DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 05/05/2025 has been entered. Claims 1-13 remain pending in the application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Although the claims fall within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter), claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection as judicial exceptions.
Regarding claim 1, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “adjust a position of a rod-shaped member with respect to the three-dimensional surface image on an image space” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. In particular, a position of a rod-shaped member can be changed manually by moving a piece of paper with the image of the rod-shaped member drawn on it or it can be changed mentally while looking at the image(s). The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “A phototherapy planning device comprising:
a memory that stores instructions, and a processor that executes the instructions stored in the memory to acquire a three- dimensional surface image showing an affected part of a subject and a three-dimensional surface shape of the subject; adjust ...; generate ...; and display the cross-sectional image", which are the steps of data gathering and mere instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 1 is therefore non-statutory and not patent eligible.
Regarding claim 2, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to generate, as the cross-sectional image, an image capable of identifying a first superimposed region in which the affected part and the light propagation region are superimposed and a non-superimposed region other than the first superimposed region”, which are mere instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 2 is therefore non-statutory and not patent eligible.
Regarding claim 3, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to acquire a first index value indicating a degree of superposition of the first superimposed region with respect to the affected part; and cause the first index value to be displayed together with the cross-sectional image”, which is mere instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 3 is therefore non-statutory and not patent eligible.
Regarding claim 4, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “an input reception unit configured to receive an operation input of an operator, wherein the processor is configured to adjust the position of the rod-shaped member on the image space, based on the operation input received by the input reception unit”, which is mere instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 4 is therefore non-statutory and not patent eligible.
Regarding claim 5, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to acquire, as the light propagation region, a region in which light emitted radially outward from a center of a shaft portion of the rod-shaped member inserted into the subject out of the rod-shaped member over an entire circumference of the rod-shaped member propagates”, which is mere instructions to implement the abstract idea on a computer and a pre-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 5 is therefore non-statutory and not patent eligible.
Regarding claim 6, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to acquire the light propagation region, based on a distance from a tip of the rod-shaped member input in advance and a position of the tip of the rod-shaped member”, which is mere instructions to implement the abstract idea on a computer and a pre-solution data gathering. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 6 is therefore non-statutory and not patent eligible.
Regarding claim 7, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to acquire a three-dimensional affected part image which is a three- dimensional image of the affected part, and compose the three-dimensional surface image and the three-dimensional affected part image to generate a composite three-dimensional image capable of identifying the three-dimensional affected part image”, which is data gathering, mere instructions to implement the abstract idea on a computer, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 7 is therefore non-statutory and not patent eligible.
Regarding claim 8, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to acquire a three-dimensional internal structure image which is a three- dimensional image of an internal structure of the subject, and generate, as the composite three-dimensional image, a three-dimensional image in which the three- dimensional surface image, the three-dimensional affected part image, and the three- dimensional internal structure image are combined”, which is data gathering, mere instructions to implement the abstract idea on a computer, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 8 is therefore non-statutory and not patent eligible.
Regarding claim 9, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to acquire, as the three-dimensional internal structure image, either a three- dimensional blood vessel distribution image showing a three-dimensional distribution of a blood vessel of the subject or a three-dimensional bone distribution image showing a three- dimensional distribution of a bone of the subject, and compose the three- dimensional surface image and either the three-dimensional blood vessel distribution image or the three-dimensional bone distribution image”, which is data gathering, mere instructions to implement the abstract idea on a computer, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 9 is therefore non-statutory and not patent eligible.
Regarding claim 10, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to generate, as the cross-sectional image, an image capable of distinguishing between the affected part and other parts of the subject other than the affected part”, which is mere instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 10 is therefore non-statutory and not patent eligible.
Regarding claim 11, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to: generate a plurality of the cross-sectional images each cross-sectional image of the plurality of cross-sectional images showing at least a tip of the rod-shaped member, and display each cross-sectional image of the plurality of the cross-sectional images side by side, each cross-sectional image of the plurality of the cross-sectional images being different in cross-sectional orientation from each other”, which is mere instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 11 is therefore non-statutory and not patent eligible.
