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
This office action is responsive to the amendment filed on 2/5/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 16, 28-30 has/have been amended;
Claim(s) 1-15 is/are cancelled;
Claim(s) 16-35 is/are presently pending.
Response to Arguments
The filing of Terminal Disclaimer obviates the double patenting rejection(s) of record.
Applicant argues on p. 10-13 of remarks that primary reference Sharma does not teach the recited “a set of pairs of values respectively corresponding to a set of different time intervals, each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value” of the independent claims. Applicant further argues that Sharma merely discloses sensors that sense changes in LES to trigger stimulation but are not configured to provide a measurement of the parameter nor determine a level of gastro-intestinal disorder as recited. After review, this is not persuasive.
First, it is noted that the independent claim recitations are open-ended with the recitation of “comprising”; MPEP 2111.03. Thus the instant claims do not strictly require a pair as in two but prior art that has a pair/two data and/or more would meet the instant claim limitation.
Sharma as cited teaches (emphasis added):
[0305] In another embodiment, the stimulator device uses a combination of data inputs from the above described sensors to generate a total score from which a stimulation therapeutic regimen is derived. For example, if the patient has not eaten for a long time and lays down, a lower (or no) therapy dose would be delivered. Since GERD is an episodic disease and certain periods are more vulnerable to a reflux event than others, detecting various patient parameters by various means and using them in an algorithm enables clinicians to target those specific reflux events. In addition, in various embodiments, multiple algorithms are programmed into the stimulator device so that treatment can be tailored to various types of GERD, based upon input relayed by the sensors. In one embodiment, data from any combination of one or more of the following parameters is used by an algorithm to determine stimulation protocol: patient feed state including type of intake (via patient input or eating detection by a physical sensor that can detect and/or evaluate liquids/solids/caloric value); patient position (via inclinometer/accelerometer); patient activity (via accelerometer/actimeter); patient reflux profile (via patient input/pH recording); LES pressure; LES electrical activity; LES mechanical activity (via accelerometer in the LES, pressure sensor, impedance measure or change thereof); gastric pressure; gastric electrical activity; gastric chemical activity; gastric temperature; gastric mechanical activity (via an accelerometer in the stomach, pressure sensor, impedance measurement and changes); patient intuition; vagal neural activity; and, splanchnic neural activity. Based on input from one or more of the above parameters, the algorithm quantifies the vulnerability for a reflux event and modifies accordingly the amplitude, frequency, pulse-width, duty cycle, ramp rate, and timing of stimulation treatment. The table below lists the parameters, measurements, and values used in an exemplary treatment protocol of one embodiment of the present invention.
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[0306] In the table above, each individual parameter is given a score of 1 or 0 depending on the value measured. In one embodiment, a summary score is tabulated using one or more parameters in the above exemplary algorithm scoring system to determine patient vulnerability to a reflux event. Based on the score, the treatment parameter is modified. Patients with a higher summary score are indicated for a greater level of treatment. For example, a patient with normal LES pressure in the upright position and a pre-prandial state will be at minimal risk for a reflux event and no therapy will be indicated. Conversely, a patient with low LES pressure in the supine position and an immediate post-prandial state will be at the highest risk for a reflux event and would receive the highest level of GERD therapy.
[0310] In another embodiment, the scoring system is tailored to be patient specific. In one embodiment, for example, for a patient with low symptom predictability as ascertained by symptom association with a standard pH test, patient symptom input is given a lower weight. In another embodiment, for a patient with mostly upright reflux on pH testing, the upright position is given a greater weight than the supine position. In yet another embodiment, for a patient with exercise induced reflux, a greater weight is given to upright activity while the same parameter receives a low weight or is eliminated from the algorithm in a patient without exercise induced reflux.
[0314] Supine time defines the period of time that is required for the patient to be in a supine position in order for the first condition listed above to be met. Supine time is programmable to a certain time period by the user. In one embodiment, supine time is set to 1 minute. In another embodiment, supine time is set to 5 minutes. In another embodiment, supine time is set to 30 minutes. In yet another embodiment, supine time is set to 60 minutes, or smaller increments thereof.
