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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/18/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
[0003]: As written it reads “This may aid in assessing diseased vessels, such as an arteries and veins within the human body to determine the need for treatment, to optimize treatment, and/or to assess its effectiveness”. However, to correct the typo, “an” should be removed.
[0035]: As written it reads “The catheterization laboratory and control room may be used to perform any number of medical imaging procedures such as angiography, fluoroscopy, computed tompgraphy (CT) […] optical coherence tomography (OCT), computed tomography”. However, to correct the typo “tompgraphy” should be “tomography”. Additionally, the examiner would recommend removing the second instance of “computed tomography”.
[0057]: As written it reads “In some embodiments, the visualization may also a depiction of the plaque burden 852 along the lumen 120”. However, to be grammatically correct “be” should be added between “also” and “a”.
[0065]: As written it reads “The first transverse view 704 may show a may show a distal reference point on the stent (such as the distal edge of the stent), the second transverse view 706 may show a may show a proximal reference point on the stent (such as the proximal edge of the stent), and the third transverse view 708 may show a MLA within the stent”. However, to correct the typos, the underlined phrases “may show a” should be removed. Additionally, to be grammatically correct “a MLA” should be “an MLA”.
Appropriate correction is required.
Claim Objections
Claims 5 and 15 are objected to because of the following informalities:
Regarding claim 5, as written it reads “wherein the pre-stent longitudinal view comprises a MLA marker identifying a location of the blood vessel comprising the MLA, and wherein the post-stent longitudinal view comprises a MSA marker identifying a location of the blood vessel comprising the MSA”. However, in order to be grammatically correct “a MLA marker” should be “an MLA marker” and “a MSA marker” should be “an MSA marker”.
Regarding claim 15, as written it reads “further comprising the intravascular imaging catheter, wherein the intravascular imaging catheter is configured for intravascular ultrasound (IVUS) or optical coherence tomography (OCT)”. However, the examiner respectfully notes that claim 1 already discloses that the apparatus includes an intravascular imaging catheter. Therefore, the examiner notes that it seems redundant to state in claim 15 that the apparatus “further comprising the intravascular imaging catheter”. Thus, the examiner would recommend removing this phrase from the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 14 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 14, the claim reads “wherein the stent in the post-stent transverse view comprises an image content of the post-stent transverse view”. However, it is unclear what is meant by the term “an image content”. This can be interpreted to be a graphical representation of the stent, information associated with the stent area/expansion, and the like. The examiner recommends clarifying what is meant by this term and noting where support for this definition can be found within the Applicant’s specification/drawings. For the sake of examination, the examiner will be interpreting the term “an image content” to be a graphical representation of the stent.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, and 15 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Gopinath US 2016/0022208 A1 “Gopinath”.
Regarding claim 1, Gopinath teaches “An apparatus, comprising:” (“FIG. 1 is a schematic diagram of data collection system and a data collection probe in accordance with an illustrative embodiment of the disclosure” [0016]. As shown in FIG. 1, the data collection system 10 includes a computing device 40 (i.e. processor), a display 46 and a probe 7 (i.e. intravascular imaging catheter), among other components. Therefore, the data collection system/probe of FIG. 1 represents an apparatus.);
“an intravascular imaging catheter configured be positioned within a blood vessel of a patient” (“As shown in FIG. 1, a probe 7 is shown prior to or after insertion in a blood vessel. The probe 7 can include other imaging modalities in addition to or in lieu of OCT such as ultrasound in one embodiment. The probe 7 is in optical communication with an OCT system 10 or other imagining system such as an IVUS system” [0024]; “As shown in FIG. 2, a blood vessel 5 can be imaged using a data collection probe 7. A guidewire 8 can be used to introduce the probe 7 into the blood vessel 5 as shown in FIG. 2.” [0035]; and “The probe 7 can include a catheter 20 having a catheter portion having one or more optical fibers 15 and a probe tip 17 disposed therein” [0040]. Therefore, probe 7 represents an intravascular imaging catheter configured be positioned within a blood vessel of a patient.); and
“a processor configured for communication with the intravascular imaging catheter, wherein the processor is configured to:” (“A computing device 40 such as a computer, processor, ASIC or other device can be part of the OCT system 10 or can be included as a separate subsystem in electrical or optical communication with the OCT system 10. The computing device 40 can include memory, storage, buses and other components suitable for processing data and software 44 such as image data processing stages configured for stent visualization, stent malapposition detection, and pullback data collection as discussed below” [0026]. As shown in FIG. 1, the computing device 40 (i.e. processor) is in communication with the probe 7 (i.e. intravascular imaging catheter) via the optical receiver 31 and the one or more optical fibers 15. Therefore, the computing device 40 represents a processor configured for communication with the intravascular imaging catheter and is configured to carry out processing functions.);
