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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/29/2026 has been entered.
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 01/29/2026. Claims 1-9 and 11-19 are pending. Claims 18 and 19 are newly added. Claims 1-9 and 11-19 are rejected under 35 U.S.C. 103 for the reasons stated in the Response to Arguments and 35 U.S.C. 103 sections below.
Response to Arguments
Applicant’s arguments, see Remarks page 6-7, filed 01/29/2026, with respect to the rejection of the claims under 35 U.S.C. 102 have been fully considered and are persuasive.
Regarding claim 1, the Applicant has amended the claim to include: “determine, based on the plurality of intravascular images, a stent expansion percentage, wherein the stent expansion percentage comprises a numerical value between 0% and 100%, wherein the stent expansion percentage is associated with the stent as a whole and not an individual stent strut; determine, based on the plurality of intravascular images, a minimum stent area (MSA) along a length of the vessel; and generate a visualization based on the plurality of intravascular images, wherein the visualization comprises: a longitudinal view of the blood vessel; a depiction of the stent in the longitudinal view; the numerical value of the stent expansion percentage; an indicator marking a location of the MSA in the longitudinal view of the blood vessel; and a numerical value of the MSA”.
The Applicant argues that Ambwani does not disclose or suggest the above limitations and therefore Ambwani does not disclose or suggest each and every feature with respect to claim 1.
The examiner respectfully acknowledges that Ambwani does not teach the above limitations, particularly with respect to the stent expansion percentage. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kunio et al. US 2019/0102906 A1 “Kunio” as discussed in the 35 U.S.C. 103 section below.
Applicant’s arguments, see Remarks page 9-11, filed 10/09/2025, with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered and are not persuasive with respect to claims 3 and 4 and are persuasive with respect to claim 11.
Regarding claims 3 and 4, these claims depend from and add additional features to amended independent claim 1. The applicant argues that Ambwani does not disclose or suggest all of the features of claim 1 and that Kunio does not affect this deficiency. Thus, the Applicant contends that Ambwani and Kunio, even when combined, do not disclose or suggest all of the features of claim 1, and therefore, claims 3 and 4.
The examiner respectfully disagrees and asserts that Kunio teaches the amended limitations of claim 1 for the reasons stated above. Additionally, due to their dependence on claim 1, claims 3 and 4 are subject to the new ground(s) of rejection in view of Kunio. Furthermore, the examiner respectfully asserts that the combination of Ambwani and Kunio teaches the limitations of claims 3 and 4 for the reasons stated in the 35 U.S.C. 103 section below.
Thus, the examiner respectfully refers the Applicant to the rejections of claims 3 and 4 as stated in the 35 U.S.C. 103 section below.
Regarding claim 11, this claim depends from and adds additional features to amended independent claim 1. The Applicant argues that Ambwani does not disclose or suggest all of the features of claim 1 and that Gopinath does not affect this deficiency. Thus, the Applicant contends that Ambwani and Gopinath, even when combined, do not disclose or suggest all of the features of claim 1, and therefore, claim 11 as well.
The examiner respectfully notes that due to its dependence on claim 1, claim 11 is subject to the new ground(s) of rejection made in view of Kunio US that Kunio et al. US 2019/0102906 A1 “Kunio” for the reasons stated above. Furthermore, the examiner respectfully asserts that Gopinath teaches the limitations of claim 11 for the reasons stated in the 35 U.S.C. 103 section below.
Thus, the examiner notes that claim 11 is subject to the new ground(s) of rejection made in view of Kunio et al. US 2019/0102906 A1 “Kunio” for the reasons stated in the 35 U.S.C. 103 section below.
Regarding newly added claims 18-19, the examiner respectfully refers the Applicant to the 35 U.S.C. 103 section below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-9, and 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable by Ambwani et al. US 2016/0335766 A1 “Ambwani” in view Kunio et al. US 2019/0102906 A1 “Kunio”.
