DETAILED ACTION
In view of the appeal brief filed on 27 May 2026, PROSECUTION IS HEREBY REOPENED. New ground of rejection set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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, see pages 10-19, filed 27 May 2026, with respect to 103 rejections have been fully considered and are persuasive. The 103 rejections of 19 December 2025 have been withdrawn.
In view of claims 1-11 and 21-22 filed on 18 November 2025, the examiner rejects claims under 101.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites an intraluminal imaging system, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 1 recites the limitations:
Measure a first anatomical feature in the plurality of image frames and a different, second anatomical feature in the plurality of image frames;
identify, from among the plurality of image frames, a target frame that is distinct from a proximal reference frame and a distal reference frame; and
wherein, to identify the target frame, the processor circuit is configured to:
identify a first image frame as a candidate for the target frame when the first image frame satisfies a plurality of criteria comprising:
a comparison of the automatic measurement for the first anatomical feature to a first threshold; and
a comparison of the automatic measurement for the second anatomical feature to a second threshold;
determine if a subset of second image frames proximate to the first image frame satisfies the plurality of criteria; and
determine the first image frame to be the target frame when the subset of second image frames satisfies the plurality of criteria.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind and mathematical concepts as it recites steps of observing the image frames, and measuring first and second anatomical features in the images (such as using a ruler to measure diameter, length, dimension, using a known mathematical formula to calculate area in each image frame), and sorting out a target frame that is not a proximal and distal reference frames (can be done by scrolling through the image frames) and making selection of a target frame (candidate target frame) based on observed first and second anatomical features (can be performed by observing plurality of cross sectional images of lumen, and determine whether the measured anatomical features such as diameter, dimension, area, plaque burden) meet threshold, which can be conducted by comparing the measurement to a predetermined value in mind. When two anatomical features are compared to a threshold and meet the criteria (whether it is greater or less than the threshold), one can determine the frame is a candidate target frame (by selection). Next, neighboring frames can be evaluated whether to meet same criteria by comparing its measured anatomical features to threshold, conclusion is made that the first frame is the target frame (judgement).
These actions fall under the Mental Processes and the Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations using a formula and definition to determine measurement.” A human, such as surgeon and/or physician, could mentally perform tasks of identifying a target frame by observing plurality of frames and select one and using measurement (by ruler) and mathematical formulas to determine first and second anatomical features (diameter, cross-sectional area, width, length and plaque burden). These steps can all be performed mind with aid of a pen and paper. Target frame is further inspected by mentally comparing measured value to a known value (known diameter and plaque burden). Additional selection/confirmation of target frame is performed by examining neighboring frames for same anatomical feature measurement and comparing the measured values to the threshold.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
generate a plurality of image frames using the imaging data;
automatically measure , in response to generating the plurality of image frames
This claim elements of generating a plurality of image frames are a mere data collection step which amounts to a pre-solution insignificant activity.
“Automatically measuring” can be performed using generic computer or calculator. The claims do not specify any particular configuration or improvement in the processor/computer itself, just simply applying the subtract task of determination of anatomical features by ruler and formula with a computer.
The steps of generating a plurality of image frames and automatically measure in response to generating the plurality of image frames is performed in order to gather data for the recited mental process step and is a necessary precursor for all uses of the recited abstract idea since no identification of target frame based on anatomical features could be carried out without first gathering necessary image data of interest (such as plurality of image frames).
The claim further recites following additional elements:
a processor circuit configured for communication with the intraluminal imaging catheter or guidewire, wherein the processor circuit is configured to:
The use of processor circuit is recited for performing the mental process set forth above and does not integrate the subtract mental process into a practical application. These are generic hardware/software components invoked merely as a tool to perform the subtract steps and does not add meaningful limitations. “Automatically measuring” can be performed using generic computer or calculator. The claims do not specify any particular configuration or improvement in the processor/computer itself, just simply applying the subtract task with a computer.
The claim further recites following additional elements:
output, to a display in communication with the processor circuit, a single screen display including: the target frame; and a graphical representation of the lumen showing a position of the target frame,
This claim elements of outputting step of a target frame and a position of the target frame, which is mere displaying and outputting the result of abstract idea and amounts to a post-solution insignificant activity. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step.
This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite
“an intraluminal imaging catheter or guidewire configured to obtain imaging data associated with a lumen of a patient while positioned within the lumen.”
This element represents well-understood, routine, conventional activity because of US patent publication Courtney et al. (US 2016/0022244) describes imaging catheters, such as intravascular catheters include commercially available IVUS catheter provides images of blood and vascular walls ([0142]).
Thus, the examiner concludes that intraluminal imaging catheter or guidewire is common use in the intravascular and intracardiac procedures.
In light of the above, claim 1 is ineligible.
Claims 2-10 and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite an intraluminal imaging system, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claims 2-10 recite the limitations:
Of claim 2, wherein the automatic measurement of the first anatomical feature and the first threshold are associated with a plaque burden, and wherein the automatic measurement of the second anatomical feature and the second threshold are associated with a cross-sectional area of the lumen.
