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 .
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 12-18 and 11 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.
Independent claim 12 recites "delivering at least a first fluid into the patient's blood vessel at a first flow rate, wherein the first fluid is less viscous than the second fluid". However, "the second fluid" lacks proper antecedent basis at this point in the claim, as it is introduced for the first time in this clause. The second fluid is not formally introduced until the subsequent step: "delivering at least a second fluid into the patient's blood vessel at a second flow rate".
Claim 11 recites "The multi-fluid injection system as claimed in claim 17". However, claim 17 is a method claim ("The method of claim 15..."), not a system claim. Furthermore, claim 11 introduces elements such as "the controller" without proper antecedent basis in the claim chain if it were to depend from claim 8. It appears claim 11 was intended to depend from claim 8 or 10, but the dependency on claim 17 renders the claim indefinite.
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.
Claims 1, 2, 3, 8, 9, 10, 12, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Capone et al. (US 2014/0224829; hereinafter “Capone”) in view of Small et al. (US 8,663,166; hereinafter “Small”).
Claim 1 recites a method of maintaining an overall flow rate during a sequential delivery of at least two fluids to a patient's blood vessel, the method comprising:
delivering at least a first fluid into the patient's blood vessel at a first flow rate;
delivering at least a second fluid into the patient's blood vessel at a second flow rate, wherein the second fluid is less viscous than the first fluid; and
adjusting at least one of a first flow profile of the first flow rate and a second flow profile of the second flow rate to dampen a transient increase in the overall flow rate during a transition between delivering one of the first fluid and the second fluid to delivering the other of the first fluid and the second fluid.
In relation to independent claim 1, Capone discloses a method of maintaining an overall flow rate during a sequential delivery of at least two fluids to a patient's blood vessel. Specifically, Capone discloses that:
"[m]any medical procedures, such as CT procedures, often involve the use of a combination of contrast media fluid and saline delivered precisely to the region of interest within a patient's body. For example, after an initial injection of contrast media fluid is performed, a bolus of saline fluid may be administered to move the contrast fluid into the region of interest. In order to have the capability of delivering two or more different types of fluids, an external selection valve (such as a stopcock) must be added upstream of the pump inlet to allow the fluid delivery system to select from one of the two available fluid sources or possibly both if a mixing device is also provided. If two interconnected pumps are present in the fluid delivery system, the system may be capable of delivering a controlled mixture of two fluids. However, each of the two pumps must be independently controlled to provide the required flow rate of its respective fluid type." (Capone, paragraph [0010].)
Capone further discloses delivering contrast (a first, more viscous fluid) and saline (a second, less viscous fluid) at respective flow rates, and that the control system dynamically adjusts flow rates based on viscosity. Specifically, Capone teaches that:
"[t]he control algorithm dynamically adjusts to changes in the flow rate and the transition of fluid types and resulting change in viscosity and density within the patient supply set 40." (Capone, paragraph [0301].)
Capone further discloses that:
"[u]sing knowledge of the instantaneous flow rate and properties of the fluid that is being delivered, such as viscosity and density, the control system 800 can estimate the pressure drop that will occur in the patient supply set 40." (Capone, paragraph [0301].)
Capone does not explicitly disclose that the adjusting step is specifically configured to "dampen a transient increase in the overall flow rate" during the transition. However, Small discloses a multi-fluid injection system that compensates for system compliance and elasticity during fluid transitions to prevent undesirable flow rate deviations. Specifically, Small teaches that:
"[t]he inherent elasticity of syringes allows back flow to the non-driven syringe during a pressure injection. Unless precautions are taken with common Y-tubing, a typical injection producing 150 psi will allow about 5 ml of the contents of the driven syringe to be pushed into the undriven side where it will contaminate that side." (Small, col. 10, lines 50-55)
Small further discloses that:
"the un-driven side of the powerhead may be driven to a sufficient displacement to prevent the movement of fluid into the tubing on the undriven side due to elasticity. The amount of amounts of fluid to drive from an un-driven syringe will be a function of the pressure used on the driven size and the type of syringe in use." (Small, col. 11, lines 31-37)
Small further teaches that:
"[i]n a combined open/closed loop approach, the initial displacement applied to the undriven side upon initiation of the injection may be obtained from measured typical values, after which a closed-loop control may be initiated to maintain an equilibrated pressure between the driven and undriven sides and/or zero flow rate on the undriven side." (Small, col. 11, lines 51-57)
This teaching directly addresses dampening transient flow rate increases caused by stored pressure energy being released during a fluid transition. Based on the above comments, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the multi-fluid delivery method of Capone to incorporate the flow compensation techniques of Small to specifically dampen transient increases in the overall flow rate during fluid transitions. Both references are directed to multi-fluid medical injection systems delivering contrast and saline, and Small explicitly teaches that compensating for system compliance during transitions prevents undesirable
flow rate deviations and improves patient safety and image quality. A person of ordinary skill in the art would have recognized that the transient flow rate increase that occurs when switching from a high-viscosity fluid (contrast) to a low-viscosity fluid (saline) is precisely the type of pressure-driven elasticity effect that Small's compensation techniques are designed to address.
