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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP2023/059369, filed on April 20, 2022.
Response to Amendment
In the amendment filed on June 29, 2026, the following has occurred: claim(s) 1-2, 5-8, 10-14 have been amended and claim(s) 16-20 have been added. Now, claim(s) 1-20 are pending.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-10: Step 2A Prong One
Claim 1 recite(s):
receiving, an access request for clinical data about one or more subjects;
obtaining, linkage information for the one or more subjects, wherein the linkage information comprises: (i) information, comprising a location and an identification of one or more of the two or more different access protocols, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects, and (ii) identifiers for the one or more subjects used for lookup in the one or more remote clinical data databases;
obtaining, one or more protocol-specific data modeling templates that each specify, for a respective access protocol of the one or more remote clinical data databases, protocol-specific data fields to be retrieved;
instantiating, using the linkage information specifying the one or more remote clinical data databases associated with the one or more subjects, a protocol-specific network socket for an identified one of the plurality of remote clinical data databases;
retrieving, clinical data contained in the protocol-specific data fields about the one or more subjects from the identified one of the plurality of remote clinical data databases; and
providing the retrieved clinical data about the one or more subjects
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people (including following rules or instructions), which is a subgrouping of Certain Methods of Organizing Human Activity. For example, but for the “via a user interface of the clinical data access system or a client application,”, “wherein the clinical data is stored in one or more of the remote clinical data databases”, “via the instantiated protocol-specific network socket,” language, the “receiving” and “retrieving” functions in the context of this claim encompasses a user following instructions in response to a request for access to clinical data. Similarly, but for the “via a linkage information registry or via a client application,”, “via a data modeling template registry using a template or template group identifier from a user interface or a remote client application, or directly via a remote client application,” language, the “obtaining” function in the context of this claim encompasses a user following instructions to identify and obtain information based on linkage information and a template or template group identifier. Similarly, the “instantiating” function in the context of this claim encompasses a user following instructions to represent a protocol-specific network socket. Finally, the “providing” function in the context of this claim encompasses a user providing the retrieved clinical data. These steps could be accomplished by a person managing medical information to be shown to another person by following rules or instructions, and therefore encompass Certain Methods of Organizing Human Activity.
Claims 2-10 incorporate the abstract idea identified above and recite additional limitations. For example, claim 2 describes the use of generic computer components. Similarly, claim 3 further describes instantiating for a second one of the plurality of remote clinical data databases. Similarly, claims 4-6 describe how a user can interact with generic computer components. Similarly, claim 7 further describes defining a data modeling template. Similarly, claim 8 further describes the instantiated protocol-specific network socket. Similarly, claim 9 further describes the linkage information. Finally, claim 10 further describes the clinical data access system. Such steps encompass Certain Methods of Organizing Human Activity.
Claims 1-10: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining
elements amount to no more than general purpose computer components programmed to perform the abstract idea.
Claims 1-10, directly or indirectly, recite the following generic computer components,
“wherein the clinical data is stored in one or more of the remote clinical data databases” in independent claim 1, “a data handler and an orchestrator” in claim 2, “the user interface or a client application” in claim 4, “the user interface or a defining or modifying tool” in claims 5-6, “a gateway service” in claim 10. As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “via a user interface of the clinical data access system or a client application,”, “via a linkage information registry or via a client application,”, “via a data modeling template registry using a template or template group identifier from a user interface or a remote client application, or directly via a remote client application,”, “via the instantiated protocol-specific network socket,” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Claims 1-10: 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 into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.")
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2106.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Claims 11-20 recite similar functions as claims 1-10, but in system form, and the additional element “processor” that amounts to a generic computer component.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Aunger et al. (U.S. Patent Pre-Grant Publication No. 2018/0211059) in view of Churchwell et al. (U.S. Patent Pre-Grant Publication No. 2013/0191161).
