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 Arguments
Applicant’s arguments received 19 March 2026, have been fully considered. Claims 1-9, 12-19, 23-24, and 27 are pending. Claims 1-3, 7, 10, 14-16, 19, and 27 have been amended.
Applicant’s efforts to address objections to the claim language are satisfactory, therefore all claim objections are withdrawn.
Applicant’s efforts to address rejections under 35 U.S.C. 112(b) have been considered. While most issues have been adequately addressed, there is still inconsistency with referring to the “predicted distribution of sensor data values”. See 112(b) rejections below.
Applicant’s efforts to overcome the rejections under 35 U.S.C. 112(d) are satisfactory, therefore all 112(d) rejections are withdrawn.
Applicant’s efforts to overcome the rejection under 35 U.S.C. 101 is satisfactory, therefore all 101 rejections are withdrawn.
Applicant’s arguments regarding the rejections under 35 U.S.C. 103 have been considered.
Applicant argues that Plotnik-Peleg does not teach generating any predictive data using gait parameters and one or more program parameters associated with a therapy program, but only teaches learning normal gait and freezing episodes.
The examiner disagrees that Pretzer-Aboff in view of Plotnik-Peleg would not have rendered obvious generating a predicted distribution of sensor data values using gait parameters and one or more program parameters associated with a therapy program. As cited in ¶318 of Plotnik-Peleg, an algorithm learns a patient’s gait and freezing episodes. It would be natural for the algorithm to determine parameters related to gait, and further the user input of suspected FOG events for training the algorithm can be considered program parameters associated with the therapy program. A user can also tag suspected FOG events to teach the algorithm. It is clear in context in Plotnik-Peleg that the algorithm is trained to monitor a patient in the future and predict FOG risks so they can be addressed quickly (note that ¶318 opens with discussion of the “FOG detection mechanism”; see also the previous paragraph, ¶317, which describes how “the methods and/or systems described herein are configured to be sensitive enough to detect FOG or future FOG risk”).
The algorithm described in Plotnik-Peleg is applied to predict FOG risk, and the examiner considers that it would have been obvious for the algorithm to function by predicting a distribution of sensor data values which, if future gait data falls within the distribution, would indicate a need to apply signals or cues to prevent and/or break out of FOG (see ¶169 of Plotnik-Peleg discussing providing signals or cues). The algorithm is trained to monitor gait, which would reasonably involve receiving sensor values (see also ¶211 describing a freezing detection and prediction algorithm which explicitly receives and processes sensor data). If the algorithm’s purpose is to receive sensor values and predict FOG risk, it seems natural to the examiner that the algorithm would compare the received sensor values with a distribution of values (i.e. a set of values) indicating FOG risk. Such a distribution would be a predicted distribution since it was determined by the algorithm previous to receiving a most recent set of gait sensor data and because the distribution is used to predict FOG risk.
Applicant remarks that Plotnik-Peleg does not teach detecting, predicting, or treating a gait disorder in which the patient’s gait may vary in many different ways, and claims that this is included in the claimed invention.
Regardless of whether Plotnik-Peleg teaches what Applicant asserts it does not teach, the examiner notes that the above limitations are not reflected in the claim language.
Applicant argues that the prior art does not disclose a reverse mapping process, however the claim language does not refer to such a process.
Applicant argues that the prior art does not assess a patient’s condition or intervene in any way to change characteristics of the patient’s gait, then refers to Plotnik-Peleg teaching that stimulation is applied to a patient to prevent or break out of a FOG situation (see ¶169 of Plotnik-Peleg). The examiner considers that Applicant’s reference to Plotnik-Peleg does indeed motivate what Applicant asserts the prior art does not teach. Plotnik-Peleg teaches applying an algorithm to monitor FOG risk (see above arguments), and ¶169 clearly intervenes to change something about the patient’s gait (to “break out” of a FOG situation would clearly require a change in a patient’s gait, and to “prevent” a FOG situation would involve a change in gait characteristics i.e. from characteristics indicating FOG risk to characteristics not indicating FOG risk).
