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 .
Election/Restrictions
Response to Election/Restriction on 4/7/26 is entered. The Restriction requirement mailed on 2/26/2026 is withdrawn in light of the response on 4/7/26.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the imaging catheter including a probe, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because legalese, claim language. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
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 9-10 is 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.
Regarding Claim 9, “…determined to be present in another of the first images that is on a proximal side of said one of the first images…” is unclear the correlation of the proximal side with respect to the image space and the guiding catheter from which the first images are acquired from. The metes and bounds are unclear.
Regarding Claim 10, “…corresponding to a proximal end” is unclear what the “proximal end” refers to. It is unclear if the proximal end is in relationship to the imaging catheter, guiding catheter or something else. The metes and bounds are unclear.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 10-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson et. al. (U.S. 20170143296, May 25, 2017)(hereinafter, “Peterson”).
Regarding Claim 1, Peterson teaches: A medical imaging apparatus for performing intravascular imaging (“…the disclosure relates to intravascular data collection and imaging.” [0038]; “As shown in FIG. 1A, a blood vessel 5 can be imaged using a data collection probe 10.” [0042]; Fig. 1A), comprising:
an imaging catheter including a probe and insertable into a vessel through a guiding catheter, wherein the imaging catheter is configured to generate cross-sectional images of the vessel from signals emitted from the probe and received by the probe (“The data collection probe 10 can include an imaging catheter 11 and an optical fiber 15.” [0042]; “The distance measurements collected using the probe 10 can be processed to generate frames of image data such as cross-sectional views or longitudinal views (L-mode views) of the blood vessel.” [0044]); and
a processor configured (“…the system 25 includes a processor, memory, or other components configured to execute various data processing stages or modules.” [0048]) to: control the imaging catheter to emit the signals and acquire the cross- sectional images of the vessel therefrom (“…guide catheter data is acquired one scan line at a time and stored in memory in communication with one or more computing devices...a given scan line can include a portion of the guide catheter and identified as a point or frame or scan line or a set thereof that includes the start of the guide catheter in the vessel or are otherwise within the guide catheter. ” [0053]),
in each of first images of the acquired images, determine a first region in which the guiding catheter is potentially present (“The probe is introduced or delivered at a desired location in the vessel 5 using a guide catheter GC…As shown in FIG. 1B, which shows a zoomed in view of the GC and probe 10, the imaging catheter 11 and probe 10 pulls back within the GC and can image through the wall of the GC. Detecting the GC in the resultant images is desirable because the GC can include structures that generate shadows which can cause it to appear as a stent or otherwise be misinterpreted by software imaging processing modules such as a stent detection or shadow detection software module.” [0042]. See Fig. 1B and 2A),
based on pixel values of the first region, determine whether the guiding catheter is present in each of the first images (“…the image processing software can identify various points, frames, pairs of points within each frame. In one embodiment, the software module can operate open or otherwise transform the previously generated binary mask representation to identify start stop pairs. These start stop pairs can refer to the start and stop of runs of a set of pixels in the binary image of the lumen.” [0072]; “The method can include performing a circle fit or chord selection on per frame basis and identify deviation and transitions therein Step A5. If a GC is present, it will be detected in set of consistent circle or chord values Step A6.” [0084]. See Fig. 10),
determine second images of the acquired images in which the guiding catheter is not present based on the determination of whether the guiding catheter is present in each of the first images (“…GC results in certain steps or downstream image processing being performed with GC containing frames excluded. In other methods, the GC frames are not excluded…the method excludes frames that include detected GC from subsequent processing Step A7...the method excludes frames that include detected GC from being displayed Step A8 such as on a cath lab device or system or other devices or displays.” [0084]. See Fig. 10), and
generate diagnostic information about the vessel using the second images (“One intravascular data has been collected relative to a blood vessel the data can be played back as a series of frames, cross-sectional views, longitudinal views, and other parameters generated by the measurements obtained from the blood vessel such as lumen diameters, side branch locations, and various other measured or detected features and information of interest.” [0038];” These data sets can be used to identify blood vessel characteristics such as lumen area and diameter, image the vessel, and identify catheters disposed in the vessel as described herein…The images generated and subsequent image processing to detect blood vessel features can have errors and artifacts introduced in them if frames containing the guide catheter are treated as images of the blood vessel. As a result, frames that include that guide catheter are identified in one embodiment. In one embodiment, the display of the guide catheter is included as part of the information displayed with regard to the image frames of the pullback. In one embodiment, once the guide catheter is identified it is excluded from subsequent image processing and/or display in one embodiment.” [0043]).
