DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 11, 12, 16-19 and 24-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 11 and 19 recite amended limitations “monitoring, by the one or more hardware processors, for a triggering activity associated with a healthcare cloud computing platform,” and the applicant’s original disclosure fails to provide support for monitoring for a trigger activity. The applicant’s specification [0038] discloses patient data may be received from monitoring devices, and [0032], [0033], [0046], [0048] and [0065] disclose triggering for record retrieval, however, there is no disclosure of the monitor devices actually monitoring for a triggering activity. Therefore, the claims are rejected for failing to comply with the written description requirement. Applicant is reminded to utilize language consistent with the applicant’s original disclosure to avoid the appearance of new matter being added to the claims.
Claims 1, 11 and 19 recite amended limitation “identifying…a set of the medical data that (i) relates to one or both of the triggering activity and the patient identifier and (ii) corresponds to a first medical concept,” and this identifying medical data related to one or both of the triggering activity is not disclosed by the applicant’s original disclosure. Therefore, the claims are rejected for failing to comply with the written description requirement. Applicant is reminded to utilize language consistent with the applicant’s original disclosure to avoid the appearance of new matter being added to the claims.
Claims 1, 11 and 19 recite amended limitations “transforming the set of the medical data, wherein: the transforming of the set of the medical data corresponds to normalizing, via the one or more hardware processors, the set of the medical data and matching to a first set of medical properties, and the first set of medical properties corresponds to a set of standards-based medical properties associated with the first medical concept,” and the applicant’s original disclosure fails to provide support for transforming the set of the medical data, wherein: the transforming of the set of the medical data corresponds to normalizing, via the one or more hardware processors, the set of the medical data and matching to a first set of medical properties. The applicant’s specification [0044] and [0046] discloses converting/transforming data by normalizing the data (e.g., such as to normalize according to a particular format) not normalizing and matching. The matching of the normalized data to medical properties occurs after the transformation process not during. Therefore, the claims are rejected for failing to comply with the written description requirement. Applicant is reminded to utilize language consistent with the applicant’s original disclosure to avoid the appearance of new matter being added to the claims.
Claims 1, 11 and 19 recite amended limitations “in response to detecting the difference: electronically storing a first set of information, associated with the first set of medical properties for the patient, in the primary medical record; electronically storing a second set of information, associated with the first set of medical properties for the patient and differing from the first set of information, in a provenance module at the healthcare cloud computing platform; refraining from electronically storing the first set of information in the provenance module at the healthcare cloud computing platform; and refraining from electronically storing the second set of information in the primary medical record,” and the applicant’s original disclosure fails to provide support for detecting the difference. The applicant’s specification [0075]-[0079] discloses determining if medical properties are the same or different not detecting. Therefore, the claims are rejected for failing to comply with the written description requirement. Applicant is reminded to utilize language consistent with the applicant’s original disclosure to avoid the appearance of new matter being added to the claims.
Claim 3 recites previously amended limitation “wherein the set of the medical data is normalized to the first set of medical properties using Fast Healthcare Interoperability Resources (FHIR),” and claim 12 recites “the medical record data is normalized, via the one or more hardware processors, to the first set of medical properties using Fast Healthcare Interoperability Resources (FHIR) a standards,” and the applicant’s original disclosure fails to provide support for these limitations. The applicant’s specification fails to disclose normalizing of medical data to medical properties. The applicant’s specification [0046] discloses transforming data by normalizing the data (e.g., such as to normalize according to a particular format) not normalizing to medical properties. Therefore, the claims are rejected for failing to comply with the written description requirement. Applicant is reminded to utilize language consistent with the applicant’s original disclosure to avoid the appearance of new matter being added to the claims.
Claim 28 discloses previously amended limitation “in response to detecting a duplication between the first set of medical properties and the second set of medical properties, storing a link or pointer to the medical data,” and the applicant’s original disclosure fails to provide support for detecting the difference. The applicant’s specification [0075]-[0079] discloses determining if medical properties are the same or different not detecting, and [0057] discloses providing a link or pointer to data, but not in response to detecting a duplication. Therefore, the claims are rejected for failing to comply with the written description requirement. Applicant is reminded to utilize language consistent with the applicant’s original disclosure to avoid the appearance of new matter being added to the claims.