Claim 8 recites a multi-fluid injection system configured to maintain an overall flow rate during a sequential delivery of at least two fluids to a patient's blood vessel, the system comprising a processor configured to control the multi-fluid injection system to:
deliver at least a first fluid into the patient's blood vessel at a first flow rate;
deliver at least a second fluid into the patient's blood vessel at a second flow rate wherein
the second fluid is less viscous than the first fluid; and
adjust at least one of a first flow profile of the first flow rate and a second flow profile of the
second flow rate to dampen a transient increase in the overall flow rate during a transition
between delivering one of the first fluid and the second fluid to delivering the other of the
first fluid and the second fluid.
In relation to independent claim 8, this claim is the system counterpart to method claim 1. Capone discloses a multi-fluid injection system comprising a processor (system controller 822) configured to control the system to deliver first and second fluids of different viscosities. Specifically, Capone discloses that:
"[t]he control system 800 comprises a system controller or computer 822 with appropriate software for controlling operation of the fluid delivery system 2." (Capone, paragraph [0242].)
Capone further discloses that the system delivers contrast and saline sequentially:
"[i]f it is assumed that two fluids, contrast and saline as in the foregoing example, are to be injected, one plunger 200 on each half of the pump 10 is retracted to fill with fluid." (Capone, paragraph [0271].)
Capone further discloses that the processor adjusts flow profiles during transitions based on viscosity:
"[t]he control algorithm dynamically adjusts to changes in the flow rate and the transition of fluid types and resulting change in viscosity and density within the patient supply set 40." (Capone, paragraph [0301].)
Small discloses the processor configured to adjust the flow profile to dampen a transient increase in the overall flow rate during a transition. Specifically, Small teaches that:
"the undriven side of the powerhead may be driven to a sufficient displacement to prevent the
movement of fluid into the tubing on the undriven side due to elasticity" and that "[i]n a combined open/closed loop approach, the initial displacement applied to the undriven side upon initiation of the injection may be obtained from measured typical values, after which a closed-loop control may be initiated to maintain an equilibrated pressure between the driven and undriven sides and/or zero flow rate on the undriven side." (Small, col. 11, lines 31-57)
This closed-loop control of the processor to maintain equilibrated pressure and zero flow rate on the undriven side is the functional equivalent of adjusting the flow profile to dampen a transient increase in the overall flow rate during a transition. Therefore, the motivation to combine is the same as for claim 1. Both Capone and Small are directed to multi-fluid medical injection systems, and a person of ordinary skill in the art would have been motivated to incorporate Small's processor-controlled elasticity compensation into the multi-fluid delivery system of Capone to prevent flow rate spikes during fluid transitions.
Claim 12 recites a method of maintaining an overall flow rate during a sequential delivery of at least two fluids to a patient's blood vessel, the method comprising:
delivering at least a first fluid into the patient's blood vessel at a first flow rate, wherein the
first fluid is less viscous than the second fluid;
delivering at least a second fluid into the patient's blood vessel at a second flow rate; and
adjusting at least one of a first flow profile of the first flow rate and a second flow profile of
the second flow rate to dampen a transient increase in the overall flow rate during a
transition between delivering one of the first fluid and the second fluid to delivering the
other of the first fluid and the second fluid.
In relation to independent claim 12, this claim is substantially identical to claim 1, except the viscosity relationship is reversed (the first fluid is less viscous than the second fluid, e.g., delivering saline first, then contrast). Capone discloses multi-fluid delivery in either order (paragraph [0010] … “an external selection valve (such as a stopcock) must be added upstream of the pump inlet to allow the fluid delivery system to select from one of the two available fluid sources or possibly both if a mixing device is also provided”). As discussed above, Small discloses compensation techniques that apply regardless of which fluid is more viscous, as the system compensates for the pressure differential during any transition. Accordingly, since this methodology was well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the method of maintaining an overall flow rate.
