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 Arguments
Applicant's arguments, see pages 6-9, filed 7/16/2025, have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 101 rejection of claims 1-19, applicant argue that the amended
limitations of claim 1 provide the technical solution to the technical problems described in the specification of the present application at (paragraphs 4, 107, 108, and 112). The problem is disclosed in [004] that “during daily activities of a user in a state in which electrodes are attached to a user, sweat or external moisture may permeate between the body and the electrodes. In this case, the impedance between the electrodes may vary, and thus the electrocardiogram of the user may vary with time.” [107-108 and 112] solves this technical problem by stating “The biosignal correcting unit 220 may correct the magnitude of the biosignal BS based on the impedance value IV (S120). The determining unit 230 may determine the health state of an object based on the magnitude of the corrected biosignal (S130). Based on the magnitude of the corrected biosignal BS and other biological information, the determining unit 230 may determine that the object probably has a health problem or may determine various health states of the object. For example, the determining unit 230 may determine whether it is necessary for the object to have a medical checkup or regular exercise for health improvements.”
After careful consideration, the examiner respectfully disagrees and argues that the technological improvement is towards an accurate determination “that the object probably has a health problem or may determine various health states of the object.” This improvement is towards an abstract idea and not the computer system itself. Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures | LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). See MPEP 2106.05(f).
Applicant further argues that claim 1 focuses on a specific means that improves the relevant technology rather than being "directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery." McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3de Page 7 of 1299 at 1314 (Fed. Cir. 2016). The specification describes the specific means for detecting impedance which may cause variations in the amplitude of a biosignal and compensating the variations in the amplitude of the biosignal (e.g., [0079]-[0088] and FIG. 5A reproduced below).
After further consideration, the examiner respectfully disagrees and argues that McRO, Inc. v. Bandai Namco Games Am. Inc. and the instant application are two different cases, which reads upon themselves separately. Therefore, one cannot argue for patent eligibility based on a comparison between two different cases. The examiner also argues that the step of correcting impedance is a filtering step to improve the accuracy of health determination. As disclosed above, this is not an improvement towards the computer system itself, and is rather an improvement towards the abstract idea.
Lastly, applicant argues that claim 1 recites a practical application: namely, compensating a biosignal based on an impedance value and determining whether the heart health state of the subject is abnormal based on the corrected biosignal, and transmitting the result to an external device for display, as supported in the specification (e.g., [0052], [0055], [0106]-[0114]).
After further consideration, the examiner respectfully disagrees and argues that transmitting results to an external device for display is not a practical application and is post-solution activity for a diagnosis process. The examiner suggest that the applicant amend the claim to provide an extra step to show what the device is doing after obtaining data other than “displaying a diagnosis.” These steps, for example, may contain stimulation therapy, surgical procedures, or something close to that nature.
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 1-4 and 8-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed
to an abstract idea without significantly more. Claim 1 recite a measuring apparatus with instructions for performing operations:
determining an average value of at least one of a plurality of waves, which are detected repeatedly and included in the biosignal as a magnitude of the biosignal;
and generating a corrected biosignal by correcting a varying magnitude of the biosignal based on the first, the second and the third impedance values, wherein a corrected magnitude of the biosignal is corrected based on the first impedance value between the plurality of electrodes including impedances between each of the plurality of electrodes and the skin of the object and further corrected based on the second impedance and the third impedance which vary depending on distances between the point of heart and the point to which each of the plurality of electrodes are attached;
determine a reference range for an increasing slope of a magnitude of the corrected biosignal based on a rate of increase in heart rate;
determine that a heart's health state of the object is an abnormal state when the increasing slope of the magnitude of the corrected biosignal is outside a reference range;
display a warning information indicating the heart's health state when heart's health state of the object is determined to be an abnormal state.
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 measuring apparatus 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?