Claims 30, 31 and 32 recite amended limitations “wherein the processing corresponds to normalizing and matching the first and second groups to third and fourth sets of medical properties for the patient in relation to a second medical concept,” and the applicant’s original disclosure fails to provide support for the normalizing groups of medical data to sets of medical properties. The applicant’s specification [0044] and [0046] discloses converting/transforming data by normalizing the data (e.g., such as to normalize according to a particular format) not normalizing medical data to medical properties. Once the data is normalized it is then matched to medical properties which occurs after the transformation/normalization process not during. Therefore, the claims are rejected for failing to comply with the written description requirement. Applicant is reminded to utilize language consistent with the applicant’s original disclosure to avoid the appearance of new matter being added to the claims.
Claim 31 recites amended limitation “ranking medical properties of the third and fourth sets of medical properties for the second medical concept to produce a higher ranked set of medical properties,” and claim 32 recites amended limitation “a subset of medical properties, of the third and fourth sets of medical properties, is selected by a ranking engine and stored in the primary medical record for the patient,” and the applicant’s original disclosure fails to provide support for ranking sets of medical properties and storing a subset of medical properties selected by the ranking engine for storage. The applicant’s specification [0059]-[0060] discloses ranking two different allergies/medical properties not a set, and then storing the higher ranked allergy/medical property not a set. Therefore, the claims are rejected for failing to comply with the written description requirement. Applicant is reminded to utilize language consistent with the applicant’s original disclosure to avoid the appearance of new matter being added to the claims.
Dependent claims 2-9, 12, 16-18 and 24-36 are also rejected for their dependency on their respective claims.
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, 11 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
At step 1, independent claims 1, 11 and 19 recite a method, a system (having one or more hardware processors), and one or more non-transitory media, respectively, and therefore are a process, a machine and a manufacture which are statutory classes of invention.
At step 2A, prong one, the claim(s) recite(s):
identifying a set of the medical data that (i) relates to one or both of the triggering activity and the patient identifier and (ii) corresponds to a first medical concept;
transforming the set of the medical data, wherein: the transforming of the set of the medical data corresponds to normalizing the set of the medical data and matching to a first set of medical properties, and the first set of medical properties corresponds to a set of standards-based medical properties associated with the first medical concept;
accessing a second set of medical properties in relation to the first medical concept from a primary medical record, for a patient corresponding to the patient identifier;
comparing the first set of medical properties for the patient to the second set of medical properties for the patient;
determining whether a difference exists between the first set of medical properties and the second set of medical properties;
in response to detecting the difference: storing a first set of information, associated with the first set of medical properties for the patient, in the primary medical record;
in response to detecting the difference: refraining from electronically storing the first set of information in the provenance module;
in response to detecting the difference: refraining from electronically storing the second set of information in the primary medical record.
These limitations, under their broadest reasonable interpretation, cover a process that could be performed mentally. That is, other than reciting a system, one or more hardware processors, and one or more non-transitory media, to perform the steps, nothing in the claim elements preclude the steps from being performed mentally/in the human mind (including an observation, evaluation, judgment, opinion) or with pen and paper. For example, a user can receive a set of medical data wherein the medical data comprises a patient identifier and mentally identify/observe a set of the medical data that (i) relates to one or both of the triggering activity and the patient identifier and (ii) corresponds to a first medical concept, mentally/with pen and paper transform the set of the medical data that corresponds to normalizing the set of the medical data and matching to a first set of medical properties, the user being able to ascertain/observe that the first set of medical properties corresponds to a set of standards-based medical properties associated with the first medical concept, mentally/with pen and paper access a second set of medical properties in relation to the first medical concept from a primary medical record, for a patient corresponding to the patient identifier, mentally/with pen and paper compare the first set of medical properties for the patient to the second set of medical properties for the patient, mentally/with pen and paper determine whether a difference exists between the first set of medical properties and the second set of medical properties, with pen and paper in response to detecting the difference: store a first set of information, associated with the first set of medical properties for the patient, in the primary medical record, and mentally/with pen and paper in response to detecting the difference: refrain from electronically storing the first set of information in the provenance module and refraining from electronically storing the second set of information in the primary medical record. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite a mental process.
