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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 22, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on November 22, 2024 are accepted.
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 1-11, 13-15, 17-19, 21 and 24-25 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the term “light” in line 4, line 6 and line 8. It is unclear if they refer to the same. Proper antecedent basis or ordinal number is required. The same rejection applies to claim 24, lines 3, 4, and 7.
Claim 1 recites “interferometric optical detector” in lines 10-11, and “the optical detector” inline 13. Consistent claim language is required. The same rejection applies to claim 24.
Claim 1 recites in lines 18-19 “one or more identified pulses of blood flow” that render the scope of the claims indefinite. Since claim 1 does not present a step of identifying one or more pulses, it is unclear what “identified pulses” refers to. It is unclear whether the pulses are identified by the iNIRS system. Clarification is required. The same rejection applies to claim 24.
Claim 1 recites in lines 16-19 that the data indicative of the combined light signals is processed to determine an indication of intracranial blood pressure for the subject based on at least one property of a pulsatile waveform of one or more identified pulses of blood flow through the subject’s brain. It is under if the above underlined portion of the limitation is obtained from the iNIRS system, from the combined light signals, or it is data provided from somewhere else. Current claim language has no link between the combined light signals and the pulsatile waveform or the pulses of blood flow. Further there is no recitation that the pulses of blood flow is identified. Clarification is required. The same rejection applies to claim 24.
Claim 2 recites “one or more pulses of blood flow”. It is unclear if it refers to the same as the term “one or more identified pulses of blood flow” recited in claim 1, lines 18-19.
Claim 5 recites “one or more identified pulses”. It is unclear whether it refers to the same as the identical term recited in claim 1, lines 18-19. Further it is unclear whether it has any link to the term “one or more pulses” recited in claim 2.
Claim 6 recites “an identified critical closing pressure” that renders the scope of the claim indefinite. Since claim 6 and all its preceding claims do not cite a critical closing pressure is identified, it is unclear if the critical closing pressure is identified by the iNIRS system. Clarification is required.
Claim 7 recites “one or more identified pulses”. It is unclear whether it refers to the same as the identical term recited in claim 1, lines 18-19.
Claim 7, the term “the cerebral blood flow index” lacks proper antecedent basis.
Claim 9 recites “extracerebral blood flow index data”. It is unclear what the link is between this term and the term “extracerebral blood flow data” recites in claim 8 that claim 9 depends on.
Claim 10 recites “combined light signals”. It is unclear if it refers to the same as the identical term recited in claim 1, line 14.
Claim 11 recites “data associated with the subject’s brain”, and “data associated with the extracerebral region”. It is unclear what type of data it refers to.
Claim 13 recites “a plurality of optical detectors”. It is unclear whether these detectors refer to the “interferometric optical detector” recited in lines 10-11 of claim 1, or these are detectors in addition to the interferometric optical detector in claim 1.
Claim 14 recites “pulsatile waveforms of pulses of blood flow”. It is unclear if it refers to the same as the term “pulsatile waveform of one or more identified pulses” recited in lines 18-19 of claim 1.
Claim 15 recites “cerebral blood flow data”. It is unclear if it refer to the same as the identical term recited in claim 13.
Claim 15 recites an identical term “extracerebral blood flow data” in line 5 and line 7. It is unclear if they refer to the same. Proper antecedent basis or ordinal number is required.
Claim 17 recites “cerebral blood flow data” and “extracerebral blood flow data”. Each of the term has an identical term recited in claim 2. It is unclear whether they refer to the same. Proper antecedent basis or ordinal number is required.
Claim 18 recites “extracerebral blood flow data”. Claim 2 recites an identical term. It is unclear whether they refer to the same. Proper antecedent basis or ordinal number is required.
Claim 19 recites “ the one or more pulses” that lacks proper antecedent basis.
Claim 21 recites “the optical detector”. It is unclear whether it refer to the “interferometric optical detector”. Consistent claim language is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 7, 13-14 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Mohseni et al., US 2021/0341280 A1, hereinafter Mohseni, in view of Durduran et al., US 2020/0090819 A1, hereinafter Durduran.
