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 16-28 were previously cancelled.
Claims 1-15 and 29-34 remain pending in the application.
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29 recites “a dull edge, and and the dull edge” in lines 7-8 The Examiner believes this is a typographical mistake and that the Applicant meant to recite ““a dull edge, and .
Appropriate correction is required.
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 1-3, 5, 29, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Camrud et al. (US Patent Pub. 20020177864), hereinafter Camrud.
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 20 with projection 34) configured to enlarge an insertion site opening, comprising:
a needle (needle 20) defining a needle lumen (lumen of needle 20) and a needle wall (wall of needle 20),
a blade (projection 134). However, the embodiment of Camrud seen in FIGS. 3-6 does not expressly state the needle including a slot extending through the needle wall; a blade disposed within the needle lumen in alignment with the slot, a connecting member disposed within the needle lumen, the connecting member operatively coupled with the blade to facilitate transitioning the blade between: a sheathed configuration, wherein the blade is entirely disposed inward of an outside surface of the needle, and a deployed configuration, wherein the blade protrudes radially outward through the slot beyond the outside surface of the needle, wherein the blade defines a sharp edge disposed opposite a dull edge, and wherein the dull edge is configured to contact the needle wall in the deployed configuration.
FIGS. 13-14 of Camrud teaches the needle including a slot (slit 40) extending through the 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]);
a blade (projection 34) disposed within the needle lumen in alignment with the slot (see FIGS. 13-14).
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 and of blade of the embodiments of FIGS. 3-6 Camrud to include a slot extending through the needle wall and a blade disposed within the needle lumen in alignment with 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. 13-14 of Camrud (see [0060-0061]). 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”.
FIGS. 15A-16B teaches a connecting member (stylet 52) disposed within the needle lumen, the connecting member operatively coupled with the blade to facilitate transitioning the blade between:
a sheathed configuration, wherein the blade is entirely disposed inward of an outside surface of the needle, and a deployed configuration, wherein the blade protrudes radially outward through the slot beyond the outside surface of the needle (“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]), wherein the blade defines a sharp edge disposed opposite a dull edge, and wherein the dull edge is configured to contact the needle wall in the deployed configuration (see Examiner annotated FIG. 15A below).
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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 the combined embodiments of FIGS. 3-6 and FIGS. 13-14 Camrud to provide a connecting member disposed within the needle lumen, the connecting member operatively coupled with the blade to facilitate transitioning the blade between: a sheathed configuration, wherein the blade is entirely disposed inward of an outside surface of the needle, and a deployed configuration, wherein the blade protrudes radially outward through the slot beyond the outside surface of the needle, wherein the blade defines a sharp edge disposed opposite a dull edge, and wherein the dull edge is configured to contact the needle wall in the deployed configuration. 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”.
Regarding claim 2, the combination of embodiments of Camrud 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) oriented within the needle lumen such that the sharp edge (edge 25) is directed radially inward in the sheathed configuration (see FIGS. 4-6); “a first position inside the needle, beneath the slot”, [0037]).
Regarding claim 3, the combination of embodiments of Camrud teach the claimed invention as discussed above concerning the rejection of claim 1, and the embodiment of Camrud 15A-16B further teaches wherein the blade (projection 134) is oriented such that the sharp edge (edge 135) is directed distally in the deployed configuration (see FIG. 15A).
Regarding claim 5, the combination of embodiments of Camrud teach the claimed invention as discussed above concerning the rejection of claim 1, and the embodiment of Camrud 15A-16B further teaches wherein the connecting member (stylet 52) is slidably disposed within the needle lumen (“the stylet position is adjustable to adjust a radial and longitudinal position of the stylet relative to the needle”, [0062]).
Regarding claim 29 according to a first interpretation, 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) extending through a needle wall (wall of needle 20) of a needle (needle 20);
placing a blade (projection 34) within a needle lumen of the needle adjacent the slot such that a sharp edge of the blade is directed radially inward with respect to the needle,
However, the embodiment of Camrud seen in FIGS. 13-14 does not expressly state placing a connecting member disposed within the needle lumen; and coupling the connecting member with the blade, wherein: the blade defines a sharp edge disposed opposite a dull edge, and the dull edge is configured to contact the needle wall in a deployed configuration.
FIGS. 15A-16B teach placing a connecting member (stylet 52) within the needle lumen (lumen of needle 130); and
coupling the connecting member with the blade (see FIG. 15A).
wherein:
the blade defines a sharp edge disposed opposite a dull edge, and
the dull edge is configured to contact the needle wall in a deployed configuration (see Examiner annotated FIG. 15A below)
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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 the embodiment of FIGS. 13-14 of Camrud to provide a connecting member disposed within the needle lumen and coupling the connecting member with 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”.
