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 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 and 8 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 6 recites the limitation "the frame" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the frame" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 7-9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahvi et al., US 20140031810, herein referred to as “Mahvi”.
Regarding claim 1, Mahvi discloses an electroporation device (Figures 8-11) comprising: a shaft (Figure 8: catheter shaft 22) defining a lumen therethrough (Figure 8: shaft 512); an expandable balloon circumferentially attached about a distal portion of the shaft (Figure 11: balloon 508); and one or more electrodes (Figure 11: electrodes 528) that are selectively deployable to extend laterally from the balloon ([0046]) and that are completely retractable into the balloon ([0046]: “The electrodes 538 can be advanced along the tube 532 until a distal end 540 of each electrode 534 extends outwardly from the external surface 506 of the balloon 508 or can be retracted into its associated shaft 540 such that the distal end 540 is inside the associated tube 532. ” and [0047]).
Regarding claim 2, Mahvi discloses an electroporation device (Figures 8-11) comprising: a shaft (Figure 8: catheter shaft 22) defining a lumen therethrough (Figure 8: shaft 512); an expandable frame circumferentially attached about a distal portion of the shaft (Figures 8-11: electrode structure 550 and tubes 532 and balloon 508); and one or more electrodes (Figure 11: electrodes 528) that are selectively deployable to extend laterally from the frame ([0046]) and that are completely retractable into the frame ([0046]: “The electrodes 538 can be advanced along the tube 532 until a distal end 540 of each electrode 534 extends outwardly from the external surface 506 of the balloon 508 or can be retracted into its associated shaft 540 such that the distal end 540 is inside the associated tube 532. ” and [0047]).
Regarding claim 3, Mahvi discloses the electroporation device of claim 1, wherein the one or more electrodes are curved electrodes (Figure 8: tubes 532 are curved, thus electrodes 528 are curved as well; [0046]).
Regarding claim 7, Mahvi discloses the electroporation device of claim 1, wherein the shaft defines a port that connects the lumen to areas external of the electroporation device ([0044]: “Shaft 512 is configured to contain internally an inflation channel for inflation of the balloon 508.”).
Regarding claim 8, Mahvi discloses the electroporation device of claim 1, wherein the balloon or the frame defines an opening configured for slidably receiving a guidewire (Figure 8: shaft 512 and [0048]: “electrode structure 103, 203, 303, 550 is electrically coupled to signal wires, which extend from the electrode structure 103, 203, 303, 550, and are in turn electrically coupled to an RF generator which allows control of several electrical parameters (frequency, wattage, etc.). ”).
Regarding claim 9, Mahvi discloses an electroporation device (Figures 8-11) comprising: a cap configured to be releasably attached to a distal end portion of a shaft of an endoscopic device (Figure 11: balloon 508 and [0044]); and one or more electrodes (Figure 11: electrodes 528)that are selectively deployable to extend distally from the cap ([0046]) and that are completely retractable into the cap ([0046]: “The electrodes 538 can be advanced along the tube 532 until a distal end 540 of each electrode 534 extends outwardly from the external surface 506 of the balloon 508 or can be retracted into its associated shaft 540 such that the distal end 540 is inside the associated tube 532. ” and [0047]).
Regarding claim 11, Mahvi discloses the electroporation device of claim 9, wherein the one or more electrodes are curved electrodes (Figure 8: tubes 532 are curved, thus electrodes 528 are curved as well; [0046]).
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated Toth, US 20150297139, herein referred to as “Toth”.
