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 .
Response to Amendments
The Amendment filed 12/24/2025 has been entered.
Claims 19-26 and 28 are cancelled.
Claims 1-18, 27, and 29 remain pending in the application.
Applicant’s amendments to the claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 10/02/2025.
Claim Rejections - 35 USC § 103
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 1-11, 12, 15, 16, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Camrud et al. (US Patent Pub. 20020177864), hereinafter Camrud, in further view of Gurtner et al. (US Patent Pub. 20100057056), hereinafter Gurtner.
Regarding claim 1, Camrud discloses a catheter placement device (“the invention provides a vascular needle adapted for use in medical procedures involving inserting a catheter into a vein or artery.”, [0002]; see FIGS. 3-6; the Examiner notes that all reference characters cited below refer to FIGS. 3-6 unless otherwise stated), comprising:
a skin nicking device (needle 30 with projection 34) configured to enlarge an insertion site opening, comprising:
a needle (needle 30) defining a needle lumen (lumen of needle 30) and a needle wall (wall of needle 130), and
a blade (projection 34).
However, the embodiment of Camrud seen in FIGS. 3-6 does not expressly state a push rod disposed within the needle lumen, the push rod including a distal portion configured to operatively engage the blade such that distal displacement of the push rod causes radially outward displacement of the blade through the slot.
FIGS. 15A-16B teaches a push rod (stylet 52) disposed within the needle lumen (lumen of needle 30), the push rod including a distal portion configured to operatively engage the blade such that proximal displacement of the push rod causes radially outward displacement of the blade through the slot (“the stylet position is adjustable to adjust a radial and longitudinal position of the stylet relative to the needle. For example, the stylet may be adjusted longitudinally so that it engages the vessel prior to or after the bevel face of the needle engages the vessel. The stylet position may be controlled or held in a given position via a hub assembly 100 secured to an end of a needle 130.”, [0062]; “projection 34 is moveable from a first position inside the cylindrical member 30 (FIG. 13) to a second position outside the cylindrical member 30 (FIG. 14). The cylindrical member 30 has an opening, such as a slit 40, in the top edge of the needle adjacent the trailing portion of the bevel face. The opening is sized to accommodate the projection”, [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle of the combined embodiments of FIGS. 3-6 of Camrud to provide a push rod including a distal portion configured to operatively engage the blade such that proximal displacement of the push rod causes radially outward displacement of the blade through the slot. Doing so provides a sheathed configuration where projection 34 is inside a needle and an unsheathed configuration wherein projection 34 is outside side the needle, as taught by the embodiments of FIGS. 15A-16B of Camrud (see [0060-0063]). Further, Camrud [0032] states “the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention”. Further, Applicant may wish to note that the Federal Circuit has held that it is permissible to combine two different embodiments disclosed in the same piece of prior art and noted that such a combination does not require “a leap of inventiveness”.
However, the embodiments of Camrud seen in FIGS. 3-6 and 15A-16B do not expressly state the needle including a slot extending longitudinally through a portion of the needle wall and terminating proximally of a distal end of the needle wall; a blade disposed within the needle lumen in alignment with the slot wherein a distal end of the blade is hingedly coupled with the needle wall defining a fulcrum.
Gurtner teaches methods and devices for performing liposuction and cutting septae (see [0008]) wherein the needle including a slot extending longitudinally through a portion of the needle wall (see Examiner annotated FIG. 3 below) and terminating proximally of a distal end of the needle wall; a blade (cutting element 4) disposed within the needle lumen in alignment with the slot wherein a distal end of the blade is hingedly coupled with the needle wall defining a fulcrum (see shoulder 8).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle of Camrud to include a slot extending longitudinally through a portion of the needle wall and terminating proximally of a distal end of the needle wall; a blade disposed within the needle lumen in alignment with the slot wherein a distal end of the blade is hingedly coupled with the needle wall defining a fulcrum. Doing so allows for the cutting element to be naturally biased from the expanded and collapsed positions when the rod is advanced, as taught by Gurtner (see [0035]).
Regarding claim 2, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 1, and the embodiment of Camrud FIGS. 3-6 further teaches wherein:
the blade (projection 34) defines a sharp edge (edge 35) disposed opposite a dull edge (edges 37 and 38; “rear 37 edges may be dull.”, [0049]), and
the blade is oriented within the needle lumen such that the sharp edge is directed radially outward (see FIGS. 4-6).
Regarding claim 3, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 1, and the embodiment of Camrud 15A-16B further teaches wherein the sharp edge is disposed at an angle with respect to the dull edge such that a proximal width of the blade is greater than a distal width of the blade (see Examiner annotated FIG. 15A. below).
