DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/03/2026 has been entered.
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 08/10/2026. Claims 1, 6-7 and 9 are amended. Claim 3 is cancelled. Claims 1-2 and 4-15 are currently pending.
The objection of claim 2 has been withdrawn due to applicant’s amendment.
The rejection of claims 6-7 and 9 under 35 U.S.C. 112(b) is withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/10/2026, with respect to the rejection(s) of claim(s) 1-2, 4-6, 8-10 and 13-14 under 35 U.S.C. 103 as being unpatentable over Schultheis in view of Nguyen; claim 7 under 35 U.S.C. 103 as being unpatentable over Schultheis in view of Nguyen and Lee; claims 11-12 under 35 U.S.C. 103 as being unpatentable over Schultheis in view of Nguyen and Zhou; and claim 15 under 35 U.S.C. 103 as being unpatentable over Schultheis in view of Nguyen and McGowan, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendment to the claims.
1) Applicant argues Nguyen discloses the insulating distance between the positive electrode and the negative electrode being fixed, as opposed to variable (Remarks, pgs. 6-8).
In response to applicant’s first argument, it is respectfully submitted Nguyen discloses specific regions of the electrodes that are insulated, and specific regions of the electrodes that are not insulated, which is considered to provide a variable distance between the electrodes as discussed below. Nguyen further describes the variable spacing/separation providing an increase or decrease in the likelihood of a spark forming between the electrodes, based on the location of the first and second exposed regions, as well as the surface areas of the first and second exposed regions, which vary relative to each other. The arguments are narrower than the claim limitations, because the claim does not describe how the distance varies, or the insulating distance varying relative to balloon inflation. Therefore, under broadest reasonable interpretation, any variation in distance is considered to meet the claimed limitation.
2) Applicant further argues the additionally cited references fail to disclose the claimed insulating distance (Remarks, pgs. 6-8).
In response to applicant’s second argument, it is respectfully submitted the additionally cited references are not relied on to teach the variable insulating distance as discussed below, therefore applicant’s argument is moot.
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(s) 1-2, 4-6, 8-10 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Schultheis (US 2023/0310054 A1) in view of Nguyen (US 2017/0135709 A1) (all references previously of record).
Regarding claim 1, Schultheis discloses (see abstract; paras. [0039]-[0127]; figs. 1-4) an electrode balloon catheter (fig. 1), comprising:
a catheter body (102, para. [0039]);
an outer balloon (104b), wherein the outer balloon is disposed at an end of the catheter body (figs. 1-2a) and is configured to store a conductive medium (paras. [0043] and [0060]);
an inner balloon (104a), wherein the inner balloon is disposed at the end of the catheter body (figs. 1-2a) and is located inside the outer balloon (figs. 1-2a); and
at least one electrode pair (electrode pair of energy guide 122a, para. [0066]) configured to receive high-voltage pulses so as to generate shock waves (para. [0066]), wherein at least one of the at least one electrode pair is disposed on a surface of the inner balloon (para. [0063]), wherein the surface of the inner balloon comprises an inner surface and an outer surface (fig. 1),
wherein the outer balloon, when inflated, is configured to fit onto a target object (fits within vessel wall, fig. 1), and wherein the inner balloon is configured to bring the at least one electrode pair closer to or farther away from the target object through an inflation thereof (para. [0068]), wherein the at least one electrode pair can be adjusted in position with respect to the target lesion by modifying a diameter of the inner balloon (diameter considered to be modified via inflation, such that the position of the electrodes would be adjusted, paras. [0063] and [0068]).
However, Schultheis fails to disclose the specific polarity of the electrode pairs, wherein the electrode pair comprises a positive electrode and a negative electrode, wherein the positive electrode and the negative electrode are insulated from each other, and wherein an insulating distance between the positive electrode and the negative electrode is variable.
Nguyen teaches (para. [0024]; fig. 2a), in the same field of endeavor, an electrode balloon catheter (fig. 1) comprising an electrode pair comprising a positive electrode (204) and a negative electrode (208), wherein the positive electrode and the negative electrode are insulated from each other (paras. [0023]-[0024]), and wherein an insulating distance between the positive electrode and the negative electrode is variable (via spark gap 215, which Nguyen discloses as including a variable distance dependent on which regions of the electrodes are insulated vs. not insulated, considered to include a variable distance because the distance is variable between insulated regions of the electrodes, see also para. [0023] describing different ratios of exposed regions of surface areas between the first and second electrodes, paras. [0022]-[0025], [0031], [0033] and [0035]), for the purpose of providing the appropriate structure to create a reliable plasma arc at the desired initiation location, increasing the likelihood of generating an arc in certain regions while decreasing the likelihood of generating an arc in other regions (paras. [0022], [0024], [0030] and [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode pairs of Schultheis to include positive and negative electrodes insulated from each other, wherein the insulating distance is variable, in order to provide the appropriate structure to create a reliable plasma arc at the desired spark gap location by increasing or decreasing the likelihood of the arc to develop in specific regions, based on the suggestions and teachings of Nguyen (paras. [0022], [0024], [0030] and [0033]).
