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 Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites “a stop within tubular member intermediate portion.” This appears to be a missing article. The claim should read “a stop within the tubular member intermediate portion” or “a stop within an intermediate portion of the tubular member.” This error does not, by itself, render the claim indefinite but should be corrected.
Appropriate correction is required.
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 6, 13, 14, and 15 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.
Claim 6 recites: “wherein the compression-resistant element includes a distal end loose within the intermediate portion, thereby defining the distal portion between the compression-resistant element distal end.” The clause ends after “between the compression-resistant element distal end” and does not state the second boundary of the recited “between” relationship. The claim should read: “wherein the compression-resistant element includes a distal end loose within the intermediate portion, thereby defining the distal portion between the compression-resistant element distal end and the tubular member distal end,” if that is the intended scope. As written, the claim fails to particularly point out and distinctly claim the subject matter because the distal portion’s boundary is incomplete.
Claim 13 recites: “wherein the tubular member comprises a second portion adjacent the proximal portion wherein all of the windings surround the primary lumen and the steering element lumen is disposed outside the windings.” The phrase “the proximal portion” lacks antecedent basis. Claim 1 introduces a proximal end, not a proximal portion. The claim should identify a previously introduced proximal portion or introduce “a proximal portion.” As written, the claim fails to particularly point out and distinctly claim the subject matter because the positional reference is undefined.
Claim 14 recites: “wherein the central lumen is defined by a liner comprising an inner surface substantially surrounding the central lumen.” Claim 1 introduces a “primary lumen,” but does not introduce a “central lumen.” The claim should read: “wherein the primary lumen is defined by a liner comprising an inner surface substantially surrounding the primary lumen,” if that is the intended scope. As written, the claim fails to particularly point out and distinctly claim the subject matter because “the central lumen” lacks antecedent basis.
Claim 15 is rejected under 35 U.S.C. § 112(b) as being indefinite. The § 112(b) rejection of claim 14 is incorporated herein because claim 15 depends from claim 14 and retains the indefinite “central lumen” recitation.
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, 8, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman et al. (US 20130046298A1; hereinafter “Kaufman”) in view of Webster, Jr. (US 5,431,168; hereinafter “Webster”) and Hayzelden (US 8,016,784; hereinafter “Hayzelden”).
In relation to independent claim 1, this claim recites an apparatus for performing a procedure within a patient's body, comprising: a tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, a central axis extending there between, and a distal portion extending distally from an intermediate portion to the distal end; a primary lumen extending between the proximal and distal ends and surrounding at least a portion of the central axis; a steering element lumen extending at least partially between the proximal and distal ends adjacent the primary lumen; a steering element slidably disposed within the steering element lumen and comprising a distal end fixed to the tubular member distal end and a proximal end adjacent the proximal end of the tubular member; an actuator on the proximal end coupled to the steering element proximal end such that, actuation of the actuator applies axial tension or compression to the steering element, thereby causing the distal portion to bend; and a compression-resistant element slidably disposed within the steering element lumen and extending from the proximal end through the intermediate portion adjacent the steering element for preventing forces from the steering element from transferring to the tubular member proximal to the distal portion. Claim 1 has been rejected in the following manner:
a tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, a central axis extending there between, and a distal portion extending distally from an intermediate portion to the distal end; a primary lumen; and a steering element lumen adjacent the primary lumen.
Kaufman discloses: “In accordance with one embodiment, an apparatus is provided for performing a procedure within a patient's body that includes a tubular member including a proximal end, a distal end sized for introduction into a patient's body, a central region extending therebetween, and a distal portion extending distally from an intermediate portion to the distal end. At least one accessory lumen and a steering element lumen extend between the proximal end and the distal end, the steering element lumen offset from the central region within the distal portion, thereby defining a steering plane intersecting the steering element lumen and the central region.” (Kaufman ¶ [0007]).
a compression-resistant element slidably disposed within the steering element lumen and extending from the proximal end through the intermediate portion adjacent the steering element for preventing forces from the steering element from transferring to the tubular member proximal to the distal portion.
Kaufman does not expressly disclose a compression-resistant element in the steering-element lumen having the stated force-control function. Webster fills the compression-resistant-coil gap by disclosing: “A tightly wound coil spring 48 is disposed in the second lumen 20 which extends through the catheter body 12. The proximal and distal ends of the coil spring 48 are fixed, e.g., by glue 49 or the like, to the wall of the catheter body 12, forming the second lumen 20. The coil spring 48 has an outer diameter slightly less than the diameter of the second lumen 20. The inner diameter of the coil spring 48 is about 0.01 inch and extends the entire length of the catheter body 12. The coil spring 48 is tightly wound so it can bend but is non-compressible.” (Webster, col. 4, approx. ll. 18–29). Webster further discloses: “The coil spring is rigidly attached by polyurethane glue or the like to the catheter body at its distal and proximal ends. Because the catheter coil spring 48 is noncompressible, tension on the puller wire 36 will not translate into compressive tension on the catheter body 12. The noncompressible coil spring 48 thereby assures that the catheter body 12 does not bend as a result of tension on the puller wire 36 and thereby assumes that rotational control of the catheter 10 is not adversely affected when the puller wire 36 is under tension.” (Webster, col. 5, approx. ll. 18–27). To the extent Webster does not expressly state that the compression-resistant element itself is slidably disposed, Hayzelden fills the movement gap by disclosing: “The compression mechanism includes a distal stop 14, a proximal stop 16, and a spring 12. The distal stop 14 is a step on the OD of the needle 138 or a component attached to the OD of the needle 138. The proximal stop 16 is also a step on the OD of the needle 138 or a component attached to the OD of the needle 138. Both the distal stop 14 and the proximal stop 16 are slidably contained within the ID of the handle 200. In one embodiment, the spring 12 is constrained by the needle 138 such that the spring 12 remains engaged with the needle 138, but is free to extend and compress proximally and distally over the OD of the needle 138 and within the ID of the handle 200.” (Hayzelden, col. 6, approx. ll. 19–30).
