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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 18, 2026 has been entered.
Response to Arguments
Applicant’s remarks filed February 18, 2026 concerning the previous obviousness rejections have been fully considered but are not persuasive.
Concerning the first interpretation, Applicant argues that there is no indication or suggestion in Hershkovich that the semi-automatic segmentation tool is applied after the manual segmentation tools. The Examiner respectfully disagrees because the claims do not explicitly require this sequence of actions to actually be carried out. Rather, the claims require “presenting on the display” icons for both of these steps, i.e. the claims require a GUI that allows a user to carry out these steps in that order. Hershkovich satisfies this limitation. As explained in the response to arguments section of the previous office action, Hershkovich shows a GUI that can include both options for a user to manually segment and use the “semi-automatic” tool, and thus provides the capability to perform the manual segmentation step(s) followed by the automatic step(s). Hershkovich does not appear to teach any mutual exclusivity of these tools which would prevent a user from selecting the semiautomatic tool after one or more of the manual segmentation steps.
Concerning the issue of whether the “semi-automatic” tool can qualify as both the manual and automatic steps (see Applicant’s remarks at page 13, last paragraph), the rejection no longer refers to the possibility of the “semi-automatic” tool being interpreted to cover both the manual and automatic steps. Instead, it is only being interpreted to cover the automatic step, which could be used after the manual step(s) in Hershkovich.
Concerning the multiple user actions (see Applicant’s remarks at page 14, first paragraph) these arguments are moot because the rejection did not equate the “user actions” in Para. 92 to the “automatic” portion of the claim. This argument was already addressed in the previous office action (see Page 2, last paragraph beginning with “Concerning the ‘multiple user actions’ …”). As noted in that response, the “multiple user actions” mentioned in Para. 92 are mapped to the claimed manual segmentation step which could be combined with the semi-automatic segmentation tool.
Moving on to the second interpretation which relies on the McLennan reference, Applicant argues that McLennan merely provides a green highlight on an image, which is not automatically cleaning up the image to obtain a cleaned up gray scale image in accordance with the claim language. The Examiner respectfully disagrees. Concerning the amendment to specify that the slice is “gray scale,” this was already addressed in the rejection since Hershkovich in view of Naveh are teaching MRI and CT images, which are both gray scale. In other words, the images being analyzed throughout the steps of the combination of references are gray scale images due to the imaging modalities being used. McLennan also uses an image that was originally acquired in gray scale (see e.g. Para. 64 and claim 3), and thus McLennan’s analysis of the image (including the threshold set by the slider discussed in the rejection) is ultimately based on the values of each pixel that originated in gray scale. McLennan is used simply to show that it was known to use a slider to allow a user to manually adjust the threshold which distinguishes between normal and abnormal tissue based on gray scale values. Given that Hershkovich in view of Naveh are only concerned with gray scale images, it follows that after the modification in view of McLennan, the resulting image slices at each step would still be in gray scale.
Concerning McLennan’s green highlight provided on the image, it is noted that Hershkovich already teaches distinguishing between normal and abnormal tissue in gray scale images/slices, thus the rejection does not necessarily require incorporating the green highlighting found in McLennan. Rather, the rejection merely requires incorporating the slider from McLennan as a way to allow the user to adjust the threshold which distinguishes normal from abnormal tissue.
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 2005/0036668 A1 to McLennan et al. (hereinafter “McLennan”).
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);
presenting on the display a user-selectable icon to automatically clean up the manually segmented grays scale slice to obtain a cleaned up manually segmented gray scale slice through the medical images (again see e.g. Para. 92; the “semi-automatic segmentation tool” could be selected by a user after one or more of the manual tools); and
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 cleaned up manually segmented gray scale slice through the medical images (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.
In the interest of being thorough, Hershkovich arguably 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. Regardless, Hershkovich 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, McLennan, teaches a medical image analysis software in which a user interface includes a slider that allows a user to adjust the threshold that distinguishes between abnormal and normal tissue (see e.g. Paras. 205-208 and FIG. 42 reproduced below).
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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 McLennan, because it would advantageously allow a user to make adjustments and/or corrections based on their expertise, and thus enable more accurate segmentation 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.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792