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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/06/2026 has been entered.
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 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.
In making the below rejections, the examiner has considered and addressed each of the applicants arguments. Claims 1-20 are currently pending and being examined.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 1-3, 8-13, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan (USPN 9,526,834) in view of Desborough (USPAP 2018/0200441).
In reference to independent claim 1, Keenan discloses an ambulatory infusion pump system (everything in fig 2 other than the user 20, shows a pump that is worn on the body meaning it is ambulatory, in reference to the term “ambulatory” it has been held that the recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex part Masham, 2 USPQ2d 1647 (1987). ), comprising:
a pump mechanism (34) configured to facilitate delivery of a medicament to a patient (20); a memory (col 2, lines 39-42 discloses “presented here is a tangible and non-transitory electronic storage medium having processor-executable instructions that, when executed by a processor architecture comprising at least one processor device”) adapted to store an open-loop basal rate profile for the patient (col 2 lines 39-54 discloses “presented here is a tangible and non-transitory electronic storage medium having processor-executable instructions that, when executed by a processor architecture comprising at least one processor device, perform a method of controlling an insulin infusion device for a user--- determining an adjusted insulin infusion rate based at least in part on the calculated IOB rate and an uncompensated insulin infusion rate, and selecting a final insulin infusion rate for the insulin infusion device, wherein either the determined adjusted insulin infusion rate, the uncompensated insulin infusion rate, or a current basal rate is selected as the final insulin infusion rate”);
a communications interface adapted to receive glucose levels from a continuous glucose monitor (col 13, lines 42-44 discloses “a sensor blood glucose/intravenous insulin infusion system can use a continuous glucose sensor”); and at least one processor (col 11, lines 12-19 discloses “The glucose sensor system 10 generates a sensor signal 16 representative of blood glucose levels 18 in the body 20, and provides the sensor signal 16 to the controller 12. The controller 12 receives the sensor signal 16 and generates commands 22 that are communicated to the insulin delivery system 14. The insulin delivery system 14 receives the commands 22 and infuses insulin 24 into the body 20 in response to the commands 22”) configured to:
cause the pump mechanism (34 which is a portion of 14) to deliver the medicament to the patient in a closed-loop mode in which therapy parameters are automatically determined and medicament is automatically delivered according to the therapy parameters based on the glucose levels from the continuous glucose monitor (col 57, lines 44-52 discloses “the insulin delivery system 14 sends sensor glucose (SG) values, sensor Isig values, calibration factors, “insulin delivered” values, and other data as needed to the controller 12 in accordance with a predetermined schedule, e.g., at five minute intervals. The controller 12 determines the desired insulin dose based on the closed-loop algorithm to maintain the patient at a target glucose setpoint, and communicates suitable control data and instructions to the insulin delivery system 14”);
terminate the closed-loop mode and activate an open-loop mode; and gradually transition from the therapy parameters from the closed-loop mode to the open-loop basal rate profile stored in memory (col 60, lines 19-22 discloses “final target glucose value 946 enables the system to make a smoother transition between open-loop and closed-loop modes (by gradually adjusting the final target glucose value 946)”).
Keenan does not teach making the transition upon entering the open-loop mode.
Desborough, a similar ambulatory pump system, teaches making the transition upon entering the open-loop mode (para 0039 discloses “In some cases, methods, systems, and devices can deliver basal insulin according to a feedback delivery mode during a certain period of time after the delivery of long-acting insulin (e.g., 24 hours), but only deliver a reduced percentage (e.g., 25%) of BBR when the system enters an open-looped mode during that certain period of time in order to ensure that the PWD does not receive excessive insulin when glucose data is not being used to modulate basal insulin deliveries.” Desborough discloses modulating the baseline basal rate of insulin when initially transitioning into open-loop mode,
para 0047 also discloses “any personalization algorithm and predetermined variations on the BBR are within the scope of the present disclosure. For example, the personalization algorithm may include 0×, 0.5×, 0.75×, 1×, 1.25×, 1.5×, 2×, 2.5×, 3×”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to initially modulate the open-loop control as taught in Desborough in the method of Keenan so “the control device may adjust the personalization of insulin delivery” para 0006, Desborough. To be clear the modification is done by modulating the open-loop basal rate initially to make the transition from open-loop to closed-loop gradual, rather than changing the closed-loop numbers to the open-loop values.
