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
This office action for the 18/660213 application is in response to the communications filed April 09, 2026.
Claims 1, 4, 10, 23, 29 and 30 were amended April 09, 2026.
Claims 1-13 and 23-30 are currently pending and considered below.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a plurality of feature collection modules, including two or more of: a genome module, a transcriptome module, an epigenome module, a microbiome module, a proteome module, an omics module, an organoids module, an imaging module, a clinical module, a stored alterations module, or a stored classifications module” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-13 and 23-30 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.
As per claim 1,
Step 1: The claim recites subject matter within a statutory category as a process.
Step 2A is a two-prong inquiry, in which Prong 1 determines whether a claim recites a judicial exception. Prong 2 determines if the additional limitations of the claim integrates the recited judicial exception into a practical application. If the additional elements of the claim fail to integrate the judicial exception into a practical application, claim is directed to the recited judicial exception, see MPEP 2106.04(II)(A).
Step 2A Prong 1: The claim contains subject matter that recites an abstract idea, with the steps of a method for identifying actionable care events in clinical data, the method comprising: receiving, as part of a multi-modal collection of clinical documents and records, a plurality of data sources comprising documents and records relating to a subject; generating a feature collection comprising a plurality of structured data fields and a plurality of metadata fields from the collection, each structured data field or each metadata field to be populated from an associated portion of the data sources; processing the data to generate output data related to data fields within the plurality of structured data fields or the plurality of metadata fields; populating the structured data fields and the plurality of metadata fields in the feature collection with the output data; generating a plurality of criteria sets corresponding to a respective plurality of actionable care events; evaluating the feature collection using the plurality of criteria sets; identifying in a first series of tasks whether any of the plurality of criteria sets are not sufficiently satisfied by the feature collection, wherein an underlying error, an indication of missing information, or an indication of incomplete information within the feature collection with respect to a criteria set is indicative of the actionable care event corresponding to the criteria set; determining, in a second series of tasks, that other data sources within the collection do not inferentially satisfy any of the identified criteria sets; and generating, based on the identifying and determining, a notification that at least one actionable care event of the one or more actionable care events applies to the subject. These steps, as drafted, under the broadest reasonable interpretation recite:
certain methods of organizing human activity (e.g., fundamental economic principles or practices including: hedging; insurance; mitigating risk; etc., commercial or legal interactions including: agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations; etc., managing personal behavior or relationships or interactions between people including: social activities; teaching; following rules or instructions; etc.) but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from being directed to certain methods of organizing human activity. The identified abstract idea, law of nature, or natural phenomenon identified above, in the context of this claim, encompasses a certain method of organizing human activity, namely managing personal behavior or relationships or interactions between people. This is because each of the limitations of the abstract idea recite a list of rules or instructions that a human person can follow in the course of their personal behavior. If a claim limitation, under its broadest reasonable interpretation, covers at least the recited methods of organizing human activity above, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. See MPEP 2106.04(a).
Step 2A Prong 2: The claim does not recite additional elements that integrate the judicial exception into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception, see MPEP 2106.05(f), such as:
“in a computer system comprising at least one processor”, “in the first database” and “performed by the at least one processor” which corresponds to merely using a computer as a tool to perform an abstract idea. Paragraph [001222] of the as-filed specification describes that the hardware that implements the steps of the abstract idea amount to nothing more than a generic computer. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“storing data from the data sources in a first database”, “from a knowledge database comprising a plurality of information from one or more sources” and “database” which corresponds to mere data gathering and/or output.
Accordingly, this claim is directed to an abstract idea.
Step 2B: The claim does not recite additional elements that amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts 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, see MPEP 2106.05(d)(II), such as:
“storing data from the data sources in a first database”, “from a knowledge database comprising a plurality of information from one or more sources” and “database” which corresponds to storing and retrieving information in memory.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 2,
Claim 2 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 2 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: receiving, in response to the notification, an order for a diagnostic test or next generation sequencing; completing the order; and generating a report based upon results of the completion of the order.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 3,
Claim 3 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 3 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the collection is received from a plurality of partner entities …, wherein the feature collection … comprises at least one single tenant data vault … and at least one multi-tenant data vault … and test requisition data from multiple of the partner entities, wherein the feature collection … further comprises at least one first … de-identified data from the at least one single tenant data vault and at least one second … de-identified data from the at least one multi-tenant data vault, and wherein data in the at least one first de-identified … and the at least one second de-identified … is accessible to one or more entities” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
“database”, “configured to store first data comprising data derived from clinical files from one of the partner entities”, “configured to store second data comprising data derived from tissue sample”, and “de-identified database configured to store” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to mere data gathering and/or output and storing and retrieving information in memory.
“via a secure file transfer service”, and “via at least one access interface” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“via a secure file transfer service”, and “via at least one access interface” which corresponds to mere data gathering and/or output.
