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 .
DETAILED ACTION
This Office Action is the first action on the merits.
Claims 1-20 are pending
Priority
This Application claims priority to Provisional Application No. 63751874 filed 31 January 2025.
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 10 December 2025 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-20 are rejected for lack of adequate written description.
Claims 1-20 recite functional steps for which the Applicant has not adequately described the steps in sufficient detail for one of ordinary skill in the art to conclude that the Applicant had possession of the invention at the time of filing.
Specifically, the claims recite (Claim 1 being representative) “An improvement to the way that computer systems operate to link electronic GER records with electronic T-Log records relating to individuals under care by a caregiver, the improvement comprising a HIPAA-compliant method of receiving and recording personal health information data in both GER and T-Log electronic formats relating to at least one individual, comparing the T-Log records to the GER records to determine a probable match, comparing any probable match to stored GER record types to determine a match, and linking the T-Log record to the matched GER record having a matched GER record type, the method comprising:
performing, by the computer system, the steps of:
a. providing a database of stored GER subject matters;
b. providing a database of stored GER events;
c. providing a database of stored GER subtypes;
d. providing a database of stored existing GER records;
e. providing a device for use by the caregiver;
f. providing a link database for storing links between GER records and T-Log records;
g. storing a GER subject matter threshold;
h. storing a GER event threshold;
i. storing a GER subtype threshold;
j. storing at least one GER record relating to the individual;
k. storing at least one T-Log record relating to the individual;
comparing said T-Log record to said GER subject matters to determine a match, including measuring a GER subject matter score relating to an accuracy of said match;
and m. determining whether said GER subject matter score exceeds said stored GER subject matter threshold;
n. comparing, if said subject matter score exceeds said stored GER subject matter threshold, said T-Log record to said GER events to determine a match, including measuring a GER event score relating to an accuracy of said match;
o. determining whether said GER event score exceeds said stored GER event threshold;
p. comparing, if said GER event score exceeds said stored GER event threshold, said T-Log record to said GER subtypes to determine a match, including measuring a GER subtype score relating to an accuracy of said match;
q. determining whether said GER subtype score exceeds said stored GER subtype threshold;
r. comparing, if said GER subtype score exceeds said stored GER subtype score threshold, said T-Log record to said existing GER records to determine a match, including measuring an existing GER score relating to an accuracy of said match;
s. determining whether said existing GER score exceeds said stored existing GER threshold;
t. storing, if said existing GER score exceeds said stored existing GER threshold, an electronic link from said T-Log record to said GER record in said link database;
and u. providing a notification of said link to said device.” The Applicant has provided no disclosure of what any of the special terms (GER subject matter, GER events, GER subtypes, GER records, GER subject matter threshold, GER event threshold, GER subtype threshold, GER subject matter score, GER event score, GER subtype score, GER score, accuracy score) used in the claim are what the thresholds are or how the scores are calculated to compare against the thresholds. The Specification states:
[Para. 0041] Artificial Intelligence/machine learning is used to improve HIPAA-compliant computer systems and methods for linking electronic GER and T-Log records relating to individuals under care by a caregiver. T-log records are compared to GER subject matters to determine whether an accuracy score exceeds a threshold. If so, the T-Log record is compared to GER events to determine whether an accuracy score exceeds a threshold. If so, the T-Log record is compared to GER subtypes to determine whether an accuracy score exceeds a threshold. If so, the T-Log record is compared to existing GER records to determine whether an accuracy score exceeds a threshold. If so, the T-Log and GER records are electronically linked and an alert is provided to the caregiver. One or more of these comparisons is performed at least in part by categorizing the T-Log record by using the one or more large language models.
[Para. 0045] Furthermore, such system and methods that performed one or more of the functions of comparing the T-Log record to the GER subject matters, comparing the T-Log record to the GER events, comparing the T-Log record to the GER subtypes, and comparing the T-Log record to the existing GER records, at least in part by categorizing the T-Log record by using one or more large language models, were and are neither routine, well-understood, nor conventional in the field of logging and reporting of events for individuals under care.
[Para. 0159] Figure 7A illustrates the QAA Process Flow (Triggered from GER Side). When a New GER 712 is created for an Individual, the Therap application retrieves the GER details, along with any Existing Alerted T-Logs 721 for that Individual that are still in 'Open' status and share the same GER type labels. This information is fetched from the Database 709A by the application and sent to the QAA text similarity endpoint 709B to determine whether the GER describes the same events as those in the T-Logs. The endpoint returns a context similarity score, which is then evaluated against a threshold value, 'T4', to classify whether the GER and an alerted T-Log are a match. If a Match 727 is identified, the matched GER 722 information is stored alongside the corresponding T-Log alert in the QAA Data Store 713, and an updated notification containing the matched GER info 723 is pushed to the QA Assistant Notification Panel 724. If no match is found 726, no further action is taken 725, and the existing alerts remain unchanged.
