DETAILED ACTION
Status of Claims
The present application is being examined under the pre-AIA first to invent provisions.
This action is in reply to the response filed 12 January 2026, on an application filed 3 June 2019, which is a continuation of an application that claims domestic priority to a provisional application filed 28 September 2012.
The Office previously received and entered the terminal disclaimer filed by Applicant on 30 August 2023 over U.S. Patent 10,403,403.
Claims 1, 9 and 15 have been amended.
Claims 1-3, 7, 9-11, 15-17 and 21-29 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 1-3, 7, 9-11, 15-17 and 21-29 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 1-3, 7, 9-11, 15-17 and 21-29 are within the four statutory categories. Claims 1, 2, 7 and 21-23 are drawn to a computerized method carried out by at least one server having at least one processor for adaptive medical data collection, which is within the four statutory categories (i.e. process). Claims 9-11 and 24-26 are drawn to a system for adaptive medical data collection, which is within the four statutory categories (i.e. machine). Claims 15-17 and 27-29 are drawn to a non-transitory computer readable storage medium having stored therein data representing instructions executable by a programmed processor for adaptive medical data collection, which is within the four statutory categories (i.e. manufacture).
Prong 1 of Step 2A
Claim 1 recites: A computerized method carried out by at least one server having at least one processor for adaptive medical data collection, the method comprising:
accessing, with at least one processor, a voice input associated with a first set of information into an Electronic Medical Record (EMR) of a patient;
automatically performing a series of actions based on the voice input, the series of actions being triggered by the voice input, and the series of actions comprising:
determining, with the at least one processor, a first potential condition in real time for the patient based on an iterative analysis using a probabilistic graphical model that receives the first set of information in the EMR of the patient and that generates a probability predicting whether the first potential condition is present by mapping the first set of information as a feature vector to the first potential condition of the patient, wherein the probabilistic graphical model is a machine learning based Bayesian model trained using a Markov Chain Monte Carlo (MCMC) method and an Expectation Maximization method trained on one or more medical databases;
identifying, with the at least one processor, a second set of information indicated as relevant to the first potential condition of the patient by applying the iterative analysis using the probabilistic graphical model based on the feature vector, wherein the second set of information indicated as relevant to the first potential condition;
generating, with the at least one processor, a first request for the second set of information identified;
determining whether the probability of one or more fields of the first potential condition is below an acceptance level;
iteratively eliminating the one or more fields of the first potential condition upon failing to meet the acceptance level;
selecting an incomplete subset of fields from one or more other fields based on the first potential condition of the patient;
based on the first request, selecting an established collection of information from the EMR associated with the first potential condition of the patient;
upon the iterative analysis, adapting a real-time preformatted electronic medical form comprising the incomplete subset of fields, wherein:
the real-time preformatted electronic medical form is a real-time adaptable form constructed of templates, or template sections selected for the patient, the second set of information is provided in the real-time by the patient is used to determine the templates, or the template sections of the real-time preformatted electronic medical form, and
the second set of information is iteratively requested to the patient and provided by the patient for the iterative analysis in the real time till the probability reaches a steady state for the first potential condition, such that entry of further the second set of information does not affect the probability for the first potential condition;
providing a context-specific suggestion, for integration of a set of fields in the real-time preformatted electronic medical form, corresponding to the patient, wherein:
the context-specific suggestion indicates a cause of the first potential condition for the patient, and
the context-specific suggestion is identified based on attributes of the patient;
providing the real-time preformatted electronic medical form having the set of fields for the established collection of information associated with the first potential condition;
populating at least a portion of the set of fields of the real-time preformatted electronic medical form with the second set of information;
receiving additional information from the EMR via at least one field of the set of fields of the real-time preformatted electronic medical form, based on populating at least the portion of the set of fields of the real-time preformatted electronic medical form with the second set of information; and
adapting the real-time preformatted electronic medical form in response to receiving the additional information, wherein the real-time preformatted electronic medical form is adapted based on a role of a user accessing the real-time preformatted electronic medical form.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract ideas of a certain method of organizing human activity because they recite a process composed of managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case the step of conferring with medical personnel and accessing and populating medical records of a patient in order to determine a probability of a diagnosis of the patient), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for claims 9 and 15 are identical as the abstract idea for claim 1 because the only difference between claims 1, 9 and 15 is that claim 1 recites a method, whereas claim 9 recites a system and claim 15 recites a non-transitory computer-readable media.
