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 .
Response to Amendment
The amendments filed 27 MARCH 2026 have been entered. Claims 1 and 3 - 20 are pending. Applicant’s amendments to the claims have overcome each and every objection to the claims previously applied in the office action dated 25 FEBRUARY 2026. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 25 FEBRUARY 2026.
Claim Objections
Claim 1 is objected to because of the following informalities: regarding the term “detecting a pulse transit time, PTT”, it is suggested to revise to “detecting a pulse transit time (PTT)” with parentheses instead of commas for readability of the claim. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: regarding the term ”includes a PPG”, it is suggested to revise to “is a photoplethysmography (PPG) sensor” for readability of the claim. Appropriate correction is required.
Claim 7 is objected to because of the following informalities:
regarding the term “watch is an electrocardiogram, EKG, sensor”, it is suggested to revise to “watch is an electrocardiogram (EKG) sensor”, with parentheses instead of commas for readability of the claim.
regarding the term “a photoplethysmography, PPG, sensor”, it is suggested to revise to “a photoplethysmography (PPG) sensor”, with parentheses instead of commas for readability of the claim.
Appropriate correction is required.
Claim 19 is objected to because of the following informalities:
there appears to be a “to” missing between “the first microphone is arranged” and “capture sound” in line 3, for readability of the claim. Appropriate correction is required.
regarding the term “having a PPG sensor”, it is suggested to revise to “having a photoplethysmography (PPG) sensor” for readability of the claim and consistency with the other claims.
regarding the term “or an EKG sensor”, it is suggested to revise to “having an electrocardiogram (EKG) sensor” for readability of the claim and consistency with the other claims.
regarding the term “measuring an average or combination PTT”, it is suggested to revise to “an average or combination pulse transit time (PTT)” to define the acronym in the claim for readability and consistency.
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 and 3 - 20 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 (line 9 – 10) recites the term “the PTT refers to a time it takes a pulse wave to travel between two arterial sites”. It is unclear if “it” is intended to mean an object or other entity that is facilitating pulse wave transport, or if it is a colloquial term, as “it” is not defined by the claim. For the purposes of examination, the term “the PTT refers to a time it takes a pulse wave to travel between two arterial sites” is deemed to claim “the PTT refers to a time duration in which a pulse wave travels between two arterial sites”. Claims 3 – 18 are similarly rejected due to their dependence on Claim 1.
Claim 9 (line 3) recites the term “the sensor signal”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited sensor signal. For the purposes of examination, the term “the sensor signal” is deemed to claim “the second signal”.
Claim 19 (lines 3 - 4) recites the term “the ear canal of the first ear”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited ear canal. For the purposes of examination, the term “the ear canal of the first ear” is deemed to claim “an ear canal of the first ear.” Claim 20 is similarly rejected due to its dependence on Claim 19.
Claim 19 (lines 6 - 7) recites the term “the ear canal of the second ear”. There is no previously-recited ear canal of the second ear. For the purposes of examination, the term “the ear canal of the second ear” is deemed to claim “an ear canal of the second ear”. Claim 20 is similarly rejected due to its dependence on Claim 19.
Claim 20 (lines 1 – 2) recites the term “the method of claim 19, further comprising: presenting the average…” and recites a method step of “presenting the average or combination PTT acoustically…”. Claim 19 has been amended to be an apparatus claim as “An audio processing system”, such that the statutory category of Claim 20 is unclear. For the purposes of examination, the term “the method of claim 19, further comprising: presenting the average…” is deemed to claim “the audio processing system of claim 19, wherein the processor is further configured to be: presenting the average…”
Claim 20 (lines 2 – 3) recites the term “through speakers of the first and second in-ear devices”. It is unclear if these are intended to be the same or different than then previously-recited first and second in-ear devices of Claim 19, from which this claim depends. For the purposes of examination, the term “through speakers of the first and second in-ear devices” is deemed to claim “through the speakers of the first in-ear device and the second in-ear device”.
Claim 20 (line 3) recites the term “through a display of the watch”. It is unclear if these are intended to be the same or different than then previously-recited display of the watch of Claim 19, from which this claim depends. For the purposes of examination, the term “through a display of the watch” is deemed to claim “through the display of the watch”.
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 and 3 – 20 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.
Regarding Claims 1 and 19, the claims recite "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 and 3 – 20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 and 3 – 20 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 and 3 – 20 recites an abstract idea.
Specifically, Independent Claims 1 and 19 recite (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim
A method, comprising:
digitally processing a microphone signal to determine a first heart activity of a user, wherein the microphone signal is produced by a microphone of a device configured to be worn in or on a first ear of the user
digitally processing a second signal to determine a second heart activity of the user, wherein the second signal is produced by a second sensor that is integral to a watch configured to be worn by the user;
detecting a pulse transit time, PTT, based on digitally processing the first heart activity of the user and the second heart activity of the user wherein the PTT refers to a time it takes a pulse wave to travel between two arterial sites
determining a blood pressure of the user based at least on digitally processing the PTT; and
presenting the blood pressure to the user on a display of the watch or as an audible message by a speaker of the device configured to be worn in or on the first ear of the user.
Claim 19
An audio processing system, comprising:
a first in-ear device having a first microphone and configured to be worn in a first ear of a user, wherein the first microphone is arranged capture sound inside the ear canal of the first ear;
a second in-ear device having a second microphone and configured to be worn in a second ear of the user, wherein the second microphone is arranged to capture sound inside the ear canal of the second ear;
a watch configured to be worn by the user and having a PPG sensor or an EKG sensor; and
a processor configured to be
determining a first heart activity from a first microphone signal of the first microphone;
determining a second heart activity from a second microphone signal of the second microphone;
processing a sensor signal from the EKG sensor or the PPG sensor to determine a third heart activity;
measuring an average or combination PTT being an average or combination of i) a first PTT measured based on a lag between the third heart activity and the second heart activity, and b) a second PTT measured based on a lag between the third heart activity and the first heart activity;
determining a blood pressure of the user based at least on the average or combination PTT: and
presenting the blood pressure to the user on a display of the watch or as an audible message by speakers of the first in-ear device and the second in-ear device.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1 and 19, these limitations include:
Observation and judgment of a microphone signal processed to determine a first heart activity of a user
Observation and judgment of a second signal processed to determine a second heart activity of a user
Observation and judgment of detecting a pulse transit time, PTT, based on digitally processing the first heart activity of the user and the second heart activity of the user wherein the PTT refers to a time it takes a pulse wave to travel between two arterial sites
Observation and judgment of a blood pressure of the user based at least on digitally processing the PTT;
Observation and judgment of a first heart activity from a first microphone signal of the first microphone
Observation and judgment of a second heart activity from a second microphone signal of the second microphone
Observation and judgment of a sensor signal from an EKG or PPG sensor to determine a third heart activity
Observation and judgment of an average or combination PTT being an average or combination of i) a first PTT measured based on a lag between the third heart activity and the second heart activity, and b) a second PTT measured based on a lag between the third heart activity and the first heart activity;
Observation and judgment of a blood pressure of the user based at least on the average or combination PTT;
Similarly, Dependent Claims 3 – 18 and 20 include the following abstract limitations, in addition to the aforementioned limitations in Independent Claims 1 and 19 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
detecting a difference in timing between the first heart activity and the second heart activity the first heart activity and the second heart activity being the same heart activity
Observation and judgment of a difference in timing between the first heart activity and the second heart activity the first heart activity and the second heart activity being the same heart activity
determining a position of the user based on processing a signal from a third sensor
Observation and judgment of a position of the user based on processing a signal from a third sensor
determining a reliability of the first heart activity of the user based on the position of the user,
Observation and judgment of a reliability of the first heart activity of the user based on the position of the user,
synchronizing the microphone signal and the second signal based on timestamps so that events in the microphone signal can be compared to events in the sensor signal using a common temporal reference
Observation and judgment of to synchronize the microphone signal and the second signal based on timestamps so that events in the microphone signal can be Observed and judged in comparison to events in the sensor signal using a common temporal reference
sensing an ultrasound signal in the microphone signal.
