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 .
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.
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.
Claim(s) 7-8, 10, and 12 is/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.
Claim 7 recites the limitation “the maximal cross-sectional” in line 30.There is insufficient antecedent basis for this limitation in the claim.
Claims 8, 10, and 12 are rejected as being dependent upon a rejected base claim.
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, 4-5, 7-8, 10, 13-14, 16-17, 19, and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maor et al., (US 20090247933; hereinafter Maor) in view of Zikorus et al., (US 20060085054; hereinafter Zikorus).
Regarding claim 1, Maor (generic catheter of Figure 10, specific balloon embodiment of Figure 18A) discloses an apparatus (121), comprising: a shaft (119); and an inflatable balloon (401) coupled to a distal end of the shaft (119), the inflatable balloon (401) comprising: a proximal ablation electrode (403) comprising a variable cross-sectional diameter which increases along a distal direction from a minimal cross-sectional diameter at a proximal end of the inflatable balloon (401) to a maximal cross-sectional diameter of the inflatable balloon (401), a distal ablation electrode (405) comprising a variable cross-sectional diameter which decreases along the distal direction from the maximal cross-sectional diameter at a proximal end of the distal ablation electrode (405) to the minimal cross-sectional diameter at a distal end of the inflatable balloon (405); and an electrically-insulating middle portion (407) comprising the maximal cross-sectional diameter of the inflatable balloon, the electrically-insulating middle portion (407) insulating the proximal ablation electrode (403) from the distal ablation electrode (405), wherein the proximal ablation electrode (403) and the distal ablation electrode (405) are each configured to expand to contact the tissue ([0104], [0115]).
Maor fails to disclose a plurality of apertures configured to permit irrigation fluid to pass therethrough and contact tissue, at least some of the plurality of apertures defined through at least one of the proximal ablation electrode and the distal ablation electrode. However, Zikorus (Figure 65) teaches an apparatus comprising a balloon (1150) comprising a plurality of apertures (1154) along the entire straight middle portion of the balloon (150), the apertures (1154) configured to permit irrigation fluid to pass therethrough and contact tissue ([0294]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor to include a plurality of apertures configured to permit irrigation fluid to pass therethrough and contact tissue, as taught by Zikorus, because the modification would create an electrically conductive path around the balloon (Zikorus; [0294]) to improve surgical efficiency by maintaining high conductivity in the target area. Furthermore, since the entire straight portion of the balloon of the modified device would include a plurality of apertures, at least a portion of the proximal ablation electrode and the distal ablation electrode which are located on the straight portion of the balloon of Maor would include at least some of the plurality of apertures of the modified device.
Regarding claim 4, Maor (Figures 1A and 18A) further discloses wherein the inflatable balloon (401) further comprises an atraumatic tip (139) disposed distally to the distal ablation electrode (405), ([0104], [0115]).
Regarding claim 5, Maor (Figures 1A and 18A) further discloses wherein the distal end of the shaft (119) protrudes from the inflatable balloon (401) to a distal tip (139), ([0104], [0115]).