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Regarding claim 4, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 2, however, the combination of embodiments of Camrud in view of Gurtner don’t expressly state wherein the blade is transitionable between a sheathed configuration and a deployed configuration such that in the sheathed configuration an entirety of the sharp edge is disposed radially inward of an outside surface of the needle, and in the deployed configuration at least a portion of the sharp edge extends radially beyond the outside surface.
The embodiment of Camrud in FIGS. 13-14 teach wherein the blade (projection 34) is transitionable between a sheathed configuration and a deployed configuration such that:
in the sheathed configuration an entirety of the sharp edge is disposed radially inward of an outside surface of the needle, and in the deployed configuration at least a portion of the sharp edge extends radially beyond the outside surface (“a needle with a slot cut in the top surface of the needle adjacent the bevel face and at least one projection positioned such that it is moveable from a first position inside the needle, beneath the slot, to a second position wherein the projection extends through the slot and away from the needle”, [0037; 0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the blade of Camrud in view of Gurtner to be transitionable between a sheathed configuration and a deployed configuration such that in the sheathed configuration an entirety of the sharp edge is disposed radially inward of an outside surface of the needle, and in the deployed configuration at least a portion of the sharp edge extends radially beyond the outside surface. Doing so allows for the cutting surface of the projection to be moveable from the first and second positions, as taught by Camrud FIGS. 13-14 (see [0035; 0061]).
Regarding claim 5, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 4, and the embodiment of Camrud FIGS. 15A-16B further teaches wherein:
the push rod is longitudinally positionable within the needle lumen between a proximal position and a distal position (“the stylet position is adjustable to adjust a radial and longitudinal position of the stylet relative to the needle. For example, the stylet may be adjusted longitudinally so that it engages the vessel prior to or after the bevel face of the needle engages the vessel. The stylet position may be controlled or held in a given position via a hub assembly 100 secured to an end of a needle 130.”, [0062]), and
the distal portion engages the blade such that distal displacement of the push rod away from the proximal position toward the distal position transitions the blade away from the sheathed configuration toward the deployed configuration (“projection 34 is moveable from a first position inside the cylindrical member 30 (FIG. 13) to a second position outside the cylindrical member 30 (FIG. 14)”, [0060]).
Regarding claim 6, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 2, and the embodiment of Camrud FIGS. 15A-16B further teaches wherein operative engagement of the distal portion with the blade includes sliding contact of the distal portion with the dull edge of the blade (“the stylet position is adjustable to adjust a radial and longitudinal position of the stylet relative to the needle.”, [0062]; the Examiner notes the distal portion of stylet 52 is fixed to projection 34 and both elements both slide together in contact with one another when moving distally from a first position to a second position, see [0037;0062]).
Regarding claim 7, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 6, and the embodiment of Camrud FIGS. 15A-16B further teaches wherein:
the distal portion includes an angled surface (see Examiner annotated FIG. 15A below), and
operative engagement of the distal portion with the blade includes sliding contact of the angled surface with the dull edge of the blade( “the stylet position is adjustable to adjust a radial and longitudinal position of the stylet relative to the needle.”, [0062]).
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Regarding claim 8, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 7, and the embodiment of Camrud FIGS. 15A-16B further teaches wherein the distal portion includes a taper defining the angled surface (“a forward or cutting edge 135 having an angle 139 that is angled in a similar direction to the bevel of bevel face 131.”, [0065]”).
Regarding claim 9, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 7, and Gurtner further teaches wherein: the push rod (rod 6) includes channel along the distal portion (see Examiner annotated FIG. 3 below), the blade is disposed within the channel, and a bottom surface of the channel defines the angled surface (see Examiner annotated FIG. 3 below).
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Regarding claim 10, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 4, and Gurtner further teaches wherein a distal end of the blade (distal end of cutting element 4) is hingedly coupled with the needle (see coupling of element 4 with shoulder 8 in FIGS. 2 and 3) wall defining a fulcrum such that the blade rotates between the sheathed configuration and the deployed configuration (see FIGS. 2 and 3).
Regarding claim 11, the combination of embodiments of Camrud in view of Gurtner teaches the claimed invention as discussed above concerning the rejection of claim 10, and Gurtner further teaches wherein the blade (cutting element 4) is biased toward the sheathed configuration (see FIG. 2) such that proximal displacement of the push rod away from the distal position toward the proximal position allows the blade to self-rotate toward the sheathed configuration (see FIG. 3).
Regarding claim 12, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 5, and the embodiment of Camrud FIGS. 15A-16B further teaches wherein the needle wall (wall of needle 130) includes a push rod barrier (surface wall of hub assembly 100) protruding radially into the needle lumen, the push rod barrier configured to engage the push rod so as to limit distal displacement of the push rod beyond the distal position (see FIG. 15A.)