Observation and judgment of an ultrasound signal in the microphone signal.
sensing an infrasound signal in the microphone signal.
Observation and judgment of an infrasound signal in the microphone signal.
capturing a third heart activity of the user by processing an output signal of a second microphone, wherein detecting the PTT is further based on the third heart activity
Observation and judgment of a third heart activity of the user by Observation and judgment of an output signal of a second microphone, wherein Observation and judgment of the PTT is further based on the third heart activity
determining a seal of the device to the first ear of the user
Observation and judgment of a seal of the device to the ear of the user to determine a reliability of the first heart activity of the user.
determining a reliability of the first heart activity of the user based on the seal.
Observation and judgment of a reliability of the first heart activity of the user based on the seal.
determining a position of the user based on a third sensor
Observation and judgment of a position of the user based on a third sensor
determining a reliability of the first heart activity of the user based on the position of the user.
Observation and judgment of a reliability of the first heart activity of the user based on the position of the user.
performing an active noise cancellation process that affects the microphone signal of the device worn in or on the first ear of the user
Observation and judgment to perform an active noise cancellation process that affects the microphone signal of the device worn in or on the first ear of the user
processing the microphone signal to detect respiratory activity
Observation and judgment of the microphone signal to detect respiratory activity
detecting the association between the first heart activity and the heart pathology further based on the respiratory activity.
Observation and judgment of the association between the first heart activity and the heart pathology further based on the respiratory activity.
all of which are grouped as mental processes or mathematical algorithms under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1 and 19 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 1 and 3 – 20), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“microphone”, “first microphone”, “second microphone”
“device worn configured to be worn in or on a first ear of the user”; “speaker”; “first in-ear device”; “second in-ear device”
“second sensor”
“watch”; “display of the watch”
“accelerometer”
“electrode”
“third sensor”
“smart phone”
“EKG sensor”
“PPG sensor”
“processor”
“digitally”
Additional elements recited include “microphone”, “first microphone”, “second microphone”, “device worn configured to be worn in or on a first ear of the user”, “speaker”, “first in-ear device”, “second in-ear device”, “second sensor”, “watch”; “display of the watch”, “accelerometer”, “electrode”, “third sensor”, “smart phone”, “EKG sensor”, “PPG sensor”, “digitally”, and “processor” in Independent Claims 1 and 19 (and their respective Dependent Claims). These components are recited at a high level of generality, , i.e., as a processor performing a generic function of processing data (the acquiring, generating, and correcting); a memory performing a generic function of storing data (the storing). These generic hardware component limitations for “microphone”, “first microphone”, “second microphone”, “device worn configured to be worn in or on a first ear of the user”, “speaker”, “first in-ear device”, “second in-ear device”, “second sensor”, “watch”; “display of the watch”, “accelerometer”, “electrode”, “third sensor”, “smart phone”, “EKG sensor”, “PPG sensor”, “digitally”, and “processor” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 1 and 3 - 20 includes pre-solution activity limitations, such as:
wherein the microphone signal is produced by a microphone of a device configured to be worn in or on a first ear of the user
wherein the second signal is produced by a second sensor that is integral to a watch configured to be worn by the user;
presenting the blood pressure to the user on a display of the watch or as an audible message by a speaker of the device configured to be worn in or on the first ear of the user.
wherein the second sensor includes an electrode that electronically measures the second heart activity of the user.
the second sensor includes a PPG.
wherein the second sensor that is integral to the watch is an electrocardiogram, EKG, sensor or a photoplethysmography, PPG, sensor.
wherein the first heart activity includes a heartbeat or a heart movement.
presenting an indication of the PTT to a display in the smart phone or in the watch.
a first in-ear device having a first microphone and configured to be worn in a first ear of a user, wherein the first microphone is arranged capture sound inside the ear canal of the first ear;
a second in-ear device having a second microphone and configured to be worn in a second ear of the user, wherein the second microphone is arranged to capture sound inside the ear canal of the second ear;
a watch configured to be worn by the user and having a PPG sensor or an EKG sensor
presenting the blood pressure to the user on a display of the watch or as an audible message by speakers of the first in-ear device and the second in-ear device.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “microphone”, “first microphone”, “second microphone”, “device worn configured to be worn in or on a first ear of the user”, “speaker”, “first in-ear device”, “second in-ear device”, “second sensor”, “watch”; “display of the watch”, “accelerometer”, “electrode”, “third sensor”, “smart phone”, “EKG sensor”, “PPG sensor”, “digitally”, and “processor” as recited in Independent Claims 1 and 19 (and their respective Dependent Claims) are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. 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 ideas identified above in Independent Claims 1 and 19 (and their dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. 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 Claims 1 and 19 (and their dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1 and 19 (and their dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 and 3 – 20 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: “microphone”, “first microphone”, “second microphone”, “device worn configured to be worn in or on a first ear of the user”, “speaker”, “first in-ear device”, “second in-ear device”, “second sensor”, “watch”; “display of the watch”, “accelerometer”, “electrode”, “third sensor”, “smart phone”, “EKG sensor”, “PPG sensor”, “digitally”, and “processor” as recited in Independent Claims 1 and 19 (and their dependent claims).
The additional elements of the “microphone”, “first microphone”, “second microphone”, “device worn configured to be worn in or on a first ear of the user”, “speaker”, “first in-ear device”, “second in-ear device”, “second sensor”, “watch”; “display of the watch”, “accelerometer”, “electrode”, “third sensor”, “smart phone”, “EKG sensor”, “PPG sensor”, “digitally”, and “processor”
in Independent Claims 1 and 19 (and their dependent claims), as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
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. 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, Verset 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.