Regarding Claim 2, Peterson teaches the claim limitations as noted above.
Peterson further teaches: wherein the processor is configured to: determine, in each of the first images, a second region in which the imaging catheter is present, and determine the first region based on the second region (“The probe is introduced or delivered at a desired location in the vessel 5 using a guide catheter GC…As shown in FIG. 1B, which shows a zoomed in view of the GC and probe 10, the imaging catheter 11 and probe 10 pulls back within the GC and can image through the wall of the GC...” [0042]; “The probe 10 including the imaging catheter 11 extends along the body of the guide catheter GC and the tip of the guide catheter as shown. The vertical dotted lines show the delineation between the tip and body sections of the guide catheter GC. As the imaging catheter 11 is retracted (pulled-back) along the length of the vessel, a plurality of scans or OCT data sets are collected as the probe or a portion thereof rotates. This is referred to as a pullback in one embodiment. During a pullback the probe moves in the proximal direction. These data sets can be used to identify blood vessel characteristics such as lumen area and diameter, image the vessel, and identify catheters disposed in the vessel as described herein.” [0043]. See Fig. 1B and 2A).
Regarding Claim 3, Peterson teaches the claim limitations as noted above.
Peterson further teaches: wherein the processor determines the first region further based on a diameter of the guiding catheter (“The right side of FIG. 2A includes the GC body and tip. These portions of the right side have an image intensity level that is greater than the intensity level on the left side. In addition, the left side of FIG. 2A shows the expansion of the lumen relative to the diameter of the GC. This variation in intensity level between lumen and GC containing frames and the expanded diameter of the lumen image frames as a transition from a GC containing frame can be used to detect the GC...[0047]. See Fig. 2A).
Regarding Claim 4, Peterson teaches the claim limitations as noted above.
Peterson further teaches: wherein the processor is configured to: determine, in each of the first images, a third region in which blood is present based on differences between pixel values of two or more of the first images that are consecutive, and determine the first region based on the third region (“Once the OCT data is obtained with a probe and stored in memory; it can be processed to generate information 47 such as a cross-sectional, a longitudinal, and/or a three-dimensional view of the blood vessel along the length of the pullback region or a subset thereof. These views can be depicted as part of a user interface.” [0051]; “If the initial processing module includes a lumen detection module the module can process the data using to determine a lumen boundary and identify one more points on the boundary. In one embodiment, the lumen detection module provides a lumen boundary as an input to the GC detection module 44b. The GC detection module 44b can detect a frame or a position of a guide catheter disposed in the lumen relative to the lumen boundary using geometric properties of the catheter, material properties of the catheter such as intensity behavior or other optical signatures, and combinations thereof.” [0052]. See Fig. 3).
Regarding Claim 5, Peterson teaches the claim limitations as noted above.
Peterson further teaches: wherein the processor is configured to: determine a center position of the imaging catheter in each of the first images, and determine a circular region having a diameter of an integral multiple of a predetermined value in a radial direction from the center position, and remove the circular region from the first region before determining whether the guiding catheter is present in each of the first images (“…the circle-fit detection method is based on one or more geometric or dimensional property. The circle-fit detection method identifies the tip of a catheter as the point or a range of points at which a diameter of the lumen undergoes a transition such a transition such as a drop, slope change, spike, or other identifiable intensity transition… The diameter of the lumen is determined based on a goodness of fit test of a plurality of lumen boundary points to a set of points constrained to define a circle. The lumen boundary points can be determined on a per frame or per lumen segment basis using one or more lumen detection methods. In one embodiment, the goodness of fit test is based on a least-squares fit of the lumen boundary points to a circle.” [0068]; “…the frame corresponding to the GC tip is stored in one memory element and used to exclude the frames or scan lines that continue after it and include the guide catheter. After identifying the catheter tip candidate frame to frames to the proximal side are evaluated using a computing device such as a processor in communication with an intravascular data collection system to determine if they fit within a tolerance of one another. In one embodiment, a circularity criterion is also imposed on the candidates.” [0071]).
Regarding Claim 6, Peterson teaches the claim limitations as noted above.