In relation to claim 2, Capone in view of Small discloses the method of claim 1, as discussed above. Regarding the additional limitation of claim 2, Small further discloses delaying the delivery of one of the first fluid and the second fluid until the other reaches a predetermined flow rate. Specifically, Small teaches that:
"[i]n a combined open/closed loop approach, the initial displacement applied to the undriven side upon initiation of the injection may be obtained from measured typical values, after which a closed-loop control may be initiated to maintain an equilibrated pressure between the driven and undriven sides and/or zero flow rate on the undriven side." (Small, col. 11, lines 51-57)
The closed-loop control to maintain "zero flow rate on the undriven side" (col. 11, lines 56-57) until the driven side reaches a predetermined pressure/flow rate is the functional equivalent of delaying delivery of one fluid until the other reaches a predetermined flow rate. Therefore, the motivation to combine is the same as for claim 1. Furthermore, one of ordinary skill in the art would have been motivated to use the specific delay technique of Small in the system of Capone to ensure smooth transitions between fluids of different viscosities without pressure-driven flow rate spikes.
In relation to claim 3, Capone in view of Small discloses the method of claim 1, as discussed above. Regarding the additional limitation of claim 3, Capone discloses adjusting flow rates using a controller based on the properties of the other fluid. Specifically, Capone teaches that:
"[i]f the estimated catheter pressure is greater than the predefined pressure limit, the actual flow rate is decreased from the targeted flow rate using a control algorithm, such as a Proportional-Integral-Derivative ('PID') control algorithm which is programmed into the control system 800, such as into the system controller 822. If the estimated catheter pressure is less than the predefined limit and the current flow rate is below the target flow rate, the current flow rate is increased using a control algorithm, such as the PID control algorithm." (Capone, paragraph [0301].)
Small further discloses adjusting one of the flow rates based on the other, teaching that:
"[i]n a closed-loop approach, a measure of pressure and/or fluid flow in the undriven sized may be used to perform closed-loop control of the ram on the undriven side to prevent flow into the undriven side due to elasticity." (Small, col. 11, lines 37-41)
This teaches adjusting the flow rate of one fluid (the undriven side) based on the measured flow rate or pressure of the other fluid (the driven side). The motivation to combine is the same as for claim 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the multi-fluid delivery method of Capone to incorporate the flow compensation techniques of Small to specifically dampen transient increases in the overall flow rate during fluid transitions. Both references are directed to multi-fluid medical injection systems delivering contrast and saline, and Small explicitly teaches that compensating for system compliance during transitions prevents undesirable flow rate deviations and improves patient safety and image quality. A person of ordinary skill in the art would have recognized that the transient flow rate increase that occurs when switching from a high-viscosity fluid (contrast) to a low-viscosity fluid (saline) is precisely the type of pressure-driven elasticity effect that Small's compensation techniques are designed to address.
In relation to claim 9, Capone in view of Small discloses the system of claim 8, as discussed above. Regarding the additional limitation of claim 9, Small further discloses the processor configured to
increase a transition time between delivering the fluids. Small teaches gradually adjusting plunger displacement during transitions to compensate for elasticity, which effectively extends and increases the transition time compared to an abrupt switch between fluids. Specifically, Small teaches that:
"[i]n a combined open/closed loop approach, the initial displacement applied to the undriven side upon initiation of the injection may be obtained from measured typical values, after which a closed-loop control may be initiated to maintain an equilibrated pressure between the driven and undriven sides and/or zero flow rate on the undriven side." (Small, col. 11, lines 51-57)
This gradual, closed-loop approach to transitioning between fluids inherently increases the transition time. Accordingly, the motivation to combine is the same as for claim 1.
In relation to claim 10, this claim is the system counterpart to method claim 2. Capone in view of Small discloses the system of claim 8, as discussed above. Small further discloses the processor configured to delay the delivery of one fluid until the other reaches a predetermined flow rate/pressure. Small teaches that:
"[i]n a combined open/closed loop approach, the initial displacement applied to the undriven side upon initiation of the injection may be obtained from measured typical values, after which a closed-loop control may be initiated to maintain an equilibrated pressure between the driven and undriven sides and/or zero flow rate on the undriven side." (Small, col. 11, lines 51-57)
The closed-loop control to maintain "zero flow rate on the undriven side" until the driven side reaches a predetermined pressure/flow rate is the functional equivalent of delaying delivery of one fluid until the other reaches a predetermined flow rate. Therefore, the motivation to combine is the same as for claim 2.