Per Applicant’s specification, the “digitally”, and “processor” is described at [0043] with “Processing logic may comprise hardware (e.g., circuitry, dedicated logic, programmable logic, a processor…” The “processor” is shown in Fig. 8 as generic block element “processor 802” and [0137]
Per Applicant’s specification, the “display of the watch” is described at [0056] with “device 102 or another device (e.g.,…a smart watch…etc.) may include a display that presents the heart pathology or lack of heart pathology…” The “display of the watch” is shown as block element “display 812” in Fig. 8.
Per Applicant’s specification, the “microphone”, “first microphone”, and “second microphone”, are described generically at [0045] with “Device 102 may include a headphone (e.g., an earbud) that is worn on or in an ear 116 of a user 104. The device 102 may include a microphone 110 that generates a microphone signal 122.” The “microphone”, “first microphone”, and “second microphone”, is shown as a microphone symbols for “microphone 110” in “device 102” box of Figure 1, “microphone 206” in Fig. 2, “microphones 322 and 308” in Fig. 3, and “microphone 414” in Fig. 4.
Per Applicant’s specification, the “device worn configured to be worn in or on a first ear of the user”, “first in-ear device”, and “second in-ear device”, is described generically in [0045] with “Device 102 may include a headphone (e.g., an earbud) that is worn on or in an ear 116 of a user 104.” and [0080] “the first device 302 and the second device 320 are respectively a first earbud and a second earbud of an earbud pair.” The “device worn in or on an ear of the user”, “first device placed over or in a first ear of a user”, and “second device placed over or in a second ear of a user” are shown as “:first device 302” and “second device 320” boxes in Figure 3.
Per Applicant’s specification, the “second sensor” is described generically at [0096] with “a second heart activity 424 of a user with a sensor (e.g., sensor 410, 408, or 412) of a wearable device worn by the user.” Including on a “wrist-worn device, a chest-worn device, an earbud, a finger worn device, other ear-worn device (or any other body worn device that may give information about the blood flow through the human body), or “a mobile device that is placed on or against the user (e.g., a mobile phone or other device).“. The “second senor” is shown as either sensor 410, 408, or 412 of Figure 4.
Per Applicant’s specification, the “watch”, “EKG sensor”, and “PPG sensor”, and “PPG” is described generically at [0099] with “sensors may include a PPG sensor. A PPG sensor may include a light emitter and photodetector that senses volumetric variations of blood circulation (e.g., in a capillary vessel),” and [0120] “The sensor may include a PPG sensor. The sensor may be worn over the user’s chest, on a user’s wrist, or at any other location.“
Per Applicant’s specification, the “accelerometer” and “third sensor” (in light of Claim 8) are described generically at [0090] as “This sensor (e.g., an accelerometer, a gyroscope, an IMU, a camera, etc.) may be integral to the second device 320, the first device 302, or another device (not shown).“
Per Applicant’s specification, the “electrode”, is described generically at [0047] with “The second sensor 120 may include an accelerometer, an electrode, a second microphone, or other sensor or combination of such sensor.”
Per Applicant’s specification, the “smart phone” is described at [0129] with “The audio processing system can be a device such as, for example, a desktop computer, a tablet computer, a smart phone…”
Accordingly, in light of Applicant’s specification, the claimed terms “microphone”, “first microphone”, “second microphone”, “device worn configured to be worn in or on a first ear of the user”, “speaker”, “first in-ear device”, “second in-ear device”, “second sensor”, “watch”; “display of the watch”, “accelerometer”, “electrode”, “third sensor”, “smart phone”, “EKG sensor”, “PPG sensor”, and “digitally”, “processor” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Anestric, 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 “microphone”, “first microphone”, “second microphone”, “device worn configured to be worn in or on a first ear of the user”, “speaker”, “first in-ear device”, “second in-ear device”, “second sensor”, “watch”; “display of the watch”, “accelerometer”, “electrode”, “third sensor”, “smart phone”, “EKG sensor”, “PPG sensor”, “digitally”, and “processor”. 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 activity[is]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Independent Claims 1 and 19 (and their dependent claims) 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. Micro, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Elfish, 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 method and system of Claims 1 and 3 – 20 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 and 3 – 20 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 for Step 2A Prong 2 in Independent Claims 1 and 19 (and their 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 instruct the practitioner to 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 and 3 – 20 apply an abstract idea to a computer and do not (I) improve the performance of the computer itself (as in Bascom and Elfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 and 3 – 20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 and 3 – 20 are not patent eligible and rejected under 35 U.S.C. 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.
Claims 1, 3 – 8, 13 – 15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Galeev et. al., (United States Patent Application Publication US 2021/0353165 A1).
Regarding Claim 1, Galeev discloses A method ([Abstract]), comprising:
digitally processing a microphone signal to determine a first heart activity of a user ([0107] “earbud (a tiny speaker)”; [0065] “one or more acoustic sensors comprising a speaker-microphone combination (such as a micro-electro-mechanical system (“MEMS”) acoustic sensor) can be used to extract reflected sound pulses from moving vessel walls.”; [0100] “By using similar sensors at a first body location…measure the pulse traveling time between the first body location and the second body location…”)(Examiner notes that the first heart activity is the pulse of a pulse wave.), wherein the microphone signal is produced by a microphone of a device configured to be worn in or on a first ear of the user ([0107] “ear device can be an earbud (a tiny speaker that can be worn inside an ear),”; [0065] “speaker-microphone combination”; Fig 10);
digitally processing a second signal to determine a second heart activity of the user [0100] “By using similar sensors at a…second body location…measure the pulse traveling time between the first body location and the second body location…”)(Examiner notes that the second heart activity is the pulse of a pulse wave.), wherein the second signal is produced by a second sensor that is integral to a watch configured to be worn by the user ([0110] “wearable device 1042”, Fig. 10; [0109] “first PPG sensor can be part of another wrist-worn device”; [0114] “pulse wave”); and
detecting a pulse transit time, PTT, based on digitally processing the first heart activity of the user and the second heart activity of the user ([0090] “pulse transit time (PTT)”; [0093] “PTT measures the traveling time of blood from a first point in the body to a second point in the body.”; [0108] “…first measurement location is at the ear and the second measurement location is at the wrist.”; [0100]), wherein the PTT refers to a time it takes a pulse wave to travel between two arterial sites ([0090]; [0093] “PTT measures the traveling time of blood from a first point in the body to a second point in the body.”; [0108]; [0100]);
determining a blood pressure of the user based at least on digitally processing the PTT (Fig 12 flow chart 1204 – 1210);
presenting the blood pressure to the user on a display of the watch ([0034] “ apparatus 100 may be a physiological monitor worn by a user to…display information pertaining to one or more physiological parameters…apparatus 100 may comprise a…wrist watch”) or as an audible message by a speaker of the device configured to be worn in or on the first ear of the user.
Regarding Claim 3, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 3, Galeev discloses wherein the second sensor includes an accelerometer ([0049] “Sensor array 115 may also comprise additional or alternative components 130 such as…accelerometers.”; Fig 3).
