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 .
Status of Claims
Claims 1-2 and 4-5 are currently amended.
Response to Arguments
Applicant's arguments filed 3/30/2026 have been fully considered but they are not persuasive.
35 U.S.C. 101: Step 2A Prong 1
Regarding claim 1, applicant argues that the subject matter recite a specific sequence of
operations in a manner that is wholly beyond the human cognitive capability in real time. The examiner respectfully disagrees and argues that the combination of determination and automated control steps can be performed in the human mind:
a first correctness determination step which determines correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a predetermined range;
a second correctness determination step which determines after the first correctness determination step correctness as to whether or not the human body is stably in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness;
and a collective measurement step which automatically collectively executes blood pressure measurement of the human body by the blood pressure measurement unit and measurement of an electrocardiographic waveform of the human body, in a case where at least a determination result of the second correctness determination step indicates correctness.
Furthermore, applicant argues that the subject matter cannot be performed in the mind
because the claim recites a concrete, technology-dependent process that requires sensor hardware, signal processing, and automated decision logic operating together within the wearable device. The examiner respectfully argues that the additional elements recite either extra-solution activity or computer implementation to perform the abstract idea. The sensor hardware is recited as extra-solution activity to perform the step of data gathering. The signal processing and automated decision logic is recited as computer implementation to perform the abstract idea of “determining sensor positional correctness, electrode contact correctness, and selective control over biometric data gathering.”
35 U.S.C. 101: Step 2A Prong 2 and Step 2B
Regarding claim 1, applicant argues that the subject matter, when taken as a whole, is directed
to a technological solution to the problem of measurement errors in wearable devices by using the specific logic and sequence to reduce noise in electrocardiographic signals and improving blood pressure measurement accuracy (specification; paragraph 20-21). The examiner respectfully disagrees and argues that this is not an improvement to the computer system itself, and is more directed to an improvement of the abstract idea.
Applicant is reminded that abstract ideas cannot provide a practical application or significantly
more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the additional elements of claims 1 and 4 are merely generically recited computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity.
35 U.S.C. 103
Regarding claims 1 and 4, applicant argues that Nuovo, alone or in combination with the prior
art, does not teach the limitations, “when a determination result of the first correctness determination unit indicates correctness” and “on condition that at least a determination result of the second correctness determination unit indicates correctness,” which recites a sequential control logic. After further search and consideration, the examiner respectfully disagrees and argues that the combination of references recites a sequential control process. More specifically, Eom discloses a sequential order because it specifically states that “it is required to check a contact state first and then to perform measurement” of the functionality for the second correction unit.
Furthermore, applicant argues that one or ordinary skill in the art would not combine Nuovo, Qiao, Eom, and Palin together to arrive at the claimed subject matter by attacking each references individually. The examiner respectfully disagrees and argues that one cannot show non-obviousness by attacking the references individually where, as here, the rejection is based on a combination of references. In re Keller, 642 F .2d 413, 208 USPQ 871 (CCPA 1981).
Only regarding claim 1, the examiner argues that process limitation cannot impart patentability to a product claim where the product is not patentably distinguished over the prior art. A functional statement cannot serve to distinguish a claim, which is not a process claim, from a reference since it does not define any structure. This is particularly so where the functional statement is conditional in nature, as to a possibility that may or may not occur. “When a determination result of the first correctness determination unit indicates correctness” and “on condition that at least a determination result of the second correctness determination unit indicates correctness.”
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 4 recite a system and method with instructions for performing operations of the device comprising:
a first correctness determination step which determines correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a predetermined range;
a second correctness determination step which determines after the first correctness determination step correctness as to whether or not the human body is stably in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness;
automatically collectively executing, by a collective measurement control step blood pressure measurement of the human body by the blood pressure measurement unit and measurement of an electrocardiographic waveform of the human body, in a case where at least a determination result of the second correctness determination step indicates correctness.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is
evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to a system and claim 4 is directed to a method with steps and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Claims 1 and 4 recite a system and method with instructions for performing operations of the
device comprising:
a first correctness determination step which determines correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a predetermined range;
a second correctness determination step which determines after the first correctness determination step correctness as to whether or not the human body is stably in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness;
automatically collectively executing, by a collective measurement control step blood pressure measurement of the human body by the blood pressure measurement unit and measurement of an electrocardiographic waveform of the human body, in a case where at least a determination result of the second correctness determination step indicates correctness.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the
limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1 and 4 recite an abstract idea of a mental process.
Claims 1 and 4 recite the abstract idea of a mental process. The limitations as drafted in the
claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic processing system and memory, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example:
“A first correctness determination step which determines correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a predetermined range;” A physician may observe the position of the worn device relative to a height of a predetermine range and make a determination.
