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
In the amendment dated 27 January 2026, the following occurred: 1, 3-5, 8, and 10 have been amended
Claims 1-20 are pending.
Priority
This application does not claim priority to any other patent document and is thus afforded a priority date corresponding to the filing date of 29 January 2024.
Notice to Applicant
The Examiner notes that the claims of co-pending application 17/850,951, 18/307,752 and 18/307,757 do not currently overlap in scope with the claims of the present application. Should the claims converge in scope, a Double Patenting rejection may be warranted.
Subject Matter Free of Prior Art
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within the independent claim. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: operating a comprehensive care artificial intelligence system configured to implement a real-time dynamic predictive artificial intelligence model that processes data within a data store to automatically identify causal relationships pertinent to the real-time patient assessment for the target patient, the comprehensive care artificial intelligence system further configured to utilize the identified causal relationships to automatically generate a real-time dynamic healthcare recommendation pertinent to the real-time patient assessment for the target patient, the comprehensive care artificial intelligence system thereafter identifies and characterizes interaction outcomes of multi-variate target patient treatment functions applied by multiple healthcare providers to determine an adverse effect that a first target patient function applied by a first healthcare provider has on a second target patient function applied by a second healthcare provider with regard to an outcome for the target patient.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 18/426,194 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim determining causal relationships between patient data and outputting a recommendation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method for surfacing dynamic personalized healthcare insight for a target patient, which are within a statutory category.
Step 2A1
The limitations of receiving input data that includes data streams of medical data for multiple patients, data streams of situational data for the multiple patients, and data streams of environmental characterization data relevant to the multiple patients, wherein the multiple patients include the target patient, the received input data including real-time medical data, real-time situational data, and real-time environmental data for the target patient; identifying a type of the received input data; storing the received input data based on the type of the received input data; processing the received input data for the target patient through a rule-based algorithm to automatically generate a real-time patient assessment for the target patient; storing the real-time patient assessment for the target patient; providing the real-time patient assessment for the target patient as an input; implement a model that processes the stored data to automatically identify causal relationships pertinent to the real-time patient assessment for the target patient; utilizing the identified causal relationships to automatically generate a real-time dynamic healthcare recommendation pertinent to the real-time patient assessment for the target patient; storing the identified causal relationships and the real-time dynamic healthcare recommendation that are pertinent to the real-time patient assessment for the target patient; identif[ing] and characterize[ing] interaction outcomes of multi-variate target patient treatment functions applied by multiple healthcare providers to determine an adverse effect that a first target patient function applied by a first healthcare provider has on a second target patient function applied by a second healthcare provider with regard to an outcome for the target patient; automatically changing the first target patient function applied by the first healthcare provider to remove the adverse effect upon determination of the adverse effect; preparing an output data stream that provides for graphical display of output information, the output information conveying both the real-time patient assessment for the target patient and the real-time dynamic healthcare recommendation pertinent to the real-time patient assessment for the target patient the output information including information on the adverse effect, the output information including information on the automatic change made to the first target patient function; and transmitting the output data stream, 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. That is, other than reciting a method that operates a comprehensive care artificial intelligence system, the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the comprehensive care artificial intelligence system and data store, this claim encompasses a person collecting/storing patient data, generating assessments, identify causal relationships, generating a recommendation, identifying and characterizing interaction outcomes, changing functions, and preparing/outputting the data in the manner described in the identified abstract idea, supra. 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 claim recites the additional elements of comprehensive care artificial intelligence system and a data store that implements the identified abstract idea. These items are described by the Applicant as portions of a general-purpose computer that is recited at a high-level of generality (i.e., general-purpose computer) such that it amounts no more than mere instructions to apply the exception using a generic computer. 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 claim further recites the additional element of using a real-time dynamic predictive artificial intelligence model to identify causal relationships pertinent to the real-time patient assessment utilize the identified causal relationships to automatically generate a real-time dynamic healthcare recommendation pertinent to the real-time patient assessment for the target patient. This represents mere instructions to implement the abstract idea on a generic computer and/or apply this technology to the abstract idea (“apply it”). Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Alternatively, or in addition, the implementation of the real-time dynamic predictive artificial intelligence model to identify causal relationships pertinent to the real-time patient assessment utilize the identified causal relationships to automatically generate a real-time dynamic healthcare recommendation pertinent to the real-time patient assessment for the target patient merely confines the use of the abstract idea (i.e., the trained model) to a particular technological environment or field of use (supervised machine learning, unsupervised machine learning, and/or reinforced machine learning; see Spec. Para. 0034) and thus fails to add an inventive concept to the claims.
