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 Claims
Claims 1-4, 6-9, 11-12, 14-21, and 39 are currently pending. Claim 40 is canceled in the Claims filed on September 10, 2026.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 6-9, 11-12, 14-21, and 39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-4, 6-9, 11-12, 14-21, and 39 are within the four statutory categories. Claims 1-4, 6-9, 11-12, 14-20, and 39 are drawn to a method for extracting patient information for clinical trial subjects, which is within the four statutory categories (i.e. process). Claim 21 is drawn to a system for extracting patient information for clinical trial subjects, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 1 recites: A method of establishing a data communication link between an electronic medical record (EMR) for a patient and an electronic record stored in an electronic data capture (EDC) system used for clinical study, the method comprising:
receiving an indication that a new clinical trial subject has been identified from a subject identification source, wherein the new clinical study subject is a patient already determined to meet inclusion/exclusion criteria for the clinical study and not linked to a patient identifier associated with the clinical study in the EDC system;
establishing a data communication link between an EMR associated with the new clinical study subject and an electronic record stored in an electronic data capture (EDC) system, wherein:
the EMR is included in an EMR system configured to store medical information for a plurality of patients, and
the EDC system is configured to store de-identified patient information for the clinical study;
retrieving, from the EMR associated with the new clinical trial subject, patient information;
transforming the retrieved patient information to match a schema of the clinical study to generate transformed patient information;
processing the transformed patient information to de-identify the retrieved patient information thereby generating de-identified patient information; and
automatically providing a portion of the de-identified patient information as input to the EDC system using the data communication link established between the EMR associated with the new clinical study subject and the electronic record stored in the EDC system.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of receiving an indication of a new clinical trial subject, establishing a link between an EMR of the new subject to a record, storing medical data for a plurality of patients, retrieving patient information from the stored EMR, transforming the retrieved patient information to match a schema of the clinical study, de-identifying the transformed patient information to generate de-identified patient information, and providing and storing the de-identified patient information for the clinical study recite limitations similar to the filtering of content in that the claim limitations choose which data (specifically identification information) should be filtered out and which data should be stored), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Claim 21 recites: A computerized system for automatically transferring data from an electronic medical record (EMR) system to an electronic data capture (EDC) system for use in a clinical study, the computerized system comprising:
a subject identification source configured to store an identifier for each of one or more potential clinical study subjects;
subject listing storage configured to pull patient information from the subject identification source to generate a current subject listing data, wherein the current subject listing data includes one or more new clinical study subjects, each of the one or more new clinical study subjects corresponding to a patient already determined to meet inclusion/exclusion criteria for the clinical study and not linked to a patient identifier associated with the clinical study in the EDC system;
a hardware processor programmed to:
request, from the subject listing storage, the current subject listing data;
establish a data communication link between an EMR associated with a new clinical study subject and an electronic record stored in the EDC system, wherein:
the EMR is included in the EMR system configured to store medical information for a plurality of patients, and
the EDC system is configured to store de-identified patient information for the clinical study;
retrieve, from the EMR associated with the one or more new clinical study subjects included in the current subject listing data, patient information;
transform the retrieved patient information to match a schema of the clinical study to generate transformed patient information;
process the transformed patient information to de-identify the retrieved patient information thereby generating de-identified patient information; and
automatically provide a portion of the de-identified patient information as input to the EDC system based, at least in part, on the link between the EMR associated with the clinical study subject and the record stored in the EDC system.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of receiving an indication of a new clinical trial subject, establishing a link between an EMR of the new subject to a record, storing medical data for a plurality of patients, retrieving patient information from the stored EMR, transforming the retrieved patient information to match a schema of the clinical study, de-identifying the transformed patient information to generate de-identified patient information, and providing and storing the de-identified patient information for the clinical study recite limitations similar to the filtering of content in that the claim limitations choose which data (specifically identification information) should be filtered out and which data should be stored), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Dependent Claims 2-4, 6-9, 11-12, 14-20, and 39 include other limitations, for example Claims 2-3 recite requesting a current subject listing and pulling the patient information in response to the request, Claim 4 recites types of subjects for the clinical trial, Claims 6-8 recite linking medical records to patient identifiers via a graphical user interface (GUI), Claim 9 recites generating the record for the clinical study subject, Claims 11-12 recite storing the de-identified patient data and transmitting the data according to healthcare data transfer standards, Claim 14 recites providing a portion of the de-identified patient information as input, Claim 15 recites de-identifying the patient data based on clinical trial requirements, Claim 16 recites types of operations to de-identify the patient information, Claims 17-19 recites retrieving patient information for a particular time window, Claim 20 recites maintaining an audit trail of all transactions associated with retrieving the patient information and generating the de-identified patient information, and Claim 39 recites receiving new information for the new clinical study subject, de-identifying the new information, and providing the new de-identified information, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04, and/or do not further narrow the abstract idea and instead only recite additional elements, which will be further addressed below. Hence dependent Claims 2-4, 6-9, 11-12, 14-20, and 39 are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1.