Step 2B: As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts 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, see MPEP 2106.05(d)(II), such as:
“via a secure file transfer service”, and “via at least one access interface” which corresponds to receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 4,
Claim 4 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 4 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the identifying step, the determining step, and the generating a notification step are performed at least in part by one or more operational or analytical applications” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 5,
Claim 5 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 5 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein a portion of the data sources includes unstructured data, the method further comprising: determining that an actionable care event applies to the subject during the processing step.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 6,
Claim 6 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 6 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the populating the feature collection …utilizes output data comprising a tagged medical term or phrase and contextual meaning.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
“database” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to mere data gathering and/or output and storing and retrieving information in memory.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 7,
Claim 7 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 7 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the method further comprises: determining whether the criteria sets are based on one or more of: clinical guidelines; adherence to clinical trial inclusion or exclusion criteria; a presence or absence of a genomic mutation; disease progression; an increase in tumor sizing; genomic sequencing; a missing genomic report that was ordered; symptoms; a presence of a cardiac condition; a detected cancer state; a billing record; or an order modification.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 8,
Claim 8 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 8 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: prior to generating the notification, checking the actionable care event against a list of eligible events.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 9,
Claim 9 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 9 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the feature collection database includes a plurality of feature collection modules, including two or more of: a genome module, a transcriptome module, an epigenome module, a microbiome module, a proteome module, an omics module, an organoids module, an imaging module, a clinical module, a stored alterations module, or a stored classifications module, wherein populating the feature collection database with the output data comprises determining whether the output data belongs in one or more of the feature collection modules,” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
“storing relevant data in a respective feature collection module.” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to mere data gathering and/or output and storing and retrieving information in memory.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 10,
Claim 10 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 10 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the determining step comprises: determining from one of only structured data or only unstructured data that other data sources within the collection does not include data that causes any of the criteria sets to be satisfied.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 11,
Claim 11 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 11 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the determining step further comprises: determining from data sourced from one or more third parties that other data sources within the collection does not include data that causes any of the identified criteria sets to be identified.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 12,
Claim 12 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 12 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein a plurality of actionable care events are identified, and wherein the notification comprises ranking the plurality of actionable care events.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 13,
Claim 13 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 13 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the multi-modal collection of clinical documents and records comprising a plurality of document or record types including two or more of clinical records, diagnoses, progress notes or reports, pathology reports, radiology reports, lab results, follow-up notes, images, imaging data, flow sheets, electronic health records, electronic medical records, organoid documentation, or sequencing results or reports.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 23,
Claim 23 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 23 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the computer system is configured to implement at least one of a machine learning algorithm or a neural network that is trained to, given specific inputs, generate information indicating a likelihood of a specific output.” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 24,
Claim 24 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 24 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the processing step includes transmitting the data to a remote system and receiving the output data from the remote system.” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“wherein the processing step includes transmitting the data to a remote system and receiving the output data from the remote system.” which corresponds to mere data gathering and/or output.
Step 2B: As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts 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, see MPEP 2106.05(d)(II), such as:
“wherein the processing step includes transmitting the data to a remote system and receiving the output data from the remote system.” which corresponds to receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 25,
Claim 25 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 25 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: presenting the notification to a user via a testing system interface; and preventing, based on the identifying and determining, the user from advancing in the testing system interface while the at least one actionable care event continues to apply to the subject.” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“further comprising: presenting the notification to a user via a testing system interface; and preventing, based on the identifying and determining, the user from advancing in the testing system interface while the at least one actionable care event continues to apply to the subject.” which corresponds to mere data gathering and/or output.
Step 2B: As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts 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, see MPEP 2106.05(d)(II), such as:
“further comprising: presenting the notification to a user via a testing system interface; and preventing, based on the identifying and determining, the user from advancing in the testing system interface while the at least one actionable care event continues to apply to the subject.” which corresponds to receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 26,
Claim 26 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 26 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: presenting the notification to a user via a testing system interface; receiving a request to advance in the testing system interface; and permitting the user to advance in the testing system interface despite the notification.” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“further comprising: presenting the notification to a user via a testing system interface; receiving a request to advance in the testing system interface; and permitting the user to advance in the testing system interface despite the notification.” which corresponds to mere data gathering and/or output.
Step 2B: As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts 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, see MPEP 2106.05(d)(II), such as:
“further comprising: presenting the notification to a user via a testing system interface; receiving a request to advance in the testing system interface; and permitting the user to advance in the testing system interface despite the notification.” which corresponds to receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 27,
Claim 27 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 27 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the multi-modal collection of clinical documents and records comprises data collected at multiple time points during a course of the subject's treatment.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 28,
Claim 28 depends from claim 2 and inherits all the limitations of the claim from which it depends. Claim 28 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the step of generating the report is performed in response to a determination that the at least one actionable care event no longer applies to the subject upon completing the order.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 29,
Claim 29 is substantially similar to claim 1. Accordingly, claim 29 is rejected for the same reasons as claim 1. Claim 29 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“A system for”, “a computer including a processing device, the processing device configured to” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 30,
Claim 30 is substantially similar to claim 1. Accordingly, claim 30 is rejected for the same reasons as claim 1. Claim 30 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“A non-transitory computer-readable storage medium having stored thereon program code instructions that, when executed by a processor, cause the processor to:” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 2, 4-13, and 23-30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Piron et al. (US 2017/0245940; herein referred to as Piron).
As per claim 1,
Piron discloses a method for identifying actionable care events in clinical data:
(Paragraph [0327] of Piron. The teaching describes that from a model of an associated device, structures and tumor from the preoperative images, can then be used to provide a computer recommended treatment plan [actionable care event] for a patient)
Piron further discloses receiving, as part of a multi-modal collection of clinical documents and records, a plurality of data sources comprising documents and records relating to a subject and storing data from the data sources in a first database in a computer system comprising at least one processor:
(Paragraph [0155] of Piron. The teaching describes that control and processing system 400 may include, or may be interfaced with, one or more recording devices or software modules that provide real-time recording of one or more aspects of the medical procedure. For example, the system may be configured to capture one or more of audio, video, sensory and multi-modal (e.g. CT, MR, US, etc.) inputs from different sources. All relevant data may be received via one or more recording devices (for example, stored in the equipment tower) and stored in memory by a recording module.)
