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 .
Response to Amendment
The amendment filed 01/23/2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection of claims 1-20 previously set forth in the Non-Final Office Action mailed 10/28/2025.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 11, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Seip et al (US 20160317129), hereinafter Seip, in view of Pinton et al (US 20200187910), hereinafter Pinton.
Regarding claim 1, Seip teaches a method for diagnosing a suspect region of a body (10) (“the subject's head 10” [0057]) using multiple imaging modalities (310) (320) (“A method and system for treating a target area of a patient, for example an area of the brain which includes an occlusion: employ an ultrasound imaging apparatus to produce an ultrasound image of a region of a subject; register the ultrasound image to a computed tomography (CT) image dataset; identify in the ultrasound image a location of a target area via a marker of the target area produced from the CT image dataset; verify the location of the target area with the ultrasound imaging apparatus” Abstract; Fig. 3) comprising:
acquiring image data (602) of the region of the body using a first imaging modality (“live ultrasound images.” [0058]; Fig. 6), wherein the image data of both imaging modalities is related to a common coordinate system (“ultrasound imaging system 320 acquires 2D and/or 3D ultrasound images of the subject's head 10 in real-time” [0057]; “ultrasound imaging system 320 (e.g., processor 322 and memory 324) may execute a registration algorithm to register CT images of the CT image dataset with live ultrasound images.” [0058]; “ultrasound imaging system 320 (e.g., processor 322 and memory 324) may execute an automatic registration algorithm which employs one or more fiducial markers in the CT image dataset and one or more corresponding fiducial markers in the ultrasound image for real-time registration… Image-fusion may provide a common coordinate system for identifying target locations for therapy delivery.” [0059]; Figs. 1-2, 4, and 6);
acquiring image data (100) (400) (604) of a region of the body (10) (“imaging the brain and skull” [0054]; Fig. 1, 4, and 6) using a second imaging modality (“CT imaging system 310 is employed for diagnosing the stroke (ischemic or hemorrhagic). If the stroke is ischemic, CT imaging system 310 employs perfusion or angiographic CT to determine the presence and location of the blood clot, the tissue core that is irreversibly infarcted, and the tissue that is potentially salvageable. CT imaging system 310 generates a CT image dataset (e.g., a 3D image dataset) which contains the CT images.” [0050]; Fig. 3);
producing images of the region of the body using the image data of each modality (“CT images… live ultrasound images.” [0058]);
detecting regions of suspect pathology in the images (“a marker 410 which indicates the location of an occlusion or blood clot in the subject's brain.” [0052]; Fig. 4; “generate ultrasound images for clot detection that overcome or partially compensate for the absence of ultrasound contrast agents for clot location.” [0067]);
merging the image data of the detected regions into a 3D dataset (“a 3D image dataset … which contains the CT images.” [0050]; “In operation, sonothrombolysis treatment and ultrasound imaging system 320 acquires 2D and/or 3D ultrasound images of the subject's head 10 in real-time, for example via headset 500. Sonothrombolysis treatment and ultrasound imaging system 320 combines the CT image dataset received from CT imaging system 310 with the real-time 2D and 3D ultrasound datasets for treatment planning, therapy delivery, and treatment monitoring.” [0057]);
selecting a region (110) (410) of the detected regions of suspect pathology (“image 400 has been annotated or marked with a marker 410 which indicates the location of an occlusion or blood clot in the subject's brain.” [0052]. “By use of the fiducial marker(s), ultrasound image 602 is registered with CT image 604, and marker 410 from CT image 604 is superimposed on ultrasound image 602 to identify the location of the target area which includes an occlusion or blood clot 110” [0060]; Fig. 6);
displaying an image of one or both modalities of the selected region of suspect pathology (602, 604) (“execute an image-fusion algorithm to present on display device 326 an overlay or a side-by-side registered view of the live ultrasound image and the CT image.” [0059]. “FIG. 6 illustrates an example of a side-by-side registered view 600 of a live ultrasound image 602 and a CT image 604 during the application of sonothrombolysis treatment to an occlusion or blood clot 110. Also shown in FIG. 6 are three different types of fiducial markers which may be employed alone or together to register ultrasound image 602 with CT image 604.” [0060]); and
displaying diagnostic information (110) (410) related to the suspect pathology (“FIG. 1 shows a cranial angiographic computed tomography (CT) image 100 which indicates the presence of an occlusion or blood clot 110.” [0044]; “a marker 410 which indicates the location of an occlusion or blood clot in the subject's brain.” [0052]; Fig. 4).
