DETAILED ACTION
Applicant’s amendments and remarks, filed May 4, 2026, are fully acknowledged by the Examiner. Currently, claims 1-5, 7-16, 18, 20-23 and 31-36 are pending with claims 6, 17, 19 and 24-30 cancelled, and claims 1, 9, 18, 20 and 34 amended. The following is a complete response to the May 4, 2026 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 .
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bakos et al. (US Pat. Pub. 2014/0039491 A1).
Regarding claim 1, Bakos provides for an apparatus comprising a shaft configured to be navigated through an anatomy toward a target tissue of a patient to a prostatic urethra of a patient (sheath 40 capable of being navigated as claimed), and
a plurality of electrodes disposed on a distal portion of the shaft and spaced axially along the shaft, the plurality of electrodes including a distal electrode and a proximal set of electrodes (electrodes 21/22/23 as in figure 5), the distal electrode configured to transition from an unexpanded configuration to an expanded configuration (23 is capable of being transitioned from an unexpanded to an expanded configuration; see [0040]) when the distal electrode is disposed at a neck of a bladder of the patient and the proximal set of electrodes are disposed in the prostatic urethra of the patient (again, the electrode 23 is functionally capable of being expanded in the claimed location),
the distal electrode configured to transition to the expanded configuration independently from the proximal set of electrodes to anchor the distal portion of the shaft relative to the prostatic urethra the target tissue (see [0067] describing the deploying of the multiple electrodes on a device with distal electrode being the first to deploy/expand from the sheath 40),
the proximal set of electrodes configured to transition from an unexpanded configuration to an expanded configuration after the distal electrode has transitioned to the expanded configuration (via the expansion of the electrodes 21 and 22 as in figure 5 to engage and expand neighboring tissue a wall of a portion of the prostatic urethra, the proximal set of electrodes configured to expand to a pressure of at least 1.5 atmospheres to exert a force on the wall of the portion of the prostatic urethra to expand the wall of the portion of the prostatic urethra (see [0027]-[0029] providing for the inflation of the balloon to 1-14psi above standard atmospheric pressure with such readily appreciated as approx.. 14,696 psi; thus the range of inflation pressure includes values above 1.5 atm [or 22.044 psi]; see also [0027]-[0029] providing that the balloons are capable of exerting a pressure on a wall via, at least, the disclosed semi-conformance),
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 a prostate to ablate a portion of the prostate (see [0041], [0045]-[0047], [0057]-[0059] and claim 17).
Regarding claim 2, Bakos provides that each electrode from the plurality of electrodes includes an expandable element and a conductive element (see [0076] providing for “a conductive balloon”).
Regarding claim 3, Bakos provides that the the shaft defines one or more lumens, the expandable elements of the plurality of electrodes being in fluid communication with the one or more lumens (see at least [0076] and [0079] providing for at least one inflation lumen for inflating the expandable elements).
Regarding claim 4, Bakos provides that each electrode from the plurality of electrodes includes a cylindrical braid formed from a plurality of conductive strands (see [0091] providing for the framework 52 forming the electrode being a conductive braid with such being for each of the electrodes 21/22/23).
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 Bakos et al. (US Pat. Pub. 2014/0039491 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 Bakos contemplates that the plurality of electrodes with a first end being fixed to the shaft and further contemplates for an adjustable length of the electrodes (See [0053]), Bakos fails to provide for 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 Bakos and specifically contemplates 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 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 a first end for each electrode fixed to the shaft and a second end that is configured to move along the shaft to provide for a specific manner of adjusting electrode length as contemplated in [0053] of Bakos. The Examiner is further of the position that the independent actuation and adjustable length of Bakos would readily length itself to alternative construction as contemplated in the teaching of Shimada with a reasonable expectation of success.
Claims 7, 18, 20, 23, 31, 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US Pat. Pub. 2014/0039491 A1) and further in view of Lemoureux et al. (US Pat. Pub. 2017/0173362 A1).
Regarding claim 7, Bakos fails to provide for the inclusion of a first marker and a second set of markers, the first marker disposed at a proximal end of the distal electrode, and each marker from the second set of markers disposed at a proximal end of a respective electrode from the proximal set of electrodes.
Lamoureux provides for a similar device as that of Bakos and specifically contemplates a shaft with a plurality of expandable elements thereon (see figures 1 and 2 with the shaft 115 and the expandable elements 120a-e). Lamoureux further provides for a respective marker at a respective proximal end of each of the expandable elements (see 122a-d at the proximal end of ones of 120a-d). 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 proximally-placed markers relative to each of the plurality of electrodes in Bakos in view of the teaching of Lamoureux. Such would provide for an exemplary manner of visualizing the placement of each of the electrodes relative to the target tissue thereby ensuring proper placement during treatment.
