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 .
Status of Claims
This action is in reply to the amendment filed on 12/8/25.
Claims 1, 3, 5 have been amended and are hereby entered.
Claims 1-8 are currently pending and have been examined.
This action is made final.
Priority
Applicant’s claim to the benefit of and priority to US Provisional Application 63/510,263 is acknowledged. Accordingly, a priority date of 06/26/23 has been given to this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are document intake device configured to receive… and transformation engine configured to convert in claim 1; transformation engine configured to receive a compressed file…, located predetermined data fields…, and transmit the C-CDA document in Claim 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For purposes of examination, Examiner is interpreting the document intake device to be a computing device in view of paras. [0037]-[0040] and Fig. 3, and is interpreting the transformation engine to be hardware/software per para. [0051].
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 1-8 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1-8 are drawn to a system, which is within the four statutory categories. Claims 1-8 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recites implementing the steps of:
extracting patient demographic and medical information contained within an image file as a text file with said patient demographic and medical information, and formatting the text file for use as a health record;
converting the text file formatted for use as a health record into a standards compliant health record
These steps amount to managing personal behavior or relationships or interactions between people and therefore recite certain methods of organizing human activity. Preparing documents in a standards compliant record format by extracting patient demographic and medical information and formatting it for use by converting it to a standards-compliant format are personal behaviors that may be performed by a healthcare provider.
The above claims are therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
an artificial intelligence/machine learning (AI/ML) model as implementing the step of extracting patient demographic and medical information contained within an image file as a text file with said patient demographic and medical information and formatting the text file for use as a health record;
transformation engine as implementing the step of converting a text file formatted for use as a health record into a standards compliant record
EHR as a means of implementing health records electronically
The broad recitation of general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools. Regarding the AI/ML model and transformation engine, the specification does not appear to disclose any particulars or structure of these elements. Per Para. [0051], these elements are understood to be general purpose computing elements/hardware that implement the steps of the abstract ideal; these elements are therefore given their broadest reasonable interpretation as general purpose computing elements used to apply the abstract idea. Regarding recitation of “EHR”, this only amounts to implementing a health record electronically, e.g., on a computer, and therefore amounts to applying the abstract idea.
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
The above claims, as a whole, are therefore directed to an abstract idea.
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Claim 1 additionally recites:
a document intake device configured to receive an image file containing patient data transmitted to the document intake device using an image file transport protocol
transmitting the standards compliant EHR as a Direct Secure Message to a Health Information Service Provider (HISP);
HISP configured to send said standards compliant EHR as a Direct Secure Message for storage as a patient record only if a patient match is found.
Regarding “a document intake device configured to receive an image file transmitted to the device using an image file transport protocol”, this amounts to insignificant extra-solution activity in the form of mere data gathering, e.g., it only amounts to obtaining the data on which to perform the abstract idea, and accordingly constitutes insignificant extra-solution activity, specifically, pre-solution activity.
Regarding “transmitting the standards compliant EHR as a Direct Secure Message to a Health Information Service Provider (HISP)” and “HISP configured to send said standards compliant EHR as a Direct Secure Message for storage as a patient record if a patient match is found”, these steps only amounts to insignificant application of the abstract idea, as it only amounts to outputting the results after performance of the abstract idea.
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
The above claims as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claim 1 only recites the aforementioned additional elements as tools for performing the steps of the abstract idea on a computer, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Likewise, as explained above, the element of “a document intake device configured to receive an image file transmitted to the device using an image file transport protocol” only amounts to insignificant extra-solution activity in the form of mere data gathering, and “transmitting the standards compliant EHR as a Direct Secure Message to a Health Information Service Provider (HISP)” and “HISP configured to send said standards compliant EHR as a Direct Secure Message for storage as a patient record if a patient match is found” only amount to insignificant application of the abstract idea.
C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d)
In addition to amounting to insignificant extra-solution activity the elements in Section B above constitute well-understood, routine and conventional activity. The elements identified in Section B. above only amount to receiving or transmitting data over a network and/or storing/retrieving data in memory, which have been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Depending Claims
Dependent claims 2-7 add further limitations which are also directed to an abstract idea and/or are insignificant extra-solution activity as detailed below. Dependent claim 8 further limits the scope of the abstract idea as set out above.