(Paragraph [0197] of Piron. The teaching describes embodiments may be implemented using processor 402)
Piron further discloses generating a feature collection database comprising a plurality of structured data fields and a plurality of metadata fields from the collection, each structured data field or each metadata field to be populated from an associated portion of the data sources, processing the data in the first database to generate output data related to data fields within the plurality of structured data fields or the plurality of metadata fields, populating the structured data fields and the plurality of metadata fields in the feature collection database with the output data, generating, from a knowledge database comprising a plurality of information from one or more data sources, a plurality of criteria sets corresponding to a respective plurality of actionable care events; and evaluating the feature collection database using the plurality of criteria sets:
(Paragraphs [0293]-[0304] of Piron. The teaching describes that the clinical data set may include imaging contrast dynamics (contrast in-flow, contrast out-flow), diffusion information (e.g. FA or ADC mapping), quantitative T1 and T2, CT contrast flow, PET tracer dynamics. In all of these cases, the resulting data [output] is a set of images, the images can be decomposed into essential criteria using feature extraction algorithms such as SIFT, SURF (Herbert Bay, Andreas Ess, Tinne Tuytelaars, Luc Van Gool, “SURF: Speeded Up Robust Features”, Computer Vision and Image Understanding (CVIU), Vol. 110, No. 3, pp. 346-359, 2008) and Principal Component Analysis. Once the data is reduced to essential criteria, searching can be done in a lower dimensional space that comprises the essential criteria instead of the entire image data points; A non-limiting example of associating scores with patient information is the association of cancer recurrence score with tumor size and tumor grade (reference: “A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients,” Habel et. al., Breast Cancer Research 2006, Vol. 8, No. 3)… The latter information is another metadata that can be used as search criteria to identify other patients in the archival data set. Such identified information can be used to infer possible outcome of the current surgical procedure, such as survival period and quality of life after surgery. This information, in turn, can aid in choosing suitable post-surgical care for the particular patient; The process of matching a new clinical image data with an archival data set is illustrated in FIG. 14A and FIG. 14B. In one non-limiting example (shown in FIG. 14A), the process starts with decomposition of the newly acquired image data (step 680) into essential criteria (step 682) and comparison of the newly estimated essential criteria values against essential criteria values already stored in a database (step 684).) (e.g. calculating a vector distance). Examples of searching algorithms include nearest neighbor classifier (step 686), Bayesian classifier and the general class of clustering algorithms.)
Piron further discloses identifying, in a first series of tasks performed by the at least one processor, whether any of the plurality of criteria sets are not sufficiently satisfied by the feature collection database, wherein an underlying error, an indication of missing information, or an indication of incomplete information within the feature collection database with respect to a criteria set is indicative of the actionable care event corresponding to the criteria set; determining, in a second series of tasks performed by the at least one processor, that other data sources within the collection do not inferentially satisfy any of the identified criteria sets and generating, based on the identifying and determining, a notification that at least one actionable care event of the one or more actionable care events applies to the subject:
(Paragraphs [0304], [0333]-[0335] and Figure 16 of Piron. The teaching describes that In one non-limiting example of using surgical path as a search criteria the path of the tools and the volume of tumor predicted to be surgically resected, can be used to search a database for similar approaches that were taken for similar tumors, tissues and critical tissue structures. For example, the search, in this case will may consist of first matching the planned surgical path to previously stored surgical paths in the archival data set. The surgical paths can be represented as a set of vectors that sequentially represent the entire path with each vector representing one segment of a piecewise surgical path. Congruence between thus described directed vector path and those previously stored in the archival data set can be estimated using such mathematical techniques as Hamming distance or Levenshtein distance (reference: “Error detecting and error correcting code,” Bell System Technical Journal, 1950, 29(2):147-160). This means that when a user is searching for the same procedure as planned, the system is not able to come up with a satisfactory exact match and has to resort to previous procedures based on similarity. These similarity estimates rely on an underlying error in the previously stored data that differs from the planned procedure. A recommended procedure is presented to the user based on the highest similarity available. The search can be further constrained to those cases where estimated volume of the planned surgical procedure matches those in the archival data set. Hence, previous surgical procedures that closely match surgical path and tumor size can be presented to the surgeon to review prior to embarking on the actual surgical procedure. The system also performs a second series of steps to associate tumor size estimates with disease prevalence information. The latter information is another metadata that can be used as search criteria to identify other patients in the archival data set. Such identified information can be used to infer possible outcome of the current surgical procedure, such as survival period and quality of life after surgery. This information, in turn, can aid in choosing suitable post-surgical care for the particular patient. The system may present a set of procedures 746 that had a particular surgical approach in that region, that the user may be informed by viewing the imaging, and actual case (a recorded movement of the surgical tools and imaging used in that region). In a similar manner, where surgical outcomes have been searched to mean patient outcomes, the economic impact of surgical approaches many be considered. The presentation of element 746 in the user interface is considered to be a notification of at least one actionable care event of the plurality of actionable care events applicable to the subject.)
As per claim 2,
Piron discloses the limitations of claim 1.
Piron further discloses further comprising: receiving, in response to the notification, an order for a diagnostic test or next generation sequencing; completing the order; and generating a report based upon results of the completion of the order:
(Paragraphs [0142] and [0146] of Piron. The teaching describes that a local tissue analysis may involve obtaining a biopsy sample during a medical procedure, and performing an analysis on the biopsy sample either intraoperatively or postoperatively. In another example, a local tissue analysis may involve obtaining a diagnostic measurement of a local region (e.g. a subset of a region associated with a medical image, or a subset of an anatomic region within a subject). It will be understood that a local tissue analysis involving a diagnostic measurement may be performed to obtain one or more spot or point measurements (optionally combining a plurality of local spot or point measurements to construct an image) or an image of a local tissue region. Pathology data may include a pathology report. In another non-limiting example, pathology data may include information associated with one or more pathological tissue types identified from the local tissue analysis such as, but not limited to, tumor type, tumor stage, tumor size, and tumor cell information. Here it is understood that a post-operative biopsy from a surgery was performed after a recommended procedure was presented to a user. The results of these biopsies would have been presented in a pathology report to the ordering user.)
As per claim 4,
Piron discloses the limitations of claim 1.