As per independent claim 1, Aunger discloses a method for accessing clinical data using a clinical data access system, wherein the clinical data access system is in communication with a plurality of remote clinical data databases, comprising:
obtaining, via a linkage information registry or via a client application, linkage information for the one or more subjects, wherein the linkage information comprises: (i) information, comprising a location and an identification of one or more of the two or more different access protocols, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects (See [0104], [0181], [0185], [0202]-[0203]: The medical trust system can provide the request to the storage systems, for example via the health communication protocol, optionally the medical trust system may maintain locations (e.g., network locations) of portions of each patient's medical information, which the Examiner is interpreting the health communication protocol and the locations of portions of each patient's medical information to encompass information, comprising a location and an identification of one or more of the two or more different access protocols as the health communication protocol can be utilized, such that a medical professional requesting access to medical information can only access the medical information according to satisfaction of the constraints ([0203]), which the Examiner is interpreting the health communication protocol to encompass an identification of one or more of the two or more different access protocols when combined with the access protocols of Churchwell described below), and (ii) identifiers for the one or more subjects used for lookup in the one or more remote clinical data databases (See [0104]: The medical trust system may store a unique identified associated with each patient, and additionally locations of portions of the patient's medical information, which the Examiner is interpreting a unique identified associated with each patient to encompass identifiers for the one or more subjects used for lookup in the one or more remote clinical data databases);
obtaining, via a data modeling template registry using a template or template group identifier from a user interface or a remote client application, or directly via a remote client application, one or more protocol-specific data modeling templates that each specify, for a respective access protocol of the one or more remote clinical data databases, protocol-specific data fields to be retrieved (See [0052]-[0053]: The medical trust system can provide the medical information back to the user device in an encrypted form according to the health communication protocol, which the Examiner is interpreting the medical trust system to encompass a remote client application, the health communication protocol to encompass a respective access protocol of the one or more remote clinical data databases, interpreting constraints to encompass one or more protocol-specific data modeling templates as the constraints specify the information that can be communicated);
instantiating, using the linkage information specifying the one or more remote clinical data databases associated with the one or more subjects, a protocol-specific network socket for an identified one of the plurality of remote clinical data databases (See [0049]-[0052], [0061]: Communications between the user device and the medical trust system are packaged according to a health communication protocol, the communications can be specific to a particular port, such as port 2047, 2041, or 1357, which is recognizable to the user device 150 and medical trust system 100 as being associated with the health communication protocol, which the Examiner is interpreting the particular port to encompass a protocol-specific network socket as the medical trust system can access one or more databases to obtain the requested medical information ([0049]-[0050]));
retrieving, via the instantiated protocol-specific network socket, clinical data contained in the protocol-specific data fields about the one or more subjects from the identified one of the plurality of remote clinical data databases (See [0049]-[0052]: The medical trust system determines that the medical professional is authorized to access the requested medical information, the medical trust system can access one or more databases or one or more storage subsystems (for example, record database 110), and obtain the medical information, which the Examiner is interpreting the portions of the patient's health record to encompass clinical data contained in the protocol-specific data fields about the one or more subjects from the identified one of the plurality of remote clinical data databases); and
providing the retrieved clinical data about the one or more subjects (See [0049]-[0052]: The requested medical information can then be provided to the user device via a network and presented to the medical professional.)
While Aunger teaches the method as described above, Aunger may not explicitly teach receiving, via a user interface of the clinical data access system or a client application, an access request for clinical data about one or more subjects, wherein the clinical data is stored in one or more of the plurality of remote clinical data databases, the plurality of remote clinical data databases comprising two or more different access protocols.
Churchwell teaches a method for receiving, via a user interface of the clinical data access system or a client application, an access request for clinical data about one or more subjects, wherein the clinical data is stored in one or more of the plurality of remote clinical data databases (See [0064]: The Application server will poll the Edge Server for the requested patient data upon user input, which the Examiner is interpreting patient data to encompass clinical data, interpreting the client interface to encompass a user interface, and interpreting various patient databases to encompass one or more of the plurality of remote clinical data databases), the plurality of remote clinical data databases comprising two or more different access protocols (See [0064]-[0067]: The EMR system maintains an Interface Portal Server which connects to other systems using standard HL7 or CCD protocols, which the Examiner is interpreting HL7 or CCD protocols to encompass the plurality of remote clinical data databases comprising two or more different access protocols as a hospital can use multiple EMR systems, provided the hospital can provide HL7 or CCD communication.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Aunger to include receiving, via a user interface of the clinical data access system or a client application, an access request for clinical data about one or more subjects, wherein the clinical data is stored in one or more of the plurality of remote clinical data databases, the plurality of remote clinical data databases comprising two or more different access protocols as taught by Churchwell. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Aunger with Churchwell with the motivation of vastly improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care (See Background of Churchwell in Paragraph [0016]).
Claim(s) 11 mirrors claim 1 only within (a) different statutory category/categories, and is rejected for the same reason as claim 1.
The additional element of “a processor is configured to:” is encompassed by Aunger in Paragraph [0125]: “a user device of one or more processors”.
As per claim 2, Aunger/Churchwell discloses the method of claim 1 as described above. Aunger may not explicitly teach further comprising, via a data handler and an orchestrator of the clinical data access system using information from the one or more protocol-specific data modeling templates:
applying data pre-processing, such as data conversion and semantics translation, on the retrieved clinical data; and
packaging the retrieved clinical data into a desired output data structure.
Churchwell teaches a method further comprising, via a data handler and an orchestrator of the clinical data access system using information from the one or more protocol-specific data modeling templates (See [0180]: The system converts data extracted from various clinical data sources into actionable, workflow correspondent information through the application of algorithms and other clinical knowledge, which the Examiner is interpreting the application of algorithms to encompass a data handler and an orchestrator of the clinical data access system):
applying data pre-processing, such as data conversion and semantics translation, on the retrieved clinical data (See [0180]: The system converts certain data into more appropriate forms depending on the source and the destination of the data, which the Examiner is interpreting converts certain data into more appropriate forms to encompass data conversion and semantics translation); and
packaging the retrieved clinical data into a desired output data structure (See [0181]: The system is configured to cause the user device to display a comprehensive merged or aggregated electronic medical patient record.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Aunger to include applying data pre-processing, such as data conversion and semantics translation, on the retrieved clinical data; and packaging the retrieved clinical data into a desired output data structure as taught by Churchwell. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Aunger with Churchwell with the motivation of vastly improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care (See Background of Churchwell in Paragraph [0016]).
