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 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 1-17, specifically independent claims 1 & 14, are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed to a physiological measurement device, which is a product. Therefore, the claim falls within a statutory category of invention.
Claim 14 is directed to a method. Therefore, the claim falls within a statutory category of invention.
Step 2A, prong 1:
Each of claims 1 & 14 recites the method steps of:
“…process/processing a digital signal representing an analog signal present at an electrode…”
“…calculate/calculating at least one vector signal from at least two processed digital signals…”
“…filter/filtering the digital signal based on a set of filter coefficients…”
“…calculate/calculating the set of filter coefficients based on the vector signal.”
Under the broadest interpretation, claims 1 & 14 recite a series of steps that are practically performable in the human mind. A human could process, filter and calculate two digital signals and calculate a vector signal from said two digital signals. In regards to claim 1, it would be practical, but for the recitation of the “signal combiner” and “processor” to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed signals.
Under the broadest reasonable interpretation, claims 1 & 14 recite method steps comprising mental processes (i.e. process/representing a digital signal) and mathematical concepts (i.e. filter, calculate). Thus, since claims 1 & 14 recite limitations that fall within the mental processes and mathematical concepts of abstract ideas, the claims are directed to an abstract idea.
Step 2A, prong 2:
Each claim as a whole fails to integrate the abstract idea into a practical application. Claim 1 and claim 14 recite the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application:
“…a signal combiner…” (data gathering, see MPEP 2106.05(g)).
“…a processor…” (mere instructions to apply an exception MPEP 2106.05(f)).
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 1 & 14 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The abiove claims are silent to providing any treatment at all to a patient.
Step 2B
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
The examiner also notes that the limitations of the dependent claims, claims 2-13 & 15-17, define calculating the set of filter coefficients, processing a digital signal, calculate multiple vector signals, etc. which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, the above dependent claims are directed to patient-ineligible subject matter.
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 3, 5-9 & 17 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.
Claim 3 recites the limitation "the unfiltered digital signal.” There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation " the measure constituting input variable of the target function.” There is insufficient antecedent basis for this limitation in the claim.
*claims 6-9 & 17 depend from claim 5.
Claim Rejections - 35 USC § 102
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 –
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) 1-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franck (EP 3372148).
Franck discloses:
1.
A physiological measurement device comprising a plurality of input channels, at least two of the input channels including a digital section configured to process a digital signal (d1, d2) representing an analog signal (e1, e2) present at an electrode assigned to the respective channel,
E.G. via the disclosed test signal 202/302 that can be connected to each of the N analog circuits 204/304, which create the response signal(s) from each channel via the disclosed ADC 206 in order to provide digital samples 208/308 for each channel {[0020]-[0021], [0026]-[0027] & (Fig 2 & 3)}.
and a signal combiner configured to calculate at least one vector signal (x) from at least two processed digital signals (df1, df2),
E.G. via the disclosed difference analyzer 310 that calculates the differential signals between channels providing calculated vector waves, wherein the differential signals further define the voltage difference measured between the electrodes and is also referred to as an ECG vector {[0012], [0027] & (Fig 3)}.
Note: The examiner is interpreting the disclosed difference analyzer 310 as being the claimed signal combiner.
wherein the digital section of at least one input channel comprises: a digital filter configured to filter the digital signal (d1, d2) based on a set of filter coefficients (Gi, G2), and a processor configured to calculate the set of filter coefficients 3(Gi, Go) based on the vector signal (x1).
E.G. via the disclosed digitally sampled response signal used to calculate parameters for individual filters that are applied to each ECG channel, for example coefficient parameters that are derived from the recorded responses, i.e. the calculated differential signal obtained from the difference analyzer 310, and used to create digital filters for the inputs of the electrode channels ([0014]-[0015]).
The examiner notes that Franck also discloses that said coefficients for the filters can be ‘derived’ based on the frontend circuitry of the ECG system, i.e. the difference analyzer 310, that provide the test signals to the ECG system [0015].
2.
The physiological measurement device according to claim 1, wherein calculating the set of filter coefficients comprises calculating at least one measure of a block of subsequent time domain samples of the vector signal (x).
E.G. via the disclosed filter parameters that are measured as a ration, i.e. common mode rejection ratio [0013], wherein said parameters are further utilized by the coefficient generator 216, ([0023]-[0025]).
3.
The physiological measurement device according to claim 1, wherein calculating the set of filter coefficients (G1, G2) is further based on the unfiltered digital signal (d1, d2).
E.G. via the disclosed coefficient parameters being derived from the recorded responded and used ‘to create digital filters’ for the inputs of the electrode channels [0014].
4.
The physiological measurement device according to claim 1, wherein calculating the set of filter coefficients is further based on a current set of filter coefficients (G1, G2)
and wherein calculating the set of filter coefficients (G1, G2) is performed repeatedly for each newly available sample of the digital signal (d1, d2) or for a block of multiple subsequent samples of the digital signal (d1, d2).
E.G. via the disclosed generator 216 using samples from each channel [0023].
5.
