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 .
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.
Response to Amendment
Acknowledgement is made to the amendment received 04/02/2026.
Acknowledgement is made to the amendment of claims 1, 7, 10-11, 13, 15, 23.
Acknowledgement is made to the cancellation of claims 2-6, 8-9, 12, 14, 20, 22, 27-47.
Acknowledgement is made to the newly added claims 48-59.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 1, 7, 10-11, 13, 15-19, 21, 23-26, and 48-59 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 103
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.
Claims 1, 7, 10-11, 13, 19, 21, 23, 48, 50, 52, 54, 55 are rejected under 35 U.S.C. 103 as being unpatentable over Danaek (US 20030233099 A1) in view of Altmann (US 20160113582 A1).
Regarding claim 1, Danaek teaches a device (Fig. 5B; device 304) for delivering pulsed electric field energy to cardiac tissue of a patient comprising:
a shaft (Fig. 5B; elongated member 102) having a proximal end and a distal end, wherein the shaft has an outer diameter; and
an energy delivery body (Fig. 5B; basket 104) located at the distal end of the shaft, the energy delivery body comprising a plurality of splines (Fig. 5B; basket legs 106) formed from shape memory material ([0125]) which are insulated along a proximal portion thereof ([0167]) wherein the energy delivery body is transitionable between a collapsed configuration and an expanded configuration ([0024], [0128], [0131]), wherein the energy delivery body also includes a distal tip (Fig. 5B; distal tip 118),
a tip electrode wire (Fig. 5B; pull wire 116) electrically connected to the distal tip and extending within the energy delivery body from the distal end of the shaft to the distal tip wherein the tip wire includes slack which allows the tip electrode wire to lengthen in the collapsed configuration ([0130]),
wherein the energy delivery body is configured to be positioned against the cardiac tissue in the expanded configuration so as to deliver pulsed electric field energy to the cardiac tissue ([0136], [0201]), and
wherein the energy delivery body is configured to transition from the collapsed configuration to the expanded configuration by self-expansion of the plurality of splines upon release of the energy delivery body from a sheath constraining the plurality of splines at the distal end of the shaft ([0125], [0131]).
However, Danaek fails to teach the distal tip as being a distal tip electrode configured to deliver energy.
Altmann teaches a catheter having a basket-shaped electrode assembly having a plurality of spines (Abstract).
Altmann further teaches the basket-shaped electrode assembly as having a distal tip containing an electrode for delivering ablation energy ([0031], [0057]). This tip provides the device with precise focal capabilities in addition to the large area the expandable portion of the assembly is able to cover ([0056]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated expandable assembly having a distal tip having an electrode for delivering energy, as is taught by Altmann, into the device as is taught by Wu, to produce the predictable result of providing both large and focal electrode capabilities, as is taught by Altmann, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Further, while Danaek does not specifically teach the device wherein the expanded configuration has an outer diameter that is less than or equal to 6 times the outer diameter of the shaft, Danaek does teach the bronchoscope as having a diameter of 2 mm and the expanded portion of the device as having a diameter of less than 15 mm, such as 12 or less mm ([0015]- [0016]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)(A).
There does not appear to be any disclosed criticality for this range. Pending a statement of criticality, the recited range does not patentably distinguish over that of the prior art.
Regarding claim 7, Danaek teaches the device as in claim 1, wherein the plurality of splines form a hollow rounded cage ([0127]- [0128])
Regarding claim 10, Danaek teaches the device as in claim1, wherein the plurality of splines is energizeable in unison so as to function in a monopolar fashion ([0021]).
Regarding claim 11, Danaek teaches the device as in claim 1, wherein the plurality of splines has a convex distal surface ([0019]).
Regarding claim 13, Danaek teaches the device as in claim 1, wherein the distal tip and the plurality of splines are energizeable in unison so as to function in a monopolar fashion ([0021]).
Regarding claim 19, Danaek teaches the device as in claim 1, wherein the expanded configuration has an outer diameter that is 3-6 times the outer diameter of the shaft and wherein the expanded configuration has an outer diameter that is 8-15mm ([0015]- [0016]).
Regarding claim 21, Danaek teaches the device as in claim 1, wherein the energy delivery body includes a sensing electrode, wherein the sensing electrode is positioned so as to avoid contact with the cardiac tissue ([0163] teaches the device as having a temperature sensor being mounted along the pull wire, and therefore teaches the limitation as broadly as is currently claimed).
Regarding claim 23, Danaek teaches the device as in claim 21, wherein plurality of splines form a rounded cage and wherein the sensing electrode is disposed within the rounded cage ([0163]).
Regarding claim 48, Danaek teaches the device of claim 1, further comprising a tip inner (Fig. 6A; ball 217) to which each of the plurality of splines is attached (Fig. 6A; legs 106 are connected to ball 217 at solder 214), the tip inner being located proximal to curved distal ends of the plurality of splines (Fig. 6A; the solder 214 which connects the distal tips of legs 106 to ball 217 are located distal of ball 217).
Regarding claim 49, Danaek teaches the device as in claim 48, further including a distal tip electrode, the plurality of splines curving and bending inward around the distal tip electrode which is located distal to the curved distal ends of the plurality of splines ([0147]).
Regarding claim 50, Danaek teaches the device as in claim 48, further including a sensing electrode positioned within the energy delivery body proximal to the curved distal ends of the plurality of splines ([0163]).
Regarding claim 52, Danaek teaches the device as in claim 49, further including a tip electrode wire electrically connected to the distal tip and extending within the energy delivery body from the distal end of the shaft to the distal tip electrode ([0130]).
In accordance with the above rejection, Altmann further teaches the distal tip as being a distal tip electrode ([0031], [0057]).
Regarding claim 54, Danaek teaches the device as in claim 1, wherein each of the plurality of splines is conductive and functions as an electrode ([0169]).
Regarding claim 55, Danaek teaches the device as in claim 1, wherein the plurality of splines extend distally beyond the distal end of the shaft in both the collapsed configuration and the expanded configuration ([0123]).
Claims 15-18 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Danaek (US 20030233099 A1) in view of Altmann (US 20160113582 A1) further in view of Wu (US 20170273738 A1).
Regarding claim 15, Danaek teaches the device as in claim 1.
However, Danaek fails to specifically teach the device further comprising a plurality of irrigation ports, wherein the device is configured so as to direct fluid through the irrigation ports in a manner that creates turbulent flow of the fluid within the energy delivery body.
Wu teaches a basket shaped electrode assembly ([0039]) having a plurality of irrigation ports to flush the device and reduce thrombus formation (Abstract).
As Wu teaches ports that provide flow (Fig. 9; perforations 23), Wu teaches the claim limitation of the irrigation ports creating turbulent flow as broadly as is currently claimed, as in accordance with MPEP 2114 this currently taught structure of the lumen providing fluid to the plurality of ports would perform the function of producing turbulent flow, as this limitation is a recitation of the intended use of the claim limitation, and as this prior art structure of the ports is capable of performing this intended use based on the recited characteristics of this element, the prior art citation of Wu currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics.
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the plurality of irrigation ports, as is taught by Wu, into the basket assembly as is taught by Danaek, to produce the predictable result of flushing the device and reducing thrombus formation, as is taught by Wu, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 16, Danaek teaches the device as in claim 15, wherein the plurality of irrigation ports is disposed near a proximal end of the energy delivery body ([0068] teaches this claim limitation as broadly as is currently claimed).
Regarding claim 17, Danaek teaches the device as in claim 15, further comprising one or more irrigation lumens which direct the fluid through the plurality of irrigation ports (Fig. 9; lumen 88).
Regarding claim 18, Danaek teaches the device as in claim 17, wherein the one or more irrigation lumens is less than the plurality of irrigation ports ([0071]).
Regarding claim 25, Wu further teaches the device as in claim 1, further comprising one or more electrodes that communicate with an electrophysiological mapping system ([0046]- [0047] teach mapping using electrodes so as to provide diagnosing and therapy to the patient).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the electrophysiological mapping system in communication with the electrodes, as is taught by Wu, into the device as is taught by Danaek, to produce the predictable result of diagnosing and therapy through the information received by a mapping system, as is taught by Wu, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 26, Wu further teaches the device as in claim 1, further comprising at least one of: (a) a steering mechanism configured to bend the energy delivery body in relation to the shaft ([0041]) and (b) a steering mechanism configured to bend the distal end of the shaft away from its longitudinal axis ([0038]- [0040] teach the device as being bendable and having puller wires).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the device as being bendable and controlled by puller wires, as is taught by Wu, into the device as is taught by Danaek, to produce the predictable result of controlling a device which is bendable for positioning of the device, as is taught by Wu, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 24 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Danaek (US 20030233099 A1) in view of Altmann (US 20160113582 A1) further in view of Keyes (US 20170347896 A1).
Regarding claim 24, Danaek teaches the device as in claim 1.
However, Danaek fails to teach the device wherein the shaft includes one or more ring electrodes.
Keyes teaches a catheter system having an expandable distal element containing electrodes for treating tissue (Abstract).
