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 .
Status of Claims
Claims 1-6, 15-21 has been examined and are addressed below. Claim 7-14, has been restricted.
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 1-6, 15-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
Claims 1-6, 15-21 are drawn to a process and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claim 1, 15 and 20-21 recite “identifying a representative distribution of plurality of characteristics for a disease”, “generating a dataset comprising a set of biomedical images wherein a distribution of the plurality of characteristics for the dataset corresponds to the representative distribution of the plurality of characteristics for a disease”, “processing the dataset using a trained machine learning model”, “outputting a result of the processing wherein the result corresponds to a prediction that a biomedical image of the dataset includes a depiction of a set for tumor cells or other structural and or functional biological entities associated with the disease, the biomedical image is associated with a diagnosis of the disease the biomedical image is associated with a classification of the disease and or the biomedical image is associated with a prognosis for the disease”.
If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Additionally the limitations can also be interpreted as mental process. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two:
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
This judicial exception is not integrated into a practical application. That the abstract idea may be performed by specifically “computer”, “one or more processor”, “non-transitory computer readable storage medium”, “computer program product”, “system”, are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims do not recite the additional element of which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, 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.
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion
-paragraph 66 recites that “a system including one or more data processors. In some embodiments, the system includes a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform part or all of one or more methods and/or part or all of one or more processes disclosed herein. Some embodiments of the present disclosure include a computer-program product tangibly embodied in a non-transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform part or all of one or more methods and/or part or all of one or more processes disclosed herein.”.
The claims do not recite the additional element of which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-6, 16-19 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 15-21 is/are rejected under 35 U.S.C. 1022a2 as being Anticipated by Sedlak (2024/0011993).
With respect to claim 1 Sedlak teaches a computer-implemented method comprising:
identifying a representative distribution of a plurality of characteristics for a disease (Sedlak paragraph 223 “”a reference threshold level (e.g., cutoff value) may be determined based on a log-normal distribution around healthy subjects (e.g., of specified age ranges), and optionally subjects with inflammatory conditions (e.g., COPD) and selection of the number of standard deviations (SDs) (e.g., at least 1.5, at least 1.6, at least 1.7, at least 1.8, at least 1.9, at least 2, at least 2.1, at least 2.2, at least 2.3, at least 2.4, at least 2.5, at least 2.6, at least 2.7, at least 2.8, at least 2.9, at least 3, at least 3.1, at least 3.2, at least 3.3, at least 3.4, at least 3.5, at least 3.6 or higher SDs) necessary to achieve the specificity of interest (e.g., at least 95% or higher specificity [including, e.g., at least 96%, at least 97%, at least 98%, at least 99%, or higher specificity] such as in some embodiments at least 99.8% specificity), e.g., based on prevalence of lung cancer or a subtype thereof);
generating a dataset comprising a set of biomedical images, wherein a distribution of the plurality of characteristics for the dataset corresponds to the representative distribution of the plurality of characteristics for the disease (Sedlak paragraph 64 “a histogram illustrating the AUC values for each possible LUAD biomarker combination based on the list in Table 3 against other cancer types. To compare against other cancers, EV scores for biomarker combinations (wherein an EV score is a multiplication of all TPM expression values in a given biomarker combination) were calculated for lung adenocarcinomas and all other tumor types in a cancer molecular database (e.g., the Cancer Genome Atlas), except for lung squamous carcinoma, and then the AUC was calculated. The histogram shows the distribution of AUC values against all other cancers. In general, biomarker combination described herein are shown to be specific to LUAD over other cancer types.”);