“control the intravascular imaging catheter to obtain pre-stent imaging data of the blood vessel before a stent is deployed within the blood vessel” (“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]; “The data collection probe 7 can be introduced and pulled back along a length of a blood vessel 5 while collecting data. As the optical fiber 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. These data sets can be used to identify regions of interest such as a stenosis or a deployed stent such as stent 12. In one embodiment, a first pull back is performed pre-stent deployment and a second pullback is after stent deployment” [0036]; “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. In one embodiment, Step A includes generating a representation of a segment of a blood vessel using intravascular data” [0074]. Therefore, during the pre-stent planning stage, intravascular data is obtained during a first pull back of the probe 7 along the length of the blood vessel 5 and is used to generate a representation of the blood vessel. Therefore, the processor (i.e. computing device 40) is configured to control the intravascular imaging catheter to obtain pre-stent imaging data of the blood vessel before a stent is deployed within the blood vessel.);
“generate a pre-stent view of the blood vessel based on the pre-stent imaging data” (See [0074] above and “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” [0065]; “These datasets can include an OCT or IVUS data set obtained during a pullback through the vessel. Four side branches SB1-SB4 are shown in the image of the blood vessel in FIG. 3” [0066]. Therefore, a representation of a blood vessel (see FIG. 3) is generated and displayed on a user interface display such that a physician can decide a segment to stent. Thus, the processor (i.e. computing device 40) is configured to generate a pre-stent view of the blood vessel based on the pre-stent imaging data (i.e. obtained during a first pullback, see [0036]).);
“control the intravascular imaging catheter to obtain post-stent imaging data of the blood vessel after the stent is deployed within the blood vessel” (See [0036] above and “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” [0067]. Therefore, a second (i.e. new) pullback of the probe 7 is performed after the stent has been deployed. Thus, the processor (i.e. computing device 40) is configured to control the intravascular imaging catheter (i.e. probe 7) to obtain post-stent imaging data of the blood vessel after the stent is deployed within the blood vessel.);
“generate a post-stent view of the blood vessel based on the post-stent imaging data, wherein the post-stent view comprises the stent” (See [0067] above. As shown in FIG. 4, the image shown on the display includes the stent. Therefore, the processor (i.e. computing device 40) is configured to generate a post-stent view of the blood vessel based on the post-stent imaging data, wherein the post-stent view comprises the stent.).; and
“output a screen display comprising the pre-stent view and the post-stent view positioned proximate to one another such that the pre-stent view and the post-stent view are displayed simultaneously” (“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]; “A shown, in FIG. 5, the VFR value obtained after stenting during a second data collection session such as an OCT or IVUS pullback is displayed along with the VFRp (predicted) from the pre-stent planning phase” [0068]; “As shown, in FIG. 5, the lumen profile is shown with the planned pre-stent target profile shown as a dotted line. The stent profile is automatically placed over the region of the lumen profile LP that corresponds to the detected stent struts. A longitudinal view of the detected stent struts is shown in the bottom panel of the FIG. 5” [0069]. As shown in FIG. 5, the pre-stent target profile is displayed on top of the display and the stent profile is displayed on the bottom of the display. Therefore, the processor is configured to output a screen display comprising the pre-stent view (i.e. top of FIG. 5) and the post-stent view positioned proximate to one another such that the pre-stent view and the post-stent view are displayed simultaneously.).
Regarding claim 2, Gopinath discloses all features of the claimed invention as discussed with respect to claim 1 above, and Gopinath further teaches “wherein the pre-stent view comprises a pre-stent longitudinal view and the post-stent view comprises a post-stent longitudinal view” (See FIG. 5. In this case, the pre-stent view (i.e. top of FIG. 5) is a longitudinal view of the blood vessel and the post-stent view (i.e. bottom of FIG. 5) is a longitudinal view of the blood vessel. Therefore, the pre-stent view comprises a pre-stent longitudinal view and the post-stent view comprises a post-stent longitudinal view.).
Regarding claim 3, Gopinath discloses all features of the claimed invention as discussed with respect to claim 2 above, and Gopinath further teaches “wherein each of the pre-stent longitudinal view and the post-stent longitudinal view extend horizontally in the screen display, wherein the pre-stent longitudinal view and the post-stent longitudinal view are arranged vertically relative to one another in the screen display” (See FIG. 5. In this case, the pre-stent longitudinal view (i.e. top of FIG. 5) and the post-stent longitudinal view (i.e. bottom of FIG. 5) extend horizontally in the screen display, wherein the pre-stent longitudinal view and the post-stent longitudinal view are arranged vertically (i.e. on the top and bottom, respectively) relative to one another in the screen display.).
