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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/19/22, 04/03/23, 03/08/24 and 07/30/25 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on December 15, 2025, amended claims 21, 22, 24, 30-32 and 37 have been entered.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under U.S.C. 101 have been fully considered. While Examiner agrees that the claimed invention does not explicitly recite mathematical calculations, Examiner argues that nothing from the claims, accompanying specification, and/or drawings suggest that the method steps cannot be practically performed mentally, or using pen/paper. Applicant argues the invention is not an abstract idea. Examiner notes that although the claims include a sensor, wearable device, data storage device and a processor, no physical aspect of the device mentioned in the claims is novel. The claims merely recite data gathering/outputting steps. Applicant further argues the claims integrate into a practical application. Examiner notes that according to MPEP 2106.04(d)(2), the practical application consists of administering a specific medication in response to the collected data. While Applicant recited the limitation “outputting instructions to dispense and/or take a medication”, Examiner notes a generic medication is not specific enough. Additionally, instruction to take a medication is not sufficient. Alternately, a practical application would consist of incorporating additional structure to the device. Lastly, Applicant argues the invention is significantly more based on the additional elements. Examiner notes there is no special purpose computer and the components of the invention are all well known in the art and conventional. Therefore, as currently claimed, the invention is not an improvement in technology. Accordingly, Examiner maintains that the identified judicial exception recites a mental process that is not integrated into a practical application. As such, the 35 USC 101 rejections are maintained. Examiner notes that incorporating a particular treatment based on the results or more structure to the claims would help move prosecution forward. Please see corresponding rejection heading below for more detailed analysis.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but were not persuasive.
Applicant argues none of the references teach determining, based on the identifying of the wearable device a first blood flow metric from a plurality of blood flow metrics that is relevant to the activity. However, Examiner disagrees and notes that Posio teaches the wearable device includes a blood pressure sensor unit [0028]. Additionally, Examiner notes that Posio teaches the wearable device monitors activity of a user [0019]. Therefore, it is inherent that in detecting the sensor is in use, blood pressure is measured based on a user performing an activity, when taking into consideration broadest reasonable interpretation.
Applicant also argues Taylor is non-analogous art and the CFD model requires high-fidelity, 3D anatomical data and complex boundary conditions to stimulate flow within a controlled, computational environment, while Posio teaches low-dimensional, real-time signals. Applicant further argues bridging these two data domains is non-trivial. Examiner notes that since Taylor teaches patient specific modeling for blood flow, which is relevant to the present application. Additionally, the higher functioning system of Taylor would be able to support the lower functioning system of Posio. Therefore, it would be obvious to combine Posio and Taylor, when taking into consideration broadest reasonable interpretation.
Applicant’s remaining arguments filed with respect to the prior art rejections raised in the previous office action were fully considered are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Zielinski reference), and updated obviousness rationale.
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 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 21 follows.
Regarding claim 21, the claim recites a computer-implemented method of calculating blood flow metrics. Thus, the claim is directed to a process, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
detecting a sensor that is continuously monitoring a user performing an activity
identifying, based on the detecting, a wearable device that includes the sensor,
determining, based on the identifying of the wearable device a first blood flow metric from a plurality of blood flow metrics that is relevant to the activity
continuously receiving sensor data from the detected sensor, the sensor data comprising activity data of a blood flow of the user or physiological characteristics of the user over a period of time in which the user performed an activity
receiving a user-specific anatomical model
continuously computing a value of the first blood flow metric of the user based on the user-specific anatomical model and the activity data
These limitations set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 21 recites based on the computed value of the first blood flow metric, causing the wearable device to output an updated health information of the user or an instruction to the user, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The outputting of health information to a user or instruction to a user does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the outputting of information or instruction. Additionally, claim 24 recites based on the continuously computed value of the first blood flow metric, outputting an instruction to dispense and/or take a medication, which is also merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The outputting of an instruction to dispense and/or take a medication does not provide an improvement to the technological field, and the method does not effect a particular treatment or effect a particular change based on the outputting of instruction. Examiner notes that a particular medication is not recited and it is not clear that it is the device itself is administering the medication.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a sensor
a wearable device that includes the sensor
The providing and recording steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the providing and recording steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
The additional limitations recite well-known structural limitations (generically recited sensors, etc.) and as such, do not amount to significantly more than the identified judicial exception. Examiner takes official notice that the additional limitations are conventional components in prior wearable analyte systems. Posio (applied in the previous office action) teaches these additional elements, showing these additional elements are well known and conventional [par. 3-5, 99].
