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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP2021-143922, filed on September 3, 2021.
Status of Claims
This Office Action is responsive to the claims filed on 08/08/2025. Claims 3, 4, 7, and 10 were previously canceled. Claims 1, 6, and 9 have been amended. Claim 12 has been newly added. Claims 1, 2, 5, 6, 8, 9, 11, and 12 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 5, 6, 8, 9, 11, and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed limitation of “the second fluoroscopy and the third fluoroscopy are performed simultaneously in parallel” (Claim 1, line 19; Claim 6, lines 17-18; Claim 9, line 19) is not described in sufficient detail that it would be clear that the applicant had possession of the claimed invention. The specification lacks the specific detail of the second and third fluoroscopy being simultaneous as claimed. Specification paragraphs [0087] describes “the third fluoroscopic image G3 is acquired. Then, the imaging control unit 31 controls the radiation source 6 and the radiation detector 5 such that the second fluoroscopy is performed under the second fluoroscopy conditions (Step ST39)” and paragraphs [0072] and [0089] describe steps of the third fluoroscopy being sequential, but does not describe the third fluoroscopy and second fluoroscopy as being “simultaneous”. Furthermore, Figure 14 shows the third fluoroscopy as occurring during the time G3 when the second fluoroscopy is paused G2. Furthermore, Figure 16 shows the of steps of the second fluoroscopy ST32/ST39 and the third fluoroscopy ST38 as being separate steps and further appear to occur in sequential order. Thus, the limitation of “the second fluoroscopy and the third fluoroscopy are performed simultaneously in parallel” is rendered as new matter. As such the claims are not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention. Therefore, the claims are rejected for including new matter.
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, 2, 5, 6, 8, 9, 11, and 12 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.
Claim 1, line 19; Claim 6, lines 17-18; Claim 9, line 19 recite the claim limitation “the second fluoroscopy and the third fluoroscopy are performed simultaneously” which is indefinite because it is unclear what the metes and bounds of “the second fluoroscopy and the third fluoroscopy are performed simultaneously” would be. It is unclear if the radiation source changing a tube voltage or a predetermined tube current during a period of time to collect images at two different doses within a time period is simultaneous such that a second and third fluoroscopic condition occurs with a set time period, as understood by at least Fig. 14 and Specification paragraphs [0073]-[0074]; OR if the radiation of the radiation source from a single instant is used for a second and third fluoroscopic image as appears to be argued in Remarks filed 08/08/2025, pg. 7-8, Rejections under 35 USC 103; OR if there are multiple radiation sources with different voltage or tube currents, such that the two fluoroscopic conditions are performed at the same time. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)); see also Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. Cir. 2014) (holding the claim phrase “unobtrusive manner’ indefinite because the specification did not “provide a reasonably clear and exclusive definition, leaving the facially subjective claim language without an objective boundary’). See MPEP 2173.05 (b) IV. For the purpose of examination, this is understood to mean changing a tube voltage or a predetermined tube current during a period of time to collect images at two different doses within a time period is simultaneous such that a second and third fluoroscopic condition occurs with a set time period, as understood by at least Fig. 14 and Specification paragraphs [0073]-[0074]; OR the radiation of the radiation source from a single instant is used for a second and third fluoroscopic image as appears to be argued in Remarks filed 08/08/2025, pg. 7-8, Rejections under 35 USC 103; OR there are multiple radiation sources with different voltage or tube currents, such that the two fluoroscopic conditions are performed at the same time.
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, 5, 6, 8, 9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz (US 20130303884) in view of Langan (US 20170039734) and Lim (US 10548557) and Sakaguchi (US 20130051527).
Regarding claim 1, Kuntz teaches a radioscopy apparatus (Paragraph [0001]; a system for radiologically guiding medical interventions on an object) comprising:
a radiation source (Paragraphs [0071] and [0072]; a source #201, #304, Figs. 2 and 3) that irradiates a subject with radiation (Paragraphs [0023] and [0071]; The object to be imaged can either comprise the full body of a patient or parts and functions thereof; acquires images of the patient… releasing electromagnetic radiation, preferably X-rays);
a radiation detector (Paragraphs [0071] and [0072]; a detector #202, #306, Figs. 2 and 3) that detects the radiation transmitted through the subject (Paragraph [0071]; detecting the released X-rays after having traversed the objection to the image #106, 302, 310, 203, Figs. 2 and 3) to generate a fluoroscopic image of the subject (Paragraphs [0071] and [0115]; system #101 acquires images of the patient… preferably X-rays; In one embodiment the CT data (CT fluoroscopy) are continuously acquired to provide 4D information); and
at least one processor (Paragraphs [0041]; a computer program for performing above described method is proposed, when executing the computer program on a computer, particularly a high performance computing device (HPC), high performance computing device (HPC) #103, Fig. 1), wherein the processor controls the radiation source and the radiation detector (Paragraph [0070]; The operator console 104 further allows modifying all functions of the interventional CT system 101 and most parameters affecting the imaging, Fig. 1) such that first fluoroscopy is performed on the subject before a treatment tool (Paragraph [0042]; catheter intervention, cardiac pace maker, stent) is inserted (Paragraph [0069]; Prior to the intervention, the prior image can for instance be sampled using a gantry-based system) under first fluoroscopy conditions (Paragraph [0069]; a fully sampled acquisition mode) including at least one of a predetermined first tube voltage or a predetermined first tube current to acquire a first fluoroscopic image of the subject (Paragraphs [0069] and [0076]; with a frame-rate of 30 frames per second, a rotation time of 10 s and a tube-current of 50 mA and tube voltage of 100 kV; Herein the prior image serves as the first image of the object to be imaged. Furthermore, the instrument used during medical intervention on the object to be imaged is not present on the prior image), and
controls the radiation source and the radiation detector such that second fluoroscopy is performed (Paragraph [0069]; During the course of the intervention, the temporal updates corresponding to undersampled sets of projections can be sampled with e.g. 18 frames per rotation) at a predetermined frame rate on the subject after the treatment tool is inserted under second fluoroscopy conditions including a second tube current smaller than the first tube current to (Paragraph [0069]; sets of projections can be sampled with e.g. 18 frames per rotation, a tube current of 30 mA and a tube voltage of 100 kV; The tube current is reduced from 50 mA to 30 mA) sequentially acquire a plurality of second fluoroscopic images of the subject (Paragraph [0077]; After the placement of the instrument and on its way through the object to be imaged low dose update data is continuously acquired in step #403 for guiding the instrument during the intervention. Furthermore, the low dose update data from step #403 is continuously reconstructed using the imaging method according to the present invention); and
that after acquiring the first fluoroscopic image, the processor controls the radiation source and the radiation detector such that third fluoroscopy which sequentially acquires a third fluoroscopic image (Paragraphs [0028] and [0184]; update scans are preferably acquired at projection angles that are different from earlier projection angles such that after several rotations a new-fully sampled dataset is produced, which can be used as update of the first image; In a further embodiment of the invention, the more than one set of projections of the object to be imaged comprises at least one fully sampled set of projections, preferably measured before, during or after the radiological intervention).