Regarding claim 18, Bakos provides for an apparatus comprising a shaft configured to be navigated through a working channel of a cystoscope to a prostatic urethra of a patient (sheath 40 capable of being navigated as claimed),
a plurality of electrodes spaced axially along a distal portion of the shaft (electrodes 21/22/23 as in figure 5), and
the plurality of electrodes configured to transition from an unexpanded configuration to an expanded configuration (each of 21/22/23 is capable of expanding as in [0040]),
a distal electrode of the plurality of electrodes is configured to transition to the expanded configuration when the distal electrode is disposed in a neck of a bladder of the patient and at least one proximal electrode of the plurality of electrodes is disposed in the prostatic urethra to anchor the distal portion of the shaft relative to the prostatic urethra (again, the electrode 23 is functionally capable of being expanded in the claimed location and with the remaining electrodes 21/22 placed as claimed),
the at least one proximal electrode is configured to be transitioned from an unexpanded configuration to an expanded configuration after the distal electrode has transitioned to the expanded configuration (via the expansion of the electrodes 21 and 22 as in figure 5 to engage and expand neighboring tissue a wall of a portion of the prostatic urethra) to engage and expand a wall of a portion of the prostatic urethra, the at least one proximal electrode is configured to expand to a pressure of at least 1.5 atmospheres to exert a force on the wall of the portion of the prostatic urethra to expand the wall of the portion of the prostatic urethra (see [0027]-[0029] providing for the inflation of the balloon to 1-14psi above standard atmospheric pressure with such readily appreciated as approx.. 14,696 psi; thus the range of inflation pressure includes values above 1.5 atm [or 22.044 psi]; see also [0027]-[0029] providing that the balloons are capable of exerting a pressure on a wall via, at least, the disclosed semi-conformance),
the distal electrode and the at least one proximal electrode in the expanded configuration configured to and deliver pulsed field ablation energy to a prostate to ablate a portion of the prostate (see [0041], [0045]-[0047], [0057]-[0059] and claim 17).
Bakos fails to provide for the inclusion of a plurality of markers, 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.
Lamoureux provides for a similar device as that of Bakos and specifically contemplates a shaft with a plurality of expandable elements thereon (see figures 1 and 2 with the shaft 115 and the expandable elements 120a-e). Lamoureux further provides for a respective marker at a respective proximal end of each of the expandable elements (see 122a-d at the proximal end of ones of 120a-d). 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 proximally-placed markers relative to each of the pluralit expandable leements in Bakos in view of the teaching of Lamoureux. Such would provide for an exemplary manner of visualizing the placement of each of the expandable elements relative to the target tissue thereby ensuring proper placement during treatment. The combination, further, would provide an indication of the relative positions of the electrodes distal to the distal end of a cystoscope in such an instance where the combined catheter is inserted through such a device.
Regarding claim 20, in view of the combination in the rejection of claim 18 above, the combination further provides for 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 at least one proximal electrode.
Regarding claim 23, Bakos further provides that each electrode from the plurality of electrodes includes a cylindrical braid formed from a plurality of conductive strands (see [0091] providing for the framework 52 forming the electrode being a conductive braid with such being for each of the electrodes 21/22/23).
Regarding claim 31, Bakos provides that each electrode from the plurality of electrodes includes an expandable element and a conductive element (see [0076] providing for “a conductive balloon”).
Regarding claim 32, Bakos provides that the shaft defines one or more lumens, the expandable elements of the plurality of electrodes configured to be in fluid communication with the one or more lumens (see at least [0076] and [0079] providing for at least one inflation lumen for inflating the expandable elements).
Regarding claim 34, Bakos provides that the distal electrode is configured to transition from the unexpanded configuration to the expanded configuration independently from the at least one proximal electrode (see [0067] describing the deploying of the multiple electrodes on a device with distal electrode being the first to deploy/expand from the sheath 40).
Claims 8, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US Pat. Pub. 2014/0039491 A1) and further in view of Lemoureux et al. (US Pat. Pub. 2017/0173362 A1) as applied to claims 7 and 20 respectively above, and further in view of Wizeman et al. (US Pat. Pub. 2008/0097424 A1).
