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 .
Claim Status
This action is in response to the application filed on December 26, 2024. Claims 1-20 are pending and have been examined.
Priority
Receipt is acknowledged that application claims priority to foreign application with application number JP2023-223281 dated December 28, 2023. Copies of certified papers required by 37 CFR 1.55 have been received. Priority is acknowledged under 35 USC 119(e) and 37 CFR 1.78.
Receipt is acknowledged that application claims priority to foreign application with application number JP2024-202104 dated November 20, 2024. Copies of certified papers required by 37 CFR 1.55 have been received. Priority is acknowledged under 35 USC 119(e) and 37 CFR 1.78.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 26, 2024 and May 13, 2025 are being considered by the examiner.
Claim Objections
Claim 7 is objected to because of the following informalities: “culculated” should be “calculated”. Appropriate correction is required.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claims 1 and 15 these claims recite the following limitations which are found to be abstract ideas not reciting a practical application or significantly more, with claim 1 being exemplary:
determine a region including the medical device in each X-ray image (abstract idea as a mental process as a human is capable of determining a region including a medical device viewed in an X-ray image);
calculate a degree to which the medical device is dwelling in the region based on the X-ray images, assign weights to a plurality of pixels included in the region based on the degree, and calculate a parameter related to the region based on the weights and pixel values of the pixels (mathematical concepts, mathematical relationships, mathematical formulas or equations, mathematical calculations);
This judicial exception is not integrated into a practical application for the following reasons. Claims 1 and 15 both recite the additional element of “and set an X-ray condition based on the parameter,” however, this limitation also recites an abstract idea as a mental process as a human is capable of setting the X-ray parameter based on an X-ray condition.
Claim 1 further recites the additional element of “processing circuitry configured to.” While this limitation includes an additional elements of a processor this is not sufficient to recite a practical application of the abstract ideas recited in claim 1 as it amounts to mere generic computer elements and thus amount to no more than a recitation of the words “apply it” (or an equivalent) or are no more than the mere instructions to implement an abstract idea or other exception on a computer. See MPEP 2106.05(f).
Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, the above recited additional elements from claims 1 and 15 do not add significantly more (also known as an “inventive concept”) to the exception. Rather, the additional elements disclosed above perform well-understood, routine, conventional computer functions.
Therefore, independent claims 1 and 15 are directed towards an abstract idea without a practical application or significantly more.
Regarding claims 2, 9-11, 13, and 16 the limitations are merely directed towards insignificant pre/post-solution extra activity that nonetheless do not integrate the abstract idea recited from claim 1 into a practical application.
Regarding claims 3-8, 12, 17-20 the limitations are merely directed towards mathematical concepts, mathematical relationships, mathematical formulas or equations, mathematical calculations that nonetheless do not integrate the abstract idea recited from claim 1 into a practical application.
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.
Claim(s) 1-3, 5, 15-17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radhakrishna et al, US 20250195850 in view of Gamm et al, US 20210027982.
Regarding claim 1, Radhakrishna teaches
An X-ray diagnosis apparatus comprising processing circuitry configured to (see Radhakrishna, Paragraph [0076], “The X-ray imaging device 1 includes a data processing apparatus 2, an X-ray source 4, and an X-ray detector 3. The data processing apparatus 2 includes at least one computing unit”):
acquire a plurality of X-ray images sequentially from a subject with a medical device inserted into a body of the subject (see Radhakrishna, Paragraph [0077], “X-ray detector 3 is configured to generate a respective detector dataset for each of the sequence of frame intervals depending on portions of the respective X-rays passing through a region of interest containing a vessel 19 of a patient 5 and a balloon catheter, 6, that has been inserted into the vessel 19, during the respective frame interval. The at least one computing unit is configured to generate a sequence of X-ray images depending on the detector datasets generated for the sequence of frame intervals”);
determine a region including the medical device in each X-ray image see Radhakrishna, Paragraph [0077], “portions of the respective X-rays passing through a region of interest containing a vessel 19 of a patient 5 and a balloon catheter, 6”;
calculate a degree to which the medical device is dwelling in the region based on the X-ray images (see Radhakrishna, Paragraph [0079], “The at least one computing unit computes the inflation duration depending on a first time difference between the first inflation starting time and the first deflation starting time in step 240”),
Radhakrishna does not expressively teach
assign weights to a plurality of pixels included in the region based on the degree,
and calculate a parameter related to the region based on the weights and pixel values of the pixels;
and set an X-ray condition based on the parameter.
