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 Arguments
Applicant’s arguments, in Applicant’s responses filed 02/02/2026, with respect to the rejections of claims 1-4, 6-11, 13-20, and 22 under 35 U.S.C. 103 in have been fully considered but they are NOT persuasive.
Applicant remarks on page 11 that the claimed invention considered as a whole directs to a laparoscopic multi-pixel charged particle radiation detector and that Mihailescu, et al., US 20160135762 A1 merely discloses a gamma radiation detector and hence completely different from the claimed invention. To which, Examiner notes that Mihailescu states in paragraph 68 that Image reconstruction of tracer distribution can be done by using Compton imaging, self-collimation effects and/or proximity imaging. If the position sensitive detector can provide electron track information, the shape of an least one electron track per detected event can be used to reconstruct the direction and energy of the incident radiation. Electron tracks can be used to image gamma rays as well as beta rays emitted in close proximity to the sensor. This collimator-less camera system can be used as is, without any tracking capabilities, or tracking methods can be used to locate the position and orientation of the imaging sensor with respect to the body of the patient. This collimator-less imaging sensor system can be used from the outside of the body of the patient, or it can be body-insertable, such as laparoscopic. Fig. 3 also shows two detectors 304 arranged in series. Meaning that, while it is true that Mihailescu teaches the laparoscopic probe is a gamma detector, it also at least teaches that it is a beta ray detector comprising multiple pixels.
Applicant also remarks on page 11 that Barrett, et al., US 20170010369 A1 relates to particle track detectors on a fixed stage and also fails to teach a laparoscopic multi-pixel charged-particle radiation detector. Examiner notes that Mihailescu teaches the claimed laparoscopic multi-pixel charged particle radiation detector, as demonstrated above.
Applicant further remarks on pages 11-12 that Mihailescu and Barrett are non-analogous to the claimed invention because Mihailescu relates to a gamma probe while Barrett directs to a charged particle probe. However, as noted above, Mihailescu is not only directed to gamma ray detection but also beta ray detection as disclosed in 68 and hence one of ordinary skill in the art, with a base reference of Mihailescu, would look to Barrett for the claimed elements directed to the semiconductor of the plurality of MOS components.
Applicant further remarks on page 12 that the claimed invention relates to problems in the field of laparoscopic probe design, different from the fixed detector stage of Barrett. However, Examiner notes that solutions to the laparoscopic probe design problem includes features of the semiconductor for which Barrett has been called upon in establishing whether the claims are novel. The fixed detector stage does not preclude design modifications to the semiconductor as it relates to Mihailescu or the instant application. Furthermore, Barrett relates to both Mihailescu and the instant application as Barrett also detects charged particles (paragraph 5).
Therefore, Mihailescu teaches the claimed laparoscopic multi-pixel charged particle radiation detector, and Mihailescu and Barrett are analogous art with respect to the claimed invention.
Therefore, the claims stand rejected.
Withdrawn Objections
Pursuant of Applicant’s amendments filed 02/02/2026, the objections made to claims 2, 4, 7-9, 12, and 19 have been withdrawn.
Withdrawn Rejections - 35 USC § 112
Pursuant of Applicant’s responses filed 02/02/2026, the rejection of claims 1-4, 6-20, and 22 under 35 U.S.C. 112(b) have been withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, 6, 12-14, 19-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu, et al., US 20160135762 A1 in view of Barrett, et al., US 20170010369 A1 and Wendler, T., WO 2015185665 A1, as evidenced by Wang et al. (Development of a Depleted Monolithic CMOS Sensor in a 150 nm CMOS Technology for the ATLAS Inner Tracker Upgrade").
Regarding claim 1, Mihailescu teaches a laparoscopic probe (paragraphs 61-62 and fig. 3 disclose a medical navigation apparatus) for detecting radiation from a radiopharmaceutical administered to a subject (paragraph 68 discloses “Image reconstruction of tracer distribution can be done by using Compton imaging, self-collimation effects and/or proximity imaging”), the laparoscopic probe comprising a detection device (medical navigation apparatus 300 of reproduced fig. 1 below and paragraph 61) comprising:
a probe head (apparatus 300 including an elongated housing assembly 302 of paragraph 61) configured to be inserted into the subject (paragraph 62),
the probe head comprising: a radiation sensor (position sensitive detector 304 of fig. 3 and paragraph 61) having a plurality of metal-oxide-semiconductors (MOS) components providing a pixel array (paragraph 61 discloses gamma ray probe/position sensitive detectors 304, shown as a 1X2 or 2X1 detector array, and paragraph 22 indicates that the detectors 304 are CMOS sensors. Of note, paragraph 13 states that “The radiation position sensitive apparatus includes an elongated housing assembly having a longitudinal axis, a gamma ray probe at least partially enclosed within the elongated housing assembly and disposed along the longitudinal axis of the elongated housing assembly”, meaning the detectors/probes 304 are arranged along a longitudinal axis of the apparatus hence forming a 1X2 or 2X1 detector array),
a semiconductor (paragraph 64 discloses semiconductor detectors including the CMOS of paragraph 22) of the plurality of MOS components configured for interaction charge carriers to be created in a depletion layer of the semiconductor in response to direct interaction with received charged particles emitted from the radiopharmaceutical (paragraph 64 states that the position sensitive detectors 304 are made using “semiconductor detectors such as silicon (Si) detectors, silicon lithium (Si(Li)) detectors, germanium (Ge) detectors, germanium lithium (GeLi) detectors, cadmium zinc tellurium (CdZnTe) detectors, cadmium tellurium (CdTe) detectors, mercuric iodide (HgI.sub.2), lead iodide (PbI.sub.2), a position sensitive scintillator crystal, multiple position sensitive scintillator crystals, segmented Si detectors, pixelated electrodes, parallel strip electrodes, co-planar strip electrodes, depleted CCD sensors, depleted CMOS sensors” and hence inherently teaches the limitation by virtue of the detectors being MOS and configured for detecting gamma radiation as evidenced by Wang1 which discloses, see pages 2-3 and fig. 1, that a typical CMOS sensor functionally includes an interaction of charge carriers that occur in a depletion zone/depth of the pixel); and
a light sealing (elongated housing assembly 302 of paragraph 61) covering arranged to prevent light from impinging on the pixel array (elongated housing 302 can be seen as including an optical window 307 for a camera. Hence the portion of the elongated housing surrounding the detectors are light sealing).
