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 .
Specification
The abstract of the disclosure is objected to because legalese, claim language is used. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6,8-9,12-18, 20 and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, limitation “…comparing from the photoacoustic image an intensity of the collagen and/or hemoglobin, if present, with an intensity of tissue proximal to the collagen and/or hemoglobin.” is a conditional limitation that is unclear whether the subsequent and proceeding recitations of the “if present” statement are to be considered in the claim or not. The metes and bounds of the claim are unclear. Analogous limitation is found in claim 12.
Regarding Claims 1, 3, 6, 9, 12, 15, 18, 20 and 26 it is unclear the metes and bounds of the limitations. It is unclear if the limitations are intended to be interpreted as the “and” or “or” of the recited limitations following for example the limitations, “…comparing from the photoacoustic image an intensity of the collagen and/or hemoglobin, if present, with an intensity of tissue proximal to the collagen and/or hemoglobin…”, “…wherein the arrays comprise one array having a planar surface configured between and adjacent to two arrays each having a curved surface, and/or wherein operating the system comprises operating transducing elements…”, “…observing the presence or absence of vascularity extension from a tumor; and/or observing for heterogeneity of the issue from the ultrasound image; and/or correlating the ultrasound image…”, “…the pulsed laser having:a wavelength ranging from 600 nm to 2000 nm,a wave period of 10 ns or less, and/or a frequency of 1 to 100 Hz.”; “…wherein the arrays comprise one array having a planar surface configured between and adjacent to two arrays each having a curved surface, and/or wherein operating the system comprises operating transducing elements…”. For the purpose of examination “and/or” will be interpreted as “or”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6,9,12-18, 20, 22, 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hashizume (U.S. 20190164286, May 30, 2109)(hereinafter, “Hashizume”) in view of Cheng et. al. (U.S. 20190117197, April 25, 2019)(hereinafter, Cheng”).
Regarding Claim 1, Hashizume teaches: An ex vivo method of identifying a state of a tumor margin in a sample (Fig. 2 and Fig. 6, [0030][0077]), the method comprising:
operating a system to generate an ultrasound image and a photoacoustic image (“The information processing apparatus 200 has a storage unit 220, an ROI generation unit 230, a display control unit 240, and a user instruction acquiring unit 260. The information processing apparatus 200 is connected to an external storage unit 210 and a display unit 250.” [0030]; “The first medical image 100 is an ultrasound image…and the third medical image 120 is a photoacoustic image…” [0033]; See Fig. 6), wherein the system comprises:
a data acquisition module which converts the ultrasound signals and the photoacoustic signals into the ultrasound image and the photoacoustic image (“The information processing apparatus according to the present embodiment generates a new ROI based on the ROI extracted from the medical images acquired by a plurality of different modalities.” [0026]; “The storage unit 220 acquires a medical image from the external storage unit 210 based on the user's selection. In the present embodiment, the user selects the third medical image 120 that is a photoacoustic image as an observation target.” [0052]), respectively,
identifying from the photoacoustic image the presence or absence of lipids and observing for a pattern and distribution of the lipids (“Generated from the absorption factor image is an image indicating the presence and proportions of biomolecules such as oxygenated hemoglobin, reduced hemoglobin, water, fat, and collagen…based on the ratio of oxygenated hemoglobin and reduced hemoglobin, an image relating to the oxygen saturation as an index of the bonding state of hemoglobin and oxygen is obtained.” [0016]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089] See Fig. 7);
identifying from the photoacoustic image the presence or absence of collagen and observing for a pattern and distribution of the collagen (“…in photoacoustic imaging, acquired is volume data indicating the three-dimensional spatial distribution of at least one kind of biological information such as the sound pressure of a photoacoustic wave (initial sound pressure), optical absorption energy density, optical absorption factor, and the concentration of a substance constituting a living body (such as oxygen saturation…the photoacoustic image includes an absorption factor image indicating absorption density distribution. Generated from the absorption factor image is an image indicating the presence and proportions of biomolecules such as oxygenated hemoglobin, reduced hemoglobin, water, fat, and collagen. For example, based on the ratio of oxygenated hemoglobin and reduced hemoglobin, an image relating to the oxygen saturation as an index of the bonding state of hemoglobin and oxygen is obtained.” [0016]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089]);
identifying from the photoacoustic image the presence or absence of hemoglobin and observing for a pattern and distribution of the hemoglobin (“FIG. 1A illustrates a photoacoustic image 120 of a blood vessel 101. The blood vessel 101 is represented by the absorption factor of hemoglobin existing in the blood in the blood vessel as image luminance. FIG. 1B is an ultrasound image of a tumor 111. FIG. 1C is an MRI image of a tumor 121 emphasized by a contrast agent.” [0021]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089]; See Figs. 1A and 7); and
comparing from the photoacoustic image an intensity of the collagen and/or hemoglobin, if present, with an intensity of tissue proximal to the collagen and/or hemoglobin (“FIG. 1A illustrates a photoacoustic image 120 of a blood vessel 101. The blood vessel 101 is represented by the absorption factor of hemoglobin existing in the blood in the blood vessel as image luminance. FIG. 1B is an ultrasound image of a tumor 111. FIG. 1C is an MRI image of a tumor 121 emphasized by a contrast agent.” [0021]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089]; See Figs. 1A and 7).