At step 2A, prong two, this judicial exception is not integrated into a practical application because the claims recite the additional elements of a system, one or more hardware processors, and one or more non-transitory media. These elements are recited at a high-level of generality such that they amount to no more than mere instructions to apply the exception using generic computer components (see MPEP 2106.05(f)). These limitations can also be viewed as an attempt to generally link the use of the judicial exception to the technological environment of a computer (see MPEP 2106.05(h)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
At step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a system, one or more hardware processors, and one or more non-transitory media amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The additional claim elements are:
monitoring for a triggering activity associated with a healthcare cloud computing platform;
simultaneously performing, by a record retrieval module in response to detecting the triggering activity, in parallel, and without user intervention: plugging into and loading via a set of application program interfaces (APIs) medical data, from a corresponding set of third- party databases disparate from the healthcare cloud computing platform, into the healthcare cloud computing platform, wherein the medical data comprises a patient identifier;
primary medical record, for a patient corresponding to the patient identifier, that resides on the healthcare cloud computing platform;
electronically storing a first set of information associated with the first set of medical properties for the patient, in the primary medical record; and
electronically storing a second set of information, associated with the first set of medical properties for the patient and differing from the first set of information, in a provenance module at the healthcare cloud computing platform;
provenance module at the healthcare cloud computing platform.
The limitations “simultaneously performing…loading via a set of application program interfaces…medical data from…a third-party database…,” “primary medical record…that resides on the healthcare cloud computing platform,” “electronically storing a first set of information…,” “electronically storing a second set of information….,” and “provenance module at the healthcare cloud computing platform,” are mere data gathering and storage, are insignificant extra-solution (pre-solution) activity and are well-understood, routine, and conventional activities. The limitation “monitoring for a triggering activity associated with a healthcare cloud computing platform,” is a field of use limitation prior to data gathering and storage, is insignificant extra-solution (pre-solution) activity and is well-understood, routine, and conventional activity.
As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity such as i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016); (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added)); and iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93). See MPEP 2106.05(d) and 2106.05(g). Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: iii. Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) . See MPEP 2106.05(a). Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). See MPEP 2106.05(f). Examples of limitations that the courts have described as merely indicating a field of use or technological environment in which to apply a judicial exception include: iv. Specifying that the abstract idea of monitoring audit log data relates to transactions or activities that are executed in a computer environment, because this requirement merely limits the claims to the computer field, i.e., to execution on a generic computer, FairWarning v. Iatric Sys., 839 F.3d 1089, 1094-95, 120 USPQ2d 1293, 1295 (Fed. Cir. 2016); vi. Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). See MPEP 2106.05(h). Thus, the claims are not patent eligible.
Dependent claims 2-9, 12, 16-18 and 24-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
At step 2A, prong one, the claim(s) recite(s):
wherein the set of the medical data is normalized to the first set of medical properties using Fast Healthcare Interoperability Resources (FHIR) standards;
the medical record data is normalized to the first set of medical properties using Fast Healthcare Interoperability Resources (FHIR) a standards;
wherein the set of the medical data is associated with an identifier of a first third-party database of the set of third- party databases, and matching the identifier to a known third party by the healthcare cloud computing platform to determine that the first third-party database is a trusted source;
wherein one or more of the first set of medical properties for the patient are compared to one or more of the second set of medical properties to determine whether the difference exists or whether a duplication exists between the first set of medical properties and the second set of medical properties;
wherein the second set of information stored in the provenance module identifies the first set of medical properties and the first medical concept;
wherein the second set of information differs from the first set of information and identifies a first third-party database of the set of third-party databases;
processing the first and second groups, wherein the processing corresponds to normalizing and matching the first and second groups to third and fourth sets of medical properties for the patient in relation to a second medical concept;
ranking medical properties of the third and fourth sets of medical properties for the second medical concept to produce a higher ranked set of medical properties;
the first and second groups are normalized and matched to third and fourth sets of medical properties for the patient in relation to a second medical concept;
wherein (a) the first set of information differs from the second set of information and (b) the second set of information describes the first set of information;
wherein the second set of information describes the electronic storing of the first set of information in the primary medical record in response to detecting the difference.