Motivation to combine. It would have been obvious to combine Kaufman with Webster and Hayzelden because each reference addresses a catheter whose internal steering member is subject to axial force during distal deflection. A person of ordinary skill in the art would have been motivated to use Webster’s non-compressible coil and Hayzelden’s movable spring structure with Kaufman’s steering-element lumen to manage pull-wire-induced compression and avoid unwanted bending outside the intended distal region.
In relation to claim 2, this claim recites: the apparatus of claim 1, wherein the compression-resistant element comprises a coil surrounding the steering element between the proximal end and the intermediate portion. Claim 2 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
the compression-resistant element comprises a coil surrounding the steering element between the proximal end and the intermediate portion.
Kaufman does not expressly disclose a coil surrounding the steering element. Webster fills that gap by disclosing: “A puller wire 36, preferably made of stainless steel, having a diameter of about 0.006 inch is disposed within and slidably extends through the coil spring 48 and sleeve 38.” (Webster, col. 4, approx. ll. 50–53).
Motivation to combine. It would have been obvious to use Webster’s coil surrounding the puller-wire in the Kaufman/Webster/Hayzelden combination because the references address the same pull-wire steering mechanism and a coil provides known compression resistance while allowing relative wire movement during actuation.
In relation to claim 8, this claim recites: the apparatus of claim 1, further comprising: a handle coupled to the tubular member proximal end; an actuator on the handle coupled to the proximal end of the steering element; and a stop fixed within the handle and disposed adjacent a proximal end of the compression- resistant element for limiting compression of the tubular member in bending when the distal end of the compression-resistant element contacts the stop. Claim 8 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
a handle coupled to the tubular member proximal end; an actuator on the handle coupled to the proximal end of the steering element.
Kaufman discloses: “In addition, the handle 13 may include one or more actuators, such as sliders, buttons, switches, and the like, e.g., for activating and/or manipulating components (also not shown) on the distal end 14 or otherwise operating the apparatus 10. For example, as shown in FIG. 1, an actuator 19 may be provided that is coupled to a proximal end of the steering element 30 (not shown), as described further below.” (Kaufman ¶ [0027]).
a stop fixed within the handle and disposed adjacent a proximal end of the compression-resistant element for limiting compression of the tubular member in bending when the distal end of the compression-resistant element contacts the stop.
Kaufman does not expressly disclose the claimed stop relation. Hayzelden fill the stop/spring/handle gap by disclosing: “The compression mechanism includes a distal stop 14, a proximal stop 16, and a spring 12. The distal stop 14 is a step on the OD of the needle 138 or a component attached to the OD of the needle 138. The proximal stop 16 is also a step on the OD of the needle 138 or a component attached to the OD of the needle 138. Both the distal stop 14 and the proximal stop 16 are slidably contained within the ID of the handle 200. In one embodiment, the spring 12 is constrained by the needle 138 such that the spring 12 remains engaged with the needle 138, but is free to extend and compress proximally and distally over the OD of the needle 138 and within the ID of the handle 200.” (Hayzelden, col. 6, approx. ll. 19–30). To the extent Hayzelden does not expressly state that a stop is “fixed” as opposed to contained in the handle, Webster fills the fixation gap by disclosing: “The coil spring is rigidly attached by polyurethane glue or the like to the catheter body at its distal and proximal ends.” (Webster, col. 5, approx. ll. 18–20).
Motivation to combine. It would have been obvious to include Hayzelden’s stop and spring arrangement in Kaufman’s actuator handle because both references address proximal handle structures that control a movable internal element during catheter operation. A person of ordinary skill in the art would have been motivated to use a stop with the compression-resistant structure to limit compression-related movement and maintain controlled positioning during bending.
In relation to independent claim 21, this claim recites: an apparatus for performing a procedure within a patient's body, comprising: a tubular member comprising a proximal end, a distal end sized for introduction into the patient's body, a central axis extending there between, and a distal portion extending distally from an intermediate portion to the distal end; a primary lumen extending between the proximal end and the distal end and surrounding at least a portion of the central axis; a steering element lumen extending at least partially between the proximal end and the distal end adjacent the primary lumen; a steering element slidably disposed within the steering element lumen and comprising a distal end fixed to the tubular member distal end and a proximal end adjacent the proximal end of the tubular member; an actuator on the proximal end coupled to the steering element proximal end such that, actuation of the actuator applies axial tension or compression to the steering element, thereby causing the distal portion to bend; a compression-resistant element slidably disposed within the steering element lumen and extending from the proximal end through the intermediate portion adjacent the steering element for preventing forces from the steering element from transferring to the tubular member proximal to the distal portion; a handle coupled to the tubular member proximal end and carrying the actuator; and a stop within the handle and disposed adjacent a proximal end of the compression- resistant element for limiting compression of the tubular member in bending when the distal end of the compression resistant element contacts the stop. Claim 21 has been rejected in the following manner:
a tubular member; adjacent primary and steering-element lumens; a slidably disposed steering element fixed distally; and an actuator applying axial tension or compression to cause distal bending.
