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 .
Amendment Entered
In response to the amendment filed on 12/15/2025, amended claims 40, 46, 50, 55, 74, 75 and 77 are entered. Claims 43, 57-70 and 72-73 have been withdrawn pursuant to an election of Species II (directed to a correction of baseline pressure) and Species A (directed to assessing intracranial pressure). Claims 40-78 remain pending in the application.
Response to Amendment
Applicant’s remarks and amendments with respect to the specification have been fully considered and overcome each and every objection previously set forth in the Non-Final Office Action mailed 07/15/2025. The objections and rejections are withdrawn in view of amendments to the specification.
Applicant’s remarks and amendments with respect to the rejection of claims 40, 50, and 56 under 35 U.S.C. 112(b) regarding insufficient antecedent basis (see pg. 17 of remarks) have been fully considered and overcome the rejection of record previously set forth in the Non-Final Office Action mailed 07/15/2025, in view of amendments to the claims.
Applicant’s remarks and amendments with respect to the rejection of claims 40, 50, and 56 under 35 U.S.C. 112(b) regarding insufficient antecedent basis (see pg. 17 of remarks) have been fully considered and overcome the rejection of record previously set forth in the Non-Final Office Action mailed 07/15/2025, in view of amendments to the claims.
Applicant’s remarks and amendments with respect to the rejection of claims 40, 46, 55, 74, 75, and 77 under 35 U.S.C. 112(b) regarding lack of clarity (see pg. 18 of remarks) have been fully considered and overcome the rejection of record previously set forth in the Non-Final Office Action mailed 07/15/2025, in view of amendments to the claims.
Applicant’s remarks and amendments with respect to the rejection of claims 40, 46, 55, 74, 75, and 77 under 35 U.S.C. 112(b) regarding the use of and/or (see pg. 18 of remarks) have been fully considered and overcome the rejection of record previously set forth in the Non-Final Office Action mailed 07/15/2025, in view of applicant arguments (see pg. 18 of remarks).
Additionally, Examiner acknowledges applicant’s note of interpretation of limitations under 35 U.S.C. 112(f) previously set forth in the Non-Final Office Action mailed 07/15/2025.
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 40 recites limitations invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structures, materials, or acts for performing the entire claimed functions and to clearly link the structures, materials, or acts to the functions.
Claim 40 recites “…an identifier unit configured to receive the pressure-related digital data from the signal converter and identify therefrom single pressure waves related to cardiac beat-induced pressure waves…” in lines 12-14. The disclosure fails to disclose any structure that performs the entire claimed function of receiving the pressure-related digital data from the signal converter and identifying from the received pressure-related digital data, single pressure waves related to cardiac-beat induced pressure waves, rendering the scope of the claim unclear.
Claims 40, 54 , and all claims dependent thereon, 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 40 recites “…a detector connected to an output of the identifier unit and configured to detect single pressure wave (SW.x)-related parameters, being one or more of single wave mean pressure (SW.meanP), and single wave amplitude (SW.dP)…” in lines 15-17. It appears “…one or more of single wave mean pressure (SW.meanP), and single wave amplitude (SW.dP)” is referring to “single pressure wave (SW.x)-related parameters”, as recited in claim 40. However, it is unclear whether the output of the identifier unit, or the single pressure wave-related parameters detected by the detector, is intended to be “one or more of” single wave mean pressure and single wave amplitude. This renders the scope of the claim unclear, as there is ambiguity regarding what data applicant intends to detect.
Claim 40 recites, “…calculate pressure stability levels (SW.x.PSL), each pressure stability level being created from consecutive single pressure waves having any one of the delta single pressure wave (dSW.x)-related parameters dSW.meanP and dSW.dP within a first set of thresholds…” in lines 24-26 and further recites “…each pressure stability level refers to an average of any one of the single pressure wave (SW.x)-related parameters SW.meanP and SW.dP…” in lines 28-29. It is unclear whether applicant intends for the pressure stability level recited in lines 28-29 to refer to an average of consecutive single pressure wave-related parameters, or if the determination of pressure stability level may use an average of any one of the single pressure wave-related parameters taken for non-consecutively sampled single pressure waves. This renders the scope of the claim unclear, as there is ambiguity regarding what data applicant intends to manipulate to calculate pressure stability level.
Claim 54 recites, “…the information provider device is configured to issue an alert based on an output from the pressure analyzer unit if parameters of a) and/or b) are outside the second set and/or the third set of thresholds…” in lines 1-4. There is insufficient antecedent basis for these limitations in the claim. It is unclear if the output from the pressure analyzer recited in claim 54 is the same output, or a different output than the output of the pressure analyzer unit recited in claim 50, from which claim 54 depends. This renders the scope of the claim unclear, as there is ambiguity regarding what output from the pressure analyzer applicant intends to use to issue an alert.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 40, 42, 47, 50-52, and 54-55 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2007/0276263 A1 to Eide.
