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 the Application
This office action is in response to the amendment filed on June 5, 2025. Claims 1, 4-5, 8-9, 12-13, and 15 have been amended. Claims 1-15 are currently pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a converter” in claims 5 and 13 and “a redactor component” in claim 14.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-8 and 13-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per Claims 5 and 13, the claims recite a system comprising “a converter”. The specification fails to recite what specific structure is tied to the converter in order to enable the converter to extract alphanumeric data from the source capture. As a result, the specification fails to provide adequate support as to how the system performs this function.
As per Claim 14, the claim recites a system comprising “a redactor component”. The specification fails to recite what specific structure is tied to the redactor component in order to enable the redactor to redact personally identifiable information from the alphanumeric data. As a result, the specification fails to provide adequate support as to how the system performs this function.
Claims 6-8 and 15 are dependent from Claims 5 and 13 and therefore contain the same deficiencies.
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.
Claims 5-8 and 13-15 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.
As per Claims 5 and 13, the claims recite a system comprising: “the final adjudicated response associated with a particular HER implementation being stored”. The claims fail to recite how the final adjudicated response is being stored. It is unclear how the final adjudicated response is being stored within the system claimed.
As per Claims 5 and 13, the claims recite a system comprising: “a source capture”; “a library of terms”; “a final response”; and “a final adjudicated response”. In view of the specification, the source capture; the library of terms; the final response; and the final adjudicated response are all considered to be data. It is unclear how this data is being comprised with the system. Is the data being stored within a database? The claims fail to recite any structural components tied to the data.
As per Claims 9 and 13, the claims recite the limitation "the final adjudicated response". The claim recites an adjudicator selecting a final response. The claims fail to recite the final response being adjudicated. There is insufficient antecedent basis for this limitation in the claim.
Claims 6-8 and 14-15 are dependent from Claims 5 and 13 and therefore contain the same deficiencies.
In addition, the claim limitation “a converter” in Claims 5 and 13 and “a redactor component” in Claim 14 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification fails to recite what specific structure is tied to the “converter” in order for it to perform the function of extracting alphanumeric data from the source capture. The specification also fails to recite what specific structure is tied to the “redactor component” in order for the system to perform the function of redacting personally identifiable information from the alphanumeric data. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 5-8 and 13-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 5 and 13 recite “one or more users” and “an adjudicator” that are comprised within a system. The specification recites in Paras. [0022-0027] the user to be a human being. The specification recites in Paras. [0014-0015; 0023] the adjudicator to be a human being. As a result, claims 5 and 13 are interpreted to include human beings being comprised within the system.
Claims 6-8 and 14-15 are dependent from Claims 5 and 13 and therefore contain the same deficiencies.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., law of nature, natural phenomenon, or an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 1-15 are directed to methods and systems, which are statutory categories of invention. (Step 1: YES).
Step 2A – Judicial Exception Analysis, Prong One:
Independent Claim 1 recites a method for converting unstructured data into structured data to respond to at least one question on an electronic case report form, the method comprising: taking a source capture of a portion of an electronic health record (EHR); converting unstructured data on the source capture into alphanumeric data; cross referencing the alphanumeric data with a library of terms; the one or more users each selecting a user response from the list of suggestions; reviewing the one or more user responses [from one or more users] and selecting a final response, thereby converting the unstructured data to structured data; and storing the final response associated with a particular HER implementation to generate a custom library of alpha-numeric data and library terms pairs associated with the particular HER implementation.
Independent Claim 5 recites a source capture of a portion of an electronic health record (EHR); extracts unstructured data on the source capture into alphanumeric data; a library of terms wherein the alphanumeric data is cross referenced against the library of terms to provide one or more users with a list of suggestions for a response; a response to the question on a case report form selected by the one or more users from the list of suggestions; and a final response, wherein the final response is selected from the one or more user responses; the final response associated with a particular HER implementation being stored to generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation.
Independent Claim 9 recites a method for answering a question in a clinical trial questionnaire, the method comprising capturing a source capture of at least a portion of unstructured data in an electronic health record; extracting the at least a portion of the unstructured data from the source capture and converting the at least a portion of unstructured data into alphanumeric data; cross referencing the alphanumeric data with a library of terms; selecting a response from the library of terms by one or more users; reviewing and selecting a final response by an adjudicator, wherein the adjudicator selects a final response from the one or more user responses to determine a preferred correlation between the alphanumeric data and the question in the clinical trial questionnaire; and storing the final adjudicated response associated with a particular EHR implementation to generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation.