Seip does not teach detecting regions of suspect pathology in the images of both modalities.
However, in the medical diagnostic ultrasound field of endeavor, Pinton discloses adaptive multifocus beamforming ultrasound methods and systems for improved penetration and target sensitivity at high frame-rates, which is analogous art. Pinton teaches detecting regions of suspect pathology (T1 and T2) ("the at least one ultrasound transducer 104 is configured to detect a position of each of two or more targets T1 and T2 continually." [0096]; Figs. 1 and 2) in the images of both modalities (“Changes in microvascularity preceed changes in tumor size in response to therapy, providing an early biomarker of response to therapy [31, 32]. This phenomena has been observed with ultrasound imaging of microvessels also, showing the ability to detect response in “responder” tumors earlier than indicated with measurements of tumor volume alone [33]. The clear advantages of CESR include superior resolution at clinically relevant depths (3-8 cm)” [0068]. “The ability to use microvessel angiogenesis imaging as a local indicator of the likelihood of malignant cancer may provide an innovative clinical diagnostic tool…The ability to use microvascular ultrasound imaging as a sensitive method for screening at-risk patients, for guidance of biopsy, or for ultimately the early detection of subresolution micro-tumors would be highly innovative.” [0080]. “This Example extends the capabilities of ultrasound in terms of resolution and ability to acquire volumetric blood flow data so that the spatial resolution characteristics match (or exceed) those of MRI while retaining ultrasound's high temporal sampling capabilities. By cross-validating this technique with perfusion MRI the vast field of high resolution blood flow imaging and functional MRI becomes accessible to ultrasound.” [0166]).
Therefore, based on Pinton’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip to have the step of detecting regions of suspect pathology in the images of both modalities, as taught by Pinton, in order to improve detection capabilities of the imaging system.
Regarding claim 4, Seip modified by Pinton teaches the method of claim 1, wherein Seip teaches that acquiring image data of a region of a body using a first imaging modality further comprises acquiring ultrasound image slices (“an implementation of the present invention may also use one dimensional array of transducer elements which produce 2D (planar) images.” [0078]); and
wherein acquiring image data of the region of the body using a second imaging modality further comprises acquiring MR or CT image data of a head (10) of a subject (“CT imaging system 310 is employed for diagnosing the stroke (ischemic or hemorrhagic). If the stroke is ischemic, CT imaging system 310 employs perfusion or angiographic CT to determine the presence and location of the blood clot, the tissue core that is irreversibly infarcted, and the tissue that is potentially salvageable. CT imaging system 310 generates a CT image dataset (e.g., a 3D image dataset) which contains the CT images.” [0050]; Fig. 3; “The fiducial markers include: a first fiducial marker 610 corresponding to the location of the temporal bone in both ultrasound image 602 and CT image 604; a second fiducial marker 620 corresponding to the location of brain stem in both ultrasound image 602 and CT image 604;” [0060]; “Transducer arrays 10a and 10b transmit ultrasonic waves into the cranium of a patient from one or both sides of the head, although other locations may also or alternately be employed such as the front of the head or the sub-occipital acoustic window at the back of the skull.” [0083]; Figs. 1-6).
Regarding claim 11, Seip modified by Pinton teaches the method of claim 1, wherein Seip teaches that merging the detected regions into a 3D dataset further comprises rendering together the image data of both modalities in one volumetric image (“a 3D image dataset… which contains the CT images.” [0050] “In operation, sonothrombolysis treatment and ultrasound imaging system 320 acquires 2D and/or 3D ultrasound images of the subject's head 10 in real-time, for example via headset 500. Sonothrombolysis treatment and ultrasound imaging system 320 combines the CT image dataset received from CT imaging system 310 with the real-time 2D and 3D ultrasound datasets for treatment planning, therapy delivery, and treatment monitoring.” [0057]; “execute an image-fusion algorithm to present on display device 326 an overlay or a side-by-side registered view of the live ultrasound image and the CT image.” [0059]).