Claim(s) 16 mirrors claim 2 only within (a) different statutory category/categories, and is rejected for the same reason as claim 2.
As per claim 3, Aunger/Churchwell discloses the method of claim 1 as described above. Aunger further teaches further comprising:
instantiating, using the linkage information for an identified second one of the plurality of remote clinical data databases, a second protocol-specific network socket for the identified second one of the plurality of remote clinical data databases (See [0049]-[0052], [0061]: Communications between the user device and the medical trust system are packaged according to a health communication protocol, the communications can be specific to a particular port, such as port 2047, 2041, or 1357, which is recognizable to the user device 150 and medical trust system 100 as being associated with the health communication protocol, which the Examiner is interpreting the particular port to encompass a second protocol-specific network socket as the medical trust system can access one or more databases to obtain the requested medical information ([0049]-[0050]));
retrieving, via the instantiated second protocol-specific network socket, clinical data contained in the protocol-specific data fields about the one or more subjects from the identified second one of the plurality of remote clinical data databases (See [0049]-[0052]: The medical trust system determines that the medical professional is authorized to access the requested medical information, the medical trust system can access one or more databases or one or more storage subsystems (for example, record database 110), and obtain the medical information, which the Examiner is interpreting the portions of the patient's health record to encompass clinical data contained in the protocol-specific data fields about the one or more subjects from the identified second one of the plurality of remote clinical data databases); and
merging and packaging the clinical data retrieved from the identified one of the plurality of remote clinical data databases and the identified second one of the plurality of remote clinical data databases (See [0049]-[0052], [0092]: The requested medical information can then be provided to the user device via a network and presented to the medical professional, and the medical trust system 100 can, in response to requests, generate combinations of information from the chunks and provide information on the fly in response.)
Claim(s) 12 mirrors claim 3 only within (a) different statutory category/categories, and is rejected for the same reason as claim 3.
As per claim 4, Aunger/Churchwell discloses the method of claim 1 as described above. Aunger further teaches wherein a user browses and selects, via the user interface or a client application, linkage information for access to the one or more of the plurality of remote clinical data databases comprising the clinical data of the one or more subjects (See [0044]-[0045]: The user device may be a thin client, and the example medical information may be generated via a back-end web application, the user device can access medical information utilizing only a web browser, which the Examiner is interpreting the user device to encompass the user interface, and access requests to encompass linkage information for access.)
Claim(s) 13 mirrors claim 4 only within (a) different statutory category/categories, and is rejected for the same reason as claim 4.
As per claim 5, Aunger/Churchwell discloses the method of claim 1 as described above. Aunger further teaches further comprising defining or modifying, via the user interface or a defining or modifying tool, linkage information to add linkage information for a new clinical data database or update linkage information for an existing clinical data database (See [0073]-[0074]: The medical professional can utilize the application executing on the user device to update the medical information, generate and include additional information (for example, additional images, notes, and so on) via the application, which the Examiner is interpreting update the medical information to encompass defining or modifying, via the user interface or a defining or modifying tool, linkage information to add linkage information for a new clinical data database or update linkage information for an existing clinical data database), the linkage information comprising at least: (i) information, comprising a location and access protocol, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects, and (ii) identifiers for the one or more subjects used for lookup in the one or more remote clinical data databases (See [0074]-[0075]: The medical trust system can receive the updates and provide them to one or more outside systems for storage, and the user device of the medical professional can receive updated information and route the updated information via the medical trust system, which the Examiner is interpreting the health information to encompass identifiers for the one or more subjects used for lookup in the one or more remote clinical data databases, and interpreting trusted with a portion of a patient's health record that corresponds to the updated or additional, information can be similarly trusted with the updated or additional information to encompass information, comprising a location and access protocol, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects.)
Claim(s) 17 mirrors claim 5 only within (a) different statutory category/categories, and is rejected for the same reason as claim 5. Claim 17 lacks the recitation of “linkage information comprising at least: (i) information, comprising a location and access protocol, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects, and (ii) identifiers for the one or more subjects used for lookup in the one or more remote clinical data databases” included in claim 5.
As per claim 6, Aunger/Churchwell discloses the method of claim 1 as described above. Aunger further teaches further comprising defining or modifying, via a defining or modifying tool or a user interface, a data modeling template for the clinical data access system (See [0044]-[0045]: The user device may be a thin client, and the example medical information may be generated via a back-end web application, the user device can access medical information utilizing only a web browser, which the Examiner is interpreting the user device can access medical information utilizing only a web browser to encompass the claimed portion.)
Claim(s) 18 mirrors claim 6 only within (a) different statutory category/categories, and is rejected for the same reason as claim 6.