Regarding claim 8, neither Bakos nor Lemoureaux provides that each of the first marker or the second set of markers is of a distinct color. Wizeman provides for the provision of a pluralty of markers and specifically contemplates the use of various colors to provide for a visual distinction between each of the marks (See [0061]). Therefore, it is the Examiner’s position that it would have ben obvious to one of ordinary skill in the art at the time of filing to have utilized different colors for each of the markers per the combination of Bakos and Lemoureaux in view of the teaching of Wizeman. Such would ensure that a user can visually distinguish each of the plurality of markers from one another when, for example, viewing the combined device within the body.
Regarding claims 21 and 22, while Bakos and Lemoureaux provide for the markers as in the rejection of claim 18 above, neither Bakos nor Lemoureaux provide that the first marker is visually different from the second marker (claim 21) or that the plurality of markers include colored markers (claim 22). Wizeman provides for the provision of a plurality of markers and specifically contemplates the use of various, visually different colors to provide for a visual distinction between each of the marks (See [0061]). 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 different colors for each of the markers per the combination of Bakos and Lemoureaux in view of the teaching of Wizeman. Such would ensure that a user can visually distinguish each of the plurality of markers from one another when, for example, viewing the combined device within the body.
Claims 9-16, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US Pat. Pub. 2014/0039491 A1) in view of Lee et al. (US Pat. Pub. 2020/0253659 A1).
Regarding claim 9, Bakos provides for an apparatus comprising a shaft configured to be disposed near a target tissue in a prostatic urethra of a patient (sheath 40 capable of being navigated as claimed), the shaft defining at least one lumen along a length thereof ((see at least [0076] and [0079] providing for at least one inflation lumen for inflating the expandable elements),
a first electrode and a second electrode (electrodes 23 and then 21/22), the first electrode including a first conductive element and a first expandable element (see [0076] providing for “a conductive balloon”), wherein the lumen of Bakos is 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 (23 is capable of being transitioned from an unexpanded to an expanded configuration; see [0040]) when the first electrode is disposed at a neck of a bladder of the patient and the second electrode is disposed in the prostatic urethra of the patient, the first electrode in the expanded configuration configured to anchor the distal portion of the shaft relative to the prostatic urethra (again, the electrode 23 is functionally capable of being expanded in the claimed location),
the second electrode including a second conductive element and a second expandable element (see [0076] providing for “a conductive balloon”), the second conductive element configured to transition from an unexpanded configuration to an expanded configuration wherein, when, the second electrode in the expanded configuration is configured to expand neighboring tissue expand to a pressure of at least 1.5 atmospheres to exert a force on a wall of a portion of the prostatic urethra to expand the wall of the portion of the prostatic urethra (via the expansion of the electrodes 21 and 22 as in figure 5 to engage and expand neighboring tissue a wall of a portion of the prostatic urethra, the proximal set of electrodes configured to expand to a pressure of at least 1.5 atmospheres to exert a force on the wall of the portion of the prostatic urethra to expand the wall of the portion of the prostatic urethra (see [0027]-[0029] providing for the inflation of the balloon to 1-14psi above standard atmospheric pressure with such readily appreciated as approx.. 14,696 psi; thus the range of inflation pressure includes values above 1.5 atm [or 22.044 psi]; see also [0027]-[0029] providing that the balloons are capable of exerting a pressure on a wall via, at least, the disclosed semi-conformance),
the first electrode and the second electrode, when the first conductive element and the second conductive element are in the expanded configuration, are configured to deliver pulsed field ablation to a prostate to ablate a portion of the prostate (see [0041], [0045]-[0047], [0057]-[0059] and claim 17).
While Bakos contemplates a first lumen for providing fluid to expand each of the first and second expandable element, Bakos fails to provide that the shaft defines both the first lumen and a second lumen along a length thereof, wherein the second lumen is 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 after the first conductive element has transitioned to the expanded configuration.
Lee discloses a similar apparats for treating within the body via the application of energy, wherein the apparatus has a plurality of expandable elements (Each of elements 320) contained on a shaft of the device. Lee further provides the utilization of separate inflation lumens to convey fluid separately to each of the expandable elements (see [0028] disclosing 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 as to be independently inflatable”; see also [0036] providing for “a pair of 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 a first lumen with the functionality to convey fluid to the first electrode and a second lumen with the functionality to convey fluid to the second electrode such that the first electrode and the second electrode are separately and independently inflatable from another. Such would allow the user to independently inflate the plurality of electrodes so as to control the timing and amount of inflation during use of the device.
