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 large number of references cited on the Information Disclosure Statements have been afforded a cursory review, similar to what would be expected of a classification search of the prior art. Should there be any references of particular relevance to the instant application claims, applicant is respectfully requested to identify such references for further review by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 11 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turovskiy et al (WO 2023/076641).
Regarding claim 1, Turovskiy et al provide an ablation balloon catheter comprising an outer catheter shaft (304 – Figure 4D, for example), an inflatable balloon (300) coupled at a first end to the outer shaft, and a translatable nose tip (308) to which a second end of the inflatable balloon is coupled. See, also, Figure 7, which shows the tip in relation to the balloon and paragraph [0158] which discloses a actuator to expand/retract the structure as is generally known in the art. There is a first electrode basket having a plurality of first splines (502a) that surround the balloon (Fig. 5C, for example), the first basket coupled to the catheter shaft at a first end and to the nose tip ((302/310) at a second end. A second electrode basket having a second plurality of splines (502b) are connected to the catheter shaft and the nose tip similar to the first basket (Figure 5c). The first and second set of splines are radially offset (Figures 5C and 5D) and each of the splines may support one or more electrodes. There is an actuator for translating the nose tip to facilitate moving the basket between collapsed and expanded states (para. [0158], for example) and the splines are configured to deploy and radially expand under inflation of the inflatable balloon with the first and second splines interposed between each other (Figure 5D).
Regarding claim 2, see Figure 5D which shows at least six splines for each basket. Regarding claim 3, see, for example, Figure 6D which shows a solid cylindrical shaped collar for securing the baskets. Regarding claim 4, each spline may have one or more electrodes (para. [0024], for example). Regarding claim 5, see again the Figures and paragraph [0024]. Regarding claim 6, the balloon may be compliant (para. [0101], for example). Regarding claims 6 and 7, the baskets may be formed of a non-compliant material such as polyimide (para. [0103], for example). Regarding claim 8, see again paragraph [0158] which discloses the well-known use of an actuator coupled to the handle to actuate the device. Regarding claim 11, the nose tip is a flexible, blunt tip (Figure 7, for example). Regarding claim 20, the electrodes may be provided on a conductive trace (para. [0103]) and regarding claim 21, the energy source may be a pulsed electric field (i.e. PFA) source (para. [0015], for example). Regarding claim 22, see Figures 11A and 11B, for example, which show a solid cylindrical collar at the proximal and distal ends of each basket catheter.
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.
Claims 9, 10, 16, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al (WO 2023/076641) in view of the teaching of Claude et al (2019/0307323).
Regarding claims 9 and 10, Turovskiy et al disclose an ablation balloon device including actuation means to expand/retract the splines as addressed previously, but fail to expressly show the actuator as a tube and its connection between the handle and the nose tip.
Claude et al disclose another balloon ablation device comprising a catheter having a balloon mounted thereon, and a plurality of splines supporting electrodes on the surface of the balloon. In particular, Claude et al teach that it is known to provide an actuator that may be used to expand/retract the splines, as well as control the shape of the balloon. The actuator includes a tube (54) that connected to the distal end of the balloon (Figure 2A) and is axially movable to allow the distal end of the balloon to be moved to control the shape of the balloon (para. [0071], for example). Paragraph [0189] specifies the actuator is on the handle, as is generally well-known in the art. Claude et al disclose the use of nitinol to make various elements, and the use of nitinol to make the actuator tube is deemed an obvious consideration for one of ordinary skill in the art given the widespread use of nitinol in fabricating various different medical components.
To have provided the Turovskiy et al device with an actuator comprising a tubular actuator to actuate the distal end of the device to expand the splines and change the shape of the balloon would have been an obvious modification for one of ordinary skill in the art at the time of the invention, particularly since Turovskiy et al disclose there is an actuator for expanding the splines and further in view of the teaching of Claude et al who provide a tubular actuator through the balloon to the distal end of the device to actuate the distal end.