Regarding claim 12, the claim is directed to an apparatus and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “the processor is configured to acquire a second index value indicating a degree of superposition of a second superimposed region in which the light propagation region and a part other than the affected part are superimposed, and cause the second index value to be displayed together with the cross-sectional image”, which is mere instructions to implement the abstract idea on a computer and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 12 is therefore non-statutory and not patent eligible.
Regarding claim 13, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “adjusting a position of a rod-shaped member with respect to the three- dimensional surface image on an image space;” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. In particular, a position of a rod-shaped member can be changed manually by moving a piece of paper with the image of the rod-shaped member drawn on it or it can be changed mentally while looking at the image(s). The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “a step of acquiring a three-dimensional surface image showing an affected part of a subject and a three-dimensional surface shape of the subject; a step of acquiring a light propagation region in which light propagates from the rod-shaped member; a step of generating a cross-sectional image that displays, in a predetermined cross- section of the three-dimensional surface image, an internal morphological image including the affected part of the subject, the rod-shaped member, and the light propagation region; and a step of causing the cross-sectional image to be displayed", which are the steps of data gathering, mere instructions to implement the abstract idea on a computer, and insignificant post-solution activity. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 13 is therefore non-statutory and not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-5, 7, 10-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hasnine (JP 2013236757), hereinafter Hasnine, in view of Otsu et al (US 20200197720), hereinafter Otsu.
Regarding claim 1, Hasnine teaches a therapy planning device (100) (“A surgery supporting device” Abstract; Fig. 2) comprising:
a memory that stores instructions, and a processor (40, 50, 60, 104) (“As shown in FIGS. 1 to 3, the surgery support apparatus 100 mainly includes a magnet system 10, a table 11, a cradle 12, an operation unit 20, a display unit 30, a calculation unit 40, a three-dimensional camera device 50, and a three-dimensional projection… device 60”, p. 6, l. 5-15; “the data collection unit 104”; p. 8, l. 14-26), that executes the instructions stored in the memory to:
acquire a three-dimensional surface image showing an affected part (“the target TG of the three-dimensional organ image VNG” p. 14, l. 18-27; Fig. 7) of a subject (HB) (“Here, a virtual subject image VHB projected by the three-dimensional projection apparatus 60 using FIG. 7 (displayed by a broken line) and a three-dimensional organ image VNG of the subject HB created from the pre-MRI data PMD (displayed by a solid line)”; p. 13, l. 15-21) and a three-dimensional surface shape (VHB) of the subject (“MR image is a three-dimensional image showing the internal appearance of the subject HB in the internal organ of the subject HB by setting a signal intensity threshold (hereinafter referred to as a three-dimensional organ image VNG). 7). The three-dimensional organ image VNG of the present embodiment shows the surface shape of the internal organ of the subject HB. The three-dimensional camera device 50 shown in FIGS. 2 and 3 has a three-dimensional camera calculation unit 51. The three-dimensional camera calculation unit 51 calculates the appearance and contour coordinates of the subject HB by photographing the appearance of the subject HB on the cradle 12 with a plurality of cameras (not shown). The 3D appearance data calculated by the 3D camera calculation unit 51 is transferred to the storage unit 42.” p. 9, l. 1-11; “the operator can confirm whether the laser beam 75L is directed to the target TG of the three-dimensional organ image VNG.”; p. 14, l. 18-27; Fig. 7);