Peterson further teaches: wherein the processor is configured to: determine a center position of the imaging catheter in each of the first images, and determine whether the guiding catheter is present in each of the first images based on pixel values of a plurality of line segments extending in a radial direction from the center portion of the imaging catheter (“Since the lumen may not be centered in the image the lines through the center of the image form chords rather than diameters. It is useful to use a histogram or other statistical plot of the data or a score for each chord. In one embodiment, a histogram is generated or a representation thereof in an electronic memory device such as one or more matrices and a peak or other transition or relative extremum of the histogram is selected as an approximation of the diameter of the guide catheter. FIG. 9 shows an exemplary set of chords that can be added to such a histogram to select the dominant chord as a diameter measure for the GC.” [0074]. See Figs. 8-9).
Regarding Claim 7, Peterson teaches the claim limitations as noted above.
Peterson further teaches: wherein the processor is configured to: calculate a statistical value of the pixel values of the first region, and determine that the guiding catheter is present in each of the first images when the statistical value is less than or equal to a threshold (“…the circle-fit detection method is based on one or more geometric or dimensional property. The circle-fit detection method identifies the tip of a catheter as the point or a range of points at which a diameter of the lumen undergoes a transition such a transition such as a drop, slope change, spike, or other identifiable intensity transition… The diameter of the lumen is determined based on a goodness of fit test of a plurality of lumen boundary points to a set of points constrained to define a circle. The lumen boundary points can be determined on a per frame or per lumen segment basis using one or more lumen detection methods. In one embodiment, the goodness of fit test is based on a least-squares fit of the lumen boundary points to a circle.” [0068];“Once a set of chords is added to the histogram, as shown in FIG. 9, in one embodiment the histogram it is smoothed using a boxcar average (running average) filter. With this set of transformed information, following the application of the filter, the peak is identified in the smoothed histogram. This peak is selected as an approximation of the diameter for this frame. Once all frames are scored or otherwise processed as described herein to select a diameter on a per frame basis from the set of chords for that frame, the overall set of selected diameters is evaluated moving across the frames. Thus, looking at FIG. 7 and moving from right to left through the plot of diameters versus frames a point or range of points corresponding to the transition associated with the guide catheter is identified by the software. The same analysis as in the “Circle-Fit” method is performed to identify the candidate catheter tip position or GC containing frames.” [0080]).
Regarding Claim 8, Peterson teaches the claim limitations as noted above.
Peterson further teaches: wherein the processor is configured to set the threshold based on distribution of the pixel values of the first region (“…the circle-fit detection method is based on one or more geometric or dimensional property. The circle-fit detection method identifies the tip of a catheter as the point or a range of points at which a diameter of the lumen undergoes a transition such a transition such as a drop, slope change, spike, or other identifiable intensity transition… The diameter of the lumen is determined based on a goodness of fit test of a plurality of lumen boundary points to a set of points constrained to define a circle. The lumen boundary points can be determined on a per frame or per lumen segment basis using one or more lumen detection methods. In one embodiment, the goodness of fit test is based on a least-squares fit of the lumen boundary points to a circle.” [0068];“Once a set of chords is added to the histogram, as shown in FIG. 9, in one embodiment the histogram it is smoothed using a boxcar average (running average) filter. With this set of transformed information, following the application of the filter, the peak is identified in the smoothed histogram. This peak is selected as an approximation of the diameter for this frame. Once all frames are scored or otherwise processed as described herein to select a diameter on a per frame basis from the set of chords for that frame, the overall set of selected diameters is evaluated moving across the frames...” [0080]).
Regarding Claim 10, Peterson teaches the claim limitations as noted above.
Peterson further teaches: wherein the processor is configured to select, as the first images, two or more of the acquired images from an image corresponding to a proximal end (“…the disclosure relates to a guide catheter detection (GCD) module and associated methods that can be used alone or as part of an intravascular image data processing pipeline. The GCD module detects the presence of the guide catheter at the proximal end of a pullback.” [0054]; “After all frames have been scored the resulting data is examined. The algorithm looks for a sharp drop of intensity when scanning from the proximal end. The figures discussed below show three cases with the proximal end on the right. The plots of various measured or otherwise determined parameters obtained using the data generated as a result of pullback the imaging catheter or probe through the artery indicate three different outcomes.” [0063]).
Regarding Claim 11, Peterson teaches the claim limitations as noted above.
Peterson further teaches: wherein the information indicates a boundary of the vessel in each of the second images (“The lumen boundary points can be determined on a per frame or per lumen segment basis using one or more lumen detection methods.” [0082]; “The method can include performing a circle fit or chord selection on per frame basis and identify deviation and transitions therein Step A5. If a GC is present, it will be detected in set of consistent circle or chord values Step A6…GC results in certain steps or downstream image processing being performed with GC containing frames excluded. In other methods, the GC frames are not excluded…the method excludes frames that include detected GC from subsequent processing Step A7...the method excludes frames that include detected GC from being displayed Step A8 such as on a cath lab device or system or other devices or displays.” [0084]. See Fig. 10).
