DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment/Argument
Amendment and argument filed on 07/16/2026 is considered. Applicants amended independent claims 19, 35, 36.
Claim rejection under 35 U.S.C 112 (b): Applicant amended independent claims clears the unclear term. The rejection is withdrawn.
Claim rejection under 35 U.S.C 102/103: Further search and consideration found prior arts Jacobs et al US 20120042214 A1, Seki et al US 20100317538 A1 and Kamath et al US 20120203467 A1. The combination of these of prior arts are applied to address the amended independent and dependent claims. Please see claim rejections below.
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.
Claim(s) 19-21, 24-29, 31-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al US 20120203467 A1 herein after “Kamath” in view of Jacobs et al US 20120042214 A1 herein after “Jacobs” and Seki et al US 20100317538 A herein after “Seki”
Regarding claim 19, Kamath teaches a diagnostic system for diagnosing a sensor that is provided in an automatic analyzer measuring analytic target components included in a sample as measurement items, and that is used to measure a plurality of measurement items (para [0002] the present invention relates to systems and methods for detecting and processing signal artifacts, including detecting, estimating, predicting, filtering, displaying, and otherwise minimizing the effects of signal artifacts in a glucose sensor data stream.) and outputs an analog electrical signal that is at least one of a current value, a voltage value, and a resistance value generated at the electrodes by the application of the predetermined voltage (para [0211] The potentiostat applies a constant potential to the working and reference electrodes to determine a current value.), the diagnostic system comprising:
a memory that stores data of the electrical signal output by the sensor (para [0214] The processor additionally can be used for the system's cache memory, for example for temporarily storing recent sensor data) and a replacement history of the sensor (para FIGS. 3A to 3D) in "real time" (e.g., inclusive of recent data within the past few minutes or hours) and can be updated (post-processed) automatically (e.g., periodically, intermittently, or continuously) or selectively (e.g., responsive to a request) when new or additional information is available (e.g., new reference data, new sensor data, etc));
From above paragraphs examiner views the memory is used for storing sensor data (i.e., electrical data or signal) and a new or replacement history of the sensor data and
a processing device that processes data recorded in the memory (In Fig. 2-4, examiner views processor 22, 42 connected (i.e., to read and process data) to the memory- EEPROM, SPRAM), wherein the processing device
reads, from the memory, data for a set reference period from among electrical signal data output by a past sensor used in the automatic analyzer, when the past sensor measured a plurality of selected measurement items (para [0211] In some embodiments (e.g., sensors such as illustrated in FIGS. 1A and 1B), a potentiostat is employed to monitor the electrochemical reaction at the electrochemical cell. The potentiostat applies a constant potential to the working and reference electrodes to determine a current value.
[0269] In some embodiments, tests are used to evaluate the best-matched pair using a reference data point against individual sensor values over a predetermined time period (e.g., about 30 minutes).
[0305] In another embodiment of ischemia detection, wherein the glucose sensor is an electrochemical sensor that includes a potentiostat, pulsed amperometric detection can be employed to determine an oxygen measurement. Pulsed amperometric detection includes switching, cycling, or pulsing the voltage of the working electrode (or reference electrode) in an electrochemical system, for example between a positive voltage (e.g., +0.6 for detecting glucose) and a negative voltage (e.g., -0.6 for detecting oxygen).
From above paragraphs examiner views the reference sensor (i.e., past sensor) data read by the processor that was used in automatic glucose analyzer and provide a glucose values (i.e., measurement items) for a time stamp (i.e., reference period) related to electrical signal.
calculates a statistical value of the data for the reference period, which was output by the past sensor during the measurement of the plurality of selected measurement items, by statistically processing the data collectively all together regardless of the different measurement items, as a single index for diagnosis (para [0170] A fast-rising potential pulse is enforced on the working (or reference) electrode of an electrochemical cell and the current flowing through this electrode is measured as a function of time.
para [0185] In some embodiments, the device can analyze a plurality of intermittent blood samples. The glucose sensor can use any method of glucose-measurement, including enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, iontophoretic, radiometric, and the like.