Regarding claim 4, Gopinath discloses all features of the claimed invention as discussed with respect to claim 2 above, and Gopinath further teaches “wherein the stent in the post-stent longitudinal view comprises a graphical representation, wherein the graphical representation of the stent within the post-stent longitudinal view corresponds to a location of the stent within the blood vessel” (See FIG. 5: Post stent analysis (i.e. bottom), “The target stent profile is generated using one or more method described herein which includes one or more user provided reference frames or other selections relative to identifying a section of a blood vessel as inputs. In one embodiment, the target stent profile is automatically placed over or overlaid upon the region of the lumen profile that corresponds to the detected stent struts such as shown in FIG. 5” [0044] and “The stented region's lumen profile LP is displayed with the target stent profile TSP overlaid as shown in FIG. 5” [0067]. Therefore, the stent in the post-stent longitudinal view (i.e. bottom of FIG. 5) comprises a graphical representation (i.e. target stent profile), wherein the graphical representation of the stent within the post-stent longitudinal view corresponds to a location of the stent within the blood vessel.).
Regarding claim 15, Gopinath discloses all features of the claimed invention as discussed with respect to claim 1 above, and Gopinath further teaches “further comprising the intravascular imaging catheter, wherein the intravascular imaging catheter is configured for intravascular ultrasound (IVUS) or optical coherence tomography (OCT)” (See [0024] as discussed in claim 1 above. Therefore, the intravascular imaging catheter (i.e. probe 7) is configured for intravascular ultrasound (IVUS) or optical coherent tomography (OCT).).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 5, and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath US 2016/0022208 A1 “Gopinath” as applied to claim 2 above, and further in view of Kunio US 2018/0271614 A1 “Kunio”.
Regarding claim 5, Gopinath discloses all features of the claimed invention as discussed with respect to claim 2 above, and Gopinath further teaches “wherein the processor is configured to: determine a minimum lumen area (MLA) based on the pre-stent imaging data”; […] wherein the pre-stent longitudinal view comprises a MLA marker identifying a location of the blood vessel comprising the MLA” (“The vertical dotted line in FIG. 3 is a minimum lumen area value or MLA” [0048]. As shown in FIG. 3 and the top of FIG. 5, the minimum lumen area is displayed on the stent planning image (i.e. pre-stent longitudinal view). In order to display this line indicating the position of the minimum lumen area (MLA) the processor must have been configured to determine a minimum lumen area (MLA) based on the pre-stent imaging data, wherein the pre-stent longitudinal view comprises a MLA marker (i.e. vertical dotted line) identifying a location of the blood vessel comprising the MLA.).
Gopinath does not teach that the processor is configured to: “determine a minimum stent area (MSA) based on the post-stent imaging data” or “wherein the post-stent longitudinal view comprises a MSA marker identifying a location of the blood vessel comprising the MSA”.
Kunio is within the same field of endeavor as the claimed invention because it involves a method for displaying an anatomical image of a coronary artery on a graphical user interface with information from a plurality of intravascular image frames (See [Abstract]).
Kunio teaches that the processor is configured to: “determine a minimum stent area (MSA) based on the post-stent imaging data” (“The lumen area n_lumen is calculated as the inner area of the detected lumen edge. If multiple stent-struts are detected, the stent area n_stent is calculated by interpolating the stent-strut(s) as an oval. In addition, the diameters of the lumen and/or the stent are calculated and its maximum and minimum values are saved as well (n_lumen_φmax, n_lumen_φmin, n_stent_φmax, n_stent_φmin). If a user adjusts the location of the lumen edge and/or the stent-strut(s) from the detected location, the information of the area and the diameters are updated accordingly” [0051]; “When n_stent is calculated, the stent underexpansion is calculated and saved as n_stent_expan. One example method to calculate n_stent_expan is the ratio of n_stent to the lumen area of the frame that is used to determine the size of a balloon catheter and/or a stent before PCI” [0052]; “The ratio of the calculated area to its original area is evaluated for each detected stent-strut, and the maximum/minimum/averaged values are saved as n_stent_bio_max, n_stent_bio_min, and n_stent_bio_ave” [0055].
Therefore, since the stent area n_stent is calculated (see [0051]) and minimum values are saved (see [0055]) the processor is configured to determine a minimum stent area (MSA) based on the post-stenting imaging data.); and
and “wherein the post-stent longitudinal view comprises a MSA marker identifying a location of the blood vessel comprising the MSA” (See [0055] and “method for displaying an anatomical image of a coronary artery with qualitative and quantitative information from an intravascular imaging system overlaid on the anatomical image” [0002]; “The present disclosure is directed to overlaying qualitative and quantitative information obtained from the intravascular imaging system onto the anatomical image of the blood vessel to more efficiently interpret the structural and molecular information as it pertains to a specific portion of the anatomical image” [0007]; “wherein quantitative information include at least one of lumen area and diameter, stent area and diameter, stent malapposition distance, stent malapposition severity, plaque size, resorption rate of bio-absorbable stent, fractional flow reserve and near-infrared autofluorescence intensity and area” [Claim 4]; “The quantitative information is displayed in a text box 52 at the bottom left hand corner of the GUI 40 as text” [0070]; “The number and the configuration of the indicator(s) are determined based on the location of the other anatomical features near the minimum lumen area, so that the indicator does not block any other anatomical features, such as nearby side branches of the coronary artery 22. The different indices may be displayed at the corner of the GUI 40 in a legend 50.” [0071] The examiner notes that FIG. 6 and 7 show this text box with the quantitative information displayed with the longitudinal image of the coronary artery.
