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 .
Drawings
The drawings are objected to because Fig. 6 recites “136a” per Applicants specification [0054] (using the Pg Pub for Paragraph numbers) the spec recites 136. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 1-2, 6-7, 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20150141982 to Lee (hereinafter Lee) in view of US 20130310823 to Gelfand et al. (hereinafter Gelfand) in further view of US 20140296736 to Abboud et al. (hereinafter Abboud).
Regarding Claim 1, an interpretation of Lee discloses medical system (abstract), comprising:
a shaft having a central lumen fluidly coupled to a proximal end of the shaft to receive a first fluid ([0052], [0056], [0060], Figs. 1-3 see also [0106]; lumen extending from proximal to distal end. To the extent “to receive . . .” is an intended use of the device the device is functionally capable of performing the intended use. Examiner notes a lumen is a bore of a tube), the central lumen extending from the proximal end to a distal end of the shaft ([0052], [0056], [0060], Figs. 1-3 see also [0106]; central/guidewire lumen) and configured to expel the first fluid from a distal opening at the distal end of the shaft;
a first electrode attached to the distal end of the shaft ([0061], Figs. 5-5A see also [0106]);
a balloon attached to the distal end of the shaft ([0055]-[0057], Figs. 1-3 see also [0106]), the balloon fluidly coupled to the proximal end of the shaft ([0017], [0053], Figs. 2-3), and configured to receive a second fluid for inflating the balloon upon insertion of the medical system into a body lumen to cause the balloon to contact tissue of the body lumen ([0017], [0053] including “A substance that flows through the lumen 21 between the inner tube 18 and the guidewire tube 19 is an inflation medium, e.g., saline, for expanding the balloon assembly 25”, [0056], [0060] see also [0106]; to the extent “to cause . . .” is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use.);
a plurality of second electrodes, including at least three second electrodes, circumferentially spaced on an outer surface of the balloon ([0055], [0058], Figs. 1, 3A-4 see also [0106]); and
a electrical connection configured to transfer electrical energy to the tissue selectively energizing electrodes as desired from an energy source ([0082] including “is connected to an ablation energy source by a respective lead wire. The ablation energy source is adapted to selectively energize each electrode as needed or desired.” See also [0106]).
An interpretation of Lee may not explicitly disclose a connector to transfer direct current to form an electrical field between the first electrode and the plurality of second electrodes to cause electroporation to the tissue.
However, in the same field of endeavor (medical devices), Gelfand teaches a connector to transfer direct current to form an electrical field between the first electrode and the plurality of second electrodes to cause electroporation to the tissue ([0181], [0185] including “as through application of an electric field (e.g. radiofrequency, alternating current, and direct current)”, [0195], [0263] including “Electrical wire lumen 157 contains wires to connect ablation electrode 1151, and temperature sensor 158 with the electrical connector of the proximal terminal.” see also [0197]). Examiner notes for purposes of compact prosecution Gelfand also teaches the central lumen is fluidly coupled to the proximal end of the shaft ([0263] including “Guide wire lumen 149 traverses the entire length of catheter 144 from distal tip 147, through balloon shaft 146, and through catheter shaft 145 to the fluid connector at the proximal terminal, not shown.”, Figs. 46-47, 50a)
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with electrodes connected by leads to an energy source as recited by Lee to include an electrical connector as recited by Gelfand because it is merely applying a known technique (including a connector at the end of the leads to connect to a source) to a known device (catheter with electrodes being connected to an energy source) ready for improvement to yield predictable results.
An interpretation of Lee may not explicitly disclose configured to expel the first fluid from a distal opening at the distal end of the shaft
However, in the same field of endeavor (medical devices), Abboud teaches to expel the first fluid from a distal opening at the distal end of the shaft ([0020] including “contrast solution can be injected through the catheter's inner guide wire lumen and into the pulmonary vein.”).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a central lumen as recited by Lee to include injecting a fluid in the central lumen as recited by Abboud because it is merely combining prior art elements (catheter with central lumen from Lee with the injection of a fluid through it as recited by Abboud) according to known methods to yield predictable results.