These limitations, under their broadest reasonable interpretation, cover a process that could be performed mentally. That is, other than reciting a system, one or more hardware processors, a third party database, a healthcare cloud computing platform, and one or more non-transitory media to perform the steps, nothing in the claim elements preclude the steps from being performed mentally/with pen and paper. For example, a user can mentally/with pen and paper normalize the set of the medical data/medical data record to the first set of medical properties using Fast Healthcare Interoperability Resources (FHIR), mentally/with pen and paper associate the set of medical data with an identifier of the third-party database and match the identifier to a known third party by the healthcare cloud computing platform to determine that the first third-party database is a trusted source, mentally/with pen and paper compare one or more of the first set of medical properties for the patient to one or more of the second set of medical properties to determine whether the difference exists or whether a duplication exists between the first set of medical properties and the second set of medical properties, mentally/with pen and paper observe that the second set of information stored in the provenance module identifies the first set of medical properties and the first medical concept, mentally/with pen and paper observe that the second set of information differs from the first set of information and identifies a first third-party database of the set of third-party databases, mentally/with pen and paper process the first and second groups by normalizing and matching the first and second groups to third and fourth sets of medical properties for the patient in relation to a second medical concept; mentally/with pen and paper rank medical properties of the third and fourth sets of medical properties for the second medical concept to produce a higher ranked set of medical properties, mentally/with pen and paper normalize and match the first and second groups to third and fourth sets of medical properties for the patient in relation to a second medical concept; mentally/with pen and paper observe the first set of information differs from the second set of information and the second set of information describes the first set of information; and mentally/with pen and paper observe that the second set of information describes the electronic storing of the first set of information in the primary medical record in response to detecting the difference. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite a mental process.
At step 2A, prong two, this judicial exception is not integrated into a practical application because the claims recite the additional elements of a system, one or more hardware processors, a third party database, a healthcare cloud computing platform, and one or more non-transitory media. These elements are recited at a high-level of generality such that they amount to no more than mere instructions to apply the exception using generic computer components (see MPEP 2106.05(f)). These limitations can also be viewed as an attempt to generally link the use of the judicial exception to the technological environment of a computer (see MPEP 2106.05(h)). Accordingly, these additional element do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
At step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a system, one or more hardware processors, a third party database, a healthcare cloud computing platform, and one or more non-transitory media amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The additional claim elements are:
wherein parallel reads and transformations of data from the set of third-party databases are performed by normalizing the data from the set of third-party databases;
wherein the set of third-party databases includes one or more of a health information exchange, immunization registry, governmental healthcare registry, pharmaceutical registry, or third-party electronic medical record provider;
wherein the first medical concept includes one or more of a healthcare organization, practitioner, encounters, problems, encounter diagnosis, allergies, medications, immunizations, lab results, clinical notes, pathology documents, cardiology documents, radiology documents, or microbiology documents;
wherein one or both of the first set of medical properties and the second set of medical properties includes at least one of: name identifiers, medical coding, text data, date of onset, date of documentation, condition type, or diagnosis coding;
providing access to the medical data from the set of third-party databases to a user accessing the primary medical record for the patient maintained by the healthcare cloud computing platform;
wherein the primary medical record for the patient is a longitudinal patient record having (a) data from a plurality of the third-party databases and (b) medical record data in the healthcare cloud computing platform;
performing parallel reads and transformations of medical record data from the set of third-party databases and normalizing the medical record data from the set of third-party databases;
wherein the provenance module is configured to electronically store historical information associated with medical data loaded from databases into the healthcare cloud computing platform;
in response to detecting a duplication between the first set of medical properties and the second set of medical properties, storing a link or pointer to the medical data;
wherein plugging into and loading the medical data comprises: plugging into and loading via a first API a first group of medical data from a first third-party database of the set of third-party databases into the healthcare cloud computing platform; and plugging into and loading via a second API a second group of medical data from a second third- party database of the set of third-party databases into the healthcare cloud computing platform;
wherein plugging into and loading the medical data comprises: plugging into and loading, via first and second APIs, first and second groups of medical data from first and second third-party databases of the set of third-party databases into the healthcare cloud computing platform, respectively;
wherein the plugging into and loading the medical data is performed via first and second APIs and produces first and second groups of medical data from first and second third-party databases of the set of third-party databases, respectively;
a subset of medical properties, of the third and fourth sets of medical properties, is selected by a ranking engine and stored in the primary medical record for the patient;
after the electronically storing of the first set of information and the second set of information, accessing the second set of information from the provenance module to locate and retrieve a subset of the medical data that was (i) collected via the plugging into and loading but that was (ii) not electronically stored as part of the first set of information into the primary medical record; and electronically storing content of the subset to the primary medical record;
(a) based on the second set of information stored in the provenance module, locating and retrieving via an API of the set of APIs a subset of the medical data, wherein the subset differs from the first set of information; and (b) electronically storing content of the subset to the primary medical record.