Hashizume does not explicitly teach the specifics of the system hardware acquisition components and thus does not explicitly teach limitations: a probe configured to deliver a pulsed laser from a laser source to a sample, wherein the laser source is operable to generate the pulsed laser; arrays coupled to the probe, wherein one of the arrays comprises transducing elements arranged thereon which are operable to transmit and collect ultrasound signals, and wherein one of the arrays comprises transducing elements arranged thereon which are operable to collect photoacoustic signals.
Cheng in the field of multi-modal detection systems teaches: “…a multimodal ultrasound/photoacoustic (US/PA) arrangement…The arrangement can include an imaging and system control console block 101, a laser subsystem block 103 communicatively coupled to the imaging and system control console block 101, and a imaging probe and imaging chamber block 105 coupled to the laser subsystem block 103, which is also communicatively coupled to the imaging and system control console block 101.” [0038]; “The imaging and system control console 101 block includes two parts: ultrasound source and data acquisition subsystem 107, and the system control console 109 comprising a host-control computer 1000 incorporating a function generator 111 and delay generator 113. The two components can be connected through any suitable connector 131, such as a PCIe cable. The ultrasound source and data acquisition subsystem 107 can act as both ultrasound emitter and receiver, which allows dual modality traditional ultrasound and photoacoustic imaging.” [0039]; “The imaging probe 121 can be comprised of at least one ultrasound transducer 129 and a fiber bundle holder 127. In some embodiment, the ultrasound transducer can be comprised of a plurality of transducer arrays. The imaging probe 121 can be used to image a tissue sample located within the sample cartridge 137.” [0042]; “The ultrasound transducer is connected to the ultrasound source and data acquisition subsystem, using any suitable connector 135, such as a Cannon HDI-format ZIF connector. Through X-Y CNC stage controlled by the host-control computer, three dimensional (3D) imaging of the excised tumor tissue can be acquired.” [0045]; “The imaging probe is used to acquire both the conventional ultrasound images and photoacoustic images… The fiber bundle can deliver the laser light from the laser subsystem. The cylindrical lens can be applied to weakly focus the light to the tissue surface to generate a photoacoustic signal.” [0052].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system in Hashizume to include a probe configured to deliver a pulsed laser from a laser source to a sample, wherein the laser source is operable to generate the pulsed laser; arrays coupled to the probe, wherein one of the arrays comprises transducing elements arranged thereon which are operable to transmit and collect ultrasound signals, and wherein one of the arrays comprises transducing elements arranged thereon which are operable to collect photoacoustic signals as taught in Cheng to “…offer a high-speed and highly-sensitive intraoperative assessment of breast cancer margin during conservation surgical procedures…” (Cheng, [0035]).
