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 and amendments filed 5/4/2026 have been fully considered but they are not persuasive. The amended claim language “wherein the measurement unit is configured to reduce environmental noise such that the electrocardiac signal enables the non-linear analysis for calculating the Lyapunov exponent under the non-contact state” is worded in a way that amounts to mere intended use/result and does not impart any further structural limitations over the prior art. The Examiner recommends adding language that clarifies how the environmental noise is actively reduced. 2114 "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (see MPEP 2111.04 and 2114). The 103 rejection is maintained below.
Applicant’s arguments and amendments, see page 7, filed 5/4/2026, with respect to USC 112 have been fully considered and are persuasive. The 112 rejection of claims 8-18 has been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 8, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Veen (US 9603542 B2) in view of Wong (WO 2004/086967 A1).
Regarding claim 8, Veen discloses an electrocardiac signal analysis device comprising: a measurement unit that detects a heart rate of a subject and outputs an electrocardiac signal (eg. Abstract, Col. 17, Ln. 14-26, Col. 24, Ln. 19-36, Fig. 1, Col. 5, Ln. 35- Col. 6, Ln. 65, Col. 5, Ln. Fig. 5, Col. 8, Ln. 25-50, Col. 9, Ln. 10-40); and an analysis unit that analyzes the electrocardiac signal obtained from the measurement unit, wherein the measurement unit includes a pair of detection electrodes of a capacitive coupling type that detect a heart rate of a subject in a non-contact state and output the heart rate as primary signals (eg. Abstract, Col. 17, Ln. 14-26, Col. 24, Ln. 19-36, Fig. 1, Col. 5, Ln. 35- Col. 6, Ln. 65, Col. 5, Ln. Fig. 5, Col. 8, Ln. 25-50, Col. 9, Ln. 10-40), a pair of active guard circuits that reduce noise included in the primary signals and output secondary signals (eg. Col. 6, Ln. 25-35, Col. 12, Ln. 10-40, Col. 13, Ln. 55-61), an amplification means that amplifies a potential difference of the secondary signals and outputs an electrocardiac signal (eg. Col. 1, Ln. 50-Col. 2, Ln. 12, Fig. 1, Col. 5, Ln. 49-60, Fig. 5, Col. 8, Ln. 25-50, Col. 20, Ln. 4-Col. 21, Ln. 65), and a feedback electrode that is configured to remove an influence of an in-phase signal of the secondary signals (eg. Col. 1, Ln. 60 – Col. 2, Ln. 5, Col. 7, Ln. 30 – Col. 9, Ln. 10, Col. 11, Ln. 40 – Col. 13, Ln. 7, Col. 14, Ln. 60 – Col. 15, Ln. 7, Col. 19, Ln. 60 – Col. 20, Ln. 15), but does not disclose the analysis unit includes a linear analytical means that linearly analyzes the electrocardiac signal to calculate an autonomic nerve index, and a non-linear analytical means that nonlinearly analyzes the electrocardiac signal to calculate a Lyapunov exponent and does not explicitly disclose wherein the measurement unit is configured to reduce environmental noise such that the electrocardiac signal enables the non-linear analysis for calculating the Lyapunov exponent under the non-contact state.
Wong teaches an analysis unit with a linear analytical means (eg. Pgs. 28-31) and a nonlinear analytical means to calculate Lyapunov component (eg. Pgs. 5-6, 31-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Veen with the analysis as taught by Wong to provide improve more accurate diagnostic capabilities with short-term, chaotic signals (eg. Wong, Pgs. 7-8).
Regarding claim 11, the combined invention of Veen and Wong discloses the linear analytical means linearly analyzes a variation in an RRI that is an interval between R waves in the electrocardiac signal and calculates a ratio of a low frequency component (LF) to a high frequency component (HF) of a heart rate variability as the autonomic nerve index (eg. Wong, Pgs. 2-3, 15-16, 23-33).
Regarding claim 14, the combined invention of Veen and Wong discloses the non-linear analytical means performs a chaotic analysis on a variation in an electrocardiac signal or in an RRI that is an interval between R waves in the electrocardiac signal to calculate a Lyapunov exponent (eg. Wong Pgs. 5-6, 31-35).
Claim(s) 9-10, 12-13, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Veen (US 9603542 B2) in view of Wong (WO 2004/086967 A1) in view of Gargiulo (US 2011/0166434 A1).
Regarding claim 9, the combined invention of Veen and Wong discloses the measurement unit includes a low-pass filter that remove noise included in the electrocardiac signal amplified by the amplification means (Eg. Veen, Col. 12, Ln. 39-50, Col. 21, Ln. 24-Col. 22, Ln. 41) but does not disclose a high pass filter.
Gargiulo discloses an electrophysiological signal sensing system that uses a high pass filter (eg. Para. 35, 75-76, 81).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Veen and Wong with the high pass filter as taught by Gargiulo since high pass filters are common in the art for filtering out noise.
Regarding claim 10, the combined invention of Veen, Wong, and Gargiulo discloses the amplification means includes a first amplifier that receives the secondary signals output from the active guard circuits, and a second amplifier that further amplifies the signal amplified by the first amplifier, and the high-pass filter and the low-pass filter are disposed between the first amplifier and the second amplifier (eg. Veen, Fig. 1, amplifier 2 Col. 8, Ln. 4-Col. 9, Ln. 10, Col. 11, Ln. 30-Col. 12, Ln. 50, buffer amplifiers which can be placed in many ways, one of ordinary skill could place these at each side of other circuit stages as a common way to isolate each circuit stage and preventing a load from affecting signal sources and maintain signal integrity).
Regarding claim 12-13, the combined invention of Veen, Wong, and Gargiulo discloses the linear analytical means linearly analyzes a variation in an RRI that is an interval between R waves in the electrocardiac signal and calculates a ratio of a lowfrequency component (LF) to a high frequency component (HF) of a heart rate variability as the autonomic nerve index (eg. Wong, Pgs. 2-3, 15-16, 23-33).
Regarding claims 15-16, the combined invention of Veen, Wong, and Gargiulo discloses the non-linear analytical means performs a chaotic analysis on a variation in an electrocardiac signal or in an RRI that is an interval between R waves in the electrocardiac signal to calculate a Lyapunov exponent (eg. Wong Pgs. 5-6, 31-35).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Veen (US 9603542 B2) in view of Wong (WO 2004/086967 A1), further in view of Gargiulo (US 2011/0166434 A1), further in view of Blomqvist (US 2019/0099097 A1)
Regarding claim 17, the combined invention of Veen, Wong, and Gargiulo discloses the invention of claim 10, but does not disclose each active guard circuit includes a guard electrode paired with the detection electrode, and the detection electrode and the guard electrode are joined via an insulating layer to be integrated as an electrode unit.
Blomqvist teaches a sensor unit that uses a guard electrode and an insulating layer (eg. Fig. 1, Para. 36-39, 50-52, 57, 65-71).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Veen, Wong, and Gargiulo with the guard electrode and insulating layers to provide the predictable result of protecting the electrodes from environmental factors (Eg. Blomqvist, Para. 39).
Regarding claim 18, the combined invention of Veen, Wong, Gargiulo, and Blomqvist discloses an entire of the electrode unit including the detection electrode and the guard electrode is made of a flexible material (eg. Blomqvist Para. 42-43).
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 MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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