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 Objections
Claims 12-22, are objected to because of the following informalities: In claim 12, lines 9, 11 and 12, recites “so-called” respectively, however “so-called” should be removed from the claim language. Further, claim 1, in line 39, recites “reiterated so as to minimize the cost function”, however should recite “reiterated
Claim 14, further objected to because of the following informalities: In claim 14, line 2, recites “n second image thanks to a colorimetric”, however should recite “n second image according to a colorimetric”. Claim 15, further objected based on its dependency on the objected claim and inherent the same objection. Appropriate correction is required.
Claim 20, further objected to because of the following informalities: In claim 20, line 4, recites “the image thanks to a segmentation”, however should recite “the image according to a segmentation”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims12-22, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12, recites the limitation "the areas" in line 19. There is insufficient antecedent basis for this limitation in the claim. Claims 13-22, are rejected based on their dependency on the rejected claim and inherent the same rejection.
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, Claim 17, recites the limitation " the N other staining techniques" in line 2, and further recites “the Ki-67 antigen, the antibodies” in line 3, and further recites “the crytokeratin 8” in line 4. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 22, is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
In regard to the non-statutory subject matter, the claimed invention is directed to a
computer program product and specification of the pending application is silent with respect to the definition of the product. Thus applying the broadest reasonable interpretation the claimed computer program product, construed and considered to include embodiments covering software per se. Hence, claimed invention being directed to an embodiment covering only software is considered non-statutory subject matter. See MPEP 2106.03. Amendments may be made to narrow the claim to cover only statutory embodiments to overcome the rejection by adding the limitation “non-transitory” to claim 22, as follows: “A computer program product comprising a non-transitory computer readable medium storing instructions….”.
Examiner’s Note: Claims 12-22, would be allowable by overcoming the rejections and objections as being set forth above.
Reasons for Allowance
The following is an examiner's statement of reason for allowance: Regarding independent claim 12, (and its respective dependent claims), Kapil (US PGPUB 2019/0392580 A1) reference discloses a method for generating a score of a histological diagnosis of a cancer patient by training a model to determine how many pixels of a digital image belong to a tissue that has been positively stained by a diagnostic antibody. Brattoli (US PGPUB 2024/0046670 A1) reference discloses aa method and system for analysing various types of pathology images using a machine learning model. However, Kapil in view of Brattoli references whether taken alone or in combination fail to disclose “a) from each biological sample first image, generating a respective first segmentation binary image using current parameters of the machine learning model; b) from each n biological sample second image, generating a respective n second segmentation binary image using current parameters of the machine learning model; c) from each n third similar image, generating a respective n third segmentation binary image using current parameters of the machine learning model; d) calculating a cost function on the basis of: a value representative of differences between the first segmentation binary images and the corresponding verified segmentation binary images; and N values representative of differences between the n second segmentation binary images and the corresponding n third segmentation binary images; wherein each of the segmentation binary images respectively comprises a first set of pixels corresponding to regions of interest of the corresponding image of the biological sample, and a second set of pixels corresponding to areas of the corresponding image of the biological sample other than the regions of interest; and wherein steps a) to d) are reiterated to minimize the cost function” and used in combination with each and every limitations of the claim
The aspect summarized above are neither anticipated nor obviated by the prior art of the record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled "Comments on Statement of Reasons for Allowance."
Pertinent Priori Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weisenfeld (US PGPUB 2023/0081232 A1) reference discloses a dataset of a plurality of biological samples (e.g., sectioned tissue samples) is generated. Generally, this includes, for each biological sample, obtaining image data of the biological sample and molecular measurement data of the biological sample (e.g., one or more analytes of the biological sample) captured at a plurality of capture areas of the biological sample. In some embodiments, fiducial markers are used to align the molecular measure data of the biological sample with the image of the biological sample. In this regard, the capture areas of the biological sample are registered to corresponding locations in the image data of the biological sample. Then, a machine learning module is trained with the datasets. Another dataset for another biological sample is generated (e.g., in the same manner as the other datasets). And, the other dataset of the other biological sample is processed through the trained machine learning module to identify gene expression, protein expression, and/or other features in the other biological sample.
Glass (US PGPUB 2022/0375606 A1) reference discloses machine learning (ML) model diagnostic assessments, such as ML model quality control of human growth factor receptor 2 (HER2) scoring in diverse breast cancer tissue types.
Berdno (US PGPUB 2021/0383091 A1) reference discloses automated systems and methods for analyzing, storing, and/or retrieving information associated with biological objects having irregular shapes. In some embodiments, the systems and methods partition an input image into a plurality of sub-regions based on localized colors, textures, and/or intensities in the input image, wherein each sub-region represents biologically meaningful data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SYED Z HAIDER whose telephone number is (571)270-5169. The examiner can normally be reached MONDAY-FRIDAY 9-5:30 EST.
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/SYED HAIDER/Primary Examiner, Art Unit 2633
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