In this case, since the method involves displaying an anatomical image of a coronary artery with quantitative information overlaid thereon, including indicators (see [0071]), the quantitative information including stent area (see [Claim 4]) and the processor calculates a minimum area of the stent struts (see [0055]), the post-stent longitudinal view comprises a MSA marker identifying a location of the blood vessel comprising the MSA.).
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 Gopinath such that the processor is configured to determine a minimum stent area (MSA) based on the post-stent imaging data and the post-stent longitudinal view comprises a MSA marker identifying a location of the blood vessel comprising the MSA as disclosed in Kunio in order to allow a user to easily evaluate the characteristics of the stent. Displaying an indicator associated with the minimum stent area on a longitudinal view of a blood vessel is one of a finite number of techniques which can be used to allow a user to easily understand the expansion of the stent with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath such that the processor is configured to determine a minimum stent area (MSA) based on the post-stent imaging data and the post-stent longitudinal view comprises a MSA marker identifying a location of the blood vessel comprising the MSA as disclosed in Kunio would yield the predictable result of enabling a user to easily distinguish characteristics of the stent.
Regarding claim 7, Gopinath in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 5 above, and Kunio further teaches “wherein the screen display comprises a numerical value of the MLA” (See [0070] as discussed in claim 5 above and “Also shown in FIG. 6 are indicators 42 for the location of the minimum lumen area that may be displayed at the edge of the coronary artery 22. A user visually reviewing the GUI 40 may quickly determine the minimum lumen area 42 based on where the indicators 42 are located. The number and the configuration of the indicator(s) are determined based on the location of the other anatomical features near the minimum lumen area, so that the indicator does not block any other anatomical features, such as nearby side branches of the coronary artery 22. The different indices may be displayed at the corner of the GUI 40 in a legend 50.” [0071]. As shown in FIG. 6, the location of the minimum lumen area is shown with indicators 42, and the lumen area is shown in the box 52. Therefore, the screen display comprises a numerical value of the MLA.).
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 Gopinath such that the screen display comprises a numerical value of the MLA as disclosed in Kunio in order to allow a user to easily evaluate the characteristics of the lumen. Displaying an indicator associated with the minimum lumen area on a longitudinal view of a blood vessel and the associated minimum lumen area is one of a finite number of techniques which can be used to allow a user to easily understand the characteristics of the lumen being examined with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath such screen display comprises a numerical value of the MLA as disclosed in Kunio would yield the predictable result of enabling a user to easily distinguish characteristics of the blood vessel being examined.
Regarding claim 8, Gopinath in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 5 above, and Kunio further teaches “wherein the screen display comprises a numerical value of the MSA” (See [0007]; [0055] and [Claim 4] as discussed with respect to claim 5 above. Therefore, since the ratio of the calculated area to its original area is evaluated for each detected stent-struct and the maximum/minimum/average values are saved (i.e. the minimum stent area is saved) (See [0055]) and quantitative information obtained from the intravascular imaging is overlayed on the anatomical image of the blood vessel (See [0007]), the screen display comprises a numerical value of the MSA.).
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 Gopinath such that the screen display comprises a numerical value of the MSA as disclosed in Kunio in order to allow a user to easily evaluate the characteristics of the stent. Displaying an indicator associated with the minimum stent area on a longitudinal view of a blood vessel and the associated minimum stent area is one of a finite number of techniques which can be used to allow a user to easily understand the characteristics of the stent being utilized with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath such screen display comprises a numerical value of the MSA as disclosed in Kunio would yield the predictable result of enabling a user to easily distinguish characteristics of the stent being utilized within the blood vessel.
Regarding claim 9, Gopinath in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 5 above, and Kunio further teaches “wherein the processor is configured to determine a cross-sectional area for a location of the blood vessel different than the location comprising the MSA, wherein the screen display comprises a numerical value of the cross-sectional area” (“A user, such as an interventional cardiologist, can place one or multiple marker(s) (70, 72) on the displayed angiography image of the coronary artery 22 where the user is planning to perform PCI. Once the user places the marker(s) (70, 72), the quantitative information (71, 73), e.g., lumen area and mean lumen diameter, is shown near the marker(s) (70, 72). The user may also select to display the quantitative information at the corner of the displayed angiography image as shown in the text box 52 of FIG. 9” [0078]. As shown in FIG. 8, these markers 70 and 72 are located proximally and distally to the minimum lumen area, respectively and the quantitative information 71, 73 (i.e. lumen area) is displayed alongside the angiography image. Therefore, the processor is configured to determine a cross-sectional area for a location of the blood vessel different than the location comprising the MSA, wherein the screen display comprises a numerical value of the cross-sectional area.).