In relation to claim 13, the analysis and motivation to combine for claim 13 are identical to those provided for claim 2, as the only difference is the reversed viscosity relationship of the first and second fluids in the independent base claim 12, which is fully accounted for by the cited prior art as
discussed in the rejection of claim 12.
In relation to claim 14, the analysis and motivation to combine for claim 14 are identical to those provided for claim 3, as the only difference is the reversed viscosity relationship of the first and second fluids in the independent base claim 12, which is fully accounted for by the cited prior art as
discussed in the rejection of claim 12.
Claims 4, 5, 6, 7, 15, 16, 17, 18, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Capone et al. (US 2014/0224829; hereinafter “Capone”) in view of Small et al. (US 8,663,166; hereinafter “Small”), as discussed above, and in further view of Spohn et al. (US 2010/0222768A1; hereinafter “Spohn”).
In relation to claim 4, Capone in view of Small discloses the method of claim 1, as discussed above. However, neither Capone nor Small explicitly discloses pulling back a plunger of a second fluid syringe to reduce a capacitance volume of the second fluid syringe. Spohn discloses a fluid delivery system that performs capacitance volume correction by pulling back (retracting) a plunger of a fluid syringe to relieve pressure and reduce the capacitance volume of the syringe. Specifically, Spohn teaches that:
"[i]n order to account for under-delivery of fluid to the patient, a method is needed to allow the injector drive piston 306 and, hence, syringe plunger 788 to over-travel by a predicted capacitance volume, and then retract to relieve the swell and depressurize the system." (Spohn, paragraph [0068].)
Spohn further teaches that:
"this pull-back repositions injector drive piston 306 back to the originally desired or intended stop position after closure of multi-position valve 712." (Spohn, paragraph [0073].)
Spohn explicitly teaches that the capacitance volume arises because:
"as syringe plunger 788 moves distally, syringe body 770 swells outward... This swelling or outward expansion results in an expansion in volume of syringe body 770 and an underdelivery of fluid to the patient upon closure of multi-position valve 712. This expansion or swelling is known as capacitance volume and is a retained volume of injection fluid that does not enter fluid path 700 and, hence, is not delivered to the patient." (Spohn, paragraph [0067].)
Based on the above comments, it would have been obvious to one of ordinary skill in the art to further modify the method of Capone and Small to include the plunger pullback technique of Spohn. Spohn explicitly teaches that pulling back the plunger to reduce capacitance volume prevents unintended fluid delivery caused by the expansion of the syringe under pressure. (Spohn, paragraphs [0068]-[0073].) One of ordinary skill in the art would have recognized that the same capacitance volume problem that Spohn addresses in a single-fluid system would have also occurred in the multi-fluid system of Capone and Small during a fluid transition, and that applying Spohn's pullback technique would have been a predictable solution to dampen the transient flow rate increase caused by the release of stored pressure energy.
In relation to claim 5, Capone in view of Small and Spohn discloses the method of claim 4, as discussed above. Regarding the additional limitation of claim 5, Spohn further discloses pulling back the plunger a distance equal to the capacitance volume of the syringe. Specifically, Spohn teaches that:
"[t]otal displacement of injector drive piston 306 is 75 ml (a programmed volume) plus 5.71 ml (over-travel volume—'A') for a total of 80.71 ml. Fluid delivery system 200 then delays at 200 ms ('B') and retracts back to the 75 ml mark." (Spohn, paragraph [0076].)
This retraction back to the 75 ml mark from the 80.71 ml position is a pullback of a distance equal to the capacitance volume (5.71 ml). Spohn further discloses that the over-travel distance is calculated by the equation:
"Over Travel (ml) = C1 + C2x + C3x² + C4 + C5y + C6y² + C7*y³ (Where: C1=−0.811; C2=0.039; C3=−0.00035; C4=9.0−5E−7; C5=0.0269; C6=4.43e−5; C7=2.607e−8; x=pressure; y=position)" (Spohn, paragraphs [0069]-[0070])…which characterizes the capacitance volume as a function of pressure and plunger position.
Based on the above comments, the motivation to combine is the same as for claim 4.
In relation to claim 6, Capone in view of Small and Spohn discloses the method of claim 4, as discussed above. Regarding the additional limitation of claim 6, Spohn further discloses that the pulling back of the plunger is controlled by a controller. Specifically, Spohn teaches that:
"[t]he foregoing methodology which resulted in the surface plot in FIG. 13 and accompanying equation utilized to calculate required capacitance volume correction factors needed for sharp bolus operation of system 200 may be implemented as an algorithm by which to control movement of injector drive piston 306 and, further, operation of multi-position valve 712. Such an algorithm may be part of the programming associated with the control devices associated with fluid injector 300 and/or fluid control module 400 or an external control device (e.g., separate controller) used to operate fluid injector 300 and/or fluid control device 400." (Spohn, paragraph [0080].)
