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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/30/2026 has been entered.
Response to Arguments
Regarding 35 U.S.C. 112
New 112(b) rejections necessitated by amendment.
Applicant's arguments filed 03/30/2026 with respect to the ultrasound images have been fully considered but they are not persuasive. Examiner first notes that no amendments nor arguments are made with respect to the longitudinal ultrasound image and the first cross-sectional image, thus the 112(b) rejections are maintained/updated in view of the amendments to the claims for such limitations.
Furthermore, regarding applicant’s arguments that “applicant has amended claim 8 to recite at least one ultrasound transducer configured to provide ultrasound imagery of an artery”. . Examiner respectfully disagrees in that the issues lies in reciting that the ultrasound transducer provides ultrasound imagery and then multiple ultrasound images are subsequently recited (e.g. a longitudinal image, a first cross-sectional image, and a second cross-sectional image), thus rendering unclear the nature of such subsequently recited images and if they are the same as or different from the ultrasound image provided by the ultrasound probe. If these images (including the second cross-sectional image) are different from the image provided by the probe, it is unclear what the ultrasound image from the probe is used for and how the ultrasound images are displayed using the system as recited. In other words, it is unclear how such a system displays the recited ultrasound images without such structure for acquiring the images if they do not correspond to the ultrasound image provided by the ultrasound probe. For at least these reasons, applicant’s arguments regarding the 112(b) rejection of claim 8 are not found persuasive and there rejection is maintained/updated in view of the amendments to the claims.
Regarding prior art
Applicant’s arguments with respect to claim 8 have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 11-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation “a longitudinal ultrasound image of the artery”. It is unclear if the longitudinal ultrasound image is the same or included in the ultrasound imagery provided by the at least one ultrasound transducer recited previously or if this is a different ultrasound image (e.g. a different ultrasound image provided by the at least one ultrasound transducer or a different ultrasound image provided by a different/distinct ultrasound transducer). For examination purposes, it has been interpreted to mean any longitudinal ultrasound image of the artery, however, clarification is required.
Claim 8 recites the limitation “a first cross-sectional ultrasound image of the artery”. It is unclear if the first cross-sectional ultrasound image is the same as the ultrasound imagery provided by the at least one ultrasound transducer or a different image provided by either the at least one ultrasound transducer or a different ultrasound transducer. For examination purposes, it has been interpreted to mean any first cross-sectional ultrasound image, however, clarification is required.
Claim 8 recites the limitation “a second cross-sectional ultrasound image of the artery”. It is unclear if the second cross-sectional ultrasound image is the same as the ultrasound imagery provided by the at least one ultrasound transducer or a different image provided by either the at least one ultrasound transducer or a different ultrasound transducer. Examiner further notes that although there is a modifier “second” in front of the cross-sectional ultrasound image of the artery, it is unclear if this is the same or different from the first cross-sectional ultrasound image. For examination purposes, it has been interpreted to mean any second cross-sectional ultrasound image, however, clarification is required.
Claim 8 recites the limitation “a longitudinal ultrasound image of the artery positioned below but vertically aligned with the pressure map”. The limitation is unclear as to what the ultrasound image is positioned below. In other words, while the limitation may be intending to mean that the ultrasound image is positioned below the pressure map and vertically aligned with the pressure map, this is not made explicitly clear by the current claim language especially in light of the word “but”. It is therefore unclear if the longitudinal ultrasound image of the artery is positioned below the angiogram image, the pressure map, or some other element that has not yet been recited or if the limitation intends for the longitudinal ultrasound image to be positioned below the pressure map and vertically aligned with the pressure map. For examination purposes, it has been interpreted that the longitudinal ultrasound image is merely below another element, however, clarification is required.
Claim 13 recites the limitation “annotations overlaid on the angiogram image, the annotations including indicators of suggested landing zones for a stent”. It is unclear if the annotations and/or indications are the same as or include any of the previously recited first set of pressure indicia or if these are different annotations/indications. In other words, it appears that pressure indicia on the angiogram may indicate a suggested landing zone for a stent, however, the limitation appears to be introducing a new element thus making the limitation unclear. For examination purposes, it has been interpreted that the annotations/indicators are different/distinct from the first set of pressure indicia, however, clarification is required.