Claims 1, 24 and 25. Mohesni teaches in FIGS. 3, 13, 15 and 17 a non-invasive intracranial pressure sensing apparatus (10) and method comprising
an interferometric near infrared spectroscopy, iNIRS, system, the iNIRS system ([0069]: the non-invasive optical detection systems described herein are interferometric in that these optical detection systems mix detected signal light against reference light in order to increase the signal-to-noise radio (SNR) of the signal light. These optical detection systems are described herein as, e/g/. being Near-Infrared Spectroscopy (iNIRS) system) comprising:
a light emitting arrangement (20) comprising:
a light source configured to emit light; a sample delivery channel coupled to the light source and arranged to be coupled to the subject's scalp to direct light from the light source towards the subject's brain tissue ([0154]: the wearable unit 150 comprises the optical source 20, interferometer 22, multi-channel optical detector chip 24, the output port 44a for emitting the sample light 34 generated by the optical source assembly 20 into the head 18 of the user 16); and
a reference channel coupled to the light source for receiving light therefrom ([0161]: the interferometer 22 (e.g., via the optical beam splitter 33) splits the source light 32 into the sample light 34 and the reference light 38 (step 206); FIG.3, the path 34);
a light detecting arrangement (24) configured to be coupled to the subject's scalp and the light emitting arrangement (FIG.3: the optical source assembly 20 and the multi-channel optical detector chip 24 are coupled),
the light detecting arrangement comprising an interferometric optical detector configured to receive: (i) reference light from the reference channel, and (ii) sample light from the subject's brain; wherein the optical detector is arranged to combine the sample light with the reference light to provide combined light signals comprising one or more components ([0161]: The interferometer 22 then delivers the sample light 34 into the brain 12 along a single detected optical path bundle 14, such that the sample light 34 is scattered by the brain 12, resulting in physiologically encoded signal light 36 that exits the brain 12 (step 208), and combines, during each of the measurement period(s), the physiologically-encoded signal light 36 and the reference light 38 into an interference light pattern 40 having a plurality of optical modes, with each optical mode having a plurality of oscillation frequency components; and FIG.13 illustrates how the light beam is emitted, split, then combined to be detected)
at a beat frequency between sample light and reference light - when two light beams of different frequencies are combined linearly, it results in the combined light beam having a beat frequency that has the average of the two original frequencies of the two beams as the primary frequency, with this primary frequency varying in a magnitude of the difference of the two original frequencies. This limitation is a feature that is resulted naturally when the reference light beam and the sample light beam are combined,
the sample light comprising light emitted from the light source ([0161]: the interferometer 22 (e.g., via the optical beam splitter 33) splits the source light 32 into the sample light 34 and the reference light 38 (step 206)); and wherein
the sensing apparatus comprises a controller (26, 28, 30) configured to process data indicative of the combined light signals ([0155]: the processor 30 is configured for processing the neural-encoded signal light 34 acquired by the wearable unit 150).
Mohseni does not teach that the light signal is processed to determine an indication of intracranial blood pressure for the subject based on at least one property of a pulsatile waveform of one or more identified pulses of blood flow through the subject's brain.
However, in an analogous iNIRS-based physiological monitoring field of endeavor, Durduran teaches
determine an indication of intracranial blood pressure for the subject based on at least one property of a pulsatile waveform of one or more identified pulses of blood flow through the subject’s brain ([0057]: techniques that may resolve the optical path length of detected photons and turn that into information about blood flow and tissue optical properties…interferometric near-infrared spectroscopy (iNIRS); and [0022]: non-invasive monitoring of pulsatile cerebral blood flow to analyze its pulse contour as an indicator for levels of intracranial pressure (ICP)).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus and the method of Mohseni employ such a feature associated with “determine an indication of intracranial blood pressure for the subject based on at least one property of a pulsatile waveform of one or more identified pulses of blood flow through the subject’s brain” as taught in Durduran for the advantage of detecting the intracranial pulsatile blood pressure as an alternative physiological parameter that the iNIR technology is capable of being operated to monitor.