In reference to independent claim 11, Keenan discloses a method of diabetes therapy, comprising: storing an open-loop basal rate profile for a patient (col 2 lines 39-54 discloses “presented here is a tangible and non-transitory electronic storage medium having processor-executable instructions that, when executed by a processor architecture comprising at least one processor device, perform a method of controlling an insulin infusion device for a user--- determining an adjusted insulin infusion rate based at least in part on the calculated IOB rate and an uncompensated insulin infusion rate, and selecting a final insulin infusion rate for the insulin infusion device, wherein either the determined adjusted insulin infusion rate, the uncompensated insulin infusion rate, or a current basal rate is selected as the final insulin infusion rate”); receiving glucose levels from a continuous glucose monitor (col 13, lines 42-44 discloses “a sensor blood glucose/intravenous insulin infusion system can use a continuous glucose sensor”); and delivering medicament to the patient with an infusion pump (34 which is a part of 14) in a closed-loop mode in which therapy parameters are automatically determined and medicament is automatically delivered according to the therapy parameters based on the glucose levels from the continuous glucose monitor (col 57, lines 44-52 discloses “the insulin delivery system 14 sends sensor glucose (SG) values, sensor Isig values, calibration factors, “insulin delivered” values, and other data as needed to the controller 12 in accordance with a predetermined schedule, e.g., at five minute intervals. The controller 12 determines the desired insulin dose based on the closed-loop algorithm to maintain the patient at a target glucose setpoint, and communicates suitable control data and instructions to the insulin delivery system 14”);
terminating the closed-loop mode and activating an open-loop mode (done in 976, 984, fig 49 and 1018-1020 fig 50); and gradually transitioning from the therapy parameters from the closed-loop mode to the open- loop basal rate profile stored in memory (col 60, lines 19-22 discloses “final target glucose value 946 enables the system to make a smoother transition between open-loop and closed-loop modes (by gradually adjusting the final target glucose value 946)”).
Keenan does not teach making the transition upon entering the open-loop mode.
Desborough, a similar ambulatory pump system, teaches making the transition upon entering the open-loop mode (para 0039 discloses “In some cases, methods, systems, and devices can deliver basal insulin according to a feedback delivery mode during a certain period of time after the delivery of long-acting insulin (e.g., 24 hours), but only deliver a reduced percentage (e.g., 25%) of BBR when the system enters an open-looped mode during that certain period of time in order to ensure that the PWD does not receive excessive insulin when glucose data is not being used to modulate basal insulin deliveries.” Desborough discloses modulating the baseline basal rate of insulin when initially transitioning into open-loop mode,
para 0047 also discloses “any personalization algorithm and predetermined variations on the BBR are within the scope of the present disclosure. For example, the personalization algorithm may include 0×, 0.5×, 0.75×, 1×, 1.25×, 1.5×, 2×, 2.5×, 3×”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to initially modulate the open-loop control as taught in Desborough in the method of Keenan so “the control device may adjust the personalization of insulin delivery” para 0006, Desborough. To be clear the modification is done by modulating the open-loop basal rate initially to make the transition from open-loop to closed-loop gradual, rather than changing the closed-loop numbers to the open-loop values.
In reference to dependent claim 2, Keenan in view of Desborough discloses the ambulatory infusion pump system of claim 1, Keenan further discloses the method wherein the gradual transition is linear (fig 24c shows a linear insulin response, col 14 lines 41-44 discloses “integral component U.sub.I of the PID controller represents a second phase insulin response 442, which is a steady increase in insulin release”).
In reference to dependent claim 3, Keenan in view of Desborough discloses the ambulatory infusion pump system of claim 1, Keenan further discloses the method wherein the gradual transition is non-linear (fig 24e shows a non-linear insulin response, col 14 lines 41-44 discloses “A proportional component U.sub.P and a derivative component U.sub.D of the PID controller may be combined to represent a first phase insulin response 440, which lasts several minutes. An integral component U.sub.I of the PID controller represents a second phase insulin response 442”).
In reference to dependent claim 8, Keenan in view of Desborough discloses the ambulatory infusion pump system of claim 1, Keenan further discloses the system wherein the closed-loop mode is terminated if the communications interface is not receiving glucose levels from the continuous glucose monitor (col 63, lines 27-31 discloses “For missed data packets totaling a time longer than the lower threshold and shorter than an upper threshold of time (e.g., 60 minutes), the missed transmission module 916 will switch the system to a pre-programmed safe basal rate, as indicated by block 982 in FIG. 49.”).
