DETAILED ACTION
A complete action on the merits of claims 1-20 follows below.
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.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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, 5, 7-8, 12, 14-15, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Viswanathan (US Pub. No. 2021/0022794).
Regarding Claim 1, Viswanathan teaches Pulse generating circuitry (Figs. 1 and 14) configured to be coupled to a plurality of electrodes 142a-142n (Fig. 1) of an electroporation system ([0004]-[0005], [0044], [0049]-[0050], [0053]), the pulse generating circuitry comprising:
at least one voltage source (1460/1460’/1460’’ Fig. 14);
a plurality of output lines (Ch. 1, Ch. 2, … Ch. N in Fig. 14);
switching circuitry (1462/1462’/1462’’ in Fig. 14, [0073]) coupled between the at least one voltage source (1460/1460’/1460’’ Fig. 14) and the plurality of output lines, each of the plurality of output lines (Ch. 1, Ch. 2, … Ch. N in Fig. 14) configured to deliver at least one voltage pulse to a corresponding electrode of the plurality of electrodes (Figs. 1, 14 and [0073]); and
current sensing circuitry 128/1450 configured to sense a current flowing through at least one of the plurality of output lines ([0062], [0067], [0084], [0119] and Figs. 1, 14).
Regarding Claim 5, Viswanathan teaches wherein the current sensing circuitry is configured to adjust a parameter of a subsequent voltage pulse based on the sensed current ([0119]).
Regarding Claim 7, Viswanathan teaches wherein the current sensing circuitry is configured to detect, based on the sensed current, a fault in the pulse generating circuitry (Figs. 7A-7B, [0033], [0044], [0048], [0055], [0062] and especially [0095]-[0097]).
Regarding Claim 8, Viswanathan teaches an electroporation system ([0004]-[0005], [0044], [0049]-[0050], [0053] and Fig. 1) comprising:
a catheter comprising a plurality of electrodes 142a-142n ([0024], Fig. 1); and
pulse generating circuitry coupled to the plurality of electrodes (Fig. 1), the pulse generating circuitry comprising:
at least one voltage source (1460/1460’/1460’’ Fig. 14);
a plurality of output lines (Ch. 1, Ch. 2, … Ch. N in Fig. 14):
switching circuitry (1462/1462’/1462’’ in Fig. 14, [0073]) coupled between the at least one voltage source (1460/1460’/1460’’ Fig. 14) and the plurality of output lines (Ch. 1, Ch. 2, … Ch. N in Fig. 14), each of the plurality of output lines configured to deliver at least one voltage pulse to a corresponding electrode of the plurality of electrodes (Figs. 1, 14 and [0073]); and
current sensing circuitry 128/1450 configured to sense a current flowing through at least one of the plurality of output lines ([0062], [0067], [0084], [0119] and Figs. 1, 14).
Regarding Claim 12, Viswanathan teaches wherein the current sensing circuitry is configured to adjust a parameter of a subsequent voltage pulse based on the sensed current ([0119]).
Regarding Claim 14, Viswanathan teaches wherein the current sensing circuitry is configured to detect, based on the sensed current, a fault in the pulse generating circuitry (Figs. 7A-7B, [0033], [0044], [0048], [0055], [0062] and especially [0095]-[0097]).
Regarding Claim 15, Viswanathan teaches a method of operating an electroporation system ([0004]-[0005], [0044], [0049]-[0050], [0053]), the method comprising:
providing a catheter including a plurality of electrodes 142a-142n ([0024], Fig. 1); coupling the plurality of electrodes to pulse generating circuitry (Figs. 1 and 14), the pulse generating circuitry including at least one voltage source (1460/1460’/1460’’ Fig. 14), a plurality of output lines (Ch. 1, Ch. 2, … Ch. N in Fig. 14), and switching circuitry (1462/1462’/1462’’ in Fig. 14, [0073]) coupled between the at least one voltage source (1460/1460’/1460’’ Fig. 14) and the plurality of output lines (Ch. 1, Ch. 2, … Ch. N in Fig. 14);
delivering, using each of the plurality of output lines (Ch. 1, Ch. 2, … Ch. N in Fig. 14), at least one voltage pulse to a corresponding electrode of the plurality of electrodes (Figs. 1, 14 and [0073]); and
sensing, using current sensing circuitry 128/1450, a current flowing through at least one of the plurality of output lines ([0062], [0067], [0084], [0119] and Figs. 1, 14).
