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 request for continued examination (“RCE”) an application filed 22 September 2025, which claims priority to a provisional application filed 14 July 2017.
Claims 1 and 16 have been amended.
Claims 1-13, 15-28 and 30 are currently pending and have been examined.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 September 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13, 15-28 and 30 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claims 1 and 16 recite the steps of automatically updating, in real-time various data. The patent application does not provide an adequate support for automatically updating, in real-time various data. For example, the specification, in paragraph [0014] recites updating data. The specification does not, however, disclose an adequate support for automatically updating, in real-time various data. Therefore, one skilled in the art of healthcare intervention, upon reading the specification, would not conclude that the inventor had possession of the claimed inventions on the day the application was filed.
To the extent that other claims rely on claims that are rejected under 35 USC 112 and fail to correct the deficiencies of the claims they rely on, those other claims are rejected for the same reasons as the claims they rely on. Appropriate correction is required.
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.
Prong 2 of Step 2A
The judicial exception is not integrated into a practical application. The additional elements of “computerized,” “a server computer,” “one or more processors,” “an input/output interface,” “a memory,” “a medical provider data storage,” “third-party data storage,” “a remote device,” and “an input/output interface of the remote device,” are recited at a high level of generality. Accordingly, the additional elements amount to no more than instructions to apply an exception by merely invoking a computer as a tool to perform the abstract idea. See MPEP 2106.04(f). Furthermore, the combination of additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, the additional elements do not integrate the abstract idea into a practical application.
Step 2B
As discussed with respect to Step 2A – Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using generic computers component. The same analysis applies here in 2B, and does not provide an inventive concept.
Dependent claims 2-13, 15, and 17-28, and 30, include other limitations, but these only serves to further limit the abstract idea, and hence is nonetheless directed towards fundamentally the same abstract idea as independent claim 1. For example, claims 2, 5, 7, 9-11, 13, 17, 20, 22, 24-26, and 28 merely define a type of data processed by the system and only serve to further limit the abstract idea; claims 3, 6, 8, 12, 18, 21, 23, 27 merely further define the abstract idea; claims 4, 15, 19, and 30, merely recite generic computer components.
Independent claim 16 recites the additional elements of “computerized,” “a server computer,” “one or more processors,” “an input/output interface,” “a memory,” “a medical provider data storage,” “third-party data storage,” “a remote device,” and “an input/output interface of the remote device.” The additional elements are analyzed in the same manner as in claim 1, and do not provide a practical application or significantly more for the same reasons, whether alone or in combination.
Dependent claims 2-13, 15, 17-28, and 30 include other limitations, but these only serve to further limit the abstract idea.
Dependent claims 4, 7, 19, and 22, include additional elements, but do not transform the abstract idea into a practical application. Claims 4, and 19, include “an executable package or file;” and claims 7 and 22 include “an electronic signature,” which is analyzed in the same manner as the “server computer” in the independent claims and does not provide a practical application or significantly more for the same reasons.
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 and amendments, filed on 22 September 2025, with respect to the 35 USC § 101 rejection have been considered. However, the argument is not persuasive.
Applicant argues on pages 2-5 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.
The Office respectfully disagrees. Please see the 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.
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
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.
/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
31 October 2025