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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/04/25 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 12/04/25 has been entered. Claims 1, 5, 12, 16, and 18-20 have been amended. Claims 2-4, 6-11, 13-15, and 17 are in the original/ previously presented form. Thus, claims 1-20 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 06/04/25.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 line 16 reads “positioned withwithin a vessel” and should likely read “positioned [[with]]within a vessel” as ‘with’ seems to have been accidentally included twice
Claim 18 line 17 reads “configured guide the one or more needles” and should likely read “configured to guide the one or more needles” for grammatical reasons
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mandrusov et al. (U.S. Patent No. 7,008,411), hereinafter Mandrusov.
Regarding claim 1, Mandrusov discloses a method of delivering a therapeutic agent to an infusion site (986, see col 15 line 7- col. 16 line 2: lipid core 915, or adventitia 986, of plaque 910 is injected with a drug==therapeutic agent via needle catheter 950 as seen in FIG. 9A), the method comprising:
positioning (see col. 16 lines 3-5: distal portion 941 of needle catheter 950 inserted into lumen of patient and guided to plaque region for treatment) a distal portion (941) of catheter shaft (940) of an infusion device (950) within a vein (930) of a patient proximate to (as seen in FIG. 9A) an infusion site (915);
advancing (see col. 15 lines 38-41: needle 945 extends from needle lumen 942) a needle (945) of the infusion device (950) through an exit port (distal end of 942, see col. 15 lines 38-41: needle 945 exits via lumen 942 therefore there MUST be an exit port at the end of the needle lumen 942 to allow needle 945 to exit out of) of the needle lumen to the infusion site (915) within a venous wall (980, see col 15 lines 30-33: needle inserted into wall 980 to get to plaque 910 as seen in FIG. 9A); and
delivering (see col. 15 line 60- col. 16 line 2: needles, including 945, form injection location and deliver treatment such as injection of drug. Thus drug is delivered through the needle), through the needle (945) traveling distally within the venous wall (980) in a direction generally parallel (needle travel only offset by degree of inflation of balloon, see col 15 lines 40-43. Thus, the needle travel direction is “generally” parallel to the longitudinal axis, see ‘Modified FIG. 9A’ below) to a longitudinal axis (axis through catheter 941) of the distal portion (941),
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an infusate (see col. 15 line 60- col. 16 line 2: a drug) to the infusion site (915) to break down tissue at or adjacent the infusion site (see col. 17 lines 46-55: needle catheter 950 can deliver metalloproteinases into adventitia 986 of plaque to provide gene therapy to the plaque 910, which as described causes breakdown of the tissue), wherein the infusate (see col. 15 line 60- col. 16 line 2: a drug) comprises a matrix metalloproteinase (see col. 17 lines 46-55: needle catheter delivers metalloproteinases).
Regarding claim 8, Mandrusov discloses the method of claim 1, and Mandrusov discloses further comprising targeting the infusion site (see col. 16 lines 3-5: distal portion 941 of needle catheter 950 inserted into lumen of patient and guided to plaque region for treatment and thus “targets” the site) with the distal end (941, see FIG.9A) of the catheter shaft (940).
Regarding claim 9, Mandrusov discloses the method of claim 8, and Mandrusov further discloses wherein targeting the infusion site (see col. 16 lines 3-5: distal portion 941 of needle catheter 950 inserted into lumen of patient and guided to plaque region for treatment and thus “targets” the site) includes at least partially expanding an expandable component (948, see FIG. 9A with balloon expanded and col. 15 lines 40-41: inflated balloon secures catheter in place.) on the distal end (941) of the catheter shaft (940), wherein expanding the expandable component at least partially straightens a portion of the vein (see FIG. 9A: section of vessel touching balloon MUST at least partially straighten along balloon due to inflated pressure by balloon to maintain device in place, see col. 15 lines 40-41).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Mandrusov as applied to claim 1 above, and further in view of di Palma et al. (U.S. PGPUB No. 2012/0059309), hereinafter Palma.
Regarding claim 2, Mandrusov discloses the method of claim 1, and Mandrusov further discloses wherein the tissue (plaque 910, see FIG. 9A is within vessel wall 980, see col. 15 lines 33-34, or adventitia 986 as described in col. 17 lines 46-55) is at least partially occluding (see cross-sectional diameter of 930 occluded in FIG. 9A) the vessel wall (980) beyond (rightward in FIG. 9A) a distal end (941) of the catheter (940), but in the first embodiment, Mandrusov is silent to the tissue “is an intraluminal tissue that is at least partially occluding the vein” and “wherein the method further comprises removing at least a portion of the intraluminal tissue after delivering the infusate to the infusion site.”