Regarding independent claim 40, Eide discloses a system for assessing at least one pressure from inside a human body or at least one body cavity and stability of baseline pressure of at least one pressure sensor applied for sampling of continuous pressure signals originating from inside the body or body cavity (see [0004], “… a system for analyzing pressure-signals derivable from pressure measurements on or in a body of a human being or animal”, pressure measurement in a body of a human being (i.e., inside a human body). See also [0057], “… this invention is not limited to specific types of pressure signals, however, the signal has to be continuous for a given time sequence…”, continuous pressure signals), the system comprising:
the at least one pressure sensor configured to measure pressure signals from the human body or body cavity at specific intervals (see Fig. 12a and [0162], “…pressure signals from the pressure transducer 47 are further converted into pressure-related digital data with a time reference…”, measurement intervals of pressure signals)
a transfer means configured to transfer the pressure signals from the pressure sensor to a sampling unit, the sampling unit outputting sampled pressure signals (see Fig. 12a and [0162], “…excitation signal is applied from the transducer 47 to the sensor 46, and the sensor 46 gives back a new signal indicative of the pressure to the transducer 47…are further converted into pressure-related digital data with a time reference, and analyzed according to the invention within the processing unit 49…provides an output that gives a first control signal 50 to a regulator device 52…regulator 52 modifies the performance of the sensor-regulating device 48…sensor-regulating device modifies the mode by which the sensor/transducer is able to sample signals indicative of pressure”, transducer 47 (i.e., a transfer means) obtains pressure signals from pressure sensor 46, sends the obtained pressure signals to processor 49, which provides an output control signal 52 to regulating device 48 (i.e., a sampling unit) to control the sampling of pressure signals);
a signal converter in communication with the sampling unit and configured to perform conversion of sampled pressure signals, from the sampling unit, into pressure- related digital data with a time reference (see Fig. 12a and [0162], “…pressure signals from the pressure transducer 47 are further converted into pressure-related digital data with a time reference, and analyzed according to the invention within the processing unit 49”, transducer 47 (i.e., signal converter) converts pressure signals from pressure sensor 46 into digital signal data with time references, sends the digital data with time reference to processor 49, which provides output control signal 52 to regulating device 48 (i.e., in communication with sampling unit)));
an identifier unit configured to receive the pressure-related digital data from the signal converter (see Fig. 12a and [0162], “…pressure signals from the pressure transducer 47 are further converted into pressure-related digital data with a time reference, and analyzed according to the invention within the processing unit 49”, pressure data sent to processing unit 49 (i.e., identifier unit of processing unit 49)), and identify therefrom single pressure waves related to cardiac beat-induced pressure waves (see [0035], “… identify from said digital data single pressure waves related to one of: cardiac beat-induced pressure waves, artifacts, and a combination of cardiac beat-induced waves and artifacts…”, identification of single pressure waves related to cardiac-beat induced pressure waves);
a detector connected to an output of the identifier unit (see [0182], “…first control signal 50 from the processing unit 49 to the regulator 52 gives another second control signal 51 to the sensor-regulating device 48, further enabling the sensor-regulating device 48 for optimum single pressure wave 1 detection…”, first control signal 50 (i.e., detector of processing unit 49)) and configured to detect single pressure wave (SW.x)-related parameters (see [0092], “…sampling rate should be sufficient to detect the various single pressure wave parameters (i.e. Pmin, Pmax, ΔP, ΔT, and ΔP/ΔT”, detection of single wave parameters), the single pressure wave (SW.x)-related parameters being one or more of single wave mean pressure (SW.meanP), and single wave amplitude (SW.dP) (see [0028], “…single pressure wave amplitude (ΔP)…”, signal pressure wave amplitude is denoted as “(ΔP)”); and
a computing device connected to an output of the detector and configured to compute one or more of delta single pressure wave (dSW.x)-related parameters representing differences in single pressure wave (dSW.x)-related parameters being one or more of change in mean pressure (dSW.meanP), and change in amplitude (dSW.dP), between a consecutive number of single pressure waves (n-i;n) (see [0164], “…analysis of single wave 1 related parameters within said time sequences 11 is performed by a processing unit 49. For each time sequence 11 a number of single pressure wave 1 related parameters are computed…”, parameters calculated for a number of time sequences. See also [0125], “…differential curve of balanced position 26 shows for consecutive time sequences differences in balanced position of amplitude (ΔP)…”, differences in balanced positions of amplitude parameters of single waves (i.e., a change in amplitude) determined for consecutive time sequences (i.e., between a consecutive number of pressure waves)),
wherein a calculation unit is connected to an output of the computing device and configured to calculate pressure stability levels (SW.x.PSL), each pressure stability level being created from consecutive single pressure waves having any one of the delta single pressure wave (dSW.x)-related parameters dSW.meanP and dSW.dP within a first set of thresholds (see Fig. 2 and [0088], “…threshold value has to be larger than a given value… If the amplitudes (ΔP) 4…different from the pre-selected values, the pair is discarded…values which are calculated are amplitude (ΔP) (delta intracranial pressure expressed in mmHg) 4…”, difference in single pressure wave amplitude is calculated (i.e., delta of a single pressure wave amplitude parameter), calculated values are compared to predefined thresholds (i.e., a first set of thresholds), and values not meeting the parameters of the predefined threshold are discarded), the first set of thresholds referring to defined pressure ranges of any one of the parameters dSW.meanP and dSW.dP (see Fig. 2 and [0088], “Amplitude (ΔP) 4 must be between 1.0 and 35.0 mmHg…”, defined pressure range for difference in single wave amplitude (i.e., first set of thresholds)), wherein each pressure stability level refers to an average of any one of the single pressure wave (SW.x)-related parameters SW.meanP and SW.dP (see [0098], “Absolute mean pressure…for the whole time sequence, the sum of mean pressure for each individual single pressure wave during said time sequence is divided by the number of single waves…”, an absolute mean pressure (i.e., pressure stability level) is determined for each single pressure wave in a consecutive time sequence by averaging a single wave mean pressure parameter),
wherein a determination unit is connected to an output of the calculation unit and configured to determine pressure differences (SW.x.PSL.PD) between different pressure stability levels (n-i;n) (SW.x.PSL) (see Fig. 6a and [0125], “…differential plot 24 presents differences within identical time sequences for absolute mean pressure…”, differences in absolute mean pressure (i.e., pressure stability level) determined for single pressure waves in a consecutive time sequence) ,
