DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 01/20/2026. Claims 1-2, 4, 6-9 and 13-14 are amended. Claim 15 is new. Claim 3 is cancelled. Claims 1-2 and 4-15 are currently pending.
The objection of claims 1, 3 and 6-7 has been withdrawn due to applicant’s amendment.
The rejection of claims 1-5, 8 and 10-14 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
The rejection of claims 6-7 and 9 under 35 U.S.C. 112(b) is maintained; see below.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/20/2026, with respect to the rejection(s) of claim(s) 1-2, 8, 10 and 13-14 under 35 U.S.C. 102(a)(2) as being anticipated by Schultheis; claims 3-6 and 9 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 Lee; claims 11-12 under 35 U.S.C. 103 as being unpatentable over Schultheis in view of Zhou, 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 Schultheis fails to disclose the energy guide being an electrode pair with a positive electrode and a negative electrode (Remarks, pg. 7).
In response to applicant’s first argument, it is respectfully submitted one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references (MPEP 2145(IV)). As discussed below, Schultheis is not relied on to teach the limitation of the electrode pairs comprising a positive electrode and a negative electrode, and the argument fails to address what the combined teaching of the applied references teaches. Therefore, the rejection is maintained.
2) Applicant further argues Schultheis fails to disclose adjusting the at least one electrode pair in position with respect to the target lesion by modifying a diameter of the inner balloon (Remarks, pg. 7).
In response to applicant’s second argument, it is respectfully submitted Schultheis discloses the one or more energy guides adhered or attached to an outer surface of the inner balloon, and further discloses each energy guide including an electrode pair (para. [0066]), such that the electrode pair of the energy guides is considered to be adjusted when adhered or attached to the outer surface of the inner balloon when the balloon is inflated.
3) Applicant further argues Nguyen, Lee and Zhou do not teach adjusting the position of the at least one electrode pair as claimed (Remarks, pgs. 8-9).
In response to applicant’s third argument, it is respectfully submitted the rejection does not rely on these references to teach the claimed limitations, therefore applicant’s arguments are moot.
Applicant’s arguments with respect to claim 15 have been fully considered, and new claim 15 has been rejected as discussed below.
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2, line 2, the phrase “an outer surface of the inner balloon” appears to be amended to recite “the” outer surface; it is requested that applicant indicate any deleted matter using a strike-through or double brackets in any future amended claims in order to comply with 37 CFR 1.121(c)(2).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 6, the claim recites “wherein the at least one electrode pair comprises a positive electrode and a negative electrode”. It is unclear whether the phrase is referring to the positive electrode and the negative electrode previously introduced, or introducing a new, separate positive electrode and negative electrode. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the positive electrode and the negative electrode previously introduced.
Regarding claim 7, the claim recites “wherein the at least one electrode pair comprises two electrodes with opposite polarities”. It is unclear whether the phrase is referring to the positive and negative electrode previously introduced, or introducing two new, separate electrodes. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the positive and negative electrode previously introduced.
Regarding claim 9, the claim recites “wherein each electrode pair comprises a positive electrode and a negative electrode” in lines 1-2. It is unclear whether the phrase includes the positive electrode and the negative electrode previously introduced, or is introducing new, separate electrodes. Further, it is unclear whether the phrase “each electrode pair” is referring to the plurality of electrode pairs previously introduced, or separate electrode pairs. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each electrode pair comprising a positive and negative electrode, including the at least one electrode pair previously introduced.
Further, the claim recites “adjacent electrode pairs”. It is unclear whether the phrase is referring to adjacent electrode pairs of the plurality of electrode pairs or separate electrode pairs. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to adjacent electrode pairs of the plurality of electrode pairs previously introduced.
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) (previously of record) in view of Nguyen (US 2017/0135709 A1) (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 fixed or 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 fixed (via spark gap 215, paras. [0024] and [0031]), for the purpose of providing the appropriate structure to create a reliable plasma arc at the desired initiation location (paras. [0024] and [0030]).
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, in order to provide the appropriate structure to create a reliable plasma arc at the desired spark gap location, based on the suggestions and teachings of Nguyen (paras. [0024] and [0030]).
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 (para. [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).
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 a positive electrode and a negative electrode (combination considered to further teach the electrode pair of Schultheis comprising a positive and negative electrode), wherein the positive electrode and the negative electrode are insulated from each other (combination considered to further teach the positive and negative electrode 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 electrode pair comprises a positive electrode and a negative electrode (combination considered to further teach each of the one or more energy guides 122a of Schultheis comprising a positive and negative electrode), 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 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) (previously of record).
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 (combination considered to further teach two electrodes in electrode pair comprising a positive and negative electrode).
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) (previously of record).
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
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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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