Regarding Claim 12, the claim limitations are the intended usage of Claim 1, since the references cited in Claim 1 have apparatus and methods capabilities, the limitations are as such rejected under the same rationale.
Peterson teaches: A method for performing intravascular imaging using an imaging catheter that includes a probe and is insertable into a vessel through a guiding catheter (“…the disclosure relates to intravascular data collection and imaging.” [0038]; “As shown in FIG. 1A, a blood vessel 5 can be imaged using a data collection probe 10.” [0042]; Fig. 1A), the method comprising:
acquiring cross-sectional images of the vessel that are taken through the imaging catheter (“…guide catheter data is acquired one scan line at a time and stored in memory in communication with one or more computing devices...a given scan line can include a portion of the guide catheter and identified as a point or frame or scan line or a set thereof that includes the start of the guide catheter in the vessel or are otherwise within the guide catheter. ” [0053]),
in each of first images of the acquired images, determining a first region in which the guiding catheter is potentially present (“The probe is introduced or delivered at a desired location in the vessel 5 using a guide catheter GC…As shown in FIG. 1B, which shows a zoomed in view of the GC and probe 10, the imaging catheter 11 and probe 10 pulls back within the GC and can image through the wall of the GC. Detecting the GC in the resultant images is desirable because the GC can include structures that generate shadows which can cause it to appear as a stent or otherwise be misinterpreted by software imaging processing modules such as a stent detection or shadow detection software module.” [0042]. See Fig. 1B and 2A),
based on pixel values of the first region, determining whether the guiding catheter is present in each of the first images (“…the image processing software can identify various points, frames, pairs of points within each frame. In one embodiment, the software module can operate open or otherwise transform the previously generated binary mask representation to identify start stop pairs. These start stop pairs can refer to the start and stop of runs of a set of pixels in the binary image of the lumen.” [0072]; “The method can include performing a circle fit or chord selection on per frame basis and identify deviation and transitions therein Step A5. If a GC is present, it will be detected in set of consistent circle or chord values Step A6.” [0084]. See Fig. 10),
determining second images of the acquired images in which the guiding catheter is not present based on the determination of whether the guiding catheter is present in each of the first images (“…GC results in certain steps or downstream image processing being performed with GC containing frames excluded. In other methods, the GC frames are not excluded…the method excludes frames that include detected GC from subsequent processing Step A7...the method excludes frames that include detected GC from being displayed Step A8 such as on a cath lab device or system or other devices or displays.” [0084]. See Fig. 10); and
generating diagnostic information about the vessel using the second images (“One intravascular data has been collected relative to a blood vessel the data can be played back as a series of frames, cross-sectional views, longitudinal views, and other parameters generated by the measurements obtained from the blood vessel such as lumen diameters, side branch locations, and various other measured or detected features and information of interest.” [0038];” These data sets can be used to identify blood vessel characteristics such as lumen area and diameter, image the vessel, and identify catheters disposed in the vessel as described herein…The images generated and subsequent image processing to detect blood vessel features can have errors and artifacts introduced in them if frames containing the guide catheter are treated as images of the blood vessel. As a result, frames that include that guide catheter are identified in one embodiment. In one embodiment, the display of the guide catheter is included as part of the information displayed with regard to the image frames of the pullback. In one embodiment, once the guide catheter is identified it is excluded from subsequent image processing and/or display in one embodiment.” [0043]).
Regarding Claim 13, Peterson teaches the claim limitations as noted above.
Claim 13 further recites limitations: further comprising: determining, in each of the first images, a second region in which the imaging catheter is present, wherein the first region is determined based on the second region. These limitations are present in claim 2 and is therefore, rejected under the same rationale.
Regarding Claim 14, Peterson teaches the claim limitations as noted above.
Claim 14 further recites limitations: wherein the first region is determined further based on a diameter of the guiding catheter. These limitations are present in claim 3 and is therefore, rejected under the same rationale.
Regarding Claim 15,Peterson teaches the claim limitations as noted above.
Claim 15 further recites limitations: further comprising: determining, in each of the first images, a third region in which blood is present based on differences between pixel values of two or more of the first images that are consecutive, wherein the first region is determined based on the third region. These limitations are present in claim 4 and is therefore, rejected under the same rationale.