“A second correctness determination step which determines after the first correctness determination step correctness as to whether or not the human body is stably in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness;” A physician may determine whether or not an electrode has sufficient contact through observation and touch.
“Automatically collectively executing, by a collective measurement control step blood pressure measurement of the human body by the blood pressure measurement unit and measurement of an electrocardiographic waveform of the human body, in a case where at least a determination result of the second correctness determination step indicates correctness.” A physician may determine whether to perform necessary calculation steps based on the first and second correction examination through observation.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial
exception into a practical application?
Claims 1, 3, and 4 recite the additional elements of a “a blood pressure measurement unit”,
“an electrocardiographic waveform measurement unit”, “a plurality of electrodes,” “an electrode contact state detection unit”, “a position detection unit”, “a controller”, “a first correctness determination unit”, “a second correctness determination unit”, “wearable device/wristwatch”, and “a collective measurement control unit” which are being interpreted as a processor of a data gathering device.
a blood pressure measurement unit, an electrocardiographic waveform measurement unit, and a plurality of electrodes are recited as pre-solution activity to the step of data gathering.
an electrode contact state detection unit, a position detection unit, a controller, a first correctness determination unit, and a second correctness determination unit are recited with no additional significant structure. The components are also recited as computer implementation to perform the analyzing steps of the claimed invention based on position and contact of the plurality of electrodes.
The wearable device/wristwatch does not recite any inventive structure. It is recited as a generic data gathering device, used in combination with a processor and sensors.
However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical
application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the
judicial exception?
The additional elements when considered individually and in combination are not enough to
qualify as significantly more than the abstract idea.
a blood pressure measurement unit, an electrocardiographic waveform measurement unit, and a plurality of electrodes are recited as pre-solution activity to the step of data gathering.
an electrode contact state detection unit, a position detection unit, a controller, a first correctness determination unit, and a second correctness determination unit are recited with no additional significant structure. The components are also recited as computer implementation to perform the analyzing steps of the claimed invention based on position and contact of the plurality of electrodes.
The wearable device/wristwatch does not recite any inventive structure. It is recited as a generic data gathering device, used in combination with a processor and sensors.
As discussed above with respect to integration of the abstract idea into a practical application, “a blood pressure measurement unit”, “an electrocardiographic waveform measurement unit”, “a plurality of electrodes,” “an electrode contact state detection unit”, “a position detection unit”, “a controller”, “a first correctness determination unit”, “a second correctness determination unit”, “wearable device/wristwatch”, and “a collective measurement control unit” which are being interpreted as a processor of a data gathering device as recited to perform the steps of:
a first correctness determination step which determines correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a predetermined range;
a second correctness determination step which determines after the first correctness determination step correctness as to whether or not the human body is stably in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness;
automatically collectively executing, by a collective measurement control step blood pressure measurement of the human body by the blood pressure measurement unit and measurement of an electrocardiographic waveform of the human body, in a case where at least a determination result of the second correctness determination step indicates correctness.
amount to no more than mere instructions to apply the exception using generic computer
components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Nuovo et al. US Pub.: US 20150335284 A1, hereinafter Nuovo) teaches a data gathering device with a processor and memory, and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections
set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Nuovo et al. US Pub.:
US 20150335284 A1, hereinafter Nuovo in view of Qiao et al. US Pub.: US 20170372582 A1, hereinafter Qiao in view of EOM et al. US Pub.: US 20160198977 A1, hereinafter Eom in view of Palin et al. US Pub.: US 20170188969 A1, hereinafter Palin.
Regarding claim 1, Nuovo teaches a biological information measurement device (10) configured
to be worn on a wrist of a human body, the biological information measurement device comprising (fig. 1; paragraph 42):
a blood pressure measurement unit (28) configured to measure a blood pressure of the human body (fig. 1; paragraph 49): The sensor units 28 may include blood pressure. Each sensor is separate to one another.
an electrocardiographic waveform measurement unit (28) which includes a plurality of electrodes and is configured to measure an electrocardiographic waveform of the human body (fig. 1; paragraph 49): The sensor units 28 may include blood pressure ECG sensor. Each sensor is separate to one another.
an electrode contact state detection unit (58) configured to detect a contact state of the human body with the plurality of electrodes (fig. 1 and 7; paragraph 49, 71-73, 77, and 86); The bioimpedance sensor array is configured to measure current flow between the electrodes and the tissue. This may be used to measure contact quality between the electrodes and tissue of a patient.
a position detection unit (28) configured to detect a position of the device (fig. 1; paragraph 49): The sensor units 28 may include proximity detectors for detecting the proximity of objects. A MEMS accelerometer may be used to measure information such as position, motion, tilt, shock, and vibration for use by processor 36. The applicant specification discloses “a triaxial acceleration sensor can be adopted as the position detection unit (paragraph 10).”