Regarding claim 1, Ambwani teaches “An apparatus, comprising:” (“FIG. 1 shows a system 3 which includes various data collection subsystems suitable for collecting data or detecting a feature of or sensing a condition of or otherwise diagnosing a subject 4” [0083]. Therefore, the system 3 shown in FIG. 1 represents an apparatus.);
“an intravascular imaging catheter configured to be positioned within a blood vessel of a patient” (“As shown in this particular example, the region of interest 25 is a subset of the vascular or peripherally vascular system such as a particular blood vessel. This can be imaged using OCT. A catheter-based data collection probe 30 is introduced into the subject 4 and is disposed in the lumen of the particular blood vessel, such as for example, a coronary artery. The probe 30 can be a variety of types of data collection probes such as for example an OCT probe, an FFR probe, an IVUS probe, a probe combining features of two or more of the foregoing, and other probes suitable for imaging within a blood vessel” [0087]. Therefore, the apparatus includes an intravascular imaging catheter (i.e. catheter-based data collection probe 30) configured to be positioned within a blood vessel of a patient (i.e. subject 4).).; and
“a processor configured for communication with the intravascular imaging catheter, wherein the processor is configured to:” (“In one embodiment, the server 50 includes one or more co-registration software modules 60 that are stored in memory 70 and are executed by processor 80. The server 50 can include other typical components for a processor-based computing server. Or more databases such as database 90 can be configured to receive image data generated, parameters of the subject, and other information generated, received by or transferred to the database 90 by one or more of the systems, devices or components shown in FIG. 1” [0094]; “Embodiments of the disclosure may be embodied in many different forms, including, but in no way limited to, computer program logic for use with a processor […] In a typical embodiment of the present disclosure, some or all of the processing of the data collected using an OCT probe and the processor-based system or used to generate a control signal or initiate a user interface command is implemented as a set of computer program instructions that is converted into a computer executable form, stored as such in a computer readable medium, and executed by a microprocessor under the control of an operating system” [0166]. Since the server 50 includes one or more co-registration software modules 60 which are executed by processor 80 which receives image data generated by one or more of the systems, devices or components shown in FIG. 1 (i.e. the probe 30), the apparatus includes a processor configured for communication with the intravascular imaging catheter (i.e. probe 30) and configured to carry out specific functions.);
“control the intravascular imaging catheter to obtain a plurality of intravascular images of the blood vessel and a stent positioned within the blood vessel to provide treatment to a blockage of the blood vessel, the stent comprising a plurality of stent struts” (“The method can include the steps of receiving optical coherence tomography data for a stented blood vessel, the optical coherence tomography data comprising a plurality of image frames […] analyzing the plurality of image frames to identify stent struts on a per frame basis” [0031]; “In one embodiment, the processor is programmed to store, using an intravascular imaging system, one or more intravascular image datasets of the blood vessel, each intravascular dataset comprising a plurality of frames” [0041]; “In one embodiment, stent struts 50 are detected in OCT image data using known techniques and an estimate of the centroid 54 of the vessel wall is also pre-computed by known methods and used by the algorithm” [0141]. Therefore, the processor is configured to control the intravascular imaging catheter (i.e. probe 30) to obtain a plurality of intravascular images (i.e. OCT frames) of the blood vessel and a stent positioned within the blood vessel (i.e. stented blood vessel) to provide treatment to a blockage of the blood vessel, the stent comprising a plurality of stent struts (i.e. stent structs 50, see FIG. 15A).); […]
“generate a visualization based on the plurality of intravascular images, wherein the visualization comprises:” (“The system can also display a user interface for display of intravascular information such as data relating to stent malapposition in a longitudinal mode on a per stent strut basis or as a bar having regions corresponding to stent, no stent, or stent apposition levels of potential interest for one or more stents in a vessel” [0012]; “FIGS. 2A-2E show additional details relating to user interface displays and intravascular data collection systems and indicators suitable therewith and angiography systems for diagnostic processes including stent delivery planning in accordance with an illustrative embodiment of the disclosure” [0050]. As shown in FIG. 2C, for example, the display includes multiple different views of the blood vessel being examined, including a longitudinal view of the blood vessel. Therefore, the processor is configured to generate a visualization based on the plurality of intravascular images (see [0031], [0041]).);
“a longitudinal view of the blood vessel” (See [0012]; “FIG. 2A shows four panels with the top right panel including an angiography display with various indicators including a first user selected position US1, a second user selected position US2, and an active frame AF. These indicators are also shown in the bottom L-mode or longitudinal panel with US1 and US2 corresponding to the vertical lines shown and the active frame AF corresponding to the vertical line in between them” [0070]. This bottom L-mode/longitudinal panel is also represented in FIGS. 2C and 3A. Therefore, the visualization generated by the processor includes a longitudinal view of the blood vessel.);
“a depiction of the stent in the longitudinal view” (“FIG. 2C shows an apposition bar/indicator bar 111 as an indicator with regions R1 to R7 which are shown in the angiography view in the top right which is shown in further detail in FIG. 2D. The top right panel shows R3 shows an area of apposition that is beyond a threshold of interest. In the L-mode, the stent struts are coded with an indicia such as symbols or color” [0071]; “This these and other indicators, the images and indicators can help as a tool to guide stent delivery based on the data shown in FIGS. 2C and 2D. The indicators can also show when a stent needs to be inflated in more detail given color coded or otherwise coded stent strut indicia in a cross-sectional or longitudinal view. In FIG. 2E, regions of a first stent 222a and a second stent 222b are shown by the apposition bar 111. A region of lumen or no stent 224 and malapposition region 223 are also shown” [0073]; “FIG. 3A shows an interface with a longitudinal view or L-mode showing an apposition bar above stent strut indicators coded based on apposition thresholds. The indicator bar 111 is shown in the middle of the GUI with no stent 224 regions and malapposition regions 223 shown” [0074].