Piron further discloses wherein the identifying step, the determining step, and the generating a notification step are performed at least in part by one or more operational or analytical applications:
(Paragraphs [0333]-[0335] and Figure 16 of Piron. The teaching describes that In one non-limiting example of using surgical path as a search criteria the path of the tools and the volume of tumor predicted to be surgically resected, can be used to search a database for similar approaches that were taken for similar tumors, tissues and critical tissue structures. For example, the search, in this case will may consist of first matching the planned surgical path to previously stored surgical paths in the archival data set. The surgical paths can be represented as a set of vectors that sequentially represent the entire path with each vector representing one segment of a piecewise surgical path. Congruence between thus described directed vector path and those previously stored in the archival data set can be estimated using such mathematical techniques as Hamming distance or Levenshtein distance (reference: “Error detecting and error correcting code,” Bell System Technical Journal, 1950, 29(2):147-160). This means that when a user is searching for the same procedure as planned, the system is not able to come up with a satisfactory exact match and has to resort to previous procedures based on similarity. These similarity estimates rely on an underlying error in the previously stored data that differs from the planned procedure. A recommended procedure is presented to the user based on the highest similarity available. The search can be further constrained to those cases where estimated volume of the planned surgical procedure matches those in the archival data set. Hence, previous surgical procedures that closely match surgical path and tumor size can be presented to the surgeon to review prior to embarking on the actual surgical procedure. The system may present a set of procedures 746 that had a particular surgical approach in that region, that the user may be informed by viewing the imaging, and actual case (a recorded movement of the surgical tools and imaging used in that region). In a similar manner, where surgical outcomes have been searched to mean patient outcomes, the economic impact of surgical approaches many be considered. The presentation of element 746 in the user interface is considered to be a notification of at least one actionable care event of the plurality of actionable care events applicable to the subject)
As per claim 5,
Piron discloses the limitations of claim 1.
Piron further discloses wherein a portion of the data sources includes unstructured data, the method further comprising: determining that an actionable care event applies to the subject during the processing step:
(Paragraphs [0293]-[0304] of Piron. The teaching describes that the clinical data set may include imaging contrast dynamics (contrast in-flow, contrast out-flow) [unstructured data], diffusion information (e.g. FA or ADC mapping), quantitative T1 and T2, CT contrast flow, PET tracer dynamics. In all of these cases, the resulting data [output] is a set of images, the images can be decomposed into essential criteria using feature extraction algorithms such as SIFT, SURF (Herbert Bay, Andreas Ess, Tinne Tuytelaars, Luc Van Gool, “SURF: Speeded Up Robust Features”, Computer Vision and Image Understanding (CVIU), Vol. 110, No. 3, pp. 346-359, 2008) and Principal Component Analysis. Once the data is reduced to essential criteria, searching can be done in a lower dimensional space that comprises the essential criteria instead of the entire image data points. A non-limiting example of associating scores with patient information is the association of cancer recurrence score with tumor size and tumor grade (reference: “A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients,” Habel et. al., Breast Cancer Research 2006, Vol. 8, No. 3). The latter information is another metadata that can be used as search criteria to identify other patients in the archival data set. Such identified information can be used to infer possible outcome of the current surgical procedure [applicable actionable care event], such as survival period and quality of life after surgery. This information, in turn, can aid in choosing suitable post-surgical care for the particular patient. The process of matching a new clinical image data with an archival data set is illustrated in FIG. 14A and FIG. 14B. In one non-limiting example (shown in FIG. 14A), the process starts with decomposition of the newly acquired image data (step 680) into essential criteria (step 682) and comparison of the newly estimated essential criteria values against essential criteria values already stored in a database (step 684).) (e.g. calculating a vector distance). Examples of searching algorithms include nearest neighbor classifier (step 686), Bayesian classifier and the general class of clustering algorithms.)
As per claim 6,
Piron discloses the limitations of claim 1.
Piron further discloses wherein the populating the feature collection database utilizes output data comprising a tagged medical term or phrase and contextual meaning:
(Paragraphs [0299] and [0300] of Piron. The teaching describes information from such pathology analyses may be added to the data set collected during the surgical procedure by associating the results of pathology analysis with the exact location and time point where the analyzed tissue sample was removed. Thus, the pathology analysis results can be considered as metadata associated with the original position and time information captured during the recording of surgical procedure. The metadata may be searched independent of position and time information to identify past surgical procedures (in the archival data) that are similar to a particular surgical procedure. In this case, the search algorithm may be a text-based searching algorithm that is commonly used in searching text strings in large volumes of text data)
As per claim 7,
Piron discloses the limitations of claim 1.
Piron further discloses wherein the method further comprises: determining whether the criteria sets are based on one or more of: clinical guidelines; adherence to clinical trial inclusion or exclusion criteria; a presence or absence of a genomic mutation; disease progression; an increase in tumor sizing; genomic sequencing; a missing genomic report that was ordered; symptoms; a presence of a cardiac condition; a detected cancer state; a billing record; or an order modification:
(Paragraph [0296] of Piron. The teaching describes that additional criteria such as tumor size, tumor location in brain anatomy tumor histology and pathology results may be used in combination with the imaging results to add clinically relevant criteria to the dataset.)
As per claim 8,
Piron discloses the limitations of claim 1.
