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 claims filed on 04 December 2025. Claims 8-14 and 16-19 were amended. Claim 15 was canceled Claims 1-7 were previously canceled. Claims 8-14 and 16-19 are currently pending and have been examined.
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.
Use of “means” in claims 11
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “user credential verification means” in lines 1-2 of claim 11.
Because this claim limitation(s) is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Use of “module” in claims 8 and 12
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 CRF module” in line 16 and the “data processing module” in line 25 of claim 8, and “appointment-card generation module” in line 1 of claim 12.
Because 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.
Claim Rejections - 35 USC § 112(b)
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 8-14 and 16-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation “the data processing module” in line 25. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this element will be considered to state “a data processing module.” Appropriate correction is required. Claims 9-14 and 16-19 inherit this deficiency.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14 and 16 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claims upon which they depends, or for failing to include all the limitations of the claim upon which it depends. The subject matter in claim 14 and in claim 16 is already recited in the newly amended claim 8, from which these claims depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 8-14 and 16-19 are rejected under 35 USC § 101
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Claims 8-14 and 16-19 fall within one or more statutory categories. Claims 8-14 and 16-19 fall within the category of a process.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 8-14 and 16-19 recite an abstract idea. Representative claim 8 recites:
… generate protocol-violation fields when data entries fail compliance checks against a clinical trial protocol;
generating an appointment card based on a clinical trial protocol and a list of planned procedures and measurements;
exporting of a list of measured parameters from the appointment card to the CRF and EHR system in order to ensure uniformity and standardization of data,
defining and then imposing a limit on the selection of possible entries for physicians to report on clinical trial results and providing possible entries to the EHR system, including templates containing possible fields and entries for fields enforcing numeric-range and pick-list constraints on each CRF field in real time, and issuing an immediate alert … whenever an entered value falls outside predefined limits;
supporting multi-dimensional event reporting … to enumerate and classify serious adverse events;
… accept entry templates and define possible entries for the templates;
receiving … source data containing electronic health records (EHR) from multiple patients seeking treatment at one or more physical clinical trial sites, where EHR data includes data relevant to the clinical trial and other medical data, including personal data, medical history and medical records;
… enabling direct statistical analysis of data … to generate disease descriptions and structured medical record templates based on the clinical trial protocol, with the templates containing a tree structure of fields and branches assigned to predefined text templates;
displaying contents of the CRF form …;
analyzing and comparing … of CRF input data with corresponding EHR data to ensure consistency by automatic reconciliation of data, and limiting acceptable input data choices to enforce uniformity and comparability of input data from different study locations and from different clinicians.
Therefore, the claim as a whole is directed to “monitoring clinical trials,” which is an abstract idea because it is a method of organizing human activity. “Monitoring clinical trials” is considered to be a method of organizing human activity because it is an example of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The broadest reasonable interpretation of the claims include monitoring and managing clinical trial participants, including healthcare providers and patients.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application. In particular, claim 8 recites the following additional element(s):
providing a system providing a case report form (CRF) and electronic health record (EHR) data store and system;
embedding conditional directives that automatically [generate the protocol-violations];
a user interface;
embedding a list and index macros into Medical Records (MR) templates;
[using] a networked system;
providing a CRF module;
processing of data entered into EHR and CRF by physicians/investigators into quantified digital values;
using programmable instructions;
a graphical user interface for user interaction on a central unit or at least one peripheral device;
a data processing module.
The additional elements individually or in combination do not integrate the exception into a practical application. These additional element merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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 they do not impose any meaningful limits on practicing the abstract idea. Claim 8 is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 8 does not include additional elements, considered individually or in combination, that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element(s), individually and in combination, merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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, claim 8 is ineligible.
Dependent claim 9 recites the method of claim 8, wherein:
clinical trial results include observations of a patient's clinical medical and physical status and test results.
This merely further limits the abstract idea of claim 8 discussed above and does not provide further additional elements. Therefore, claim 9 is considered to be ineligible.
