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 Objections
Claims 1 and 15 are objected to because the limitation, “the angular region in which x-ray irradiation is recommended among the plurality of angular regions” lacks venue. The recommended angular region is not determined by capable claimed structure (claim 1) nor is there a step for determining the recommended angular region (claim 15).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4-7, 10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernhardt (US 2011/0317815 A1).
Regarding claims 1 and 15, Bernhardt discloses an x-ray imaging system and method of displaying a dose (Fig.1), including:
a) an imaging unit including an x-ray irradiation unit having an x-ray source 12 that irradiates a subject 9 on a table with x-rays and an x-ray detection unit 14 that detects x-rays emitted from the x-ray irradiation unit;
b) a moving mechanism 10 configured to change an imaging unit angle 16 which is an angle of the imaging unit;
c) a dose calculation processing unit 20 configured to calculate a dose of x-rays irradiated onto the subject 9; and
d) a display unit 30 configured to display the dose of x-rays calculated by the dose calculation processing unit 20; where
e) the dose calculation processing unit 20 includes:
i) a model dose calculating unit 28 configured to calculate a dose distribution 42 on a surface of a 3D virtual model 40 representing the subject 9 on the table, based on the dose of the x-rays irradiated onto the subject 9 by the imaging unit (par.0029);
ii) an angle associating unit 28 configured to associate the imaging unit angle 16 with a surface of the virtual model 40, based on the imaging unit angle 16 and a position on the surface of the virtual model 40 to be irradiated with x-rays (par.0030); and
iii) an angular dose calculating unit 28 configured to calculate the dose 42 in each of a plurality of angular regions partitioned by each of predetermined angular intervals of the imaging unit angle 16, based on the dose distribution 42 on the surface of the virtual model 40 calculated by the model dose calculation unit 20 and the imaging unit angle associated with the surface of the virtual model 40 by the angle associating unit 28 (Fig.1); where
f) the display unit 30 is configured to display an angular dose image capable of identifying magnitude of the dose 42 in each of the plurality of angular regions calculated by the angular dose calculating unit 28 (Fig.1, also see pars.0030-0031); and where
g) the display unit 30 is configured to display the angular region in which x-ray irradiation is recommended among the plurality of angular regions in the angular dose image in an identifiable manner (since the claim does not state what structure determines the recommendation, then the limitation is anticipated either due to (I) the nature of the color-coded display enables the operator to make their own recommendation by being able to see lower-dose areas of the surface of the virtual model (pars.0030-0031), and/or (II) the disclosure that predicts/recommends the amount of time left for exposure of a given area given the cumulative dose corresponding to a maximum threshold (pars.0021).
With respect to claim 2, Bernhardt further discloses:
h) the dose calculation processing unit 20 further includes a positional relation acquisition unit that acquires a virtual positional relation between the virtual model 40 and the imaging unit, based on a positional relation between the table and the imaging unit (par.0030);
i) the angle associating unit 28 is configured to update an association of the imaging unit angle 16 on the surface of the virtual model 40, based on the virtual positional relation acquired by the positional relation acquisition unit, when the positional relation between the table and the imaging unit is changed (the displayed model tracks the position of the imaging unit while coupled: par.0030); and
j) the angular dose calculation unit 28 is configured to update the dose 42 in each of the plurality of angular regions, based on the association of the imaging unit angle 16 on the surface of the updated virtual model 40 (par.0030).
With respect to claim 4, Bernhardt further discloses that the display unit 30 is configured to display the angular dose image in which the plurality of angular regions is partitioned by each of the predetermined angular intervals of the imaging unit angle in a grid pattern (Fig.1), and the magnitude of the dose 42 in each of the plurality of angular regions partitioned in a grid pattern is capable of being identified (par.0031).
With respect to claim 5, Bernhardt further discloses that the dose calculation processing unit 20 further includes a storing processing unit 19 that stores historical information on the dose distribution on the surface of the virtual model 40, based on x-ray irradiation by the imaging unit; and the display unit 30 is configured to display the angular dose image at a predetermined timing in the past, based on the historical information stored by the storing processing unit 19 (pars.0009 and 0030).
