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 .
Response to Arguments
Applicant’s remarks in the Pre-appeal Brief Request for Review dated July 27, 2026 have been fully considered and are persuasive as indicated in the Notice of Panel Decision dated September 11, 2026. After further search and consideration, new grounds of rejection are made below.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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 1-4, 8-15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0372705 A1 to Hershkovich et al. (hereinafter “Hershkovich”) in view of US 2020/0146586 A1 to Naveh et al. (hereinafter “Naveh”) in view of US 9,846,937 B1 to Sharma et al. (hereinafter “Sharma”).
Regarding Claims 1-3, 9-13, 15 and 19-20, Hershkovich teaches a computer-implemented method for generating at least one transducer layout for delivering tumor treating fields to a subject (see e.g. Paras. 89-98 and FIGS. 11A-D), the method comprising:
presenting on a display one or more user-selectable icons to display a slice through medical images of the subject (see e.g. Paras. 89-93 and FIGS. 11A-B), wherein the medical images are magnetic resonance imaging (MRI) medical images or computer tomography (CT) medical images (see e.g. Paras. 41 and 58-69) wherein the medical images comprise voxels (see e.g. Paras. 69 and 93);
presenting on the display one or more user-selectable icons to manually segment the slice through the medical images to obtain a manually segmented gray scale slice through the medical images (see e.g. Para. 92 discussing segmentation tools including manual tools; see also FIG. 11B; standard MRI and CT images are in gray scale);
presenting on the display a user-selectable icon to generate a plurality of transducer layouts for application of tumor treating fields to the subject based on the (see e.g. Paras. 96-98 and FIG. 11D).
Hershkovich fails to specifically teach that the imaging data is magnetic resonance imaging (MRI) medical images and computer tomography (CT) medical images registered together, wherein the slice comprises corresponding slices through the MRI medical images and the CT medical images overlaid on each other. Naveh teaches an extremely similar imaging software used for determining TTFields electrode array layouts in which both MRI and CT image data are registered together and slices are overlaid (see e.g. steps S12 and S13 in FIG. 1; also see FIG. 2). The advantage of this is explained in e.g. Para. 15 of Naveh (“Because skull defects, bone flaps, and metal plates are highly visible in CT images, those features can be identified and outlined from a CT image set, and combined with the images of tissue obtained from the MRI scans (which provides superior anatomical accuracy of non-rigid tissue such as the brain)”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Hershkovich to include both MRI and CT image data registered together and overlaid, as taught in Naveh, because it would at least yield the advantages described in Para. 15 of Naveh concerning the increased accuracy of detecting a greater variety of tissue and material types.
Hershkovich fails to teach presenting on the display a user-selectable icon to automatically clean up the manually segmented slice to obtain a cleaned up manually segmented slice through the medical images, and fails to teach the additional details of this automatic clean up tool being a slider that adjusts a gray scale threshold for distinguishing between normal and abnormal tissue as stated in e.g. claims 2-3. Another reference, Sharma, teaches a medical image analysis software for use with CT and MRI images (see e.g. Col. 13 lines 48-58: “Aspects of this invention also describe a way to extract more information from a set of images of the same region, acquired separately using different modalities. Again, such situations are frequent in medical imaging. For example, a patient might have a CT scan of the brain and then MRI of the brain. Furthermore, MRI of the brain itself commonly contains multiple different types of images acquired separately and based on different tissue properties” and claim 1) in which gray scale intensities are used to distinguish normal from abnormal tissue (see e.g. Col. 10 lines 45-51: “By merging information from original image with that from “good” or “bad” pixel density grids, the current invention will allow for creation of a new image in which the details of outlines of various organs defined in the original image are maintained but the distinction between the normal and abnormal tissues have been highlighted by addition/subtraction of good/bad density grids.”) a user interface includes a slider that allows a user to adjust the threshold that distinguishes between abnormal and normal tissue (see four instances of the word “slider” in Sharma, most notably at Col. 17 lines 17-37: “It will also be appreciated that there are other options for selecting the intensity threshold. For example, the selection may be made on the basis of mathematic calculations that take into account the intensities of structures that the user is interested in and the amount of noise in the image. Additionally, the computer program may also have a slider that can be moved to set the threshold at various levels from darkest to the brightest intensities. This feature will allow exploration of different parts of the image and obviate the need for needing to apply more complex mathematical calculations for setting this threshold. The “good intensity threshold” may also be guessed based on the a-priori knowledge of the structures that may exist in the image but are otherwise not visible. For example, specifically in the field of medical imaging, if user has a-priori knowledge that presence of disease in a particular tissue has the potential of moving the intensity of the affected tissue towards a brighter intensities, the user may select the normal appearing tissue as the “good intensity threshold” even when the original image does not demonstrate any evidence for presence of disease.”; also see Col. 18 lines 21-23 and lines 40-44).
It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Hershkovich to incorporate an automatic clean up tool including a slider that allows a user to adjust the threshold which distinguishes between normal and abnormal tissue, akin to that seen in Sharma, because it would advantageously allow a user to make adjustments and/or corrections based on their expertise, and thus enable more accurate differentiation of healthy and abnormal tissue, and thus also more accurate and effective generation of transducer layouts to be achieved.
Regarding Claims 4 and 14, see e.g. Para. 92 of Hershkovich (various types of abnormal tissue types, including tumors, can be identified).
Regarding Claims 8 and 18, see e.g. Paras. 92-93 of Hershkovich (various segmentation tools include user-assigned tissue types).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shamir ‘261: see Para. 53 discussing segmentation tools such as a brush or a slider that adjusts the threshold for distinguishing between two tissue types;
Bomzon ‘572: see Paras. 74-75 discussing some segmentation tool types.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at (571)-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