adjust a position of a rod-shaped member (74) (ND) when inserting the rod-shaped member into the affected part on an image space, with respect to the three-dimensional surface image (“The operator confirms whether the MR image is displayed in a desired cross section and sequence. The surgeon adjusts the position and angle of the virtual needle 74 while observing the MR image.” p. 8, l. 1-6; “the three-dimensional position measurement unit 71 transmits the information on the three-dimensional position and tip direction of the virtual needle 74 to the calculation unit 40."; p. 10, l. 9-25. “The virtual needle 74 is moved so that the XY plane and the OB plane overlap the target TG. The coordinates and angle of the virtual needle 74 are measured by the three-dimensional position measuring device 70 and transmitted to the two-dimensional image processing unit 43 in real time.” p. 14, l. 8-17. “The surgeon can confirm the laser beam 75L that shines toward the virtual subject image VHB, and can confirm the insertion point of the subject HB (see FIG. 7). In addition, the operator can confirm whether the laser beam 75L is directed to the target TG of the three-dimensional organ image VNG. Note that the three-dimensional image processing unit 44 can display not only the appearance of the three-dimensional organ image VNG but also the appearance of the target TG by changing the threshold value of the signal intensity of the pre-MRI data PMD.”; p. 14, l. 18-27; Figs. 4, 7, 9 a-c);
generate a cross-sectional image (“The four cross-sectional views” p. 11, l. 29 – p. 12, l. 2; seen in Figs. 4, 7, 9 a-c) that displays, in a predetermined cross-section of the three-dimensional surface image, an internal morphological image including the affected part of the subject (“The two-dimensional image processing unit 43 reconstructs an arbitrary cross-sectional two-dimensional MR image based on the two-dimensional arbitrary cross-sectional nuclear magnetic resonance signal sent from the data collection unit 104. Further, based on the nuclear magnetic resonance signal of the three-dimensional voxel sent from the data collection unit 104, a two-dimensional MR image of an arbitrary cross section is reconstructed."; p. 8, l. 27-32), the rod-shaped member (74), and the light propagation region (75L) (“FIG. 4 is a diagram showing an arbitrary cross section of the MR image displayed on the display unit 30. The two-dimensional image processing unit 43 reconstructs an image of a two-dimensional arbitrary cross section based on two-dimensional high-speed MR imaging or three-dimensional MR imaging that was previously captured. The four cross-sectional views displayed on the display unit 30 are an XY plane perpendicular to the virtual needle 74, an OB plane horizontal to the virtual needle 74, a YZ plane perpendicular to the body axis of the subject HB, and a body axis of the subject HB. XZ plane parallel to the XZ plane. The XY plane, OB plane, YZ plane, and XZ plane of the subject HB are planes including a target TG such as a tumor.” p. 11, l. 29 – p. 12, l. 2; “The two-dimensional image processing unit 43 reconstructs an image of the virtual line 76 that is an extension line of the virtual needle 74 and an arbitrary cross section, and displays the image on the display unit 30. In step S <b> 16, the virtual needle 74 turns on the laser light source 75 at the tip, and projects the laser light 75 </ b> L onto the extension line to which the virtual needle 74 is directed. The surgeon can confirm the laser beam 75L that shines toward the virtual subject image VHB, and can confirm the insertion point of the subject HB (see FIG. 7). In addition, the operator can confirm whether the laser beam 75L is directed to the target TG of the three-dimensional organ image VNG.” p. 14, l. 8-27); and
display the cross-sectional image (“The two-dimensional image processing unit 43 reconstructs an image of the virtual line 76 that is an extension line of the virtual needle 74 and an arbitrary cross section, and displays the image on the display unit 30.” p. 14, l. 8-27; Fig. 2).
While teaching a light propagation region (75L; 76) in which light propagates from the rod-shaped member (“The two-dimensional image processing unit 43 reconstructs an image of the virtual line 76 that is an extension line of the virtual needle 74 and an arbitrary cross section, and displays the image on the display unit 30."; p. 14, l. 8-17; Figs. 4, 7, 9 a-c), Hasnine does not teach the therapy being phototherapy; acquiring a light propagation region in which light propagates from the rod-shaped member.