Kaufman discloses: “A steering element may be slidably disposed within the steering element lumen including a distal end fixed to the tubular member distal end and a proximal end coupled to an actuator on the tubular member proximal end such that, actuation of the actuator applies axial tension or compression to the steering element, thereby causing the distal portion to deflect substantially within the steering plane.” (Kaufman ¶ [0010]).
a compression-resistant element in the steering-element lumen for preventing steering-element forces from transferring to the tubular member proximal to the distal portion.
Kaufman does not expressly disclose the claimed compression-resistant element. Webster fills that gap by disclosing: “The coil spring is rigidly attached by polyurethane glue or the like to the catheter body at its distal and proximal ends. Because the catheter coil spring 48 is noncompressible, tension on the puller wire 36 will not translate into compressive tension on the catheter body 12. The noncompressible coil spring 48 thereby assures that the catheter body 12 does not bend as a result of tension on the puller wire 36 and thereby assumes that rotational control of the catheter 10 is not adversely affected when the puller wire 36 is under tension.” (Webster, col. 5, approx. ll. 18–27).
a handle carrying the actuator and a stop within the handle adjacent the compression-resistant element for limiting compression when contacted.
Kaufman discloses a handle with an actuator coupled to a steering-element proximal end: “In addition, the handle 13 may include one or more actuators, such as sliders, buttons, switches, and the like, e.g., for activating and/or manipulating components (also not shown) on the distal end 14 or otherwise operating the apparatus 10. For example, as shown in FIG. 1, an actuator 19 may be provided that is coupled to a proximal end of the steering element 30 (not shown), as described further below.” (Kaufman ¶ [0027]). Kaufman does not expressly disclose the claimed stop relationship. Hayzelden fill the stop/spring-in-handle gap by disclosing: “The compression mechanism includes a distal stop 14, a proximal stop 16, and a spring 12. The distal stop 14 is a step on the OD of the needle 138 or a component attached to the OD of the needle 138. The proximal stop 16 is also a step on the OD of the needle 138 or a component attached to the OD of the needle 138. Both the distal stop 14 and the proximal stop 16 are slidably contained within the ID of the handle 200. In one embodiment, the spring 12 is constrained by the needle 138 such that the spring 12 remains engaged with the needle 138, but is free to extend and compress proximally and distally over the OD of the needle 138 and within the ID of the handle 200.” (Hayzelden, col. 6, approx. ll. 19–30).
Motivation to combine. It would have been obvious to combine Kaufman’s handle and axially actuated steering element with Webster’s noncompressible coil and Hayzelden’s handle stop/spring arrangement because the references collectively address controlling the axial position and compression response of an internal catheter component. A person of ordinary skill in the art would have been motivated to provide the known spring-and-stop arrangement in the handle to manage compression-related travel of the coil-supported steering assembly during distal bending.
Claims 3, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman et al. (US 20130046298A1; hereinafter “Kaufman”) in view of Webster, Jr. (US 5,431,168; hereinafter “Webster”) and Hayzelden (US 8,016,784; hereinafter “Hayzelden”), as discussed above, and in further view of Nguyen (US 2002/0161330A1).
In relation to claim 3, this claim recites the apparatus of claim 2, wherein the coil comprises one of a tightly wound coil, a counter-wound coil tube, a coil tube with an attached tensile element, and a laser cut tube. Claim 3 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 2 is incorporated herein.
the coil comprises one of a tightly wound coil, a counter-wound coil tube, a coil tube with an attached tensile element, and a laser cut tube.
The base combination does not expressly identify one of the listed coil constructions. Nguyen fills that gap by disclosing: “Each compression coil 58 is tightly wound on itself to provide flexibility, i.e., bending, but to resist compression. The inner diameter of each compression coil 58 is slightly larger than the diameter of its associated puller wire 52. For example, when a puller wire 52 has a diameter of about 0.007 inch, the corresponding compression coil 58 preferably has an inner diameter of about 0.008 inch. The coating on the puller wires 52 allows them to slide freely within the compression coils 58.” (Nguyen ¶ [0041]).
Motivation to combine. It would have been obvious to use Nguyen’s expressly tightly wound compression coil in the base combination because Nguyen identifies the predictable combination of bending flexibility and compression resistance required for a pull-wire support structure.
In relation to claim 4, this claim recites: the apparatus of claim 1, wherein the compression-resistant element includes a distal end fixed to the tubular member within the intermediate portion, thereby defining the distal portion between the compression-resistant element distal end and the tubular member distal end. Claim 4 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
the compression-resistant element includes a distal end fixed to the tubular member within the intermediate portion.
The base combination does not expressly disclose a compression-resistant-element distal end fixed at the claimed selected location. Nguyen fills that gap by disclosing: “A first compression coil extends through the lumen of the catheter body in surrounding relation to the first puller wire. The first compression coil has a distal end anchored in the catheter body or in the first off-axis lumen of the tip section at a first anchor position.” (Nguyen ¶ [0009]). Nguyen also discloses: “The distal end of each compression coil 58 is anchored in its corresponding small off-axis lumen 26 and 27 by a glue joint.” (Nguyen ¶ [0045]).
thereby defining the distal portion between the compression-resistant element distal end and the tubular member distal end.
Kaufman discloses a selected distal bending region: “At the transition region 21, the steering element lumen 18b is offset from the central axis 16, the center of mass, or other central region extending through the distal portion 20. Thus, an axial force on the steering element 30 creates a bending moment due to this offset, thereby causing the distal portion 22 to deflect substantially within a steering plane, e.g., within the plane of the view of FIG. 2A or in direction 36 shown in FIG. 2C.” (Kaufman ¶ [0035]).
