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 12/11/2025.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC §101 rejections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC § 112(b) rejections set forth in the previous office action.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 13 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 Asirvatham and claim 13 was rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davies. Now, based on amendments to the claim language, claims 1 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whisenant.
Claim Rejections - 35 USC § 102
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 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 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, 7-8, 11, 13-15, 17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whisenant et al., US 20110130619, herein referred to as “Whisenant”.
Regarding claim 1, Whisenant discloses a method for creating a perforation at a target location between an aorta and a left atrium of a patient’s heart (Figures 2-11 and 17), the method comprising: advancing an operative distal tip of a flexible wire toward the target location (Figures 2-3: filament member 140 and [0039]); wherein advancing the operative distal tip toward the target location comprises: advancing the operative distal tip of the flexible wire into a right atrium of the patient's heart (Figure 2 and [0039]: “a catheter 130 is directed to the right atrium 102 through the inferior vena cava 112, such as by a femoral vein”); advancing a dilator along the flexible wire to position the operative distal tip adjacent a transatrial septum of the patient's heart (Figure 2: catheter 130 and [0039]: “The catheter 130 may include known components, such as a dilator and stylet, and may be used to perform a procedure such as puncturing the septum 132”); energizing the operative distal tip to create a perforation through the transatrial septum (Figures 2-3: catheter 130 and [0039]: “The catheter 130 may include known components, such as a dilator and stylet, and may be used to perform a procedure such as puncturing the septum 132”); advancing the operative distal tip into the left atrium ([0041]: “For example, it is contemplated that a portion of the anastomosis device 134 may protrude into the left atrium such as shown in FIG. 13.”); and advancing the dilator along the flexible wire to enlarge the perforation through the transatrial septum (Figure 3 and [0040]: “an anastomosis device 134 may be inserted through and coupled to the septum 132”); advancing the dilator along the flexible wire to direct the operative distal tip of the flexible wire adjacent the target location on a wall of the aorta (Figure 10 and [0046]); energizing the operative distal tip of the flexible wire to create the perforation at the target location (Figure 17 and [0063]: “The anastomosis can then be made at any suitable location in the left atrium wall that is adjacent the aorta 126. Once the anastomosis is made, the anastomosis device 352, with the integrated pumping device 354, may then be deployed from the catheter 130 and implanted within the wall between the left atrium 104 and the aorta 126.”); advancing the operative distal tip across the wall through the perforation at the target location (Figure 17 and [0063]: “The anastomosis can then be made at any suitable location in the left atrium wall that is adjacent the aorta 126. Once the anastomosis is made, the anastomosis device 352, with the integrated pumping device 354, may then be deployed from the catheter 130 and implanted within the wall between the left atrium 104 and the aorta 126.”); and advancing the dilator through the perforation to enlarge the perforation at the target location (Figure 17 and [0063]: “The anastomosis can then be made at any suitable location in the left atrium wall that is adjacent the aorta 126. Once the anastomosis is made, the anastomosis device 352, with the integrated pumping device 354, may then be deployed from the catheter 130 and implanted within the wall between the left atrium 104 and the aorta 126.”).
Regarding claim 4, Whisenant discloses the method of claim 1, wherein the operative distal tip creates the perforation at the target location from the left atrium into the aorta (Figure 17 and [0063]: “The anastomosis can then be made at any suitable location in the left atrium wall that is adjacent the aorta 126. Once the anastomosis is made, the anastomosis device 352, with the integrated pumping device 354, may then be deployed from the catheter 130 and implanted within the wall between the left atrium 104 and the aorta 126.”).
Regarding claim 7, Whisenant discloses the method of claim 1, wherein the operative distal tip creates the perforation at the target location from the aorta into the left atrium (Figure 17 and [0063]: “The anastomosis can then be made at any suitable location in the left atrium wall that is adjacent the aorta 126. Once the anastomosis is made, the anastomosis device 352, with the integrated pumping device 354, may then be deployed from the catheter 130 and implanted within the wall between the left atrium 104 and the aorta 126.”).
Regarding claim 8, Whisenant discloses the method of claim 1, wherein the operative distal tip is energized using on or more of radio-frequency energy, mechanical energy, electrical energy, radiant energy and thermal energy ([0011] wherein the puncturing is a form of mechanical energy).
Regarding claim 11, Whisenant discloses the method of claim 1, wherein the dilator is curved (Figure 2: catheter 130 and Figure 17: anastomosis device 352).
Regarding claim 13, Whisenant discloses a system for creating a perforation at a target location between an aorta and a left atrium of a patient's heart (Figures 2-11 and 17), the system comprising: a flexible wire having an operative distal tip for creating another perforation through a transatrial septum (Figures 2-3: filament member 140 and [0039]) of the patient's heart when energized and creating the perforation at the target location when energized ([0039]: “The catheter 130 may include known components, such as a dilator and stylet, and may be used to perform a procedure such as puncturing the septum 132”); and a dilator configured to position the operative distal tip adjacent the transatrial septum (Figures 2-3 and [0039]: “The catheter 130 may include known components, such as a dilator and stylet, and may be used to perform a procedure such as puncturing the septum 132”), enlarge the other perforation through the transatrial septum (Figure 3 and [0040]: “an anastomosis device 134 may be inserted through and coupled to the septum 132”), position the operative distal tip adjacent the target location on a wall of the aorta (Figure 10 and [0046] and Figure 17), and enlarge the perforation at the target location (Figure 17 and [0063]: “The anastomosis can then be made at any suitable location in the left atrium wall that is adjacent the aorta 126. Once the anastomosis is made, the anastomosis device 352, with the integrated pumping device 354, may then be deployed from the catheter 130 and implanted within the wall between the left atrium 104 and the aorta 126.”), the dilator having at least one open lumen for receiving the flexible wire (Figure 3).
Regarding claim 14, Whisenant discloses the system of claim 13, wherein the flexible wire is a radio frequency wire or a mechanical puncture wire ([0011] wherein the puncturing is a form of mechanical energy).
Regarding claim 15, Whisenant discloses the system of claim 13, wherein the flexible wire is configured to provide support for placement of a device between the aorta and the left atrium across the perforation at the target location (Figure 17 and [0063]: “The anastomosis can then be made at any suitable location in the left atrium wall that is adjacent the aorta 126. Once the anastomosis is made, the anastomosis device 352, with the integrated pumping device 354, may then be deployed from the catheter 130 and implanted within the wall between the left atrium 104 and the aorta 126.”).
Regarding claim 17, Whisenant discloses the system of claim 13, wherein the dilator is curved (Figure 2: catheter 130 and Figure 17: anastomosis device 352).
Regarding claim 20, Whisenant discloses the system of claim 13, wherein the operative distal tip is energized using one or more of radio-frequency energy, mechanical energy, electrical energy, radiant energy, or thermal energy ([0011] wherein the puncturing is a form of mechanical energy).
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 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 2-3, 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Whisenant in view of Garibotto et al., US 20020123698, herein referred to as “Garibotto”.
Regarding claim 2, Whisenant discloses the method of claim 1, but does not explicitly disclose a method further comprising advancing a lasso catheter in plane with the operative distal tip prior to creation of the perforation at the target location, wherein, when the operative distal tip exits after advancing through the perforation at the target location, the lasso catheter engages the operative distal tip.
However, Garibotto teaches a method comprising advancing a lasso catheter in plane with the operative distal tip prior to creation of the perforation at the target location (Figure 18A), wherein, when the operative distal tip exits after advancing through the perforation at the target location, the lasso catheter engages the operative distal tip (Figure 18B).
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 method disclosed by Whisenant so that it includes advancing a lasso catheter in plane with the operative distal tip prior to creation of the perforation at the target location, wherein, when the operative distal tip exits after advancing through the perforation at the target location, the lasso catheter engages the operative distal tip as taught by Garibotto so that the device can reach two separate locations for treatment (Garibotto [0120]).
Regarding claim 3, Whisenant in view of Garibotto discloses the method of claim 2, and Garibotto further discloses a method further comprising flossing the flexible wire after the lasso catheter engages the operative distal tip (Figures 18A-B).
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 method disclosed by Whisenant so that it includes flossing the flexible wire after the lasso catheter engages the operative distal tip as taught by Garibotto so that the device can reach two separate locations for treatment (Garibotto [0120]).
Regarding claim 16, Whisenant discloses the system of claim 13, but does not explicitly disclose a system further comprising a lasso catheter configured to be positioned in plane with the operative distal tip, wherein when the operative distal tip exits after advancing through the perforation at the target location, the lasso catheter is configured to retain the operative distal tip, wherein the lasso catheter permits the flexible wire to be flossed.
However, Garibotto teaches a system comprising a lasso catheter configured to be positioned in plane with the operative distal tip (Figure 18A), wherein when the operative distal tip exits after advancing through the perforation at the target location, the lasso catheter is configured to retain the operative distal tip (Figure 18B), wherein the lasso catheter permits the flexible wire to be flossed (Figures 18A-B).
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 system disclosed by Whisenant so that it includes a lasso catheter configured to be positioned in plane with the operative distal tip, wherein when the operative distal tip exits after advancing through the perforation at the target location, the lasso catheter is configured to retain the operative distal tip, wherein the lasso catheter permits the flexible wire to be flossed as taught by Garibotto so that the device can reach two separate locations for treatment (Garibotto [0120]).
Regarding claim 19, Whisenant discloses the system of claim 13, but does not explicitly disclose a system wherein the operative distal tip of the flexible wire comprises one or more pressure sensor for measuring at least one pressure gradient within the patient’s heart or an anchor to support the flexible wire in position after the perforation at the target location is created.
However, Garibotto teaches a system (Figure 3A) wherein the operative distal tip of the flexible wire comprises one or more pressure sensor for measuring at least one pressure gradient within the patient’s heart or an anchor to support the flexible wire in position after the perforation at the target location is created ([0092]: “If left in place, the second guidewire 306 may be used to substantially anchor the curved distal portion 330 adjacent the interstitial channel 84 and/or may be used for introducing subsequent devices (not shown).”).
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 system disclosed by Whisenant so that it includes an anchor to support the flexible wire in position after the perforation at the target location is created as taught by Garibotto so that subsequent devices can be introduced (Garibotto [0092]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Whisenant in view of MacDonald et al., US 20200397472, herein referred to as “MacDonald”.
Regarding claim 18, Whisenant discloses the system of claim 13, wherein visualization markers are disposed on the flexible wire ([0043]: “The filament member 140 may also be formed of a material, or include markers formed therein, that is (are) detectable by various imaging techniques to verify its position within the heart and veins.”). Whisenant does not explicitly disclose a system wherein visualization markers are disposed on the dilator and the flexible wire.
However, MacDonald teaches a system (Figure 6A) wherein visualization markers are disposed on the dilator ([0102]: “In an embodiment, the dilator contains a radiopaque marker at the distal tip so that the tip position is easily visible under fluoroscopy.”) and the flexible wire ([0105]: “The sheath guide wire may have guide wire markings to help the user determine where the tip of the wire is with respect to the dilator.”).
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 system disclosed by Whisenant so that it includes visualization markers disposed on the dilator and the flexible wire as taught by MacDonald so that the tip position is easily visible under fluoroscopy (MacDonald [0102]).
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 Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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