Keyes further teaches having ring electrodes on either side of the expandable electrode assembly so as to deliver energy for treatment or mapping ([0035]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the electrodes as being ring electrodes, as is taught by Keyes, into the shaft, as is taught by Wu, to produce the predictable result of delivering energy to treat or map a device, as is taught by Keyes, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 51, Danaek as above incorporated teaches the device as in claim 50, wherein the sensing electrode comprises an electrode extending around the tip inner ([0163] teaches the temperature sensor as extending around the wire, the ball being positioned at the distalmost end of said wire).
In accordance with the above rejection of claim 24, Keyes further teaches the electrodes as being a ring electrode ([0035]).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Tang (US 20180153434 A1).
Regarding claim 53, Danaek teaches the device as in claim 52.
However, Danaek fails to teach the device wherein the tip electrode wire is slacked when the energy delivery body is in the expanded configuration.
Tang teaches a device having electrodes which is deflectable (Abstract).The electrodes are taught as being connected to at least one lead wire ([0008]). The lead wires being provided with an excess length relative to the length of the shaft to allow for this deflection, or positional movement of the device ([0049]).
Tang further teaches the lead wires as being provided with a degree of slack so as to avoid breakage during this deflection, or movement, of the device ([0049]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the lead wire which contains slack when in a non-extended position, as is taught by Tang, into the device which is extendable and contains a lead wire as is taught by Danaek, to produce the predictable result of avoiding breakage during movement of the device, as is taught by Tang, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 56-59 are rejected under 35 U.S.C. 103 as being unpatentable over Danaek (US 20030233099 A1).
Regarding claim 56, Danaek teaches a system ([0121]) for delivering pulsed electric field energy to cardiac tissue of a patient, the system comprising:
a treatment catheter (Fig. 5B; device 304) comprising:
a shaft (Fig. 5B; elongated member 102) having a proximal end and a distal end, the shaft having an outer diameter; and
an energy delivery body (Fig. 5B; basket 104) located at the distal end of the shaft, wherein the energy delivery body comprises a plurality of splines (Fig. 5B; basket legs 106) that are transitionable between a collapsed configuration and an expanded configuration ([0024], [0128], [0131]), wherein the energy delivery body is configured to be positioned against the cardiac tissue in the expanded configuration so as to deliver energy to the cardiac tissue; and
wherein the plurality of splines are energizable in unison to deliver pulsed electric field energy monopolarly ([0021], [0201], [0121] discusses the energy as being able to be monopolar RF energy delivered in pulses to the target tissue); and
a generator ([0034], [0200]- [0202]) electrically coupleable to the treatment catheter, the generator comprising at least one energy delivery algorithm configured to provide an electrical signal of pulsed electric field energy,
wherein the pulsed electric field energy is below a threshold for inducing coagulative thermal damage ([0199] teaches power supply as providing power to the RF electrodes in a mode which will operate up to 75 °C, for references which discuss known coagulation temperature ranges see the references provided in the conclusion).
Further, while Danaek does not specifically teach the device wherein the expanded configuration has an outer diameter no greater than six times the outer diameter of the shaft, Danaek does teach the bronchoscope as having a diameter of 2 mm and the expanded portion of the device as having a diameter of less than 15 mm, such as 12 or less mm ([0015]- [0016]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)(A).
Further, there does not appear to be any disclosed criticality for this range. Pending a statement of criticality, the recited range does not patentably distinguish over that of the prior art.
Regarding claim 57, Danaek teaches the system of claim 56, wherein the pulsed electric field energy is below a threshold for inducing coagulative thermal damage ([0199] teaches power supply as providing power to the RF electrodes in a mode which will operate up to 75 °C, for references which discuss known coagulation temperature ranges see the references provided in the conclusion).
Regarding claim 58, Danaek teaches the system of claim 55, wherein the electrical signal comprises a waveform selected from the group consisting of:(i) a biphasic waveform having voltage imbalance between positive and negative phases,(ii) a biphasic waveform having unequal pulse widths,(iii) a biphasic balanced waveform, and (iv) a monophasic waveform ([0202]- [0203] teach this claim limitation as broadly as is currently required by the claim limitation).
Regarding claim 59, Danaek teaches the system of claim 55, wherein the energy delivery body comprises a plurality of splines formed from shape memory material and being configured to transition from the collapsed configuration to the expanded configuration by self-expansion upon release from a sheath constraining the plurality of splines ([0125] teaches the legs as being comprised of a shape memory alloy).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Wu/Waldstreicher reference are moot in view of the new rejections under Danaek and Altmann.
Conclusion
Prior art references made of record and not relied upon:
US 20130261368 A1- [0083] discusses higher temperatures as causing coagulation, such as 100 degrees C
US 20070016235 A1- [0195] teaches coagulation as occurring at 100 to 150 degrees in centigrade
US 20050096644 A1- [0003], [0018] teach an electrode temperature above 100 degrees C as resulting in coagulum formation
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 extension fee 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 date of this final action.
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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