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Mihailescu does not teach wherein the semiconductor of the plurality of MOS components has a depletion depth matching an interaction depth of the charged particles emitted from the radiopharmaceutical, wherein the pixel array is configured to detect the created interaction charge carriers in the depletion layer are detectable across multiple pixels.
However, within the same field of endeavor, Barrett teaches methods and systems for 3D imaging of in vivo and ex vivo tissues, the disclosed systems and methods employing an autoradiographic approach where particles emitted by a radioactive composition within the tissue are detected according the abstract, wherein the method and systems applied in endoscopy according to paragraphs 106 and 162. Barrett teaches wherein the semiconductor of the plurality of MOS components has a depletion depth matching an interaction depth of the charged particles emitted from the radiopharmaceutical (paragraph 6 states that “a charged particle track detector is used to independently detect particles at a plurality of positions along their respective trajectories. For example, suitable track detectors include scintillator-based detectors, microchannel plate-based image intensifiers coupled to a thick scintillation material or a CCD or other video camera type detector where the sensitive region, active region or depletion region is thick enough to stop the particle. The recorded track can be analyzed to determine features of each track such as the point at which the charged particle entered the thick detector, the particle's direction at that point and the total energy deposited in that track. In embodiments, these features are used in an iterative tomographic reconstruction algorithm for accurate determination of a 3D image of the distribution of the source of particles within the tissue, for example, by determining positions and directions of the detected particles interacting with a charged particle track detector”. That is, the sensitive/active/depletion region of the detectors (CMOS sensors according to paragraph 77) are thick enough such that all of the charged particles interactions occur within the sensitive/active/depletion region), wherein the pixel array is configured to detect the created interaction charge carriers in the depletion layer are detectable across multiple pixels (figs. 6a-6c disclose a 2 dimensional array of pixels overlaid on a particle generating object 550 and tissue 551, the tissue having been administered with radiopharmaceutical according to paragraph 6. Paragraph 92 then states that “After a plurality of particles are interacted with a system for measuring particle tracks, such as described herein, the interaction points and directions of travel for the particles can be used to reconstruct an image of the particle generating object, here represented as an activity distribution”. That is, the interaction points and direction of travel is detected across different pixels as shown. And in a case where the array of pixels is a 3-dimensional pixel array or voxel grid, the interaction points and direction of travel are detected across pixels in both a thickness/depth direction and a planar direction).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, wherein the semiconductor of the plurality of MOS components has a depletion depth matching an interaction depth of the charged particles emitted from the radiopharmaceutical; and wherein the pixel array is configured to detect the created interaction charge carriers in the depletion layer across multiple pixels, as taught by Barrett, as such modification would provide a clinically practical, less labor intensive, high-resolution 3D imaging of in vivo tissue (paragraph 4), with a reasonable expectation of success, as Mihailescu is also concerned with providing a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Mihailescu in view of Barrett does not teach a grip configured to be at least partially inserted into the subject and to manipulate the probe head inside the subject.
However, Wendler teaches a device (7) for detecting a nuclear radiation distribution in a patient comprises: a robot arm (20) with a plurality of joints (22, 24) and an end effector (25) movable about at least three degrees of freedom by way of the joints (22, 24) (see abstract), the device further comprising a grip (see gripper 230 of figs. 6a and 6b reproduced below) configured to be at least partially inserted into the subject (the end effector 25 and preferably also the distal joint 24 are completely insertable into the body 2 of the patient, paragraph 5 of page 7, and the gripper as seen in fig. 6c is distal to the distal joint 24 and hence the gripper is also completely insertable into the body 2) and to manipulate the probe head inside the subject (the last paragraph of page 4 indicates that the distal articulation unit of the robotic arm, that is the end effector and distal articulation including the gripper 230, allows rotational movement about three spatial axes of the nuclear probe).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, as modified by Barrett, to include an array of detectors; a grip configured to be at least partially inserted into the subject and to manipulate the probe head inside the subject, as taught by Wendler, which would allow high flexibility of movement, even in the presence of obstacles, of the nuclear probe (last paragraph of page 4) and hence provide improved image quality through access to the region of interest (paragraph 3 of page 3), with a reasonable expectation of success, as Mihailescu is also concerned with providing a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Regarding claim 3, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 1.