Regarding claim 7, Maor (generic catheter/method of Figures 10 and 16, specific balloon embodiment of Figure 18A) discloses a probe (121), ([0104]), comprising: a guidewire configured to access tissue of a human subject by traversing a lumen of the tissue; a tube (introducer sheath), dimensioned to access and penetrate into the lumen while being threaded over the guidewire, the tube (introducer sheath) being shaped to define a tube lumen (introducer sheath lumen), ([0118]); and an inflatable balloon (401) coupled to a distal end of a shaft (119) and comprising a plurality of expandable electrodes (403, 405), the inflatable balloon (401) comprising: a proximal ablation electrode (403) extending over a proximal-portion circumference of the inflatable balloon (401), the proximal-portion circumference defined by a first conical section; a distal ablation electrode (405) extending over a distal-portion circumference of the inflatable balloon (401), the distal-portion circumference defined by a second conical section; and an electrically-insulating middle portion (407) separating the proximal ablation electrode (403) from the distal ablation electrode (405), ([0115]), the plurality of expandable electrodes (403, 405) configured to: traverse the tube lumen (introducer sheath lumen), subsequently to traversing the tube lumen (introducer sheath lumen), expand distally to a distal end of the tube (introducer sheath) by inflation of the inflatable balloon (401), and while at least one of the plurality of expandable electrodes (403, 405) contacts the tissue, convey ablation energy to the tissue by virtue of electrical current passing between the plurality of expandable electrodes (403, 405), wherein the electrically-insulating middle portion (407) comprising a maximal cross- sectional diameter, wherein a variable cross-sectional diameter of the proximal ablation electrode (403) increases along a distal direction from a first minimal cross-sectional diameter at a proximal end of the proximal ablation electrode (403) to the maximal cross- sectional diameter of the inflatable balloon (401) at a distal end of the proximal ablation electrode (403), and wherein a variable cross-sectional diameter of the distal ablation electrode (405) decreases along a distal direction from the maximal cross-sectional diameter of the inflatable balloon (401) at a proximal end of the distal ablation electrode (405) to a second minimal cross-sectional diameter at a distal end of the inflatable balloon (401), and wherein the proximal ablation electrode (403) and the distal ablation electrode (405) are each configured to expand to contact tissue ([0077], [0104], [0115], [0118]).
Maor fails to disclose a plurality of apertures configured to permit irrigation fluid to pass therethrough and contact tissue, at least some of the plurality of apertures defined through at least one of the proximal ablation electrode and the distal ablation electrode. However, Zikorus (Figure 65) teaches an apparatus comprising a balloon (1150) comprising a plurality of apertures (1154) along the entire straight middle portion of the balloon (150), the apertures (1154) configured to permit irrigation fluid to pass therethrough and contact tissue ([0294]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor to include a plurality of apertures configured to permit irrigation fluid to pass therethrough and contact tissue, as taught by Zikorus, because the modification would create an electrically conductive path around the balloon (Zikorus; [0294]) to improve surgical efficiency by maintaining high conductivity in the target area. Furthermore, since the entire straight portion of the balloon of the modified device would include a plurality of apertures, at least a portion of the proximal ablation electrode and the distal ablation electrode which are located on the straight portion of the balloon of Maor would include at least some of the plurality of apertures of the modified device.
Regarding claim 8, Maor (Figures 1A, 16, and 18A) further discloses wherein the plurality of expandable electrodes (403, 405) are configured to convey the ablation energy without permanent deformation of any of the plurality of expandable electrodes (403, 405), ([0077], [0104], [0115], [0118]).
Regarding claim 10, Maor (Figures 1A, 16, and 18A) further discloses wherein the shaft (119) comprises at least one conductor (133, 135) configured to transfer the electrical current to the plurality of expandable electrodes (401, 405) without permanent damage to the at least one conductor (133, 135), ([0104]-[0105], [0115]).
Regarding claim 13, Maor (generic catheter/method of Figures 10 and 16, specific balloon/method embodiment of Figure 18A) a method for ablating tissue of a human subject, the method comprising: inserting a guidewire into a lumen of the human subject; threading a tube (introducer sheath) over the guidewire, the tube (introducer sheath) being dimensioned to penetrate the lumen so that a distal end of the tube (introducer sheath) is in proximity to a target region to be ablated ([0118]); after threading the tube (introducer sheath) over the guidewire, traversing an inflatable balloon (401) comprising a plurality of expandable electrodes (403, 405) through the tube (introducer sheath), the inflatable balloon (401) comprising: a proximal ablation electrode (403) comprising a variable cross-sectional diameter which increases along a distal direction from a minimal cross-sectional diameter at a proximal end of the inflatable balloon (401) to a maximal cross-sectional diameter; a distal ablation electrode (405) comprising a variable cross-sectional diameter which decreases along the distal direction from the maximal cross-sectional diameter of the inflatable balloon (401) to the minimal cross-sectional diameter at a distal end of the inflatable balloon (401); and an electrically-insulating middle portion (407) comprising the maximal cross-sectional diameter and separating the proximal ablation electrode (403) from the distal ablation electrode (405); subsequently to traversing the inflatable balloon (401) through the tube (introducer sheath), causing the plurality of expandable electrodes (403, 405) to expand distally to the distal end of the tube (introducer sheath) such that at least one of the plurality of expandable electrodes (403, 405) contacts the target region to be ablated; by passing electrical current between the plurality of expandable electrodes (403, 405), conveying electrical energy to the contacted target region so as to ablate the target region, and wherein the proximal ablation electrode (403) and the distal ablation electrode (405) are each configured to expand to contact tissue ([0077], [0104], [0115], [0118]).