However, Palma teaches a method of delivering a therapeutic agent to an infusion site (see FIG. 7D and [0051]: method of treating a thrombus with an infusion device), the method comprising delivering an infusate to an infusion site (134) to break down tissue (see [0055]: a drug is delivered to the tissue 134 to soften==breakdown the tissue), wherein the tissue is an intraluminal tissue (134, see [0055]: drug delivered to thrombus/ clot==intraluminal tissue) that is at least partially occluding a vein (see FIG. 7D where 134 obstructs cross-sectional diameter of vessel shown) beyond a distal end (126) of a catheter (110), wherein the method further comprises removing at least a portion of the intraluminal tissue (134) after delivering the infusate to the infusion site (see FIG. 7D and [0055]: drug is delivered to the obstruction and then the obstruction and any fragments are removed and/or aspirated from the vessel).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method comprising delivering an infusate to tissue disclosed in Mandrusov to specifically deliver the infusate to intralimunal tissue at least partially occluding a vein as taught by Palma for the purpose of facilitating removal of the tissue in a case where the tissue occludes the vessel lumen (see [0055]), thus achieving the tissue “is an intraluminal tissue that is at least partially occluding the vein”
Next, therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of delivering a therapeutic agent to an infusion site to breakdown tissue disclosed in Mandrusov to include removing the treated tissue after delivering the infusate as taught by Palma for the purpose of removing as much of the obstructive material as possible in order to prevent formations of new obstructions (see [0008]), thus achieving “wherein the method further comprises removing at least a portion of the intraluminal tissue after delivering the infusate to the infusion site.”
Regarding claim 3, Mandrusov discloses the method of claim 1, but Mandrusov is silent to “wherein the infusion site is a boundary layer between a thrombotic material and a vessel wall, and wherein advancing the needle toward the infusion site includes penetrating the boundary layer to access a space between the thrombotic material and the vessel wall.”
However, Palma teaches a method of delivering a therapeutic agent to an infusion site (see FIG. 7D and [0051]: method of treating a thrombus with an infusion device), the method comprising delivering an infusate to an infusion site (134) to break down tissue (see [0055]: a drug is delivered to the tissue 134 to soften==breakdown the tissue), wherein the infusion site is a boundary layer between a thrombotic material and a vessel wall (see [0008]: drug delivery can be at the outermost edges of clot and see [0055]: drug delivery to the outermost portions==edge of thrombus, which would be the layer between the thrombus and the vessel wall), wherein advancing the device (see [0049]: advancing device to the site) toward the infusion site includes penetrating the boundary layer to access a space between the thrombotic material and the vessel wall (see [0054]: infusion portion 20 advanced until within clot in FIG. 7D and then [0055]: infusion portion 20 delivers drug to outermost edges of clot. Therefore, the infusion portion MUST penetrate the boundary layer to access the outermost edge== “a space” between the thrombotic material and the vessel wall).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of delivering an infusate to an infusion site comprising advancing a needle disclosed in Mandrusov to specifically use the needle to deliver an infusate to a boundary layer between a thrombotic material and a vessel wall in a manner such that the boundary layer is penetrated as taught by Palma for the purpose of softening the thrombotic material and facilitating the material for removal (see [0055]) such that the material is removed effectively to avoid the formation of new obstructions (see [0008]), thus achieving “wherein the infusion site is a boundary layer between a thrombotic material and a vessel wall and wherein advancing the needle toward the infusion site includes penetrating the boundary layer to access a space between the thrombotic material and the vessel wall”.
Regarding claim 4, the modified system of Mandrusov teaches the method of claim 3, but Mandrusov is silent to “wherein the infusate at least partially breaks down a bond between the thrombotic material and the vessel wall, and wherein the method further comprises removing at least a portion of the thrombotic material after delivering the infusate to the infusion site.”
However, Palma teaches a method of delivering a therapeutic agent to an infusion site (see FIG. 7D and [0051]: method of treating a thrombus with an infusion device), the method comprising delivering an infusate to an infusion site (134) to break down tissue (see [0055]: a drug is delivered to the tissue 134 to soften==breakdown the tissue), wherein the infusate at least partially breaks down a bond between the thrombotic material and the vessel wall (see [0008]: the method of drug delivery “breaks the clot away from the inner vessel wall”==breaks the bond between the thrombotic material and the vessel wall), and wherein the method further comprises removing at least a portion of the thrombotic material after delivering the infusate to the infusion site (see FIG. 7D and [0055]: drug is delivered to the obstruction and then the obstruction and any fragments are removed and/or aspirated from the vessel).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of delivering a therapeutic agent to an infusion site disclosed in Mandrusov to deliver to an infusion site of thrombotic material such that the drug delivery at least partially breaks the bond between the thrombotic material and the vessel wall as taught by Palma for the purpose of softening the material for removal (see [0055]), minimizing remnants attached to the inner vessel wall that may obstruct bloodflow (see [0008]), and ensuring that the material is removed effectively to avoid the formation of new obstructions (see [0008]), thus achieving “wherein the infusate at least partially breaks down a bond between the thrombotic material and the vessel wall”.
Next, therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of delivering a therapeutic agent to an infusion site to breakdown tissue disclosed in Mandrusov to include removing the treated tissue after delivering the infusate as taught by Palma for the purpose of removing as much of the obstructive material as possible in order to prevent formations of new obstructions (see [0008]), thus achieving “wherein the method further comprises removing at least a portion of the thrombotic material after delivering the infusate to the infusion site.”
Regarding claim 6, Mandrusov discloses the method of claim 1, and Mandrusov further discloses wherein advancing (see col. 15 lines 38-41: needle 945 extends from needle lumen 942) the needle (945) to the infusion site (915) includes advancing the needle (945) into the tissue (see col. 17 lines 46-55: needle catheter delivers metalloproteinases into adventitia 986 of plaque to provide gene therapy to the plaque 910 and col. 15 line 60- col. 16 line 2: needles, including 945, form injection location and deliver treatment such as injection of drug. Thus, the needle must be advanced into the tissue/ adventitia to enable drug delivery through the needle).