Independent Claim 13 recites a source capture of at least a portion of unstructured data an electronic health record; extracts alphanumeric data from the source capture; a library of terms, wherein the alphanumeric data is cross referenced with the library of terms; one or more users, wherein the one or more users selects a response from the library of terms; and an adjudicator, wherein the adjudicator selects a final response from the one or more user responses to determine a preferred correlation between the alphanumeric data and the question in the clinical trial questionnaire; and the final adjudicated response associated with a particular EHR implementation being stored to generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation.
The claims, as drafted, recite an abstract idea. Per MPEP § 2106.04(a)(2), subsection III, if a claim limitation, under its broadest reasonable interpretation, recites activity that can be performed in the human mind, or by a human using a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. The claim limitations recite the conversion of observed EHR data into an alphanumeric format, comparison of said alphanumeric data to other terms, selecting a response; and determining the optimal correlation between the entities. Such a process can be performed by a human, with or without aid of pen and paper, as this constitutes basic mental processes of observation, translation, and comparison. Therefore, the limitations sufficiently amount to mental processes, and thus, recite an abstract idea. The claims are also interpreted to fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The concept of presenting a list of suggestions for a response to one or more users; a user selecting a response; reviewing the responses; selecting a final response; and storing a final response are activities directed to managing personal behavior or relationship or interactions between people.
Dependent Claims 10 and 14 recite redacting personally identifiable information from the alphanumeric data. This limitation amounts to mere data exclusion, which can be performed in the mind.
Each of the preceding dependent claims only serve to further limit or specify the abstract features of independent Claims 9 and 13, and hence, are directed towards the same abstract idea
Accordingly, the claims recite an abstract idea. (Step 2A, Prong One: YES).
Step 2A – Judicial Exception Analysis, Prong Two:
The judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer (MPEP § 2106.05(f)) and/or insignificant pre-/post-solution activity (MPEP § 2106.05(g)).
The claims are abstract but for the recitation of the additional claim elements including “wherein the list of suggestions is AI driven,” (Claims 3 and 11) “further comprising a storage database,” (Claims 6 and 8) “wherein selecting a response from the library of terms is Al driven” (Claim 11) “by an Al driven process,” (Claims 12 and 15) “a converter that,” (Claims 5 and 13) “further comprising a redactor component for.” (Claim 14).
The above-identified additional claim elements fail to integrate the abstract idea into a practical application, as they merely recite what are understood to be standard computer technology at a high level of generality, such that they amount to mere instructions to apply the abstract idea to the specific technical elements. For example, the storage database is only nominally referenced in the Specification and is depicted in the Drawings as a labeled cylindrical element, devoid of distinct structural features. Therefore, it is assumed to be a generic database used to perform paradigmatic functions. Similarly, the use of an AI driven process is only described in passing throughout the Specification, excluding any detailed description as to what the process entails – i.e., the training techniques used, the training data employed, etc. The redactor component and converter are not referenced in the disclosure, and thus are assumed to constitute generic computer components for the purposes of analysis under 35 U.S.C. § 101. Accordingly, the aforementioned additional claim elements amount to mere instructions to apply the abstract idea (MPEP § 2106.05(f)(2) see case involving a commonplace business method or mathematical algorithm being applied on a general purpose computer within the “Other examples.. i.”). Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S. Ct. 2347, 1357 (2014)).
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements, alone or as an ordered combination, amount to no more than a recitation of instructions to implement the abstract idea on a computer. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements recited above amount to no more than mere instructions to apply the exception using generic computer components. The specification recites via Para. 0029-0030 a high-level recitation of a generic computer being capable of performing the claimed functions of the claimed method. Fig. 1 and the specification recites the claimed database as a generic computer database for storing of data. Therefore, the additional elements in isolation do not amount to significantly more than the abstract idea (see: MPEP 2106.05(f) for additional guidance on the “mere instruction to apply an exception” and MPEP 2106.05(g)).
Accordingly, the additional claim elements do not amount to significantly more than the abstract idea, and thus, are not patent eligible. (Step 2B: NO).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reiner (US 2010/0145720), hereinafter Reiner.