Hence Claims 1-4, 6-9, 11-12, 14-21, and 39 recite the aforementioned abstract idea.
Prong 2 of Step 2A
Claims 1 and 21 are not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the subject identification source, the EMR system, the EDC system, the hardware processor) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of computer components comprising the hardware processor, the subject identification source, the subject listing storage, the medical records storage, and the EDC system, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see [0031]-[0035] of the as-filed Specification, and see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language reciting that the patient information is specifically for new clinical trial subjects not linked to a patient identifier of a clinical study in the EDC system, which amounts to limiting the abstract idea to the field of healthcare/clinical trials, e.g. see MPEP 2106.05(h).
Additionally, dependent 2-4, 6-9, 11-12, 14-20, and 39 include other limitations, but these limitations also amount to no more than generally linking the abstract idea to a particular technological environment or field of use (e.g. the type of implantable medical device recited in dependent Claim 4), and/or do not include any additional elements beyond those already recited in independent Claim 1, and hence also do not integrate the aforementioned abstract idea into a practical application.
Hence Claims 1-4, 6-9, 11-12, 14-21, and 39 do not include additional elements that integrate the judicial exception into a practical application.
Step 2B
Claims 1 and 21 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the subject identification source, the EMR system, the EDC system, the hardware processor), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, wherein the additional elements comprise limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The present Specification expressly disclosing that the structural additional elements are well-understood, routine, and conventional in nature:
[0031]-[0035] of the as-filed Specification discloses that the additional elements (i.e. the subject identification source, the EMR system, the EDC system, the hardware processor) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. storing data, providing access to the data, and receiving data);
Relevant court decisions: The functional limitations interpreted as additional elements are analogized to the following examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives an indication that a new clinical trial subject has been identified, retrieves patient information from an EMR, and provides de-identified patient information to an EDC system over a network, for example the Internet, e.g. see [0035] of the as-filed Specification;
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the current invention recites storing patient data in an EMR, and retrieving the patient data from storage in order to de-identify the data and provide the de-identified data to the EDC system;
Dependent Claims 2-4, 6-9, 11-12, 14-20, and 39 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly generally link the abstract idea to a particular technological environment or field of use (e.g. the type of implantable medical device recited in dependent Claim 4), and/or the limitations recited by the dependent claims do not recite any additional elements not already recited in independent Claim 1, and hence do not amount to “significantly more” than the abstract idea.
Hence, Claims 1-4, 6-9, 11-12, 14-21, and 39 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-4, 6-9, 11-12, 14-21, and 39 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free From Prior Art
Claims 1-4, 6-9, 11-12, 14-21, and 39 are not presently rejected under 35 U.S.C. 102 or 103, and hence would be in condition for allowance if amended to overcome the rejections presented under 35 U.S.C. 101. The following represents Examiner’s characterization of the most relevant prior art references and the differences between the present claim language and the prior art references in view of 35 U.S.C. 102 and/or 103:
With regards to 35 U.S.C. 102 and/or 103, the following represents the closest prior art to the claimed invention, as well as the differences between the prior art and the limitations of the presently claimed invention.
Dvorak (US 2010/0070306) teaches the anonymization of patient data and the exchange and storage of the anonymized patient data in various databases. However, Dvorak does not teach that the patient records comprise clinical study participants, or that the databases are specifically EDC systems. Additionally, Dvorak does not teach transforming the patient information to match a schema of a clinical study, processing the transformed patient information to de-identify the patient information, and further does not teach providing a portion of the de-identified patient information to an EDC system.
Raduchel (US 2017/0161439) teaches receiving a request to add a new medical record for a patient for a medical study, and further teaches that the requests may be formatted according to formats used by the storage systems for the records. However, Raduchel does not teach that the medical records are for patients who are not yet enrolled in the medical study by virtue of the record not being linked to a patient identifier associated with the medical study in the EDC system. Additionally, Raduchel does not teach transforming patient data retrieved from an EMR into a schema of a particular clinical study, processing the transformed patient information to de-identify the patient information, and further does not teach providing a portion of the de-identified patient information to the EDC system.
Francois (US 2016/0110523) teaches providing access to all or part of de-identified information. Francois further teaches that the system is configured for identifying or enrolling subjects in clinical trials and/or gathering data pertaining to clinical trials. Additionally, Francois teaches that the data processed by the system may be in various formats and may convert data to an appropriate format for transmission to a user, but does not teach that the conversion is for a particular schema of a clinical study, and further does not teach processing the transformed patient information to de-identify the patient information, and further does not teach providing a portion of the de-identified patient information to the EDC system. Furthermore, Francois does not teach that the medical records are for patients who are not yet enrolled in the medical study by virtue of the record not being linked to a patient identifier associated with the medical study in the EDC system.
