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
Acknowledgment is made to the amendment received 9/4/2025.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claim 1 was rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salahieh. Now, based on amendments to the claim language, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Yang et al., US 20210315629.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al., US 20140243821, herein referred to as “Salahieh”, in view of Yang et al., US 20210315629, herein referred to as “Yang”.
Regarding claim 1, Salahieh discloses a balloon-type electrode catheter (Figures 6 and 8-9) comprising: a catheter shaft (Figure 6: elongate member 316 and Figure 8: catheter 226) insertable into a body ([0005]); a balloon (Figure 8: inflatable element 216) provided at a part including a distal end of the catheter shaft (Figures 6 and 8: inflatable element 216 is at a distal end of the catheter shaft), the balloon being inflatable with a fluid ([0080]: “Fluid flow into inflatable element 116 causes inflatable element 116 to expand. ”) supplied from a part including a proximal end of the catheter shaft ([0080]: “Once the expandable portion is in position, fluid from fluid reservoir 326 is pumped in an open loop control configuration, under constant flow, through irrigation line 328 and into inflatable element 116 by pump 330. ”); and an electrode disposed on a surface of the balloon (Figure 8: conduction material 218), wherein the balloon includes a through hole (Figure 8: irrigation apertures 238) configured to communicate an inside and an outside of the balloon to discharge the fluid in the balloon to the outside of the balloon ([0095]: “The irrigation fluid flowing through irrigation apertures 238 fills the space between the cylindrical section 222 and tissue, and current from the helical electrode is carried through the conductive irrigation fluid and into the adjacent tissue.” And [0097]), the balloon in an inflated state includes a distal end large diameter portion ([0095]: “ The proximal and distal portions of inflatable element 216 have diameters that are greater than the intermediate section, such that the expandable portion has a general dumbbell shape.”), a proximal end large diameter portion positioned closer to the proximal end of the catheter shaft than the distal end large diameter portion is (Figure 8 and [0095]: “ The proximal and distal portions of inflatable element 216 have diameters that are greater than the intermediate section, such that the expandable portion has a general dumbbell shape.”), a small diameter portion (Figure 8: cylindrical section 222) positioned between the distal end large diameter portion and the proximal end large diameter portion and being smaller in diameter than the two large diameter portions ([0095]: “The proximal and distal portions of inflatable element 216 have diameters that are greater than the intermediate section, such that the expandable portion has a general dumbbell shape.”), a distal end inclined portion connecting the distal end large diameter portion and the small diameter portion (Figure 8), and a proximal end inclined portion connecting the proximal end large diameter portion and the small diameter portion (Figure 8), the electrode is exposed at least at the small diameter portion (Figure 8: conduction material 218 is exposed at cylindrical section 222), and the through hole is disposed in at least one of the distal end inclined portion or the proximal end inclined portion (Figure 8: there are irrigation apertures 238 at the distal end inclined portion). Salahieh does not explicitly disclose a balloon-type electrode catheter wherein a peripheral edge portion of a septum through hole provided in a septum inside the body fits in a constricted portion comprised of the small diameter portion, the distal end inclined portion, and the proximal end inclined portion, the peripheral edge portion contacts with the electrode exposed at the small diameter portion, and the peripheral edge portion is ablated by energizing the electrode.
However, Yang teaches a balloon-type electrode catheter (Figure 1) wherein a peripheral edge portion of a septum through hole provided in a septum inside the body fits in a constricted portion comprised of the small diameter portion (Figure 8 and Figure 1: middle portion 26), the distal end inclined portion, and the proximal end inclined portion ([0042]: “each lobe 24a and 24b tapers is diameter as they extend toward the middle portion 26. This tapering creates a wedge shape as between the first lobe 24a, the second lobe 24b, and the middle portion 26. This wedge shape traps the septal wall being ablated from both sides of the septal wall and thereby isolating blood that is flowing within respective atria from the septal wall being ablated. ”), the peripheral edge portion contacts with the electrode exposed at the small diameter portion (Figure 2: ablation element 29 and [0043]), and the peripheral edge portion is ablated by energizing the electrode ([0043]: “The ablation element 28 is configured to deliver ablation energy, such as cryogenic ablation energy, solely to the middle portion 26 to avoid collateral damage to surrounding tissue or blood other than the septal wall.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the balloon-type electrode catheter disclosed by Salahieh so that a peripheral edge portion of a septum through hole provided in a septum inside the body fits in a constricted portion comprised of the small diameter portion, the distal end inclined portion, and the proximal end inclined portion, the peripheral edge portion contacts with the electrode exposed at the small diameter portion, and the peripheral edge portion is ablated by energizing the electrode as taught by Yang to avoid collateral damage to surrounding tissue or blood other than the septal wall (Yang [0043]).