Regarding claim 15, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 5, and the embodiment of Camrud FIGS. 15A-16B further teaches wherein the skin nicking device includes an actuator (proximal handle of stylet 52) operatively coupled with the push rod (stylet 52), the actuator configured to displace the push rod between the proximal position and the distal position (“the stylet position is adjustable to adjust a radial and longitudinal position of the stylet relative to the needle.”, [0062]).
Regarding claim 16, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 5, and the embodiment of Camrud FIGS. 15A-16B further teaches wherein the skin nicking device includes a locking mechanism (hub assembly 100) configured to lock the push rod in at least one of proximal position or the distal position (“stylet position may be controlled or held in a given position via a hub assembly 100 secured to an end of a needle 130”, [0062]).
Regarding claim 27, Camrud discloses a manufacturing method of a catheter placement device (The above specification, examples and data provide a complete description of the manufacture and use of the composition of the invention. Since many embodiments of the invention may be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended., [0068]), comprising:
forming a slot (slit 40, see FIGS. 13-14) extending through a needle wall (“cylindrical member 30 has an opening, such as a slit 40, in the top edge of the needle adjacent the trailing portion of the bevel face”, [0060]) of a needle (needle 20);
placing a blade (projection 34) within the slot such that:
a sharp edge of the blade is directed radially outward with respect to the needle (see FIG. 13), and
the sharp edge is disposed inward of an outside surface of the needle (see FIGS. 13-14).
However, the embodiment of Camrud seen in FIGS. 13-14 does not expressly state inserting a push rod within a needle lumen of the needle such that an angled surface of the push rod engages the blade.
FIGS. 15A-16B teach inserting a push rod (stylet 52) within a needle lumen (lumen of needle 130) of the needle such that an angled surface of the push rod engages the blade (See FIG. 15A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle of the embodiment of FIGS. 13-14 of Camrud to provide a push rod within a needle lumen of the needle such that an angled surface of the push rod engages the blade. Doing so provides a sheathed configuration where projection 34 is inside a needle and an unsheathed configuration wherein projection 34 is outside side the needle, as taught by the embodiments of FIGS. 15A-16B of Camrud (see [0060-0063]). Further, Camrud [0032] states “the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention”. Further, Applicant may wish to note that the Federal Circuit has held that it is permissible to combine two different embodiments disclosed in the same piece of prior art and noted that such a combination does not require “a leap of inventiveness”.
However, the combination of the embodiments of Camrud don’t expressly state wherein the slot longitudinally extends through a portion of the needle wall, the slot terminating proximally of a distal end of the needle wall and hingedly coupling a distal end of the blade to the needle wall defining a fulcrum, wherein the blade is pivotable through the slot about the fulcrum.
Gurtner teaches methods and devices for performing liposuction and cutting septae (see [0008]) wherein the slot longitudinally extends through a portion of the needle wall (see Examiner annotated FIG. 3 below), the slot terminating proximally of a distal end of the needle wall and hingedly coupling a distal end of the blade to the needle wall defining a fulcrum, wherein the blade is pivotable through the slot about the fulcrum (see shoulder 8).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle of Camrud to include a slot longitudinally extending through a portion of the needle wall, the slot terminating proximally of a distal end of the needle wall and hingedly coupling a distal end of the blade to the needle wall defining a fulcrum, wherein the blade is pivotable through the slot about the fulcrum. Doing so allows for the cutting element to be naturally biased from the expanded and collapsed positions when the rod is advanced, as taught by Gurtner (see [0035]).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Camrud et al. (US Patent Pub. 20020177864), hereinafter Camrud, in further view of Gurtner et al. (US Patent Pub. 20100057056), hereinafter Gurtner, in further view of Kraus et al. (US Patent No. 5578009), hereinafter Kraus.
Regarding claim 13, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 1, however, Camrud in view of Gurtner does not expressly state wherein the push rod includes a push rod lumen defining an open proximal end and an open distal end, the push rod lumen configured for insertion of a guidewire therethrough.
Kraus teaches a balloon-tipped catheter system for angioplasty procedures (see Col 1 Lines 45-46) wherein the push rod (push rod 34) includes a push rod lumen (lumen 36) defining an open proximal end and an open distal end (see FIG. 3), the push rod lumen configured for insertion of a guidewire therethrough (“a guidewire 29 passing through the push rod”, Col 4 Lines 9-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the push rod of Camrud in view of Gurtner to include a lumen defining an open proximal end and an open distal end, the push rod lumen configured for insertion of a guidewire therethrough. Doing so allows the placement and replacement of guidewires and catheters, as taught by Kraus (see Col 5 Line 21- Line 33).
