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 .
Status of Claims
Claims 1, 2, 6-20, and 41-43 are pending in the present application with claims 1, 41, and 42 being independent, as set forth in the Preliminary Amendment dated May 9, 2024.
Claim Objections
Claim 13 is objected to because of the following informalities:
In claim 13, line 2, it appears that "CHIRP" should be changed to --chirp--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 2, 6-20, and 41-43 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.
Each of independent claims 1, 41, and 42 recites, inter alia, "based on the first optical signal, the second optical signal, and the motion signal, calculating one or more physical parameters of a dynamic model for a mechanical system including the wearable device, a strap securing the wearable device to the user, and the mechanical actuator." While [0122] and [0128]-[0129] discuss how system parameters (e.g., lumped elasticity, strap tension, etc.) can be calculated based on time-based data from accelerometers/gyroscopes of the wearable device, it would not be clear to one of ordinary skill in the art how generic "motion data" from (e.g., accelerometers/gyroscopes of) the wearable device can be used to generate the recited physical parameters of the dynamic model for the mechanical system including the wearable device, a strap securing the wearable device to the user, and the mechanical actuator. For instance, in relation to A(t) and G(t) in the equations and corresponding discussion at [0128]-[0129], it is not clear what kind of time-related accelerometer/gyroscopic data would be used for calculation of the parameters. Similarly, with respect to "calculating a blood pressure of the user by applying the motion signal to the dynamic model" as called for in independent claims 1, 41, and 42, it is not clear what kind of time-related accelerometer/gyroscopic data would be used for calculation of the blood pressure as discussed in [0126].
Furthermore, the term “suitable” in claim 19 is a relative term which renders the claim indefinite. The term “suitable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The remaining claims are rejected based on their dependency from one of the above claims.
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.
Claim 41 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter for not falling within at least one of the four categories of patent eligible subject matter:
Claim 41 is directed to "A computer program product comprising computer executable code embodied in a non-transitory computer readable medium…" (Emphasis added). However, the present specification never appears to state that a "computer program product" does not include “transitory” signals and the above use of the open-ended term "comprising" leaves open the possibility that, in addition to the recited computer executable code embodied in a non-transitory computer readable medium, the computer program product also includes transitory signals.
The USPTO is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319(Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01.
When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. §101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
As the scope of claim 41 therefore includes transitory signals which are not within one of the four statutory categories of 35 U.S.C. §101, claim 41 is rejected under 35 U.S.C. §101.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. §101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. §101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. §101 by adding the limitation "non-transitory" to the claim. Cf. Animals — Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. §101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).
The Examiner suggests amending claim 41 to recite --A non-transitory computer program product…-- in the next Response.
Claims 1, 2, 6-20, and 41 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
As claims 1, 2, and 6-20 are directed to a method (i.e., a process) the claims are all within at least one of the four statutory categories. 35 USC §101. While claim 41 is not within one of the four statutory categories as noted above, it will be analyzed below in the interest of completeness.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 41 includes limitations that recite at least one abstract idea. Specifically, independent claim 41 recites:
A computer program product comprising computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more devices, causes the one or more devices to perform the steps of:
acquiring a first optical signal from a wearable device while the wearable device is placed for use on a body of a user;
applying a mechanical pressure to the wearable device with a mechanical actuator;
acquiring a second optical signal from the wearable device while applying the mechanical pressure;
acquiring a motion signal from the wearable device, at least a portion of the motion signal acquired while applying the mechanical pressure;
based on the first optical signal, the second optical signal, and the motion signal, calculating one or more physical parameters of a dynamic model for a mechanical system including the wearable device, a strap securing the wearable device to the user, and the mechanical actuator;
calculating a blood pressure of the user by applying the motion signal to the dynamic model; and
displaying the blood pressure to a user.
The Examiner submits that the foregoing underlined limitations constitute (a) "certain
methods of organizing human activity" because calculating one or more physical parameters of a dynamic model for a mechanical system including the wearable device, a strap securing the wearable device to the user, and the mechanical actuator based on the first optical signal, the second optical signal, and the motion signal and then calculating a blood pressure of the user by applying the motion signal to the dynamic model relates to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). These recitations, under their broadest reasonable interpretation, are similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
The Examiner also submits that the foregoing underlined limitations constitute (b) “mental processes” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). As an example, a person could practically in their mind with pen and paper calculate one or more physical parameters of a dynamic model based on the first optical signal, the second optical signal, and the motion signal. For instance, the user could generate a simplistic physics model that couples motion of the wearable device that includes a strap relative to underling tissue within or around a measurement volume where blood pressure readings of the user are being acquired. Any technique for resolving optical and motion signals during vibration and optical signals without vibration can be used to calculate parameters such as strap tension, tissue elasticity, etc. can be used ([0123] of the present application). Thereafter, the user's blood pressure can be calculated by applying the motion signal (e.g., data from an accelerometer) to the model (e.g. using the equation disclosed at [0126] of the specification) and displayed to a user. These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis found to be "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Finally, the Examiner submits that the foregoing underlined limitations constitute (c) "mathematical concepts" because they represent mathematical calculations. Under its broadest reasonable interpretation in light of the specification, calculating the user's blood pressure by applying the motion signals to the dynamic model encompasses the mathematical concept of applying a mathematical computation as evidenced by paragraphs [0126]-[0153] and equations 1-3 of the originally filed specification.
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 6-9, 19, and 20 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claims 6-9 recite various types of the calculated physical parameters (e.g., strap tension, tissue elasticity, spring constant) which just further defines the at least one abstract idea discussed above.
-Claim 19 calls for testing tension on a strap of the wearable device via analyzing a test optical signal for motion artifacts indicative of a "suitable" tension range for measuring BP with the wearable device which can be practically performed in the human mind such as via reviewing/analyzing the signal on a screen ("mental processes").
-Claim 20 calls for calculating a change in blood pressure based on a change in a pulse shape acquired by the wearable device from a first pulse acquired temporally proximal to measuring the motion signal from the wearable device to a second pulse acquired temporally distal to measuring the motion signal; and calculating a blood pressure for the user based on the calculated blood pressure and the change in blood pressure. These limitations are practically performable in the human mind ("mental processes") and constitute "mathematical concepts" because they represent mathematical calculations under its broadest reasonable interpretation in light of the specification.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A computer program product comprising computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more devices, causes the one or more devices to perform the steps of (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)):
acquiring a first optical signal from a wearable device while the wearable device is placed for use on a body of a user (extra-solution activity (data gathering) as noted below, see MPEP § 2106.05(g));
applying a mechanical pressure to the wearable device with a mechanical actuator (merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished, see MPEP § 2106.05(f));
acquiring a second optical signal from the wearable device while applying the mechanical pressure (extra-solution activity (data gathering) as noted below, see MPEP § 2106.05(g));
acquiring a motion signal from the wearable device, at least a portion of the motion signal acquired while applying the mechanical pressure (extra-solution activity (data gathering) as noted below, see MPEP § 2106.05(g));
based on the first optical signal, the second optical signal, and the motion signal, calculating one or more physical parameters of a dynamic model for a mechanical system including the wearable device, a strap securing the wearable device to the user, and the mechanical actuator;
calculating a blood pressure of the user by applying the motion signal to the dynamic model; and
displaying the blood pressure to a user.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the computer program product including computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more devices, causes the one or more devices to perform the recited steps, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of acquiring the optical and motion signals, the Examiner submits that these additional limitations merely add insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)).
Regarding the additional limitations of generically applying a "mechanical pressure" to the wearable device with a mechanical actuator, the Examiner submits that this limitation amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). More specifically, the claim lacks details/specific steps as to how the mechanical pressure is applied with the mechanical actuator such that it attempts to cover any solution without restrictions on how the result is accomplished. Id.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 41 and analogous independent claim 1 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 41 and analogous independent claims 1 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claim 2 recites how the wearable device is at least one of: a physiological monitor, a photoplethysmography monitor, a heart rate monitor, and a wrist-worn monitor with a strap which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claims 10-13 recite generic, high-level descriptions of the mechanical actuator/pressure (e.g., haptic output/stimulus generating a time-varying vibration or "chirp") which still just merely recites the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished (see MPEP § 2106.05(f)).
-Claims 14 and 15 recite how the motion signal includes data from an accelerometer or gyroscope which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 16 recites how the (abstract idea of) calculating one or more physical parameters includes evaluating at least one of the physical parameters with a machine learning model based on inputs from one or more sensors of the wearable device which amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Claims that do not delineate steps through which the machine learning technology achieves an alleged improvement do not render the claims patent eligible. Id., p. 13.
-Claim 17 recites how the first and second optical signals are acquired when the user is at rest which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 18 recites how the first and second optical signals include a PPG signal which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 19 calls for acquiring a baseline optical signal and acquiring a test optical signal during the haptic stimulus which merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). This claim also calls for applying a haptic stimulus after acquiring the baseline optical signal which amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). More specifically, the claim lacks details/specific steps as to how the haptic stimulus is applied such that it attempts to cover any solution without restrictions on how the result is accomplished. Id.
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 41 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the computer program product including computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more devices, causes the one or more devices to perform the recited steps, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of generically applying a "mechanical pressure" to the wearable device with a mechanical actuator, the Examiner submits that this limitation amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). More specifically, the claim lacks details/specific steps as to how the mechanical pressure is applied with the mechanical actuator such that it attempts to cover any solution without restrictions on how the result is accomplished. Id.
Regarding the additional limitations directed to acquiring the optical and motion signals which the Examiner submits merely adds insignificant extra-solution activity to the abstract idea (see MPEP § 2106.05(g)) as discussed above, the Examiner has reevaluated such limitations and determined such limitations to not be unconventional as they merely consist of receiving/transmitting data over a network. See Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1321, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); See MPEP 2106.05(d)(II).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claim 2 recites how the wearable device is at least one of: a physiological monitor, a photoplethysmography monitor, a heart rate monitor, and a wrist-worn monitor with a strap which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claims 10-13 recite generic, high-level descriptions of the mechanical actuator/pressure (e.g., haptic output/stimulus generating a time-varying vibration or "chirp") which still just merely recites the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished (see MPEP § 2106.05(f)).
-Claims 14 and 15 recite how the motion signal includes data from an accelerometer or gyroscope which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 16 recites how the (abstract idea of) calculating one or more physical parameters includes evaluating at least one of the physical parameters with a machine learning model based on inputs from one or more sensors of the wearable device which amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Claims that do not delineate steps through which the machine learning technology achieves an alleged improvement do not render the claims patent eligible. Id., p. 13.
-Claim 17 recites how the first and second optical signals are acquired when the user is at rest which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 18 recites how the first and second optical signals include a PPG signal which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 19 calls for acquiring a baseline optical signal and acquiring a test optical signal during the haptic stimulus which merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). Furthermore, the Examiner has reevaluated such limitations and determined such limitations to not be unconventional as they merely consist of receiving/transmitting data over a network. See Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1321, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); See MPEP 2106.05(d)(II). This claim also calls for applying a haptic stimulus after acquiring the baseline optical signal which amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). More specifically, the claim lacks details/specific steps as to how the haptic stimulus is applied such that it attempts to cover any solution without restrictions on how the result is accomplished. Id.
Therefore, claims 1, 2, 6-20, and 41 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 10, 14, 18, and 41-43 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent App. Pub. No. 2017/0367597 to Fortin ("Fortin"):
Regarding claim 1, Fortin discloses a method comprising:
acquiring a first optical signal from a wearable device while the wearable device is placed for use on a body of a user ([0042] discloses how a watch system (wearable device) placed on a user's wrist measures a PPG signal (acquiring first optical signal));
applying a mechanical pressure to the wearable device with a mechanical actuator ([0043] discusses how actuator applies contact pressure CP);
acquiring a second optical signal from the wearable device while applying the mechanical pressure ([0043] discusses how PPG is measured when the CP is at one of a number of different pressure levels);
acquiring a motion signal from the wearable device, at least a portion of the motion signal acquired while applying the mechanical pressure ([0019], [0027], [0038] discloses how an accelerometer of motion sensor can continuously obtain a signal which would therefore be obtained while the mechanical/contact pressure is being applied);
based on the first optical signal, the second optical signal, and the motion signal, calculating one or more physical parameters of a dynamic model for a mechanical system including the wearable device, a strap securing the wearable device to the user, and the mechanical actuator ([0025]-[0027] discusses implementing a transfer function (dynamic model) for a mechanical system including the wearable device, a strap securing the device to the user, and the actuator (see Figure 2, where the device can be implemented as a wrist watch per [0023] which would include a strap) based on the optical signals and the signals from the accelerometer/motion sensor; furthermore, part of implementing the transfer function would necessarily involve calculating internal "physical parameters" based on the inputs);
calculating a blood pressure of the user by applying the motion signal to the dynamic model (the output of the transfer function/dynamic model is the user's BP signal which is based on motion signal per [0027] and Figure 2); and
displaying the blood pressure to a user (display 702 in Figure 7).
Regarding claim 2, Fortin discloses the method of claim 1, further including wherein the wearable device is at least one of: a physiological monitor, a photoplethysmography monitor, a heart rate monitor, and a wrist-worn monitor with a strap ([0023], [0042] discloses a wrist watch which would include a strap; also see strap 601 in Figure 6).
Regarding claim 10, Fortin discloses the method of claim 1, further including wherein the mechanical actuator includes a haptic output device associated with the wearable device (as the actuator 205/605 of wearable device in Figures 2/6 applies a contact pressure per [0025], it is a "haptic output device").
Regarding claim 14, Fortin discloses the method of claim 1, further including wherein the motion signal includes data from an accelerometer ([0027] and claim 5 disclose an accelerometer).
Regarding claim 18, Fortin discloses the method of claim 1, further including wherein at least one of the first optical signal and the second optical signal includes a photoplethysmography signal ([0024]-[0025] disclose PPG signals).
Regarding claim 41, Fortin discloses a computer program product comprising computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more devices, causes the one or more devices to perform steps (Figure 2 and [0025], [0030] illustrate disclose controllers, software, etc. that would be implemented as computer executable code embodied in memory that cause devices (e.g., processor(s) to perform steps).
The remaining limitations of claim 41 are disclosed by Fortin as discussed above in relation to claim 1.
Regarding claim 42, Fortin discloses a system comprising:
a wearable device including one or more motion sensors (the left side of Figure 6 is the "wearable device" which includes motion sensor/accelerometer per [0027] and claim 5);
a strap securing the wearable device to a user (watch strap 601 attached to wrist 600);
a mechanical actuator (actuator 605); and
one or more processors implemented by computer executable code to perform steps (Figure 2 and [0025], [0030] illustrate disclose controllers, software, etc. that would be implemented as computer executable code embodied in memory that cause devices (e.g., processor(s) to perform steps).
The remaining limitations of claim 42 are disclosed by Fortin as discussed above in relation to claim 1.
Regarding claim 43, Fortin discloses the method of claim 42, further including wherein the one or more processors are disposed on at least one of the wearable device, a user device, and a remote server ([0201] notes how processing can take place in the system 201 (the wearable device), a smartphone/tablet (user device), or another computer connected to the Internet (remote server).
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.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2017/0367597 to Fortin ("Fortin") in view of U.S. Patent App. Pub. No. 2017/0281024 to Narasimhan et al. ("Narasimhan"):
Regarding claim 15, Fortin discloses the method of claim 1, further including wherein the motion signal includes data from at least one of [an] accelerometer… ([0027] and claim 5).
However, Fortin appears to be silent regarding the accelerometer being a three-axis accelerometer or a three-axis gyroscope.
Nevertheless, Narasimham teaches (Abstract, [0088]) that it was known in the healthcare informatics art to utilize any suitable accelerometer such as a three-axis accelerometer for use in predicting a patient's BP.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the accelerometer of Fortin to be a three-axis accelerometer as taught by Narasimham because a three-axis accelerometer is a common "suitable" accelerometer for use in predicting a patient's BP, because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention, and because there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2017/0367597 to Fortin ("Fortin") in view of U.S. Patent App. Pub. No. 2019/0298193 to Krause et al. ("Krause"):
Regarding claim 16, Fortin discloses the method of claim 1, but appears to be silent regarding wherein calculating one or more physical parameters includes evaluating at least one of the physical parameters with a machine learning model based on inputs from one or more sensors of the wearable device.
Nevertheless, Krause teaches ([0153], [0163]-[0164]) that it was known in the healthcare informatics art to input various types of sensor values from a wearable device into an ML model (e.g., neural network, deep learning engine, etc.) predict a user's blood pressure, where the ML model would necessarily calculate/evaluate various parameters to arrive at the BP prediction based on the inputs because that is how ML models work. This arrangement advantageously improves the accuracy of the predictions ([0078]-[0080]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for calculating the one or more physical parameters to include evaluating at least one of the physical parameters with a machine learning model based on inputs from one or more sensors of the wearable device in the system of Fortin as taught by Krause to advantageously improve the accuracy of the BP predictions. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 17, Fortin discloses the method of claim 1, but appears to be silent regarding wherein at least one of the first optical signal and the second optical signal is acquired when the user is at rest.
Nevertheless, Krause teaches ([0162]) that it was known in the healthcare informatics art to continuously measure a user's BP using a wearable device including at times when the user is at rest, wherein measurement of the user's BP is based on acquired PPG/PWV (optical) signals per [0036], [0048], [0061] (such that the acquired signals are acquired when the user is at rest). This arrangement advantageously allows the user's "baseline" BP to be measured and compared to the user's BP while engaged in activity to assess the user's health status.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for at least one of the first and second optical signals to be acquired when the user is at rest in the system of Fortin as taught by Krause to advantageously allow the user's "baseline" BP to be measured and compared to the user's BP while engaged in activity to assess the user's health status, because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention, and because there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2017/0367597 to Fortin ("Fortin") in view of U.S. Patent App. Pub. No. 2023/0371821 to Zhang et al. ("Zhang"):
Regarding claim 20, Fortin discloses the method of claim 1, but appears to be silent regarding calculating a change in blood pressure based on a change in a pulse shape acquired by the wearable device from a first pulse acquired temporally proximal to measuring the motion signal from the wearable device to a second pulse acquired temporally distal to measuring the motion signal; and calculating a blood pressure for the user based on the calculated blood pressure and the change in blood pressure.
Nevertheless, Zhang teaches ([0020], [0123], [0127] that it was known in the healthcare informatics art to determine a change in a target pulse pressure both before a body position of a user has changed and upon change of a body position of the user as measured by an accelerometer (i.e., determine change in first and second pulses determined distal and proximal to a measured motion signal) and calibrating a determined blood pressure based on the change to advantageously improve the accuracy of the determined blood pressure ([0003]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have calculated a change in blood pressure based on a change in a pulse shape acquired by the wearable device from a first pulse acquired temporally proximal to measuring the motion signal from the wearable device to a second pulse acquired temporally distal to measuring the motion signal; and calculated a blood pressure for the user based on the calculated blood pressure and the change in blood pressure in the system of Fortin as taught by Zhang to advantageously improve the accuracy of the determined blood pressure. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The references on the attached PTO-892 disclose various devices for calculating physiological parameters of a user such as BP and the like based on various types of received sensor signals such as PPG signals, motion signals, and the like to allow users to monitor their health states.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686