Applicant argues that Plotnik-Peleg does not disclose combining a gait parameter with a program parameter because, during a FOG event, a patient has stopped walking, so there are no gait parameters. The examiner disagrees and refers to the arguments above concerning the algorithm disclosed by Plotnik-Peleg. The examiner further argues that a system monitoring a person’s gait would be monitoring gait parameters even if a person has stopped walking; just because a parameter may have a value of 0 does not mean the parameter is unmonitored (for example, a car stopped at a red light can still monitor velocity even though the car is not moving).
Finally, Applicant argues that combining a gait parameter with a program parameter is not obvious. The examiner refers to their arguments above, which they believe already addresses this argument.
See 103 rejections below.
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.
Claims 17-19 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.
Claims 17-19 refer to “said predicted distribution of sensor data values.” This has insufficient antecedent basis, as claim 1 referred to “the predicted distribution of sensor data values.” For examination purposes, it will be assumed that both refer to the same thing. To correct this, use “the” or “said” consistently in each claim.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6, 9, 16-19, 23-24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1).
Regarding claim 1, Pretzer-Aboff discloses a system for applying sensory stimulation to a subject's foot or ankle based on detected gait kinematics for therapy, training, or movement assistance (Abstract: “A device adapted to be secured to the foot of a user includes one or more vibration actuators configured to provide vibrations to the user's foot”; ¶6: “The controller may…operate in a feedback mode in which the plurality of vibration actuators are activated to provide vibration to the foot of the user based directly upon information sensed by the one or more force or acceleration sensors.” ¶18: “The systems and methods disclosed herein are usable to improve a user's gait, e.g., by developing or maintaining the user's natural walking ability. Generally, these systems and related methods for generating vibration that assists a user walking under the user's own power to avoid Freezing of Gait”), said system comprising:
at least one item of footwear (Fig. 1A, shoe 110) incorporating one or more sensors (Fig. 1A, force or acceleration sensors 130-130c), one or more vibration actuators (Fig. 1A, vibration actuators 150a and 150b), a data processor (Fig. 1A, microprocessor 170), memory (¶25: “Vibratory system 100 may include a data storage component), and a data transceiver (¶27: “The communications modules 180, 181, 183 are preferably transceivers”; see Fig. 1A, wireless communication module 180), and
a remote computing system comprising data communication means and data processing means (¶26: “A centralized monitoring center may remotely monitor user data from multiple systems at the same time. Sensor data may be further processed and analyzed to identify characteristics of the user's gait”; Fig. 1A, remote monitoring unit 182 and cloud 184).
Pretzer-Aboff does not explicitly disclose all of the remaining limitations of claim 1.
Plotnik-Peleg teaches a method and system for detecting, predicting, and treating freezing of gait (FOG) (Abstract). As part of the invention, Plotnik-Peleg teaches generating sensor data associated with movement of a subject, and communicating the sensor data to a computing system, which is then configured to process the sensor data to generate one or more parameters associated with a subject’s gait kinematics (¶318: “a short monitoring period may be carried out during which [an] algorithm learns [a] patient's normal (e.g., variable or not) gait as well as freezing episodes”) and generate, using the parameters and one or more program parameters associated with a program of therapy, training, or movement assistance (¶318: the monitoring may include input from “a user [to] tag suspected FOG events and these can be used to subsequently teach the algorithm”), predictions about the kind of movement which indicates a risk for FOG (¶48: “measurements of gait are used to identify an increased risk for imminent FOG and preventive action is optionally taken”). If further measured data satisfies the predictions, sensory stimulation may be applied (¶169: “such a system, in addition to or alternatively to providing warnings, provides signals or cues to help prevent and/or break out of a FOG situation. This could be in the form of vibratory or auditory cues or electrical stimulation to a limb or other part of the body.”).
