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 .
Examiner’s Note: Claim 16 is currently erroneously associated with a “Withdrawn” claim status in the claim set filed on 11/25/25. In order to expedite examination, it is assumed that the claim status for claim 16 should be “Currently Amended”. Applicant should provide the correct claim status in the next response.
Election/Restrictions
Claims 1-15 and 24-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/25.
Applicant’s election without traverse of Invention II, claims 16-23 [and new claims 30-34] in the reply filed on November 25, 2025 is acknowledged.
Claim Objections
Claims 32-33 are objected to because of the following informalities:
In claim 32, in line 2, --- plurality of --- should be inserted after “one of the”.
In claim 32, in line 3, --- the one or more --- should be inserted before “cerebral blood metrics”.
In claim 33, in line 1, --- plurality of --- should be inserted before “channels”.
Appropriate correction is required.
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.
Claim(s) 16-17, 19-22, 30 and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brake et al. (US Pub No. 2020/0386535) in view of Atsumori et al. (“Development of wearable optical topography system for mapping the prefrontal cortex activation”, April 2009) and Kastrup et al. (“Cerebral Blood Flow-Related Signal Changes during Breath-Holding”, August 1999), as evidenced by Kleiser et al. (“Course of Carotid Artery Occlusions with Impaired Cerebrovascular Reactivity”, 1992).
With regards to claim 16, Brake et al. disclose a system, the system comprising:
a plurality of light sources (i.e. “source fibers”) (paragraph [0159], referring to the iSVS system (2500), wherein “Non-contact source and detector fibers coupled to the third fiber coupler FC3 were mounted above the human subject forehead over the prefrontal cortex area”; paragraphs [0130]-[0131], referring to the iSVS system including one or more lasers that generate a laser beam; Figures 7, 25);
a plurality of light detectors (i.e. “detector fibers”) (paragraph [0159], referring to the iSVS system (2500), wherein “Non-contact source and detector fibers coupled to the third fiber coupler FC3 were mounted above the human subject forehead over the prefrontal cortex area”; paragraph [0133], referring to the “one or more sensors”; Figures 7, 25) and
one or more processors (paragraphs [0005]-[0006], [0106], [0134], referring to the one or more processors) configured to:
cause, using the plurality of light sources, light to be emitted into the head of the wearer (paragraph [0146], referring to the processor sending control signals to activate the lasers; paragraph [0127], referring to the forehead of a human subject being illuminated by the output beam from the fibers; paragraph [0169], referring to “Non-contact source and detector fibers coupled to the third fiber coupler FC3 were mounted above the human subject forehead over the prefrontal cortex area”; Figure 25);
obtain, using the plurality of light detectors, information indicative of light reflected from one or more structures within the head of the wearer, wherein a portion of the obtained information spans a time period during which the wearer was holding their breath (paragraphs [0169]-[0174], referring to the iSVS system collecting the diffused light from the forehead at various source-detector separations and recorded by the camera, wherein the mesurements were taken while the human subject (26) went through a breath-holding task; Figures 25, 30, 32, in particular, see Figure 30, wherein the signal is recorded during phases of normal breathing and breath holding); and
based on the obtained information, determine one or more cerebral blood metrics (i.e. cerebral blood flow) (paragraphs [0094]-[0095], referring to the interferometric speckle visibility spectroscopy (iSVS) methods and/or systems can perform interferometric measurements that enable sensitive, high-speed monitoring of blood flow dynamics, wherein the iSVS methods can be used to measure blood flow dynamics non-invasively using the dynamic properties of a captured optical field that has interacted with blood in a volume of interest; paragraphs [0104], [0130], referring to the complex amplitude and phase of the speckle field includes data at different locations that can represent contributions from different areas and path length distributions and can be used to extract more information from the sample, such as mapping the blood flow at different locations in the brain, indicating the activity of different parts of the brain; paragraphs [0170]-[0172], [174], referring to viewing rCBF changes due to the breath holding task; Figures 30-32).
However, though Brake et al. do disclose that the plurality of light sources and the plurality of light detectors are situated around the forehead of the subject (paragraphs [0127], [0169], see Figure 25), Brake et al. do not specifically disclose that the system further comprises a headband configured to encircle a head of the wearer of a headset, wherein the plurality of light sources and the plurality of light detectors are attached to the headband.
Further, though Brake et al. do disclose determining changes in blood flow (paragraph [0174]; Figures 30-32), Brake et al. do not specifically disclose that the one or more processors are further configured to determine a likelihood the wearer will experience a stroke over a predetermined future time period based on the one or more cerebral blood metrics.