Of claim 3, wherein, to identify the proximal reference frame, the processor circuit is configured to identify a second image frame to be representative of a nearest tissue of the lumen proximal to the target frame that satisfies a third threshold, wherein the third threshold is associated with a plaque burden or a cross-sectional area of the lumen.
Of claim 4, wherein, to identify the distal reference frame, the processor circuit is configured to identify a third image frame to be representative of a nearest tissue of the lumen distal to the target frame that satisfies the third threshold.
Of claim 5, wherein the processor circuit is configured to define a target region between multiple candidate target frames with no reference frames identified between the multiple candidates for the target frame.
Of claim 6, wherein, to determine the first image frame to be the target frame, the processor circuit is configured to determine the first image frame to satisfy a criterion associated with a plaque burden or a cross-sectional area of the multiple candidates for the target frame within the target region.
Of claim 7, wherein, to determine the first image frame to be the target frame, the processor circuit is configured to determine the first image frame to be representative of a desired location to be dilated with a stent.
Of claim 8, wherein, to identify the proximal reference frame, the processor circuit is configured to identify a second image frame to be representative of a desired position of a proximal edge of the stent, and wherein, to identify the distal reference frame, the processor circuit is configured to identify a third image frame to be representative of a desired position of a distal edge of the stent.
Of claim 9, wherein, to determine the first image frame to be the target frame comprises, the processor circuit is configured to determine the first image frame to have a minimum cross-sectional area within a stent positioned in the lumen.
Of claim 10, wherein the processor circuit is configured to detect a proximal edge and a distal edge of the stent, wherein, to identify the proximal reference frame, the processor circuit is configured to identify a second image frame to be representative of the proximal edge of the stent, and wherein, to identify the distal reference frame, the processor circuit is configured to identify a third image frame to be representative of the distal edge of the stent.
Of claim 21, wherein the processor circuit is configured to:
identify the proximal reference frame, wherein the proximal reference frame is located proximal of the target frame; and
identify the distal reference frame, wherein the distal reference frame is located distal of the target frame, wherein the single screen display comprises the proximal reference frame and the distal reference frame,
wherein the graphical representation of the lumen shows respective positions of the proximal reference frame and the distal reference frame.
Of claim 22, wherein the target frame is representative of a narrowing of the lumen with restricted fluid flow.
These underlined limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind and mathematical concepts as it recites steps of observing the image frames, and measuring first and second anatomical features in the images (such as using a ruler to measure diameter, length, dimension, using a known mathematical formula to calculate area in each image frame), and sorting out a target frame that is not a proximal and distal reference frames (can be done by scrolling through the image frames) and making selection of a target frame (candidate target frame) based on observed first and second anatomical features (can be performed by observing plurality of cross sectional images of lumen, and determine whether the measured anatomical features such as diameter, dimension, area, plaque burden) meet threshold, which can be conducted by comparing the measurement to a predetermined value in mind. When two anatomical features are compared to a threshold and meet the criteria (whether it is greater or less than the threshold), one can determine the frame is a candidate target frame (by selection). Next, neighboring frames can be evaluated whether to meet same criteria by comparing its measured anatomical features to threshold, conclusion is made that the first frame is the target frame (judgement).
For claims 5 and 7-8, a surgeon can observe the images, analyze the images using mental process of opinion (for desired stent location), and using known dimension of the stent, decide where its both ends would sit, and draw a conclusion on a desired place for stent (judgement).
For claims 10 and 21, using known length of the stent, a surgeon can estimate proximal and distal end of the stent location, which would be proximal and distal image frames, this process can be conducted by observing the images and based on the length of the stent, one can select frames to be distal and proximal by selecting proximal frame and adding length of the stent, to calculate a position of the distal frame using mathematical relationships of length which draw conclusion of selection of distal and proximal frames.
These actions fall under the Mental Processes and Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and performing mathematical calculations . A human, such as surgeon and/or physician, could mentally perform tasks of identifying a target frame by observing plurality of frames and select one and using measurement (by ruler) and mathematical formulas to determine first and second anatomical features (diameter, cross-sectional area, width, length and plaque burden). These steps can all be performed mind with aid of a pen and paper. Target frame is further inspected by mentally comparing measured value to a known value (known diameter and plaque burden). Additional selection/confirmation of target frame and proximal and distal frames can be performed by observation and opinion of physician.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claims 2-10 and 21-22 recite the following additional elements:
a processor circuit
automatically measuring, using the processor circuit,
The use of processor circuit is recited for performing the mental process set forth above and does not integrate the subtract mental process into a practical application. These are generic hardware/software components invoked merely as a tool to perform the subtract steps and does not add meaningful limitations. “Automatically measuring” can be performed using generic computer or calculator. The claims do not specify any particular configuration or improvement in the processor/computer itself, just simply applying the subtract task with a computer.