Regarding Claim 2, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Hashizume further teaches: wherein the state of the tumor margin is negative, positive, or comprises a dye (“…the photoacoustic image includes an absorption factor image indicating absorption density distribution. Generated from the absorption factor image is an image indicating the presence and proportions of biomolecules such as oxygenated hemoglobin, reduced hemoglobin, water, fat, and collagen. For example, based on the ratio of oxygenated hemoglobin and reduced hemoglobin, an image relating to the oxygen saturation as an index of the bonding state of hemoglobin and oxygen is obtained.” [0016]; “FIG. 1A illustrates a photoacoustic image 120 of a blood vessel 101. The blood vessel 101 is represented by the absorption factor of hemoglobin existing in the blood in the blood vessel as image luminance. FIG. 1B is an ultrasound image of a tumor 111. FIG. 1C is an MRI image of a tumor 121 emphasized by a contrast agent.” [0021]; “…image data including the region of interest with respect to the tumor region in a medical image is generated and superimposed on the medical image. In relation to the present embodiment, the case where the ROI is a tumor region extracted from the medical image…” [0023]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089]).
Regarding Claim 3, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Hashizume does not teach: wherein operating the system comprises operating the laser source to generate the pulsed laser having: a wavelength ranging from 600 nm to 2000 nm,
a wave period of 10 ns or less, and/or a frequency of 1 to 100 Hz.
Cheng in the field of multi-modal detection systems teaches: “PA imaging through the excitation at ˜1200 nm, can allow for fat to be visualized, providing a new contrast to assist margin assessment, especially with regards to imaging of breast due to fat being the major form of normal tissue in breast.” [0036]; “… the Raman laser 117, can have a resonator end mirror 240 that can be coated with high reflectivity at 1197 nm (R>99%) and high transmission at 1064 nm. An output coupler 242 can be coated with high reflectivity at 1064 nm (R>99%) and 40% transmission at 1197 nm.” [0040].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify operating the system in the combination of references comprises operating the laser source to generate the pulsed laser having: a wavelength ranging from 600 nm to 2000 nm as taught in Cheng to “…offer a high-speed and highly-sensitive intraoperative assessment of breast cancer margin during conservation surgical procedures…” (Cheng, [0035]).
Regarding Claim 4, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Hashizume does not teach: wherein operating the system comprises having the laser source configured at an angle to the probe to deliver the pulsed laser to the sample, or having the laser source deliver the pulsed laser to the sample via a fiber, wherein one end of the fiber is configured at an angle to the probe.
Cheng in the field of multi-modal detection systems teaches: “FIG. 4B, the imaging probe can be comprised of a transducer array 429, a fiber bundle 427, a cylindrical lens 439, and two glass slides 441, 443. The fiber bundle can deliver the laser light from the laser subsystem. The cylindrical lens can be applied to weakly focus the light to the tissue surface to generate a photoacoustic signal…a collinear imaging probe comprises a transducer array that is held within a cover mount assembly 445, 447. The fiber bundle and cylindrical lens is located within the cover mount assembly 445, 447 and glass slides 441, 443 are located proximate to the cylindrical lens 439 and transducer array 429.” [0052].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify operating the system in the combination of references comprises having the laser source deliver the pulsed laser to the sample via a fiber, wherein one end of the fiber is configured at an angle to the probe as taught in Cheng to “…offer a high-speed and highly-sensitive intraoperative assessment of breast cancer margin during conservation surgical procedures…” (Cheng, [0035]).
Regarding Claim 5, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Hashizume does not teach: wherein operating the system comprises operating the probe in heavy water or having the probe incorporated with heavy water.
Cheng in the field of multi-modal detection systems teaches: “ The chamber can comprise a top cover 301, gas springs 303, 305, hand handle 307, CNC stage 309, imaging probe holder 311, imaging probe 313, water drainage tube 315, surface mount hinges 317, 319, compression plate 321, water illustration 323, tissue-pressing rod 325, changeable plate with a plastic wrap or film 327, changeable tissue cartridge 329, cartridge holder 331, vertical elevation stage 333, and bottom cover 335.” [0046]; “The sample chamber can be comprised of three parts: an imaging probe 313 with the X-Z scanning stage 309, a sample cartridge 329 with pre-filled ultrasound gel, and a water tank or sample cartridge holder 331 with the imaging window… The sample cartridge can then be placed in the water tank or sample cartridge holder. In one exemplary embodiment, the water tank or sample cartridge holder dimension can be about 240 mm long by about 140 mm wide by about 150 mm high. Clinical saline solution can be added to the cartridge and water tank, and can act as a coupling medium for the imaging probe.” [0047].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify operating the system in the combination of references comprises operating the probe in heavy water or having the probe incorporated with heavy water as taught in Cheng to “…offer a high-speed and highly-sensitive intraoperative assessment of breast cancer margin during conservation surgical procedures…” (Cheng, [0035]).
