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
The applicant elects claims 6 and 24 without traverse. Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/5/2026.
Claim Interpretation
Claim 26 recites the limitation of “whether the optical sub-system is mounted on a living head.” which in an interpretation it may be construed as a conditional limitation where the limitations followed by the conditional limitations may not be given a full weight in light of the below decisions as for considering the other case scenario of “” not being “”.
In the recent Ex parte Gopalan decision, the PTAB addressed a claim where all of the features were recited in a conditional manner. A first step of “identifying … an outlier” was performed if “traffic is outside of a prediction interval.” A second step of “identifying” was performed “only when a count of outliers … is greater than or equal to two, and exceeds an anomaly threshold.” These were the only two elements of the independent claim. Thus, if the traffic is never outside Gopalan’s prediction interval, then the steps of the method are never performed.
However, the PTAB distinguished Schulhauser and noted that this construction “would render the entire claim meaningless.” Gopalan at p. 5. The Board went on to state, “Although each of these steps is conditional, they are integrated into one method or path and do not cause the claim to diverge into two methods or paths, as in Schulhauser. Thus, we conclude that the broadest reasonable interpretation of claim 1 requires the performance of both steps…” Id. at p. 6.”
Claim Objections
Claims 1, 3, 20, 22 and 27 are objected to because of the following informalities:
Claims 1, 3, 20, 22 and 27 recite the limitation of “and/or” which should rather be either “and” or “or” to prevent any possible ambiguity due to the interpretation.
Appropriate correction is required.
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.
Claim 24 is 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 24 recites the limitation of “displacements of at least one of the optical and the radio transceiver sub-systems” which is not clear what is being displaced or how it is being, or what causes anything to be displaced.
Claim Rejections - 35 USC § 102
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.
Claims 1, 8, 9 20, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (US 20120271129 A1)
Regarding claim 1, Wang teaches a system for detecting and/or assessing a subdural hematoma (“The NIR light is transmitted in the optical fiber 130 to the optical probe 120, which in turn delivers the NIR light (i.e. incident light) into a living tissue 125 or blood (not shown) of a patient. The living tissue can include brain tissues in a patient's head” [0026]), comprising;
an optical sub-system being configured for emitting light towards a predetermined location coinciding with a predetermined area of a head of a subject (“The NIR light is transmitted in the optical fiber 130 to the optical probe 120, which in turn delivers the NIR light (i.e. incident light) into an living tissue 125 or blood (not shown) of a patient. The living tissue can include brain tissues in a patient's head” [0026]), and sensing the emitted light returning from the predetermined location, wherein the optical sub-system is further configured for generating a respective set of signals responsively to interactions of the emitted light with skull-contained matter of the subject (“The optical probe 120 also collects NIR light scattered by the living tissue or blood of the patient, and transmit the collected NIR light to the optical detector 140 via the optical fiber 131” [0026]);
a radio transceiver sub-system configured for emitting sub-optical radiation towards the predetermined location and generating a signal responsively to an interaction of the radiation with the skull-contained matter of the subject (“the MRFM unit 110 includes a plurality of RF wave sources (i.e. RF oscillators) RF 1, RF 2 . . . RF N, wherein Nis an integer bigger than 1. The RF wave sources RF 1, RF 2 . . . RF N” [0028]); and
a data processor configured to:
analyze the signals of the optical sub-system and the radio transceiver sub-system (“The control and data acquisition unit 150 can demodulate the electronic signals from the modulating RF frequencies, and extract [HbO] and [Hb] in the living tissue 125 from the electronic signals” [0026]),
and detect and/or assess a subdural hematoma of the subject based on the analysis (“non-invasive detecting, measuring and monitoring of hemoglobin concentration, and oxygen saturation of hemoglobin in blood, and living tissues which includes the brain” [0009]),
wherein the analysis for detection and/or assessment of a subdural hematoma of the subject does not comprise an analysis of a fluorescent signal associated with near-infrared (NIR) fluorescent molecules (Wang does not teach an analysis of a fluorescent signal associated with near-infrared (NIR) fluorescent molecules).