However, in the surgical treatments field of endeavor, Otsu discloses a treatment method, which is analogous art. Otsu teaches the therapy being phototherapy (“inserting an optical fiber into the catheter, reducing an influence of blood in the artery on a near-infrared ray, irradiating at least one of a tumor, the vicinity of the tumor, or a regional lymph node with a first near-infrared ray by the optical fiber, and irradiating an antibody-photosensitive substance bound to a tumor cell membrane in the tumor cell with a second near-infrared ray having a shorter wavelength than that of the first near-infrared ray." Abstract);
acquiring a light propagation region (includes “C” and three arrows in Figs. 3A-B and 4A-B; “the camera image” [0140]) in which light propagates from the rod-shaped member (“In the irradiating with the first near-infrared ray, the needle may have a light-transmitting portion capable of transmitting a near-infrared ray at a distal portion, and the first near-infrared ray may be emitted from the optical fiber located inside the needle through the light-transmitting portion. Thereby, the first near-infrared ray emitted from the optical fiber can reach a wide range of the irradiation target site without being obstructed by the needle.” [0023]. “Next, as shown in FIG. 14, the operator causes the needle tip 81 of the elongated tube 80 to come into contact with and puncture the tumor C while checking the camera image and/or ultrasound image of the endoscope 70. Thereby, the position of the elongated tube 80 is fixed with respect to the tumor C.” [0140]. The light propagation region is acquired by the camera).
Therefore, based on Otsu’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Hasnine to have the therapy being phototherapy; and to acquire a light propagation region in which light propagates from the rod-shaped member, as taught by Otsu, in order to maximize the phototherapy effectiveness by irradiating the target location by light (Otsu: [0140]).
Regarding claim 2, Hasnine modified by Otsu teaches the phototherapy planning device as recited in claim 1, wherein Hasnine teaches that the processor is configured to generate, as the cross-sectional image, an image capable of identifying a first superimposed region (75L in Fig. 7) in which the affected part and the light propagation region are superimposed and a non-superimposed region (VNG in Fig. 7) other than the first superimposed region (“The operator confirms whether the MR image is displayed in a desired cross section... The surgeon adjusts the position and angle of the virtual needle 74 while observing the MR image.” p. 8, l. 1-6; “The four cross-sectional views displayed on the display unit 30 are an XY plane perpendicular to the virtual needle 74, an OB plane horizontal to the virtual needle 74, a YZ plane perpendicular to the body axis of the subject HB, and a body axis of the subject HB. XZ plane parallel to the XZ plane. The XY plane, OB plane, YZ plane, and XZ plane of the subject HB are planes including a target TG such as a tumor.” p. 11, l. 29 – p. 12, l. 2 “The virtual needle 74 is moved so that the XY plane and the OB plane overlap the target TG. The coordinates and angle of the virtual needle 74 are measured by the three-dimensional position measuring device 70 and transmitted to the two-dimensional image processing unit 43 in real time.” p. 14, l. 8-14. “The two-dimensional image processing unit 43 reconstructs an image of the virtual line 76 that is an extension line of the virtual needle 74 and an arbitrary cross section, and displays the image on the display unit 30…The surgeon can confirm the laser beam 75L that shines toward the virtual subject image VHB, and can confirm the insertion point of the subject HB (see FIG. 7). In addition, the operator can confirm whether the laser beam 75L is directed to the target TG of the three-dimensional organ image VNG. Note that the three-dimensional image processing unit 44 can display not only the appearance of the three-dimensional organ image VNG but also the appearance of the target TG by changing the threshold value of the signal intensity of the pre-MRI data PMD.”; p. 14, l. 14-27; Figs. 4, 7, 9 a-c).