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.
Claims 8 and 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (US 12533100 A1), hereinafter Cohen in view of Sonck et al. (US 20220175260 A1), hereinafter Sonck or in the alternative, Cohen in view of Sonck, Hendriks et al. (US 20070066898 A1), hereinafter Hendriks and Suzuki (US 20120215091 A1), hereinafter Suzuki.
Regarding claim 8,
Cohen teaches a system (at least fig. 1A can corresponding disclosure in at least Col. 5 line 57- Col. 6 line 19) comprising:
A guidewire (at least fig. 1A (“pressure sensing guidewire”) and corresponding disclosure in at least Col. 8 line 6-21) having a pressure sensor associated with a distal portion of the guidewire (Col. 8 lines 25-27 which discloses the distal pressure sensor of the pressure-sensing guidewire);
A catheter (at least fig. 1C (102) and corresponding disclosure in at least Col. 12 lines 12-34) having at least one ultrasound transducer (at least fig. 1C (124) and corresponding disclosure in at least Col. 12 lines 35-54) configured to provide ultrasound imagery of an artery (col. 13 lines 11-35 which disclose echo data received is processed to reconstruct and image of the lumen 120 which may be an artery);
A display system (at least fig. 1A (130/132) and corresponding disclosure in at least Col. 11 lines 52-56) configured to receive pressure sensor data from the guidewire and ultrasound image data from the catheter, the display system comprising instructions that are executable (Col. 12 lines 45-54 which discloses for example, the processor 134 can execute computer readable instructions stored on the non-transitory tangible computer readable medium) to cause the display system to generate a display image including, concurrently (Col. 21 lines 16-24 which disclose each of these modalities may be displayed simultaneously):
An angiogram image of the artery (at least fig. 14 (1410) and corresponding disclosure in at least Col. 34 lines 21-34. See also [0160] which discloses the graphical user interface 1500 includes an extraluminal image 1510 [0161] which discloses the image 1510 may be an x-ray image. This image 1510 may be an image obtained with or without contrast. the x-ray imaging system 151 may be configured to obtain x-ray images with contrast (e.g., angiogram or venogram). See also [0094] which discloses in other embodiments, a contrast agent is present within the patient vasculature. In that regard, the fluoroscopy images 810 may alternatively be angiogram images or any suitable type of extraluminal images. [0091] which discloses the registration of physiological data, intravascular data, and an angiogram image may be referred to as tri-registration. In some embodiments, tri-registration may refer to the correlation of three separate imaging modalities. Each of these modalities may be displayed simultaneously and [0058] which discloses lumen may be an artery. Examiner thus notes that the extraluminal image 1410 is considered an angiogram when performed with contrast as disclosed in [0161]),
A pressure map (at least fig. 14 (1492) and corresponding disclosure in at least Col. 36 lines 6-25. See also at least fig. 9 (914) and corresponding disclosure in at least Col. 28 lines 23-43) of pressure measurements received from the pressure sensor (Col. 22 lines 7-15 which discloses as the pressure-sensing guidewire is pulled through the patient vasculature, it may acquire pressure data 730. In an example, the pressure data 730 shown in FIG. 7 may be iFR measurements. However, the pressure data may be any suitable data, including FFR data, iFR data, or any other measurements or metrics relating to blood pressure, blood flow, or other physiological data acquired during a pullback of a guidewire), and
A longitudinal ultrasound image (at least fig. 14 (1450) and corresponding disclosure in at least Col. 35 line 35 – Col. 36 line 5. See also at least fig. 9 (910) and corresponding disclosure in at least Col. 27 line 53-Col. 28 line 11) of the artery positioned below but vertically aligned with the pressure map (see at least figs. 14 and 9 where the longitudinal ultrasound image is positioned below the angiogram and vertically aligned with the pressure map); and