Regarding Claim 2, an interpretation of Lee further discloses wherein the medical system includes a pair of first electrodes, each first electrode attached to the distal end of the shaft ([0061], Figs. 5-5A see also [0106]).
Regarding Claim 6, an interpretation of Lee further discloses wherein the balloon is a single balloon surrounding an outer circumference of the shaft ([0017] including “at least one balloon member with an outer surface and at least one electrode on the outer surface”, Fig. 9 see also [0106]; Examiner notes that while not recited for this element currently in view of compact prosecution goals, this is also disclosed by Stewart [0059] discussing various alternatives).
Regarding Claim 7, an interpretation of Lee further discloses wherein the shaft includes a distal tip at the distal end of the shaft, and wherein the first electrode is proximal of the distal tip ([0061], Figs. 5-5A see also [0106]).
Regarding Claim 11, an interpretation of Lee further discloses wherein the shaft further includes a fluid lumen in fluid communication with the balloon ([0017], [0053] including “A substance that flows through the lumen 21 between the inner tube 18 and the guidewire tube 19 is an inflation medium, e.g., saline, for expanding the balloon assembly 25”, [0056], [0060] see also [0106]), the fluid lumen extending from the proximal end of the shaft to the balloon ([0017], [0053], [0056], [0060], Figs. 2-3 see also [0106]).
Regarding Claim 12, an interpretation of Lee further discloses a fluid port configured to connect the medical system to a fluid supply of the second fluid ([0052], [0060] see also [0106]).
Regarding Claim 13, an interpretation of Lee further discloses the first fluid or the second fluid ([0053] see also [0106]).
Regarding Claim 14, an interpretation of Lee further discloses wherein the first fluid or the second fluid comprises saline ([0053] see also [0106]).
Regarding Claim 15, an interpretation of Lee further discloses wherein each of the first electrode and each second electrode of the plurality of second electrodes is electrically coupled to one or more wires ([0053], [0059], [0061], [0082] see also [0106]; Each electrode is connected to a lead wire).
While Lee discloses electrodes coupled to a energy source via the electrodes, an interpretation of Lee may not explicitly disclose is electrodes electrically coupled to the connector via one or more wires.
However, in the same field of endeavor (medical devices), Gelfand teaches electrodes electrically coupled to the connector via one or more wires ([0263]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with electrodes connected by leads to an energy source as recited by Lee to include an electrical connector as recited by Gelfand because it is merely applying a known technique (including a connector at the end of the leads to connect to a source) to a known device (catheter with electrodes being connected to an energy source) ready for improvement to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Gelfand in further view of Abboud in further view of US 20150018821 to Zarins et al. (hereinafter Zarins).
Regarding Claim 3, while Lee discloses a plurality of first electrodes (see rejection of claim 1 above) an interpretation of Lee may not explicitly disclose wherein the balloon is positioned between the pair of first electrodes at the distal end of the shaft.
However, in the same field of endeavor (medical devices), Zarins teaches wherein the balloon is positioned between the pair of first electrodes at the distal end of the shaft ([0036]-[0037], [0039], Figs. 5-6 see also [0016]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee to include the “first” electrodes are on opposites sides of the balloon as recited by Zarins in order to drive current as desired through the vessel wall by having the balloon between the first electrodes ([0037], [0041]). Separately and additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee to include the balloon between the “first” electrodes as recited by Zarins because it is merely combining prior art elements (electrode catheter balloon system of Lee with the particular layout of “first” electrodes as recited by Zarins) according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 4-5, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Gelfand in further view of Abboud in further view of US 20190030328 to Stewart et al. (hereinafter Stewart).
Regarding Claim 4, an interpretation of Lee discloses energizing each of individual electrodes selectively as desired ([0082]) and multiple first electrodes (see rejection above; ring elections fig. 5A).
an interpretation of Lee may not explicitly disclose wherein one of the first electrodes is configured to form a first electrical field with the plurality of second electrodes, and the other of the first electrodes is configured to from a second electrical field with the plurality of second electrodes
However, in the same field of endeavor (medical devices), Stewart teaches wherein the electric field and can be controlled by controlling whether each electrode has a positive polarity, a negative polarity or is disconnected, disclosing numerous alternatives ([0057], [0062]-[0063], [0078], [0095] see also [0055], [0068]). With the control recited by Stewart it would be obvious to set up a field between each of the “first electrodes” and a plurality of “second electrodes” ([0057], [0062]-[0063], [0078], [0090], [0095], Fig. 17 see also [0055], [0068]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee to include the configuration of desired electrical fields as recited by Stewart because it enhances patient safety and increase ablation efficiency by allowing for the selective delivery of energy to individual electrodes based on electrode-tissue contact/proximity and/or proximity between electrodes. ([0005], [0051], [0096]).