Regarding claim 16, Turovskiy et al broadly disclose the use of a visualization device (i.e. camera) in the system (para. [0170], for example), but fail to expressly show the visualization device within the balloon. Claude et al teach that a camera/visualization device (32) may be located within the balloon for viewing tissue during the procedure. See, for example, Figures 2A and 5.
To have provided the Turovskiy et al device with a visualization means (i.e. camera) in the balloon to allow for viewing tissue during the procedure would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Claude et al fairly teach it is known to provide a camera in a similar balloon ablation system.
Regarding claim 24, Turovskiy et al provide an ablation balloon catheter comprising an outer catheter shaft (304), an inflatable balloon (300), a translatable nose tip (Figure 7)and a first electrode basket having a plurality of splines (502a) wherein the splines contain electrodes as addressed with respect to claim 1 above. Turovskiy et al further disclose an actuator as addressed with respect to claim 1 to collapse the splines, and the balloon may be used to expand the splines. Turovskiy et al disclose a camera may be provided with the device, but fail to expressly show the camera (i.e. endoscope) in the balloon. As addressed above, Claude et al disclose an endoscope (i.e. camera) in the balloon device, and providing such a camera in the Turovskiy et al device would be an obvious design consideration for one of ordinary skill in the art for the same reasons addressed previously. Regarding claim 25, Turovskiy et al provide a second electrode basket including a second set of splines (502b – Figures 5c and 5d) with the second splines radially offset from the first set of splines (Figure 5D) and each of the splines containing one or more electrodes and configured to deploy radially under inflation of the balloon (Figure 5D).
Claims 12-15 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al (WO 2023/076641) in view of the teaching of Paddock et al (6,238,389).
As addressed previously, Turovskiy et al disclose an actuator that may be advanced/retracted to expand/retract the splines, but Turovskiy et al fail to specifically show the slider located in the handle. The examiner maintains that the use of sliders or rotating levers to actuate an actuator to advance/retract to operate an end effector is generally well known in the art. In particular, Paddock et al disclose a similar balloon ablation device and provide an actuator movable by a slider (66) contained within the handle of the device. See, for example, Figures 5A-5C). The slider is actuated to move the actuator proximally/distally to effect operation of an end effector.
To have provided the Turovskiy et al device with a slider on the handle to actuate the actuator and move it longitudinally to expand/retract the splines would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Paddock et al fairly teach it is known to provide a slider on a handle of a catheter device to provide longitudinal movement to an actuator.
Regarding claim 13, the slider of Paddock when extended (i.e. pushed forward) moves the actuator forward as is generally known in the art and would result in the movement of the splines in the Turovskiy et al device in the collapsed (i.e. extended) state. Regarding claims 14 and 15, Paddock et al also provide springs (71,72) to bias the slider in the extended position.
Regarding claim 23, Turovskiy et al disclose an ablation balloon catheter comprising an outer shaft, an inflatable balloon (300) and an axially translatable nose tip with an electrode basket surrounding the balloon as addressed previously. See, for example, Figures 5C and 5D. Turovskiy et al broadly disclose an actuator for actuating the splines as addressed previously, but fail to show the actuator and/or disclose the actuator is spring biased to the extended position as required by this claim.
As addressed previously, the examiner maintains that the use of sliders or rotating levers to actuate an actuator to advance/retract to operate an end effector is generally well known in the art. In particular, Paddock et al disclose a similar balloon ablation device and provide an actuator movable by a slider (66) contained within the handle of the device. See, for example, Figures 5A-5C). The slider is actuated to move the actuator proximally/distally to effect operation of an end effector, and the slider is spring biased (springs (71,72) to the extended position.
To have provided the Turovskiy et al device with a spring-biased slider on the handle to actuate the actuator and move it longitudinally to expand/retract the splines would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Paddock et al fairly teach it is known to provide a slider on a handle of a catheter device to provide longitudinal movement to an actuator.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al (WO 2023/076641) in view of the teaching of Claude et al (2019/0307323) and further in view of the teaching of Paddock et al (6,238,389).