Regarding Claim 16, Peterson teaches the claim limitations as noted above.
Claim 16 further recites limitations: further comprising: determining a center position of the imaging catheter in each of the first images, and determining a circular region having a diameter of an integral multiple of a predetermined value in a radial direction from the center position; and removing the circular region from the first region before determining whether the guiding catheter is present in each of the first images. These limitations are present in claim 5 and is therefore, rejected under the same rationale.
Regarding Claim 17, Peterson teaches the claim limitations as noted above.
Claim 17 further recites limitations: further comprising: determining a center position of the imaging catheter in each of the first images, wherein whether the guiding catheter is present in each of the first images is determined based on pixel values of a plurality of line segments extending in a radial direction from the center portion of the imaging catheter. These limitations are present in claim 6 and is therefore, rejected under the same rationale.
Regarding Claim 18, Peterson teaches the claim limitations as noted above.
Claim 18 further recites limitations: further comprising: calculating a statistical value of the pixel values of the first region, wherein the guiding catheter is determined to be present in each of the first images when the statistical value is less than or equal to a threshold. These limitations are present in claim 7 and is therefore, rejected under the same rationale.
Regarding Claim 19, Peterson teaches the claim limitations as noted above.
Claim 19 further recites limitations: further comprising: setting the threshold based on distribution of the pixel values of the first region. These limitations are present in claim 8 and is therefore, rejected under the same rationale.
Regarding Claim 20, Peterson teaches: A non-transitory computer readable storage medium storing a program causing a computer to execute a method for performing intravascular imaging using an imaging catheter that includes a probe and is insertable into a vessel through a guiding catheter (“The data collection probe 10 can include an imaging catheter 11 and an optical fiber 15.” [0042]; “The distance measurements collected using the probe 10 can be processed to generate frames of image data such as cross-sectional views or longitudinal views (L-mode views) of the blood vessel.” [0044]; “The computer program may be fixed in any form (e.g., source code form, computer executable form, or an intermediate form) either permanently or transitorily in a tangible storage medium, such as a semiconductor memory device (e.g., a RAM, ROM, PROM, EEPROM, or Flash-Programmable RAM), a magnetic memory device (e.g., a diskette or fixed disk), an optical memory device (e.g., a CD-ROM), a PC card (e.g., PCMCIA card), or other memory device.” [0092]), the method comprising:
acquiring cross-sectional images of the vessel that are taken through the imaging catheter (“…guide catheter data is acquired one scan line at a time and stored in memory in communication with one or more computing devices...a given scan line can include a portion of the guide catheter and identified as a point or frame or scan line or a set thereof that includes the start of the guide catheter in the vessel or are otherwise within the guide catheter. ” [0053]);
in each of first images of the acquired images, determining a first region in which the guiding catheter is potentially present(“The probe is introduced or delivered at a desired location in the vessel 5 using a guide catheter GC…As shown in FIG. 1B, which shows a zoomed in view of the GC and probe 10, the imaging catheter 11 and probe 10 pulls back within the GC and can image through the wall of the GC. Detecting the GC in the resultant images is desirable because the GC can include structures that generate shadows which can cause it to appear as a stent or otherwise be misinterpreted by software imaging processing modules such as a stent detection or shadow detection software module.” [0042]. See Fig. 1B and 2A);
based on pixel values of the first region, determining whether the guiding catheter is present in each of the first images (“…the image processing software can identify various points, frames, pairs of points within each frame. In one embodiment, the software module can operate open or otherwise transform the previously generated binary mask representation to identify start stop pairs. These start stop pairs can refer to the start and stop of runs of a set of pixels in the binary image of the lumen.” [0072]; “The method can include performing a circle fit or chord selection on per frame basis and identify deviation and transitions therein Step A5. If a GC is present, it will be detected in set of consistent circle or chord values Step A6.” [0084]. See Fig. 10);
determining second images of the acquired images in which the guiding catheter is not present based on the determination of whether the guiding catheter is present in each of the first images (“…GC results in certain steps or downstream image processing being performed with GC containing frames excluded. In other methods, the GC frames are not excluded…the method excludes frames that include detected GC from subsequent processing Step A7...the method excludes frames that include detected GC from being displayed Step A8 such as on a cath lab device or system or other devices or displays.” [0084]. See Fig. 10), and
generating diagnostic information about the vessel using the second images (“One intravascular data has been collected relative to a blood vessel the data can be played back as a series of frames, cross-sectional views, longitudinal views, and other parameters generated by the measurements obtained from the blood vessel such as lumen diameters, side branch locations, and various other measured or detected features and information of interest.” [0038];” These data sets can be used to identify blood vessel characteristics such as lumen area and diameter, image the vessel, and identify catheters disposed in the vessel as described herein…The images generated and subsequent image processing to detect blood vessel features can have errors and artifacts introduced in them if frames containing the guide catheter are treated as images of the blood vessel. As a result, frames that include that guide catheter are identified in one embodiment. In one embodiment, the display of the guide catheter is included as part of the information displayed with regard to the image frames of the pullback. In one embodiment, once the guide catheter is identified it is excluded from subsequent image processing and/or display in one embodiment.” [0043]).