With respect to claim 6, Bernhardt further discloses that the dose calculation processing unit 20 includes a dose prediction unit that calculates a predicted value for the dose of x-rays to be irradiated by the imaging unit, based on the dose distribution on the surface of the virtual model 40 calculated by the model dose calculating unit 20, 28 (par.0021); and the display unit 30 is configured to display the predicted angular dose image based on the predicted value predicted by the dose prediction unit (par.0021 and p.4, text of claim 29).
With respect to claim 7, Bernhardt further discloses that the dose calculation processing unit 20 further includes an irradiation region calculation unit that calculates an irradiation region 17 which is a region of the surface of the virtual model 40 to be irradiated with x-rays at a current imaging unit angle 16 (last sentence of par.0030); and the display unit 30 is configured to display an indication 17 of the angular region that is included in the irradiation region 16 from the plurality of angular regions in the angular dose image (Fig.1).
Regarding claim 10, Bernhardt discloses an x-ray imaging system and method of displaying a dose (Fig.1), including:
a) an imaging unit including an x-ray irradiation unit having an x-ray source 12 that irradiates a subject 9 on a table with x-rays and an x-ray detection unit 14 that detects x-rays emitted from the x-ray irradiation unit;
b) a moving mechanism 10 configured to change an imaging unit angle 16 which is an angle of the imaging unit;
c) a dose calculation processing unit 20 configured to calculate a dose of x-rays irradiated onto the subject 9; and
d) a display unit 30 configured to display the dose of x-rays calculated by the dose calculation processing unit 20; where
e) the dose calculation processing unit 20 includes:
i) a model dose calculating unit 28 configured to calculate a dose distribution 42 on a surface of a 3D virtual model 40 representing the subject 9 on the table, based on the dose of the x-rays irradiated onto the subject 9 by the imaging unit (par.0029);
ii) an angle associating unit 28 configured to associate the imaging unit angle 16 with a surface of the virtual model 40, based on the imaging unit angle 16 and a position on the surface of the virtual model 40 to be irradiated with x-rays (par.0030); and
iii) an angular dose calculating unit 28 configured to calculate the dose 42 in each of a plurality of angular regions partitioned by each of predetermined angular intervals of the imaging unit angle 16, based on the dose distribution 42 on the surface of the virtual model 40 calculated by the model dose calculation unit 20 and the imaging unit angle associated with the surface of the virtual model 40 by the angle associating unit 28 (Fig.1); where
f) the display unit 30 is configured to display an angular dose image capable of identifying magnitude of the dose 42 in each of the plurality of angular regions calculated by the angular dose calculating unit 28 (Fig.1, also see pars.0030-0031); and where
g) an operation unit configured to accept an input operation by an operator (standard computer interface including mouse, par.0020, also see 24), and where the moving mechanism 10 is configured to change the imaging unit angle so that the selected angular region 16 is irradiated with x-rays when an operation to select one of the plurality of angular regions in the angular dose image is accepted by the operation unit (pars.0018-0020).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bernhardt, as applied to claim 1 above, in view of Abe (US 2016/0113608 A1).
With respect to claim 8, Bernhardt does not specifically disclose that the display is configured to display, separately from the angular dose image, a maximum value of the dose in the angular region included in the irradiation region in an identifiable manner. Bernhardt generally teaches relaying such information to the operator without any details of how the information is displayed (par.0021).
Abe teaches the practice of displaying a maximum value of the dose in the angular region XD included in the irradiation region (Fig.9B, par.0126) separate from the dose image (Fig.9A), where the images of Figs.9A and 9B are displayed at the same time (par.0118-0126). In this manner, patient safety is improved by providing the numerical value, in addition to the graphical indication, for the operator to verify the dose and avoiding exceeding dose thresholds.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Bernhardt to further display the maximum value of the dose in the angular region included in the irradiation region in an identifiable manner, separate from the angular dose image, in order to improve patient outcomes by providing additional concrete verification of dose values, as taught by Abe.
