DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted August 22, 2025. The present application is a CON of application 17/480,098 (now abandoned) which is CON of application 16/516,357 (now abandoned), which is a CON of application 14/857,034 (now U.S. Patent Number 10,360,343), which is a CON of application 14/217,165 (now U.S. Patent Number 9,990,471). Claims 1, 4, and 6 are amended. Claims 1 – 12 are pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The objection to the drawings is withdrawn based upon the amendment submitted August 22, 2025.
Claim Rejections - 35 USC § 112
The objection to claim 4 is withdrawn based upon the amendment submitted August 22, 2025.
The objection to claim 9 is withdrawn based upon the amendment submitted August 22, 2025.
Claim Rejections - 35 USC § 101
Claims 1 – 12 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 One
Claims 1 – 12 are drawn to a method, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 1 recites performing adaptive data collection to enhance the quality of data and efficiency of collection and utilization of data related to one or more users with accounts including the following: (a) collecting information from one or more users on an ongoing basis during a first state, wherein the information includes a first type of data collected at a first frequency; (b) identifying a first set of triggers that warrant transitioning to a second state with respect to a subset of users, wherein the first set of triggers is discerned in whole or in part from the information collected from the users in step (a); (c) adjusting, during the second state, the type of information collected from the subset of users in step (b) by collecting a second type of data from the users, wherein the second type of data differs from the first type of data and is targeted at a potential condition relating to the first set of triggers; and (d) adjusting, during the second state, the frequency with which the second type of data is collected from the subset of users in step (b) to a first adjusted frequency, wherein the first adjusted frequency differs from the first frequency.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover the mental process of adjusting the frequency of data collection of a patient. If a claim limitation, under its broadest reasonable interpretation, covers concepts performed in the human mind, including an observation, evaluation, judgment, or opinion, then it falls within the “Mental Process” grouping of abstract ideas. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “behavioral support agent system”, “client devices”, “behavioral support agent server”, “system”
Claims 3, 6: “system”
Claim 12: “apparatus”, “processor”, “a non-transitory computer-readable medium storing instructions operative, when executed by the processor”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0048] FIG. 1 illustrates an embodiment of a system architecture of a BSA system 100 of the present invention (frequently referred to herein as the "system"). Users employ various Client Devices 110 to connect (in this embodiment, via the Internet 150) to a BSA Server 115 that functions as an ever-present user-friendly interactive behavioral support agent. In other embodiments, system components may be interconnected via LAN, WAN or other network connections. Even while users are not interacting with BSA server 115 via their Client Devices 110, BSA Server 115 may interact with various External Data Sources 160 to exchange information that can be employed in subsequent user interactions (with third-party organizations and physical devices as well as with BSA server 115).
[0049] It should be emphasized that the functionality embodied in BSA Server 115 and Client Devices 110 can be allocated among various different hardware and software components. For example, BSA Server 115 could be implemented as a single server computer or as multiple interconnected computers. The connectivity among the various components of BSA system 100 can also vary in other embodiments. For example, certain External Data Sources 160 may connect directly to Client Devices 110, while others may connect to BSA Server 115.
[0051] Client Devices 110 can include server, desktop, laptop and mobile devices, such as smartphones, with various hardware peripherals, such as monitors and touch screens, keyboards, mice and touchpads, wearable devices like smart-watches, among others. Software in Client Devices 110 can include operating systems and applications, as well as smartphone "apps." In one embodiment, Client Devices 110 utilize a web browser client to communicate with BSA Server 115, while other embodiments employ one or more smartphone apps. In another embodiment, Client Devices 110 employ a user-friendly graphical, voice-enabled and touch and text-based interface that facilitates an engaging interactive experience, enhanced via a natural language engine, as discussed in greater detail below.
