DETAILED ACTION
A complete action on the merits of pending claims 37-56 appears 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.
Claim Objections
Claim 41 objected to because of the following informalities:
There needs to be a period at the end of claim 41.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 37-39, 42-51, and 53-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cosman US 20150320481.
Regarding claims 37 and 46-49, Cosman teaches a generator coupled to the processor (par. [0110]) and to be operatively coupled to at least two electrodes (Fig. 1C electrode tips 150 on probe 150), at least one of the at least two electrodes to be placed in a target region of a tissue site; a sensor, wherein the sensor is a current sensor or voltage sensor (par. [0198] sensors measure current and temperature); and a memory coupled to the processor, the memory comprising program instructions to perform operations comprising: generating a plurality of electrical pulses between the at least two electrodes (pars. [0090] and [0117]); sensing at least one treatment parameter during the generation of the plurality of electrical pulses; receiving an indication of the at least one treatment parameter; detecting an abnormal condition of an irreversible electroporation (IRE) treatment procedure based in part on the indication of the at least one treatment parameter; pausing generation of at least one of the plurality of electrical pulses in response to detection of the abnormal condition; receiving an indication to resume the IRE treatment procedure; and resuming the IRE treatment procedure including resuming generation of the at least one of the plurality of electrical pulses to complete the IRE treatment procedure (pars. [0092] and [0113] a down time of no energy being sent because of an impedance, current, or voltage indication, then the up time can start again).
Regarding claims 38 and 50, wherein the treatment parameter is a voltage value (par. [0117] max voltage set to prevent sub-optimal heating of tissue).
Regarding claims 39 and 51, wherein the abnormal condition includes the voltage value exceeding a predetermined threshold (par. [0117] max voltage set to prevent sub-optimal heating of tissue).
Regarding claims 42 and 53, Cosman teaches wherein the treatment parameter is a current value (pars. [0055] and [0198] sensed parameter can be current).
Regarding claims 43 and 54, Cosman teaches wherein the abnormal condition includes the current value exceeding a predetermined threshold (par. [0055] and [0117] current monitoring and thresholds to determine up and down times of generator based upon sensed parameters).
Regarding claims 44 and 55, Cosman teaches wherein the abnormal condition includes the current value being below a predetermined threshold (par. [0126] minimum current value).
Regarding claims 45 and 56, Cosman teaches wherein the abnormal condition is insufficient to provide an effective ablation (par. [0117] sub-optimal heating during ablation procedure).
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.
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 40, 41, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Cosman in view of Scherman US 20070242743.
Regarding claims 40, 41, and 52, Cosman does not explicitly teach wherein the operations further comprise reducing a voltage of the plurality of electrical pulses in response to the detection of the abnormal condition wherein the voltage is reduced by 5-10%.
Scherman, in an analogous device, teaches reducing the voltage of the device in response to a sensed resistance (par. [0189]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Cosman to reduce the voltage by 5-10% or any percent. Scherman has the voltage reduced proportional to a change in resistance to maintain a constant condition in the therapeutic field (Scherman par. [0189]).
Conclusion
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/R.T.C./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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