DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The proposed reply filed on 06/17/2026 has been entered. Claims 1-3 and 5-21 remain pending in the current application. The amendments to the claims have overcome the claims’ objections.
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.
Claim(s) 1-3, 5-11 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teixeira Dos Santos Paulo et al. (US 2018/0055347, hereinafter Paulo).
Regarding claim 1, Paulo teaches an integrated imaging and device deployment platform comprising (figure 1, element 100, para. 0082; endoluminal probe 100):
a catheter having an outer surface, a first end, and a second end opposite the first end (fig. 2, element 100, para. 0083; a side view of the endoluminal probe 100 and its components, specifically the operating control element 105, the flexible cylindrical extension element 106 and the probe sensing and interface element 107 in accordance with an embodiment hereof.);
an imaging unit coupled to the catheter, the imaging unit comprising an imaging window defining a field of view, the imaging unit configured to selectively move between a retracted position proximate to the second end of the catheter and an extended position such that the field of view faces outwardly from the second end of the catheter (figs. 4.1-4.6, element 114, paras. 0088-0090; The probe sensing and interface element 111 is composed by two components, the sensing element 112 and the probe working channel outlet 113 as represented in FIG. 4.1 to FIG. 4.8. The sensing element 112 in the probe sensing and interface element 111 integrates a miniaturized high definition three dimension ultrasonic transducer 114. In the progression mode the three dimension ultrasonic transducer 114 is rotated downwards to the working channel outlet 114 to preserve the same diameter as the flexible cylindrical element 106 during the progression of the probe until the anatomical endovascular or endocardiac structure to treat. When the probe sensing and interface element 111 reaches the desired anatomical location to intervene, the sensing element 113 is rotated upwards 180° around a longitudinal axis of the probe to open the working channel outlet 113. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure.);
a delivery unit coupled to the catheter, the delivery unit being configured to deploy a device from a first position to a second position, wherein the device is located within the catheter in the first position and the device extends outwardly from the second end of the catheter in the second position (figs. 8.1-8.4, paras. 0014-0019 and 0105; said probe comprising: a flexible tube having a longitudinal hollow which defines a working channel for receiving and guiding transcatheter devices or instruments for the surgical procedure. the endoluminal probe 100 is introduced thru the femoral artery until the ascending aorta to perform a deployment of a transcatheter aortic valve 126. The endoluminal probe 100 allow a safe and accurate deployment of the transcatheter aortic valve 126 regarding the coronary ostium and the aortic valve annulus and the degree and location of the calcification in the native aortic valve. The examiner notes that the probe comprise a working channel configured for deploying a transcatheter or other surgical tool from a retracted position where the tool is within the working channel with hatch door closed to an extended position where the hatched door is open and the tool extend beyond the distal end of the catheter.), and wherein, with the imaging unit in the retracted position and the device in the first position, the field of view of the imaging unit faces inwardly towards the second end of the catheter and the device within the catheter (figs. 4.1-4.5, paras. 0088-0090 and 0093; In the progression mode the three dimension ultrasonic transducer 114 is rotated downwards to the working channel outlet 114 to preserve the same diameter as the flexible cylindrical element 106 during the progression of the probe until the anatomical endovascular or endocardiac structure to treat. In the progression mode the (possibly higher definition) three dimension ultrasonic transducer 114 is rotated inwards to the working channel outlet 113 to protect the higher definition transducer interface and to preserve the same diameter as the flexible cylindrical element 106 during the progression of the probe until the anatomical endovascular or endocardiac structure to treat. The examiner notes that in a retracted position the hatched door is closed with the transducer imaging window facing inward towards the working channel and the device inside the working channel.); and
an actuator configured to move the imaging unit between the retracted position and the extended position (paras. 0037 and 0084; The operating control element 105 additionally incorporates the electrical motors and cables to operate the fine guiding of the flexible cylindrical extension element 106 and the probe sensing and interface element 107. probe comprises an embedded motor cable for opening or closing the hinge of the hatch door.).
Regarding claim 2, Paulo teaches the integrated imaging and device deployment platform of claim 1, wherein with the imaging unit in the extended position and the device in the second position, the field of view faces towards the device (figs. 4.2 and 8, para. 0090; When the probe sensing and interface element 111 reaches the desired anatomical location to intervene, the sensing element 113 is rotated upwards 180° around a longitudinal axis of the probe to open the working channel outlet 113. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure.).