As per Claim 13, Reiner teaches a system for answering a question in a clinical trial questionnaire, the system comprising a source capture of at least a portion of unstructured data an electronic health record (see: Reiner, paragraphs 21, 55, 95, 102, 142, and 147-148, is met by the extraction of data elements from an unstructured free text medical report obtained by the system); a converter that extracts alphanumeric data from the source capture; a library of terms (see: Reiner, paragraphs 21, 55, 95, 102, 142, and 147-148, is met by the extraction of data elements from an unstructured free text medical report), wherein the alphanumeric data is cross referenced with the library of terms (see: Reiner, paragraphs 21, 95, 100-102, is met by the mapping of the free text concepts to the standardized lexicon); one or more users, wherein the one or more users selects a response from the library of terms (see: Reiner, paragraphs 103-105, 120-124, and 169-172, is met by the selection of actions by a user to accept, deny and edit, and utilize the automatic edit function for reviewing the NLP process); and an adjudicator, wherein the adjudicator selects a final response from the one or more user responses to determine a preferred correlation between the alphanumeric data and the question in the clinical trial questionnaire; and the final adjudicated response associated with a particular EHR implementation being stored to generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation (see: Reiner, paragraphs 155 and 160-162, is met by saving the final report in a structured data format after a user has reviewed the discrepancies and made a selection based on the matching of the text to the report. The concept of the final adjudicated response being stored “to” generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation is directed to “intended use”. The claims fail to explicitly recite the actual function of generating a custom library based on the final adjudicated response. Therefore, it does not further limit the scope of the claim limitation and under the broadest reasonable claim interpretation, the functional step being claimed is storing the final adjudicated response.).
As per Claim 15, Reiner teaches the limitations of Claim 13. Reiner further teaches wherein the final response selected by the adjudicator is further used by an Al driven process as an input for selecting the response from the library of terms by the one or more users for subsequent source captures associated with the particular EHR implementation (see: Reiner, paragraphs 100 and 176, is met by the storing of mapped reports to the reports database for future data mining and analyses).
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) 1-9 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reiner (US 2010/0145720), hereinafter Reiner, in view of Handley (US 2006/0088214), hereinafter Handley
As per Claim 1, Reiner teaches a method for converting unstructured data into structured data to respond to at least one question on an electronic case report form (see: Reiner, Abstract, paragraphs 20-21, 54, 61, and 150, figs. 1-2B, is met by the use of a method for converting unstructured data into structured text), the method comprising: taking a source capture of a portion of an electronic health record (EHR) (see: Reiner, paragraphs 21, 55, 95, 102, 142, and 147-148, is met by the extraction of data elements from an unstructured free text medical report); cross referencing the alphanumeric data with a library of terms (see: Reiner, paragraphs 21, 95, 100-102, is met by the mapping of the free text concepts to the standardized lexicon) and presenting one or more users with a list of suggestions for a response (see: Reiner, paragraphs 120-124, 151, 153, and 163, is met by the authorizing physician presented with options to leave “as is”, edit, or elect the automated editing); the one or more users each selecting a user response from the list of suggestions (see: Reiner, paragraphs 103-105, 120-124, and 169-172, is met by the selection of actions by a user to accept, deny and edit, and utilize the automatic edit function for reviewing the NLP process); reviewing the one or more user responses and selecting a final response, thereby converting the unstructured data to structured data; and storing the final response associated with a particular EHR implementation to generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation (see: Reiner, paragraphs 155 and 160-162, is met by saving the final report in a structured data format after a user has reviewed the discrepancies and made a selection. The concept of the final adjudicated response being stored “to” generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation is directed to “intended use”. The claims fail to explicitly recite the actual function of generating a custom library based on the final adjudicated response. Therefore, it does not further limit the scope of the claim limitation and under the broadest reasonable claim interpretation, the functional step being claimed is storing the final adjudicated response.).
Reiner fails to specifically teach the following limitation(s), which is/are taught by Handley: converting unstructured data on the source capture into alphanumeric data (see: Handley, Abstract, paragraphs 17, 19, and 56, figs. 4, 6, and 9, is met by the generation of alphanumeric symbols for scanned credit card information and the use of an OCR system).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the functionalities of Reiner to include an OCR system that could convert scanned document data into alphanumeric strings, as taught by Handley, with the motivation of automatically categorizing storing unstructured information from documents (see: Handley, paragraph 1).