Regarding claim 4, Hasnine modified by Otsu teaches the phototherapy planning device as recited in claim 1, wherein Hasnine teaches that an input reception unit (20) (“The display unit 30 can display a GUI operation screen… The operation unit 20 includes a keyboard having a pointing device. The operation unit 20 is connected to the calculation unit 40. The operation unit 20 is operated by the operator via the display unit 30.” p. 7, l. 34 - p. 8, l. 10) configured to receive an operation input of an operator (“The operator confirms … The surgeon adjusts” p. 8, l. 1-6), wherein the processor is configured to adjust the position of the rod-shaped member on the image space, based on the operation input received by the input reception unit (“The operator confirms whether the MR image is displayed in a desired cross section and sequence. The surgeon adjusts the position and angle of the virtual needle 74 while observing the MR image.” p. 8, l. 1-6; “the surgeon confirms the real-time MR image and advances the virtual needle 74 to the target TG as shown in FIG. 9C while adjusting the approach direction of the virtual needle 74. When the virtual needle 74 reaches the target TG, the insertion needle ND also reaches the target TG.”; p. 16, l. 1-5).
Regarding claim 5, Hasnine modified by Otsu teaches the phototherapy planning device as recited in claim 1.
While teaching the light propagation region (75L; 76) in which light propagates from the rod-shaped member (“The two-dimensional image processing unit 43 reconstructs an image of the virtual line 76 that is an extension line of the virtual needle 74 and an arbitrary cross section, and displays the image on the display unit 30."; p. 14, l. 8-17; Figs. 4, 7, 9 a-c), Hasnine does not teach that the processor is configured to acquire, as the light propagation region, a region in which light emitted radially outward from a center of a shaft portion of the rod-shaped member inserted into the subject out of the rod-shaped member over an entire circumference of the rod-shaped member propagates.
However, in the surgical treatments field of endeavor, Otsu discloses a treatment method, which is analogous art. Otsu teaches that the processor is configured to acquire, as the light propagation region, a region (includes region “C” and a region of three arrows in Figs. 3A-B and 4A-B pointing to region “C”) in which light emitted radially outward from a center of a shaft portion of the rod-shaped member inserted into the subject out of the rod-shaped member over an entire circumference of the rod-shaped member propagates (“In the irradiating with the first near-infrared ray, the needle may have a light-transmitting portion capable of transmitting a near-infrared ray at a distal portion, and the first near-infrared ray may be emitted from the optical fiber located inside the needle through the light-transmitting portion. Thereby, the first near-infrared ray emitted from the optical fiber can reach a wide range of the irradiation target site without being obstructed by the needle.” [0023]. “The irradiation unit 43 is appropriately designed so as to emit a near-infrared ray at a predetermined irradiation angle in a predetermined direction using a lens, a diffuser, a mirror, or the like. Note that, the structure of the irradiation unit 43 is not limited as long as it can emit light to the outside. For example, as shown in FIG. 3A, the irradiation unit 43 emits a near-infrared ray at a predetermined irradiation angle in the distal end direction. Note that, the irradiation direction (the direction in which the center of the irradiation angle is located) is not particularly limited. For example, the irradiation unit 43 may emit the near-infrared ray in a direction substantially orthogonal to the optical fiber 41 as shown in FIG. 3B.” [0046] “The irradiation direction of near-infrared rays from the optical fiber 41 is appropriately selected. For example, the irradiation direction of the near-infrared rays may be the distal end direction of the optical fiber 41, the direction orthogonal to the axial direction of the optical fiber 41, or all directions (i.e., the distal end direction, the direction orthogonal to the axial direction, and the directions between the distal end direction and the direction orthogonal to the axial direction). The operator can appropriately select the optical fiber to be used according to the near-infrared ray irradiation target site.” [0088]).
Therefore, based on Otsu’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Hasnine to have the processor that is configured to acquire, as the light propagation region, a region in which light emitted radially outward from a center of a shaft portion of the rod-shaped member inserted into the subject out of the rod-shaped member over an entire circumference of the rod-shaped member propagates, as taught by Otsu, in order to maximize the phototherapy effectiveness by irradiating the entire target by light (Otsu: [0140]).
