DETAILED ACTION
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.
Claims 1-9, are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Regarding claim 1:
Claim 1 is directed to idea of itself (abstract idea) without significantly more for the following reason(s):
Step 1: Claim 1 recites a process/method claim. Thus, the claim is directed to a method, which is one of the statutory categories of the invention.
Step 2A prong 1, In order to apply step 2A, a recitation of claim 1, is described below. The limitations of the claim that describes an abstract idea are bolded.
obtaining a section image that is related to an object tissue section, the section image including a plurality of cell-image portions that correspond respectively to a plurality of cells of the object tissue section;
for each of the cell-image portions, determining a number of proto-oncogenes according to a number of first markers which are shown in the cell-image portion, each of which indicates a proto-oncogene, and determining a number of specific chromosomes according to a number of second markers which are shown in the cell-image portion, each of which indicates a specific chromosome (Mental processes (observation, evaluation, judgment, and/or opinion))
performing statistical analysis based on the numbers of proto-oncogenes determined respectively for the cell-image portions and the numbers of specific chromosomes determined respectively for the cell-image portions to obtain a statistical result that indicates, for each of a plurality of preliminary cell clusters, a number of a group of the cells of the object tissue section that belong to the preliminary cell cluster, each of the preliminary cell clusters corresponding to a distinct pair of one of the numbers of proto-oncogenes and one of the numbers of specific chromosomes (Mathematical concepts - Mathematical Calculation – MPEP 2106.04{a}{2}{1}{C} (i-vi)); and
according to a thickness of the object tissue section, a representative radius related to the cells of the object tissue section, and a plurality of distribution data sets that correspond respectively to various reference hit probabilities each related to a reference tissue section, performing regression analysis on the statistical result to obtain a result of cell-cluster analysis that indicates, for each of estimated cell clusters, a ratio of a number of cells that belong to the estimated cell cluster to a total number of the cells of the object tissue section, the cells of the estimated cell cluster having an identical number of proto-oncogenes and an identical number of specific chromosomes (Mathematical concepts - Mathematical Calculation – MPEP 2106.04{a}{2}{1}{C} (i-vi))).
The limitations as analyzed include concepts directed to the "Mathematical Concepts"
grouping of abstract ideas (including mathematical relationships, mathematical formulas or equations, mathematical calculations) (see MPEP § 2106.04(a)(2), subsection I). A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation (see MPEP 2106.04(a)(2)(1)(C). Thus, limitations noted above also fall into the "Mathematical Concepts" groupings of abstract ideas. The limitations as analyzed also include concepts directed to the "mental process" groupings of abstract ideas performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III). The steps are simple enough/broadly claimed that they could be performed mentally or with pen and paper. Thus, limitations noted above also fall into the "mental process" groupings of abstract ideas.
Step 2A prong 2, Under step 2A prong two, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present general field of use or insignificant extra-solution activity. In particular, the claim recites the additional limitations: obtaining a section image that is related to an object tissue section, the section image including a plurality of cell-image portions that correspond respectively to a plurality of cells of the object tissue section (insignificant extra-solution activity - mere data gathering MPEP 2106.05(g))). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, claim 1 as a whole is not significantly more than the abstract idea itself and is ineligible.
Step 2B, The claim does not include additional elements that are sufficient to amount to significantly more than the abstract idea when considering both individually and as a whole. Under step 2B, limitations that are insignificant extra-solution activity under step 2A, Prong 2, need to be re-evaluated to determine whether they are well-understood, routine, conventional activities.
Specifically, the limitations “obtaining a section image that is related to an object tissue section, the section image including a plurality of cell-image portions that correspond respectively to a plurality of cells of the object tissue section” is generic computer components carrying out the abstract idea and data gathering and output. See MPEP 2106.04(d) referencing MPEP 2106.05(h). Further said limitations are Well-Understood, Routine, and Conventional, MPEP § 2106.05(d) (II) provides support that mere data collecting is well understood, routine, and conventional: "The courts have recognized the following computer functions as well- understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra- solution activity:
• Receiving or transmitting data over a network, e.g., using the Internet to gather
data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary
computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d
607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image
transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d
1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google,
Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives
and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P.,
773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014)
• Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP
Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788
F.3d at 1363, 115 USPQ2d at 1092-93
• Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115
USPQ2d at 1092-93
Hence, the additional limitations do not integrate the exception into a practical application and do not amount to claiming significantly more than the recited judicial exception. For the foregoing reasons, claim 1 is directed to an abstract idea without significantly more, and is rejected as not patent eligible under 35 U.S.C. 101. The same conclusion is reached for the dependent claims.
Regarding dependent claims 2-9.
Claims 2-9 further describe concepts directed to the "Mathematical Concepts"
grouping of abstract ideas (including mathematical relationships, mathematical formulas or equations, mathematical calculations) (see MPEP § 2106.04(a)(2), subsection I). A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation (see MPEP 2106.04(a)(2)(1)(C). Thus, limitations noted above also fall into the "Mathematical Concepts" groupings of abstract ideas. There are no additional elements do not integrate the abstract idea into a practical application to impose any meaningful limits on practicing the abstract idea. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Examiner’s Note: Any indication of allowable subject matter is being held in abeyance pending the response to the rejection under 35 USC § 101.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Lee (US PGPUB 2022/0215679 A1) reference discloses a method of determining a density of cells in a cell image, an electronic device and a storage medium are disclosed. The method acquires a cell image and extracts mapped features of the cell image by an autoencoder. The mapped features are inputted into a neural network classifier to obtain a feature category and a density range corresponding to the feature category is obtained. The density range is output.
Liu (US PGPUB 2022/0155232 A1) reference discloses a method comprises performing offline initial image-based unsupervised clustering and performing online image-based single cell sorting.
Craybuck (US PGPUB 2021/0395780 A1) reference discloses artificial expression constructs for selectively modulating gene expression in selected central nervous system cell types are described. The artificial expression constructs can be used to selectively express synthetic genes or modify gene expression in excitatory cortical neurons, such as primarily within cortical layers 2/3, 4, 5, and 6 and including those with extratelencephalic (ET) projections, intratelencephalic (IT) projections, and pyramidal tract (PT) projections.
Dupouy (US PGPUB 2019/0347465 A1) reference discloses a method which is a useful tool for use in the field of diagnosis, prevention and/or treatment of disease or disorders, in particular in the field of cancer management and therapy.
Barbeau (US PGPUB 2014/0274742 A1) reference discloses methods and techniques to identify carcinogenesis pathways and markers for early cancer diagnosis. Cell sampling is performed on a single tumor with multiple samples being taken from the tumor and outward toward the periphery and beyond. Large scale analysis is performed, such as whole genomic sequencing, to identify the differences between the cells of the various samples. The differences are evaluated to determine which differences represent a change along the carcinogenesis pathway.
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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