Motivation to combine. It would have been obvious to use Nguyen’s selected distal coil anchor in the base combination because a fixed coil endpoint provides a known way to define the start of a deflectable portion. A person of ordinary skill in the art would have been motivated to coordinate that known anchor position with Kaufman’s distal bending region for predictable localization of deflection.
In relation to claim 5, this claim recites: the apparatus of claim 1, wherein the compression-resistant element includes a distal end fixed to the tubular member within the intermediate portion such that forces from the steering element are transferred to the distal portion, thereby causing the distal portion to deflect when axial forces are applied to the steering element. Claim 5 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
the compression-resistant element includes a distal end fixed to the tubular member within the intermediate portion.
The base combination does not expressly disclose the selected fixed distal end. Nguyen fills that gap by disclosing: “The distal end of each compression coil 58 is anchored in its corresponding small off-axis lumen 26 and 27 by a glue joint.” (Nguyen ¶ [0045]).
such that forces from the steering element are transferred to the distal portion, thereby causing the distal portion to deflect when axial forces are applied to the steering element.
Kaufman discloses: “During use, the actuator 19 may be activated, e.g., directed proximally or distally relative to the handle 13 and/or the proximal end 12, to apply an axial force to the steering element 30, e.g., tension (when the steering element 30 is pulled) or compression (when the steering element 30 is advanced). Within the intermediate portion 22, because the steering element lumen 18 b and consequently the steering element 30 are generally aligned with the central axis 16, center of mass, or other central region of the intermediate portion 22, little or no bending moment is applied by this force. In addition, or alternatively, the proximal and intermediate portions 24, 22 of the apparatus 10 may be constructed to prevent or minimize bending forces caused by actuation of the steering element 50.” (Kaufman ¶ [0034]). Kaufman further discloses: “At the transition region 21, the steering element lumen 18b is offset from the central axis 16, the center of mass, or other central region extending through the distal portion 20. Thus, an axial force on the steering element 30 creates a bending moment due to this offset, thereby causing the distal portion 22 to deflect substantially within a steering plane, e.g., within the plane of the view of FIG. 2A or in direction 36 shown in FIG. 2C.” (Kaufman ¶ [0035]).
Motivation to combine. It would have been obvious to use Nguyen’s fixed compression-coil end with Kaufman’s axial-force-induced bending arrangement because both structures govern the location at which steering force produces bending. A person of ordinary skill in the art would have been motivated to fix the coil end at a selected location so the transferred steering force produces the desired distal deflection.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman et al. (US 20130046298A1; hereinafter “Kaufman”) in view of Webster, Jr. (US 5,431,168; hereinafter “Webster”) and Hayzelden (US 8,016,784; hereinafter “Hayzelden”), as discussed above, and in further view of Mirarchi et al. (US 5,562,619; hereinafter “Mirarchi”).
In relation to claim 6, this claim recites the apparatus of claim 1, wherein the compression-resistant element includes a distal end loose within the intermediate portion, thereby defining the distal portion between the compression-resistant element distal end. Claim 6 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
the compression-resistant element includes a distal end loose within the intermediate portion.
The base combination does not expressly disclose an unsecured distal end. Webster discloses: “As an alternative to sleeve 38, coil spring 48 may extend completely through the catheter body 12 and tip portion 14 as shown in FIG. 4. In such an embodiment, the portion of the coil spring 48 extending through the second lumen 20 in the catheter body 12 is tightly wound and essentially non-compressible as in FIG. 1. In the tip portion 14, however, the coil spring 51 is loosely wound and therefore flexible and compressible.” (Webster, col. 4, approx. ll. 36–43). Mirarchi fills the unsecured-end gap by disclosing: “While in the presently preferred embodiment the proximal end only of the coil is securely attached to the catheter body, it is within the scope of broader aspects of the invention to attach either the distal or proximal ends of the coil to the catheter body.” (Mirarchi, col. 7, approx. ll. 40–47).
thereby defining the distal portion between the compression-resistant element distal end.
Kaufman discloses the selected distal portion that deflects after axial actuation: “At the transition region 21, the steering element lumen 18b is offset from the central axis 16, the center of mass, or other central region extending through the distal portion 20. Thus, an axial force on the steering element 30 creates a bending moment due to this offset, thereby causing the distal portion 22 to deflect substantially within a steering plane, e.g., within the plane of the view of FIG. 2A or in direction 36 shown in FIG. 2C.” (Kaufman ¶ [0035]).
Motivation to combine. It would have been obvious to select Webster’s loose distal coil portion and Mirarchi’s disclosed attachment state for the compression-resistant coil in the base combination because the references collectively teach that coil winding and attachment conditions may be selected to balance flexibility and support. A person of ordinary skill in the art would have been motivated to leave a distal coil end unsecured to accommodate a selected flexible distal region.
In relation to claim 7, this claim recites the apparatus of claim 6, further comprising a stop within tubular member intermediate portion adjacent the distal end of the compression-resistant element for limiting compression of the tubular member in bending when the distal end of the compression resistant element contacts the stop. Claim 7 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
a stop within tubular member intermediate portion adjacent the distal end of the compression-resistant element for limiting compression of the tubular member in bending when the distal end of the compression resistant element contacts the stop.