Regarding Claim 6, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Hashizume does not teach: wherein the arrays comprise one array having a planar surface configured between and adjacent to two arrays each having a curved surface, and/or wherein operating the system comprises operating transducing elements arranged on the planar surface at a higher frequency than or same frequency as transducing elements arranged on the curved surface.
Cheng in the field of multi-modal detection systems teaches: “The sample cartridge can be in any suitable shape to facilitate in supporting a sample that will be analyzed by the imaging system… The pyramidal shape allows the cartridge to support various sized samples. The inverted pyramidal shape helps to support the sample within the cartridge along with the coupling medium. This allows for the imaging system to better analyze the sample in its totality without having to adjust the cartridge or sample after the sample has been placed inside the cartridge. This shape helps to provide an even surface for imaging the first and second sample face. The imaging probe is used to acquire both the conventional ultrasound images and photoacoustic images. In one exemplary embodiment the imaging probe can be 103×35×35 mm.sup.3. As shown in FIG. 4B, the imaging probe can be comprised of a transducer array 429, a fiber bundle 427, a cylindrical lens 439, and two glass slides 441, 443. The fiber bundle can deliver the laser light from the laser subsystem. The cylindrical lens can be applied to weakly focus the light to the tissue surface to generate a photoacoustic signal.” [0052].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the arrays in the combination of references to comprise one array having a planar surface configured between and adjacent to two arrays each having a curved surface, and/or wherein operating the system comprises operating transducing elements arranged on the planar surface at a higher frequency than or same frequency as transducing elements arranged on the curved surface as taught in Cheng to “…offer a high-speed and highly-sensitive intraoperative assessment of breast cancer margin during conservation surgical procedures…” (Cheng, [0035]).
Regarding Claim 9, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Hashizume further teaches: further comprising: observing the presence or absence of vascularity extension from a tumor; and/or observing for heterogeneity of the issue from the ultrasound image; and/or correlating the ultrasound image and the photoacoustic image to a histopathological microscopic image (“Generated from the absorption factor image is an image indicating the presence and proportions of biomolecules such as oxygenated hemoglobin, reduced hemoglobin, water, fat, and collagen…based on the ratio of oxygenated hemoglobin and reduced hemoglobin, an image relating to the oxygen saturation as an index of the bonding state of hemoglobin and oxygen is obtained.” [0016]; “FIG. 1A illustrates a photoacoustic image 120 of a blood vessel 101. The blood vessel 101 is represented by the absorption factor of hemoglobin existing in the blood in the blood vessel as image luminance. FIG. 1B is an ultrasound image of a tumor 111. FIG. 1C is an MRI image of a tumor 121 emphasized by a contrast agent.” [0021]; “…image data including the region of interest with respect to the tumor region in a medical image is generated and superimposed on the medical image. In relation to the present embodiment, the case where the ROI is a tumor region extracted from the medical image…” [0023]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089] See Fig. 7).