In regard to claim 25, Mohseni further teaches
a non-transitory computer program product comprising computer program instructions configured to program a controller to control operation of a light emitting arrangement and a light detecting arrangement to perform the method of claim 24 ([0080]: any suitable memory can be used for computing device 26. The memory can be a type of computer-readable media, namely computer-readable storage media. Computer-readable storage media may include…non-transitory, removable, and non-removable media for storage of information such as computer readable instructions, data structures, program modules, or other data; and [0155]: the controller 28 is configured for controlling the operational functions of the wearable unit 150).
Claim 7. Durduran further teaches
obtain cerebral blood flow index data for blood flow through the subject's brain, and wherein the pulsatile waveform of one or more identified pulses of blood flow through the subject's brain comprises a pulsatile waveform for the cerebral blood flow index ([0007]: the method makes use of properties in the pulse contour, i.e., waveform, of pulsatile blood flow time series; [0020]: requires only pulsatile blood flow as a real-time input to a classification/regression algorithm in order to provide an index/value as a biomarker).
Claims 13 and 14. Mohseni further teaches that
the iNIRS system comprises a plurality of optical detectors ([0017]: the non-invasive optical detection system may further comprise an optical detector chip. The plurality of optical detectors, analog compression circuitry and digital compression circuitry are integrated).
Durduran further teaches that
each optical detector is configured to obtain cerebral blood flow data for the subject's brain; and determine the indication of intracranial blood pressure based on properties of pulsatile waveforms of pulses of blood flow through the subject's brain ([0022]: one application of the invention is the non-invasive monitoring of pulsatile cerebral blood flow to analyze its pulse contour as an indicator for levels of intracranial pressure (ICP))
Claims 2-5 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mohseni et al., US 2021.0341280 A1, hereinafter Mohseni, in view of Durduran et al., US 2020/0090819 A1, hereinafter Durduran, further in view of Sutin et al., US 2018/0070830 A1, hereinafter Sutin.
Claim 2. Durduran further teaches
obtaining cerebral blood flow data indicative of one or more pulses of blood flow through the subject's brain ([0022]: non-invasive monitoring of pulsatile cerebral blood flow to analyze its pulse contour as an indicator for levels of intracranial pressure (ICP)).
Neither Mohseni nor Durduran teaches obtain extracerebral blood flow data indicative of one or more pulses of blood flow through an extracerebral region of the subject's body.
However, in an analogous NIR-based pulsative blood pressure measurement field of endeavor, Sutin teaches
obtain extracerebral blood flow data indicative of one or more pulses of blood flow through an extracerebral region of the subject's body ([0142]: the method described herein ca utilize measurement at two, three, four, give, six, or more, up to n source-detector distances. Use of multiple source-detector distances can provide better discrimination between various different depths of measurement, such as between cerebral and extra-cerebral measurements; and [0163]: measurements at multiple distances facilitate the discrimination of cerebral parameters from the confounding effects of the scalp…These aspects also enable novel strategies for simultaneous TD and DCS, especially including two-layer fitting of TPSF and DCS to quantify cerebral and extra-cerebral optical properties and blood flow).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Mohseni and Durduran combined employ such a feature associated with “obtain extracerebral blood flow data indicative of one or more pulses of blood flow through an extracerebral region of the subject's body”, as taught in Sutin for the advantage of increase the sensitivity of the measurement of cerebral blood flow, as suggested in Sutin, [0143].
Claim 3. Mohseni, Durduran and Sutin combined teaches all the limitations of claim 2.
In regard to the claimed feature, as applied to claim 1, Mohseni and Durduran combined teaches using NIR optical signal-based blood flow data to determine intracranial blood flow (Durduran: [0057]), and as applied to claim 2, Sutin teaches that the NIR based optical signals comprise both the cerebral blood flow data and extracerebral blood flow data, when Mohseni, Durduran and Sutin are combined, it teaches that the intracranial blood pressure is determined or indicated based on both the cerebral blood flow data and the extracerebral blood flow data.
Claim 4. Durduran further teaches that
the extracerebral blood flow data contains an indication of blood pressure for the pulses of blood flow through the extracerebral region of the subject's body ([0021]: the pulsatile blood flow is altered by external factors, like…narrowing or blockage of the vessels as in cases such as plaque deposition, peripheral arterial disease or stroke) – as the pulsatile blood flow signal is altered by external factors, the alteration of the pulsatile blood flow signal indicates the presence of these external factors that are all associated with blood pressure. .