However, Gamm in a similar invention in the same field of endeavor teaches
assign weights to a plurality of pixels included in the region based on the degree (see Gamm, Paragraph [0023], “the assignment of weights to the registered settings of the first parameter could for example include a determination such that a given registered setting of the first parameter receives a weight, which increases with the dwell time per pixel of the scanning method and/or which increases with the number of pixels of the recorded image”),
and calculate a parameter related to the region based on the weights and pixel values of the pixels (see Gamm, Paragraph [0023], “the second parameters characterize a scanning method used when recording a particle beam-microscopic image and the assignment of weights to the registered settings of the first parameter could for example include a determination”);
and set an X-ray condition based on the parameter (see Gamm, Paragraph [0021], “a recording of a particle beam-microscopic image with a high magnification that was triggered by the user is an indication that the first parameters, which influence the image quality, were set “well” in the estimation of the user. Accordingly, it is expedient to increase the weight of these settings”).
The combination of Radhakrishna and Gamm are analogous art because they are both in the same field of endeavor of using a probe to interact with an object being imaged and forming images via a transmitted or scattered signal detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to assign weights which increases with the dwell time per pixel or increases with the number of pixels in of the recorded image as taught in the method of Gamm in the system of Radhakrishna to increase image quality (Gamm, Paragraph [0023]).
Regarding claim 2, Radhakrishna in view of Gamm teaches the X-ray diagnosis apparatus according to claim 1,
wherein the processing circuitry is configured to determine a movement amount of the medical device between the X-ray images based on a position of the medical device in each of the X-ray images, and evaluate the degree based on the movement amount (see Radhakrishna, Paragraph [0079], “The at least one computing unit determines a first inflation starting time of a first inflation phase, during which the diameter 18 is increasing, based on the tracked diameter 18 in step 230. The at least one computing unit determines a first deflation starting time of a first deflation phase, during which the diameter 18 is decreasing and that lies after the first inflation phase, based on the tracked diameter 18 in step 240”).
The rationale of claim 1 has been applied herein.
Regarding claim 3, Radhakrishna in view of Gamm teaches the X-ray diagnosis apparatus according to claim 1,
wherein the processing circuitry is configured to determine a length of time when the medical device is dwelling based on a position of the medical device in each of the plurality of X-ray images, and evaluate the degree based on the length of time (see Radhakrishna, Paragraph [0079], “The at least one computing unit computes the inflation duration depending on a first time difference between the first inflation starting time and the first deflation starting time in step 240”).
The rationale of claim 1 has been applied herein.
Regarding claim 5, Radhakrishna in view of Gamm teaches the X-ray diagnosis apparatus according to claim 1,
wherein the processing circuitry is configured to calculate a parameter related to the region based on a position of a marker assigned to the medical device in each of the X-ray images and the pixel values (see Radhakrishna, Paragraph [0044], “a first marker position of a first radio-opaque marker of the balloon catheter and a second marker position of a second radio-opaque marker of the balloon catheter are determined based on the sequence of x-ray images and, for example, tracked over the sequence of x-ray images”).
The rationale of claim 1 has been applied herein.
As per claim 15, Claim 15 claims an X-ray condition setting method comprising: the same limitations as Claim 1. Therefore, the rejection and rationale are analogous to that made in Claim 1.
As per claim 16, Claim 16 claims the same limitations as Claim 2 and is dependent on a similarly rejected independent claim. Therefore, the rejection and rationale is analogous to that made in Claim 2.
As per claim 17, Claim 17 claims the same limitations as Claim 3 and is dependent on a similarly rejected independent claim. Therefore, the rejection and rationale is analogous to that made in Claim 3.
As per claim 19, Claim 19 claims the same limitations as Claim 5 and is dependent on a similarly rejected independent claim. Therefore, the rejection and rationale is analogous to that made in Claim 5.
Claim(s) 4, 13-14, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radhakrishna et al, US 20250195850 in view of Gamm et al, US 20210027982 in view of Nakada et al, US 20140187921.