Regarding Claim 12, Hashizume teaches: A method of determining a state of a tumor (Fig. 2 and Fig. 6, [0030][0077]), the method comprising:
operating a system to generate an ultrasound image and a photoacoustic image (“The information processing apparatus 200 has a storage unit 220, an ROI generation unit 230, a display control unit 240, and a user instruction acquiring unit 260. The information processing apparatus 200 is connected to an external storage unit 210 and a display unit 250.” [0030]; “The first medical image 100 is an ultrasound image…and the third medical image 120 is a photoacoustic image…” [0033]; See Fig. 6), wherein the system comprises:
a data acquisition module which converts the ultrasound signals and the photoacoustic signals into the ultrasound image and the photoacoustic image (“The information processing apparatus according to the present embodiment generates a new ROI based on the ROI extracted from the medical images acquired by a plurality of different modalities.” [0026]; “The storage unit 220 acquires a medical image from the external storage unit 210 based on the user's selection. In the present embodiment, the user selects the third medical image 120 that is a photoacoustic image as an observation target.” [0052]), respectively,
identifying from the ultrasound image the presence or absence of an abnormal tissue or a lesion (“An ROI image 130 illustrated in FIG. 1B is volume data including an ROI 131, which is extracted from the region of a tumor 111 in the ultrasound image 100.” [0023]; “the information processing apparatus 200 according to the second embodiment changes the display of the ROI images regarding the positions of the ROIs acquired by a plurality of different modalities and the position of the ROI closer to the actual tumor region in the generated ROI images.” [0074]);
identifying from the photoacoustic image the presence or absence of lipids and observing for a pattern and distribution of the lipids (“Generated from the absorption factor image is an image indicating the presence and proportions of biomolecules such as oxygenated hemoglobin, reduced hemoglobin, water, fat, and collagen…based on the ratio of oxygenated hemoglobin and reduced hemoglobin, an image relating to the oxygen saturation as an index of the bonding state of hemoglobin and oxygen is obtained.” [0016]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089] See Fig. 7),
identifying from the photoacoustic image the presence or absence of water and observing for a pattern and distribution of the water (“Generated from the absorption factor image is an image indicating the presence and proportions of biomolecules such as oxygenated hemoglobin, reduced hemoglobin, water, fat, and collagen…based on the ratio of oxygenated hemoglobin and reduced hemoglobin, an image relating to the oxygen saturation as an index of the bonding state of hemoglobin and oxygen is obtained.” [0016]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089] See Fig. 7);
identifying from the photoacoustic image the presence or absence of collagen and observing for a pattern and distribution of the collagen (“…in photoacoustic imaging, acquired is volume data indicating the three-dimensional spatial distribution of at least one kind of biological information such as the sound pressure of a photoacoustic wave (initial sound pressure), optical absorption energy density, optical absorption factor, and the concentration of a substance constituting a living body (such as oxygen saturation… the photoacoustic image includes an absorption factor image indicating absorption density distribution. Generated from the absorption factor image is an image indicating the presence and proportions of biomolecules such as oxygenated hemoglobin, reduced hemoglobin, water, fat, and collagen. For example, based on the ratio of oxygenated hemoglobin and reduced hemoglobin, an image relating to the oxygen saturation as an index of the bonding state of hemoglobin and oxygen is obtained.” [0016]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089]);
identifying from the photoacoustic image the presence or absence of hemoglobin and observing for a pattern and distribution of the hemoglobin (“FIG. 1A illustrates a photoacoustic image 120 of a blood vessel 101. The blood vessel 101 is represented by the absorption factor of hemoglobin existing in the blood in the blood vessel as image luminance. FIG. 1B is an ultrasound image of a tumor 111. FIG. 1C is an MRI image of a tumor 121 emphasized by a contrast agent.” [0021]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089]; See Figs. 1A and 7); and
comparing from the photoacoustic image an intensity of the collagen and/or hemoglobin, if present, with an intensity of tissue proximal to the collagen and/or hemoglobin (“FIG. 1A illustrates a photoacoustic image 120 of a blood vessel 101. The blood vessel 101 is represented by the absorption factor of hemoglobin existing in the blood in the blood vessel as image luminance. FIG. 1B is an ultrasound image of a tumor 111. FIG. 1C is an MRI image of a tumor 121 emphasized by a contrast agent.” [0021]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089]; See Figs. 1A and 7).
Hashizume does not explicitly teach the specifics of the system hardware acquisition components and thus does not explicitly teach limitations: a probe configured to deliver a pulsed laser from a laser source to a sample, wherein the laser source is operable to generate the pulsed laser; arrays coupled to the probe, wherein one of the arrays comprises transducing elements arranged thereon which are operable to transmit and collect ultrasound signals, and wherein one of the arrays comprises transducing elements arranged thereon which are operable to collect photoacoustic signals.