As shown in FIG. 2C, the stent is present within the longitudinal (i.e. bottom) view of the blood vessel and includes indicators which are colored coded to correspond with the apposition bar (i.e. representative of misalignment between stent and wall of the blood vessel). Therefore, the visualization generated by the processor includes a depiction of the stent in the longitudinal view (see FIG. 2C).); […] and
“output, to a display in communication with the processor, the visualization for a user to assess a deployment of the stent” (See [0012]; FIG. 2C; and “The indicator bar 111 can be used for stent planning and review and to indicate regions in an intravascular image where there is apposition or another metric relative to a stent strut” [0071]. Therefore, the processor is configured to output, to a display in communication with the processor, the visualization for a user to assess a deployment of the stent (i.e. stent planning and review via the apposition bar 111, see FIG. 2C).).
Ambwani does not teach “determine, based on the plurality of intravascular images, a stent expansion percentage, wherein the stent expansion percentage comprises a numerical value between 0% and 100%, wherein the stent expansion percentage is associated with the stent as a whole and not an individual stent strut”; “determine, based on the plurality of intravascular images, a minimum stent area (MSA) along a length of the vessel”; or that the visualization comprises: “[…] the numerical value of the stent expansion percentage; an indicator marking a location of the MSA in the longitudinal view of the blood vessel; and a numerical value of the MSA”.
Kunio is within the same field of endeavor as the claimed invention because it involves a system and method for processing an intravascular image including a plurality of image frames acquired during a pullback of an imaging catheter inserted into a vessel and includes a step of obtaining positions of sent struts detected in the intravascular image (see [Abstract]).
Kunio teaches a processor which is configured to: “determine, based on the plurality of intravascular images, a stent expansion percentage, wherein the stent expansion percentage comprises a numerical value between 0% and 100%, wherein the stent expansion percentage is associated with the stent as a whole and not an individual stent strut” (“Assuming that the frame number in Group G.sub.S′ starts G.sub.S′.sub.-1-th and n frames are in Group G.sub.S′. From G.sub.S′.sub.-1-th, stent area is measured and stent expansion is evaluated by comparing the stent area (A.sub.S) and the reference area (A.sub.R).
Expansion [%]=(A.sub.S/A.sub.R)×100” [0060]; “Once stent expansion evaluation is completed, the results may be displayed on a monitor. Referring now to FIG. 13A, the stent expansion value is shown as a graph 180 underneath the longitudinal view 182, which is created from the OCT pullback. The longitudinal view 182 of the stented segment includes the lumen borders 181 as well as the stent-struts 183 that form the stented region. In this case, a user can interpret the stent expansion value along a range of the stented segment in the longitudinal direction. In the graph shown in FIG. 13A, the user may recognize that the area in the graph where the stent expansion value falls below 80% is an area where stent underexpansion may exist by way of example” [0064]; “In FIG. 13B, the stent expansion is shown by an indicator 186, which may enable a user to more readily interpret the level of stent expansion. For example, in step S120, the CPU 70 generates a stent expansion indicator. The indicator 186 could be two or three levels and the range of each level may be preset or modified by a user. The indicator in FIG. 13B is a three level indicator. Each level associated with the indicator refers to a range of stent expansion values. For example, a first level may refer to a range of stent expansion values that are 90% or greater which may correspond to good stent expansion. A second level may refer to a range of stent expansion values that are between 80% and 90% which may refer to sufficient stent expansion. A third level may refer to a range of stent expansion values that are below 80% which may refer to insufficient stent expansion or stent underexpansion. The indicator 186 may be color coded for example, where a green color represents a first level, yellow color represents a second level and red color represents a third level” [0065].