[0204] The present invention has been described herein with reference to specific embodiments as illustrated in the accompanying drawings. Many variations of the embodiments of the functional components and dynamic operation (including use-case scenarios) of BSA system 100 described above will be apparent to those skilled in the art without departing from the spirit of the present invention, including but not limited to different allocations of the hardware and software functionality of BSA Server 115 and Client Devices 110 among one or more server, desktop, mobile or other computing devices, operating systems and firmware and software modules (including mobile smartphone apps and various networked online devices). Hardware and software functionality can be implemented interchangeably, and computer hardware can include peripherals such as monitors, keyboards, mice, trackpads and a variety of other peripheral I/O, user-wearable and other monitoring devices, including tangible memory and other storage devices (specifically non-transitory computer-accessible storage media in which data and software can be embodied). Moreover, the healthcare sector may be interpreted broadly (encompassing, for example, medicine, nutrition, nutraceuticals, cosmetics, fitness and lifestyle among others), and the functionality described herein may be applied outside of the healthcare sector without departing from the spirit of the present invention.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 5 and 7 – 11 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 102
The rejection of Claim(s) 1 – 8 and 12 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by McIlroy et al., herein after McIlroy (U.S. Patent Number 5,583,758) are withdrawn based upon the amendment submitted August 22, 2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 – 8 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McIlroy et al., herein after McIlroy (U.S. Patent Number 5,583,758) in view of Woellenstein et al., herein after Woellenstein (U.S. Publication Number 2008/0021287 A1).
Claim 1 (Currently Amended). McIlroy teaches a method for performing adaptive data collection to enhance the quality of data and efficiency of collection and utilization of data related to one or more users with accounts on a behavioral support agent system (Abstract discloses a method capable of monitoring a patient), whereby users employ client devices to connect to a behavioral support agent server (column 1, lines 34 – 35 discloses implementation in computer hardware and software; column 4, line 61 through column 5, line 1 discloses a system implemented on an IBM compatible personal computer having at least four megabytes of main memory and an eighty megabyte hard disk drive, with Microsoft Windows as the user interface and Paradox as the data base management software. Individual personal computers can be networked to give multiple users access to a common data base), the method comprising the following steps:
(a) collecting information from one or more users of the system on an ongoing basis during a first state, wherein the information includes a first type of data collected at a first frequency (Fig 18 discloses monitoring a patient at a particular frequency for each phase of the treatment; column 5, lines 7 – 20 discloses guidelines intended to lead a system through a sequence of interactive data collection queries based on the specified health care condition observed in an individual patient; column 5, line 66 through column 6, line 9 discloses a clinical decision component that facilitates the collection of data to support analysis of the use and impact of the guidelines);
(b) identifying a first set of triggers that warrant transitioning the system to a second state with respect to a subset of users, wherein the first set of triggers is discerned in whole or in part from the information collected from the users in step (a) (Figure 18 discloses observing the patient’s symptom progression and transitioning to a different phase of the treatment; column 2, line 59 through column 3, line 9 discloses diagnosis based guidelines that can be used during various steps of the clinical decision process including before treatment, at any stage of existing treatment, or after treatment has been provided);
(c) adjusting, during the second state, the type of information collected from the subset of users in step (b) by collecting a second type of data from the users, wherein the second type of data differs from the first type of data and is targeted at a potential condition relating to the first set of triggers (Figure 18 discloses monitoring different parameters at different phases of the treatment; column 7, line 54 through column 8, line 12 discloses application of a guideline to an individual’s health condition and consists of four phases (entry, question/data collection, assessment, and recommendation) where the question/data collection phase are organized similar to a decision tree so that the next question is identified based on the previous answer thus collecting a second type of data from the user).
McIlroy fails to explicitly teach the following limitations met by Woellenstein as cited:
(d) adjusting, during the second state, the frequency with which the second type of data is collected from the subset of users in step (b) to a first adjusted frequency, wherein the first adjusted frequency differs from the first frequency (paragraph 11 discloses a patient is monitored through continual remote patient management where physiological measures are collected from the patient on a substantially regular basis, the collected physiological measures are analyzed to evaluate patient status based on an assessment to recognize a trend in status quo, progression, regression, onset, or absence of a health condition affecting the patient and then an actionable change in the patient is identified. The collection of the physiological measures is dynamically adjusted in response to the actionable change; paragraph 24 discloses “Clinician-specified, automated, and patient-specified criteria define a set of triggers that can cause the temporal, volumetric, or compositional metrics for patient data collection to increase or decrease based on the type of change in patient well-being sensed or on other factors. The patient data collection metrics can be further adjusted, as required, as patient well-being improves or deteriorates and normal patient data collection can be resumed upon patient recovery, clinician directive, or other direction.”).
It would have been obvious to one of ordinary skill at the time of the invention to expand the method of McIlroy to further include adaptively adjusting patient data collection in an automated patient management environment, where physiological measures are collected from the patient on a substantially regular basis, analyzed to recognize a trend, and then the collection of the physiological measures are dynamically adjusted in response to the change needed for the patient as disclosed by Brandt.
