Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in response to application 18/411112 filled on 01/12/2024.
Claims 1-11 are currently pending and have been examined below.
Detailed Action
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.
Claim 1 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. Claim 1 recites “changing one or more values, in on more data fields of one or more FHIR resources of the first set of data and one or more FHIR resources of the second set of data; wherein the steps of establishing references and changing one or more values, result in a fourth plurality of FHIR resources that are in the target version of FHIR format”. It is unclear where these limitations are taught in the specification. The specification does not recite changing any values at all.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites “changing one or more values, in on more data fields of one or more FHIR resources of the first set of data and one or more FHIR resources of the second set of data; wherein the steps of establishing references and changing one or more values, result in a fourth plurality of FHIR resources that are in the target version of FHIR format”. It is not clear to the Examiner what this limitation means. For purpose of examination. The Examiner interprets this limitation to mean that changing a format to target format when linking accounts.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-5 and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smurro (US 2021/0313077 A1) in view of Barnard et al. (US 2024/0021280 A1).
In claim 1, program executable by at least one processor of a computer device, the program comprising sets of instructions for:
Smurro teaches:
receiving, at the computer device, a first plurality of personal health records for a specific individual from a corresponding first plurality of sources via a network, wherein each of the first plurality of personal health records includes a first plurality of fast healthcare interoperability resources (FHIR) and a first plurality of Consolidated Clinical Document Architecture (C-CDA) resources, wherein the first plurality of FHIR resources are in a corresponding plurality of FHIR format versions (Para. 39 and 88 wherein “appended imagery metadata and semantic metadata and annotations, and saving them together in single file format structures as may be required or allowed by standards for clinical documentation or biomedical records storage, including those as specified in DICOM, C-CDA and FHIR Standards for interoperable health information exchange.”) ;
receiving, at a client device, a second plurality of personal health records for the specific individual from a corresponding second plurality of sources in a plurality of formats other than FHIR format (Para. 82 wherein “As such CIFs can be stored as in archives conforming to health level seven (HL7), integrating the healthcare enterprise (IHE), cross-enterprise document sharing (XDS), cross-enterprise document sharing for imaging (XDS-I), Extensible Markup Language (XML), in Tagged Image file format (TIFF), as well as in RDF triples and RDF/XML for metadata model specification.” See also Para. 102) ;
processing one or more of the first plurality of FHIR resources and the first plurality of C-CDA resources to form a processed second plurality of FHIR resources, so that all of the processed second plurality of FHIR resources are in a target version of FHIR format, wherein the processed second plurality of FHIR resources are a first set of data (Para. 105);
extracting a third plurality of FHIR resources in the target version of FHIR format from the second plurality of personal health records, where the third plurality of FHIR resources are a second set of data (Para. 29 and 153) ;
establishing references in computer memory between one or more FHIR resources of the first set of data and one or more FHIR resources of the second set of data; and
Smurro does not explicitly teach however Barnard teaches:
changing one or more values, in one or more data fields of one or more FHIR resources of the first set of data and one or more FHIR resources of the second set of data (Para. 128 wherein “user can review and confirm or change. In some implementations, the fields are configured to display data that is automatically extracted from the report);
wherein the steps of establishing references and changing one or more values, result in a fourth plurality of FHIR Resources that are in the target version of FHIR format (Para. 197 and 208).
It would have been obvious to one of ordinary skill in the art at the time of filling to combine the augmenting clinical intelligence with federated learning, imaging analytics and outcomes decision support as taught in Smurro with the oncology workflow for clinical decision support for tracking changes of extracted data as taught in Barnard. The well-known elements described are merely a combination of old elements, and in combination, each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 2, Smurro teaches the program of claim 1 further comprises sets of instructions for:
generating, at the client device, a user interface (Para. 92);
displaying the user interface on a computer monitor, wherein the user interface includes a plurality of user controls, and each of the plurality of user controls includes a plurality of data fields, wherein each of the plurality of user controls relates to a specific FHIR type;
on the user interface, enabling selection of a first user control of the plurality of user controls (Para. 218);
on the user interface, enabling selection of a first data field of the plurality of data fields of the first user control (Para. 120 and 218); and
responding to the selection of the first data field of the first user control by displaying a set of information on the computer monitor, wherein the set of information includes a plurality of data elements of a corresponding plurality of FHIR types related to the specific individual (Para. 120).