Mihailescu further teaches wherein the radiation sensor comprises an image sensor (paragraph 61 states that “Medical navigation apparatus 300 contains an elongated housing assembly 302, gamma ray probes 304 disposed at a distal end of the housing assembly, and a tracking camera 306 having a tracking field of view 305 that is lateral to the longitudinal axis of the housing assembly, the tracking camera 306 having a known proximity to the position sensitive detectors 304”, the position sensitive detectors 304 being CMOS according to paragraph 22).
Regarding claim 4, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 1.
Mihailescu further teaches wherein the laparoscopic probe is operable in a first mode, in which the laparoscopic probe is configured to enable detection by the radiation sensor of a radiation imaging effect (paragraph 68 discloses the position sensitive detectors 304, provide electron track information, so that “the shape of an least one electron track per detected event can be used to reconstruct the direction and energy of the incident radiation. Electron tracks can be used to image gamma rays as well as beta rays emitted in close proximity to the sensor”. This comprises the first mode, that is an image reconstruction mode), and wherein the laparoscopic probe is operable in a second mode, in which the laparoscopic probe is configured to enable detection by the radiation sensor of the presence of the charged particles emitted from the radiopharmaceutical (paragraph 7 states that “Generally, the embodiments of the present invention relate to a scanning sufficiency device that is able to instantaneously report to a user how well a particular area of a subject's body has been scanned. The devices described herein improve scanning quality and reduce errors by better defining the precise location of a detected signal”, and paragraph 67 states that “the position sensitive detector is a collimator-less gamma ray probe with a 4 pi field of view. The memory of this radiation position sensitive apparatus includes instructions for execution by a processor to convert scanning data collected by the gamma ray probe into a reconstructed diagram identifying the location of a radiation source relative to a fiducial”. The identifying of a location of a detected signal comprises the second mode of operation of the apparatus as claimed).
Regarding claim 6, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 1.
Mihailescu further teaches a gamma radiation detector configured to detect gamma radiation (paragraph 68 states that “Image reconstruction of tracer distribution can be done by using Compton imaging, self-collimation effects and/or proximity imaging. If the position sensitive detector can provide electron track information, the shape of an least one electron track per detected event can be used to reconstruct the direction and energy of the incident radiation. Electron tracks can be used to image gamma rays as well as beta rays emitted in close proximity to the sensor”, meaning the gamma ray probes 304 of paragraph 61 detect gamma and beta rays).
Regarding claim 12, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 1.
Mihailescu further teaches wherein the depletion depth is an optimal depletion layer depth for an energy spectrum of the charged particles particular to the radiopharmaceutical (paragraph 68 states that “Image reconstruction of tracer distribution can be done by using Compton imaging, self-collimation effects and/or proximity imaging. If the position sensitive detector can provide electron track information, the shape of an least one electron track per detected event can be used to reconstruct the direction and energy of the incident radiation”. Meaning that the detectors 304 comprise an optimal layer depth which allows the detection of the charged particles such that a reconstruction of the direction and energy of the incident radiation is possible. This is teaching is view of the 35 U.S.C. 112(b) rejection of claim 12 above, that outlines the claims failure to define the “optimal depletion layer depth”. Of note, Mihailescu teaches interaction of charge carriers that occur in a depletion zone/depth of the pixel as evidenced by Wang above).
Regarding claim 13, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 1.
Modified Mihailescu further teaches a method of operating the laparoscopic probe (paragraphs 61-62 and fig. 3 disclose a medical navigation apparatus) of claim 1 (abstract), the method comprising:
receiving a detection signal from the radiation sensor of the laparoscopic probe, the detection signal being representative of the interaction charge carriers being created in the depletion layer of the semiconductor of the plurality of MOS components providing the pixel array (paragraph 68 discloses resolving gamma ray interactions within the sensor and paragraph 64 states that the position sensitive detectors 304 are made using “semiconductor detectors such as silicon (Si) detectors, silicon lithium (Si(Li)) detectors, germanium (Ge) detectors, germanium lithium (GeLi) detectors, cadmium zinc tellurium (CdZnTe) detectors, cadmium tellurium (CdTe) detectors, mercuric iodide (HgI.sub.2), lead iodide (PbI.sub.2), a position sensitive scintillator crystal, multiple position sensitive scintillator crystals, segmented Si detectors, pixelated electrodes, parallel strip electrodes, co-planar strip electrodes, depleted CCD sensors, depleted CMOS sensors” and hence inherently teaches the limitation by virtue of the detectors being MOS and configured for detecting gamma radiation as evidenced by Wang2 which discloses, see pages 2-3 and fig. 1, that a typical CMOS sensor functionally includes an interaction of charge carriers that occur in a depletion zone/depth of the pixel);
determining whether the detection signal is indicative of detection events at multiple neighboring pixels of the pixel array (paragraph 68 discloses resolving at least one electron track per detected event by the detectors 304, which are arranged along a longitudinal axis of the apparatus hence forming a 1X2 or 2X1 detector array and hence the detect signal is indicative of detection events at multiple neighboring pixels of the 1X2 or 2X1 pixel array shown in fig. 3); and
if a determination is made that the detection signal is indicative of detection events at multiple neighboring pixels of the pixel array, determining that the radiation sensor has received the charged particles (paragraph 68 indicates detecting beta rays, stating that “If the position sensitive detector can provide electron track information, the shape of an least one electron track per detected event can be used to reconstruct the direction and energy of the incident radiation. Electron tracks can be used to image gamma rays as well as beta rays emitted in close proximity to the sensor”. Meaning that for the detection events, a determination is made that the detection signal is indicative of gamma or beta event, which is a charged particle. Note also that paragraph 68 discloses “Image reconstruction of tracer distribution can be done by using Compton imaging, self-collimation effects and/or proximity imaging”). NB: while Mihailescu has been demonstrated above as teaching all the limitations above, the “if…” limitations are contingent limitations and hence are not further limiting of the process. See MPEP 2111.04(II) and Ex Parte Schulhauser, Appeal No. 2013-007847 (PTAB April 28, 2016).
