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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/6/2026 has been entered.
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 - 7, 11 - 14, and 21 - 29 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.
Claim 1 has been amended to recite limitations directed towards ‘automatically re-determining the target location and the reference location in response to the user input changing the user-selectable lumen metric’.
Applicant’s remarks filed 7/6/2026 do not specify where support may be found in the disclosure for the claim amendments. The specification does not appear to clearly disclose automatically re-determining both “the target location” and “the reference location” in response to change of a single “user-selectable lumen metric”. For example, the specification discusses only “changes in target or landing locations that occur when, for example, the lumen metric (e.g., the variable APPSET 3 or APPSET 10) is changed” ([0084], as published).
Claim 1 and all claims depending therefrom are thus found to introduce 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 - 7, 11 - 14, and 21 - 29 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 is indefinite because it is unclear how receiving the user input changing the user-selectable lumen metric causes the processor circuit to ‘automatically re-determine the target location and the reference location’ in response thereto. As discussed in the 112(a) rejections above, the specification does not appear to disclose the claimed subject matter. It is unclear what algorithm is used to determine the new reference location.
Claims 2 - 7, 11 - 14, and 21 - 29 are indefinite by virtue of dependency.
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 (i.e., changing from AIA to pre-AIA ) 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.
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 - 2, 4 - 7, 11 - 14, 21 - 25, and 27 - 29 are rejected under 35 U.S.C. 103 as being unpatentable over Chao et al. (US 2020/0129158, of record) in view of Plakas et al. (US 2014/0378850).
Regarding claim 1, Chao shows an intravascular ultrasound imaging system (“intraluminal ultrasound imaging system”, claim 1). The system comprises:
an intravascular imaging catheter (catheter, [0043] and fig. 1) configured for intravascular ultrasound (IVUS) (IVUS, [0044]) or optical coherence tomography (OCT) (OCT, [0045]); and
a processor circuit configured for communication with the intravascular imaging catheter (“processor circuit configured for communication with an intraluminal ultrasound imaging catheter”, claim 1) and a display (monitor 108, [0043] and fig. 1), wherein the processor circuit is configured to:
control the intravascular imaging catheter to obtain a first plurality of intravascular images obtained during movement of the intravascular imaging catheter within a vasculature of a patient (“receive a plurality of intraluminal ultrasound images obtained by the intraluminal ultrasound imaging catheter while the intraluminal ultrasound imaging catheter is moved through a body lumen of a patient”, claim 1), the vasculature comprising a plurality of segments and a compression ([0061] - [0062] and figs. 3 - 4; compressed portion, claim 16) within at least one segment (“the body lumen comprises a plurality of segments”, claim 13; vessel segments, [0063] - [0064] and fig. 5);
for at least one segment, based on the first plurality of intravascular images, automatically determine a target location within the compression and a reference location comprising a healthy portion of the vasculature (“… reference location … target location …compressed portion of the body lumen …” claims 16 - 17; [0063]; ”… healthy tissue … narrowest part of the vessel segment 520”, [0064] and fig. 5); and
output, to the display, a screen display comprising the target location, the reference location, and at least one quantity associated with the target location and reference location (“diameter, area, percent compression, or percent improvement of the lumen at each location along the pullback”, [0030]; “… output … stylized graphic …”, claims 16 - 17; [0063] - [0064] and screen display 500 in fig. 5).
Chao fails to show that the target or reference location is determined based on a user-selectable lumen metric, and automatically re-determining the target and reference locations in response to receiving user input changing the user-selectable lumen metric.
Plakas discloses identification and quantification of stenosis in arteries ([0001]). Plakas teaches the target or reference location (“… possible stenosis sections (non-reference sections) and reference sections based on the ASI…”, [0045] - [0046]) is determined based on a user-selectable lumen metric (“… the ratio threshold is provided by the user and may be dependent on the process or data type in the same manner as the ASI threshold above. In alternative embodiments, a different calculated parameter is used instead …”, [0057]), and automatically re-determining the target and reference locations in response to receiving user input changing the user-selectable lumen metric (“… the user may select a further display threshold …and redisplay the image with the new threshold applied”, [0078]; “… lumen diameter at the nearest reference point”, [0081]. Note that the ‘nearest reference point’ depends on the threshold and corresponding identification of non-reference sections vs. reference sections).