Kuntz does not teach acquiring the third fluoroscopic image at a frame rate lower than the predetermined frame rate is further performed under the first fluoroscopy conditions while performing the second fluoroscopy; and
the second fluoroscopy and the third fluoroscopy are performed simultaneously in parallel.
Langan, however, teaches a radioscopy apparatus (Paragraph [0005]; an X-ray source and an X-ray detector of a tomographic imaging system) comprising:
a radiation source (Paragraph [0027]; imaging system #10 includes a source of X-ray radiation #12, Fig. 1);
a radiation detector (Paragraph [0027]; and a detector #14, Fig. 1);
first fluoroscopy conditions to acquire a first fluoroscopic image of the subject (Paragraph [0054]; 2D projections or other low quality (LQ) images generated using a first set of parameters #114, Fig. 4);
second fluoroscopy is performed at a predetermined frame rate (Paragraph [0054]; one or more of a high frame rate (e.g., approximately 30 frames per second or greater)) under second fluoroscopy conditions to sequentially acquire a plurality of second fluoroscopic images of the subject (Paragraph [0054]; In the depicted example, high quality and/or 3D imaging may be acquired using second parameters #124 that specify one or more of a high frame rate, Fig. 4);
and that after acquiring the first fluoroscopic image (Paragraph [0055]; thus resuming projection or image acquisition using the fist parameters #114, Fig. 4 shows a second step #114 occurring after the first step of #114), the processor controls the radiation source and the radiation detector such that third fluoroscopy which sequentially acquires a third fluoroscopic image (Paragraph [0055]; thus resuming projection or image acquisition) at a frame rate lower than the predetermined frame rate (Paragraphs [0054] and [0055]; The first parameters #114 may specify one or more of a low frame rate (e.g., approximately 5 frames per second); using the fist parameters #114) is further performed under the first fluoroscopy conditions (Paragraph [0055]; thus resuming projection or image acquisition using the fist parameters #114, Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of Kuntz such that after acquiring the first fluoroscopic image, the processor controls the radiation source and the radiation detector such that third fluoroscopy which sequentially acquires a third fluoroscopic image at a frame rate lower than the predetermined frame rate is further performed under the first fluoroscopy conditions. This would reduce the amount of imaging when the interventional device leaves the region of interest, and thus reduce the overall radiation dose to the patient (Langan, Paragraphs [0053] and [0058]).
Together Kuntz and Langan do not explicitly teach the acquiring the third fluoroscopic is further performed while performing the second fluoroscopy; and
the second fluoroscopy and the third fluoroscopy are performed simultaneously in parallel.
Lim, however, teaches a radioscopy apparatus (Col. 2, ln. 8-10; include X-ray apparatus and an X-ray imaging method which may reduce an amount of radiation to which an object is exposed) comprising:
a radiation source (Col. 9, ln. 25-30; The X-ray apparatus 100 may include an X-ray radiator 120, Fig. 1) that irradiates a subject with radiation (Col. 9, ln. 35-40; X-ray radiator 120 includes the X-ray source 122 receiving the high voltage from the high voltage generator 121 to generate and radiate X-rays; Col. 8, ln. 64-67; object may be a human, Fig. 2);
a radiation detector (Col. 9, ln.25-30; a detector 130, Fig. 1) that detects the radiation transmitted through the subject (Col. 10, ln. 20-28; detector 130 detects an X-ray that is radiated from the X-ray radiator 120 and has been transmitted through an object) to generate a fluoroscopic image of the subject (Col. 12, ln. 21-27; the controllers 113 and 150 generate a medical image of the object by using image data received via the detector 130); and
at least one processor (Col. 9, ln. 25-31; and a controller 150, Fig. 1; Col. 41, ln. 20-25; at least one processing element to implement any above described embodiment), and controls the radiation source and the radiation detector such that second fluoroscopy (Col. 37, ln. 43-56; Fig. 14, pulse signal pattern of pulses 1412, 1414, 1416, 1418) is performed at a predetermined frame rate (Col. 37, ln. 43-56; a plurality of pulses 1412, and 1414 included in one cycle P have the predetermined pattern 1401; Fig. 14 shows the pulses 1412 and 1414 with Amplitude A11 occurs at rate of 2 times per cycle P) on the subject after the treatment tool is inserted (Col. 14, ln. 36-61; catheter may be correctly inserted into a target position of an object. Accordingly, the user may perform an operation by acquiring a fluoroscopic image during the operation and checking the position of a target object) under second fluoroscopy conditions (Col. 16, ln. 63-Col. 17, ln. 21; generate an X-ray, a high voltage generator 121 generates a high voltage to be applied… pulse amplitude may correspond to a tube current flowing between the anode and the cathode of an X-ray tube included in the high voltage generator; Col. 37, ln. 50-56; amplitude value is A11, Fig. 14) including a second tube current (Col. 37, ln. 50-56; Fig. 14 shows amplitude value is A11) smaller than the first tube current (Col. 37, ln. 50-56; that A14>A11, Fig. 14) to sequentially acquire a plurality of second fluoroscopic images of the subject (Col. 16, ln. 39-62; An x-ray image is sequentially obtained for each pulse as shown in Figs. 4-5; Fig. 14 shows pulses 1412, 1414, 1416, and 1418 are sequentially applied), and
the processor controls the radiation source and the radiation detector such that third fluoroscopy (Col. 37, ln. 43-56; Fig. 14, pulse signal pattern of pulses 1411, 1415, 1419; Fig. 14 shows amplitude value is A14), which sequentially acquires a third fluoroscopic image (Col. 16, ln. 39-62; An x-ray image is sequentially obtained for each pulse as shown in Figs. 4-5) at a frame rate lower than the predetermined frame rate (Col. 37, ln. 43-56; pulse 1411 included in one cycle P have the predetermined pattern 1401; Fig. 14 shows the pulses 1411 with Amplitude A14 occurs at rate of 1 times per cycle P, which is less than the rate of pulses with amplitude value A11), is further performed while performing the second fluoroscopy (Col. 37, ln. 43-56; a pulse signal 1400 including a pattern of pulses 1411, 1412, and 1414; Fig. 14 shows the pattern of pulses 1411 is performed while performing the pattern of pulses 1412/1414 which is considered to read on the claimed limitation of being performed while performing the second fluoroscopy as understood in its broadest reasonable interpretation and Applicant Specification and Drawing Fig. 14),
whereby the second fluoroscopy and the third fluoroscopy are performed in parallel (Fig. 14 shows the pattern of pulses 1411 is performed while performing the during the same time period P as the pattern of pulses 1412/1414 which is considered to be in parallel as understood in its broadest reasonable interpretation and in view of Applicant Drawings, Fig. 14, whereby the second and third fluoroscopy both occur in the same time period G3+G2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the apparatus of Kuntz in view of Langan to image pulse patterns such that the third fluoroscopic is further performed while performing the second fluoroscopy whereby the second fluoroscopy and the third fluoroscopy are performed in parallel as taught by Lim because it would have allowed reducing the total amount of radiation applied to the patient while producing natural fluoroscopic images (Lim, Col. 40, ln. 66-Col. 41, ln. 10) and further allowed producing final higher quality images at a higher frame rate than the capture rate of the high radiation imaging by performing adjustments based on the images captured with lower radiation (Col. 41, ln. 11-19), thereby providing an accurate diagnosis of a patient (Col. 1, ln. 54-Col. 2, ln. 4).