Claim 2 recites limitations pertaining to receive a fax or scanned image with embedded text information, which amounts to extra-solution activity in the form of mere data gathering; this further represents well understood routine and conventional activity, e.g., transmitting/receiving data over a network. MPEP 2106.05(d). Claim 2 further recites limitations pertaining to extract said text information and apply data correction techniques including spell and grammar check adapted for use with medical records to obtain a clean document including fields with patient demographic information and provider information; and create a document which includes said fields in a standardized format for storing and transporting data which are also certain methods of organizing human activity including managing personal behaviors, as a person could extract text, perform a grammar/spell check to create a clean document, and create a document with fields in a standardized format. Recitation of “optical character recognition” only amounts to mere instructions to apply the abstract idea. MPEP 2106.05(f). Claim 2 also recites limitations pertaining to package the received fax or scanned image with the extracted text information and said document which includes said fields in said standardized format into a compressed file. which only amounts to mere instructions to implement the abstract idea on a computer, e.g., using a computer to compile and access data electronically. These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 3 recites limitations pertaining to transformation engine is configured to: receive a file containing fields including patient demographic and medical information, which amounts to insignificant extra-solution activity in the form of mere data gathering; this further amounts to transmitting/receiving data over a network which has been held to be well understood, routine and conventional when claimed at a high level of generality. MPEP 2106.05(d). Claim 3 also recites limitations pertaining to decompress the received file to obtain a document which includes said fields in a standardized format, which amounts to mere instructions to which only amounts to mere instructions to implement the abstract idea on a computer, e.g., using a computer to compile, share and access data electronically. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Claim 3 also recites and confirm that said document is a medical record and locate predetermined defined fields in the decompressed file and create a Continuity of Care Document (CCD) with said defined fields as a Consolidated Clinical Document Architecture (C-CDA) document which are also certain methods of organizing human activity including managing personal behaviors, as a person could confirm a document is a medical record, locate specific fields in a file, and create a CCD with defined fields as a C-CDA document. Claim 3 also recites transmit the C-CDA document to a Health Information Service Provider (HISP), which only amounts to which amounts to insignificant extra-solution activity in the form of transmitting/receiving data over a network which has been held to be well understood, routine and conventional when claimed at a high level of generality. MPEP 2106.05(d). These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 4 recites limitations pertaining to wherein said standardized format for storing and transporting data is a JavaScript Object Notation (JSON) formatted document, which amounts to insignificant extra-solution activity in the form of transmitting/receiving data over a network which has been held to be well understood, routine and conventional when claimed at a high level of generality. MPEP 2106.05(d). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 5 recites limitations pertaining to using natural language processing (NLP) techniques to identify and extract specific pieces of information from unstructured text, and then convert the extracted specific pieces of information into a JSON format for processing or storage, which is also certain methods of organizing human activity as a person could identify and extract specific pieces of information from an unstructured text document and convert the data format. Claim 5 also recites the AI/ML model as implementing the steps; as discussed above with respect to independent Claim 1, high level recitation of AI/ML model only amounts to mere instructions to apply the abstract idea. MPEP 2106.5(f). These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 6 recites limitations pertaining to the JSON file is analyzed to confirm it is a medical document, which is also certain methods of organizing human activity including managing personal behavior, as a person could look at a file to confirm it is a medical document. Claim 6 also recites the image file is packaged with the text file, and the JSON file as a zip file and sent to the transformation engine which decompresses the zip file, which only amounts to mere instructions to implement the abstract idea on a computer, e.g., using a computer to compile, share and access data electronically. These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 7 recites limitations pertaining to wherein pre-defined fields in the JSON file are located and creating a CCD, which are also certain methods of organizing human activity including managing personal behavior, as a person could locate pre-defined fields and create a CCD document. Claim 7 also recites limitations pertaining to the CCD is securely transmitted to the HISP, which only amounts to insignificant extra-solution activity, e.g., outputting the data for transmission after performance of the abstract idea, which amounts to insignificant extra-solution activity in the form of transmitting/receiving data over a network which has been held to be well understood, routine and conventional when claimed at a high level of generality. MPEP 2106.05(d). These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
The dependent claims have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of claim 1. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Beyond the limitations which recite the abstract idea, the claims recite additional elements consistent with those identified above with respect to the independent claims which encompass adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Dependent claims 2-8 recite additional subject matter which amounts to additional elements consistent with those identified in the analysis of Claim 1 above. As discussed above with respect to Claim 1 and integration of the abstract idea into a practical application, recitation of these additional elements (e.g., transformation engine) only amounts to invoking computers as a tool to perform the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Dependent claims 2-8, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 1-8 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward et. al. (US Publication 20230385559A1) in view of De Araujo et. al. (US Publication 20220245270A1), and further in view of Ebrahimi et. al. (US Publication 20220044395A1).