In reference to dependent claim 9, Keenan in view of Desborough discloses the ambulatory infusion pump system of claim 1, Keenan further discloses a system wherein the closed-loop mode is terminated if it is determined the glucose levels from the continuous glucose monitor may be inaccurate or unreliable (col 63, lines 9-14 disclose “Should the model-predicted glucose and the sensor glucose values differ significantly, the system will exit closed loop mode. Accordingly, the model supervisor module 914 regulates whether the system remains in the closed-loop mode 974 or switches to the open-loop mode 976.”).
In reference to dependent claim 10, Keenan in view of Desborough discloses the ambulatory infusion pump system of claim 1, Keenan further discloses a system wherein the closed-loop mode is manually terminated by the patient (col 62, lines 27-30 discloses “The closed-loop mode may be ended in response to a user-initiated command, automatically in response to the detection of operating conditions that are usually indicative of open-loop operation, or the like.”).
In reference to dependent claim 12, Keenan in view of Desborough discloses the method of claim 11, Keenan further discloses a system wherein gradually transitioning includes linearly transitioning to the open-loop basal rate profile (fig 24c shows a linear insulin response, col 14 lines 41-44 discloses “integral component U.sub.I of the PID controller represents a second phase insulin response 442, which is a steady increase in insulin release”).
In reference to dependent claim 13, Keenan in view of Desborough discloses the method of claim 11, Keenan further discloses a system wherein gradually transitioning includes a non-linear transition to the open-loop basal rate profile (fig 24e shows a non-linear insulin response, col 14 lines 41-44 discloses “A proportional component U.sub.P and a derivative component U.sub.D of the PID controller may be combined to represent a first phase insulin response 440, which lasts several minutes. An integral component U.sub.I of the PID controller represents a second phase insulin response 442”).
In reference to dependent claim 18, Keenan in view of Desborough discloses the method of claim 11, Keenan further discloses the method wherein the closed-loop mode is terminated if glucose levels are not being received from the continuous glucose monitor (col 63, lines 27-31 discloses “For missed data packets totaling a time longer than the lower threshold and shorter than an upper threshold of time (e.g., 60 minutes), the missed transmission module 916 will switch the system to a pre-programmed safe basal rate, as indicated by block 982 in FIG. 49.”).
In reference to dependent claim 19, Keenan in view of Desborough discloses the method of claim 11, Keenan further discloses the method wherein the closed-loop mode is terminated if it is determined the glucose levels from the continuous glucose monitor may be inaccurate or unreliable (col 63, lines 9-14 disclose “Should the model-predicted glucose and the sensor glucose values differ significantly, the system will exit closed loop mode. Accordingly, the model supervisor module 914 regulates whether the system remains in the closed-loop mode 974 or switches to the open-loop mode 976.”).
In reference to dependent claim 20, Keenan in view of Desborough discloses the method of claim 11, Keenan further discloses the method wherein closed loop the closed-loop mode is manually terminated by the patient (col 62, lines 27-30 discloses “The closed-loop mode may be ended in response to a user-initiated command, automatically in response to the detection of operating conditions that are usually indicative of open-loop operation, or the like.”).
Claims 4-7 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan (USPN 9,526,834) in view of Desborough (USPAP 2018/0200441) further in view of Rack-Gomer (USPAP 2015/0289823).
In reference to dependent claim 4, Keenan in view of Desborough teaches the ambulatory infusion pump system of claim 1, however
Keenan and Desborough are silent to wherein the processor is further configured to determine a risk of hyperglycemia or hypoglycemia from the open-loop basal rate profile and a speed for the gradual transition is based on the risk.
