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 .
Claims 1, 5, 10, 13, 17, and 22-23 and 4 have been amended. Claim 24 is cancelled. Claims 25 is new. Claims 8-9 and 11-12 were previously cancelled. Claims 1-7, 10, 13-23, and 25 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 10, 13-23, and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “generating, using a machine learning model that processes the processed pathology image as input, an annotated pathology image associated with the patient, wherein the annotated pathology image includes annotations for different classes of tissues indicating a tumor regression.” The specification fails to disclose how this is done using a singular image from the patient. To determine if there is tumor regression, at least two images or a series of images is typically used. Comparing the patient’s current tumor size to other images from other patients would not be indicative of tumor regression as the previous size is unknown. The specification does not describe the data used to train the machine learning model that is used as including the patient’s prior imaging photos. The current claim requires processing the patient’s image to generate an annotated pathology image associated with the patient, but it is not disclosed how this is being done.
Claims 2-7, 10 and 25 are rejected as they depend from claim 1.
Claims 13 and its dependents, claims 14-22, are rejected for similar reasons. Claims 23 is rejected for similar reasons.
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.
Claims 1, 3-7, 13-20, 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Faust (U.S. Pub. No. 2020/0272864 A1) in view of Van Der Koijk (U.S. Pub. No. 2018/0052962 A1).
Regarding claim 1, Faust discloses a computer-implemented method for predicting a clinical outcome of a patient, the method comprising:
processing a pathology image associated with a patient (Paragraphs [0097] and [0128] discuss receiving pathology images of a patient.), wherein the processing includes:
determining a region of interest of the pathology image (Paragraph [0108] discusses determining a region of interest with the corresponding image data.); and
segmenting the pathology image into a plurality of tiles, wherein each of the plurality of tiles has a uniform size (Paragraphs [0103] and [0185] discuss segmenting the image into images patches or tiles, for example 1024 x 1024, construed as the tiles being a uniform size.);
generating, using a machine learning model that processes the processed pathology image as input (Paragraphs [0091],[0106] and [0110] discuss a convolutional neural network being trained to classify and annotate input data, wherein the input data is images.), an annotated pathology image associated with the patient, wherein the annotated pathology image includes annotations for different classes of tissues (Paragraphs [0091], [0103-0104], [0106] and [0110] discuss the convolutional neural network outputting the results of the analysis, including any annotations for different classes of tissues.); and
determining, based on determined areas for each of the different classes of tissues the annotated pathology image, a metric indicative of the clinical outcome of the patient (Paragraphs [0116] and [0182] discuss outputting the results, which include an aggregate percentage score or prediction scores displayed as a percentage for each class across the whole slide and lists the most likely diagnosis.),
but Faust does not appear to explicitly disclose wherein the annotations for different classes of tissues indicate a tumor regression.
Van Der Koijk teaches wherein the annotations for the different classes of tissues indicate a tumor regression (Paragraphs [0031], [0060] and [0069] discuss the adaptative treatment engine analyzing the patient’s tumor response, including shrinkage, construed as indicating tumor regression.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Faust to include indicating a tumor regression, as taught by Van Der Koijk, in order to “adapt a new treatment (Van Der Koijk, Paragraph [0032]).”
Regarding claim 3, Faust discloses a wherein the pathology image comprises a histopathology slide image (Paragraph [0089] discusses wherein the pathology images include histopathologic slides.).
Regarding claim 4, Faust discloses a wherein the machine learning model has been trained on a plurality of training data items, and wherein each training data item includes an annotated pathology image with tissue classes (Paragraph [0103] discusses the machine learning model having been trained on annotated images to differentiate between tumor classes.).
Regarding claim 5, Faust discloses a generating rendering data, when rendered by a user device, causes the user device to display a user interface that displays the annotated pathology image associated with the patient and the indicated clinical outcome of the patient (Paragraph [0129] discusses an interface application on one or more user devices that displays the pathology images with annotated information.).
Regarding claim 6, Faust discloses wherein the user interface comprises a user selectable element to upload the pathology image for applying the machine learning model (Paragraphs [0128] and [0133] discuss that a user may interact with the interface application by selecting data to input into a digital pathology platform or external system, which is used for training.).
Regarding claim 7, Faust discloses wherein the different classes of tissues comprise tumor, necrosis, and normal background, wherein the normal background indicates an uninvolved tissue (Paragraphs [0103] and [0230] discuss the different classes of tissue including tumor, necrosis, and normal tissue.),
but Faust does not appear to explicitly disclose wherein the different classes of tissue comprise tumor regression.
Van Der Koijk teaches wherein the different classes of tissues comprise a tumor regression (Paragraphs [0031], [0060] and [0069] discuss the adaptative treatment engine analyzing the patient’s tumor response, including shrinkage, construed as indicating tumor regression.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Faust to include indicating a tumor regression, as taught by Van Der Koijk, in order to “adapt a new treatment (Van Der Koijk, Paragraph [0032]).”
2025Attorney Docket No. 317EP.001US01
Claim 13 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above. Claim 13 further recites:
one or more computers (Faust discloses in paragraph [0021] that computers are used to implement the invention. See also Figure 1.); and
one or more storage devices storing instructions that are operable, when executed by the one or more computers, to cause the one or more computers to perform operations (Faust discloses in paragraph [0021] that a computer product with non-transitory computer readable media storing program instructions to perform the disclosed steps.).