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.
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of Ramakrishna et. al. (U.S. 20170215837, August 3, 2017)(hereinafter, “Ramakrishna”).
Regarding Claim 9, Peterson teaches the claim limitations as noted above.
Peterson furth teaches: wherein the processor is configured to: based on pixel values of the first region in one of the first images, determine that a guiding catheter candidate is present in said one of the first images, determine that the guiding catheter is present in said one of the first images when a guiding catheter candidate is determined to be present in another of the first images that is on a proximal side of said one of the first images (“FIG. 2B shows a schematic representation of a similar view. The guide catheter is shown on the right or proximal side of the image. The lumen without the guide catheter and the imaging catheter or intravascular data collection probe is shown on the left or the distal side of the figure.” [0057];“The method can include performing a circle fit or chord selection on per frame basis and identify deviation and transitions therein Step A5. If a GC is present, it will be detected in set of consistent circle or chord values Step A6…GC results in certain steps or downstream image processing being performed with GC containing frames excluded. In other methods, the GC frames are not excluded…the method excludes frames that include detected GC from subsequent processing Step A7...the method excludes frames that include detected GC from being displayed Step A8 such as on a cath lab device or system or other devices or displays.” [0084]. See Fig. 10),
with regards to limitation, and determine that a calcified plaque is present when the guiding catheter candidate is determined not to be present in said another of the first images, Peterson further teaches: “The probe is introduced or delivered at a desired location in the vessel 5 using a guide catheter GC…As shown in FIG. 1B, which shows a zoomed in view of the GC and probe 10, the imaging catheter 11 and probe 10 pulls back within the GC and can image through the wall of the GC. Detecting the GC in the resultant images is desirable because the GC can include structures that generate shadows which can cause it to appear as a stent or otherwise be misinterpreted by software imaging processing modules such as a stent detection or shadow detection software module.” [0042]; “The software modules can include for example a lumen detection module, a stent detection module, and a side branch detection module. In one embodiment, GC detection is performed prior to stent and side branch detection. The software modules or programs 44 can include an image data processing pipeline or component modules thereof and one or more graphical user interfaces (GUI). An exemplary image processing pipeline 50 for transforming collected OCT data into two dimensional and three dimensional views of blood vessels and stents is depicted in FIG. 3.” [0049].
Peterson does not explicitly state calcified plaque determination is present.
Ramakrishna in the field of intravascular catheter systems teaches: “This may allow the physician to determine the age of the occlusion, how hard or soft the occlusion is, how organized the occlusion is and/or is there is any underlying plaque. For example, an acute thrombus (e.g. recent thrombus) may provide a soft sound in contrast to a chronic thrombus which may provide a hard sound when the tip 20 is tapped against the occlusion 26. The presence of underlying plaque may also vary the frequency and/or amplitude of the sound waves thus allowing a physician to further characterize the occlusion. For example, an occlusion formed of an acute thrombus may provide a first sound waveform, an occlusion formed of an acute thrombus with underlying plaque may provide a second waveform, an occlusion formed of a chronic thrombus may provide a third waveform, and an occlusion formed of a chronic thrombus with underlying plaque may provide a fourth waveform. Each of these waveforms may be different from one another such that the occlusion 26 may be characterized.” [0060].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Peterson to include determination of calcified plaque is present as taught in Ramakrishna “… to determine the age and/or type of lesion and determine an appropriate treatment.” (Hosmane, [0060]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et. al. U.S. 20210282642 teaches an multimodal imaging catheter system for early detection of plaque lesion.
Emo U.S. 20190021598 teaches a cardiovascular catheter system for diagnosis and stent analysis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMAL FARAG whose telephone number is (571)270-3432. The examiner can normally be reached 8:30 - 5:30 M-F.
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798
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