Regarding Claim 1, Ward discloses:
a document intake device configured to receive an image file containing patient data transmitted to the document intake device using an image file transport protocol (Fig. 1; Para. [0046] teaches on the operations of Fig. 1 being performed using a computing device such as that shown in Fig. 7; the computing device is interpreted as “document intake device”; as shown in Fig. 1, a scanned document (“image file”) is read and a page image is extracted; the scanned document may be a PDF or TIFF (interpreted as image file); the scanned document may be a medical record which is interpreted as containing patient data);
an artificial intelligence/machine learning (AI/ML) model configured to extract patient demographic and medical information contained within said image file as a text file with said patient demographic and medical information ([0047]-[0048] teach on performing OCR to convert the text contained in the page image to first text data; a structured data detection algorithm is performed to detect the structured data contained in the page image and identify a plurality of elements of the structured data; OCR is performed to convert respective contents of each of the plurality of elements to second text data; the OCRed text (first and second data) is merged and a NLP algorithm (interpreted as AI/ML model) is executed to retrieve information from the first and second text data including demographic information (“patient demographic information”) and clinical information (“medical information”)).
Ward does not explicitly teach the following, but De Araujo, which is directed to a personal health record system, teaches:
an artificial intelligence/machine learning (AI/ML) model configured to…format said text file for use as said EHR by a transformation engine ([0070] teaches on user health database module 118 (“transformation engine”) which may perform data standardization for transforming records into a format compatible with a data warehouse; [0102] further teaches that patient data can be segmented into categories, e.g., diagnosis, medication, patient allergies, lab values, etc. using OCR and machine learning);
said transformation engine configured to convert said text file formatted for use as said EHR into said standards compliant EHR ([0020] teaches on classifying obtained healthcare data as structured or unstructured; prior to storing the obtained data, it may be converted to a standard format such as FHIR, interpreted as “standards compliant”; [0070] teaches on user health database module 118 (“transformation engine”) which may perform data standardization for transforming records into a format compatible with a data warehouse); [0071] further teaches on an example of the user healthcare database module 118 (transformation engine) converting a new healthcare record to structured FHIR format (FHIR is interpreted as ‘standards compliant’) following the successful performance of OCR; [0102] also teaches on segmenting patient data such as medications, provider data, diagnosis, allergies, images, etc. and normalizing it into FHIR (standards compliant) – interpreted as EHR data)
and transmit said standards compliant EHR as a Direct Secure Message to a Health Information Service Provider (HISP) ([0048] teaches on a health information exchange (HIE) securely transmitting healthcare data between patients, providers and other entities (interpreted as synonymous with direct secure message) connected to the system to provide synchronous digital exchange of patient data; HIE is interpreted as reading on broadest reasonable interpretation of HISP; the healthcare data in standard format such as FHIR of paras. [0020] is interpreted as the standards compliant EHR);
said HISP configured to send said standards compliant EHR as a Direct Secure Message for storage as a patient record only if a patient match is found ([0079] teaches on managing patient healthcare data via an HIE system (interpreted as HISP); the system validates the patient’s identity in order to continue the process (Fig. 8) (interpreted as patient match; if the patient is not validated, the process ends and EHR data is not sent/retrieved); healthcare data is shared through HIE; PHR may be augmented/created by storing healthcare data in memory of server; per [0048], which teaches on a health information exchange (HIE) securely transmitting healthcare data between patients, providers and other entities, it is interpreted as synonymous with direct secure message.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward with these teachings of De Araujo to format the text file of Ward for use as said EHR by a transformation engine, convert the text file into a standards compliant EHR, and transmit the standards compliant EHR as a Direct Secure Message to a Health Information Service Provider (HISP), where the HISP configured to send said standards compliant EHR as a Direct Secure Message for storage as a patient record if a patient match is found, with the motivation of standardizing formatting into a common format to provide efficiency and to securely transmit healthcare data of a patient to protect patient privacy (De Araujo [0048], [0052], [0061]).