Therefore, in order to generate the stent expansion value graph shown in FIG. 13A and the indicator 186 in FIG. 13B, the processor had to first determine, based on the plurality of intravascular image (i.e. acquired during the OCT pullback), a stent expansion percentage , wherein the stent expansion percentage comprises a numerical value between 0% and 100% (i.e. 90% or greater, 80%-90%, 80% or less), wherein the stent expansion score is associated with the stent as a whole (i.e. all of the stent struts) and not an individual stent strut.);
“determine, based on the plurality of intravascular images, a minimum stent area (MSA) along a length of the vessel” (See [0060], [0064], [0065] above. As shown in FIG. 13A, for example, the minimum stent area would correspond to the position on the graph 180 where the stent expansion score dips below 80%. Therefore, the processor is configured to determine, based on the plurality of intravascular images (i.e. obtained during the OCT pullback), a minimum stent area (i.e. minimum point on the stent expansion graph shown in FIG. 13A) (MSA) along a length of the vessel.); […]
the visualization comprises: “the numerical value of the stent expansion percentage” (See [0064] and [0065]. Since the stent expansion value is displayed on a graph beneath the longitudinal view 181 (i.e. FIG. 13A) or as an indicator 186 above the longitudinal view 181 (i.e. FIG. 13B), the visualization comprises the numerical value of the stent expansion percentage.);
“an indicator marking a location of the MSA in the longitudinal view of the blood vessel; and a numerical value of the MSA” (See [0065] above. Since the indicator 186 displays the stent expansion in a color coded manner, wherein red indicates the third level of stent expansion (i.e. stent expansion values below 80%), the visualization includes an indicator marking a location of the MSA in the longitudinal view of the blood vessel, and a numerical value of the MSA (i.e. the color corresponding to the numerical value in the key shown in FIG. 13B).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Ambwani such that the processor is configured to determine, based on the plurality of intravascular images, a stent expansion percentage, wherein the stent expansion percentage comprises a numerical value between 0% and 100%, wherein the stent expansion percentage is associated with the stent as a whole and not an individual stent strut, and determine, based on the plurality of intravascular images, a minimum stent area (MSA) along a length of the vessel) and the visualization comprises the numerical value of the stent expansion percentage, an indicator marking a location of the MSA in the longitudinal view of the blood vessel, and a numerical value of the MSA as disclosed in Kunio in order to allow a physician/cardiologist to easily assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004]). Calculating a stent expansion percentage/minimum stent area are two of a finite number of techniques which can be used to determine whether to intervene during a stenting procedure (see Kunio: [0004]) with a reasonable expectation of success. Thus, modifying the apparatus of Ambwani such that the processor is configured to determine, based on the plurality of intravascular images, a stent expansion percentage, wherein the stent expansion percentage comprises a numerical value between 0% and 100%, wherein the stent expansion percentage is associated with the stent as a whole and not an individual stent strut, and determine, based on the plurality of intravascular images, a minimum stent area (MSA) along a length of the vessel) and the visualization comprises the numerical value of the stent expansion percentage, an indicator marking a location of the MSA in the longitudinal view of the blood vessel, and a numerical value of the MSA as disclosed in Kunio would yield the predictable result of allowing a physician to easily assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004]).
Regarding claim 2, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ambwani further teaches “wherein the visualization further comprises: an intravascular image of the plurality of intravascular images” (See FIG. 2C and [0071] as discussed in claim 1 above and “With regard to FIG. 2C, the two user selected points of interest are shown as U1 and U2. R3 corresponds to a region of malapposition of interest” [0072]. In this case, the top right panel in FIG. 2C, is an intravascular image (i.e. cross-sectional/transverse image) of the plurality of intravascular images (see [0031], [0041]) at region R3, which is an area of apposition that is beyond a threshold of interest. Thus, the top right panel highlights an area of the intravascular image identifying the location where the stent is misaligned with the wall of the blood vessel. Therefore, the visualization further comprises: an intravascular image of the plurality of intravascular images (see top right panel in FIG. 2C).).
Regarding claim 3, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above and Kunio further teaches “wherein the intravascular image comprises a cross-sectional view at the location of the MSA” (“Stent underexpansion is a scenario where the stent is well-apposed, but not well-expanded. FIG. 4C is an image frame illustrating a cross-sectional view of the lumen 100 and stent-struts 102 at the position 108 shown in FIG. 4A. The image frame at position 108 is an example of stent underexpansion” [0043]. In this case, stent underexpansion is indicative of a stent expansion value (i.e. percentage) which is 80% or below, wherein the stent expansion value is calculated by comparing the stent area (AS) and the reference area (AR) (see [0060]). Therefore, FIG. 4C represents an intravascular image which comprises a cross-sectional view at the location of the MSA (i.e. position 108 shown in FIG. 4A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Ambwani such that the intravascular image displayed comprises a cross-sectional view at the location of the MSA as disclosed in Kunio in order to allow a physician to easily view and assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004]). Displaying a cross-sectional intravascular image at the location of the MSA is one of a finite number of techniques which can be used to indicate where areas of stent underexpansion are present with a reasonable expectation of success. Thus, modifying the apparatus of Ambwani such that the intravascular image displayed comprises a cross-sectional view at the location of the MSA as disclosed in Kunio would yield the predictable result of allowing a physician to easily view and assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004]).
Regarding claim 4, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above and Ambwani further teaches “wherein the visualization further comprises a numerical value of a minimum stent diameter” (“FIG. 2C shows an apposition bar/indicator bar 111 as an indicator with regions R1 to R7 which are shown in the angiography view in the top right which is shown in further detail in FIG. 2D. The top right panel shows R3 shows an area of apposition that is beyond a threshold of interest. In the L-mode, the stent struts are coded with an indicia such as symbols or color. The regions of apposition of interest in the apposition bar remain on display even if the dataset is rotated in order to bring the important areas to the attention of a user for stent planning and patient diagnosis. In this sense, indicators can be persistent to direct a user's focus during a planning or other procedure” [0071]. As shown in FIG. 2C, right above the apposition bar/indicator bar 111 is a symbol for the diameter of the stent (i.e. in mm) within the angiography view. FIG. 2C also includes first and second user selected positions US1 and US2 with an active frame AF between them. At first user selected position US1, the diameter of the stent is 3.35 mm, while at the second user selected position US2, the diameter of the stent is 3.31 mm. At the active frame AF position, the diameter of the stent is 3.13 mm. Therefore, since the diameter of the stent at the AF position is less than that of both the user selected position US1 and user selected position US2, the diameter at the AF position represents a minimum stent diameter. Therefore, the visualization comprises a numerical value of a minimum stent diameter.).
