DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted September 11, 2025. Claims 1, 5 – 7, 10, 12, 15, and 19 – 20 are amended. Claims 1 – 20 are pending.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 15, and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The present application claims “wherein the determined first movement is characterized by a metric indicating an intensity of the first movement”, however, the specification fails to disclose a metric indicating an intensity of the movement. The specification of the present application discloses “[0050] The monitor 120 may confirm the first parameter(s) 122 and/or the second parameter(s) 126 based on the movement or position of the patient 102. For instance, the monitor 120 may confirm the first parameter(s) 122 and/or the second parameter(s) 126 detected during a time interval based on determining that the movement ( e.g., a velocity, acceleration, jerk, etc.) of the patient 102, during the time
interval, is less than a threshold movement ( e.g., a threshold velocity, acceleration, jerk, etc.). In some cases, the monitor 120 may confirm the first parameter(s) 122 and/or the second parameter(s) 126 based on determining that the position of the patient 102 is substantially unchanged during the time interval. For example, the monitor 120 may determine that the patient 102 has remained sitting upright during the time interval or has remained laying down during the interval. The movement or position of the patient 102 may therefore be an independent factor for confirming the first parameter(s) 122 and/or the second parameter(s) 126.” The specification mentions velocity, acceleration, etc., however, the specification fails to disclose how the intensity of movement is captured or detected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 – 2, 4 – 10, and 13 – 20 s/are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al., herein after Baker (U.S. Publication Number 2018/0214091 A1) in view of Kaikenger et al., herein after Kaikenger (U.S. Publication Number 2018/0146913 A1) further in view of McCombie et al., herein after McCombie (U.S. Publication Number 2015/0164437 A1).
Claim 1 (Currently Amended). Baker teaches a patient monitoring system, comprising:
a support structure configured to support an individual (paragraph 3 discloses a patient support assembly);
a first sensor integrated with the support structure and configured to detect a first parameter of the individual during the time interval (paragraph 3 discloses a patient monitoring system including a wearable sensor configured to acquire physiological data of a patient and a patient support assembly in communication with the wearable sensor; paragraph 20 discloses the sensor includes one or more components capable of acquiring physiological data, and sense one or more physiological signals; paragraph 48 discloses a time1 and a time2 indicating a change in time (interval); paragraph 86 discloses updated data is received during a period of time which can be seconds, minutes, or hours, indicating a time interval);
a second sensor integrated with the support structure and configured to detect a second parameter of the individual during the time interval (paragraph 20 discloses the sensor includes one or more physiological signals, multiple sensors can be used and positioned at different locations on the patient’s body; paragraph 48 discloses a time1 and a time2 indicating a change in time (interval); paragraph 86 discloses updated data is received during a period of time which can be seconds, minutes, or hours, indicating a time interval)); and
a monitor operably connected to the first sensor and the second sensor (paragraph 31 discloses one or more aspects of patient support assembly may be viewed or controlled by a caregiver, remotely, such as via an app on a smart phone or tablet, some embodiments include a wireless display including a touchscreen), the monitor comprising:
a display configured to output the first parameter (paragraph 31 discloses a wireless display including a touchscreen; paragraph 51 discloses a gateway in communication with displays viewable by one or more caregivers);
a transceiver configured to transmit, over a single transmission to an electronic medical record (EMR) server, data identifying the individual and indicating the first parameter (paragraph 21 discloses transmitting processed patient vital sign parameters; paragraph 80 discloses a network communication interface which facilitates communication between patient support assembly and various devices in the patient care system including network devices such as an electronic health record and clinician interfaces);
at least one processor communicatively coupled to the input device and the transceiver (paragraph 89 discloses at least one central processing unit, memory and a system bus that couples memory to the CPU, a basic input/output system contains the basic routines that help to transfer information within the computing device); and
memory storing instructions that, when executed by the at least one processor (paragraph 4 discloses a memory that stores instructions that when executed by the processing unit, cause the control unit to receive patient status, analyze patient status, and adjust an alarm setting);
Baker Hfails to explicitly teach the following limitations met by Kaikenger as cited:
cause the at least one processor to perform operations comprising:
determining, based on the second parameter, a first movement of at least a portion of the individual occurring during the time interval (paragraph 33 discloses a controller is configured to monitor the sensors to determine relative movement of the patient over time; paragraph 37 discloses the sensors may be configured for detecting additional characteristics of the patient such as heart rate, temperature, blood pressure, EKG, muscle movement, or other similar information, indicating one or more sensors used to measure one or more parameters),
confirming an accuracy of the first parameter based on determining that the position of the individual is substantially unchanged during the time interval (paragraph 12 discloses generating an alarm signal if the difference between the second position of the patient and the first position of the patient is indicative of an increased risk of the patient developing pressure ulcers due to inadequate movement of the patient’s limbs over the time interval; paragraph 35 discloses if the change in position or angle is inadequate to prevent pressure ulcers from developing on the patient, the controller generates an alarm signal to alert a caregiver, patient rotation system, and/or a hospital information system so that the patient may be repositioned; paragraph 52 discloses if the change in the orientation of the shoulder and hip lines is relatively small, the controller determines that the patient is supporting themselves on the same pressure
areas over the elapsed time period between data sets and the controller determines that the patient should be repositioned to relieve the pressure areas); and
based on confirming the accuracy of the first parameter, causing the transceiver to transmit the data to the EMR server (paragraph 54 discloses the controller is operable to notify the hospital information system of information related to the sensors, where the subroutine is operable to associate information regarding the sensors with the patient so that the information may be properly placed in the health information database and associated with the particular patients electronic medical record).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Baker to further include a system for preventing pressure ulcers on a patient supported on a patient support apparatus, where the system is configured to sense movement of the patient overtime as disclosed by Kaikenger.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Baker in this way since to provide information indicating whether the patient has moved relative to the patient support apparatus, and indicating whether the patient remains supported by the same pressure areas (Kaikenger: paragraph 4).
Baker and Kikenger Hfail to explicitly teach the following limitations met by McCombie as cited:
wherein the determined first movement is characterized by a metric indicating an intensity of the first movement (paragraph 10 discloses a body-worn monitor that measures a patient's vital signs ( e.g. metric) while simultaneously characterizing their activity state (e.g. resting, walking, convulsing, falling), which indicates the intensity of the movement; paragraph 16 discloses a time-dependent motion waveform which includes a signature (e.g. a rapid change in value) that can be further processed to indicate falling, thus an intensity of movement)
determining that the metric of the first movement is less than a threshold level corresponding to the metric (paragraph 27 discloses the processing component can process at least one motion waveform to determine a number of times the patient moves from lying in a first position to lying in a different position, and generate an alarm parameter if the number is less than a threshold value (e.g. once per four hours)).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Baker and Kikenger to further include a graphical mapping system for continuously monitoring a patient’s vital signs, motion, and location as disclosed by McCombie.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Baker and Kikenger in this way since to improve the safety of hospitalized patients, particularly those in lower-acuity areas, it is desirable to have a vital sign monitor operating algorithms featuring: 1) a low percentage of false positive alarms/alerts; and 2) a high percentage of true positive alarms/alerts (McCombie: paragraph 10).
Claim 2 (Previously Presented). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 1. Baker teaches a system wherein the first parameter comprises at least one of a heart rate of the individual, a blood pressure of the individual, a respiration rate of the individual, a capnograph of the individual, an oxygenation level of the individual, a temperature of the individual, a weight of the individual on the support structure, or a presence of moisture between the support structure and the individual (paragraph 20 discloses the sensor can include one or more components capable of acquiring physiological data, where the example sensors may include heart rate, respiration rate, and more; paragraph 40 discloses the patient support assembly includes RADAR, LIDAR, optical or other electromagnetic sensing systems for detection of patient movement, heart rate, and respiration rate),
and wherein the first parameter is different from the second parameter (paragraph 20 discloses the sensor can include one or more components capable of acquiring physiological data, where the example sensors may include heart rate, respiration rate, and more which indicates more than one sensor).