Piron further discloses further comprising: prior to generating the notification, checking the actionable care event against a list of eligible events:
(Paragraphs [0333]-[0335] and Figure 16 of Piron. The teaching describes that In one non-limiting example of using surgical path as a search criteria the path of the tools and the volume of tumor predicted to be surgically resected, can be used to search a database for similar approaches that were taken for similar tumors, tissues and critical tissue structures. For example, the search, in this case will may consist of first matching the planned surgical path to previously stored surgical paths in the archival data set. The surgical paths can be represented as a set of vectors that sequentially represent the entire path with each vector representing one segment of a piecewise surgical path. Congruence between thus described directed vector path and those previously stored in the archival data set can be estimated using such mathematical techniques as Hamming distance or Levenshtein distance (reference: “Error detecting and error correcting code,” Bell System Technical Journal, 1950, 29(2):147-160). This means that when a user is searching for the same procedure as planned, the system is not able to come up with a satisfactory exact match and has to resort to previous procedures based on similarity. These similarity estimates rely on an underlying error in the previously stored data that differs from the planned procedure. A recommended procedure is presented to the user based on the highest similarity available. The search can be further constrained to those cases where estimated volume of the planned surgical procedure matches those in the archival data set. Hence, previous surgical procedures that closely match surgical path and tumor size can be presented to the surgeon to review prior to embarking on the actual surgical procedure. The system may present a set of procedures 746 that had a particular surgical approach in that region, that the user may be informed by viewing the imaging, and actual case (a recorded movement of the surgical tools and imaging used in that region). In a similar manner, where surgical outcomes have been searched to mean patient outcomes, the economic impact of surgical approaches many be considered. The presentation of element 746 in the user interface is considered to be a notification of at least one actionable care event of the plurality of actionable care events applicable to the subject)
As per claim 9,
Piron discloses the limitations of claim 1.
Piron further discloses wherein the feature collection database includes a plurality of feature collection modules, including two or more of: a genome module, a transcriptome module, an epigenome module, a microbiome module, a proteome module, an omics module, an organoids module, an imaging module, a clinical module, a stored alterations module, or a stored classifications module, wherein populating the feature collection database with the output data comprises determining whether the output data belongs in one or more of the feature collection modules, and storing relevant data in a respective feature collection module:
(Paragraph [0296] of Piron. The teaching describes that additional criteria such as tumor size, tumor location in brain anatomy tumor histology and pathology results may be used in combination with the imaging results to add clinically relevant criteria to the dataset. These types of data constitute data that was collected from an imagine module and clinical module)
As per claim 10,
Piron discloses the limitations of claim 1.
Piron further discloses wherein the determining step comprises: determining from one of only structured data or only unstructured data that other data sources within the collection does not include data that causes any of the criteria sets to be satisfied:
(Paragraphs [0333]-[0335] and Figure 16 of Piron. The teaching describes that In one non-limiting example of using surgical path as a search criteria the path of the tools and the volume of tumor predicted to be surgically resected, can be used to search a database for similar approaches that were taken for similar tumors, tissues and critical tissue structures. For example, the search, in this case will may consist of first matching the planned surgical path to previously stored surgical paths in the archival data set. The surgical paths can be represented as a set of vectors that sequentially represent the entire path with each vector representing one segment of a piecewise surgical path. Congruence between thus described directed vector path and those previously stored in the archival data set can be estimated using such mathematical techniques as Hamming distance or Levenshtein distance (reference: “Error detecting and error correcting code,” Bell System Technical Journal, 1950, 29(2):147-160). This means that when a user is searching for the same procedure as planned, the system is not able to come up with a satisfactory exact match and has to resort to previous procedures based on similarity. These similarity estimates rely on an underlying error in the previously stored data that differs from the planned procedure. A recommended procedure is presented to the user based on the highest similarity available. The search can be further constrained to those cases where estimated volume of the planned surgical procedure matches those in the archival data set. Hence, previous surgical procedures that closely match surgical path and tumor size can be presented to the surgeon to review prior to embarking on the actual surgical procedure. The system may present a set of procedures 746 that had a particular surgical approach in that region, that the user may be informed by viewing the imaging, and actual case (a recorded movement of the surgical tools and imaging used in that region). In a similar manner, where surgical outcomes have been searched to mean patient outcomes, the economic impact of surgical approaches many be considered. The presentation of element 746 in the user interface is considered to be a notification of at least one actionable care event of the plurality of actionable care events applicable to the subject. The use of image data in the similarity match is interpreted as a starting point for other data sources within the data collection, such as structured data or any other type of data that does not cause the criteria sets to be satisfied)
As per claim 11,
Piron discloses the limitations of claim 1.
wherein the determining step further comprises: determining from data sourced from one or more third parties that other data sources within the collection does not include data that causes any of the identified criteria sets to be identified:
(Paragraphs [0296], [0333]-[0335] and Figure 16 of Piron. The teaching describes that In one non-limiting example of using surgical path as a search criteria the path of the tools and the volume of tumor predicted to be surgically resected, can be used to search a database for similar approaches that were taken for similar tumors, tissues and critical tissue structures. For example, the search, in this case will may consist of first matching the planned surgical path to previously stored surgical paths in the archival data set. The surgical paths can be represented as a set of vectors that sequentially represent the entire path with each vector representing one segment of a piecewise surgical path. Congruence between thus described directed vector path and those previously stored in the archival data set can be estimated using such mathematical techniques as Hamming distance or Levenshtein distance (reference: “Error detecting and error correcting code,” Bell System Technical Journal, 1950, 29(2):147-160). This means that when a user is searching for the same procedure as planned, the system is not able to come up with a satisfactory exact match and has to resort to previous procedures based on similarity. These similarity estimates rely on an underlying error in the previously stored data that differs from the planned procedure. A recommended procedure is presented to the user based on the highest similarity available. The search can be further constrained to those cases where estimated volume of the planned surgical procedure matches those in the archival data set. Hence, previous surgical procedures that closely match surgical path and tumor size can be presented to the surgeon to review prior to embarking on the actual surgical procedure. The system may present a set of procedures 746 that had a particular surgical approach in that region, that the user may be informed by viewing the imaging, and actual case (a recorded movement of the surgical tools and imaging used in that region). In a similar manner, where surgical outcomes have been searched to mean patient outcomes, the economic impact of surgical approaches many be considered. The presentation of element 746 in the user interface is considered to be a notification of at least one actionable care event of the plurality of actionable care events applicable to the subject. Additional criteria such as tumor size, tumor location in brain anatomy tumor histology and pathology results may be used in combination with the imaging results to add clinically relevant criteria to the dataset. This establishes pathology information as relevant for determining the proper procedure that is collected from a third party)
As per claim 12,
Piron discloses the limitations of claim 1.