Maor fails to disclose that the electrically-insulating middle portion comprising a plurality of apertures configured to permit irrigation fluid to pass therethrough such that, at least while conveying electrical energy to the contacted target region, irrigation fluid is delivered through the plurality of apertures. However, Zikorus (Figure 65) teaches an apparatus comprising a balloon (1150) comprising a plurality of apertures (1154) configured to permit irrigation fluid to pass therethrough while conveying electrical energy to a contacted target region ([0294]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor to include a plurality of apertures configured to permit irrigation fluid to pass therethrough such that, at least while conveying electrical energy to the contacted target region, irrigation fluid is delivered through the plurality of apertures, as taught by Zikorus, because the modification would create an electrically conductive path around the balloon (Zikorus; [0294]) to improve surgical efficiency by maintaining high conductivity in the target area. Furthermore, since the entire straight portion of the balloon of the modified method would include a plurality of apertures, at least a portion of the proximal ablation electrode and the distal ablation electrode which are located on the straight portion of the balloon of Maor would include at least some of the plurality of apertures of the modified method.
Regarding claim 14, Maor (Figures 1A, 16, and 18A) further discloses wherein conveying the electrical energy comprises conveying the electrical energy without permanent deformation of any of the plurality of expandable electrodes (403, 405), ([0077], [0104], [0115], [0118]).
Regarding claim 16, Maor (Figures 1A, 16, and 18A) further discloses wherein the inflatable balloon (401) is connected to a distal end of a shaft (119), and wherein traversing the inflatable balloon (401) through the tube (introducer sheath) comprises using the shaft (119) to traverse the inflatable balloon (401) through the tube (introducer sheath), ([0077], [0104], [0115], [0118]).
Regarding claim 17, Maor (Figures 1A, 16, and 18A) further discloses wherein the shaft (119) includes at least one conductor (133, 135) configured to transfer the electrical current to the plurality of expandable electrodes (401, 405) without permanent damage to the at least one conductor (133, 135), ([0104]-[0105], [0115]).
Regarding claim 19, Maor (Figures 1A, 16, and 18A) further discloses wherein conveying the electrical energy comprises conveying the electrical energy so as to irreversibly electroporate the target region ([0009], [0077], [0104], [0115], [0118]).
Regarding claim 31, Maor/Zikorus teaches at least some of the plurality of apertures defined through the electrically-insulating middle portion of the inflatable balloon (as explained in the rejection of claim 1, the entire straight portion of the balloon of Maor would include the plurality of apertures in the modified device, wherein the straight portion includes the electrically-insulating middle portion of the inflatable balloon; therefore, at least some of the plurality of apertures would be defined through the electrically-insulating middle portion of the inflatable balloon in the modified device).
Regarding claim 32, Maor/Zikorus teaches the at least some of the plurality of apertures defined through at least one of the proximal ablation electrode and the distal ablation electrode being proximate a boundary between the electrically-insulating middle portion of the inflatable balloon and the at least one of the proximal ablation electrode and the distal ablation electrode (as explained in the rejection of claim 1, the entire straight portion of the balloon of Maor would include the plurality of apertures in the modified device, wherein the straight portion includes the electrically-insulating middle portion of the inflatable balloon and the boundary between the electrically-insulating middle portion of the inflatable balloon and the proximal ablation electrode and the distal ablation electrode; therefore, at least some of the plurality of apertures would be defined through at least one of the proximal ablation electrode and the distal ablation electrode being proximate a boundary between the electrically-insulating middle portion of the inflatable balloon and the at least one of the proximal ablation electrode and the distal ablation electrode).