Regarding claim 5, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ambwani further teaches “wherein the visualization further comprises at least one of: an indicator marking a proximal reference on the longitudinal view; or an indicator marking a distal reference on the longitudinal view” (See [0071] as discussed in claim 1 and “R5 is the gap in between them […] R1 and R7 are distal and proximal areas in which no stent is present and correspond to vessel lumen” [0072]. As shown in FIG. 2C, the regions R1, R5 and R7 are present on the longitudinal image (i.e. bottom image). In this case R5 is distal to the region R1. Therefore, the visualization further comprises at least one of: an indicator marking a proximal reference on the longitudinal view (i.e. R1) or an indicator marking a distal reference on the longitudinal view (i.e. R5 or R7).).
Regarding claim 6, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ambwani further teaches “wherein the visualization further comprises at least one of: a numerical value of a distal measurement based on the plurality of intravascular images; and a numerical value of a proximal measurement based on the plurality of intravascular images” (See longitudinal (i.e. bottom) image in FIG. 2A and FIG. 2C and “FIG. 2A shows four panels with the top right panel including an angiography display with various indicators including a first user selected position US1, a second user selected position US2 and an active frame AF. […] The middle panel shows the values of the US1 and US2 positions in mm as vessel positions and a calculated MLA” [0070]. As shown in FIG. 2A and FIG. 2C, the diameter of the blood vessel is displayed in the middle panel at the user selected positions US1 and US2. In this case, since the user can select the locations of the positions US1 and US2, the user can set the proximal reference and the distal reference as the locations for US1 and US2, (i.e. the positions from which the diameter of the blood vessel is determined). Therefore, the visualization further comprises at least one of: a numerical value (i.e. diameter) associated with the blood vessel at the proximal reference (i.e. US1 positioned at R1, for example) or a numerical value associated with the blood vessel at the distal reference (i.e. US2 positioned at R5 or R7, for example).).
Regarding claim 7, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 5 above, and Ambwani further teaches “wherein at least one of: in the visualization, the indicator marking the proximal reference and a proximal end of the depiction of the stent are proximate to one another along the longitudinal view; or in the visualization the indicator marking the distal reference and a distal end of the depiction of the stent are proximate to one another along the longitudinal view” (See R1 and R2 in FIG. 2C. In this case, the region R1 represents the proximal reference and the region R2 represents the proximal end of the depiction of the stent. Thus, in the visualization, the indicator marking the proximal reference (i.e. R1 and a proximal end of the depiction of the stent (i.e. R2) are proximate to one another along the longitudinal view; or in the visualization, the indicator marking the distal reference (i.e. R5) and a distal end of the depiction of the stent (i.e. R4) are proximate to one another along the longitudinal view.).
Regarding claim 8, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 5 above, and Ambwani further teaches “wherein the visualization further comprises: an indicator marking a proximal end of the stent on the longitudinal view; and an indicator marking a distal end of the stent on the longitudinal view” (See FIGS. 2C and 2E and “R3 corresponds to a region of malapposition of interest. R2 corresponds to a first stent and R6 corresponds to a second stent” [0072]. In this case, the region R3 represents a malapposition of the first stent (i.e. R2), with the region R4 representing the rest of the first stent (see FIG. 2E). Therefore, the visualization further comprises an indicator marking a proximal end of the stent on the longitudinal view (i.e. R2) and an indicator marking a distal end of the stent on the longitudinal view (i.e. R4).).
Regarding claim 12, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ambwani further teaches "wherein a first portion of the depiction of the stent comprises a different visual appearance than a second portion of the depiction of the stent, wherein the different visual appearance is representative of a location where the stent is misaligned with a wall of the blood vessel” (See [0071]; [0073]; and [0074] as discussed in claim 1 above. As shown in FIG. 2C, the stent is present within the longitudinal (i.e. bottom) view of the blood vessel and includes indicators which are colored coded to correspond with the apposition bar (i.e. representative of misalignment between stent and wall of the blood vessel). Therefore, the visualization generated by the processor includes a depiction of the stent in the longitudinal view (see FIG. 2C), wherein a first portion of the depiction of the stent comprises a different visual appearance than a second portion of the depiction of the stent (i.e. different colored regions R1-R7 in FIG. 2C), wherein the different visual appearance is representative of a location where the stent is misaligned with a wall of the blood vessel (see apposition bar 111).).
