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 .
Claim Objections
Claims 1, 4, 7-9, and 12-15 are objected to because of the following informalities:
Claim 1, line 4: “the helical anchor member” should read –the helical anchor or needle member--;
Claim 4, line 2: “needle that selectively extendable” should read –needle that is selectively extendable--;
Claim 4, line 3: “and within” should read –and is positioned within--;
Claim 4, line 3: “the helical anchor member.” should read –the helical anchor or needle member.--;
Claim 7, line 2: “the helical anchor member” should read –the helical anchor or needle member--;
Claim 8, line 2: “the helical anchor member” should read –the helical anchor or needle member--;
Claim 9, line 9: “the helical anchor member” should read –the helical anchor or needle member--;
Claim 13, line 2: “the helical anchor members” should read –the helical anchor or needle members--;
Claim 14, line 2: “the helical anchor members” should read –the helical anchor or needle members--;
Claim 15, line 1: “the helical anchor members” should read –the helical anchor or needle members--; and
Claim 15, line 2: “the helical anchor members” should read –the helical anchor or needle members--.
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 9-16 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 9 recites the limitation "the catheter devices" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding dependent claims 10-16, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
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 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Long et al., US 20110190764, herein referred to as “Long”.
Regarding claim 1, Long discloses an electroporation catheter device ([0031] and Figure 4) comprising: a catheter shaft (Figure 4: shaft 204); and a helical anchor or needle member that is selectively extendable from a distal end of the catheter shaft (Figure 4: spiral coil 211 of second electrode 208 and [0067]), wherein the helical anchor member is configured to deliver pulsed-electric field non-thermal electroporation ablation energy to tissue of a heart ([0033] and [0074]).
Regarding claim 4, Long discloses the catheter device of claim 1, further comprising a straight needle (Figure 4: first electrode 206) that selectively extendable from the distal end of the catheter shaft ([0072]: “When the distal end 210 of second electrode 208 is rotated, or advanced, into the tissue, as described above, the distal end 205 of first electrode 206 can also be advanced into the tissue.”) and within an interior region defined by the helical anchor member (Figure 4: first electrode 206 and [0066]: “More particularly, in at least one embodiment, axis 209 can be aligned with axis 207 such that first electrode 206 is positioned in the center of, or in at least substantially the center of, the spiral coil 211 of second electrode 208.”).
Claims 9-10 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLeod et al., US 20200196893, herein referred to as “McLeod”.
Regarding claim 9, McLeod discloses a method for treating ventricular fibrillation of a heart ([0016]), the method comprising: using one or more of the catheter devices to deliver pulsed-electric field non-thermal electroporation ablation energy to one or more target locations of the heart (Figure 1 and [0002] and [0009]), wherein said one or more of the catheter devices are electroporation catheter devices comprising: a catheter shaft (Figure 1: catheter sheath 102); and a helical anchor or needle member that is selectively extendable ([0039]: “calibrating an external signal can aid in limiting the number of locations for deploying a plunge electrode”) from a distal end of the catheter shaft (Figure 1: tip portion 104 and [0029]: “tip portion 104 can be an electrode… tip portion 104 can be a single spoke, a tine, a hook, a helix, or other component capable of piercing tissue”), wherein the helical anchor member is configured to deliver pulsed-electric field non-thermal electroporation ablation energy to tissue of a heart ([0029] and [0009]).
Regarding claim 10, McLeod discloses the method of claim 9, wherein the one or more target locations of the heart includes an endocardial space of the heart ([0030]: “tip portion 104 of the probe 106 will be in contact with an endocardial or epicardial surface of the heart”), the mid-myocardium of the heart ([0047]), and an epicardial space of the heart ([0030]: “tip portion 104 of the probe 106 will be in contact with an endocardial or epicardial surface of the heart”).
Regarding claim 16, McLeod discloses the method of claim 9, further comprising monitoring tissue impedance prior to and during the delivery of the pulsed-electric field non-thermal electroporation ablation energy ([0029]: “tip portion 104 can be registered using impedance based monitoring or electromagnetic field location. In some cases, impedance based monitoring or electromagnetic field location can be used to determine a location and/or an orientation of mapping catheter 100.” And Figures 2-3).
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 are rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Rubinsky et al., US 20190160222, herein referred to as “Rubinsky”.
Regarding claim 2, Long discloses the catheter device of claim 1, but does not explicitly disclose a catheter device further comprising a balloon member attached at a distal end portion of the catheter shaft.
However, Rubinsky teaches a catheter device (Figure 1A) further comprising a balloon member attached at a distal end portion of the catheter shaft (Figures 1A and 2: balloon 19).
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 catheter device disclosed by Long so that it has a balloon member attached at a distal end portion of the catheter shaft as taught by Rubinsky so that pressure applied by an inflated balloon compresses stenosis or a lesion (Rubinsky [0003]).
Regarding claim 3, Long in view of Rubinsky discloses the catheter device of claim 2, and Rubinsky further discloses a catheter device further comprising one or more electrodes on an outer surface of the balloon or in an interior of the balloon (Figure 2: first and second longitudinal electrodes 25 and 27).
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 catheter device disclosed by Long so that it includes one or more electrodes on an outer surface of the balloon or in an interior of the balloon as taught by Rubinsky to treat only a vessel wall without impacting any blood present within the vessel lumen (Rubinsky [0111]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Henschel et al., US 20220000550, herein referred to as “Henschel”.
Regarding claim 5, Long discloses the catheter device of claim 1, but does not explicitly disclose a catheter device further comprising one or more electrodes on the catheter shaft.
However, Henschel teaches a catheter device (Figures 10-13) further comprising one or more electrodes on the catheter shaft (Figure 11: active electrodes 58).
