DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 18th, 2026 has been entered.
Amendment Entered
In response to the amendment filed on May 18th, 2026, amended claims 1, 6, 8-9, 11, and 36 are entered. Claims 12-18 remain withdrawn from consideration. Claims 1-11 and 31-37 are currently under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the specification objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(a) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered but are not fully persuasive. Although a majority of the rejections have been withdrawn in view of the amendment, the rejection for claim 10 has been maintained, and further clarified below.
Specifically, at Pg. 11 of the Reply, Applicant argues that “Applicant has amended claim 10…Applicant respectfully submits that this amendments renders the § 112(b) rejection of claim 10 moot”. Examiner would like to point out that Claim 10 has not been amended and is currently represented as “Previously Presented”. Therefore, the rejection of claim 10 under 35 U.S.C. 112(b) has been maintained.
Applicant's arguments, filed on May 18th, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive. The rejections are maintained, and further clarified, in view of the amendment.
At Pg. 14 of the Reply, Applicant argues that “it is clear that the alleged abstract idea has been integrated into a practical application as an improvement to systems for monitoring blood pressure and determining whether to screen users for heart health conditions…therefore provides an improved automated and objective system for monitoring blood pressure and identifying users who warrant further diagnosis of heart health conditions”. Examiner respectfully disagrees. The determination of a screening score does not provide an improvement to the technological field, as the step does not effect a particular treatment or effect a particular change based on the screening score determined by the measurement signal, nor does the method use a particular machine to perform the Abstract Idea. Furthermore, according to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
“The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification).” MPEP 2106.05(a). “That is, the claim must include the components or steps of the invention that provide the improvement described in the specification.” Id.
“[I]n McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea.” MPEP 2106.05 (a). There is no improvement to a computer or other technology. Unlike McRO, the claimed system invokes a computer as a tool to perform a mathematical concept and/or mental process.
The claimed steps do not improve the functioning of the data acquisition or the storing in the database. “It is important to note, the judicial exception alone cannot provide the improvement.” MPEP 2106.05(a). The sensors and one or more processors perform the same with or without the claimed abstract idea. Therefore, it is unclear how the abstract idea can improve the standard functions of the additional elements. Thus, any improvement resides solely within the abstract idea.
The Examiner would like to emphasize that the current claims do not have any limitations drawn to performing any decisions, procedures, or steps in response to the determination. The claim language simply calculates and displays data. At most, the user interface will display instructions for the user to initiate the second monitoring phase. Therefore, there is nothing outside of the abstract idea that shows integration into practical application.
At Pg. 15 of the Reply, Applicant cites the Federal Circuit’s decision in EcoServices, LLC v. Certified Aviation Services, LLC, No. 2019-1602 (Fed. Cir. Oct. 8 2020), arguing that in EcoServices, “the court held that claims directed to an automated system for washing jet engines were patent-eligible under § 101, even though the claims automated a task previously performed by human operators and recited allegedly generic components such as a ‘washing unit,’ an ‘information detector,’ and a ‘control unit’…the same reasoning applies here”. Examiner respectfully disagrees.
EcoServices recited patent eligible subject matter because the Federal Circuit found that the claims did not recite an abstract idea. Conversely, the claims of the instant application recite the abstract idea of processing the first measurement signal output, determining a screening score, and determining whether the screening score exceeds at least one threshold.
In this case, the computer is simply used as a tool. Even with the new amendments, the claims still recite mental processes performed on a computer control system. The “Federal Circuit has explained, ‘[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.’ Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015).” MPEP 2106.04(a)(2) III. There is no time limit recited for performing the steps. The claimed steps can be performed via pen and paper or in a person’s mind with no time limit. The computer is merely utilized as a tool to perform the mental steps. Therefore, EcoServices is not relevant nor analogous to the current claims.
At Pg. 16 of the Reply, Applicant once again cites the Applicant’s Specification in order to provide examples of how the system provides the improvement, similar to EcoServices. The Examiner would like to emphasize that the claims are significantly broader than the Specification, and that the Applicant is arguing more than what is actually being claimed. Regardless of the analysis of the Federal Circuit decision in EcoServices, LLC v. Certified Aviation Services, LLC, No. 2019-1602 (Fed. Cir. Oct. 8 2020), each case is judged on its own merit. In this case, the newly added limitations of the abstract idea still recite steps that may be completed in the mind, with data obtained through generic sensors and further outputting data on a user interface.
