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 Amendment
Applicant’s amendments with respect to claim(s) 1-6 and 9-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the arguments. However, applicant’s amendments did overcome the Section 101 rejection. The amendments to claims 1 and 11 amount to more than the substance of claims 7 and 8 and include more limitations directed to different legions not found in the original claims. Thus, further search was required.
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.
Claim(s) 1, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Yamada et al in view of Sakashita 2022/0358640.
Regarding claims 1, 11 and 12 Yamada discloses a medical image diagnosis system comprising: at least one processor (figure 12, processor 26); and at least one memory that stores a command to be executed by the at least one processor (memory and storage elements 23 and 24), wherein the at least one processor performs first determination of determining presence or absence of an abnormality from a medical image obtained by imaging a subject (paragraph 41), and performs second determination of determining whether or not the medical image is normal (non-cancerous) in a case in which it is determined that the abnormality (cancer) is absent in the first determination (true negative paragraphs 46-51). Claim 12 requires computer hardware and software equivalent to Yamada et al.
Yamada also shows a first determination determines that the abnormality is present in a case in which the specific lesion is detected by at least one of the plurality of first trained models (lesion type is considered a model), and the second determination is performed by a second trained model that detects whether any lesion is present from the medical image in a case in which the medical image is input, and the second determination determines that the medical image is not normal in a case in which any lesion is detected by the second trained model (so depending on type it may be abnormal to have a lesion but the lesion is not abnormal meaning it may cause disease).
Although Yamada fails to specifically teach all the newly added limitations to claims 1 and 11, Sakashita does (figures 3 and 4). Specifically note figure 4 of Sakashita wherein the first determination is performed by a plurality of first trained models (Lesion type 73 paragraph 58), each of the plurality of first trained models detects specific lesion different with each other from the medical image (figure 4 step S11 where new and different lesions are added to the models). Since both systems are trainable medical image analyzers it would have been obvious to one of ordinary skill in the art before the time of filing to combine teaching to better analyze medical images. One would be motivated to do so to improve the detection of harmful lesions and improve patient’s health care.
Claim(s) 2-5 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada et al in view of Sakashita in further view of Oh et al US 2019/0125306.
Regarding claim 2, Yamada teaches the medical image diagnosis system according to claim 1, wherein, for a first case in which it is determined that the abnormality is present in the first determination (feature A is present paragraph 107), a second case in which it is determined that the abnormality is absent in the first determination (feature B is absent) and it is determined that the medical image is not normal in the second determination (R1 in figure 7 is the group of not normal sets see paragraph 114),
Although Yamada and Sakashita fail to specifically teach the third case in which it is determined that the abnormality is absent in the first determination and it is determined that the medical image is normal (true negative) in the second determination. However, Oh does (see paragraph where abnormalities are absent and the medical is normal see paragraph 234). It should also be noted that Oh et al teach that many different kinds of medical assist images (i.e. different display) are presented in various cases. Therefore, Oh et al teach the at least one processor displays a diagnosis result of the medical image on a display differently for the third case than for the first and second cases. Since all three systems are trained on presence/absence of abnormalities in medical images, it would have been obvious to one of ordinary skill in the art before the time of filings to combine teachings and produce different types of displays based on variable conditions found. In other word, Oh et al teach that one of ordinary skill in the art would know what type of read assistance one would need to determine if cancer is present (230). Or if a potential area needs closer looking (i.e. highlighted) images can be enhanced in different way. Also see paragraphs 212 which displays read assistance images even when the object is normal.
Regarding claims 3 and 4, it should be noted that Oh et al teaches at least three different types of displays which are different than one another (paragraphs 200 – 206 which shows legion detected CAD image, bone suppression image, marked image and abnormality map). Clearly one of ordinary skill in the art would recognize that these different types of displays are available to select from. Even selecting different colors/highlights would be within the level of one of ordinary skill in that simply making selection on a user interface will result in different types of displays. Also see paragraph 260 of Oh et al.
Regarding claim 5, Oh et al and Yamada can be used on lungs and other organs wherein the at least one processor performs the first determination and the second determination for each organ of the subject from the medical image (Oh paragraphs 228, 265).
Regarding claim 9, Oh teaches the medical image diagnosis system according to claim 8, wherein the second trained model outputs a probability that the input medical image is normal (See Oh paragraphs 257+ which classify probable stages).
Regarding claim 10, Oh teaches the medical image diagnosis system according to claim 8, wherein the second trained model is a trained model that has been trained by using combinations of a normal medical image, an abnormal medical image, and labels indicating whether or not the medical image is normal, as a training data set (see paragraph 14).
Allowable Subject Matter
Claim 6 is 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Meyer is cited as teaching medical image analysis.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/CHRISTOPHER S KELLEY/Supervisory Patent Examiner, Art Unit 2482
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