Together Kuntz, Langan, and Lim do not explicitly teach the second fluoroscopy and the third fluoroscopy are performed simultaneously.
Sakaguchi, however, teaches the second fluoroscopy and the third fluoroscopy are performed simultaneously (Paragraph [0049]; when a first noise quantity 301 of an X-ray image is obtained, it is possible to obtain a first noise image 302 and a first X-ray dose 303. Thereafter, it is possible to calculate a second noise image 306 from a second noise quantity 305 corresponding to a second X-ray dose 304 when the obtained first X-ray dose 303 is decreased to 1/N; Paragraph [0050]; it is possible to generate a simulated image corresponding to a desired X-ray dose by adding the X-ray image to the second noise image; Paragraph [0054]; and may simultaneously display more simulated images. In addition, this case is based on the assumption that the X-ray image is displayed on the main monitor, and the simulated images are displayed on the sub-monitor; The act of obtaining the X-ray image is and the first noise image 302 from the same x-ray dose is considered to read on the limitation of second fluoroscopy and the third fluoroscopy are performed simultaneously as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of Kuntz in view of Langan and Lim such that the second fluoroscopy and the third fluoroscopy are performed simultaneously because it would have allowed generating simulated X-ray images of the desired dose when the actual X-ray dose is decreased or increased (Sakaguchi, Paragraph [0045]-[0046]), thereby ensuring the image quality remains stable during the process.
Regarding claim 5, together Kuntz, Langan, and Lim teach all of the limitations of claim 1 as noted above. Kuntz further teaches a fluoroscopic image display device (Paragraph [0039] and [0067]; updated images reconstructed iteratively during the course of the intervention can be displayed in real-time on a screen; displays #102, Fig. 1) comprising at least one processor (Paragraphs [0041], [0067], and [0184]; According to the invention a computer program for performing above described method is proposed, when executing the computer program on a computer, particularly a high performance computing device (HPC) #103; wherein the reconstruction is performed by processing means… the processing means comprise a processor, Fig. 1), wherein the processor acquires the first fluoroscopic image acquired by the radioscopy apparatus according to claim 1, as noted above in the rejection of claim 1, sequentially acquires the second fluoroscopic images acquired by the radioscopy apparatus according to claim 1, as noted above, sequentially extracts a region of the treatment tool from each of the second fluoroscopic images (Paragraph [0085]; algorithms that track instruments can be used. There e.g. connected pixels in the data set can be identified, a comparison with a data base of possible instruments can be performed; the changes (e.g. catheters, guidewires, etc.) are removed), sequentially combines the region of the treatment tool with the first fluoroscopic image to sequentially derive a composite fluoroscopic image (Paragraphs [0089] and [0100]; In operation #720, the image #708, which in the first run corresponds to the prior image #706, is added to the volumetric difference image #718; This image is fed back into the iterative loop and serves as the base image #708 for the next iteration of the reconstruction algorithm; the result including the guide wire is shown reconstructed through the PRIDICT reconstruction that uses a fully sampled prior image and an undersampled set of projections) at the predetermined frame rate (Paragraphs [0078] and [0080]; all following scans can be performed as under sampled scans with a lower dose, which can be performed continuously; During the intervention the interventionist is continuously provided with updated images on-the-fly; allowing for real-time interventional guidance), displays the composite fluoroscopic image (Paragraphs [0074] and [0094]; The updated image is then provided to the interventionist by displaying the updated image on the display array #102; If it is fulfilled, the image is fed back into #808 replacing this image and image #808 can be displayed to the operator, Fig. 8), sequentially acquires the third fluoroscopic image acquired by the radioscopy apparatus according to claim 3, as noted above, sequentially combines the region of the treatment tool extracted from the second fluoroscopic image (Paragraph [0085]; algorithms that track instruments can be used. There e.g. connected pixels in the data set can be identified, a comparison with a data base of possible instruments can be performed; the changes (e.g. catheters, guidewires, etc.) are removed) acquired until a next third fluoroscopic image is acquired with the sequentially acquired third fluoroscopic images to sequentially derive other composite fluoroscopic images (Paragraphs [0085] and [0122]; The projections of the update scans #606 are acquired at angular positions that are different from earlier projection positions so that after several rotations a new-fully sampled dataset is produced which can be used as a sliding prior; One embodiment employs a registration algorithm that compensates for movements of the patient or system between acquisition of the prior scan and the update scans. In one embodiment a new prior image is constantly updated from the projection data), and sequentially displays the other composite fluoroscopic images instead of the composite fluoroscopic image (Paragraph [0094]; the image is fed back into #808 replacing this image and image #808 can be displayed to the operator; Examiner notes the prior image for which the combined image is based on is continually updated from the new-fully sampled dataset and thus the images displayed are based on the new dataset. This is considered to read on the claimed limitation of sequentially displays the other composite fluoroscopic images instead of the composite fluoroscopic image in its broadest reasonable interpretation).
Regarding claim 6, Kuntz teaches a radioscopy method (Paragraph [0001]; an imaging method for radiologically guiding an instrument during medical interventions) in a radioscopy apparatus (Paragraph [0001]; a system for radiologically guiding medical interventions on an object) including a radiation source (Paragraphs [0071] and [0072]; a source #201, #304, Figs. 2 and 3) that irradiates a subject with radiation (Paragraphs [0023] and [0071]; The object to be imaged can either comprise the full body of a patient or parts and functions thereof; acquires images of the patient… releasing electromagnetic radiation, preferably X-rays) and a radiation detector (Paragraphs [0071] and [0072]; a detector #202, #306, Figs. 2 and 3) that detects the radiation transmitted through the subject (Paragraph [0071]; detecting the released X-rays after having traversed the objection to the image #106, 302, 310, 203, Figs. 2 and 3) to generate a fluoroscopic image of the subject (Paragraphs [0071] and [0115]; system #101 acquires images of the patient… preferably X-rays; In one embodiment the CT data (CT fluoroscopy) are continuously acquired to provide 4D information), the radioscopy method comprising:
controlling the radiation source and the radiation detector (Paragraph [0070]; The operator console 104 further allows modifying all functions of the interventional CT system 101 and most parameters affecting the imaging, Fig. 1) such that first fluoroscopy is performed on the subject before a treatment tool (Paragraph [0042]; catheter intervention, cardiac pace maker, stent) is inserted (Paragraph [0069]; Prior to the intervention, the prior image can for instance be sampled using a gantry-based system) under first fluoroscopy conditions (Paragraph [0069]; a fully sampled acquisition mode) including at least one of a predetermined first tube voltage or a predetermined first tube current to acquire a first fluoroscopic image of the subject (Paragraphs [0069] and [0076]; with a frame-rate of 30 frames per second, a rotation time of 10 s and a tube-current of 50 mA and tube voltage of 100 kV; Herein the prior image serves as the first image of the object to be imaged. Furthermore, the instrument used during medical intervention on the object to be imaged is not present on the prior image);
controlling the radiation source and the radiation detector such that second fluoroscopy is performed (Paragraph [0069]; During the course of the intervention, the temporal updates corresponding to undersampled sets of projections can be sampled with e.g. 18 frames per rotation) at a predetermined frame rate on the subject after the treatment tool is inserted under second fluoroscopy conditions including a second tube current smaller than the first tube current to (Paragraph [0069]; sets of projections can be sampled with e.g. 18 frames per rotation, a tube current of 30 mA and a tube voltage of 100 kV; The tube current is reduced from 50 mA to 30 mA) sequentially acquire a plurality of second fluoroscopic images of the subject (Paragraph [0077]; After the placement of the instrument and on its way through the object to be imaged low dose update data is continuously acquired in step #403 for guiding the instrument during the intervention. Furthermore, the low dose update data from step #403 is continuously reconstructed using the imaging method according to the present invention); and
after acquiring the first fluoroscopic image, controlling the radiation source and the radiation detector such that third fluoroscopy which sequentially acquires a third fluoroscopic image (Paragraphs [0028] and [0184]; update scans are preferably acquired at projection angles that are different from earlier projection angles such that after several rotations a new-fully sampled dataset is produced, which can be used as update of the first image; In a further embodiment of the invention, the more than one set of projections of the object to be imaged comprises at least one fully sampled set of projections, preferably measured before, during or after the radiological intervention).