The base combination does not expressly disclose a stop mounted in the catheter or lumen with a contact that limits movement under compression. Hayzelden fill that gap by disclosing: “In one embodiment, the proximal needle hard stop 22 is attached to or mounted in the catheter shaft 101 inner surface. In another embodiment, the proximal needle hard stop 22 is attached or mounted in the needle lumen’s inner surface. The proximal needle hard stop 22 can be a step and/or an attached component of suitable dimensions and properties in the ID of the catheter shaft 101 or in the needle lumen provided within the catheter shaft 101. As the interference 109 meets the proximal needle hard stop 22, the needle 138 is prevented from retracting (moving proximally) any further.” (Hayzelden, col. 7, approx. ll. 5–16). Hayzelden further disclose: “The compressive forces on the catheter shaft 101 cause the catheter shaft 101 to shorten.” (Hayzelden, col. 5, approx. ll. 26-27).
Motivation to combine. It would have been obvious to include Hayzelden’s catheter-or lumen-mounted stop in the claim 6 combination because the stop provides a known contact structure for limiting relative movement when a catheter shaft experiences compression. A person of ordinary skill in the art would have been motivated to place the stop adjacent the loose coil end to limit the coil’s permitted travel during bending and compression.
Claims 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman et al. (US 20130046298A1; hereinafter “Kaufman”) in view of Webster, Jr. (US 5,431,168; hereinafter “Webster”) and Hayzelden (US 8,016,784; hereinafter “Hayzelden”), as discussed above, and in further view of Leeflang et al. (US 2014/0323964A1).
In relation to claim 9, this claim recites: the apparatus of claim 1, wherein the tubular member comprises: one or more reinforcement members comprising windings extending around the primary lumen between the proximal and distal ends; and one or more layers surrounding the one or more reinforcement members, wherein the tubular member comprises a first portion in which at least some of the windings pass between the primary lumen and the steering element lumen and at least some of the windings surrounding both the primary lumen and the steering element lumen. Claim 9 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
one or more reinforcement members comprising windings extending around the primary lumen between the proximal and distal ends; and one or more layers surrounding the one or more reinforcement members.
The Kaufman/Webster/Hayzelden combination does not expressly disclose the stated reinforcement-winding arrangement. Leeflang fills that gap by disclosing: “In accordance with one embodiment, a tubular device is provided, e.g., for a catheter or sheath, comprising a proximal end and a distal end sized for introduction into a patient's body. The tubular device may include a central lumen extending between the proximal and distal ends; an auxiliary lumen extending between the proximal and distal ends adjacent the central lumen; and one or more reinforcement members including windings extending helically around the central lumen between the proximal and distal ends. At least some of the windings may pass between the central and auxiliary lumens and at least some of the windings surrounding both the central and auxiliary lumens. In addition, one or more layers may surround the one or more reinforcement members and/or the lumens.” (Leeflang ¶ [0008]).
a first portion in which at least some of the windings pass between the primary lumen and the steering element lumen and at least some of the windings surrounding both the primary lumen and the steering element lumen.
The Kaufman/Webster/Hayzelden combination does not expressly disclose windings passing between the primary and steering-element lumens while other windings surround both. Leeflang fills that gap by disclosing: “In accordance with another embodiment, an apparatus is provided for performing a procedure within a patient's body that includes a tubular member including a proximal end, a distal end sized for introduction into a patient's body, a central axis extending therebetween, and a distal portion extending distally from an intermediate portion to the distal end; a primary lumen extending between the proximal and distal ends and aligned with and/or otherwise surrounding the central axis; a steering element lumen adjacent the primary lumen and offset from the central axis; and one or more reinforcement members including windings extending helically along at least the distal portion. At least some of the windings pass between the primary and steering element lumens and at least some of the windings surround both the primary and steering element lumens. A steering element may be slidably disposed within the steering element lumen and may include a distal end fixed to the tubular member distal end and a proximal end coupled to an actuator on the tubular member proximal end such that, actuation of the actuator applies axial tension or compression to the steering element, thereby causing the distal portion to bend.” (Leeflang ¶ [0009]).
Motivation to combine. It would have been obvious to incorporate Leeflang’s multi-lumen reinforcement-winding construction into the Kaufman/Webster/Hayzelden combination’s steerable tubular member because both references address a tubular device with an adjacent steering lumen and a distal portion bent by axial steering force. A person of ordinary skill in the art would have been motivated to use Leeflang’s pass-between and surround-both windings to reinforce the walls adjacent the steering lumen while retaining a multi-lumen structure.
In relation to claim 10, this claim recites: the apparatus of claim 9, wherein the tubular member comprises a second portion in which either a) all of the windings surround both the primary lumen and the steering element lumen orb) all of the windings surround the primary lumen and the steering element lumen is disposed outside the windings. Claim 10 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 9 is incorporated herein.
a second portion in which either a) all of the windings surround both the primary lumen and the steering element lumen or b) all of the windings surround the primary lumen and the steering element lumen is disposed outside the windings.
The Kaufman/Webster/Hayzelden combination does not expressly state the claimed alternative as a “second portion.” Leeflang fills the alternative-coverage gap by disclosing: “Thus, in this manner, all of the reinforcement members 6 may surround the primary mandrel 2a, while only some windings 43 a may surround the auxiliary mandrel 2b, as shown in FIG. 4D.” (Leeflang ¶ [0081]). Leeflang further discloses: “Thus, as reinforcement members 6 continue to be braided around the primary mandrel 2a, the auxiliary mandrel 2b remains outside the braid, as shown in FIG. 8.” (Leeflang ¶ [0096]).
