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 Amendment
The amendment filed 06 February 2026 has been entered. Claim(s) 1 and 13 are currently amended. Claims 1-21 are pending in the application.
Claim Objections
Claims 1-12, 14, and 16-21 are objected to because of the following informalities: the term “facility” in each of these claims has the potential to be interpreted as a physical building. Accordingly, examiner recommends changing the term “facility” to --device-- or another suitable structural term that cannot be interpreted as a physical building. Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “image capture unit,” “scan unit,” “drive unit,” and “computer unit” in claims 1, 3, 10-11, and 15-16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-2, 4-7, 10-11, 13-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brauers et al. (US PGPub No. 2008/0208063), hereinafter Brauers, in view of Shahparnia et al. (US PGPub No. 2018/0042556), hereinafter Shahparnia, and further in view of Crockford (US PGPub No. 2013/0245480).
Regarding claims 1 and 13, Brauers teaches a sensor selection facility for a differential voltage measurement system (Fig. 1 and par. 0026: “patient monitoring system 1 according to the present invention is adapted for an ECG measurement by means of capacitive measurement”),
the differential voltage measurement system including a signal measurement circuit for measuring bioelectrical signals with a number of signal paths and capacitive sensor electrodes for acquiring a measurement signal (Fig. 1: capacitive electrodes 2; par. 0026: “the system 1 comprises a number of capacitive non-contact electrodes 2 arranged in the form of a matrix 3 […] Each electrode 2 is individually selectable for carrying out a capacitive measurement by means of a control unit 5. The control unit 5 is connected to all electrodes 2 via a number of connecting lines”),
the sensor selection facility comprising processing circuitry configured to cause the sensor selection facility to, ascertain positions of the capacitive sensor electrodes relative to a body of the patient (par. 0034: “From the capacitance values of each electrode 2 the exact position of the patient is determined by means of the analyzing unit”);
and to define a combination strategy for combining the bioelectrical signals from the capacitive sensor electrodes based on the anticipated quality (par. 0034: “The process of selecting suitable electrodes 2 may include a preselection (according to the parameters described above) as well as a final selection, preferably taking into account the kind of measurement”).
Brauers does not explicitly teach wherein the combination strategy is defined before a measurement signal is received at the capacitive sensor electrodes. However, in an analogous art, Shahparnia teaches a sensor selection system and method comprising creating an image of a user’s body (Fig. 2G and par. 0048: “A controller or processor coupled to sense circuitry can form an image of the user's position and/or location on the mat (step 256 of process 250)”) and defining a combination strategy based on the image and an anticipated quality of measurement signals from electrodes, namely, the strategy of using measurement signals from the electrodes located directly underneath the user’s body with a higher anticipated quality (par. 0067: “the monitoring system can be configured such that measurements from the electrodes located directly underneath the user's body are included in the ECG measurement, since these electrodes can have higher coupling to the user's electrical impulses […] the electrodes located directly under the user's body can be effected by less movement than electrodes located in the immediate periphery (i.e., adjacent to the electrodes located directly under the body of the user) of the user's body”), wherein defining the combination strategy occurs before a measurement signal is received at the capacitive sensor electrodes (see Fig. 2G: steps of forming an image of the user’s body 256 and disabling/disconnecting unused electrodes 260 occurring before a ballistocardiograph measurement signal is taken at the electrodes 262; par. 0049: “The BCG measurement, taken in step 262 of process 250;” examiner interprets disabling electrodes in step 260 before a measurement being taken in step 262 as a combination strategy being defined before a measurement signal is received at the capacitive sensor electrodes).
Shahparnia teaches that disabling a number of electrodes (that is, defining a combination strategy prior to receiving a measurement signal at the electrodes) provides the advantage of conserving power (par. 0048: “the controller can disable or disconnect the drive and/or sense electrodes to conserve power, for example (step 260 of process 250)”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Brauers by configuring the processing circuitry to define the combination strategy before a measurement signal is received at the capacitive sensor electrodes, as taught by Shahparnia, in order to conserve power, as taught by Shahparnia.
