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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/18/25 has been entered.
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.
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.
Claim(s) 1, 4-8, 12, 14, 17-18, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US 2014/0275996) in view of Sakaguchi (US 2023/0245307).
Stigall shows an apparatus and method for an intravascular ultrasound (IVUS) imaging system, comprising: a display ([0103]; Figs. 10, 12); an interface configured to couple to an IVUS catheter ([0039]); a processor coupled to the interface and the display ([0102], [0109]-[0110]); and a memory device comprising instructions, which when executed by the processor ([0102]) cause the IVUS imaging system to: receive a series of IVUS images of a vessel of a patient, the series of IVUS images comprising a plurality of frames ([0064]); receive, for each of the plurality of frames, an indication of an amount of calcium in the vessel ([0066]); generate a graphical component comprising an indication of calcium in the vessel (dense calcium 305; [0066]); generate a GUI comprising a longitudinal view of the vessel and the graphical component configured to indicate a location of the calcium along a longitudinal axis of the vessel (vessel lumen trace 260 including dense calcium 305; [0066]); and render the GUI and send the rendered GUI to the display ([0066], Figs. 10, 12).
Stigall also shows wherein the graphical component is a first graphical component, the memory device further comprising instructions that when executed by the processor cause the IVUS imaging system to: generate a second graphical component comprising the longitudinal view of the vessel (vessel lumen trace 260, [0066]); and generate the GUI comprising the first graphical component and the second graphical component ([0066], Figs. 10, 12); the memory device further comprising instructions that when executed by the processor cause the IVUS imaging system to generate the GUI comprising overlaying the first graphical component over a portion of the second graphical component to indicate the location of the calcium along the longitudinal axis of the vessel (Fig. 12); wherein the second graphical component comprises an indication of a distal bracket (rectangular outline of bar graph considered to include brackets, Fig. 12), a proximal bracket (rectangular outline of bar graph considered to include brackets, Fig. 12), a minimum region (various regions may be considered a minimum region, such as the region having a minimum amount of calcium in relation to the longitudinal length of the vessel, Fig. 12), a vessel profile view (top surface of vessel lumen trace 260, Fig. 12) and a mirror of the vessel profile view (bottom surface of vessel lumen trace 260, Fig. 12); wherein the vessel profile view comprises a graphical representation of a vessel border and a lumen border of the vessel along the longitudinal axis and wherein the indication of the calcium comprises a marked region along the longitudinal axis between the vessel border and the lumen border (calcium 305, Fig. 12); wherein the marked region is graphically represented in the vessel profile view, the mirror of the vessel profile view, or the vessel profile view and the mirror of the vessel profile view (Fig. 12); wherein the marked region comprises a shading, a coloring, or a pattern different from other regions (Fig. 12); wherein the indication of the calcium comprises one or more icons (Fig. 12).
Stigall fails to show generate a graphical representation of a lumen and a vessel profile of a portion of the vessel based on the series of IVUS images; generate a graphical user interface (GUI) comprising: a longitudinal view of the vessel, the graphical representation of the lumen and the vessel profile, a mirror representation of the graphical representation of the lumen and the vessel profile mirrored about a longitudinal axis of the portion of the vessel, and the graphical component configured to indicate a location of the calcium along a longitudinal axis of the portion of the vessel.
Sakaguchi discloses systems and methods for calculating plaque burden (abstract). Sakaguchi teaches generate a graphical representation of a lumen and a vessel profile of a portion of the vessel based on the series of IVUS images ([0032], [0052]-[0060], Fig. 5); generate a graphical user interface (GUI) comprising: a longitudinal view of the vessel, the graphical representation of the lumen and the vessel profile, a mirror representation of the graphical representation of the lumen and the vessel profile mirrored about a longitudinal axis of the portion of the vessel, and the graphical component configured to indicate a location of the calcium along a longitudinal axis of the portion of the vessel ([0052]-[0060], Fig. 5).
It would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the invention of Stigall to generate a GUI comprising a mirror of the vessel and lumen profile mirrored along a longitudinal axis with the graphical component configured to indicate a location of the calcium along a longitudinal axis of the vessel as taught by Sakaguchi, as this type of display will allow the user to more easily visualize the location of calcium in relation to the blood vessel. Furthermore, the display will help enable the user to grasp the state of the blood vessel and determine a treatment area to be treated as described by Sakaguchi ([0060])
It is additionally noted that Stigall provides various graphical user interfaces for displaying plaque/calcium in relation to the blood vessel (Figs. 10-12), and it would be within the level of one of ordinary skill in the art to modify the graphical user interface to include different forms for displaying the plaque/calcium in relation to the blood vessel, including by using a mirrored format of the diagnostic information to allow the user to more readily grasp the state of the blood vessel.
Claim(s) 9-10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stigall (US 2014/0275996) in view of Sakaguchi (US 2023/0245307) as applied to claims 8 and 12 above, and further in view of Lee (US 2016/0310101).
Stigall fails to show wherein the icons comprise one or more of a ¼ circle, a ½ circle, or a ¾ circle; wherein the marked region further comprises an expansion button; receive, from an input device, an indication the expansion button is clicked; generate a graphical representation of a calcium map responsive to the indication the expansion button is clicked; and display the calcium map on the display; generate a third graphical component comprising a cross-section view of a one of the plurality of frames; and generate the GUI comprising the first graphical component, the second graphical component, and the third graphical component.
Lee discloses methods and apparatus for displaying ultrasonic images. Lee teaches wherein the icons comprise one or more of a ¼ circle, a ½ circle, or a ¾ circle (plaques 331 and 332 are represented as circular shapes which comprise portions of a circle; [0114], [0124], [0140], [0145]; Fig. 3A); wherein the marked region further comprises an expansion button (various user inputs to select cut line in first image for displaying second image of plaque, [0085]-[0086]); receive, from an input device, an indication the expansion button is clicked ([0086]); generate a graphical representation of a calcium map responsive to the indication the expansion button is clicked (display second image of plaque based on user input of cut line, [0086]); and display the calcium map on the display (generate second volume data corresponding with plaque of a blood vessel, [0077]-[0082], [0088]; plaque display; [0162], [0174]); generate a third graphical component comprising a cross-section view of a one of the plurality of frames; and generate the GUI comprising the first graphical component, the second graphical component, and the third graphical component (display second image of plaque based on user input of cut line, [0086]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Stigall and Sakaguchi to utilize various types of graphical user interface elements, such as representing icons in any of a variety of shapes, including circular shapes as taught by Lee, as the selection of a particular shape may be made by one of ordinary skill in the art without undue experimentation, and as different shapes/icons may be desired by different users. Furthermore, it would have been obvious to provide an expansion button to generate a diagnostic map as taught by Lee, in order to allow the user to have control over displaying various additional diagnostic information corresponding to specific points selected along the displayed length of the vessel.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797