Atsumori et al. disclose the development of a small, light and wearable optical topography (OT) system that covers the entire forehead in order to measure changes in the concentrations of oxy-Hb and deoxy-Hb in the prefrontal cortex, wherein the wearable system has advantages over conventional OT systems that use optical fibers to irradiate the scalp and detect light transmitted through the tissue in the human head, but optical fibers limit the subject’s head position (Abstract; pg. 1, right column, last paragraph). As depicted in Figure 2, the wearable OT system comprises a probe unit that is worn on a subject’s head and contains optical devices such as light sources and detectors and further has a flexible pad with eight irradiation points and eight detection points to fit the subject’s foreheads (pg. 2, Section II.; Figures 1-2, note that the probe unit is depicted in Figure 2 as comprising a headband that encircles the head of the wearer of the headset/probe unit).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the system of Brake et al. further comprise a headband configured to encircle a head of the wearer of a headset, wherein the plurality of light sources and the plurality of light detectors are attached to the headband, as taught by Atsumori et al., in order to free up the wearer’s head position (Abstract; pg. 1, right column, last paragraph).
However, the above combined references do not specifically disclose that the one or more processors are further configured to determine a likelihood the wearer will experience a stroke over a predetermined future time period based on the one or more cerebral blood metrics.
Kastrup et al. disclose a system for assessing regional cerebral blood flow (rCBF) changes during breath-holding, wherein the non-invasive assessment of rCBF changes provides a determination of a cerebrovascular reactivity (CVR) assessment, wherein an impaired CVR assessment can indicate an increased risk of stroke (Abstract; pg. 1237, right column, first paragraph, note that an increased “risk” of stroke determination implies that there is a high probability/likelihood that a stroke will happen in the future and thus over a predetermined time period (i.e. “future” time period) that does not include the instant time period; further note that Kastrup et al. cites Kleiser et al. [cited by Kastrup et al. as reference “32”] as the study which documents the determination of increased risk of stroke being associated with impaired CVR assessment, wherein Kleiser et al. disclose that such an estimation of risk/probability/likelihood of stroke is associated with predetermined future time periods, thus providing evidence that the determination of the risk/likelihood that a subject will experience a stroke is over a “predetermined future time period” (i.e. see right panel of Figure 2 of Kleiser et al., wherein probabilities/likelihoods of stroke are determined over a predetermined future time period (i.e. 1-36 months))). The assessment of CVR is thus recognized as an important parameter in the management of cerebrovascular diseases (Abstract; pg. 1237, right column, first paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the one or more processors of the above combined references be further configured to determine a likelihood the wearer will experience a stroke over a predetermined future time period based on the one or more cerebral blood metrics, as taught by Kastrup et al., in order to provide effective management of cerebrovascular diseases (Abstract; pg. 1237, right column, first paragraph).
With regards to claim 17, as discussed above, the above combined references meet the limitations of claim 16. However, the above combined references do not specifically disclose that the plurality of light sources comprise a plurality of light emission packages, each light emission package comprising at least two light sources configured to emit light in different wavelengths. Atsumori et al. disclose that the wearable probe unit has a flexible pad with eight irradiation points and eight detection points to fit the subject’s foreheads, wherein each irradiation point has a pair of vertical-cavity surface emitting laser (VCSEL) diodes with 790 and 850 nm wavelengths and a monitor photodiode (i.e. silicon photodiode (SiPD)) mounted in a TO-can package (pg. 2, right column, first paragraph-pg. 3, first paragraph; Figures 1-3). The probe unit has eight can packages with two-wavelength VCSEL, and thus has 16 light sources in all and wherein each Si-PD detects light from up to six VCSEL diodes (pg. 3, left column, last paragraph-right column, 1st paragraph; Figures 1-3). The use of VCSEL diodes as a light source and Si-PDs as detectors reduces the power consumption of the optical devices and the use of the packages allows the system to be simplified and the weight of the probe unit be reduced (pg. 2, right column, 1st paragraph; pg. 3, left column, last paragraph; Figures 1-3). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the plurality of light sources of the above combined references comprise a plurality of light emission packages, each light emission package comprising at least two light sources configured to emit light in different wavelengths, as taught by Atsumori et al., in order to reduce the power consumption and further simplify and reduce the weight of the system (pg. 2, right column, 1st paragraph; pg. 3, left column, last paragraph).