Mandrusov is silent to “wherein the tissue is an intraluminal tissue that is at least partially occluding the vein, wherein the infusion site is a space within the intraluminal tissue”, and advancing the needle into the “intraluminal” tissue
However, Palma teaches a method of delivering a therapeutic agent to an infusion site (see FIG. 7C and [0051]: method of treating a thrombus with an infusion device), the method comprising delivering an infusate to an infusion site (134) to break down tissue (see [0055]: a drug is delivered to the tissue 134 to soften==breakdown the tissue), wherein the tissue is an intraluminal tissue (134, see [0055]: drug delivered to thrombus/ clot==intraluminal tissue) that is at least partially occluding a vein (see FIG. 7C where 134 obstructs cross-sectional diameter of vessel shown), wherein the infusion site (134) is a space within (see [0008]: drug can be delivered to inner core of clot) the intraluminal tissue (134), and advancing a drug delivery device (see [0049]: advancing device to the site) into the intraluminal tissue (see [0050]: infusion device delivers drug to center of thrombus mass or see [0055]: to the outermost portions of the mass)
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method comprising delivering an infusate to tissue disclosed in Mandrusov to specifically deliver the infusate to intraluminal tissue at least partially occluding a vein as taught by Palma for the purpose of facilitating removal of the intraluminal tissue in a case where the tissue occludes the vessel lumen (see [0055]), thus achieving “wherein the tissue is an intraluminal tissue that is at least partially occluding the vein, wherein the infusion site is a space within the intraluminal tissue”, and advancing the needle into the “intraluminal” tissue
Claims 5, 10, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mandrusov as applied to claim 1 above, and further in view of Stigall et al. (U.S. PGPUB No. 2015/0112188), hereinafter Stigall.
Regarding claim 5, Mandrusov discloses the method of claim 1, and Mandrusov further discloses wherein the needle (945, see FIG.9A) delivers the infusate (such as a vulnerable plaque treatment agent, see col 15 lines 30-48) in a direction generally parallel to the longitudinal axis (needle travel only offset by degree of inflation of balloon, see col 15 lines 40-43. Thus, the needle travel direction is “generally” parallel to the longitudinal axis, see ‘Modified FIG. 9A’ below).
Mandrusov is silent to the needle direction being specifically “parallel”.
However, Stigall teaches a method of delivering a needle (1681, see FIG. 1H) to an infusion site (see [0048]) comprising an infusion device (as seen in FIG. 1H) with the needle (1681), wherein the needle (1681) is delivered in a direction parallel to the longitudinal axis (see [0048]: needle exits the exit port parallel to the flat support surface of the catheter support surface).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exit port of the catheter shaft disclosed in the device used for the method of Mandrusov to be formed on a support surface of the catheter shaft such that the needle is delivered in a direction parallel to the longitudinal axis as taught by Stigall for the purpose of penetrating and directing the needle through the vessel wall at a maintained height such that the needle cannot inadvertently puncture through the outer side of the vessel wall (see [0048]), thus achieving the needle direction being specifically “parallel”.
Regarding claim 10, Mandrusov discloses the method of claim 8, but Mandrusov is silent to “wherein the exit port includes a rotatable guide component to adjust a distance between the needle and a central longitudinal axis of the catheter shaft before advancing the needle out of the exit port, and wherein targeting the infusion site includes adjusting the distance between needle and the central longitudinal axis of the catheter shaft.”
However, Stigall teaches a method of delivering a therapeutic agent to an infusion site (see [0041]: saline with contrast agent is delivered to tissue) using a catheter shaft (bottom side of catheter shaft 1688, see FIGs. 4A-B) comprising a longitudinal axis (longitudinal axis through center of catheter shaft), a needle (1680), and an exit port (1670) to target an infusion site (see [0054]: a vessel wall), wherein the exit port (1670) includes a rotatable guide component (see [0054]: 1680 is rotated to control puncture height into vessel wall) to adjust a distance (see [0054] a puncture height—such as two separate heights shown in FIGs. 4A and 4B) between the needle (1680) and a central longitudinal axis (see [0054]: rotation is about longitudinal axis) of the catheter shaft (1688) before advancing the needle (see [0054]: forward advancement can occur after rotation) out of the exit port (1670), and wherein targeting the infusion site includes adjusting the distance between needle and the central longitudinal axis of the catheter shaft (see [0054]: puncture height is set prior to entering vessel wall or “targeting” the infusion site).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of targeting an infusion site in a vessel wall disclosed in Mandrusov to include adjusting the distance between the needle and the longitudinal axis of the catheter shaft using a rotatable guide component of the exit port before advancing the needle out of the exit port as taught by Stigall for the purpose of controlling the puncture height/ depth of the needle into the vessel wall (see [0054]), thus achieving “wherein the exit port includes a rotatable guide component to adjust a distance between the needle and a central longitudinal axis of the catheter shaft before advancing the needle out of the exit port, and wherein targeting the infusion site includes adjusting the distance between needle and the central longitudinal axis of the catheter shaft.”