Regarding claim 2, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1. Schultheis further discloses wherein at least one of the at least one electrode pair is disposed on the outer surface of the inner balloon (para. [0063]).
Regarding claim 4, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1. Schultheis (as modified) further teaches wherein the insulating distance between the positive and negative electrodes is configured within a predetermined range (see ratios of first and second surface areas, paras. [0023] and [0031] of Nguyen).
Regarding claim 5, Schultheis (as modified) teaches the electrode balloon catheter according to claim 4. Schultheis (as modified) further teaches wherein the predetermined range is from 0.01 mm to 10 mm (spark gap sizes of .003 and .004 inches, which is ~.08-0.1mm and therefore falls within the claimed range, paras. [0015] and [0031] of Nguyen).
Regarding claim 6, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1. Schultheis (as modified) further teaches wherein the electrode pair comprises the positive electrode and the negative electrode (combination considered to further teach the electrode pair of Schultheis comprising the positive and negative electrodes), wherein the positive electrode and the negative electrode are insulated from each other (combination considered to further teach the positive and negative electrodes insulated from each other), and wherein the positive electrode and the negative electrode are flexibly connected (via spark gap 215, considered to be flexibly connected to help maintain flexibility of overall system, paras. [0018], [0024] and [0031] of Nguyen).
Regarding claim 8, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1. Schultheis further discloses wherein the at least one electrode pair comprises a plurality of electrode pairs (one or more energy guides 122a, para. [0064]), wherein the plurality of electrode pairs are arranged axially along and circumferentially around the inner balloon that is inflated (para. [0064]; figs. 1-2a).
Regarding claim 9, Schultheis (as modified) teaches the electrode balloon catheter according to claim 8. Schultheis (as modified) further teaches wherein each of the plurality of electrode pairs comprises the positive electrode and the negative electrode (combination considered to further teach each of the one or more energy guides 122a of Schultheis comprising the positive and negative electrodes), wherein the positive electrode and the negative electrode of each electrode pair are arranged axially along the inner balloon that is inflated (para. [0064]; figs. 1-2a of Schultheis), wherein the positive and negative electrodes in adjacent electrode pairs of the plurality of electrode pairs are connected by electrical leads (via first and second wires, paras. [0005] and [0018] of Nguyen).
Regarding claim 10, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1. Schultheis further discloses wherein the inner balloon is made of a compliant material or a non-compliant material (paras. [0049]-[0052]).
Regarding claim 13, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1. Schultheis further discloses wherein an inflated outer balloon has a diameter of 0.75 mm to 30.0 mm (para. [0053]) and an axial length of 3 mm to 300 mm (para. [0055]).
Regarding claim 14, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1. Schultheis further discloses wherein an inflated inner balloon has a diameter of 0.5 mm to 29.0 mm (paras. [0053]-[0054]) and an axial length of 3 mm to 300 mm (para. [0055]).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schultheis in view of Nguyen as applied to claim 1 above, and further in view of Lee (US 2014/0128859 A1).
Regarding claim 7, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1.
Schultheis (as modified) further teaches wherein the at least one electrode pair comprises two electrodes with opposite polarities which are the positive electrode and the negative electrode (combination considered to further teach two electrodes in electrode pair comprising the positive and negative electrodes).
However, Schultheis (as modified) fails to teach wherein each of the two electrodes is formed on the surface of the inner balloon by electroplating or is provided in a form of a flexible circuit.
Lee teaches (paras. [0059]-[0071]; figs. 1a-2a), in the same field of endeavor, an electrode balloon catheter (figs. 1a-b) comprising an electrode pair comprising two electrodes with opposite polarities (bipolar electrode pair 3102 and 3104), wherein each electrode is formed on the surface of the balloon by being provided in the form of a flexible circuit (para. [0071), for the purpose of providing a localized field of tissue and enhanced bonding of the electrodes to the balloon, increasing robustness of the device (paras. [0115], [0121] and [0205]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode pairs of Schultheis (as modified) to be attached to the inner balloon via a flexible circuit, in order to provide a sensed tissue volume that is localized, and enhanced bonding of the electrodes to the balloon, increasing robustness of the device, based on the suggestions and teachings of Lee (paras. [0115], [0121] and [0205]).