A first cross-sectional ultrasound image (at least fig. 14 (1430) and corresponding disclosure in at least Col. 34 lines 21-35) of the artery, wherein a location of the first cross-sectional ultrasound image from within the artery corresponds with a location of a first displayed indicator positioned along the longitudinal ultrasound image of the artery (Col. 34 lines 50-56 which discloses Also shown within the graphical user interface 1400 is the IVUS image 1430. In that regard, a plurality of IVUS images (including the image 1430) can be co-registered to the pathway 1440. The IVUS image 1430 may be an IVUS image obtained at the location identified by the indicator 1422. The IVUS image 1430 may alternatively be an IVUS image obtained at the location identified by the indicator 1494 and Col. 38 lines 20-30 which discloses the indicator may identify the location along the ILD at which the IVUS image was acquired. In this way, the indicator of the ILD may correspond to the indicator of the extraluminal image. In some embodiments, as a user moves the indicator within the extraluminal image, the indicator of the ILD may move to a corresponding position and a new IVUS image may be shown. Similarly, if a user moves the indicator of the ILD, the indicator of the extraluminal image may move to a corresponding location and a new IVUS image may be shown. See also fig. 9 and Col. 28 lines 12-18 which discloses (109) As an example, an indicator 912 may identify a location along the vessel as shown in the ILD 910. This indicator 912 may simultaneously correspond to the location 741 along the pathway 740 and the same location 841 along the pathway 840. As a result, the IVUS image obtained at the location 841 may be displayed at the location of the indicator 912 as part of the ILD 910 as shown by the arrow 961)
A second cross-sectional ultrasound image (at least fig. 14 (1430) and corresponding disclosure in at least Col. 34 lines 21-35) from within the artery, wherein a location of the second cross-sectional ultrasound image from within the artery corresponds with a second displayed indicator positioned along the longitudinal ultrasound image of the artery (Col. 34 lines 50-56 which discloses Also shown within the graphical user interface 1400 is the IVUS image 1430. In that regard, a plurality of IVUS images (including the image 1430) can be co-registered to the pathway 1440. The IVUS image 1430 may be an IVUS image obtained at the location identified by the indicator 1422. The IVUS image 1430 may alternatively be an IVUS image obtained at the location identified by the indicator 1494 and Col. 38 lines 20-30 which discloses the indicator may identify the location along the ILD at which the IVUS image was acquired. In this way, the indicator of the ILD may correspond to the indicator of the extraluminal image. In some embodiments, as a user moves the indicator within the extraluminal image, the indicator of the ILD may move to a corresponding position and a new IVUS image may be shown. Similarly, if a user moves the indicator of the ILD, the indicator of the extraluminal image may move to a corresponding location and a new IVUS image may be shown. Examiner notes that the second cross-sectional ultrasound image is considered to be the same image in light of the 112(b) rejection above or is the new IVUS image corresponding to the movement of the indicator within the ILD by the user)
A first set of pressure indica position on the angiogram, each indicia of the first set of pressure indica correlating to a location of the pressure sensor within the artery (Col. 37 lines 6-7 which discloses the extraluminal image may include a roadmap as well as a plurality of dots. And Col. 37 lines 20-25 which discloses the plurality of dots may correspond to locations at which physiology measurements, such as pressure measurements, were received)
A second set of pressure indicia positioned on the pressure map, each indicia of the second set of pressure indicia correlating to an associated one of the first set of pressure indicia (examiner notes that the pressure data (i.e. data points of line 1492) are considered pressure indicia where each indicia (i.e. data point) correlates to an associated one of the first set of pressure indicia (i.e. locations at which pressure measurements were received).
Cohen fails to explicitly teach the guidewire having a group of pressure sensors, each indicia of the first set of pressure indicia correlating to a location of an associated pressure sensor of the group of pressure sensors within the artery.