Regarding claim 13, Mandrusov discloses the method of claim 1, and Mandrusov further discloses wherein: the infusion site (986, see FIG. 9A col 15 line 7- col. 16 line 2: lipid core 915, or adventitia 986) is external to the vein (in the vessel wall 980) of the patient; the method further comprises pressing an engagement surface (948) at the distal end (941) of the catheter shaft (940) against a vessel wall (see catheter in use in the vessel as shown in FIG. 9A with balloon 948 pressing against wall of vessel 930 to secure the device in place, see col. 15 line 40-41) to conform the vessel wall to the engagement surface (see FIG. 9A: section of vessel touching balloon MUST at least conform along balloon due to inflated pressure by balloon to maintain device in place, see col. 15 lines 40-41); and advancing (see col. 15 lines 38-41: needle 945 extends from needle lumen 942) the needle (945) to the infusion site (986) includes penetrating through the vessel wall (980) conformed to the engagement surface (948, see FIG. 9A) to access the infusion site (986).
Mandrusov is silent to the method further comprises pressing an engagement surface “of a housing” at the distal end of the catheter shaft against a vessel wall to conform the vessel wall to the engagement surface
However, Stigall teaches a method of delivering a therapeutic agent to an infusion site, the method further comprises pressing (see [0046]: 1685 presses distal portion of catheter 1640 firmly against vessel wall) an engagement surface (surface of 1640, see [0046-0048] for the embodiment of FIG. 1H) of a housing (see ‘Modified FIG. 5A’ below for visual of how the device of FIG. 1H is used within a vessel wall 144 as described in [0047-0048])
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at the distal end of a catheter shaft (1660 in FIG. 1H) against a vessel wall (144) to conform the vessel wall (144) to the engagement surface (see [0047]: balloon causes vessel wall to conform along the distal portion of support catheter engagement surface and [0048]: inflation of balloon causes vessel wall to conform around edges of shaft).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for delivering a therapeutic agent to an infusion site disclosed in Mandrusov to include pressing an engagement surface of a housing against the vessel wall as taught by Stigall for the purpose of allowing the needle to enter the vessel wall in a controlled manner by reducing movement of the catheter during the procedure (see [0046]), thus achieving the method further comprises pressing an engagement surface “of a housing” at the distal end of the catheter shaft against a vessel wall to conform the vessel wall to the engagement surface.
Regarding claim 15, the modified system of Mandrusov teaches the method of claim 13, and Mandrusov discloses (See col 15 lines 60-62 FIG.9A in use with full assembly shown in FIG. 10A—see col. 16 lines 15-16: FIG. 10A is a catheter with sensing capabilities as disclosed for FIG.9A in col 15 lines 60-62-- and thus FIG. 10A-B will be referred to for further details regarding fully assembled device for us of method disclosed in FIG. 9A) further comprising advancing (see FIG. 10B and col. 16 lines 37-44: ultrasonic element sends ultrasonic waves against plaque and thus must be advanced to the plaque region in order to deliver waves to the site as disclosed) an imaging component (1034) out of a second lumen (1024) at the distal portion (distal portion shown in FIG. 10B) of the catheter device (1001) to image the infusion site (see col. 16 lines 37-57: imaging component generates ultrasound waves for processing to differentiate between anatomic boundaries and structures).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mandrusov as applied to claim 1 above, and further in view of Guo et al. (U.S. PGPUB No. 2012/0259314), hereinafter Guo.
Regarding claim 7, Mandrusov disclosed the method of claim 1, but Mandrusov is silent to “wherein the infusate includes collagenase.”
However, Guo teaches a method of delivering an infusate to an infusion site (see [0022]), wherein the infusate includes collagenase (see [0023]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusate of the method disclosed in Mandrusov to include collagenase as taught by Guo for the purpose of providing an initial mediator to enhance the therapeutic effect at the infusion site and to use an enzyme known in the art for treating occlusions (see [0023]), thus achieving “wherein the infusate includes collagenase.”
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Mandrusov as applied to claim 1 above, and further in view of Parmentier (U.S. PGPUB No. 2018/0280005).
Regarding claim 11, Mandrusov discloses the method of claim 1, and Mandrusov further discloses an ultrasound transducer (see col 16 lines 37-57) but Mandrusov is silent to “further comprising energizing the infusate at the infusion site, wherein energizing the infusate increases and/or accelerates the break down of the intraluminal tissue.”
However, Parmentier teaches a method of removing an occlusive element from a blood vessel (see [0021]) further comprising energizing the distal end of the catheter at the infusion site (see [0021]: ultrasound applied to distal end of catheter), wherein energizing the distal end of the catheter increases and/or accelerates the break down of the intraluminal tissue (see [0021]: ultrasound energy dissolves vascular occlusions).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound transducer disclosed in Mandusov to energize the distal end of the catheter (where the infusate of Mandrusov is delivered) as taught by Parmentier for the purpose of vibrating/ energizing the infusate and infusion site area to aid in the dissolving of the vascular occlusion (see [0021]), thus achieving “further comprising energizing the infusate at the infusion site, wherein energizing the infusate increases and/or accelerates the break down of the intraluminal tissue.”
Regarding claim 12, the modified system of Mandrusov teaches the method of claim 11, but Mandrusov is silent to “wherein energizing the infusate includes directing ultrasound energy into the infusion site.”
However, Parmentier teaches a method of removing an occlusive element from a blood vessel (see [0021]) further comprising energizing the distal end of the catheter at the infusion site (see [0021]: ultrasound applied to distal end of catheter), wherein energizing the distal end of the catheter includes directing ultrasound energy into the site (see [0021]: ultrasound energy is directed to the distal end of the catheter to vibrate and dissolve the occlusion).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound transducer disclosed in Mandusov to energize the distal end of the catheter (where the infusate of Mandrusov is delivered into the infusion site) with ultrasound energy as taught by Parmentier for the purpose of vibrating/ energizing the infusate and infusion site area to aid in the dissolving of the vascular occlusion (see [0021]), thus achieving “wherein energizing the infusate includes directing ultrasound energy into the infusion site.”