Claim(s) 12 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maor/Zikorus, as applied to claims 7 and 13 above, and further in view of Lafontaine (US 20040106952).
Regarding claim 12, Maor/Zikorus teaches the probe according to claim 7, but fails to teach that the tissue includes a ligament of Marshall. However, Lafontaine teaches a balloon catheter treating tissue including a ligament of Marshall as a source of atrial fibrillation ([0003], [0019], [0031). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor/Zikorus such that the tissue includes a ligament of Marshall, as taught by Lafontaine, because the modification would enable treatment of atrial fibrillation using a ligament of Marshall as a source (Lafontaine; [0003]).
Regarding claim 18, Maor/Zikorus teaches the method according to claim 7, but fails to teach that the tissue includes a ligament of Marshall. However, Lafontaine teaches a balloon catheter treating tissue including a ligament of Marshall as a source of atrial fibrillation ([0003], [0019], [0031). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor/Zikorus such that the tissue includes a ligament of Marshall, as taught by Lafontaine, because the modification would enable treatment of atrial fibrillation using a ligament of Marshall as a source (Lafontaine; [0003]).
Claim(s) 23 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maor/Zikorus, as applied to claims 1, 7, and 13 above, and further in view of Schwartz et al., (US 20180153437; hereinafter Schwartz).
Regarding claim 23, Maor/Zikorus teaches the apparatus according to claim 1, but fails to teach the electrically-insulating middle portion further comprising one or more electrophysiological signal sensing electrodes disposed thereon configured to detect electrophysiological signals. However, Schwartz (Figure 8C) teaches an apparatus (800) comprising one or more electrophysiological signal sensing electrodes (810) disposed on an electrically-insulating middle portion (central portion of balloon 832), the electrophysiological signal sensing electrodes (810) configured to detect electrophysiological signals ([0065], [0143], [0303]: impedance). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor/Zikorus to include one or more electrophysiological signal sensing electrodes disposed on the electrically-insulating middle portion and configured to detect electrophysiological signals, as taught by Schwartz, because the modification would track the position of the apparatus during a procedure to aid in treatment (Schwartz; [0006]).
Regarding claim 26, Maor/Zikorus teaches the apparatus according to claim 1, but fails to teach wherein the proximal ablation electrode and the distal ablation electrode are further configured for impedance-based position tracking. However, Schwartz (Figure 8C) teaches a balloon catheter (800) comprising electrodes (810) configured to measure impedance ([0065], [0143], [0303]). The apparatus also uses impedance-based position tracking for navigation during treatment ([0020]-[0021], [0107], [0190]-[0192]). Therefore, the impedance measured by electrodes (810) may be used for the impedance-based position tracking of the apparatus. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor/Zikorus to include the proximal ablation electrode and the distal ablation electrode further configured for impedance-based position tracking, as taught by Schwartz, because the modification would track the position of the apparatus during a procedure to aid in treatment (Schwartz; [0006]).
Regarding claim 27, Maor/Zikorus teaches the probe according to claim 7, but fails to teach wherein the proximal ablation electrode and the distal ablation electrode are further configured for impedance-based position tracking. However, Schwartz (Figure 8C) teaches a balloon catheter (800) comprising electrodes (810) configured to measure impedance ([0065], [0143], [0303]). The apparatus also uses impedance-based position tracking for navigation during treatment ([0020]-[0021], [0107], [0190]-[0192]). Therefore, the impedance measured by electrodes (810) may be used for the impedance-based position tracking of the apparatus. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor/Zikorus to include the proximal ablation electrode and the distal ablation electrode further configured for impedance-based position tracking, as taught by Schwartz, because the modification would track the position of the apparatus during a procedure to aid in treatment (Schwartz; [0006]).