While Plotnik-Peleg does not explicitly teach that the predictions involve generating predicted distributions of sensor data values, however it would have been obvious to do so in order to provide some quantitative method for concluding whether a set of sensor measurements satisfy or do not satisfy the predictions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Plotnik-Peleg with the invention of Pretzer-Aboff by:
configuring said sensors to, during a calibration phase, generate calibration sensor data associated with movement of a subject wearing the item of footwear and said data transceiver is configured to communicate the calibration sensor data to said remote computing system, and
configuring said remote computing system to
receive, via the data communication means, the calibration sensor data from the item of footwear, and process, using the data processing means, the calibration sensor data to:
generate one or more gait parameters associated with the subject's gait kinematics;
generate, using the gait parameters and one or more program parameters associated with a program of therapy, training, or movement assistance, a predicted distribution of sensor data values within which further sensor data generated by the one or more sensors is predicted to fall in the event of movement of the subject requiring sensory stimulation to be applied in accordance with the program of therapy, training or movement assistance,
communicate, via the data communication means, the predicted distribution of sensor data values to said data transceiver, and
configuring said data transceiver to receive the predicted distribution of sensor data values and said memory to store the predicted distribution of sensor data values,
whereupon, during an operational phase said data processor is configured to monitor further sensor data from the one or more sensors, and, in the event that the further sensor data from the one or more sensors falls within the predicted distribution of sensor data values, said data processor is configured to control the one or more vibration actuators to provide sensory stimulation in accordance with the program of therapy, training or movement assistance.
Doing so would enable one to use past data to make predictions about future risk events, then monitor for risk factors and provide physical stimuli to prevent or mitigate FOG. Furthermore, by sending the predictions directly to the shoe, risk factors can be monitored and addressed even in the event that communications with a remote computing module fails.
Regarding claim 23, claim 23 recites the method applied by the system of claim 1 and is therefore rejected for the same reasons.
Regarding claim 24, claim 24 recites an arrangement for fitting to an item to be sued in a system according to claim 1, but does not recite any further limitations not found within claim 1. Claim 24 is therefore rejected for the same reasons as claim 1.
Regarding claim 27, claim 27 recites a non-transitory computer-readable medium having thereon a computer program, implemented in a processor in an item of footwear, which is capable of performing the method performed by the data processor of claim 1. Pretzer-Aboff discloses that the controller 17 is programmed (¶24). The other limitations of claims 27 are found in claim 1. It would have been obvious to one of ordinary skill in the art to provide software to enable the item of footwear to perform its functions autonomously. Other arguments for the rejection of claim 27 are found in the rejection of claim 1.
Regarding claim 2, claim 2 merely recites collecting more sensor data, using the extra data to update the predictive distribution, and sending the updated distribution to the item of footwear so it may compare values to the updated predictive distribution. It would have been obvious to one of ordinary skill in the art practicing the invention of Pretzer-Aboff in view of Plotnik-Peleg to do this in order to make more accurate FOG predictions. Plotnik-Peleg also implies a similar process of collecting more data to refine predictions (¶318: “a short monitoring period may be carried out during which [an] algorithm learns [a] patient's normal (e.g., variable or not) gait as well as freezing episodes” and “a user [may] tag suspected FOG events and these can be used to subsequently teach the algorithm”; it is common in teaching to progress iteratively from worse to better predictions as more data is gathered). The rest of the limitations are found in the language of claim 1.
Regarding claim 3, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 2. Furthermore, it would have been obvious to one of ordinary skill in the art practicing the invention of Pretzer-Aboff in view of Plotnik-Peleg to configure the data processing means to periodically generate the updated predicted distribution of sensor data values at a predetermined interval and/or responsive to an update signal from said remote computing system. Doing so would enable the remote computing system to make more accurate FOG predictions over time (see rejection of claim 2; note that the limitations of claim 2 imply the limitations of claim 3, since the remote computing system would surely generate a command signal to perform an update to the predicted distribution prior to carrying out the command).