The combination of the Claude et al teaching with the Turovskiy et al system has been addressed previously. While both Claude et al and Turovskiy et al disclose an actuator to actuate the end effector, neither reference specifically shows the actuator on the handle and having a spring bias to maintain the actuator in the extended position.
As addressed above, Paddock et al disclose a similar balloon ablation device and provide an actuator movable by a slider (66) contained within the handle of the device. See, for example, Figures 5A-5C). The slider is actuated to move the actuator proximally/distally to effect operation of an end effector, and the slider is spring biased (springs (71,72) to the extended position.
To have provided the Turovskiy et al device, as modified by the teaching of Claude et al, with a spring-biased slider on the handle to actuate the actuator and move it longitudinally to expand/retract the splines would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Paddock et al fairly teach it is known to provide a slider on a handle of a catheter device to provide longitudinal movement to an actuator.
Claims 1-8, 11, 16-22, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Melsky et al (2022/0323143) in view of the teaching of Turovskiy et al (WO 2023/076641).
Regarding claim 1, Melsky et al provide an ablation balloon catheter comprising an outer catheter shaft (2) and an inflatable balloon (8) at a first end of the shaft. A first electrode basket (4) is coupled to the outer catheter shaft with a second end coupled to a nose tip (Figure 1, for example). The basket is expandable to expand the splines and there is an actuator to collapse the splines (para. [0113], for example). The basket includes a plurality of splines with a plurality of electrodes on the splines. Melsky et al fails to disclose a second electrode basket having splines rotationally offset from the splines of the first electrode basket as claimed. The examiner maintains that providing two overlapping baskets, as opposed to one basket with a greater number of splines, is an obvious design expedient that results in essentially the same structure. However, Turovskiy et al is cited that it is generally known to provide two distinct baskets whereby the splines (502a) of one basket are radially offset from the splines (502b) of the second basket. See, for example, Figures 5C and 5D. Turovskiy et al also disclose an actuator coupled to the distal tip to expand/collapse the baskets (para. [0158], for example).
To have provided the Melsky et al basket as two individual baskets having radially offset splines would have been an obvious design consideration for one of ordinary skill in the art at the time of the invention since Turovskiy et al fairly teach it is known to provide an analogous ablation balloon catheter device with two inter-woven baskets provided over a balloon structure.
Regarding claim 2, the number of splines is deemed an obvious design consideration, and Turovskiy et al disclose a device that comprises 6 splines per basket. Regarding claim 3, both Melsky et al and Turovskiy et al disclose a solid cylindrical collar at the proximal and distal ends of the basket structure. Regarding claims 4 and 5, both Melsky et al and Turovskiy et al disclose multiple electrodes on each spline element of the basket. Regarding claim 6, both Melsky et al (Abstract, for example) and Turovskiy et al disclose a compliant balloon and a non-compliant basket material. Regarding claim 7, both Melsky et al (para. [0055]) and Turovskiy et al disclose the use of polyimide for the basket structure. Regarding claim 8, Turovskiy et al disclose an actuator comprising an elongate member connected to a handle (para. [0156], for example). Regarding claim 11, Melsky et al (Figure 3, for example) and Turovskiy et al disclose a flexible, blunt tip for the catheter body. Regarding claims 16-18, Melsky et al disclose an endoscope mounted to the balloon and movable axially and rotatably within the balloon (para. [0078-0082], for example). Regarding claim 20, both Melsky et al (para. [0137], for example) and Turovskiy et al provide electrodes as a conductive trace connected to an ablative energy source. Regarding claim 21, both Melsky et al (para. [0037], for example) and Turovskiy et al disclose the use of PFA as the ablation energy source. Regarding claim 22, both Melsky et al (Figure 1, for example) and Turovskiy et al disclose basket structures having solid cylindrical shaped collar body on the proximal and distal ends of the basket.
Regarding claim 24, Melsky et al disclose an ablation balloon catheter comprising an outer catheter shaft (2), and inflatable balloon (8) coupled to the catheter and a forward-looking endoscope disposed within the balloon (para. [0078-0082], for example). There is a nose tip (7) to which the balloon is coupled, and a first electrode basket having a plurality of splines (4) that surround the balloon, the splines having electrodes (5). Melsky et al fail to expressly disclose an actuator for translating the nose tip to expand/collapse the splines.