Regarding claim 13, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kunio further teaches "wherein the processor is configured to: perform a comparison between the stent expansion percentage and a threshold” (See [0064], [0065] as discussed in claim 1 above and “A user viewing the graph is able to determine where the stent expansion value falls below a certain threshold such as 80% for example. The user may also determine where stent expansion is sufficient based on viewing the graph” [0063]; In this case, in order to plot the stent expansion on the graph shown in FIG. 13A, the graph including thresholds at 100% and 80%, the processor had to perform a comparison between the stent expansion percentage and a threshold. Furthermore, in order to display the indicator 186 with different colors/characteristics (i.e. dotted lines (i.e. green), solid lines (i.e. red), semisolid lines (i.e. yellow), corresponding to the thresholds 90% or greater; 80% or less, and 80-90%, respectively, the processor must have been configured to perform a comparison between the stent expansion percentage and a threshold.);
“modify the visualization based on the comparison” (See [0065]. Since the indicator 186 may be color coded according to the stent expansion values, wherein 90% or greater is represented in green, 80-90% is represented in yellow and 80% or less is represented in red, the processor must be configured to modify the visualization based on the comparison.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Ambwani such that the processor is configured to perform a comparison between the stent expansion percentage and a threshold and modify the visualization based on the comparison as disclosed in Kunio in order to allow a physician to easily view and assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004]). Comparing the stent expansion percentage (i.e. stent expansion value) to a threshold one of a finite number of techniques which can be used to indicate where areas of stent underexpansion are present with a reasonable expectation of success. Thus, modifying the apparatus of Ambwani such that processor is configured to perform a comparison between the stent expansion percentage and a threshold and modify the visualization based on the comparison as disclosed in Kunio would yield the predictable result of allowing a physician to easily view and assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004]).
Regarding claim 14, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kunio further teaches "wherein the stent expansion percentage is configured to represent varying degrees of expansion” (See Kunio: [0065] as discussed with respect to claim 1 above. Therefore, since the indicator 186 is color coded to represent different values of stent expansion, the stent expansion percentage is configured to represent varying degrees of expansion.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Ambwani such that the stent expansion percentage is configured to represent varying degrees of expansion (i.e. see indicator 186 in FIG. 13B) in order to allow a physician/cardiologist to easily assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004]).
Regarding claim 9, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 13 above, and Ambwani further teaches “wherein, to modify the visualization, the processor is configured to include a recommendation for the user to modify an expansion of the stent” (“One or more indicators such as longitudinal indicators, as a non-limiting example, can be generated in response to stent detection processing and lumen boundary detection and displayed relative to angiography, OCT, and IVUS images. These can be viewed by a user to plan stent delivery and inflate or adjust a stent delivery by reviewing a co-registered OCT image and an angiography image with relevant indicators of interest” [0013]; “Given the levels and location of malapposition the user can refer to OCT and annotated angiography to further expand or move a stent as part of delivery planning” [0082]. Therefore, since one or more indicators (i.e. not limited) are generated and displayed relative to images such that a user can plan/adjust stent delivery and inflate (i.e. expand) or adjust the stent, to modify the visualization, the processor is configured to include a recommendation for the user to modify an expansion of the stent in response to the comparison indicating that the stent is misaligned with the wall of the blood vessel.).
Regarding claim 15, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 14 above, and Kunio further teaches "wherein the numerical value of 0% for the stent expansion percentage corresponds to the stent being completely unexpanded and the numerical value of 100% for the stent expansion percentage corresponds to the stent being completely expanded” (See Kunio: [0064] and [0065] as discussed with respect to claim 1 above. In this case, when the stent expansion score is 90% or greater (i.e. 100%, for example), this means that the stent is properly expanded (i.e. good stent expansion). Furthermore, when the stent expansion score is below 80% (i.e. 0%, for example), this means that the stent is insufficiently expanded or under expanded (i.e. poor stent expansion). Thus, the numerical value of 0% for stent expansion percentage corresponds to the stent being completely unexpanded (i.e. poor stent expansion) and the numerical value of 100% for the stent expansion percentage corresponds to the stent being completely expanded.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Ambwani such that the numerical value of 0% for the stent expansion percentage corresponds to the stent being completely unexpanded and the numerical value of 100% for the stent expansion percentage corresponds to the stent being completely expanded as disclosed in Kunio in order to allow a physician/cardiologist to easily assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004]).