Sonck, in a similar field of endeavor involving vascular devices, teaches a guidewire having a group of pressure sensors associated with a distal end of the guidewire ([0149] which discloses the pressure wire (i.e. guidewire [0144] or [0148]) can comprise multiple pressure sensors, the multiple pressure sensors are provided at different positions along the length of the pressure wire. Examiner notes that such a group of pressure sensors are thus associated with a distal end of the guidewire in its broadest reasonable interpretation in that they are positioned along a length of the wire which has a distal end) and
a pressure map of pressure measurements (see at least fig. 5 depicting the FFR over the length.. i.e. a map) received from the group of pressure sensors ([0050]-[0052] which discloses according to an embodiment, there is provided a method, wherein said set of multiple of relative pressure values were obtained: by means of a manual or motorized pullback of a pressure wire comprising at least one pressure sensor; by means of a pressure wire comprising a multiple of built-in pressure sensors and [0146] which discloses [0146] In yet another particular embodiment there is no need for a motorized pullback device but instead the FFR curve is obtained by a pressure wire comprise a multiple of built-in pressure sensor)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cohen to include a group of pressure sensors on the guide-wire as taught by Sonck in order to allow for pressure measurements/pressure maps to be obtained without requiring a pull-back method (Sonck [0148]). Furthermore, such a modification would allow for pressure measurements to be obtained at different positions even when stationary (Sonck [0149]).
Examiner notes that in the modified system since each indicia of the first set of pressure indicia as taught by Cohen correlates to a position of an associated pressure measurement, and the pressure measurements are obtained by an associated pressure sensor of the group of pressure sensors within the artery as taught by Sonck that each indicia of the first set of pressure indicia necessarily correlates to a location of an associated pressure sensor of the group of pressure sensors within the artery.
Alternatively, Examiner further notes that in light of the 112(b) rejection, it has been interpreted that the longitudinal ultrasound image of the artery is positioned below any element, however, in an instance where the limitation requires that the longitudinal ultrasound image of the artery is positioned below the pressure map, Cohen, or Cohen, as modified, fails teaches the pressure map overlaid on the ultrasound image and thus fails to explicitly teach the longitudinal ultrasound image positioned below the pressure map.
Nonetheless, Cohen teaches in Col. 31 lines 9-19 that pressure map data (i.e. dots 1114 of fig. 11) may be shown overlaid over the longitudinal ultrasound image, proximate to the ILD 1110 or at any other location.
Alternatively, Hendriks, in a similar field of endeavor teaches a longitudinal ultrasound image (at least fig. 6 (600) and corresponding disclosure in at least [0097]) positioned above a pressure map (at least fig. 6 (604) and corresponding disclosure in at least [0097]) and vertically aligned with the pressure map.
Examiner notes that it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cohen such that the pressure map is separate from the longitudinal ultrasound image and vertically aligned with the longitudinal ultrasound image as taught by Hendricks in order to allow for enhanced visualization of the pressure map data. In other words, separating the pressure map data such that it is not overlaid on the longitudinal ultrasound image but remains vertically aligned with the longitudinal ultrasound image would allow a user to better see the pressure data points while still maintaining the registration between the pressure data with respect to the longitudinal ultrasound image.
Furthermore, while Hendriks teaches the longitudinal ultrasound image above the pressure map, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have further modified Cohen such that the longitudinal ultrasound image is below the pressure map as such a modification amounts to merely a rearrangement of parts (i.e. displayed data) which would not have modified the operation of the system. In other words, the placement of the longitudinal ultrasound image to be below the pressure map as opposed to above the pressure map is merely an obvious matter of design choice (See MPEP 2144).
Examiner further notes it has been interpreted that the first cross-sectional image and second cross-sectional image may be the same or are different images displayed at different times, however, if applicant intends for the first cross-sectional image and second cross-sectional images are different images displayed simultaneously, this feature is not explicitly taught by Cohen, or Cohen, as modified.
