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 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.
Claim 11 (12 by dependency) is 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 11 (12 by dependency) recites “wherein at least one of an ECG measurement unit, a Doppler measurement unit, an ultrasound measurement unit, and a sound recording unit”. Examiner notes that this is an incomplete sentence. It is unclear what the claim is reciting.
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.
Claim(s) 1-8, 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gillberg et al. (US 2015/0157231 A1 - cited by Applicant), hereinafter Gillberg.
Regarding Claim 1 and 13, Gillberg teaches: An evaluation system and method for evaluating an estimate of a placement of implantable electrode poles of an implantable medical device, in particular of a subcutaneous implantable cardioverter defibrillator device (paragraph 0004, 0042), comprising;
an arrangement of at least two electrodes configured to be placed on a patient (figure 1, paragraph 0043), and
a measurement device comprising an excitation circuitry for generating an excitation signal for injection into the patient using said arrangement of electrodes (paragraph 0057), a sensing circuitry for sensing a sense signal in reaction to said excitation signal using said arrangement of electrodes (paragraph 0058), and a processing circuitry for processing said sense signal to identify said estimate of the placement of the implantable electrode poles of the implantable medical device (figures 1-2; paragraph 0052, 0131),
wherein the processing circuitry is configured to determine a characteristic value indicative of a cardiac motion based on said sense signal and to identify said estimate of the placement based on a comparison of characteristic values of different sense signals obtained, using said arrangement of electrodes, at different locations on the patient (paragraph 0048; 0068).
Regarding Claim 2, Gillberg teaches: The evaluation system according to claim 1, wherein said excitation circuitry is configured to inject said excitation signal into the patient using a first pair of electrodes of said arrangement of electrodes, and said sensing circuitry is configured to sense said sense signal using a second pair of electrodes of said arrangement of electrodes (paragraph 0110-0112; 0127-0129).
Regarding Claim 3, Gillberg teaches: The evaluation system according to claim 2, wherein said sensing circuitry is configured to sense said different sense signals using said second pair of electrodes at different relative locations of the electrodes of the second pair of electrodes (paragraph 0112, 0127-0129).
Regarding Claim 4, Gillberg teaches: The evaluation system according to claim 2, wherein said arrangement of electrodes, comprises a multiplicity of electrodes including a multiplicity of different second pairs of electrodes, wherein said sensing circuitry is configured to sense said different sense signals using different second pairs of electrodes at different relative locations of the electrodes of the second pairs of electrodes (paragraph 0112, 0127-0129).
Regarding Claim 5, Gillberg teaches: The evaluation system according to claim 4, wherein said multiplicity of electrodes is arranged on a carrier to be placed on the patient (figures 1-2B).
Regarding Claim 6, Gillberg teaches: The evaluation system according to claim 5, wherein said carrier comprises a visual indication device for visually indicating electrode locations associated with said placement of the implantable electrode poles of the implantable medical device (paragraph 0064; figure 1 shows a computer with a display).
Regarding Claim 7, Gilbert teaches: The evaluation system according to claim 1, wherein said excitation signal is a voltage signal and said sense signal is a current signal, or that said excitation signal is a current signal and said sense signal is a voltage signal (paragraph 0096).
Regarding Claim 8, Gillberg teaches: The evaluation system according to claim 1, wherein the processing circuitry is configured to derive a measurement signal indicative of an impedance signal from said excitation signal and said sense signal and to determine said characteristic value based on the measurement signal (paragraph 0096).
Regarding Claim 10, Gilberg teaches: The evaluation system according to claim 1, wherein the processing circuitry is configured to determine said characteristic value based on a maximum, a minimum, an integral, and/or a derivative of at least a portion of said sense signal or a signal derived from said sense signal (paragraph 0061).
Regarding Claim 11, Gillberg teaches: The evaluation system according to claim 1, wherein at least one of an ECG measurement unit, a Doppler measurement unit, an ultrasound measurement unit, and a sound recording unit (paragraph 0072).
Regarding Claim 12, Gillberg teaches: The evaluation system according to claim 11, wherein the processing circuitry is configured to identify at least one portion of said sense signal or a signal derived from said sense signal based on a physiological event identified using an output of said at least one of a ECG measurement unit, a Doppler measurement unit, an ultrasound measurement unit, and a sound recording unit (paragraph 0111).
Regarding Claim 14, Gilberg teaches: The evaluation system according to claim 13, wherein said different sense signals are sensed, using the sensing circuitry, in iterative measurements using said arrangement of electrodes (paragraph 0110).
Regarding Claim 15, Gilberg teaches: The evaluation system according to claim 13, wherein the estimate of the placement of the implantable electrode poles of the implantable medical device is identified to correspond to the locations of electrodes at which the largest characteristic value is obtained (paragraph 0048).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert in view of Penner (US 20100094376 A1).
Regarding Claim 9, Gilbert teaches: The evaluation system according to claim 1, but does not mention wherein said excitation circuitry is configured to generate said excitation signal in a frequency range between 0.01 Hz to 10 MHz, preferably in a range between 1 kHz to 100 KHz.
Penner teaches electrical stimulation of the body can range between 10-50 Hz (paragraph 0080). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system to include wherein said excitation circuitry is configured to generate said excitation signal in a frequency range between 0.01 Hz to 10 MHz, preferably in a range between 1 kHz to 100 KHz as the substitution of on stimulation parameter for another would have yielded predictable results to one of ordinary skill.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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