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.
Status of the Claims
The current office action is made responsive to claims filed 02/20/2025.
Claims 1-20 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 102
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, 5-9, and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Werneth (US 20230241100 A1).
Regarding claim 1, Werneth teaches an electroporation system ([0003], [0005]) comprising:
a catheter (fig. 1; ablation catheter 1) comprising a plurality of electrodes ([0126]- [0127]); and
a pulse generator (Fig. 1; single power source 4) coupled to the catheter, the pulse generator configured to:
generate a first waveform to be delivered between at least one active electrode on the catheter and at least one first return electrode ([0129]- [0130]);
generate a second waveform to be delivered between the at least one active electrode and at least one second return electrode ([0129]- [0130]); and
cause delivery of the first and second waveforms over the same time period such that at least the first and second waveforms are superimposed onto one another to create a combined waveform at the at least one active electrode ([0130]).
Regarding claim 2, Werneth teaches the electroporation system in accordance with claim 1, wherein at least one of the at least one first return electrode is an electrode on the catheter ([0130]).
Regarding claim 3, Werneth teaches the electroporation system in accordance with claim 1, wherein at least one of the at least one first return electrode is an external patch electrode ([0129]).
Regarding claim 5, Werneth teaches the electroporation system in accordance with claim 1, wherein at least one of the first and second waveforms includes non-square wave pulses ([0126]).
Regarding claim 6, Werneth teaches the electroporation system in accordance with claim 1, wherein the first waveform is a bipolar waveform ([0130]), and wherein the second waveform is a monopolar waveform ([0129]).
Regarding claim 7, Werneth teaches the electroporation system in accordance with claim 1, wherein the first waveform is a biphasic waveform ([0130], [0177]- [0178]), and wherein the second waveform is a monophasic waveform ([0129], [0177]- [0178]).
Regarding claim 8, Werneth teaches the electroporation system in accordance with claim 1, wherein the first and second waveforms are both bipolar waveforms ([0177]- [0178]).
Regarding claim 9, Werneth teaches the electroporation system in accordance with claim 1, wherein the catheter is at least one of a loop catheter assembly, a linear catheter assembly ([0127]), a basket catheter assembly, a grid catheter assembly, a balloon catheter assembly, a sheath, and a sleeve.
Regarding claim 14, Werneth teaches a pulse generator for use with an electroporation system ([0003], [0005]), the pulse generator configured to be coupled to a catheter including a plurality of electrodes ([0126]- [0127]) and configured to:
generate a first waveform to be delivered between at least one active electrode on the catheter and at least one first return electrode ([0129]- [0130]);
generate a second waveform to be delivered between the at least one active electrode and at least one second return electrode ([0129]- [0130]); and
cause delivery of the first and second waveforms over the same time period such that at least the first and second waveforms are superimposed onto one another to create a combined waveform at the at least one active electrode ([0130]).
Regarding claim 15, Werneth teaches the pulse generator in accordance with claim 14, wherein the first waveform is a bipolar waveform ([0130]), and wherein the second waveform is a monopolar waveform ([0129]).
Regarding claim 16, Werneth teaches the pulse generator in accordance with claim 14, wherein the first waveform is a biphasic waveform ([0130], [0177]- [0178]), and wherein the second waveform is a monophasic waveform ([0129], [0177]- [0178]).
Regarding claims 17-19, the recited methods are considered inherent in the ordinary use of the device as described in claims 1-3 and 14.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Werneth (US 20230241100 A1) in view of Demarais (US 20070203549 A1).
Regarding claim 4, Werneth teaches the electroporation system in accordance with claim 1.
However, Werneth fails to teach the electroporation system wherein at least one of the at least one first return electrode is an intra-vascular electrode located on an additional catheter.
Demarais teaches a system having an active electrode for intravascular insertion into a patient ([0043]- [0044]).
Demarais further teaches the system comprising two guidewires, where the active electrode is on the first guidewire and the return electrode is on the second guidewire ([0045]- [0046]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known position of the return electrode as being on a second elongated member, such as a guidewire, for insertion into a patient, as is taught by Demarais, into the system having a plurality of return electrodes as is taught by Werneth, to produce the predictable result of a return electrode being positioned at a known return electrode position, as is taught by Demarais, 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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Werneth (US 20230241100 A1) in view of Russel (US 5440475 A).
Regarding claim 10, Werneth teaches the electroporation system in accordance with claim 1, wherein the first and second waveforms are both sinusoidal waveforms ([0135]- [0139] teaches the power unit which is capable of delivering a variety of sinusoidal signals to the electrodes).
However, Werneth fails to teach the electroporation system wherein the combined waveform generated from at least the first and second waveforms includes a plurality of effective square wave pulses.
Russel teaches the known capability of a square wave being formed by combining more than one sinusoidal wave having the same frequency as the square wave (Co. 1, Line 60- Col. 2, Line 5).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known relationship of the formation of a square wave from the combination of more than one sinusoidal waves, as is taught by Russel, into the power unit which is capable of delivering a variety of sinusoidal signals as is taught by Werneth, to produce the predictable result of using a known power source which delivers a variety of signals in combination to produce multiple known wave waves, such as sinusoidal waves which when combined produce a square wave, as is taught by Russell, 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 11-12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Werneth (US 20230241100 A1) in view of Gillbe (US 20100152817 A1).
Regarding claim 11, Werneth teaches the electroporation system in accordance with claim 1.
However, Werneth fails to teach the electroporation system wherein the combined waveform includes at least one effective pulse that has a longer effective pulse width than any of the pulses in the first and second waveforms.
Gillbe teaches the known relationship of individual short pulses being added together in turn to construct a longer pulse of a composite waveform ([0112]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known result of a plurality of individual short pulses which when added together construct a longer pulse in the form of a composite waveform, as is taught by Gillbe, into the generator capable of delivering a variety of waveforms simultaneously, as is taught by Werneth, to produce the predictable result of a longer pulse being formed from the combination of a plurality of waveforms being added together, as is taught by Gillbe, 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 12, in accordance with the above rejection of claim 11, Gillbe teaches the electroporation system in accordance with claim 11, system wherein the at least one effective pulse is a continuous pulse ([0122]).
Regarding claim 20, the recited methods are considered inherent in the ordinary use of the device as described in claim 11.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Werneth (US 20230241100 A1) in view of Yu (US 20050267548 A1).
Regarding claim 13, Werneth teaches the electroporation system in accordance with claim 11.
However, Werneth fails to teach the electroporation system wherein the at least one effective pulse includes a plurality of closely spaced smaller pulses.
Yu teaches a composite pulse generating device (Abstract).
Yu further teaches the formation of a composite waveform having composite pulses as being from a plurality of pulse sequences which are combined, the composite pulses being in the form of a plurality of stepped pulses ([0057]- [0062]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the ability to produce a composite pulse being composed of a plurality of combined stepped pulses by the formation of a composite waveform, as is taught by Yu, into the generator for producing a plurality of waveforms simultaneously as is taught by Werneth, to produce the predictable result of providing a composite pulse sequence from a plurality of pulses in combination, as is taught by Yu, 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 3810036 A- Col. 2, Lines 49-55 teach the well-known relationship of a square wave being made up of more than one sinusoidal wave
US 20070203482 A1- Abstract, [0007] teach the known ability to selectively provide pure monopolar, pure bipolar, and a blend of monopolar and bipolar modes of energy delivery
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