Shahparnia further teaches an image capture unit (Fig. 1: camera 108) that can be used to acquire image data of a patient (par. 0038: “Camera 108 can be a video camera configured to perform one or more functionalities, including, but not limited to, determining the position of the user's body, determining the location of the user's body”), and the combined reference differs from the claimed invention only in that it does not explicitly teach wherein the image capture unit is used to create the image of the user’s body relative to the positions of the electrodes. However, in an analogous art, Crockford teaches a sensor selection facility comprising an image capture unit (Fig. 1: camera 131) that acquires image data of a patient, which is then used to create an image of a user’s body and ascertain positions of capacitive sensor electrodes relative to the patient (par. 0115: “The use of a camera 131 allows the position of the user's limbs on the mat relative to the electrodes to be monitored”). Crockford further teaches that using a camera in this way additionally allows movement artefacts to be removed from the measurement signal (par. 0115: “Artefacts in the signals from the electrodes that correspond to movement observed by the camera can be filtered from the signal using filtering algorithms well known in the art”).
One of ordinary skill in the art would have recognized that applying the known technique taught by Crockford (using an image capture image to generate an image of a user’s body relative to electrode positions) to the system of the combined reference would have yielded predictable results (in that the image data is generated one way or the other) and resulted in an improved system, since Crockford teaches that an image capture unit is additionally capable of monitoring movement artifacts.
The method limitations of claim 13 are also taught by the combination of Brauers in view of Shahparnia and Crockford because one using the device of the combined reference, as configured, would necessarily perform the method of claim 13.
Regarding claim 2, the combination teaches the device of claim 1 as described previously. Brauers further teaches wherein the processing circuitry is further configured to cause the sensor selection facility to select and switch on one or more among the capacitive sensor electrodes based on the anticipated quality (par. 0026: “Each electrode 2 is individually selectable for carrying out a capacitive measurement by means of a control unit 5” and par. 0034: “If suitable electrodes 2 have been determined and (pre)selected, the real capacitive ECG measurement is performed. The process of selecting suitable electrodes 2 may include a preselection (according to the parameters described above) as well as a final selection”).
Regarding claims 4 and 17, the combination teaches the devices of claims 1 and 2 as described previously. Brauers further teaches wherein the processing circuitry is configured to cause the sensor selection facility to: ascertain anatomical landmarks on the body and ascertain the positions of the capacitive sensor electrodes relative to the body based on positions of the anatomical landmarks (par. 0034: “From the position data it is even possible to determine the location of the patient's extremities. Thus electrodes 2 can preferably be selected according to their position relative to suitable measuring points of the patient's body, e.g. the lower end of an arm or the middle of the thorax”). Crockford further teaches that the image capture unit is capable of ascertaining anatomical landmarks on the body based on the image data (par. 0116: “The provision of a camera 131 may alternatively allow the control unit to adapt its processing of the acquired ECG signals in dependence on the position of the user's limbs as detected by the camera relative to the electrodes”), and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the image capture unit to perform the steps taught by Brauers, for the same reasons set forth in the rejection of claim 1.
Regarding claims 5-6 and 18-19, the combination teaches the devices of claims 1 and 2 as described previously. Brauers further teaches wherein the processing circuitry is configured to cause the sensor selection facility to combine the bioelectrical signals to obtain a combined aggregated signal such that the combined aggregate signal has at least a minimum signal quality or an optimum signal quality (par. 0027: “the system 1 is adapted to find out the most suitable electrodes 2 for carrying out the intended capacitive measurement” and par. 0031: “Thus the electrodes that show the best performance, e.g. in terms of signal coupling, can be determined”).