[0346] It should be appreciated that any activation by an internal clock can be configured to cycle daily or a few times daily or be synchronized to meal times, as signaled manually by a patient. It should further be appreciated that the timing of meal times or other physiologically relevant events can be saved and/or learned, thereby enabling the device to default to standard initiation of stimulation time or termination of stimulation time based upon past data gathered. The setting of stimulation times may be set by a physician, based on an interview with a patient or based on the detection of eating using pH sensing or some other automated eating detection mechanism. In one embodiment, stimulation is initiated in advance of a predefined meal time to achieve an increase in LES tone before the patient eats. For example, if a patient's predefined meal time is 2 pm, then stimulation is set to initiate in advance of 2 pm, such as 1:30 pm. If the patient then reports symptoms between 4-6 pm, then, in the future, stimulation may be reinitiated at 3 pm. If a patient's predefined meal time is 12 pm, then set stimulation is set to initiate in advance of 12 pm, such as 11:30 am. If the patient then reports symptoms between 2-4 pm, stimulation may be reinitiated at 1 pm.
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[0362] Referring to FIG. 15, in one embodiment, the process 1500 implemented by the stimulator system comprises collecting 1505 pH data periodically or continuously over a predefined period, such as 1, 2, 6, 12, 24, 36, 48, or 60 hours, or any time increment in between. Circuitry within the stimulator analyzes the pH data 1510 to determine if, within the predefined period, such as 24 hours, pH is less than a predefined value, such as 4, for a percentage of time higher than a threshold value, such as 1, 2, 3, 4, 5, 10, 15, or 20 hours, or any increment therein 1515. The processor may analyze pH data 1510 by integrating periods in which the pH is less than the predefined value compared with stimulation times and separately integrate periods with stimulation in a most recent time period (i.e. last 6 hours) to periods without stimulation in the most recent time period.
From the above, it is clear that Sharma teaches an algorithm that collects various data in order to make a determination as to gastro-intestinal disorder based on the data. Specifically, Sharma teaches the limitations of:
wherein said first value is determined based on a measurement of the parameter corresponding to the given time interval ([0305] and Table 3 have various parameters such as patient position and patient activity);
wherein said second value is determined based on a measurement of gastro-esophageal content corresponding to the given time interval ([0305] and Table 3 have various parameters for gastro-esophageal content such as “patient feed state including type of intake (via patient input or eating detection by a physical sensor that can detect and/or evaluate liquids/solids/caloric value)” and “gastric chemical activity; gastric temperature”; Table 3 has “Fat content of meal” “Patient pH Profile”);
These data are collected at the same time and so read on “the given time interval”.
Because Sharma utilizes an algorithm and teaches collecting data over time periods or continuously, Sharma meets the limitation of
determine a set of pairs of values respectively corresponding to a set of different time intervals, each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value (Fig. 15 “Collect pH data continuously…integrate periods”; [0362] “collecting 1505 pH data periodically or continuously over a predefined period”; the algorithm is in a loop and Sharma teaches that the data is collected and analyzed and thus different data sets are analyzed over different times and so read on the “different time intervals”; further, Sharma teaches in [0306] and [0310] that the different data are combined for a summary score to determine patient vulnerability to a reflux event.)
determine a level of gastro-intestinal disorder based on the determined set of pairs of values (Sharma teaches in [0306] and [0310] that the different data are combined for a summary score to determine patient vulnerability to a reflux event.)
Thus, Sharma as cited teaches the limitations.
Furthermore, Sharma teaches (emphasis added):
[0357] In another embodiment, the stimulator/sensing system disclosed herein can locally store a plurality of programmatic instructions that, when executed by circuitry within the IPG, uses data received from a capsule to automatically refine stimulation parameters within a pre-defined range of boundaries. The data may be continuously streamed from the sensing capsule to the IPG and may be subject to continuous monitoring and processing. The data may comprise any one of pH data, pressure data, LES pressure data, temperature, impedance, incline, or other physiological data.
[0359] For example, where a meal event, sleeping event, or other event which may cause, be related to, or be associated with a GERD event, is expected to occur at a specific time during the day (either because previously sensed data has determined a pattern indicating the existence of such an event or because patient data expressly indicates that such an event should be expected), stimulation parameters may be modified or otherwise established in order to provide the requisite level, degree or amount of stimulation before the anticipated event, such as 5 minutes, 10 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, or some increment therein. The determination of stimulation parameters, including start time, end time, pulse frequency, duration, ramp rate, duty cycle, and/or amplitude, can be determined independent of the patient's immediate physiological state and not causally related to the patient's existing condition. Rather, historical data patterns from sensors, including pressure data, LES pressure data, temperature, impedance, incline, or other physiological data, can be used to define the GERD profile of a patient, namely when, in the course of a day, a patient is likely to experience a GERD event, and then used to proactively normalize LES function in advance of the GERD event. To properly generate and mine data patterns, it is preferable to capture both the magnitude of the physiological data (i.e. pH<4), the duration (for one hour), and the timing (around 1pm). It is further preferable to associate different physiological data with each other to see if a predictive pattern may exist between data sets and to further correlate that data with the patient's own reporting of pain, discomfort, acid reflux, or other sensations to better determine when a GERD event is likely to occur in a day.