Ward/De Araujo do not teach the following, but Ebrahimi, which is directed to a system for processing, communication and viewing of medical imaging study data, teaches:
using an image file transport protocol ([0081] teaches on using C-FIND, C-MOVE and C-GET, which are understood to be image transfer protocols).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo with these teachings of Ebrahimi to use an image file transport protocol with the motivation of using standard protocols for communication of images (Ebrahimi [0081]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward et. al. (US Publication 20230385559A1) in view of De Araujo et. al. (US Publication 20220245270A1), further in view of Ebrahimi et. al. (US Publication 20220044395A1), as applied to Claim 1 above, and further in view of Mitchell et. al. (US Patent 6684188B1).
Regarding Claim 2, Ward/De Araujo/Ebrahimi teach the limitations of Claim 1. Ward further discloses wherein the AI/ML model is configured to: receive a fax or scanned image with embedded text information and extract said text information by optical character recognition ([0004] teaches on reading a scanned image; [0047]-[0048] teach on performing OCR to convert the text contained in the page image to first text data; a structured data detection algorithm is performed to detect the structured data contained in the page image and identify a plurality of elements of the structured data; OCR is performed to convert respective contents of each of the plurality of elements to second text data; the OCRed text (first and second data) is merged and a NLP algorithm (interpreted as AI/ML model) is executed to retrieve information from the first and second text data including demographic information (“patient demographic information”) and clinical information (“medical information”) to obtain a document including fields with patient demographic information and provider information ([0107] teaches on an example in which medical records of stroke patients were analyzed using OCR to identify 5 elements including birthdate (interpreted as patient demographic information) and provider name (interpreted as provider information); these elements are interpreted as “fields”).
Ward does not disclose the following, but De Araujo further teaches:
create a document which includes fields in a standardized format for storing and transporting data ([0052] teaches on a warehouse server which obtains PHR data; the server may assign data values to various categories such as provider, diagnosis, allergies, etc. (interpreted as fields); the warehouse server may standardize data of disparate sources or formats to a common format; the server is understood to allow storage/transporting of the data per [0054] which teaches on providers accessing the information from the data warehouse server).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi with these teachings of De Araujo, to create a document with standardized formatting for storing/transporting data fields with the motivation of providing efficiency (De Araujo [0052]).
Ward/De Araujo do not teach, but Ebrahimi, which is directed to a system for processing, communication and viewing of medical imaging study data, further teaches:
package the received fax or scanned image with the extracted text information and said document which includes said fields in said standardized format into a compressed file ([0088] teaches on the compressed image file and associated JSON metadata are compressed and packaged within a zip file; the metadata is interpreted as being synonymous with text file).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi with these teachings of Ebrahimi, to package the scanned image and extracted text information and document including fields in a standardized format (this element is taught by Ward/De Araujo with respect per Claim 1), with the motivation of providing for fast and efficient transfer of the data because compressed data requires lower storage and less bandwidth (Ebrahimi [0096]).
Ward/De Araujo/Ebrahimi do not teach the following, but Mitchell, which is directed to production of medical records, teaches: apply data correction techniques including spell and grammar check adapted for use with medical records to obtain a clean document (Col 9 lines 7-8 teach on a knowledge base using a rule syntax written into a computer program; correct spelling and grammar are built into the knowledge base; this documentation is used to produce accurate medical records – interpreted as “clean” document).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi with these teachings of Mitchell, to incorporate data correction techniques including spell and grammar check into the system of Ward/De Araujo/Ebrahimi, with the motivation of generating a high quality textual report in narrative or prose form which is accurate, concise and readable, which is important and useful in today’s world with increased litigation (Col 9 lines 8-12).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward et. al. (US Publication 20230385559A1) in view of De Araujo et. al. (US Publication 20220245270A1), and further in view of Ebrahimi et. al. (US Publication 20220044395A1) as applied to Claim 1 above, and further in view of Tambasco et. al. (US Publication 20150379199A1), further in view of Plumptre (“What is C-CDA?”), and further in view of Dantsker et. al. (US Publication 20150066538A1).
Regarding Claim 3, Ward/De Araujo/Ebrahimi teach the limitations of Claim 1. Ebrahimi, which is directed to a system for processing, communication and viewing of medical imaging study data, further teaches: receive a compressed file containing fields, decompress the received file to obtain a document which includes said fields in a standardized format and ([0088]-[0094] teach on file compression in which the data may be converted to PNG format or other suitable lossless image compression format (interpreted as standardize format); the files may be bundled into a ZIP file; [0095] teaches on decompressing the zip file container).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify Ward/De Araujo/Ebrahimi with these teachings of Ebrahimi, to compress files and decompress the files containing the patient demographic/medical information of Ward, to obtain data in a standard format, with the motivation of providing for fast and efficient transfer of the data because compressed data requires lower storage and less bandwidth (Ebrahimi [0096]).