As per claim 7, Aunger/Churchwell discloses the method of claims 1 and 6 as described above. Aunger further teaches wherein defining a data modeling template for the clinical data access system comprises:
identifying one or more protocol-specific data fields to be retrieved or updated (See [0073]-[0075]: The user device of the medical professional can receive updated information and route the updated information via the medical trust system, which the Examiner is interpreting the updated information to encompass one or more protocol-specific data fields to be retrieved or updated.)
While Aunger discloses the method wherein defining a data modeling template for the clinical data access system comprises: identifying one or more protocol-specific data fields to be retrieved or updated, Aunger may not explicitly teach wherein defining a data modeling template for the clinical data access system comprises:
specifying data pre-processing to be applied to retrieved data; and
specifying how retrieved data fields will be organized and packaged in an output data structure and a data formatting language utilized.
Churchwell teaches a method wherein defining a data modeling template for the clinical data access system comprises:
specifying data pre-processing to be applied to retrieved data (See [0180]: The system converts certain data into more appropriate forms depending on the source and the destination of the data, which the Examiner is interpreting converts certain data into more appropriate forms to encompass data pre-processing to be applied to retrieved data); and
specifying how retrieved data fields will be organized and packaged in an output data structure and a data formatting language utilized (See [0181]: The system is configured to cause the user device to display a comprehensive merged or aggregated electronic medical patient record.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Aunger to include defining a data modeling template for the clinical data access system comprises: specifying data pre-processing to be applied to retrieved data; and specifying how retrieved data fields will be organized and packaged in an output data structure and a data formatting language utilized as taught by Churchwell. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Aunger with Churchwell with the motivation of vastly improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care (See Background of Churchwell in Paragraph [0016]).
Claim(s) 19 mirrors claim 7 only within (a) different statutory category/categories, and is rejected for the same reason as claim 7.
As per claim 8, As per claim 8, Aunger/Churchwell discloses the method of claim 1 as described above. Aunger may not explicitly teach wherein the instantiated protocol-specific network socket generates a request to query or update the clinical data in the identified one of the plurality of remote clinical data databases, and wherein the instantiated protocol-specific network socket parses a response received to the query using a messaging format of a designated access protocol.
Churchwell teaches a method wherein the instantiated protocol-specific network socket generates a request to query or update the clinical data in the identified one of the plurality of remote clinical data databases (See [0058]-[0060]: The server may verify authorized access, may determine how the patient data is displayed, captured, and validated, and will be configured to broadcast patient data updates to the appropriate EMR systems and/or HIE systems, which the Examiner is interpreting broadcast patient updates to encompass generates a request to query or update the clinical data in the identified one of the plurality of remote clinical data databases, and the SSL to encompass the instantiated protocol-specific network socket), and wherein the instantiated protocol-specific network socket parses a response received to the query using a messaging format of a designated access protocol (See [0064]: The Edge Server sends the requested information using standard, HIPAA-compliant encrypted HL7 and/or C32 messaging protocols, which the Examiner is interpreting to encompass the query using a messaging format of a designated access protocol.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Aunger to include the instantiated protocol-specific network socket generates a request to query or update the clinical data in the identified one of the plurality of remote clinical data databases, and wherein the instantiated protocol-specific network socket parses a response received to the query using a messaging format of a designated access protocol as taught by Churchwell. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Aunger with Churchwell with the motivation of vastly improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care (See Background of Churchwell in Paragraph [0016]).
Claim(s) 14 mirrors claim 8 only within (a) different statutory category/categories, and is rejected for the same reason as claim 8.
As per claim 9, Aunger/Churchwell discloses the method of claim 1 as described above. Aunger further teaches wherein the linkage information further comprises access and/or authentication credentials or encryption/decryption keys for one or more of the plurality of remote clinical data databases (See [0047]-[0048]: The medical information may be encrypted, and the software agent may decrypt the information according to satisfaction of particular constraints, which the Examiner is interpreting the medical information may be encrypted to encompass the linkage information further comprises access and/or authentication credentials or encryption/decryption keys as authentication the user ([0048]).)
Claim(s) 15 mirrors claim 9 only within (a) different statutory category/categories, and is rejected for the same reason as claim 9.
As per claim 10, Aunger/Churchwell discloses the method of claim 1 as described above. Aunger further teaches wherein the clinical data access system further comprises a gateway service that handles dynamic data update requests by listening to and receiving event-triggered push messages from the remote clinical data databases (See [0093], [0226]: Hospitals and/or medical groups may store portions of the health record that are updated by respective medical professionals, which the Examiner is interpreting the medical trust system to encompass a gateway service that handles dynamic data update requests, and interpreting the updates by medical professionals to encompass an event-triggered push message), using the protocol-specific network sockets and data handlers to process the received clinical data, storing the dynamic data updates locally and sending dynamic data updates to the client application periodically or upon request (See [0040]-[0046], [0209]-[0210]: The system can monitor changes to the patient's health record, such that versions of the health record can be generated, which the Examiner is interpreting the update portions of health records and storing the accessed information to encompass using the protocol-specific network sockets and data handlers to process the received clinical data, storing the dynamic data updates locally and sending dynamic data updates to the client application periodically or upon request.)