Regarding claim 14, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 13.
Mihailescu further teaches wherein the radiation sensor comprises an image sensor and wherein receiving a detection signal from the radiation sensor comprises receiving image data from the image sensor, the image data being representative of a radiation imaging effect sensor (paragraph 61 states that “Medical navigation apparatus 300 contains an elongated housing assembly 302, gamma ray probes 304 disposed at a distal end of the housing assembly, and a tracking camera 306 having a tracking field of view 305 that is lateral to the longitudinal axis of the housing assembly, the tracking camera 306 having a known proximity to the position sensitive detectors 304”, the position sensitive detectors 304 being CMOS according to paragraph 22).
Regarding claim 19, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 13.
Mihailescu further teaches operating the laparoscopic probe in a first mode, in which the laparoscopic probe is configured to enable detection by the radiation sensor of a radiation imaging effect (paragraph 68 discloses the position sensitive detectors 304, provide electron track information, so that “the shape of an least one electron track per detected event can be used to reconstruct the direction and energy of the incident radiation. Electron tracks can be used to image gamma rays as well as beta rays emitted in close proximity to the sensor”. This comprises the first mode, that is an image reconstruction mode); and operating the laparoscopic probe in a second mode, in which the laparoscopic probe is configured to enable detection by the radiation sensor of the presence of the charged particles (paragraph 7 states that “Generally, the embodiments of the present invention relate to a scanning sufficiency device that is able to instantaneously report to a user how well a particular area of a subject's body has been scanned. The devices described herein improve scanning quality and reduce errors by better defining the precise location of a detected signal”, and paragraph 67 states that “the position sensitive detector is a collimator-less gamma ray probe with a 4 pi field of view. The memory of this radiation position sensitive apparatus includes instructions for execution by a processor to convert scanning data collected by the gamma ray probe into a reconstructed diagram identifying the location of a radiation source relative to a fiducial”. The identifying of a location of a detected signal comprises the second mode of operation of the apparatus as claimed).
Regarding claim 20, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 1.
Modified Mihailescu teaches a non-transitory computer-readable medium having executable instructions thereon which, when executed by a processor (paragraph 10 states “at least one processor and a memory operatively coupled with the sensor and the tracking system, the memory having instructions for execution by the at least one processor”), cause the processor to:
receiving a detection signal from the radiation sensor of the laparoscopic probe, the detection signal being representative of the interaction charge carriers being created in the depletion layer of the semiconductor of the plurality of MOS components providing the pixel array (paragraph 68 discloses resolving gamma ray interactions within the sensor and paragraph 64 states that the position sensitive detectors 304 are made using “semiconductor detectors such as silicon (Si) detectors, silicon lithium (Si(Li)) detectors, germanium (Ge) detectors, germanium lithium (GeLi) detectors, cadmium zinc tellurium (CdZnTe) detectors, cadmium tellurium (CdTe) detectors, mercuric iodide (HgI.sub.2), lead iodide (PbI.sub.2), a position sensitive scintillator crystal, multiple position sensitive scintillator crystals, segmented Si detectors, pixelated electrodes, parallel strip electrodes, co-planar strip electrodes, depleted CCD sensors, depleted CMOS sensors” and hence inherently teaches the limitation by virtue of the detectors being MOS and configured for detecting gamma radiation as evidenced by Wang3 which discloses, see pages 2-3 and fig. 1, that a typical CMOS sensor functionally includes an interaction of charge carriers that occur in a depletion zone/depth of the pixel);
determining whether the detection signal is indicative of detection events at multiple neighboring pixels of the pixel array (paragraph 68 discloses resolving at least one electron track per detected event by the detectors 304, which are arranged along a longitudinal axis of the apparatus hence forming a 1X2 or 2X1 detector array and hence the detect signal is indicative of detection events at multiple neighboring pixels of the 1X2 or 2X1 pixel array shown in fig. 3); and
if a determination is made that the detection signal is indicative of detection events at multiple neighboring pixels of the pixel array, determining that the radiation sensor has received the charged particles (paragraph 68 indicates detecting beta rays, stating that “If the position sensitive detector can provide electron track information, the shape of an least one electron track per detected event can be used to reconstruct the direction and energy of the incident radiation. Electron tracks can be used to image gamma rays as well as beta rays emitted in close proximity to the sensor”. Meaning that for the detection events, a determination is made that the detection signal is indicative of gamma or beta event, which is a charged particle. Note also that paragraph 68 discloses “Image reconstruction of tracer distribution can be done by using Compton imaging, self-collimation effects and/or proximity imaging”). NB: while Mihailescu has been demonstrated above as teaching all the limitations above, the “if…” limitations are contingent limitations and hence are not further limiting of the process. See MPEP 2111.04(II) and Ex Parte Schulhauser, Appeal No. 2013-007847 (PTAB April 28, 2016).