and a controller (36) which controls the electrocardiographic waveform measurement unit (28) and the blood pressure measurement unit (28) (fig. 1; paragraph 49 and 55-56);
However, Nuovo does not teach wherein the controller includes a first correctness determination unit configured to determine, on a basis of an output of the position detection unit, correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a predetermined range; a second correctness determination unit configured to determine, on a basis of an output of the electrode contact state detection unit and information including baseline fluctuation of the electrocardiographic waveform and/or posture fluctuation of the device, whether or not the human body is stably in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness; and a collective measurement control unit which automatically performs control to collectively execute blood pressure measurement of the human body by the blood pressure measurement unit and measurement of an electrocardiographic waveform of the human body by the electrocardiographic waveform measurement unit, on condition that at least a determination result of the second correctness determination unit indicates correctness.
Qiao, in the same field of endeavor, teaches wherein the controller includes a first correctness determination unit (201) configured to determine, on a basis of an output of the position detection unit, correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a predetermined range (paragraph 20-22, 41, 46, 58, and 83); The wearing state detection unit 201 may detect whether the device is worn or is worn correctly and is positioned at a height within a predetermined range based on body slump only according to one of the pressure data, the tri-axis acceleration and temperature data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor array and processor of Nuovo to add a tri-axis accelerometer and wearing state detection unit of Qiao for the benefit of determining whether the device is worn or is worn correctly and is positioned at a height within a predetermined range based on body slump to increase the accuracy of data collection.
Eom, in the same field of endeavor, teaches a second correctness determination unit configured to determine, on a basis of an output of the electrode contact state detection unit and information including baseline fluctuation of the electrocardiographic waveform and/or posture fluctuation of the device, whether or not the human body is stably in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness (paragraph 110). The apparatus confirms whether a closed circuit is formed, based on contact between the electrodes and tissue. When the electrodes and a body part do not properly come into contact with each other, the closed circuit is not formed. This performs the functionality of the second correction unit because it specifically states “it is required to check a contact state first and then to perform measurement.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Nuovo in view of Qiao to add the contact correction step of Eom for the benefit of determining whether the device is in the most optimal contact state with the patient’s tissue to increase the accuracy of data collection.
Palin, in the same field of endeavor, teaches a collective measurement control unit (110 or 130) which automatically performs control to collectively execute blood pressure measurement of the human body by the blood pressure measurement unit and measurement of an electrocardiographic waveform of the human body by the electrocardiographic waveform measurement unit, on condition that at least a determination result of the second correctness determination unit indicates correctness (paragraph 60-61). Gateway 110 or server 130 acts as a collective measurement control unit because it may monitor the conditions continuously, or, for example, around the times when a measurement is desired, and collect the measurement result automatically when conditions are propitious. In this case, when the second correctness determination unit states the conditions are propitious.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Nuovo in view of Qiao and Palin to add the server from Palin for the benefit of collecting data efficiently when the device is at an optimal state. Also user action is no longer required to perform the calculation step.
Regarding claim 2, Nuovo in view of Eom in view of Palin does not teach wherein a height within
the predetermined range is set to be the same as a height of a heart of the human body.
Qiao further teaches wherein a height within the predetermined range is set to be the same as a height of a heart of the human body (paragraph 20-22, 41, 46, 58, and 83). The wearing state detection unit 201 may detect whether the device is worn or is worn correctly only according to one of the pressure data, the tri-axis acceleration and temperature data. In this case, the height of the device in comparison to the heart may be measure by a comparison between thresholds/ranges. Specifically, the tri-axis acceleration and pressure data may be used.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor array and processor of Nuovo to add a tri-axis accelerometer and wearing state detection unit of Qiao for the benefit of determining whether the device is worn or is worn correctly to increase the accuracy of data collection.
Regarding claim 3, Nuovo in view of Qiao in view of Eom in view of Palin teaches the claimed
invention and Qiao teaches wherein the biological information measurement device (10) is a wristwatch-type wearable device (fig. 1; paragraph 42).