Piron further discloses wherein a plurality of actionable care events are identified, and wherein the notification comprises ranking the plurality of actionable care events;
(Paragraphs [0333]-[0335] and Figure 16 of Piron. The teaching describes that In one non-limiting example of using surgical path as a search criteria the path of the tools and the volume of tumor predicted to be surgically resected, can be used to search a database for similar approaches that were taken for similar tumors, tissues and critical tissue structures. For example, the search, in this case will may consist of first matching the planned surgical path to previously stored surgical paths in the archival data set. The surgical paths can be represented as a set of vectors that sequentially represent the entire path with each vector representing one segment of a piecewise surgical path. Congruence between thus described directed vector path and those previously stored in the archival data set can be estimated using such mathematical techniques as Hamming distance or Levenshtein distance (reference: “Error detecting and error correcting code,” Bell System Technical Journal, 1950, 29(2):147-160). This means that when a user is searching for the same procedure as planned, the system is not able to come up with a satisfactory exact match and has to resort to previous procedures based on similarity. These similarity estimates rely on an underlying error in the previously stored data that differs from the planned procedure. A recommended procedure is presented to the user based on the highest similarity available. The search can be further constrained to those cases where estimated volume of the planned surgical procedure matches those in the archival data set. Hence, previous surgical procedures that closely match surgical path and tumor size can be presented to the surgeon to review prior to embarking on the actual surgical procedure. The system may present a set of procedures 746 that had a particular surgical approach in that region, that the user may be informed by viewing the imaging, and actual case (a recorded movement of the surgical tools and imaging used in that region). In a similar manner, where surgical outcomes have been searched to mean patient outcomes, the economic impact of surgical approaches many be considered. The presentation of element 746 in the user interface is considered to be a notification of at least one actionable care event of the plurality of actionable care events applicable to the subject)
As per claim 13,
Piron discloses the limitations of claim 1.
Piron further discloses wherein the multi-modal collection of clinical documents and records comprising a plurality of document or record types including two or more of clinical records, diagnoses, progress notes or reports, pathology reports, radiology reports, lab results, follow-up notes, images, imaging data, flow sheets, electronic health records, electronic medical records, organoid documentation, or sequencing results or reports:
(Paragraph [0242] of Piron. The teaching describes that the system may utilize patient data already available, by way of current diagnostic imaging scans, lab results, patient information (EMR), to better inform surgery, pathology and outcomes for the case in progress. The information associated with the case in progress would likewise be recorded, tracked, and submitted to same informatics systems (EMR, image databases, lab results,), in a manner that they will contribute additional information for the next case In this way, the system may acts as an adaptive decision making system such that more patients treated, and the more often information is entered into a system for a patient, the more powerful the ability of the system to present more data to the physician for more effective decision making.)
As per claim 23,
Piron discloses the limitations of claim 1.
Piron further discloses wherein the computer system is configured to implement at least one of a machine learning algorithm or a neural network that is trained to, given specific inputs, generate information indicating a likelihood of a specific output:
(Paragraph [0327] of Piron. The teaching describes the model of the associated device, structures and tumor from the preoperative images, can then be used, for example, to provide a computer recommended treatment plan, or an evaluation of a user selected treatment plan. This computer model is construed as a type of machine learning algorithm)
As per claim 24,
Piron discloses the limitations of claim 1.
Piron further discloses wherein the processing step includes transmitting the data to a remote system and receiving the output data from the remote system:
(Paragraph [0189] of Piron. The teaching describes that control and processing unit 400 is interfaced with other external devices, such as tracking system 120, data storage 442, and external user input and output devices 444, which may include, for example, one or more of a display, keyboard, mouse, foot pedal, microphone and speaker. Data storage 442 may be any suitable data storage device, such as a local or remote computing device (e.g. a computer, hard drive, digital media device, or server) having a database stored thereon.)
As per claim 25,
Piron discloses the limitations of claim 1.
further comprising: presenting the notification to a user via a testing system interface; and preventing, based on the identifying and determining, the user from advancing in the testing system interface while the at least one actionable care event continues to apply to the subject:
(Paragraphs [0333]-[0335] and Figure 16 of Piron. The teaching describes that In one non-limiting example of using surgical path as a search criteria the path of the tools and the volume of tumor predicted to be surgically resected, can be used to search a database for similar approaches that were taken for similar tumors, tissues and critical tissue structures. For example, the search, in this case will may consist of first matching the planned surgical path to previously stored surgical paths in the archival data set. The surgical paths can be represented as a set of vectors that sequentially represent the entire path with each vector representing one segment of a piecewise surgical path. Congruence between thus described directed vector path and those previously stored in the archival data set can be estimated using such mathematical techniques as Hamming distance or Levenshtein distance (reference: “Error detecting and error correcting code,” Bell System Technical Journal, 1950, 29(2):147-160). This means that when a user is searching for the same procedure as planned, the system is not able to come up with a satisfactory exact match and has to resort to previous procedures based on similarity. These similarity estimates rely on an underlying error in the previously stored data that differs from the planned procedure. A recommended procedure is presented to the user based on the highest similarity available. The search can be further constrained to those cases where estimated volume of the planned surgical procedure matches those in the archival data set. Hence, previous surgical procedures that closely match surgical path and tumor size can be presented to the surgeon to review prior to embarking on the actual surgical procedure. The system may present a set of procedures 746 that had a particular surgical approach in that region, that the user may be informed by viewing the imaging, and actual case (a recorded movement of the surgical tools and imaging used in that region). In a similar manner, where surgical outcomes have been searched to mean patient outcomes, the economic impact of surgical approaches many be considered. The presentation of element 746 in the user interface is considered to be a notification of at least one actionable care event of the plurality of actionable care events applicable to the subject. Here it is understood that the user may or may not prevent themselves from advancing within the user interface while one or more care events is applicable to a subject. Specifically, once the user is informed by viewing the imaging used and actual case, the user is understood as having the ability to prevent themselves from progressing until the care event applicability has been resolved. Otherwise the user may take the additional step to advance in the interface about patient outcomes and impact of the care events.)