Regarding claim 22, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 1.
Mihailescu in view of Barrett fails to teach wherein the grip is deployable or retractable.
However, Wendler further teaches wherein the grip (see gripper 230 of figs. 6a and 6b reproduced below) is deployable or retractable (third paragraph of page 9 states that “The inner grippers 250 shown in Figs. 10c and 1d0 are variations of the grippers of Figs. 10a and 10b in which the nuclear probe 100 is fixed by moving the fingers 252a, 252b apart from each other. For this purpose, the coupling element 130 is designed as an opening with two zuwei nanderwei [sic] send gripping portions, and the inner hook 250 is designed to retract into the opening and by moving apart the fingers 252 a, 252 b can be pressed from the inside against the gripping portions”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, as modified by Barrett and Wendler, wherein the grip is deployable or retractable, as taught by Wendler, which would allow high flexibility of movement, even in the presence of obstacles, of the nuclear probe (last paragraph of page 4) and hence provide improved image quality through access to the region of interest (paragraph 3 of page 3), with a reasonable expectation of success, as Mihailescu is also concerned with providing a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu in view of Barrett and Wendler, as applied to claim 1 above, and further in view of Cui, et al., US 20110286576.
Regarding claim 2, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 1.
Mihailescu in view of Barrett and Wendler fail to teach wherein the laparoscopic probe further comprises: a collimator operable to filter out the charged particles emitted from the radiopharmaceutical that impinge upon the collimator at an angle above a threshold angle of incidence, thereby to cooperate with the light sealing covering and the radiation sensor to enable detection by the radiation sensor of a radiation imaging effect.
However, within the same field of endeavor, Cui teaches radiation imaging probe (paragraph 7), for endocavity insertion (paragraph 28), the radiation imaging probe, defined by a detector module that, preferably, comprises a plurality of semiconductor radiation detectors with a specific electrode configuration for imaging (paragraph 8), and the detector module of the present invention may be further defined by a collimator positioned on top of the plurality of semiconductor radiation detectors wherein the endoscopic probe further comprises: a collimator (collimator of paragraph 10) operable to filter out the charged particles emitted from the radiopharmaceutical that impinge upon the collimator at an angle above a threshold angle of incidence (paragraph 10 describes the collimator as apertures in a predefined angle which guide incidence of photons), thereby to cooperate with the light sealing covering and the radiation sensor (figs. 2A-2C portray the arrangement of the collimator, tube/sheath/sleeve, which is the light sealing cover, and the pixel array, which is the radiation sensor) to enable detection by the radiation sensor of a radiation imaging effect (the arrangement in figs. 2A-2B allow the accomplishment of the intended purpose of enabling detection by the radiation sensor of a radiation imaging effect, stating in 57 that “by using a trans-rectal probe, the imaging detector array can be very close to the prostate gland, thereby greatly increasing its efficiency in detecting and imaging the gamma rays emitted from the radioactive tracer(s), e.g., Indium-111 or other gamma emitting isotope, taken up in the gland as compared to large Anger cameras placed outside the body”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu as modified by Barrett and Wendler, such that the laparoscopic probe further comprises: a collimator operable to filter out the charged particles emitted from the radiopharmaceutical that impinge upon the collimator at an angle above a threshold angle of incidence, thereby to cooperate with the light sealing covering and the radiation sensor to enable detection by the radiation sensor of a radiation imaging effect, as taught by Cui, as such modification would improve the accuracy of the detection of the photons (paragraph 6), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu in view of Barrett and Wendler, as applied to claim 1 above, and further in view of Raylman, et al., US 5,932,879 A and Kojima, et al., US 20030108147.
Regarding claim 7, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 6.
Mihailescu in view of Barrett and Wendler fails to teach wherein the laparoscopic probe is configured for a first mode, in which the laparoscopic probe is configured to detect the charged particles emitted from the radiopharmaceuticals, and a second mode, in which the laparoscopic probe is configured to use the gamma radiation detector to detect gamma radiation.
However, Raylman further teaches wherein the laparoscopic probe is configured to be operate in a first mode, in which the laparoscopic probe is configured to detect the charged particles (see col. 11, lines 53-57 for the discriminating means col. 12, lines 7-9 for the detection of Beta particles, which is considered a first mode of radiation detection), and
a second mode, in which the laparoscopic probe is configured to use the gamma radiation detector to detect gamma radiation (col. 12, lines 10-12 for the detection of gamma radiation, which is considered a second mode of radiation detection).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, as modified by Barret and Wendler such that the laparoscopic probe is configured to operate in a first mode, in which the laparoscopic probe is configured to detect the charged particles and a second mode, in which the laparoscopic probe is configured to use the gamma radiation detector to detect gamma radiation to include a gamma radiation detector configured to detect gamma radiation, as taught by Raylman, to improve the detection sensitivity of the system (see col. 2, lines 50-55), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Mihailescu in view of Barrett, Wendler and Raylman fail to teach that the system is switchable between the first and second mode of radiation detection.
