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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claims recite amplification means, linear, and non-linear analytical means, which the Examiner interprets as amplifier circuits and a processor.
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 8-14 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.
Regarding claim 8, it is unclear whether the analytical means are the same processor or are separate processor parts. Further clarification is required.
Claims 9-15 depend on claim 8 and do not remedy the issues, therefore are also rejected.
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.
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
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/MICHAEL J LAU/Examiner, Art Unit 3796