Spohn further teaches that:
"[m]ovement of the pressurizing element is controlled by an algorithm associated with a computer." (Spohn, Abstract.)
Based on the above comments, the motivation to combine is the same as for claim 4.
In relation to claim 7, Capone in view of Small and Spohn discloses the method of claim 6, as discussed above. Regarding the additional limitation of claim 7, the combination of Capone, Small, and Spohn teaches that the pulling back of the plunger by the controller is based on information including fluid viscosities, catheter size, capacitance of the second fluid syringe, and a volume of fluid in the injection system.
As to fluid viscosities and catheter size, Capone discloses that the control algorithm uses:
"knowledge of the instantaneous flow rate and properties of the fluid that is being delivered, such as viscosity and density" and that the system "estimates the pressure drop that will occur in the patient supply set 40" including the catheter. (Capone, paragraph [0301].)
Capone further teaches that:
"a patient supply set 40 with a smaller diameter bore could be provided for low flow rate procedures to provide improved flexibility, reduce the amount of flush that must be delivered to the patient at the end of each fluid injection to clear the patient supply set 40, and provide a faster response time at the beginning of each fluid injection." (Capone, paragraph [0299].)
As to capacitance of the second fluid syringe and volume of fluid in the injection system, Spohn discloses that the over-travel (and hence the pullback distance) is "dominated primarily by system pressure and axial position of syringe plunger 788 within syringe 702" (Spohn, paragraph [0068]), where the axial position of the plunger corresponds directly to the remaining volume of fluid in the syringe. Spohn further discloses that the over-travel equation uses "x=pressure; y=position" (Spohn, paragraphs [0069]-[0070]), confirming that the pullback is based on both the system pressure (which reflects fluid viscosity and flow rate) and the volume of fluid remaining in the syringe (the capacitance of the syringe).
As to the amount of fluid to drive from the un-driven syringe, Small teaches that:
"[t]he amount of amounts of fluid to drive from an un-driven syringe will be a function of the pressure used on the driven size and the type of syringe in use." (Small, col. 11, lines 34-37)
Small further provides specific values:
"when a 125 ml syringe having a flat plunger face sold by the present assignee is driven at 50 PSI, the undriven side should be driven approximately 1.72 ml to compensate for movement of fluid due to elasticity. With this syringe, at 100 PSI, the driven amount is 2.28 ml, at 150 PSI, 3.45 ml, at 200 PSI, 4.32 ml, at 250 PSI, 5.37 ml, and at 300 PSI, 6.78 ml." (Small, col. Lines 44-50)
Based on the above comments, the motivation to combine is the same as for claim 4. One of ordinary skill in the art would have recognized that using all available system information — including fluid viscosities, catheter size, syringe capacitance, and fluid volume — to determine the correct pullback distance would have yielded more accurate capacitance compensation and smoother flow rate transitions, as taught collectively by Capone, Small, and Spohn.
In relation to claim 15, the analysis and motivation to combine for claim 15 are identical to those provided for claim 4, as the only difference is the reversed viscosity relationship of the first and second fluids in the independent base claim 12, which is fully accounted for by the cited prior art as
discussed in the rejection of claim 12.
In relation to claim 16, the analysis and motivation to combine for claim 16 are identical to those provided for claim 5, as the only difference is the reversed viscosity relationship of the first and second fluids in the independent base claim 12, which is fully accounted for by the cited prior art as discussed in the rejection of claim 12.
In relation to claim 17, the analysis and motivation to combine for claim 17 are identical to those provided for claim 6, as the only difference is the reversed viscosity relationship of the first and second fluids in the independent base claim 12, which is fully accounted for by the cited prior art as discussed in the rejection of claim 12.
In relation to claim 18, the analysis and motivation to combine for claim 18 are identical to those provided for claim 7, as the only difference is the reversed viscosity relationship of the first and second fluids in the independent base claim 12, which is fully accounted for by the cited prior art as discussed in the rejection of claim 12.
In relation to claim 11, this claim is the system counterpart to method claim 4. Capone in view of Small and Spohn discloses the system of claim 8, and further discloses the controller pulling back a plunger of a second fluid syringe to reduce a capacitance volume, as taught by Spohn (see analysis for claim 4 above, incorporated herein by reference). Additionally, the motivation to combine is the same as for claim 4.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783