Regarding claim 7, Hasnine modified by Otsu teaches the phototherapy planning device as recited in claim 1, wherein Hasnine teaches that the processor is configured to acquire a three-dimensional affected part image which is a three-dimensional image of the affected part (“The storage unit 42 also stores … three-dimensional image data obtained by image reconstruction of the nuclear magnetic resonance signals collected by the data collection unit 104”; p. 8, l. 14-26; “The three-dimensional image processing unit 44 reconstructs a three-dimensional appearance MR image at a desired signal intensity based on the nuclear magnetic resonance signals collected in three dimensions. The three-dimensional appearance MR image is a three-dimensional image showing the internal appearance of the subject HB in the internal organ of the subject HB by setting a signal intensity threshold (hereinafter referred to as a three-dimensional organ image VNG). 7). The three-dimensional organ image VNG of the present embodiment shows the surface shape of the internal organ of the subject HB.” p. 8, l. 33 – p. 9, l.5), and
compose the three-dimensional surface image and the three-dimensional affected part image to generate a composite three-dimensional image capable of identifying the three-dimensional affected part image (“a projector (60) three-dimensionally projecting a synthetic image created by superimposing the subject photographed by the appearance photographing device and a three-dimensional volume image photographed by the modality”; Abstract, p.1, l. 9-12. “A projection device that three-dimensionally projects a composite image obtained by superimposing a three-dimensional volume image photographed by a subject and a modality photographed by an appearance photographing device, based on the position of the subject detected by the position detection device"; p. 4, l. 1-12. “The virtual subject image VHB and the three-dimensional organ image VNG are both projected at the same magnification, and the contour coordinates of the virtual subject image VHB and the three-dimensional organ image VNG are corrected so as to match. The virtual subject image VHB is projected translucently so that the three-dimensional organ image VNG can be observed.”; p. 9, l. 24-26).
Regarding claim 10, Hasnine modified by Otsu teaches the phototherapy planning device as recited in claim 1, wherein Hasnine teaches that the processor is configured to generate, as the cross-sectional image, an image capable of distinguishing between the affected part and other parts of the subject other than the affected part (“an MR image showing an arbitrary cross section including a target TG displayed on the display unit 30.”; p. 5, l. 23-24. “FIG. 4 is a diagram showing an arbitrary cross section of the MR image displayed on the display unit 30. The two-dimensional image processing unit 43 reconstructs an image of a two-dimensional arbitrary cross section based on two-dimensional high-speed MR imaging or three-dimensional MR imaging that was previously captured. The cross-sectional image highlights the target, the affected part, and therefore capable of distinguishing between the affected part and other parts of the body other than the affected part, located away from the target).
Regarding claim 11, Hasnine modified by Otsu teaches the phototherapy planning device as recited in claim 1, wherein Hasnine teaches that the cross-sectional image generation unit is configured to generate a plurality of the cross-sectional images each cross-sectional image of the plurality of the cross-sectional images showing at least a tip of the rod-shaped member (“The four cross-sectional views displayed on the display unit 30 are an XY plane perpendicular to the virtual needle 74, an OB plane horizontal to the virtual needle 74, a YZ plane perpendicular to the body axis of the subject HB, and a body axis of the subject HB. XZ plane parallel to the XZ plane. The XY plane, OB plane, YZ plane, and XZ plane of the subject HB are planes including a target TG such as a tumor.” p. 11, l. 29 – p. 12, l. 2; Figs. 4, 9 a-c), and
display each cross-sectional image of the plurality of the cross-sectional images side by side, the plurality of the cross-sectional images being different in cross-sectional orientation from each other (seen in Fig. 4).