Regarding claim 29 according to a second interpretation, 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) extending through a needle wall (wall of needle 20) of a needle (needle 20);
placing a blade (triangular component of projection 34) within a needle lumen of the needle adjacent the slot such that a sharp edge of the blade is directed radially inward with respect to the needle,
wherein:
the blade defines a sharp edge disposed opposite a dull edge, and
the dull edge is configured to contact the needle wall in a deployed configuration (see Examiner annotated FIG. 15A below);
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placing a connecting member (proximal arm of projection 34) disposed within the needle lumen; and
coupling the connecting member with the blade.
Regarding claim 32, Camrud discloses the claimed invention as discussed above concerning the rejection of claim 29 according to the second interpretation, and Camrud further discloses wherein coupling the connecting member (proximal arm of projection 34) with the blade (triangular component of projection 34) includes fixedly attaching the connecting member to the blade. (see FIG. 5).
Regarding claim 33, Camrud discloses the claimed invention as discussed above concerning the rejection of claim 32, and Camrud further discloses fixedly attaching the connecting member (proximal arm of projection 34) to the needle wall (see FIG. 6).
Claims 4, 6-8, 30, and 31 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 4, the combination of embodiments of Camrud teach the claimed invention as discussed above concerning the rejection of claim 1, however, Camrud does not expressly state wherein the blade rotates between the sheathed configuration and the deployed configuration.
Gurtner teaches methods and devices for performing liposuction and cutting septae (see [0008]) wherein the blade (cutting element 4) rotates between the sheathed configuration and the deployed configuration (see FIGS. 2 and 3).
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 to rotate between the sheathed configuration and the deployed configuration. Doing so allows for cutting element 4 to retracted to prevent undesirable tissue damage, as taught by Gurtner (see [0038]).
Regarding claim 6, the combination of embodiments of Camrud teach the claimed invention as discussed above concerning the rejection of claim 5, however, Camrud does not expressly state wherein the connecting member is coupled with the blade such that longitudinal displacement of the connecting member causes the blade to rotate.
Gurtner teaches methods and devices for performing liposuction and cutting septae (see [0008]) wherein the connecting member (rod 6) is coupled with the blade (cutting element 4) such that longitudinal displacement of the connecting member causes the blade to rotate (see FIGS. 2-3).
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 connecting member of Camrud to be coupled with the blade such that longitudinal displacement of the connecting member causes the blade to rotate. Doing so allows for cutting element 4 to retracted to prevent undesirable tissue damage, as taught by Gurtner (see [0038]).
Regarding claim 7, Camrud in view of Gurtner teaches the claimed invention as discussed above concerning the rejection of claim 6, and Camrud further teaches wherein:
the connecting member is longitudinally positionable within the needle lumen between a first position (first position, see [0037]) and a second position (second position, see [0037]), such that:
displacement of the connecting member away from the first position toward the second position transitions the blade away from sheathed configuration toward the deployed configuration (see FIGS. 13-14; see [0060]), and
displacement of the connecting member away from the second position toward the first position transitions the blade away from deployed configuration toward the sheathed configuration (see FIGS. 13-14; see [0060]).
Regarding claim 8, Camrud in view of Gurtner teaches the claimed invention as discussed above concerning the rejection of claim 7, and Camrud further teaches wherein the first position is proximal the second position (the Examiner notes the first position is when the blade of Camrud is inside the needle, which is proximal to when the blade is outside the needle in the second position).
Regarding claim 30, the combination of embodiments of Camrud teach the claimed invention as discussed above concerning the rejection of claim 29 according to the first interpretation, however, Camrud does not expressly state wherein coupling the connecting member with the blade includes rotatably coupling the connecting member with the blade.
Gurtner teaches methods and devices for performing liposuction and cutting septae (see [0008]) wherein coupling the connecting member (rod 6) with the blade (cutting element 4) includes rotatably coupling the connecting member with the blade (see FIGS. 2-3).
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 connecting member of Camrud to be coupled with the blade such that its rotatably coupled. Doing so allows for cutting element 4 to retracted to prevent undesirable tissue damage, as taught by Gurtner (see [0038]).
Regarding claim 31, the combination of embodiments of Camrud teach the claimed invention as discussed above concerning the rejection of claim 29 according to the first interpretation, however, Camrud does not expressly state wherein rotatably coupling the blade with the needle wall.
Gurtner teaches methods and devices for performing liposuction and cutting septae (see [0008]) comprising rotatably coupling the blade (cutting element 4) with the needle wall (see rotatably engagement between cutting element 4 and shoulder 8).