Claim(s) 20 mirrors claim 10 only within (a) different statutory category/categories, and is rejected for the same reason as claim 10.
Response to Arguments
In the Remarks filed on June 29, 2026, the Applicant argues that the newly amended and/or added claims overcome the Claim Objection(s), 35 U.S.C. 101 rejection(s), and 35 U.S.C. 103 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the Claim Objection(s). However, the Examiner does not acknowledge that the newly added and/or amended claims overcome the 35 U.S.C. 101 rejection(s) and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) Applicant asserts that the claims as a whole are not directed to a method or system of managing personal behavior or relationships or interactions between people (i.e., following rules or instructions). MPEP § 2106.04(a)(2)(II)(C) provides numerous examples of claims and applications that recite ''following rules or instructions." While the very specific facts of these examples do not align perfectly with the claims at issue (which notably is not a requirement for examples, otherwise they would not be useful as examples), they are extremely informative. The claims at issue do not align with any of the examples provided in MPEP § 2106.04(a)(2)(II)(C), as the claims at issue do not recite ''following rules or instructions." For example, the claimed method ''for use in training a convolutional neural network using a training data set'' is not similar to the provided examples of ''rules for playing games," or ''assigning hair designs to balance head shape," or ''a series of instructions of how to hedge risk." Thus, In re Marco Guldenaar Holding B.V recited simply rules for a human to follow, and thus recited ''following rules or instructions'' pursuant to ''certain methods of organizing human activity." The present claims are not a set of rules, such as rules for a game or any other rules. In contrast to the claims of In re Brown, the present claims recite steps that are not instructions to a human being to follow when accessing clinical data using a clinical data access system. For example, among other things, a human being does not ''follow[] rules or instructions'' in order to ''instantiat[e], using linkage information specifying the one or more remote clinical data databases associated with the one or more subjects, a protocol-specific network socket for an identified one of the plurality of remote clinical data databases." Indeed, a human being does not instantiate a protocol-specific network socket. Further, a human being does not ''follow[] rules or instructions'' in order to ''retriev[e], via the instantiated protocol-specific network socket, clinical data contained in the protocol-specific data fields about the one or more subjects from the identified one of the plurality of remote clinical data databases." Indeed, a human being does not retrieve clinical data via an instantiated protocol-specific network socket. Indeed, the Patent Office's characterization of the claims improperly abstracts away the actual claim limitations, including the requirement that the clinical data access system communicate with a plurality of remote clinical data databases having two or more different access protocols, obtain protocol-specific data modeling templates specifying protocol-specific data fields to be retrieved, instantiate a protocol-specific network socket for an identified remote clinical data database, and retrieve clinical data via the instantiated protocol-specific network socket. These are machine-to-machine networking operations for protocol-specific access to remote data repositories. A human cannot practically instantiate a protocol-specific network socket or retrieve data from a remote clinical database via that instantiated socket using the database's access protocol. Thus, the claims as a whole are not directed to a certain method of organizing human activity or to a mental process. In other words, in order to hedge risk, a human being would initiate a series of transactions between said commodity provider and consumers, identify market participants, and initiate a series of transactions between said commodity provider and said market participants. There is nothing recited in the claims that a human being could not do to hedge risk, when following instructions. In contrast to the claims of Bilski v. Kappas, the present claims recite steps that are not instructions to a human being to follow when accessing clinical data using a clinical data access system. For example, among other things, a human being does not ''follow[] rules or instructions'' in order to ''instantiat[e], using linkage information specifying the one or more remote clinical data databases associated with the one or more subjects, a protocol-specific network socket for an identified one of the plurality of remote clinical data databases." Indeed, a human being does not instantiate a protocol-specific network socket. Further, a human being does not ''follow[] rules or instructions'' in order to ''retriev[e], via the instantiated protocol-specific network socket, clinical data contained in the protocol-specific data fields about the one or more subjects from the identified one of the plurality of remote clinical data databases." Indeed, a human being does not retrieve clinical data via an instantiated protocol-specific network socket. Thus, Applicant has compared the present claims to the only provided examples (i.e., In re Marco Guldenaar Holding B.V, In re Brown, and Bilski v. Kappas identified by the Patent Office), to show how the present claims are unlike these examples of ''following rules or instructions'' by a human being. Accordingly, Applicant respectfully asserts that that the claims are directed to patent-eligible subject matter under the Alice framework. Applicant respectfully requests that the rejection of the pending claims under 35 U.S.C. §101 be withdrawn;