Rack-Gomer, a similar glucose control system teaches wherein the processor is further configured to determine a risk of hyperglycemia or hypoglycemia (para 0245 discloses “Several mathematical frameworks and inputs can be employed to determine a user's risk state of hypoglycemia and hyperglycemia. One example of how to estimate a user's risk state is described below, which employs parameters and variables including the current glucose level, the current glucose rate of change, and the glucose change direction to provide a risk value. In certain implementations of systems and methods according to present principles, glucose acceleration, as well as duration of time in a hypoglycemic or hyperglycemic state are added as inputs to arrive at a GUI.” GUI is Glycemic Urgency Index) from the open-loop basal rate profile (the “parameters” in the cite above) and a speed for the gradual transition (moderate insulin delivery in the cite below can be interpreted to be transitioning from closed to open) is based on the risk (para 0322 discloses “ the GUI may be translated or transformed to an insulin pump command using an appropriate mapping, look-up table, or function. The same may be displayed to the user, to enter as a pump command on a separate pump, or may be directly provided to a pump to dispense insulin in a closed loop system. In more detail, the same may be used to moderate insulin delivery, e.g., suspending, reducing, or increasing basal or bolus insulin delivery, based on glycemic risk state.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the risk determination method as taught in Rack-Gomer in the pump of Keenan in view of Desborough “to provide alerts and alarms which are more useful to the user, i.e., more “actionable”, in the sense that users become aware of or can deduce easily an appropriate action to take given the alert or alarm. Such are also more accurate in the sense of more correctly reflecting a current glycemic urgency assessment for the user” para 0102; Rack-Gomer.
In reference to dependent claim 5, Keenan in view of Desborough and Rack-Gomer teaches the ambulatory infusion pump system of claim 4, Rack-Gomer further discloses a method wherein the speed for the gradual transition is greater if there is a low risk of both hyperglycemia and hypoglycemia (para 0322 discloses “ the GUI may be translated or transformed to an insulin pump command using an appropriate mapping, look-up table, or function. The same may be displayed to the user, to enter as a pump command on a separate pump, or may be directly provided to a pump to dispense insulin in a closed loop system. In more detail, the same may be used to moderate insulin delivery, e.g., suspending, reducing, or increasing basal or bolus insulin delivery, based on glycemic risk state.” The cite speaks to moderating insulin delivery as a function of the risk, GUI, as a natural result the lower the risk of hyperglycemia and hypoglycemia the speed would be lower).
In reference to dependent claim 6, Keenan in view of Desborough and Rack-Gomer teaches the ambulatory infusion pump system of claim 4, Rack-Gomer further discloses a method wherein the at least one processor is configured to determine the risk of hyperglycemia or hypoglycemia based on one or more of a most recent glucose level from the continuous glucose monitor (para 0245 discloses “Several mathematical frameworks and inputs can be employed to determine a user's risk state of hypoglycemia and hyperglycemia. One example of how to estimate a user's risk state is described below, which employs parameters and variables including the current glucose level, the current glucose rate of change, and the glucose change direction to provide a risk value. In certain implementations of systems and methods according to present principles, glucose acceleration, as well as duration of time in a hypoglycemic or hyperglycemic state are added as inputs to arrive at a GUI.” GUI is Glycemic Urgency Index), a most recent glucose level trend based on the glucose levels from the continuous glucose monitor (“current glucose rate of change” above), a future glucose level prediction and whether and how long the closed-loop made was delivering medicament greater or lower than the open- loop basal rate profile.
In reference to dependent claim 7, Keenan in view of Desborough and Rack-Gomer teaches the ambulatory infusion pump system of claim 4, Rack-Gomer further discloses a method wherein it is determined that the risk of hyperglycemia and hypoglycemia is low if the patient's glucose levels are within a target glucose range (para 0222 discloses “In Region II, the glucose value is seen to be occupying a range of hyperglycemic values (e.g., 180-400 mg/dL) 293 over a period of time Δt.sub.1. If the time Δt.sub.1 exceeds a predetermined threshold, and the case of FIG. 9 assumes so, then such may indicate a reason for the GUI to rise, even though the user is only mildly hyperglycemic or has not experienced a further increase in their glucose value. Region II of FIG. 9 illustrates a hyperglycemic range, and it will be understood that occupation of hypoglycemic ranges similarly raises GUI values, particularly as durations in which a user occupies a hypoglycemic range are associated with likely further hypoglycemic excursions.” The cite discloses how the lowest GUI, or risk, is in a target range for example below 180, para 0223 discloses the lower end of the range at about 70.).
In reference to dependent claim 14, Keenan in view of Desborough teaches the method of claim 11, however
Keenan and Desborough are silent to determining a risk of hyperglycemia or hypoglycemia from the open-loop basal rate profile and a speed for the gradual transition is based on the risk.