Regarding claim 4, Radhakrishna in view of Gamm does not teach the X-ray diagnosis apparatus according to claim 1,
wherein the processing circuitry is configured to calculate a parameter related to the region based on a position of a tip end of the medical device in each of the X-ray images and the pixel values.
However, Nakada in a similar invention in the same field of endeavor teaches
wherein the processing circuitry is configured to calculate a parameter related to the region based on a position of a tip end of the medical device in each of the X-ray images and the pixel values (see Nakada, Paragraph [0096], “an acquisition unit that acquires a first X-ray image from the plurality of X-ray images from the second image acquisition unit, the rotation angle at the tip end of the catheter and the second rotation angle from the catheter tip-end rotation angle calculation unit, the catheter rotation axis from the catheter rotation axis determination unit, and image-capturing parameter information at a time of capturing the first X-ray image from the image-capturing parameter information acquisition unit,” rotation angle at the tip end of the catheter is considered to be calculate a parameter related to the region based on a position of a tip end).
The combination of Radhakrishna, Gamm, and Nakada are analogous art because they are all in the same field of endeavor of using a probe to interact with an object being imaged and forming images via a transmitted or scattered signal detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to calculate the rotation angle at the tip end of the catheter as taught in the apparatus of Nakada in the system of Radhakrishna in view of Gamm to accurately grasp the direction of the tip end of the catheter in order to align, at a branching portion of the blood vessel, the direction of the tip end of the catheter with the branching direction of a target blood vessel (Nakuda, Paragraph [0004]).
Regarding claim 13, Radhakrishna in view of Gamm does not teach the X-ray diagnosis apparatus according to claim 1,
wherein the processing circuitry is further configured to cause the region to be displayed on a display unit.
However, Nakada in a similar invention in the same field of endeavor teaches
wherein the processing circuitry is further configured to cause the region to be displayed on a display unit (see Nakada, Paragraph [0031], “FIG. 11A is a view showing a state, according to the first embodiment, where an example of the rotation angle of the tip end of the catheter to be presented to a user is displayed on a display”).
The combination of Radhakrishna, Gamm, and Nakada are analogous art because they are all in the same field of endeavor of using a probe to interact with an object being imaged and forming images via a transmitted or scattered signal detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to present the rotation angle tip end of the catheter to a user on a display; and superimpose the rotation angle theta on the X-ray image that is monitored during catheter manipulation by a surgeon as taught in the apparatus of Nakada in the system of Radhakrishna in view of Gamm to accurately grasp the direction of the tip end of the catheter in order to align, at a branching portion of the blood vessel, the direction of the tip end of the catheter with the branching direction of a target blood vessel (Nakuda, Paragraph [0004]).
Regarding claim 14, Radhakrishna in view of Gamm in view of Nakada further teaches the X-ray diagnosis apparatus according to claim 13,
wherein the processing circuitry is configured to sequentially display newly acquired X-ray images on the display unit and (see Nakada, Paragraph [0091], “a second image acquisition unit that acquires a plurality of X-ray images including the tip end portion of the catheter captured by a plurality of X-ray image capturing devices provided at different positions”)
displays the region on the X-ray images for regular time interval in a superimposing manner (see Nakada, Paragraph [0149], “the presenting unit 106 may display the rotation angle .theta. of the tip end of the catheter 10 by superimposing the same on an X-ray image displayed on a display which is monitored during catheter manipulation by a surgeon”).
The rationale of claim 13 has been applied herein.
As per claim 18, Claim 18 claims the same limitations as Claim 4 and is dependent on a similarly rejected independent claim. Therefore, the rejection and rationale is analogous to that made in Claim 4.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radhakrishna et al, US 20250195850 in view of Gamm et al, US 20210027982 in view of Masuda et al, JP 2019150296 A.
Regarding claim 9, Radhakrishna in view of Gamm does not teach the X-ray diagnosis apparatus according to claim 1,
wherein the processing circuitry is configured to determine the region by combining a plurality of regions newly determined out of a plurality of regions determined from sequentially acquired X-ray images so that an area of the region does not exceed an upper limit value.