Dependent claim 10 recites the method of claim 8, wherein:
the peripheral is selected from a personal computer, laptop, tablet, or smartphone.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 10 is ineligible.
Dependent claim 11 recites the method of claim 8, wherein:
user-credential verification means selected from a user name and password, a fingerprint reader, a retinal scanner, and a magnetic-stripe card reader.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 11 is ineligible.
Dependent claim 12 recites the method of claim 8, wherein:
generation of the appointment card invokes a translation engine containing a repository of medical terms and disease-classification codes and is configured to render appointments and procedure lists in a physician's native language.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 12 is ineligible.
Dependent claim 13 recites the method of claim 8, wherein:
the CRF module employs a template engine supporting conditional text blocks defined by if-else directives that evaluate clinical-protocol compliance and selectively display protocol-violation fields.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 13 is ineligible.
Dependent claim 14 recites the method of claim 8, wherein:
the CRF module supports multi-dimensional event reporting by embedding list and endlist directives and index macros into medical report (MR) templates to enumerate and classify serious adverse events.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 14 is ineligible.
Dependent claim 16 recites the method of claim 8, further comprising:
enforcing numeric-range and pick-list constraints on each CRF field and issuing an immediate alert to the user interface whenever an entered value falls outside predefined limits.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 16 is ineligible.
Dependent claim 17 recites the method of claim 8, further comprising:
flagging affected fields for clarification and dispatching a notification of any discrepancy upon detecting any discrepancy between a CRF entry and the corresponding EHR record, to the at least one peripheral device.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 17 is ineligible.
Dependent claim 18 recites the method of claim 8, wherein:
anonymizing personal identifiers in the EHR data stored before exporting, ensuring that all downstream monitoring and consistency checks are performed on de-identified patient data.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 18 is ineligible.
Dependent claim 19 recites the method of claim 8, wherein:
rendering MR templates as static text segments interspersed with interactive variable placeholders that, when selected, launch context-sensitive editors tailored to a data type of the variable placeholder.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 19 is ineligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8-11, 13-14, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Poppa et al. (U.S. 2020/0243169), hereinafter “Poppa,” in view of Guda (U.S. 2021/0055942), hereinafter “Guda.”
Regarding Claim 8, method for automated monitoring of clinical trials conducted at physical locations, comprising:
providing a system providing a case report form (CRF) (See Poppa [0021] the system can use electronic case report forms, designed to record protocol-related clinical study data. See also [0117].) and electronic health record (EHR) data store and system (See Poppa [0018] the system includes the use of an EHR system, an electronic platform that contains individual electronic health records for patients and may be maintained by healthcare organizations and institutions. See also [0072]-[0073].);
embedding conditional directives that automatically generate protocol-violation fields when data entries fail compliance checks against a clinical trial protocol (See Poppa [0149] the system includes an automatic case record validation routine. [0150] flagging case record values as valid/invalid or out-of-bounds, and many more possible flags or metatags may be applied. A monitor may request that certain value ranges for particular types of source data values be flagged as “of interest” or “clinically significant” to thereby speed the review of the case records while the monitor may be engaged with reviewing other materials, sites, and/or subjects. See also [0156]. Fig. 8 and [0152] the disclosed routine includes yes/no questions for case review that meet the broadest reasonable interpretation of “if-else directives.” See also Fig. 9 and [0156]. [0157] While an example case record field and/or case record value validation subroutine has been shown with example tests, other tests/validations/comparisons/reviews options may be present. There may be statistical testing for fraudulent or fabricated data.);
generating an appointment card based on a clinical trial protocol and a list of planned procedures and measurements (See Poppa [0012] the system includes a study protocol, that outlines the study design, such as who should participate in the trial (inclusion and exclusion criteria) and the objective(s), design, methodology, statistical considerations, and organization of the trial. [0016] the system can implement the use of subject binders, a collection of source documents and other source data for an individual participant in a clinical trial (EMR & non-EMR source documents, such as questionnaires, external lab results, or research-related evaluations that may not be part of standard of care). A participant's subject binder may also contain other documents, such as checklists or worksheets, or participant informed consent forms or HIPAA authorizations for that participant. A site's set of records and Source Documents pertaining to a specific Subject for a specific Study. [0107] the system can store the source data from the subject binder in a universally accessible location. The broadest reasonable interpretation of this element includes the use of a subject binder for storing protocol related to patient participation such as appointments, planned procedures, and measurements. See also [0078].);