Regarding claim 8, Wang teaches wherein the optical sub-system comprises a plurality of light sources, each configured for emitting light in a respective direction (“near infrared (NIR) light sources” abst; also see e.g., figs. 3A),
wherein the predetermined location is adjusted by selecting a respective one of the plurality of light sources (“the optical path is not simply the geometrical separation between the light source and the optical detector, as shown in FIGS. 3A and 3B. The optical path changes with different tissue under measurement” [0032]).
Regarding claim 9, Wang teaches wherein the optical sub-system comprises a plurality of light sensors, each of the plurality of light sensors configured for sensing light from a respective direction (“one or more optical detectors that each can receive scattered lights from the living tissue” abst),
wherein the predetermined location is adjusted by selecting a respective one of the plurality of light sensors (“the optical path is not simply the geometrical separation between the light source and the optical detector, as shown in FIGS. 3A and 3B. The optical path changes with different tissue under measurement” [0032]).
Regarding claim 20, Wang teaches wherein the data processor is configured for delineating a boundary within the skull-contained matter at least partially encompassing a region having functional and/or structural properties that are different from regions outside the boundary (“measure the optical paths precisely and therefore obtain correct information” [0033]; “optical paths, and can calibrate manufacturing-related variability and errors in mechanical, electronic and optical parameters in a single optical path, which result in higher accuracy” [0010]; also e.g., see fig. 5).
Regarding claim 22, Wang teaches wherein the data processor is configured to provide functional and/or structural information for each of a plurality of predetermined locations (“accurate and precise measurements of oxyhemoglobin concentration, deoxyhemoglobin concentration, and oxygen saturation in blood and living tissues.” [0008]).
Regarding claim 24 (as the claim best understood in light of the 35 USC 112 rejections above), Wang teaches wherein the data processor is configured to analyze the signals to determine displacements of at least one of the optical and the radio transceiver sub-systems (“Many factor can affect the accuracies of detected signals using RF modulated NIR light sources: for example, variation of intensity and phase of light sources, differences in coupling efficiencies between light source and tissue and between tissue and optical detector, differences in of sensitivities of optical detectors, manufacturing errors in the distances between light source and optical detectors, the optical inhomogeneity of tissue to the NIR lights, etc. Multiple optical paths can differentiate the optical properties of hemoglobin in blood and/or in living tissues. Inhomogeneities in the living tissue 125 as well as errors and/or deviations in the optical paths caused during manufacturing process may lead to measurement accuracy and validity that can severely impact clinic practices.” [0038]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-5, 10-12, 15, 17, 25-26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Stein et al (US 20160030001).
Regarding claim 2, Wang teaches all the claimed limitations except for actuator to adjust.
However, in the same field of endeavor, Stein teaches invention relates to devices and methods to produce a more complete picture of a traumatic event in the brain [0002]. Transducers are arranged on actuators. The actuators are able to move, rotate, or change the position of the transducers for aid in analysis and the collection of data [0007]. A microwave-based thermoacoustic tomography (TAT) device would be used to image deeply seated lesions and objects in biological tissues and the phased array Doppler or single receiver Doppler would present blood flow. Because malignant tissue absorbs microwaves more strongly than benign tissue, cancers can be imaged with good spatial resolution and contrast [0061]. Different frequencies of light of the laser would excite vascular wall, gaseous emboli, and fatty emboli, in superficial or deeper vasculature, both in the skull or the general circulation, to determine probability or likelihood of stroke or other vascular disorder [0068]. FIG. 5 further illustrates Novel Enhanced Apparatus with Helmet/Carotid Collar Means On-Boarded. A diagram of the x-y actuators positioning scheme is shown [0081].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with actuator as taught by Stein because allowing the preparation for and evaluation of the safest and most appropriate diagnosis and treatment ([0005] of Stein).
Regarding claim 3, Wang teaches all the claimed limitations except for actuator is configured for adjusting a position of the at least one light source.
However, in the same field of endeavor, Stein teaches invention relates to devices and methods to produce a more complete picture of a traumatic event in the brain [0002]. Transducers are arranged on actuators. The actuators are able to move, rotate, or change the position of the transducers for aid in analysis and the collection of data [0007]. Method comprises the steps outputting optical excitation energy to said region of interest [0053]. Different frequencies of light of the laser would excite vascular wall, gaseous emboli, and fatty emboli, in superficial or deeper vasculature, both in the skull or the general circulation, to determine probability or likelihood of stroke or other vascular disorder [0068]. FIG. 5 further illustrates Novel Enhanced Apparatus with Helmet/Carotid Collar Means On-Boarded. A diagram of the x-y actuators positioning scheme is shown [0081].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with actuator as taught by Stein because allowing the preparation for and evaluation of the safest and most appropriate diagnosis and treatment ([0005] of Stein).