Fusari (US 2016/0314280) teaches receiving a request to identify potential participants in a clinical study, and tracks patients who have been recruited and agreed to participate in the study. However, Fusari does not teach establishing a data communication link between an EMR and a record stored in an EDC. Additionally, Fusari does not teach transforming patient data retrieved from an EMR into a scheme of a particular clinical study, processing the transformed patient information to de-identify the patient information, and further does not teach providing a portion of the de-identified patient information to the EDC system.
DeMeyer (US 2011/0313782) teaches a plurality of clinical trial systems in communications with one another via a middleware/integration platform, wherein a first system may enroll a new patient in a clinical trial, send a message to the middleware platform, and transmit a second message to another clinical trial system to notify that clinical trial system that a new patient has been enrolled in the clinical trial of the first system. However, DeMeyer does not teach retrieving patient information from an EMR, transforming the retrieved patient information to match the schema of the clinical study, de-identifying the transformed patient information, and providing a portion of the de-identified patient information as input to the EDC.
The aforementioned references are understood to be the closest prior art. Various aspects of the claimed invention are known individually, but for the reasons disclosed above, the particular manner in which the elements of the present invention are claimed, when considered as an ordered combination, distinguishes from the aforementioned references and hence the invention recited in Claims 1-4, 6-9, 11-12, 14-21, and 39 is not considered to be disclosed by and/or obvious in view of the inventions of the closest prior art references.
Response to Arguments
Applicant’s arguments, see Remarks, filed September 10, 2026, with respect to the rejections of Claims 1-4, 6-9, 11-12, 14-21, and 39 under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicant alleges that the claimed invention is patent eligible because it integrates any alleged abstract idea into a practical application, specifically analogizing the claimed invention and its accompanying Specification to the invention and background of Example 42 of the USPTO-issued Subject Matter Eligibility Examples, e.g. see pgs. 11-12 of Remarks – Examiner disagrees.
The invention of Example 42 recites a method that allows for users to access patients’ medical records and receive updated patient information in real time from other users, which recites a method of organizing human activity because it is a method of managing interactions between people. Furthermore, the invention of Example 42 was deemed patent eligible because it integrated the abstract idea into a practical application because it recited a specific improvement over prior art systems by allowing remote users to share information in real time in a standardized format regardless of the format in which the information was input by the user. Additionally, the background of Example 42 disclosed that the invention addressed the difficulty in sharing updated patient information with other health care providers immediately. In contrast, the claimed invention recites an EMR in communications with an EDC, wherein data retrieved from the EMR is converted to a schema of a clinical study before being provided to the EDC, but there is no disclosure of this operation occurring and/or being shared with multiple disparate entities in real-time. Additionally, the invention of Example 42 explicitly claimed that the information was in a first, non-standardized format and converted to a second, standardized format, and in contrast, the claimed invention does not define the initial format of the information retrieved from the EMR, and presumably the transforming step would become unnecessary if the retrieved information were already in a “matching schema” of the clinical study. For example, the aforementioned functionality is disclosed in [0026] of the as-filed Specification, which states that “if the information is stored in the patient’s EMR according to particular standard (e.g. standardized FHIR data models), the information may be provided to the EDS from the EMR without transformation.” Hence, unlike the invention of Example 42, the claimed invention processes data that may already be in a standardized format. Therefore, the claimed invention is not properly analogized to the invention of Example 42.
Additionally, regarding the “particular technique for transforming data from a patient’s medical record,” Examiner notes that a “particular transformation or reduction of a particular article to a different state or thing” may represent significantly more than an abstract idea. However, “an ‘article’ includes a physical object or substance,” rather than data, e.g. see MPEP 2106.05(c). Moreover, the present Claims merely recite “transforming the retrieved patient information to match a schema of the clinical study,” without reciting any details regarding the transformation. That is, the claimed invention does not recite a particular transformation because it does not recite an “article,” and even assuming, arguendo, that it did recite an article, it does not recite a transformation of the article with sufficient particularity/detail to demonstrate a practical application of the abstract idea.
For the aforementioned reasons, Claims 1-4, 6-9, 11-12, 14-21, and 39 are rejected under 35 U.S.C. 101.
Applicant’s arguments, see Remarks, filed September 10, 2026, with respect to the rejections of Claims 1-4, 6-9, 11-12, 14-21, and 39 under 35 U.S.C. 103 have been fully considered and are persuasive for the reasons disclosed above. Hence, the rejections of Claims 1-4, 6-9, 11-12, 14-21, and 39 under 35 U.S.C. 103 are withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Ennist (US 2020/0105380) – teaches determining whether candidate patients should be enrolled in clinical trials based on predicted values meeting criteria.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P GO whose telephone number is (703)756-1965. The examiner can normally be reached Monday-Friday 9am-6pm Pacific.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H CHOI can be reached at (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN P GO/Primary Examiner, Art Unit 3681