Regarding claim 28, Maor/Zikorus teaches the method according to claim 13, but fails to teach determining a position of the proximal ablation electrode and the distal ablation electrode using impedance-based position tracking. However, Schwartz (Figure 8C) teaches a method for using a balloon catheter (800) comprising electrodes (810) configured to measure impedance ([0065], [0143], [0303]). The apparatus also uses impedance-based position tracking for navigation during treatment ([0020]-[0021], [0107], [0190]-[0192]). Therefore, the impedance measured by electrodes (810) may be used for the impedance-based position tracking of the apparatus. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor/Zikorus to include the step of determining a position of the proximal ablation electrode and the distal ablation electrode using impedance-based position tracking, as taught by Schwartz, because the modification would track the position of the apparatus during a procedure to aid in treatment (Schwartz; [0006]).
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maor/Zikorus, as applied to claim 1 above, and further in view of Mathur et al., (US 20130165990; hereinafter Mathur).
Regarding claims 29-30, Maor/Zikorus teaches the apparatus according to claim 1, but fails to teach wherein the proximal ablation electrode comprises: a first proximal electrode extending at least partially around a proximal-portion circumference of the proximal ablation electrode; and a second proximal electrode extending at least partially around the proximal-portion circumference, wherein the first proximal electrode the second proximal electrode are separated by a proximal electrically-insulating portion; wherein the distal ablation electrode portion comprises: a first distal electrode extending at least partially around a distal-portion circumference of the distal ablation electrode; and a second distal electrode extending at least partially around the distal-portion circumference, wherein the first distal electrode the second distal electrode are separated by a distal electrically-insulating portion. However, Mathur (Figure 50A) teaches a balloon catheter comprising a proximal portion including a first proximal electrode (5003) extending at least partially around a proximal-portion circumference of the proximal portion and a second proximal electrode (5004) extending at least partially around a proximal-portion circumference of the proximal portion, each proximal electrode (5003/5004) being separated from an adjacent proximal electrode (5004/5003) by a proximal electrically-insulating portion (electrically-insulating surface of the balloon separating the two electrodes circumferentially); as well as a distal portion including a first distal electrode (5002) extending at least partially around a distal-portion circumference of the distal portion and a second distal electrode (5005) extending at least partially around a distal-portion circumference of the distal portion, each distal electrode (5002/5005) being separated from an adjacent distal electrode (5005/5002) by a distal electrically-insulating portion (electrically-insulating surface of the balloon separating the two electrodes circumferentially), ([0464]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Maor/Zikorus to include first and second discrete proximal electrodes in the proximal portion (rather than one fully-circumferential proximal electrode), as well as first and second discrete distal electrodes in the distal portion (rather than one fully-circumferential distal electrode), as taught by Mathur, because the modification would treat targeted tissue using the discrete electrodes, rather than a fully-circumferential electrode, to achieve a desired therapeutic result by a remodeling of the treated tissue (Mathur, [0379]).
Response to Arguments
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive. In response to Applicant’s argument that the Moar/Zikorus combination fails to teach the newly amended limitation “a plurality of apertures configured to permit irrigation fluid to pass therethrough and contact tissue, at least some of the plurality of apertures defined through at least one of the proximal ablation electrode and the distal ablation electrode” in claim 1, as well as similar amendments in claims 7 and 13, Examiner respectfully disagrees. The Maor/Zikorus combination teaches an inflatable balloon device, as disclosed by Maor, modified to include a plurality of apertures in the entire straight portion of the balloon, as taught by Zikorus. Since Maor includes a portion of the proximal ablation electrode and the distal ablation electrode in the entire straight portion, at least a portion of the proximal ablation electrode and the distal ablation electrode which are located on the straight portion of the balloon of Maor would include at least some of the plurality of apertures of the modified device. Therefore, Examiner maintains that the Maor/Zikorus combination teaches the invention as claimed at least in amended claims 1, 7, and 13.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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