Regarding claim 16, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kunio further teaches "wherein the stent expansion percentage is distinct from a measurement in the plurality of intravascular images” (“Subsequently in step S480, for the selected first OCT image frame, the distance between the lumen edge and stent-strut detected in first OCT image frame is measured. In step S490, stent apposition is evaluated. The stent apposition is evaluated by comparing the measured distance between the lumen edge and stent-strut to the stent-strut width that is obtained from the stent information. […] The process repeats until each OCT image frame selected in step S460 is evaluated and a stent apposition value is obtained” [0066]. In this case, the distance between the lumen edge and stent-strut represents a measurement which is used to evaluate stent apposition, which is distinct from the stent expansion percentage (i.e. stent expansion value). Thus, the stent expansion percentage is distinct from a measurement (i.e. corresponding to the stent apposition value) in the plurality of intravascular images (i.e. OCT image frames).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Ambwani such that the stent expansion percentage is distinct from a measurement (i.e. of stent apposition) in the plurality of intravascular images as disclosed in Kunio in order to allow a physician to better assess the characteristics of the stent when performing a stenting procedure. The stent apposition value is one of a finite number of measurements which is distinct from the stent expansion percentage (i.e. value) which can be used to assess the characteristics of a stent with a reasonable expectation of success. Thus, modifying the apparatus of Ambwani such that the stent expansion percentage is distinct from a measurement (i.e. of stent apposition) in the plurality of intravascular images as disclosed in Kunio would yield the predictable result of allowing a physician to better assess the characteristics of the stent when performing a stenting procedure.
Regarding claim 17, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kunio further teaches "wherein the stent expansion percentage is determined based on a plurality of factors comprising two or more of: the alignment information of the plurality of stent struts expansion at edges of the stent; one or more measurements in the plurality of intravascular images; or a positioning of the stent along the blood vessel” (See [0060] and [0064] as discussed with respect to claim 1 above. In this case, the positioning of the stent along the blood vessel (see lumen border 181 within FIG. 13A), determines whether the stent is properly expanded. Therefore, since the stent expansion value is calculated based on comparing the stent area (i.e. measurement) for multiple OCT images (i.e. included in the OCT pullback) to the reference area (see [0060]) and the positioning of the stent along the blood vessel determines whether the stent is properly expanded, the stent expansion percentage is determined based on a plurality of factors comprising: 1) one or more measurements (i.e. of stent area which is compared to reference area) in the plurality of intravascular images (i.e. OCT images) and 2) position of the stent along the blood vessel.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Ambwani such that the stent expansion percentage is determined based on a plurality of factors comprising: one or more measurements in the plurality of intravascular images; and a positioning of the stent along the blood vessel as disclosed in Kunio in order to allow a physician/cardiologist to easily assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004]). The stent expansion value in Kunio is determined based on stent area at the position(s) in which the stent is located along the blood vessel. Thus, modifying the apparatus of Ambwani such that the stent expansion percentage is determined based on a plurality of factors comprising: one or more measurements in the plurality of intravascular images; and a positioning of the stent along the blood vessel as disclosed in Kunio would yield the predictable result of allowing a physician/cardiologist to easily assess the expansion of the stent during the procedure such that they can intervene if the stent expansion value is low (i.e. only 70% or less) (see Kunio: [0004])
Regarding claim 18, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ambwani further teaches "wherein the visualization further comprises highlighting that identifies where the stent is misaligned with a wall of the blood vessel” (“See FIG. 2C and [0071] as discussed in claim 1 above and “With regard to FIG. 2C, the two user selected points of interest are shown as U1 and U2. R3 corresponds to a region of malapposition of interest” [0072]. In this case, the top right panel in FIG. 2C, is an intravascular image (i.e. cross-sectional/transverse image) of the plurality of intravascular images (see [0031], [0041]) at region R3, which is an area of apposition that is beyond a threshold of interest. Thus, the top right panel highlights an area of the intravascular image identifying the location where the stent is misaligned with the wall of the blood vessel. Therefore, the visualization further comprises: an intravascular image of the plurality of intravascular images (see top right panel in FIG. 2C) and a highlighted area on the intravascular image identifying the location where the stent is misaligned with the wall of the blood vessel).
Claim(s) 11 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ambwani et al. US 2016/0335766 A1 “Ambwani” and further in view of Kunio et al. US 2019/0102906 A1 “Kunio” as applied to claim 1 above, and further in view of Gopinath US 2016/0022208 A1 “Gopinath”.
Regarding claim 11, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 1 above. However, the combination does not teach “wherein the processor is configured to: output, to the display, a screen display comprising: a pre-stent plan option; and a post-stent check option; and when the post-stent check option is selected by the user: provide, on the display, a workflow for the user to use the intravascular imaging catheter to obtain the plurality of intravascular images of the blood vessel and the stent; and output the visualization to the display”.
Gopinath is within the same field of endeavor as the claimed invention because it involves computer-based methods, devices and systems suitable for pre-stent planning, stent planning and post-stent planning using one or more computing devices (see [Abstract]).