The limitations “wherein parallel reads and transformations…,” and “performing parallel reads and transformations…” are mere data gathering and mere instructions to apply an exception. The limitations “wherein the third-party database includes…,” “wherein the first medical concept includes…,” “wherein one or both of the first set of medical properties include…,” and “wherein the primary medical record…,” are field of use limitations. The limitation “providing access to the medical data…” is mere instructions to apply an exception. The limitations “wherein plugging into and loading …,” “a subset of medical properties, of the third and fourth sets of medical properties, is selected by a ranking engine and stored…,” “after the electronically storing…,” “wherein the provenance module is configured…,” and “in response to detecting a duplication…storing a link or pointer…,” and “based on the second set of information stored…,” are mere data gathering and storage, are insignificant extra-solution activity and are well-understood, routine, and conventional activities.
As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity such as i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016); (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added)); and iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93). See MPEP 2106.05(d) and 2106.05(g). Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: iii. Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) . See MPEP 2106.05(a). Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015), and examples where the courts have found the additional elements to be mere instructions to apply an exception, because they recite no more than an idea of a solution or outcome include: i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017). See MPEP 2106.05(f). Examples of limitations that the courts have described as merely indicating a field of use or technological environment in which to apply a judicial exception include: iv. Specifying that the abstract idea of monitoring audit log data relates to transactions or activities that are executed in a computer environment, because this requirement merely limits the claims to the computer field, i.e., to execution on a generic computer, FairWarning v. Iatric Sys., 839 F.3d 1089, 1094-95, 120 USPQ2d 1293, 1295 (Fed. Cir. 2016); vi. Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). See MPEP 2106.05(h). Thus, the claims are not patent eligible.
Support for Amendments and Newly Added Claims
Applicants are respectfully requested, in the event of an amendment to claims or submission of new claims, that such claims and their limitations be directly mapped to the specification, which provides support for the subject matter. This will assist in expediting compact prosecution and reducing potential 35 USC § 112(a) or 35 USC § 112, 1st paragraph issues that can arise when claims are amended. MPEP 714.02 recites: “Applicant should also specifically point out the support for any amendments made to the disclosure. See MPEP § 2163.06. An amendment which does not comply with the provisions of 37 CFR 1.121(b), (c), (d), and (h) may be held not fully responsive. See MPEP § 714.” Amendments not pointing to specific support in the disclosure may be deemed as not complying with provisions of 37 C.F.R. 1.121(b), (c), (d), and (h) and therefore held not fully responsive. Generic statements such as “Applicants believe no new matter has been introduced” may be deemed insufficient. The examiner thanks the Applicant in advance for providing support for any amendments or newly added claims.