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Schultheis in view of Nguyen as applied to claim 1 above, and further in view of Zhou (US 2014/0039358 A1).
Regarding claim 11, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1.
Schultheis further discloses wherein the catheter body comprises an inner tube (118, para. [0042]) and an outer tube (110), wherein the inner tube is received in the outer tube and protrudes out of a distal end of the outer tube (fig. 1), wherein: a proximal end of the outer balloon is fixedly attached to the outer tube (secured to shaft 110, para. [0045]); a distal end of the outer balloon is fixedly attached to the inner tube (secured to shaft 118); an outer-balloon fluid supply lumen in communication with the outer balloon is formed between the inner and outer tubes (outer balloon inflation lumen, paras. [0043] and [0047]); and an inner-balloon fluid supply lumen (inflation lumen for inner balloon 104a, para. [0043]).
However, Schultheis (as modified) fails to teach wherein each of a proximal end and a distal end of the inner balloon is fixedly attached to the inner tube; and an inner-balloon fluid supply lumen in communication with the inner balloon is provided within the inner tube.
Zhou teaches (paras. [0029]-[0053]; figs. 1-4), in the same field of endeavor, an electrode balloon catheter (figs. 1-2) comprising an inner balloon (154, para. [0029]) and an outer balloon (142), wherein each of a proximal end and a distal end of the inner balloon is fixedly attached to an inner tube (attached to 130 and 122 which are coupled together, paras. [0032] and [0043]; fig. 2), and an inner-balloon fluid supply lumen (124, para. [0045]) is in communication with the inner balloon and provided within the inner tube (para. [0043]; fig. 2), for the purpose of delivering different fluids to each of the balloons depending on the desired application of fluid (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schultheis (as modified) to include distinct inflation lumens for the inner balloon and outer balloon formed in the inner and outer tubes, respectively, such that the inner balloon is connected to the inner tube as claimed, in order to provide the capability of delivering different fluids to each of the balloon depending on the desired application of the device, aiding in tracking and/or positioning of the balloon member or reducing the amount of fluid required to inflate the balloons, based on the suggestions and teachings of Zhou (para. [0033]).
Regarding claim 12, Schultheis (as modified) teaches the electrode balloon catheter according to claim 11. Schultheis (as modified) further teaches wherein the catheter body further comprises a handle (128, para. [0039] of Schultheis) that is located at a proximal end (fig. 1 of Schultheis), wherein a proximal end of the inner tube and a proximal end of the outer tube are connected to the handle (fig. 1 of Schultheis), wherein the handle is provided with an outer-balloon fluid inlet and an inner-balloon fluid inlet (combination considered to further teach distinct inflation lumens for the inner balloon and the outer balloon, paras. [0044]-[0045] of Zhou), wherein the outer-balloon fluid inlet is connected to the outer-balloon fluid supply lumen, and wherein the inner-balloon fluid inlet is connected to the inner-balloon fluid supply lumen (combination considered to further teach distinct fluid inlets connected to respective outer balloon inflation lumen and inner balloon inflation lumen).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schultheis in view of Nguyen as applied to claim 1 above, and further in view of McGowan (US 2020/0397453 A1).
Regarding claim 15, Schultheis (as modified) teaches the electrode balloon catheter according to claim 1.
However, Schultheis (as modified) fails to teach wherein at least one of the at least one electrode pair is disposed on the inner surface of the inner balloon.
McGowan teaches (paras. [0061]-[0062]; figs. 2-3), in the same field of endeavor, a balloon catheter (100) comprising a photoacoustic transducer disposed on an inner surface of an inner balloon (disposed on inner surface of balloon 122, which may be surrounded by an outer balloon, para. [0061]), in place of the transducer being disposed on the outer surface of the balloon (para. [0061]).
The substitution of one known element (the structure for inducing fractures located on the inner surface of the inner balloon) for another (the structure for inducing fractures located on the outer surface of the inner balloon, para. [0061] of McGowan, para. [0063] of Schultheis) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the electrode pair located on the inner surface of the inner balloon as taught by McGowan, would have yielded predictable results, specifically, inducing fractures in the lesion by providing variations in placement of the electrode pair to treat different areas of tissue.
Conclusion
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/BRIGID K BYRD/Examiner, Art Unit 3771