As per claim 3, Smurro teaches the program of claim 1 wherein the said receiving of the second plurality of personal health records and extracting the third plurality of FHIR resources in the target version of FHIR format, further comprises sets of instructions for:
receiving at the client device, a plurality of Digital Imaging and Communications in Medicine (DICOM) images related to the specific individual (Para 32);
extracting image data in a plurality of key value pairs from each of the plurality of DICOM images (para. 29);
generating an imaging study FHIR resource in the target version of FHIR format for the image data (para. 67); and
displaying the plurality of DICOM images through an image viewer in the said user interface (Para. 67).
As per claim 4, Smurro teaches the program of claim 1, further comprising sets of instructions for:
enabling input of a search text in a user control, on the said user interface (Para. 10 and Fig. 26);
searching for the search text in the fourth plurality of FHIR resources related to the specific individual, wherein the step of searching results in a fifth plurality of FHIR resources, and wherein the fifth plurality of FHIR resources are a search result (Fig. 26);
displaying the search result on the user interface, in a plurality of user controls, wherein each of the plurality of user controls relates to a specific FHIR type (Para. 113); and
Smurro does not explicitly teach however Barnard teaches:
highlighting the search text in the displayed search result on the user interface (Para. 28). The motivation to combine references is the same as seen in claim 1.
As per claim 2, Smurro teaches the program of claim 1, further comprising sets of instructions for:
generating an Application Programming Interface (API) (Para. 69 and 71);
wherein the API enables exporting of a plurality of personal health records from the fourth plurality of FHIR resources in a desired version of FHIR format (Para. 69 and 71); and
wherein the API enables a consumer to access aggregated and updated FHIR resources generated from originally disconnected and incomplete personal health records (para. 69 and 71).
As per claim 8, Smurro teaches the program of claim 1, wherein the first plurality of sources includes at least one of a group consisting of: an electronic Health Record System (EHR), a wearable device, and an IoMT device (Para. 102).
As per claim 9, Smurro teaches the rogram of claim 1, wherein the second plurality of sources includes at least one of a group consisting of: a paper copy from doctor's office, a printed paper received from healthcare organization, a handwritten script, a laboratory report, an imaging report, and a Dicom image (Para. 84).
As per claim 10, Smurro teaches the program of claim 1 wherein each of the first plurality of personal health records is a computer readable file selected from the group consisting of an XML file and a JSON file (Para. 13 and 82).
As per claim 11, Smurro teaches the said program of claim 1 wherein each of the second plurality of personal health records is a computer readable file selected from a group consisting of a JPEG/JPG file, a Dicom file, a PNG file, a BMP file, a TIFF file, a PDF file, a Word (DOCX) file, an Excel (XLS) file, a PowerPoint (PPT) file, and an HTML file (Para. 13).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smurro (US 2021/0313077 A1) in view of Barnard et al. (US 2024/0021280 A1) as applied to claim 1-5 and 8-11 above, and further in view of Ginsburg (US 2020/0294640 A1).
As per claim 6, Smurro in view of Barnard teach the program of claim 1. Smurro and Barnard do not explicitly teach however Ginsburg teaches further comprising sets of instructions for:
displaying in a chart user control, on the said user interface, a plurality of values for a Vital Observation FHIR resource of a specific type, related to the specific individual (Para. 172 and 191);
enabling in the chart user control, selection of each of the plurality of values for the Vital Observation FHIR resource of the specific type (Para. 172 and 191); and
wherein selection of a value of the plurality of values for the Vital Observation FHIR resource of the specific type, results in display of information in a user control on the said user interface, from one or more related FHIR resources for the specific individual (Para. 272).
As per claim 6, Smurro in view of Barnard teach the program of claim 1. Smurro and Barnard do not explicitly teach however Ginsburg program of claim 1, further comprising sets of instructions for:
displaying in a chart user control, on the said user interface, a plurality of values for a Lab Observation FHIR resource of a specific type, related to the specific individual (Para. 172 and 191);
enabling in the chart user control, selection of each of the plurality of values for the Lab Observation FHIR resource of the specific type (Para. 172 and 191); and
wherein selection of a value of the plurality of values for the Lab Observation FHIR resource of the specific type, results in display of information in a user control on the said user interface, from one or more related FHIR resources for the specific individual (Para. 272). The motivation to combine references is the same as seen in claim 6.
It would have been obvious to one of ordinary skill in the art at the time of filling to combine the augmenting clinical intelligence with federated learning, imaging analytics and outcomes decision support as taught in Smurro with the oncology workflow for clinical decision support for tracking changes of extracted data as taught in Barnard further with the data command center visual display system as taught in Ginsburg. The well-known elements described are merely a combination of old elements, and in combination, each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAROUN P KANAAN whose telephone number is (571)270-1497. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/Primary Examiner, Art Unit 3687