Regarding claim 16, Seip teaches a tangible, non-transitory computer readable medium comprising computer executable instructions (“a software algorithm executed by a processor…312" [0089]; “a software algorithm executed by a processor (e.g., processor 322)" [0096]; Fig. 3) which, when said computer executable instructions are run on a computer (312) (322) (Fig. 3), cause the computer to implement a method of:
acquiring image data (602) of a region of a body (10) (“imaging the brain and skull” [0054]; “the subject's head 10” [0057]; Fig. 1, 4, and 6) using a first imaging modality (“live ultrasound images.” [0058]; Fig. 6);
acquiring image data (100) (400) (604) of the region of the body (“imaging the brain and skull” [0054]; Fig. 1, 4, and 6) using a second imaging modality (“CT imaging system 310 is employed for diagnosing the stroke (ischemic or hemorrhagic). If the stroke is ischemic, CT imaging system 310 employs perfusion or angiographic CT to determine the presence and location of the blood clot, the tissue core that is irreversibly infarcted, and the tissue that is potentially salvageable. CT imaging system 310 generates a CT image dataset (e.g., a 3D image dataset) which contains the CT images.” [0050]; Fig. 3), wherein the image data of both imaging modalities is related to a common coordinate system (“ultrasound imaging system 320 acquires 2D and/or 3D ultrasound images of the subject's head 10 in real-time” [0057]; “ultrasound imaging system 320 (e.g., processor 322 and memory 324) may execute a registration algorithm to register CT images of the CT image dataset with live ultrasound images.” [0058]; “ultrasound imaging system 320 (e.g., processor 322 and memory 324) may execute an automatic registration algorithm which employs one or more fiducial markers in the CT image dataset and one or more corresponding fiducial markers in the ultrasound image for real-time registration… Image-fusion may provide a common coordinate system for identifying target locations for therapy delivery.” [0059]; Figs. 1-2, 4, and 6);
producing images of the region of the body using the image data of each modality modality (“CT images… live ultrasound images.” [0058]);
detecting regions of suspect pathology in the images (“a marker 410 which indicates the location of an occlusion or blood clot in the subject's brain.” [0052]; Fig. 4; “generate ultrasound images for clot detection that overcome or partially compensate for the absence of ultrasound contrast agents for clot location.” [0067]);
merging the image data of the detected regions into a 3D dataset (“a 3D image dataset … which contains the CT images.” [0050]; “In operation, sonothrombolysis treatment and ultrasound imaging system 320 acquires 2D and/or 3D ultrasound images of the subject's head 10 in real-time, for example via headset 500. Sonothrombolysis treatment and ultrasound imaging system 320 combines the CT image dataset received from CT imaging system 310 with the real-time 2D and 3D ultrasound datasets for treatment planning, therapy delivery, and treatment monitoring.” [0057]);
selecting a region (110) (410) of the detected regions of suspect pathology (“image 400 has been annotated or marked with a marker 410 which indicates the location of an occlusion or blood clot in the subject's brain.” [0052]. “By use of the fiducial marker(s), ultrasound image 602 is registered with CT image 604, and marker 410 from CT image 604 is superimposed on ultrasound image 602 to identify the location of the target area which includes an occlusion or blood clot 110” [0060]; Fig. 6);
displaying an image of one or both modalities of the selected region of suspect pathology (602, 604) (“execute an image-fusion algorithm to present on display device 326 an overlay or a side-by-side registered view of the live ultrasound image and the CT image.” [0059]. “FIG. 6 illustrates an example of a side-by-side registered view 600 of a live ultrasound image 602 and a CT image 604 during the application of sonothrombolysis treatment to an occlusion or blood clot 110. Also shown in FIG. 6 are three different types of fiducial markers which may be employed alone or together to register ultrasound image 602 with CT image 604.” [0060]); and
displaying diagnostic information (110) (410) related to the suspect pathology (“FIG. 1 shows a cranial angiographic computed tomography (CT) image 100 which indicates the presence of an occlusion or blood clot 110.” [0044]; “a marker 410 which indicates the location of an occlusion or blood clot in the subject's brain.” [0052]; Fig. 4).
Seip does not teach detecting regions of suspect pathology in the images of both modalities.