However, Masuda in a similar invention in the same field of endeavor teaches
wherein the processing circuitry is configured to determine the region by combining a plurality of regions newly determined out of a plurality of regions determined from sequentially acquired X-ray images so that an area of the region does not exceed an upper limit value (see Masuda, Paragraph [0010], “the extraction means divides the imaging target region into a plurality of regions and extracts a specific region from the divided plurality of regions in which the temporal change of the ultrasound image is greater than that of the other regions, until the measurement error of the position of the tip of the catheter is less than a predetermined threshold,” dividing the image into regions and selecting the region based on temporal changes in the image and measurement position of the tip of the catheter is applicable to ultrasound imaging and x-ray imaging).
The combination of Radhakrishna, Gamm, and Masuda are analogous art because they are all in the same field of endeavor of using a probe to interact with an object being imaged and forming images via a transmitted or scattered signal detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to extract a specific region from the divided plurality of regions until the measurement error of the position tip of the catheter is less than a predetermined threshold as taught in the device of Masuda in the system of Radhakrishna in view of Gamm to accurately detect the position of the catheter tip (Masuda, Paragraph [0007]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radhakrishna et al, US 20250195850 in view of Gamm et al, US 20210027982 in view of Akiyama et al, US 20180021000 in further view of Nakada et al, US 20140187921.
Regarding claim 12, Radhakrishna in view of Gamm does not teach the X-ray diagnosis apparatus according to claim 1,
wherein the processing circuitry is configured to determine a second region by processing a first region,
However, Akiyama in a similar invention in the same field of endeavor teaches
wherein the processing circuitry is configured to determine a second region by processing a first region (see Akiyama, Paragraph [0016], “And the processing circuitry is configured to obtain positions corresponding to the region of interest in the first X-ray image and in the second X-ray image on a basis of the position information and to generate a subtraction image by calculating a difference between the region of interest in the third X-ray image and a region corresponding to the region of interest in the first X-ray image and calculating a difference between a region other than the region of interest in the third X-ray image and a region corresponding to the region other than the region of interest in the second X-ray image”),
The combination of Radhakrishna, Gamm, and Akiyama are analogous art because they are in the same field of endeavor of using a probe to interact with an object being imaged and forming images via a transmitted or scattered signal detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, for the processing circuitry to obtain positions corresponding to the region of interest in the x-ray images on a basis of position information to generate a subtraction image by calculating a difference as taught in the apparatus of Akiyama in the device of Radhakrishna in view of Gamm to reduce the radiation exposure amount of the subject while generating a sharp X-ray image of the region of interest (Akiyama, Paragraph [0004]).
Radhakrishna in view of Gamm in view of Akiyama does not expressively teach
and calculate the parameter based on a position of the medical device in each of the X-ray images and pixel values of a plurality of pixels included in the second region.
However, Nakeda in a similar invention in the same field of endeavor teaches
and calculate the parameter based on a position of the medical device in each of the X-ray images and pixel values of a plurality of pixels included in the second region (see Nakada, Paragraph [0096], “an acquisition unit that acquires a first X-ray image from the plurality of X-ray images from the second image acquisition unit, the rotation angle at the tip end of the catheter and the second rotation angle from the catheter tip-end rotation angle calculation unit, the catheter rotation axis from the catheter rotation axis determination unit, and image-capturing parameter information at a time of capturing the first X-ray image from the image-capturing parameter information acquisition unit”).
The combination of Radhakrishna, Gamm, Akiyama, and Nakada are analogous art because they are all in the same field of endeavor of using a probe to interact with an object being imaged and forming images via a transmitted or scattered signal detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to acquire X-ray image from plurality of X-ray images, the rotation angle at the tip end of the catheter, and image-capturing parameter information as taught in the apparatus of Nakada in the system of Radhakrishna in view of Gamm in view of Akiyama to accurately grasp the direction of the tip end of the catheter in order to align, at a branching portion of the blood vessel, the direction of the tip end of the catheter with the branching direction of a target blood vessel (Nakuda, Paragraph [0004]).
Allowable Subject Matter
Claims 6-8, 10-11, and 20 are rejected under 35 U.S.C. 101 and are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to overcome the 35 U.S.C. 101 rejection and in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIQUE JAMES whose telephone number is (703)756-1655. The examiner can normally be reached 9:00 am - 6:00 pm EST.
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/DOMINIQUE JAMES/Examiner, Art Unit 2666
/EMILY C TERRELL/Supervisory Patent Examiner, Art Unit 2666
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