wherein the pressure stability levels (SW.x.PSL) have definable time durations (SW.x.PSL.TD) relating to a time duration of the pressure stability levels (SW.x.PSL) (see Fig. 6a and [0125], “Time sequence for time sequence in the continuous series of time sequences, differences between the two pressure recordings were computed with regard to absolute mean pressure…differential plot 24 presents differences within identical time sequences for absolute mean pressure…”, differences in absolute mean pressure (i.e., pressure stability level) determined for single pressure waves in a consecutive time sequence, the time sequence related to the continuous series of single pressure wave (i.e., the time duration of pressure stability/instability)),
wherein a presentation unit is connected to an output of the determination unit and configured to present baseline pressure indicator (BPi) plots (see [0156] “…reference curves have been computed, indicating both normal and abnormal curves. Such reference curves may be shown on the display of the apparatus or on other monitor systems…”, reference curves (i.e., baseline pressure indicator plots) presented on display of apparatus), being created from the pressure stability levels (SW.x.PSL) and with beginning pressure differences and ending pressure differences (SW.x.PSL.PD) for each pressure stability level (SW.x.PSL) (see Fig. 6 and [0125], “…indicated the scale for differences in absolute mean pressure 23. The differential pressure curve 24 shows the trend distribution of differences in absolute pressure within identical time sequences…”, plots created from absolute mean pressure (i.e., pressure stability level) and differences in pressure level (i.e., from beginning of measurement to end of measurement of consecutive single wave pressures) shown), the beginning pressure difference being defined as a difference between a present pressure stability level and a previous pressure stability level and the ending pressure difference being defined as a difference between a present pressure stability level and a next pressure stability level (see Fig. 6 and [0125], “…plot within said differential plot 24 presents differences within identical time sequences for absolute mean pressure…”, difference between single wave pressure stability level between consecutive measured levels (i.e., beginning pressure difference between current and previous value of Fig. 6, and ending pressure difference between current and next value)),
wherein the BPi plots provide information about stability of baseline pressure of the pressure sensor (see Fig. 6 and [0125], “…indicated the scale for differences in absolute mean pressure 23. The differential pressure curve 24 shows the trend distribution of differences in absolute pressure within identical time sequences…”, plots show distribution of absolute mean pressure (i.e., pressure stability level)) and are a function of at least one of:
a) combinations of the pressure differences between different pressure stability levels (SW.x.PSL), calculated from a same type of single pressure wave (SW.x)-related parameters, the pressure differences being outside or inside a second set of thresholds, reflecting deviations from nominal reference pressure differences (see [0115], “…the single waves 1 with pre-selected characteristics of…amplitude 4 are computed, and the matrix 36 of single wave combinations computed, with presentation of the distribution of single wave combinations…numerical combinations 38 may be presented on the display of the apparatus… presentation on the display of monitoring systems is possible”, single pressure wave combinations determined for the same characteristic (i.e., amplitude difference) of a type of pressure wave. See also Figs. 6a-c, 9a-9d, and [0151], “…amplitudes of the single waves are computed as relative pressure differences”, differences in single pressure wave characteristic (i.e., amplitude difference) determined as relative differences (i.e., nominal reference pressure differences). See also [0057], “…Identification of correct…values are made by means of pre-determined thresholds for the single wave amplitude (ΔP)…”, parameter difference values compared to pre-determined thresholds (i.e., second set of thresholds), implying determining a nominal relative difference to a pre-determined threshold, where identification of a correct value is based on relationship of the measured parameter to the pre-determined threshold (i.e., reflecting deviations of the single wave parameter from the nominal reference by whether or not the measured parameter falls inside (correct) or outside (incorrect) of the pre-determined thresholds). See also Fig. 6 and [0125], “differences between computation of absolute mean pressure and single pressure wave parameters...differential pressure curve 24 shows the trend distribution of differences in absolute pressure within identical time sequences…”, plots created from combinations of absolute mean pressure levels (i.e., pressure stability levels) that reflect differences in pressure stability level as a deviation in a single wave parameter (i.e., difference in amplitude) interpreted as reflecting deviations from the measured single wave parameter from nominal reference pressure difference), and
b) relationships between different and simultaneous pressure stability levels (n-1; n) calculated from different types of single pressure wave (SW.x)-related parameters, the relationships being outside or inside a third set of thresholds, reflecting deviations from nominal reference relationships (claim 40 recites, “…wherein the BPI plots… are a function of at least one of.. a) and b)…”. See discussion above regarding a)), and wherein the presentation unit is configured to indicate if parameters of a) and/or b) are outside the second set and/or the third set of thresholds and thereby define instability of baseline pressure of the pressure sensor relationships sensor (see Eide [0109], “…Rejected portions of trend plot may be indicated by color of graph or background…”, presentation unit indicates whether or not portions of the plot are rejected (i.e., parameter a) is outside the second set of thresholds, indicative of instability of pressure sensor baseline pressure) using background color).
Regarding claim 42, Eide discloses the system as claimed in claim 40 above. Eide further discloses wherein the body cavity is a cranio-spinal cavity, and wherein the pressure sensor is configured to measure intracranial pressure (ICP) signals from the cranio-spinal cavity (see [0011], “…pressures in a human or animal body cavity relate to…intracranial pressure, cerebrospinal fluid pressure…analysis of pressure signals derivable from monitoring of single waves in blood vessels, the intracranial compartment, the cerebrospinal fluid (CSF) system…”, intracranial pressure signals measured in the intracranial compartment).
Regarding claim 47, Eide discloses the system as claimed in claim 40 above. Eide further discloses wherein the presentation unit is configured to issue an alert if parameters of a) and/or b) are outside the second set and/or the third set of thresholds, the alert being at least one of: a warning color of at least one part of the baseline pressure indicator plot shown on an output monitor screen of the presentation unit, a warning noise from the presentation unit, and a descriptive information displayed or printed by the presentation unit (see [0109], “…Rejected portions of trend plot may be indicated by color of graph or background…”, presentation unit indicates whether or not portions of the plot are rejected (i.e., parameter a)) is outside the second set of thresholds, indicative of instability of pressure sensor baseline pressure) using background color of BPi plot).
Regarding claim 50, Eide discloses the system as claimed in claim 40 above. Eide further discloses wherein the pressure to be assessed is intracranial pressure (ICP) in the human (see [0011], “…pressures in a human or animal body cavity relate to…intracranial pressure…”),
wherein the pressure sensor is insertable into a cranio-spinal cavity of the human or in communication with fluid of the cranio-spinal cavity (see [0011], “…analysis of pressure signals derivable from monitoring of single waves in blood vessels, the intracranial compartment, the cerebrospinal fluid (CSF) system…”, pressure sensor (see analysis of claim 40 above) insertable into intracranial compartment (i.e., cranio-spinal cavity) and in contact with cerebrospinal fluid), the pressure sensor being configured to measure ICP signals (see [0125], “…Intracranial pressure was measured simultaneously by…sensors located within the brain parenchyma…”, sensors measuring ICP), which represent differences in pressure between atmospheric pressure and pressure inside the cranio-spinal cavity (see [0157], “…pressures measured within brain parenchyma and epidurally are relative to atmospheric pressure, and represent absolute pressures…”, pressures of the ICP measured relative to atmospheric pressure (i.e., represent a difference between measured pressure inside the cranio-spinal cavity and atmospheric pressure)) , and
wherein a pressure analyzer unit is in communication with the pressure sensor (see Fig. 12a and [0162], “…pressure signals from the pressure transducer 47 are further converted into pressure-related digital data with a time reference, and analyzed according to the invention within the processing unit 49”, pressure signals from pressure transducer are sent to processing unit 49 for analysis (i.e., pressure analyzer unit within processing unit 49)), the pressure analyzer unit being configured to:
process and analyze the ICP signals from the pressure sensor (see Fig. 12a and [0162], “…pressure signals…analyzed according to the invention within the processing unit 49”, pressure data analyzed (i.e., analysis of pressure signals is indicative of the pressure signals also being processed) within processing unit 49 (i.e., analyzer unit within processing unit 49));
based on the processing and analyzing of the ICP signals (see [0125], “…Intracranial pressure was measured…”, based on Intracranial pressure analysis measurements), provide one or more baseline pressure indicator (BPi) plots created from pressure stability levels (SW.x.PSL) of definable time durations (SW.x.PSL.TD) (see Eide Fig. 6 and [0125], “…plot within said differential plot 24 presents differences within identical time sequences for absolute mean pressure…”, plot (i.e., Bpi plot) difference between single wave pressure stability level (i.e., absolute mean pressure) across identical time sequences (i.e., definable time durations)), calculated from single pressure wave (SW.x)-related parameters from a predefined number of single pressure waves having delta single pressure wave (dSW.x)-related parameters within a first set thresholds (see Fig. 2 and [0088], “…threshold value has to be larger than a given value… If the amplitudes (ΔP) 4…different from the pre-selected values, the pair is discarded…values which are calculated are amplitude (ΔP) (delta intracranial pressure expressed in mmHg) 4…”, difference in single pressure wave amplitude is calculated (i.e., delta of a single pressure wave amplitude parameter), calculated values are compared to predefined thresholds (i.e., a first set of thresholds), and values not meeting the parameters of the predefined threshold are discarded), the first set of thresholds referring to defined pressure ranges of any one of parameters dSW.meanP and dSW.dP (see Fig. 2 and [0088], “Amplitude (ΔP) 4 must be between 1.0 and 35.0 mmHg…”, defined pressure range for difference in single wave amplitude (i.e., first set of thresholds)), and with the beginning pressure differences and the ending pressure differences for each pressure stability level (SW.x.PSL.PD) (see Fig. 6 and [0125], “…indicated the scale for differences in absolute mean pressure 23. The differential pressure curve 24 shows the trend distribution of differences in absolute pressure within identical time sequences…”, plots created from absolute mean pressure (i.e., pressure stability level) and differences in pressure level (i.e., from beginning of measurement to end of measurement of consecutive single wave pressures) shown),
wherein the pressure analyzer unit has an outlet and an information provider device configured to output information about the stability of baseline pressure of the pressure sensor from the BPi plot (see Fig. 6 and [0125], “…indicated the scale for differences in absolute mean pressure 23. The differential pressure curve 24 shows the trend distribution of differences in absolute pressure within identical time sequences…”, plots show distribution of absolute mean pressure (i.e., pressure stability level of pressure sensor). See also [0162], “…analyzed according to the invention within the processing unit 49…analysis of single pressure waves provides an output that gives a first control signal 50 to a regulator device 52…”, pressure analyzer unit (i.e., of processing unit 49) provides an output (i.e., via an outlet) to regulator device). See also [0115], “…presentation on the display of monitoring systems…”, presenting analysis of pressure signals on a display (i.e., information provider) of device)), the information being the function of the at least one of:
a) the combinations of the pressure differences between different pressure stability levels (SW.x.PSL) (see [0115], “…the single waves 1 with pre-selected characteristics of…amplitude 4 are computed, and the matrix 36 of single wave combinations computed, with presentation of the distribution of single wave combinations…numerical combinations 38 may be presented on the display of the apparatus… presentation on the display of monitoring systems is possible”, single pressure wave combinations determined for the same characteristic (i.e., amplitude difference) of a type of pressure wave. See also Figs. 6a-c, 9a-9d, and [0151], “…amplitudes of the single waves are computed as relative pressure differences”, differences in single pressure wave characteristic (i.e., amplitude difference) determined as relative differences (i.e., nominal reference pressure differences). See also [0057], “…Identification of correct…values are made by means of pre-determined thresholds for the single wave amplitude (ΔP)…”, parameter difference values compared to pre-determined thresholds (i.e., second set of thresholds), implying determining a nominal relative difference to a pre-determined threshold, where identification of a correct value is based on relationship of the measured parameter to the pre-determined threshold (i.e., reflecting deviations of the single wave parameter from the nominal reference by whether or not the measured parameter falls inside (correct) or outside (incorrect) of the pre-determined thresholds). See also Fig. 6 and [0125], “differences between computation of absolute mean pressure and single pressure wave parameters...differential pressure curve 24 shows the trend distribution of differences in absolute pressure within identical time sequences…”, plots created from combinations of absolute mean pressure levels (i.e., pressure stability levels) that reflect differences in pressure stability level as a deviation in a single wave parameter (i.e., difference in amplitude) interpreted as reflecting deviations from the measured single wave parameter from nominal reference pressure difference), and
b) the relationships between the different and simultaneous pressure stability levels (n-1; n) wherein parameters of a) and/or b) outside the second and/or the third sets of thresholds define instability of baseline pressure of the pressure sensor (claim 50 recites, “…wherein the BPI plots… are a function of at least one of.. a) and b)…”. See discussion above regarding a)), and
wherein the information provider device is further configured to indicate if parameters of a) and/or b) are outside the second and/or the third sets of thresholds based on an output from the pressure analyzer unit (see [0109], “…Rejected portions of trend plot may be indicated by color of graph or background…”, information provider (i.e., display) indicates whether or not portions of the plot are rejected (i.e., parameter a) is outside the second set of thresholds, indicative of instability of pressure sensor baseline pressure) using background color).
Regarding claim 51, Eide discloses the system as claimed in claim 50/40 above. Eide further discloses, wherein the pressure sensor is configured to measure the ICP signals within one of: a cerebrospinal fluid compartment and a brain tissue compartment, inside or outside a dura of the cranio-spinal cavity (see [0011], “…pressures in a human or animal body cavity relate to…intracranial pressure, cerebrospinal fluid pressure…analysis of pressure signals derivable from monitoring of single waves in blood vessels, the intracranial compartment, the cerebrospinal fluid (CSF) system…”, intracranial pressure signals measured in the intracranial compartment).
Regarding claim 52, Eide discloses the system as claimed in claim 50/40 above. Eide further discloses, wherein the pressure sensor is one of: a solid ICP pressure sensor, a fiberoptic ICP pressure sensor, a fluid-based ICP pressure sensor, a fluid-based ICP pressure sensor being of a disposable pressure transducer type, an ICP air-pouch sensor, and an ICP air-pouch sensor being of an intraparenchymal probe type (see [0012], “…pressure related data may be derived…a continuous pressure signal is measured…Examples of such sensors are solid or fiber-optic mechanical sensors for invasive monitoring, and sensors for invasive monitoring of pressure within a fluid system such as…cerebrospinal fluid, …”, examples of a fluid based ICP sensor and a fiberoptic ICP pressure sensor).
Regarding claim 54, Eide discloses the system as claimed in claim 50/40 above. Eide further discloses, wherein the information provider device is configured to issue an alert based on an output from the pressure analyzer unit if parameters of a) and/or b) are outside the second set and/or the third set of thresholds, and thereby define the presence of instability of baseline pressure of the pressure sensor (see Eide [0109], “…Rejected portions of trend plot may be indicated by color of graph or background…”, information provider device (i.e., display) indicates whether or not portions of the plot are rejected (i.e., parameter a) is outside the second set of thresholds, indicative of instability of pressure sensor baseline pressure) using background color).
Regarding claim 55, Eide discloses the system as claimed in claim 54/50/40 above. Eide further discloses, wherein the alert comprises at least one of: a warning color of at least one part of the baseline indicator plot shown on an output monitor screen of the information provider, a warning noise from the information provider device, and a descriptive information from the information provider device (see Eide [0109], “…Rejected portions of trend plot may be indicated by color of graph or background…”, information provider device (i.e., display) indicates whether or not portions of the plot are rejected (i.e., parameter a) is outside the second set of thresholds, indicative of instability of pressure sensor baseline pressure) using background color (i.e., a warning color of part of the baseline indicator plot shown)).
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.
Claims 41, 44-46, 48-49, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Eide.
Regarding claim 41, Eide discloses the system as claimed in claim 40 above. Eide further discloses, a reference pressure scale (see [0096], “…pressure scales…refer to the absolute pressure levels that are relative to the atmospheric zero pressure level…”, computing absolute mean pressure (i.e., pressure stability level), computed with pressure measurements of pressure sensor 46, applies absolute pressure levels relative to absolute zero (i.e., reference pressure)).
However, Eide fails to disclose “…wherein the stability of baseline pressure refers to a stability of a reference pressure of the pressure sensor”. Although Eide does not explicitly disclose baseline pressure stability as stability of a reference pressure of a pressure sensor, Eide discloses determining stability of baseline pressure (see [0098]), and a reference pressure scale relative to absolute pressure (see [0096]).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the system disclosed by Eide to measure a stability of a reference pressure of the pressure sensor, for the purpose of calibrating the pressure sensor, as evidence by Eide (see [0008]).
Regarding claim 44, Eide discloses the system as claimed in claim 40 above. Eide further discloses, wherein the first set of thresholds relate to pressure ranges of dSW.x (see Fig. 2 and [0088], “…threshold value has to be larger than a given value… If the amplitudes (ΔP) 4…different from the pre-selected values, the pair is discarded…values which are calculated are amplitude (ΔP) (delta intracranial pressure expressed in mmHg) 4…”, difference in single pressure wave amplitude is calculated and compared to predefined thresholds (i.e., a first set of thresholds)), the second set of thresholds relate to pressure ranges of SW.x.PSL.PD of various time durations (SW.x.PSL.TD) of the same type of single pressure wave (SW.x)-related parameters (see [0115], “…the single waves 1 with pre-selected characteristics of…amplitude 4 are computed, and the matrix 36 of single wave combinations computed, with presentation of the distribution of single wave combinations…numerical combinations 38 may be presented on the display of the apparatus… presentation on the display of monitoring systems is possible”, single pressure wave combinations determined for the same characteristic (i.e., amplitude difference) of a type of pressure wave. See also Figs. 6a-c, 9a-9d, and [0151], “…amplitudes of the single waves are computed as relative pressure differences”, differences in single pressure wave characteristic. See also [0057], “…Identification of correct…values are made by means of pre-determined thresholds for the single wave amplitude (ΔP)…”, parameter difference values compared to pre-determined thresholds (i.e., second set of thresholds).
However, Eide fails to disclose “…the third set of thresholds relate to ratios for combinations of pressure stability levels (SW.x.PSL) of different types of single pressure wave (SW.x)-related parameters”.
Eide further discloses computing single pressure wave parameters as functions of two multiple single wave parameters (see [0151], “example of how one single pressure wave parameter may be expressed as a function of two other single pressure wave parameters…”).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Eide to have a third threshold (relating to ratios of combinations of pressure stability levels for different types of single pressure wave related parameters) for the purpose of determining relationships between single pressure wave parameters to determine influence of different single wave pressure parameters on each other, as evidence by Eide (see [0151]).
Regarding claim 45, Eide discloses the system as claimed in claim 40 above. Eide further discloses determining pressure differences between different pressure stability levels (SW.x.PSL.PD) (see Fig. 6a and [0125], “…differential plot 24 presents differences within identical time sequences for absolute mean pressure…”, differences in absolute mean pressure (i.e., pressure stability level) determined. Furthermore, Eide discloses computing sums and standard deviations of absolute mean pressures (see Eide [0137]-[0138], “…Absolute mean pressure for said time sequence 11, computed as the sum of absolute mean pressure… Standard deviation for mean pressure of mean pressure…”).
However, Eide fails to disclose “…wherein the pressure differences between different pressure stability levels (SW.x.PSL.PD) refer to differences in average pressure of the pressure stability levels (SW.x.PSL)”.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Eide to determine pressure differences between different pressure stability levels applying differences in average pressure of the pressure stability levels, for the purpose of accounting for all measured pressure signals in a measurement time, as evidence by Eide (see [0097]).
Regarding claim 46, Eide discloses the system as claimed in claim 40 above. Eide further discloses determining pressure differences between consecutive pressure waves for different pressure stability levels (SW.x.PSL.PD) (see Eide Fig. 6a and [0125], “…differential plot 24 presents differences within identical time sequences for absolute mean pressure…”, differences in absolute mean pressure (i.e., pressure stability level) determined for single pressure waves in a consecutive time sequence (i.e., nearby)), and selectable ranges in the second set of thresholds (the second set of thresholds discussed above regarding claim 71).
However, Eide fails to disclose wherein nearby pressure stability levels (SW.meanP.PSLn-1 versus SW.meanP.PSLn) are merged into one pressure stability level (SW.x.PSL) if pressure differences between different pressure stability levels (SW.x.PSL.PD) are within selectable ranges in the second set of thresholds.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Eide to merge nearby pressure stability levels (if pressure differences are within selectable ranges of the second set of thresholds) (relating to ratios of combinations of pressure stability levels for different types of single pressure wave related parameters), for the purpose of comparing relative pressure differences, as evidence by Eide (see [[0157]).
Regarding claims 48 and 49, Eide discloses the system as claimed in claim 40 above. Eide further discloses previously established measurements stored in a database (see Eide [0151], “…establish a database of individual pressure recordings that may provide a reliable relationship between the single pressure wave parameters…”) and establishing criteria to determine inclusion of single wave pressure measurements in determining relationships (see Eide [0151], “…selected criteria are established to determine whether or not an individual pressure recording may be included in determining the relationship between single pressure wave parameters”).
However, Eide fails to explicitly disclose wherein the second set of thresholds is created from previously established measurements and stored in a database and wherein the third set of thresholds is created from previously established measurements and stored in a database.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Eide to create the second and third thresholds using measurements established in a database, since it has been held that to provide a mechanical or automatic means to replace manual activity, which accomplishes the same result, is within the ambit of a person of ordinary skill in the art. See In re Venner, 120 USPQ 192 (CCPA 1958) (see MPEP § 2144.04).
Regarding claim 53, Eide discloses the system as claimed in claim 50/40 above. Eide further discloses wherein the first set of thresholds relate to pressure ranges of dSW.x (see Fig. 2 and [0088], “…threshold value has to be larger than a given value… If the amplitudes (ΔP) 4…different from the pre-selected values, the pair is discarded…values which are calculated are amplitude (ΔP) (delta intracranial pressure expressed in mmHg) 4…”, difference in single pressure wave amplitude is calculated and compared to predefined thresholds (i.e., a first set of thresholds)), the second set of thresholds relate to pressure ranges of SW.x.PSL.PD of various time durations (SW.x.PSL.TD) of the same type of single pressure wave (SW.x)-related parameters (see [0115], “…the single waves 1 with pre-selected characteristics of…amplitude 4 are computed, and the matrix 36 of single wave combinations computed, with presentation of the distribution of single wave combinations…numerical combinations 38 may be presented on the display of the apparatus… presentation on the display of monitoring systems is possible”, single pressure wave combinations determined for the same characteristic (i.e., amplitude difference) of a type of pressure wave. See also Figs. 6a-c, 9a-9d, and [0151], “…amplitudes of the single waves are computed as relative pressure differences”, differences in single pressure wave characteristic. See also [0057], “…Identification of correct…values are made by means of pre-determined thresholds for the single wave amplitude (ΔP)…”, parameter difference values compared to pre-determined thresholds (i.e., second set of thresholds).
However, Eide fails to disclose “…the third set of thresholds relate to ratios for combinations of pressure stability levels of different types of single pressure wave (SW.x)- related parameters”.
Eide further discloses computing single pressure wave parameters as functions of two multiple single wave parameters (see [0151], “example of how one single pressure wave parameter may be expressed as a function of two other single pressure wave parameters…”).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Eide to have a third threshold (relating to ratios of combinations of pressure stability levels for different types of single pressure wave related parameters) for the purpose of determining relationships between single pressure wave parameters to determine influence of different single wave pressure parameters on each other, as evidence by Eide (see [0151]).
Claims 56, 71, and 74-78 are rejected under 35 U.S.C. 103 as being unpatentable over Eide in view of US 2022/0257136 A1 to Hu et al. (“Hu”).
Regarding claim 56, Eide discloses the system as claimed in claim 50/40 above. Eide further discloses presenting pressure data (see Eide [0015], “…presented on the display of the apparatus, though this is no limitation of the scope of the invention. For example, presentation on the display of monitoring systems is possible”, presentation of pressure data on display, (i.e., output from information provider)).
However, Eide fails to disclose wherein the information output from the information provider device provides a basis for any subsequent correction of the ICP signals.
Hu teaches a system including an implantable apparatus for measuring intracranial pressure (see abstract) using barometric pressure sensing to compensate for pressure measured by a system (see [0113], “…electronics assembly 82 can include a barometric pressure sensing system that can be used to measure barometric conditions to compensate pressure measured by an implant…”). Additionally, Hu teaches the electronics assembly supports electronics for detecting, processing, and transmitting sensor data (see [0068]).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Eide to provide a basis for correction of ICP signals (based on information output from the information provider device), for the purpose of presenting a user with updated information during real-time monitoring, as evidence by Eide (see Eide [0015]).
Furthermore, one of ordinary skill in the art would have had predictable success combining Eide and Hu since both teachings relate to the same narrow field of endeavor, i.e., utilizing biosensors for assessment of intracranial pressure.
Regarding claim 71, Eide discloses the system as claimed in claim 50/40 above. Eide further discloses selection of data according to predefined criteria (see Eide [0094], “…single pressure waves 1 occurring between two time sequences are included in the first or second time sequence according to selected criteria”), computing mean pressure levels using pressure differences (see Eide Fig. 6 and [0125], “…indicated the scale for differences in absolute mean pressure 23. The differential pressure curve 24 shows the trend distribution of differences in absolute pressure within identical time sequences…”, plots show distribution of absolute mean pressure (i.e., pressure stability level)) and presenting pressure data (see Eide [0115], “…presented on the display of the apparatus, though this is no limitation of the scope of the invention. For example, presentation on the display of monitoring systems is possible”).
However, Eide fails to disclose a mean pressure correcting unit, for correcting pressure alterations caused by instability of baseline pressure of the at least one pressure sensor, is coupled to the determination unit and configured to correct the mean pressure (SW.meanP) levels related to the baseline pressure instability as a function of the pressure differences between different pressure stability levels (SW.x.PSL.PD), the corrections being selectable according to predefined criteria, and wherein the presentation unit is coupled to the mean pressure correcting unit and configured to present the corrected mean pressure.
Hu teaches a system including an implantable apparatus for measuring intracranial pressure (see abstract) with electronic circuitry including barometric pressure sensing to compensate for pressure measured by a system (see [0113], “…electronics assembly 82 can include a barometric pressure sensing system that can be used to measure barometric conditions to compensate pressure measured by an implant…”). Additionally, Hu teaches the electronics assembly supports electronics for detecting, processing, and transmitting sensor data (see [0068]).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify Eide to include a mean pressure correcting unit (coupled to the determination unit, described above regarding claim 40) to correct mean pressure levels related to instability of baseline pressure of a pressure sensor, for the purpose of compensating for barometric pressure differences, as evidence by Hu (see [0113]). Additionally, one of ordinary skill in the art would have had predictable success combining Eide and Hu since both teachings relate to the same narrow field of endeavor, i.e., utilizing biosensors for assessment of intracranial pressure.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Eide/Hu combination to make the correction of mean pressure levels selectable according to predefined criteria, for the purpose of decreasing measurement drift, as evidence by Hu (see [0005]).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to couple the presentation unit (of Eide) to the mean pressure correction unit of the Eide/Hu combination), since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1993).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Eide/Hu combination present the corrected mean pressure (on a presentation unit coupled to a mean pressure correcting unit), for the purpose of presenting a user with updated information during real-time monitoring, as evidence by Eide (see Eide [0015]).
Regarding claim 74, the Eide/Hu combination discloses the system as claimed in claim 71/40 above. Eide further discloses determining absolute mean pressure of single pressure waves (see [0017], “…absolute mean pressure for each identified single pressure wave (wavelength Pmin−Pmin) within said time sequence…”) and a reference pressure scale (see [0096], “…pressure scales…refer to the absolute pressure levels that are relative to the atmospheric zero pressure level…”, pressure measurements of pressure sensor 46, applies absolute pressure levels relative to absolute zero (i.e., atmospheric reference pressure)).
However, Eide fails to disclose “…wherein single wave mean pressure (SW.meanP) represents a static pressure relative to a reference pressure, the reference pressure being atmospheric pressure”. Although Eide does not explicitly disclose single wave mean pressure as a static pressure relative to a reference pressure, Eide discloses determining a single wave mean pressure within a specified time (see [0017]), and a reference pressure scale relative to absolute pressure (see [0096]).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the system disclosed by the Eide/Hu combination to represent single wave mean pressure as a static pressure relative to a reference pressure (i.e., atmospheric), for the purpose of identifying single pressure waves during a specified time period of continuous pressure monitoring, as evidence by Eide (see [0083]).
Regarding claim 75, the Eide/Hu combination discloses the system as claimed in claim 71/40 above. Eide further discloses determining pressure differences between consecutive pressure waves for different pressure stability levels (SW.x.PSL.PD) (see Eide Fig. 6a and [0125], “…differential plot 24 presents differences within identical time sequences for absolute mean pressure…”, differences in absolute mean pressure (i.e., pressure stability level) determined for single pressure waves in a consecutive time sequence (i.e., nearby)). The Eide/Hu combination further discloses selectable ranges in the second set of thresholds (the second set of thresholds of the Eide/Hu combination, discussed above regarding claim 71).
However, the Eide/Hu combination fails to disclose wherein nearby pressure stability levels(SW.meanP.PSLn-1 versus SW.meanP.PSLn) are merged into one pressure stability level (SW.x.PSL) if pressure differences between different pressure stability levels (SW.x.PSL.PD) are within selectable ranges in the second set of thresholds.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Eide/Hu combination to merge nearby pressure stability levels (if pressure differences are within selectable ranges of the second set of thresholds) (relating to ratios of combinations of pressure stability levels for different types of single pressure wave related parameters), for the purpose of comparing relative pressure differences, as evidence by Eide (see [[0157]).
Regarding claim 76, the Eide/Hu combination discloses the system as claimed in claim 71/40 above. Eide further discloses wherein the first set of thresholds relate to pressure ranges of dSW.x (see Fig. 2 and [0088], “…threshold value has to be larger than a given value… If the amplitudes (ΔP) 4…different from the pre-selected values, the pair is discarded…values which are calculated are amplitude (ΔP) (delta intracranial pressure expressed in mmHg) 4…”, difference in single pressure wave amplitude is calculated and compared to predefined thresholds (i.e., a first set of thresholds)), the second set of thresholds relate to pressure ranges of SW.x.PSL.PD of various time durations (SW.x.PSL.TD) of the same type of single pressure wave (SW.x)-related parameters (see [0115], “…the single waves 1 with pre-selected characteristics of…amplitude 4 are computed, and the matrix 36 of single wave combinations computed, with presentation of the distribution of single wave combinations…numerical combinations 38 may be presented on the display of the apparatus… presentation on the display of monitoring systems is possible”, single pressure wave combinations determined for the same characteristic (i.e., amplitude difference) of a type of pressure wave. See also Figs. 6a-c, 9a-9d, and [0151], “…amplitudes of the single waves are computed as relative pressure differences”, differences in single pressure wave characteristic. See also [0057], “…Identification of correct…values are made by means of pre-determined thresholds for the single wave amplitude (ΔP)…”, parameter difference values compared to pre-determined thresholds (i.e., second set of thresholds).
However, Eide fails to disclose “…the third set of thresholds relate to ratios for combinations of pressure stability levels (SW.x.PSL) of different types of single pressure wave (SW.x)-related parameters”.
Eide further discloses computing single pressure wave parameters as functions of two multiple single wave parameters (see [0151], “example of how one single pressure wave parameter may be expressed as a function of two other single pressure wave parameters…”).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Eide/Hu to have a third threshold (relating to ratios of combinations of pressure stability levels for different types of single pressure wave related parameters) for the purpose of determining relationships between single pressure wave parameters to determine influence of different single wave pressure parameters on each other, as evidence by Eide (see [0151]).
Regarding claim 77, the Eide/Hu combination discloses the system as claimed in claim 71/40 above. Eide further discloses wherein the presentation unit is configured to present the corrected mean pressure (SW.MeanPcor) (present the corrected mean pressure on a presentation unit coupled to a mean pressure correcting unit of the Eide/Hu combination, described above regarding claim 71)), as descriptive information (see Eide [0115], “…numerical value combinations 38 may be presented on the display of the apparatus…”, numerical value combinations indicative of descriptive information displayed), in addition to the measured mean pressure (SW.MeanP) (see Eide [0115], “…presented on the display of the apparatus, though this is no limitation of the scope of the invention. For example, presentation on the display of monitoring systems is possible”, presenting pressure data (i.e., measured mean pressure)).
Regarding claim 78, the Eide/Hu combination discloses the system as claimed in claim 71/40 above. Eide further discloses presenting mean pressure (see Eide [0115], “…presented on the display of the apparatus, though this is no limitation of the scope of the invention. For example, presentation on the display of monitoring systems is possible”) and a reference pressure scale (see [0096], “…pressure scales…refer to the absolute pressure levels that are relative to the atmospheric zero pressure level…”). Additionally, the Eide/Hu combination further discloses presenting corrected mean pressure (of the Eide/Hu combination, discussed above regarding claim 71).
However, the Eide/Hu combination fails to disclose wherein readings of the corrected mean pressure and any non-corrected mean pressure (meanP) are presented on a common pressure baseline.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Eide/Hu to present readings of corrected and non-corrected mean pressure (on a common baseline) for the purpose of presenting a user with updated information during real-time monitoring, as evidence by Eide (see [0015]).
Response to Arguments
Applicant's arguments filed 12/15/2025 regarding the rejection of claims 40, 54, and all claims dependent thereon, under 35 U.S.C. 112(b) have been fully considered but they are not persuasive.
Regarding the rejection of claim 40 for insufficient structure under 35 U.S.C. 112(f) interpretation (see pg. 17 of remarks), applicant argues that cited figures and associated portions of text provide additional details of various aspects of the “identifier unit” as recited in claim 40. This argument is not considered persuasive, because the disclosure fails to disclose any structure that performs the entire claimed function of both receiving the pressure-related digital data from the signal converter and identifying from the received pressure-related digital data single pressure waves related to cardiac-beat induced pressure waves, rendering the scope of the claim unclear. Therefore, the rejection of claim 40 under 35 U.S.C. 112(b) is maintained.
Regarding the rejection of claim 40 for lack of clarity under 35 U.S.C. 112(b) (see pg. 18 of remarks), applicant argues that claim 40 has been amended to address clarity issues raised. However, it is unclear whether the output of the identifier unit, or the single pressure wave-related parameters detected by the detector, is intended to be “one or more of” single wave mean pressure and single wave amplitude. Therefore, the rejection of claim 40 under 35 U.S.C. 112(b) is maintained.
Regarding the rejection of claim 54 for insufficient antecedent basis under 35 U.S.C. 112(b), in the arguments filed 12/15/2025, applicant does not address the rejection of claim 54 under 35 U.S.C. 112(b) regarding lack of antecedent basis set forth in the previously mailed Non-Final Office Action, and no claim amendments have been entered to address the rejection of claim 54 under 35 U.S.C. 112(b) regarding lack of antecedent basis. Therefore, the rejection of claim 54 under 35 U.S.C. 112(b) is maintained.
Applicant's arguments filed 12/15/2025 regarding the rejection of claims 40, 42, 47, 50-52, and 54-55 under 35 U.S.C. 102 have been fully considered but they are not persuasive.
Applicant argues that the prior art of record does not anticipate the recited features of amended independent claim 40 (see pg. 6-7 of remarks). This argument is considered not persuasive in view of the treatment of independent claim 40 above, as necessitated by amendment.
Applicant's arguments filed 12/15/2025 regarding the rejection of claims 41, 44-46, 48, 49, 53, 56, 71, and 74-78 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that Eide and Hu, taken individually or in combination, fail to teach or suggest the features recited in dependent claims 41, 44-46, 48-49, 53, 56, 71, and 74-78. In particular, applicant argues that Hu fails to cure the deficiencies of Eide.
This argument is considered not persuasive in view of the treatment of claims 41, 44-46, 48-49, 53, 56, 71, and 74-78, as necessitated by amendment. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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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/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
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