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 Chao to have the target or reference location be determined based on a user-selectable lumen metric, and to include automatically re-determining the target and reference locations in response to receiving user input changing the user-selectable lumen metric, as taught by Plakas, in order to draw the user’s attention to regions, as suggested by Plakas ([0073]).
Regarding claim 2, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows obtaining a second plurality of intravascular images, wherein the second plurality of intravascular images depicts a stent that is aligned longitudinally with the target location (stents 440, [0070] and fig. 7);
based on the second plurality of intravascular images, automatically determining a proximal end of the stent, a distal end of the stent (“stents 440, which are detected automatically by the system and included on the GILD 610”, [0070] and fig. 7), and a location within the stent where the stent is most constricted (“post-treatment marker 735 is in the same location previously occupied by the target marker 534”, [0070] and fig. 7); and
outputting, to the screen display, the proximal end of the stent, the distal end of the stent, the location where the stent is most constricted, and at least one quantity associated with the constriction (post-treatment gain calculation 738, [0070] and fig. 7).
Regarding claim 4, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows the vasculature comprises peripheral venous vasculature and wherein the plurality of segments comprises at least one of a common iliac vein (CIV), an external iliac vein (EIV), a common femoral vein (CFV), or a femoral vein ([0063] and fig. 5).
Regarding claims 5 - 6, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows the at least one segment comprises multiple segments, and wherein the screen display simultaneously shows the target location and reference location for each of the multiple segments ([0063] and fig. 5).
Regarding claim 7, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows at least one of the target location or the reference location is determined at least in part by variation of the aspect ratio along a segment (relative diameter or cross-sectional area, [0064]; “… selected automatically …”, [0065]).
Chao fails to show that the user-selectable lumen metric comprises an aspect ratio.
Plakas teaches the user-selectable lumen metric comprises an aspect ratio (measured-to-expected ratio, [0054] - [0057]).
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 Chao to have the user-selectable lumen metric comprise an aspect ratio, as taught by Plakas, in order to help quantify stenosis, as suggested by Plakas ([0069]).
Regarding claim 11, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows the target and reference locations are determined based at least in part on a length of the movement of the catheter within the vasculature, as the target and reference locations are determined during a pullback procedure ([0063]).
Regarding claim 12, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows the target location or the reference location is determined based at least in part on the segment in which the compression is located, as the target location is at the compression ([0063] - [0064] and fig. 5).
Regarding claim 13, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows the vasculature comprises a vein (implicit), wherein the target location or the reference location is determined based at least in part on an artery (artery, [0052]; the walls of the vein are compressed as a result of the contact with the artery, [0060]) adjacent the vein (implicit).
Regarding claim 14, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows the screen display comprises at least one of a roadmap image or an image longitudinal display (ILD) ([0078] and fig. 10).
Regarding claim 231, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows determining
for each intravascular image in the first plurality of intravascular images, a measured value of the lumen metric (“… graphical representation indicative of the diameter, area, percent compression, or percent improvement of the lumen at each location along the pullback …”, [0030]; [0038] - [0040]; cross-sectional area of the vessel for each tomographic section, [0079]).
Chao fails to show that the lumen metric is user-selectable, and that the target or reference location is determined based on a threshold for the user-selectable lumen metric by comparing the measured value to the threshold.
Plakas teaches a lumen metric is user-selectable (“… the ratio threshold is provided by the user … same manner as the ASI threshold above … different calculated parameter is used instead …”, [0057]; “… the user may select a further display threshold …and redisplay the image with the new threshold applied”, [0078]) and that the target or reference location is determined based on a threshold for the user-selectable lumen metric by comparing the measured value to the threshold (“… possible stenosis sections (non-reference sections) and reference sections based on the ASI…”, [0045] - [0046]).