[0360] In one embodiment, the implanted stimulator 1415 is configured to check the reliability of the data by processing it to determine whether the data is indicative of the sensor being in an improper location. In one embodiment where the temporary sensor is a capsule measuring pH data intended to measure esophageal pH, such a determination process may be conducted by: a) monitoring the received pH data over a predefined period of time to determine if it is indicative of a high pH environment, such as the patient's stomach as opposed to the esophagus, b) monitoring the received data signal, such as an RF signal, over a predefined period of time to determine if the signal strength has significantly changed or modified, indicating a change in physical location, or c) monitoring a received accelerometer or inclinometer data signal from the pH capsule, over a predefined period of time, to determine if the capsule is in a proper physical orientation. Depending on the reliability check, the implanted stimulator 1415 may use, or discard, the sensed data. If no reliable data is received by the implanted stimulator 1415, it does not modify stimulation parameters or otherwise engage in a processing routine adapted to use the sensed data to determine how the simulation parameters should be modified. If reliable data is received by the implanted stimulator 1415, it modifies stimulation parameters or otherwise engages in a processing routine adapted to use the sensed data to determine how the simulation parameters should be modified.
From the above, it is clear that Sharma is teaching the concept of measuring data over a time, correlating the data in order to obtain patterns to determine a level of gastro-intestinal disorder to obtain treatment parameters, and repeating/looping this in order to continuously provide patient care.
The citations in the rejection(s) below have been updated in light of the above in order to provide more clarity of the record; but this does not constitute new grounds of rejection; MPEP 1207.03(a) II Factual Situations That Do Not Constitute a New Ground of Rejection: Citing a different portion of a reference to elaborate upon that which has been cited previously; Considering, in order to respond to applicant’s arguments, other portions of a reference submitted by the applicant.
Terminal Disclaimer
The terminal disclaimer filed on 2/5/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Application No. 18/551417 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claim(s) 16-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma (US 20110307027 A1; 12/15/2011; cited in IDS; cited in previous office action).
Regarding claim 16, Sharma teaches a system for monitoring gastro-intestinal disorders (Abstract), comprising:
a gastro-intestinal probe configured to perform gastro-esophageal content measurements of a patient (Fig. 14);
at least one sensor configured to measure a parameter of the patient, said parameter being dependent to a patient activity and/or a patient movement and posture ([0300]; [0305]; [0311]); and
a processor configured to ([0357]; [0362]; [0394]):
determine a set of pairs of values respectively corresponding to a set of different time intervals, wherein each pair of values corresponding to a given time interval of the set of different time intervals comprises a first value and a second value (Fig. 15; [0305]; [0308]; [0314]; [0346]; reference is teaching measuring different sensor values at different times with the different sensor values paired/compared to one another for same time point; specifically, Fig. 15 “Collect pH data continuously…integrate periods”; [0362] “collecting 1505 pH data periodically or continuously over a predefined period”; the algorithm is in a loop and Sharma teaches that the data is collected and analyzed and thus different data sets are analyzed over different times and so read on the “different time intervals”; further, Sharma teaches in [0306] and [0310] that the different data are combined for a summary score to determine patient vulnerability to a reflux event.),
wherein said first value is determined based on a measurement of the parameter corresponding to the given time interval (Fig. 15; [0305]; [0308]; [0314]; [0346]; specifically [0305] and Table 3 have various parameters such as patient position and patient activity); and
wherein said second value is determined based on a measurement of gastro- esophageal content corresponding to the given time interval (Fig. 15; [0305]; [0308]; [0314]; [0346]; specifically [0305] and Table 3 have various parameters for gastro-esophageal content such as “patient feed state including type of intake (via patient input or eating detection by a physical sensor that can detect and/or evaluate liquids/solids/caloric value)” and “gastric chemical activity; gastric temperature”; Table 3 has “Fat content of meal” “Patient pH Profile”); and
determine a level of gastro-intestinal disorder based on the determined set of pairs of values ([0305]-[0310]; Sharma teaches in [0306] and [0310] that the different data are combined for a summary score to determine patient vulnerability to a reflux event.; see also [0359]-[0360] in which data is obtained periodically or continuously, analyzed for correlations and patterns to determine level of gastro-intestinal disorder in order to best treat it with the appropriate stimulation parameters such as strength and timing).