Regarding claim 3, Paulo teaches the integrated imaging and device deployment platform of claim 1, wherein the imaging unit is configured to move relative to the delivery unit (paras. 0083 and 0090, The flexible cylindrical extension element 106 is designed to be introduced into a peripheral major artery or vein throughout a vascular introducer and be manually advanced until the desired anatomical vascular or cardiac structure. The progression and regression in the vascular and cardiac structure of the flexible cylindrical extension element 106 and the probe sensing and interface element 107 is obtained by pushing and pulling of the endoluminal probe 100 throughout the vascular introducer. When the probe sensing and interface element 111 reaches the desired anatomical location to intervene, the sensing element 113 is rotated upwards 180° around a longitudinal axis of the probe to open the working channel outlet 113. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure. The examiner notes that the probe working channel and the hatched door move relative to each other when in progression mode and the door is closed and when in intervention mode, the hatched door extends from retracted position as the tool extends from the working channel.).
Regarding claim 5, Paulo teaches the integrated imaging and device deployment platform of claim 1, wherein the actuator is configured to navigate and position the imaging unit and the delivery unit (para. 0084; The operating control element 105 additionally incorporates the electrical motors and cables to operate the fine guiding of the flexible cylindrical extension element 106 and the probe sensing and interface element 107.).
Regarding claim 6, Paulo teaches the integrated imaging and device deployment platform of claim 1, wherein the imaging unit coupled to the catheter is configured to be actuated with at least two degrees of movement about the catheter (figs. 4.1-4.5, paras. 0037, 0087, and 0090; the probe sensing and interface element 111 in both progression and intervention modes. When the probe sensing and interface element 111 reaches the desired anatomical location to intervene, the sensing element 113 is rotated upwards 180° around a longitudinal axis of the probe to open the working channel outlet 113. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure.).
Regarding claim 7, Paulo teaches the integrated imaging and device deployment platform of claim 1, wherein the imaging unit is connected to the catheter by a hinged connection and is configured to move between the retracted position and the extended position (para. 0019; wherein the hatch door is coupled to the distal end of the flexible tube by a hinge for opening and closing the working channel outlet, wherein the ultrasonic transducer is placed at said hatch door.).
Regarding claim 8, Paulo teaches the integrated imaging and device deployment platform of claim 1, wherein the actuator comprises a pull wire connected to the imaging unit and is configured to selectively move the imaging unit between the retracted position and the extended position (paras. 0047 and 0084; one of the motor cables is a push-pull motor cable having the tunnelled passage opening and attachment placed in the ring-shaped unit opposite the ball-joint placement, in particular the tunnelled passage being ribbon-shaped. The operating control element 105 additionally incorporates the electrical motors and cables to operate the fine guiding of the flexible cylindrical extension element 106 and the probe sensing and interface element 107.).
Regarding claim 9, Paulo teaches the integrated imaging and device deployment platform of claim 1, wherein the imaging unit is radially movable relative to the delivery unit (para. 0090; When the probe sensing and interface element 111 reaches the desired anatomical location to intervene, the sensing element 113 is rotated upwards 180° around a longitudinal axis of the probe to open the working channel outlet 113. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure.).
Regarding claim 10, Paulo teaches the integrated imaging and device deployment platform of claim 1, wherein the actuator is configured such that movement of the delivery unit causes automatic movement of the imaging unit from the retracted position to the extended position (paras. 0084, 0090, 0092; The operating control element 105 additionally incorporates the electrical motors and cables to operate the fine guiding of the flexible cylindrical extension element 106 and the probe sensing and interface element 107. rvene, the sensing element 113 is rotated upwards 180° around a longitudinal axis of the probe to open the working channel outlet 113. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for a better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure. The examiner notes that the deployment of a tool through the working channel pushes the hinged door from closed configuration to an open configuration to allow the advancement of the tool and visualization of the working field).
Regarding claim 11, Paulo teaches the integrated imaging and device deployment platform of claim 1, wherein the actuator is configured to selectively lock the imaging unit at a selected position during use of the platform (fig. 8, paras. 0065 and 0090; A push-pull motor cable is a cable able to transmit motion by its pulling. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure.).