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Mandrusov in view of Stigall as applied to claim 13 above, and further in view of Flaherty et al. (U.S. PGPUB No. 2014/0180222), hereinafter Flaherty.
Regarding claim 14, the modified system of Mandrusov teaches the method of claim 13, and Mandrusov further discloses wherein the vessel (930, see FIG. 9A) is a first vessel (see col 15 lines 34-35: 930 is arterial lumen), and wherein the infusion site (915 or adventitia 986, see col. 16 lines 1- 2) is in a vessel wall (980) adjacent (see FIG. 9A) the first vessel (930).
Modified Mandrusov is silent to wherein the infusion site is in “a second” vessel adjacent the first vessel.
However, Flaherty teaches a method of advancing a needle (30, see FIG. 13j and [0131]) to a treatment site (LAD, a target vessel), wherein the infusion site is in a second vessel (LAD, the target vessel) adjacent a first vessel (AIV, a resident vessel).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of advancing a needle to an infusion site disclosed in Mandrusov to include advancing the needle to an infusion site of a second vessel adjacent the first vessel as taught by Flaherty for the purpose of using the IVUS image to guide the needle into the second vessel requiring treatment to ensure that the needle is proper aimed to enter the treatment site of an occluded adjacent vessel (see [0131]), thus achieving wherein the infusion site is in “a second” vessel adjacent the first vessel.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mandrusov (U.S. Patent No. 7,008,411) in view of Wilson et al. (U.S. PGPUB No. 2015/0359630), hereinafter Wilson.
Regarding claim 16, Mandrusov discloses an infusion device (1001, se FIG. 10A), comprising
a handle assembly (1054, see col 17 lines 8- 21: needle adjustment knob moves needle in and out of lumen and this a user would grasp this area, making it a “handle assembly”;
a catheter shaft (1010) having a proximal portion (rightward portion of 1010 extending into 1050 as seen in FIG.10A) coupled to (see col 17 lines 8- 21: proximal end 1050 of catheter coupled to handle assembly 1054) the handle assembly (1054) and a distal portion (leftward portion of 1010 in FIG. 10A), wherein the catheter shaft (1010) includes:
a lumen (1012) extending from (see col. 16 line 58- col. 17 line 21: needle lumen 1012 allows movement of needle from handle 1054 and out distal end and therefore the lumen MUST extend the length of the device from proximal to distal end to enable free needle movement within) the proximal portion (rightward portion of 1010 extending into 1050) to the distal portion (leftward portion of 1010 in FIG. 10A);
the distal portion (leftward portion of 1010 in FIG. 10A) having an exit port (see needle 1013 extending from lumen 1012 in FIG. 10A—thus there must be an exit port of the lumen that allows needle 1013 to extend through) in communication with the lumen (1012); and
an expandable component (1026, see col. 16 line 13-36: inflatable balloon 1026 as shown in FIG. 10A. See col 15 lines 60-62 FIG.9A in use with full assembly shown in FIG. 10A—see col. 16 lines 15-16: FIG. 10A is a catheter with sensing capabilities as disclosed for FIG.9A in col 15 lines 60-62-- and thus FIG. 9A will be referred to now for further details. The expandable balloon of FIG.9A is numeral 948) at the distal portion (leftward portion of 1010 in FIG. 10A) and positioned to press against a tissue wall (see catheter in use in the vessel as shown in FIG. 9A with balloon 948 pressing against wall of vessel 930 to secure the device in place, see col. 15 line 40-41) to at least partially straighten (see FIG. 9A: section of vessel touching balloon MUST at least partially straighten along balloon due to inflated pressure by balloon to maintain device in place, see col. 15 lines 40-41) a section of a vessel (930) to orient (see col. 15 lines 42-43: balloon provides penetration angle==orientation for needle) the exit port (port where needle 945 extends through) toward an infusion site (915) distal (rightward in FIG. 9A, 915 more distal than distal portion of catheter 941) to the distal portion (941) of the catheter shaft (940); and
a needle (1013, see FIG. 10A) positioned within the lumen (see col. 17 lines 8-13: needle 1013 is moved within lumen at target position) and slidably movable (see col. 16 line 58- col. 17 line 21: needle 1013 controllably moved in/out==slidable of needle lumen by 1054) along a path (path within lumen 1012) parallel to (see needle lumen 1012 parallel to a long. Axis in FIG. 10A) a longitudinal axis (horizontal axis extending through 1010 in FIG. 10A) of the catheter shaft (1010) to access the infusion site (see col. 16 line 58- col. 17 line 21: needle 1013 controllably moved to target position) after the expandable component (948, see FIG. 9A) expands (see col. 15 lines 42-43: balloon provides penetration angle for needle so needle would have to be placed after balloon), wherein the needle (1013) includes a fluid lumen (see col. 16 lines 60-66: fluid channel within needle) to deliver a drug (see col. 17 lines 22-27: drugs delivered via needle) to break down thrombotic tissue (see col. 17 lines 46-55: needle catheter 950 can deliver metalloproteinases, which are MMPS, see col. 8 lines 2-16, which aligns with Applicant’s disclosure of breaking down thrombotic tissue that is achieved by MMPs in Applicant’s [0048]) at the infusion site (915), and wherein the needle (945) is configured to move distally (rightward in FIG. 9A within wall 980) within the infusion site in a direction parallel to (needle travel only offset by degree of inflation of balloon, see col 15 lines 40-43. Thus, the balloon could be inflated to achieve a parallel angle and therefore the needle is “configured to” move distally within the infusion site in a direction parallel to the longitudinal axis) the longitudinal axis (axis through catheter 941) to deliver the drug (see col. 15 line 60- col. 16 line 2: needles, including 945, form injection location and deliver treatment such as injection of drug. Thus drug is delivered through the needle).