(2) under Step 2A, Prong 2 of the subject matter eligibility analysis under 35 U.S.C. § 101, the Patent Office must ''evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception." If a claim applies, relies on, or uses ''the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception," then the claim is directed to patent eligible subject matter under Step 2A, Prong 2 and the Alice/101 analysis is complete (i.e., it does not proceed to Step 2B). 2019 Eligibility Guidance, pg. 54. Applicant affirms the conclusion above that the claims are not directed to a judicial exception, and respectfully asserts that the claims do indeed incorporate any judicial exception into a practical application. Even assuming, arguendo, that the claims are directed to an abstract idea, the elements of the independent claims integrate the exception into a practical application. The Patent Office asserts that: This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract idea. Applicant respectfully disagrees, as the claims integrate any such abstract idea into a practical application. The present specification explains that the disclosed clinical data interchange framework provides a uniform interface for data access by using protocol-specific data access and processing instructions specified in external templates. Specification, paragraph [0027]. The specification further explains that heterogeneous health record systems store data in different formats and that a template can be defined for each protocol specifying the data to be accessed using the proper resource naming of the protocol, the local data structure, mappings, and additional processing. Specification, paragraph [0028]. Consistent with that technical framework, the claimed system loads templates defined for the protocols of identified remote databases, instantiates a protocol-specific network socket to handle communications with the identified remote database, applies designated protocol specifications to generate requests and parse responses, and uses the messaging format of the designated access protocol. Specification, paragraphs [0068]-[0072]. These limitations impose a particularized architecture for interoperable access to heterogeneous EHR systems, rather than merely implementing a human activity on a generic computer. The claims therefore recite a specific improvement to computer/network functionality: protocol-specific sockets and template-driven field selection that enable uniform clinical data access across remote databases using different access protocols. This technical focus is consistent with eligibility principles recognizing claims directed to improvements in computer functionality and network technology, including Enfish and SRI. Because the claims are not directed to an abstract idea and, in any event, integrate the alleged concept into a practical application, Applicants respectfully request withdrawal of the §101 rejection of claims 1-15;
(3) with regard to independent claims 1 and 11, Aunger in view of Churchwell fails to suggest or render obvious a method or system for accessing clinical data, wherein a clinical data access system is in communication with a plurality of remote clinical data databases, comprising: receiving, via a user interface of the clinical data access system or a client application, an access request for clinical data about one or more subjects, wherein the clinical data is stored in one or more of the plurality of remote clinical data databases, the plurality of remote clinical data databases comprising two or more different access protocols; obtaining, via a linkage information registry or via a client application, linkage information for the one or more subjects, wherein the linkage information comprises: (i) information, comprising a location and an identification of one or more of the two or more different access protocols, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects, and (ii) identifiers for the one or more subjects used for lookup in the one or more remote clinical data databases; obtaining, via a data modeling template registry using a template or template group identifier from a user interface or a remote client application, or directly via a remote client application, one or more protocol-specific data modeling templates that each specify, for a respective access protocol of the one or more remote clinical data databases, protocol-specific data fields to be retrieved; instantiating, using the linkage information specifying the one or more remote clinical data databases associated with the one or more subjects, a protocol-specific network socket for an identified one of the plurality of remote clinical data databases; retrieving, via the instantiated protocol-specific network socket, clinical data contained in the protocol-specific data fields about the one or more subjects from the identified one of the plurality of remote clinical data databases; and providing the retrieved clinical data about the one or more subjects. Thus, the linkage information comprises ''information, comprising a location and an identification of one or more of the two or more different access protocols, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects." However, paragraph [104] (and the remainder of Aunger alone or in combination with Churchwell) fails to disclose or suggest linkage information that comprises an identification of one or more of the two or more different access protocols, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects. While Aunger discloses communication between a ''medical trust system 100'' and ''storage systems'' using a ''health communication protocol," this is a default standard protocol for EVERY storage system, and is not an identification of one or more possible different access protocols for communication. Churchwell does not remedy this deficiency. Thus, Aunger in view of Churchwell fails to disclose or suggest linkage information that comprises an identification of one or more of the two or more different access protocols, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects. The method/system comprises ''one or more protocol-specific data modeling templates that each specify, for a respective access protocol of the one or more remote clinical data databases, protocol-specific data fields to be retrieved." As discussed above, Aunger in view of Churchwell does not disclose an identification of one or more of a plurality of different access protocols, instead having a blanket health communication protocol for every and all communication. Thus, the assertion that the Patent Office is interpreting ''the health communication protocol to encompass a respective access protocol of the one or more remote clinical data databases'' is deficient;
(4) the assertion that the Patent Office is ''interpreting constraints to encompass one or more protocol-specific data modeling templates as the constraints specify the information that can be communicated'' is not supported by the Aunger disclosure. Aunger' s constraints are access-control and decryption conditions associated with encrypted medical information. For example, Aunger explains that constraints may require a particular person to be logged into a user device, a particular user device to be used, or a particular application to be required to view received information. See, e.g., Aunger paragraph [0038]. Aunger further describes identification of an authorized medical professional or authorized device, a valid access time period, and decryption based on the user identity, device identity, or time of access. See, e.g., Aunger paragraphs [0056], [0062], and [0066]. Those disclosures solely concern whether encrypted medical information may be accessed or decrypted; they do not describe a data modeling template registry, do not describe selecting templates using template IDs or template group IDs, and do not describe templates that enumerate protocol-specific data fields to be retrieved for