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 Gopinath such that the processor is configured to determine a cross-sectional area for a location of the blood vessel different than the location comprising the MSA, wherein the screen display comprises a numerical value of the cross-sectional area as disclosed in Kunio in order to allow a user to easily evaluate the characteristics of the blood vessel being examined. Displaying markers at one or more positions and the quantitative information associated with those positions is one of a finite number of techniques which can be used to allow a user to easily understand the characteristics of the blood vessel being utilized with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath that the processor is configured to determine a cross-sectional area for a location of the blood vessel different than the location comprising the MSA, wherein the screen display comprises a numerical value of the cross-sectional area as disclosed in Kunio would yield the predictable result of enabling a user to easily distinguish characteristics of the blood vessel being examined.
Regarding claim 10, Gopinath in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 5 above, and Kunio further teaches “wherein the screen display comprises a numerical value of an expansion of the stent” (“FIG. 13 is another schematic diagram of the GUI 40 at post-PCI (post-stenting) stage that allows the user to visualize stent-related information such as stent malapposition or stent underexpansion. For stenting, the qualitative information regarding stent apposition and expansion can be overlaid as a color-coded map or different shades as an indicator on the displayed angiography image” [0082]; “In FIG. 13, the user has selected stent malapposition as shown by the filled in button 94. If the user would like to review information regarding stent underexpansion the user would select button 96 […] If a user wants to know how severe stent malapposition or underexpansion is at a specific location, a cursor may be placed on the ROI path 24 and a user can move it to the desired location. The severity information (a part of the quantitative information) can be shown either near the cursor or at the corner of the GUI 40. In FIG. 13, the severity information is displayed in the corner of the GUI” [0083]. Therefore, since the severity information associated with stent underexpansion is displayed, the screen display comprises a numerical value of an expansion of the stent.).
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 Gopinath such that the screen display comprises a numerical value of an expansion of the stent as disclosed in Kunio in order to allow a user to easily evaluate the characteristics of the stent. Displaying a numerical value of an expansion of a stent (i.e. underexpansion, see [0083]) is one of a finite number of techniques which can be used to allow a user to easily understand the characteristics of the stent being utilized with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath such screen display comprises a numerical value of an expansion of the stent as disclosed in Kunio would yield the predictable result of enabling a user to easily distinguish characteristics of the stent being utilized within the blood vessel.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath US 2016/0022208 A1 “Gopinath” and Kunio US 2018/0271614 A1 “Kunio” as applied to claim 5 above, and further in view of Cai et al. US 2015/0073279 A1 “Cai” and Elbasiony et al. US 2014/0257087 A1 “Elbasiony”.
Regarding claim 6, Gopinath in view of Kunio discloses all features of the claimed invention as discussed with respect to claim 5 above, however, the combination does not teach “wherein the screen display comprises: a first pre-stent transverse view proximate to the pre-stent longitudinal view and representative of the location of the vessel comprising the MLA”;
Cai is within the same field of endeavor as the claimed invention because it involves an ultrasound imaging system which displays longitudinal views and cross-sectional views concurrently (see [0015], FIG. 6).
Cai teaches “wherein the screen display comprises: a first pre-stent transverse view proximate to the pre-stent longitudinal view and representative of the location of the vessel comprising the MLA” (“The method includes the following steps: […] form a series of cross-sectional images that are longitudinally-offset from one another along a length of the lumen; during the intravascular ultrasound imaging procedure, concurrently displaying i) a most recent image from the series of cross-sectional images and ii) a previous image from the series of cross-sectional images, wherein the previous image is either a) selected by the operator or b) automatically selected as having a maximum or minimum of a selected image characteristic” [0005]; “It may, however, be useful to concurrently display, in real-time during the IVUS procedure (e.g., a pull-back procedure), at least two images, such as the most recently processed image and a previously-obtained image that has some particular or selected image characteristic (e.g., maximum or minimum lumen area or diameter)” [0046]; “For example, in the embodiment of FIG. 6, the second cross-sectional image 604 (with minimum lumen area) is selected first” [0061]. As shown in FIG. 6, the cross sectional images 602 and 604 do not contain stents (i.e. are pre-stent transverse views) and are displayed proximate to the longitudinal view 606 (i.e. the pre-stent longitudinal view). The cross-sectional image 604, in this case is representative of the location of the vessel comprising the MLA (i.e. minimum lumen area, see [0046], [0061]) Therefore, the screen display comprises a first pre-stent transverse view proximate to the pre-stent longitudinal view and representative of the location of the vessel comprising the MLA.).