As can be seen, there is no specific description as to how to properly define any of the special terms used, what the thresholds, what the scores are, as well as how the scores are calculated and compared against the threshold. Any definitions could potentially read on the as-claimed invention. The Examiner simply cannot tell what these items are or how they are manipulated. The system amounts to a black box into which information is inputted and calculated; however, there is no disclosure as to what any of the terms are going into the box, nor how the box calculates any of the scores. The only special term recited in the claims that is defined are the T-log records. As such, the claimed invention lacks adequate written description. MPEP 2161.01.
The Examiner prospectively notes that this written description rejection is not based on whether one skilled in the art would know how to program a computer to perform any form of comparing and determination (i.e., an enablement rejection), but rather is directed to the Applicant’s lack of specificity as to how the special terms are specifically defined, as well as how the scores and threshold are specifically calculated with respect to the Applicant’s claimed invention.
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 1-20 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.
Claims 1, 7 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite systems, which are within a statutory category.
Step 2A1
The limitations of:
Claim 1
f. storing links between GER records and T-Log records;
g. storing a GER subject matter threshold;
h. storing a GER event threshold;
i. storing a GER subtype threshold;
j. storing at least one GER record relating to the individual;
k. storing at least one T-Log record relating to the individual;
comparing said T-Log record to said GER subject matters to determine a match, including measuring a GER subject matter score relating to an accuracy of said match;
and m. determining whether said GER subject matter score exceeds said stored GER subject matter threshold;
n. comparing, if said subject matter score exceeds said stored GER subject matter threshold, said T-Log record to said GER events to determine a match, including measuring a GER event score relating to an accuracy of said match;
o. determining whether said GER event score exceeds said stored GER event threshold;
p. comparing, if said GER event score exceeds said stored GER event threshold, said T-Log record to said GER subtypes to determine a match, including measuring a GER subtype score relating to an accuracy of said match;
q. determining whether said GER subtype score exceeds said stored GER subtype threshold;
r. comparing, if said GER subtype score exceeds said stored GER subtype score threshold, said T-Log record to said existing GER records to determine a match, including measuring an existing GER score relating to an accuracy of said match;
s. determining whether said existing GER score exceeds said stored existing GER threshold;
t. storing, if said existing GER score exceeds said stored existing GER threshold, an electronic link from said T-Log record to said GER record;
and u. providing a notification of said link.
Claim 7
d. storing links between T-Log records and GER records;
e. storing a GER event threshold;
f. storing at least one T-Log record relating to the individual having an open alert status;
g. storing at least one GER record relating to the individual;
h. comparing said GER record to said at least one T-Log record having an open alert status to determine a match, including measuring a GER event score relating to an accuracy of said match;
i. determining whether said GER event score exceeds said stored GER event threshold;
j. storing, if said GER event score exceeds said stored GER event threshold, an electronic link from said T-Log record to said GER record;
and k. providing a notification of said link,
Claim 11
f. storing links between GER records and T-Log records;
configured to:
compare said T-Log record to said GER subject matters to determine a match, including measuring a GER subject matter score relating to an accuracy of said match;
determine whether said GER subject matter score exceeds said stored GER subject matter threshold;
compare, if said subject matter score exceeds said stored GER subject matter threshold, said T-Log record to said GER events to determine a match, including measuring a GER event score relating to an accuracy of said match;
determine whether said GER event score exceeds said stored GER event threshold;
compare, if said subject matter score exceeds said stored GER event threshold, said T-Log record to said GER subtypes to determine a match, including measuring a GER subtype score relating to an accuracy of said match;
determine whether said GER subtype score exceeds said stored GER subtype threshold;
compare, if said GER subtype score exceeds said stored GER subtype score threshold, said T-Log record to said existing GER records to determine a match, including measuring an existing GER score relating to an accuracy of said match;
determine whether said existing GER score exceeds said stored existing GER threshold;
store, if said existing GER score exceeds said stored existing GER threshold, an electronic link from said T-Log record to said GER record; and
provide a notification of said link,
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to link electronic GER records with electronic T-Log records in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “providing, storing, comparing and determining” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a system implemented by a data processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional element of a computer system having a memory and a processor that implements the identified abstract idea. The computer system having a memory and a processor is not described by the applicant and is recited at a high-level of generality (i.e., a generic computer performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claims further recites the additional elements of a database of stored GER subject matters, database of stored GER events, database of stored GER subtypes, database of stored existing GER records, device, link database, database of stored existing T-Log records having an open alert status, database for storing at least one T-Log record relating to the individual, database for storing a GER subject matter threshold, database for storing a GER event threshold, database for storing a GER subtype threshold, database for storing at least one GER record relating to the individual and computer program configured to run on said computer system. The database of stored GER subject matters, database of stored GER events, database of stored GER subtypes, database of stored existing GER records, device, link database, database of stored existing T-Log records having an open alert status, database for storing at least one T-Log record relating to the individual, database for storing a GER subject matter threshold, database for storing a GER event threshold, database for storing a GER subtype threshold, database for storing at least one GER record relating to the individual and computer program configured to run on said computer system merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer system having a memory and a processor to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a database of stored GER subject matters, database of stored GER events, database of stored GER subtypes, database of stored existing GER records, device, link database, database of stored existing T-Log records having an open alert status, database for storing at least one T-Log record relating to the individual, database for storing a GER subject matter threshold, database for storing a GER event threshold, database for storing a GER subtype threshold, database for storing at least one GER record relating to the individual and computer program configured to run on said computer system were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such the claims are not patent eligible.