Regarding Claim 5, an interpretation of Lee may not explicitly disclose wherein the connector is configured to selectively transfer direct current to the one of the first electrodes without transferring direct current to the other of the first electrodes.
However, in the same field of endeavor (medical devices), Stewart teaches wherein the electric field and can be controlled by controlling whether each electrode has a positive polarity, a negative polarity or is disconnected, disclosing numerous alternatives ([0057], [0062]-[0063], [0078], [0095] see also [0055], [0068]). Stewart further teaches wherein the connector is configured to selectively transfer direct current to the one of the first electrodes without transferring direct current to the other of the first electrodes ([0061], [0063], [0077], [0095]; Fig. 3).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee to include the configuration of desired electrical fields as recited by Stewart because it enhances patient safety and increase ablation efficiency by allowing for the selective delivery of energy to individual electrodes based on electrode-tissue contact/proximity and/or proximity between electrodes. ([0005], [0051], [0096]).
Regarding Claim 8, an interpretation of Lee may not explicitly disclose wherein the first electrode has a first polarity and each second electrode of the plurality of second electrodes has a second polarity opposite of the first polarity.
However, in the same field of endeavor (medical devices), Stewart teaches wherein the first electrode has a first polarity and each second electrode of the plurality of second electrodes has a second polarity opposite of the first polarity ([0057], [0062]-[0063], [0078] including “a single electrode may be referred to as a “plurality of electrodes” for purposes of comparison to a different plurality of electrodes”, [0090], [0095], Figs. 3, 17 see also [0055], [0068]; Discloses controlling whether each electrode has a positive polarity, a negative polarity or is disconnected).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee to include the configuration of desired electrical fields as recited by Stewart because it enhances patient safety and increase ablation efficiency by allowing for the selective delivery of energy to individual electrodes based on electrode-tissue contact/proximity and/or proximity between electrodes. ([0005], [0051], [0096]).
Claim Rejections - 35 USC § 103
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Gelfand in further view of Abboud in further view of US 20160008590 to Mallaby (hereinafter Mallaby).
Regarding Claim 9, an interpretation of Lee discloses a “shaft” with a “central lumen” (guidewire lumen) and further discloses wherein the central lumen extends from the proximal end to the distal end of the shaft ([0052], [0056], [0060], Figs. 1-3 see also [0106]; central/guidewire lumen).
An interpretation of Lee may not explicitly disclose a seal at the proximal end of the shaft.
However, in the same field of endeavor (medical devices), Mallaby teaches a seal at the proximal end of the shaft ([0023]-[0025], Fig. 2).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified medical device with a central lumen as recited by Lee to include a seal at the proximal end of the central lumen to avoid the practitioner from halting the procedure without need and by extension avoiding additional cost in time, materials and avoiding patient discomfort ([0023]).
Regarding Claim 10, an interpretation of Lee may not explicitly disclose a medical device configured to be inserted through the seal and extended distally of the distal opening via the central lumen.
However, in the same field of endeavor (medical devices), Mallaby teaches a medical device configured to be inserted through the seal and extended distally of the distal opening via the central lumen ([0023]-[0025], Fig. 2; Examiner notes 21 CFR 870.1330. Examiner also notes, for purposes of compact prosecution, that while Stewart is not currently relied on for this element it also discloses this element see [0062], Fig. 2).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified medical device with a central lumen as recited by Lee to include a seal at the proximal end of the central lumen to avoid the practitioner from halting the procedure without need and by extension avoiding additional cost in time, materials and avoiding patient discomfort ([0023]).