exporting of a list of measured parameters from the appointment card to the CRF and EHR system (See Poppa [0113] the system includes the use of stored study data that can be used to fill out the case report forms. See also [0117]) in order to ensure uniformity and standardization of data (Examiner notes that this language is considered to be intended use and is not given patentable weight. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation (see MPEP 2103(I)(C)).),
… enforcing numeric-range and pick-list constraints on each CRF field in real time (See Poppa [0149] the system includes an automatic case record validation routine. [0150] flagging case record values as valid/invalid or out-of-bounds, and many more possible flags or metatags may be applied. A monitor may request that certain value ranges for particular types of source data values be flagged as “of interest” or “clinically significant” to thereby speed the review of the case records while the monitor may be engaged with reviewing other materials, sites, and/or subjects. See also [0156].), and issuing an immediate alert to a user interface whenever an entered value falls outside predefined limits (See Poppa [0125] For example, research study records associated with a particular trial identifier may include predetermined data ranges for study data. Upon obtaining new study data, trial data processing service may compare the obtained study data to the predetermined data ranges for the study data and, if the study data is outside the predetermined data range, the trial data processing service may flag the study data for further follow up/investigation. [0126] a notification may be provided to the research coordinator responsible for the flagged study data so the flagged study data may be updated and re-validated.);
… enumerate and classify serious adverse events (See Poppa [0150] flagging case record values as valid/invalid or out-of-bounds, and many more possible flags or metatags may be applied. A monitor may request that certain value ranges for particular types of source data values be flagged as “of interest” or “clinically significant” to thereby speed the review of the case records while the monitor may be engaged with reviewing other materials, sites, and/or subjects. See also [0156].);
receiving, through a networked system (See Poppa Fig. 1 and [0066] the system includes network connectivity.), source data containing electronic health records (EHR) from multiple patients seeking treatment at one or more physical clinical trial sites (See Poppa [0113] the system includes the use of stored study data that can be used to fill out the case report forms. See also [0007].), where EHR data includes data relevant to the clinical trial and other medical data, including personal data, medical history and medical records (See Poppa [0018] the system includes the use of an EHR system, an electronic platform that contains individual electronic health records for patients and may be maintained by healthcare organizations and institutions. See also [0072]-[0073].);
providing a CRF module that is configured to accept entry templates and define possible entries for the templates (See Poppa [0021] the system can use electronic case report forms. [0117] the system can compare data enter to document templates.);
processing of data entered into EHR and CRF by physicians/investigators into quantified digital values (See Poppa [0118] the system can extract potential study data from the identified locations, and automatically transcribe the potential study data into the case report form.), enabling direct statistical analysis of data using programmable instructions configured to generate disease descriptions and structured medical record templates based on the clinical trial protocol (See Poppa [0012] the system includes a study protocol, or description of the trial, including eligible participants and objectives. [0018] the system also includes EHR data that includes diagnoses and treatments of participants. Therefore, it is understood that the system includes a description of the illness or condition being study in the clinical trial.);
displaying contents of the CRF form on a graphical user interface for user interaction on a central unit or at least one peripheral device (See Poppa [0114] the research study data acquisition and quality control application may provide a user interface via display for the input of information. [0069] the devices used in the system can include general purpose computers and mobile devices.);
analyzing and comparing by a data processing module of CRF input data with corresponding EHR data (See Poppa [0065] the system can obtain study data from source data or documents and verify transcribed study data against associated source data or documents. [0119] the system can analyze the potential study data for indications of invalidity. See also [0023] and [0121]. [0123] the validation of study data refers to testing whether the study data obtained by trial data processing service matches the underlying source data and that the underlying source data is valid against any predetermined parameters that may exist.) to ensure consistency by automatic reconciliation of data (Examiner notes that this language is considered to be intended use and is not given patentable weight. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation (see MPEP 2103(I)(C)).), and limiting acceptable input data choices (See Poppa [0115] the system can display an editable study data form, the research coordinator may then manually copy the relevant study data from the representation of the file to the fillable study data form. This limits input choice to those parts of the form that the system leaves editable. [0113] the case report forms can be used to consolidate data from various other records and forms. Therefore, it is understood that the case report forms are pre-defined and used to make the input data more uniform. See also Fig. 10) to enforce uniformity and comparability of input data from different study locations and from different clinicians (Examiner notes that this language is considered to be intended use and is not given patentable weight. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation (see MPEP 2103(I)(C)).).
