DETAILED ACTION
Applicant’s amendments and remarks, filed in the October 27, 2025 response, are fully acknowledged by the Examiner. Currently, claims 1-23 and 31-36 are pending with claims 24-30 canceled, claims 31-36 newly added and claims 6, 10 and 17 amended. The following is a complete response to the October 27, 2025 communication.
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 .
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.
Election/Restrictions
Applicant’s election of Group I, claims 1-23 in the reply filed on October 27, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Newly filed claims 31-36 are being considered in the instant response as directed to elected Group I.
Claims 24-30, previously directed to Group II as indicated in the August 26, 2025 Restriction Requirement, are withdrawn from consideration as Applicant has cancelled these claims in the instant response.
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 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waldstreicher et al. (US Pat. Pub. 2019/0231425 A1).
Regarding claim 1, Waldstreicher provides for an apparatus comprising a shaft configured to be navigated through an anatomy toward a target tissue of a patient (106), and a plurality of electrodes disposed on a distal portion of the shaft and spaced axially along the shaft (plurality of 108 as in figure 46), the plurality of electrodes including a distal electrode (distal most 108) and a proximal set of electrodes (at least two of 108 proximal to the distalmost 108), the distal electrode configured to transition from a unexpanded configuration to an expanded configuration independently from the proximal set of electrodes to anchor the distal portion of the shaft relative to the target tissue (see [0414] providing that “expansion of one or more energy delivery bodies 108 can be controlled independently”), the proximal set of electrodes configured to transition from a unexpanded configuration to an expanded configuration to engage and expand neighboring tissue (via the expansion of the proximal 108 as defined above),
the plurality of electrodes, after the distal electrode and the proximal set of electrodes are in the expanded configuration, being configured to deliver pulsed field ablation to the target tissue (see at least [0326] with the 108 functionally capable of delivering pulsed field ablation).
Regarding claim 2, Waldstreicher provides that each electrode from the plurality of electrodes includes an expandable element and a conductive element (see, for example, [0385] providing for each 108 being a braided element where a first wire 120 is an expandable element and another 120 is a conductive element).
Regarding claim 3, Waldstreicher provides that the shaft defines one or more lumens (a lumen defined through the shaft 106), and that the expandable elements of the plurality of electrodes being in fluid communication with the one or more lumens (fluid communication exists between the lumen in the shaft 106 and the structure of each of 108).
Regarding claim 4, Waldstreicher provides that each electrode from the plurality of electrodes includes a cylindrical braid formed from a plurality of conductive strands (see at least [0385] providing for the braid formed by 120).
Regarding claim 6, Waldstreicher provides that the claimed apparatus is capable of treating a target tissue that is a prostate of the patient and that the plurality of electrodes are configured to engage and expand a wall of the a urethra. The Examiner is of the position that claimed target tissue locations set forth in claim 6 are directed to further functional recitations of the claimed apparatus. It is well established that such a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the Examiner does not find that the claimed tissue locations result in a structural different between the instant claim and that of Waldstreicher.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Waldstreicher et al. (US Pat. Pub. 2019/0231425 A1) as applied to claim 1 above, and further in view of Shimada et al. (US Pat. Pub. 2022/0095979 A1).
Regarding claim 5, while Waldstreicher provides for the fixing of a single electrode at one end to the shaft such that both the first and second electrode moved along the shaft so as to transition each electrode from the unexpanded to the expanded configuration, Waldstreicher fails to provide that each electrode from the plurality of electrodes has a first end that is fixed to the shaft and a second end that is configured to move along the shaft as the electrode is transitioned from the unexpanded configuration to the expanded configuration.
Shimada discloses a similar device as that of Waldstreicher that includes a first and a second expandable electrode (see figure 2 with 204 and 206) wherein each electrode is fixed at one end (at 208) and movable at the other end (209) to transition each electrode from the unexpanded to the expanded configuration (see [0070]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized proximal attachment points and distal movement portions for each of the electrodes of Waldstreicher to provide for an alternative manner of independently actuating the electrodes from the unexpanded to the expanded configuration. Waldstreicher already contemplates the independent actuation (see [0414] providing that “expansion of one or more energy delivery bodies 108 can be controlled independently”) as well as the inclusion of individual pull wires (see [00389]) that would readily lend to the alternative construction contemplated with the combination with Shimada.