Para [0215] In some alternative embodiments, wherein the potentiostat is configured to continuously measure the analyte, for example, using a current-to-frequency converter, the processor module can be programmed to request a digital value from the A/D converter at a predetermined time interval, also referred to as the acquisition time. In these alternative embodiments, the values obtained by the processor are advantageously averaged over the acquisition time due the continuity of the current measurement);
Examiner views an average of current values (i.e., statistically collectively processed value) using A/D is determined for a reference electrode for reference time or period during the measurement of multiple glucose samples (i.e., multiple measurement items).
reads, from the memory, data recorded during a set evaluation period from among electrical signal data output by a sensor for diagnosis that is being used in the automatic analyzer, when the sensor for diagnosis measured the plurality of selected measurement items, ( [0269] In some embodiments, tests are used to evaluate the best-matched pair using a reference data point against individual sensor values over a predetermined time period (e.g., about 30 minutes.
para [0305] Pulsed amperometric detection includes switching, cycling, or pulsing the voltage of the working electrode (or reference electrode) in an electrochemical system, for example between a positive voltage (e.g., +0.6 for detecting glucose) and a negative voltage (e.g., -0.6 for detecting oxygen).
From above paragraphs examiner views a working electrode data read by the processor that was used in automatic glucose analyzer and provide a voltage value for a time period (i.e., evaluation period) using an electrical signal.
calculates a statistical value of the data for the evaluation period in a same manner as with calculation of the statistical value of the data for the reference period (para [0170] A fast-rising potential pulse is enforced on the working (or reference) electrode of an electrochemical cell and the current flowing through this electrode is measured as a function of time.
Para [0215] In some alternative embodiments, wherein the potentiostat is configured to continuously measure the analyte, for example, using a current-to-frequency converter, the processor module can be programmed to request a digital value from the A/D converter at a predetermined time interval, also referred to as the acquisition time. In these alternative embodiments, the values obtained by the processor are advantageously averaged over the acquisition time due the continuity of the current measurement);
Examiner views an average of current values (i.e., statistically collectively processed value) using A/D is determined for a working electrode for evaluation time or period during the measurement of multiple glucose samples (i.e., multiple measurement items).
Kamath does not teach emits light from a reaction product of the sample and a reagent by applying a predetermined voltage to electrodes
determines whether the sensor for diagnosis has an abnormality based on a difference obtained from the statistical value of the reference period and the statistical value of the evaluation period.
Seki teaches emits light from a reaction product of the sample and a reagent by applying a predetermined voltage to electrodes (para [0027] Concrete examples of a waveform of voltage or current applied in these electrochemical analysis s include appropriate pulse waveforms, differential pulse waveforms, triangular pulse waveforms and step pulse waveforms.
[0028] A third microanalysis measuring method according to the present invention is characterized by including: feeding a sample containing an analyte and a reagent producing a color or emitting light by reaction specific to the analyte,
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Seki into Kamath for the purpose of reacting a reagent and a sample using an electric source on an electrode so that a chemical reaction provide the intended examination result for sample by emitting light.
Kamath and Seki does not teach determines whether the sensor for diagnosis has an abnormality based on a difference obtained from the statistical value of the reference period and the statistical value of the evaluation period.
Jacobs teaches determines whether the sensor for diagnosis has an abnormality based on a difference obtained from the statistical value of the reference period and the statistical value of the evaluation period (para [0092] FIG. 17 shows an exemplary screen shot based on the data and thresholds from Example 4. The schematic shows a listing of various monitored variables, their respective thresholds and the values on various time points. When the individual thresholds are exceeded (not necessarily resulting in triggering an alert for an impending failure), the variable is flagged. For flagging, different colors, flashing values and other techniques may be used as is well known to those having ordinary skill in the art.).
In Fig. 17 examiner views a comparison of sensor values from Monday through Sunday (evaluation period) with respect to spec (reference period) to diagnose whether the sensor is abnormal.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Jacbos into Kamath for the purpose of comparing the reference period data to a evaluation period data of a sensor, to determine if the sensor is working properly or not.
Claims 35 and 36 are rejected as claim 1 above having same claim limitation.
Regarding claim 20 the combination of Kamath, Seki and Jacobs teaches, the diagnostic system according to claim 19, Kamath teaches wherein the reference period is a period set by excluding a predetermined period before replacement of the past sensor ([0267] In one embodiment, a time corresponding sensor data comprises one or more sensor data points that occur, for example, 15.+-.5 min after the reference glucose data timestamp (e.g., the time that the reference glucose data is obtained))
[0269] In some embodiments, tests are used to evaluate the best-matched pair using a reference data point against individual sensor values over a predetermined time period (e.g., about 30 minutes).
From above paragraph examiner views the new or replaced sensor data is collected after 15 min (i.e., set excluded time) the reference sensor (i.e., past sensor) collects the data for a predetermined time period (i.e., reference time period).