Gopinath further teaches “wherein the processor is configured to: output, to the display, a screen display comprising: a pre-stent plan option; and a post-stent check option” (“In one embodiment, the method includes generating and displaying a difference between the post-stent lumen profile and the pre-stent target profile or a value correlated with the difference on a per frame or per segment basis” [0013]; “FIG. 5 is a schematic diagram of the stent planning schematic diagram of FIG. 3 in the top portion of the figure, which provides the pre-stent target profile as an input to the post-stent comparative analysis in accordance with an illustrative embodiment of the disclosure” [0020]; “In one embodiment, a method generates one or more stent profiles, such as a target stent profile, that are configurable by a user during a pre-stent planning stage by selecting one or more reference frames” [0030]; “Pre-stent planning: Physician decides on the segment of blood vessel, with a lesion or other stenosis, to stent and the stent size using the stent planning tool which can include a user interface display such as shown in FIG. 3. The selection of the references specifies the range of stent sizes possible” [0065]; “Post-stent analysis: after the stent has been deployed, such as shown in the interface or display representation of FIG. 4, a new pullback is acquired, which collects intravascular data relative to the blood vessel and the newly deployed stent. As shown by the new pullback, in contrast with FIG. 3, in the second pullback shown in FIG. 4, two side branches have been blocked, SB1 and SB4, after stenting and only two were detected, SB2 and SB4. In one embodiment, the stent profile analysis software automatically identifies the stented region using the stent detection feature. The stented region's lumen profile LP is displayed with the target stent profile TSP overlaid as shown in FIG. 5” [0067].
In this case, in order for the pre-stent profile (i.e. top of FIG. 5) to be displayed with the post-stent lumen profile (i.e. bottom of FIG. 5), the processor must be configured to: output, to the display, a screen display comprising: a pre-stent plan option (i.e. pre-stent profile); and a post-stent check option (i.e. post-stent lumen profile).); and
“when the post-stent check option is selected by the user: provide, on the display, a workflow for the user to use the intravascular imaging catheter to obtain the plurality of intravascular images of the blood vessel and the stent; and output the visualization to the display” (See [0067] above and “FIG. 7 shows an exemplary process flow for performing a diagnostic evaluation relative to a deployed stent. In one embodiment, the method includes steps A to E or a subset thereof with one or more user selections from an intravascular imaging system” [0074]; “In one embodiment, Step C includes receiving a selection of a second reference relative to a representation of a segment of a blood vessel. In one embodiment, Step D includes generating a target stent profile using the first reference and the second reference. In one embodiment, Step E includes generating a blood vessel lumen profile after deployment of a stent in the blood vessel. In one embodiment, Step F includes comparing the target stent profile to one or more regions of the blood vessel lumen profile. In one embodiment, Step G includes displaying output including one or more differences from comparison” [0075]. Therefore, when the post-stent check option is selected by the user: provide, on the display, a workflow for the user to use the intravascular imaging catheter to obtain a plurality of intravascular images of the blood vessel and the stent; and output the visualization to the display.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Ambwani such that the processor is configured to output, to the display, a screen display comprising: a pre-stent plan option (i.e. pre-stent profile); and a post-stent check option (i.e. post-stent lumen profile); and when the post-stent check option is selected by the user: provide, on the display, a workflow (i.e. steps shown in Gopinath: FIG. 7) for the user to use the intravascular imaging catheter to obtain the plurality of intravascular images of the blood vessel and the stent; and output the visualization to the display (see FIG. 5) as disclosed in Gopinath in order to allow a user to effectively perform pre-stent and post-stent planning within a blood vessel.
Regarding claim 19, Ambwani in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 6 above, however the combination does not teach “wherein the distal measurement and the proximal measurement each comprise a diameter”.
Gopinath teaches “wherein the distal measurement and the proximal measurement each comprise a diameter” (“In one embodiment, the method includes the step of adjusting the shape includes stepping up the stent profile at each detected side branch if a distal reference diameter is less than the proximal reference diameter. In one embodiment, the method includes the step of adjusting the shape includes stepping down the stent profile at each detected side branch if a distal reference diameter is greater than the proximal reference diameter” [0013]. In order to adjust the stent profile, in this case, the distal reference diameter and the proximal reference diameter must be measured. Therefore, the distal measurement and the proximal measurement each comprise a diameter.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Ambwani in view of Kunio such that the distal measurement and the proximal measurement each comprise a diameter as disclosed in Gopinath in order to allow a physician to distinguish whether the stent profile needs to be adjusted based on the comparison between the distal and proximal diameters. Measuring the distal end proximal diameters of a stent is one of a finite number of techniques which can be used to evaluate whether the stent is expanded sufficiently with a reasonable expectation of success. Thus, modifying the apparatus of Ambwani in view of Kunio such that the distal measurement and the proximal measurement each comprise a diameter as disclosed in Gopinath would yield the predictable result of allowing a physician to distinguish whether the stent profile needs to be adjusted based on the comparison between the distal and proximal diameters.
Conclusion
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797