Poppa does not disclose:
defining and then imposing a limit on the selection of possible entries for physicians to report on clinical trial results and providing possible entries to the EHR system, including templates containing possible fields and entries for fields;
supporting multi-dimensional event reporting by embedding a list and index macros into Medical Records (MR) templates to enumerate and classify serious adverse events;
with the templates containing a tree structure of fields and branches assigned to predefined text templates.
Guda teaches:
defining and then imposing a limit on the selection of possible entries for physicians to report on clinical trial results and providing possible entries to the EHR system, including templates containing possible fields and entries for fields (See Guda Fig. 2 and [0031] the system has multiple sections for the CRF with variables required to be entered on each section. Fig. 3 and [0032] variables can be entered into the CRF.);
supporting multi-dimensional event reporting by embedding a list and index macros into Medical Records (MR) templates (See Guda Fig. 3 on the right side of the user interface allows for the addition of fields and groups of fields. This supports multidimensional data entry.)) to enumerate and classify serious adverse events (Examiner notes that this language is considered to be intended use because the “multi-dimensional event reporting” is not required to be performed as written and is not given patentable weight. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation (see MPEP 2103(I)(C)).);
with the templates containing a tree structure of fields and branches assigned to predefined text templates (See Guda Fig. 2 and [0031] the system has multiple sections for the CRF with variables required to be entered on each section. Fig. 3 and [0032] variables can be entered into the CRF. Fig. 3 shows the different selectable sections for entering the data into templates. These meet the broadest reasonable interpretation of a tree structure.).
The system of Guda is applicable to the disclosure of Poppa as they both share characteristics and capabilities, namely, they are directed to collecting clinical trial data. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Poppa to include more extensive data structures and multilingual capabilities as taught by Guda. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Poppa in order to make multilingual reporting less difficult by having the data collection use the same underlying database structures across regions/languages (see Guda [0005]).
Regarding claim 9, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa further discloses a method, in which:
clinical trial results include observations of a patient's clinical medical and physical status and test results (See Poppa [0016] the system can use subject binders which include EMR & non-EMR source documents, such as questionnaires, external lab results, or research-related evaluations that may not be part of standard of care. [0021] the system can use case report forms designed to record protocol-related study data. See also [0012].).
Regarding claim 10, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa further discloses a method, wherein:
the peripheral is selected from a personal computer, laptop, tablet, or smartphone (See Poppa [0069] the devices used in the system can include general purpose computers and mobile devices.).
Regarding claim 11, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa further discloses a method, comprising:
user-credential verification means selected from a user name and password, a fingerprint reader, a retinal scanner, and a magnetic-stripe card reader (See Poppa [0107] user needs credentials to access the trial data. See also [0108]. [0044] the monitor can have access via login. This is understood to include a username and password.).