As per Claim 5, Reiner teaches a system for converting unstructured data into structured data to respond to at least one question on an electronic case report form (see: Reiner, Abstract, paragraphs 20-21, 54, 61, and 150, figs. 1-2B, is met by the use of a system for converting unstructured data into structured text), the system comprising: a source capture of a portion of an electronic health record (EHR) (see: Reiner, paragraphs 21, 55, 95, 102, 142, and 147-148, is met by the extraction of data elements from an unstructured free text medical report); a library of terms wherein the alphanumeric data is cross referenced against the library of terms to provide one or more users with a list of suggestions for a response (see: Reiner, paragraphs 21, 95, 100-102, is met by the mapping of the free text concepts to the standardized lexicon); a response to the question on an electronic case report form selected by the one or more users from the list of suggestions (see: Reiner, paragraphs 103-105, 120-124, and 169-172, is met by the selection of actions by a user to accept, deny and edit, and utilize the automatic edit function for reviewing the NLP process); and a final response, wherein the final response is selected from the one or more user responses; the final response associated with a particular EHR implementation being stored to generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation (see: Reiner, paragraphs 155 and 160-162, is met by saving the final report in a structured data format after a user has reviewed the discrepancies and made a selection. The concept of the final adjudicated response being stored “to” generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation is directed to “intended use”. The claims fail to explicitly recite the actual function of generating a custom library based on the final adjudicated response. Therefore, it does not further limit the scope of the claim limitation and under the broadest reasonable claim interpretation, the functional step being claimed is storing the final adjudicated response.).
Reiner fails to specifically teach the following limitation(s), which is/are taught by Handley: a converter that extracts unstructured data on the source capture into alphanumeric data (see: Handley, Abstract, paragraphs 17, 19, and 56, figs. 4, 6, and 9, is met by the generation of alphanumeric symbols for scanned credit card information and the use of an OCR system).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the functionalities of Reiner to include an OCR system that could convert scanned document data into alphanumeric strings, as taught by Handley, with the motivation of automatically categorizing storing unstructured information from documents (see: Handley, paragraph 1).
As per Claim 2, Reiner and Handley teach the limitations of Claim 1. Reiner further teaches further comprising storing some or all of the final response, the one or more user responses and associated metainformation in a storage database (see: Reiner, paragraphs 3-4, 21, 100, 132, and 151, is met by the storing of the final report in the reports databases after it has been converted into structured data or edited by the reviewer).
As per Claims 3 and 7, Reiner and Handley teach the limitations of Claims 1 and 5, respectively. Reiner further teaches wherein the list of suggestions is Al driven (see: Reiner, paragraphs 95 and 106, is met by the NLP technology used to extract and analyze the free text).
As per Claims 4 and 8, Reiner and Handley teach the limitations of Claims 1 and 5, respectively. Reiner further teaches using a previously stored alpha-numeric data and library terms pair to identify an answer to a question in an electronic case report form in a newly received EHR associated with the particular EHR implementation (see: Reiner, paragraphs 0246, 0259, 0261, 0270-0280, discloses using previously stored data and terms pairs to identify an answer to a question received a physician in regards to a new medical record of a patient).
As per Claim 6, Reiner and Handley teach the limitations of Claim 5. Reiner further teaches further comprising a storage database storing some or all of the final response, the one or more user responses and associated metainformation (see: Reiner, paragraphs 3-4, 21, 100, 132, and 151, is met by the storing of the final report in the reports databases after it has been converted into structured data or edited by the reviewer).
As per Claim 9, Reiner teaches a method for answering a question in a clinical trial questionnaire, the method comprising capturing a source capture of at least a portion of unstructured data in an electronic health record (see: Reiner, paragraphs 21, 55, 95, 102, 142, and 147-148, is met by the extraction of data elements from an unstructured free text medical report obtained by the system); extracting the at least a portion of the unstructured data from the source capture (see: Reiner, paragraphs 21, 55, 95, 102, 142, and 147-148, is met by the extraction of data elements from an unstructured free text medical report); cross referencing the alphanumeric data with a library of terms (see: Reiner, paragraphs 21, 95, 100-102, is met by the mapping of the free text concepts to the standardized lexicon); selecting a response from the library of terms by one or more users (see: Reiner, paragraphs 103-105, 120-124, and 169-172, is met by the selection of actions by a user to accept, deny and edit, and utilize the automatic edit function for reviewing the NLP process); reviewing and selecting a final response by an adjudicator, wherein the adjudicator selects a final response from the one or more user responses to determine a preferred correlation between the alphanumeric data and the question in the clinical trial questionnaire; and storing the final adjudicated response associated with a particular EHR implementation to generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation (see: Reiner, paragraphs 155 and 160-162, is met by saving the final report in a structured data format after a user has reviewed the discrepancies and made a selection based on the matching of the text to the report. The concept of the final adjudicated response being stored “to” generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation is directed to “intended use”. The claims fail to explicitly recite the actual function of generating a custom library based on the final adjudicated response. Therefore, it does not further limit the scope of the claim limitation and under the broadest reasonable claim interpretation, the functional step being claimed is storing the final adjudicated response.).