Claims 9-17, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Sodden et al (WO 2023/161492 A1) further in view of Lee et al. (US Pat. Pub. 2020/0253659 A1).
Regarding claim 9, Soden provides for an apparatus comprising a shaft configured be disposed near a target tissue of a patient (1010),
a first electrode (element 1003) including a first conductive element and a first expandable element (with respect to the element embodiment in figure 5C and page 28; 5-11, the expandable body is a balloon forming the expandable element and the electrode 301 as the conductive element), and
a second electrode (element 1002) including a second conductive element and a second expandable element (with respect to the element embodiment in figure 5C and page 28; 5-11, the expandable body is a balloon forming the expandable element and the electrode 301 as the conductive element), at least one of the first electrode or the second electrode in the expanded configuration configured to engage and expand neighboring tissue (via each of 1003 and 1002 being capable of expansion into tissue), and the first electrode and the second electrode configured to deliver pulsed field ablation to the target tissue (see at least page 17; 10-18 providing for the ability to deliver PFA via the electrodes capable of delivering energy capable of electroporation).
Soden fails to specifically provide, with respect to the embodiment in figures 13a/b and 5c for the shaft to define a first lumen and a second lumen along a length thereof, the first lumen configured to convey fluid to the first expandable element to expand the first expandable element such that the first conductive element transitions from an unexpanded configuration to an expanded configuration and, the second lumen configured to provide fluid to expand the second expandable element such that the second conductive element transitions from an unexpanded configuration to an expanded configuration.
Lee provides for a similar apparatus for treating within the body via the application of energy wherein the apparatus includes a first expandable element and a second expandable element (each of the elements 320). Lee further provides for a first lumen configured to convey fluid to the first expandable element to expand the first expandable element transitions from an unexpanded configuration to an expanded configuration and, for the second lumen configured to provide fluid to expand the second expandable element such that the second expandable element transitions from an unexpanded configuration to an expanded configuration. Such is provided for in [0028] of Lee teaching that “[e]ach of the proximal and distal balloons can be fed by a separate lumen that extends to a proximal end of the device so as to be independently inflatable” and further provided for in [0036] for “a pair of balloon inflation ports 822 that allow for independent balloon inflation”.
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the first and second lumen arrangement contemplated in Lee for the individual expansion of each of the first and second balloon of the device of Soden. Such would provide the ability to independent control inflation of the elements at a target location to ensure that proper contact is achieved between the element and the lumen within the body.
Regarding claim 10, in view of the combination with Lee above, the combination further provides that the first lumen terminates in a first opening defined by the a distal portion of the shaft and the second lumen terminates in a second opening defined by the distal portion of the shaft (see, again, [0036] providing for “a pair of balloon inflation ports 822 that allow for independent balloon inflation).
Regarding claim 11, in view of the combination with Lee above, the combination further provides that the first expandable element is disposed around the first opening, and the second expandable element is disposed around the second opening (see, again, [0036] providing for “a pair of balloon inflation ports 822 that allow for independent balloon inflation).
Regarding claim 12, Soden provides that the first expandable element and the second expandable element are inflatable balloons (balloons as in page 28; 5-11).
Regarding claim 13, Soden provides for a third electrode (1001) including a third conductive element and a third expandable element (with respect to the element embodiment in figure 5C and page 28; 5-11, the expandable body is a balloon forming the expandable element and the electrode 301 as the conductive element).
The combination in the rejection of claim 9 above fails to specifically provide that the second lumen is configured to convey fluid to the third expandable element to expand the third expandable element such that the third conductive element transitions from an unexpanded configuration to an expanded configuration. However, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the second lumen of the combination with Lee above to inflated both the second and third expandable elements. Lee readily contemplates that multiple balloons can be inflated by individual lumens or via a common lumen (see [0028]). Thus, the Examiner is of the position that the selection of filling two expandable elements of the plurality of elements with a common lumen would have been obvious to one of ordinary skill in the art that would function equally as well to convey an inflation fluid to the second and third expandable element in use.
