with the illumination system and the photodetection system for time of flight (ToF) data acquisition (section 1, paragraph 1; section 2.1.3; page 12), wherein the optical measurement system comprises a first reference optical path between the light source and photodetection system to couple at least a portion of the beam to the photodetection system to provide a first reference signal, wherein the first reference optical path comprises a tissue mimicking phantom with one or more known optical properties (figure 11 and page 7), wherein the processing circuit is configured to:
measure a ToF distribution for photons detected in response to the light beam being directed towards the target region (section 1, paragraph 1; section 2.1.3; page 12);
determine one or more optical properties of the target region from measured ToF distribution (table 1 and first paragraph of page 10) ;
measure a ToF distribution for photons detected in response to the at least a portion of the light beam being directed towards the phantom along the first reference optical path (figure 11; for more details see Section 2 of Wabnitz, which Ban describes [see Ban, page 7] as providing more details of the experimental setup, as explained with reference to claim 25 above; for distribution, also see both histogram of flight times and distribution of flight times);
determine one or more calibration factors for use in determining the one or more optical properties of the target region (pages 7 and 9-10); and
determine one or more optical biomarker values based, at least in part, on the one or more optical properties of the target region (pages 17-18; for optical property, also see table 1 and first paragraph of page 10).
Ban doesn’t explicitly teach the reference optical path uses the beam from the light source.
Like Ban (and like the instant application), Lacerenza is directed to a time domain spectroscopy system and teaches an optical measurement system including an illumination system with a light source configured to illuminate a target region of the body (the arm in figure 4, when the phantom is not in place), at an injection point, with a pulsed or modulated beam of light (section 2.1) thereby producing scattered light from the interaction of the light beam with the target region (the arm in figure 4, when the phantom is not in place), a photodetection system configured to detect scattered light exiting the target region at a distance from the injection point and provide a measurement signal (figure 4), and a processing circuit in communication with the illumination system and the photodetection system for time of flight (ToF) data acquisition (section 2.2), wherein the optical measurement system comprises a first reference optical path between the light source and photodetection system to couple at least a portion of the beam to the photodetection system to provide a first reference signal (figure 4, the path where the signal is detected from the phantom), wherein the first reference optical path comprises a tissue mimicking phantom with one or more known optical properties (figure 4), wherein the processing circuit is configured to:
measure a ToF distribution for photons detected in response to the light beam being directed towards the target region (first paragraph of section 3; section 3.1 and 3.2);
determine one or more optical properties of the target region from measured ToF distribution (first paragraph of section 3; section 3.1 and 3.2);
measure a ToF distribution for photons detected in response to the at least a portion of the light beam being directed towards the phantom along the first reference optical path (section 3.3);
determine one or more optical biomarker values based, at least in part, on the one or more optical properties of the target region (figure 2; and section 3.1 and 3.2).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ban such that the reference optical path, including the phantom, uses the same light source and light detector that is used to measure the target area in order to ensure that the calibration is as precise as possible by limiting differences between the target measurement and reference measurement, and also provide indications of potential problems with the measuring results such as motion artifacts (see section 3 of Lacernza).
Regarding claim 2¸Ban teaches the processing circuit is configured to: extract one or more optical properties of the phantom from the shape of the measured ToF distribution (page 9); and determine, based on a comparison of the extracted one or more optical properties with the known optical properties of the phantom, a first calibration factor to apply to one or more optical properties extracted from the shape of the ToF distribution measured from the target region (pages 7 and 9-10; also see the discussion with respect to claim 25, above).
Regarding claim 3¸Ban teaches the processing circuit is further configured to:extract the instrument response function (IRF) from the measured ToF distribution of photons detected from the phantom based at least in part on the known optical properties of the phantom (page 12; section 2.2; it interacts with the phantom not the body; for pulses also, see page 4; for modulated, see pencil laser beam);store the extracted IRF (implicit in the cited section).
Regarding claim 4¸Ban teaches the optical measurement system is configured to operate in a measurement mode in which the ToF distribution of photons detected from the target region is measured, and a first reference mode in which the ToF distribution of photons detected from the phantom is measured (since it measures the phantom at one time and the target at a different time).
Regarding claim 6¸Ban teaches the optical measurement system comprises a second reference optical path (where the second reference optical path is the same as the first reference path)between the illumination system and photodetection system to couple at least a portion of the light beam directly (in the same sense of applicant’s instant application, which reads, “directly to the detector, so that the signal does not travel inside the target region,” as it does not go to the target region when measuring the IRF) to the photodetection system and provide a second reference signal, and wherein the processing circuit is further configured to:measure the IRF for photons detected in response to the at least a portion of the light beam being directed towards the photodetection system along the second reference optical path (page 12; section 2.2; it interacts with the phantom not the body; for pulses also, see page 4; for modulated, see pencil laser beam); andstore the measured IRF (implicit in the cited sections).