Regarding claim 14, Toth teaches a method of administering pulsed electrical field electroporation energy ([0383]) to treat a disorder of a gastrointestinal tract of a patient ([0087]), the method comprising: deploying the electroporation device of claim 1 to a target location within the gastrointestinal tract of the patient (Figure 6B); deploying the one or more electrodes to extend laterally or distally and to penetrate into tissue at the target location ([0144]: “The tips of the probes 624a-e may be inserted into or placed near to one or more intended treatment zones 640a,b. ” and [0145]: “A first probe 624d is shown with a plurality of electrodes 632a,b configured for monitoring electrophysiological activity in the vicinity thereof before, during, and/or after a procedure. In aspects, the electrode 632a,b may be configured to delivery energy in the form of an RF current into the surrounding tissues, one of the electrodes 632b,a, an electrode 636 on the elongate member 638 or a remotely placed electrode may act as a return path for the current.”); and energizing the one or more electrodes with pulsed electrical field electroporation energy to deliver the pulsed electrical field electroporation energy to the tissue at the target location ([0145]: “In aspects, the electrode 632a,b may be configured to delivery energy in the form of an RF current into the surrounding tissues,” and [0383]).
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 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Mahvi (Figures 8-11) in view of Embodiment B of Mahvi (Figures 6-7).
Regarding claim 4, Embodiment A of Mahvi discloses the electroporation device of claim 1, but does not explicitly disclose a device wherein the one or more electrodes are straight electrodes.
However, Embodiment B of Mahvi teaches a device wherein the one or more electrodes are straight electrodes (Figures 6-7: protrusions 322 and electrodes 304a are straight).
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 device disclosed by Embodiment A of Mahvi so that the one or more electrodes are straight electrodes as taught by Embodiment B of Mahvi so that the electrodes may have distal sharpness and strength to penetrate to a predetermined depth of the cavity tissue (Mahvi [0041]).
Regarding claim 12, Embodiment A of Mahvi discloses the electroporation device of claim 9, but does not explicitly disclose a device wherein the one or more electrodes are straight electrodes.
However, Embodiment B of Mahvi teaches a device wherein the one or more electrodes are straight electrodes (Figures 6-7: protrusions 322 and electrodes 304a are straight).
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 device disclosed by Embodiment A of Mahvi so that the one or more electrodes are straight electrodes as taught by Embodiment B of Mahvi so that the electrodes may have distal sharpness and strength to penetrate to a predetermined depth of the cavity tissue (Mahvi [0041]).
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mahvi in view of Placek et al., US 20100222677, herein referred to as “Placek”.
Regarding claim 5, Mahvi discloses the electroporation device of claim 1, but does not explicitly disclose a device wherein the one or more electrodes are helical electrodes.
However, Placek teaches a device wherein the one or more electrodes are helical electrodes ([0051]: “The needle electrodes will typically be pre-shaped in a straight configuration but in other embodiments could be pre-shaped curved, helical, or have other geometries. ”).
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 device disclosed by Mahvi so that the one or more electrodes are helical electrodes as taught by Placek because a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 13, Mahvi discloses the electroporation device of claim 9, but does not explicitly disclose a device wherein the one or more electrodes are helical electrodes.
However, Placek teaches a device wherein the one or more electrodes are helical electrodes ([0051]: “The needle electrodes will typically be pre-shaped in a straight configuration but in other embodiments could be pre-shaped curved, helical, or have other geometries. ”).
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 device disclosed by Mahvi so that the one or more electrodes are helical electrodes as taught by Placek because a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mahvi in view of Townley et al., US 20160331459, herein referred to as “Townley”.
Regarding claim 6, Mahvi discloses the electroporation device of claim 1, but does not explicitly disclose a device further comprising one or more flexible circuits attached to the balloon or the frame.
However, Townley teaches a device (Figure 14) further comprising one or more flexible circuits attached to the balloon or the frame (Figure 14: flex circuit 1476).
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 device disclosed by Mahvi so that one or more flexible circuits are attached to the balloon or the frame as taught by Townley to facilitate the creation of complex electrode arrays (Townley [0123]).
Regarding claim 10, Mahvi discloses the electroporation device of claim 9, but does not explicitly disclose a device further comprising one or more flexible circuits attached to the cap.
However, Townley teaches a device (Figure 14) further comprising one or more flexible circuits attached to the cap (Figure 14: flex circuit 1476).
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 device disclosed by Mahvi so that one or more flexible circuits are attached to the cap as taught by Townley to facilitate the creation of complex electrode arrays (Townley [0123]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794