Regarding claim 4, Wang teaches all the claimed limitations except for actuator is configured for adjusting a position of the optical sensing elements independently from each other.
However, in the same field of endeavor, Stein teaches invention relates to devices and methods to produce a more complete picture of a traumatic event in the brain [0002]. Transducers are arranged on actuators. The actuators are able to move, rotate, or change the position of the transducers for aid in analysis and the collection of data [0007]. Method comprises the steps outputting optical excitation energy to said region of interest [0053]. Different frequencies of light of the laser would excite vascular wall, gaseous emboli, and fatty emboli, in superficial or deeper vasculature, both in the skull or the general circulation, to determine probability or likelihood of stroke or other vascular disorder [0068]. FIG. 5 further illustrates Novel Enhanced Apparatus with Helmet/Carotid Collar Means On-Boarded. A diagram of the x-y actuators positioning scheme is shown [0081]. The device as shown in FIG. 6 comprises a temporal sensor 601, a carotid sensor 602, and a cervical sensor 603 to be actuated independently [0082].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with actuator as taught by Stein because allowing the preparation for and evaluation of the safest and most appropriate diagnosis and treatment ([0005] of Stein).
Regarding claim 5, Wang teaches all the claimed limitations except for actuator is configured to move the platform in respective to the static structure.
However, in the same field of endeavor, Stein teaches invention relates to devices and methods to produce a more complete picture of a traumatic event in the brain [0002]. Transducers are arranged on actuators. The actuators are able to move, rotate, or change the position of the transducers for aid in analysis and the collection of data [0007]. Method comprises the steps outputting optical excitation energy to said region of interest [0053]. Different frequencies of light of the laser would excite vascular wall, gaseous emboli, and fatty emboli, in superficial or deeper vasculature, both in the skull or the general circulation, to determine probability or likelihood of stroke or other vascular disorder [0068]. FIG. 5 further illustrates Novel Enhanced Apparatus with Helmet/Carotid Collar Means On-Boarded. A diagram of the x-y actuators positioning scheme is shown [0081]. The device as shown in FIG. 6 comprises a temporal sensor 601, a carotid sensor 602, and a cervical sensor 603 to be actuated independently [0082].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with actuator as taught by Stein because allowing the preparation for and evaluation of the safest and most appropriate diagnosis and treatment ([0005] of Stein).
Regarding claim 10, Wang teaches all the claimed limitations except for plurality of antennas and adjusted the plurality of antennas.
However, in the same field of endeavor, Stein teaches invention relates to devices and methods to produce a more complete picture of a traumatic event in the brain [0002]. Transducers are arranged on actuators. The actuators are able to move, rotate, or change the position of the transducers for aid in analysis and the collection of data [0007]. A microwave-based thermoacoustic tomography (TAT) device would be used to image deeply seated lesions and objects in biological tissues and the phased array Doppler or single receiver Doppler would present blood flow. Because malignant tissue absorbs microwaves more strongly than benign tissue, cancers can be imaged with good spatial resolution and contrast [0061]. Different frequencies of light of the laser would excite vascular wall, gaseous emboli, and fatty emboli, in superficial or deeper vasculature, both in the skull or the general circulation, to determine probability or likelihood of stroke or other vascular disorder [0068]. FIG. 5 further illustrates Novel Enhanced Apparatus with Helmet/Carotid Collar Means On-Boarded. A diagram of the x-y actuators positioning scheme is shown [0081].
wherein the radio transceiver sub-system comprises a plurality of antennas, each configured for emitting sub-optical radiation in a respective direction (“a microwave-based thermoaccoustic tomography (TAT) device would be used to image deeply seated lesions and objects in biological tissues … malignant tissue absorbs microwaves more strongly than benign tissue” [0061]),
wherein the predetermined location is adjusted by selecting a respective one of the plurality of antennas (“Transducers are arranged on actuators. The actuators are able to move, rotate, or change the position of the transducers for aid in analysis and the collection of data” [0007]).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with actuator as taught by Stein because allowing the preparation for and evaluation of the safest and most appropriate diagnosis and treatment ([0005] of Stein).