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered and are not persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The preceding rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
On page 16-22, the applicant argues that:
Regarding the 101 rejection,
A mental process performed in the human mind with the aid of a pen and paper, as set forth in the MPEP regarding subject-matter eligibility considerations, is NOT the same as and does not equate to a process purportedly performed in the mind with the aid of hardware microprocessors…Claim 1, under its broadest reasonable interpretation, does not cover performance in the mind with pen and paper…Contrary to the assertions by the Examiner, these operations require action by a processor and cannot be practically performed inside the mind. Since the limitations of claim 1 require actions by a hardware processor and cannot be practically applied in the mind, claim 1 does NOT recite an abstract idea grouping of mental processes. See MPEP Section 2106.04(a)(2)(ll) ("[c]laims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind, for instance when the human mind is not equipped to perform the claim limitations); see also SRI Int'l (declining to identify the claimed collection and analysis of network data as abstract because 'the human mind is not equipped to detect suspicious activity by using network monitors and analyzing network packets' ... ) and CyberSource ... (distinguishing Research Corp ... as directed to inventions that 'could not, as a practical matter, be performed entirely in a human's mind')." Further, citing to Synopsys v. Mentor Graphics, the MPEP has acknowledged that a claim "involving a several-step manipulation of data" is one example of a claim that "cannot be practically performed in the human mind" and therefore does not recite a mental process. See MPEP Section 2106.04(a)(2)(ll)(A). Similarly, claim 1 involves a several-step complex and sequential manipulation of data, e.g., to create new unique data based on the "transforming ... storing ... refraining," that could not except arguably in a most simplistic scenario be performed in the human mind, even with the aid of pencil and paper. Consequently, by virtue of at least these reasons, claim 1 does nor recite an abstract idea grouping of mental processes, and is statutory.
Improvement in a Technical Field…Independent claim 1 (a) does not fall in any excluded category, (b) recites additional elements that in combination with the other claim elements integrate any alleged judicial exception into a practical application… claim 1 improves a technical field selected from the group comprising: big data healthcare, bio-inspired computing, clinical data analytics, clinical decision support systems, cloud computing, computational algorithms, computer data storage, computer engineering, digital healthcare, electronic medical record (EMR) systems, fast healthcare interoperability resources (FHIR) systems, health informatics, healthcare software, health technology, information engineering, information systems, information technology, and software engineering. To be clear, the improvements referenced herein SHOULD NOT be characterized by the Office as pertaining to computer functionality only - they are, additionally or alternatively, to a technical field as explained above. Claim 1 is directed to an IMPROVEMENT IN A TECHNOLOGY FIELD by virtue of reciting a veritable cornucopia of technological improvements. See paragraphs reference in Section I above and instances in application including the terms: "accurate," "comparison," "effici," "improve," "increasing," "less," "more," "new," "parallel," "reduc," "simultaneous," and "single." It is respectfully submitted that the Office's rejection impermissibly disregards the factual assertions of Applicant's application which elucidate such technical-field improvements…Applicant and including claims directed to prong-two § 101 improvements, e.g., regarding the above mentioned mapping implementations.
Practical Application: Building a Data Structure… The additional claim elements recited in each of the claims integrate any purported excluded category into a practical application…Considering at least these elements, the claim as a whole is not directed to a judicial exception by virtue of integrating any excluded category into a practical application. As another example, in reference to the § 101 rejections, claim 1 further contains the elements "electronically storing a first set ... in the primary medical record; electronically storing a second set ... in a provenance module ...; refraining from electronically storing the first set ... in the provenance module ...; and refraining from electronically storing the second set ... in the primary medical record," which recite significantly more than the excluded category and which when viewed as a whole in combination with the other claim elements clearly do not tie up any excluded category such that others cannot practice it. To be clear, the additional elements referenced herein are present NOT ONLY in the independent claims - they are, additionally or alternatively, in the dependent claims as explained above.
Additional and Other Elements Provide Significantly More…The additional elements with other elements in claim 1 recite significantly more than the excluded category, such as evidenced by the claim 1 additional elements outlined above. Further, the fact that claim 1 is allowable over the cited references of record, based not (merely) on the excluded category but (at least in part) on these very additional elements and as established herein, speaks powerfully as evidence that the claim recites significantly more than the excluded category. Consequently, by virtue of at least the foregoing reasons, claim 1 is directed to statutory subject matter.
Establishing Well-Understood, Routine, and Conventional… Applicant requests that the Office provide updated citations evidencing that all additional elements recited in each of the current claims are well-known, routine, and conventional as required by MPEP Section 2106.05(d) and the Berkheimer Memo.
Regarding the 112 rejections, that “Claims 1-28 are rejected under 35 U.S.C. § 112(a) based on support issues. See Office Action, pages 2-6. Claims 10, 13-15, and 20-23 have been canceled as set forth above. Applicant respectfully traverses the remaining rejections. Further, the set of claims is amended.”