Claim Rejections - 35 USC § 103
Claim(s) 16, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Gelfand in further view of Stewart.
Regarding Claim 16, an interpretation of Lee discloses a medical system, comprising:
a shaft ([0052]-[0053], [0060], Figs. 1-3 see also [0106]) including:
a central lumen extending from a proximal end to a distal end of the shaft ([0052], [0056], [0060], Figs. 1-3 see also [0106]; central/guidewire lumen.), and configured to deliver a first fluid to a target site in a body lumen that is distal of the medical system ([0052], [0056], [0060], Figs. 1-3 see also [0106]; central/guidewire lumen. To the extent “to deliver . . .” is an intended use of the device the device is functionally capable of performing the intended use. Examiner notes a lumen is a bore of a tube, the “central” lumen of the catheter runs to the distal end); and
a fluid lumen configured to deliver a second fluid ([0017], [0053] including “A substance that flows through the lumen 21 between the inner tube 18 and the guidewire tube 19 is an inflation medium, e.g., saline, for expanding the balloon assembly 25”, [0056], [0060] see also [0106]; to the extent “to deliver . . .” is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use.);
a first electrode attached to a distal end of the shaft ([0061], Figs. 5-5A see also [0106]);
a balloon attached to the distal end of the shaft ([0055]-[0057], Figs. 1-3 see also [0106]), the balloon fluidly coupled to the fluid lumen and configured to receive the second fluid to inflate the balloon in the body lumen to contact tissue in the body lumen ([0017], [0053] including “A substance that flows through the lumen 21 between the inner tube 18 and the guidewire tube 19 is an inflation medium, e.g., saline, for expanding the balloon assembly 25”, [0056], [0060] see also [0106]; to the extent “to deliver . . .” is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use.);
a electrical connection configured to transfer electrical energy to the tissue selectively energizing electrodes from an energy source ([0082] including “is connected to an ablation energy source by a respective lead wire. The ablation energy source is adapted to selectively energize each electrode as needed or desired.” See also [0106]); and
a plurality of second electrodes circumferentially disposed on an outer surface of the balloon ([0055], [0058], Figs. 1, 3A-4 see also [0106]), the plurality of second electrodes including three or more second electrodes ([0055], [0058], Figs. 1, 3A-4 see also [0106]).
an interpretation of Lee may not explicitly disclose a connector configured to transfer direct current.
However, in the same field of endeavor (medical devices), Gelfand a connector configured to transfer direct current ([0181], [0185] including “as through application of an electric field (e.g. radiofrequency, alternating current, and direct current)”, [0195], [0263] including “Electrical wire lumen 157 contains wires to connect ablation electrode 1151, and temperature sensor 158 with the electrical connector of the proximal terminal.” see also [0197]). Examiner notes for purposes of compact prosecution Gelfand also teaches the central lumen is fluidly coupled to the proximal end of the shaft ([0263] including “Guide wire lumen 149 traverses the entire length of catheter 144 from distal tip 147, through balloon shaft 146, and through catheter shaft 145 to the fluid connector at the proximal terminal, not shown.”, Figs. 46-47, 50a)
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with electrodes connected by leads to an energy source as recited by Lee to include an electrical connector as recited by Gelfand because it is merely applying a known technique (including a connector at the end of the leads to connect to a source) to a known device (catheter with electrodes being connected to an energy source) ready for improvement to yield predictable results.
An interpretation of Lee in view of Gelfand may not explicitly disclose each second electrode of the plurality of second electrodes having a different polarity than the first electrode to cause an electrical field to be formed as the balloon is inflated to electroporate the tissue in response to the first electrode and the plurality of second electrodes receiving the direct current from the connector.
