DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to the response filed 4 May 2026, which claims priority to a provisional application filed 14 July 2017.
Claims 1-13, 15-28 and 30 are currently pending and have been examined.
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 1-13, 15-28, and 30 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 1-13, 15-28, and 30 are within the four statutory categories. Claims 1-13 and 15 are drawn to a computerized method for creating an electronic consent based-medical record, which is within the four statutory categories (i.e. process). Claims 16-28 and 30 are drawn to a system for creating an electronic consent based-medical record, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 1 recites: A computerized method for creating an electronic consent-based medical record comprising:
providing a server computer comprising one or more processors communicably coupled to an input/output interface, a memory, and a medical provider data storage containing an electronic health record for the patient, and a third-party data storage communicably coupled to the server via the input/output interface, wherein the third-party data storage contains an electronic educational information for a plurality of medical procedures, a set of consent-based questions for each of the plurality of medical procedures, an electronic consent form for each of the plurality of medical procedures, and an electronic consent-based medical record for one or more patients;
receiving a medical procedure identifier for a patient via the input/output interface;
automatically creating the electronic consent-based medical record for the patient and storing the electronic consent-based medical record in the data storage using the one or more processors, wherein the electronic consent-based medical record comprises a data structure comprising a medical data for the patient, a selected electronic consent form for a medical procedure associated with the medical procedure identifier, a selected electronic educational information for the medical procedure associated with the medical identifier, a set of consent-based questions for the medical procedure associated with the medical identifier, an electronic consent, and an electronic authorization;
automatically receiving the medical data from the electronic health record for the patient within the medical provider data storage via the input/output interface;
automatically storing the medical data in the electronic consent-based medical record for the patient in the third-party data storage;
automatically selecting one of the electronic consent forms for the medical procedure associated with the medical procedure identifier for the patient from the plurality of electronic consent forms within the third-party data storage,
automatically selecting one of the electronic education information for the medical procedure associated with the medical procedure identifier for the patient from the plurality of electronic consent forms within the third-party data storage;
automatically selecting one of the sets of consent-based questions for the medical procedure associated with the medical procedure identifier for the patient from the plurality of sets of consent-based questions within the third-party storage;
automatically storing the selected electronic consent form, the selected electronic education information and the selected set of consent-based questions in in the electronic consent-based medical record for the patient in the third-party data storage using the one or more processors, wherein the electronic educational information comprises one or more of a video, an audio recording, an electronic document, an electronic presentation, an image, or a hyperlink;
downloading the selected electronic educational information, the selected electronic consent form and the selected set of consent-based questions for the medical procedure for the patient from the electronic consent-based medical record to a remote device prior to a meeting with the patient;
automatically updating, in real-time, the selected electronic educational information, the selected electronic consent form or the selected set of consent-based questions for the medical procedure for the patient on the remote device whenever a change is made on the server to the selected electronic educational information, the selected electronic consent form or the selected set of consent-based questions for the medical procedure for the patient;
electronically providing the selected electronic educational information, the selected electronic consent form and the selected set of consent-based questions for the medical procedure to the patient at a meeting with the patient via an input/output interface of the remote device;
receiving a completed electronic consent form, a completed set of consent-based questions and the electronic consent from the patient via the input/output interface of the remote device after electronically providing the selected electronic educational information, the selected electronic consent form and the selected set of consent-based questions for the medical procedure to the patient;
automatically storing the completed electronic consent form, a completed set of consent-based questions and electronic consent from the patient in the electronic consent-based medical record in the third-party data storage using the one or more processors;
receiving the electronic authorization from the medical provider indicating that the patient reviewed the electronic educational information, answered the consent-based questions and provided the electronic consent via the input/output interface, wherein the electronic authorization from the medical provider provides a first level of verification that the patient provided informed consent;
automatically storing the electronic authorization from the medical provider in the electronic consent-based medical record for the patient in the third-party data storage using the one or more processors;
providing a third-party report from an independent physician validating the electronic consent-based medical record to the medical provider after storing the completed consent form, the completed set of consent-based questions and electronic consent from the patient and the electronic authorization from the medical provider in the electronic consent-based medical record for the patient in the third-party data storage, wherein the third-party report from the independent physician provides a second level of verification that the patient provided informed consent; and
automatically sending the completed electronic consent form, the completed set of consent-based questions for the medical procedure, the electronic consent and the electronic authorization from the medical provider to the electronic health record for the patient within the medical provider data storage.
