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 6/11/2026.
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 2, 11, and 14 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.
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 8 is 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 8 recites the limitation "the balloon" in lines 1-2. 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 9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rodriguez et al., US 20190336757, herein referred to as “Rodriguez”.
Regarding claim 9, Rodriguez discloses an electroporation device (Figures 9-10 and [0351]) comprising: a cap configured to be releasably attached to a distal end portion of a shaft of an endoscopic device (Figures 9-10: cap 402) and comprising a recess located at a distal end of the cap and comprising one or more side walls and a bottom surface (Figures 9-10: cap 402); and one or more electrodes (Figures 9-10: electrodes 400) that are selectively deployable to extend distally from the cap (Figure 10 and [0324]) and that are completely retractable into the cap (Figure 9).
Regarding claim 11, Rodriguez discloses the electroporation device of claim 9, wherein the one or more electrodes are curved electrodes (Figure 10: electrodes 400 are curved).
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, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mahvi et al., US 20140031810, herein referred to as “Mahvi”, in view of Maor et al., US 20090248012, herein referred to as “Maor”.
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 expandable frame ([0046]) and that are completely retractable into the expandable 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]). Mahvi does not disclose an electroporation device wherein the expandable frame is a self-expandable frame.
However, Maor teaches an electroporation device (Abstract) wherein the expandable frame is a self-expandable frame ([0101]: “In one embodiment the electrode assembly 26 is comprised of shape memory material such as nitinol which returns to a pre-determined shape upon release.”).
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 Mahvi so that the expandable frame is a self-expandable frame as taught by Maor so that it returns to a pre-determined shape upon release (Maor [0101]).
Regarding claim 3, Mahvi in view of Maor discloses the electroporation device of claim 2, and Mahvi further discloses an electroporation device 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 in view of Maor discloses the electroporation device of claim 2, and Mahvi further discloses an electroporation device 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 in view of Maor discloses the electroporation device of claim 2, and Mahvi further discloses an electroporation device wherein the balloon or the self-expandable 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.). ”).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Mahvi (Figures 8-11) in view of Maor, further in view of Embodiment B of Mahvi (Figures 6-7).
Regarding claim 4, Embodiment A of Mahvi in view of Maor discloses the electroporation device of claim 2, 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]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mahvi in view of Maor, further in view of Placek et al., US 20100222677, herein referred to as “Placek”.
Regarding claim 5, Mahvi in view of Maor discloses the electroporation device of claim 2, 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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mahvi in view of Maor, further in view of Townley et al., US 20160331459, herein referred to as “Townley”.
Regarding claim 6, Mahvi in view of Maor discloses the electroporation device of claim 2, but does not explicitly disclose a device further comprising one or more flexible circuits attached to the self-expanding frame.
However, Townley teaches a device (Figure 14) further comprising one or more flexible circuits attached to the frame (Figure 14: flex circuit 1476). IN combination with Maor, the flexible circuits are attached to the self-expanding frame.
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]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez in view of Townley et al., US 20160331459, herein referred to as “Townley”.
Regarding claim 10, Rodriguez 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 one or more side walls and the bottom surface of the recess of 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 Rodriguez so that one or more flexible circuits are attached to the one or more side walls and the bottom surface of the recess of the cap as taught by Townley to facilitate the creation of complex electrode arrays (Townley [0123]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez in view of Mahvi.
Regarding claim 12, Rodriguez discloses the electroporation device of claim 9, but does not explicitly disclose a device wherein the one or more electrodes are straight electrodes.
However, 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 Rodriguez so that the one or more electrodes are straight electrodes as taught by Mahvi so that the electrodes may have distal sharpness and strength to penetrate to a predetermined depth of the cavity tissue (Mahvi [0041]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez in view of Placek.
Regarding claim 13, Rodriguez 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 Rodriguez 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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez in view of Toth, US 20150297139, herein referred to as “Toth”.
Regarding claim 14, Rodriguez discloses the electroporation device of claim 9, and 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 an electroporation device 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]).
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 Rodriguez so that it is used in the method disclosed by Toth to alter the hormonal secretions from one or more organs, to modulate the growth of an organ, alter the growth rate or rate of perineural invasion of a tumor, or the like (Toth Abstract).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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