Regarding claim 14, in view of the combination with Lee above, Lee further provides for the inclusion of a flow control mechanism at the proximal end of the shaft, wherein the flow control mechanism includes a first configuration in which fluid is allowed to flow through the first lumen and is prevented from flowing through the second lumen (see figure 8 with the proximal assembly at 822 with the two separate ports for inflation; inflation through the first port for the first lumen would allow flow through the first lumen and then not through the second lumen).
Regarding claim 15, in view of the combination in the rejection of claim 14 above, the combination with Lee further provides that the flow control mechanism includes a second configuration in which fluid is allowed to flow through the second lumen (inflation through the second port for the second lumen would allow flow through the second lumen).
Regarding claim 16, Soden provides that the first electrode and the second electrode each include a cylindrical braid formed from a plurality of conductive strands (see page 21; 27-33 for the bodies to be “a polymeric balloon to expand a flexible electrode fabric”).
Regarding claim 17, Soden provides that the claimed apparatus is capable of treating a target tissue that is a prostate of the patient and that the first and second electrodes are configured to engage and expand a wall of the a urethra. The Examiner is of the position that claimed target tissue locations set forth in claim 17 are directed to further functional recitations of the claimed apparatus. It is well established that such a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the Examiner does not find that the claimed tissue locations result in a structural different between the instant claim and that of Soden.
Regarding claim 35, in view of the combination in the rejection of claim 9 above, the combination provides that the first electrode is configured to transition from the unexpanded configuration to the expanded configuration independently from the second electrode ([0028] of Lee teaching that “[e]ach of the proximal and distal balloons can be fed by a separate lumen that extends to a proximal end of the device so as to be independently inflatable” and further provided for in [0036] for “a pair of balloon inflation ports 822 that allow for independent balloon inflation”).
Regarding claim 36, Soden provides that the first electrode is disposed distal to the second electrode (see figures 13a/b with 1003 distal to 1002).
Claims 7, 8, 18-23, 31, 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Waldstreicher et al. (US Pat. Pub. 2019/0231425 A1) further in view of Spencer et al. (US Pat. Pub. 2013/0041391 A1).
Regarding claims 7, Waldstreicher fails to provide that the shaft further includes a first marker and a second set of markers, the first marker disposed at a proximal end of the distal electrode, each marker from the second set of markers disposed at a proximal end of an electrode from the proximal set of electrodes. Spencer discloses an exemplary manner of providing a plurality of markers relative to an expandable element of a catheter. Spencer specifically provides for the inclusion of markers (375) to be positioned relative to an expandable element (352) with such to be positioned at a proximal end of the element (see [0093]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a plurality of markers with a marker disposed at the proximal end of each of the electrodes of Waldstreicher in view of the teaching of Spencer. Such would provide, as discussed in [0093] of Spencer, for the ability to place the plurality of electrodes at desired locations within the body.
Regarding claim 8, in view of the combination with Spencer in claim 7 above, the combination would provide that each of the first marker or the second set of markers is of a distinct color ((via the bands 375 of Spencer having a color) .
Regarding claim 18, Waldstreicher provides for an apparatus comprising a shaft configured to be navigated through a working channel of a cystoscope to a urethra of a patient (106 is capable of being inserted as claimed), a plurality of electrodes spaced axially along a distal portion of the shaft (plurality of 108 s in figure 46), the plurality of electrodes configured to transition from an unexpanded configuration to an expanded configuration (see [0414] providing that “expansion of one or more energy delivery bodies 108 can be controlled independently”) in which at least one of the plurality of electrodes is configured to engage and expand a wall of the urethra (via the ability of each electrode 108 to expand) and deliver pulsed field ablation energy to at least a portion of the urethra and prostate tissue adjacent thereto (see at least [0326] with the 108 functionally capable of delivering pulsed field ablation).