Claim 4 (Previously Presented). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 1. Baker teaches a system further comprising: wherein the second sensor comprises at least one of a load cell, a temperature sensor, a camera, or a microphone (Figure 5 discloses a camera/microphone; paragraph 20 discloses a temperature sensor; paragraph 38 discloses a plurality of load cells).
Claim 5 (Currently Amended). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 1. Baker teaches a system wherein the operations further comprise determining, based on the second parameter, that the individual is at least one of supported by the support structure, sitting upright on the support structure, or laying down on the support structure (paragraph 24 discloses a sensor can be configured to acquire data often, but non-continuously, for various physiological parameters; paragraph 34 discloses the patient support assembly is capable of being adjusted between various configuration of flat to upright; paragraph 61 discloses algorithms receive and process parameters relating to a patient and patient support assembly, the algorithms can determine actions, such as patient support assembly adjustments, based on one or more of: vital signs, patient age, diagnosis, patient movement, and physician orders. For example, a patient at risk for aspiration, algorithms cause patient support assembly to set, or prompt the clinician to set, a head of bed angle to a minimum angle, such as 30 degrees),
and wherein the first movement is determined based on sound captured by the second sensor (Figure 5 discloses a camera/microphone; paragraph 80 discloses communication between patient support assembly and various devices in example patient care system, including networked devices such as EHR and clinician interfaces such as personal computers, laptops, carts-on-wheels, and the like, including a camera/microphone).
Claim 6 (Currently Amended). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 4.
Baker Hfails to explicitly teach the following limitations met by Kaikenger as cited:
wherein: determining the first movement comprises determining that the individual has not sat up or laid down during the time interval (paragraph 12 discloses generating an alarm signal if the difference between the second position of the patient and the first position of the patient is indicative of an increased risk of the patient developing pressure ulcers due to inadequate movement of the patient’s limbs over the time interval, indicating lack of movement), and
the portion of the individual comprises a limb of the individual (paragraph 12 discloses generating an alarm signal if the difference between the second position of the patient and the first position of the patient is indicative of an increased risk of the patient developing pressure ulcers due to inadequate movement of the patient’s limbs over the time interval, indicating lack of movement; claim 8).
The motivation to combine the teachings of Baker, Kaikenger, and McCombie is discussed in the rejection of claim 1, and incorporated herein.
Claim 8 (Previously Presented). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 7. Baker teaches a system wherein the second sensor comprises at least one of a load cell, a temperature sensor, a camera, a moisture sensor, or a microphone integrated with the support structure (Figure 5; paragraph 20 discloses temperature sensors; paragraph 80 discloses camera/microphone).
Claim 9 (Previously Presented). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 7. Baker teaches a system wherein the transceiver is configured to transmit the data identifying the individual and indicating the vital sign to an aggregator, the aggregator being configured to transmit the data in a single transmission to the EMR server (paragraph 21 discloses transmitting processed patient vital sign parameters; paragraph 80 discloses a server that includes a network communication interface, which facilitates communication between patient support assembly and various devices in the patient care system including network devices such as an electronic health record and clinician interfaces).
Claim 10 (Currently Amended). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 7. Baker teaches a system wherein the operations further comprise: determining, based on the parameter determined by the second sensor, that the individual is at least one of supported by the support structure, sitting upright on the support structure, or laying down on the support structure (paragraph 24 discloses a sensor can be configured to acquire data often, but non-continuously, for various physiological parameters; paragraph 34 discloses the patient support assembly is capable of being adjusted between various configuration of flat to upright; paragraph 61 discloses algorithms receive and process parameters relating to a patient and patient support assembly, the algorithms can determine actions, such as patient support assembly adjustments, based on one or more of: vital signs, patient age, diagnosis, patient movement, and physician orders. For example, a patient at risk for aspiration, algorithms cause patient support assembly to set, or prompt the clinician to set, a head of bed angle to a minimum angle, such as 30 degrees).