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 Gopinath in view of Kunio such that the screen display comprises first pre-stent transverse view proximate to the pre-stent longitudinal view and representative of the location of the vessel comprising the MLA as disclosed in Cai in order to allow a user to better understand the blood vessel being examined. Displaying cross-sectional (i.e. transverse) views of a blood vessel alongside a longitudinal view of the blood vessel is one of a finite number of techniques which can be used to display features of a blood vessel with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath such that the screen display comprises first pre-stent transverse view proximate to the pre-stent longitudinal view and representative of the location of the vessel comprising the MLA as disclosed in Cai would yield the predictable result of enabling a user to view multiple images of a blood vessel when performing an assessment thereof.
Gopinath in view of Kunio and Cai does not teach that the screen display comprises “a first post-stent transverse view proximate to the post-stent longitudinal view and representative of the location of the vessel comprising the MLA, wherein the first-post stent transverse view depicts the stent”.
Elbasiony is within the same field of endeavor as the claimed invention because it involves computer-based methods, devices and systems suitable for displaying stent malapposition in a 2D or 3D image (See [Abstract]).
Elbasiony teaches that the screen display comprises “a first post-stent transverse view proximate to the post-stent longitudinal view and representative of the location of the vessel comprising the MLA, wherein the first-post stent transverse view depicts the stent” (“FIG. 3B and FIG. 6 shows a two-dimensional cross-section of a vessel having a stent. Each image shown in FIGS. 3A, 4A and 4B has been processed using an image data processing pipeline and a stent detection module or stage as described below” [0059]; “In addition, as shown in FIGS. 3A and 3B, line segment 142 corresponds to the minimum lumen diameter in the cross-section shown while line segment 143 corresponds to maximum lumen diameter shown” [0078]; “Each of these three stent struts 121, 125, and 127 are shown disposed within the lumen in contrast with other stent struts shown as closer to or substantially in contact with the vessel wall such as stent struts 123, 129, and 140” [0081]. As shown in FIG. 3A, the display shows a cross-sectional image of a vessel (i.e. at the top) along with a longitudinal view (i.e. bottom), each of which depicting the stent (i.e. stent struts 123, 129, 140). Therefore, the screen display comprises a first post-stent transverse view (i.e. top of FIG. 3A) proximate to the post-stent longitudinal view and representative of the location of the vessel comprising the MLA (i.e. line segment 142, corresponding to the minimum lumen diameter/area), wherein the first-post stent transverse view depicts the stent (i.e. stent struts 123, 129, 140).).
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 Gopinath in view of Kunio and Cai such that the display screen comprises a first post-stent transverse view proximate to the post-stent longitudinal view and representative of the location of the vessel comprising the MLA, wherein the first-post stent transverse view depicts the stent as disclosed in Elbasiony in order to allow a user to allow a user to better assess and identify locations in which a malapposed stent is present (see Elbasiony: [0083]). Displaying cross-sectional (i.e. transverse) views of a blood vessel containing a stent alongside a longitudinal view of the blood vessel containing the stent is one of a finite number of techniques which can be used to display features of a blood vessel with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath such that the display screen comprises a first post-stent transverse view proximate to the post-stent longitudinal view and representative of the location of the vessel comprising the MLA, wherein the first-post stent transverse view depicts the stent as disclosed in Elbasiony would yield the predictable result of enabling a user to view multiple images of a blood vessel containing a stent when performing an assessment of the positioning/expansion of the stent.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath US 2016/0022208 A1 “Gopinath” as applied to claims 1 and 2 above, and further in view of Cai et al. US 2015/0073279 A1 “Cai” and Elbasiony et al. US 2014/0257087 A1 “Elbasiony”.
Regarding claim 11, Gopinath discloses all features of the claimed invention as discussed with respect to claim 2 above, however Gopinath does not teach “wherein the screen display comprises: a plurality of a pre-stent transverse views proximate to the pre-stent longitudinal view”.
Cai teaches “wherein the screen display comprises: a plurality of a pre-stent transverse views proximate to the pre-stent longitudinal view” (“FIG. 6 illustrates one embodiment of a display 600 that includes a first cross-sectional image 602, a second cross-sectional image 604, and a longitudinal view 606 based on the images processed to that time. At the end of an IVUS pull-back procedure or other imaging run or procedure, the first and second cross-sectional images 602, 604 are automatically selected based on one or more imaging characteristics” [0059]. These cross-sectional images 602 and 604 do not contain depictions of stents, therefore, they constitute pre-stent transverse views. As shown in FIG. 6, the first cross-sectional image 602 and the second cross-sectional image 604 are displayed proximate to the longitudinal image 606. Therefore, the screen display comprises a plurality of pre-stent transverse views proximate to the pre-stent longitudinal view.).
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 Gopinath such that the screen display comprises a plurality of pre-stent transverse views proximate to the pre-stent longitudinal view as disclosed in Cai in order to allow a user to better understand the blood vessel being examined. Displaying cross-sectional (i.e. transverse) views of a blood vessel alongside a longitudinal view of the blood vessel is one of a finite number of techniques which can be used to display features of a blood vessel with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath such that the screen display comprises a plurality of pre-stent transverse views proximate to the pre-stent longitudinal view as disclosed in Cai would yield the predictable result of enabling a user to view multiple images of a blood vessel when performing an assessment thereof.