Nonetheless, Suzuki, in a similar field of endeavor involving ultrasound imaging of vessels, teaches concurrent display of a first cross-sectional ultrasound image and a second cross sectional image different from the first cross-sectional image ([0161] which discloses it is possible to employ a construction in which two indicators 903, or two or more indicators 903 are displayed. Also, in a case in which two indicators 903 are displayed, it is also possible to employ an arrangement in which two cross-sectional images corresponding to the positions of two points appointed by the indicator 903 respectively are displayed and concurrently, the distance between the two points is calculated and displayed), wherein a location of the first cross-sectional ultra-sound image from within the artery corresponds with a location of a first displayed indicator positioned along a longitudinal ultrasound image of a vessel (at least figs. 9/12 (902) and corresponding disclosure in at least [0138]) and a location of the second cross-sectional ultrasound image corresponds with a second displayed indicator positioned along the longitudinal ultrasound image of the vessel ([0161] which discloses it is possible to employ a construction in which two indicators 903, or two or more indicators 903 are displayed. Also, in a case in which two indicators 903 are displayed, it is also possible to employ an arrangement in which two cross-sectional images corresponding to the positions of two points appointed by the indicator 903 respectively are displayed and concurrently, the distance between the two points is calculated and displayed).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cohen, as currently modified, to include a second cross-sectional ultrasound image as taught by Suzuki in order to allow for a user to simultaneously visualize two cross-sectional ultrasound images while allowing for a distance between such images to be calculated and displayed (Suzuki [0161]) thereby providing further diagnostic value regarding distances along the longitudinal ultrasound image and corresponding data thereof of the system of Cohen.
Regarding claim 17,
Cohen, as modified, teaches the elements of claim 8 as previously stated. Sonck, as applied to claim 8 above, further teaches wherein the group of pressure sensors is configured to detect a physiological parameter at at least two different locations within the artery ([0149] which discloses the multiple pressure sensors are provided at different positions along the length of the pressure wire. Thus examiner notes that the group of pressure sensors are configured to detect a physiological parameter (i.e. pressure) at a same time (i.e. when stationary and not during a pull-back procedures), thus are configured to detect a pressure at the two different locations during a single heartbeat of a patient (i.e. simultaneously, thus during any single heartbeat)).
Regarding claim 18,
Cohen, as modified, teaches the elements of claim 17 as previously stated. Sonck, as applied to claim 17 above, further teaches further comprising a proximal pressure sensor ([0149] which discloses the pressure wire can comprise multiple pressure sensors (e.g. at least 10, at least 20, etc.) and the multiple pressure sensors are provided at different positions along the length of the pressure wire. Examiner notes that the group of pressure sensors may thus be considered the most distal pressure sensors and any additional pressure sensor (e.g. a 10th pressure sensor located proximally of the nine most distal (i.e. the group of pressure sensors) is the additional pressure sensor).
Regarding claim 19,
Cohen, as modified, teaches the elements of claim 18 as previously stated. Sonck, as applied to claim 17 above, further teaches wherein the additional pressure sensor is configured to detect a pressure within the artery during the same single heartbeat as the first group of sensors ([0149] which discloses the multiple pressure sensors are provided at different positions along the length of the pressure wire. Thus examiner notes that the group of pressure sensors are configured to detect a physiological parameter (i.e. pressure) at a same time (i.e. when stationary and not during a pull-back procedures), thus are configured to detect a pressure at the two different locations during a single heartbeat of a patient (i.e. simultaneously, thus during any single heartbeat)).
Regarding claim 20,
Cohen, as modified, teaches the elements of claim 19 as previously stated. Sonck, as applied to claim 17 above, further teaches wherein the additional pressure sensor is associated with the guidewire and located proximally of the group of pressure sensors (([0149] which discloses the pressure wire can comprise multiple pressure sensors (e.g. at least 10, at least 20, etc.) and the multiple pressure sensors are provided at different positions along the length of the pressure wire. Examiner notes that the group of pressure sensors may thus be considered the most distal pressure sensors and any proximal pressure sensor (e.g. a 10th pressure sensor located proximally of the nine most distal (i.e. the group of pressure sensors) is the proximal pressure sensor).