Regarding claim 13, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa further discloses a method, wherein:
the CRF module employs a template engine supporting conditional text blocks defined by if-else directives that evaluate clinical-protocol compliance and selectively display protocol-violation fields (See Poppa [0150] flagging case record values as valid/invalid or out-of-bounds, and many more possible flags or metatags may be applied. A monitor may request that certain value ranges for particular types of source data values be flagged as “of interest” or “clinically significant” to thereby speed the review of the case records while the monitor may be engaged with reviewing other materials, sites, and/or subjects. Fig. 8 and [0152] the disclosed routine includes yes/no questions for case review that meet the broadest reasonable interpretation of “if-else directives.” See also Fig. 9 and [0156]. [0157] While an example case record field and/or case record value validation subroutine has been shown with example tests, other tests/validations/comparisons/reviews options may be present. There may be statistical testing for fraudulent or fabricated data.).
Regarding claim 14, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa does not further disclose a method, wherein:
the CRF module supports multi-dimensional event reporting by embedding list and endlist directives and index macros into medical report (MR) templates to enumerate and classify serious adverse events.
Guda teaches:
the CRF module supports multi-dimensional event reporting by embedding list and endlist directives and index macros into medical report (MR) templates (See Guda Fig. 3 on the right side of the user interface allows for the addition of fields and groups of fields. This supports multidimensional data entry.)) to enumerate and classify serious adverse events (Examiner notes that this language is considered to be intended use because the “multi-dimensional event reporting” is not required to be performed as written and is not given patentable weight. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation (see MPEP 2103(I)(C)).).
The system of Guda is applicable to the disclosure of Poppa as they both share characteristics and capabilities, namely, they are directed to collecting clinical trial data. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Poppa to include more extensive data structures and multilingual capabilities as taught by Guda. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Poppa in order to make multilingual reporting less difficult by having the data collection use the same underlying database structures across regions/languages (see Guda [0005]).
Regarding claim 16, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa further discloses a method, comprising:
enforcing numeric-range and pick-list constraints on each CRF field and issuing an immediate alert to the user interface whenever an entered value falls outside predefined limits (See Poppa [0125] For example, research study records associated with a particular trial identifier may include predetermined data ranges for study data. Upon obtaining new study data, trial data processing service may compare the obtained study data to the predetermined data ranges for the study data and, if the study data is outside the predetermined data range, the trial data processing service may flag the study data for further follow up/investigation.[0126] a notification may be provided to the research coordinator responsible for the flagged study data so the flagged study data may be updated and re-validated.).
Regarding claim 17, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa further discloses a method, comprising:
flagging affected fields for clarification and dispatching a notification of any discrepancy upon detecting any discrepancy between a CRF entry and the corresponding EHR record, to the at least one peripheral device (See Poppa [0119] the system can analyze the potential study data for indications of invalidity and flag such indications for manual review. [0126] a notification can be sent based on the flagged study data. See also [0023]. [0069] the devices used in the system can include general purpose computers and mobile devices.).
Regarding claim 19, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa further discloses a method, comprising:
rendering MR templates as static text segments interspersed with interactive variable placeholders that, when selected, launch context-sensitive editors tailored to a data type of the variable placeholder (See Poppa Fig. 10 and [0158] review interface with static text and boxes for editing variable text. See also Fig. 11 and [0159]. These meet the broadest reasonable interpretation of context specific editors because the data fields are labeled and show whether the data should match a number exactly or meet a more/less condition.) .
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Poppa et al. (U.S. 2020/0243169), hereinafter “Poppa,” in view of Guda (U.S. 2021/0055942), hereinafter “Guda,” and further in view of Shah (U.S. 2004/0093240), hereinafter “Shah.”
Regarding claim 12, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa does not further disclose a method, wherein:
generation of the appointment card invokes a translation engine containing a repository of medical terms and disease-classification codes
and is configured to render appointments and procedure lists in a physician's native language.