Regarding claims 7 and 20, the combination teaches the devices of claim 1 and 2 as described previously. Brauers does not explicitly teach wherein the processing circuitry is configured to cause the sensor selection facility to combine the bioelectrical signals in a weighted manner to generate an aggregate signal. However, Crockford further teaches combining signals from various electrodes in a weighted manner (par. 0128: “An average of the signals of a plurality of electrodes could be calculated for use as the electrode signal from the respective user interaction region. Preferably the average is a weighted mean”) in order to minimize noise and allow the system to cope with suboptimal placement of the patient’s body (par. 0128: “the outputs of two or more electrodes at each user interaction region can be combined so as to minimise the effect of noise and allow the system to cope with sub-optimal placement of the user's hands or feet on the mat […] the contribution having the greatest weight is from an electrode positioned such that it engages with thenar eminence or hypothenar eminence (in the case of a hand) or the heel of the foot (in the case of the foot). The weighting applied to these EP sensors which typically yield the best ECG signal is preferably at least 50% more than that of any other electrode”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by configuring the combination module to generate an aggregate signal by averaging the bioelectrical signals from the electrodes in a weighted mean, as taught by Crockford, in order to minimize noise and allow the system to cope with suboptimal placement of the patient’s body, as taught by Crockford.
Regarding claim 10, the combination teaches the device of claim 1 as described previously. Brauers does not explicitly teach wherein the processing circuitry is configured to cause the sensor selection facility to ascertain the combination strategy based on one of: movements of the patient, or operating status data of a scan unit of a medical imaging facility. However, Crockford further teaches determining a combination strategy based upon movements of a patient (par. 0115: “The camera could alternatively or additionally be used to identify movement of the user's hands such as tremors at the time of data acquisition. Artefacts in the signals from the electrodes that correspond to movement observed by the camera can be filtered from the signal using filtering algorithms well known in the art” and par. 0121: “when significant movement is detected by an accelerometer (or by the camera, as described above), variations in the signal from the corresponding electrode could be suppressed; and any periodic variations above a predetermined frequency (preferably around 30-100 Hz) present in both the output from the accelerometer and the electrode signal could be filtered from the electrode signal”), which reduces noise and improves the quality of the ECG signal (par. 0121: “Vibrations and movement of the user introduces noise into the signal detected by electrodes 303. […] the effect of this noise on the electrode signal can be mitigated and the quality of signal improved”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by configuring the combination module to determine the combination strategy based upon movements of the patient, as suggested by Crockford, in order to reduce noise and improve the ECG signal quality, as taught by Crockford.
Regarding claim 11, the combination teaches the device of claim 1 as described previously. Brauers further teaches a differential voltage measurement system (Fig. 1: patient monitoring system 1) comprising: at least one first electrode and one second electrode for measuring bioelectrical signals (Fig. 1: electrodes 2);
a measurement facility including a signal measurement circuit for measuring the bioelectrical signals and a drive unit for driving the at least one first electrode and the one second electrode according to a combination strategy defined by the sensor selection facility (Fig. 1: control unit 5; par. 0026: “Each electrode 2 is individually selectable for carrying out a capacitive measurement by means of a control unit 5. The control unit 5 is connected to all electrodes 2 via a number of connecting lines;” claim 7: “a control unit that selects electrodes for measurement of a patient parameter based on the determined position of the patient”).
Regarding claims 14-15, the combination teaches the method of claim 13 as described previously. Brauers further teaches a non-transitory computer program product with a computer program and a non-transitory computer-readable medium storing program parts of a computer program for carrying out the method of claim 13 when the program is executed (par. 0019: “an analyzing unit is preferably used, which analyzing unit comprises a computer adapted to execute a computer program […] Prior to execution the computer program is loaded into the computer by reading the computer program from the carrier, for example by means of a CD-ROM player, or from the internet, and storing it in the memory of the computer. The computer includes inter alia a central processor unit (CPU), a bus system, memory means, e. g. RAM or ROM, storage means, e. g. floppy disk or hard disk units and input/output units”).
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Brauers in view of Shahparnia and Crockford and further in view of Van Dam (WO 2021/242097).
Brauers in view of Shahparnia and Crockford teaches the devices of claims 1 and 2 as described previously. The combination does not explicitly wherein the image capture unit includes a 3D camera. However, in an analogous art, Van Dam teaches the use of a 3D camera for measuring positions of ECG electrodes (page 6, lines 30-31: “positions of the electrodes on the chest are measured with a 3D camera”), which provides the ability to increase reliability of the recorded results (page 4, lines 15-20: “relating a location of ECG leads relative to the model, preferably by means of measurement data from a 3D imaging device, such as a camera. With such steps, the placement may be controlled in order to improve the reliability of the results of performing this method”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the camera of the combined reference with the 3D camera of Van Dam in order to increase reliability of the recorded results, as taught by Van Dam.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Brauers in view of Shahparnia and Crockford and further in view of Aliamiri et al. (US PGPub No. 20190133468), hereinafter Aliamiri.