Motivation to combine. It would have been obvious to select the disclosed Leeflang section in which reinforcement continues around the primary mandrel while the auxiliary mandrel remains outside the braid for the second portion of the claim 9 combination. A person of ordinary skill in the art would have been motivated to use this configuration to establish a transition or side-port region while preserving reinforcement around the primary lumen.
In relation to claim 11, this claim recites: the apparatus of claim 9, wherein the first portion includes the intermediate portion of the tubular member. Claim 11 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 9 is incorporated herein.
the first portion includes the intermediate portion of the tubular member.
The Kaufman/Webster/Hayzelden combination does not expressly disclose a first reinforcement-winding portion that includes an intermediate portion. Leeflang fills the location gap by disclosing: “In accordance with one embodiment, a tubular device is provided, e.g., for a catheter or sheath, comprising a proximal end and a distal end sized for introduction into a patient's body. The tubular device may include a central lumen extending between the proximal and distal ends; an auxiliary lumen extending between the proximal and distal ends adjacent the central lumen; and one or more reinforcement members including windings extending helically around the central lumen between the proximal and distal ends.” (Leeflang ¶ [0008]). Leeflang further discloses an intermediate portion for the multi-lumen tubular device: “In another embodiment, shown in FIG. 2, an apparatus 110 may be provided that includes an auxiliary or steering lumen 118b that extends helically around an intermediate portion 122 of the apparatus 110 to the proximal portion 120.” (Leeflang ¶ [0054]).
Motivation to combine. It would have been obvious to locate the Leeflang first winding portion along the intermediate portion of the Kaufman/Webster/Hayzelden combination tubular member because Leeflang expressly teaches reinforcement windings extending between the proximal and distal ends and an auxiliary/steering lumen traversing an intermediate portion. A person of ordinary skill in the art would have been motivated to continue the reinforcement configuration through the intermediate region to support the lumen-bearing shaft during steering.
In relation to claim 12, this claim recites: the apparatus of claim 11, wherein the first portion includes the distal portion of the tubular member.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
the first portion includes the distal portion of the tubular member.
The Kaufman/Webster/Hayzelden combination does not expressly identify the same “first portion” terminology for the distal portion. Leeflang fills the distal-location gap by disclosing: “In accordance with another embodiment, an apparatus is provided for performing a procedure within a patient's body that includes a tubular member including a proximal end, a distal end sized for introduction into a patient's body, a central axis extending therebetween, and a distal portion extending distally from an intermediate portion to the distal end; a primary lumen extending between the proximal and distal ends and aligned with and/or otherwise surrounding the central axis; a steering element lumen adjacent the primary lumen and offset from the central axis; and one or more reinforcement members including windings extending helically along at least the distal portion.” (Leeflang ¶ [0009]).
Motivation to combine. It would have been obvious to extend the reinforcement-winding portion to the distal portion of the claim 11 combination because Leeflang expressly places its helical reinforcement windings along at least the distal portion. A person of ordinary skill in the art would have been motivated to provide the disclosed reinforcement where the steering element produces distal bending.
In relation to claim 13, this claim recites the apparatus of claim 9, wherein the tubular member comprises a second portion adjacent the proximal portion wherein all of the windings surround the primary lumen and the steering element lumen is disposed outside the windings.
Base rejection incorporated.
The rejection of claim 9 is incorporated herein.
a second portion adjacent the proximal portion wherein all of the windings surround the primary lumen and the steering element lumen is disposed outside the windings.
The Kaufman/Webster/Hayzelden combination does not expressly use the undefined “proximal portion” phrase in claim 13. Leeflang fills the structural-configuration gap by disclosing: “Thus, as reinforcement members 6 continue to be braided around the primary mandrel 2 a, the auxiliary mandrel 2 b remains outside the braid, as shown in FIG. 8.” (Leeflang ¶ [0096]). Leeflang also discloses: “Subsequently, when jacket material 7 is applied around the reinforcement-wrapped mandrels 2, the auxiliary mandrel 2b may extend out of the jacket material 7 at one end. When the auxiliary mandrel 2b is removed, a side port may be provided on the end of the jacketed tubular body that communicates with the resulting auxiliary lumen 18 b. This end may be positioned inside the handle 20, e.g., as shown in FIG. 3, before or after inserting a steering element 30 through the auxiliary lumen 18b.” (Leeflang ¶ [0097]).
Motivation to combine. It would have been obvious to use Leeflang’s primary-mandrel-only reinforcement configuration at the proximal/handle-adjacent portion of the claim 9 combination because Leeflang expressly associates the outside-braid auxiliary mandrel with a side-port end positioned inside the handle. A person of ordinary skill in the art would have been motivated to use that construction to route the steering element to the proximal actuator without surrounding the steering lumen with the braid in that portion.
In relation to claim 14, this claim recites the apparatus of claim 1, wherein the central lumen is defined by a liner comprising an inner surface substantially surrounding the central lumen. Claim 14 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
the central lumen is defined by a liner comprising an inner surface substantially surrounding the central lumen.
The Kaufman/Webster/Hayzelden combination does not expressly disclose a liner defining the claim’s “central lumen.” Leeflang fills the liner gap by disclosing: “In an exemplary embodiment, the central lumen 18 a is defined by an inner liner 40 a including an inner surface 41 a. The inner liner 40 a may be formed from lubricious material, e.g., PTFE, to provide a lubricious inner surface 41 a. Alternatively, the inner liner 40 may be formed from one or more layers of thermoplastic or other polymeric material including one or more coatings on the inner surface 41 a having desired properties, e.g., a hydrophilic and/or lubricious coating.” (Leeflang ¶ [0043]).