Kuntz does not teach acquiring the third fluoroscopic image at a frame rate lower than the predetermined frame rate is further performed under the first fluoroscopy conditions while performing the second fluoroscopy, whereby the second fluoroscopy and the third fluoroscopy are performed simultaneously.
Langan, however, teaches a radioscopy apparatus (Paragraph [0005]; an X-ray source and an X-ray detector of a tomographic imaging system) comprising:
a radiation source (Paragraph [0027]; imaging system #10 includes a source of X-ray radiation #12, Fig. 1);
a radiation detector (Paragraph [0027]; and a detector #14, Fig. 1);
first fluoroscopy conditions to acquire a first fluoroscopic image of the subject (Paragraph [0054]; 2D projections or other low quality (LQ) images generated using a first set of parameters #114, Fig. 4);
second fluoroscopy is performed at a predetermined frame rate (Paragraph [0054]; one or more of a high frame rate (e.g., approximately 30 frames per second or greater)) under second fluoroscopy conditions to sequentially acquire a plurality of second fluoroscopic images of the subject (Paragraph [0054]; In the depicted example, high quality and/or 3D imaging may be acquired using second parameters #124 that specify one or more of a high frame rate, Fig. 4);
and that after acquiring the first fluoroscopic image (Paragraph [0055]; thus resuming projection or image acquisition using the fist parameters #114, Fig. 4 shows a second step #114 occurring after the first step of #114), the processor controls the radiation source and the radiation detector such that third fluoroscopy which sequentially acquires a third fluoroscopic image (Paragraph [0055]; thus resuming projection or image acquisition) at a frame rate lower than the predetermined frame rate (Paragraphs [0054] and [0055]; The first parameters #114 may specify one or more of a low frame rate (e.g., approximately 5 frames per second); using the fist parameters #114) is further performed under the first fluoroscopy conditions (Paragraph [0055]; thus resuming projection or image acquisition using the fist parameters #114, Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Kuntz such that after acquiring the first fluoroscopic image, the processor controls the radiation source and the radiation detector such that third fluoroscopy which sequentially acquires a third fluoroscopic image at a frame rate lower than the predetermined frame rate is further performed under the first fluoroscopy conditions. This would reduce the amount of imaging when the interventional device leaves the region of interest, and thus reduce the overall radiation dose to the patient (Langan, Paragraphs [0053] and [0058]).
Together Kuntz and Langan do not explicitly teach the acquiring the third fluoroscopic is further performed while performing the second fluoroscopy, whereby the second fluoroscopy and the third fluoroscopy are performed simultaneously..
Lim, however, teaches a radioscopy method in a radioscopy apparatus (Col. 2, ln. 8-10; include X-ray apparatus and an X-ray imaging method which may reduce an amount of radiation to which an object is exposed) including a radiation source (Col. 9, ln. 25-30; The X-ray apparatus 100 may include an X-ray radiator 120, Fig. 1) that irradiates a subject with radiation (Col. 9, ln. 35-40; X-ray radiator 120 includes the X-ray source 122 receiving the high voltage from the high voltage generator 121 to generate and radiate X-rays; Col. 8, ln. 64-67; object may be a human, Fig. 2) and a radiation detector (Col. 9, ln.25-30; a detector 130, Fig. 1) that detects the radiation transmitted through the subject (Col. 10, ln. 20-28; detector 130 detects an X-ray that is radiated from the X-ray radiator 120 and has been transmitted through an object) to generate a fluoroscopic image of the subject (Col. 12, ln. 21-27; the controllers 113 and 150 generate a medical image of the object by using image data received via the detector 130), the radioscopy method comprising:
controlling the radiation source and the radiation detector such that second fluoroscopy (Col. 37, ln. 43-56; Fig. 14, pulse signal pattern of pulses 1412, 1414, 1416, 1418) is performed at a predetermined frame rate (Col. 37, ln. 43-56; a plurality of pulses 1412, and 1414 included in one cycle P have the predetermined pattern 1401; Fig. 14 shows the pulses 1412 and 1414 with Amplitude A11 occurs at rate of 2 times per cycle P) on the subject after the treatment tool is inserted (Col. 14, ln. 36-61; catheter may be correctly inserted into a target position of an object. Accordingly, the user may perform an operation by acquiring a fluoroscopic image during the operation and checking the position of a target object) under second fluoroscopy conditions (Col. 16, ln. 63-Col. 17, ln. 21; generate an X-ray, a high voltage generator 121 generates a high voltage to be applied… pulse amplitude may correspond to a tube current flowing between the anode and the cathode of an X-ray tube included in the high voltage generator; Col. 37, ln. 50-56; amplitude value is A11, Fig. 14) including a second tube current (Col. 37, ln. 50-56; Fig. 14 shows amplitude value is A11) smaller than the first tube (Col. 37, ln. 50-56; that A14>A11, Fig. 14) current to sequentially acquire a plurality of second fluoroscopic images of the subject (Col. 16, ln. 39-62; An x-ray image is sequentially obtained for each pulse as shown in Figs. 4-5; Fig. 14 shows pulses 1412, 1414, 1416, and 1418 are sequentially applied); and
controlling the radiation source and the radiation detector such that third fluoroscopy (Col. 37, ln. 43-56; Fig. 14, pulse signal pattern of pulses 1411, 1415, 1419; Fig. 14 shows amplitude value is A14), which sequentially acquires a third fluoroscopic image (Col. 16, ln. 39-62; An x-ray image is sequentially obtained for each pulse as shown in Figs. 4-5) at a frame rate lower than the predetermined frame rate (Col. 37, ln. 43-56; pulse 1411 included in one cycle P have the predetermined pattern 1401; Fig. 14 shows the pulses 1411 with Amplitude A14 occurs at rate of 1 times per cycle P, which is less than the rate of pulses with amplitude value A11), is further performed while performing the second fluoroscopy (Col. 37, ln. 43-56; a pulse signal 1400 including a pattern of pulses 1411, 1412, and 1414; Fig. 14 shows the pattern of pulses 1411 is performed while performing the pattern of pulses 1412/1414 which is considered to read on the claimed limitation of being performed while performing the second fluoroscopy as understood in its broadest reasonable interpretation and Applicant Specification and Drawing Fig. 14)
whereby the second fluoroscopy and the third fluoroscopy are performed in parallel (Fig. 14 shows the pattern of pulses 1411 is performed while performing the during the same time period P as the pattern of pulses 1412/1414 which is considered to be in parallel as understood in its broadest reasonable interpretation and in view of Applicant Drawings, Fig. 14, whereby the second and third fluoroscopy both occur in the same time period G3+G2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the apparatus of Kuntz in view of Langan to image pulse patterns such that the third fluoroscopic is further performed while performing the second fluoroscopy whereby the second fluoroscopy and the third fluoroscopy are performed in parallel as taught by Lim because it would have allowed reducing the total amount of radiation applied to the patient while producing natural fluoroscopic images (Lim, Col. 40, ln. 66-Col. 41, ln. 10) and further allowed producing final higher quality images at a higher frame rate than the capture rate of the high radiation imaging by performing adjustments based on the images captured with lower radiation (Col. 41, ln. 11-19), thereby providing an accurate diagnosis of a patient (Col. 1, ln. 54-Col. 2, ln. 4).