The underlined limitations constitute: “certain methods of organizing human activity.” For example, a person may follow rules or instructions to obtain and store a patient’s medical consent. The limitations below merely describe receiving a procedure from a doctor, identifying procedure information, generating consent questions for the procedure, sending the procedure information to the patient for their consent and review, sending the consent to a doctor for authentication and storing the information. The instant claims are similar to the method of organizing human activity of MPEP 2106.04(a)(2)(II)(C)(iii) stating an example of managing personal behavior is “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982).”
Furthermore, the abstract idea for claim 16 is identical to the abstract idea for claim 1 because the only difference between claims 1 and 16 is that claim 1 recites a method, whereas claim 8 recites a system.
Dependent claims 2-13, 15, 16-28 and 30 include other limitations, for example claims 3, 4, 6, 7, 12, 18-22, 27 further disclose details regarding the electronic consent and/or questions, and claims 8-11, 13, 17, 23-26, 28 requests or provide additional 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. Additionally, any limitations in dependent claims 2-13, 15, 16-28 and 30 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2-13, 15, 16-28 and 30 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 16.
Prong 2 of Step 2A
Claims 1-20 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the structural components of the computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs 40 and 56-60 of the present Specification, 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 limiting the data to healthcare-related data, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 2-13, 15, 16-28 and 30 include other limitations, but these limitations also amount to no more than mere instructions to apply the exception (e.g.
The executable file and encrypting of communication of claims 2, 15, 19 and 30), generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2-13, 15, 16-28 and 30), and/or do not include any additional elements beyond those already recited in independent claims 1 and 16, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1-20 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 structural components of the computer), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs 40 and 56-60 of the Specification discloses that the additional elements (i.e. the structural components of the computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log); and
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Dependent claims 2-13, 15, 16-28 and 30 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1 and 16, and/or the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g.
The executable file and encrypting of communication of claims 2, 15, 19 and 30), generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2-13, 15, 16-28 and 30), and hence do not amount to “significantly more” than the abstract idea.
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 1-13, 15-28, and 30 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
Applicant’s arguments filed on 4 May 2026, with respect to the 35 USC § 112 rejection have been considered and the arguments are persuasive. Accordingly, this rejection has been withdrawn.
Applicant’s arguments filed on 4 May 2026, with respect to the 35 USC § 101 rejection have been considered. However, the argument is not persuasive.
Applicant argues on pages 2-6 that the claims comprise statutory material because:
A. The claims as amended improve the technical field of electronic medical records and “the creation, data acquisition and storage of an accurate, electronic, secure, multi-level verified patient consent.”
B. The combination of additional elements integrates the judicial exception into a practical application similar to Example 42 of the PEG, under Step 2A – Prong Two.
C. The claims recite additional elements, such as creating a medical record, providing real time updates, that amount to significantly more than the judicial exception,
The Office respectfully disagrees. Please see the updated statutory rejection of the claims above, wherein the claims are shown to be directed to an abstract idea without significantly more.
Regarding argument A., MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, the Office cannot find, nor has the Applicant identified, any technological problem that was caused by the technological environment to which the claims are confined.
MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, the Applicant’s argued problem is not a technological problem caused by the computing environment. The problem of maintaining patient records and acquiring patient consent was not a problem cause by the computer, is it a problem that existed and/or exists regardless of whether a computer is involved in the process. At best, Applicant’s identified problem is a business problem. Because no technological problem is present, the claims do not provide a practical application.
Argument B. is not persuasive because any additional elements are performing generic computer functions. The data structure and electronic consent-based medical record, as claimed, are similarly performing a generic computer function of data storage. The same is true of the remote device, data storage and the interactions between the server and the remote device and data storage. Further, there is no evidence on record that the various additional elements of the claim are arranged in an unconventional manner.
Argument C. is not persuasive. The elements identified as “additional elements” are identified above as being part of the abstract idea, and do not amount to significantly more, either alone or in combination with the rest of the claimed elements.
Accordingly, the statutory rejection is upheld.
Applicant’s arguments and amendments, filed on 5 July 2024, with respect to the 35 USC § 103 rejection have been considered and are persuasive.