Regarding Claim 4, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 4, Galeev discloses wherein the second sensor includes an electrode ([0049] “In the implementation depicted, sensor array 115 may comprise one or more ECG electrodes 120”; Fig 3; [0025] “an upper module…The wearable device may be worn on a user's body such that one or more sensors of the upper and lower modules contact a targeted area of tissue…the wearable device is a watch, band, or strap that can be worn on the wrist of a user such that the upper and lower modules are each in contact with a side of the wrist.”; [0027] “upper module…ECG sensors/electrodes…”) that electronically measures the second heart activity of the user ([0100] “By using similar sensors at a…second body location…measure the pulse traveling time between the first body location and the second body location…”; [0046] “…collect and analyze physiological information…”; “…ECG electrode (such as that shown in FIG. 1) to collect a more precise heart rate measurement.”)
Regarding Claim 5, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 5, Galeev discloses wherein detecting the PTT includes detecting a difference in timing between the first heart activity and the second heart activity ([0121] “obtaining the PTT using the first pulse arrival time and second pulse arrival time.”; [0100] “difference in arrival time of a pulse at the first and second body locations…can be used to calculate the PTT.”, [0122] “… the first sensor can be a second PPG sensor and the first body location is an ear of the user, and the first PPG sensor can be an optical sensor that is placed over and facing a radial artery of the user.”) the first heart activity and the second heart activity being the same heart activity [0121] “first pulse arrival time and second pulse arrival time.”)
Regarding Claim 6, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 6, Galeev discloses wherein the second sensor includes a PPG (Fig 3; [0044] “lower module 150 comprises one or more optical detectors 160 and light sources 165 for collecting PPG”).
Regarding Claim 7, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 7, Galeev discloses wherein the second sensor that is integral to the watch is an electrocardiogram, EKG, sensor or a photoplethysmography, PPG, sensor. ([0025] “an upper module…The wearable device may be worn on a user's body such that one or more sensors of the upper and lower modules contact a targeted area of tissue…the wearable device is a watch, band, or strap that can be worn on the wrist of a user such that the upper and lower modules are each in contact with a side of the wrist.”; [0027] “upper module…may comprise one or more sensors, including…optical/PPG sensors, ECG sensors/electrodes…”; Fig. 3),
Regarding Claim 8, Galeev discloses as described above, The method of claim 7. For the remainder of Claim 8, Galeev discloses determining a position of the user based on processing a signal from a third sensor ([0027] “Each of the upper and lower modules may comprise one or more sensors, including…accelerometers…”; [0066] “one or more accelerometers…determining whether and to what
extent the user is in motion (i.e., whether the user is walking...sitting…”) and determining a reliability of the first heart activity of the user based on the position of the user ([0061] “Data collected from at least one or more of…accelerometers…can be used for determining physiological information.: [0078] “when one or more accelerometers or gyroscopic components of apparatus 100 indicate that a user is still, at rest, or sleeping…collect information from the user while artifacts…from physical movement are absent), wherein the third sensor is an accelerometer in the device worn in or on the first ear ([0027] “Each of the upper and lower modules may comprise one or more sensors, including…accelerometers…”; Fig. 10, “ear device 1034”; [0107] “an ear device 1034 (e.g., a device that can be inserted in the ear).”; [0065]).
Regarding Claim 13, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 13, Galeev discloses wherein the first heart activity includes a heartbeat ([0031] “the physiological information sensed, measured, analyzed, or displayed can include but is not limited to heart rate information…”)(Examiner notes that the heart rate is the number of heart beats in a given time.) or a heart movement.
Regarding Claim 14, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 14, Galeev discloses further comprising determining a seal of the device to the first ear of the user ([0055] “apparatus 100…pressure sensor…ensure that the user is wearing the apparatus 100 tightly enough…sensors are in sufficient contact with the targeted area of the user’s tissue”, “one or more pressure sensors of the upper…modules 110, 150 can be used to make the same determination”)(Examiner notes that “contact” with the tissue indicates a level of seal between the device and the body part, in the case of the upper sensors, the ear.) and determining a reliability of the first heart activity of the user based on the seal ([0055] “apparatus 100…pressure sensor…ensure that the user is wearing the apparatus 100 tightly enough…sensors are in sufficient contact with the targeted area of the user’s tissue”, [0055] “…to collect accurate physiological information”)(Examiner notes that “contact” with the tissue indicates a level of seal between the device and the body part, in the case of the upper sensors, the ear, and if it is in “insufficient contact”, that would yield a qualitatively unreliable measurement.).
Regarding Claim 15, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 15, Galeev discloses further comprising determining a position of the user based on a third sensor ([0055] “pressure sensor of the upper and/or lower modules”, “…ensure that the user is wearing the apparatus 100 tightly enough…sensors are in sufficient contact with a targeted area of the user’s tissue”, “being worn too loosely”)(Examiner notes that the pressure sensor determines a body position of the user relative to the sensor, whether the position is too close, correct position, too far away.) and determining a reliability of the first heart activity of the user based on the position of the user ([0055] “apparatus 100…alert the user …if apparatus 100 is being worn too loosely or too tightly to ensure accurate measurements.”)
Regarding Claim 17, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 17, Galeev discloses wherein processing the microphone signal (Fig. 12, Box 1202 “Extract…using sensor data of the wearable device, features related to a pulse wave”), processing the second signal (Fig. 12, Box 1202 “Extract…using sensor data of the wearable device, features related to a pulse wave”) and detecting the pulse transit time, PTT (Fig. 12, Box 1204 “Determine a pulse transit time (PTT)”); are performed by a processor ([0008] “..wearable device includes a processor”; [0080] “processor-based computing system…present in or used in conjunction with…apparatus 100”) in a smart phone or in the watch configured to be worn by the user, ([0034] “ apparatus 100 may be a physiological monitor worn by a user to…analyze…information pertaining to one or more physiological parameters… apparatus 100 may comprise a…wrist watch.”) the method further comprising presenting an indication of the PTT to a display in the smart phone or in the watch ([0034] “ apparatus 100 may be a physiological monitor worn by a user to…display information pertaining to one or more physiological parameters…apparatus 100 may comprise a…wrist watch”)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Galeev in view of Barnacka 2021, (United States Patent Application Publication US 2021/0045647 A1), hereinafter Barnacka 2021, further in view of Block et. al., “Conventional pulse transit times as markers of blood pressure changes in humans”).