Together Kuntz, Langan, and Lim do not explicitly teach the second fluoroscopy and the third fluoroscopy are performed simultaneously.
Sakaguchi, however, teaches the second fluoroscopy and the third fluoroscopy are performed simultaneously (Paragraph [0049]; when a first noise quantity 301 of an X-ray image is obtained, it is possible to obtain a first noise image 302 and a first X-ray dose 303. Thereafter, it is possible to calculate a second noise image 306 from a second noise quantity 305 corresponding to a second X-ray dose 304 when the obtained first X-ray dose 303 is decreased to 1/N; Paragraph [0050]; it is possible to generate a simulated image corresponding to a desired X-ray dose by adding the X-ray image to the second noise image; Paragraph [0054]; and may simultaneously display more simulated images. In addition, this case is based on the assumption that the X-ray image is displayed on the main monitor, and the simulated images are displayed on the sub-monitor; The act of obtaining the X-ray image is and the first noise image 302 from the same x-ray dose is considered to read on the limitation of second fluoroscopy and the third fluoroscopy are performed simultaneously as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of Kuntz in view of Langan and Lim such that the second fluoroscopy and the third fluoroscopy are performed simultaneously because it would have allowed generating simulated X-ray images of the desired dose when the actual X-ray dose is decreased or increased (Sakaguchi, Paragraph [0045]-[0046]), thereby ensuring the image quality remains stable during the process.
Regarding claim 8, together Kuntz, Langan, and Lim teach all of the limitations of claim 1 as noted above. Kuntz further teaches acquiring the first fluoroscopic image acquired by the radioscopy apparatus according to claim 1, as noted in the rejection of claim 1 above;
sequentially acquiring the second fluoroscopic images acquired by the radioscopy apparatus according to claim 3, as noted above;
sequentially extracting a region of the treatment tool from each of the second fluoroscopic images (Paragraph [0085]; algorithms that track instruments can be used. There e.g. connected pixels in the data set can be identified, a comparison with a data base of possible instruments can be performed; the changes (e.g. catheters, guidewires, etc.) are removed);
sequentially combining the region of the treatment tool with the first fluoroscopic image to sequentially derive a composite fluoroscopic image (Paragraphs [0089] and [0100]; In operation #720, the image #708, which in the first run corresponds to the prior image #706, is added to the volumetric difference image #718; This image is fed back into the iterative loop and serves as the base image #708 for the next iteration of the reconstruction algorithm; the result including the guide wire is shown reconstructed through the PRIDICT reconstruction that uses a fully sampled prior image and an undersampled set of projections) at the predetermined frame rate (Paragraphs [0078] and [0080]; all following scans can be performed as under sampled scans with a lower dose, which can be performed continuously; During the intervention the interventionist is continuously provided with updated images on-the-fly; allowing for real-time interventional guidance);
displaying the composite fluoroscopic image (Paragraphs [0074] and [0094]; The updated image is then provided to the interventionist by displaying the updated image on the display array #102; If it is fulfilled, the image is fed back into #808 replacing this image and image #808 can be displayed to the operator, Fig. 8);
sequentially acquiring the third fluoroscopic image acquired by the radioscopy apparatus according to claim 1, as noted above;
sequentially combining the region of the treatment tool extracted from the second fluoroscopic image (Paragraph [0085]; algorithms that track instruments can be used. There e.g. connected pixels in the data set can be identified, a comparison with a data base of possible instruments can be performed; the changes (e.g. catheters, guidewires, etc.) are removed) acquired until a next third fluoroscopic image is acquired with the sequentially acquired third fluoroscopic images to sequentially derive other composite fluoroscopic images (Paragraphs [0085] and [0122]; The projections of the update scans #606 are acquired at angular positions that are different from earlier projection positions so that after several rotations a new-fully sampled dataset is produced which can be used as a sliding prior; One embodiment employs a registration algorithm that compensates for movements of the patient or system between acquisition of the prior scan and the update scans. In one embodiment a new prior image is constantly updated from the projection data); and
sequentially displaying the other composite fluoroscopic images instead of the composite fluoroscopic image (Paragraph [0094]; the image is fed back into #808 replacing this image and image #808 can be displayed to the operator; Examiner notes the prior image for which the combined image is based on is continually updated from the new-fully sampled dataset and thus the images displayed are based on the new dataset. This is considered to read on the claimed limitation of sequentially displays the other composite fluoroscopic images instead of the composite fluoroscopic image in its broadest reasonable interpretation).