Ward/De Araujo/Ebrahimi do not teach the following, but Tambasco,
locate predetermined defined fields in said file and create a Continuity of Care Document (CCD) with said defined fields as a Clinical Document Architecture (CDA) document ([0038] teaches on determining that at least one patient information field includes a reportable condition (interpreted as locating predetermined defined fields); a CCD being generated according to the Clinical Document Architecture (CDA) which is the HL7 authored healthcare documentation standard; [0039] teaches on predefined fields, e.g., the body comprising the clinical report and content organized into one or more sections, each section comprising a narrative block and one or more coded entries such as medications, allergies, immunizations, problems, vital signs).
transmit theCDA document to said HISP ([0038]-[0040] teach on generating a CCD as a CDA document; once the selected/extracted data has been packaged, the patient portal interface transmits the data to patient portal 10; per [0042] the transmission may be via one or more secured mechanisms, e.g., DIRECT messaging); [0043] teaches on the portal interface and patient portal being part of the same/different secured network such as those provided by a HISP).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi with these teachings of Tambasco, to locate fields in the decompressed file of Ebrahimi, and create a CCD with defined fields as CDA document, because CDA is a base standard that provides common architecture, coding, semantic framework, and markup language for the creation of electronic clinical documents (Tambasco [0038]).
Tambasco teaches a “CDA” (clinical document architecture) document rather than a C-CDA (consolidated clinical document architecture) document. Plumptre, which is directed to origins and usage of C-CDA, teaches
C-CDA (page 1, second paragraph, the C-CDA provides a set of rules to achieve easier data exchange between healthcare organizations).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi/Tambasco with these teachings of Plumptre, to substitute the C-CDA of Plumptre with the CDA of Tambasco, with the motivation of using the C-CDA as it consolidates the most common CDA documents into one easier-to-administer implementation guide (page 4, para. 4).
Ward/De Araujo/Ebrahimi/Tambasco/Plumptre do not teach the following, but Dantsker, which is directed to resource allocation based on medical data criticality, teaches
confirm that said document is a medical record ([0128] teaches on a processor determining whether received data includes a direct medical data indicator that it is medical data; per [0027] “medical data” may include user’s health records).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi/Tambasco/Plumptre with these teachings of Dantsker, to confirm that the document obtained by decompressing the received file of Ward/De Araujo/Ebrahimi is a medical record, with the motivation of ensuring that the obtained document is handled as medical data (Dantsker [0130]).
Claim(s) 4, 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward et. al. (US Publication 20230385559A1) in view of De Araujo et. al. (US Publication 20220245270A1), and further in view of Ebrahimi et. al., further in view of Tambasco et. al. (US Publication 20150379199A1) and further in view of Plumptre (“What is C-CDA?”), further in view of Dantsker et. al. (US Publication 20150066538A1) as applied to Claim 3 above, and further in view of Virkar et. al. (US Publication 20190156927 A1).
Regarding Claim 4, Ward/De Araujo/Ebrahimi/Tambasco/Plumptre/Dantsker teach the limitations of Claim 3 but do not teach the following. Virkar, which is directed to systems and methods for managing clinical research, teaches: wherein said standardized format for storing and transporting data is a JavaScript Object Notation (JSON) formatted document ([0032] teaches on converting clinical data to JSON for storage in a data repository).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi/Tambasco/Plumptre/Dantsker with these teachings of Virkar, to use JSON format as the standardized format for data storage and transport in the system of Ward/De Araujo/Ebrahimi, because JSON is lightweight, self-describing and built for easy integration into other data formats and applications ([0033]).