Regarding Claim 19, Galeev discloses An audio processing system ([Abstract]; [0065]), comprising:
a first in-ear device having a first microphone ([0065] “one or more acoustic sensors comprising a speaker-microphone combination (such as a micro-electro-mechanical system ("MEMS") acoustic sensor)…”; Fig. 10) and configured to be worn in a first ear of a user (Fig. 10, “ear device 1034”; [0107] “an ear device 1034 (e.g., a device that can be inserted in the ear).”; [0065]), wherein the first microphone is arranged capture sound inside the ear canal of the first ear ([0065] “one or more acoustic sensors comprising a speaker-microphone combination…extract reflected sound pulses from moving vessel walls.”)
a watch configured to be worn by the user and having a PPG sensor or an EKG sensor (Fig. 10; [0109] “first PPG sensor can be part of another wrist-worn device”; [0114] “pulse wave”); and
a processor ([0082] “processor 805”; Fig. 8) configured to be
determining a first heart activity from a first microphone signal of the first microphone ([0107] “earbud (a tiny speaker)”; [0065] “…one or more acoustic sensors comprising a speaker-microphone combination (such as a micro-electro-mechanical system (“MEMS”) acoustic sensor) can be used to extract reflected sound pulses from moving vessel walls.”; [0100] “By using similar sensors at a first body location…measure the pulse traveling time between the first body location and the second body location…”)(Examiner notes that the first heart activity is the pulse of a pulse wave.)
processing a sensor signal from the EKG sensor or the PPG sensor to determine a third heart activity [0100] “By using similar sensors at a…second body location…measure the pulse traveling time between the first body location and the second body location…”)(Examiner notes that the second heart activity is the pulse of a pulse wave.; Fig. 10; [0109] “first PPG sensor can be part of another wrist-worn device”; [0114] “pulse wave”);
b) a second PTT measured based on a lag between the third heart activity and the first heart activity (Fig. 12, Block 1204: “Determine a pulse transit time (PTT)”; [0108] “the first measurement location is at the ear and the second measurement location is at the wrist.”; [0106] “the PTT can be calculated using the distance and the respective arrival times at the first measurement location and the second location.”; [0113] “…Extracted features can be absolute values of points of interest of one or more of the signals 1100, ratios of values related to different points of interest, differences between the features…”; [0065]);
determining a blood pressure of the user (Fig 12, Block 1210 “obtain…the blood pressure of the user”) based at least on the PTT (Fig 12, Blocks 1204 and 1210 “obtain…the blood pressure of the user”); and
presenting the blood pressure to the user on a display of the watch ([0034] “ apparatus 100 may be a physiological monitor worn by a user to…display information pertaining to one or more physiological parameters…apparatus 100 may comprise a…wrist watch”) or as an audible message by speakers of the first in-ear device and the second in-ear device.
Galeev does not particularly disclose a second in-ear device having a second microphone and configured to be worn in a second ear of the user, wherein the second microphone is arranged to capture sound inside the ear canal of the second ear; determining a second heart activity from a second microphone signal of the second microphone; measuring an average or combination PTT being an average or combination of i) a first PTT measured based on a lag between the third heart activity and the second heart activity, and based at least on the average or combination PTT. Galeev is open to having a second in-ear microphone and collecting a second heart activity from a second signal, as it is not particularly noted by Galeev in which ear the earbud must be worn. It could be in a left ear and then in a right ear. To that end, if the difference between the first and second heart activity is which ear the data is gathered from, the second heart activity can be measured the same way as the first heart activity from the right ear instead of the left ear. In the case of making the measurements in series with a single earbud, then Galeev does disclose a second in-ear device having a second microphone and configured to be worn in a second ear of the user, wherein the second microphone is arranged to capture sound inside the ear canal of the second ear (Fig. 10, “ear device 1034”; [0107] “an ear device 1034 (e.g., a device that can be inserted in the ear).”; [0065]); determining a second heart activity from a second microphone signal of the second microphone ([0107] “earbud (a tiny speaker)”; [0065] “…one or more acoustic sensors comprising a speaker-microphone combination (such as a micro-electro-mechanical system (“MEMS”) acoustic sensor) can be used to extract reflected sound pulses from moving vessel walls.”; [0100])
Block teaches a blood pressure change measurement method of calculating pulse transit times between measurements at the ear, finger, and toe, with 6 conventional PTTs (cPTTs) calculated for time delays between different combinations of the ear, finger, and toe [Abstract]. Specifically for Claim 19, Block teaches measuring an average or combination PTT being an average or combination ([Page 3, 2nd Full Paragraph] “determined the cPTTs as the time delays (averaged over the sub-segment)…”) of i) a first PTT measured based on a lag between the third heart activity (Fig 1 (A) “Finger PPG”) and the second heart activity (Fig 1 (A) “Toe PPG”; [Page 3, 2nd Full Paragraph] “determined the cPTTs as the time delays (averaged over the sub-segment)…”…finger and toe PPG feet (finger-toe dPTT).”), and b) a second PTT measured based on a lag between the third heart activity (Fig 1 (A) “Finger PPG”) and the first heart activity (Fig 1 (A) “Ear PPG”; ([Page 3, 2nd Full Paragraph] “determined the cPTTs as the time delays (averaged over the sub-segment)…”) between… ear and finger PPG feet (ear-finger dPTT)…”) and a blood pressure of the user based at least on the average or combination PTT ([Page 5, “Discussion” Section] “cPTTs detected from ECG, ear, finger, and toe PPG waveforms in terms of tracking BP changes induced by interventions in humans”; [Page 4, Top] “…mean correlation coefficients (i.e., the average of the correlation coefficients over the subjects) of the six cPTTs for each BP.”)
Block provides a motivation to combine at [Page 5, 3rd Full Paragraph] with “Our study may be notable relative to previous efforts in that it comprised…(2) acquisition of multiple cPTTs instead of just the popular finger PAT (see Figs. 1A and 3)” and [Page 5, Paragraph 5] “We found that toe PAT (the time delay between the ECG R-wave and the ensuing foot of the toe PPG waveform) was best in tracking the intervention-induced BP changes amongst six cPTTs (see Fig. 5).” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using multiple locations of PPG measurements for differential pulse transit time measurement would be useful for determining a more accurate pulse transit time and also potential differences in the blood pressure that are best measured between particular regions.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the cardiovascular signal measurement monitor system and method that analyses multiple sensor outputs disclosed in Galeev with the averaged signal cPTT and dPTT calculations at three body locations taught by Block, creating a single cardiovascular measurement method that uses cardiac signals from at least three body locations and blood pressure change information to determine blood pressure for a subject.
Block does not teach a second in-ear device having a second microphone and configured to be worn in a second ear of the user, wherein the second microphone is arranged to capture sound inside the ear canal of the second ear; determining a second heart activity from a second microphone signal of the second microphone;
As described above, Galeev is open to having a second in-ear microphone and collecting a second heart activity from a second signal, as it is not particularly noted in which ear the earbud must be worn. The same earbud could be used for one ear and then the other, and data can be successfully gathered from either ear.