Regarding claim 21,
Cohen, as modified teaches the elements of claim 21 as previously stated. Sonck, as applied to claim 17 above, further teaches wherein the pressure map is defined based on a relationship of data from each individual pressure sensor the pressure sensors as compared to data of the additional pressure sensor (see at least fig. 5 depicting the FFR over the length.. i.e. a map [0050]-[0052] which discloses according to an embodiment, there is provided a method, wherein said set of multiple of relative pressure values were obtained: by means of a manual or motorized pullback of a pressure wire comprising at least one pressure sensor; by means of a pressure wire comprising a multiple of built-in pressure sensors and [0146] which discloses in yet another particular embodiment there is no need for a motorized pullback device but instead the FFR curve is obtained by a pressure wire comprise a multiple of built-in pressure sensor. Examiner notes that the limitation “based on” is broad and that the pressure map of fig. 5 is generated based on data from each of the sensors and thus is based on any relationship of the data compared to data of the additional pressure sensor in its broadest reasonable interpretation)
Regarding claim 22,
Cohen, as modified, teaches the elements of claim 8 as previously stated. Cohen further teaches further comprising an input unit (Col. 3 lines 46-49 which discloses the processor circuit is configured to receive, from a user input device in communication with the processor circuit, a user input selecting a portion of the longitudinal view and the screen display further comprises an indicator overlaid on the longitudinal view and identifying the portion of the longitudinal view), wherein the location of the first displayed indicator is selectively positionable along the longitudinal ultrasound image of the artery via the input device (Col. 38 lines 27-30 which discloses if a user moves the indicator of the ILD, the indicator of the extraluminal image may move to a corresponding location and a new IVUS image may be shown)
Additionally, Suzuki further an input unit (at least fig. 3 (334) and corresponding disclosure in at least, wherein the first displayed indicator (903) is selectively positionable along the longitudinal ultrasound image of the vessel via the input device ([0138] which discloses moving indicator 903 in the axial direction through the instruction input unit 334)
Regarding claim 23,
Cohen, as modified, teaches the elements of claim 8 as previously stated. Cohen further teaches further comprising wherein the location of the second displayed indicator is selectively positionable along the longitudinal ultrasound image of the artery via the input device (Col. 38 lines 27-30 which discloses if a user moves the indicator of the ILD, the indicator of the extraluminal image may move to a corresponding location and a new IVUS image may be shown)
Additionally, Suzuki further an input unit (at least fig. 3 (334) and corresponding disclosure in at least, wherein the location of the second displayed indicator (903) is selectively positionable along the longitudinal ultrasound image of the vessel via the input device ([0138] which discloses moving indicator 903 in the axial direction through the instruction input unit 334)
Examiner notes that in the alternatively modified system including the teachings of two different indicators as taught by Suzuki that a person having ordinary skill in the art would have recognized that both indicators are selectively positionable in the same manner as the single indicator of Cohen.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen and Sonck, or Cohen, Sonck, Hendriks, and Suzuki, as applied to claim 10 above, or alternatively Cohen and Sonck, as applied to claim 10 above, and further in view of Cai et al. (US 20230157672 A1), hereinafter Cai.
Regarding claim 11,
Cohen, as modified, teaches the elements of claim 10 as previously stated. Cohen further teaches wherein the first cross-sectional ultrasound image is of an area of the artery including a lesion (Col. 11 line 52-Col. 12 line 5 which discloses the processor 134 outputs image data such that an image of the lumen 120, such as a cross-sectional image of the vessel 120, is displayed on the display 132. Examiner notes that the nature of the area of the artery including a lesion is considered an intended use of the system. A limitation directed towards intended use must result in a structural difference between the prior art and the claimed invention, where the prior art system must merely be capable of displaying a cross-sectional ultrasound image of an area of the artery including a lesion. Thus it is noted that the Cohen teaches acquiring/displaying cross-sectional images of an artery, thus the display is configured to display images of an area of the artery and is capable of displaying such a first cross-sectional image in an instance where the artery comprises a lesion, such a cross-sectional image of the vessel (e.g. during a pull-back procedure) would be of an area including a lesion)
Alternatively, since Cohen does not explicitly teach imaging a vessel including a lesion, Cai, in a similar field of endeavor involving intravascular ultrasound, teaches a first cross-sectional image is of an area of a vessel including a lesion ([0122] which discloses fig. 5 is a flow chart depicting an example process by which an image (i.e. cross sectional images may be processed/segmented and may undergo image classification to identify a lesion).