Regarding claim 7¸Ban teaches the processing circuit is further configured to:extract the one or more optical properties of the target region from the shape of the measured ToF distribution by comparison to a model ToF curve derived from a theoretical diffusive media model convolved with the stored IRF; and/or determine, based on the stored IRF, a second calibration factor to apply to the ToF distribution to correct for drift in the optical measurement system for use in determining an overall attenuation of light by the target region (page 9, first paragraph; table 1; section 2.2).
Regarding claim 8¸Ban teaches the optical measurement system is configured to operate in a measurement mode in which the ToF distribution of photons detected from the target region is measured, and a second reference mode in which the IRF is measured (section 2).
Regarding claim 17, in the above combination the processing circuit is configured to measure a series of ToF distributions over a period of time to monitor the one or more optical biomarker values; anddetect a motion artefact in at least one of the ToF distributions based on dynamic changes in the shape and/or attenuation of the ToFdistributions (Lacernza: page 4 and figure 4; as explained on page 4, the determination of the degree of artefacts is based on a property of the change in hemoglobin over a series of times; also see citations above).
Regarding claim 20¸Ban teaches the one or more optical biomarkers are selected from the group comprising: tissue oxygen saturation, arterial oxygen saturation, oxy-haemoglobin, deoxy- haemoglobin, lipid, water, collagen, hydration, glucose, melanin, thyrosine,thyroglobulin, cytochrome c-oxidise, carboxy-haemoglobin, methe-haemoglobin (pages 16-18).
Regarding claim 21¸Ban teaches the photodetection system comprises an array of single photon detectors and wherein the processing circuit comprises a plurality of time-to-digital converters (TDC), each TDC coupled to a respective one or group of single photon detectors in the array, wherein the array of single photon detectors is divided into two or more segments each comprising a subgroup of single photon detectors and the outputs of the or each TDC associated with a respective segment or subgroup are coupled together (pages 1 and 5),wherein the optical measurement system is configured to couple scattered light exiting the target region to a first segment of the array to provide the measurement signal, and to couple the at least a portion of the light beam directed along the first reference optical path comprising the tissue mimicking phantom to a second segment of the array to provide the first reference signal (where the first and second segment may be the same or different), and wherein the processing circuit is configured to:determine a ToF of photons detected at each single photon detector in a respective segment based, at least in part, on the coupled output of the or each TDC associated with that segment; andgenerate, for each segment, a ToF distribution of the sum of photons detected by the subgroup of single photon detectors in the respective segment accumulated over a plurality of light pulses (pages 1 and 5).
Regarding claim 23¸Ban teaches the determined one or more optical biomarker values include tissue oxygen saturation, arterial oxygen saturation, oxy-haemoglobin, and deoxy-haemoglobin (pages 1 and 5).
The above combination suggests but doesn’t explicitly teach the wearable device is or comprises a pulse oximeter (suggested because it uses pulsed light to measure oxygen hemoglobin in the body). Additionally, Official Notice is taken that it is well known in the art of optical measuring and testing for wearable devices to be or to comprise a pulse oximeter. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the wearable device of the above combination comprise a pulse oximeter in order to provide a full characterization of the oxygen saturation in the body
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ban and Lacerne as applied to claim 1 above, and further in view Cochran.
Regarding clam 10, Ban teaches the optical measurement system is further configured to perform diffuse optical spectroscopy in a hardware mode, the method comprising: operating the optical measurement system in a mode; measuring a timecourse of the amount of scattered light detected from the target region in response to a beam of light being directed to the target region (pages 16-17); determining one or more optical biomarker values based, at least in part, on an optical property of the target region extracted from the measured timecourse (pages 17-18; for optical property, also see table 1 and first paragraph of page 10); and applying a correction factor to the one or more optical biomarker values based, at least in part, on one or more static and/or dynamic optical properties determined in the ToF measurement mode (implicit in page 11 and averaging on pages 18-18).