Regarding claim 20, Paulo teaches a method of deploying a device using an integrated imaging and device deployment platform, comprising (figure 1, element 100, para. 0082; endoluminal probe 100):
providing an integrated imaging and device deployment platform, the platform comprising a catheter (fig. 2, element 100, para. 0083; a side view of the endoluminal probe 100 and its components, specifically the operating control element 105, the flexible cylindrical extension element 106 and the probe sensing and interface element 107 in accordance with an embodiment hereof.), a delivery unit comprising a device (figs. 8.1-8.4, paras. 0014-0019 and 0105; said probe comprising: a flexible tube having a longitudinal hollow which defines a working channel for receiving and guiding transcatheter devices or instruments for the surgical procedure.), an imaging unit comprising an imaging window (figs. 4.1-4.6, element 114, paras. 0088-0090; The probe sensing and interface element 111 is composed by two components, the sensing element 112 and the probe working channel outlet 113 as represented in FIG. 4.1 to FIG. 4.8. The sensing element 112 in the probe sensing and interface element 111 integrates a miniaturized high definition three dimension ultrasonic transducer 114.) and an actuation mechanism (paras. 0037 and 0084; The operating control element 105 additionally incorporates the electrical motors and cables to operate the fine guiding of the flexible cylindrical extension element 106 and the probe sensing and interface element 107. probe comprises an embedded motor cable for opening or closing the hinge of the hatch door.), the imaging window defining a field of view (para. 0088; The sensing element 112 in the probe sensing and interface element 111 integrates a miniaturized high definition three dimension ultrasonic transducer 114), the catheter comprising a first end and a second end opposite the first end (fig. 2, element 100, para. 0083; a side view of the endoluminal probe 100 and its components, specifically the operating control element 105, the flexible cylindrical extension element 106 and the probe sensing and interface element 107 in accordance with an embodiment hereof.), the imaging unit configured to selectively move between a retracted position proximate to the second end of the catheter and an extended position such that the field of view faces outwardly from the second end of the catheter (figs. 4.1-4.6, element 114, paras. 0088-0090; The probe sensing and interface element 111 is composed by two components, the sensing element 112 and the probe working channel outlet 113 as represented in FIG. 4.1 to FIG. 4.8. The sensing element 112 in the probe sensing and interface element 111 integrates a miniaturized high definition three dimension ultrasonic transducer 114. In the progression mode the three dimension ultrasonic transducer 114 is rotated downwards to the working channel outlet 114 to preserve the same diameter as the flexible cylindrical element 106 during the progression of the probe until the anatomical endovascular or endocardiac structure to treat. When the probe sensing and interface element 111 reaches the desired anatomical location to intervene, the sensing element 113 is rotated upwards 180° around a longitudinal axis of the probe to open the working channel outlet 113. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure.);
navigating the device of the integrated imaging and device deployment platform to a target location within a patient with the imaging unit in the retracted position (figs. 4.1-4.5, paras. 0088-0090 and 0093; In the progression mode the three dimension ultrasonic transducer 114 is rotated downwards to the working channel outlet 114 to preserve the same diameter as the flexible cylindrical element 106 during the progression of the probe until the anatomical endovascular or endocardiac structure to treat. In the progression mode the (possibly higher definition) three dimension ultrasonic transducer 114 is rotated inwards to the working channel outlet 113 to protect the higher definition transducer interface and to preserve the same diameter as the flexible cylindrical element 106 during the progression of the probe until the anatomical endovascular or endocardiac structure to treat. The examiner notes that in a retracted position the hatched door is closed with the transducer imaging window facing inward towards the working channel and the device inside the working channel.);
activating the actuation mechanism to move the delivery unit toward the target location to deploy the device from a first position to a second position, wherein the device is located within the catheter in the first position and the device extends outwardly from the second end of the catheter in the second position (paras. 0014-0015, 0084, and 0105; said probe comprising: a flexible tube having a longitudinal hollow which defines a working channel for receiving and guiding transcatheter devices or instruments for the surgical procedure. The operating control element 105 additionally incorporates the electrical motors and cables to operate the fine guiding of the flexible cylindrical extension element 106 and the probe sensing and interface element 107. The endoluminal probe 100 is introduced thru the femoral artery until the ascending aorta to perform a deployment of a transcatheter aortic valve 126. The endoluminal probe 100 allow a safe and accurate deployment of the transcatheter aortic valve 126 regarding the coronary ostium and the aortic valve annulus and the degree and location of the calcification in the native aortic valve. The examiner notes that the probe comprise a working channel configured for deploying a transcatheter or other surgical tool from a retracted position where the tool is within the working channel with hatch door closed to an extended position where the hatched door is open and the tool extend beyond the distal end of the catheter.), and wherein, with the imaging unit in the retracted position and the device in the first position, the field of view of the imaging unit faces inwardly towards the second end and towards the device within the catheter(figs. 4.1-4.5, paras. 0088-0090 and 0093; In the progression mode the three dimension ultrasonic transducer 114 is rotated downwards to the working channel outlet 114 to preserve the same diameter as the flexible cylindrical element 106 during the progression of the probe until the anatomical endovascular or endocardiac structure to treat. In the progression mode the (possibly higher definition) three dimension ultrasonic transducer 114 is rotated inwards to the working channel outlet 113 to protect the higher definition transducer interface and to preserve the same diameter as the flexible cylindrical element 106 during the progression of the probe until the anatomical endovascular or endocardiac structure to treat. The examiner notes that in a retracted position the hatched door is closed with the transducer imaging window facing inward towards the working channel and the device inside the working channel.);