The physiological measurement device according to claim 1, wherein calculating the set of filter coefficients (G1, G2) comprise performing an optimization step, the measure constituting input variable of the target function.
E.G. via the disclosed use of a degree of common mode interference removal measured as a ratio, i.e. a common mode rejection ratio (CMRR) [0013].
Note: The applicant states that the common mode rejection behavior is gradually improved while the filter coefficients are successively adjusted [SPEC 0014], in which the ‘improvement’ step includes an optimization run. The examiner is interpreting the disclosed use of the CMRR as being the measure constituting input variable of the target function.
6.
The physiological measurement device according to claim 5, wherein the target function (CF) comprises a weighted sum of multiple measures (CF k).
E.G. ([0013]-[0014]).
7.
The physiological measurement device according to claim 5, wherein performing the optimization step is subject to at least one constraint related to a certain set of filter coefficients (Gi, G2).
E.G. ([0013]-[0014]).
8.
The physiological measurement device according to claim 5, wherein performing the optimization step is subject to at least one constraint related to a similarity measure characterizing a similarity of two different sets of filter coefficients (Gi, G2).
E.G. via the disclosed step of calculating coefficients for filtering signals associated with other channels to be similar, i.e. identical, [0017].
9.
The physiological measurement device according to claim 5, wherein the target function (CF) comprises the similarity measure characterizing a similarity of two different sets of filter coefficients.
E.G. [0017].
10
The physiological measurement device according to claim 1, wherein the digital section is configured to process a digital signal (di, d2) representing an analog signal (e1, e2) present at an electrode assigned to the respective channel and sensed from a patient during use of the device.
E.G. via the disclosed ECG device 108 associated with system that provides multiple channels and samples of ADC output data ([0017]-[0018]).
11.
The physiological measurement device according to claim 1, wherein the processors is configured to calculate multiple vector signals (x1, X2, X3, Xi) from the filtered digital signals (df1, df2, df2, dfi), wherein the digital section of one channel includes at most one digital filter.
E.G. via the disclosed equation (1) that illustrates a set of matrices [0024].
12.
The physiological measurement device according to claim 1, wherein the processor is configured to an indication (BI) from a back end and to determine the at least one measure and/or the target function based on the received indication.
E.G. via the disclosed use of a user interface [0009], which can assist in storing coefficients and used during the normal operation for filtering the electrophysiological signals ([0017]-[0018]).
13.
The physiological measurement device according to claim 1, wherein the signal combiner is configured to calculate the vector signal (x1) from a further vector signal (x3).
E.G. via the disclosed physiological measurements obtained that are indicative of the voltage difference between the electrodes attached to various locations on a person’s body [0012], which correspond to vectors between said electrodes [0018].
14.
A method for physiological measurement comprising processing at least two digital signals (di, d2) each representing an analog signal (e1, €2) present at an electrode assigned to a digital section of a respective one of a plurality of input channels of a physiological measurement device,
E.G. via the disclosed test signal 202/302 that can be connected to each of the N analog circuits 204/304, which create the response signal(s) from each channel via the disclosed ADC 206 in order to provide digital samples 208/308 for each channel {[0020]-[0021], [0026]-[0027] & (Fig 2 & 3)}.
wherein processing the digital signal (d1, d2) comprises digitally filtering the digital signal (d1, d2) of the respective input channel based on a set of filter coefficients (Gi, G2);
E.G. via the disclosed digitally sampled response signal used to calculate parameters for individual filters that are applied to each ECG channel, i.e. ECG channel that can refer to an ECG vector, and generate coefficients for said filters that can be applied during operation of the measurement device {[0014]-[0015], [0019], [0027] & (Figs. 2 & 3)}.
calculating at least one vector signal (x) from at least two processed digital signals (df1, df2);
E.G. via the disclosed difference analyzer 310 that calculates the differential signals between channels providing calculated vector waves, wherein the differential signals further define the voltage difference measured between the electrodes and is also referred to as an ECG vector {[0012], [0027] & (Fig 3)}.
Note: The examiner is interpreting the disclosed difference analyzer 310 as being the claimed signal combiner.
and calculating the set of filter coefficients (Gi, G2) based on the vector signal(x).
E.G. via the disclosed digitally sampled response signal used to calculate parameters for individual filters that are applied to each ECG channel, i.e. ECG channel that can refer to an ECG vector, and generate coefficients for said filters that can be applied during operation of the measurement device {[0014]-[0015], [0019], [0027] & (Figs. 2 & 3)}.
15.
A non-transitory computer readable medium that stores therein a computer program product which, when executed on a processor, causes the method as claimed in claim 14 to be performed.
E.G. via the disclosed system being ‘embodied’ as software [0019].
16.
The physiological measurement device according to claim 2, wherein the at least one measure is a statistical measure.
E.G. via the disclosed common mode rejection ratio [0013].
17.
The physiological measurement device according to claim 7, wherein performing the optimization step is subject to a constraint that includes at least one equality constraint and/or at least one inequality constraint.
E.G. ([0013]-[0014]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796