However, in the same field of endeavor (medical devices), Stewart teaches wherein the electric field and can be controlled by controlling whether each electrode has a positive polarity, a negative polarity or is disconnected, disclosing numerous alternatives ([0057], [0062]-[0063], [0078], [0095] see also [0055], [0068]); therefore rendering obvious the second electrode of the plurality of second electrodes having a different polarity than the first electrode to cause an electrical field to be formed as the balloon is inflated to electroporate the tissue in response to the first electrode and the plurality of second electrodes receiving the direct current from the connector ([0057], [0062]-[0063], [0068] including “Electroporation is a phenomenon causing cell membranes to become “leaky” (that is, permeable for molecules for which the cell membrane may otherwise be impermeable or semipermeable).”, [0078] including “a single electrode may be referred to as a “plurality of electrodes” for purposes of comparison to a different plurality of electrodes”, [0090], [0095], Figs. 3, 17 see also [0055], [0068]; Discloses controlling whether each electrode has a positive polarity, a negative polarity or is disconnected as well as changing patterns in or to have the desired pattern. ).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee in view of Gelfand to include the configuration of desired electrical fields as recited by Stewart because it enhances patient safety and increase ablation efficiency by allowing for the selective delivery of energy to individual electrodes based on electrode-tissue contact/proximity and/or proximity between electrodes. ([0005], [0051], [0096]).
Regarding Claim 18, an interpretation of Lee further discloses wherein the balloon is a single balloon surrounding an outer circumference of the shaft ([0017] including “at least one balloon member with an outer surface and at least one electrode on the outer surface”, Fig. 9 see also [0106]; Examiner notes that while not recited for this element currently in view of compact prosecution goals, this is also disclosed by Stewart [0059] discussing various alternatives).
Claim Rejections - 35 USC § 103
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Gelfand in further view of Stewart in further view of Zarins.
Regarding Claim 17, an interpretation of Lee further discloses wherein the medical system includes a pair of first electrodes each attached to the distal end of the shaft ([0061], Figs. 5-5A see also [0106]).
While Lee discloses a plurality of first electrodes, an interpretation of Lee may not explicitly disclose wherein the balloon is positioned between the pair of first electrodes at the distal end of the shaft.
However, in the same field of endeavor (medical devices), Zarins teaches wherein the balloon is positioned between the pair of first electrodes at the distal end of the shaft ([0036]-[0037], [0039], Figs. 5-6 see also [0016]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee to include the “first” electrodes are on opposites sides of the balloon as recited by Zarins in order to drive current as desired through the vessel wall by having the balloon between the first electrodes ([0037], [0041]). Separately and additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee to include the balloon between the “first” electrodes as recited by Zarins because it is merely combining prior art elements (electrode catheter balloon system of Lee with the particular layout of “first” electrodes as recited by Zarins) according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Gelfand in further view of Stewart in further view of Zarins.
Regarding Claim 19, an interpretation of Lee further discloses medical system, comprising:
a shaft ([0052]-[0053], [0060], Figs. 1-3 see also [0106]);
a pair of first electrodes attached to a distal end of the shaft ([0061], Figs. 5-5A see also [0106]);
a balloon surrounding an outer circumference of the shaft ([0055]-[0057], Figs. 1-3 see also [0106]), the balloon being fluidly coupled to a proximal end of the shaft to receive fluid from a fluid supply and configured to receive the fluid to inflate the balloon to contact tissue in a body lumen ([0017], [0053] including “A substance that flows through the lumen 21 between the inner tube 18 and the guidewire tube 19 is an inflation medium, e.g., saline, for expanding the balloon assembly 25”, [0056], [0060] see also [0106]; to the extent “to deliver . . .” is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use.);
a plurality of second electrodes disposed on and circumferentially spaced apart along an outer surface of the balloon to ([0055], [0058], Figs. 1, 3A-4 see also [0106]), as the balloon is inflated, provide circumferential contact with the tissue along an inner surface of the body lumen, the plurality of second electrodes including more than two electrodes ([0055], [0058], Figs. 1, 3A-4 see also [0106]); and
a electrical connection configured to transfer electrical energy from a source to the electrodes ([0082] including “is connected to an ablation energy source by a respective lead wire. The ablation energy source is adapted to selectively energize each electrode as needed or desired.” See also [0106]);
an interpretation of Lee may not explicitly disclose a connector configured to transfer direct current.