The claim further recites the additional element of a remote computing device. The remote computing device 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, this additional element does not integrate the abstract idea into a practical application.
Step 2B
The claim does 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 general-purpose computer 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”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using the real-time dynamic predictive artificial intelligence model to identify causal relationships pertinent to the real-time patient assessment utilize the identified causal relationships to automatically generate a real-time dynamic healthcare recommendation pertinent to the real-time patient assessment for the target patient was found to represent mere instructions to implement the abstract idea on a generic computer and/or apply this technology to the abstract idea (“apply it”) and/or confine the use of the abstract idea (i.e., the trained AI model) to a particular technological environment or field of use (supervised machine learning, unsupervised machine learning, and/or reinforced machine learning; see Spec. Para. 0034). This has been re-evaluated under the “significantly more” analysis and determined to be insufficient to provide significantly more. MPEP 2106.05(I) indicates that mere instructions to implement the abstract idea on a generic computer and/or confining the use of the abstract idea to a particular technological environment or field of use cannot provide significantly more.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of remote computing device was 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. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
Claims 2-20 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 also includes the feature of training the real-time dynamic predictive artificial intelligence model. When given its broadest reasonable interpretation in light of the disclosure, the training of a machine learning model represents the creation of mathematical interrelationships between data. As such, the training of the machine learning model represents a mathematical concept that is interpreted to be part of the identified abstract idea, supra. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Claim(s) 3, 17, 18, 19 merely describe(s) they type(s) of data, which further defines the abstract idea.
Claim(s) 4, 5 merely describe(s) identifying situations and generating a recommendation, which further defines the abstract idea.
Claim(s) 6 merely describe(s) determining a probability of effectiveness of a recommendation, which further defines the abstract idea.
Claim(s) 7 merely describe(s) a location from which data is received, which further defines the abstract idea.
Claim 7 also includes the additional element of a computing device of the target patient having one or more applications, which is analyzed in the same manner as the remote computing device of a user in Claim 1.
Claim(s) 8, 9 merely describe(s) outputting data and/or the makeup of the system, which further defines the abstract idea.
Claim 8, 9 also includes the additional element of a graphical user interface configured for display on the remote computing device, which is analyzed in the same manner as the remote computing device in Claim 1, i.e., it is part of the remote computing device.
Claim 9 includes the additional element of a cloud computing system which generally links under steps 2A2 and 2B. Generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim(s) 10 merely describe(s) determining an urgency level for the recommendation, which further defines the abstract idea.
Claim(s) 11 merely describe(s) a data curation policy, which further defines the abstract idea.
Claim(s) 12 merely describe(s) the data, which further defines the abstract idea.
Claim(s) 13, 14, 15, 16 merely describe(s) providing additional data, which further defines the abstract idea.
Claim(s) 20 merely describe(s) the target patient, which further defines the abstract idea.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the subject matter eligibility rejection of Claims 1-20, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
The Applicant submits that the Office has NOT provided a sufficiently clear and specific explanation as to why claim 1 is rejected under 35 U.S.C. 101.
Regarding (a), the Examiner respectfully disagrees. The rejection meets the requirements of MPEP 2106.
Per MPEP 2106.07 (a), the Office must provide an explanation as to why each of the specific claim limitations(s) is identified as reciting the judicial exception. With reference back to MPEP 2106.07, supra, the rejection under 35 U.S.C. 101 should set forth a prima facie case of ineligibility under the substantive law. Therefore, it is not enough for the Office to make a simple conclusory statement that particular claim features are directed to "managing personal behavior including following rules or instructions." Rather, it is incumbent on the Office to provide articulated reasoning with rational underpinning in order to adequately support a prima facie case of ineligibility under the substantive law.