One of ordinary skill in the art at the time of the invention would have been motivated to expand the method of McIlroy in this way to adaptively tailor the collection of physiological measures responsive to changes in the well-being of patients, where data collection metrics would automatically increase or decrease relative to temporal, volumetric, and compositional sampling needs in response to objective and subjective patient inputs (Woellenstein: paragraph 9).
Method and Apparatus claims 6 and 12 repeat the subject matter of claim 1. As the underlying processes of claims 6 and 12 have been shown to be fully disclosed by the teachings of McIlroy and Woellenstein in the above rejections of claim 1; as such, these limitations (6 and 12) are rejected for the same reasons given above for claim 1 and incorporated herein.
Claim 2 (Original). McIlroy and Woellenstein teach the method of claim 1. McIlroy teaches a method wherein the first set of triggers includes symptoms evidencing a possible medical condition (Figure 18 and column 15, line 30 through column 16, line 33 disclose progressing the patient to different phases of the treatment based on the patient’s condition; column 7, lines 54 – 61 discloses a guideline is identified by a recognized health condition description which may be stated as a symptom or diagnosis).
Method claim 7 repeats the subject matter of claim 2. As the underlying processes of claim 7 have been shown to be fully disclosed by the teachings of McIlroy and Woellenstein in the above rejections of claim 2; as such, these limitations (claim 7) are rejected for the same reasons given above for claim 2 and incorporated herein.
Claim 3 (Original). McIlroy and Woellenstein teach the method of claim 1. McIlroy teaches a method wherein the information is obtained both from users of the system and from external data sources (Figures 14 and 18 disclose entering data; column 3, lines 10 – 25 discloses a user inputs an individual’s health data into a new or existing case file in response to inquiries implemented in a health condition specific guideline).
Method claim 8 repeats the subject matter of claim 3. As the underlying processes of claim 8 have been shown to be fully disclosed by the teachings of McIlroy and Woellenstein in the above rejections of claim 3; as such, these limitations (claim 8) are rejected for the same reasons given above for claim 3 and incorporated herein.
Claim 4 (Currently Amended). McIlroy and Woellenstein teach the method of claim 1. McIlroy teaches a method wherein the first adjusted frequency with which information is collected from the subset of users is greater than the first frequency, and is decreased in a third state to a second adjusted frequency below the first adjusted frequency but still above the first frequency, and then returned to the first frequency (Figure 18 discloses transitioning the patients throughout the treatment as needed; column 9, lines 21 – 25 discloses sub-classifications to identify severity levels of the illness, where the sub-classifications should be standard grouping so they will be consistent with data in future analyses).
Claim 5 (Original). McIlroy and Woellenstein teach the method of claim 1. McIlroy teaches a method wherein the first set of users includes a plurality of users from whom information is collected during the second state (Figure 18 discloses collecting data from the patients being treated; column 2, lines 9 – 19 discloses collecting information on individuals having a health concern and guide the user to a system selected treatment based on the information collected).
Claims 9 – 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McIlroy et al., herein after McIlroy (U.S. Patent Number 5,583,758) in view of Woellenstein et al., herein after Woellenstein (U.S. Publication Number 2008/0021287 A1) further in view of Brandt et al., herein after Brandt (U.S. Publication Number 2004/0153341 A1).
Claim 9 (Previously Presented). McIlroy and Woellenstein teach the method of claim 6.
McIlroy and Woellenstein fail to explicitly teach the following limitations met by Brandt as cited:
wherein the first subset of users comprises a portion of the second subset of users (paragraph 50 discloses patients with large infusion volumes (first subset of users) would often be associated with conditions that relate to low blood pressure such as blood loss and dehydration. Some of these patients would also have orders for blood products, for clotting factors, and for tests that monitor for blood loss, or other
orders relating to hydration status such as electrolytes, urine output, and urine osmolality (second subset, which is encompassed by the first subset)).
It would have been obvious to one of ordinary skill at the time of the invention to expand the method of McIlroy and Woellenstein to further include a healthcare information system intended for use by a healthcare provider that is responsible for monitoring the health and/or welfare of patient’s in its care as disclosed by Brandt.