Claim 28 is rejected under substantially the same basis as claim 16 above.
Claim 29 is rejected under substantially the same basis as claim 16 above.
Claim 30 is rejected under substantially the same basis as claim 16 above.
Regarding claim 17, Sharma teaches a patient interface configured to receive inputs from the patient, said inputs corresponding to patient reported symptoms, PRS, wherein the level of gastro-intestinal disorder is determined based on the determined set of pairs of values and the inputs corresponding to the PRS ([0288]; [0289] “physical symptoms”; [0297]; [0305] “patient input”; [0305]-[0310]).
Regarding claim 18, Sharma teaches another sensor configured to measure another parameter of the patient (Fig. 14; [0300]; [0305]), said another parameter being dependent to pain and/or stress of the patient ([0305]; [0359] “correlate that data with the patient’s own reporting of pain”), wherein inputs corresponding to the PRS are adapted according to measures of the other parameter ([0305]-[0310]; [0359]-[0362]; the reference is teaching using different parameters including sensed parameters dependent on pain/stress to obtain pattern via data analysis and specifically teaches “measured parameter is used as a modifier for another parameter” in [0307]).
Regarding claim 19, Sharma teaches wherein the other sensor is a sensor among a heart rate sensor, a blood pressure sensor, a temperature sensor ([0303]; [0305] “temperature”), a breathing rate sensor, an oxygen saturation sensor, a lactate level sensor, a sodium level sensor, a uric acid level sensor, a potassium level sensor, a stress-related hormones sensor; and
wherein measures of the other parameter are obtained based on the output of the other sensor ([0303]; [0305]).
Regarding claim 20, Sharma teaches wherein the level of gastro-intestinal disorder is determined by weighting the second value according to the first value ([0305]-[0310], [0307] “measured parameter is used as a modifier for another parameter”).
Claim 31 is rejected under substantially the same basis as claim 20 above.
Claim 34 is rejected under substantially the same basis as claim 20 above.
Regarding claim 21, Sharma teaches wherein the sensor is one among an accelerometer sensor ([0311] “accelerometer”), a gyroscope sensor, heart rate sensor, an output of a blood pressure sensor, an output of a temperature sensor ([0303]; [0305] “temperature”), an output of a breathing rate sensor, an output of an oxygen saturation sensor and a flexible angular sensor.
Regarding claim 22, Sharma teaches wherein the first value is determined based on an output of a clock ([0346]), a geolocation information and/or an activity input given by the patient ([0291]; [0305]; [0382] “patient inputs (symptoms, eating, sleeping events”).
Claim 33 is rejected under substantially the same basis as claim 22 above.
Claim 35 is rejected under substantially the same basis as claim 22 above.
Regarding claim 23, Sharma teaches wherein the first value is determined based on a past first value determined based on a past measurement of the parameter ([0305]-[0310]; [0359] “historical data patterns”; [0360] “data over a predefined period of time”).
Claim 32 is rejected under substantially the same basis as claim 23 above.
Regarding claim 24, Sharma teaches wherein the gastro-intestinal probe comprises at least one probe sensor among a pH sensor and a impedance sensor (Fig. 14, 1410; [0305] “pH recording…impedance measure”; [0359] “impedance”; [0356]; [0362] “pH data”); and
wherein said gastro-esophageal content measurements are obtained based on the output of the at least one probe sensor ([0305]).
Regarding claim 25, Sharma teaches wherein the gastro-intestinal probe comprises a plurality of probe sensors arranged in array (Fig. 14; [0305]; [0370]; the reference is teaching multiple sensors and so inherently teaches the sensors are an array since Merriam-Webster dictionary definition of “array” is “ group of elements forming a complete unit”; (https://www.merriam-webster.com/dictionary/array));
wherein said gastro-esophageal content measurements are obtained based on the outputs of the plurality of probe sensors ([0305]).
Regarding claim 26, Sharma teaches a receiving wireless communication unit configured to receive gastro-esophageal content measurements from the gastro-intestinal probe, and wherein the gastro-intestinal probe comprises a transmitting wireless communication unit configured to transmit gastro-esophageal content measurements (Fig. 14; [0221] “wireless”; [0288] “transmitter”; [0367]-[0368]; [0372]).
Regarding claim 27, Sharma teaches a device, said device comprising the receiving wireless communication unit and said device being a user equipment or a patient worn device (Fig. 14; [0288]-[0289]).
Conclusion
THIS ACTION IS MADE FINAL. 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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792