Ban doesn’t explicitly teach the above embodiment also features continuous wave mode
Like Ban (and like the instant application), Cochran is directed to a time domain spectroscopy on the human body and teaches the optical measurement system is further configured to perform continuous wave (CW) diffuse optical spectroscopy in a hardware CW mode, the method comprising: operating the optical measurement system in a CW mode in the same device that also operates the time domain mode (page 1; section 3) ; measuring a timecourse of the amount of scattered light detected from the target region in response to a continuous beam of light being directed to the target region (page 2); determining one or more optical biomarker values based, at least in part, on an optical property of the target region extracted from the measured timecourse (page 2). Additionally, Cochran teaches this provides the benefit of permitting both absolute assignment of tissue optical properties and rapid measurements (page 1).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such it combines TD and CW modes, or in other words, such wherein the optical measurement system is configured to perform ToF measurements and continuous wave (CW) measurements of scattered light, wherein the optical measurement system comprises a ToOF measurement mode for ToF measurements of scattered light, and one of a hardware CW measurement mode for CW measurements of scattered light and a software CW measurement mode in which the processing circuit is configured extract a CW measurement signal representing the amount of scattered light from the measured ToF distribution by summing all or a part of the measured ToF distribution,wherein, in the software or hardware CW measurement mode, the processing circuit is configured to:measure a timecourse of the amount of scattered light detected from the target region in response to the continuous beam of light being directed to the target region;determine one or more optical biomarker values based, at least in part, on an optical property of the target region extracted from the measured timecourse; and apply a correction factor to the measured timecourse and/or the one or more optical biomarker values based, at least in part, on one or more static and/or dynamic optical properties or optical biomarker values determined in the ToF measurement mode, optionally or preferably, derived from an optical biomarker value of a superficial layer of the target region determined in the ToF measurement mode – in order to permit both absolute assignment of tissue optical properties and rapid measurements.
Claims 11-12, 14-16, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ban and Lacerenza as applied to claim 1 above, and further in view of Re.
Regarding claim 11, Ban doesn’t explicitly teach the processing circuit is configured to determine the presence of and/or one or more optical properties of a superficial layer of the target region based on the attenuation and/or shape of the measured ToFdistribution.
Like Ban (and like the instant application), Re is directed to time domain spectroscopy and teaches detecting the presence of and/or determining one or more optical properties of a superficial layer of the target region based on the attenuation and/or shape of the measured ToF distribution (abstract and pages 1-4).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ban such that the processing circuit is configured to determine the presence of and/or one or more optical properties of a superficial layer of the target region based on the attenuation and/or shape of the measured ToFdistribution in order to obtain more accurate results by distinguishing the effects of the superficial layer from the effects of the deeper layers.
Regarding claim 12, the above combination suggests the processing circuit is configured to:determine an overall attenuation of photons by the target region based on a comparison of the integrated photon count of the measured ToF distribution and the output of the light source;determine an effective attenuation of photons by the target region based on one or more optical properties of the target region extracted from the shape of the measured ToF distribution; anddetermine the presence of and/or the one or more optical properties of a superficial layer of the target region based on a comparison of the overall attenuation with the effective attenuation (suggested since the attenuation in Re corresponds to the reduced scattering coefficient and absorption described in Re).
Regarding claim 14, in the above combination the light source is configured to provide a pulsed or modulated beam of light at a plurality of different wavelengths, and the processing circuit is configured to:control the light source to illuminate the target region with a pulsed or modulated beam of light at a plurality of different wavelengths;measure, for each respective wavelength, a ToF distribution of detected photons; anddetermine the presence of and/or one or more static or dynamic optical properties of a superficial layer of the target region based on analysis of the attenuation and/or shape of the measured ToF distribution at each wavelength (Re, pages 1-6).
Regarding claim 15, in the above combination the processing circuit is configured to determine an optical biomarker value of the superficial layer based, at least in part, on the determined one or more optical properties of the superficial layer (see the citations above).
Regarding claim 16, in the above combination the processing circuit is configured to determine the presence of and/or one or more optical properties of a superficial layer of the target region based on the attenuation and/or shape of the measured ToF distribution (Re: abstract and pages 1-4);the processing circuit is configured to determine an optical biomarker value of the superficial layer based, at least in part, on the determined one or more optical properties of the superficial layer; and wherein the correction factor is derived from an optical biomarker value of the superficial layer.
Regarding claim 22¸Ban teaches the optical measurement system comprises a second reference optical path (where the second reference optical path is the same as the first reference path)between the illumination system and photodetection system to couple at least a portion of the light beam directly (in the same sense of applicant’s instant application, which reads, “directly to the detector, so that the signal does not travel inside the target region,” as it does not go to the target region when measuring the IRF) to the photodetection system and provide a second reference signal, and wherein the processing circuit is further configured to:measure the IRF for photons detected in response to the at least a portion of the light beam being directed towards the photodetection system along the second reference optical path (page 12; section 2.2; it interacts with the phantom not the body; for pulses also, see page 4; for modulated, see pencil laser beam); andstore the measured IRF (implicit in the cited sections); and wherein the optical measurement system is configured to couple the at least a portion of the light beam directed along the second reference optical path to a third segment of the array to provide the second reference signal (where the third segment may or may not be the same as the first and second).