However, Kojima teaches a radiological imaging apparatus including radiation detectors for alpha, beta, gamma and x-ray radiation (see abstract), whereby the system includes a signal discriminator 61 of fig. 1 and a selector switch 62 configured to switch between conveying gamma ray detection signal output and X-ray detection signal output from a radiation detector 4 (see paragraph 109 includes receiving gamma ray detection signals and X-rays, and paragraph 110 discloses “the .gamma.-ray detection signal output from a second radiation detector 4 in the first layer is conveyed to a .gamma.-ray discriminator 8, and the X-ray detection signal output from a first radiation detector 4 is conveyed to the X-ray signal processor 66. These detection signal transmission operations are performed in accordance with a switching operation of the selector switch 62 of the signal discriminator 61”. That is, here, Kojima explicitly mentions a switch for performing detections of both X-ray and gamma rays).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu as modified by Wendler and Raylman, such that the system is switchable between the first and second mode of radiation detection, as taught by Kojima, allowing the improvement of measurement accuracy by the detection and correcting for gamma ray radiation that may impact image quality (see abstract and paragraphs 4-5), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Claims 8-11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu in view of Barrett and Wendler, as applied to claim 1, and further in view of Raylman (US 5,932,879).
Regarding claim 8, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 1.
Mihailescu further teaches a computing device comprising a processor for processing detection events and for signaling a detection to a user (paragraph 10 discloses “at least one processor to show an instantaneous image, at least one processor and a memory operatively coupled with the sensor and the tracking system, the memory having instructions for execution by the at least one processor”),
Mihailescu in view of Barrett and Wendel does not teach wherein the processor is configured to distinguish detection events resulting from the charged particles emitted from the radiopharmaceutical from detection events resulting from gamma radiation.
However, within the same field of endeavor, Raylman teaches an intraoperative system for preferentially detecting beta radiation over gamma radiation emitted from a radiopharmaceutical, the system comprising ion-implanted silicon charged-particle detectors for generating signals in response to received beta particles; a preamplifier located in proximity to the detector filters which amplifies the signal (see abstract). Raylman teaches wherein a processor (means for processing 13 col. 13, lines 7-11) is configured to distinguish detection events resulting from the charged particles from detection events resulting from gamma radiation (col. 19, lines 37-41 state that “the gamma ray or photon component of the signal from the front detector will be substantially reduced or eliminated after subtraction of the signal from the rear detector, resulting in a more accurate reading of the beta emissions”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, as modified by Barrett and Wendler, such that the processor is configured to distinguish detection events resulting from the charged particles from detection events resulting from gamma radiation, as taught by Raylman, to improve the detection sensitivity of the system (see col. 2, lines 50-55), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Regarding claim 9, Mihailescu in view of Barrett, Wendler and Raylman teaches all the limitations of claim 8 above.
Modified Mihailescu above teaches wherein, to distinguish detection events resulting from the charged particles emitted from the radiopharmaceutical from detection events resulting from gamma radiation emitted from the radiopharmaceutical (see rejection of claim 1 above), the processor (paragraph 10 discloses “at least one processor to show an instantaneous image, at least one processor and a memory operatively coupled with the sensor and the tracking system, the memory having instructions for execution by the at least one processor”) is configured to:
receive a signal from the radiation sensor, the signal being representative of interaction charge carriers being created in the depletion layer of the semiconductor of the plurality of MOS components providing the pixel array (paragraph 68 discloses resolving gamma ray interactions within the sensor and paragraph 64 states that the position sensitive detectors 304 are made using “semiconductor detectors such as silicon (Si) detectors, silicon lithium (Si(Li)) detectors, germanium (Ge) detectors, germanium lithium (GeLi) detectors, cadmium zinc tellurium (CdZnTe) detectors, cadmium tellurium (CdTe) detectors, mercuric iodide (HgI.sub.2), lead iodide (PbI.sub.2), a position sensitive scintillator crystal, multiple position sensitive scintillator crystals, segmented Si detectors, pixelated electrodes, parallel strip electrodes, co-planar strip electrodes, depleted CCD sensors, depleted CMOS sensors” and hence inherently teaches the limitation by virtue of the detectors being MOS and configured for detecting gamma radiation as evidenced by Wang4 which discloses, see pages 2-3 and fig. 1, that a typical CMOS sensor functionally includes an interaction of charge carriers that occur in a depletion zone/depth of the pixel);
determine whether the signal is indicative of detection events at multiple neighboring pixels of the pixel array (paragraph 68 discloses resolving at least one electron track per detected event by the detectors 304, which are arranged along a longitudinal axis of the apparatus hence forming a 1X2 or 2X1 detector array and hence the detect signal is indicative of detection events at multiple neighboring pixels of the 1X2 or 2X1 pixel array shown in fig. 3); and
if a determination is made that the signal is indicative of detection events, determine that the radiation sensor has received the charged particle of the received charged particles emitted from the radiopharmaceutical (paragraph 68 indicates detecting beta rays, stating that “If the position sensitive detector can provide electron track information, the shape of an least one electron track per detected event can be used to reconstruct the direction and energy of the incident radiation. Electron tracks can be used to image gamma rays as well as beta rays emitted in close proximity to the sensor”. Meaning that for the detection events, a determination is made that the detection signal is indicative of gamma or beta event, which is a charged particle. Note also that paragraph 68 discloses “Image reconstruction of tracer distribution can be done by using Compton imaging, self-collimation effects and/or proximity imaging”). NB: while Mihailescu has been demonstrated above as teaching all the limitations above, the “if…” limitations are contingent limitations and hence are not further limiting of the process. See MPEP 2111.04(II) and Ex Parte Schulhauser, Appeal No. 2013-007847 (PTAB April 28, 2016).