Regarding claim 4, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1. Plotnik-Peleg further teaches that the gait parameters include one or more of step length, rhythm, asymmetry, and step characteristics (¶188: “one or more of the following features which may be found in FOG patients (especially secondary to PD) are measured and/or monitored, especially in response to various provocations: Impairments in step length scaling, reduced dynamic control of postural stability, increased gait asymmetry, poor bilateral coordination of gait and rhythmicity”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Plotnik-Peleg with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the gait parameters to include one or more of step length, rhythm, asymmetry, and step characteristics. Doing so would enable one to consider how those factors may individually or in combination affect FOG.
Regarding claim 6, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, and Pretzer-Aboff further discloses that the item of footwear incorporates a plurality of vibration actuators (Abstract: “A device adapted to be secured to the foot of a user includes one or more vibration actuators”).
Regarding claim 9, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, and Pretzer-Aboff further discloses that the sensory stimulation is tactile cueing (¶18: “these systems and related methods [are] for generating vibration that assists a user walking under the user's own power to avoid Freezing of Gait (FoG).” Tactile cueing describes physical sensations to describe actions, convey information, or help someone develop a skill, such as avoiding FOG.).
Regarding claim 16, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1. Furthermore, Plotnik-Peleg teaches that FOG is related to falling risk (¶5: “FOG has a grave impact on quality of life as it is largely associated with falls”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Plotnik-Peleg with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the program of therapy, training or movement assistance to be a program of movement assistance for alerting a subject to a potential fall, the predicted distribution of sensor data values corresponding to a range of sensor values predicted to arise in the event the subject's gait kinematics change in such a way indicating an imminent fall, said data processor thereby operable to control the one or more vibration actuators to generate sensory stimulation in the event of an imminent fall being detected. Doing so would enable one to attempt to mitigate fall risks, which are a serious health hazard and are associated with FOG.
Regarding claim 17, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1 and further teaches the limitations of claim 17 (the “program of therapy, training or movement assistance” for both Pretzer-Aboff and Plotnik-Peleg is a program of training patients to avoid or mitigate the effects of FOG; see rejection of claim 1).
Regarding claim 18, inasmuch as movement indicating an imminent FOG episode can be described as undesirable movement, the arguments for rejecting claim 17 may be used to reject claim 18.
Regarding claim 19, inasmuch as movement indicating an imminent FOG episode can be described as desirable movement, the arguments for rejecting claim 17 may be used to reject claim 18 (one could argue that the movement is desirable in the sense that it presages FOG without actually signaling an episode of FOG, thus it grants the technology an opportunity to prevent FOG. In any case, whether the movement is considered “desirable” or “undesirable” is a matter of perspective.).
Claims 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1), and further in view of Galica (“Subsensory Vibrations to the Feet Reduce Gait Variability in Elderly Fallers”).
Regarding claim 5, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1 but does not teach the limitations of claim 5.
Galica teaches that subsensory vibrations can reduce gait variability, which may reduce fall risk (Abstract).
Plotnik-Peleg also teaches that high gait variability may account for higher FOG risk (¶304: “high variability of gait…could account [for] a higher risk for FOG’s”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Galica and Plotnik-Peleg with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the one or more vibration actuators to be configured to generate sub-sensory vibration. Doing so could reduce gait variability, thereby reducing probable risk factors for FOG.
Regarding claim 7, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1 but does not teach the limitations of claim 7.
Following the reasoning in the rejection of claim 5, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Galica and Plotnik-Peleg with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the one or more vibration actuators to be configured to generate sub-sensory vibration (see rejection of claim 5).
Noting the above, it also would have been obvious to configure the data processor to actuate each vibration actuator to generate foot stimulating vibration at a vibration level determined during a calibration process in which a subject's sensory perception is assessed at each foot position corresponding to a position of each vibration actuator thereby accommodating differences in sensory perception across the subject's foot. Doing so would enable one to assess the sensory threshold at each actuator location, thereby enabling one to provide sub-sensory vibration from any of the actuators.