Cheng in the field of multi-modal detection systems teaches: “…a multimodal ultrasound/photoacoustic (US/PA) arrangement…The arrangement can include an imaging and system control console block 101, a laser subsystem block 103 communicatively coupled to the imaging and system control console block 101, and a imaging probe and imaging chamber block 105 coupled to the laser subsystem block 103, which is also communicatively coupled to the imaging and system control console block 101.” [0038]; “The imaging and system control console 101 block includes two parts: ultrasound source and data acquisition subsystem 107, and the system control console 109 comprising a host-control computer 1000 incorporating a function generator 111 and delay generator 113. The two components can be connected through any suitable connector 131, such as a PCIe cable. The ultrasound source and data acquisition subsystem 107 can act as both ultrasound emitter and receiver, which allows dual modality traditional ultrasound and photoacoustic imaging.” [0039]; “The imaging probe 121 can be comprised of at least one ultrasound transducer 129 and a fiber bundle holder 127. In some embodiment, the ultrasound transducer can be comprised of a plurality of transducer arrays. The imaging probe 121 can be used to image a tissue sample located within the sample cartridge 137.” [0042]; “The ultrasound transducer is connected to the ultrasound source and data acquisition subsystem, using any suitable connector 135, such as a Cannon HDI-format ZIF connector. Through X-Y CNC stage controlled by the host-control computer, three dimensional (3D) imaging of the excised tumor tissue can be acquired.” [0045]; “The imaging probe is used to acquire both the conventional ultrasound images and photoacoustic images… The fiber bundle can deliver the laser light from the laser subsystem. The cylindrical lens can be applied to weakly focus the light to the tissue surface to generate a photoacoustic signal.” [0052].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system in Hashizume to include a probe configured to deliver a pulsed laser from a laser source to a sample, wherein the laser source is operable to generate the pulsed laser; arrays coupled to the probe, wherein one of the arrays comprises transducing elements arranged thereon which are operable to transmit and collect ultrasound signals, and wherein one of the arrays comprises transducing elements arranged thereon which are operable to collect photoacoustic signals as taught in Cheng to “…offer a high-speed and highly-sensitive intraoperative assessment of breast cancer margin during conservation surgical procedures…” (Cheng, [0035]).
Regarding Claim 13, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Hashizume further teaches: wherein the state of the tumor is benign, malignant, or indeterminate (“When the number of the blood vessels is larger than a predetermined value, according to the diagnostic index regarding the diameters of the blood vessels, the malignancy of the tumor (ROI) is considered as higher with increase in the thinness of the blood vessels.” [0083];” . Examples of the diagnostic index includes the oxygen saturation of one each blood vessel, the frequency of the number of blood vessels by oxygen saturation, the oxygen saturation distribution information in the region of the third ROI image 170, and others. It is known that, since a tumor actively takes in oxygen, the oxygen saturation tends to be low around the tumor. According to the diagnostic index regarding the oxygen saturation, it is considered that the malignancy of the tumor (ROI) is higher as the oxygen saturation is lower in the peripheral region of the tumor, that is, the region of the third ROI image.” [0084]).
Regarding Claim 14, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Hashizume further teaches: wherein the tumor is a breast cancer tumor (“In relation to the present embodiment, as an example of an ultrasound image, descriptions will be given as to a B-mode image of a breast as a tomographic image formed by scanning the breast with an ultrasonic wave beam.” [0014]).
Regarding Claim 15, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Claim 15 further recites limitations: wherein operating the system comprises operating the laser source to generate the pulsed laser having: a wavelength ranging from 600 nm to 2000 nm, a wave period of 10 ns or less, and/or a frequency of 1 to 100 Hz. These limitations are present in claim 3 and is therefore, rejected under the same rationale.
Regarding Claim 16, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Claim 16 further recites limitations: wherein operating the system comprises having the laser source configured at an angle to the probe to deliver the pulsed laser to the sample, or having the laser source deliver the pulsed laser to the sample via a fiber, wherein one end of the fiber is configured at an angle to the probe. These limitations are present in claim 4 and is therefore, rejected under the same rationale.