Claim 5. Durduran further teaches
determine the indication of intracranial blood pressure for the subject based on: (i) the pulsatile waveform of one or more identified pulses of blood flow through the subject's brain, and (ii) a corresponding pulsatile waveform for the blood pressure for one or more pulses of blood flow through the extracerebral region of the subject's body ([0021]: the pulsatile blood flow is altered by external factors, like pressure as in cases such as elevated ICP, narrowing or blockage of the vessels as in cases such as plaque deposition, peripheral arterial disease or stroke) – the factor of elevated ICP is considered the recited condition (i), and the rest of the factors are considered the recited condition (ii).
Claim 17. Mohseni, Durduran and Sutin combined teaches all the limitations of claim 2.
As applied to claim 1, Mohesni teaches the iNIRS system comprising a source-detector channel (Mohesni: FIG.3).
As applied to claim 2, Sutin teaches that the blood flow is measured in both the cerebral and extracerebral regions using up to n source-detector distances (Sutin: [0142]).
Sutin further teaches a multiple source configuration in FIG.3. The detector and each of the multiple sources are considered one source-detector channel.
As Sutin teaches measuring the blood flow in the cerebral region, the source-detector channel that is used to detect the blood flow in the cerebral region is considered the “cerebral source-detector channel” as claimed.
As Sutin also teaches measuring the blood flow in the extracerebral region, the source-detector channel that is used to detect the blood flow in the extracerebral region is considered the “extracerebral source-detector channel” as claimed.
Claim 18. As applied to claim 2, Sutin teaches that the blood flow is measured in both the cerebral and extracerebral regions using up to n source-detector distances (Sutin: [0142]).
Sutin further teaches a detector 314 in FIG.4.
As Sutin teaches that the blood flow in the extracerebral region is measured, the detector that is used to receive signal for being analyzed to derive the blood flow information in the extracerebral region is considered th “extracerebral blood flow sensor” as claimed.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mohseni et al., US 2021.0341280 A1, hereinafter Mohseni, in view of Durduran et al., US 2020/0090819 A1, hereinafter Durduran, further in view of Sutin et al., US 2018/0070830 A1, hereinafter Sutin, further in view of Sutin et al., US 2018/0103861, hereinafter Sutin ‘861.
Claim 6. Mohseni, Durduran and Sutin combined teaches all the limitations of claim 5.
Neither of Mohseni, Durduran and Sutin teaches “determine the indication of intracranial blood pressure for the subject based on an identified critical closing pressure for a blood vessel in the subject's brain”.
However, in an analogous intracranial pressure measurement field of endeavor, Sutin teaches
determine the indication of intracranial blood pressure for the subject based on an identified critical closing pressure for a blood vessel in the subject's brain ([0042]: the pressure-axis intercept in the pulsatile pressure-flow relationship curve, namely the critical closing or zero flow pressure (CrCP), is directly related to ICP; [0052]: the zero flow pressure quantifies the magnitude of ICP).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Mohseni, Durduran and Sutin combined employ such a feature associated with “determine the indication of intracranial blood pressure for the subject based on an identified critical closing pressure for a blood vessel in the subject's brain”, as taught in Sutin ‘861 for the advantage of “quantifying the magnitude of ICP”, as suggested in Sutin ‘861, [0052].
Claims 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mohseni et al., US 2021.0341280 A1, hereinafter Mohseni, in view of Durduran et al., US 2020/0090819 A1, hereinafter Durduran, further in view of Kholiqov et al., “Scanning interferometric near-infrared spectroscopy”. Opt Lett. 2022 January 01; 47(1):110-113, hereinafter Kholiqov.
Claim 8. Mohseni and Durduran combined teaches all the limitations of claim 1.
Neither Mohseni nor Durduran teaches “obtain the extracerebral blood flow data using the iNIRS system”.