As per claim 26,
Piron discloses the limitations of claim 1.
Piron further comprising: presenting the notification to a user via a testing system interface; receiving a request to advance in the testing system interface; and permitting the user to advance in the testing system interface despite the notification:
(Paragraphs [0333]-[0335] and Figure 16 of Piron. The teaching describes that In one non-limiting example of using surgical path as a search criteria the path of the tools and the volume of tumor predicted to be surgically resected, can be used to search a database for similar approaches that were taken for similar tumors, tissues and critical tissue structures. For example, the search, in this case will may consist of first matching the planned surgical path to previously stored surgical paths in the archival data set. The surgical paths can be represented as a set of vectors that sequentially represent the entire path with each vector representing one segment of a piecewise surgical path. Congruence between thus described directed vector path and those previously stored in the archival data set can be estimated using such mathematical techniques as Hamming distance or Levenshtein distance (reference: “Error detecting and error correcting code,” Bell System Technical Journal, 1950, 29(2):147-160). This means that when a user is searching for the same procedure as planned, the system is not able to come up with a satisfactory exact match and has to resort to previous procedures based on similarity. These similarity estimates rely on an underlying error in the previously stored data that differs from the planned procedure. A recommended procedure is presented to the user based on the highest similarity available. The search can be further constrained to those cases where estimated volume of the planned surgical procedure matches those in the archival data set. Hence, previous surgical procedures that closely match surgical path and tumor size can be presented to the surgeon to review prior to embarking on the actual surgical procedure. The system may present a set of procedures 746 that had a particular surgical approach in that region, that the user may be informed by viewing the imaging, and actual case (a recorded movement of the surgical tools and imaging used in that region). In a similar manner, where surgical outcomes have been searched to mean patient outcomes, the economic impact of surgical approaches many be considered. The presentation of element 746 in the user interface is considered to be a notification of at least one actionable care event of the plurality of actionable care events applicable to the subject. Here it is understood that the user may or may not prevent themselves from advancing within the user interface while one or more care events is applicable to a subject. Specifically, once the user is informed by viewing the imaging used and actual case, the user is understood as having the ability to prevent themselves from progressing until the care event applicability has been resolved. Otherwise the user may take the additional step to advance in the interface about patient outcomes and impact of the care events.)
As per claim 27,
Piron discloses the limitations of claim 1.
Piron further discloses wherein the multi-modal collection of clinical documents and records comprises data collected at multiple time points during a course of the subject's treatment:
(Paragraph [0242] of Piron. The teaching describes that the system may utilize patient data already available, by way of current diagnostic imaging scans, lab results, patient information (EMR), to better inform surgery, pathology and outcomes for the case in progress. The information associated with the case in progress would likewise be recorded, tracked, and submitted to same informatics systems (EMR, image databases, lab results,), in a manner that they will contribute additional information for the next case In this way, the system may acts as an adaptive decision making system such that more patients treated, and the more often information is entered into a system for a patient, the more powerful the ability of the system to present more data to the physician for more effective decision making. These data points are construed as having been taken at multiple time points in the course of the subject’s treatment)
As per claim 28,
Piron discloses the limitations of claim 2.
Piron further discloses wherein the step of generating the report is performed in response to a determination that the at least one actionable care event no longer applies to the subject upon completing the order:
(Paragraphs [0142] and [0146] of Piron. The teaching describes that a local tissue analysis may involve obtaining a biopsy sample during a medical procedure, and performing an analysis on the biopsy sample either intraoperatively or postoperatively. In another example, a local tissue analysis may involve obtaining a diagnostic measurement of a local region (e.g. a subset of a region associated with a medical image, or a subset of an anatomic region within a subject). It will be understood that a local tissue analysis involving a diagnostic measurement may be performed to obtain one or more spot or point measurements (optionally combining a plurality of local spot or point measurements to construct an image) or an image of a local tissue region. Pathology data may include a pathology report. In another non-limiting example, pathology data may include information associated with one or more pathological tissue types identified from the local tissue analysis such as, but not limited to, tumor type, tumor stage, tumor size, and tumor cell information. Here it is understood that a post-operative biopsy from a surgery was performed after a recommended procedure was presented to a user. The results of these biopsies would have been presented in a pathology report to the ordering user. Because the report would have been generated post-surgery and the surgery was the care event that was recommended in the notification, the report was generated when the actionable care event was no longer applicable.)
As per claim 29,
Claim 29 is substantially similar to claim 1. Accordingly, claim 29 is rejected for the same reasons as claim 1.
Piron further discloses that this invention is a system that comprises a computer including a processing device that is configured to implement the steps of the claim:
(Paragraph [0197] of Piron. The teaching describes embodiments may be implemented using processor 402)
As per claim 30,
Claim 30 is substantially similar to claim 1. Accordingly, claim 30 is rejected for the same reasons as claim 1.
Piron further discloses that this invention is a system that comprises a computer including a processing device that is configured to implement the steps of the claim via a non-transitory computer-readable storage medium having stored thereon program code instructions:
(Paragraph [0200] of Piron. The teaching describes a computer readable storage medium can be used to store software and data which when executed by a data processing system causes the system to perform various methods)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Piron in view of Carlson et al. (US 2021/0240853; herein referred to as Carlson).