For particularly two ears collecting data at the same time, Barnacka 2021 teaches a system and method for cardiovascular monitoring that uses and in-ear biosensor system that includes left and right earbuds. Specifically for Claim 19, Barnacka 2021 teaches with a second in-ear device ([0040] “left and right earbuds placed…within ear canals of the individuals…”; Fig 1A)(Examiner notes that the “right earbud” could be the second in-ear device.), having a second microphone and configured to be worn in a second ear of the user (Fig 1A; [0040] “left and right earbuds placed…within ear canals of the individuals…”; [0029] “one or more infrasound/vibration sensors that detect biosignals including cardiovascular signals (CV signals)“), wherein the second microphone is arranged to capture sound inside the ear canal of the second ear ([0040] “left and right earbuds placed…within ear canals of the individuals…detect biosignals (CV signals)…”)
determining a second heart activity from a second microphone signal of the second microphone ([0123] “ left and right earbuds 103L,R…earbuds 103 each include at least one infrasound/vibration sensor that detects biosignals including cardiovascular activity signals (CV signals) 101...”; Fig. 1);
Barnacka 2021 provides a motivation to combine at [0089] with “the biosignals are detected at each of the earbuds 103L,R at substantially the same times. This “stereo effect” can be utilized to improve a signal to noise ratio of the biosignals and thus more robustly identify/characterize the biosignals.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that obtaining biomeasurements in stereo for an improved signal-to-noise ratio would be a convenient measurement method that would increase the overall accuracy of results from the system. This aligns with Galeev’s disclosed goal with use of in-ear microphone data to enhance the supplement the measured biosignal, as disclosed at [0065] with “All of the features or parameters described above, collected using a PPG system comprising one or more light sources and/or one or more optical detectors, can be supplemented with additional sensors…one or more acoustic sensors comprising a speaker-microphone combination…extract reflected sound pulses from moving vessel walls.” Galeev discloses uses multiple measurements to enhance the measured biosignal, as does Barnacka 2021.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the cardiovascular signal measurement earbud disclosed in Galeev with the stereo set of two earbud cardiovascular signal measurement devices taught by Barnacka 2021, creating a single cardiovascular measurement system that can measure cardiovascular signals at the ear in a stereo manner from each ear to improve the signal to noise ratio of the biosignals.
Regarding Claim 20, Galeev in view of Block and Barnacka 2021 discloses as described above in Claim 19, The method of claim 19. For the remainder of Claim 20, Galeev discloses presenting the PTT acoustically through speakers of the first and second in-ear devices or visually through a display of the watch ([0034] “ apparatus 100 may be a physiological monitor worn by a user to…display information pertaining to one or more physiological parameters…apparatus 100 may comprise a…wrist watch”).
Galeev does not specifically disclose the average or combination PTT
Block teaches the average or combination PTT ([Page 3, 2nd Full Paragraph] “determined the cPTTs as the time delays (averaged over the sub-segment)…”).
The motivation to combine Galeev and Block for Claim 20 is similar to that described in more detail in Claim 19. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the cardiovascular signal measurement monitor system and method that analyses multiple sensor outputs disclosed in Galeev with the averaged signal cPTT and dPTT calculations at three body locations taught by Block, creating a single cardiovascular measurement method that uses cardiac signals from at least three body locations and blood pressure change information to determine blood pressure for a subject.
Regarding Claim 12, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 12, Galeev discloses detecting the PTT ([0090] “pulse transit time (PTT)”; [0093] “PTT measures the traveling time of blood from a first point in the body to a second point in the body.”; [0108] “…first measurement location is at the ear and the second measurement location is at the wrist.”; [0100])
Galeev does not particularly disclose further comprising capturing a third heart activity of the user by processing an output signal of a second microphone, wherein detecting the PTT is further based on the third heart activity, wherein the second microphone is worn in or on a second ear of the user. As discussed above for Claim 19, Galeev is open to having a second microphone and collecting a third heart activity from an output signal of a microphone in the other ear, as it is not particularly noted by Galeev in which ear the earbud must be worn. It could be worn in a left ear and then in a right ear. To that end, if the difference between the first and third heart activity is which ear the data is gathered from, the third heart activity can be measured the same way as the first heart activity from the right ear instead of the left ear. In the case of making the measurements in series with a single earbud, then Galeev would broadly disclose a capability for capturing a third heart activity of the user by processing an output signal of a second microphone ([0107] “earbud (a tiny speaker)”; [0065] “…one or more acoustic sensors comprising a speaker-microphone combination (such as a micro-electro-mechanical system (“MEMS”) acoustic sensor) can be used to extract reflected sound pulses from moving vessel walls.”; [0100]), wherein detecting the PTT is further based on the third heart activity ([0090] “pulse transit time (PTT)”; [0093] “PTT measures the traveling time of blood from a first point in the body to a second point in the body.”; [0108] “…first measurement location is at the ear and the second measurement location is at the wrist.”; [0100]), wherein the second microphone is worn in or on a second ear of the user (Fig. 10, “ear device 1034”; [0107] “an ear device 1034 (e.g., a device that can be inserted in the ear).”; [0065]);
For detecting PTT based on at least 3 body locations, Block teaches wherein detecting the PTT is further based on the third heart activity [Page 5, “Discussion” Section] “cPTTs detected from ECG, ear, finger, and toe PPG waveforms in terms of tracking BP changes induced by interventions in humans”; [Page 4, Top] “…mean correlation coefficients (i.e., the average of the correlation coefficients over the subjects) of the six cPTTs for each BP.”).
The motivation for Claim 12 to combine Galeev with Block is similar to that described in more detail in Claim 19. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the cardiovascular signal measurement monitor system and method that analyses multiple sensor outputs disclosed in Galeev with the averaged signal cPTT and dPTT calculations at three body locations taught by Block, creating a single cardiovascular measurement method that uses cardiac signals from at least three body locations and blood pressure change information to determine blood pressure for a subject.
Block does not teach capturing a third heart activity of the user by processing an output signal of a second microphone, wherein the second microphone is worn in or on a second ear of the user. As described above, Galeev is open to having a second in-ear microphone and collecting a third heart activity from an output signal of the second in-ear microphone, as it is not particularly noted in which ear the earbud must be worn. The same earbud could be used for one ear and then the other, and data can be successfully gathered from either ear.
For particularly two ears collecting data at the same time, Barnacka 2021 teaches capturing a third heart activity of the user by processing an output signal of a second microphone ([0123] “ left and right earbuds 103L,R…earbuds 103 each include at least one infrasound/vibration sensor that detects biosignals including cardiovascular activity signals (CV signals) 101...”; Fig. 1), wherein the second microphone is worn in or on a second ear of the user ([0123] “ left and right earbuds 103L,R…earbuds 103 each include at least one infrasound/vibration sensor that detects biosignals including cardiovascular activity signals (CV signals) 101...”; Fig. 1)
The motivation for Claim 12 to combine Galeev with Barnacka 2021 is similar to that described in more detail in Claim 19. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the cardiovascular signal measurement earbud disclosed in Galeev with the stereo set of two earbud cardiovascular signal measurement devices taught by Barnacka 2021, creating a single cardiovascular measurement system that can measure cardiovascular signals at the ear in a stereo manner from each ear to improve the signal to noise ratio of the biosignals.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Galeev in view of Barnacka 2021, (United States Patent Application Publication US 2021/0045647 A1), hereinafter Barnacka 2021.