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 catheter device disclosed by Long so that it includes one or more electrodes on the catheter shaft as taught by Henschel to create particular ablation patterns based on the goal of the procedure (Henschel [0092]).
Regarding claim 6, Long discloses the catheter device of claim 1, but does not explicitly disclose a catheter device further comprising a location sensor to assist in anatomical mapping.
However, Henschel teaches a catheter device (Figure 14) further comprising a location sensor to assist in anatomical mapping ([0095]: “In such a configuration, the exposed non-anodized regions of the active electrodes 58 may be used for sensing and mapping and the anodized portion will be included for delivery of PEF energy.”).
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 catheter device disclosed by Long so that it includes a location sensor to assist in anatomical mapping as taught by Henschel to provide highly localized methods of detection and therapy (Henschel [0004]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Long (Figure 4) in view of Embodiment B of Long (Figure 14).
Regarding claim 7, Embodiment A of Long discloses the catheter device of claim 1, but does not explicitly disclose a catheter device wherein the catheter shaft or the helical anchor member defines a port for delivering a fluid.
However, Embodiment B of Long teaches a catheter device (Figure 14) wherein the catheter shaft or the helical anchor member defines a port for delivering a fluid (Figure 14: apertures 532 and [0079]-[0080]).
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 catheter device disclosed by Embodiment A of Long so that the catheter shaft or the helical anchor member defines a port for delivering a fluid as taught by Embodiment B of Long so that a fluid can be applied directly to the tissue being treated without having to remove a surgical instrument from the tissue and/or without having to insert an additional surgical instrument into the tissue to supply the therapeutic fluid (Long [0079]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Nemati, US 20130274837, herein referred to as “Nemati”.
Regarding claim 8, Long discloses the catheter device of claim 1, but does not explicitly disclose a catheter device wherein the catheter shaft or the helical anchor member is configured to deliver photo- biomodulation light.
However, Nemati teaches a catheter device (Figure 6) wherein the catheter shaft or the helical anchor member is configured to deliver photo-biomodulation light ([0024] and [0071]).
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 catheter device disclosed by Long so that the catheter shaft or the helical anchor member is configured to deliver photo-biomodulation light as taught by Nemati to cause a variety of therapeutic effects, like increased collagen production, increased fibroblast production, and increased macrophage activity (Nemati [0003]).
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over McLeod in view of Killu et al., US 20180318003, herein referred to as “Killu”.
Regarding claim 11, McLeod discloses the method of claim 9, but does not explicitly disclose a method wherein the one or more target locations of the heart includes a ventricular septum of the heart.
However, Killu teaches a method wherein the one or more target locations of the heart includes a ventricular septum of the heart ([0019]).
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 McLeod so that the one or more target locations of the heart includes a ventricular septum of the heart as taught by Killu so that the method can treat HCM (Killu [0011]).
Regarding claim 12, McLeod in view of Killu discloses the method of claim 11, and Killu further discloses a method further comprising using two of the catheter devices and penetrating the ventricular septum with two of the helical anchor or needle members on a same side of the ventricular septum (Figures 3 and 4 and [0019]). In combination with McLeod, there is a helical anchor or needle member at the end of each catheter.
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 McLeod so that it includes using two of the catheter devices and penetrating the ventricular septum with two of the members on a same side of the ventricular septum as taught by Killu so that the method can treat HCM (Killu [0011]).
Regarding claim 13, McLeod in view of Killu discloses the method of claim 12, and Killu further discloses a method wherein a first one of the helical anchor members functions as an anode ([0026]: “In some embodiments, a first device with one or more electrodes (e.g., a first set of anodes) is placed endocardially, and a second device with one or more electrodes (e.g., a second set of cathodes) is placed in the pericardial space or the coronary vasculature.”) and a second one of the helical anchor members functions as a cathode ([0026]: “In some embodiments, a first device with one or more electrodes (e.g., a first set of anodes) is placed endocardially, and a second device with one or more electrodes (e.g., a second set of cathodes) is placed in the pericardial space or the coronary vasculature.”). In combination with McLeod, there is a helical anchor or needle member at the end of each catheter.
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 McLeod so that a first one of the members functions as an anode and a second one of the members functions as a cathode as taught by Killu so that the method can treat HCM (Killu [0011]).
Regarding claim 12, McLeod in view of Killu discloses the method of claim 11, and Killu further discloses a method further comprising using two of the catheter devices and penetrating the ventricular septum with two of the helical anchor members on opposite sides of the ventricular septum (Figures 3 and 4 and [0019] and [0034]). In combination with McLeod, there is a helical anchor or needle member at the end of each catheter.
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 McLeod so that it includes using two of the catheter devices and penetrating the ventricular septum with two of the members on opposite sides of the ventricular septum as taught by Killu so that the method can treat HCM (Killu [0011]).
Regarding claim 15, McLeod in view of Killu discloses the method of claim 14, and Killu further discloses a method wherein a first one of the helical anchor members functions as an anode ([0026]: “In some embodiments, a first device with one or more electrodes (e.g., a first set of anodes) is placed endocardially, and a second device with one or more electrodes (e.g., a second set of cathodes) is placed in the pericardial space or the coronary vasculature.”) and a second one of the helical anchor members functions as a cathode ([0026]: “In some embodiments, a first device with one or more electrodes (e.g., a first set of anodes) is placed endocardially, and a second device with one or more electrodes (e.g., a second set of cathodes) is placed in the pericardial space or the coronary vasculature.”). In combination with McLeod, there is a helical anchor or needle member at the end of each catheter.
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 McLeod so that a first one of the members functions as an anode and a second one of the members functions as a cathode as taught by Killu so that the method can treat HCM (Killu [0011]).
Conclusion
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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/NORA W RHODES/Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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