moving the imaging unit from the retracted position to the extended position with the field of view facing outwardly from the second end of the catheter and toward the target location to acquire real-time imaging information regarding an anatomy of the patient via the imaging unit (para. 0090; When the probe sensing and interface element 111 reaches the desired anatomical location to intervene, the sensing element 113 is rotated upwards 180° around a longitudinal axis of the probe to open the working channel outlet 113. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure.); and
using the information from the imaging unit to position the delivery unit at the target location for the device (para. 0105; FIG. 8.1—the endoluminal probe 100 is introduced thru the femoral artery until the ascending aorta to perform a deployment of a transcatheter aortic valve 126. The endoluminal probe 100 allow a safe and accurate deployment of the transcatheter aortic valve 126 regarding the coronary ostium and the aortic valve annulus and the degree and location of the calcification in the native aortic valve. FIG. 8.4—the endoluminal probe 100 is introduced thru the femoral artery thru the true lumen until the ascending aorta to identify the tear from an ascending aorta dissection and place by direct reconstruction three dimensional real-time vision a sealing endoprosthesis stent 132 to occlude and correct the dissection.).
Regarding claim 21, Paulo teaches the integrated imaging and device deployment platform of claim 2, wherein with the imaging unit in the extended position and the device in the second position, the device is located within the field of view of the imaging unit (paras. 0090 and 0105; When the probe sensing and interface element 111 reaches the desired anatomical location to intervene, the sensing element 113 is rotated upwards 180° around a longitudinal axis of the probe to open the working channel outlet 113. In the Intervention mode the three dimension ultrasonic transducer 114 is positioned in an upper position for better angle to point the three dimension ultrasonic transducer 114 frontward in the same direction as the working channel outlet 113 to allow the anterior sensing and visualization of the working channel outlet 113 working field in the anatomical endovascular or endocardiac structure.).
Allowable Subject Matter
Claims 12-19 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of record fail to disclose or render obvious the device of claim 12 and dependent claims thereof, when taken as a whole to include an integrated imaging and device deployment platform comprising: a catheter having an outer surface defining a recess; an imaging unit connected to the catheter, the imaging unit comprising an imaging window defining a field of view, and a steerable distal end portion configured to selectively move between a retracted position in which the field of view faces inwardly towards the recess in the outer surface of the catheter and an extended position; a delivery unit connected to the catheter, the delivery unit being configured to deploy a device from a first position to a second position; a loop extending from the catheter, the loop surrounding the device when the device is in the second position; and wherein, with the imaging unit in the extended position and the device in the second position, the field of view faces towards the device and the loop surrounding the device.
Bielewicz, teaches a catheter surface comprising a recess and a transducer comprising an imaging window configured to be disposed in the recess when the transducer is in a retracted position and extend to a forward looking configuration when in extended position to visualize a tool deployed from the lumen of the catheter. However, Bielewicz fails to explicitly teach that when the transducer is in retracted position within the recess, the field of view faces the recess and when in extended position a loop extending from the catheter and surrounding the device is in the field of view of the transducer.
Paulo, teaches a probe comprising a working channel for deploying and guiding a device and hatched door where an ultrasound transducer is attached to. When the device is in progression mode, the hatched door is closed with the transducer facing the working channel and the device within the working channel; and when in intervention mode, the hatched door is open and the transducer facing forward, such that the working field of the device is within the field of view of the transducer. However, Paulo, fails to teach of suggest a catheter surface defining a recess and when the transducer is in retracted position within the recess, the field of view faces the recess and when in extended position a loop extending from the catheter and surrounding the device is in the field of view of the transducer.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3 and 20-21 have been considered but are moot in view of the claims amendments because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see remarks, filed on 06/17/2026, with respect to amendments to claim 12 and its dependent claims have been fully considered and are persuasive. The rejection of claims 12-19 has been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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/ZAINAB MOHAMMED ALDARRAJI/Patent Examiner, Art Unit 3797
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