Thus, It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cohen, as currently modified, to include a first cross-sectional image of an area of a vessel including a lesion, in order to allow for identification of lesions in the blood vessel during the pull-back imaging procedure and further allow for scoring of the lesion to therefore allow for a treatment strategy to be determined accordingly ([0127]-[0128])
Regarding claim 12,
Cohen, as modified, teaches the elements of claim 11 as previously stated. Cohen, or Cohen, as modified, further teaches wherein the second cross-sectional ultrasound image is a reference image (Cohen Col. 38 lines 27-30 which discloses a new IVUS image may be shown) for comparison with the first cross-sectional image (Examiner notes that the limitation is considered an intended use. A limitation directed towards intended use must result in a structural difference between the prior art and the claimed invention, where the prior art must merely teach a reference image which is capable of being used for comparison with the first cross-sectional image. Examiner thus notes that any of the images acquired during the pull-back procedure including the first cross-sectional image and the second cross-sectional image would be capable of being used for comparison with each other, thus Cohen teaches the second cross-sectional ultrasound image as recited and Suzuki [0161] which discloses an arrangement in which two cross-sectional images corresponding to the positions of two points appointed by the indicator 903 respectively are displayed, where the second cross-sectional image is considered a reference image which is capable of being used for comparison with the first cross-sectional image).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Cohen and Sonck, or Cohen, Sonck, Hendriks, and Suzuki, as applied to claim 8 above, and further in view of Gopinath et al. (US 20200295659 A1), hereinafter Gopinath.
Regarding claim 13,
Cohen, as modified, teaches the elements of claim 8 as previously stated. Cohen fails to explicitly teach annotations overlaid on the angiogram image, the annotations including indications of suggested landing zones for a stent.
Gopinath, in a similar field of endeavor involving vascular imaging, teaches annotations overlaid on an angiogram image, the annotations including indications of suggested landing zones for a stent (see fig. 3C (LZ on the angiogram image) and corresponding disclosure in at least [0126] and [0096] which discloses when selecting landing zones to deploy a particular stent)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cohen, as currently modified, to include landing zones as taught by Gopinath in order to help inform stent selection and co-registration and help landing zones be evaluated and changed (Gopinath [0126]). Such a modification would thus enhance the procedure of Cohen by providing a stent recommendation on not only the longitudinal image (see fig. 10 (1010)), but also on the angiogram image. Thus providing more information to a user to readily see the recommended stent position aligned with multiple images.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cohen and Sonck, or Cohen, Sonck, Hendriks, and Suzuki, as applied to claim 8 above, and further in view of Tominaga et al. (US 20240013385 A1), hereinafter Tominaga.
Regarding claim 14,
Cohen, as modified, teaches the elements of claim 8 as previously stated. Cohen further teaches further including additional indicia (at least fig. 10 (1010) and corresponding disclosure in at least Col. 29 lines 27-40) representing a suggested stent length (Col. 29 lines 27-40 which discloses a depiction of a stent 1010. Can be overlaid on the ILD and stent placement recommendation may include a length of stent) positioned in alignment with the longitudinal ultrasound image (see at least fig. 10)
It is unclear if the indicia representing a suggested stent length is in alignment with an indication of a lesion on the longitudinal ultrasound image.