Mandrusov is silent to “a housing at” the distal portion having an exit port in communication with the lumen, “a transition surface adjacent the exit port and an offset surface distal to the exit port.”
However, Wilson teaches an infusion device (2001, see FIG.20) comprising a catheter (2003) having a housing (see ‘Modified FIG. 20’ below)
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at a distal portion (leftward portion of catheter 2003 with housing as seen in ‘Modified FIG. 20’ above) having an exit port in communication with a lumen (see ‘Modified FIG. 20’ above. Also, the embodiments of the invention include a needle coupled to a lumen via the exit port such as shown in FIG. 15.5a with needle 1512’, exit port 1514’, and lumen which delivers fluid through needle, see [0106]. FIG. 20 does not describe these previously taught structures so FIG. 15.5a and [0106] is provided for reference that FIG. 20 is still showing the same structural features without providing the structures a specific numeral), a transition surface (see ‘Modified FIG. 20’ above) adjacent the exit port (see ‘Modified FIG. 20’ above) and an offset surface (see ‘Modified FIG. 20’ above) distal to (leftward in ‘Modified FIG. 20’ above) the exit port (see ‘Modified FIG. 20’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal portion of the catheter disclosed in Mandrusov to include a housing at the distal portion with the exit port, transition surface, and offset surface as taught by Wilson for the purpose of forming the visualization mechanism with a controllable deflection angle permitted by the structures of the housing portion (see [0122]), thus achieving “a housing at” the distal portion having an exit port in communication with the lumen, “a transition surface adjacent the exit port and an offset surface distal to the exit port.”
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mandrusov in view of Wilson as applied to claim 16 above, and further in view of Palma (U.S. PGPUB No. 2012/0059309) and Stigall (U.S. PGPUB No. 2015/0112188).
Regarding claim 17, the modified system of Mandrusov teaches the infusion device of claim 16, but Modified Mandrusov is silent to “wherein the infusion site is within a boundary layer of the thrombotic tissue with a vessel wall, and wherein the exit port includes a rotatable guide component to adjust a height of the needle above the offset surface to target the needle toward the boundary layer before advancing the needle out of the exit port.”
However, Palma teaches an infusion device comprising a catheter shaft (110, see FIG. 7D) delivering a drug (see [0054-0055]: delivering drug to thrombus) to an infusion site (thrombus 134), wherein the infusion site is within a boundary layer of the thrombotic tissue with a vessel wall (see [0008]: drug delivery can be at the outermost edges of clot and see [0055]: drug delivery the outermost portions==edge of thrombus, which would be the boundary layer of the thrombus and the vessel wall).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion device taught by Modified Mandrusov to deliver the infusate to an infusion site within a boundary layer of a thrombotic material and the vessel wall as taught by Palma for the purpose of softening the thrombotic material and facilitating the material for removal (see [0055]) such that the material is removed effectively to avoid the formation of new obstructions (see [0008]), thus achieving “wherein the infusion site is within a boundary layer of the thrombotic tissue with a vessel wall”.
Modified Mandrusov in view of Palma remain silent to “wherein the exit port includes a rotatable guide component to adjust a height of the needle above the offset surface to target the needle toward the boundary layer before advancing the needle out of the exit port.”
However, Stigall teaches an infusion device (see FIGs. 4A-B) comprising a catheter shaft (bottom side of catheter shaft 1688, see FIGs. 4A-B), a needle (1680), and an exit port (1670) wherein the exit port (1670) includes a rotatable guide component (see [0054]: 1680 is rotated to control puncture height into vessel wall) to adjust a height (see [0054] a puncture height—such as two separate heights shown in FIGs. 4A and 4B) of the needle (1680) above an offset surface (1640) to target the needle (see [0054]: puncture height is set prior to entering vessel wall or “targeting” the boundary layer at the infusion site) toward a boundary layer before advancing the needle out of the exit port (see [0054]: forward advancement can occur after rotation).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion device delivering infusate to a boundary layer between thrombotic material and a vessel wall taught by Modified Mandrusov in view of Palma to include adjusting the distance between the needle and the longitudinal axis of the catheter shaft using a rotatable guide component of the exit port before advancing the needle out of the exit port as taught by Stigall for the purpose of controlling the puncture height/ depth of the needle into the puncture target (see [0054]), such as the boundary layer, thus achieving “wherein the exit port includes a rotatable guide component to adjust a height of the needle above the offset surface to target the needle toward the boundary layer before advancing the needle out of the exit port.”
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (U.S. PGPUB No. 2019/0201070), hereinafter Fischell, in view of Stigall (U.S. PGPUB No. 2015/0112188).
