Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of the Application
Claims 1-6 and 8-14 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendment to the Claims and Remarks filed on 06/27/2025.
Claim 1 is currently amended.
Claim 7 has been cancelled and is not considered at this time.
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 1-6 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 2-7 of U.S. Patent No. 11,610,691 (‘691 Patent) in view of Goldberg et al. (US 2011/0161107 A1). Although the conflicting claims are not identical, they are not patentably distinct from each other. Both claim 1 the instant application and Claim 2 of the ‘691 Patent are drawn to a method of implementing personalized health and wellness programs. The claim limitations of the ‘691 patent anticipate the limitations of Claim 1 of the instant application with the exception of specifically determining an outcome for the user.
Claim 2 of the ‘691 patent embodies all of the limitations of Claim 1 of the instant application with the exception of: determining an outcome for the user. Before the filing of the instant application, determining an outcome for a user of a personalized health and wellness program was old and well-known to persons of ordinary skill in the art. For example, U.S. Patent Application No. 2011/0161107 by inventor Goldberg et al. discloses “determining an outcome for the user” at [0066] care plan has goals for the patient to reach a desired health status, and the goal modules determine the patient progress/status by scoring results of parts of the plan numerically. [0067] patient results are tracked to measure patient change (outcome) from the start of the plan. The Goldberg reference in combination with the ‘961 patent renders the claims of the instant application not patentably distinct.
Claim 3 of the ‘691 patent embodies all of the limitations of Claim 2 of the instant application with the exception of determining an outcome for the user.
Claim 4 of the ‘691 patent embodies all of the limitations of Claim 3 of the instant application with the exception of determining an outcome for the user.
Claim 5 of the ‘691 patent embodies all of the limitations of Claim 4 of the instant application with the exception of determining an outcome for the user.
Claim 6 of the ‘691 patent embodies all of the limitations of Claim 5 of the instant application with the exception of determining an outcome for the user.
Claim 7 of the ‘691 patent embodies all of the limitations of Claim 6 of the instant application with the exception of determining an outcome for the user.
Before the filing of the instant application, determining an outcome for a user of a personalized health and wellness program was old and well-known to persons of ordinary skill in the art. For example, U.S. Patent Application No. 2011/0161107 by inventor Goldberg et al. discloses “determining an outcome for the user” at [0066] care plan has goals for the patient to reach a desired health status, and the goal modules determine the patient progress/status by scoring results of parts of the plan numerically. [0067] patient results are tracked to measure patient change (outcome) from the start of the plan. The Goldberg reference in combination with the ‘961 patent renders the claims of the instant application not patentably distinct.
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 1-6 and 8-14 are rejected 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 1-6 and 8-14 fall within the statutory category of a process.
Step 2A, Prong One
As per Claim 1, the limitations of receiving health data pertaining to a user; analyzing the health data using customized algorithms configured to leverage relationships between the health data to generate a plurality of user health profile, selecting a user health profile from a plurality of user health profiles based on the health data, each of the plurality of user health profiles being associated with a health and wellness program and a set of interventions; receiving user activity data and updated health data pertaining to the user’s participation in the associated health and wellness program; selecting in real-time a new set of interventions based on the user activity data, wherein selecting the new set of interventions comprises selecting a first type of communication based on the user activity data, sending the first type of communication to the user, and selecting a second type of communication based on user feedback to the first type of communication and the user activity data; selecting a new user health profile from the plurality of user health profiles based on at least one of the user activity data and updated health data; and determining an outcome for the user, under its broadest reasonable interpretation, covers management of personal behavior or personal interactions. The steps of receiving health data, selecting a user health profile based on health data, receiving user activity data and updated health data pertaining to participation in the health and wellness program, selecting a new set of interventions based on user activity data which includes selecting a first type of communication, sending the first type of communication to the user, and selecting a second type of communication based on user feedback to the first type of communication and user activity data, selecting a new user health profile, and determining an outcome for the user describe generation and management of a patient’s personalized health and wellness program, which is activity performed by a patient’s care provider in the care of a patient’s health which is interaction between a patient and care provider. If a claim limitation, under its broadest reasonable interpretation, covers the management of personal behavior or personal interactions, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The limitation including analyzing the health data using customized algorithms configured to leverage relationships between the health data to generate a plurality of user health profile, wherein the algorithms determine correlations between the health data to develop one or more health and wellness programs recite mathematical concepts including the use of an algorithm to analyze data for leveraging relationships between data which is a mathematical concept/mathematical relationship. Algorithms which determine correlations between data are also mathematical concepts/ mathematical relationships. The use of mathematical relationships, concepts and calculations falls into the abstract grouping of mathematical concepts and is directed to an abstract idea. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claims recite the additional element – a dashboard server to execute the abstract idea and receiving data from health devices, which amounts to mere instructions to apply the exception. The dashboard server is recited at a high-level of generality such that it is a general purpose computing component. The health devices are recited at a high-level of generality such that they are general purpose computing components. The use of a computer of other machinery in its ordinary capacity for tasks such as receiving or transmitting data is found by the courts to be mere instructions to apply the exception, as per MPEP 2106.05(f)(2) and does not integrate the abstract idea into a practical application or provide significantly more than the abstract idea. Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional element of dashboard server to execute the abstract idea amounts to mere instructions to apply the exception. The dashboard server is a general purpose computing component as described in the specification as part of a front-end cloud server ([0055]). The additional element of receiving health data from health devices amounts to no more than mere instructions to apply the exception using a generic computing component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Receiving health data is an element that is found to be well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data, which has been found to be well-understood, routine and conventional computer functions by the Court (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). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims 2-6 and 8-14 add further limitations which are also directed to an abstract idea. For example, Claims 2, 6, 8-12, and 14 further specifies or limits the elements of the independent claims, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1. Claim 3 includes simultaneously transmitting notifications to each of the plurality of users associated with a same health profile regarding each of the users’ participation in the health and wellness program. Humans are capable of sending a plurality of messages simultaneously and this step is managing personal interactions between people, therefore the claim is directed to certain methods of organizing human activity. Claim 4 includes determining the degree to the user is aware of their health metrics and motivated to change based on health and activity data which is an activity performed by a care provider in managing a patient’s health program and is therefore directed to certain methods of organizing human activity, similar to the independent claim. Claim 5 includes selecting a new set of interventions based on the degree to which the user is aware of their health metrics and motivated to change which is also certain methods of organizing human activity, similar to Claim 4, because this involves managing a patient’s health program. Claim 13 includes using genetic data to generate a genetic profile for the user that is used to select the health profile. This is also activity performed by a care provider in the management of a patient’s health program and is therefore directed to certain methods of organizing human activity for the same reasons as the independent claims. Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
Response to Arguments
Applicant' s arguments, see Page 5, “Response to Rejections of Claims 1-6 for Double Patenting”, filed 06/27/2025 have been fully considered. Applicant’s arguments with regard to the statutory/same invention double patenting rejection are persuasive. The amendments to Claim 1 have overcome the statutory obviousness-type double patenting as claiming the same invention as that of Claim 2 of patent 11,929,180. Therefore, the statutory rejection has been withdrawn.
Applicant’s arguments with respect to the non-statutory double patenting rejection over patent 11,929,180 of claims 1-6 have been fully considered and are persuasive. Therefore, the rejection of 03/28/2025 is withdrawn due to the terminal disclaimer filed on 06/27/2025.
Applicant’s arguments with regard to the non-statutory obviousness-type double patenting over claims 2-7 of patent 11,610,691 are not persuasive. Applicant argues that a Terminal Disclaimer has been filed. However, there is no Terminal Disclaimer filed in the application for patent 11, 610,691. The only terminal disclaimer filed is for patent 11,929,180.
Applicant' s arguments, see Pages 5-8, “Claim Rejections Under 35 U.S.C. §101”, filed 06/27/2025 have been fully considered but they are not persuasive.
Applicant argues that the claims integrate the abstract idea into a practical application because they provide a specific technical improvement through use of specialized algorithms that process complex health data. Examiner respectfully disagrees. The claims include the use of customized algorithms to analyze health data to generate user health profiles and determine correlations between the health data to develop health and wellness programs. The use of an algorithm for calculations to determine a result amounts to mathematical relationships and calculations. Therefore, this is merely a mathematical concept and is directed to the abstract idea such that it is not an additional element which is considered for integration into a practical application.
Applicant also argues that messaging all patients within a group collectively provides a technical solution. Examiner respectfully disagrees as this is part of the abstract idea of certain methods of organizing human activity and therefore cannot be considered as an integration into a practical application. The act of messaging a group of individuals is directed to the abstract idea of organizing human activity because this is activity performed by a person as an interaction with other people. Therefore, the rejection would be maintained.
Applicant also argues that the claims integrate the abstract idea into a practical application through technological improvements through the specific technical implementation of analyzing the health data using customized algorithms which leverage understandings of the relationships between the medical, genetic, fitness, environmental, and nutrition data to generate a user profile. Applicant further argues that the use of specialized algorithms to process multiple types of complex health data is a specific technical solution which provides a technical improvement. Examiner respectfully disagrees. The claim limitations described are directed to the abstract idea of mathematical concepts and regardless of whether they are described as specialized algorithms, these are still part of the abstract idea and therefore are not additional elements and cannot integrate the abstract idea into a practical application.
Applicant argues that the technical solution enables delivery of chronic care management services to a large number of Medicare patients in a time and cost effective manner. Examiner notes that as per MPEP 2106.05(f)(2), “claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). The use of a computer to carry out steps of the abstract idea and resulting in a more efficient process amount to mere instructions to apply the exception. Additionally, the improvements in time and cost which are results of the abstract idea itself, such as the sorting of patients into groups associated with user profiles that define health and wellness programs and tiered interventions, are improvements to the abstract idea and not technological improvements. No matter how much of an advance in the field of delivering chronic care management service the claims recite, the advance lies entirely in the realm of abstract ideas, with no plausibly alleged innovation in the nonabstract application realm. An advance of that nature is ineligible for patenting.
Conclusion
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 Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682