Guda teaches:
generation of the appointment card … is configured to render appointments and procedure lists in a physician's native language (See Guda [0030] the system includes the ability to collect data in forms using multiple different languages. [0036] the system allows for adding variables and data sets in different languages. The entry boxes are same across each language, and therefore the they are uniform and pre-defined.).
The system of Guda is applicable to the disclosure of Poppa as they both share characteristics and capabilities, namely, they are directed to collecting clinical trial data. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Poppa to include more extensive data structures and multilingual capabilities as taught by Guda. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Poppa in order to make multilingual reporting less difficult by having the data collection use the same underlying database structures across regions/languages (see Guda [0005]).
Shah teaches:
generation of the appointment card invokes a translation engine containing a repository of medical terms and disease-classification codes (See Shah [0080] the system is connected to dictionaries and standards. This includes ICD codes and other standards. [0092] the system includes an autoencoding component that codes disease categories to the data. This is understood to be a translation from the data without the codes to the data labeled with the codes.).
The system of Shah is applicable to the disclosure of Poppa in view of Guda as they both share characteristics and capabilities, namely, they are directed to monitoring clinical trials. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Poppa to include medical codes generation as taught by Shah. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Poppa in order to reduce the tremendous inefficiencies and redundancies that exist in known processes for conducting clinical trials (see Shah [0011]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Poppa et al. (U.S. 2020/0243169), hereinafter “Poppa,” in view of Guda (U.S. 2021/0055942), hereinafter “Guda,” and further in view of Tidor (U.S. 20150269355), hereinafter “Tidor.”
Regarding claim 18, Poppa in view of Guda discloses the method of claim 8 as discussed above. Poppa does not further disclose a method, comprising:
anonymizing personal identifiers in the EHR data stored before exporting, ensuring that all downstream monitoring and consistency checks are performed on de-identified patient data.
Tidor teaches:
anonymizing personal identifiers in the EHR data stored before exporting (See Tidor [0029] clinical trial data can be provided to a monitor maintaining patient confidentiality and the blind or double-blind nature of the clinical trial. [0082] data can be accessed and output can be reported in de-identified form.), ensuring that all downstream monitoring and consistency checks are performed on de-identified patient data (Examiner notes that this language is considered to be intended use and is not given patentable weight. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation (see MPEP 2103(I)(C)).
The system of Tidor is applicable to the disclosure of Poppa in view of Guda as they both share characteristics and capabilities, namely, they are directed to data collection in clinical trials. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Poppa to include de-identifying patient data as taught by Tidor. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Poppa in order to implement privacy and security consistent with best practices and legal requirements for handling personal medical information and health records (see Tidor Abstract).
Response to Arguments
Applicant's arguments filed 04 December 2025, with respect to the 35 U.S.C. §101 rejection of the claims, have been fully considered but they are not persuasive. Applicant argues that the claims include additional elements that integrate the abstract idea into a practical application and include significantly more than the judicial exception (see Applicant Remarks pages 7-9). This is not persuasive. There is no improvement to the functioning of a computer. The additional elements recited in the claims, including the newly amended ones, amount to merely reciting the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). The additional elements in the claims do not integrate the abstract idea into a practical application (under Step 2A Pring Two) and do not make the claims amount to significantly more than the judicial exception (under Step 2B).
Applicant also briefly argues that the present claims are analogous to Example 37 and Example 42 of the Patent Eligibility guidance. (see Applicant Remarks page 9). This is not persuasive. The present claims are not analogous to those examples. The present claims recited an abstract and the additional elements in the present claims do not integrate the abstract idea into a practical application or amount to significantly more. Accordingly, the claims remain rejected as being directed to ineligible subject matter.
Applicant's arguments filed 04 December 2025, with respect to the prior art used in the previous 35 U.S.C. §103 rejection of the claims, have been fully considered and are persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of the previously recited Poppa and Guda references.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rosenberg (U.S. 2008/0270420) discloses a system for verifying clinical trial data.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.L.H./Examiner, Art Unit 3684
/KENNETH BARTLEY/Primary Examiner, Art Unit 3684