The examiner respectfully disagrees because:
Regarding the 101 issue,
The claims disclose a system and one or more hardware processors which are generic computing components. These elements are recited at a high-level of generality such that they amount to no more than mere instructions to apply the exception using generic computer components (see MPEP 2106.05(f)). These limitations can also be viewed as an attempt to generally link the use of the judicial exception to the technological environment of a computer (see MPEP 2106.05(h)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016)… claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. Examples of claims that recite mental processes include: claims to "comparing BRCA sequences and determining the existence of alterations," where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014); a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011)…Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675…The patentee in FairWarning claimed a system and method of detecting fraud and/or misuse in a computer environment, in which information regarding accesses of a patient’s personal health information was analyzed according to one of several rules (i.e., related to accesses in excess of a specific volume, accesses during a pre-determined time interval, or accesses by a specific user) to determine if the activity indicates improper access. 839 F.3d. at 1092, 120 USPQ2d at 1294. The court determined that these claims were directed to a mental process of detecting misuse, and that the claimed rules here were "the same questions (though perhaps phrased with different words) that humans in analogous situations detecting fraud have asked for decades, if not centuries." 839 F.3d. at 1094-95, 120 USPQ2d at 1296. See MPEP Section 2106.04(a)(2)(III). Additionally, the applicant argues that claim 1 involves a several-step complex manipulation of data to create new, unique data, that could not except arguably in a most simplistic scenario be performed in the human mind, even with the aid of pencil and paper. However, the claims fail to show the creation of new and unique data only loading data, normalizing the data, comparing the data for duplication, and then storing the data. Accordingly, the claims recite a mental process.
The applicant argues that claim 1 involves a several-step complex manipulation of data to create new, unique data, that could not except arguably in a most simplistic scenario be performed in the human mind, even with the aid of pencil and paper. However, the claims fail to show the creation of new and unique data only loading data, normalizing the data, comparing the data for duplication, and then storing the data not complex manipulation of data. The applicant argues that the claims are an improvement based upon mapping implementations. However, the claims normalize data via known techniques (FHIR standards), and then matches the normalized data to retrieved and/or stored data. Thus, the claims fail to recite any mapping improvements only well-understood and conventional techniques. Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: iii. Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) . See MPEP 2106.05(a). Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). See MPEP 2106.05(f). Thus, the claims are not patent eligible.
Storage of data or refraining from the storage of data in a provenance module or another storage device is not an improvement in a technical field nor does it integrate the abstract idea into a practical application. Storage of data is mere data gathering and storage, is insignificant extra-solution activity and is well-understood, routine, and conventional activity. As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity such as i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016); (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added)); and iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93). See MPEP 2106.05(d) and 2106.05(g). Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: iii. Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) . See MPEP 2106.05(a). Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Thus, the claims are not patent eligible.
The fact that claim 1 is allowable over the cited references of record does equate to significantly more than the excluded category. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because with respect to integration of the abstract idea into a practical application, the additional elements of a system, one or more hardware processors, and one or more non-transitory media amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Thus, the claims are not patent eligible.
The examiner has consistently provided the following examples of well-understood, routine, and conventional citations: As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity such as i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016); (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added)); and iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93). See MPEP 2106.05(d) and 2106.05(g). Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: iii. Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) . See MPEP 2106.05(a). Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). See MPEP 2106.05(f). The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. Adding a final step of storing data (post-solution activity) to a process that recites identifying, transforming, comparing and determining (mental processes) does not add a meaningful limitation to the process of identifying the data, transforming the data, comparing the data, and determining whether the data is a duplicate of currently stored data and whether or not the data and/or additional information will be stored based on it being a duplicate or not. In the claims, the provenance module is only used for storage of data, not for any type of transformation, etc. The claims fail to provide any additional significance of the use of the provenance module other than as a storage unit. See MPEP 2106.05 (g). Therefore, the claims are not patent eligible.
Regarding the 112 issues, the amended claims raise new 112(a) issues. As such, the preceding 112(a) rejections are either reiterated or newly applied based upon the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DIEDRA M MCQUITERY whose telephone number is (571)272-9607. The examiner can normally be reached Monday - Thursday, 8 am - 6 pm (C.S.T.).
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/Diedra McQuitery/Primary Examiner, Art Unit 2166
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