Regarding Claim 9, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 9, Galeev does not specifically disclose further comprising synchronizing the microphone signal and the second signal based on timestamps so that events in the microphone signal can be compared to events in the sensor signal using a common temporal reference. However, Galeev does broadly disclose aligning signals temporally by stacking them in order to make comparisons between them for features, as shown in Fig. 11 and [0113] “typical signals 1100 that relate to a pulse wave and from which features can be extracted…”
Barnacka 2021 teaches further comprising synchronizing the microphone signal and the second signal based on timestamps (Fig 6., [0053] “plots exemplary signals/waveforms associated with cardiovascular activity from different medical diagnostics systems, on a same time scale…”) so that events in the microphone signal can be compared to events in the sensor signal using a common temporal reference (Fig. 6, [0053] “plots…signals/waveforms…on a same time scale…references some CV function measurements relative to each of the signals for comparison”)
Barnacka 2021 provides a motivation to combine at [0176] “Wiggers diagram that illustrates operation of the left ventricle 314 for the same individual 100 over a single cardiac cycle. The diagram…includes a plot of a CV signal 101 obtained by the CV monitoring system over the same time frame for comparison.”) A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that aligning temporally-measured signals measured from multiple sensors, such as cardiovascular pulse signals, would be useful for making comparisons between features measured by the different sensors.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine and aligning signals temporally by stacking them for feature comparison purposes with Barnacka 2021’s taught diagram of plotting cardiovascular signals from difference sensors aligned over the same time frame for comparison, creating a single cardiovascular measurement system that can compare cardiovascular signal features that are measured with its multiple sensors.
Regarding Claim 11, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 11, Galeev does not disclose wherein processing the microphone signal includes sensing an infrasound signal in the microphone signal.
Barnacka 2021 teaches wherein processing the microphone signal includes sensing an infrasound signal in the microphone signal ([0029] “The at least one earbud includes one or more infrasound/vibration sensors that detect biosignals including cardiovascular signals (CV signals) from the individual.”; [0132] “infrasound/vibration sensors 276…detect sounds and vibrations…”).
Barnacka 2021 provides a motivation to combine at [0088] with “The biologically-originating sound detected inside the ear canal by the earbuds 103 is mostly in the infrasound range. In particular, the infrasound and vibration sensors can detect biosignals from the individual 100 that are associated with operation of the cardiovascular system of the individual 100, also known as CV signals 101.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that measuring the infrasound in the ear would be useful for particularly obtaining the biosignal-originating portions of the acoustic signals measured at the ear.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the ear microphone sensors for measuring cardiovascular signals disclosed in Galeev with measuring the infrasound portion of the acoustic signal using earbud sensors taught by Barnacka 2021, creating a single cardiovascular measurement method that uses infrasound measurement at the ear to analyzed cardiovascular function for a subject.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Galeev in view of Yan, et. al., (WO 2022/033554 A1), hereinafter Yan.
Regarding Claim 10, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 10, Galeev does not disclose wherein processing the microphone signal includes sensing an ultrasound signal in the microphone signal.
Yan teaches a pulse wave measurement system that uses sensors at two locations on a subject, measuring ultrasound signals to determine pulse transit time [Abstract]. Specifically for Claim 10, Yan teaches wherein processing the microphone signal includes sensing an ultrasound signal in the microphone signal ([Page 4, Paragraphs 8 and 9] “The ranging sensor of the first device sends out ultrasonic waves to the ranging sensor of the second device and starts to calculate the transit time; …first device receives the ultrasonic wave reflected by the second device, the first device finishes calculating the transit time”).
Yan provides a motivation to combine at [Page 11, 5th Full Paragraph] with “After the first ranging sensor 114 obtains the above-mentioned round-trip time of the ultrasonic wave, the vertical distance between the first ranging sensor 114 and the second ranging sensor 124 can be obtained through the propagation speed of the ultrasonic wave in the air.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that measuring the ultrasonic signals relative to two sensors would be useful for obtaining the distance between the sensors for pulse transit time calculations.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the sensors at multiple locations for measuring cardiovascular signals and calculating pulse transit time disclosed in Galeev with measuring the ultrasonic signals using the multiple location sensors taught by Yan, creating a single cardiovascular measurement method that uses ultrasonic measurement between two locations (such as the ear and wrist) to determine distance for pulse transit time calculations for a subject.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Galeev in view of Deriso (United States Patent Application Publication US 2019/0125270 A1).
Regarding Claim 16, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 16, Galeev discloses device worn in or on the first ear of the user ((Fig. 10, “ear device 1034”; [0107] “an ear device 1034 (e.g., a device that can be inserted in the ear)” [0065])
Galeev does not disclose performing an active noise cancellation process that affects the microphone signal of the device.
Deriso teaches a heart monitoring device that uses a plurality of sensors to obtain cardiovascular data and confirm that the data originates from the intended user, using microphone sensing and voice recognition through machine learning. Specifically for Claim 16, Deriso teaches performing an active noise cancellation process that affects the microphone signal of the device. ([0107] “heart monitoring device 130 further implements a noise cancellation model to improve a signal to noise ratio of the detected acoustic signals.”)
Deriso provides a motivation to combine at [0107] with “heart monitoring device 130 further implements a noise cancellation model to improve a signal to noise ratio of the detected acoustic signals.”) A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that implementing noise cancellation would be useful for obtaining clear audio signals in a device that measures audio.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microphone within an earbud sensor associated with the cardiovascular signal measurement monitor system and method disclosed in Galeev with the noise cancellation for acoustic signals taught by Deriso, creating a single cardiovascular acoustic measurement method that uses noise cancellation for an earbud microphone sensor to increase the clarity and usefulness of the data.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Galeev in view of Sandler et. al., (United States Patent Application Publication US 2004/0249293 A1).
Regarding Claim 18, Galeev discloses as described above, The method of claim 1. For the remainder of Claim 18, Galeev discloses further comprising processing the microphone signal to detect respiratory activity ([0031] “the physiological information sensed, measured, analyzed, or displayed can include but is not limited to…respiration rate…”; [0065] “speaker-microphone combination…”)
Galeev does not disclose and detecting the association between the first heart activity and the heart pathology further based on the respiratory activity.
Sandler teaches apparatuses and methods that use the acoustic characteristics of blood flow to assess vascular conditions, including combining cardiac and respiratory signals to detect stenosis. Specifically for Claim 18, Sandler teaches and detecting the association between the first heart activity and the heart pathology further based on the respiratory activity ([0070] “acoustic spectra may be calculated for parts of a cardiac or respiratory cycle to increase stenosis detection accuracy"; [0088] “The comparisons of the signal characteristics may be based on comparisons of acoustic characteristics from a plurality of sensors…and comparisons between different phases of cardiac and respiratory cycles.”)