Regarding claim 21 the combination of Kamath, Seki and Jacobs teaches, the diagnostic system according to claim 19, Kamath teaches wherein, based on a replacement history of the past sensor, the processing device calculates a time point that is a predetermined period back from the time of replacement of the past sensor, and specifies a set period ending at that time point as the reference period (para [0346] In some embodiments of the max-average algorithm, an acceptance filter can also be applied to new sensor data to minimize effects of high non-physiological data. In the acceptance filter, each sampled data point (e.g., every 30 seconds) is tested for acceptance into the maximum average calculation. Each new point is compared against the most representative estimate of the sensor curve at the previous sampling interface (e.g., 30-second time point), or at a projection to a current estimated value.).
[0445] At block 556, a self-diagnostic module compares the new calibrated sensor data with previous calibrated sensor data, for example, the most recent calibrated sensor data value. In comparing the new and previous sensor data, a variety of parameters can be evaluated. In one embodiment, the rate of change and/or acceleration (or deceleration) of change of various analytes, which have known physiological limits within the body, and sensor data can be evaluated accordingly. For example, a limit can be set to determine if the new sensor data is within a physiologically feasible range, indicated by a rate of change from the previous data that is within known physiological (and/or statistical) limits. Similarly, any algorithm that predicts a future value of an analyte can be used to predict and then compare an actual value to a time corresponding predicted value to determine if the actual value falls within a statistically and/or clinically acceptable range based on the predictive algorithm, for example.
From above paragraph examiner views based on a previous sensor (i.e., replacement history of the past sensor), the processing device calculates a time points interval for sensing period (i.e., reference period) of the new sensor after the time point the previous sensor is replaced by new sensor.
Regarding claim 24 the combination of Kamath, Seki and Jacobs teaches the diagnostic system according to claim 19, Kamath teaches wherein the processing device calculates the statistical value of the data for a reference period and the statistical value of the data for an evaluation period by statistically calculating all of a set number of data extracted for each of two or more selected measurement items (para [0267] In one embodiment, a time corresponding sensor data comprises one or more sensor data points that occur, for example, 15.+-.5 min after the reference glucose data timestamp (e.g., the time that the reference glucose data is obtained).
para [0269] In some embodiments, tests are used to evaluate the best-matched pair using a reference data point against individual sensor values over a predetermined time period (e.g., about 30 minutes). In one such embodiment, the reference data point is matched with sensor data points at 5-minute intervals and each matched pair is evaluated. The matched pair with the best correlation can be selected as the matched pair for data processing. In some alternative embodiments, matching a reference data point with an average of a plurality of sensor data points over a predetermined time period can be used to form a matched pair.).
From above paragraphs examiner views measurement item as glucose. The selected glucose data (i.e., statistical values) is calculated for the reference sensor for reference period and for sensor for an evaluation period by processor in order to check the matched pair.
Regarding claim 25 the combination of Kamath, Seki and Jacobs teaches the diagnostic system according to claim 19, Kamath teaches wherein the statistical value of the data for a reference period and the statistical value of the data for an evaluation period are at least one of, or a value based on at least one of, a mean value, a moving average value, a median value, and a standard deviation (From above paragraph [0269] examiner views the glucose value (i.e., statistical value) for the reference period and evaluation period are based on a best correlation value (i.e., use of standard deviation) or average value).
Regarding claim 26 the combination of Kamath, Seki and Jacobs teaches the diagnostic system according to claim 19, Kamath teaches wherein the processing device determines that the sensor for diagnosis has the abnormality when a difference between the data for an evaluation period and the data for a reference period is greater than a first determination value (para [0418] In one embodiment, wherein estimation is used in outlier detection and/or in matching data pairs for a continuous glucose sensor (see FIGS. 5 and 6), the estimated glucose data can be plotted against reference glucose data on a clinical error grid (for example, Clarke Error Grid or rate grid) and then compared to the measured glucose data for that estimated time period plotted against the same reference analyte data on the same clinical error grid. In alternative embodiments, other clinical error analysis methods can be used, such as Consensus Error Grid, rate of change calculation, consensus grid, and standard clinical acceptance tests, for example. The deviation can be quantified by percent deviation, or can be classified as pass/fail, for example.
Para [0045] In certain embodiments, identifying a disparity between predicted and measured analyte data can be used to identify a shift in signal baseline responsive to an evaluated difference between the predicted data and time-corresponding measured data. In some alternative embodiments, a shift in signal baseline and/or sensitivity can be determined by monitoring a change in the conversion function; namely, when a conversion function is re-calculated using the equation y=mx+b, a change in the values of m (sensitivity) or b (baseline) above a pre-selected "normal" threshold, can be used to trigger a fail-safe or further diagnostic evaluation.).