However, in the medical diagnostic ultrasound field of endeavor, Pinton discloses adaptive multifocus beamforming ultrasound methods and systems for improved penetration and target sensitivity at high frame-rates, which is analogous art. Pinton teaches detecting regions of suspect pathology (T1 and T2) ("the at least one ultrasound transducer 104 is configured to detect a position of each of two or more targets T1 and T2 continually." [0096]; Figs. 1 and 2) in the images of both modalities (“Changes in microvascularity preceed changes in tumor size in response to therapy, providing an early biomarker of response to therapy [31, 32]. This phenomena has been observed with ultrasound imaging of microvessels also, showing the ability to detect response in “responder” tumors earlier than indicated with measurements of tumor volume alone [33]. The clear advantages of CESR include superior resolution at clinically relevant depths (3-8 cm)” [0068]. “The ability to use microvessel angiogenesis imaging as a local indicator of the likelihood of malignant cancer may provide an innovative clinical diagnostic tool…The ability to use microvascular ultrasound imaging as a sensitive method for screening at-risk patients, for guidance of biopsy, or for ultimately the early detection of subresolution micro-tumors would be highly innovative.” [0080]. “This Example extends the capabilities of ultrasound in terms of resolution and ability to acquire volumetric blood flow data so that the spatial resolution characteristics match (or exceed) those of MRI while retaining ultrasound's high temporal sampling capabilities. By cross-validating this technique with perfusion MRI the vast field of high resolution blood flow imaging and functional MRI becomes accessible to ultrasound.” [0166]).
Therefore, based on Pinton’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip to have the step of detecting regions of suspect pathology in the images of both modalities, as taught by Pinton, in order to improve detection capabilities of the imaging system.
Regarding claim 17, Seip teaches a multimodality imaging system (300) (Fig. 3) for diagnosing a suspect region of a body (10) (“imaging the brain and skull” [0054]; “the subject's head 10” [0057]; Fig. 1, 4, and 6) comprising:
a first imaging modality (320) configured to acquire image data (602) of a region of the body (“imaging the brain and skull” [0054]; “the subject's head 10” [0057]; Fig. 1, 4, and 6) (“live ultrasound images.” [0058]; Figs. 3, 6);
a second imaging modality (310) configured to acquire image data (100) (400) (604) of the region of the body, wherein the image data of both imaging modalities is related to a common coordinate system (“ultrasound imaging system 320 acquires 2D and/or 3D ultrasound images of the subject's head 10 in real-time” [0057]; “ultrasound imaging system 320 (e.g., processor 322 and memory 324) may execute a registration algorithm to register CT images of the CT image dataset with live ultrasound images.” [0058]; “ultrasound imaging system 320 (e.g., processor 322 and memory 324) may execute an automatic registration algorithm which employs one or more fiducial markers in the CT image dataset and one or more corresponding fiducial markers in the ultrasound image for real-time registration… Image-fusion may provide a common coordinate system for identifying target locations for therapy delivery.” [0059]; Figs. 1-4, and 6); and
an image processor (312) (322) (Fig. 3) configured to:
produce images of the region of the body using the image data of each modality (“CT images… live ultrasound images.” [0058]);
detect regions of suspect pathology in the images (“a marker 410 which indicates the location of an occlusion or blood clot in the subject's brain.” [0052]; Fig. 4; “generate ultrasound images for clot detection that overcome or partially compensate for the absence of ultrasound contrast agents for clot location.” [0067]);
merge the image data of the detected regions into a 3D dataset (“a 3D image dataset … which contains the CT images.” [0050]; “In operation, sonothrombolysis treatment and ultrasound imaging system 320 acquires 2D and/or 3D ultrasound images of the subject's head 10 in real-time, for example via headset 500. Sonothrombolysis treatment and ultrasound imaging system 320 combines the CT image dataset received from CT imaging system 310 with the real-time 2D and 3D ultrasound datasets for treatment planning, therapy delivery, and treatment monitoring.” [0057]);
select a region (110) (410) of the detected regions of suspect pathology (“image 400 has been annotated or marked with a marker 410 which indicates the location of an occlusion or blood clot in the subject's brain.” [0052]. “By use of the fiducial marker(s), ultrasound image 602 is registered with CT image 604, and marker 410 from CT image 604 is superimposed on ultrasound image 602 to identify the location of the target area which includes an occlusion or blood clot 110” [0060]; Fig. 6);
display images of one or both modalities of the selected region of suspect pathology (602, 604) (“execute an image-fusion algorithm to present on display device 326 an overlay or a side-by-side registered view of the live ultrasound image and the CT image.” [0059]. “FIG. 6 illustrates an example of a side-by-side registered view 600 of a live ultrasound image 602 and a CT image 604 during the application of sonothrombolysis treatment to an occlusion or blood clot 110. Also shown in FIG. 6 are three different types of fiducial markers which may be employed alone or together to register ultrasound image 602 with CT image 604.” [0060]); and
display diagnostic information (110) (410) related to the suspect pathology (“FIG. 1 shows a cranial angiographic computed tomography (CT) image 100 which indicates the presence of an occlusion or blood clot 110.” [0044]; “a marker 410 which indicates the location of an occlusion or blood clot in the subject's brain.” [0052]; Fig. 4).