Regarding (b), the Examiner respectfully submits that that a prima facie case has been established and that a proper rejection has been presented in accord with MPEP 2106. For instance, the rejection clearly indicates the identified abstract idea and describes why the identified abstract idea represents certain methods of organizing human activity where it states:
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It is unclear what the Applicant feels is missing from the rejection. To be crystal clear, the identified abstract idea represents a series of rules or instruction for a person or persons to follow, with or without the aid of a computer (“certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions”)), “for surfacing dynamic personalized healthcare insight for a target patient” (See Spec. Para. 0003). The particular way the “surfacing dynamic personalized healthcare insight for a target patient” is performed (the instructions / steps) is the identified abstract idea. The additional elements were also identified and a reasoned explanation as to why they so not provide a practical application or significantly more has been provided. In short, a prima facie case of ineligibility has been established.
The Applicant submits that the above-mentioned features of amended claim 1 serve to further establish the subject matter of amended claim 1 as patent eligible.
Regarding (c), the Examiner respectfully disagrees. These features have been addressed and are part of the abstract idea.
In particular, the Applicant submits that amended claim 1 does NOT recite an abstract idea concerning "certain methods of organizing human activity," per MPEP 2106.04(a). More specifically, the Applicant submits that amended claim 1 does NOT recite either managing personal behavior or relationships or interactions between people.
Regarding (d), the Examiner respectfully disagrees and notes that the Applicant has provided no arguments as to why the claimed invention does not represent Certain Methods of Organizing human activity. The Examiner has satisfied the notice requirement, however Applicant has not provided any actual argument in rebuttal.
The Applicant also submits that at least the above-mentioned features amended claim 1 recite a practical application that improves the technical field of healthcare of a target patient by multiple healthcare providers, which renders amended claim 1 patent eligible under Step 2A, Prong 2, of the Patent Subject Matter Eligibility Analysis.
Regarding (e), the Examiner respectfully disagrees. MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the computer (the comprehensive care artificial intelligence system and a data store) nor is there an improvement to another technology as no other technology is claimed. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application.
Applicant’s argument that the field of “healthcare of a target patient by multiple healthcare providers” is a technology and the claimed invention improves this field is not reflected in the claimed invention. The claims are confined to a general-purpose computer and do not claim the entire field of healthcare / patients/ providers. Moreover, the entire field of “healthcare of a target patient by multiple healthcare providers” is not reasonably understood to be a problem arising in technology, as it is instead a problem arising in healthcare itself. The claimed invention is using a computer as a tool and any improvement present is an improvement to the abstract idea of, to paraphrase, collecting/storing patient data, generating assessments, identify causal relationships, generating a recommendation, identifying and characterizing interaction outcomes, changing functions, and preparing/outputting the data. Finally, where Applicant’s line of reasoning correct, the invention in Alice Corp. would have been subject matter eligible because it was an improvement to the technology of settlement risk mitigation.
Step 2B of the subject matter eligibility test determines whether or not the claim as a whole amounts to significantly more than the judicial exception recited in the claim. The Applicant submits that amended claim 1 does amount to significantly more than any asserted judicial exception recited in the claim, at least because amended claim 1 recites: [the identifying and characterizing, operating, automatically changing, and outputting information] steps of the claim.
Regarding (f), the Examiner respectfully disagrees and notes that the Applicant has provided no arguments as to why these features provide significantly more.
Regarding the double patenting rejection of Claims 1-20, the Examiner has considered the Applicant’s arguments in view of the present amendments and withdraws the rejection with regard to applications 18/307,752 and 18/307,757. The double patenting rejection with regard to application 18/426,194 remains as the claimed inventions are not patentably distinct from each other.
Rejection under 35 U.S.C. § 112
Regarding the indefiniteness rejection of Claims 3-5, the Applicant has amended the claims to overcome the bases of rejection.
Rejection under 35 U.S.C. § 103
Regarding the rejection of Claims 1-20, the Examiner has considered the Applicant’s arguments in light of the present amendments and withdraws the prior art rejection.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Minor et al. (U.S. Pre-Grant Patent Publication No. 2007/0136035) which discloses a mathematical system for predicting multi-variable outcomes from multi-variable inputs.
Seward (U.S. Pre-Grant Patent Publication No. 2010/0094648) which discloses a system for analyzing medical data to detect a disease state by identifying feature sets and output a diagnosis.
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 concerning this communication or earlier communications from the examiner should be directed to JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 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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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683