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 Chao to have the lumen metric be user-selectable, and to have the target or reference location be determined based on a threshold for the user-selectable lumen metric by comparing the measured value to the threshold, as taught by Plakas, in order to facilitate drawing the user’s attention to regions, as suggested by Plakas ([0073]).
Regarding claim 212, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows determining a plurality of diameters ([0064]) in each of the intravascular images, wherein the measured value of the aspect ratio for each image is based on the diameters for the respective intravascular image (“relative diameter … of the target area 524 as compared with the reference area 522 … expressed as a percentage, a fraction or ratio, … other means of representing fractional or relative values. “, [0064] and difference calculations 526, 536, 546 in fig. 5).
Chao fails to show that the user-selectable lumen metric comprises the aspect ratio.
Plakas teaches the user-selectable lumen metric comprises the aspect ratio (measured-to-expected ratio, [0054] - [0057]).
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 Chao to have the user-selectable lumen metric comprise an aspect ratio, as taught by Plakas, in order to help quantify stenosis, as suggested by Plakas ([0069]).
Regarding claim 223, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows the plurality of diameters comprises a maximum diameter in the respective intravascular image and a minimum diameter in the respective intravascular image (“widest part of the vessel segment 520… narrowest part of the vessel segment 520”, [0064]), wherein the measured value of the aspect ratio for each for each intravascular image comprises the maximum diameter divided by the minimum diameter (“relative diameter … of the target area 524 as compared with the reference area 522 … expressed as a percentage, a fraction or ratio, … other means of representing fractional or relative values. “, [0064] and difference calculations 526, 536, 546 in fig. 5).
Regarding claim 24, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Further, in the combined invention of the prior art, the target location would be determined based on a plurality of consecutive intravascular images in the first plurality of intravascular images for which the measured value of the user-selectable lumen metric satisfies the threshold, as the threshold dictates the target locations (see art rejection of claim 23), and the images as consecutively acquired (Chao: [0038] - [0040]).
Regarding claim 25, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above.
Chao fails to show that the user-selectable lumen metric comprises an area, a minimum diameter, a maximum diameter, an effective diameter, an average diameter, an aspect ratio, or a flow resistance of the vasculature.
Plakas teaches the user-selectable lumen metric comprises an aspect ratio (measured-to-expected ratio, [0054] - [0057]).
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 Chao to have the user-selectable lumen metric comprise an aspect ratio, as taught by Plakas, in order to help quantify stenosis, as suggested by Plakas ([0069]).
Regarding claim 27, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above.
Chao fails to show that the target or reference location is determined based on a threshold for the user-selectable lumen metric.
Plakas teaches a target or reference location is determined based on a threshold for the user-selectable lumen metric (“… possible stenosis sections (non-reference sections) and reference sections based on the ASI…”, [0045] - [0046]; “… the ratio threshold is provided by the user … same manner as the ASI threshold above … different calculated parameter is used instead …”, [0057]; “… the user may select a further display threshold …and redisplay the image with the new threshold applied”, [0078]).
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 Chao to have the target or reference location be determined based on a threshold for the user-selectable lumen metric, as taught by Plakas, in order to facilitate drawing the user’s attention to regions, as suggested by Plakas ([0073]). The threshold comprises a percentage of an average value of the user-selectable lumen metric for the at least one segment at least because the threshold is 100% of itself.
Regarding claim 28, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above.
Chao fails to show that the target or reference location is determined based on
a threshold for the user-selectable lumen metric, wherein the threshold and the user-selectable lumen metric each have a default value, and wherein the user input changes the user-selectable lumen metric and the threshold such that the user input overrides the default values.