Regarding claim 13, Hasnine teaches a therapy planning method (“The operator confirms whether the MR image is displayed in a desired cross section and sequence. The surgeon adjusts the position and angle of the virtual needle 74 while observing the MR image.” p. 8, l. 1-6) comprising:
a step of acquiring a three-dimensional surface image showing an affected part (“the target TG of the three-dimensional organ image VNG” p. 14, l. 18-27; Fig. 7) of a subject (HB) (“Here, a virtual subject image VHB projected by the three-dimensional projection apparatus 60 using FIG. 7 (displayed by a broken line) and a three-dimensional organ image VNG of the subject HB created from the pre-MRI data PMD (displayed by a solid line)”; p. 13, l. 15-21) and a three-dimensional surface shape (VHB) of the subject (“MR image is a three-dimensional image showing the internal appearance of the subject HB in the internal organ of the subject HB by setting a signal intensity threshold (hereinafter referred to as a three-dimensional organ image VNG). 7). The three-dimensional organ image VNG of the present embodiment shows the surface shape of the internal organ of the subject HB. The three-dimensional camera device 50 shown in FIGS. 2 and 3 has a three-dimensional camera calculation unit 51. The three-dimensional camera calculation unit 51 calculates the appearance and contour coordinates of the subject HB by photographing the appearance of the subject HB on the cradle 12 with a plurality of cameras (not shown). The 3D appearance data calculated by the 3D camera calculation unit 51 is transferred to the storage unit 42.” p. 9, l. 1-11; “the operator can confirm whether the laser beam 75L is directed to the target TG of the three-dimensional organ image VNG.”; p. 14, l. 18-27; Fig. 7);
a step of adjusting a position of a rod-shaped member (74) (ND) with respect to the three-dimensional surface image on an image space (“The operator confirms whether the MR image is displayed in a desired cross section and sequence. The surgeon adjusts the position and angle of the virtual needle 74 while observing the MR image.” p. 8, l. 1-6; “The virtual needle 74 is moved so that the XY plane and the OB plane overlap the target TG. The coordinates and angle of the virtual needle 74 are measured by the three-dimensional position measuring device 70 and transmitted to the two-dimensional image processing unit 43 in real time.” p. 14, l. 8-17. “The surgeon can confirm the laser beam 75L that shines toward the virtual subject image VHB, and can confirm the insertion point of the subject HB (see FIG. 7). In addition, the operator can confirm whether the laser beam 75L is directed to the target TG of the three-dimensional organ image VNG. Note that the three-dimensional image processing unit 44 can display not only the appearance of the three-dimensional organ image VNG but also the appearance of the target TG by changing the threshold value of the signal intensity of the pre-MRI data PMD.”; p. 14, l. 18-27; Figs. 4, 7, 9 a-c);
a step of generating a cross-sectional image (“The four cross-sectional views” p. 11, l. 29 – p. 12, l. 2; seen in Figs. 4, 7, 9 a-c) that displays, in a predetermined cross-section of the three-dimensional surface image, an internal morphological image including the affected part of the subject (“The two-dimensional image processing unit 43 reconstructs an arbitrary cross-sectional two-dimensional MR image based on the two-dimensional arbitrary cross-sectional nuclear magnetic resonance signal sent from the data collection unit 104. Further, based on the nuclear magnetic resonance signal of the three-dimensional voxel sent from the data collection unit 104, a two-dimensional MR image of an arbitrary cross section is reconstructed."; p. 8, l. 27-32), the rod-shaped member (74), and the light propagation region (75L) (“FIG. 4 is a diagram showing an arbitrary cross section of the MR image displayed on the display unit 30. The two-dimensional image processing unit 43 reconstructs an image of a two-dimensional arbitrary cross section based on two-dimensional high-speed MR imaging or three-dimensional MR imaging that was previously captured. The four cross-sectional views displayed on the display unit 30 are an XY plane perpendicular to the virtual needle 74, an OB plane horizontal to the virtual needle 74, a YZ plane perpendicular to the body axis of the subject HB, and a body axis of the subject HB. XZ plane parallel to the XZ plane. The XY plane, OB plane, YZ plane, and XZ plane of the subject HB are planes including a target TG such as a tumor.” p. 11, l. 29 – p. 12, l. 2; “The two-dimensional image processing unit 43 reconstructs an image of the virtual line 76 that is an extension line of the virtual needle 74 and an arbitrary cross section, and displays the image on the display unit 30. In step S <b> 16, the virtual needle 74 turns on the laser light source 75 at the tip, and projects the laser light 75 </ b> L onto the extension line to which the virtual needle 74 is directed. The surgeon can confirm the laser beam 75L that shines toward the virtual subject image VHB, and can confirm the insertion point of the subject HB (see FIG. 7). In addition, the operator can confirm whether the laser beam 75L is directed to the target TG of the three-dimensional organ image VNG.” p. 14, l. 8-27); and
a step of causing the cross-sectional image to be displayed (“The two-dimensional image processing unit 43 reconstructs an image of the virtual line 76 that is an extension line of the virtual needle 74 and an arbitrary cross section, and displays the image on the display unit 30.” p. 14, l. 8-27; Fig. 2).