However, in an analogous iNIRS-based human brain assessment field of endeavor, Kholiqov teaches
obtain the extracerebral blood flow data using the iNIRS system (p.6, last paragraph: Although iNIRS cannot eliminate extracerebral signals, Fig.4(a) suggests that the fine TOF relation of iNIRS may enable the separation of cerebral and extracerebral dynamics by model fitting).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Mohseni and Durduran combined employ such a feature of “obtain the extracerebral blood flow data using the iNIRS system”, as taught in Kholiqov for the advantage of “accurately characterizing superficial tissue to help improve specificity for the human brain”, as suggested in Kholiqov, Abstract.
Claim 21. Mohseni and Durduran combined teaches all the limitations of claim 1.
Neither Mohseni nor Durduran teaches “obtain time of flight data based on the combined light signals, wherein the time-of-flight data comprises a data surface containing a time-ordered series of time-of-flight distributions for photons of sample light reaching the optical detector from the light source”.
However, in an analogous iNIRS-based human brain assessment field of endeavor, Kholiqov teaches
obtain time of flight data based on the combined light signals, wherein the time-of-flight data comprises a data surface containing a time-ordered series of time-of-flight distributions for photons of sample light reaching the optical detector from the light source (p.2, ¶-2: iNIRS measures the TOF-resolved optical field autocorrelation after multipole scattering in tissue. When applied to the forehead, iNIRS recently suggested incipient brain sensitivity at TOFs of 500-600 ps. Here we further develop iNIRS for multi-dimensional TOF-resolved imaging of the human forehead) – the subsequent content discusses details in regard to the TOF feature.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus of Mohseni and Durduran combined employ such a feature of “obtain time of flight data based on the combined light signals, wherein the time of flight data comprises a data surface containing a time-ordered series of time of flight distributions for photons of sample light reaching the optical detector from the light source”, as taught in Kholiqov for the advantage of “accurately characterizing superficial tissue to help improve specificity for the human brain”, as suggested in Kholiqov, Abstract.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mohseni et al., US 2021.0341280 A1, hereinafter Mohseni, in view of Durduran et al., US 2020/0090819 A1, hereinafter Durduran, further in view of Eide et al., US 2007/0060836 A1, hereinafter Eide.
Claim 19. Mohseni and Durduran combined teaches all the limitations of claim 1.
As applied to claim 1, Durduran teaches “determine the indication of intracranial blood pressure based on at least one property of the one or more pulses of blood flow through the subject's brain ([0057]: techniques that may resolve the optical path length of detected photons and turn that into information about blood flow and tissue optical properties…interferometric near-infrared spectroscopy (iNIRS); and [0022]: non-invasive monitoring of pulsatile cerebral blood flow to analyze its pulse contour as an indicator for levels of intracranial pressure (ICP)).
Neither Mohseni or Durduran teaches that the property is a difference between diastolic and systolic values for the pulses.
However, in an analogous pulse pressure determination field of endeavor, Eide teaches
determine the property of the one or more pulses based on a difference between diastolic and systolic values for the one or more pulses ([0007]: the intracranial pressure wave…resemble the arterial blood pressure wave, that is characterized by a systolic rise followed by a diastolic decline and a dicrotic notch; and [0014]: with regard to a single pulse pressure waves, the invention provides measurement and analysis of the following parameters: …c) amplitude is defined as the pressure difference between the systolic maximum pressure and the diastolic minimum pressure during the series of increasing pressure of the single wave).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the apparatus and the method of Mohseni and Durduran combined employ such a feature associated with “determine the property of the one or more pulses based on a difference between diastolic and systolic values for the one or more pulses” as taught in Eide for the advantage of providing further details in regard to the pulse waves based on which the intracranial pressure is determined.
Allowable Subject Matter
Claims 9-11 and 15 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 limitations recited in claim 9 in regard to the features of “the iNIRS system is configured to obtain extracerebral blood flow index data, and wherein the controller is configured to process the extracerebral blood flow index data to obtain values for extracerebral blood pressure", are not taught or disclosed in the prior arts.
Dependent claims 10-11 are allowable at least by virtue of their respective dependency upon an allowable claim.
The limitations recited in claim 15 in regard to the features of “obtain extracerebral blood flow data for different extracerebral regions of the subject's body based on combined light signals associated with the different detectors ", in combination with other limitations recited in the claim, are not taught or disclosed in the prior arts.
Conclusion
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798