Gopinath and Cai does not teach that the screen display comprises “a plurality of a post-stent transverse views proximate to the post-stent longitudinal view”.
Elbasiony teaches “a plurality of a post-stent transverse views proximate to the post-stent longitudinal view” (See FIG. 3A and “The system includes one or more memory devices; and a computing device in communication with the memory device, wherein the memory device comprises instructions executable by the computing device to cause the computing device to: process, one or more image detection software modules, a plurality of images obtained from an optical coherence tomography pullback with respect to a blood vessel using a data collection probe such that a lumen border and a plurality of stent struts are detected” [0015]. The image shown on the top in FIG. 3A represents a post-stent transverse view. It is displayed proximate to the post-stent longitudinal view. Although FIG. 3A shows a single post-stent transverse views, it would be obvious to one of ordinary skill in the art to display the plurality of images (i.e. in which the stent structs are present) obtained from an OCT pullback with respect to a blood vessel (see [0015]) in order to verify features of the stent.).
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 Gopinath in view of Cai such that the screen display displays a plurality of post-stent transverse views (i.e. obtained during an OCT pullback with respect to a blood vessel and in which a plurality of stent struts are present) proximate to the post-stent longitudinal view as disclosed in Elbasiony in order to allow a user to assess the characteristics of the stent, such as malapposition (See Elbasiony: [0081]). Displaying a plurality of post-stent transverse views acquired from an OCT pullback with respect to a blood vessel is one of a finite number of techniques which can be used to assess the positioning of a stent with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath in view of Cai such that the screen display displays a plurality of post-stent transverse views (i.e. obtained during an OCT pullback with respect to a blood vessel and in which a plurality of stent struts are present) proximate to the post-stent longitudinal view as disclosed in Elbasiony would yield the predictable result of enabling a user to assess the characteristics of the stent.
Regarding claim 12, Gopinath in view of Cai and Elbasiony discloses all features of the claimed invention as discussed with respect to claim 11 above, and Cai further teaches “wherein the plurality of pre-stent transverse views comprise pre-stent views of a proximal reference location and a distal reference location” (“For example, in the embodiment of FIG. 6, the second cross-sectional image 604 (with minimum lumen area) is selected first and then the first cross-sectional image 602 is selected from the subset of images distal (i.e., before) the second cross-sectional image 604. It will be understood that other embodiments might select a first cross-sectional from a subset of images proximal (i.e., after) the second cross-sectional image or any other suitable method of arrangement for selecting images” [0061]. In this case, when the first cross-sectional image 604 is selected from the subset of images distal to the second cross-sectional image 602, the second cross-sectional image 602 represents an image at a proximal reference location and the first cross-sectional image 604 represents an image at a distal reference location. Conversely, when the when the first cross-sectional image 604 is selected from the subset of images proximal to the second cross-sectional image 602, the second cross-sectional image 602 represents an image at a distal reference location and the first cross-sectional image 604 represents an image at a proximal reference location. Therefore, the plurality of pre-stent transverse views comprise pre-stent views of a proximal reference location and a distal reference location.).
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 Gopinath such that the screen display comprises a plurality of pre-stent transverse views proximate to the pre-stent longitudinal view as disclosed in Cai in order to allow a user to better understand the blood vessel being examined. Displaying cross-sectional (i.e. transverse) views of a blood vessel alongside a longitudinal view of the blood vessel is one of a finite number of techniques which can be used to display features of a blood vessel with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath such that the screen display comprises a plurality of pre-stent transverse views proximate to the pre-stent longitudinal view as disclosed in Cai would yield the predictable result of enabling a user to view multiple images of a blood vessel when performing an assessment thereof.
Gopinath in view of Cai does not teach “wherein the plurality of post-stent transverse views comprise post-stent views of the proximal reference location and the distal reference location”.
Elbasiony teaches “wherein the plurality of post-stent transverse views comprise post-stent views of the proximal reference location and the distal reference location” (See [0015] as discussed with respect to claim 11 above. In this case, as the since a plurality of images are obtained during the pullback of an OCT device (i.e. from a distal end to a proximal end), the images include the proximal reference location and the distal reference location. Therefore, the plurality of post-stent transverse views comprise post-stent views of the proximal reference location and the distal reference location.).
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 Gopinath in view of Cai such that the screen display displays a plurality of post-stent transverse views, wherein the plurality of post-stent transverse views comprise post-stent views of the proximal reference location and the distal reference location as disclosed in Elbasiony in order to allow a user to assess the characteristics of the stent, such as malapposition (See Elbasiony: [0081]). Displaying a plurality of post-stent transverse views acquired from an OCT pullback with respect to a blood vessel is one of a finite number of techniques which can be used to assess the positioning of a stent with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath in view of Cai such that the screen display displays a plurality of post-stent transverse views of the proximal reference location and the distal reference location as disclosed in Elbasiony would yield the predictable result of enabling a user to assess the characteristics of the stent.