Nonetheless, Tominaga, in a similar field of endeavor involving vascular devices, teaches indicia representing a suggested stent length (see at least fig. 13 dotted lines and corresponding disclosure in at least [0077]) is in alignment with an indication of a lesion (at least fig. 13 (MLA) and corresponding disclosure in at least [0077]) on a longitudinal ultrasound image (see at least fig. 13 depicting a longitudinal ultrasound image and [0077] which discloses the various calculated values (i.e. stent size , the plaque burden, the average lumen diameter, etc. may be displayed in a superimposed manner or in an annotation manner on the IVUS image in the longitudinal tomographic view and transverse tomographic view, for example).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cohen, as currently modified, to include the suggested stent length in alignment with an indication of a lesion as taught by Tominaga in order to assist the operator in performing the stent implant by allowing for a positional relationship between a lesion and the stent for covering the lesion to be observed in the longitudinal image accordingly (Tominaga [0076]-[0077]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen and Sonck, or Cohen, Sonck, Hendriks, and Suzuki, as applied to claim 8 above, and further in view of Parks et al. (US 2005014884 A1), hereinafter Parks.
Regarding claim 15,
Cohen, as modified, teaches the elements of claim 8 as previously stated. Sonck, as applied to claim 8 above, further teaches wherein the group of pressure sensors includes at least two sensors spaced apart ([0149] which discloses in a particular embodiment the pressure wire can comprise multiple pressure sensors, e.g. at least 10, at least 20, at least 30, at least 40, at least 50, or more pressure sensors. It is clear that according to such embodiments of the pressure wire, the multiple pressure sensors are provided at different positions along the length of the pressure wire)
It is unclear if the at least two sensors are spaced apart between approximately .5 cm and approximately 2.0 cm using a center-to-center spacing.
Parks, in a similar field of endeavor involving, vascular pressure sensing, teaches wherein pressure sensors (at least fig. 1 (112) and corresponding disclosure in at least [0065]) are spaced 1.0 cm apart between approximately .5 cm and approximately 2.0 cm using a center-to-center spacing (see [0089] which discloses separating sensor by 1.2 centimeters or less and having 32 sensors may be more preferred. IN one embodiment a spacing of one centimeter and the use of 36 circumferential sensors is used. See also at least claim 11 which recites including pressure sensors spaced at 1 cm center to center. And claim 27 reciting said pressure sensors are spaced at one centimeter intervals)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cohen, as currently modified, to include spacing the pressure sensors apart between approximately .5 cm and approximately 2.0 cm using a center-to-center spacing as taught by Parks in order to yield a high spatial resolution of the pressure mapping, which allows for detailed pressure profile mapping of the entire region of interest of most patients (Parks [0089]).
Regarding claim 16,
Cohen, as modified, teaches the elements of claim 8 as previously stated. Sonck, as applied to claim 8 above, further teaches wherein the group of sensors includes eleven sensors spaced from each other ([0149] which discloses in a particular embodiment the pressure wire can comprise multiple pressure sensors, e.g. at least 10, at least 20, at least 30, at least 40, at least 50, or more pressure sensors. It is clear that according to such embodiments of the pressure wire, the multiple pressure sensors are provided at different positions along the length of the pressure wire)
It is unclear if the pressure sensors are spaced approximately 1.0 cm apart from each other using a center to center spacing.
Parks, in a similar field of endeavor involving, vascular pressure sensing, teaches wherein pressure sensors (at least fig. 1 (112) and corresponding disclosure in at least [0065]) are spaced approximately 1.0 cm apart from each other using a center-to-center spacing (see [0089] which discloses separating sensor by 1.2 centimeters or less and having 32 sensors may be more preferred. IN one embodiment a spacing of one centimeter and the use of 36 circumferential sensors is used. See also at least claim 11 which recites including pressure sensors spaced at 1 cm center to center. And claim 27 reciting said pressure sensors are spaced at one centimeter intervals)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cohen, as currently modified, to include spacing the pressure sensors approximately 1.0 cm apart from each other using a center-to-center spacing as taught by Parks in order to yield a high spatial resolution of the pressure mapping, which allows for detailed pressure profile mapping of the entire region of interest of most patients (Parks [0089]).
Conclusion
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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