Rack-Gomer, a similar glucose control system teaches determining a risk of hyperglycemia or hypoglycemia (para 0245 discloses “Several mathematical frameworks and inputs can be employed to determine a user's risk state of hypoglycemia and hyperglycemia. One example of how to estimate a user's risk state is described below, which employs parameters and variables including the current glucose level, the current glucose rate of change, and the glucose change direction to provide a risk value. In certain implementations of systems and methods according to present principles, glucose acceleration, as well as duration of time in a hypoglycemic or hyperglycemic state are added as inputs to arrive at a GUI.” GUI is Glycemic Urgency Index) from the open-loop basal rate profile (the “parameters” in the cite above) and a speed for the gradual transition (moderate insulin delivery in the cite below can be interpreted to be transitioning from closed to open) is based on the risk (para 0322 discloses “ the GUI may be translated or transformed to an insulin pump command using an appropriate mapping, look-up table, or function. The same may be displayed to the user, to enter as a pump command on a separate pump, or may be directly provided to a pump to dispense insulin in a closed loop system. In more detail, the same may be used to moderate insulin delivery, e.g., suspending, reducing, or increasing basal or bolus insulin delivery, based on glycemic risk state.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the risk determination method as taught in Rack-Gomer in the pump of Keenan in view of Desborough “to provide alerts and alarms which are more useful to the user, i.e., more “actionable”, in the sense that users become aware of or can deduce easily an appropriate action to take given the alert or alarm. Such are also more accurate in the sense of more correctly reflecting a current glycemic urgency assessment for the user” para 0102; Rack-Gomer.
In reference to dependent claim 15, Keenan in view of Desborough and Rack-Gomer teaches the method of claim 14, Rack Gomer further discloses a method wherein the speed for the gradual transition is greater if there is a low risk of both hyperglycemia and hypoglycemia (para 0322 discloses “ the GUI may be translated or transformed to an insulin pump command using an appropriate mapping, look-up table, or function. The same may be displayed to the user, to enter as a pump command on a separate pump, or may be directly provided to a pump to dispense insulin in a closed loop system. In more detail, the same may be used to moderate insulin delivery, e.g., suspending, reducing, or increasing basal or bolus insulin delivery, based on glycemic risk state.” The cite speaks to moderating insulin delivery as a function of the risk, GUI, as a natural result the lower the risk of hyperglycemia and hypoglycemia the speed would be lower).
In reference to dependent claim 16, Keenan in view of Desborough and Rack-Gomer teaches the method of claim 14, Rack Gomer further discloses a method wherein determining the risk of hyperglycemia or hypoglycemia includes using one or more of a most recent glucose level from the continuous glucose monitor (para 0245 discloses “Several mathematical frameworks and inputs can be employed to determine a user's risk state of hypoglycemia and hyperglycemia. One example of how to estimate a user's risk state is described below, which employs parameters and variables including the current glucose level, the current glucose rate of change, and the glucose change direction to provide a risk value. In certain implementations of systems and methods according to present principles, glucose acceleration, as well as duration of time in a hypoglycemic or hyperglycemic state are added as inputs to arrive at a GUI.” GUI is Glycemic Urgency Index), a most recent glucose level trend based on the glucose levels from the continuous glucose monitor (“current glucose rate of change” above), a future glucose level prediction and whether and how long the closed-loop mode was delivering medicament greater or lower than the open-loop basal rate profile.
In reference to dependent claim 17, Keenan in view of Desborough and Rack-Gomer teaches the method of claim 14, Rack Gomer further discloses a method wherein it is determined that the risk of hyperglycemia and hypoglycemia is low if the patient’s glucose levels are within a target glucose range (para 0222 discloses “In Region II, the glucose value is seen to be occupying a range of hyperglycemic values (e.g., 180-400 mg/dL) 293 over a period of time Δt.sub.1. If the time Δt.sub.1 exceeds a predetermined threshold, and the case of FIG. 9 assumes so, then such may indicate a reason for the GUI to rise, even though the user is only mildly hyperglycemic or has not experienced a further increase in their glucose value. Region II of FIG. 9 illustrates a hyperglycemic range, and it will be understood that occupation of hypoglycemic ranges similarly raises GUI values, particularly as durations in which a user occupies a hypoglycemic range are associated with likely further hypoglycemic excursions.” The cite discloses how the lowest GUI, or risk, is in a target range for example below 180, para 0223 discloses the lower end of the range at about 70.).
Response to Arguments
Applicant's arguments filed on 03/06/2026 have been considered but, unless otherwise addressed below, are moot in view of the new ground(s) of rejection.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783
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