Seip does not teach detecting regions of suspect pathology in the images of both modalities.
However, in the medical diagnostic ultrasound field of endeavor, Pinton discloses adaptive multifocus beamforming ultrasound methods and systems for improved penetration and target sensitivity at high frame-rates, which is analogous art. Pinton teaches detecting regions of suspect pathology (T1 and T2) ("the at least one ultrasound transducer 104 is configured to detect a position of each of two or more targets T1 and T2 continually." [0096]; Figs. 1 and 2) in the images of both modalities (“Changes in microvascularity preceed changes in tumor size in response to therapy, providing an early biomarker of response to therapy [31, 32]. This phenomena has been observed with ultrasound imaging of microvessels also, showing the ability to detect response in “responder” tumors earlier than indicated with measurements of tumor volume alone [33]. The clear advantages of CESR include superior resolution at clinically relevant depths (3-8 cm)” [0068]. “The ability to use microvessel angiogenesis imaging as a local indicator of the likelihood of malignant cancer may provide an innovative clinical diagnostic tool…The ability to use microvascular ultrasound imaging as a sensitive method for screening at-risk patients, for guidance of biopsy, or for ultimately the early detection of subresolution micro-tumors would be highly innovative.” [0080]. “This Example extends the capabilities of ultrasound in terms of resolution and ability to acquire volumetric blood flow data so that the spatial resolution characteristics match (or exceed) those of MRI while retaining ultrasound's high temporal sampling capabilities. By cross-validating this technique with perfusion MRI the vast field of high resolution blood flow imaging and functional MRI becomes accessible to ultrasound.” [0166]).
Therefore, based on Pinton’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip to have the step of detecting regions of suspect pathology in the images of both modalities, as taught by Pinton, in order to improve detection capabilities of the imaging system.
Claim Rejections - 35 USC § 103
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.
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, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Seip and Pinton as applied to claim 1, and further in view of Hirsch (US 20170311803), hereinafter Hirsch.
Regarding claim 2, Seip modified by Pinton teaches the method of claim 1, wherein Seip teaches that acquiring image data of a region of a body using a first imaging modality further comprises acquiring ultrasound image slices (“an implementation of the present invention may also use one dimensional array of transducer elements which produce 2D (planar) images.” [0078]).
Seip modified by Pinton does not teach acquiring near infrared spectroscopy (NIRS) image data of a head of a subject.
However, in the brain imaging field of endeavor, Hirsch discloses methods, computer-readable media, and systems for measuring brain activity, which is analogous art. Hirsch teaches acquiring near infrared spectroscopy (NIRS) image data of a head of a subject (“FIG. 6 depicts the optode placement and locations of fNIRS channels. The use of 10 emitters and 10 recorders results in 30 channels in one hemisphere of each brain placed in homologous locations with a spatial resolution of approximately 3 cm.” [0019]).
Therefore, based on Hirsch’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip and Pinton to have the step of acquiring near infrared spectroscopy (NIRS) image data of a head of a subject, as taught by Hirsch, in order to facilitate the detection and diagnosis of suspect regions.
Regarding claim 12, Seip modified by Pinton and Hirsch teaches the method of claim 2, wherein Seip teaches that acquiring image data of a region of a body using a first imaging modality further comprises acquiring ultrasound image data (602) of a brain (“imaging the brain” [0054]; Fig. 6).
Seip modified by Pinton does not teach acquiring near infrared spectroscopy (NIRS) image data of the brain.