Regarding claim 8, Pretzer-Aboff in view of Plotnik-Peleg and Galica teaches the limitations of claim 7. Noting that vibrations are typically associated with a frequency and amplitude, it would have been obvious to cause the vibration level to comprise a predetermined vibration frequency and/or predetermined vibration amplitude in order to provide a predetermined sub-sensory vibration.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1), and further in view of Sperling (GB 2538445 A).
Regarding claim 10, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, but does not explicitly teach the limitations of claim 10.
Sperling teaches including a vibration motor in the insole of an item of footwear (Pg. 8, ¶1: “the insole comprises a pressure sensor 120 and a vibration motor 130”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Sperling with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the one or more vibration actuators to be embedded insole of the at least one item of footwear in order to provide vibration to the person’s foot.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1), and further in view of Cha (US 10132646 B1).
Regarding claim 13, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, and Pretzer-Aboff further discloses that the sensors comprise one or more of an accelerometer (Abstract). Pretzer-Aboff in view of Plotnik-Peleg does not explicitly teach that the one or more sensors comprise one or more inertial measurement units (IMUs) comprising one or more of an accelerometer, gyroscope, and magnetometer.
Cha discloses a shoe with an IMU to gather ambulation data (Fig. 1, shoe 5 with IMU 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Cha with the invention of Pretzer-Aboff in view of Plotnik-Peleg to cause the one or more sensors to comprise one or more inertial measurement units (IMUs) comprising one or more of an accelerometer, gyroscope, and magnetometer. IMUs are useful for tracking an object’s motion, including a person’s.
Regarding claim 14, Pretzer-Aboff in view of Plotnik-Peleg and Cha teaches the limitations of claim 13. Pretzer-Aboff further discloses that the one or more sensors comprise a foot-pressure sensor (¶21: “In the exemplary embodiment shown in FIG. 1A, force (e.g. pressure) sensors 130a-130c include a heel sensor 130a configured to sense a force exerted by the user's heel, a ball sensor 130b configured to sense a force exerted by the ball of the user's foot, and a toe sensor 130c configured to sense a force exerted by one or more of the user's toes.”).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1), and further in view of Ashby (US 20190151712 A1).
Regarding claim 15, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, but does not explicitly teach the limitations of claim 15.
Ashby teaches a shoe which includes sensors enabling one to track distance traveled (¶5: “a shoe includes…a sensor coupled to and surrounded by the [shoe’s] sole.” ¶11: “The sensor can include an accelerometer and a gyroscope, wherein the accelerometer and gyroscope can be configured to detect one of a stride length, distance traveled, or gait cadence.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Ashby with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the at least one item of footwear to further incorporate movement distance tracking means configured to generate movement distance data associated with a distance moved by the item of footwear, and by causing said remote computing system to run thereon a movement distance analysis function, wherein said data transceiver is configured to communicate the movement distance data to said remote computing system for analysis by the movement distance analysis function to generate movement distance analysis data. Doing so would enable one to incorporate distance data among the number of factors which may individually or in combination provide a prediction regarding FOG risk.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ghassemzadeh (US 9418342 B2) teaches a method and apparatus for determining a mode of motion where testing data including gait data is received and algorithms are applied to calculate a likelihood that the testing data indicates a number of different modes of motion; then the mode with the highest likelihood is determined to be the mode of motion (Abstract).
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 ETHAN WESLEY EDWARDS whose telephone number is (571)272-0266. The examiner can normally be reached Monday - Friday, 7:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Schechter can be reached at (571) 272-2302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ETHAN WESLEY EDWARDS
Examiner
Art Unit 2857
/E.W.E./
Examiner, Art Unit 2857
/ANDREW SCHECHTER/
Supervisory Patent Examiner, Art Unit 2857