As per claim 3,
Piron discloses the limitations of claim 1.
Piron further teaches wherein the collection is received from a plurality of partner entities via a secure file transfer service, and wherein the feature collection database comprises at least one single tenant data vault configured to store first data comprising data derived from clinical files from one of the partner entities and at least one multi-tenant data vault configured to store second data comprising data derived from tissue sample and test requisition data from multiple of the partner entities:
(Paragraphs [0188] and [0194] and Figure 5 of Piron. The teaching describes control and processing unit 400 may include one or more processors 402, a memory 404, a system bus 406, one or more input/output interfaces 408, and a communications interface 410, and storage device 412. Storage device 412 may be employed to store information associated with a medical procedure, such as, but not limited to, local tissue analysis data, surgical plan data, pathology data, and recorded time-dependent medical procedure data. This is a single tenant data vault which has the instant subject’s information, the feature collection database. One or more processing engines may be provided for process information associated with prior tissue analyses, and such engines are represented by analysis engine 486. For example, in some embodiments, an analysis engine is provided to evaluate similarity criteria between of one or more local tissue analyses performed on a subject, and prior local tissue analyses stored in data storage device 442, or otherwise accessible, such as through an external network. Examples of such methods are described in the forthcoming description and accompanying flow charts. As described in detail below, similarity criteria may involve the evaluation of one or more metrics associated with one or more local tissue analyses performed on a subject, and one or more prior local tissue analyses, where the prior local tissue analyses may be associated with the medical history of the subject and/or a collection of other subjects. This establishes a multi-tenant data vault configured to store second data comprising data derived from tissue sample and test requisition data from multiple of the partner entities. The partner entities transmit data via the external I/O devices which are considered to be a secure file transfer service.)
Piron does not explicitly teach wherein the feature collection database further comprises at least one first de-identified database configured to store de-identified data from the at least one single tenant data vault and at least one second de-identified database configured to store de-identified data from the at least one multi-tenant data vault, and wherein data in the at least one first de-identified database and the at least one second de-identified database is accessible to one or more entities via at least one access interface.
However, Carlson teaches a feature collection database further comprises at least one first de-identified database configured to store de-identified data from the at least one single tenant data vault and at least one second de-identified database configured to store de-identified data from the at least one multi-tenant data vault, and wherein data in the at least one first de-identified database and the at least one second de-identified database is accessible to one or more entities via at least one access interface:
(Paragraphs [0035]-[0045] and Figure 1 of Carlson. The teaching describes a structured de-id application programming interface (“API”) module 100 may receive, e.g., from one or more client devices 106 operated by medical personnel, researchers, patients, etc., a request that includes or identifies a payload of data to be de-identified. In some implementations, the payload may specify, e.g., within external data sources 111 (e.g., remote hospitals, deployed personal physiological sensors, etc.) or internal data sources 112 (e.g., EMRs, hospital information systems, or “HIS”, etc.), input data or other data sources that provide data to be de-identified, as well as locations for storing the resulting de-identified data. All modality-specific components make use of this central service, ensuring that the outputs are consistently de-identified to meet regulatory requirements and to facilitate creation of a multi-modal linked dataset.)
It would have been obvious to one of ordinary skill in the art before the time of filing to add to the teaching of Piron, the de-identification function of databases in Carlson. Paragraph [0034] of Carlson teaches that patient healthcare data can be extremely useful for a variety of purposes, such as disease research, development of drugs and other treatments, etc. However, this data is typically considered highly sensitive, and therefore may be covered by national, regional, hospital, or business regulations. Each set of regulations may impose or alter requirements for how patient healthcare data is handled. This particularly applies to de-identification, in which protected health information (“PHI”) is identified and either modified (e.g., obfuscated) or removed in order to limit risk to patients and care providers. Various agreements or regulations may identify any number elements, or may allow for the elements to be transformed rather than removed, balancing research requirements and other privacy safeguards with re-identification risk. This suggests that there is an inherent benefit to including medical data outside of a particular facility to ensure better patient outcomes. One of ordinary skill in the art would have looked to Carlson to achieve the advantage of sharing and collecting information outside of its local network. One of ordinary skill in the art would have added to the teaching of Piron, the teaching of Carlson based on this incentive without yielding unexpected results.
Response to Arguments
Applicant's arguments filed April 09, 2026 have been fully considered.
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 112 are persuasive. The Applicant has made amendments to the claims that obviate the previous rejection. Accordingly, these rejections are withdrawn.
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 101 are not persuasive.
The Applicant argues that the pending claims provide an improvement to technology. Specifically, the determination step within a second series of tasks in response to a plurality of criteria sets are not sufficiently satisfied establishes an improvement in processing capability in that avoiding the determination step reduces additional processing load when no errors are found in the identifying step.
The Examiner respectfully disagrees. There are two problems with this argument. The first is, as written, the claims will always perform the “determining” step. The “identifying” and “determining” steps are not functionally linked. The second problem is that the Examiner is not convinced that merely choosing when to process data based on data threshold would change the processing capability of the processor itself. The way the processor would process the second series of tasks appears to be the same with or without the additional processing load [if the identifying step properly linked the error condition as a prerequisite for the determination step]. The only difference between always determining or selectively determining is the amount of data that would need to be processed. The Examiner is not convinced that the processing capability is changing in this interlude. If the capability of a processor is not changing, there is not a basis to conclude that the processor is being improved, as improvement necessitates change.
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 102 are not persuasive.
The Applicant argues that the cited prior art does not teach the claimed two-step analysis, generally or in particular.
The Examiner disagrees for the reasons indicated in the updated rejection above.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHAD A NEWTON whose telephone number is (313)446-6604. The examiner can normally be reached M-F 8:00AM-4:00PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H. CHOI can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAD A NEWTON/Primary Examiner, Art Unit 3681
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