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 .
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 1-5 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ramanathan (US 2012/0101398) in view of Yoon et al. (2021/0228896).
Regarding claim 1 and 12, Ramanathan discloses a method of optimizing an electrode array structure in electrotherapy, the method comprising: obtaining information on a region-of-interest (one or more region 364 and 366) and critical organs (fig.14; patient’s heart 362) from input patient data (fig.14; GUI 360); setting an overall shape and an overall area of an electrode array based on the obtained information on the region-of-interest (ROI) and critical organs [0131]. Ramanathan teaches a user can position individual virtual electrodes on each region of interest 364 and 366, such as placing electrodes 368 in region 364 and virtual electrodes 370 in region 366. In the illustrated example, the region 364 corresponds to the patient's left ventricle and the region 366 corresponds to the patient's right ventricle [0131]. However, Ramanathan does not specifically disclose setting an area ratio occupied by a plurality of unit electrodes constituting the electrode array to the overall area of the electrode array; repeatedly performing the setting of the overall shape and the overall area and/or the setting of the area ratio until an electric field transmitted to the region-of-interest (ROI) and the critical organs is optimized; and deriving a customized electrode array structure in which the electric field is optimized and derive a customized electrode array structure that optimizes an electric field delivered to the region-of-interest (ROI) and the critical organ based on electric field simulation results.
Yoon teaches an apparatus and method for alternating electric fields therapy using an optimization algorithm, and an apparatus for alternating electric fields therapy for treating tumors in a patient by applying electric fields to the tumors and normal tissues using one or more pairs of electrode pads containing most of the electrodes and including an image classifier to classify at least one organ in the patient's image for each organ (abstract). Yoon teaches the electric field optimizer 130 can set the magnitude of voltage applied to the electrodes by considering the types of tumors to be treated, the position of the tumors, and the boundary conditions between the tumors and normal tissues. The electric field optimizer 130 can set the electrode weighting as a variable (overall area), divide most of the electrodes into those applying voltage and a ground electrode (plurality of unit electrodes constituting the electrode array), and set the frequency of most of the electrodes depending on the type of tumor [0033]. The electrodes are arranged on an electrode pad of a predetermined size via an electric field optimization unit, and the voltage magnitude applied to the plurality of electrodes is calculated to create at least one treatment plan, preferably three or more. Additional treatment plans may also be generated. The established treatment plans are set such that sizes and numbers of different electrodes are variously and variably changed, and the plurality of established treatment plans are individually analyzed and evaluated, thereby extracting conditions that yield to optimal results (setting the appropriate ratio, see [0051]). Furthermore, FIGS. 4 and 5 illustrate diagrams comparing simulations by an apparatus for alternating electric fields therapy using an optimization algorithm, as embodied in the present disclosure, and the conventional method ([0024], [0055] and [0057]) .Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device of Ramanathan setting an area ratio occupied by a plurality of unit electrodes constituting the electrode array to the overall area of the electrode array and a system that is configured to use simulation for treatment as taught by Yoon for the purpose of protecting the boundary tissues and saving energy.
Regarding claim 2, Ramanathan/Yoon teaches the method of claim 1, wherein obtaining information on a region-of-interest (ROI) and critical organs comprises dividing the region-of-interest (ROI) and the critical organ from the input medical image of the patient (fig.14 of Ramanathan).
Regarding claim 3, Ramanathan/Yoon teaches the method of claim 2, wherein the information on a region-of-interest (ROI) contains information about a size, a shape, and an internal depth of the body of the patient, and the information on critical organ contains information about a shape and a location of the critical organ (fig.13-14 of Ramanathan).
Regarding claim 4, Ramanathan/Yoon teaches the method of claim 3, wherein the setting of the overall shape and the overall area comprises setting the overall shape of the electrode array based on a shape of a region-of-interest (ROI) from a viewpoint of the skin to which the electrode is attached ([0131 - [0134] of Ramanathan or [0031] of Yoon).
Regarding claim 5, Ramanathan/Yoon teaches the method of claim 4, wherein the setting of the overall shape and the overall area comprises setting the overall shape of the electrode array by additionally considering the shape and position of the critical organ ([0131-[0134] of Ramanathan or [0031] of Yoon).
Regarding claim 9, Ramanathan/Yoon teaches the method of claim 1, wherein the area ratio is set so that the intensity of the electric field is equal to or greater than the intensity of the electric field that can maximize the clinical treatment effect with reference to correlation information between the area ratio of the electrode array and the intensity of the electric field transferred to the region-of-interest ([0033] of Yoon).
Regarding claim 10, Ramanathan/Yoon teaches the method of claim 1, wherein the repeatedly performing the setting of the overall shape, the overall area and the setting of the area ratio comprises simulating an electric field transmitted to the region-of-interest (ROI) and the critical organ according to the ratio and the overall shape previously set, and repeatedly changing any of the overall shape, the overall area and the setting of the area ratio until the electric field transmitted to the region-of-interest (ROI) and the critical organ satisfies a predetermined criterion from the simulation results ([0033] of Yoon).
Regarding claim 11, Ramanathan/Yoon teaches the method of claim 1, wherein deriving a customized electrode array structure can be implemented by customizing electrode array structure or by selectively applying a voltage to only a unit electrode corresponding to the overall shape of the electrode array while using an electrode array template having a predetermined structure ([0032]-[0032] of Yoon).
Regarding claim 13, Ramanathan/Yoon teaches the system of claim 12, wherein the variables of the electrode array include an entire shape and an entire area of the electrode array, and a ratio of an area occupied by a plurality of unit electrodes constituting the electrode array to the entire area of the electrode array ([0032]-[0033] of Yoon).
Allowable Subject Matter
Claim 6-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Both Ramanathan/Yoon remain silent wherein the overall area of the electrode array is a saturation critical area, which is an area where the average intensity of the electric field transmitted to the region-of-interest (ROI) starts to be constant, based on the set overall shape of the electrode array. Claim 7 and 8 depend on claim 6 and therefore are objected.
Conclusion
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794