respective access protocols. Aunger's port and transport disclosures likewise do not cure the deficiency. Aunger states that communications may be packaged according to a health communication protocol over UDP, TCP, a particular port, HTTP, or HTTPS. See, e.g., Aunger paragraph [0052]. Aunger also states that encrypted medical information may be inaccessible absent satisfaction of constraints specified via the protocol. See, e.g., Aunger paragraph [0053]. These disclosures at most address transport and enforcement of access restrictions. They do not teach an externally stored or otherwise obtainable registry of reusable protocol-specific data modeling templates, nor any template object that identifies an access protocol and specifies retrievable data resources or fields for that protocol. Churchwell does not remedy this deficiency. The Office Action relies on Churchwell for user-input-based polling and related data handling. Churchwell discloses that an application server polls an edge server for requested patient data upon user input, and that the edge server sends requested information using HL7 and/or C32 messaging protocols. See, e.g., Churchwell, paragraph [0064]. Churchwell also generally describes encrypted communications using SSL or web services. See, e.g., Churchwell, paragraph [0058]. These passages do not disclose a data modeling template registry, a template identifier, a template group identifier, or protocol-specific templates specifying which protocol-specific fields are to be retrieved. Polling for requested patient data using HL7/C32 transport is different from selecting a stored data modeling template that drives protocol-specific field retrieval;
(5) further regarding the obtained linkage information that comprises an identification of one or more of the two or more different access protocols, regarding each of the one or more remote clinical data databases associated with each of the one or more subjects. Thus, the system includes a user interface or a defining or modifying tool that allows a user to define or modify the linkage information, specifically ''to add linkage information for a new clinical data database or update linkage information for an existing clinical data database." However, there is no disclosure or suggestion in Aunger/Churchwell of using a user interface or a defining or modifying tool ''to add linkage information for a new clinical data database or update linkage information for an existing clinical data database." Indeed, the Patent Office's own characterization of the defining/modifying demonstrates this, suggesting that the defining/modifying is ''to update the medical information, generate and include additional information (for example, additional images, notes, and so on)." None of this is, for example, adding ''linkage information for a new clinical data database or update[ing] linkage information for an existing clinical data database.";
(6) regarding claim 6 (''further comprising defining or modifying, via the defining or modifying tool or a user interface, a data modeling template for the clinical data access system''), Aunger/Churchwell fails to disclose or suggest this defining/modifying. Thus, the Patent Office's analysis concerns how a user is defining/modifying (i.e., via a web browser) rather than what the user is defining/modifying. The claim requires that the user define or modify ''a data modeling template for the clinical data access system." There is no teaching or suggestion to use a web browser to modify ''a data modeling template'' as recited in the claims (i.e., ''one or more protocol-specific data modeling templates that each specify, for a respective access protocol of the one or more remote clinical data databases, protocol-specific data fields to be retrieved'');
(7) to satisfy a prima facie case of obviousness under 35 U.S.C. § 103, there must be an articulated reason for combining two or more references. That ''reason for combining'' cannot come from the present application. MPEP § 2142 states that ''impermissible hindsight must be avoided and the legal conclusion must be reached on the basis of the facts gleaned from the prior art'' (emphasis added). ''' Any judgement on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper''' (MPEP § 2145(X)(A), quoting In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971), (emphasis added). Further, a ''reason for combining'' cannot be just a beneficial result that the combination of prior art elements would achieve. For example, in Ex parte Wooten (Appeal 2023-000259, U.S. Pat. App. No. 15/255,198, 20 June 2023), the PTAB determined that providing a beneficial result is not sufficient to set forth a prima facie case of obviousness under 35 U.S.C. § 103. In the present case, the Patent Office assertion that''[o]ne of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Aunger with Churchwell with the motivation of vastly improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care (See Background of Churchwell in Paragraph [0016])'' is simply a statement that ''only describes a result of the combination and not a reason one of ordinary skill in the art would have sought to modify [Aunger] in view of [Churchwell]'s teaching." For example, consider the motivation of ''improv[ing] the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care'' without the benefit of Applicant's disclosure. If one of skill in the art were handed Aunger and told to ''improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care," what - other than the roadmap found in Applicant's disclosure - leads one of skill in the art to modify Aunger to include the ''receiving'' as taught by Churchwell. Even more concerning, how does including the ''receiving'' of Churchwell improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care? There are potentially an unlimited number of ways to modify Aunger to ''improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care," so what leads one of skill in the art to use this exact approach, other than Applicant's roadmap? There must be a motivation not to simply ''improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care," but a motivation to make the very specific modification proposed by the Patent Office, without the benefit of hindsight. In other words, one of skill in the art would NOT have had the benefit of Applicant's disclosure to use as a road map. With that in mind, why would one of skill in the art have made the very specific modification proposed by the Patent Office, rather than any of a million other possible modifications? The proposed motivation, simply to ''improve the ability to easily and quickly access stored patient data in a readily usable format at the point and time of patient care'' does not provide the unprompted motivation to make the very specific proposed modification (again, without the benefit of Applicant's disclosure as a road map). Accordingly, it is respectfully requested that the rejections under 35 U.S.C. § 103 be withdrawn, and respectfully submitted that the claims are in condition for allowance.