With regards to claim 19, Brake et al. disclose that the plurality of light detectors comprise a plurality of light detector packages, each light detection package comprises at least two light detectors (paragraph [0129], referring to the iSVS system including one or more cameras (770) having one or more sensors (i.e. at least two light detectors), wherein each camera encompasses a package for the plurality of sensors/light detectors as the plurality of sensors/light detectors are contained within the camera housing; paragraphs [0106], [0133] referring to the camera having a detector array, such as a CCD camera).
With regards to claim 20, Brake et al. disclose that a light detector of the at least two light detectors of a light detection package comprises a camera (paragraph [0129], referring to the iSVS system including one or more cameras (770) having one or more sensors (i.e. at least two light detectors), wherein each camera encompasses a package for the plurality of sensors/light detectors as the plurality of sensors/light detectors are contained within the camera housing; paragraphs [0106], [0133] referring to the camera having a detector array, such as a CCD camera).
With regards to claim 21, Brake et al. disclose that the obtained information comprises a speckle pattern obtained using images captured by the camera (paragraph [0064], referring to the camera capturing a two-dimensional speckle pattern containing speckle grains; Abstract, paragraphs [0070], [0099], [0106]-[0107], referring to the off-axis interferogram captured by the camera, wherein the interferogram includes both sample speckle field data and reference beam data; paragraphs [0100]-[0101], referring to the interferogram being depicted as an image (210); Figures 2-4).
With regards to claim 22, Brake et al. disclose that the one or more cerebral blood metrics comprise a cerebral blood flow determined based on the speckle pattern (Abstract, paragraphs [0172]-[0174], referring to the measured visibility factor being used to calculate the blood flow index (BFI) based on the tissue scattering parameters, wherein the visibility factor, as set forth in paragraphs [0078]-[0091] is determined based on the speckle pattern).
With regards to claim 30, Brake et al. disclose that the one or more cerebral blood metrics comprise one or more of cerebral blood flow, cerebral blood volume and/or cerebral blood oxygenation (paragraphs [0104], [0130], referring to the complex amplitude and phase of the speckle field includes data at different locations that can represent contributions from different areas and path length distributions and can be used to extract more information from the sample, such as mapping the blood flow at different locations in the brain, indicating the activity of different parts of the brain; paragraphs [0170]-[0172], [174], referring to viewing rCBF changes due to the breath holding task; Figures 30-32).
With regards to claim 32, Atsumori et al. disclose that the headband comprises a plurality of channels, each channel comprising one or more of the light detectors, wherein the light detectors of the channels are configured to measure cerebral blood metrics from different brain regions (Abstract, pg. 2, left column, 2nd paragraph, referring to the “multichannel” and wearable OT system that has 22 measurement points, enough to cover the large area of the forehead including bilateral templates, and thus covers different brain regions/areas within the covered large area of the forehead; Figures 2-3, wherein as depicted in Figures 2-3, each channel comprises one or more of the light detectors (PD)).
With regards to claim 33, Atsumori et al. disclose that two or more of the channels comprise a shared light source of the plurality of light sources (Figures 2-3, in particular, see Figure 2 wherein there are 22 channels [represented by circles], which is more than the number of light sources [i.e. 8 light sources represented by white squares], and therefore it would follow that two or more of the channels would comprise a shared light source as there are more measurement channels than light sources).
Claim(s) 18 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brake et al. in view of Atsumori et al. and Kastrup et al. [as evidenced by Kleiser et al.], as applied to claims 16 and 17 above, and further in view of Orbach (CN 101198277).
With regards to claims 18 and 31, as discussed above, the above combined references meet the limitations of claims 16 and 17. Further, Atsumori et al. disclose that the at least two light sources comprise a laser configured to emit light in an infrared wavelength range, and a light source configured to emit in a near infrared wavelength range (pg. 2, right column, first paragraph-pg. 3, right column, first paragraph, referring to the pair of VCSEL diodes with 790 and 850 nm, wherein each VCSEL diode needs a driving signal from a laser driver, and thus corresponds to lasers, wherein one VCSEL emits light at a wavelength of 790 nm, which is within the infrared wavelength range, and the other VCSEL diode emits light at a wavelength of 850 nm, which is within the NIR wavelength range [note that the NIR wavelength range is within the IR range and specifically covers a 750-1300 nm wavelength range; Figures 1-3). Additionally, with regards to claim 31, Atsumori et al. disclose that the plurality of light detectors comprise a photodiode (pg. 2, right column, first paragraph – pg. 3, left column, first paragraph, referring to the use of a silicon photodiode (Si-PD) as a detector).