From above paragraph and figures examiner views the sensor data or measured is compared against the reference data for same estimated time period (i.e., reference and evaluation time period) by a processor to diagnose if sensor has pass/failed (i.e., diagnose abnormality of the sensor) using deviation or change value above a normal baseline, threshold (i.e., greater than first determination)
Regarding claim 27 the combination of Kamath, Seki and Jacobs teaches the diagnostic system according to claim 26, Kamath teaches wherein the processing device determines whether the difference between the data for an evaluation period and the data for a reference period is greater than the first determination value by a significance test based on the statistical value of the reference period and the statistical value of the evaluation period (para [0157] The term "Clarke Error Grid" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to an error grid analysis, which evaluates the clinical significance of the difference between a reference glucose value and a sensor generated glucose value, taking into account 1) the value of the reference glucose measurement, 2) the value of the sensor glucose measurement, 3) the relative difference between the two values, and 4) the clinical significance of this difference. See Clarke et al., "Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose," Diabetes Care, Volume 10, Number 5, September-October 1987, which is incorporated by reference herein in its entirety.).
From above paragraph examiner views the clinical significance test compares the differences between reference and sensor value against a standard value (i.e., first determination value) using a Clark Error Grid.
Regarding claim 29 the combination of Kamath, Seki and Jacobs teaches the diagnostic system according to claim 26, Kamath teaches wherein, based on the statistical value of the reference period and the statistical value of the evaluation period, when the difference between the data for an evaluation period and the data for a reference period is smaller than a second determination value set to be smaller than the first determination value, the processing device determines that the sensor for diagnosis is normal. (para [0418] In one embodiment, wherein estimation is used in outlier detection and/or in matching data pairs for a continuous glucose sensor (see FIGS. 5 and 6), the estimated glucose data can be plotted against reference glucose data on a clinical error grid (for example, Clarke Error Grid or rate grid) and then compared to the measured glucose data for that estimated time period plotted against the same reference analyte data on the same clinical error grid. In alternative embodiments, other clinical error analysis methods can be used, such as Consensus Error Grid, rate of change calculation, consensus grid, and standard clinical acceptance tests, for example. The deviation can be quantified by percent deviation, or can be classified as pass/fail, for example.
Para [0045] In certain embodiments, identifying a disparity between predicted and measured analyte data can be used to identify a shift in signal baseline responsive to an evaluated difference between the predicted data and time-corresponding measured data. In some alternative embodiments, a shift in signal baseline and/or sensitivity can be determined by monitoring a change in the conversion function; namely, when a conversion function is re-calculated using the equation y=mx+b, a change in the values of m (sensitivity) or b (baseline) above a pre-selected "normal" threshold, can be used to trigger a fail-safe or further diagnostic evaluation.).
From above paragraph and figures examiner views the sensor data or measured is compared against the reference data for same estimated time period (i.e., reference and evaluation time period) by a processor to diagnose if sensor has passed (i.e., diagnose normality of the sensor) using deviation or change value below a normal baseline, threshold (i.e., greater than first determination).
Regarding claim 31 the combination of Kamath, Seki and Jacobs teaches the diagnostic system according to claim 19, Kamath teaches comprising a user interface configured such that a determination condition of the sensor for diagnosis can be set (para [0437] If acceptability is determined, then processing continues to block 530 to convert sensor data using the new conversion function and continuously display calibrated sensor data on the user interface.).
Here examiner views the accepted sensor calibration data (i.e., sensor diagnosis) is set or displayed using a user interface.
Regarding claim 32 the combination of Kamath, Seki and Jacobs teaches the diagnostic system according to claim 24, Kamath teaches comprising a user interface configured such that a determination condition of the sensor for diagnosis can be set (para [0437] At block 524, the evaluation module re-evaluates the acceptability of newly received reference data with time corresponding converted sensor data that has been converted using the new conversion function (block 536). The flow continues to decision block 538 to assess the results of the evaluation, such as described with reference to decision block 526, above. If acceptability is determined, then processing continues to block 530 to convert sensor data using the new conversion function and continuously display calibrated sensor data on the user interface.), wherein the user interface is configured such that at least one of the reference period and the measurement item can be set (para [0428] Some evaluation data, such as described in the paragraph above, can be used to evaluate an optimum time for reference analyte measurement. Correspondingly, the user interface can then prompt the user to provide a reference data point for calibration within a given time period.).
In above paragraphs examiner views the user interface is used to set or display the sensor acceptability (i.e., diagnosis condition), reference period and the measurement item (i.e., analyte measurement).