Regarding claims 10 and 11, in view of the combination with Lee in the rejection of claim 9 above, the combined arrangement further provides that the first lumen terminates in a first opening defined by a distal portion of the shaft and the second lumen terminates in a second opening defined by the distal portion of the shaft (via [0036] of Lee providing for “a pair of balloon inflation ports 822 that allow for independent balloon inflation with such necessarily communication with an opening in each of the balloons per the combination). The combination with Lee further provides that the first expandable element is disposed around the first opening, and the second expandable element is disposed around the second opening (necessary, again, for the individual control of each balloon as in [0036] of Lee).
Regarding claim 12, Bakos provides that the first expandable element and the second expandable element are inflatable balloons (see [0076] providing for “a conductive balloon”).
Regarding claim 13, Bakos provides for a third electrode including a third conductive element and a third expandable element (electrode 23). The Examiner is of the position that the combination with Lee in the rejection of claim 9 above further provides for the second lumen to be 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. Such, again, would allow the user to independently inflate the first electrode from the second/third electrodes so as to control the timing and amount of inflation during use of the device.
Regarding claims 14 and 15, in view of the combination with Lee above, the combination further provides for a proximal end of the shaft is coupled to a flow control mechanism including a first configuration in which fluid is allowed to flow through the first lumen and is prevented from flowing through the second lumen and wherein the flow control mechanism includes a second configuration in which fluid is allowed to flow through the second lumen (see [0036] of Lee providing for the part of inflation ports 822 and vales that allow for the independent inflation control).
Regarding claim 16, Bakos provides that the first electrode and the second electrode each include a cylindrical braid formed from a plurality of conductive strands (see [0091] providing for the framework 52 forming the electrode being a conductive braid with such being for each of the electrodes 21/22/23).
Regarding claim 35, in view of the combination with Lee above, the first electrode is configured to transition from the unexpanded configuration to the expanded configuration independently from the second electrode (via the provision of the independent lumens and the independent control as in [0028] and [0036] of Lee).
Regarding claim 36, Bakos provides that the first electrode is disposed distal to the second electrode (electrode 23 is distal to 21/22, see figure 5).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US Pat. Pub. 2014/0039491 A1) and further in view of Lemoureux et al. (US Pat. Pub. 2017/0173362 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 Bakos contemplates that the plurality of electrodes with a first end being fixed to the shaft and further contemplates for an adjustable length of the electrodes (See [0053]), Bakos fails to provide for 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 Bakos and specifically contemplates 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 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 a first end for each electrode fixed to the shaft and a second end that is configured to move along the shaft to provide for a specific manner of adjusting electrode length as contemplated in [0053] of Bakos. The Examiner is further of the position that the independent actuation and adjustable length of Bakos would readily length itself to alternative construction as contemplated in the teaching of Shimada with a reasonable expectation of success.
Response to Arguments
Applicant’s arguments, see pages 9-11 of the Remarks filed May 4, 2026, with respect to the rejections of each of independent claims 1, 9 and 18 under respective ones of 35 U.S.C. 102 and 103 utilizing Waldestreicher (US Pat. Pub. 2019/0231425) as the primary reference have been fully considered and are persuasive. In particular, the Examiner is of the position that the apparatus of Waldestreicher including the shaft and plurality of electrode are not functionally capable of being placed in the manner presently set forth in each of independent claims 1, 9 and 18. Said differently, the Examiner fails to find that the distal-most electrode of Waldestreicher can be placed, in use, at the neck of the bladder of the patient, while one or more second electrodes are disposed within the prostatic urethra as claimed. Therefore, the prior rejections based on the Waldestreicher reference have been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bakos et al. (US Pat. Pub. 2014/0039491 A1).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US Pat. Pub. 2014/0039491 A1) as applied to claim 1 above, and further in view of Shimada et al. (US Pat. Pub. 2022/0095979 A1).
Claims 7, 18, 20, 23, 31, 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US Pat. Pub. 2014/0039491 A1) and further in view of Lemoureux et al. (US Pat. Pub. 2017/0173362 A1).
Claims 8, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US Pat. Pub. 2014/0039491 A1) and further in view of Lemoureux et al. (US Pat. Pub. 2017/0173362 A1) as applied to claims 7 and 20 respectively above, and further in view of Wizeman et al. (US Pat. Pub. 2008/0097424 A1).
Claims 9-16, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US Pat. Pub. 2014/0039491 A1) in view of Lee et al. (US Pat. Pub. 2020/0253659 A1).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (US Pat. Pub. 2014/0039491 A1) and further in view of Lemoureux et al. (US Pat. Pub. 2017/0173362 A1) as applied to claim 18 above, and further in view of Shimada et al. (US Pat. Pub. 2022/0095979 A1).
It is the Examiner’s position that the newly proffered rejection are tenable for at least the reasoning set forth in the action above.
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 RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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