However, the above combined references do not specifically disclose that the light source configured to emit in a near infrared wavelength range is a light emitting diode (LED) or that the plurality of light sources comprises a light emitting diode.
Orbach discloses methods and systems for physiological and psycho-physiological monitoring, wherein the system comprises one or more wearable sensor modules which sense one or more physiological parameters (Abstract). The sensor module comprises a light source and a light detector, wherein a light emitting diode (LED) may alternatively be used instead of a vertical cavity surface emitting laser (VCSEL) (paragraph [0172]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the light source configured to emit in a NIR wavelength range of the above combined references with a light emitting diode (LED), as taught by Orbach, as the substitution of one known light source for another yields predictable results (i.e. illuminating a patient/tissue) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brake et al. in view of Atsumori et al. and Kastrup et al. [as evidenced by Kleiser et al.], as applied to claim 16 above, and further in view of Sie et al. (US Pub No. 2021/0338083).
With regards to claim 23, as discussed above, the above combined references meet the limitations of claim 16. However, the above combined references do not specifically disclose that a distance between a light source of the plurality of light sources and a light detector of the plurality of light detectors is adjustable by changing a position of the light source and/or the light detector on the headband.
Sie et al. disclose a system for object characterization using light scattering, wherein changes in the speckle field over time may provide information about blood flow in the targeted area (Abstract; paragraphs [0026]-[0027]). The system comprises a laser, a source fiber that delivers laser radiation to an object and a detector fiber that receives scattered laser radiation, wherein the location of the scattering portion within the object may be adjusted by adjusting the distance between the source and detector fibers (Abstract; paragraph [0034]). The depth of the scattering portion may be increased by increasing the distance between source and detector fibers (paragraph [0034]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have a distance between a light source of the plurality of light sources of the above combined references and a light detector of the plurality of light detectors of the above combined references be adjustable by changing a position of the light source and/or the light detector on the headband, as taught by Sie et al., in order to adjust the location and/or depth of the scattering portion within the head of the user, thereby ensuring that the desired target region is observed (paragraph [0034]).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brake et al. in view of Atsumori et al. and Kastrup et al. [as evidenced by Kleiser et al.], as applied to claim 16 above, and further in view of Strasser et al. (US Pub No. 2021/0106238).
With regards to claim 34, as discussed above, the above combined references meet the limitations of claim 16. However, the above combined references do not specifically disclose that the one or more processors are further configured to provide a representation of the one or more cerebral blood metrics as input to a trained machine learning model, wherein the likelihood the wearer will experience the stroke over the predetermined future time period is based on an output of the trained machine learning model.
Strasser et al. disclose a system for detecting an anomalous event in a person, wherein the anomalous event can comprise a stroke event (Abstract; paragraphs [0013], [0029]). A wearable device for detecting stroke can comprise a patch that may be used to estimate cerebral blood flow, wherein the blood flow is a signal that can be used to detect stroke (paragraphs [0115]-[0116], [0124], [0166], [0200]). A data processing module may employ various machine learning methods to identify patterns, extract patterns, identify parameters indicative of stroke onset, etc. (paragraph [0194]). A machine-learning algorithm is used to determine the relationship between a system’s inputs and outputs using learning data that is representative of all the behavior found in the system (paragraph [0194]). A deep learning network may comprise a Leverage Recurrent Neural Network (RNN) implementation, wherein RNN are proven highly effective in handling time series data, assumes training inputs are time dependent, capable of accurately modeling/predicting changes through time, capable of generating an actual output value for a data point versus giving just a range, and each time slice is its own feed forward network specified by a user (paragraph [0194]). In some embodiments, the system for providing comprehensive stroke care can comprise a stroke risk level assessment (paragraph [0195]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the one or more processors of the above combined references be further configured to provide a representation of the one or more cerebral blood metrics as input to a trained machine learning model, wherein the likelihood the wearer will experience the stroke over the predetermined future time period is based on an output of the trained machine learning model, as taught by Strasser et al., in order to be able to identify patterns and parameters indicative of stroke and accurately model and predict the changes through time (paragraph [0194]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sathiyamoorthy et al. (US Pub No. 2025/0127448) discloses using optical sensors located on the head of a patient in order to determine cerebral blood flow for detecting stroke (Abstract; paragraphs [0006]-[0009]).
Mourad et al. (US Pub No. 2006/0079773) disclose recording acoustic backscatter as a human subject holds his breath in order to observe changes in blood volume and intracranial pressure (Abstract; paragraphs [0194]-[0196]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/ Primary Examiner, Art Unit 3798