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the claimed limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people (including following rules or instructions), which is a subgrouping of Certain Methods of Organizing Human Activity. The Examiner maintains that the Applicant’s claims are directed to following rules or instructions as the Applicant’s claimed steps recite a list of instructions that a person could possibly follow given the use of generic computer components and the recited instructions. The Examiner maintains that the Applicant’s newly amended claims are not similar to “vii. a method of training a neural network for facial detection comprising: collecting a set of digital facial images, applying one or more transformations to the digital images, creating a first training set including the modified set of digital facial images; training the neural network in a first stage using the first training set, creating a second training set including digital non-facial images that are incorrectly detected as facial images in the first stage of training; and training the neural network in a second stage using the second training set” (See MPEP 2106.04(a)(1)) as the Applicant’s newly amended claims recite limitations that amount to receiving and communicating data, and determining representations for the protocol-specific network socket for an identified one of the plurality of remote clinical data databases. The Examiner maintains that the claimed limitations, as recited, does not describe the machine-to-machine computer component that is used to “instantiate” a protocol-specific network socket for an identified one of the plurality of remote clinical data databases, only that the “linkage information” is used, the Examiner maintains that “instantiate” (defined as to represent (an abstraction) by a concrete instance) could be accomplished by a person if given the rules or instructions. Further, the Examiner maintains that a person could “retrieve data…” as a person can interact with a database by using a generic computer. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract idea. The Examiner does not acknowledge that the Applicant’s newly amended claims recite a clear improvement to the functioning of a computer or to any other technology or technical field as the Applicant’s claims are similar to “iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48” that the courts have indicated may not be sufficient to show an improvement to technology.
In response to argument (3), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Aunger in view of Churchwell teaches the newly amended and added claims as described above in the 35 U.S.C. 103 rejection(s). The Examiner maintains that Aunger’s disclosure in Paragraphs [0104], [0181], [0185], [0202]-[0203] teach an identification of one or more of the two or more different access protocols when combined with the access protocols of Churchwell in Paragraphs [0064]-[0067]. The 35 U.S.C. 103 rejection(s) stand.
In response to argument (4), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Aunger/Churchwell teaches the “one or more protocol-specific data modeling templates” as Aunger in Paragraphs [0070]-[0071] describes the information that is obtained from an access request, and the storage system may respond with requested medical information and can indicated constraints associated with usage of the requested medical information (Aunger in Paragraph [0053]). The 35 U.S.C. 103 rejection(s) stand.
In response to argument (5), the Examiner does not find the Applicant’s argument(s) persuasive. Aunger describes “user interface elements” on the “user device” in Paragraphs [0128], [0136], and “modifying” by an outside entity in Paragraph [0031] and “modifying or hiding portions of a health record” in Paragraph [0091], which the Examiner maintains that Aunger/Churchwell teaches a defining or modifying tool ''to add linkage information for a new clinical data database or update linkage information for an existing clinical data database" as modification can be made to the health records and the health records can be identified with a unique identifier ([0104]). The 35 U.S.C. 103 rejection(s) stand.
In response to argument (6), the Examiner does not find the Applicant’s argument(s) persuasive. Aunger describes “modifying” by an outside entity in Paragraph [0031] and “modifying or hiding portions of a health record” in Paragraph [0091], which the Examiner maintains that Aunger/Churchwell teaches a defining or modifying tool ''to add linkage information for a new clinical data database or update linkage information for an existing clinical data database" as modification can be made to the health records and the health records can be identified with a unique identifier ([0104]). The 35 U.S.C. 103 rejection(s) stand.
In response to argument (7), the Examiner does not find the Applicant’s argument(s) persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the noted features of Churchwell with teaching of Aunger since the combination of the two references is merely combining prior art elements according to known methods to yield predictable results (KSR rational A). It can be seen that each element claimed is present in either Aunger or Churchwell. Providing access to suitable electronic medical record patient databases (as taught by Churchwell) does not change or affect the system that can maintain health records of patients of Aunger. Maintaining health records of patients would be performed the same way even with the addition of providing access to the suitable electronic medical record patient databases. Since the functionalities of the elements in Aunger and Churchwell do not interfere with each other, the results of the combination would be predictable. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The 35 U.S.C. 103 rejection(s) stand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Englund et al. (U.S. Patent Pre-Grant Publication No. 2013/0110547), describes MedMaster Mobility provides a seamless way to populate the Electronic Health record (EHR). It is designed to fit in the workflow, style and work habits of users.
Myers et al. (U.S. Patent Pre-Grant Publication No. 2013/0030838), describes a system and methods for accessing patient medical records from national and non-national healthcare system records databases.
Shin et al. (“A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study”), describes a system architecture that was designed in accordance with regulations by a multidisciplinary team including radiologists, engineers, clinical trial specialists, and regulatory medicine professionals.
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 Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683
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