Plakas teaches a target or reference location is determined based on a threshold for the user-selectable lumen metric (“… possible stenosis sections (non-reference sections) and reference sections based on the ASI…”, [0045] - [0046]; “… the ratio threshold is provided by the user … same manner as the ASI threshold above … different calculated parameter is used instead …”, [0057]; “… the user may select a further display threshold …and redisplay the image with the new threshold applied”, [0078]), wherein the threshold and the user-selectable lumen metric each have a default value (implicit), and wherein the user input changes the user-selectable lumen metric and the threshold such that the user input overrides the default values (“… different parameter … is measured or calculated instead of or in addition to each diameter”, [0040]; “… different index or measure is calculated instead of or in addition to the atherosclerosis index”, [0044]; divides the unbranched vessel section 74 into possible stenosis sections and reference sections based on a different index or measure … a threshold value for the index is applied”, [0046]; “… different value for the ratio threshold … threshold is provided by the user … different calculated parameter is used”, [0057]; [0077] - [0078]).
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 Chao to have the target or reference location be determined based on a threshold for the user-selectable lumen metric, wherein the threshold and the user-selectable lumen metric each have a default value, and wherein the user input changes the user-selectable lumen metric and the threshold such that the user input overrides the default values, as taught by Plakas, in order to facilitate drawing the user’s attention to regions, as suggested by Plakas ([0073]).
Regarding claim 29, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above. Chao further shows the at least one quantity comprises a difference between a value of the user-selectable lumen metric at the target location and a value of the lumen metric at the reference location (difference calculation, [0064]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable Chao and Plakas as applied to claim 2 above, and further in view of Nair et al. (US 2020/0129147, of record).
Regarding claim 3, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above.
Chao is silent as to whether or not the determining the reference location, the proximal end of the stent, the distal end of the stent, or the location within the stent where the stent is most constricted involves a machine learning algorithm.
Nair discloses intraluminal ultrasound imaging. Nair teaches determining the reference location, the proximal end of the stent, the distal end of the stent, or the location within the stent where the stent is most constricted (“post-stent inspection to determine the status of a stent that has been positioned in a lumen”, [0049] and figs. 5 - 7; “compression 330 and with a stent 440 expanded inside it”, [0046] and fig. 4, stent border, [0067]; stent contour, [0082]) involves a machine learning algorithm (machine learning, [0010], [0063], [0074]).
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 Chao and Plakas to have the determining the reference location, the proximal end of the stent, the distal end of the stent, or the location within the stent where the stent is most constricted involve a machine learning algorithm, as taught by Nair, in order to facilitate enabling easy editing of measurements and borders during use of IVUS, as suggested by Nair ([0007]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable Chao and Plakas as applied to claim 1 above, and further in view of Ciompi et al. (US 2012/0283569).
Regarding claim 26, the combined invention of Chao and Plakas discloses the claimed invention substantially as noted above.
Chao fails to show identifying a reference zone comprising a plurality of consecutive reference candidate frames and a target zone comprising a plurality of consecutive target candidate frames.
Ciompi discloses intraluminal ultrasound imaging. Ciompi teaches identifying a reference zone comprising a plurality of consecutive reference candidate frames and a target zone comprising a plurality of consecutive target candidate frames (“ … automatic classification technique … to group and label frames belonging to homogeneous events”, [0052]; “set of successive frames belonging to a same clinical condition”, [0054] - [0058]).
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 Chao and Plakas to include identifying a reference zone comprising a plurality of consecutive reference candidate frames and a target zone comprising a plurality of consecutive target candidate frames, as taught by Ciompi, in order to identify frames belonging to a same clinical condition, as suggested by Ciompi ([0054]).
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. Plakas is introduced to address the amended features.
Conclusion
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
1 It is noted that the 103 rejection of claim 23 is presented out of order in the instant Office Action because claims 21 and 22 depend from claim 23.
2 It is noted that the 103 rejection of claim 21 is presented out of order in the instant Office Action because claims 21 and 22 depend from claim 23.
3 It is noted that the 103 rejection of claim 22 is presented out of order in the instant Office Action because claims 21 and 22 depend from claim 23.
Prosecution Insights