Motivation to combine. It would have been obvious to use Leeflang’s central-lumen liner in Kaufman’s tubular member because both references concern a multi-lumen steerable catheter. A person of ordinary skill in the art would have been motivated to define the central/primary lumen with a liner to provide a controlled inner surface and retain lumen integrity during bending.
In relation to claim 15, this claim recites: the apparatus of claim 14, wherein the liner comprises a lubricious coating on the inner surface. Claim 15 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 14 is incorporated herein.
the liner comprises a lubricious coating on the inner surface.
The Kaufman/Webster/Hayzelden combination does not expressly disclose the claimed coating. Leeflang fills the coating gap by disclosing: “In an exemplary embodiment, the central lumen 18 a is defined by an inner liner 40 a including an inner surface 41 a. The inner liner 40 a may be formed from lubricious material, e.g., PTFE, to provide a lubricious inner surface 41 a. Alternatively, the inner liner 40 may be formed from one or more layers of thermoplastic or other polymeric material including one or more coatings on the inner surface 41 a having desired properties, e.g., a hydrophilic and/or lubricious coating.” (Leeflang ¶ [0043]).
Motivation to combine. It would have been obvious to apply Leeflang’s lubricious coating to the inner surface of the claim 14 combination liner because the passage expressly identifies a lubricious or hydrophilic coating as a desired inner-surface property. A person of ordinary skill in the art would have been motivated to reduce friction for instruments or fluids passing through the lumen.
In relation to claim 16, this claim recites: the apparatus of claim 1, wherein the steering element lumen is defined by a liner comprising an inner surface substantially surrounding the steering element lumen. Claim 16 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
the steering element lumen is defined by a liner comprising an inner surface substantially surrounding the steering element lumen.
The Kaufman/Webster/Hayzelden combination does not expressly disclose an auxiliary/steering-lumen liner having an inner surface. Leeflang fills that gap by disclosing: “Optionally, as shown in FIG. 1C, an inner liner 40b may also at least partially surround the auxiliary lumen 18b, which may be formed from a lubricious material and/or may include one or more coatings on its inner surface 41b, similar to the inner liner 40a.” (Leeflang (US20140323964) ¶ [0044]).
Motivation to combine. It would have been obvious to add Leeflang’s auxiliary-lumen liner to Kaufman’s steering-element lumen because both references address a steering element that moves in an adjacent lumen. A person of ordinary skill in the art would have been motivated to use a liner to provide a suitable inner surface for steering-element movement.
In relation to claim 17, this claim recites: the apparatus of claim 1, wherein the steering element lumen is smaller than the primary lumen. Claim 17 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
the steering element lumen is smaller than the primary lumen.
The Kaufman/Webster/Hayzelden combination does not expressly disclose the claimed lumen-size relation. Leeflang fills that gap by disclosing: “In an exemplary embodiment, the auxiliary mandrel 2b may have a substantially smaller diameter or other cross-section than the primary mandrel 2a.” (Leeflang ¶ [0068]).
Motivation to combine. It would have been obvious to form the steering lumen smaller than the primary lumen in the Kaufman/Webster/Hayzelden combination apparatus because Leeflang expressly identifies a smaller auxiliary mandrel relative to the primary mandrel. A person of ordinary skill in the art would have been motivated to reserve a larger cross-section for the primary lumen while providing a smaller lumen sufficient for the steering element.
In relation to claim 18, this claim recites: the apparatus of claim 1, wherein the primary lumen communicates with an outlet in the distal end. Claim 18 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
the primary lumen communicates with an outlet in the distal end.
Kaufman discloses a lumen communicating with a distal outlet: “Generally, the apparatus 10 is an elongate tubular member including a proximal end 12, a distal end 14 sized for insertion into a body lumen, a central longitudinal axis 16 extending therebetween, and one or more lumens 18 extending between the proximal and distal ends 12, 14. For example, as shown in FIGS. 2A and 2B, the apparatus 10 may include an accessory lumen 18a sized for receiving or carrying one or more instruments or other elements (not shown) therethrough. In exemplary embodiments, the accessory lumen 18a may be sized for receiving or carrying a guide wire, procedure catheter, cardiac lead, needle, or other instrument (not shown), one or more wires or other conductors, one or more optical fibers, one or more tubes or accessory lumens, one or more mechanical elements, one or more sensors, and/or sized for delivering fluids or other flowable agents or materials therethrough. The accessory lumen 18a may communicate with an outlet 14a in the distal end 14 (e.g., as shown in FIG. 1) or may be enclosed within or adjacent the distal end 14, e.g., to isolate the accessory lumen 18a and/or elements carried therein from the environment outside the apparatus 10.” (Kaufman ¶ [0024]). Kaufman does not expressly identify the outlet-bearing accessory lumen as a “primary lumen.” Leeflang fills that nomenclature/central-lumen gap by disclosing: “In one embodiment, shown in FIG. 1A, the central lumen 18a may exit at or communicate with an outlet 17 in the distal end 14, e.g., to allow a guidewire or other instrument (not shown) to pass therethrough and/or for delivering or aspirating fluid therethrough.” (Leeflang ¶ [0031]).
Motivation to combine. It would have been obvious to use Leeflang’s central-lumen distal outlet in Kaufman’s multi-lumen apparatus because both disclosures identify a central/accessory lumen extending toward the distal end. A person of ordinary skill in the art would have been motivated to provide a known outlet for guidewire passage, instrument delivery, fluid delivery, or aspiration.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflang et al. (US 2014/0323964A1; hereinafter “Leeflang”) in view of Samson et al. (US 6,143,013; hereinafter “Samson”) and Fuentes (US 20120277671A1).