Regarding claims 11 and 12, Wang teaches all the claimed limitations except for initial detection notifications.
However, in the same field of endeavor, Stein teaches invention relates to devices and methods to produce a more complete picture of a traumatic event in the brain [0002]. Transducers are arranged on actuators. The actuators are able to move, rotate, or change the position of the transducers for aid in analysis and the collection of data [0007]. A microwave-based thermoacoustic tomography (TAT) device would be used to image deeply seated lesions and objects in biological tissues and the phased array Doppler or single receiver Doppler would present blood flow. Because malignant tissue absorbs microwaves more strongly than benign tissue, cancers can be imaged with good spatial resolution and contrast [0061]. Different frequencies of light of the laser would excite vascular wall, gaseous emboli, and fatty emboli, in superficial or deeper vasculature, both in the skull or the general circulation, to determine probability or likelihood of stroke or other vascular disorder [0068].
wherein, based on the analysis of the signals of the optical sub-system, the data processor is configured to generate an initial detection notification (“invention allows for remote determination of parameters that indicate whether the patient is a possible stroke or a stroke risk patient. The results of the assessment allow for a patient to then be redirected to the nearest stroke treating hospital, thus saving valuable treatment time, allowing the preparation for and evaluation of the safest and most appropriate diagnosis and treatment” [0005]), and
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with notification as taught by Stein because allowing the preparation for and evaluation of the safest and most appropriate diagnosis and treatment ([0005] of Stein).
Regarding claim 15, Wang teaches all the claimed limitations except for further comprising one or more additional sensors selected from the group consisting of one or more ultrasound transceivers, one or more electrical impedance sensors, one or more electroencephalogram (EEG) sensors, one or more electromyography (EMG) sensors and one or more temperature sensors,
wherein the data processor is configured to receive from the one or more additional sensors information regarding a respective attribute of the subject.
However, in the same field of endeavor, Stein teaches invention relates to devices and methods to produce a more complete picture of a traumatic event in the brain [0002].
further comprising one or more additional sensors selected from the group consisting of one or more ultrasound transceivers (“In some embodiments, ultrasound transducers transmit and sense ultrasound waves to characterize a patient's brain and measure blood parameters” [0007]), one or more electrical impedance sensors (“the measurement of the impedance, preferably by raw data transfer and radiofrequency (RF) analyses.” Claim 36), temperature sensors (“a microwave-based thermoaccoustic tomography (TAT) device” [0061]),
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with additional sensors as taught by Stein because allowing the preparation for and evaluation of the safest and most appropriate diagnosis and treatment ([0005] of Stein).
Regarding claim 17, Wang teaches wherein the sub-optical radiation comprises a plurality of frequencies, a first of the plurality of frequencies being at least 10 times a second of the plurality of frequencies (“radio frequency (RF) wave sources that can genarate RF waves at different RF frequencies” [0014]).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of Wang to radiate 10 times a second of the plurality of frequencies.
Regarding claim 25, Wang teaches wherein the data processor is configured to analyze signals received from the optical sub-system to determine proximity between the optical sub-system and the head (“RF modulated NIR light sources: for example, variation of intensity and phase of light sources, differences in coupling efficiencies between light source and tissue and between tissue and optical detector, differences in of sensitivities of optical detectors, manufacturing errors in the distances between light source and optical detectors” [0038]; “the detected light intensity can be approximately represented as Ic(f)=Io*Sc*g(f,d,ua,us) Eqn. (1) where Ic(f) is intensity of the detected light at detecting point C; Io is the amplitude of original source intensity modulated by a RF wave; f is the frequency of the RF wave; d is the distance between the light entry point and the light exit point;” [0042]).
Regarding claim 26, Wang teaches wherein the data processor is configured to analyze signals received from the radio transceiver sub-system to determine whether the optical sub-system is mounted on a living head (“an optical probe that can direct the NIR lights modulated at different RF frequencies to a living tissue, and wherein the optical probe comprises a plurality of light-emitting points that each can couple one of the NIR lights into the living tissue” [0011]).