Regarding claim 18, Fischell discloses an infusion device (see FIG. 12), comprising:
a handle assembly (see FIG. 16 and [0073]);
a catheter shaft (92) having a proximal end portion (portion of 92 shown in FIG. 16, see also [0162]) coupled to the handle assembly (as in FIG. 16) and a distal end portion (portion of 92 shown in FIG.12 terminating at distal end 102), wherein the catheter shaft (92) includes:
one or more needle lumens (lumens of sheath 92, see ‘Modified FIG. 12’ below and [0158] & [0163]: lumen of sheath 92 is advanced/retracted over the needles)
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extending from the proximal end portion (see ‘Modified FIG. 16’ above) to one or more corresponding exit ports (see openings of 92 at distal end, near 102) adjacent the distal end portion (as shown in FIG.12);
a central shaft (98, see ‘Modified FIG. 12’ above indicating central shaft of 98) at the distal end portion (98 extends through distal end portion of 92),
an expandable component (96, see [0157-0158]) circumferentially surrounding (see [0157]: 96 affixed to shaft 98 at ring 108 and therefore circumferentially surrounds at least at 108) the central shaft (98); and
one or more needle guide components (97, see [0155]) around (see [0155]: circumferential deployment) the expandable component (96);
one or more needles (99) slidably extending through (see [0158] & [0163]: lumen of sheath 92 is advanced/retracted over the needles and thus the needles are “slidably extending” relative to movement of the sheath) one of the one or more needle lumens (see lumens in ‘Modified FIGs. 16 and 12’ above) and into (see [0155]) one of the one or more needle guide components (97), wherein each of the one or more needles (99) includes a fluid lumen (117, see FIG. 14 and [0160]) positioned to supply an infusate (see [0160-0162]: 117 fluidly coupled to inflation lumen 91 for supplying infusate to infusion site such as ostial wall) to an infusion site (delivery to ostial wall such as best visualized in FIG. 6C) distal to the distal end portion (distal end of sheath 30 as shown in FIG. 6C is similar to sheath 92 of FIG. 12. As shown in FIG. 6C, the ostial wall/ infusion site is located distal to/rightward of the distal end portion) when the catheter shaft (98) is positioned withwithin a vessel of a patient (see [0162]), and wherein the one or more needle guide components (97) are configured guide the one or more needles (99) to extend distally into a vein wall and travel within the vein wall (see [0159]: penetration depth of needle is limited. Therefor the needles must extend and travel/ be positioned distally within the wall until meeting the penetration limiter) in a direction generally parallel to a longitudinal axis (see [0150]: uniform circumferential deployment would require needles arranged parallel relative to the longitudinal axis of shaft which forms the center of the circle circumference) of the distal portion (see FIG. 12) of the catheter shaft (98).
Fischell (FIG. 12) is silent to one or more needle guide components “attached to” the expandable component “and individually corresponding to each of the one or more needle lumens”; and the one or more needles “each” slidably extending through an “individual” one of the one or more needle lumens.
However, in another embodiment (see FIG. 10), Fischell teaches an infusion device comprising one or more needle guide components (75, see [0199]) attached to (see [0119]: tubes 75 attached to balloon and held in place by band 77) the expandable component (76, see [0119-0120]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more needle guide components disclosed in Fischell (FIG.12) to be attached to the expandable component as taught by Fischell (FIG. 10) for the purpose of using the expandable component to control the positioning of the needles (see [0119]) and for allowing the expandable component to act as a center point of the needles while centering the device within the target vessel (see [0137]), thus achieving the one or more needle guide components “attached to” the expandable component.
Fischell (FIG. 12) in view of Fischell (FIG. 10) remain silent to the one or more needle guide components “individually corresponding to each of the one or more needle lumens” and the one or more needles “each” slidably extending through an “individual” one of the one or more needle lumens.
However, Stigall teaches an infusion device (see FIG. 1H and FIG. 5A) comprising one or more needle guide components (structure 1670, see FIG. 1F, [0048], and [0051]) individually corresponding to each of (see FIG. 1F, lumen provided with structure 1670) an one or more needle lumens (1683) and one or more needles (1680) each slidably extending through an individual one of the one or more needle lumens (1683, see [0051]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more needle guide components disclosed in Fischell to individually correspond to each of the one or more needle lumens and slidably extend through each of the one or more needle lumens as taught by Stigall (such as by forming individual needle lumens for each of the needle guide components in the sheath 92 of Fischell) for the purpose of providing extra stability and support to the needle to prevent the needle from deviating from its desired path into the vessel wall during deployment (see [0051]), thus achieving the one or more needle guide components “individually corresponding to each of the one or more needle lumens”; one or more needle “each” slidably extending through an “individual” one of the one or more needle lumens.
Regarding claim 19, the modified system of Fischell teaches the infusion device of claim 18, but Fischell (FIG. 12) is silent to “wherein the expandable component positions each of the one or more needle guide components a distance away from a central longitudinal axis of the catheter shaft.”
However, in another embodiment, Fischell (see FIG. 10) teaches an infusion device comprising a catheter shaft (78) and an expandable component (76, see [0119-0120]) and one or more needle guide components (75, see [0119]), wherein the expandable component (76) positions each of (see [0119] & [0135-0137]) the one or more needle guide components (75) a distance away (distance of inflation height, see [0119] & [0135-0137]) from a central longitudinal axis (horizontal axis through center of shaft 78) of the catheter shaft (78).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more needle guide components disclosed in Fischell (FIG.12) to be attached to the expandable component as taught by Fischell (FIG. 10) for the purpose of using the expandable component to control the positioning of the needles (see [0119]) and for allowing the expandable component to act as a center point of the needles while centering the device within the target vessel (see [0137]), thus achieving “wherein the expandable component positions each of the one or more needle guide components a distance away from a central longitudinal axis of the catheter shaft.”
