DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to the newly amended claim(s) have been considered but are moot in view of the rejection below. As noted below, Lavallee discloses:
[0152] The mobile base 10 may comprise base motorization means adapted to automatically move the base 10.
Therefore, paragraph [0152] teaches the newly added limitation that clarifies wherein “the spatial position of the mobile X-ray device being variable by the device trolley being movable automatically or manually relative to a surface on which the device trolley is supported.” This paragraph, in combination with Kilian-Meneghin, teaches every aspect of the claimed invention. As stated previously and below, Kilian-Meneghin teaches a fixed C-arm installation and does not explicitly teach computing the distribution as a function of the spatial position of a mobile X-ray device or of the adjustable recording system relative to the trolley. However, it would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Lavalee’s mobile device to include the teachings of Kilian-Meneghin such that the system determines and displays, substantially in real time, information dependent upon a scattered-radiation distribution. Both references address operator safety and such a modification would improve the operator’s awareness of the radiation distribution. Since Lavallee’s mobile device already determines its spatial position via the base-position determining means, a person of ordinary skill would recognize that providing this known position information into Kilian-Meneghin’s calculation would permit the scatter-distribution display to update dynamically as the mobile device is repositioned, thus improving accuracy.
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-9, 11-18, 20, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lavallee (US 20240000406 A1) in view of Kilian-Meneghin (“Evaluation of Methods of Displaying the Real-Time Scattered Radiation Distribution during Fluoroscopically-Guided Interventions for Staff Dose Reduction”, Proceedings Volume 10573, Medical Imaging 2018: Physics of Medical Imaging; 1057366 (2018)).
With regards to claims 1 and 23, Lavallee discloses a mobile X-ray device comprising:
a device trolley 10 operable to vary a spatial position of the mobile X-ray device [0145];
an adjustable recording system that is arranged on the device trolley, the adjustable recording system comprising an X-ray source 31 and an X-ray detector 32 for recording X-ray images of an object [0091], a position of the adjustable recording system being adjustable relative to the device trolley [0100]; and
a system controller configured to actuate the mobile X-ray device [0174], wherein the spatial position of the mobile X-ray device being variable by the device trolley being movable automatically or manually relative to a surface on which the device trolley is supported [0152].
Lavallee further discloses a base-position determining means configured to determine the position of the mobile base in the horizontal plane [0149-0151] (thereby teaching the claimed spatial position of the mobile X-ray device).
Lavallee does not teach the claimed calculation unit and display unit. However, Lavallee does disclose wherein a user interface may be displayed on the trolley [0245]. In addition, Kilian-Meneghin teaches a method and system for displaying real-time scattered radiation distribution comprising:
a calculation unit configured for real-time determination of a scattered radiation distribution from an X-ray radiation generated by the X-ray source in at least parts of a surrounding area of an X-ray device (Introduction) as a function multiple influencing variables that are variable over time, including an item of patient information (Section 2.1-2.3, scatter dose determination and display utilizes information from the Dose Tracking System, which is based on patient position relative to the gantry geometry and beam parameters (also patient dependent), wherein the gantry geometry relative to the patient is variable over time depending upon the patient’s region of interest), a spatial position of the mobile X-ray device (Section 3, For these three images, the selected scatter dose slice presents the distribution’s dependence upon C-arm gantry angle; Fig. 3); a recording parameter (Section 2.3, varying kVp), and a position of the recording system (Section 2.3, Real-time information from this system on patient location in the beam, as well as gantry geometry and beam parameters allows a graphic to be constructed on a display of the room mimicking the scatter from the procedure conditions; Section 3, the selected scatter dose slice presents the distribution’s dependence upon C-arm gantry angle); and
a display unit configured to display, substantially in real time, at least one item of information dependent upon the determined scattered radiation distribution in at least one part of surroundings of the X-ray device (Fig. 3; Section 2.2, real-time display of individual staff dose rate estimates). Furthermore, Kilian-Meneghin teaches a fixed C-arm installation and does not explicitly teach computing the distribution as a function of the spatial position of a mobile X-ray device or of the adjustable recording system relative to the trolley. However, it would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Lavalee’s mobile device to include the teachings of Kilian-Meneghin such that the system determines and displays, substantially in real time, information dependent upon a scattered-radiation distribution. Both references address operator safety and such a modification would improve the operator’s awareness of the radiation distribution. Since Lavallee’s mobile device already determines its spatial position via the base-position determining means, a person of ordinary skill would recognize that providing this known position information into Kilian-Meneghin’s calculation would permit the scatter-distribution display to update dynamically as the mobile device is repositioned, thus improving accuracy.
With regards to claim 3, Kilian-Meneghin teaches wherein the display unit is configured for visual display of an item of information dependent upon the determined scattered radiation distribution in at least one part of the surroundings of the mobile X-ray device (Fig. 3, displaying scattered radiation distribution and dose rates).