Claims 2-6, 8-10,12-20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2,8,12,18 merely describe(s) providing and comparing data, which further defines the abstract idea.
Claim(s) 2,8,12,18 also includes the additional element of “a database storing at least one authorization profile associated with the caregiver” which is analyzed the same as the “a database of stored GER subject matters” and does not provide a practical application or significantly more for the same reasons.
Claim(s) 3,9,13,19 merely describe(s) comparing data, which further defines the abstract idea.
Claim(s) 3,9,13,19 also includes the additional element of using a large language model. This represents mere instructions to implement the abstract idea on a generic computer. Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application nor provide “significantly more” because it does not impose any meaningful limits on practicing the abstract idea. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible). Alternatively, or in addition, the implementation of the large learning model to link electronic GER records with electronic T-Log records merely confines the use of the abstract idea (i.e., the trained model) to a particular technological environment or field of use and thus fails to add an inventive concept to the claims.
Claim(s) 4, 14 merely describe(s) providing, storing, and comparing vital sign contents, which further defines the abstract idea.
Claim(s) 4, 14 also includes the additional element of “a database of stored vital sign contents” which is analyzed the same as the “a database of stored GER subject matters” and does not provide a practical application or significantly more for the same reasons.
Claim(s) 5,15 merely describe(s) providing a notification, which further defines the abstract idea.
Claim(s) 6,16 merely describe(s) providing a notification, which further defines the abstract idea.
Claim(s) 10,20 merely describe(s) not changing the open alert status, which further defines the abstract idea.
Subject Matter Free of Prior Art
Claim(s) 1-20 recite subject matter that is free of prior art. In particular, the cited prior art of record fails to teach or suggest, as best understood by the examiner, the combination of:
Claims 1, 7, 11 describe(s) an improvement to the way that computer systems operate to link electronic GER records with electronic T-Log records relating to individuals under care by a caregiver, the improvement comprising a HIPAA-compliant method of receiving and recording personal health information data in both GER and T-Log electronic formats relating to at least one individual, comparing the T-Log records to the GER records to determine a probable match, comparing any probable match to stored GER record types to determine a match, and linking the T-Log record to the matched GER record having a matched GER record type, the method comprising:
performing, by the computer system, the steps of:
a. providing a database of stored GER subject matters;
b. providing a database of stored GER events;
c. providing a database of stored GER subtypes;
d. providing a database of stored existing GER records;
e. providing a device for use by the caregiver;
f. providing a link database for storing links between GER records and T-Log records;
g. storing a GER subject matter threshold;
h. storing a GER event threshold;
i. storing a GER subtype threshold;
j. storing at least one GER record relating to the individual;
k. storing at least one T-Log record relating to the individual;
comparing said T-Log record to said GER subject matters to determine a match, including measuring a GER subject matter score relating to an accuracy of said match;
and m. determining whether said GER subject matter score exceeds said stored GER subject matter threshold;
n. comparing, if said subject matter score exceeds said stored GER subject matter threshold, said T-Log record to said GER events to determine a match, including measuring a GER event score relating to an accuracy of said match;
o. determining whether said GER event score exceeds said stored GER event threshold;
p. comparing, if said GER event score exceeds said stored GER event threshold, said T-Log record to said GER subtypes to determine a match, including measuring a GER subtype score relating to an accuracy of said match;
q. determining whether said GER subtype score exceeds said stored GER subtype threshold;
r. comparing, if said GER subtype score exceeds said stored GER subtype score threshold, said T-Log record to said existing GER records to determine a match, including measuring an existing GER score relating to an accuracy of said match;
s. determining whether said existing GER score exceeds said stored existing GER threshold;
t. storing, if said existing GER score exceeds said stored existing GER threshold, an electronic link from said T-Log record to said GER record in said link database;
and u. providing a notification of said link to said device.
Claims 2-6, 8-10,12-20 depend on Claims 1,7 and 11 and are also subject matter free of prior art
Conclusion
The prior art made of record and not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Feldschuh et al (US Publication No. 9767127) disclose methods for record linkage and comparing attributes.
McNair et al (US Publication No. 20240355440) discloses methods, systems, and computer-readable media for determining related records.
HUANG et al (Foreign Publication CN-113342810-A) discloses a method and device for matching record link data.
NEUMANN et al (Foreign Publication EP-3093776-A1) discloses a method of and a server device (120) for record linkage.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN C EDOUARD whose telephone number is (571)270-0107. The examiner can normally be reached M-F 730 - 430.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571) 272 - 6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN C EDOUARD/Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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