Regarding Claim 6, Ward/De Araujo/Ebrahimi/Tabasco/Plumptre/Dantsker/Virkrar teach the limitations of Claim 4. Ward does not disclose, but Ebrahimi, which is directed to a system for processing, communication and viewing of medical imaging study data, teaches: wherein the image file is packaged with the text file ([0088] teaches on the compressed image file and associated JSON metadata are compressed and packaged within a zip file; the metadata is interpreted as being synonymous with text file), and the JSON file as a zip file ([0088] teaches on the compressed image file and associated JSON metadata are compressed and packaged within a zip file) and sent to the transformation engine which decompresses the zip file ([0095] teaches on one or more client terminals decompressing the zip file container).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi/Tabasco/Plumptre/Dantsker/Virkrar with these teachings of Ebrahimi, to package the image file and associated metadata (interpreted as text file of Ward/De Araujo/Ebrahimi) and the JSON file as a zip file which can later be decompressed by a receiving entity, with the motivation of providing for fast and efficient transfer of the data because compressed data requires lower storage and less bandwidth (Ebrahimi [0096]).
Ward/De Araujo/Ebrahimi/Tabasco/Plumptre/Virkar do not teach the following, but Dantsker, which is directed to resource allocation based on medical data criticality, teaches
the file is analyzed to confirm it is a medical document ([0128] teaches on a processor determining whether received data includes a direct medical data indicator that it is medical data; per [0027] “medical data” may include user’s health records).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi/Tambasco/Plumptre/Dantsker/Virkar with these teachings of Dantsker, to analyze the JSON file of Tambasco to confirm that it is a medical record, with the motivation of ensuring that the obtained document is handled as medical data (Dantsker [0130]).
Regarding Claim 7, Ward/De Araujo/Ebrahimi/Tambasco/Plumptre/Dantsker/Virkar teach the limitations of Claim 6. Tambasco, which is directed to user-based remote capturing of health and medical data, further teaches wherein pre-defined fields in the file are located ([0033] teaches on a record-based template including various fields and information with annotations identifying the field type; an image analyzer can compare identified items to record-based templates to determine if the identified item matches any of the fields within the templates), the CCD is created ([0040]) and securely transmitted to the HISP ([0040] teaches on generating the CCD; once the selected/extracted data has been packaged, the patient portal interface transmits the data to patient portal 10; per [0042] the transmission may be via one or more secured mechanisms, e.g., DIRECT messaging); [0043] teaches on the portal interface and patient portal being part of the same/different secured network such as those provided by a HISP).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi/Tambasco/Plumptre/Dantsker with these teachings of Tambasco, to locate pre-defined fields in the JSON file (taught by Virkar per Claim 4), create the CCD and securely transmit it to a HISP with the motivation of locating predefined fields to determine the type of field or type of information associated with the identified item (Tambasco [0033]) and providing secure messaging between entities for sharing/accessing patient medical data (Tambasco [0042]).
Regarding Claim 8, Ward/De Araujo/Ebrahimi/Tambasco/Plumptre/Dantsker teach the limitations of Claim 7. Tambasco, which is directed to user-based remote capturing of health and medical data, further teaches wherein the CCD is created using a pre-built template ([0040] teaches on generating the CCD using one or more CDA-based templates).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi/Tambasco/Plumptre/Dantsker with these teachings of Tambasco, to create the CCD using a pre-built template, with the motivation of using a template designed to satisfy a specific information exchange scenario and define the CDA structures to be used to document the applicable clinical information (Tambasco [0040]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward et. al. (US Publication 20230385559A1) in view of De Araujo et. al. (US Publication 20220245270A1), further in view of Ebrahimi et. al. (US Publication 20220044395A1) as applied to Claim 1 above, and further in view of Virkar et. al. (US Publication 20190156927 A1).
Regarding Claim 5, Ward/De Araujo/Ebrahimi teach the limitations of Claim 1. Ward further discloses wherein the AI/ML model uses natural language processing (NLP) techniques to identify and extract specific pieces of information from unstructured text ([0106] teaches on extracting structured data from unstructured images; [0107] teaches on extracting specific pieces of information (patient and provider names, birthdate, note date, facility metadata) from unstructured data using OCR/NLP).
Ward/De Araujo/Ebrahimi do not teach the following, but Virkar, which is directed to systems and methods for managing clinical research, teaches: convert said extracted specific pieces of information into a JSON format for processing or storage ([0032] teaches on converting clinical data to JSON for storage in data repository).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Ward/De Araujo/Ebrahimi with these teachings of Virkar, to convert the structured data of Ward/De Araujo/Ebrahimi to a JSON format for storage, because JSON is lightweight, self-describing and built for easy integration into other data formats and applications ([0033]).
Response to Applicant’s Remarks/Arguments
Claim Objections
The objection to Claim 3 and corresponding dependent claims is withdrawn in view of Applicant’s amendment to Claim 3.