Regarding claim 4, Nuovo a method of a biological information measurement device (10)
configured to be being worn on a wrist of a human body (fig. 1; paragraph 42):
and includes a blood pressure measurement unit (28) configured to measure a blood pressure of the human body (fig. 1; paragraph 49): The sensor units 28 may include blood pressure. Each sensor is separate to one another.
an electrocardiographic waveform measurement unit (28) which includes a plurality of electrodes and is configured to measure an electrocardiographic waveform of the human body (fig. 1; paragraph 49): The sensor units 28 may include ECG sensor. Each sensor is separate to one another.
an electrode contact state detection unit (58) configured to detect a contact state of the human body with the plurality of electrodes (fig. 1 and 7; paragraph 49, 71-73, 77, and 86); The bioimpedance sensor array is configured to measure current flow between the electrodes and the tissue. This may be used to measure contact quality between the electrodes and tissue of a patient.
and a position detection unit (28) configured to detect a position of the device, the control method comprising (fig. 1; paragraph 49): The sensor units 28 may include proximity detectors for detecting the proximity of objects. A MEMS accelerometer may be used to measure information such as position, motion, tilt, shock, and vibration for use by processor 36. The applicant specification discloses “a triaxial acceleration sensor can be adopted as the position detection unit (paragraph 10).”
However, Nuovo does not teach determining by a first correctness determination step which determines, on a basis of an output of the position detection unit, correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a predetermined range; determining by a second correctness determination step after the first correctness determination step, on a basis of an output of the electrode contact state detection unit and information including baseline fluctuation of the electrocardiographic waveform and/or posture fluctuation of the device, correctness as to whether or not the human body is stably in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness; and automatically collectively executing, by a collective measurement control step blood pressure measurement of the human body by the blood pressure measurement unit and measurement of an electrocardiographic waveform of the human body by the electrocardiographic waveform measurement unit, in a case where at least a determination result of a second correctness determination step indicates correctness.
Qiao, in the same field of endeavor, teaches determining by a first correctness determination step which determines, on a basis of an output of the position detection unit, correctness as to whether or not a wrist of the human body on which the device is worn is positioned at a height within a predetermined range (paragraph 20-22, 41, 46, 58, and 83); The wearing state detection unit 201 may detect whether the device is worn or is worn correctly and is positioned at a height within a predetermined range based on body slump only according to one of the pressure data, the tri-axis acceleration and temperature data.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor array and processor of Nuovo to add a tri-axis accelerometer and wearing state detection unit of Qiao for the benefit of determining whether the device is worn or is worn correctly and is positioned at a height within a predetermined range based on body slump to increase the accuracy of data collection.
Eom, in the same field of endeavor, teaches determining by a second correctness determination step after the first correctness determination step, on a basis of an output of the electrode contact state detection unit and information including baseline fluctuation of the electrocardiographic waveform and/or posture fluctuation of the device, correctness as to whether or not the human body is stably in contact with the plurality of electrodes when a determination result of the first correctness determination unit indicates correctness (paragraph 110). The apparatus confirms whether a closed circuit is formed, based on contact between the electrodes and tissue. When the electrodes and a body part do not properly come into contact with each other, the closed circuit is not formed. This performs the functionality of the second correction unit because it specifically states “it is required to check a contact state first and then to perform measurement.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Nuovo to add the contact correction step of Eom for the benefit of determining whether the device is in the most optimal contact state with the patient’s tissue to increase the accuracy of data collection.
Palin, in the same field of endeavor, teaches automatically collectively executing, by a collective measurement control step blood pressure measurement of the human body by the blood pressure measurement unit and measurement of an electrocardiographic waveform of the human body by the electrocardiographic waveform measurement unit, in a case where at least a determination result of the second correctness determination step indicates correctness (paragraph 60-61). Gateway 110 or server 130 acts as a collective measurement control unit because it may monitor the conditions continuously, or, for example, around the times when a measurement is desired, and collect the measurement result automatically when conditions are propitious. In this case, when the second correctness determination unit states the conditions are propitious.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Nuovo to add the server from Palin for the benefit of collecting data efficiently when the device is at an optimal state. Also user action is no longer required to perform the calculation step.
Regarding claim 5, Nuovo in view of Eom in view of Palin does not teach wherein a height within
the predetermined range is set to be the same as a height of a heart of the human body.
Qiao further teaches wherein a height within the predetermined range is set to be the same as a height of a heart of the human body (paragraph 20-22, 41, 46, 58, and 83). The wearing state detection unit 201 may detect whether the device is worn or is worn correctly only according to one of the pressure data, the tri-axis acceleration and temperature data. In this case, the height of the device in comparison to the heart may be measure by a comparison between thresholds/ranges. Specifically, the tri-axis acceleration and pressure data may be used.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor array and processor of Nuovo to add a tri-axis accelerometer and wearing state detection unit of Qiao for the benefit of determining whether the device is worn or is worn correctly to increase the accuracy of data collection.
Regarding claim 6, Nuovo in view of Qiao in view of Eom in view of Palin teaches the claimed
invention and Qiao teaches non-transitory computer readable medium storing a program for causing a biological information measurement device to execute each step of the control method according to claim 4 (paragraph 106).
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 THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights