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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2024 has been entered.
Claims Pending
Applicant’s cancellation of claims 2 and 21 in the response filed 12/30/2024, previous cancellation of claims 5, 7-8, and 11, and previous withdrawal of claims 16-20 and 22-34 is acknowledged.
Claims 1, 3-4, 6, 9-10, 12-15, and 35 are the current claims hereby under examination
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 1, 3-4, 6, 9-10, 12-15, and 35 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 1 recites the limitations “if an artifact is present in the voiding volume sample data, including: comparing a morphology of a potential artifact to morphologies of known artifacts, and comparing a value of the voiding volume sample data before and after the potential artifact; and if an artifact is determined to be present in the voiding volume sample data and the value of the voiding volume sample data before the potential artifact is less than or equal to the volume sample data after the potential artifact, removing a portion of the voiding volume sample data that represents a detected artifact.”, which fails to effectively define the metes and bounds of the claim as it is unclear as to whether the conditions followed by each “if…” statement occur within the claim. As such, the claim is indefinite. For examination purposes, each “if…” statement will be interpreted as a “when…” statement.
Claim 1 recites the limitation “less than or equal to the volume sample data” in lines 14-15. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as -voiding volume sample data-.
Claim 13 recites the limitations “if the voiding volume sample data increases in amplitude and thereafter decreases into the trough and thereafter increases to reach the post baseline, the artifact is identified as a positive form artifact; and if the voiding volume sample data decreases in amplitude and thereafter increases to reach the post baseline, the artifact is identified as a negative form artifact.”, which fails to effectively define the metes and bounds of the claim as it is unclear as to whether the conditions followed by each “if…” statement occur within the claim. As such, the claim is indefinite. For examination purposes, each “if…” statement will be interpreted as a “when…” statement.
Claims 3-4, 6, 9-10, 12-15, and 35 are dependent on claim 1, and as such are also rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-4, 6, 9-10, 12-15, and 35 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards a judicial exception without significantly more. These claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception or that are sufficient to amount to significantly more than the judicial exception.
Step 1 of the subject matter eligibility test
Claim 1 is directed towards a method, which describes one of the four statutory categories of patentable subject matter.
Step 2A of the subject matter eligibility test
Prong 1: Claim 1 recites the abstract idea of a mental process as follows: “receiving voiding volume sample data representative of voiding volume sample data”, “calculating a slope of the voiding volume sample data”, “calculating an average slope”, “adjusting the slope by the average slope”, “if the calculated slope reaches a trigger threshold: determining if an artifact is present in the voiding volume sample data”, “comparing a morphology of a potential artifact to morphologies of known artifacts”, “comparing a value of the voiding volume sample data before and after the potential artifact”, “if an artifact is determined to be present in the voiding volume sample data and the value of the voiding volume sample data before the potential artifact is less than or equal to the volume sample data after the potential artifact, removing a portion of the voiding volume sample data that represents a detected artifact”
The receiving voiding volume sample data representative of voiding volume sample data, calculating a slope of the voiding volume sample data, calculating an average slope, adjusting the slope by the average slope, if the calculated slope reaches a trigger threshold: determining if an artifact is present in the voiding volume sample data, comparing a morphology of a potential artifact to morphologies of known artifacts, comparing a value of the voiding volume sample data before and after the potential artifact, and if an artifact is determined to be present in the voiding volume sample data and the value of the voiding volume sample data before the potential artifact is less than or equal to the volume sample data after the potential artifact, removing a portion of the voiding volume sample data that represents a detected artifact can be practically performed by the human mind, with the aid of a pen and paper, but for performance on a generic processor, in a computer environment, or merely using the computer as a tool to perform the steps.
A person of ordinary skill in the art could reasonably receive voiding volume sample data by being handed a piece of paper with the data on it. A person of ordinary skill in the art could reasonably calculate a slope of voiding volume sample data based on having a piece of paper with voiding volume sampled data. A person of ordinary skill in the art could reasonably adjust a slope by an average slope mentally, with a pen and paper, or with a generic computer. A person of ordinary skill in the art could reasonably determine if an artifact is present in voiding volume sample data based on having voiding volume sample data with a pen and paper or generic computer. A person of ordinary skill in the art could reasonably mentally compare a morphology of potential artifacts to known artifacts based on having a piece of paper with known artifacts. A person of ordinary skill in the art could reasonably compare a value of voiding volume sample data before and after an artifact based on having a piece of paper with voiding volume sample data with a pen and paper or generic computer. A person of ordinary skill in the art could reasonably remove a portion of voiding volume data that represents an artifact based on having a piece of paper with voiding volume sample data with a pen and paper or generic computer. There is currently nothing to suggest an undue level of complexity in the calculating, adjusting, determining, comparing, removing, or receiving steps. Therefore, a person would be able to practically be able to perform the calculating, adjusting, determining, comparing, and removing steps mentally or with the aid of pen and paper.
Prong Two: Claim 1 does not recite additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., a uroflowmeter device).
For claim 1. The additional elements merely serve to gather data to be used by the abstract idea. The uroflowmeter device is merely used as a pre-solution step of necessary data gathering to be used by the abstract idea. The uroflowmeter device is merely used as additional types data gathering. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing that is performed remains in the abstract realm, i.e. the gathered data is not used for a treatment or meaningful purpose. Additionally, there is no overall improvement to existing technology present. The mental process merely functions on generic computer elements that do not change the functionality of the device itself. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test for Claim 1:
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
A Uroflowmeter device as disclosed by Brohan (US Pub. No. 20080275366), hereinafter Brohan, “A uroflowmeter is a well-known device for measuring the rate of urine flow. Uroflowmeters that are commonly used today operate using one of three well-known methods: (1) a rotating disk method, (2) an electronic dipstick method, or (3) a gravimetric method.” (Par. 4) and Corcos (US Pub. No. 20050288608) hereinafter Corcos “A number of uroflowmeters are known in the art…” (Par. 5-7)
are all well-understood, routine, and conventional.
Claims 3-4, 6, 9-10, 12-15, and 35 do not include additional elements, alone or in combination that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) as all of the elements are directed to the further describing of the abstract idea, pre-solution activities, and computer implementation.
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely further describe the abstract idea:
calculating the average slope comprises using a least-squares best fit model (Claim 3),
wherein the trigger threshold comprises a lower slope value when the calculated slope is at or below 0 mL/s (Claim 4),
wherein an artifact comprises volumetric data comprising an event (Claim 6),
wherein removing a portion of voiding volume sample data that represents the detected artifact comprises interpolating voiding volume sample data from each side of the detected artifact (Claim 9),
applying a bandpass filter prior to calculating the slope of the voiding volume sample data (Claim 10),
determining a trigger, wherein the trigger is a point when the trigger threshold is reached (Claim 12),
determining a baseline, wherein the baseline is an area prior to a start of the potential artifact (Claim 12),
determining a post-baseline, wherein the post-baseline is an area after an end of the potential artifact (Claim 12),
determining a trough, wherein the trough is the lowest local minima bounded by the trigger and time after an event (Claim 12),
determining a post-peak, wherein the post-peak is the largest local maxima bounded by the trigger and the post-baseline (Claim 12),
determining an onset, wherein determining the onset comprises at least one of: locating a local minima or flat area in a span prior from a pre-peak that is less than 10% of a pre-peak amplitude from the baseline, wherein the located local minima or flat area is the onset, or locating a first point that is the steepest positive slope between the baseline and the trigger, then locating a second point that is the flattest point between the first point and the baseline, wherein the second point is the onset (Claim 12),
if the voiding volume sample data increases in amplitude and thereafter decreases into the trough and thereafter increases to reach the post baseline , the artifact is identified as a positive form artifact (Claim 13),
if the voiding volume sample data decreases in amplitude and thereafter increases to reach the post baseline, the artifact is identified as a negative form artifact (Claim 13),
determining a baseline delta, wherein the baseline delta is a difference between the baseline and the post-baseline; and if the baseline delta is above a certain value, then the potential artifact is determined to not be an artifact (Claim 14),
determining a peak-to-trough amplitude, wherein the peak-to-trough amplitude is a difference between the lowest and highest value between the baseline and the post-baseline, comparing the peak-to-trough amplitude to a baseline delta; and if the baseline delta value is higher than 15% of the peak-to-trough amplitude, determine that the potential artifact is not an artifact (Claim 15),
determining a duration of the potential artifact using a peak-to-peak amplitude based on a normalization of a baseline and wherein the removing a portion of the voiding volume sample data that represents a detected artifact further comprises removing the detected artifact based on the determined duration of the potential artifact (Claim 35).
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
A Uroflowmeter device as disclosed by Brohan and Corcos as indicated above.
are all well-understood, routine, and conventional.
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, data gathering, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements improves the functioning of a mobile device, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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 claims are generally directed towards a method of analyzing uroflowmeter data. The method comprises receiving data from a uroflowmeter device and calculating the slope of the sample data. If the slope reaches a trigger threshold, the method further involves determining if an artifact is present. If the artifact is determined to be present and a value of the sample data before the sample data is less than or equal to the value of the data after the artifact, the method further involves removing the detected artifact from the data.
Claim(s) 1, 3-4, 6, 9, 10, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oh (US Pub. No. 20200268302) hereinafter Oh, and further in view of Garcia (US Pub. No. 20140188402) hereinafter Garcia, and Axelrod (US Pub. No. 20170231521) hereinafter Axelrod.
Regarding claim 1, Oh discloses A method of providing uroflowmeter data (Abstract (“generating an output that includes information of one or more lower urinary tract dysfunction associated with the one or more identified urodynamic parameters.”)), the method comprising:
receiving volume sample (Par. 53, (“In embodiments, the physician may perform uroflowmetry with the patient placed in the standing or sitting position to measure the total amount of voided volume as well as the flow rate. FIGS. 2A and 2B show exemplary data from uroflowmetry for two different patients, respectively, according to embodiments of the present disclosure”)) data representative of volume sample data from a uroflowmeter device (Fig. 13, step 1302);
calculating a slope of the volume sample data (Par. 102, (“the diagnostic engine 1108 may extract features from the plots in 3A-3C to identify bladder compliance, where the features may include the slope of the curve 376 during the storage phase and the bladder volumes when the patient has the first sensation of filling,”)).
Modified Oh fails to explicitly disclose voiding volume.
However, Oh does teach in an alternate embodiment voiding volume (Par. 49, “In embodiments, other types of measuring devices may be used in place of the volume sensor 128. For instance, load cell (gravimetric) or rotating disc technologies may be used to measure the flow rate or voided volume. In another example, the dipstick method, which uses a capacitive technique, may be used to measure urine depth in the container 126. In yet another example, the drop spectrometry may be used to determine the flow rate by counting the rate of drops of urine leaving the meatus. In embodiments, the electrical signal from the volume sensor 128 may be transmitted through a wire or wireless communication channel and processed to determine the flow rate, flowmetric curve pattern, and the total voided volume of the patient.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Oh with an alternate embodiment of Oh to include voiding volume through the substitution of measured metrics as differing urodynamic studies are known in the art (Oh (Par. 7, 49)) and it would have yielded the predictable result of providing information regarding the bladder health of the patient.
Modified Oh fails to explicitly disclose calculating a slope of the voiding volume sample data, comprising: calculating an average slope; and adjusting the slope by the average slope.
However, Oh does disclose calculating a slope of volume sample data (Par. 102, (“the diagnostic engine 1108 may extract features from the plots in 3A-3C to identify bladder compliance, where the features may include the slope of the curve 376 during the storage phase and the bladder volumes when the patient has the first sensation of filling,”)).
Garcia teaches calculating an average slope (Par. 166, “regression techniques useful for determining statistical associations of data sets, such as, linear regression (e.g., Least Quantile of Squares ("LQS"), Least Trimmed of Squares ("LTS")), non-linear regression, rank correlation, least mean square fit, mean absolute deviation, and mean absolute relative difference, or the like may be used.”);
and adjusting the slope by the average slope (Par. 166, “regression techniques useful for determining statistical associations of data sets, such as, linear regression (e.g., Least Quantile of Squares ("LQS"), Least Trimmed of Squares ("LTS")), non-linear regression, rank correlation, least mean square fit, mean absolute deviation, and mean absolute relative difference, or the like may be used.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Oh with that of Garcia to include calculating a slope of the voiding volume sample data of Oh, comprising: calculating an average slope; and adjusting the slope by the average slope through the substitution of analysis techniques as differing data analysis techniques are known in the art (Garcia (Par. 166)) and it would have yielded the predictable result of improving data quality.
Modified Oh fails to explicitly disclose if the calculated slope reaches a trigger threshold: determining if an artifact is present in the voiding volume sample data, including: comparing a morphology of a potential artifact to morphologies of known artifacts, and comparing a value of the voiding volume sample data before and after the potential artifact; and if an artifact is determined to be present in the voiding volume sample data and the value of the voiding volume sample data before the potential artifact is less than or equal to the volume sample data after the potential artifact, remove a portion of the voiding volume sample data that represents a detected artifact.
However, Oh does teach voiding volume sample data (Par. 49, “In embodiments, other types of measuring devices may be used in place of the volume sensor 128. For instance, load cell (gravimetric) or rotating disc technologies may be used to measure the flow rate or voided volume. In another example, the dipstick method, which uses a capacitive technique, may be used to measure urine depth in the container 126. In yet another example, the drop spectrometry may be used to determine the flow rate by counting the rate of drops of urine leaving the meatus. In embodiments, the electrical signal from the volume sensor 128 may be transmitted through a wire or wireless communication channel and processed to determine the flow rate, flowmetric curve pattern, and the total voided volume of the patient.”).
Axelrod teaches if the calculated slope (Par. 33, (slope determination)) reaches a trigger threshold (Par. 18):
determining if an artifact is present in the volume sample data, including (Par. 20):
comparing a morphology of a potential artifact to morphologies of known artifacts (Par. 20,21), and
comparing a value of the volume sample data before and after the potential artifact (Par. 23,24); and
if an artifact is determined to be present in the volume sample data and the value of the volume sample data before the potential artifact is less than or equal to the volume sample data after the potential artifact (Par. 21, 24, (“if a region of the time series has a spectrum that is, overall, of higher intensity than the preceding and succeeding time periods over the entire region of interest in frequency”)), remove a portion of the volume sample data that represents a detected artifact (Par. 24, (“if a region of the time series has a spectrum that is, overall, of higher intensity than the preceding and succeeding time periods over the entire region of interest in frequency, and yet shows little or no structure comprised of peaks, but rather has the smooth characteristics such as are commonly referred to as “white noise” or “pink noise”, then it is likely that the time region is corrupted by artifacts and should be eliminated from the analysis.”)).
Oh, Garcia, and Axelrod are considered to be analogous art to the claimed invention as they are involved with the analysis of biological data.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Oh and Garcia with that of Axelrod to include if the calculated slope reaches a trigger threshold: determining if an artifact is present in the voiding volume sample data, including: comparing a morphology of a potential artifact to morphologies of known artifacts, and comparing a value of the voiding volume sample data before and after the potential artifact; and if an artifact is determined to be present in the voiding volume sample data and the value of the voiding volume sample data before the potential artifact is less than or equal to the volume sample data after the potential artifact, remove a portion of the voiding volume sample data that represents a detected artifact through the substitution of the artifact analysis of Oh with that of Axelrod (Oh (Par. 36)) as it would have yielded the predictable result of allowing multiple data channels to be examined at the same time (Axelrod (Par. 22)) and provide a clean data set as the output (Axelrod (Abstract)).
Regarding claim 3, modified Oh fails to explicitly disclose the limitations of the claim.
However, Garcia further teaches wherein calculating the average slope comprises using a leastsquares best fit model (Par. 118 (linear interpolation of the data values)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Oh, Garcia, and Axelrod with that of Garcia to include wherein calculating the average slope comprises using a leastsquares best fit model through the substitution of analysis techniques as differing data analysis techniques are known in the art (Garcia (Par. 166)) and it would have yielded the predictable result of improving data quality.
Regarding claim 4, modified Oh fails to explicitly disclose the limitations of the claim.
However, Axelrod further teaches wherein the trigger threshold comprises a lower slope value when the calculated slope is at or below 0 ml/s (Par. 33, (“In various embodiments of the method, artifacts and aberrant data patterns may include any one or more of peaks, peak edges, or excessive slopes that are aberrant in comparison with previously acquired data sets.”) (Fig. 9, (observable that there is an artifact going in the direction of having a negative slope)).
Therefore, it would have been further obvious to modify the method of Oh, Garcia, and Axelrod with that of Axelrod to include wherein the trigger threshold comprises a lower slope value when the calculated slope is at or below 0 ml/s through the combination of references as it would have yielded the predictable result of factoring in previous data to ensure the most optimal analysis (Axelrod (Par. 33).
Regarding claim 6, modified Oh further discloses wherein an artifact comprises volumetric data comprising an event (Par. 42), but fails to explicitly disclose the rest of the limitations.
However, Axelrod further teaches wherein the event comprises at least one of: a door opening, a door closing, an HVAC system running, footsteps, and mechanical vibrations (Par. 113).
Therefore, it would have been further obvious to modify the method of Oh, Garcia, and Axelrod with that of Axelrod to include wherein the event comprises at least one of: a door opening, a door closing, an HVAC system running, footsteps, and mechanical vibrations through the substitution of artifact events as it would have yielded the predictable result of identifying artifacts that are caused by the user themselves that may impact the data.
Regarding claim 9, modified Oh fails to explicitly disclose the limitations of the claim.
However, Axelrod teaches wherein removing the portion of volume sample data which represents the detected artifact comprises interpolating volume sample data from each side of the detected artifact (Par. 23).
Therefore, it would have been further obvious to modify the method of Oh, Garcia, and Axelrod with that of Axelrod to include wherein removing the portion of voiding volume sample data which represents the detected artifact comprises interpolating voiding volume sample data from each side of the detected artifact for the reasoning as indicated in claim 1 above.
Regarding claim 10, modified Oh fails to explicitly disclose the limitations of the claim.
However, Axelrod teaches further comprising applying a bandpass filter prior to calculating the slope of the volume sample data (Par. 13).
Therefore, it would have been further obvious to modify the method of Oh, Garcia, and Axelrod with that of Axelrod to include further comprising applying a bandpass filter prior to calculating the slope of the voiding volume sample data through the combination of references as it would have yielded the predictable result of processing and cleaning the raw dataset prior to analysis.
Regarding claim 12, modified Oh fails to explicitly disclose the limitations of the claim.
However, Axelrod teaches wherein determining if an artifact is present in the volume sample data comprises:
determining a trigger, wherein the trigger is a point when the trigger threshold is reached (As indicated in modified Fig. 9 below);
determining a baseline, wherein the baseline is an area prior to a start of the potential artifact (As indicated in modified Fig. 9 below);
determining a post-baseline, wherein the post-baseline is an area after an end of the potential artifact (As indicated in modified Fig. 9 below);
determining a trough, wherein the trough is the lowest local minima bounded by the trigger and time after an event (As indicated in modified Fig. 9 below);
determining a post peak, wherein the post-peak is the largest local maxima bounded by the trigger and the post-baseline(As indicated in modified Fig. 9 below); and
determining an onset, wherein determining the onset comprises at least one of:
locating a local minima or flat area in a span prior from a pre-peak that is less than 10% of a pre-peak amplitude from the baseline, wherein the located local minima or flat area is the onset (As indicated in modified Fig. 9 below) (Fig. 9 (the onset is even with the baseline)), or
locating a first point that is the steepest positive slope between the baseline and the trigger, then locating a second point that is the flattest point between the first point and the baseline, wherein the second point is the onset.
Therefore, it would have been further obvious to modify the method of Oh, Garcia, and Axelrod with that of Axelrod to include wherein determining if an artifact is present in the voiding volume sample data comprises: determining a trigger, wherein the trigger is a point when the trigger threshold is reached; determining a baseline, wherein the baseline is an area prior to a start of the potential artifact; determining a post-baseline, wherein the post-baseline is an area after an end of the potential artifact; determining a trough, wherein the trough is the lowest local minima bounded by the trigger and time after an event; determining a post peak, wherein the post-peak is the largest local maxima bounded by the trigger and the post-baseline; and determining an onset, wherein determining the onset comprises at least one of: locating a local minima or flat area in a span prior from a pre-peak that is less than 10% of a pre-peak amplitude from the baseline, wherein the located local minima or flat area is the onset , or locating a first point that is the steepest positive slope between the baseline and the trigger, then locating a second point that is the flattest point between the first point and the baseline, wherein the second point is the onset through the combination of references as artifact shapes are known in the art (Axelrod (Par. 20)) and it would have yielded the predictable result of recognizing the exact type of artifact (Axelrod (Par. 20)).
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Axelrod (Modified Fig. 9)
Regarding claim 13, modified Oh fails to explicitly disclose the limitations of the claim.
However, Axelrod further teaches if the volume sample data increases in amplitude and thereafter decreases into the trough and thereafter increases to reach the post baseline, the artifact is identified as a positive form artifact (Fig. 9, artifact on the left (observable that the artifact increases, then goes into the trough and that the post baseline level is higher than the trough)); and
if the volume sample data decreases in amplitude and thereafter increases to reach the post baseline, the artifact is identified as a negative form artifact (Fig. 9, artifact on right (observable that the artifact line decreases and then increases to a post baseline level)).
Therefore, it would have been further obvious to modify the method of Oh, Garcia, and Axelrod with that of Axelrod to include if the voiding volume sample data increases in amplitude and thereafter decreases into the trough and thereafter increases to reach the post baseline, the artifact is identified as a positive form artifact; and if the voiding volume sample data decreases in amplitude and thereafter increases to reach the post baseline, the artifact is identified as a negative form artifact through the combination of references as negative and positive form artifacts are artifact shapes that are known (Axelrod (Par. 20, Fig. 9)) and it would have yielded predictable results as indicated in claim 12 above.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable Oh in view of Garcia and Axelrod as applied to claim 12 above, and further in view of Coyle (US Pub. No. 20050119586) hereinafter Coyle
Oh, Garcia, and Axelrod teach the method of claim 12 above.
Regarding claim 14, modified Oh fails to explicitly disclose the limitations of the claim.
However, Coyle teaches determining a baseline delta, wherein the baseline delta is a difference between the baseline and the post-baseline (Par. 91 (comparison of baseline before and after)); and if the baseline delta is above a certain value, then the potential artifact is determined to not be an artifact (Par. 83, “True breath rule”).
Oh, Garcia, Axelrod, and Coyle are considered to be analogous art to the claimed invention as they are involved with biological data analysis.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Oh, Garcia, and Axelrod with that of Coyle to include determining a baseline delta, wherein the baseline delta is the difference between the baseline and the post-baseline; and if the baseline delta is above a certain value, then the potential artifact is determined to not be an artifact through the combination of references as it would have yielded the predictable result of ensuring that the data collection is of the desired parameters (Coyle (Claim 47)).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oh, Garcia, Axelrod, and Coyle as applied to claim 14 above, and further in view of Navakatikyan (US Pub. No. 20080228100) hereinafter Navakatikyan.
Oh, Garcia, Axelrod, and Coyle teach the method of claim 14 above.
Regarding claim 15, modified Oh fails to explicitly disclose the limitations of the claim.
However, Navakatikyan teaches determining a peak-to-trough amplitude, wherein the peak-to-trough amplitude is a difference between the lowest and highest value between the baseline and the post-baseline (Par. 164, Fig. 5A-B);
comparing the peak-to-trough amplitude to the baseline delta (Par. 164).
Oh, Garcia, Axelrod, Coyle, and Navakatikyan are considered to be analogous art to the claimed invention as they are involved with biological data analysis.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Oh, Garcia, Axelrod, and Coyle with that of Navakatikyan to include determining a peak-to-trough amplitude, wherein the peak-to-trough amplitude is a difference between the lowest and highest value between the baseline and the post-baseline; comparing the peak-to-trough amplitude to the baseline delta through the combination of references as these are quantifications of recognized events (Navakatikyan (Par. 164)) would have yielded the predictable result of quantifying key data points in the graph (Navakatikyan (Par. 164)).
Coyle further teaches if the baseline delta (Par. 83 (Predetermined threshold)) value is higher than 15% of the peak-to-tough amplitude, determine that the potential artifact is not an artifact (Claim 47, Par. 83 (determination of the absence of an artifact if volume is less than 25% a predetermined threshold)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Oh, Garcia, Axelrod, Coyle, and Navakatikyan with that of Coyle to include teaches if the baseline delta value is higher than 15% of the peak-to-tough amplitude, determine that the potential artifact is not an artifact for the reasoning as indicated in claim 14 above.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oh in view of Garcia and Axelrod as applied to claim 1 above, and further in view of Navakatikyan.
Oh, Garcia, and Axelrod teach the method of claim 1 above.
Regarding claim 35, modified Oh fails to explicitly disclose further comprising determining a duration of the potential artifact using a peak-to-peak amplitude based on a normalization of a baseline.
However, Navakatikyan teaches further comprising determining a duration using a peak-to-peak amplitude (Par. 164, (quantification of peak to peak time of the wave recorded)) based on a normalization of a baseline (Par. 164 (lift by a constant amount)).
Oh, Garcia, Axelrod, and Navakatikyan are considered to be analogous art to the claimed invention as they are involved with biological data analysis.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Oh, Garcia, and Axelrod with that of Navakatikyan to include further comprising determining a duration of the potential artifact of Axelrod using a peak-to-peak amplitude based on a normalization of a baseline through the combination of references as normalization is needed for comparison between subjects (Axelrod (Par. 121)) and these quantifications of recognized events (Navakatikyan (Par. 164)) would have yielded the predictable result of quantifying key data points in the graph (Navakatikyan (Par. 164)) for the user. Modified Oh fails to explicitly disclose and wherein the removing a portion of the voiding volume sample data that represents a detected artifact further comprises removing the detected artifact based on the determined duration of the potential artifact.
However, Axelrod further teaches and wherein the removing a portion of the volume sample data that represents a detected artifact further comprises removing the detected artifact based on the determined potential artifact (Par. 24, (“if a region of the time series has a spectrum that is, overall, of higher intensity than the preceding and succeeding time periods over the entire region of interest in frequency, and yet shows little or no structure comprised of peaks, but rather has the smooth characteristics such as are commonly referred to as “white noise” or “pink noise”, then it is likely that the time region is corrupted by artifacts and should be eliminated from the analysis.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Oh, Garcia, Axelrod, and Navakatikyan with that of Axelrod to include wherein the removing a portion of the voiding volume sample data that represents a detected artifact further comprises removing the detected artifact based on the determined duration of the potential artifact of Navakatikyan through the combination of references as it would have yielded the predictable result of allowing multiple data channels to be examined at the same time (Axelrod (Par. 22)) and provide a clean data set as the output (Axelrod (Abstract)).
Response to Arguments
Applicant's arguments filed 12/30/2024, regarding the previous 103 rejection, have been fully considered and are deemed as not persuasive.
The applicant’s arguments, that the prior art does not teach the added limitation regarding the average slope, has been fully considered and deemed as somewhat persuasive. As a result, the rejection has been modified with the use of Garcia as indicated in the 103 rejection above.
The applicant's argument, that the prior art does not teach the added voiding measurements, have been fully considered and deemed as not persuasive. As the limitation was not previously addressed, the limitation has been addressed in the 103 rejection as indicated above.
In response to the applicant's argument in regards to claim 1, that Axelrod is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Axelrod directly involves the removal and replacement of artifacts in biological data, and as such is considered to be analogous art to the claimed invention.
The applicant’s arguments in regard to claim 1, stating that there is no motivation behind the substitution of the artifact analysis of Oh and Axelrod is not persuasive. As stated above, the substitution of the artifact Analysis of Oh with that of Axelrod would have yielded the predictable result of allowing multiple data channels to be examined at the same time (Axelrod (Par. 22)) and provide a clean data set as the output (Axelrod (Abstract)).
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).
The applicant’s arguments, regarding the dependent claims, have been fully considered, and deemed as not persuasive, as simply stating that the prior art reference does not teach the indicated claim limitation does not amount to a sufficient argument.
The applicant’s arguments regarding the dependent claims, rely on the arguments related to the independent claim, and as such are also deemed as not persuasive.
Conclusion
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/ARI SINGH KANE PADDA/ Examiner, Art Unit 3791
/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791
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