With respect to claim 14, Bernhardt does not specifically disclose that the display unit is further configured to display a pre-acquired 3D image of an inside of the subject, and to display the dose of the angular region at the imaging unit angle corresponding to a display angle of the displayed 3D image in an identifiable manner.
Abe teaches the practice of displaying both the angular dose image (Figs.8, 9A and 10A) and a pre-acquired 3D image of the inside of the subject (Figs.8, 9B and 10B), where the dose of the angular region at the imaging unit angle corresponding to a display angle of the displayed 3D image is identified (Figs.9B and 10B, par.0126). In this manner, the angular dose image and the 3D image are locked in sync such that the operator may move one image and both move together to present the selected imaging unit angle to the operator for efficiently evaluating the appropriate angles for the next imaging angle (pars.0118-0126).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Bernhardt to additionally display a pre-acquired 3D image of an inside of the subject, and to display the dose of the angular region at the imaging unit angle corresponding to a display angle of the displayed 3D image in an identifiable manner in order to significantly improve the accuracy and convenience for the operator to select the optimal angles for subsequent imaging, as taught by Abe.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bernhardt, as applied to claim 1 above, in view of Penenberg (US 2016/0287345 A1).
With respect to claim 13, Bernhardt does not specifically disclose a touchscreen that also displays the angular dose image, though Bernhardt does teach that moving a cursor, such as with a mouse, changes the orientation of the angular dose image for displaying the angular dose image corresponding to the selected imaging unit angle (par.0018).
Penenberg teaches the routine practice of providing images on a touchscreen with controls for manipulating the images on the same screen (pars.0025 and 0028; also see Figs.5-8). The skilled artisan readily appreciates the proven intuitive nature of providing images on touchscreens that also accept input for manipulating the images and/or selecting view angles.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Bernhardt to provide the angular dose image and corresponding inputs for displaying a plurality of imaging unit angles and for changing the imaging unit angle, as generally taught by Penenberg, as a routine means of improving operator accuracy and efficiency through the intuitive nature of touchscreens.
Claims 3, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Bernhardt, as applied to claim 1 above, in view of Withagen (US 2014/0307855 A1).
With respect to claim 3, Bernhardt does not specifically disclose that the angular dose calculation unit is configured to calculate the dose in each of the plurality of angular regions partitioned by each of the predetermined angular intervals with a modified size, when an operation to change a size of each of the predetermined angular intervals partitioning the plurality of angular regions is accepted by the operation unit, where the display unit is configured to display the angular dose image with the angular intervals changed.
Withagen teaches the practice of accepting an input to change the region of the angular dose image to be displayed, where the axis units are changed to represent a zooming in or out of the angular dose image and recalculating the dose for each region as needed (Fig.6; pars.0116-0118). In this manner, the operator may adjust the scale of the image and/or region of interest as desired for convenient viewing of the angular dose image.
It would have been obvious to one of ordinary skill in the art at the time of the invention for Bernhardt to have the angular dose calculation unit be configured to calculate the dose in each of the plurality of angular regions partitioned by each of the predetermined angular intervals with a modified size, when an operation to change a size of each of the predetermined angular intervals partitioning the plurality of angular regions is accepted by the operation unit, where the display unit is configured to display the angular dose image capable of identifying the magnitude of the dose in each of the plurality of angular regions with the size of the predetermined angular interval changed, in order to improve the efficiency of operation by enabling the flexibility for the operator to view a desired region at a desired scale, as taught by Withagen.
With respect to claim 11, Bernhardt further discloses that the display unit 30 is further configured to display the angular dose image in which the magnitude of the dose in each of the plurality of angular regions is color-coded (pars.0030-0031).
However, Bernhardt does not specifically disclose the additional limitation of displaying a color scale image showing the color coding of the plurality of angular regions in the angular dose image corresponding to the magnitude of the dose.
Withagen teaches the routine practice of providing angular dose images (Figs.3, 4 and 6; par.0108) with a separately-provided color scale 615 that numerically correlates the magnitude of dose levels with the color scale (illustrated in Fig.6 as patient thicknesses; however, pars.0108 and 0113 state that the values may be dose-specific; also see pars.0109-0112).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Bernhardt to additionally provide a separate color scale image in order to provide an intuitive numerical grounding to the color-coded angular dose image, as taught by Withagen, for improved efficiency of operation and patient safety.
With respect to claim 12, Withagen further teaches displaying a preset dose threshold in the color scale image in an identifiable manner to facilitate alerting the operator (avoiding “red” areas, par.0109).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Bernhardt to further display a preset dose threshold in the color scale image in an identifiable manner, as taught by Withagen, in order to further improve safety through intuitive visualizations.
Response to Arguments
Applicant's arguments with respect to claims 1, 10 and 15 have been fully considered but they are not persuasive. Applicant argues:
Claims 1 and 15 require active recommendations of an angular region; and
Bernhardt does not disclose a 1-to-1 causality between selecting an angular region on the angular dose map and the moving mechanism moving the x-ray imaging system to the corresponding angular region, as required by claim 10.
The Examiner respectfully disagrees on both points. As a matter of note, the Examiner separated the rejection of claim 10 from the rejection of claims 1 and 15 for clarity of record.
(A) The issue here is one of claim construction. The Examiner readily agrees that Bernhardt does not perform the recommendation as disclosed by Applicant. The active aspect of Bernhardt’s disclosure in par.0021 displays the predicted time remaining at the existing angular region based on cumulative dose, rather than recommending an angular region for the next imaging sequence. However, the claim does not establish the recommendation. The display is neither claimed, nor disclosed, as being capable of performing the recommendation; it simply displays information that is supposed to be provided by upstream components, but that information has not been provided to the display in the claims. The claims must first positively recite determining the recommended angular region by a capable component prior to display. The function or act of displaying data without venue carries no patentable weight. Without generating a recommendation, then the displayed recommendation is anticipated by the operator’s mental activities based on prior art dose maps. The Examiner wishes to note that adding details to the displayed information does not remedy the deficiency and incurs potentially unnecessary loss of claim scope. No claim scope is lost by claiming an essential element, particularly since Applicant emphasizes the machine-generated recommendation as the inventive concept and does not intend to encompass operator judgement, all as stated on p.11 of the Remarks filed 6/26/2026.
Regarding part (B), Bernhardt states that the movement of the C-arm x-ray imaging system is coupled to the movement of the angular dose image as a system default (par.0019: “…it is of advantage if the coupling of the angular position of the visualization of the model to the current angular position of the x-ray apparatus is effected automatically when or even before the x-ray apparatus can emit its radiation…”). Bernhardt further states that the two may be temporarily decoupled by an override function so that the operator may freely observe/manipulate the model without unnecessary movement of the C-arm between imaging sequences (par.0018). The switch of par.0020 is then engaged to re-couple the angular dose image motion with the C-arm motion in order to ensure safe operation once the operator selects the next angular region on the virtual model (par.0019). As such, Bernhardt exactly anticipates the claimed invention, where the moving mechanism is configured to change the imaging unit angle so that the selected angular region is irradiated with x-rays when an operation to select one of the plurality of angular regions in the angular dose image is accepted by the operation unit, as required by claim 10.
For at least these reasons, Applicant’s arguments are not persuasive, and the rejections have been maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 THOMAS R ARTMAN whose telephone number is (571)272-2485. The examiner can normally be reached Monday-Thursday 10am-6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Makiya can be reached on 571.272.2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THOMAS R. ARTMAN
Primary Examiner
Art Unit 2884
/THOMAS R ARTMAN/ Primary Examiner, Art Unit 2884
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