The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to Applicant’s submission filed on 2 June 2026. THIS ACTION IS NON-FINAL.
In response to the restriction requirement, Applicant’s election with traverse of the instant application in the reply filed on 20 January 2026 is acknowledged.
Status of Claims
Claims 11-17, 20-38, 40-41 are pending.
Claims 1-10, 18-19, 39, 42-77 are cancelled.
Clams 28-38, 40-41 are withdrawn.
Claim 11 includes limitations interpreted under 35 U.S.C. 112(f), because it uses a generic placeholder coupled with functional language without reciting sufficient structure to achieve the function.
Claims 11-17, 20-27 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Claims 11-17, 20-27 are rejected under 35 U.S.C. 112(b) as indefinite.
Claim 11-17, 20-27 are rejected under 35 U.S.C. 101 for being directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
There is no art rejection for claims 11-17, 20-27.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
In claim 11, claim limitations "cohort selection and retraining module", ”product inference module", “external feedback/data collection module” have been interpreted under 35 U.S.C. 112(f), because they use a generic placeholder coupled with functional language without reciting sufficient structure to achieve the function. The specification does not provide descriptions of the structure of these elements.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim(s) limitations treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 112
112(b) Rejection
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.
A claim is indefinite if, when read in light of the specification, it fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention. Nautilus, Inc. v. Biosig Instruments, Inc., 110 USPQ.2d 1688, U.S. Supreme Court (2014).
Claims 11-17, 20-27 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 pre-AIA the applicant regards as the invention.
Regarding claim 11, including metaphorical terminology lacking structural / procedural definitions: a "cohort selection and retraining module", ”product inference module", “external feedback/data collection module”, the specification does not provide sufficient structural / procedural description to determine the scope of these limitations, the claims are therefore indefinite.
Regarding claims 11-17, 20-27, which depend on above rejected claim 11, are rejected for the same reason.
Regarding claim 22, “the research platform module”, lack of antecedent basis, the claim is therefor indefinite. For the purpose of applying prior art, this limitation is construed to be “a research platform module”.
Claims 24-26 are rejected for not further limit the subject matter of the claim it depends from. Because the recited “input” values in claim 24-26 are not subsets of claim 23’s own input Markush group, these claims do not properly narrow claim 23 – they appear to substitute in limitations copied from a different module’s input list (claim 20), which is not a proper dependent-claim narrowing and renders the claims of unclear scope. The claims are therefore indefinite.
Regarding claim 24, reading literally, claim 24 would require the research ingestion module’s input to be identical to what claim 23 defined as its output (de-identified matched patent data) – creating either a nonsensical self-referential limitation or an ambiguous relationship between input and output and a POSITA cannot resolve with reasonable certainty. The claim is therefore indefinite.
35 U.S.C. 112(a) Rejections
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.
Claims 11-17, 20-27 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 11, including metaphorical terminology lacking support of structural / procedural description: a "cohort selection and retraining module", ”product inference module", “external feedback/data collection module”, the specification does not provide sufficient structural / procedural description for these limitations. The claims are therefore rejected for failing to comply with the written description requirement.
Regarding claims 11-17, 20-27, which depend on above rejected claim 1, are rejected for the same reason.
35 U.S.C. 112(d) Rejections
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24-26 are rejected for not further limit the subject matter of the claim it depends from. Because the recited “input” values in claim 24-26 are not subsets of claim 23’s own input Markush group, these claims do not properly narrow claim 23 – they appear to substitute in limitations copied from a different module’s input list (claim 20), which is not a proper dependent-claim narrowing and renders the claims of unclear scope.
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.
Judicial Exception
Claims 11-17, 20-27 of the claimed invention are directed to a judicial exception, an abstract idea, without significantly more.
(Independent Claims) With regards to claim 11,
Step 1: The claim recites a machine, which falls into one of the statutory categories.
Step 2A – Prong 1: the claim, in part, recites: “…. selects classes of training samples for a classification model or re-trains the classification model; b) … produces raw data for ingestion into the data feedback loop system …” (mental process and/or math concept), as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting generic computer elements, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the language about generic computer elements, “selects”, “produces”, in the limitation citied above encompasses collecting / analyzing / generating data related to classification models, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A – Prong 2: This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of: (a) “cohort selection and retraining module”, “product inference module”, “external feedback/data collection module”, which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)); (b) “… receives data from real-world execution of the classification model”, which is extra-solution activity of pre-solution data gathering (see MPEP.2106.05(g)); The claim is directed to an abstract idea.