However, in the brain imaging field of endeavor, Hirsch discloses methods, computer-readable media, and systems for measuring brain activity, which is analogous art. Hirsch teaches acquiring near infrared spectroscopy (NIRS) image data of the brain (“FIG. 6 depicts the optode placement and locations of fNIRS channels. The use of 10 emitters and 10 recorders results in 30 channels in one hemisphere of each brain placed in homologous locations with a spatial resolution of approximately 3 cm.” [0019]).
Therefore, based on Hirsch’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip and Pinton to have the step of acquiring near infrared spectroscopy (NIRS) image data of the brain, as taught by Hirsch, in order to facilitate the detection and diagnosis of suspect regions in the brain.
Regarding claim 18, Seip modified by Pinton teaches the multimodality imaging system of claim 17, wherein Seip teaches that the second imaging modality further comprises an ultrasound imaging system (320) (fig. 3) adapted to acquire ultrasound signals from a brain and produce ultrasound image data (602) using the acquired ultrasound signals of the brain (“imaging the brain” [0054]; Fig. 6).
Seip modified by Pinton does not teach that the first imaging modality further comprises a near infrared spectroscopy (NIRS) system adapted to acquire NIRS signals from the brain and produce NIRS image data using the acquired NIRS signals.
However, in the brain imaging field of endeavor, Hirsch discloses methods, computer-readable media, and systems for measuring brain activity, which is analogous art. Hirsch teaches a near infrared spectroscopy (NIRS) system adapted to acquire NIRS signals from the brain and produce NIRS image data using the acquired NIRS signals (“FIG. 6 depicts the optode placement and locations of fNIRS channels. The use of 10 emitters and 10 recorders results in 30 channels in one hemisphere of each brain placed in homologous locations with a spatial resolution of approximately 3 cm.” [0019]).
Therefore, based on Hirsch’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip and Pinton to have the first imaging modality that further comprises a near infrared spectroscopy (NIRS) system adapted to acquire NIRS signals from the brain and produce NIRS image data using the acquired NIRS signals, as taught by Hirsch, in order to facilitate the detection and diagnosis of suspect regions in the brain.
Claims 5 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Seip, Pinton, and Hirsch as applied to claim 2 and further in view of Nurmikko (US 20200253491), hereinafter Nurmikko.
Regarding claim 5, Seip modified by Pinton and Hirsch teaches the method of claim 2.
Seip modified by Pinton and Hirsch does not teach that detecting regions of suspect pathology further comprises detecting regions of suspect pathology by processing NIRS and ultrasound images.
However, in the medical imaging field of endeavor, Nurmikko discloses mobile wearable combinatorial ultrasound/near infrared sensor system, which is analogous art. Nurmikko teaches that detecting regions of suspect pathology further comprises detecting regions of suspect pathology by processing NIRS and ultrasound images (“An apparatus includes a mobile, neck wearable combinatorial ultrasound/near infrared sensors system configured for detection of embolic events in carotid arteries.” Abstract. “The device is tailored to particular patient's anatomy and physiology to allow continuous tracking of the target blood vessel with optimal signal-to-noise ratio, false-positive event rate and power consumption.” [0018]. “Referring again to FIG. 1, the multiple components 10, 16, 18, 20, 22 as parts provide a single wearable device aimed at maximally comprehensive continuous interrogation of the patient's hemodynamic state. A key component is US-NIRS based, transcutaneous, vascular microemboli detector/classifier, configured for 24/7 wearable use.” [0023]).
Therefore, based on Nurmikko’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip, Pinton, and Hirsch to have the step of detecting regions of suspect pathology further comprises detecting regions of suspect pathology by processing NIRS and ultrasound images, as taught by Nurmikko, in order to improve the detection of pathology with optimal signal-to-noise ratio, false-positive event rate and power consumption.
Regarding claim 13, Seip modified by Pinton and Hirsch teaches the method of claim 2.
Seip modified by Pinton and Hirsch does not teach that acquiring NIRS image data of a head of a subject further comprises acquiring NIRS image data from a plurality of NIRS emitters and sensors which are in a known spatial relation to an ultrasound transducer array.