At Pgs. 16-17 of the Reply, Applicant argues that under Step 2B, the combination of the additional elements “represents a specific, unconventional technical architecture that goes well beyond the mere application of an abstract idea on a generic computer”. Examiner respectfully disagrees. Under Step 2B, the claim utilizes a “pulsatility spot-check sensor” and a “different pulsatility sensor”, which is recited at such a high level of generality that it amounts to insignificant pre-solution/extra-solution activity, e.g., mere data gathering steps 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 engaged in by medical professionals prior to Applicant's invention. Other than the sensors, the user interface, application, and one or more processors are considered generic computing elements. And specifically in claim 1, the “user interface” is only recited to “display instructions”. Therefore, the “user interface” may also be categorized as insignificant extra-solution activity in the form of data-outputting. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the “pulsatility spot-check sensor”, the “different pulsatility sensor”, and generic computing elements 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)). Thus, the claimed invention does not amount to significantly more than the abstract idea.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 102 and 103 have been fully considered. The rejections are withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 and 31-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “cause the user interface to display instructions for collecting a pulsatility measurement using the pulsatility spot-check sensor in accordance with a first monitoring phase”, “cause the user interface to display instructions for the user to initiate a second monitoring phase using use of the different pulsatility sensor in response to the determining”, and “wherein the second monitoring phase comprises collecting at least two BP measurements during a predefined measurement period to diagnose the heart health condition of the user”. However, the Application’s Specification fails to provide support for the aforementioned limitations, as there are no limitations regarding displaying instructions for collecting a pulsatility measurement, displaying instructions for the user to initiate a second monitoring phase, and wherein the second monitoring phase comprises collecting at least two BP measurements during a predefined measurement period. Although the Applicant has recited that “[s]upport for the amendments can be found in [0045]-[0046], [0050]-[0052], [0054]-[0055], [0058], and [0063]-[0064]” (see Pg. 9 of the Reply), the specified paragraphs fail to recite sufficient written support for the claim limitations.
Claim 11 recites “generating the recommendation for the user to initiate use of the different pulsatility sensor includes facilitating a physical acquisition of the different pulsatility sensor”. However, the Application’s Specification fails to provide support for the aforementioned limitations, as there are no limitations regarding generating the recommendation for the user to initiate use of the different pulsatility sensor includes facilitating a physical acquisition of the different pulsatility sensor. Although the Applicant has recited that “[s]upport for the amendments can be found in [0045]-[0046], [0050]-[0052], [0054]-[0055], [0058], and [0063]-[0064]” (see Pg. 9 of the Reply), the specified paragraphs fail to recite sufficient written support for this claim limitation.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 31-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a user interface” in line 3 and “a signal analysis application” in line 4. Claim 1 later goes on to recite wherein the user interface and signal analysis application complete steps such as displaying, processing, and determining different elements. However, it is unclear as to whether these elements are separate from one another, or tied together. For example, a signal analysis application may have a user interface implemented within the application so that the user may interact with the application. However, a user interface is not always required for an application, as some applications work in the background without direct user interaction. On the contrary, a user interface may be present even without an application present. Therefore, it is unclear as to whether the claims are drawn towards a signal analysis application that encompasses a user interface and uses data obtained from sensors, or if the claims are drawn towards a system that is configured to run a signal analysis application, along with a separate user interface and separate independent sensors. Clarification is requested.
Claim 1 recites “one or more processors in electronic communication with the pulsatility spot-check sensor” in lines 11-12. However, the claim limitations go on to further recite wherein the one or more processors are programmed with instructions, that when executed, cause actions affecting not only the pulsatility spot-check sensor, but also the user interface, the signal analysis application, and the different pulsatility sensor. It is unclear as to whether the Applicant meant to have the one or more processors to be in electronic communication with specifically only the pulsatility spot-check sensor, or if the Applicant meant to have the one or more processors to be in electronic communication with the other elements (user interface, the signal analysis application, and the different pulsatility sensor) as well.
Claim 1 recites “in response to the determining” in line 26. It is unclear as to whether this conditional limitation occurs if the determination is made that the screening score exceeds at least one threshold or not. Clarification is requested.
Claim 10 recites “the different pulsatility sensor measures BP to calculate a metric” in lines 2-3. The typical function of a sensor is to collect data; therefore, it is unclear as to how a sensor can "calculate a metric". For examination purposes, the Examiner will interpret that “the different pulsatility sensor measures the BP and the one or more processors calculates a metric based on the measured BP”.
Claim 11 recites the limitation "the recommendation" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner notes that claim 11 seems to be referring back to claim 1, which had previously recited “generate a recommendation for the user to initiate”, which has since been amended to recite “cause the user interface to display instructions for the user to initiate”.
Claims 35 and 36 both recite “wherein adapting the intervention comprises optimizing” in lines 1-2. It is unclear as to how the one or more processors can adapt the intervention through optimizing the one or more parameters, as the optimization of the one or more parameters seems to be a result of the efforts made by the user, such as through adjusting medication dosages, lifestyle changes, etc., rather than steps completed by the one or more processors. Clarification is requested.
Claim 37 recites “a user interface” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “user interface” from independent claim 1, or a separate element. Furthermore, Claim 37 later recites “a distinct version of the user interface” in line 5. It is unclear as to whether the previously introduced “user interface” of independent claim 1 is one of the “distinct version[s]”, or a separate element. Clarification is requested.
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 1-11 and 31-37 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.
Each of Claims 1-11 and 31-37 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1-11 and 31-37 recite a system for monitoring blood pressure of a user. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1-11 and 31-37 recites at least one step or instruction for processing and determining, which is grouped as a mental process under the 2019 PEG. The claimed steps of processing and determining can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Accordingly, each of Claims 1-11 and 31-37 recites an abstract idea.
Specifically, Claim 1 recites the abstract idea of: “cause the signal analysis application to process the first measurement signal output by the pulsatility spot-check sensor to determine a screening score for the first monitoring phase indicative of a heart health condition of the user, cause the signal analysis application to determine whether that the user's screening score for the first monitoring phase exceeds at least one threshold”. The steps of measuring pulsatility and BP and displaying instructions recites steps for data-gathering and data-outputting, which are categorized under insignificant extra-solution activity.