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Independent claims 32 and 37 are also not patent eligible for substantially similar reasons.
Additionally, regarding claim 32, the device recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited sensor system is a generic sensor and configured to perform pre-solutional data gathering activity, the interface is configured to perform insignificant extra-solution activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a processor as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application
Dependent claims 22-31, 33-36 and 38-40 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 21-40 are not patent eligible under 35 USC 101.
Claim 37 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because "non-transitory computer-readable recording medium" is not a process, machine, manufacture, or composition of matter. ”non-transitory computer-readable recording medium” is not tangible, as it is not tied to a structural element.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-26 and 31-40 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0340920 A1 to Posio in view of US 2014/0243663 A1 to Taylor, US 2018/0055386 A1 to Zielinski and 2016/0027342 A1 to Ben-Haim.
Posio and Taylor were applied in the previous office action and Applicant’s IDS filed on 10/19/22
Ben-Haim was applied in the previous office action
As to claims 21, 32 and 37, Posio teaches a computer-implemented method, system and medium of calculating blood flow metrics comprising:
Posio teaches detecting a sensor that is continuously monitoring a user performing an activity; identifying, based on the detecting, a wearable device that includes the sensor, (physiological monitoring associated with user [0003]-[0005], [0019] “said system may be used to monitor physical activity and/or inactivity during the day and/or night (e.g. 24 hours a day)” [0099]); determining, based on the identifying of the wearable device a first blood flow metric from a plurality of blood flow metrics that is relevant to the activity ([0028] Examiner notes the wearable device includes a blood pressure sensor unit; [0019] Examiner also notes the device monitors activity of a user; Therefore, it is inherent that in detecting the sensor is in use, blood pressure is measured based on a user performing an activity) receiving sensor data from the detected sensor ([0099]), the sensor data comprising activity data of the user's blood flow or the user's physiological characteristics (200-16 senses physiological characteristics during activity [0033]-[0034], [0099]) over a period of time in which the user performed an activity (200-216 monitors over duration of activity [0019]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the manual input of physiological characteristics with the system of Posio to automate instant input of physiological data into the anatomical model for computing an updated value.
Posio does not teach receiving a user-specific anatomical model; computing a value of the first blood flow metric of the user based on the user-specific anatomical model and the activity data. Taylor teaches receiving a user-specific anatomical model (abstract, [0106]); computing a value of the selected first blood flow metric of the user based on the user-specific anatomical model and the activity data (abstract; [0107]-[0108]; adjusting boundary conditions based on data concerning patient’s physical conditions such as exercise [0226], [0238]).
Posio and Taylor do not teach based on computed value of the first blood flow metric, causing the wearable device to output an updated health information of the user or an instruction to the user. Zielinski teaches based on computed value of the first blood flow metric, causing the wearable device to output an updated health information of the user or an instruction to the user ([0099]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for instructing a patient to perform a clinical action ([0099])
Posio, Taylor and Zielinski do not teach continually updating the user-specific anatomical model based on the received sensor data. Ben-Haim teaches continually updating the user-specific anatomical model based on the received sensor data ([273], [299], [560]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for determining how the model reacts to sensor data.
Posio, Taylor, Zielinski and Ben-Haim do not teach based on the received sensor data, outputting an instruction to dispense and/or take a medication. Tran teaches based on the received sensor data, outputting an instruction to dispense and/or take a medication ([225], [493]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for monitoring any type health related data of the user.
As to claims 22, 33 and 38, Taylor, Posio, Zielinski and Ben-Haim make obvious the computer-implemented method of claim 1. Taylor further teaches: wherein the user-specific anatomical model includes a first value of the first blood flow metric and wherein the computed value of the first blood flow metric is a second value of the first blood flow metric ([0226], [0238]).
As to claims 23, 34 and 39, Taylor, Posio, Zielinski and Ben-Haim make obvious the computer-implemented method of claim 2. Taylor further teaches updating the user-specific anatomical model based on the computed second value of the first blood flow metric ([0226], [0238]). Ben-Haim further teaches continually updating the user-specific anatomical model ([273], [299], [560])
As to claim 24, Taylor, Posio, Zielinski and Ben-Haim make obvious the computer-implemented method of claim 2. Taylor further teaches updating the user-specific anatomical model based on the computed second value of the first blood flow metric ([0226], [0238]). Ben-Haim further teaches continually updating the user-specific anatomical model ([273], [299], [560]). Zielinski further teaches based on the continuously computed value of the first blood flow metric, outputting an instruction to dispense and/or take a medication ([0099])
As to claims 35 and 40, Taylor, Posio, Zielinski and Ben-Haim make obvious the computer-implemented method of claim 2. Taylor further teaches determining the blood flow model to use to compute the value of the first blood flow metric; and updating the blood flow model based on the received sensor data ([0226], [0238]).
As to claims 25 and 36, Taylor, Posio, Zielinski and Ben-Haim make obvious the computer-implemented method of claim 24. Taylor further teaches wherein the blood flow model is based on a user-specific boundary condition, and updating the blood flow model comprises updating the user-specific boundary condition based on the sensor data (abstract; [0107]-[0108]; adjusting boundary conditions based on data concerning patient’s physical conditions such as exercise [0226], [0238]).
As to claims 26, Taylor, Posio, Zielinski and Ben-Haim make obvious the computer-implemented method of claim 24. Taylor further teaches wherein the blood flow model is based on the user-specific anatomical model (abstract; [0107]-[0108]; adjusting boundary conditions based on data concerning patient’s physical conditions such as exercise [0226], [0238])
As to claim 31, Taylor, Posio, Zielinski and Ben-Haim make obvious the computer-implemented method of claim 24. Taylor further teaches based on the detected sensor, selecting a second blood flow metric from the plurality of blood flow metrics; and computing a value of the selected second blood flow metric of the user based on the user-specific anatomical model and the activity data (abstract; [0107]-[0108]; adjusting boundary conditions based on data concerning patient’s physical conditions such as exercise [0226], [0238]).
Claims 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Posio, Taylor, Zielinski and Ben-Haim, as applied to claim 21 and 9 above, and further in view of US 9,087,147 to Fonte (cited by Applicant).
Fonte was applied in the previous office action and cited in Applicant’s IDS filed on 10/19/22
As to claim 27, Posio, Taylor, Zielinski and Ben-Haim do not teach receiving stored sensor data associated with the user, wherein the stored sensor data is collected at a first point in time prior to collection of the sensor data of the user's blood flow or collection of the sensor data of the user's physiological characteristics; determining a blood flow model based on the stored sensor data; and computing the second value of the blood flow metric of the user further based on the determined blood flow model. Fonte discloses receiving stored sensor data associated with the user, wherein the stored sensor data is collected at a first point in time prior to collection of the sensor data of the user's blood flow or collection of the sensor data of the user's physiological characteristics (“already obtained” col 48, In 3-7; “prior Ml” col 48, In 10); determining a blood flow model based on the stored sensor data (col 48, In 11-31); and computing the second value of the blood flow metric of the user further based on the determined blood flow model (col 20, In 24-30; col 27, In 25-48; cl 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the stored data of Fonte in the method of Posio, Taylor, Zielinski, and Ben-Haim to correlate data taken over time with needed adjustment of the model.
As to claim 28, Posio, Taylor, Zielinski and Ben-Haim do not teach receiving stored sensor data associated with an individual other than the user; determining a blood flow model based on the stored sensor data; and computing the second value of the blood flow metric of the user further based on the determined blood flow model. Fonte discloses receiving stored sensor data associated with an individual other than the user (“population of patient-specific data” col 51, In 35-43); determining a blood flow model based on the stored sensor data (col 51, In 38-43); and computing the second value of the blood flow metric of the user further based on the determined blood flow model (col 51, In 44-51). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the stored data of Fonte in the method of Posio, Taylor, Zielinski and Ben-Haim to correlate data taken over time with needed adjustment of the model.
As to claim 29, Posio, Taylor, Zielinski and Ben-Haim do not teach identifying a user group associated with the user; and identifying the individual based on the user group associated with the user. Fonte identifying a user group associated with the user; and identifying the individual based on the user group associated with the user (col 48, In 7-10; col 49, In 8-14). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify a user group and the individual as taught by Fonte in the method of Posio, Taylor, Zielinski and Ben-Haim to adjust the model based on data from a population with characteristics closest to the individual.
As to claim 30, Posio, Taylor, Zielinski and Ben-Haim do not teach based on the selected first blood flow metric, selecting which sensor data to use for the computing the value of the first blood flow metric. Fonte teaches based on the selected first blood flow metric, selecting which sensor data to use for the computing the value of the first blood flow metric (col 66, ln 46-49). It would have been obvious to one of ordinary skill in the art to select one of the corresponding sensors 200-216 as a data source for the desired blood flow information as taught by Fonte in the method of Posio, Taylor, Zielinski and Ben-Haim, to provide the correct data needed for adjusting the model.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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