With regards to claims 4 and 7, the combination of Lavallee and Kilian-Meneghin does not teach wherein the display unit is configured for projection of the item of information dependent upon the determined scattered radiation distribution in the at least one part of the surroundings of the mobile X-ray device. However, Kilian-Meneghin does teach wherein the display is configured such that the distributions are superimposed on either a ceiling-view 2D graphic of the patient and table for reference or a 3D augmented reality (AR) display featuring a real-time video feed of the interventional room (Abstract). Since projectors were generally well known in the art, substituting the display taught by Kilian-Meneghin with the known claimed display and projector would have been obvious since the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
With regards to claims 5 and 6, Kilian-Meneghin teaches wherein the display unit is configured for color-based visual marking of at least one part of an area surrounding the X-ray device with regard to the scattered radiation distribution determined for a volume arranged above the area (Fig. 3).
With regards to claim 8, Lavallee discloses wherein the mobile X-ray device is formed by a mobile computed tomography unit with a rotatable gantry [0095, 0112], and wherein the X-ray source is configured to generate a fan beam or a cone beam [0006].
With regards to claim 9, Lavallee discloses wherein the X-ray device is formed by a mobile C-arm X-ray device with an adjustable C-arm [0113, 0127], and wherein the X-ray source is configured to generate a cone beam [0006].
With regards to claims 11 and 12, Kilian-Meneghin teaches a camera sensor configured to determine position information of at least one person located in the surrounding area (Section 2.2).
With regards to claim 13, Kilian-Meneghin teaches an evaluation unit configured to evaluate the position information of the person with regard to the determined scattered radiation distribution (Section 2.2, motion tracking of staff members).
With regards to claim 14, the combination of Lavallee and Kilian-Meneghin does not teach the claimed acoustic output. Nevertheless, those skilled in the art recognize that such a modification would have been known. Audible and visual alarms to alert personnel when radiation acceptable radiation levels have been exceeded, were well known to prevent harm. In view of the recited benefit, it would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify the combination of Lavallee and Kilian-Meneghin with the claimed acoustic output.
With regards to claim 15, Lavallee discloses wherein the adjustable recording system is configured to record volume image data [0094].
With regards to claim 16, Kilian-Meneghin teaches wherein the calculation unit is configured for real-time determination of the scattered radiation distribution with the use of a pretrained machine algorithm (Section 2.3, utilizing information from our Dose Tracking System (DTS) that was initially designed to provide a color-coded map of real-time skin dose on a patient graphic).
With regards to claim 17, Kilian-Meneghin teaches wherein the calculation unit is configured for real-time determination of the scattered radiation distribution with the use of at least one further variable or non-variable influencing variable (Section 3, location of the camera sensor).
With regards to claim 18, the combination of Lavallee and Kilian-Meneghin teaches the claimed invention according to the claims above, as well as:
providing an algorithm for determining a scattered radiation distribution (Kilian-Meneghin; Fig. 3) generated by a scattering of an X-ray beam generated by an X-ray source of the mobile X-ray device (Lavallee; Fig. 1) in a surrounding area of the mobile X-ray device as a function of a plurality of influencing variables that are variable over time during the duration of the method, including an item of patient information (Section 2.1-2.3, scatter dose determination and display utilizes information from the Dose Tracking System, which is based on patient position relative to the gantry geometry and beam parameters (also patient dependent), wherein the gantry geometry relative to the patient is variable over time depending upon the patient’s region of interest), a spatial position of the mobile X-ray device (Section 3, For these three images, the selected scatter dose slice presents the distribution’s dependence upon C-arm gantry angle; Fig. 3); a recording parameter (Section 2.3, varying kVp), and a position of the recording system (Section 2.3, Real-time information from this system on patient location in the beam, as well as gantry geometry and beam parameters allows a graphic to be constructed on a display of the room mimicking the scatter from the procedure conditions; Section 3, the selected scatter dose slice presents the distribution’s dependence upon C-arm gantry angle);
activating the mobile X-ray device with regard to emission of an X-ray beam (Lavallee; [0174]);
providing current values of the plurality of variable influencing variables (Kilian-Meneghin; Fig. 3; Section 2.1-3);
real-time determining of the scattered radiation distribution by the algorithm with the use of the current values of the plurality of variable influencing variables (Kilian-Meneghin; Fig. 3; Section 3);
substantially real-time displaying of at least one item of information dependent upon the determined scattered radiation distribution in at least one part of the surroundings of the mobile X-ray device (Kilian-Meneghin; Fig. 3; Section 3, dose rates); and
repeating the providing of the current values of the plurality of variable influencing variables, the real-time determining of the scattered radiation distribution, and the substantially real-time displaying in a continuous, triggered, or temporally spaced manner as long as the X-ray beam is activated (Kilian-Meneghin; Fig. 3; Section 3, providing displays at different C-arm positions).
The combination of Lavallee and Kilian-Meneghin does not explicitly teach wherein the algorithm is a pretrained machine learning algorithm. However, those skilled in the art recognize that such a modification would have been known and considered obvious in order to improve efficiency. As such, it would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify the combination of Lavallee and Kilian-Meneghin with the pretrained machine learning algorithm.
With regards to claim 20, Kilian-Meneghin teaches wherein at least one further variable or non-variable influencing variable is used (Section 3, location of the camera sensor).
With regards to claim 22, Kilian-Meneghin teaches wherein the recording parameter is an X-ray voltage (Section 2.3, varying kVp).
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 MARCUS H TANINGCO whose telephone number is (571)272-1848. The examiner can normally be reached Monday-Friday 9am-6pm EST.
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/MARCUS H TANINGCO/ Primary Examiner, Art Unit 2884