Claim 13 (Previously Presented). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 7. Baker teaches a system wherein the transceiver is configured to transmit the data to the EMR server in a single transmission (paragraph 21 discloses transmitting processed patient vital sign parameters; paragraph 80 discloses a server that includes a network communication interface which facilitates communication between patient support assembly and various devices in the patient care system including network devices such as an electronic health record and clinician interfaces), and wherein the operations further comprise:
accessing historical data, associated with the individual, from the EMR (paragraph 48 discloses comparing live data received from patient support assembly and EMR to historical patient data; paragraph 83 discloses data includes historical data and other data, such as diagnosis, treatment, and medications, entered into a patient’s EMR);
determining a baseline corresponding to the vital sign based on the historical data (paragraph 83 discloses data includes historical data and other data, such as diagnosis, treatment, and medications, entered into a patient’s EMR where the historical data in the patient’s EMR is interpreted as the baseline; paragraph 87 discloses patient health trends can be identified); and
causing the transceiver to transmit the data to the EMR server based at least in part on a comparison between the vital sign detected by the first sensor and the baseline (paragraph 48 discloses a gateway determines an updated patient status by comparing live data received from patient support assembly and EMR to historical data for that patient. Broadly, updated patient status looks for changes in the patient's health, such as deterioration, which could indicate a future incident is possible; paragraph 86 discloses the gateway device referenced above transmits a request for updated patient-related data to the patient support assembly and/or electronic medical records database).
Claim 14 (Original). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 7. Baker teaches a system wherein the first sensor is physically integrated with the support structure (paragraph 3 discloses a patient support assembly; paragraph 3 discloses a patient monitoring system including a wearable sensor configured to acquire physiological data of a patient and a patient support assembly in communication with the wearable sensor; paragraph 20 discloses the sensor includes one or more components capable of acquiring physiological data, and sense one or more physiological signals).
System and method claims 7 and 15 – 20 repeat the subject matter of claims 1 – 2, 4 – 6, 8 – 10, and 13 – 14. As the underlying processes of claims 7 and 15 – 20 have been shown to be fully disclosed by the teachings of Baker, Kaikenger, and McCombie in the above rejections of claims 1 – 2, 4 – 6, 8 – 10, and 13 – 14; as such, these limitations (7 and 15 – 20) are rejected for the same reasons given above for claims 1 – 2, 4 – 6, 8 – 10, and 13 – 14 and incorporated herein.
Claim(s) 3, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al., herein after Baker (U.S. Publication Number 2018/0214091 A1) in view of Kaikenger et al., herein after Kaikenger (U.S. Publication Number 2018/0146913 A1) further in view of McCombie et al., herein after McCombie (U.S. Publication Number 2015/0164437 A1) and in view of Hallwachs (U.S. Publication Number 2015/0363563 A1).
Claim 3 (Original). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 1.
Baker, Kaikenger, and McCombie fail to explicitly teach the following limitations met by Hallwachs as cited:
wherein the transceiver is configured to transmit the data in a single data stream (paragraph 21 discloses the central server to request an aggregated patient data record and to combine the requested aggregated patient data record with identifying PHI information for transmission; paragraph 77 discloses the SNG (Single Network Gateway) can include a logical network function that can be an embedded function of the SNA (Single Network Appliance) forming a single unit for deployment, all sensor network functions can be connected to any external component via open and global standards based connectivity, e.g., a first communication line connecting the SNG and a network of a secure data message using the HL7 protocol to an electronic medical record (EMR) system, on behalf of the patient).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Baker, Kaikenger, and McCombie to further include automated deployment of remote measurement, patient monitoring, and home care and multi- media collaboration in health care and telemedicine as disclosed by Hallwachs.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Baker, Kaikenger, and McCombie in this way since to provide improved patient care by providing a greater number of sensors and/or by gathering different types of data (e.g. by monitoring different physiological sensors) with sensors (Hallwachs: paragraph 61).