Turovskiy et al disclose a substantially analogous device comprising a catheter having a balloon structure and a basket structure over the balloon as addressed previously. In particular, Turovskiy et al teach that it is known to provide an actuator to the distal tip of the device to control the expansion/collapse of the basket structure (para. [0158], for example).
To have provided the Melsky et al device with an actuator coupled to the distal tip of the device to control the expansion and collapse of the basket structure would have been an obvious alternative means to control the actuation of the basket to one of ordinary skill in the art at the time of the invention since Turovskiy et al fairly teach it is known to use such an actuator to expand and collapse a basket structure provided over a balloon.
Regarding claim 25, Turovskiy et al also disclose the use of separate first and second baskets disposed over a balloon with the splines of the first and second baskets radially offset. To have provided such a second basket to the Melsky et al device would have been an obvious consideration for the skilled artisan for the same reasons addressed with respect to claim 1 above.
Claims 9, 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Melsky et al (2022/0323143) in view of the teaching of Turovskiy et al (WO 2023/076641) and further in view of the teaching of Claude (2019/0307323).
The combination of the Turovskiy et al teachings with the Melsky et al system have been addressed above. While Turovskiy et al provide a teaching of using an actuator to control deployment of the basket structure, the actuator is not expressly shown. It is noted that slidable actuators are generally well-known in the art.
Claude et al disclose another balloon ablation device comprising a catheter having a balloon mounted thereon, and a plurality of splines supporting electrodes on the surface of the balloon. In particular, Claude et al teach that it is known to provide an actuator that may be used to expand/retract the splines, as well as control the shape of the balloon. The actuator includes a tube (54) that connected to the distal end of the balloon (Figure 2A) and is axially movable to allow the distal end of the balloon to be moved to control the shape of the balloon (para. [0071], for example). Paragraph [0189] specifies the actuator is on the handle, as is generally well-known in the art. Claude et al disclose the use of nitinol to make various elements, and the use of nitinol to make the actuator tube is deemed an obvious consideration for one of ordinary skill in the art given the widespread use of nitinol in fabricating various different medical components.
To have provided the Melsky et al device, as modified by the teachings of Turovskiy et al, with an actuator comprising a tubular member to actuate the distal end of the device to expand the splines and change the shape of the balloon would have been an obvious modification for one of ordinary skill in the art at the time of the invention, particularly since Turovskiy et al disclose there is an actuator for expanding the splines and further in view of the teaching of Claude et al who provide a tubular actuator through the balloon to the distal end of the device to actuate the distal end.
Claims 12-15, 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Melsky et al (2022/0323143) in view of the teaching of Turovskiy et al (WO 2023/076641) and further in view of the teaching of Paddock et al (6,238,389).
The combination of the Turovskiy et al teachings with the Melsky et al system have been addressed above. Again, while Turovskiy et al disclose an actuator to actuate the splines of the basket member, there is no depiction of the actuator mechanism in the figures and no express showing of a slider in the handle. The examiner continues to assert that the use of sliding actuators in medical devices is generally well-known in the art.
Paddock et al, as addressed previously, disclose a similar balloon ablation device and provide an actuator movable by a slider (66) contained within the handle of the device. See, for example, Figures 5A-5C. The slider is actuated to move the actuator proximally/distally to effect operation of an end effector, and the slider is spring biased (springs (71,72) to the extended position.
To have provided the Melsky et al device, as modified by the teaching of Turovskiy et al, with a spring-biased slider on the handle to actuate the actuator and move it longitudinally to expand/retract the splines would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Paddock et al fairly teach it is known to provide a slider on a handle of a catheter device to provide longitudinal movement to an actuator.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Salahieh et al (11,684,415) and Basu et al (2018/0184982) disclose other balloon catheter devices having a basket structure over the balloon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/ February 13, 2026