Claim 1 recite an apparatuses with instructions to perform the method and a device comprising:
determining an average value of at least one of a plurality of waves, which are detected repeatedly and included in the biosignal as a magnitude of the biosignal;
and generating a corrected biosignal by correcting a varying magnitude of the biosignal based on the first, the second and the third impedance values, wherein a corrected magnitude of the biosignal is corrected based on the first impedance value between the plurality of electrodes including impedances between each of the plurality of electrodes and the skin of the object and further corrected based on the second impedance and the third impedance which vary depending on distances between the point of heart and the point to which each of the plurality of electrodes are attached;
determine a reference range for an increasing slope of a magnitude of the corrected biosignal based on a rate of increase in heart rate;
determine that a heart's health state of the object is an abnormal state when the increasing slope of the magnitude of the corrected biosignal is outside a reference range;
display a warning information indicating the heart's health state when heart's health state of the object is determined to be an abnormal state.
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, claim 1 recite an abstract idea of a mental process.
Claim 1 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 data device with a processor 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:
“Determining an average value of at least one of a plurality of waves, which are detected repeatedly and included in the biosignal as a magnitude of the biosignal.” A physician may take the average of a plurality of waves manually using mean equation.
“And generating a corrected biosignal by correcting a varying magnitude of the biosignal based on the first, the second and the third impedance values, wherein a corrected magnitude of the biosignal is corrected based on the first impedance value between the plurality of electrodes including impedances between each of the plurality of electrodes and the skin of the object and further corrected based on the second impedance and the third impedance which vary depending on distances between the point of heart and the point to which each of the plurality of electrodes are attached.” The physician can make the correction by using each of the impedance values separately, by using an impedance formula and filtering equations.
“Determine a reference range for an increasing slope of a magnitude of the corrected biosignal based on a rate of increase in heart rate.” A physician may determine a reference range based on a patient heart rate.
“Determine that a heart's health state of the object is an abnormal state when the increasing slope of the magnitude of the corrected biosignal is outside a reference range.” A physician may determine a patient health state by making a comparison between a corrected biosignal and a reference range.
“Display a warning information indicating the heart's health state when heart's health state of the object is determined to be an abnormal state.” A physician may give a diagnosis by displaying or vocalizing the health determination state of the patient.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial ‘
exception into a practical application?
Claim 1 recite the additional elements of a “plurality of electrodes”, “biosignal sensing circuit”, “impedance measuring circuit”, “amplifier”, “data receiving device”, “processor”, “memory”, “external device”, “receiving device”, “display” and a “communication unit”. The electrodes, biosignal sensing circuit, impedance measuring circuit, amplifier, transmitting data from receiving or external devices, display, and communication unit relate to the insignificant extra-solution activity of data gathering and diagnostics. The “data receiving device”, “processor”, “memory” and a “communication unit” is being interpreted as a processor of a generic data gathering device. 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. As discussed above with respect to integration of the abstract idea into a practical application, “plurality of electrodes”, “biosignal sensing circuit”, “impedance measuring circuit”, “amplifier”, “data receiving device”, “processor”, “memory”, “external device”, “receiving device”, “display” and a “communication unit”. The electrodes, biosignal sensing circuit, impedance measuring circuit, amplifier, transmitting data from receiving or external devices, display, and communication unit relate to the insignificant extra-solution activity of data gathering and diagnostics. The “data receiving device”, “processor”, “memory” and a “communication unit” is being interpreted as a processor of a generic data gathering device, respectively, as recited to perform the steps of:
determining an average value of at least one of a plurality of waves, which are detected repeatedly and included in the biosignal as a magnitude of the biosignal;
and generating a corrected biosignal by correcting a varying magnitude of the biosignal based on the first, the second and the third impedance values, wherein a corrected magnitude of the biosignal is corrected based on the first impedance value between the plurality of electrodes including impedances between each of the plurality of electrodes and the skin of the object and further corrected based on the second impedance and the third impedance which vary depending on distances between the point of heart and the point to which each of the plurality of electrodes are attached;
determine a reference range for an increasing slope of a magnitude of the corrected biosignal based on a rate of increase in heart rate;
determine that a heart's health state of the object is an abnormal state when the increasing slope of the magnitude of the corrected biosignal is outside a reference range;
display a warning information indicating the heart's health state when heart's health state of the object is determined to be an abnormal state.
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 also well‐understood, routine (For example HWANG et al. (U.S. Patent Application Publication Number: US 2015/0327815 A1, hereinafter Hwang) teaches a data gathering device that comprises the processor 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.
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 on (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