Regarding claim 33 the combination of Kamath, Seki and Jacobs teaches the diagnostic system according to claim 19, Kamath teaches
wherein the sensor is a flow cell type (para [0171] The term "pulsed amperometric detection" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to an electrochemical flow cell and a controller, which applies the potentials and monitors current generated by the electrochemical reactions.).
From above paragraph examiner views the sensor used is a electrochemical flow cell type.
Regarding claim 34 the combination of Kamath, Seki and Jacobs teaches the diagnostic system according to claim 19, Kamath teaches wherein the electrical signal is at least one of current, voltage and resistance (para [0210] In one exemplary embodiment, the sensor is an enzyme-based electrochemical sensor, wherein the glucose-measuring working electrode measures the hydrogen peroxide produced by the enzyme catalyzed reaction of glucose being detected and creates a measurable electronic current).
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kamath, Seki and Jacobs in view of Lesher (US 20170285624 A1)
Regarding claim 22 the combination of Kamath, Seki and Jacobs teaches, the diagnostic system according to claim 20, the combination does not clearly teach wherein the processing device, with respect to a reference sample that can be measured multiple times in the same lot prior to measurement of a patient's sample, records success or failure data of measurement of the reference sample in the memory each time the measurement is performed using the past sensor,
reads, from the memory, a history of the measurement of the reference sample performed during the predetermined period, and
sets the reference period for the past sensor when all measurements of the reference sample performed during the predetermined period are successful.
Lesher teaches wherein the processing device, with respect to a reference sample that can be measured multiple times in the same lot prior to measurement of a patient's sample, records success or failure data of measurement of the reference sample in the memory each time the measurement is performed using the past sensor (para [0040] At block 200, a quality control (QC) measurement may be performed on the target diagnostic analyzer 110a. For example, the target diagnostic analyzer 110a may be powered on. A message may be displayed on the target diagnostic analyzer 110a instructing an operator to select a QC sample of a given level from, for example, lot A.), [0041] At block 205, the target diagnostic analyzer 110a may measure the quantities of the constituents of the QC sample. [0044] If at block 220, the response indicates that the QC measurements were normal, then at block 225, the target diagnostic analyzer 110a may be permitted to proceed to patient sample processing.
From above paragraphs examiner views the QC sample (i.e. reference sample) is measured for quantities of constituents of QC sample (i.e., measured multiple times) in the same lot A, once the QC results were normal (i.e, success) testing is performed for patient’s sample.
reads, from the memory, a history of the measurement of the reference sample performed during the predetermined period (para [0043] At block 215, the target diagnostic analyzer 110a may receive a response associated with the previously communicated QC measurements from the central server 155. para [0127] Each cell in the chart indicates whether QC measurements were performed at a given time on a given day.), and
From above paragarphs examiner views the previously communicated QC measurements (i.e., history of measurements of reference samples) performed during a given or predetermined time period.
sets the reference period for the past sensor when all measurements of the reference sample performed during the predetermined period are successful (para [0127] Each cell in the chart indicates whether QC measurements were performed at a given time on a given day. The value of the cell indicates the type of measurement, if any, that was performed. An empty cell indicates that no QC measurements were performed. A value of “P” indicates that two levels of QC samples were measured, such as level 1 and level 2 QC samples. A value of “S” indicates that the target diagnostic analyzer 110a was being serviced. A value of “F” indicates that the target diagnostic analyzer 110a failed a QC measurement. A value of “B” indicates a background counts pass.).
From above paragraphs examiner views the reference samples were tested for a given or predetermined time (set reference period) during those time the measurements are passing or successful.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the invention to have incorporated Lesher into Kamath for the purpose of testing diagnositic device with quality control sample and record the success or failure of the device before testing the patient sample, so that the accurate result can obtained when used or tested for the patient sample for proper diagnosis of patient condition.
Regarding claim 23 Kamath, Seki, Jacobs and Lesher teaches, the diagnostic system according to claim 22, Kamath teaches wherein the reference sample is at least one of a quality control sample, a standard sample used for calibration, and a dummy sample (para [0425] Initial calibration and re-calibration of the sensor require a reference analyte value. Accordingly, the receiver can receive reference analyte data at any time for appropriate processing.).
Allowable Subject Matter
Claim 28 and 30 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Okuno et al US 20020128801 A1 discusses quality control in analyzers.
Wardlaw et al US 6748337 B2 teaches predicting failures in clinical analyzers.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARAD TIMILSINA whose telephone number is (571)272-7104. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Catherine Rastovski can be reached at 571-270-0349. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARAD TIMILSINA/ Examiner, Art Unit 2857
/Catherine T. Rastovski/ Supervisory Primary Examiner, Art Unit 2857