The claims further recites following additional elements:
wherein the single screen display comprises the proximal reference frame and the distal reference frame,
wherein the graphical representation of the lumen shows respective positions of the proximal reference frame and the distal reference frame.
This claim elements of outputting step of a target frame, proximal and distal reference frames and graphical representation of the lumen. This claim elements of outputting step of a target frame and a position of the frames in the lumen graphical representation, which is mere displaying and outputting the result of abstract ideas and amounts to a post-solution insignificant activity. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step.
This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no invention concept in the claims.
In light of the above, claims 2-10 and 21-22 are ineligible.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a method for intraluminal imaging thus is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 11 recites the limitations:
Measuring a first anatomical feature in the plurality of image frames and a different, second anatomical feature in the plurality of image frames;
identifying, from among the plurality of image frames, a target frame that is distinct from a proximal reference frame and a distal reference frame; and
wherein, to identify the target frame, the processor circuit is configured to:
identifying a first image frame as a candidate for the target frame when the first image frame satisfies a plurality of criteria comprising:
a comparison of the automatic measurement for the first anatomical feature to a first threshold; and
a comparison of the automatic measurement for the second anatomical feature to a second threshold;
determining if a subset of second image frames proximate to the first image frame satisfies the plurality of criteria; and
determining the first image frame to be the target frame when the subset of second image frames satisfies the plurality of criteria.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of observing the image frames, and measuring first and second anatomical features in the images (such as using a ruler to measure diameter, length, dimension, area in each image frame), and sorting out a target frame that is not a proximal and distal reference frames (can be done by scrolling through the image frames) and making selection of a target frame (candidate target frame) based on observed first and second anatomical features (can be performed by observing plurality of cross sectional images of lumen, and determine whether the measured anatomical features (such as diameter, dimension, area, plaque burden) meet threshold, which can be conducted by comparing the measurement. When two anatomical features are compared to a threshold and meet the criteria (Whether it is greater or less than the threshold), one can determine the frame is a candidate target frame (by selection). Next, neighboring frames can be analyzed whether to meet same criteria by comparing its measured anatomical features to threshold, conclusion is made that the first frame is the target frame.
These actions fall under the Mental Processes adm Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion) and performing mathematical calculations” A human, such as surgeon and/or physician, could mentally perform tasks of identifying a target frame by observing plurality of frames and select one and using measurement (by ruler) and mathematical formulas to determine first and second anatomical features (diameter, cross-sectional area, width, length and plaque burden). These steps can be all performed mind with aid of a pen and paper. Target frame is further inspected by mentally comparing measured value to a known value (known diameter and plaque burden). Additional selection/confirmation of target frame is performed by examining neighboring frames for same anatomical feature measurement and comparing the measured values to the threshold.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
generating a plurality of image frames using the imaging data;
automatically measuring, using the processor circuit, in response to generating the plurality of image frames
This claim elements of generating a plurality of image frames are a mere data collection step which amounts to a pre-solution insignificant activity.
“Automatically measuring” can be performed using generic computer that can calculate. The claims do not specify any particular configuration or improvement in the processor/computer itself, just simply applying the subtract task of determination of anatomical features by ruler and formula with a computer.
The steps of generating a plurality of image frames and automatically measure in response to generating the plurality of image frames is performed in order to gather data for the recited mental process step and is a necessary precursor for all uses of the recited abstract idea since no identification of target frame based on anatomical features could be carried out without first gathering necessary image data of interest (such as plurality of image frames).
The claim further recites following additional elements:
a processor circuit in communication with the intraluminal imaging catheter or guidewire, automatically measuring, using the processor circuit,
The use of processor circuit is recited for performing the mental process set forth above and does not integrate the subtract mental process into a practical application. These are generic hardware/software components invoked merely as a tool to perform the subtract steps and does not add meaningful limitations. “Automatically measuring” can be performed using generic computer or calculator. The claims do not specify any particular configuration or improvement in the processor/computer itself, just simply applying the subtract task with a computer.
The claim further recites following additional elements:
outputting, to a display in communication with the processor circuit, a single screen display including: the target frame; and a graphical representation of the lumen showing a position of the target frame,
This claim elements of outputting step of a target frame and a position of the target frame, This claim elements of outputting step of a target frame and a position of the target frame, which is mere displaying and outputting the result of abstract idea and amounts to a post-solution insignificant activity. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step.
This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite
“image data obtained by the intraluminal imaging catheter or guidewire positioned within a lumen.”
This element represents well-understood, routine, conventional activity because of US patent publication Courtney et al. (US 2016/0022244) describes imaging catheters, such as intravascular catheters include commercially available IVUS catheter provides images of blood and vascular walls ([0142]).
Thus, the examiner concludes that intraluminal imaging catheter or guidewire is common use in the intravascular and intracardiac procedures.
In light of the above, claim 11 is ineligible.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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