While teaching a light propagation region (75L; 76) in which light propagates from the rod-shaped member (“The two-dimensional image processing unit 43 reconstructs an image of the virtual line 76 that is an extension line of the virtual needle 74 and an arbitrary cross section, and displays the image on the display unit 30."; p. 14, l. 8-17; Figs. 4, 7, 9 a-c), Hasnine does not teach the therapy being phototherapy; a step of acquiring a light propagation region in which light propagates from the rod-shaped member.
However, in the surgical treatments field of endeavor, Otsu discloses a treatment method, which is analogous art. Otsu teaches the therapy being phototherapy (“inserting an optical fiber into the catheter, reducing an influence of blood in the artery on a near-infrared ray, irradiating at least one of a tumor, the vicinity of the tumor, or a regional lymph node with a first near-infrared ray by the optical fiber, and irradiating an antibody-photosensitive substance bound to a tumor cell membrane in the tumor cell with a second near-infrared ray having a shorter wavelength than that of the first near-infrared ray." Abstract);
a step of acquiring a light propagation region (includes “C” and three arrows in Figs. 3A-B and 4A-B; “the camera image” [0140]) in which light propagates from the rod-shaped member (“In the irradiating with the first near-infrared ray, the needle may have a light-transmitting portion capable of transmitting a near-infrared ray at a distal portion, and the first near-infrared ray may be emitted from the optical fiber located inside the needle through the light-transmitting portion. Thereby, the first near-infrared ray emitted from the optical fiber can reach a wide range of the irradiation target site without being obstructed by the needle.” [0023]. “Next, as shown in FIG. 14, the operator causes the needle tip 81 of the elongated tube 80 to come into contact with and puncture the tumor C while checking the camera image and/or ultrasound image of the endoscope 70. Thereby, the position of the elongated tube 80 is fixed with respect to the tumor C.” [0140]).
Therefore, based on Otsu’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Hasnine to have the therapy being phototherapy; and a step of acquiring a light propagation region in which light propagates from the rod-shaped member, as taught by Otsu, in order to maximize the phototherapy effectiveness by irradiating the target location by light (Otsu: [0140]).
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hasnine and Otsu as applied to claim 2, and further in view of Endo (US20230027950), hereinafter Endo.
Regarding claim 3, Hasnine modified by Otsu teaches the phototherapy planning device as recited in claim 2.
While Hasnine teaches indicating a degree of superposition of the first superimposed region with respect to the affected part (“The surgeon can confirm the laser beam 75L that shines toward the virtual subject image VHB, and can confirm the insertion point of the subject HB (see FIG. 7). In addition, the operator can confirm whether the laser beam 75L is directed to the target TG of the three-dimensional organ image VNG. Note that the three-dimensional image processing unit 44 can display not only the appearance of the three-dimensional organ image VNG but also the appearance of the target TG by changing the threshold value of the signal intensity of the pre-MRI data PMD.”; p. 14, l. 18-27; Figs. 4, 7, 9a-c), Hasnine as modified by Otsu does not teach the processor configured to acquire a first index value indicating a degree of superposition of the first superimposed region with respect to the affected part, and cause the first inde