processing the dataset using a trained machine learning model; and outputting a result of the processing, wherein the result corresponds to a prediction that a biomedical image of the dataset includes a depiction of a set of tumor cells or other structural and/or functional biological entities associated with the disease, the biomedical image is associated with a diagnosis of the disease, the biomedical image is associated with a classification of the disease, and/or the biomedical image is associated with a prognosis for the disease (Sedlak paragraph 342 “a subject or population of subjects that are amenable to provided technologies for detection of lung cancer may be determined to have normal X-ray imaging, sputum testing, low-dose CT scanning, and/or molecular tests based on cell-free nucleic acids, serum proteins (e.g., CEA, CYFRA 21-1, NSE, ProGRP, and/or SCCA). In some embodiments, such subjects may have received a negative indication of lung cancer from such diagnostic tests. In some embodiments, such subjects may have received a positive indication of lung cancer from such diagnostic tests. In some embodiments, technologies provided herein can be used in combination with other diagnostics assays including e.g., but not limited to: (i) physicals, general practitioner visits, cholesterol/lipid blood tests, diabetes (type 2) screening, colonoscopies, blood pressure screening, thyroid function tests, prostate cancer screening, mammograms, HPV/Pap smears, and/or vaccinations; (ii) chest X-ray imaging, sputum testing, chest low-dose CT scanning, and/or molecular tests based on cell-free nucleic acids, serum proteins (e.g., CEA, CYFRA 21-1, NSE, ProGRP, and/or SCCA); (iii) a genetic assay to screen blood plasma for genetic mutations in circulating tumor DNA and/or protein biomarkers linked to cancer; (iv) an assay involving immunofluorescence staining to identify cell phenotype and marker expression, followed by amplification and analysis by next-generation sequencing; and/or (v) EGFR, KRAS, ALK, ROAS1, HER2, BRAF, and RET germline, somatic, and circulating cell mutation assays, or assays involving cell-free tumor DNA, liquid biopsy, serum protein and cell-free DNA, and/or circulating tumor cells”).
Claim 15 is rejected as above.
Claim 20 is rejected as above.
Claim 21 is rejected as above.
With respect to claim 2 Sedlak teaches the computer-implemented method of claim 1, further comprising, prior to processing the dataset using the trained machine learning model: determining the distribution of the plurality of characteristics in the dataset; determining a difference between the distribution and the representative distribution; and modifying the dataset based on the difference (Sedlak paragraph 190-191).
Claim 16 is rejected as above.
With respect to claim 3 Sedlak teaches the computer-implemented method of claim 1, further comprising: identifying a threshold criterion for a metric associated with the prediction; determining that the metric satisfies the threshold criterion; and availing the trained machine learning model for subsequent processing of biomedical images (Sedlak paragraph 207).
With respect to claim 4 Sedlak teaches the computer-implemented method of claim 3, further comprising: determining that the metric does not satisfy the threshold criterion; availing the trained machine learning model for subsequent processing of biomedical images; performing the subsequent processing of another set of biomedical images using the trained machine learning model; and outputting another result of the subsequent processing, wherein the other result indicates the prediction and a confidence level of the prediction based on the metric not satisfying the threshold criterion (Sedlak paragraph 302).
Claim 17 is rejected as above.
With respect to claim 5 Sedlak teaches the computer-implemented method of claim 1, wherein the prediction characterizes a presence of, quantity of and/or size of the set of tumor cells or the other structural and/or functional biological entities, the diagnosis of the disease, the classification of the disease, and/or the prognosis of the disease (Sedlak paragraph 124).
Claim 18 is rejected as above.
With respect to claim 6 Sedlak teaches the computer-implemented method of claim 1, wherein the plurality of characteristics comprise clinical characteristics and technical characteristics, wherein the clinical characteristics include one or more variants of the disease, a relapse rate, one or more international prognostic index risk factors, and/or one or more demographic factors, and wherein the technical characteristics include one or more types of data acquisition methods, one or more types of scanner, and/or one or more types of staining protocol (Sedlak paragraph 316).
Claim 19 is rejected as above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINALD R REYES whose telephone number is (571)270-5212. The examiner can normally be reached 8:00-4:30 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid R. Merchant can be reached at (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
REGINALD R. REYES
Primary Examiner
Art Unit 3684
/REGINALD R REYES/Primary Examiner, Art Unit 3684
Prosecution Insights