Regarding claim 9, Kuntz teaches a non-transitory computer-readable storage medium (Paragraph [0041]; The computer program is preferably stored on a machine readable storage medium or on a removable CD-Rom, Flash memory, DVD or USB-stick) that stores a radioscopy program (Paragraph [0041]; a computer program for performing above described method is proposed) that causes a computer (Paragraph [0041]; on a computer, particularly a high performance computing device (HPC)) to perform a radioscopy method (Paragraph [0001]; an imaging method for radiologically guiding an instrument during medical interventions) in a radioscopy apparatus (Paragraph [0001]; a system for radiologically guiding medical interventions on an object) including a radiation source (Paragraphs [0071] and [0072]; a source #201, #304, Figs. 2 and 3) that irradiates a subject with radiation (Paragraphs [0023] and [0071]; The object to be imaged can either comprise the full body of a patient or parts and functions thereof; acquires images of the patient… releasing electromagnetic radiation, preferably X-rays) and a radiation detector (Paragraphs [0071] and [0072]; a detector #202, #306, Figs. 2 and 3) that detects the radiation transmitted through the subject (Paragraph [0071]; detecting the released X-rays after having traversed the objection to the image #106, 302, 310, 203, Figs. 2 and 3) to generate a fluoroscopic image of the subject (Paragraphs [0071] and [0115]; system #101 acquires images of the patient… preferably X-rays; In one embodiment the CT data (CT fluoroscopy) are continuously acquired to provide 4D information), the radioscopy program causing the computer to execute (Paragraph [0041]; a computer program for performing above described method is proposed, when executing the computer program on a computer particularly, a high performance computing device (HPC)):
a procedure of controlling the radiation source and the radiation detector (Paragraph [0070]; The operator console 104 further allows modifying all functions of the interventional CT system 101 and most parameters affecting the imaging, Fig. 1) such that first fluoroscopy is performed on the subject before a treatment tool (Paragraph [0042]; catheter intervention, cardiac pace maker, stent) is inserted under first fluoroscopy conditions (Paragraph [0069]; Prior to the intervention, the prior image can for instance be sampled using a gantry-based system) including at least one of a predetermined first tube voltage or a predetermined first tube current to acquire a first fluoroscopic image of the subject (Paragraphs [0069] and [0076]; with a frame-rate of 30 frames per second, a rotation time of 10 s and a tube-current of 50 mA and tube voltage of 100 kV; Herein the prior image serves as the first image of the object to be imaged. Furthermore, the instrument used during medical intervention on the object to be imaged is not present on the prior image);
a procedure of controlling the radiation source and the radiation detector such that second fluoroscopy is performed (Paragraph [0069]; During the course of the intervention, the temporal updates corresponding to undersampled sets of projections can be sampled with e.g. 18 frames per rotation) at a predetermined frame rate on the subject after the treatment tool is inserted under second fluoroscopy conditions including a second tube current smaller than the first tube current to (Paragraph [0069]; sets of projections can be sampled with e.g. 18 frames per rotation, a tube current of 30 mA and a tube voltage of 100 kV; The tube current is reduced from 50 mA to 30 mA) sequentially acquire a plurality of second fluoroscopic images of the subject (Paragraph [0077]; After the placement of the instrument and on its way through the object to be imaged low dose update data is continuously acquired in step #403 for guiding the instrument during the intervention. Furthermore, the low dose update data from step #403 is continuously reconstructed using the imaging method according to the present invention); and
after acquiring the first fluoroscopic image (Paragraph [0055]; thus resuming projection or image acquisition using the fist parameters #114, Fig. 4 shows a second step #114 occurring after the first step of #114), a procedure of controlling the radiation source and the radiation detector such that third fluoroscopy which sequentially acquires a third fluoroscopic image (Paragraph [0055]; thus resuming projection or image acquisition) at a frame rate lower than the predetermined frame rate (Paragraphs [0054] and [0055]; The first parameters #114 may specify one or more of a low frame rate (e.g., approximately 5 frames per second); using the fist parameters #114) is further performed under the first fluoroscopy conditions (Paragraph [0055]; thus resuming projection or image acquisition using the fist parameters #114, Fig. 4).
Kuntz does not teach acquiring the third fluoroscopic image at a frame rate lower than the predetermined frame rate is further performed under the first fluoroscopy conditions while performing the second fluoroscopy, the second fluoroscopy and the third fluoroscopy are performed simultaneously.
Langan, however, teaches a radioscopy apparatus (Paragraph [0005]; an X-ray source and an X-ray detector of a tomographic imaging system) comprising:
a radiation source (Paragraph [0027]; imaging system #10 includes a source of X-ray radiation #12, Fig. 1);
a radiation detector (Paragraph [0027]; and a detector #14, Fig. 1);
first fluoroscopy conditions to acquire a first fluoroscopic image of the subject (Paragraph [0054]; 2D projections or other low quality (LQ) images generated using a first set of parameters #114, Fig. 4);
second fluoroscopy is performed at a predetermined frame rate (Paragraph [0054]; one or more of a high frame rate (e.g., approximately 30 frames per second or greater)) under second fluoroscopy conditions to sequentially acquire a plurality of second fluoroscopic images of the subject (Paragraph [0054]; In the depicted example, high quality and/or 3D imaging may be acquired using second parameters #124 that specify one or more of a high frame rate, Fig. 4);
and that after acquiring the first fluoroscopic image (Paragraph [0055]; thus resuming projection or image acquisition using the fist parameters #114, Fig. 4 shows a second step #114 occurring after the first step of #114), the processor controls the radiation source and the radiation detector such that third fluoroscopy which sequentially acquires a third fluoroscopic image (Paragraph [0055]; thus resuming projection or image acquisition) at a frame rate lower than the predetermined frame rate (Paragraphs [0054] and [0055]; The first parameters #114 may specify one or more of a low frame rate (e.g., approximately 5 frames per second); using the fist parameters #114) is further performed under the first fluoroscopy conditions (Paragraph [0055]; thus resuming projection or image acquisition using the fist parameters #114, Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the storage medium of Kuntz such that after acquiring the first fluoroscopic image, the processor controls the radiation source and the radiation detector such that third fluoroscopy which sequentially acquires a third fluoroscopic image at a frame rate lower than the predetermined frame rate is further performed under the first fluoroscopy conditions. This would reduce the amount of imaging when the interventional device leaves the region of interest, and thus reduce the overall radiation dose to the patient (Langan, Paragraphs [0053] and [0058]).
Together Kuntz and Langan do not explicitly teach the acquiring the third fluoroscopic is further performed while performing the second fluoroscopy, the second fluoroscopy and the third fluoroscopy are performed simultaneously.