Step 2B Analysis: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claim recites the additional elements of: (a) “cohort selection and retraining module”, “product inference module”, “external feedback/data collection module”, which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)); (b) “… receives data from real-world execution of the classification model”, which is extra-solution activity of pre-solution data gathering (see MPEP.2106.05(g)), which is extra-solution activity of pre-solution data gathering (see MPEP.2106.05(g)). The courts have found limitations directed to obtaining information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). Accordingly, the additional elements individually or in combination do not amount to significantly more than the judicial exception. The claim is not patent eligible.
(Dependent claims)
Claims 11-17, 20-27 are dependent on claim 11 and include all the limitations of claim 11. Therefore, claims 11-17, 20-27 recite the same abstract ideas.
With regards to claim 12, The claim recites additional element of “wherein the external feedback/data collection module is operatively linked to the cohort selection and retraining module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein the external feedback/data collection module is operatively linked to the cohort selection and retraining module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 13, The claim recites additional element of “wherein the cohort selection and retraining module further comprises a training module that trains the classification model”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein the cohort selection and retraining module further comprises a training module that trains the classification model”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 14, The claim recites additional element of “wherein the classification model is trained using a federated learning approach”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein the classification model is trained using a federated learning approach”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 15, The claim recites additional element of “wherein the classification model is trained using an active learning approach”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein the classification model is trained using an active learning approach”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 16, the claim recites further limitation of “… productionizes a validated model to prepare for deployment” (mental process and/or math concept), which is further process of analyzing / processing data for classification models, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
The claim recites additional element of “further comprising an evaluation/deployment module … wherein the evaluation/deployment module is operatively linked between the cohort selection and retraining module and the product inference module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “further comprising an evaluation/deployment module … wherein the evaluation/deployment module is operatively linked between the cohort selection and retraining module and the product inference module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 17, The claim recites additional element of “wherein data flows from the evaluation/deployment module to the product inference module and back to the evaluation/deployment module or forward to the external feedback/data collection module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein data flows from the evaluation/deployment module to the product inference module and back to the evaluation/deployment module or forward to the external feedback/data collection module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 20, the claim recites additional limitation of “…1) an input selected from a) de-identified patient data matched with a sample, b) feedback loop batching specifications, c) ingested data quality specifications, and d) a combination thereof; and 2) an output of a validated classification model”, which is extra-solution activity of pre-solution data (MPEP 2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “… 1) an input selected from a) de-identified patient data matched with a sample, b) feedback loop batching specifications, c) ingested data quality specifications, and d) a combination thereof; and 2) an output of a validated classification model”, which is extra-solution activity of pre-solution data input (see MPEP 2016.05(g)). The courts have found limitations directed to obtaining information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). The courts have found similar case not eligible, e.g. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016) (Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception. Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 21, The claim recites additional element of “further comprising a data ingestion module that ingests data, wherein the data ingestion module is operatively linked between the external feedback/data collection module and the cohort selection and retraining module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “further comprising a data ingestion module that ingests data, wherein the data ingestion module is operatively linked between the external feedback/data collection module and the cohort selection and retraining module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 22, the claim recites further limitation of “… processes clinical metadata or labels with quality control metrics, matches the clinical metadata with patient molecular data, or pushes the matched clinical metadata and molecular data to the research platform module” (mental process and/or math concept), which is further process of analyzing / processing data for classification models, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
The claim recites additional element of “further comprising a research ingestion module … wherein the research ingestion module is operatively linked between the external feedback/data collection module and the cohort selection and retraining module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “further comprising a research ingestion module … wherein the research ingestion module is operatively linked between the external feedback/data collection module and the cohort selection and retraining module”, stating high level connectivity, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 23, the claim recites additional limitation of “…1) an input selected from: a) processed sample molecular data, b) disease and clinical condition labels, c) clinical data, and d) a combination thereof; and 2) an output of de-identified patient data matched with a sample”, which is extra-solution activity of pre-solution data (MPEP 2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “…1) an input selected from: a) processed sample molecular data, b) disease and clinical condition labels, c) clinical data, and d) a combination thereof; and 2) an output of de-identified patient data matched with a sample”, which is extra-solution activity of pre-solution data input (see MPEP 2016.05(g)). The courts have found limitations directed to obtaining information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). The courts have found similar case not eligible, e.g. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016) (Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception. Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 24, the claim recites additional limitation of “wherein the input comprises de- identified patient data matched with a sample”, which is extra-solution activity of pre-solution data (MPEP 2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein the input comprises de- identified patient data matched with a sample”, which is extra-solution activity of pre-solution data input (see MPEP 2016.05(g)). The courts have found limitations directed to obtaining information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). The courts have found similar case not eligible, e.g. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016) (Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception. Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 25, the claim recites additional limitation of “wherein the input comprises feedback loop batching specifications”, which is extra-solution activity of pre-solution data (MPEP 2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein the input comprises feedback loop batching specifications”, which is extra-solution activity of pre-solution data input (see MPEP 2016.05(g)). The courts have found limitations directed to obtaining information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). The courts have found similar case not eligible, e.g. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016) (Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception. Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 26, the claim recites additional limitation of “wherein the input comprises ingested data quality specifications”, which is extra-solution activity of pre-solution data (MPEP 2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein the input comprises ingested data quality specifications”, which is extra-solution activity of pre-solution data input (see MPEP 2016.05(g)). The courts have found limitations directed to obtaining information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). The courts have found similar case not eligible, e.g. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016) (Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception. Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 27, the claim recites additional limitation of “1) an input selected from a) a deployed model, b) a validated model, c) blood sample data, and d) a combination thereof; and 2) an output selected from a) processed sample molecular data, b) patient test results, c) patient metadata, d) de-identified labeled patient sample data, e) de-identified sample molecular data, and f) a combination thereof”, which is extra-solution activity of pre-solution data (MPEP 2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “1) an input selected from a) a deployed model, b) a validated model, c) blood sample data, and d) a combination thereof; and 2) an output selected from a) processed sample molecular data, b) patient test results, c) patient metadata, d) de-identified labeled patient sample data, e) de-identified sample molecular data, and f) a combination thereof”, which is extra-solution activity of pre-solution data input (see MPEP 2016.05(g)). The courts have found limitations directed to obtaining information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). The courts have found similar case not eligible, e.g. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016) (Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception. Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
Allowable Subject Matter
Claims 11-17, 20-27 include allowable subject matter since when reading the claims in light of the specification, as per, MPEP §2111.01 or Toro Co. v. White Consolidated Industries Inc., 199F.3d 1295, 1301, 53 USPQ2d 1065, 1069, 1069 (Fed.Cir. 1999), none of the references of record alone or in combination disclose or suggest the combination of limitations specified in claims 11-17, 20-27.
In interpreting the claims, in light of the specification filed on 28 May 2026, the Examiner finds the claimed invention to be patentably distinct from the prior arts of record.
Regarding the amended independent claims, the primary reason for the allowance is the inclusion of the specific process / structure of data feedback loop for ML system comprising cohort selection and re-training of classes training examples, raw data ingestion, and including real-world execution outcome-linked feedback.
None of the cited prior art references, singly or in combination, fully teaches all limitations of independent claim 7.
Regarding the dependent claims, which include all the limitations of the independent claims, are also allowed.
The followings are references close to the invention claimed:
Cohen et al, US_PGPUB NO.20180068083A1 [hereafter Cohen] shows classification system for cancer prediction. However Sculley does not teach the specific claimed process / structure of process / structure of data feedback loop for ML system comprising cohort selection and re-training of classes training examples, raw data ingestion, and including real-world execution outcome-linked feedback.
Prismon et al, US_PGPUB NO.20150205602A1 [hereafter Prismon] shows data feedback from real-world execution. However Prismon does not teach the specific claimed process / structure of process / structure of data feedback loop for ML system comprising cohort selection and re-training of classes training examples, raw data ingestion, and including real-world execution outcome-linked feedback.
Brinbaum et al, US-PATENT NO.10304000B2 [hereafter Brinbaum] shows cohort selection for data analysis. However Brinbaum does not teach the specific claimed process / structure of process / structure of data feedback loop for ML system comprising cohort selection and re-training of classes training examples, raw data ingestion, and including real-world execution outcome-linked feedback.
Baylor et al, “TFX: a tensorFlow-based production-scale machine learning platform”, KDD 2017 [hereafter Baylor] shows dataflow of a ML system. However Baylor does not teach the specific claimed process / structure of process / structure of data feedback loop for ML system comprising cohort selection and re-training of classes training examples, raw data ingestion, and including real-world execution outcome-linked feedback.
Sculley et al, “Hidden technical debt in machine learning systems”, NIPS 2015 [hereafter Sculley] shows feedback loop in ML systems. However Sculley does not teach the specific claimed process / structure of process / structure of data feedback loop for ML system comprising cohort selection and re-training of classes training examples, raw data ingestion, and including real-world execution outcome-linked feedback.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TSU-CHANG LEE whose telephone number is 571-272-3567. The fax number is 571-273-3567.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Omar Fernandez Rivas, can be reached 571-272-2589.
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/TSU-CHANG LEE/
Primary Examiner, Art Unit 2128
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