Regarding claim 14, the combination of embodiments of Camrud in view of Gurtner in view of Kraus teaches the claimed invention as discussed above concerning the rejection of claim 13, and Kraus further teaches comprising the guidewire (guidewire 29) disposed within the push rod lumen (lumen 36)
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kraus et al. (US Patent No. 5578009), hereinafter Kraus, in further view of Camrud et al. (US Patent Pub. 20020177864), hereinafter Camrud.
Regarding claim 17, Kraus discloses a catheter assembly (a balloon-tipped catheter system, see Col 1 Line 45), comprising:
a catheter including a catheter tube (tube of balloon 12) proximally coupled to a catheter hub (bumper 33) having one or more extension legs (lumens 32) proximally coupled therefrom, the catheter tube defining one or more lumens (lumens 35 and 36) wherein each of the one or more lumens is in fluid communication with one of the extension legs (see FIG. 3). However, Kraus does not expressly state the catheter placement device according to any of the preceding claims, the catheter placement device coupled with the catheter.
Camrud teaches a hollow medical needle for medical applications (see [0002]) having a catheter placement device according to any of the preceding claims (see claim 1), the catheter placement device coupled with the catheter (“the invention provides a vascular needle adapted for use in medical procedures involving inserting a catheter into a vein or artery.”, [0002]; “The invention additionally involves a catheterization assembly made up of a needle with a secondary cutting surface, a guidewire, and a catheter, and methods of using the needle and catheterization assembly.”, [0039]; see FIG. 15A;
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Kraus to include the catheter placement device according to any of the preceding claims, the catheter placement device coupled with the catheter. Doing so provides percutaneous or surgical routes of a vein or artery for catheterization, as taught by Camrud (see [0003]).
Regarding claim 18, Kraus in view of Camrud teaches the claimed invention as discussed above concerning the rejection of claim 17, and Kraus further teaches wherein the needle of the catheter placement device is inserted into one of the one or more lumens of the catheter tube (“Exchange of the guidewire without removal of the balloon can also be accomplished, simply by removing the existing guidewire through the guidewire lumen 35 without removing the push rod 34 and without the need for passing the guidewire through the slit 37, and replacing the withdrawn guidewire with a new guidewire. The guidewire lumen 35 in the push rod and the internal tubular member opening 38 are held in alignment during this procedure by the fixed orientation of the push rod relative to the balloon, which is in turn maintained by the complementary non-circular cross sections of the bumper lumen 35 and the inflation/deflation line 32”, Col 5 Line 21 Line 32.; the Examiner notes that the lumens are capable of fixed positioning while internal elements are moved in and out. The Examine is of the position this is sufficient disclosure to teach or suggest that the needle of Camrud can be inserted and removed from the catheter tube of Kraus).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Camrud et al. (US Patent Pub. 20020177864), hereinafter Camrud, in further view of Gurtner et al. (US Patent Pub. 20100057056), hereinafter Gurtner, in further view of Whisson et al. (US Patent No. 5728073), hereinafter Whisson.
Regarding claim 29, the combination of embodiments of Camrud in view of Gurtner teach the claimed invention as discussed above concerning the rejection of claim 27, however, Camrud in view of Gurtner does not expressly state comprising forming a protrusion on an inside surface of the needle lumen to define a push rod barrier configured to limit distal displacement of the push rod within the needle lumen.
Whisson teaches a syringe having retractable needle (Abstract) comprising forming a protrusion on an inside surface of the needle lumen to define a push rod barrier configured to limit distal displacement of the push rod within the needle lumen (“In order to lockingly retain the needle support in the second position and limit the movement of the plunger the wall of the body 11 on the corresponding side of the tubular member 21, and at the location of the second transverse slot 30 is formed with an aperture 31 which is configured to receive the protrusion 28 on rotation of the needle support 24 within the tubular member 20”, Col 3 Lines 35-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle lumen of Camrud in view of Gurtner to form a protrusion on an inside surface of the needle lumen to define a push rod barrier configured to limit distal displacement of the push rod within the needle lumen. Doing so helps avoid inadvertent stick injuries during disposal of the syringe, as taught by Whisson (see Col 1 Lines 8-10).
Response to Arguments
Applicant’s arguments, see Remarks pages 7-10, filed 12/24/2025, with respect to the rejection(s) of claim(s) 1-18, 27, and 29 under 35 U.S.C. 103 to Camrud et al. (U.S. Patent Pub 20020177864) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 to Camrud et al. (U.S. Patent Pub 20020177864) in view of Gurtner et al. (US Patent Pub. 20100057056).
Conclusion
THIS ACTION IS MADE FINAL. 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 NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744.The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
02/05/2026 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783