35 USC 112(b) Rejections
The rejections of Claims 1 and corresponding dependent claims, and Claim 5, under 35 USC 112(b) are withdrawn in view of Applicant’s amendments to Claims 1 and 5.
35 USC 101 Rejections
Applicant’s remarks have been fully considered but are not persuasive. Regarding remarks at bottom of page 4, the Examiner respectfully disagrees with Applicant’s position pertaining to the claims being directed to certain methods of organizing human activity including managing personal behavior or relationships or interactions between people. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent personal behaviors that a person or persons, with or without the aid of a computer, would follow to obtain (extract) patient demographic and medical information, format it in a standards-compliant format in order to provide a standards compliant record. Examiner submits that the additional elements (e.g., system architecture) only amount to mere instructions to apply the abstract idea using computing elements. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a personal behaviors that a person or persons would follow to obtain (extract) patient demographic and medical information, format it in a standards-compliant format in order to provide a standards compliant record, the claimed invention is directed to an abstract idea. This argument is not persuasive.
Regarding remark at bottom of page 4 that the claims “make no reference to personal behavior, or relationships or interactions between people”, the Examiner submits that multiple CAFC decisions that the Office has characterized as Certain Method of Organizing Human Activity did not actively recite a person or persons performing the steps of the claims (see, e.g., EPG, TLI communications, Ultramercial). Because whether a human is required to perform the step of the claim is not a requirement for claims to encompass certain method of organizing human activity, this argument is not persuasive.
Regarding Argument 1 at page 5, “The Claim is Directed to a Practical Application”, Examiner respectfully disagrees with Applicant’s position. Examiner initially notes that a claim being “Directed to a Practical Application” is not a consideration for subject matter eligibility; see MPEP 2106. Further, Applicant has not provided specific arguments other than to assert that “This is not generic “idea of organizing information. It is a concrete technological pipeline that improves interoperability and secure transmission of healthcare records”. Regarding integration of a judicial exception into a practical application, please see 2106.04(d)(II) which states, “The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h)”; and, see MPEP 2106.05(a) which states, “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” Applicant has not provided, nor can Examiner find evidence of, how any of the additional elements identified above in main 101 analysis section are providing an improvement over prior art systems. As discussed above in 101 section, the additional elements identified above are understood to be computing components functioning in their normal operating capacity, or have been identified as insignificant extra-solution activity, which are not sufficient to integrate the judicial exception into a practical application. Therefore, this argument is not persuasive.
Regarding Argument 2 at page 5, “Integration into a Technical Environment”, Applicant asserts, “these are not mental steps or generic computer functions; they are specific technical operations that improve healthcare IT systems”. Examiner asserts that the abstract idea was never classified as mental processes; therefore the first remark with respect to “mental steps” is not persuasive. Regarding “generic computer functions” and “specific technical operations”, Examiner respectfully disagrees. Please see above argument with respect to MPEP citations and integration of a judicial exception into a practical application. The specification does not appear to disclose any description of the additional elements and how they provide a technological improvement. Using general purpose computing elements in their normal capacity only amounts to mere instructions to apply the abstract idea. MPEP 2106.05(f). Further, Examiner notes that “integration into a technical environment” is not a consideration for subject matter eligibility; see MPEP 2106. Further, while none of the additional elements were classified as “generally linking”, Examiner submits that generally linking the use of a judicial exception to a particular technological environment or field of use is not sufficient to integrate a judicial exception into a practical application (MPEP 2106.05(h)). Therefore, this argument is not persuasive.
Regarding Argument 3 at page 5, “Improvement over Conventional Systems”, Applicant has not cited to, nor can Examiner find evidence in specification, of how the claimed additional elements provide an improvement over conventional systems (MPEP 2106.05(a)). Examiner submits that combining two abstract ideas (converting image data to text data to populate EHRs and transforming, e.g., manipulating/modifying, structured data) may be an improvement to the abstract idea itself, but per MPEP 2106.05(a), as cited above with respect to Argument 1, it is not sufficient to integrate the judicial exception into a practical application (“It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements”). This argument is not persuasive.