Waldstreicher fails to provide for the claimed a plurality of markers, wherein each marker from the plurality of markers disposed at a proximal end of a respective electrode from the plurality of electrodes to indicate when the respective electrode is disposed distal to a distal end of the cystoscope.
Spencer discloses an exemplary manner of providing a plurality of markers relative to an expandable element of a catheter. Spencer specifically provides for the inclusion of markers (375) to be positioned relative to an expandable element (352) with such to be positioned at a proximal end of the element (see [0093]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a plurality of markers with a marker disposed at the proximal end of each of the electrodes of Waldstreicher in view of the teaching of Spencer. Such would provide, as discussed in [0093] of Spencer, for the ability to place the plurality of electrodes at desired locations within the body.
Regarding claim 19, Waldstreicher provides that the plurality of electrodes includes a distal electrode and a proximal electrode (a distal and a proximal one of electrodes 108).
Regarding claim 20, in view of the combination with Spencer in claim 18 above, the combination would provide that the plurality of markers includes a first marker disposed at a proximal end of the distal electrode and a second marker disposed at a proximal end of the proximal electrode. Specifically, Spencer provides that the bands 375 are “positioned proximal and distal of the balloons 375”.
Regarding claim 21, in view of the combination with Spencer in claim 18 above, the combination would provide that the first marker is visually different from the second marker (via the first marker and second marker to be located at different locations along the device so as to be visually differentiated at different locations).
Regarding claim 22, in view of the combination with Spencer in claim 18 above, the combination would provide the plurality of markers include colored markers (via the bands 375 of Spencer having a color).
Regarding claim 23, Waldstreicher provides that each electrode from the plurality of electrodes includes a cylindrical braid formed from a plurality of conductive strands (see at least [0385] providing for the braid formed by 120).
Regarding claim 31, Waldstreicher provides that each electrode from the plurality of electrodes includes an expandable element and a conductive element (see, for example, [0385] providing for each 108 being a braided element where a first wire 120 is an expandable element and another 120 is a conductive element).
Regarding claim 32, Waldstreicher provides that the shaft defines one or more lumens, (a lumen defined through the shaft 106), and that the expandable elements of the plurality of electrodes being in fluid communication with the one or more lumens (fluid communication exists between the lumen in the shaft 106 and the structure of each of 108).
Regarding claim 34, Waldstreicher provides that the distal electrode is configured to transition from the unexpanded configuration to the expanded configuration independently from the proximal electrode (see [0414] providing that “expansion of one or more energy delivery bodies 108 can be controlled independently”).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Waldstreicher et al. (US Pat. Pub. 2019/0231425 A1) further in view of Spencer et al. (US Pat. Pub. 2013/0041391 A1) as applied to claim 18 above, and further in view of Shimada et al. (US Pat. Pub. 2022/0095979 A1).
Regarding claim 33, while Waldstreicher provides for the fixing of a single electrode at one end to the shaft such that both the first and second electrode moved along the shaft so as to transition each electrode from the unexpanded to the expanded configuration, Waldstreicher fails to provide that each electrode from the plurality of electrodes has a first end that is fixed to the shaft and a second end that is configured to move along the shaft as the electrode is transitioned from the unexpanded configuration to the expanded configuration. Spencer fails to cure this deficiency.
Shimada discloses a similar device as that of Waldstreicher that includes a first and a second expandable electrode (see figure 2 with 204 and 206) wherein each electrode is fixed at one end (at 208) and movable at the other end (209) to transition each electrode from the unexpanded to the expanded configuration (see [0070]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized proximal attachment points and distal movement portions for each of the electrodes of Waldstreicher to provide for an alternative manner of independently actuating the electrodes from the unexpanded to the expanded configuration. Waldstreicher already contemplates the independent actuation (see [0414] providing that “expansion of one or more energy delivery bodies 108 can be controlled independently”) as well as the inclusion of individual pull wires (see [00389]) that would readily lend to the alternative construction contemplated with the combination with Shimada.
Conclusion
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794