Regarding claim 10, Mihailescu in view of Barratt, Wendler, Raylman teaches all the limitations of claim 9.
Mihailescu in view of Barrett and Wendler fail to teach wherein the processor is further configured to: if a determination is made that that signal is not indicative of detection events at multiple neighboring pixels of the pixel array, determining that the radiation sensor has received gamma radiation emitted from the radiopharmaceutical.
However, Raylman further teaches wherein the processor is further configured to: if a determination is made that that signal is not indicative of detection events at multiple neighboring pixels of the pixel array, determining that the radiation sensor has received gamma radiation emitted from the radiopharmaceutical (col. 3, lines 1-5 state that “the step of discriminating a component of an electrical signal produced by said detector when struck by said beta particles and said gamma radiation. Said component of said electrical signal may be produced by said detector when struck by said gamma radiation”. And col. 16 lines 15-21 state that “the photon sensitivity was calculated by dividing the pure photon count rate by the amount of activity on the disk. The ability of the detector to distinguish between positron events and photon events, or its "selectivity," was determined by dividing the pure positron sensitivity by the photon sensitivity”, meaning that for all events, the detector distinguishes positron, that is charged particle events, from photon events, that gamma events).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, as modified by Barret and Wendler wherein the processor is further configured to: if a determination is made that that signal is not indicative of detection events at multiple neighboring pixels of the pixel array, determining that the radiation sensor has received gamma radiation emitted from the radiopharmaceutical, as taught by Raylman, to improve the detection sensitivity of the system (see col. 2, lines 50-55), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87). NB: while modified Mihailescu has been demonstrated above as teaching all the limitations above, the “if…” limitations are contingent limitations and hence are not further limiting of the process. See MPEP 2111.04(II) and Ex Parte Schulhauser, Appeal No. 2013-007847 (PTAB April 28, 2016).
Regarding claim 11, Mihailescu in view of Barrett, Wendler and Raylman teaches all the limitations of claim 8.
Mihailescu in view of Barrett and Wendler fails to teach wherein the processor (paragraph 10 discloses “at least one processor to show an instantaneous image, at least one processor and a memory operatively coupled with the sensor and the tracking system, the memory having instructions for execution by the at least one processor”) is further configured to: discard detection events resulting from gamma radiation emitted from the radiopharmaceutical.
However, Raylman further teaches wherein the processor (means for processing 13 col. 13, lines 7-11) is further configured to: discard detection events resulting from gamma radiation emitted from the radiopharmaceutical(col. 19, lines 37-41 state that “the gamma ray or photon component of the signal from the front detector will be substantially reduced or eliminated after subtraction of the signal from the rear detector, resulting in a more accurate reading of the beta emissions”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, as modified by Barrett and Wendler wherein the processor (paragraph 10) is further configured to: discard detection events resulting from gamma radiation emitted from the radiopharmaceutical, as taught by Raylman, to improve the detection sensitivity of the system (see col. 2, lines 50-55), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Regarding claim 18, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 13.
Mihailescu in view of Barrett and Wendler fail to teach if a determination is made that that signal is not indicative of detection events at multiple neighboring pixels of the pixel array, determining that the radiation sensor has received gamma radiation.
However, Raylman further teaches if a determination is made that that signal is not indicative of detection events at multiple neighboring pixels of the pixel array, determining that the radiation sensor has received gamma radiation (col. 3, lines 1-5 state that “the step of discriminating a component of an electrical signal produced by said detector when struck by said beta particles and said gamma radiation. Said component of said electrical signal may be produced by said detector when struck by said gamma radiation”. And col. 16 lines 15-21 state that “the photon sensitivity was calculated by dividing the pure photon count rate by the amount of activity on the disk. The ability of the detector to distinguish between positron events and photon events, or its "selectivity," was determined by dividing the pure positron sensitivity by the photon sensitivity”, meaning that for all events, the detector distinguishes positron, that is charged particle events, from photon events, that gamma events).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, as modified by Barret and Wendler wherein the processor is further configured to: if a determination is made that that signal is not indicative of detection events at multiple neighboring pixels of the pixel array, determining that the radiation sensor has received gamma radiation emitted from the radiopharmaceutical, as taught by Raylman, to improve the detection sensitivity of the system (see col. 2, lines 50-55), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87). NB: while modified Mihailescu has been demonstrated above as teaching all the limitations above, the “if…” limitations are contingent limitations and hence are not further limiting of the process. See MPEP 2111.04(II) and Ex Parte Schulhauser, Appeal No. 2013-007847 (PTAB April 28, 2016).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu in view of Barret and Wendler, as applied to claim 14, and further in view of Kobayashi, T., US 20150363918.
Regarding claim 15, Mihailescu in view of Barrett and Wendler teaches all the limitations of claim 14.
Mihailescu in view of Barrett and Wendler fails to teach wherein determining whether the detection signal is indicative of detection events at multiple neighboring pixels of the pixel array comprises: comparing the received image data with fixed pattern noise data to produce a corrected image, the fixed pattern noise data derived from an average of a plurality of dark noise images collected using the laparoscopic probe.