Regarding Claim 17, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Claim 17 further recites limitations: wherein operating the system comprises operating the probe in heavy water or having the probe incorporated with heavy water. These limitations are present in claim 5 and is therefore, rejected under the same rationale.
Regarding Claim 18, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Claim 18 further recites limitations: wherein the arrays comprise one array having a planar surface configured between and adjacent to two arrays each having a curved surface, and/or wherein operating the system comprises operating transducing elements arranged on the planar surface at a higher frequency than or same frequency as transducing elements arranged on the curved surface. These limitations are present in claim 6 and is therefore, rejected under the same rationale.
Regarding Claim 20, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Hashizume further teaches: further comprising: observing for heterogeneity of the tissue from the ultrasound image; and/or correlating the ultrasound image and the photoacoustic image to a histopathological microscopic image (“Generated from the absorption factor image is an image indicating the presence and proportions of biomolecules such as oxygenated hemoglobin, reduced hemoglobin, water, fat, and collagen…based on the ratio of oxygenated hemoglobin and reduced hemoglobin, an image relating to the oxygen saturation as an index of the bonding state of hemoglobin and oxygen is obtained.” [0016]; “FIG. 1A illustrates a photoacoustic image 120 of a blood vessel 101. The blood vessel 101 is represented by the absorption factor of hemoglobin existing in the blood in the blood vessel as image luminance. FIG. 1B is an ultrasound image of a tumor 111. FIG. 1C is an MRI image of a tumor 121 emphasized by a contrast agent.” [0021]; “…image data including the region of interest with respect to the tumor region in a medical image is generated and superimposed on the medical image. In relation to the present embodiment, the case where the ROI is a tumor region extracted from the medical image…” [0023]; “The diagnostic index acquiring unit 270 acquires a diagnostic index from the region of the third medical image 120 that is equivalent to the image region of the third ROI image 170…the diagnostic index acquiring unit 270 acquires the number of blood vessels and distribution information in the image region. When the user adds the oxygen saturation image to the third medical image 120 as a photoacoustic image, the diagnostic index acquiring unit 270 may also acquire the oxygen saturations corresponding to the acquired blood vessels.” [0089] See Fig. 7).
Regarding Claim 22, Hashizume teaches: A system operable to generate an ultrasound image and a photoacoustic image (“The information processing apparatus 200 has a storage unit 220, an ROI generation unit 230, a display control unit 240, and a user instruction acquiring unit 260. The information processing apparatus 200 is connected to an external storage unit 210 and a display unit 250.” [0030]; “The first medical image 100 is an ultrasound image…and the third medical image 120 is a photoacoustic image…” [0033]; See Fig. 6), wherein the system comprises:
a data acquisition module which converts the ultrasound signals and the photoacoustic signals into the ultrasound image and the photoacoustic image (“The information processing apparatus according to the present embodiment generates a new ROI based on the ROI extracted from the medical images acquired by a plurality of different modalities.” [0026]; “The storage unit 220 acquires a medical image from the external storage unit 210 based on the user's selection. In the present embodiment, the user selects the third medical image 120 that is a photoacoustic image as an observation target.” [0052]), respectively.
Hashizume does not explicitly teach the specifics of the system hardware acquisition components and thus does not explicitly teach limitations: a probe configured to deliver a pulsed laser from a laser source to a sample, wherein the laser source is operable to generate the pulsed laser; arrays coupled to the probe, wherein one of the arrays comprises transducing elements arranged thereon which are operable to transmit and collect ultrasound signals, and wherein one of the arrays comprises transducing elements arranged thereon which are operable to collect photoacoustic signals.