Lim, however, teaches a non-transitory computer-readable storage medium that stores a radioscopy program (Col. 7, ln. 11-19; a non-transitory computer readable storage storing an X-ray imaging method) that causes a computer to perform (Col. 41, ln. 20-26; computer readable medium, to control at least one processing element to implement any above described embodiment) a radioscopy method in a radioscopy apparatus (Col. 2, ln. 8-10; include X-ray apparatus and an X-ray imaging method which may reduce an amount of radiation to which an object is exposed) including a radiation source (Col. 9, ln. 25-30; The X-ray apparatus 100 may include an X-ray radiator 120, Fig. 1) that irradiates a subject with radiation (Col. 9, ln. 35-40; X-ray radiator 120 includes the X-ray source 122 receiving the high voltage from the high voltage generator 121 to generate and radiate X-rays; Col. 8, ln. 64-67; object may be a human, Fig. 2) and a radiation detector (Col. 9, ln.25-30; a detector 130, Fig. 1) that detects the radiation transmitted through the subject (Col. 10, ln. 20-28; detector 130 detects an X-ray that is radiated from the X-ray radiator 120 and has been transmitted through an object) to generate a fluoroscopic image of the subject (Col. 12, ln. 21-27; the controllers 113 and 150 generate a medical image of the object by using image data received via the detector 130), the radioscopy program causing the computer to execute:
a procedure of controlling the radiation source and the radiation detector such that second fluoroscopy (Col. 37, ln. 43-56; Fig. 14, pulse signal pattern of pulses 1412, 1414, 1416, 1418) is performed at a predetermined frame rate (Col. 37, ln. 43-56; a plurality of pulses 1412, and 1414 included in one cycle P have the predetermined pattern 1401; Fig. 14 shows the pulses 1412 and 1414 with Amplitude A11 occurs at rate of 2 times per cycle P) on the subject after the treatment tool is inserted (Col. 14, ln. 36-61; catheter may be correctly inserted into a target position of an object. Accordingly, the user may perform an operation by acquiring a fluoroscopic image during the operation and checking the position of a target object) under second fluoroscopy conditions (Col. 16, ln. 63-Col. 17, ln. 21; generate an X-ray, a high voltage generator 121 generates a high voltage to be applied… pulse amplitude may correspond to a tube current flowing between the anode and the cathode of an X-ray tube included in the high voltage generator; Col. 37, ln. 50-56; amplitude value is A11, Fig. 14) including a second tube current (Col. 37, ln. 50-56; Fig. 14 shows amplitude value is A11) smaller than the first tube current (Col. 37, ln. 50-56; that A14>A11, Fig. 14) to sequentially acquire a plurality of second fluoroscopic images of the subject (Col. 16, ln. 39-62; An x-ray image is sequentially obtained for each pulse as shown in Figs. 4-5; Fig. 14 shows pulses 1412, 1414, 1416, and 1418 are sequentially applied); and
a procedure of controlling the radiation source and the radiation detector such that third fluoroscopy (Col. 37, ln. 43-56; Fig. 14, pulse signal pattern of pulses 1411, 1415, 1419; Fig. 14 shows amplitude value is A14), which sequentially acquires a third fluoroscopic image (Col. 16, ln. 39-62; An x-ray image is sequentially obtained for each pulse as shown in Figs. 4-5) at a frame rate lower than the predetermined frame rate (Col. 37, ln. 43-56; pulse 1411 included in one cycle P have the predetermined pattern 1401; Fig. 14 shows the pulses 1411 with Amplitude A14 occurs at rate of 1 times per cycle P, which is less than the rate of pulses with amplitude value A11), is further performed while performing the second fluoroscopy (Col. 37, ln. 43-56; a pulse signal 1400 including a pattern of pulses 1411, 1412, and 1414; Fig. 14 shows the pattern of pulses 1411 is performed while performing the pattern of pulses 1412/1414 which is considered to read on the claimed limitation of being performed while performing the second fluoroscopy as understood in its broadest reasonable interpretation and Applicant Specification and Drawing Fig. 14),
whereby the second fluoroscopy and the third fluoroscopy are performed in parallel (Fig. 14 shows the pattern of pulses 1411 is performed while performing the during the same time period P as the pattern of pulses 1412/1414 which is considered to be in parallel as understood in its broadest reasonable interpretation and in view of Applicant Drawings, Fig. 14, whereby the second and third fluoroscopy both occur in the same time period G3+G2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the apparatus of Kuntz in view of Langan to image pulse patterns such that the third fluoroscopic is further performed while performing the second fluoroscopy whereby the second fluoroscopy and the third fluoroscopy are performed in parallel as taught by Lim because it would have allowed reducing the total amount of radiation applied to the patient while producing natural fluoroscopic images (Lim, Col. 40, ln. 66-Col. 41, ln. 10) and further allowed producing final higher quality images at a higher frame rate than the capture rate of the high radiation imaging by performing adjustments based on the images captured with lower radiation (Col. 41, ln. 11-19), thereby providing an accurate diagnosis of a patient (Col. 1, ln. 54-Col. 2, ln. 4).
Together Kuntz, Langan, and Lim do not explicitly teach the second fluoroscopy and the third fluoroscopy are performed simultaneously.
Sakaguchi, however, teaches the second fluoroscopy and the third fluoroscopy are performed simultaneously (Paragraph [0049]; when a first noise quantity 301 of an X-ray image is obtained, it is possible to obtain a first noise image 302 and a first X-ray dose 303. Thereafter, it is possible to calculate a second noise image 306 from a second noise quantity 305 corresponding to a second X-ray dose 304 when the obtained first X-ray dose 303 is decreased to 1/N; Paragraph [0050]; it is possible to generate a simulated image corresponding to a desired X-ray dose by adding the X-ray image to the second noise image; Paragraph [0054]; and may simultaneously display more simulated images. In addition, this case is based on the assumption that the X-ray image is displayed on the main monitor, and the simulated images are displayed on the sub-monitor; The act of obtaining the X-ray image is and the first noise image 302 from the same x-ray dose is considered to read on the limitation of second fluoroscopy and the third fluoroscopy are performed simultaneously as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of Kuntz in view of Langan and Lim such that the second fluoroscopy and the third fluoroscopy are performed simultaneously because it would have allowed generating simulated X-ray images of the desired dose when the actual X-ray dose is decreased or increased (Sakaguchi, Paragraph [0045]-[0046]), thereby ensuring the image quality remains stable during the process.
Regarding claim 11, together Kuntz, Langan, and Lim teach all of the limitations of claim 1 as noted above. Kuntz further teaches a non-transitory computer-readable storage medium (Paragraph [0041]; The computer program is preferably stored on a machine readable storage medium or on a removable CD-Rom, Flash memory, DVD or USB-stick) that stores a fluoroscopic image display program (Paragraph [0041]; a computer program for performing above described method is proposed) that causes a computer to execute (Paragraph [0041]; a computer program for performing above described method is proposed, when executing the computer program on a computer particularly, a high performance computing device (HPC)):
a procedure of acquiring the first fluoroscopic image acquired by the radioscopy apparatus according to claim 1, as noted in the rejection of claim 1 above;
a procedure of sequentially acquiring the second fluoroscopic images acquired by the radioscopy apparatus according to claim 1, as noted above;
a procedure of sequentially extracting a region of the treatment tool from each of the second fluoroscopic images (Paragraph [0085]; algorithms that track instruments can be used. There e.g. connected pixels in the data set can be identified, a comparison with a data base of possible instruments can be performed; the changes (e.g. catheters, guidewires, etc.) are removed);
a procedure of sequentially combining the region of the treatment tool with the first fluoroscopic image to sequentially derive a composite fluoroscopic image (Paragraphs [0089] and [0100]; In operation #720, the image #708, which in the first run corresponds to the prior image #706, is added to the volumetric difference image #718; This image is fed back into the iterative loop and serves as the base image #708 for the next iteration of the reconstruction algorithm; the result including the guide wire is shown reconstructed through the PRIDICT reconstruction that uses a fully sampled prior image and an undersampled set of projections) at the predetermined frame rate (Paragraphs [0078] and [0080]; all following scans can be performed as under sampled scans with a lower dose, which can be performed continuously; During the intervention the interventionist is continuously provided with updated images on-the-fly; allowing for real-time interventional guidance);
a procedure of displaying the composite fluoroscopic image (Paragraphs [0074] and [0094]; The updated image is then provided to the interventionist by displaying the updated image on the display array #102; If it is fulfilled, the image is fed back into #808 replacing this image and image #808 can be displayed to the operator, Fig. 8);
a procedure of sequentially acquiring the third fluoroscopic image acquired by the radioscopy apparatus according to claim 1, as noted above;
a procedure of sequentially combining the region of the treatment tool extracted from the second fluoroscopic image (Paragraph [0085]; algorithms that track instruments can be used. There e.g. connected pixels in the data set can be identified, a comparison with a data base of possible instruments can be performed; the changes (e.g. catheters, guidewires, etc.) are removed) acquired until a next third fluoroscopic image is acquired with the sequentially acquired third fluoroscopic images to sequentially derive other composite fluoroscopic images (Paragraphs [0085] and [0122]; The projections of the update scans #606 are acquired at angular positions that are different from earlier projection positions so that after several rotations a new-fully sampled dataset is produced which can be used as a sliding prior; One embodiment employs a registration algorithm that compensates for movements of the patient or system between acquisition of the prior scan and the update scans. In one embodiment a new prior image is constantly updated from the projection data); and
a procedure of sequentially displaying the other composite fluoroscopic images instead of the composite fluoroscopic image (Paragraph [0094]; the image is fed back into #808 replacing this image and image #808 can be displayed to the operator; Examiner notes the prior image for which the combined image is based on is continually updated from the new-fully sampled dataset and thus the images displayed are based on the new dataset. This is considered to read on the claimed limitation of sequentially displays the other composite fluoroscopic images instead of the composite fluoroscopic image in its broadest reasonable interpretation).