Allowable Subject Matter
Claims 9 and 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 9, the prior art of record (taken alone or in combination) fails to anticipate or render obvious, “an optical measurement system including an illumination system with a light source configured to illuminate a target region of the body, at an injection point, with a pulsed or modulated beam of light thereby producing scattered light from the interaction of the light beam with the target region, a photodetection system configured to detect scattered light exiting the target region at a distance from the injection point and provide a measurement signal, and a processing circuit in communication with the illumination system and the photodetection system for time of flight (ToF) data acquisition, wherein the optical measurement system comprises a first reference optical path between the light source and photodetection system to couple at least a portion of the beam to the photodetection system to provide a first reference signal, wherein the first reference optical path comprises a tissue mimicking phantom with one or more known optical properties, wherein the processing circuit is configured to:measure a ToF distribution for photons detected in response to the light beam being directed towards the target region;determine one or more optical properties of the target region from measured ToF distribution;measure a ToF distribution for photons detected in response to the at least a portion of the light beam being directed towards the phantom along the first reference optical path;determine one or more calibration factors for use in determining the one or more optical properties of the target region; anddetermine one or more optical biomarker values based, at least in part, on the one or more optical properties of the target region … wherein the first reference optical path comprises a delay line to temporally separate the first reference signal from the measurement signal and permit simultaneous measurement of the ToF distribution for the phantom and the ToF distribution for the target region,” in combination with the other claimed limitations.
Regarding claim 19, the prior art of record (taken alone or in combination) fails to anticipate or render obvious, “an optical measurement system including an illumination system with a light source configured to illuminate a target region of the body, at an injection point, with a pulsed or modulated beam of light thereby producing scattered light from the interaction of the light beam with the target region, a photodetection system configured to detect scattered light exiting the target region at a distance from the injection point and provide a measurement signal, and a processing circuit in communication with the illumination system and the photodetection system for time of flight (ToF) data acquisition, wherein the optical measurement system comprises a first reference optical path between the light source and photodetection system to couple at least a portion of the beam to the photodetection system to provide a first reference signal, wherein the first reference optical path comprises a tissue mimicking phantom with one or more known optical properties, wherein the processing circuit is configured to:measure a ToF distribution for photons detected in response to the light beam being directed towards the target region;determine one or more optical properties of the target region from measured ToF distribution;measure a ToF distribution for photons detected in response to the at least a portion of the light beam being directed towards the phantom along the first reference optical path;determine one or more calibration factors for use in determining the one or more optical properties of the target region; anddetermine one or more optical biomarker values based, at least in part, on the one or more optical properties of the target region … the processing circuit is configured to measure a series of ToF distributions over a period of time to monitor the one or more optical biomarker values; anddetect a motion artefact in at least one of the ToF distributions based on dynamic changes in the shape and/or attenuation of the ToFdistributions… the processing circuit is configured to measure a series of ToF distributions over a period of time to monitor the one or more optical biomarker values; anddetect a motion artefact in at least one of the ToF distributions based on dynamic changes in the shape and/or attenuation of the ToFdistributions… the processing circuit is configured to:detect a motion artefact in at least one of the ToF distribution based on a comparison of the shape of the rising portion of the measured ToF distribution with a model ToF distribution derived from a theoretical diffusive media model convolved with the IRF; andin response to detecting a motion artefact:extract the one or more optical properties of the target region from the shape of the tail portion of the ToF distribution; and/or compare the shape of the rising portion of the ToF distribution with a database of simulated motion artefacts, apply a correction to the model ToF curve based on a selected one of the simulated motion artefacts, and extract the one or more optical properties of the target region from the shape of the ToF distribution using the corrected model ToF distribution,” in combination with the other claimed limitations.
Additional Prior Art
US 20240023846 A1 discloses
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US 5386295 A reads, “The use of a standard in reference arm can also provide a correction for a drift in the exciting wavelength of the light source 28. “
“The reference can be a "standard", that is, a substance or configuration of substances that has an invariant composition with regard to the type of spectroscopy performed and can provide for a signal at appropriate wavelengths.”
“Gain correction can also be provided by the use of a standard for reference 16, as discussed above, rather than a reflective substrate or the like. “
“ Use of a standard for reference 16 permits correlation of changes in excitation frequency to correct for wavelength drift.”
US 2003/0095695 Reads, “The phantom samples run substantially along the torso of the patient, and the samples are included in each CT slice with simultaneous scanning.”
Conclusion
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/RUFUS L PHILLIPS/ Examiner, Art Unit 2877
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