With regards to the 103 rejection of claims 1-13, 15-28, and 30, the prior art of record teaches: A computerized method for creating an electronic consent-based medical record comprising:
providing a server computer comprising one or more processors communicably coupled to an input/output interface, a memory, and a medical provider data storage containing an electronic health record for the patient, and a third-party data storage communicably coupled to the server via the input/output interface, wherein the third-party data storage contains an electronic educational information for a plurality of medical procedures, a set of consent-based questions for each of the plurality of medical procedures, an electronic consent form for each of the plurality of medical procedures, and an electronic consent-based medical record for one or more patients;
receiving a medical procedure identifier for a patient via the input/output interface;
creating the electronic consent-based medical record for the patient and storing the electronic consent-based medical record in the data storage using the one or more processors, wherein the electronic consent-based medical record comprises a data structure comprising a medical data for the patient, a selected electronic consent form for a medical procedure associated with the medical procedure identifier, a selected electronic educational information for the medical procedure associated with the medical identifier, a set of consent-based questions for the medical procedure associated with the medical identifier, an electronic consent, and an electronic authorization;
receiving the medical data from the electronic health record for the patient within the medical provider data storage via the input/output interface;
storing the medical data in the electronic consent-based medical record for the patient in the third-party data storage;
selecting one of the electronic consent forms for the medical procedure associated with the medical procedure identifier for the patient from the plurality of electronic consent forms within the third-party data storage,
selecting one of the electronic education information for the medical procedure associated with the medical procedure identifier for the patient from the plurality of electronic consent forms within the third-party data storage;
selecting one of the sets of consent-based questions for the medical procedure associated with the medical procedure identifier for the patient from the plurality of sets of consent-based questions within the third-party storage;
storing the selected electronic consent form, the selected electronic education information and the selected set of consent-based questions in in the electronic consent-based medical record for the patient in the third-party data storage using the one or more processors, wherein the electronic educational information comprises one or more of a video, an audio recording, an electronic document, an electronic presentation, an image, or a hyperlink;
downloading the selected electronic educational information, the selected electronic consent form and the selected set of consent-based questions for the medical procedure for the patient from the electronic consent-based medical record to a remote device prior to a meeting with the patient;
electronically providing the selected electronic educational information, the selected electronic consent form and the selected set of consent-based questions for the medical procedure to the patient at a meeting with the patient via an input/output interface of the remote device;
receiving a completed electronic consent form, a completed set of consent-based questions and the electronic consent from the patient via the input/output interface of the remote device after electronically providing the selected electronic educational information, the selected electronic consent form and the selected set of consent-based questions for the medical procedure to the patient;
storing the completed electronic consent form, a completed set of consent-based questions and electronic consent from the patient in the electronic consent-based medical record in the third-party data storage using the one or more processors;
receiving the electronic authorization from the medical provider indicating that the patient reviewed the electronic educational information, answered the consent-based questions and provided the electronic consent via the input/output interface, wherein the electronic authorization from the medical provider provides a first level of verification that the patient provided informed consent;
storing the electronic authorization from the medical provider in the electronic consent-based medical record for the patient in the third-party data storage using the one or more processors;
providing a third-party report from an independent physician validating the electronic consent-based medical record to the medical provider after storing the completed consent form, the completed set of consent-based questions and electronic consent from the patient and the electronic authorization from the medical provider in the electronic consent-based medical record for the patient in the third-party data storage, wherein the third-party report from the independent physician provides a second level of verification that the patient provided informed consent; and
sending the completed electronic consent form, the completed set of consent-based questions for the medical procedure, the electronic consent and the electronic authorization from the medical provider to the electronic health record for the patient within the medical provider data storage.
However, they fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims, in particular:
“selecting one of the sets of consent-based questions for the medical procedure associated with the medical procedure identifier for the patient from the plurality of sets of consent-based questions within the third-party storage;
storing the selected electronic consent form, the selected electronic education information and the selected set of consent-based questions in the electronic consent-based medical record for the patient in the third-party data storage using the one or more processors,” (emphasis added) as recited in the claims.
While each and every element of the present invention is taught by the aforementioned references, combining the references as an ordered combination would not have been obvious to one ordinarily skilled in the art because doing so would require improper hindsight reasoning in view of the Present Specification, and furthermore, there is not teaching, suggestion, or motivation to combine the aforementioned references present in the aforementioned references themselves or in knowledge generally available to one of ordinary skill in the art.
The closest prior art of record is as follows:
U.S. Patent Publication No. 20140141397 to Dunn
U.S. Patent Publication No. 20170116384 to Ghani
U.S. Patent Publication No. 20160110504 A1 to Fialkov
U.S. Patent Publication No. 20150302536 A1 to Wahl
WIPO Patent Publication No. WO 2010052638-A1 to Dias-Alf
U.S. Patent Publication No. 20140108056 to Smith
U.S. Patent Publication No. 2015/0046174 to Mainwaring
U.S. Patent Publication No. 2002/0148893 to Walsh
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
14 May 2026
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