Regarding claim 13, Gopinath discloses all features of the claimed invention as discussed with respect to claim 1 above, however, Gopinath does not teach “wherein the pre-stent view comprises a pre-stent transverse view and the post-stent view comprises a post-stent transverse view”.
Cai teaches “wherein the pre-stent view comprises a pre-stent transverse view” (“FIG. 6 illustrates one embodiment of a display 600 that includes a first cross-sectional image 602, a second cross-sectional image 604, and a longitudinal view 606 based on the images processed to that time. At the end of an IVUS pull-back procedure or other imaging run or procedure, the first and second cross-sectional images 602, 604 are automatically selected based on one or more imaging characteristics” [0059]. These cross-sectional images 602 and 604 do not contain depictions of stents, therefore, they constitute pre-stent transverse views. As shown in FIG. 6, the first cross-sectional image 602 and the second cross-sectional image 604 are displayed proximate to the longitudinal image 606. Therefore, the screen display displays a pre-stent transverse view.).
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 Gopinath such that the screen display displays a pre-stent transverse view as disclosed in Cai in order to allow a user to better understand the blood vessel being examined. Displaying cross-sectional (i.e. transverse) views of a blood vessel alongside a longitudinal view of the blood vessel is one of a finite number of techniques which can be used to display features of a blood vessel with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath displays a pre-stent transverse view as disclosed in Cai would yield the predictable result of enabling a user to view multiple images of a blood vessel when performing an assessment thereof.
Gopinath in view of Cai does not teach that “the post-stent view comprises a post-stent transverse view”.
Elbasiony teaches that the post-stent view comprises a post-stent transverse view” (“FIG. 3B and FIG. 6 shows a two-dimensional cross-section of a vessel having a stent. Each image shown in FIGS. 3A, 4A and 4B has been processed using an image data processing pipeline and a stent detection module or stage as described below” [0059]; “In addition, as shown in FIGS. 3A and 3B, line segment 142 corresponds to the minimum lumen diameter in the cross-section shown while line segment 143 corresponds to maximum lumen diameter shown” [0078]; “Each of these three stent struts 121, 125, and 127 are shown disposed within the lumen in contrast with other stent struts shown as closer to or substantially in contact with the vessel wall such as stent struts 123, 129, and 140” [0081]. As shown in FIG. 3A, the display shows a cross-sectional image of a vessel (i.e. at the top) along with a longitudinal view (i.e. bottom), each of which depicting the stent (i.e. stent struts 123, 129, 140). Therefore, the screen display displays a post-stent transverse view.).
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 Gopinath in view of Cai such that the display screen displays a post-stent transverse view as disclosed in Elbasiony in order to allow a user to allow a user to better assess and identify locations in which a malapposed stent is present (see Elbasiony: [0083]). Displaying cross-sectional (i.e. transverse) views of a blood vessel containing a stent alongside a longitudinal view of the blood vessel containing the stent is one of a finite number of techniques which can be used to display features of a blood vessel with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath in view of Cai such that the display displays a post-stent transverse view as disclosed in Elbasiony would yield the predictable result of enabling a user to view multiple images of a blood vessel containing a stent when performing an assessment of the positioning/expansion of the stent.
Regarding claim 14, Gopinath in view of Cai and Elbasiony discloses all features of the claimed invention as discussed with respect to claim 13 above, and Elbasiony further teaches “wherein the stent in the post-stent transverse view comprises an image content of the post-stent transverse view” (See [0059] and [0081] as discussed with respect to claim 13 above. As shown in FIGS. 3A and 3B, the post-stent transverse view includes stents 123, 129 and 140. Therefore, the stent in the post-stent transverse view comprises an image content of the post-stent transverse view.).
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 Gopinath in view of Cai such that the display screen displays a post-stent transverse view, wherein the stent in the post-stent transverse view comprises an image content of the post-stent transverse view as disclosed in Elbasiony in order to allow a user to allow a user to better assess and identify locations in which a malapposed stent is present (see Elbasiony: [0083]). Displaying cross-sectional (i.e. transverse) views of a blood vessel containing a stent alongside a longitudinal view of the blood vessel containing the stent is one of a finite number of techniques which can be used to display features of a blood vessel with a reasonable expectation of success. Thus, modifying the apparatus of Gopinath in view of Cai such that the display screen displays a post-stent transverse view, wherein the stent in the post-stent transverse view comprises an image content of the post-stent transverse view as disclosed in Elbasiony would yield the predictable result of enabling a user to view multiple images of a blood vessel containing a stent when performing an assessment of the positioning/expansion of the stent.
Conclusion
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797