Claim 11 (Previously Presented). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 7.
Baker, Kaikenger, and McCombie fail to explicitly teach the following limitations met by Hallwachs as cited:
Wherein the operations further comprise receiving a user input, via the monitor, indicating a validity of the vital sign output by the display, the processor causing the transceiver to transmit the data to the EMR server based at least in part on the user input (paragraph 127 discloses the care path can include a series of stages, during each of which a portion of the patient's care can take place, with each of the portions collectively defining a prescription and care delivery process for the patient. Between each of the stages the patient's EMR can be updated in the EMR sub-system to reflect information gathered during the previous stage, thereby allowing the following stage to be based on accurate, current information).
The motivation to combine the teachings of Baker, Kaikenger, McCombie, and Hallwachs is discussed in the rejection of claim 3, and incorporated herein.
Claim 12 (Currently Amended). Baker, Kaikenger, and McCombie teach the patient monitoring system of claim 7. Baker teaches the vital sign being a first vital sign, the data being first data (paragraph 41 discloses patient vitals), the monitoring system further comprising:
a third sensor operably connected to the monitor and configured to detect a second vital sign of the individual, (paragraph 38 discloses movement sensors such as radar, lidar, and pressure transducers; paragraph 77 discloses detection of patient movement, heart rate, and respiration rate) wherein:
the display is configured to output the second vital sign with the first vital sign (paragraph 31 discloses a wireless display including a touchscreen; paragraph 51 discloses a gateway in communication with displays viewable by one or more caregivers),
Baker, Kaikenger, and McCombie fail to explicitly teach the following limitations met by Hallwachs as cited:
the operations further comprise determining that a position of the individual confirms the accuracy of the second vital sign (paragraph 61 discloses the care provider can therefore be better able to treat the patient because the care provider can have a more complete and accurate picture of the patient's condition and/or because the care provider can receive sensor-gathered data even when the patient is remotely located from the care provider ( e.g., by receiving information over a network)), and
the transceiver is further configured to transmit, to the EMR system, second data indicating the second vital sign (paragraph 127 discloses between each of the stages the patient's EMR can be updated in the EMR sub-system to reflect information gathered during the previous stage, thereby allowing the following stage to be based on accurate, current information).
The motivation to combine the teachings of Baker, Kaikenger, McCombie, and Hallwachs is discussed in the rejection of claim 3, and incorporated herein.
Response to Arguments
Applicant's arguments filed September 11, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
The Applicant argues the Office Action fails to teach or suggest “determining, based on the second parameter, a first movement of at least a portion of the individual occurring during the time interval, wherein the determined first movement is characterized by a metric indicating an intensity of the first movement; determining that the metric of the first movement is less than a threshold level corresponding to the metric; confirming an accuracy of the first parameter based on: the second parameter, and determining that the metric of the first movement is less than the threshold level,” as recited by amended independent claim 1. It is respectfully submitted that the Examiner has applied new passages of the prior art to the amended claims. The Examiner notes that the amended limitations were not in the previously pending claims; as such, Applicant’s remarks with the regard to the amendments of the application are addressed in the above Office Action.
The Applicant argues McCombie or the remaining applied references do not teach or suggest “confirming an accuracy of the first parameter based on: the second parameter, and determining that the metric of the first movement is less than the threshold level,”. The Examiner respectfully disagrees. The Examiner submits McCombie discloses a body-worn monitor that measures a patient's vital signs ( e.g. metric) while simultaneously characterizing their activity state (e.g. resting, walking, convulsing, falling), which indicates the intensity of the movement (paragraph 10) and
the processing component can process at least one motion waveform to determine a number of times the patient moves from lying in a first position to lying in a different position, and generate an alarm parameter if the number is less than a threshold value (e.g. once per four hours) (paragraph 27). Thus, Applicant’s argument is not persuasive and the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.K.R/Examiner, Art Unit 3682 /ROBERT A SOREY/Primary Examiner, Art Unit 3682