Regarding claim 2, Salahieh in view of Yang discloses the balloon-type electrode catheter according to claim 1, and Salahieh further discloses a balloon-type electrode catheter wherein the through hole is disposed in at least the distal end inclined portion (Figure 8: there are irrigation apertures 238 at the distal end inclined portion).
Regarding claim 3, Salahieh in view of Yang discloses the balloon-type electrode catheter according to claim 1, and Salahieh further discloses a balloon-type electrode catheter wherein the through hole is disposed in both of the distal end inclined portion and the proximal end inclined portion (Figure 8: there are irrigation apertures 238 at the distal end inclined portion and there are unlabeled apertures at the proximal end inclined portion).
Regarding claim 4, Salahieh in view of Yang discloses the balloon-type electrode catheter according to claim 2, and Salahieh further discloses a balloon-type electrode catheter wherein the through hole is disposed to avoid the electrode (Figure 8: irrigation apertures 238 avoid conduction material 218).
Regarding claim 5, Salahieh in view of Yang discloses the balloon-type electrode catheter according to claim 1, and Salahieh further discloses a balloon-type electrode catheter comprising: a lead wire (Figure 6: guidewire 310) extending from the part including the proximal end of the catheter shaft toward the part including the distal end of the catheter shaft (Figure 6: guidewire 310 extends from the proximal end to the distal end); and a connecting member disposed closer to the distal end of the catheter shaft than the balloon is (Figure 8: nerve conduction electrodes 215), the connecting member electrically connecting the lead wire and the electrode ([0096]: “The conduction electrodes are wired to the sensing circuits in the controller via wires traveling within the catheter shaft, as in the irrigation lumen, or additional lumens (not shown), or multiple conductors may be applied to the outer surface of the shaft (not shown).”), wherein the electrode extends from the connecting member to the small diameter portion (Figure 8: conduction material 218 is exposed at cylindrical section 222) through the distal end inclined portion and includes an end portion disposed closer to the proximal end is (Figure 8: nerve conduction electrodes 215) of the catheter shaft than the small diameter portion is ([0096]: “The conduction electrodes are wired to the sensing circuits in the controller via wires traveling within the catheter shaft, as in the irrigation lumen, or additional lumens (not shown), or multiple conductors may be applied to the outer surface of the shaft (not shown).”).
Regarding claim 6, Salahieh in view of Yang discloses the balloon-type electrode catheter according to claim 5, and Salahieh further discloses a balloon-type electrode catheter comprising an insulating film (Figure 8: insulation material 234) covering at least part of a region of the electrode from the connecting member to the distal end inclined portion ([0095]: “A conductive layer and an insulation layer are disposed on the catheter as in the embodiment in FIGS. 1-5.” And [0059]-[0060]).
Regarding claim 7, Salahieh in view of Yang discloses the balloon-type electrode catheter according to claim 1, and Salahieh further discloses a balloon-type electrode catheter wherein the catheter shaft includes a supply lumen configured to cause the fluid to flow into the balloon (Figure 9: irrigation lumen 228) and a discharge lumen configured to discharge gas in the balloon ([0104]: “Inflatable element 116 is then inflated with a suitable inflation fluid (e.g., liquid or gas) delivered through the irrigation lumen and out port 130 to expand, or inflate, inflatable element 116, as shown in FIG. 11C… inflatable element 116 is deflated ”).
Regarding claim 8, Salahieh in view of Yang discloses the balloon-type electrode catheter according to claim 7, and Salahieh further discloses a balloon-type electrode catheter wherein the supply lumen includes a supply port in the balloon (Figure 9: irrigation port 230), the supply port being configured to cause the fluid to flow into the balloon ([0097]: “The fluid enters the inflatable element 216 at irrigation port 230 as shown by arrows 1006.”), the discharge lumen includes a discharge port in the balloon, the discharge port being configured to cause the gas to flow out of the balloon ([0097]: “ The fluid then flows out of inflatable element 216 at irrigation apertures 238, shown by arrows 1007.” And [0104]: “ Inflatable element 116 is then inflated with a suitable inflation fluid (e.g., liquid or gas) delivered through the irrigation lumen and out port 130 to expand, or inflate, inflatable element 116, as shown in FIG. 11C), and the supply port is positioned closer to the distal end of the catheter shaft than the discharge port is (Figure 9: irrigation port is closer to the distal end that arrows 1007).
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.
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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