Sandler provides a motivation to combine at [0070] with “In addition, the acoustic spectra may be calculated for parts of a cardiac or respiratory cycle to increase stenosis detection accuracy.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using multiple types of data, including cardiac and respiratory signals, would allow for discerning which signal results correctly indicate stenosis in a subject’s cardiovascular system.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microphone sensor associated with the cardiovascular signal measurement monitor system and method that analysis multiple sensor outputs (including cardiovascular and respiratory signals) disclosed in Galeev with the acoustic and respiratory signal calculations to increase stenosis detection accuracy taught by Sandler, creating a single cardiovascular measurement method that uses cardiac and respiratory signals as calculation inputs to determine evidence for stenosis.
Response to Arguments
Applicant's arguments filed 27 March 2026 have been fully considered but they are not persuasive.
Regarding 35 U.S.C. 101 Rejections:
Applicant argues at [Page 6, Paragraph 5] – [Page 6, bottom] that enabling the user to learn their blood pressure at any time while they are wearing a headphone and a smart watch is considered a technological improvement. In general, a user could learn their blood pressure at a time while they are wearing a headphone and smart watch if they have their blood pressure taken at a doctor’s office while incidentally wearing these accessories, and being told the result. There is nothing particular recited that makes a technological improvement to the watch or headphone themselves. The argument is not persuasive.
Applicant argues at [Page 7, Paragraph 1] that claim 1 does not “read like a generic term” because Claim 1 recites a specific technological improvement on electronic blood pressure measurement techniques. As discussed in the 35 U.S.C. 101 rejection above and discussion above, there is nothing particular recited in Claim 1 that presents a technological improvement on electronic blood pressure measurement techniques. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The argument is not persuasive.
Applicant argues at [Page 7, Paragraph 2] that the office action improperly characterizes “all of the elements recited in the claims as generic computing and hardware devices,” such that no technique for blood pressure measurement and its direct display to a user could ever be patented, even with a novel and nonobvious combination of existing sensors and digital processing techniques. Looking to the 35 U.S.C. 101 rejection above, the additional elements that are characterized as generic computing and hardware devices are the “microphone” (“first microphone”, “second microphone”), “device worn configured to be worn in or on a first ear of the user”, (“first in-ear device”, “second in-ear device”), “speaker”, “watch” (“display of the watch”), “accelerometer” (“third sensor”), “smart phone”, “electrode” (“EKG sensor”, “second sensor”), “PPG sensor”, and “processor”. There is nothing provided regarding the structure of these elements that indicates that they include structure or improved technical performance other than their baseline as generic accessory and sensor elements being used in their usual manner, the microphone elements to record sounds, the earbud to be worn in the ear, the watch to be worn on the wrist and display information, the PPG sensor and electrode EKG sensor to record pulsatile data, the accelerometer to record motion data, and the processor to process data. In terms of patentability, if a blood pressure measurement technique with display to a user does not recite a judicial exception (passes Step 2A – Prong 1), integrates into a practical application (passes Step 2A – Prong 2), or provides an inventive concept by amounting to more than mere instructions to apply the exception using a generic computer component (passes Step 2B), then it is patent-eligible. While generic components may be recited, if they are used in a way that is more than well-understood, routine, and conventional, then they may overcome Step 2b. As discussed above, this is not the case for Claims 1 and 3 – 20. The argument is not persuasive. The argument is not persuasive.
Applicant argues at [Page 7, Paragraph 3] that Claim 19 recites a specific technique for blood pressure measurement that uses left and right in-ear devices, a smart watch, measures PTT to find blood pressure, and presents the result to a user with a visual or audio message, which is a specific practical application that is not abstract. There is nothing in particular that improves the technology of the in-ear devices (earbud) or smart watch themselves. Regarding presenting a result to a user with a visual or audio message, this limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity, for instance the step of printing a menu that was generated through an abstract process in Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1241-42 (Fed. Cir. 2016) and the mere generic presentation of collected and analyzed data in Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354 (Fed. Cir. 2016).
In general, measuring PTT to find blood pressure is a well-known mathematical relationship between PTT and blood pressure. As recited, it is the abstract idea of processing the first heart activity of the user and the second heart activity of the user by determining the time it takes a pulse wave to travel between two arterial sites. This can be performed by a human researcher by aligning the extra-solution data-gathering sensor data and determining a time difference. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The argument is not persuasive.
Regarding 35 U.S.C. 102/103 Rejections:
Applicant argues at [Page 7, Paragraphs 4 -6] that Galeev does not suggest replacing the first PPG sensor in the ear device with an acoustic sensor (a microphone). Galeev recites at [0107] “earbud (a tiny speaker)”; [0065] “one or more acoustic sensors comprising a speaker-microphone combination (such as a micro-electro-mechanical system (“MEMS”) acoustic sensor) can be used to extract reflected sound pulses from moving vessel walls.” Further, Galeev use of in-ear microphone data to enhance the supplement a measured PPG sensor biosignal with, as disclosed at [0065] with “All of the features or parameters described above, collected using a PPG system comprising one or more light sources and/or one or more optical detectors, can be supplemented with additional sensors…one or more acoustic sensors comprising a speaker-microphone combination…extract reflected sound pulses from moving vessel walls.” The argument is not persuasive.
Based on the applicant’s amendments to Claim 19 - 20, a new ground(s) of rejection is made based on Galeev in view of Block, further in view of Barnacka 2021.
Applicant argues at [Page 8, Paragraph 5] that Galeev and Block are directed to blood pressure estimation using only PPG sensors and cannot be combined with a reference that uses acoustic sensors. Due to the amendments, the new combination is of Galeev in view of Block in view of Barnacka 2021, and Barnacka is used for the concept of having 2 in-ear sensors instead of 1, as disclosed in Galeev. Further, Galeev does disclose using in-ear microphone measurements of cardiovascular data at [0065] as discussed above, such that it can supplement its PPG measurements. The argument is not persuasive.
Applicant argues at [Page 8, Paragraph 6] that Block does not suggest that a sensor is located in the ear canal. As described in the 35 U.S.C. 103 rejection above, Galeev discloses that the sensors are used in the ear as earbuds. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The argument is not persuasive.
The remainder of Applicant’s arguments with respect to claims 19 - 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any remaining teaching or matters specifically challenged in the arguments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yang et. al., (“Pulse Transit Time Measurement Using Seismocardiogram, Photoplethysmogram, and Acoustic Recordings: Evaluation and Comparison”, Ref U on PTO-892) teaches a method of pulse transit time measurement using SCG-acoustic and SCG-PPG measurements, including an earbud sensor, to obtain PTT measurements.
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 MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272 - 4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA JO MONTGOMERY/
Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
Prosecution Insights