Regarding claim 12, together Kuntz, Langan, Lim, and Sakaguchi teach all of the limitations of claim 1 as noted above.
Sakaguchi further teaches the first fluoroscopic image, the second fluoroscopic image, and the third fluoroscopic image are output by the radiation detector (Paragraph [0029]; he X-ray detection unit 105 detects the X-rays generated from the X-ray generation unit 104 and generates an X-ray image.; Paragraph [0030]; The interface unit 106 receives an X-ray image from the X-ray detection unit 105 and performs analog-to-digital conversion, protocol conversion, and the like.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of Kuntz in view of Langan, Lim, and Sakaguchi such that the first fluoroscopic image, the second fluoroscopic image, and the third fluoroscopic image are output by the radiation detector as further taught by Sakaguchi because it would have been a well understood method of collecting and processing x-ray images that further would have allowed storing the image for further processing (Paragraph [0030]-[0034]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Langan and Lim as applied to claim 1 above, and further in view of Ohta (US 20110164724).
Regarding claim 2, together Kuntz, Langan, and Lim teach all of the limitations of claim 1 as noted above. Kuntz further teaches the processor detects the treatment tool from one of the second fluoroscopic images (Paragraphs [0075] and [0085]; This allows to track instruments using other means than standard CT absorption measurements and the detection of instruments is more robust; Alternatively or additionally, algorithms that track instruments can be used. There e.g. connected pixels in the data set can be identified, a comparison with a data base of possible instruments can be performed).
Together Kuntz, Langan, and Lim do not teach an irradiation field stop that regulates a range in which the subject is irradiated with the radiation; and setting the irradiation field stop such that a range, which includes the detected treatment tool and is narrower than that in a case in which the first fluoroscopic image is acquired, is irradiated with the radiation, and regulates the radiation with the set irradiation field stop and irradiates the subject with the radiation to perform the second fluoroscopy after the one second fluoroscopic image is acquired.
Ohta, however, teaches a radioscopy apparatus (Paragraph [0019]; a radiation image capturing device) comprising:
a radiation source (Paragraph [0072]; radiation irradiating device #18 includes a radiation source #42, Fig. 3) that irradiates a subject with radiation (Paragraph [0062]; a radiation irradiating device #18 that irradiates radiation X of a radiation dose according to predetermined imaging conditions onto the patient #14, Fig. 1);
a radiation detector (Paragraph [0065]; a radiation detector #36) that detects the radiation transmitted through the subject (Paragraph [0065]; such that the radiation X irradiated from the radiation irradiating device #18 transmits the object table #16A and the patient #14 and is detected by a radiation detector #36, Figs. 1 and 2) to generate a fluoroscopic image of the subject (Paragraph [0069]; detects a radiation dose of the radiation X that is transmitted through the patient #14 and that is irradiated from the irradiation surface #36A, and outputs image information that indicates a radiation image according to the radiation dose);
and an irradiation field stop (Paragraph [0072]; diaphragm unit #44… that includes four slit plates #44A, 44B, 44C, and 44D, Fig. 3) that regulates a range in which the subject is irradiated with the radiation (Paragraphs [0074] and [0191]; a range from a state where the opening region 51 is fully closed to a state where the opening region 51 holds a rectangular shape in plan view and has the maximum area; In this exemplary embodiment, the diaphragm unit #44 is controlled such that the direct rays of the radiation X are irradiated tracking the region of interest that changes with time);
and a processor (Paragraph [0097]; a Central Processing Unit (CPU) #114 that performs the overall operation of the device) that detects the treatment tool (Paragraph [0165]; information that indicates the position of the insertion opening of the catheter 60 indicated by the coordinate information stored in the step for preparing the IVR), sets the irradiation field stop such that a range, which includes the detected treatment tool (Paragraphs [0165] and [0166]; the information that indicates the position of the insertion opening of the catheter #60 …that instructs setting of the opening state of the diaphragm unit #44) and is narrower than that in a case in which the first fluoroscopic image is acquired (Paragraphs [0158], [0159], [0165], and [0166]; as a preparing step of the IVR… the setting instruction information indicates the center of the opening region #51, a shape of the opening region #51 is a predetermined shape, and an area of the opening region #51 is a predetermined area which is previously set as an area which is narrower than an area of the fully open state; change states of the slit plates 44A to 44D of the diaphragm unit 44 to fully open states through the console 26, and controls the radiation source 42 to emit the radiation X with a predetermined exposure dose), is irradiated with the radiation (Paragraphs [0159] and [0166]; direct rays of the radiation X are irradiated is a region of interest), and regulates the radiation with the set irradiation field stop and irradiates the subject with the radiation (Paragraph [0167]; the predetermined area is preferably appropriately set according to the size of the treatment object part or the cumulative exposure dose of the radiation X with respect to the same patient) to perform the second fluoroscopy after the one second fluoroscopic image is acquired (Paragraphs [0169]-[0171]; electric charge is accumulated in the storage capacitor #76 of each pixel portion #80 of the radiation detector #36… The electric charge accumulated in each storage capacitor #76 as the electric signal sequentially flows to each data line #86 line by line. The electric signal that flows to each data line #86 is converted into digital image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of Kuntz in view of Langan and Lim to include an irradiation field stop that regulates a range in which the subject is irradiated with the radiation; and further set the irradiation field stop such that a range, which includes the detected treatment tool and is narrower than that in a case in which the first fluoroscopic image is acquired, is irradiated with the radiation, and regulates the radiation with the set irradiation field stop and irradiates the subject with the radiation to perform the second fluoroscopy after the one second fluoroscopic image is acquired. This would allow only the area which contains the object to be imaged and thus suppress excess exposure dose to the patient (Ohta, Paragraph [0187]).
Response to Arguments
Claim Rejections under – 35 U.S.C. § 112
The amendments to the claims raises new rejections under 35 USC 112 (a) and (b) which are now presented.
Claim Rejections under – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
11/10/25
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