One of ordinary skill in the art at the time of the invention would have been motivated to expand the method of McIlroy and Woellenstein in this way to provide a system that would lessen the burden of maintaining the order sets for healthcare treatment or services (Brandt: paragraph 6).
Claim 10 (Previously Presented). McIlroy and Woellenstein teach the method of claim 6.
McIlroy and Woellenstein fail to explicitly teach the following limitations met by Brandt as cited:
wherein the first subset of users is a single user (paragraph 50 discloses patients with large infusion volumes (first subset of users) would often be associated with conditions that relate to low blood pressure such as blood loss and dehydration. Some of these patients would also have orders for blood products, for clotting factors, and for tests that monitor for blood loss, or other orders relating to hydration status such as electrolytes, urine output, and urine osmolality (second subset, which is encompassed by the first subset) where it is obvious the second subset of users includes patients of the first subset).
The motivation to combine the teachings of McIlroy, Woellenstein, and Brandt is discussed in the rejection of claim 9, and incorporated herein.
Claim 11 (Previously Presented). McIlroy and Woellenstein teach the method of claim 6.
McIlroy and Woellenstein fail to explicitly teach the following limitations met by Brandt as cited:
wherein the second subset of users is a single user (paragraph 50 discloses patients with large infusion volumes (first subset of users) would often be associated with conditions that relate to low blood pressure such as blood loss and dehydration. Some of these patients would also have orders for blood products, for clotting factors, and for tests that monitor for blood loss, or other orders relating to hydration status such as electrolytes, urine output, and urine osmolality (second subset, which is encompassed by the first subset) where it is obvious the second subset of users includes patients of the first subset and could be the same patient).
The motivation to combine the teachings of McIlroy, Woellenstein, and Brandt is discussed in the rejection of claim 9, and incorporated herein.
Response to Arguments
Applicant's arguments filed August 22, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Response to 35 USC § 101 Rejection
The Applicant argues the claims are integrated into a practical application. The Examiner respectfully disagrees. The additional elements of the present claims fail to integrate the exception into a practical application of the exception. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
The Applicant argues the claims recite significantly more than the abstract idea. The Examiner respectfully disagrees. The Applicant’s specification states “The present invention has been described herein with reference to specific embodiments as illustrated in the accompanying drawings. Many variations of the embodiments of the functional components and dynamic operation (including use-case scenarios) of BSA system 100 described above will be apparent to those skilled in the art without departing from the spirit of the present invention, including but not limited to different allocations of the hardware and software functionality of BSA Server 115 and Client Devices 110 among one or more server, desktop, mobile or other computing devices, operating systems and firmware and software modules (including mobile smartphone apps and various networked online devices). Hardware and software functionality can be implemented interchangeably, and computer hardware can include peripherals such as monitors, keyboards, mice, trackpads and a variety of other peripheral I/O, user-wearable and other monitoring devices, including tangible memory and other storage devices (specifically non-transitory computer-accessible storage media in which data and software can be embodied). Moreover, the healthcare sector may be interpreted broadly (encompassing, for example, medicine, nutrition, nutraceuticals, cosmetics, fitness and lifestyle among others), and the functionality described herein may be applied outside of the healthcare sector without departing from the spirit of the present invention” (paragraph 204 of the published specification). The generic computer cited by the Applicant is a general link to execute the abstract idea. The processor, as used in the recited claims, is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
Response to 35 USC § 102 Rejection
The Applicant’s argument is moot as the rejection of Claim(s) 1 – 8 and 12 is/are rejected under pre-AIA 35 U.S.C. 102(b) are withdrawn based upon the amendment submitted August 22, 2025.
Response to 35 USC § 103 Rejection
The Applicant argues the rejections are distinguishable from the teachings of the references and state of the art at the time of filing. The Examiner respectfully disagrees. The arguments with respect to the claim amendments have been considered but are moot because the arguments do not apply the combination of references being used in the current rejection, but merely state, for example, “Brandt discusses updating existing standard of care for one or more disease conditions based on a change in frequency of prescribed treatments. Brandt does not suggest dynamic reclassification of users into first and second subsets based on system-detected triggers as claimed and it does not suggest a change in the rate of data collection.” Thus, Applicant’s argument is not persuasive and the rejection is maintained.
.
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 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 KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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/K.K.R/Examiner, Art Unit 3682
/ROBERT A SOREY/Primary Examiner, Art Unit 3682