Reiner fails to specifically teach the following limitation(s), which is/are taught by Handley: converting the at least a portion of unstructured data into alphanumeric data (see: Handley, Abstract, paragraphs 17, 19, and 56, figs. 4, 6, and 9, is met by the generation of alphanumeric symbols for scanned credit card information and the use of an OCR system).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the functionalities of Reiner to include an OCR system that could convert scanned document data into alphanumeric strings, as taught by Handley, with the motivation of automatically categorizing storing unstructured information from documents (see: Handley, paragraph 1).
As per Claim 11, Reiner, and Handley teach the limitations of Claim 9. Reiner further teaches wherein selecting a response from the library of terms is Al driven (see: Reiner, paragraphs 95 and 106, is met by the NLP technology used to extract and analyze the free text).
As per Claims 12, Reiner, and Handley teach the limitations of Claims 9. Reiner further teaches wherein the final response selected by the adjudicator is further used by an Al driven process as an input for selecting the response from the library of terms by the one or more users for subsequent source captures associated with the particular EHR implementation (see: Reiner, paragraphs 100 and 176, is met by the storing of mapped reports to the reports database for future data mining and analyses).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reiner (US 2010/0145720), hereinafter Reiner, in view of Handley (US 2006/0088214), hereinafter Handley, further in view of Hwang et al. (US 2015/0127375), hereinafter Hwang.
As per Claims 10, Reiner, and Handley teach the limitations of Claims 9. Reiner and Handley fail to specifically teach the following limitation(s), which is/are taught by Hwang: redacting personally identifiable information from the alphanumeric data (see: Hwang, paragraphs 10 and 53-54, is met by the removing of patient’s personal identification information before entry into the first medical database).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the functionalities of Reiner and Handley to include the removal of a patient’s personal identification information, as taught by Hwang, with the motivation of protecting a patient’s privacy (see: Hwang, paragraph 54).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reiner (US 2010/0145720), hereinafter Reiner, in view of Hwang et al. (US 2015/0127375), hereinafter Hwang.
As per Claims 14, Reiner teaches the limitations of Claim 13. Reiner fails to specifically teach the following limitation(s), which is/are taught by Hwang: redacting personally identifiable information from the alphanumeric data (see: Hwang, paragraphs 10 and 53-54, is met by the removing of patient’s personal identification information before entry into the first medical database).
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the functionalities of Reiner to include the removal of a patient’s personal identification information, as taught by Hwang, with the motivation of protecting a patient’s privacy (see: Hwang, paragraph 54).
Response to Arguments
Applicant's arguments filed 6/05/2025 have been fully considered but they are not persuasive.
In regards to the 101 rejection, Applicant argues “that the application of the “abstract idea” test should be inapplicable when the purpose of the invention is to replace a manual process. The invention must produce the same results as the manual process (or an improved version thereof), or the invention would not perform its intended function.” Examiner respectfully disagrees. MPEP 2106.05(f) states that mere instructions to implement an abstract idea (i.e. manual process) on a computer is not enough to qualify as “significantly more”. Implementing an abstract idea (i.e. manual process) on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B (please refer to rejection above), similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. The claims merely invoke a computer as a tool to perform an existing process. The use of the computer in its ordinary capacity for tasks (e.g., to receive, store, analyze, or transmit data) or simply adding a general purpose computer after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more.
In regards to the 102/103 rejection, Applicant argues that the prior art of record fails to disclose “ storing the final response associated with a particular EHR implementation to generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation”. Examiner respectfully disagrees. Examiner asserts that Reiner discloses storing the final response associated with a particular EHR implementation (paragraphs 155 and 160-162, is met by saving the final report in a structured data format after a user has reviewed the discrepancies and made a selection). The concept of the final adjudicated response being stored “to” generate a custom library of alpha-numeric data and library terms pairs associated with the particular EHR implementation is directed to “intended use”. The claims fail to explicitly recite the actual function of generating a custom library based on the final adjudicated response. Therefore, it does not further limit the scope of the claim limitation and under the broadest reasonable claim interpretation, the functional step being claimed is storing the final adjudicated response. In response to Applicant’s arguments regarding “these independent claims now recite a system that allows for AI-based individualized customization of each EHR implementation use at each individual healthcare location”. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., AI-based individualized customization, each individual healthcare location, etc…) are not recited in the rejected independent claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
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FONYA M. LONG
Supervisory Patent Examiner
Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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