Further, dependent Claims 2-11 and 31-37 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claim 1 (and its dependent Claims 2-11 and 31-37) is not integrated into a practical application under 2019 PEG because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “user interface”, “signal analysis application”, “pulsatility spot-check sensor”, “different pulsatility sensor”, “one or more processors” recited in independent Claim 1; the elements listed within the group recited in dependent claim 3; “smartphone camera” recited in dependent claim 4; the elements listed within the group recited in dependent claim 8; “wearable bracelet” recited in dependent claim 9; and “display”, “user interface” in dependent claim 37 are generically recited elements which do not improve the functioning of a computer, or any other technology or technical field and/or serve as data-gathering and data-outputting elements. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1 (and its dependent claims) is not integrated into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., one or more processors). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and its dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 (and its dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-11 and 31-37 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “user interface”, “signal analysis application”, “pulsatility spot-check sensor”, “different pulsatility sensor”, “one or more processors” recited in independent Claim 1; the elements listed within the group recited in dependent claim 3; “smartphone camera” recited in dependent claim 4; the elements listed within the group recited in dependent claim 8; “wearable bracelet” recited in dependent claim 9; and “display”, “user interface” in dependent claim 37. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks and/or serve as data-gathering and data-outputting elements. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by: the Background in the Applicant’s specification; Applicant’s specification (paragraphs [0050-0052] and [0058-0062]) which discloses that the sensors comprise generic computer components that are configured to perform the generic functions (e.g. measuring blood pressure) that are well-understood, routine, and conventional activities previously known to the pertinent industry; and Applicant’s specification (paragraphs [0366-0379]) which discloses that the system comprises generic computer components that are configured to perform the generic computer processing functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Accordingly, in light of Applicant’s specification, the claimed term “one or more processors” and “application” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the system. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-11 and 31-37 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement.
Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system of Claims 1-11 and 31-37 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-11 and 31-37 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment.
As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-11 and 31-37 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-11 and 31-37 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-11 and 31-37 are not patent eligible and rejected under 35 U.S.C. 101.
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 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.
Claims 1-11, 31-34, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Mills et al (U.S. Publication No. 2014/0121546; previously cited) in view of Goldner et al (U.S. Publication No. 2022/0361823; previously cited).
Regarding Claim 1, Mills discloses a system for monitoring blood pressure (BP) of a user (Device and method for the continuous non-invasive measurement of blood pressure; Abstract) comprising:
a user interface (user interface 110);
a pulsatility spot-check sensor adapted to measure a pulsatility of blood of the user at at least one discrete point in time and output a first measurement signal (Blood pressure monitor 100 is connected via continuous BP interface 106 to a set of finger cuffs 120 (only one of which is used at any one time) to receive a continuous blood pressure signal; [0026]);
a different pulsatility sensor (arm cuff 140; [0026]; Figure 1), wherein the different pulsatility sensor is:
(i) of a different type than the pulsatility spot-check sensor (Examiner’s Note: An arm cuff is a different type than a finger cuff), and
(ii) adapted to measure BP of the user periodically and without user initiation (The controller 102 analyses the calibrated continuous blood pressure signal and issues instructions to the arm cuff blood pressure measurement device 140 to take a calibration blood pressure measurement when a threshold associated with the calibrated continuous blood pressure signal exceeds a predetermined threshold (as discussed with reference to FIG. 2). The controller 102 may issue an instruction for the arm cuff 140 to take a calibration blood pressure measurement at other times, such as at the start of a continuous blood pressure measurement; [0026]);
one or more processors (controller 102) in electronic communication with the pulsatility spot-check sensor, the one or more processors programmed with instructions that, when executed:
cause the user interface to display instructions for collecting a pulsatility measurement using the pulsatility spot-check sensor in accordance with a first monitoring phase (Blood pressure monitor 100 is connected via continuous BP interface 106 to a set of finger cuffs 120 (only one of which is used at any one time) to receive a continuous blood pressure signal; [0026]; The controller 102 analyses the calibrated continuous blood pressure signal and issues instructions to the arm cuff blood pressure measurement device 140 to take a calibration blood pressure measurement when a threshold associated with the calibrated continuous blood pressure signal exceeds a predetermined threshold (as discussed with reference to FIG. 2). The controller 102 may issue an instruction for the arm cuff 140 to take a calibration blood pressure measurement at other times, such as at the start of a continuous blood pressure measurement or when requested by the user via user interface 110; [0026]; If one of the threshold values is exceeded, then a new calibration blood pressure measurement is taken 240; [0031]; Examiner’s Note: The Examiner notes wherein the limitation “for collecting a pulsatility measurement using the pulsatility spot-check sensor in accordance with a first monitoring phase” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations),
process the first measurement signal output by the pulsatility spot-check sensor to determine a screening score for the first monitoring phase indicative of a heart health condition of the user (Before measurements are recorded the continuous blood pressure signal is initially calibrated 210 using a calibration blood pressure signal…the calibrated blood pressure signal is continuously monitored to check whether one or more preselected threshold values have been exceeded 230; [0031]; it was found that a rapid change in pulse pressure may indicate that the calibration of the measurement may no longer be correct. The embodiment therefore uses a rate of change in pulse pressure as an additional or alternative trigger for checking the calibration of the blood pressure measurements. An arm cuff measurement for checking the calibration is in particular triggered if the pulse pressure decreases by more than 50% within 90 seconds or increases by more than 100% within 90 seconds; [0034]),
determine whether the screening score for the first monitoring phase exceeds at least one threshold (The controller 102 analyses the calibrated continuous blood pressure signal and issues instructions to the arm cuff blood pressure measurement device 140 to take a calibration blood pressure measurement when a threshold associated with the calibrated continuous blood pressure signal exceeds a predetermined threshold (as discussed with reference to FIG. 2); [0026]; The calibrated blood pressure signal is continuously monitored to check whether one or more preselected threshold values have been exceeded 230; [0031]; An arm cuff measurement for checking the calibration is in particular triggered if the pulse pressure decreases by more than 50% within 90 seconds or increases by more than 100% within 90 seconds; [0034]), and
cause the user interface to display instructions for the user to initiate a second monitoring phase using the different pulsatility sensor in response to the determining (The controller 102 analyses the calibrated continuous blood pressure signal and issues instructions to the arm cuff blood pressure measurement device 140 to take a calibration blood pressure measurement when a threshold associated with the calibrated continuous blood pressure signal exceeds a predetermined threshold (as discussed with reference to FIG. 2). The controller 102 may issue an instruction for the arm cuff 140 to take a calibration blood pressure measurement at other times, such as at the start of a continuous blood pressure measurement or when requested by the user via user interface 110; [0026]; If one of the threshold values is exceeded, then a new calibration blood pressure measurement is taken 240; [0031]; it was found that a rapid change in pulse pressure may indicate that the calibration of the measurement may no longer be correct. The embodiment therefore uses a rate of change in pulse pressure as an additional or alternative trigger for checking the calibration of the blood pressure measurements. An arm cuff measurement for checking the calibration is in particular triggered if the pulse pressure decreases by more than 50% within 90 seconds or increases by more than 100% within 90 seconds…in the embodiment the signal is recalibrated if the pulse pressure decreases by more than 60% since the last calibration or calibration check or increases by more than 150% since the last calibration or calibration check; [0034]; Examiner’s Note: The Examiner notes wherein the limitation “for the user to initiate a second monitoring phase using the different pulsatility sensor in response to the determining” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations), wherein the second monitoring phase comprises collecting at least two BP measurements during a predefined measurement period to diagnose the heart health condition of the user (Blood pressure monitor 100 is connected via continuous BP interface 106 to a set of finger cuffs 120 (only one of which is used at any one time) to receive a continuous blood pressure signal, and via calibration BP interface 108 to arm cuff 140 to receive a calibration blood pressure signal when requested. Interfaces 106 and 108 are connected to controller 102 which may calculate a calibrated continuous blood pressure signal based on the blood pressure signals received from finger cuffs 120 and arm cuff 140 through interfaces 106 and 108. The controller executes its functions based on executable software code stored in memory 104. The controller 102 analyses the calibrated continuous blood pressure signal and issues instructions to the arm cuff blood pressure measurement device 140 to take a calibration blood pressure measurement when a threshold associated with the calibrated continuous blood pressure signal exceeds a predetermined threshold (as discussed with reference to FIG. 2). The controller 102 may issue an instruction for the arm cuff 140 to take a calibration blood pressure measurement at other times, such as at the start of a continuous blood pressure measurement or when requested by the user via user interface 110. Blood pressure signals may be stored in the memory 104 for future analysis and patient records; [0026]).
Mills fails to disclose a signal analysis application; and wherein the one or more processors are programmed with instructions that, when executed: cause the signal analysis application to complete the steps of processing and determining.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), comprising a signal analysis application; and wherein the one or more processors are programmed with instructions that, when executed: cause the signal analysis application to complete the steps of processing and determining (the system 102 can include various application programming interfaces (APIs) and/or communication interfaces that can allow interfacing between user devices 104, databases, and/or any other components; [0030]; The users can be individual users (e.g., patients, healthcare professionals, etc.), computing devices, software applications, objects, functions, and/or any other types of users and/or any combination thereof. For example, upon obtaining any of the input data discussed above, the user device 104 can generate an instruction and/or command to the system 102, e.g., to process the obtained data, store the data in the database 106, extract additional data from one or more databases, and/or perform analysis of the data; [0033]; The healthcare guidance can be generated locally onboard the device 200, by a user device that receives health measurement data from the device 200 (e.g., via a mobile application on a user's smartphone or smartwatch), by a cloud computing system or remote server that receives health measurement data from the device 200, or any suitable combination thereof; [0057]; These computer programs, which can also be referred to programs, software, software applications, applications, components, or code, include machine instructions for a programmable processor, and can be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language; [0102]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the application teachings of Goldner into the invention of Mills in order to enable the system to communicate to the user personalized healthcare tracking and guidance, such as one or more predictions, recommendations, suggestions, feedback, and/or diagnosis for a number of diseases, conditions, or health states (Goldner [0057]).
Regarding Claim 2, Mills discloses wherein the pulsatility spot-check sensor is adapted to perform a spot check BP measurement (The first blood pressure signal may be a continuous and/or non-invasive blood pressure signal, such as that provided from a single finger cuff (such as one of the finger cuffs described in the above US patent, for example); [0009]; Examiner’s Note: The finger cuff is capable of performing a spot check BP measurement).
Regarding Claim 3, Mills discloses wherein the pulsatility spot-check sensor is selected from a group consisting of: a camera, a photoplethysmographic sensor, a sensor embedded in a wearable device (Blood pressure monitor 100 is connected via continuous BP interface 106 to a set of finger cuffs 120 (only one of which is used at any one time) to receive a continuous blood pressure signal; [0026]; Examiner’s Note: A finger cuff is capable of being worn, and therefore would qualify as a wearable device), a sensor embedded in a kiosk, a toilet sensor, a sensor embedded in a smartphone, a sensor embedded in a computer, a sensor embedded in a tablet, a sensor embedded in a smartwatch, a sensor embedded in a fitness tracker, a sensor embedded in a smart ring, a sensor embedded in a wearable smart band, a sensor embedded in a non-wearable smart device, a sensor embedded in a dedicated medical device, a security camera, a thermal imaging camera, a sensor embedded in a facial recognition kiosk, a sensor embedded in an airport body scanner, a sensor embedded in an interactive screen, a sensor embedded in a smart mirror, a sensor embedded in a motion detector, a sensor embedded in an automated teller machine (ATM), a sensor embedded in a traffic light radar, a sensor of a drone, a sensor used in border control equipment, a sensor embedded in a seat, a sensor embedded in a handrail, a sensor embedded in a shopping cart, a sensor embedded in exercise equipment, a sensor embedded in an elevator handrail, a sensor embedded in an escalator handrail, a sensor embedded in a supermarket checkout counter, a sensor embedded in a turnstile, a sensor embedded in a car steering wheel, a sensor embedded in a smart streetlight, a sensor embedded in a smart city lamp post, a sensor embedded in a digital signage display, and a sensor embedded in a vehicle.
Regarding Claim 4, Mills fails to disclose wherein the pulsatility spot-check sensor comprises a smartphone camera.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein the pulsatility spot-check sensor comprises a smartphone camera (The user devices 104 can obtain any of the above data and can provide output in various ways, such as using one or more of the following components: a microphone (either a separate microphone or a microphone imbedded in the device), a speaker, an interface, a screen (e.g., using a touchscreen, a stylus pen, and/or in any other fashion), a keyboard, a mouse, a camera, a camcorder, a telephone, a smartphone, a tablet computer, a personal computer, a laptop computer, a sensor (e.g., a sensor included in or operably coupled to the user device 104), and/or any other device); [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the smartphone teachings of Goldner into the invention of Mills in order to enable the sensor to take multiple forms in order to obtain data and provide output in various ways (Goldner [0029]).
Regarding Claim 5, Mills discloses wherein the different pulsatility sensor is adapted to perform continuous or semi-continuous BP measurements (Once the blood pressure signal has been calibrated, calibrated continuous blood pressure measurements may be taken 220. The calibrated blood pressure signal is continuously monitored to check whether one or more preselected threshold values have been exceeded 230…By continuously monitoring the blood pressure measurements and recalibrating whenever threshold values are exceeded, the number of calibration measurements may be limited whilst still ensuring the accuracy of the measurements; [0031]).
Regarding Claim 6, Mills fails to disclose wherein the one or more processors are further programmed with instructions that, when executed, cause the one or more processors to: calculate, from the measured BP from the different pulsatility sensor, a metric selected from a group consisting of a Time-in-Target Range (TTR) parameter, a Hi-Load parameter, a Cumulative Blood Pressure Load (CBPL) parameter, a BP Severity Score (BPSS), a Time- Weighted Average BP (TWABP) parameter, a BP Deviation Index (BPDI), a Cumulative Hypertension Duration (CHD) parameter, a BP Stability Coefficient (BPSC), a Standard Deviation of BP (SD-BP) parameter, a Coefficient of Variation (CoV-BP) parameter, an Average Squared Real Variability (ASRV-BP) parameter, a Maximum BP Excursion Duration (MaxBED) parameter, a Symmetrical Weighting Index (SWI), an Acute Hypertensive Event Index with Extreme Non-Linearity (AHEI+) parameter, an Acute Hypertensive Event Index with Dynamic Spike Reinforcement (AHEI++) parameter, a Chronic Hypertensive Exposure Index with Non-linear Time Reinforcement (CHEI+) parameter, a Combined Acute and Chronic Index(CACI), a Consecutive Hypertensive Hours Index (CHHI), a Continuous Hypertensive Exposure Percentage (CHEP), a Persistent Hypertension Days Index (PHDI), a Rate of BP Normalization (RBPN) parameter, Cumulative Exposure to Extreme BP (CEEB) parameter, a Threshold-Based Hypertensive Exposure Vector (THEV), a Threshold-Based Hypertensive Exposure Curve (THEC), and a Combined Systolic and Diastolic Hypertensive Marker (CSDHM);assess a cardiovascular risk; and apply an artificial intelligence (Al) model to classify the user according to cardiovascular risk based on the calculated metric.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein the one or more processors are further programmed with instructions that, when executed, cause the one or more processors to: calculate, from the measured BP from the different pulsatility sensor, a metric selected from a group consisting of a Time-in-Target Range (TTR) parameter (the blood pressure event prediction can be based on an average blood pressure over a period of time within a target range; [0021]), a Hi-Load parameter, a Cumulative Blood Pressure Load (CBPL) parameter, a BP Severity Score (BPSS), a Time- Weighted Average BP (TWABP) parameter, a BP Deviation Index (BPDI), a Cumulative Hypertension Duration (CHD) parameter, a BP Stability Coefficient (BPSC), a Standard Deviation of BP (SD-BP) parameter, a Coefficient of Variation (CoV-BP) parameter, an Average Squared Real Variability (ASRV-BP) parameter, a Maximum BP Excursion Duration (MaxBED) parameter, a Symmetrical Weighting Index (SWI), an Acute Hypertensive Event Index with Extreme Non-Linearity (AHEI+) parameter, an Acute Hypertensive Event Index with Dynamic Spike Reinforcement (AHEI++) parameter, a Chronic Hypertensive Exposure Index with Non-linear Time Reinforcement (CHEI+) parameter, a Combined Acute and Chronic Index(CACI), a Consecutive Hypertensive Hours Index (CHHI), a Continuous Hypertensive Exposure Percentage (CHEP), a Persistent Hypertension Days Index (PHDI), a Rate of BP Normalization (RBPN) parameter, Cumulative Exposure to Extreme BP (CEEB) parameter, a Threshold-Based Hypertensive Exposure Vector (THEV), a Threshold-Based Hypertensive Exposure Curve (THEC), and a Combined Systolic and Diastolic Hypertensive Marker (CSDHM);
assess a cardiovascular risk (When the predicted increase in blood pressure falls into ranges that put the user at possible risk of hypertension, the system can send a notification to the user of the risk; [0013]); and
apply an artificial intelligence (Al) model to classify the user according to cardiovascular risk based on the calculated metric (the system 102 can analyze the obtained input data, including historical data, current real-time data, continuously supplied data, and/or any other data (e.g., using a statistical analysis, machine learning analysis, etc.), and generate output data…the user account 109 can periodically or continuously retrieve data and transmit all or a portion of the data to, for example, trained machine learning models, input data to machine learning models, generate values (e.g., forecast, predictions, etc.); [0034-0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the classification teachings of Goldner into the invention of Mills in order to accurately analyze the data to calculate when predicted increase in blood pressure falls into ranges that put the specific user at possible risk of hypertension (Goldner [0013]).
Regarding Claim 7, Mills fails to disclose wherein the different pulsatility sensor is further adapted to provide personalized recommendations to the user for managing a BP condition.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein the different pulsatility sensor is further adapted to provide personalized recommendations to the user for managing a BP condition (Referring now to FIG. 4A, the user device 402 can include, without limitation, an interface 403 displaying a notification with a recommendation 405. The recommendation 405 can include, without limitation, a prompter motivator indicating that it's time to exercise. The recommendation 405 can also include contributing health factors (e.g., sleep, diet, etc.) associated with a predicted reduction in blood pressure; [0023]; upon obtaining any of the input data discussed above, the user device 104 can generate an instruction and/or command to the system 102, e.g., to process the obtained data, store the data in the database 106, extract additional data from one or more databases, and/or perform analysis of the data…the output data can also include predictions of a patient's health state, interpretations, recommendations, notifications, instructions, support, and/or other information related to the obtained input data; [0033-0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the recommendation teachings of Goldner into the invention of Mills in order to provide personalized guidance for the user based on their specific obtained input data in order to manage their health condition (Goldner [0033-0034]).
Regarding Claim 8, Mills discloses wherein the different pulsatility sensor is selected from a group consisting of: a sensor embedded in a wearable device (arm cuff 140; [0026]; Examiner’s Note: An arm cuff is capable of being worn, and therefore would qualify as a wearable device), a bed sensor, a camera, a steering wheel sensor, a sensor embedded in a wearable bracelet, a band-embedded sensor, a sensor embedded in a ring, a sensor embedded in a smartwatch, a sensor embedded in a pair of glasses, a clothing-embedded sensor, a sensor embedded in the user's house, a sensor embedded in a mirror, a shoe-embedded sensor, a hat-embedded sensor, a sensor embedded in a smartphone, a sensor embedded in a smartphone accessory, a sensor embedded in a personal computer, a sensor embedded in a webcam, a sensor embedded in a computer accessory, a sensor embedded in a tablet, a sensor embedded in a case, a sensor embedded in a socket, a sock-embedded sensor, a sensor embedded in a hearing aid, a jewelry-embedded sensor, a sensor embedded in a pair of headphones, a sensor embedded in a pair of earbuds, a sensor embedded in a gaming headset, and a sensor embedded in a virtual reality headset.
Regarding Claim 9, Mills fails to disclose wherein the different pulsatility sensor comprises a wearable bracelet.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein the different pulsatility sensor comprises a wearable bracelet (at least one wearable device 104 c (e.g., a smartwatch, fitness tracker, wearable blood pressure monitor, etc.); [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the wearable bracelet teachings of Goldner into the invention of Mills in order to enable the sensor to take a wearable form, making the device easy for the user to carry continuously.
Regarding Claim 10, although Mills discloses wherein the pulsatility spot-check sensor measures BP by measuring only mmHg ([0013], [0033], [0039]), Mills fails to teach wherein the different pulsatility sensor measures BP to calculate a metric selected from a group consisting of time-in-target range (TTR) and cumulative blood pressure load (CBPL).
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein the different pulsatility sensor measures BP to calculate a metric selected from a group consisting of time-in-target range (TTR) (the blood pressure event prediction can be based on an average blood pressure over a period of time within a target range; [0021]) and cumulative blood pressure load (CBPL).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the metric calculation teachings of Goldner into the invention of Mills in order to accurately determine one or more blood pressure event predictions during a period of time (Goldner [0021]).
Regarding Claim 11, Mills fails to disclose wherein generating the recommendation for the user to initiate use of the different pulsatility sensor includes facilitating a physical acquisition of the different pulsatility sensor.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein generating the recommendation for the user to initiate use of the different pulsatility sensor includes facilitating a physical acquisition of the different pulsatility sensor (some or all of the user devices 104 are configured to continuously obtain any of the above data (e.g., health-related information and/or contextual information) from the patient over a particular time period (e.g., hours, days, weeks, months, years). For example, data can be obtained at a predetermined time interval (e.g., once every minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 60 minutes, 2 hours, etc.), at random time intervals, user-set intervals, regular intervals, irregular intervals, or combinations thereof; [0028]; The system 102 can perform such analyses at any suitable frequency and/or any suitable number of times (e.g., once, multiple times, on a continuous basis, etc.). For example, when updated input data is supplied to the system 102 (e.g., from the user devices 104), the system 102 can reassess and update its previous output data, if appropriate. In performing its analysis, the system 102 can also generate additional queries to obtain further information (e.g., from the user devices 104, the database 106, or third party sources). In some embodiments, the user device 104 can automatically supply the system 102 with such information. Receipt of updated/additional information can automatically trigger the system 102 to execute a process for reanalyzing, reassessing, or otherwise updating previous output data; [0034]; A user can use a web portal, mobile app, or another means to link to data sources or accounts (e.g., health tracker account, dietary logging system account, exercise tracker account, etc.). In some embodiments, the user can authorize and allow access and/or retrieval of additional health data from these linked data sources or accounts. In some embodiments, the user can authorize the user account 109 (e.g., a cloud based account) to access and retrieve health data from one or more of user devices, such as the wearable devices 104 c, biosensors 104 a, and other devices 104 of FIG. 1, and/or device 200 of FIG. 2. The user account 109 can periodically or continuously retrieve data and transmit all or a portion of the data to, for example, trained machine learning models, input data to machine learning models, generate values (e.g., forecast, predictions, etc.) disclosed herein; [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the facilitation teachings of Goldner into the invention of Mills in order to enable the user to access and retrieve additional health data from multiple devices (Goldner [0036]).
Regarding Claim 31, Mills discloses wherein the pulsatility spot-check sensor is configured to measure the user's BP at at least one discrete point in time (The first blood pressure signal may be a continuous and/or non-invasive blood pressure signal, such as that provided from a single finger cuff (such as one of the finger cuffs described in the above US patent, for example); [0009]).
Regarding Claim 32, Mills fails to disclose wherein the screening score is a measurement of a risk of hypertension.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein the screening score is a measurement of a risk of hypertension (When the predicted increase in blood pressure falls into ranges that put the user at possible risk of hypertension, the system can send a notification to the user of the risk; [0013]; The input data can be used to generate predictions, recommendations, guidance, and/or other information for assisting a user in monitoring and/or managing a disease, condition, or other health state, such as any of the following: hypertension, cardiovascular diseases, cardiovascular health, stress, trauma, drug use, physical performance, nutrition, mental and behavioral health, wellness, and/or combinations thereof. For example, the methods herein can be used to predict hypertension-related events, hypertension progression, hypotension-related events, and hypotension progression and then generate personalized guidance for actions that the user may take to improve, mitigate, and/or slow the progression of the disease or condition…the blood pressure event predictions can be, for example, whether the blood pressure of the user will be one or more of the following: outside of an acceptable blood pressure range (e.g., a target systolic blood pressure range, a target diastolic blood pressure range, a user defined blood pressure range, etc.), below a threshold hypotension value, above a threshold hypertension value, or the like; [0020-0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the risk teachings of Goldner into the invention of Mills in order to promptly notify the user when their predicted increase in blood pressure falls into ranges that put the specific user at possible risk of hypertension (Goldner [0013]).
Regarding Claim 33, Mills fails to disclose wherein the one or more processors are further programmed with instructions that, when executed, cause the one or more processors to: select an intervention for the user; and track a progress of the intervention.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein the one or more processors are further programmed with instructions that, when executed, cause the one or more processors to: select an intervention for the user (Referring now to FIG. 4A, the user device 402 can include, without limitation, an interface 403 displaying a notification with a recommendation 405. The recommendation 405 can include, without limitation, a prompter motivator indicating that it's time to exercise. The recommendation 405 can also include contributing health factors (e.g., sleep, diet, etc.) associated with a predicted reduction in blood pressure; [0023]; upon obtaining any of the input data discussed above, the user device 104 can generate an instruction and/or command to the system 102, e.g., to process the obtained data, store the data in the database 106, extract additional data from one or more databases, and/or perform analysis of the data…the output data can also include predictions of a patient's health state, interpretations, recommendations, notifications, instructions, support, and/or other information related to the obtained input data; [0033-0034]); and
track a progress of the intervention (The system can receive a goal set by the user that he/she would like to decrease or increase their blood pressure by a certain desired amount (e.g., 10 mmHg, 5 mmHg) over a future time period (e.g., the next day(s), week(s), month(s)). In response, the system can identify the optimal subset of features (e.g., the subset that achieves the highest rank or accuracy) that can achieve the desired amount of decrease/increase in blood pressure of the user. For example, the system can determine that a combination of increased hours of sleep (e.g., 2 more hours a day), earlier bed time (e.g., going to bed 30 minutes earlier), increased cardio or aerobic exercise (e.g., running or lifting weights), decreased dosages/intakes of insulin (80% of current dosage), a more balanced diet (e.g., fewer carbs, lowered LDL cholesterol, more protein), and/or drinking less alcohol (e.g., 1 less beer a day) can decrease the systolic or diastolic blood pressure in the coming week/month. The system can recommend self-care such as lifestyle changes, routines, and habits to the user to help him/her reach the goals and objectives. In some embodiments, the system can also check-up on whether the user has been following the recommendations. If the predicted blood pressure for the coming week has declined, for example, the system can determine that the user has been following the recommendations. In such instances, the system can recommend new recommendations or modify the previous recommendations to match the changes and improvements or to newly set objectives by the user; [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the intervention teachings of Goldner into the invention of Mills in order to help the user reach their goals and objectives with personalized recommendations, determine if the user has been following the recommendations, modify the previous recommendations to match possible changes and improvements, or to set new objectives (Goldner [0014]).
Regarding Claim 34, Mills fails to disclose wherein the one or more processors are further programmed with instructions that, when executed, cause the one or more processors to: receive further measurements of the BP of the user from the different pulsatility sensor after an initiation of the intervention; evaluating a change in a BP pattern of the user by comparing the further measurements to the measured BP before the initiation of the intervention; and adapting the intervention based on the evaluating.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein the one or more processors are further programmed with instructions that, when executed, cause the one or more processors to: receive further measurements of the BP of the user from the different pulsatility sensor after an initiation of the intervention; evaluating a change in a BP pattern of the user by comparing the further measurements to the measured BP before the initiation of the intervention; and adapting the intervention based on the evaluating (The system can receive a goal set by the user that he/she would like to decrease or increase their blood pressure by a certain desired amount (e.g., 10 mmHg, 5 mmHg) over a future time period (e.g., the next day(s), week(s), month(s)). In response, the system can identify the optimal subset of features (e.g., the subset that achieves the highest rank or accuracy) that can achieve the desired amount of decrease/increase in blood pressure of the user. For example, the system can determine that a combination of increased hours of sleep (e.g., 2 more hours a day), earlier bed time (e.g., going to bed 30 minutes earlier), increased cardio or aerobic exercise (e.g., running or lifting weights), decreased dosages/intakes of insulin (80% of current dosage), a more balanced diet (e.g., fewer carbs, lowered LDL cholesterol, more protein), and/or drinking less alcohol (e.g., 1 less beer a day) can decrease the systolic or diastolic blood pressure in the coming week/month. The system can recommend self-care such as lifestyle changes, routines, and habits to the user to help him/her reach the goals and objectives. In some embodiments, the system can also check-up on whether the user has been following the recommendations. If the predicted blood pressure for the coming week has declined, for example, the system can determine that the user has been following the recommendations. In such instances, the system can recommend new recommendations or modify the previous recommendations to match the changes and improvements or to newly set objectives by the user; [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the intervention teachings of Goldner into the invention of Mills in order to help the user reach their goals and objectives with personalized recommendations, determine if the user has been following the recommendations, modify the previous recommendations to match possible changes and improvements, or to set new objectives (Goldner [0014]).
Regarding Claim 37, although Mills discloses a display configured to display a user interface (user interface 110; [0026]; Figure 1), Mills fails to disclose wherein the one or more processors are further programmed with instructions that, when executed, cause the one or more processors to: access a list of personas, each persona corresponding to a rationale for using the system and a distinct version of the user interface; assigning a persona from the list of personas to the user; and adapting the user interface based on the distinct version associated with the persona.
In a similar technical field, Goldner teaches wearable blood pressure biosensors, systems, and methods for short-term blood pressure predictions (Abstract), wherein the one or more processors are further programmed with instructions that, when executed, cause the one or more processors to: access a list of personas, each persona corresponding to a rationale for using the system and a distinct version of the user interface; assigning a persona from the list of personas to the user; and adapting the user interface based on the distinct version associated with the persona (the database 106 includes data for multiple users, such as a plurality of patients (e.g., at least 50, 100, 200, 500, 1000, 2000, 3000, 4000, 5000, or 10,000 different patients). The data can be appropriately anonymized to ensure compliance with various privacy standards…one or more users can access the system 102 via the user devices 104, e.g., to send data to the system 102 (e.g., health-related information, contextual information) and/or receive data from the system 102 (e.g., predictions, notifications, recommendations, instructions, support, etc.). The users can be individual users (e.g., patients, healthcare professionals, etc.), computing devices, software applications, objects, functions, and/or any other types of users and/or any combination thereof. For example, upon obtaining any of the input data discussed above, the user device 104 can generate an instruction and/or command to the system 102, e.g., to process the obtained data, store the data in the database 106, extract additional data from one or more databases, and/or perform analysis of the data. The instruction/command can be in a form of a query, a function call, and/or any other type of instruction/command; [0032-0033]; The health measurements produced by the device 200 can be used to generate personalized healthcare tracking and guidance, such as one or more predictions, recommendations, suggestions, feedback, and/or diagnosis for a number of diseases, conditions, or health states; [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the user interface teachings of Goldner into the invention of Mills in order to enable the system to communicate to the user personalized healthcare tracking and guidance, such as one or more predictions, recommendations, suggestions, feedback, and/or diagnosis for a number of diseases, conditions, or health states (Goldner [0057]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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