However, in the same field of endeavor (medical devices), Gelfand a connector configured to transfer direct current ([0181], [0185] including “as through application of an electric field (e.g. radiofrequency, alternating current, and direct current)”, [0195], [0263] including “Electrical wire lumen 157 contains wires to connect ablation electrode 1151, and temperature sensor 158 with the electrical connector of the proximal terminal.” see also [0197]). Examiner notes for purposes of compact prosecution Gelfand also teaches the central lumen is fluidly coupled to the proximal end of the shaft ([0263] including “Guide wire lumen 149 traverses the entire length of catheter 144 from distal tip 147, through balloon shaft 146, and through catheter shaft 145 to the fluid connector at the proximal terminal, not shown.”, Figs. 46-47, 50a)
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with electrodes connected by leads to an energy source as recited by Lee to include an electrical connector as recited by Gelfand because it is merely applying a known technique (including a connector at the end of the leads to connect to a source) to a known device (catheter with electrodes being connected to an energy source) ready for improvement to yield predictable results.
an interpretation of Lee may not explicitly disclose to form one or more electrical fields between the pair of first electrodes and the plurality of second electrodes to cause electroporation to the tissue.
However, in the same field of endeavor (medical devices), Stewart teaches wherein the electric field and can be controlled by controlling whether each electrode has a positive polarity, a negative polarity or is disconnected, disclosing numerous alternatives ([0057], [0062]-[0063], [0078], [0095] see also [0055], [0068]); therefore rendering obvious to form one or more electrical fields between the pair of first electrodes and the plurality of second electrodes to cause electroporation to the tissue ([0057], [0062]-[0063], [0068] including “Electroporation is a phenomenon causing cell membranes to become “leaky” (that is, permeable for molecules for which the cell membrane may otherwise be impermeable or semipermeable).”, [0078] including “a single electrode may be referred to as a “plurality of electrodes” for purposes of comparison to a different plurality of electrodes”, [0090], [0095], Figs. 3, 17 see also [0055], [0068]; Discloses controlling whether each electrode has a positive polarity, a negative polarity or is disconnected as well as changing patterns in or to have the desired pattern. ).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee in view of Gelfand to include the configuration of desired electrical fields as recited by Stewart because it enhances patient safety and increase ablation efficiency by allowing for the selective delivery of energy to individual electrodes based on electrode-tissue contact/proximity and/or proximity between electrodes. ([0005], [0051], [0096]).
While Lee discloses a plurality of first electrodes, an interpretation of Lee may not explicitly disclose wherein the balloon is positioned between the pair of first electrodes at the distal end of the shaft.
However, in the same field of endeavor (medical devices), Zarins teaches wherein the balloon is positioned between the pair of first electrodes at the distal end of the shaft ([0036]-[0037], [0039], Figs. 5-6 see also [0016]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee to include the “first” electrodes are on opposites sides of the balloon as recited by Zarins in order to drive current as desired through the vessel wall by having the balloon between the first electrodes ([0037], [0041]). Separately and additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the catheter with a plurality of “first” electrodes connected by leads to an energy source as recited by Lee to include the balloon between the “first” electrodes as recited by Zarins because it is merely combining prior art elements (electrode catheter balloon system of Lee with the particular layout of “first” electrodes as recited by Zarins) according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Gelfand in further view Stewart in further view of Zarins in further view of Mallaby.
Regarding Claim 20, an interpretation of Lee discloses a “shaft” with a “central lumen” (guidewire lumen) and further discloses wherein the central lumen extends from the proximal end to the distal end of the shaft ([0052], [0056], [0060], Figs. 1-3 see also [0106]; central/guidewire lumen).
An interpretation of Lee may not explicitly disclose a seal at the proximal end of the shaft.
However, in the same field of endeavor (medical devices), Mallaby teaches a seal at the proximal end of the shaft ([0023]-[0025], Fig. 2).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified medical device with a central lumen as recited by Lee to include a seal at the proximal end of the central lumen to avoid the practitioner from halting the procedure without need and by extension avoiding additional cost in time, materials and avoiding patient discomfort ([0023]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20120259269 (cited in IDS dated 1/21/25) see [0035]-[0037], Figs. 2-3
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R MOSS whose telephone number is (571)272-3506. The examiner can normally be reached Monday - Friday (9:30 am - 5:30 pm).
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, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James Moss/Examiner, Art Unit 3792
Prosecution Insights