2025Attorney Docket No. 317EP.001US01
Claim 14 recites substantially similar limitations as those already addressed in claim 2, and, as such, is rejected for similar reasons as given above.
Claim 15 recites substantially similar limitations as those already addressed in claim 3, and, as such, is rejected for similar reasons as given above.
Claim 16 recites substantially similar limitations as those already addressed in claim 4, and, as such, is rejected for similar reasons as given above.
Claim 17 recites substantially similar limitations as those already addressed in claim 5, and, as such, is rejected for similar reasons as given above.
Claim 18 recites substantially similar limitations as those already addressed in claim 6, and, as such, is rejected for similar reasons as given above.
Claim 19 recites substantially similar limitations as those already addressed in claim 7, and, as such, is rejected for similar reasons as given above.
Regarding claim 20, Faust discloses a wherein the metric indicative of the clinical outcome of the patient comprises a percent residual viable tumor, wherein the percent residual viable tumor is computed based on areas of the different classes of tissues in the pathology image (Paragraphs [0116] and [0127] discuss prediction scores displayed as a percentage for the tumor using the different classes of tissues in the image.).
Claim 23 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above. Claim 23 further includes: one or more computer-readable storage medium storing instructions that, when executed by one or more computers, cause the one or more computers to perform operations (Faust discloses in paragraph [0021] that a computer product with non-transitory computer readable media storing program instructions to perform the disclosed steps that is used by a computer.).
Regarding claim 25, Faust wherein determining the metric indicative of the clinical outcome of the patient comprises: determining an area for each of the different classes of tissues of the annotated pathology image, wherein determining the metric uses the determined areas for each of the different classes of tissues of the annotated pathology image (Paragraphs [0116], [0182] and [0256-0257] discuss using lesional areas to analyze the different classes of tissue, which is used to determine clinical outcome of the patient.).
Claims 2, 10 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Faust in view of Van Der Koijk, and in further view of Golden (U.S. Pub. No. 2020/0380675 A1).
Regarding claim 2, Faust discloses a wherein the clinical outcome of the patient comprises responsiveness to one or more treatment regimens, survival, and disease progression (Paragraphs [0150], [0239] and [0274] discuss outcomes including survival, prognostic outcomes and progression.),
but Faust does not appear to explicitly disclose wherein the clinical outcome of the patient comprises disease recurrence.
Golden teaches wherein the clinical outcome of the patient comprises disease recurrence (Claims 312 and 323 recite wherein the clinical outcomes predicted include cancer recurrence.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Faust to include disease recurrence, as taught by Golden, in order to “provide radiologists better tools to improve the PPV of malignancy prediction which would allow them to reduce the number of invasive biopsy procedures for patients who do not stand to benefit from them (Golden, Paragraph [0277]).”
Regarding claim 10, Faust discloses wherein processing the pathology image further comprises:
normalizing color of the pathology image based on color of a set of pathology images, wherein the set of pathology images includes the pathology image associated with the patient (Paragraphs [0120], [0345] and [0394] discusses normalizing images including color from a series of images taken from the same patient.);
applying image transformations to the pathology image, wherein the image transformations include rotation (Paragraph [0315] discusses rotating and adjusting brightness of image.);
but Faust does not appear to explicitly disclose applying image transformations to the pathology image, wherein the image transformations include shift, flip, zoom, affine transformation, and adjusting contrast.
Golden teaches applying image transformations to the pathology image, wherein the image transformations include shift, flip, zoom, affine transformation, and adjusting contrast (Paragraphs [0026], [0029], [0035], [0359] discuss the image transformations including shift, flip, zoom, affine transformation and adjusting contrast. Examiner notes that Golden also discusses normalizing the images (see at least paragraph [0120]).).
Therefore, it would have been obvious to one ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the images of Faust to include additional transformations, as taught by Golden, for a more optimal reading of the image (Golden, Paragraph [0359]).
Claim 22 recites substantially similar limitations as those already addressed in claim 10, and, as such, is rejected for similar reasons as given above.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Faust in view of Van Der Koijk, and in further view of Saltz (U.S. Pub. No. 2020/0388029 A1).
Regarding claim 21, Faust does not appear to explicitly disclose wherein the metric indicative of the clinical outcome of the patient comprises a percent regression and a percent necrosis in the pathology image.
Saltz teaches wherein the metric indicative of the clinical outcome of the patient comprises a percent regression and a percent necrosis in the pathology image (Paragraphs [0089], [0327] and [0368] discuss providing a TIL fraction or percentage for regression or necrosis of the tumor.).
Therefore, it would have been obvious to one ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the analysis of Faust to include percent regression and percent necrosis, as taught by Saltz, in order to “generate tumor infiltrating lymphocyte maps that are useful in generating prognostic values in diagnosis and/or related classification (Saltz, Paragraph [0019]).”
Response to Arguments
Claims Rejections – 35 U.S.C. § 101
Applicant’s arguments with respect to the section 101 rejection are moot as the rejection has been withdrawn.
Claims Rejections – 35 U.S.C. § 103
Applicant’s arguments are directed towards the amendments, which have been addressed in the above rejection.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686