Regarding remarks at page 6, “Precedent”, Applicant has not provided specific remarks with respect to different case law, so Examiner will address as best understood:
Regarding Enfish, Examiner respectfully disagrees that the instant claims are analogous. Regarding Enfish, the court concluded the claims were not directed to an abstract idea, but rather an improvement to computer functionality. It was the specification’s discussion of the prior art and how the invention improved the way the computer stores and retrieves data in memory in combination with the specific data structure recited in the claims that demonstrated eligibility (MPEP 2106.05(a)); the claimed invention improved the functioning of the computer itself. Applicant has not cited to, nor can Examiner find, similar improvement in the instant claims. These remarks are not persuasive.
Regarding Finjan, the claims were determined to provide a physical improvement to the computer by implementing behavior-based virus scanning according to a security profile that is specific to a user, which allowed a computer system to do things it previously could not do, as discussed in specification; hence, the court identified an improvement in computer functionality and verified that the claims recited additional elements that reflected the improvement. Applicant has not cited to, nor can Examiner find, evidence of anything in the instant claims or specification that is analogous to Finjan. These remarks are not persuasive.
Regarding McRO, Examiner respectfully disagrees that the claims are analogous. In McRO, the court concluded the claims were not directed to an abstract idea, but rather an improvement to computer functionality as the claims allowed a computer to perform 3-D lip-syncing animation using a new morph weight algorithm that allowed the computer to perform animation tasks that only a human could previously perform. The instant claims do not recite any analogous limitations to Enfish or McRO. These remarks are not persuasive.
Regarding Diehr, the claims in Diehr were directed to a novel method of curing rubber by using an equation to constantly monitor the temperature of the rubber mold to determine when to open the mold, to solve problems of the prior art systems with under/over-curing rubber. The instant claims do not recite using the judicial exception to control an external device in a particular way that is akin to Diehr. These remarks are not persuasive.
For all of the above reasons, the rejections of Claims 1-8 under 35 USC 101 are maintained.
35 USC 103 Rejections
Applicant’s remarks have been fully considered but are not persuasive. Regarding remarks at page 7 pertaining to Ward, Examiner submits that the limitations cited by Applicant are taught by DeAraujo. Regarding remarks to DeAraujo, Examiner maintains the position that the applied reference reads on the broadest reasonable interpretation of the claim language. The claim recites that a text file is converted for use as an EHR into “standards compliant EHR”. The claim does not define what “standards compliant EHR” entails. As FHIR is a standard, it is understood to read on the broadest reasonable interpretation of the claim language as drafted. Regarding remark that DeAraujo operates on data already in electronic format and not OCR-derived image files, Examiner submits that this element is taught by Ward. As shown in the claim mapping above, it is the combination of Ward/De Araujo that teaches on this limitation, e.g., Ward uses OCR to convert image files to text, and De Araujo teaches on the limitations pertaining to formatting the text (that has been converted from image, taught by Ward) and converting it to standards compliant format. Regarding remark pertaining to conditional transmission of a Direct Secure Message only upon patient match, Examiner respectfully disagrees and submits that validating an identity reads on the broadest reasonable interpretation of a patient match as it serves to verify the patient and conditionally proceed with the process; Examiner submits that validating a patient’s identity encompasses confirming identity, e.g., linking (matching) a patient to a specific record. Regarding remarks directed to HIE/HISP, Examiner submits that the applied references reads on the broadest reasonable interpretation of the claim language as the functions of DeAraujo’s HIE read on the functions of the instant HISP as DeAraujo teaches on securely exchanging healthcare data in a standardized format as required by the claim language. Regarding remarks directed to Ebrahimi, Examiner submits that the applied reference teaches on “using an image transport file”, as stated by Applicant (“so while C-FIND< C-MOVE, C-GET may be considered to be image transfer files…”). Regarding remarks 4 and 5 at page 9, Examiner submits that in Non-Final Action and in this action, a motivation to combine has been shown for all elements. The combination of references applied teaches on the claim elements of Claim 1. The rejection of Claim 1 is maintained. Regarding the rejection of dependent Claims 2-8, the Applicant has not offered any arguments with respect to these claims other than to reiterate the argument(s) present for the claims from which they depend. As such, the rejection of these claims is also maintained. For all of the above reasons, the rejections of Claims 1-8 under 35 USC 103 are maintained.
Conclusion
In the interest of expediting prosecution, Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20200043577A1, teaching on a method and device for establishing an electronic medical record from a paper medical record
US Publication 20090070380A1, teaching on extracting data elements from a medical document and formatting according to a standard
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 extension fee 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 date of this final action.
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682