However, in the medical imaging field of endeavor, Nurmikko discloses mobile wearable combinatorial ultrasound/near infrared sensor system, which is analogous art. Nurmikko teaches that acquiring NIRS image data of a head of a subject further comprises acquiring NIRS image data from a plurality of NIRS emitters and sensors (28) which are in a known spatial relation to an ultrasound transducer array (26) (“The microarray 16 in the hemodynamic neck device 10 includes a US-NIRS microarray patch configuration with “sentry” sensors operating continuously for event detection and “interrogator” sensors brought online to verify and characterize potential events. More specifically, as shown in FIG. 2, the microarray 16, also referred to as neck electronics, includes a US acoustic module 26, a NIRS optical module 28 and auxiliary sensors 30.” [0020]. “Referring again to FIG. 1, the multiple components 10, 16, 18, 20, 22 as parts provide a single wearable device aimed at maximally comprehensive continuous interrogation of the patient's hemodynamic state. A key component is US-NIRS based, transcutaneous, vascular microemboli detector/classifier, configured for 24/7 wearable use. The linear arrays of miniaturized NIRS sensors/emitters and US transducers are lined up along the carotid arteries around the neck area, actively guided by the NIRS detection of blood pressure.” [0023]).
Therefore, based on Nurmikko’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip, Pinton, and Hirsch to have the step of acquiring NIRS image data from a plurality of NIRS emitters and sensors which are in a known spatial relation to an ultrasound transducer array, as taught by Nurmikko, in order to improve the detection of pathology with optimal signal-to-noise ratio, false-positive event rate and power consumption.
Regarding claim 14, Seip modified by Pinton, Hirsch, and Nurmikko teaches the method of claim 13.
Seip teaches registering the ultrasound image data to the common system of spatial coordinates on the basis of detected features in the ultrasound data (“ultrasound imaging system 320 (e.g., processor 322 and memory 324) may execute an automatic registration algorithm which employs one or more fiducial markers in the CT image dataset and one or more corresponding fiducial markers in the ultrasound image for real-time registration… Image-fusion may provide a common coordinate system for identifying target locations for therapy delivery.” [0059]; Figs. 1-2, 4, and 6. “The fiducial markers include: a first fiducial marker 610 corresponding to the location of the temporal bone in both ultrasound image 602 and CT image 604; a second fiducial marker 620 corresponding to the location of brain stem in both ultrasound image 602 and CT image 604; and a third fiducial marker 630 corresponding to the location of a particular blood vessel in both ultrasound image 602 and CT image 604. By use of the fiducial marker(s), ultrasound image 602 is registered with CT image 604, and marker 410 from CT image 604 is superimposed on ultrasound image 602 to identify the location of the target area which includes an occlusion or blood clot 110 and at which location sonothrombolysis treatment should be applied.” [0060] Fig. 6).
Seip modified by Pinton and Hirsch does not teach registering the NIRS image data and the ultrasound image data.
However, in the medical imaging field of endeavor, Nurmikko discloses mobile wearable combinatorial ultrasound/near infrared sensor system, which is analogous art. Nurmikko teaches registering the NIRS image data and the ultrasound image data (“The microarray 16 in the hemodynamic neck device 10 includes a US-NIRS microarray patch configuration with “sentry” sensors operating continuously for event detection and “interrogator” sensors brought online to verify and characterize potential events. More specifically, as shown in FIG. 2, the microarray 16, also referred to as neck electronics, includes a US acoustic module 26, a NIRS optical module 28 and auxiliary sensors 30.” [0020]. “Referring again to FIG. 1, the multiple components 10, 16, 18, 20, 22 as parts provide a single wearable device aimed at maximally comprehensive continuous interrogation of the patient's hemodynamic state. A key component is US-NIRS based, transcutaneous, vascular microemboli detector/classifier, configured for 24/7 wearable use. The linear arrays of miniaturized NIRS sensors/emitters and US transducers are lined up along the carotid arteries around the neck area, actively guided by the NIRS detection of blood pressure.” [0023]).
Therefore, based on Nurmikko’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip, Pinton, and Hirsch to have the step of registering the NIRS image data and the ultrasound image data, as taught by Nurmikko, in order to improve the detection of pathology with optimal signal-to-noise ratio, false-positive event rate and power consumption.
Claims 3, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Seip, Pinton, and Hirsch as applied to claims 2, 4, and 18 and further in view of Hamilton et al (US 20170188993), hereinafter Hamilton.
Regarding claim 3, Seip modified by Pinton and Hirsch teaches the method of claim 2.