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 to be rotatably coupled with the needle wall. Doing so allows for cutting element 4 to retracted to prevent undesirable tissue damage, as taught by Gurtner (see [0038]).
Claims 9-12 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 Mirochinik et al. ( US Patent No. 10188403), hereinafter Mirochinik.
Regarding claim 9, the combination of embodiments of Camrud teach the claimed invention as discussed above concerning the rejection of claim 1, however, Camrud does not expressly state wherein: the blade is a first blade and the skin nicking device further includes a second blade, the slot is a first slot and the needle further includes a second slot, and the connecting member is a first connecting member and the skin nicking device further includes a second connecting member coupled with the second blade to facilitate transitioning the second blade between: the sheathed configuration, wherein the second blade is entirely disposed inward of an outside surface of the needle, and the deployed configuration, wherein the second blade protrudes radially outward through the second slot beyond the outside surface of the needle.
Mirochinik teaches cutting and removal devices for bone tissue (Abstract) wherein: the blade (teeth 111; see FIGS. 1A-1B) is a first blade (first tooth of teeth 111) and the skin nicking device further includes a second blade (second tooth of teeth 111),
the slot (recess 115) is a first slot (recess of first tooth of 111) and the needle further includes a second slot (recess of second tooth of 111), and
the connecting member (“cutting tooth 111 is connected to the shaft 107, for example connected using a hinge or a pivot”, Col 10 Lines 24-26) is a first connecting member (hinge of first tooth of 111) and the skin nicking device further includes a second connecting member (hinge of second tooth of 111) coupled with the second blade to facilitate transitioning the second blade between:
the sheathed configuration (closed configuration, see Col 9 Lines 26-36), wherein the second blade is entirely disposed inward of an outside surface of the needle (See FIG. 1A), and
the deployed configuration (open configuration, see Col 9 Lines 26-36), wherein the second blade protrudes radially outward through the second slot beyond the outside surface of the needle (see FIG. 1B).
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 Camrud wherein the blade is a first blade and the skin nicking device further includes a second blade, the slot is a first slot and the needle further includes a second slot, and the connecting member is a first connecting member and the skin nicking device further includes a second connecting member coupled with the second blade to facilitate transitioning the second blade between: the sheathed configuration, wherein the second blade is entirely disposed inward of an outside surface of the needle, and the deployed configuration, wherein the second blade protrudes radially outward through the second slot beyond the outside surface of the needle. Doing so allows for a plurality of cutting elements that can act independently of one another or configured to work together, as taught by Mirochinik (see Col 10 Lines 50-55).
Regarding claim 10, Camrud in view of Mirochinik teaches the claimed invention as discussed above concerning the rejection of claim 9, and Mirochinik further teaches wherein the second slot (recess of second tooth of 111) is disposed opposite the first slot (recess of first tooth of 111; see FIG. 1B).
Regarding claim 11, Camrud in view of Mirochinik teaches the claimed invention as discussed above concerning the rejection of claim 9, and Mirochinik further teaches wherein:
the first connecting member (hinge of first tooth of 111) is configured to rotationally bias the first blade away from the sheathed configuration toward the deployed configuration (the Examiner notes that rotation of the device actuates teeth from a closed to open configuration, see Col 6 Lines 29-50), and
the second connecting member (hinge of second tooth of 111) is configured to rotationally bias the second blade away from the sheathed configuration toward the deployed configuration (the Examiner notes that rotation of the device actuates teeth from a closed to open configuration, see Col 6 Lines 29-50).
Regarding claim 12, Camrud in view of Mirochinik teaches the claimed invention as discussed above concerning the rejection of claim 9, and Mirochinik further teaches wherein the first and second connecting members (hinges of teeth 111) are attached to the needle wall (shaft 107, see FIG. 1B).
Claims 14 and 15 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 14, 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) distally coupled to a catheter hub (bumper 33) having one or more extension legs (lumens 32) proximally coupled thereto, 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 15, Kraus in view of Camrud teaches the claimed invention as discussed above concerning the rejection of claim 14, 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).
Allowable Subject Matter
Claims 13 and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 12/24/2025 have been fully considered but they are not persuasive.
In regards to the Applicant’s argument that Camrud does not teach claim 1 and 29 as amended “wherein the blade defines a sharp edge disposed opposite a dull edge, and wherein the dull edge is configured to contact the needle wall in the deployed configuration.”
This is not persuasive for the following reasons:
See the Examiner annotated FIG. 15A below where the dull and sharp edges of projection 134 are in a deployed configuration while the dull edge can be seen in contact with the needle wall.
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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
05/14/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights