DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's amendments filed 9/12/2025 merit new grounds for rejection in view of Castellanos (U.S. Patent Application Publication No. 2002/0183599) and Matsuo et al. (Matsuo et al., Intracardiac Flow Dynamics with Bi-directional Ultrasonic Pulsed Doppler Technique: SYMPOSIUM ON EVALUATION OF CARDIAC FUNCTIONS THROUGH NON-INVASIVE TECHNIQUES, JAPANESE CIRCULATION JOURNAL, 1977-1978).
With respect to the rejections under 35 U.S.C. § 103, Applicant’s arguments filed 9/12/2025 have been fully considered but they are not persuasive.
On p. 8, Applicant states that the amendments, which now require “bidirectional waveform vascular analysis” therefore require computer implementation, and are not directed to an abstract idea.
This is not persuasive, because the claims always required implementation on a general purpose computer as identified by the Examiner in the rejection below. The mobile measurement device processes information, therefore acting as a general purpose computer for the implementation of the identified abstract idea. The claims do not comprise any steps, structures, or features requiring a special purpose computer, or functions by a computer that are inherently tied to the computer arts or improvements to computer technology.
Instead, the claims are directed to algorithmic steps of a process that can be performed mentally, or with the aid of pen and paper and the additional elements include a general purpose computer solely for implementing the identified abstract idea. Therefore, the claims are not patent eligible.
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 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claims 1 and 14 claim a method and system for generating a protocol or report for a user based on acquired sensor data regarding the environment, physiology, and anatomy of a human user with at least a blood glucose sensor and vascular waveform sensor.
Claims 2-3, 6, 8, 11-13, 15-16, and 19-21 add type of sensor data.
Claims 4-5 and 17-18 add additional devices integrated into wearable devices.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 1 (and equivalently in claim 14) recites the following limitations:
performing bidirectional waveform vascular analysis of the vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis;
correlating the blood glucose data with the vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis;
generating, based on correlating the blood glucose data with the vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis at least one of: a protocol for exercise, a protocol for sports performance, a protocol for patient lifestyle, a protocol for patient stress management, or a report of expected effects of several aspects of treatment
The above identified elements comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual performing the claimed bidirectional analysis, correlation, and protocol or report generation mentally or with a pencil and paper. They do not require any computer implementation and therefore are directed to a mental process of assessing a subject and recommending a protocol for the subject using human observation and analytical decision-making.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claims 1, 14: mobile measurement device, plurality of sensors including a blood glucose sensor and vascular system sensor
claim 4, 17: one of a ring-mounted computer, eyewear-mounted computer, or shoe device
claim 5, 18: contact lens sensor
claim 7: transmitting data
claims 11-12, 19-20: obtaining environment and anatomy data
claim 13, 21: sensor including any of EEG, blood pressure, respiratory rate, body temperature, oxygen absorption
The sensors are recited without reference to a sensor structure or particular data acquired, (e.g. electrode, ECG, etc., the claims only designate a blood glucose sensor and vascular system sensor of any type, even the sensors in claims 13 and 21 only require the physiological parameter and not a particular sensor structure). In claims 11-12 and 19-20, the environmental and anatomical data is acquired without reference to any sensing by the device, and amount to broadly, data gathering from previously gathered data. The sensor is only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The computer and mobile measurement device appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter as they are portions of a processor based program.
The contact lens, ring mounted computer, eyewear mounted computer, or device integrated into shoes does not transform the abstract idea into subject eligible subject matter because they are broadly claimed features that serve only to nominally tie the abstract idea to a field of use or technology.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The additional elements were identified in the above section under Step 2A Prong Two.
The sensors are recited without reference to a sensor structure or particular data acquired, (e.g. electrode, ECG, etc., the claims only designate a blood glucose sensor and vascular system sensor of any type, even the sensors in claims 13 and 21 only require the physiological parameter and not a particular sensor structure). In claims 11-12 and 19-20, the environmental and anatomical data is acquired without reference to any sensing by the device, and amount to broadly, data gathering from previously gathered data. The sensor is only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The computer and mobile measurement device appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter as they are portions of a processor based program.
The contact lens, ring mounted computer, eyewear mounted computer, or device integrated into shoes does not transform the abstract idea into subject eligible subject matter because they are broadly claimed features that serve only to nominally tie the abstract idea to a field of use or technology.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-2, 4, 6-15, 17, and 19-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stivoric et al. (U.S. Patent Application Publication No. 2008/0167572) hereinafter referred to as Stivoric; in view of Castellanos (U.S. Patent Application Publication No. 2002/0183599) hereinafter referred to as Castellanos; in view of Matsuo et al. (Matsuo et al., Intracardiac Flow Dynamics with Bi-directional Ultrasonic Pulsed Doppler Technique: SYMPOSIUM ON EVALUATION OF CARDIAC FUNCTIONS THROUGH NON-INVASIVE TECHNIQUES, JAPANESE CIRCULATION JOURNAL, 1977-1978) hereinafter referred to as Matsuo.
Regarding claim 1, Stivoric teaches a method comprising:
obtaining sensor data from a mobile measurement device configured to process information from:
the environment (¶[0107] contextual data), physiology of a human wearer (¶[0139] sensors), and anatomy of the human wearer (Table 1, personal characteristics, ¶[0216]);
wherein the sensor data is obtained from a plurality of sensors, wherein the plurality of sensors includes at least a blood glucose sensor (Table 1, continual measurements, blood glucose levels, ¶[0216], and ¶[0150]);
obtaining blood glucose data based on the blood glucose sensor (Table 1, continual measurements, blood glucose levels, ¶[0216], and ¶[0150]);
generating, based on the blood glucose data, at least one of:
a protocol for patient lifestyle (¶[0168]); a protocol for patient stress management; or a report of expected effects of several aspects of treatment (¶[0052], ¶[0217]).
Stivoric does not teach a vascular sensor, obtaining vascular waveforms based on the vascular system sensor; performing bidirectional waveform vascular analysis; correlating the blood glucose data with the vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis; generating, based on correlating the blood glucose data with the vascular function information including data representing vascular condition based on the bidirectional waveform analysis, at least one of: a protocol for patient lifestyle; a protocol for patient stress management; or a report of expected effects of several aspects of treatment.
Attention is drawn to the Castellano reference, which teaches a vascular sensor, obtaining vascular waveforms based on the vascular system sensor (¶[0052], ¶[0054]);
correlating the blood glucose data with the vascular function information including data representing vascular condition based on a waveform vascular analysis (¶[0054], ¶[0103]);
generating, based on correlating the blood glucose data with the vascular function information including data representing vascular condition (¶¶[0102-0104]), at least one of:
a protocol for patient lifestyle; a protocol for patient stress management; or a report of expected effects of several aspects of treatment (¶¶[0102-0104], ¶[0108]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the monitoring method of Stivoric to include Doppler vascular analysis, and correlation with other physiological data, as taught by Castellano, for the purpose of improving personal lifestyle and health (Castellano ¶[0191]).
Stivoric as modified does not make explicit a bidirectional waveform vascular analysis.
Attention is drawn to the Matsuo reference, which teaches a bidirectional waveform vascular analysis (Fig. 1-2, p. 515, col 2 ¶ 2).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the analysis of method of Stivoric as modified, to include bidirectional waveform analysis, as taught by Matsuo, because Matsuo teaches that bidirectional Doppler waveform analysis correctly identifies cardiac blood flow patterns and is useful in obtaining information about the vascular analysis (Matsuo, p. 527, § Summary 1) and 2)).
Regarding claim 2, Stivoric as modified teaches the method of Claim 1.
Stivoric further teaches wherein the sensor data includes data indicative of rate of change in heartbeat (¶[0223], Table 1 beat to beat variability of heart beats, heart rate).
Regarding claim 4, Stivoric as modified teaches the method of Claim 1.
Stivoric teaches further wherein the mobile measurement device includes at least one of: a ring-mounted computer (¶[0109]).
Regarding claim 6, Stivoric as modified teaches the method Claim 1.
Stivoric further teaches wherein obtaining sensor data includes obtaining sensor data during a period where the human wearer is asleep (¶[0169]).
Regarding claim 7, Stivoric as modified teaches the method of Claim 1.
Stivoric teaches further comprising the mobile measurement device communicating to a medical office sensor data collected over time from the human wearer by the mobile measurement device(¶¶[0111-0112] clinical monitor receiver utilized in a medical setting, ¶[0045]).
Regarding claim 8, Stivoric as modified teaches the method of Claim 1.
Stivoric teaches further comprising combining the sensor data obtain from the mobile measurement device with detections of urinalysis (¶[0150]) to identify one or more of: blood glucose, proteins, ketone, blood in urine; or specific gravity of urine (¶[0150]).
Regarding claim 9, Stivoric as modified teaches the method of Claim 1.
Stivoric teaches further comprising, prior to the generating, performing a physiological analysis of the data (¶[0189], ¶[0217] analysis).
Regarding claim 10, Stivoric as modified teaches the method of Claim 9.
Stivoric further teaches wherein performing the physiological analysis includes at least one of: determining trend values; or determining whether a current value in the sensor data has crossed a particular threshold that is associated with a physiological condition or change, or a quantitative descriptor or condition (¶¶[0050-0051]).
Regarding claim 11, Stivoric as modified teaches the method of Claim 1 wherein obtaining sensor data includes obtaining sensor data from the environment that indicates at least one of: ambient temperature (¶[0052] ambient temperature).
Regarding claim 12, Stivoric as modified teaches the method of Claim 1.
Stivoric further teaches wherein obtaining sensor data includes obtaining sensor data from the anatomy of the human wearer that indicates at least one of: blood pressure, pulse, oximetry, weight, or height (Table 1, weight, height, blood pressure, heart rate).
Regarding claim 13, Stivoric as modified teaches the method of Claim 1.
Stivoric further teaches wherein the plurality of sensors further includes two or more selected from a group that consists of: a blood pressure sensor (Table 1, blood pressure, ¶[0172]), respiratory rate sensor (Table 1, respiration), a body temperature sensor (¶[0042]).
Regarding claims 14-15, 17, and 19-21, the claims are directed to a system comprising substantially the same subject matter as claims 1-2, 4, 11, and 12-13 and are rejected under substantially the same sections of Stivoric, Castellano, and Matsuo.
Claims 3 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stivoric, Castellano, and Matsuo as applied to claim 1 above, and further in view of Naghavi et al. (U.S. Patent Application Publication No. 2008/0255471) hereinafter referred to as Naghavi.
Regarding claim 3/16, Stivoric as modified teaches the method of Claim 1/14.
Stivoric does not explicitly teach wherein the data representing vascular condition includes data indicative of relative condition of endothelium of the human wearer.
Attention is drawn to the Naghavi reference, which teaches sensor data includes data indicative of relative condition of endothelium of the human wearer (¶¶[0014-0015]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the sensing method of Stivoric as modified to include vascular health data indicative of endothelial function, as taught by Naghavi, because it improves diagnostic ability to assess cardiovascular health conditions (Naghavi ¶[0295]).
Claims 5 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stivoric, Castellano, and Matsuo as applied to claim 1 above, and further in view of Abreu (U.S. Patent Application Publication No. 2007/0016074) hereinafter referred to as Abreu.
Regarding claim 5/18, Stivoric as modified teaches the method of Claim 1/14.
Stivoric does not teach further comprising receiving sensor data from one or more contact lenses configured to measure capillary blood flow.
Attention is brought to the Abreu reference, which teaches receiving sensor data from one or more contact lenses configured to measure capillary blood flow (¶[0956], ¶[0206]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the monitoring method of Stivoric as modified to include a contact lens sensor, as taught by Abreu, because it is a location for undisturbed sensor placement and apposition, as well as, discreet for a desirable cosmetic appearance (Abreu ¶[0206]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792