While Seip teaches that displaying the images of both modalities of the selected region of suspect pathology further comprises registering the images of the two modalities to the head to indicate an anatomical relationship of the images (Fig. 6), Seip modified by Pinton and Hirsch does not explicitly teach registering to a template of the head.
However, in the medical imaging field of endeavor, Hamilton discloses systems and methods for determining clinical indications, which is analogous art. Hamilton teaches registering to a template of the head (“this vascular anatomical mapping procedure includes co-registration of subject head coordinates with anatomical medical imaging (MRI, MRA, CT, CTA, etc.) (e.g., subject specific or using age and/or gender-matched template) via identifiable fiducial points (e.g., tragus, eye corner, eye at brow, top of ear).” [0089]).
Therefore, based on Hamilton’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip, Pinton, and Hirsch to have the step of registering the images of the two modalities to a template of the head to indicate an anatomical relationship of the images, as taught by Hamilton, in order to facilitate analyses of pathology.
Regarding claim 15, Seip modified by Pinton and Hirsch teaches the method of claim 4.
While Seip teaches registering the ultrasound image slices and the MR or CT image data to a head (Fig. 6), Seip modified by Pinton and Hirsch does not explicitly teach registering to an anatomical template of a head.
However, in the medical imaging field of endeavor, Hamilton discloses systems and methods for determining clinical indications, which is analogous art. Hamilton teaches registering to an anatomical template of the head (“this vascular anatomical mapping procedure includes co-registration of subject head coordinates with anatomical medical imaging (MRI, MRA, CT, CTA, etc.) (e.g., subject specific or using age and/or gender-matched template) via identifiable fiducial points (e.g., tragus, eye corner, eye at brow, top of ear).” [0089]).
Therefore, based on Hamilton’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip, Pinton, and Hirsch to have the step of registering the images of the two modalities to an anatomical template of the head to indicate an anatomical relationship of the images, as taught by Hamilton, in order to facilitate analyses of pathology.
Regarding claim 19, Seip modified by Pinton and Hirsch teaches the multimodality imaging system of claim 18.
While Seip teaches that the display of images of one or both modalities of the selected region of suspect pathology further comprises spatially registering the second modality image data and ultrasound image data to a head (Fig. 6), Seip modified by Pinton does not explicitly teach NIRS image data of a head.
However, in the brain imaging field of endeavor, Hirsch discloses methods, computer-readable media, and systems for measuring brain activity, which is analogous art. Hirsch teaches acquiring near infrared spectroscopy (NIRS) image data of a head (“FIG. 6 depicts the optode placement and locations of fNIRS channels. The use of 10 emitters and 10 recorders results in 30 channels in one hemisphere of each brain placed in homologous locations with a spatial resolution of approximately 3 cm.” [0019]).
Therefore, based on Hirsch’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip and Pinton to use NIRS image data of a head, as taught by Hirsch, in order to facilitate the detection and diagnosis of suspect regions.
Seip modified by Pinton and Hirsch does not explicitly teach spatially registering to a head template.
However, in the medical imaging field of endeavor, Hamilton discloses systems and methods for determining clinical indications, which is analogous art. Hamilton teaches spatially registering to a head template (“this vascular anatomical mapping procedure includes co-registration of subject head coordinates with anatomical medical imaging (MRI, MRA, CT, CTA, etc.) (e.g., subject specific or using age and/or gender-matched template) via identifiable fiducial points (e.g., tragus, eye corner, eye at brow, top of ear).” [0089]).
Therefore, based on Hamilton’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Seip, Pinton, and Hirsch to have the step of spatially registering to a head template, as taught by Hamilton, in order to facilitate analyses of pathology.
Allowable Subject Matter
Claims 6-10 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 01/23/2026 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Seip in view of Pinton, with respect to claims 1-5 and 11-19.
Response to the 35 U.S.C. §102 and §103 rejection arguments on pages 8-10 of the REMARKS.
Claims 1-20
The Applicant argues that “the Examiner has not shown that Seip detects regions of suspect pathology in ultrasound images.” (Page 8). The Examiner agrees and therefore the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Seip in view of Pinton. The dependent claims are not allowable because the independent claims are not allowable and because additional secondary references meet additional limitations of the dependent claims, with the exception of claims 6-10 and 20.
Conclusion
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
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