Regarding Claim 18, Viswanathan teaches further comprising adjusting a parameter of a subsequent voltage pulse based on the sensed current ([0119]).
Regarding Claim 20, Viswanathan teaches further comprising detecting, based on the sensed current, a fault in the pulse generating circuitry (Figs. 7A-7B, [0033], [0044], [0048], [0055], [0062] and especially [0095]-[0097]).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2-4, 9-11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan as applied above in view of Soden (US Pub. No. 2022/0298464).
Regarding Claims 2-3, 9-10 and 16, Viswanathan teaches the invention as applied above including the current sensing circuitry (“Each of the electrode channels (1401, 1402, 1403) may be coupled to a sensing circuit (1450) and current sense resistor (1452). In some embodiments, the sensing circuit (1450) may measure current flow through the current sense resistor (1452). The sensing circuit (1450) may be used to: measure output current, with this measurement used subsequently for current control; and detect excessively large or unsafe current levels, whereupon current output may be switched off completely” [0084] and “a sensing circuit may be configured to measure an output current of the set of electrode channels. The processor may be further configured to, in response to the output current measured by the sensing circuit being different from a predetermined output current, adjust at least one of a voltage delivered by the set of energy sources or a resistance of the set of resistors to adjust the output current measured by the sensing circuit closer to the predetermined output current” [0009]); however, does not specifically teach wherein the current sensing circuitry comprises: a current transformer coupled to the at least one output line; and signal processing circuitry coupled to the current transformer and wherein the current sensing circuitry further comprises a rectifier coupled between the current transformer and the signal processing circuitry.
In the same field of invention, Soden teaches “an electroporation apparatus comprising a plurality of electroporation probe terminals, a transformer for providing stepped-up voltage, and a switching circuit for delivering pulses to the probe terminals for electroporation” [0014] in addition to “transformer 11, 12 steps up the input voltage to 1.5 kV in this example, which is rectified by a rectifier 13 of conventional construction” [0104] and allowing “the controller to automatically adjust the voltage level to ensure that the current is not excessive, thereby automatically avoiding adverse effects of significantly reduced impedance” [0194].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have the current sensing circuitry comprises: a current transformer coupled to the at least one output line in order to step up the input voltage; and the signal processing circuitry of Viswanathan disclosed in [0009] to be coupled to the current transformer and wherein the current sensing circuitry further comprises a rectifier (such as rectifier 13 of Soden) coupled between the current transformer and the signal processing circuitry in order to convert the AC signal to DC signal to therefore allow the signal processing circuitry to automatically adjust the voltage level to ensure that the current is not excessive as Soden teaches.
Regarding Claims 4, 11 and 17, Viswanathan in view of Soden teaches wherein the transformer is configured to generate a signal in response to current flowing through the at least one output line, wherein the rectifier is configured to rectify the generated signal, and wherein the signal processing circuitry is configured to compare the rectified signal to a threshold value ([0023], [0119] of Viswanathan and [0104], [0194] of Soden).
Claims 6, 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan as applied above in view of Forsyth (US Pub. No. 2020/0289185).
Regarding Claims 6, 13 and 19, Viswanathan teaches the invention as applied above, but not wherein the current sensing circuitry is configured to estimate, based on the sensed current, a total charge delivered to at least one electrode of the plurality of electrodes.
In the same field of invention, Forsyth teaches “a total charge delivered during the first and second pulses, or net charge delivered in the first and second pulses, may be calculated” in [0142] and “Rather than single pulses, the operation may be to perform a burst of any number of pulses while tracking total charge delivered, followed by one or more corrective outputs to negate charge imbalance” in [0143].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have the current sensing circuitry estimate and track the total charge applied to the electrodes during electroporation in order to prevent charge imbalance as Forsyth teaches.
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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