Regarding claim 20, the modified system of Fischell teaches the infusion device of claim 18, and Fischell (FIG. 12) further discloses wherein the one or more corresponding exit ports (see openings of 92 at distal end, near 102, in FIG. 12) are each positioned a first distance (see ‘Modified FIG. 12i’ below)
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from a central longitudinal axis (horizontal axis through center of catheter shaft 98) of the catheter shaft (98), and wherein each of the one or more needles (99) is configured to transition between (see [0158]) the first distance (as seen in ‘Modified FIG. 12i’ above) and a second distance (see ‘Modified FIG. 12i’ above).
Fischell (FIG. 12) is silent to “the expandable component is configured to position the one or more needle guide components a second distance away from the central longitudinal axis, the first distance being less than the second distance.”
However, in another embodiment, Fischell (see FIG.10) teaches an infusion device with one or more exit ports (lumens through manifold 71 for each injector tube 75, see [0119]), wherein the one or more exit ports (lumens through manifold 71) are each positioned a first distance (see ‘Modified FIG. 10’ below)
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from a central longitudinal axis (horizontal axis through 78) of the catheter shaft (78), the expandable component (76) is configured to position the one or more needle guide components (75) a second distance (see ‘Modified FIG. 10’ above) away from the central longitudinal axis (see ‘Modified FIG. 10’ above), the first distance being less than the second distance (see first distance shorter than second in ‘Modified FIG. 10’ above), and wherein each of a one or more needles (79) is configured to transition between the first distance and the second distance (see [0119] and [0135-0137]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more needle guide components disclosed in Fischell (FIG.12) to be attached to the expandable component as taught by Fischell (FIG. 10) for the purpose of using the expandable component to control the positioning of the needles (see [0119]) and for allowing the expandable component to act as a center point of the needles while centering the device within the target vessel (see [0137]), thus achieving “the expandable component is configured to position the one or more needle guide components a second distance away from the central longitudinal axis, the first distance being less than the second distance.”
Response to Arguments
Applicant's arguments filed 12/04/25 have been fully considered but they are not persuasive.
On pages 8-9, Applicant argues that Mandrusov does not teach the needle “moves and delivers the drug in a direction parallel to the longitudinal axis” and therefore the 35 U.S.C. § 102 claim rejection of claim 1 should be withdrawn. However, the examiner disagrees and has maintained the rejection of claim 1. Claim 1 requires the needle “traveling distally within the venous wall in a direction generally parallel to a longitudinal axis of the distal portion.” In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the needle moving and delivering the drug exactly parallel to the longitudinal axis) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the examiner has maintained the 35 U.S.C. § 102 rejection of claim 1 under Mandrusov. However, should Applicant disagree, a 35 U.S.C. § 103 rejection of claim 1 under Mandrusov in view of Stigall could be made that addresses a “parallel” direction instead of “generally” parallel, similar to that as applied to claim 5 (see rejection of claim 5 above). The examiner references the rejection of claim 5 as pertinent to the arguments presented against claim 1 in hopes of expediting prosecution.
On pages 10-12, Applicant argues that the independent claim rejections of claim 1 and 18 should be withdrawn and therefore all subsequent depending claim rejections should be withdrawn. The examiner disagrees (see explanations above) and thus has maintained the depending claim rejections.
On pages 12-13, Applicant argues that Mandrusov does not teach the needle “moves and delivers the drug in a direction parallel to the longitudinal axis” and therefore the 35 U.S.C. § 103 claim rejection of claim 16 should be withdrawn. However, the examiner disagrees and has maintained the rejection of claim 16. Claim 16 requires “wherein the needle is configured to move distally within the infusion site in a direction parallel to the longitudinal axis….” In response to applicant's argument that the needle must travel in a parallel direction and deliver the drug in a parallel direction to the longitudinal axis, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Because Mandrusov teaches the penetration angle and travel direction of the needle controllable via the expandable component (see rejection of claim 16 above), the needle is “configured to” move distally in a direction parallel to the longitudinal axis. Therefore, Mandrusov meets the limitation as currently claimed and the examiner has maintained the rejection of claim 16. However, should Applicant disagree, a 35 U.S.C. § 103 rejection of claim 16 under Mandrusov in view of Stigall for a positive recitation of a parallel direction, similar to that as applied to claim 5. The examiner references the rejection of claim 5 as pertinent to claim 16 in hopes of expediting prosecution.
On page 13, Applicant argues that the independent claim rejection of claim 16 should be withdrawn and therefore the depending claim rejection of claim 17 should subsequently be withdrawn. The examiner disagrees (see explanations above) and thus has maintained the depending claim rejection of claim 17.
Lastly, applicant’s arguments with respect to claim(s) 18-20 (see page 9) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
A new 35 U.S.C. § 103 rejection of claims 18-20 in view of the amendment has been made under Fischell in view of Stigall, rendering the arguments moot.
No further arguments are presented. Thus, the examiner was not persuaded by the arguments as detailed above and has maintained the claim rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783