However, within the same field of endeavor, Kobayashi teaches a system for acquiring and processing radiation information from a subject (paragraph 24 discloses “The radiographic apparatus 100 includes a radiation generation apparatus 101,…a detection apparatus 104 which outputs image data according to radiation having passed through the subject 102. The detection apparatus 104 is an imaging unit which includes an imaging device in which a plurality of image sensors (pixels) are two-dimensionally arranged, generates image data by detecting radiation for each image sensor (pixel), and outputs the generated image data”); the system further including performance of dark imaging, where an average image of the obtained dark images is used as a dark image (step S201 of fig. 2 and paragraph 30) is used in a dark correction step (Step S203 of fig. 2 and paragraph 32) of acquired radiographic data (Step S202 of fig. 2 and paragraph 31).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu as modified by Barrett and Wendler, to compare the received image data with fixed pattern noise data to produce a corrected image, the fixed pattern noise data derived from an average of a plurality of dark noise images collected using the laparoscopic probe, as taught by Kobayashi, to attain highly accurate results (see paragraph 32), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu in view of Barrett, Wendler and Kobayashi, as applied to claim 15 above, and further in view of Miyamoto, US 20120250974.
Regarding claim 16, Mihailescu in view of Barrett, Wendler and Kobayashi teaches all the limitations of claim 15.
Mihailescu in view of Barrett, Wendler and Kobayashi fails to teach wherein determining whether the detection signal is indicative of detection events at multiple neighboring pixels of the pixel array further comprises: comparing pixel values of pixels of the corrected image with a threshold value to produce a binary image, wherein the pixel value of each pixel of the binary image is representative of whether the pixel value of a corresponding pixel of the corrected image is above the threshold value.
However, within the same field of endeavor, Miyamoto teaches a method of generating a binary image for contrast image generation of a region of interest (see fig. 6 and abstract) whereby, according to paragraph 53, a binary live image and a binary mask image are obtained by comparing all pixels in a live image and a mask image with the corresponding binarization thresholds, so that images include 0 indicative of pixel values equal to or larger than the thresholds and 1 indicative of the other pixel.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, as modified by Barrett, Wendler and Kobayashi, to compare pixel values of pixels of the corrected image with a threshold value to produce a binary image, wherein the pixel value of each pixel of the binary image is representative of whether the pixel value of a corresponding pixel of the corrected image is above the threshold value, as taught by Miyamoto, to improve the accuracy of information from the contrast based imaging. (see paragraph 61), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Regarding claim 17, Mihailescu in view of Barrett, Wendler and Kobayashi, Miyamoto teaches all the limitations of claim 16 above.
Mihailescu in view of Barrett, Wendler and Kobayashi fail to teach wherein determining whether the detection signal is indicative of detection events at multiple neighboring pixels of the pixel array further comprises: for at least one pixel of the binary image, determining how many adjacent pixels have the same value as the pixel.
However, within the same field of endeavor, Miyamoto further teaches wherein determining whether the detection signal is indicative of detection events at multiple neighboring pixels of the pixel array further comprises: for at least one pixel of the binary image, determining how many adjacent pixels have the same value as the pixel (See step S602 of fig. 6 and paragraphs 51 and 56 which provide examples of regions that are excluded due to the thresholding step from inclusion in the binary image because the pixels do not meet the threshold requirement. These regions are defined for groups of pixels).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Mihailescu, as modified by Barrett, Wendler and Kobayashi, such that determining whether the detection signal is indicative of detection events at multiple neighboring pixels of the pixel array further comprises: for at least one pixel of the binary image, determining how many adjacent pixels have the same value as the pixel, as taught by Miyamoto, to improve the accuracy of information from the contrast based imaging (see paragraph 61), with a reasonable expectation of success, as Mihailescu is also concerned accurately determining the sources of radiation (paragraph 42), which then provides a gamma radiation detector with improved resolution, contrast and lower noise levels (paragraph 87).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20040054248 A1 teaches a radioactive emission probe in communication with a position tracking system and the use thereof in a variety of systems and methods of medical imaging and procedures.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Farouk A Bruce whose telephone number is (408)918-7603. The examiner can normally be reached Mon-Fri 8-5pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached on (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FAROUK A BRUCE/ Examiner, Art Unit 3793
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
1 Wang, et al., Development of a Depleted Monolithic CMOS Sensor in a 150 nm CMOS Technology for the ATLAS Inner Tracker Upgrade", Journal of Instrumentation, Vol. 12 C01039, pp. 1-9.
2 Wang, et al., Development of a Depleted Monolithic CMOS Sensor in a 150 nm CMOS Technology for the ATLAS Inner Tracker Upgrade", Journal of Instrumentation, Vol. 12 C01039, pp. 1-9.
3 Wang, et al., Development of a Depleted Monolithic CMOS Sensor in a 150 nm CMOS Technology for the ATLAS Inner Tracker Upgrade", Journal of Instrumentation, Vol. 12 C01039, pp. 1-9.
4 Wang, et al., Development of a Depleted Monolithic CMOS Sensor in a 150 nm CMOS Technology for the ATLAS Inner Tracker Upgrade", Journal of Instrumentation, Vol. 12 C01039, pp. 1-9.
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