Regarding claim 29, Wang teaches all the claimed limitations except for acquire a fluorescent signal from a near-infrared (NIR) fluorophore introduced into the vasculature of the subject; and analyze the acquired fluorescent signal to evaluate parameters of blood flow abnormalities.
However, in the same field of endeavor, Stein teaches invention relates to devices and methods to produce a more complete picture of a traumatic event in the brain [0002]. Spectroscopy would be used to evaluate oxygenation, tissue efficacy, and as part of the determination of cerebral perfusion in combination with transcranial doppler and phased array ultrasound and special fluorescent intravascular injection [0049]. Administrating to a patient ICN green or other photo-acoustic or fluorescing agent (see claim 45).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with fluorophore introduced into the vasculature as taught by Stein because allowing the preparation for and evaluation of the safest and most appropriate diagnosis and treatment ([0005] of Stein).
Claims 6 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Nahman (US 20150099980 A1).
Regarding claim 6, Wang teaches all the claimed limitations except for wherein the at least one light source and the radio transceiver sub-system are mounted on the platform.
However, in the same field of endeavor, Nahman teaches invention relates to devices and methods for detection of internal bleeding and hematoma [0001]. A device for detection of internal bleeding in a patient's body is provided. An optical interface for transmitting IR light through an area of a skin of a patient and to collect IR light from the area of the skin, is provided (abst). FIGS. 11A and 11B illustrate a device for detecting bleeding in an internal layer of the body, whereas the reference signal comprises an RF signal having a wavelength corresponding to a frequency in the range of 0.5-3 MHz. The illustrated device (1100) comprises a reference signal interface (1150) comprising a first electrical contact (1120) and a second electrical contact (1124). The first electrical contact is configured to be attached to the body on the area of the skin being illuminated by the IR light, or proximal thereto [0082]. the antenna may be substantially integrated with the pad of the optical interface (1020), as is described above in FIG. 13A [0081].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with light source and the radio transceiver sub-system are mounted on the platform as taught by Nahman because there is a need in the art for devices, systems and methods for early detection of internal bleeding and hematoma ([0016] of Nahman).
Regarding claim 27, Wang teaches all the claimed limitations except for wherein the data processor is configured to analyze signals received from the radio transceiver sub-system to determine dielectric properties of the tissue and to transmit control signals to the optical sub-system based on the determined dielectric properties.
However, in the same field of endeavor, Nahman teaches invention relates to devices and methods for detection of internal bleeding and hematoma [0001]. A device for detection of internal bleeding in a patient's body is provided. An optical interface for transmitting IR light through an area of a skin of a patient and to collect IR light from the area of the skin, is provided (abst). RF radiation as a reference signal to detect changes in dielectric characteristics which are typically due to changes in the water content in the area of interest. RF radiation in the range of about 100 MHz to about 10 GHz may be used. Biological tissues are known to enable significant RF penetration. Changes in dielectric characteristics include the imaginary part of the dielectric constant. FIG. 9 illustrates the sensitivity of the dielectric constant to water and compares frequency dependence of the imaginary part of the dielectric constant for free and bound water. "1" represents free water (salinity S=0% o); "2" represents free water (salinity S=2% o); and "3" represents bound water. It is appreciated that a substantially minute variation in water characteristics (e.g. 2% of salinity) generates such a different absorption spectrum e.g. between 0.1-1 GHz. Subsequently, RF signal may be used, at a selected wavelength, as a reference signal, having a similar absorption spectrum in blood and in other fluids known to accumulate in the body following a surgical intervention [0074]. An RF reference signal source (not shown in this figure) generates the RF reference signal transmitted by the transmitting antenna. In some embodiments the RF source may be housed in the control unit, and an RF signal is delivered from the source to the transmitting antenna using the illustrated wired connection (1050) between them. In some embodiments the RF source is substantially attached to the transmitting antenna, in which embodiments the control unit supplies to the antenna power and control commands [0077].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with processor is configured to analyze signals received from the radio transceiver sub-system to determine dielectric properties as taught by Nahman because there is a need in the art for devices, systems and methods for early detection of internal bleeding and hematoma ([0016] of Nahman).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797