Cheng in the field of multi-modal detection systems teaches: “…a multimodal ultrasound/photoacoustic (US/PA) arrangement…The arrangement can include an imaging and system control console block 101, a laser subsystem block 103 communicatively coupled to the imaging and system control console block 101, and a imaging probe and imaging chamber block 105 coupled to the laser subsystem block 103, which is also communicatively coupled to the imaging and system control console block 101.” [0038]; “The imaging and system control console 101 block includes two parts: ultrasound source and data acquisition subsystem 107, and the system control console 109 comprising a host-control computer 1000 incorporating a function generator 111 and delay generator 113. The two components can be connected through any suitable connector 131, such as a PCIe cable. The ultrasound source and data acquisition subsystem 107 can act as both ultrasound emitter and receiver, which allows dual modality traditional ultrasound and photoacoustic imaging.” [0039]; “The imaging probe 121 can be comprised of at least one ultrasound transducer 129 and a fiber bundle holder 127. In some embodiment, the ultrasound transducer can be comprised of a plurality of transducer arrays. The imaging probe 121 can be used to image a tissue sample located within the sample cartridge 137.” [0042]; “The ultrasound transducer is connected to the ultrasound source and data acquisition subsystem, using any suitable connector 135, such as a Cannon HDI-format ZIF connector. Through X-Y CNC stage controlled by the host-control computer, three dimensional (3D) imaging of the excised tumor tissue can be acquired.” [0045]; “The imaging probe is used to acquire both the conventional ultrasound images and photoacoustic images… The fiber bundle can deliver the laser light from the laser subsystem. The cylindrical lens can be applied to weakly focus the light to the tissue surface to generate a photoacoustic signal.” [0052].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system in Hashizume to include a probe configured to deliver a pulsed laser from a laser source to a sample, wherein the laser source is operable to generate the pulsed laser; arrays coupled to the probe, wherein one of the arrays comprises transducing elements arranged thereon which are operable to transmit and collect ultrasound signals, and wherein one of the arrays comprises transducing elements arranged thereon which are operable to collect photoacoustic signals as taught in Cheng to “…offer a high-speed and highly-sensitive intraoperative assessment of breast cancer margin during conservation surgical procedures…” (Cheng, [0035]).
Regarding Claim 24, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Claim 24 further recites limitations: wherein the laser source is configured at an angle to the probe to deliver the pulsed laser to the sample, or the laser source delivers the pulsed laser to the sample via a fiber, wherein one end of the fiber is configured at an angle to the probe. These limitations are present in claim 4 and is therefore, rejected under the same rationale.
Regarding Claim 25, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Claim 25 further recites limitations: wherein the probe is operable in heavy water or the probe is incorporated with heavy water. These limitations are present in claim 5 and is therefore, rejected under the same rationale.
Regarding Claim 26, the combination of Hashizume and Cheng teach the claim limitations as noted above.
Claim 26 further recites limitations: wherein the arrays comprise one array having a planar surface configured between and adjacent to two arrays each having a curved surface, and/or wherein the transducing elements arranged on the planar surface are operable at a higher frequency than or same frequency as the transducing elements arranged on the curved surface. These limitations are present in claim 6 and is therefore, rejected under the same rationale.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hashizume and Cheng as applied to claim 1 above, and further in view of Scepanovic et. al. (U.S. 20070167836, July 19, 2007)(hereinafter, “Scepanovic”).
Regarding Claim 8, the combination of Hashizume and Cheng teach the claim limitations as noted above.
The combination of references does not teach: wherein observing for the pattern and distribution of the collagen further comprises observing the thickness of the collagen.
Scepanovic in the field of multi-modal disease diagnosis system teaches: “The artery specimens were then fixed and submitted for routine pathology examination, which was performed by a cardiovascular pathologist blinded to the spectroscopy results. The histopathology examination of the lesions included an assessment of a number of histologic features of vulnerable plaque, including thickness of the fibrous cap, size of the necrotic core, superficial foam cells, intraplaque hemorrhage and ulceration. The histopathology results are summarized in Table 5. A vulnerable plaque index (VPI) was assigned to each specimen. Of the 17 lesions, 4 exhibited VPI scores .gtoreq.10 and were classified as vulnerable plaques.” [0052].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify observing for the pattern and distribution of the collagen in the combination of references further comprises observing the thickness of the collagen as taught in Scepanovic to “…provide depth-sensitive information useful in mapping cancers and pre-cancers…” (Scepanovic, [0012]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Baba U.S. 20150327772 teaches a photoacoustic breast imaging system
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798