Brauers in view of Shahparnia and Crockford teaches the device of claim 1 as described previously but does not explicitly teach wherein the processing circuitry is configured to cause the sensor selection facility to: ascertain a combination of the bioelectrical signals using an algorithm based on artificial intelligence; or ascertain a second combination of the bioelectrical signals based on a parameterized model; or wherein the algorithm is trained using time series data as input parameters; or the parameterized model is adapted using the time series data.
However, in an analogous art, Aliamiri teaches a bioelectrical monitoring system that uses artificial-intelligence based analysis for quality assessment in signal processing (par. 0021: “a quality assessment network implemented by training an auxiliary convolutional neural network (CNN) using raw biological sensor signal as input to accurately assess the quality of signals collected from the biophysiological sensor, without manually constructing quality measurements” and par. 0038: “the quality assessment network 210 filters out PPG data sample segments with poor signal quality (node 214) and only allow the good signal quality PPG data sample segments (212) to move to the next stage”), including training the artificial-intelligence based analysis unit with time series data (par. 0052: “PPG data is collected from 19 patients with 1443 PPG segments collected by a wearable device. Each PPG segment contained 30 seconds of data with a sampling rate of 100 Hz resulting in 3000 samples per segment […] A quality index range from 1 (lowest quality) to 10 (highest quality) manually annotated by human experts also comes along with each PPG sample” and par. 0055: “the quality assessment network includes a multimodal neural network is designed which accepts two inputs, the preprocessed PPG signal with length of 30 seconds and the vigorous motion measure mentioned above, and predicts the probability of a signal being good quality or not. The motion variable is injected at the last stage along with learned features of PPG from convolutional layers. The model is trained by binary good-poor quality labels described above”).
Aliamiri teaches that training a quality assessment neural network allows a bioelectrical monitoring system to accurately filter out bad signals (par. 0066: “By training a quality assessment network, the system is capable of accurately filtering out bad signals”). It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of the combined reference to utilize an artificial-intelligence based analysis unit trained on time series data to assess the signal quality, as taught by Aliamiri, in order to make the system capable of accurately filtering out bad signals, as taught by Aliamiri.
Claims 12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Brauers in view of Shahparnia and Crockford and further in view of Berson (US Patent No. 6,073,039).
Brauers in view of Shahparnia and Crockford teaches the device of claim 11 as described previously but does not teach a medical imaging system, comprising a medical imaging facility and the differential voltage measurement system of claim 11, or further comprising a synchronization facility for synchronizing an imaging procedure of the medical imaging facility using the bioelectrical signals from the differential voltage measurement system. However, in an analogous art, Berson teaches a medical imaging system, comprising a medical imaging facility (col 1, line 49: “monitoring of the ECG during MRI procedures”) and a synchronization facility for synchronizing an imaging procedure of the medical imaging facility using the bioelectrical signals from a differential voltage measurement system (col 6, lines 4-8: “In addition, the ECG may be useful for timing the acquisition of the image from the MRI apparatus. For example, a processor (not shown) may be provided which receives the ECG and directs the MRI apparatus in the timing of the pulses sequences used to obtain the image”), which may provide a reliable method for imaging the heart at particular positions in the cardiac cycle (col 6, lines 8-14: “the processor may direct the MRI apparatus to initiate a sequence when a particular portion of the ECG has been received or at a predetermined time after that portion of the ECG. This can be used to provide a reliable method for imaging the heart at particular positions in the cardiac cycle”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the sensor selection facility of the combined reference with the medical imaging system and synchronization facility taught by Berson in order to provide a reliable method for imaging the heart at particular positions in the cardiac cycle, as taught by Berson.
Response to Arguments
Applicant’s arguments, filed 06 February 2026, with respect to the rejection(s) of claim(s) 1 and 13 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shahparnia. As described previously, Shahparnia teaches defining a combination strategy before a measurement signal is received at capacitive sensor electrodes.
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.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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