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 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 and 22-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adler (US 2016/0073885; hereinafter Adler) in view of Courtney et al. (US 2013/0216114; hereinafter Courtney) and Ustun et al. (“Automated Identification of Minimal Myocardial Motion for Improved Image Quality on MR Angiography at 3T”, AJR: 188, pages W283-W290, March 2007; hereinafter Ustun).
Adler shows an imaging system for a patient (abstract) comprising: an imaging probe ([0032]-[0033], [0038]), comprising: an elongate shaft comprising a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion ([0038]); a rotatable optical core comprising a proximal end and a distal end, wherein at least a portion of the rotatable optical core is positioned within the lumen of the elongate shaft ([0033], [0038], [0040]); and an optical assembly positioned proximate the distal end of the rotatable optical core, the optical assembly configured to direct light to tissue to be imaged, and to collect reflected light from the tissue to be imaged ([0033], [0038], [0040]); and an imaging assembly constructed and arranged to optically couple to the imaging probe, the imaging assembly configured to emit light into the imaging probe and receive the reflected light collected by the optical assembly ([0033], [0038], [0040]), wherein the imaging system is configured to perform a pullback procedure in a blood vessel to be imaged, and wherein the pullback procedure is initiated based on heart motion data obtained from an angiographic system ([0028], [0040], [0045], [0056]-[0058]).
Adler also shows wherein the system is configured to initiate the pullback procedure during a relatively low motion portion of a heart cycle of the patient, the analysis comprising evaluation of relative motion between the imaging probe and anatomical reference structures over a plurality of heart cycles (marker does not appear to move in all frames which is considered a low motion portion of heart cycle, [0051]); wherein the imaging probe comprises a radiographic marker ([0049]), and wherein the system is configured to determine the relatively low motion portion of the heart cycle of the patient based on an analysis of the movement of the radiographic marker ([0051], [0053]-[0055]); wherein the imaging system is further configured to determine a latency period with the angiographic system, and wherein the imaging system is configured to initiate the pullback procedure further based on the determined latency period (delay period, [0044]-[0052]); wherein the system comprises a clock configured to register a first timeframe of a calibration pullback of the imaging probe, wherein the angiographic system is configured to register a first image frame that captures an initial motion of the calibration pullback of the imaging probe, and wherein the latency period is determined by comparing the first time frame to the first image frame (delay period, [0044]-[0052]).
Adler fails to show (i) receive, prior to initiating a pullback procedure of the imaging probe, angiographic image data relating to the motion of the heart obtained from the angiographic system, (ii) analyze the angiographic image data to determine when the motion of the heart is minimal, (iii) in response to a determination that the motion of the heart is minimal, initiate the pullback procedure in a blood vessel to be imaged.
Adler also fails to show wherein the system is configured to stop the pullback procedure within no more than one-half of a heart cycle; wherein the system is configured to initiate the injection of a flushing material to clear blood from a target area of the blood vessel to be imaged, and wherein the injection of the flushing material continues over several heart cycles; the system is configured to initiate the pullback further based on the system determining that clearing of the blood vessel has been achieved; wherein the system is configured to produce a metronome that produces an output representing the cardiac rhythm of the patient; wherein the metronome identifies a low motion part of the cardiac cycle; wherein the pullback procedure is performed at a pullback speed of at least 50mm/sec; wherein the system is configured to initiate the pullback procedure further based on detection of a T-wave; wherein the system is configured to initiate the pullback procedure further based on at least one additional triggering condition; wherein the blood vessel to be imaged comprises a blood vessel of the heart.
Courtney discloses systems and methods for improved visualization during minimally invasive procedures. Courtney teaches (iii) in response to a determination that the motion of the heart is minimal, initiate the pullback procedure in a blood vessel to be imaged (time acquisition of imaging data where cardiac motion may have an impact on image quality, [0104]). Courtney teaches wherein the system is configured to stop the pullback procedure within no more than one-half of a heart cycle (motorized control for stopping pullback procedure encompasses stopping within the time period; sufficiently small overshoot; [0096], [0152], [0161]); wherein the system is configured to initiate the injection of a flushing material to clear blood from a target area of the blood vessel to be imaged and wherein the injection of the flushing material continues over several heart cycles ([0072]-[0073], [0093]-[0094]); the system is configured to initiate the pullback further based on the system determining that clearing of the blood vessel has been achieved ([0137], [0147], [0152]); wherein the system is configured to produce a metronome that produces an output representing the cardiac rhythm of the patient (cardiac sensor, [0104]); wherein the metronome identifies a low motion part of the cardiac cycle (acquire images during a particular phase of cardiac cycle, such as systole or diastole; [0104]); wherein the pullback procedure is performed at a pullback speed of at least 50mm/sec (control pullback speed including greater than 2 mm/s; [0144]-[0146]); wherein the system is configured to initiate the pullback procedure further based on detection of a T-wave (ECG-triggered initiation encompasses T-wave, [0104]); wherein the system is configured to initiate the pullback procedure further based on at least one additional triggering condition ([0104], [0152]); wherein the blood vessel to be imaged comprises a blood vessel of the heart ([0017]-[0018]).
Ustun discloses automated identification of minimal myocardial motion for MR angiography. Ustun teaches (i) receive, prior to initiating a pullback procedure of the imaging probe, angiographic image data relating to the motion of the heart obtained from the angiographic system (page 284, column 1), (ii) analyze the angiographic image data to determine when the motion of the heart is minimal (time point of minimal displacement is identified and transferred to the scanner; page 284, column 2; page 287, column 3).
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 invention of Adler to control starting/stopping of the pullback procedure based upon additional triggers such as when it is determined that the flushing material has been cleared or ECG-triggered initiation as taught by Courtney, in order to provide additional control options for the user of the system in order to obtain higher quality images and a more accurate representation of the patient’s anatomy, thereby improving the accuracy of the diagnosis.
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 Adler and Courtney to utilize angiographic information to determine when the motion of the heart is minimal as taught by Ustun, as a substitute for the ECG based triggering techniques taught by Courtney, as Ustun teaches that using image analysis to determine when motion of the heart is minimal provides an advantage over ECG based techniques (page 283, column 3-page 284, column 1; page 287, column 3).
Furthermore, it would have an obvious design choice to one of ordinary skill in the art, without undue experimentation, to stop the pullback procedure within no more than one-half of a heart cycle or to control a stop time as otherwise desired by the operator, in order to obtain accurate images of the desired region of interest as described by Courtney ([0161]).
Furthermore, it would have an obvious design choice to one of ordinary skill in the art, without undue experimentation, to initiate the pullback procedure based on detection of a T-wave, or any other identified feature of interest in the electrocardiogram data, as the selection of the timepoint may vary from user to user depending on the user’s preference or the patient’s condition, and as Courtney describes the benefits of ECG-triggered initiation ([0104]).
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
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 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