In relation to claim 19, this claim recites: a tubular device for a catheter or sheath comprising a proximal end and a distal end sized for introduction into a patient's body, the tubular device comprising: a lumen extending at least partially between the proximal and distal ends; a plurality of reinforcement members comprising windings extending helically around the lumen at least partially between the proximal and distal ends; and one or more layers surrounding the one or more reinforcement members, wherein the reinforcement members have a braiding configuration where at least one of a density and a pitch angle of the reinforcement members vary around a periphery of the lumen. Claim 19 has been rejected in the following manner:
a tubular device for a catheter or sheath comprising a proximal end and a distal end sized for introduction into a patient's body; a lumen; reinforcement-member windings extending helically around the lumen; and one or more layers surrounding the reinforcement members.
Leeflang discloses: “In accordance with one embodiment, a tubular device is provided, e.g., for a catheter or sheath, comprising a proximal end and a distal end sized for introduction into a patient's body. The tubular device may include a central lumen extending between the proximal and distal ends; an auxiliary lumen extending between the proximal and distal ends adjacent the central lumen; and one or more reinforcement members including windings extending helically around the central lumen between the proximal and distal ends. At least some of the windings may pass between the central and auxiliary lumens and at least some of the windings surrounding both the central and auxiliary lumens. In addition, one or more layers may surround the one or more reinforcement members and/or the lumens.” (Leeflang ¶ [0008]). Leeflang further discloses: “The reinforcement layer 42 may include one or more reinforcing members, e.g., wound in a braided or other helical configuration around the inner liner 40 a, and the outer jacket 44 may include one or more tubular layers surrounding the reinforcement layer 42 and/or between the reinforcement layer 42 and the inner liner 40 a.” (Leeflang ¶ [0048]).
a braiding configuration where at least one of a density and a pitch angle of the reinforcement members vary around a periphery of the lumen.
Leeflang does not expressly state variation of braid density or pitch angle using the exact language “around a periphery of the lumen.” Leeflang does, however, disclose: “The reinforcement layer 42 may be configured to substantially transfer torsional forces between the proximal and distal ends 12, 14, e.g., to allow the apparatus 10 to be twisted from the proximal end 12 to rotate the distal end 14 about the longitudinal axis 16 within a patient's body. In addition, the reinforcement layer 42 may allow the distal end 14 of the apparatus 10 to be advanced or otherwise manipulated within a patient's body from the proximal end 12 without substantial risk of buckling and/or kinking. The pitch of the reinforcement layer 42 may be varied along the length of the apparatus 10, e.g., in order to optimize mechanical properties of various segments or portions of the apparatus 10.” (Leeflang ¶ [0050]).
Samson fills the multiple-pitch/density gap by disclosing: “This invention additionally includes catheter sections with braids having more than one pitch or diameter or braid density in a Section. The Stiffness of the catheter Section may be varied continuously by continuously varying the pitch or in a stepwise fashion by Stepwise varying the pitch. The pitch may be varied during production of the braid or by changing the diameter of the braid after production.” (Samson, col. 8, approx. ll. 49–55).
Fuentes further fills the variable-braiding-parameter gap by disclosing: “After the inner braid 204 has been formed, the intermediate jacket 206 is extruded onto the inner braid 204 and the inner jacket 202, as shown in FIG. 2C. A braiding machine can then be operated to wind a wire on the intermediate jacket 206 to form the outer braid 208, as shown in FIG. 2D. It will be appreciated that the pic rate of the outer braid 208 can also be varied along the length of the catheter to balance the desire for torsional rigidity with desire for flexibility, as shown by the varied pic rate between s3 and s4.” (Fuentes ¶ [0048]).
Motivation to combine. It would have been obvious to incorporate Samson’s multiple-pitch/braid-density teachings and Fuentes’s variable pic-rate teachings into Leeflang’s braided reinforcement around a lumen because all three references seek to tailor catheter mechanical performance with reinforcement geometry. A person of ordinary skill in the art would have been motivated to vary a braid’s density or pitch angle in Leeflang’s peripheral helical reinforcement to select torsional rigidity, flexibility, and stiffness characteristics.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of non-statutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,195,395. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the cited patent discloses an apparatus for performing a procedure within a patient's body, comprising:
a tubular member comprising a proximal end, a distal end sized for introduction into the patient's body, a central axis extending therebetween, and a distal portion extending distally from an intermediate portion to the distal end;
a primary lumen extending between the proximal end and the distal end and surrounding at least a portion of the central axis;
a steering element lumen extending at least partially between the proximal and distal ends adjacent the primary lumen;
a steering element slidably disposed within the steering element lumen and comprising a distal end fixed to the tubular member distal end and a proximal end adjacent the proximal end of the tubular member;
an actuator on the proximal end coupled to the steering element proximal end such that, actuation of the actuator applies axial tension or compression to the steering element, thereby causing the distal portion to bend;
a compression-resistant element slidably disposed within the steering element lumen and extending from the proximal end through the intermediate portion adjacent the steering element for preventing forces from the steering element from transferring to the tubular member proximal to the distal portion;
a handle coupled to the tubular member proximal end and carrying the actuator; and a stop fixed within the handle and disposed adjacent a proximal end of the compression-resistant element for limiting compression of the tubular member in bending when the distal end of the compression-resistant element contacts the stop.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
Prosecution Insights