Dependent claims 2, 3, 7, 10, 11, 16, 17 and 21-29 include other limitations, for example claims 2, 7, 10, 16, 17 and 21-29 recites limitations directed to identifying conditions, and populating the forms, claims 3 and 11 describes types of data used by the system, 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, 3, 7, 10, 11, 16, 17 and 21-29 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2, 3, 7, 10, 11, 16, 17 and 21-29 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 9 and 15.
Prong 2 of Step 2A
Claims 1. 9 and 15 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 and the recitation of templates, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs 54-61 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 directed to the real-time preformatted electronic medical form, which amounts to limiting the abstract idea to the field of healthcare, and the limitations reciting a graphical model composed of various model methods, 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, 3, 7, 10, 11, 16, 17 and 21-29 include other limitations, but these limitations also amount to no more than mere instructions to apply the exception (e.g.
the recitation of templates in dependent claim 28), generally linking the abstract idea to a particular technological environment or field of use (e.g. the claim language directed to the real-time preformatted electronic medical form of claims 2, 10, 16, 17, 22, 24-27 and 29), and/or do not include any additional elements beyond those already recited in independent claims 1, 9 and 15, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1, 9 and 15 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 dispensing device and the one or more processors), 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 54-61 of the Specification discloses that the additional elements (i.e. the one or more processors) 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, 3, 7, 10, 11, 16, 17 and 21-29 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, 9 and 15, and/or the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. the recitation of templates in dependent claim 28), and/or generally link the abstract idea to a particular technological environment or field of use (e.g. the claim language directed to the real-time preformatted electronic medical form of claims 2, 10, 16, 17, 22, 24-27 and 29), 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 1-3, 7, 9-11, 15-17 and 21-29 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
With regard to the rejection of the claims under 35 USC 101, Applicant argues on pages 13-16 that the claims comprise statutory material because:
A. Step 2A, Prong 1: The present claims do not fall within any of the methods of organizing human activity. “The Applicant submits that the claimed invention is not merely performing a mental process, but improves computer functioning by automatically eliminating one or more fields and hence reducing the load on the overall system.”
B. Step 2A, Prong 2: The claimed invention reduces computational complexity which in turn reduces storage requirements and improves accuracy of form generation and determination of first condition, all of which constitute technological improvement.” The claims reflect “a specific improvement that addressed the technical problem of ‘customized forms for different users and different medical facilities’ in adaptive medical data collection systems, while allowing machine learning model to optimize system performance, improve accuracy and reduce system complexity.”
C. The PTAB previously indicated that different claims in a related case comprise statutory material.
The Office respectfully disagrees. Please see the statutory rejection of the claims, issued above, where the claims are shown to be directed to an abstract idea without significantly more.
Regarding A., MPEP 2106. 04(a)(2)(11) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, andfollowing rules or instructions). The Office submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to manage medical record forms. The Office submits that healthcare itself is inherently represents the organization of human activity. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a series of rules or instructions that a person or persons would follow to manage medical record forms, the claimed invention is directed to an abstract idea.
Regarding B., there is no nexus between the claimed invention and the stated improvement. It is not clear from reading the present claims that these improvements would occur.
Regarding C., the related material comprises a different claimset and is therefore irrelevant to the present claims.
Accordingly, the prior art rejection is upheld.
Conclusion
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 extension fee 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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
30 January 2025