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 .
Status of Claims
The Amendment filed 08/07/2026 has been entered.
Claims 12-20 have been cancelled.
Claims 1-11 and 21-27 remain pending in the application.
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 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, in further view of Mitchell et al. (U.S. Patent Pub. 20160220786), hereinafter Mitchell.
Regarding claim 1, Kraus discloses a catheter placement system (a balloon-tipped catheter system, see Col 1 Line 45), comprising:
a catheter (balloon 12), comprising:
a catheter tube (tube of balloon 12) having two or more lumens (lumens 35 and 36) extending therealong; and two or more extension legs (lumens 32), each of the two or more extension legs in fluid communication with one of the two or more lumens (see FIG. 3). However, Kraus does not expressly state a skin nicking device disposed within one of the two or more lumens, wherein: the skin nicking device includes a blade at a distal end of the skin nicking device, the blade configured to nick a skin adjacent an insertion site of the catheter during use to enlarge the insertion site, and the blade protrudes from an aperture of the one of the two or more lumens.
Camrud teaches a hollow medical needle for medical applications (see [0002]) having a skin nicking device (needle 20 with projection 34) disposed within one of the two or more lumens (lumen of needle 30), wherein:
the skin nicking device includes a blade (projection 34) at a distal end of the skin nicking device (see FIG. 3), the blade configured to nick a skin adjacent an insertion site of the catheter during use to enlarge the insertion site, and
the blade protrudes from an aperture (slot 40) of the one of the two or more lumens (lumen of member 30).
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 a skin nicking device disposed within one of the two or more lumens, wherein: the skin nicking device includes a blade at a distal end of the skin nicking device, the blade configured to nick a skin adjacent an insertion site of the catheter during use to enlarge the insertion site, and the blade protrudes from an aperture of the one of the two or more lumens. Doing so provides percutaneous or surgical routes of a vein or artery for catheterization, as taught by Camrud (see [0003]).
However, Camrud does not expressly state the aperture extending through a side wall of the catheter proximal a distal end of the catheter.
Mitchell teaches an integrated catheter assembly for rapid vascular insertion (Abstract) comprising the aperture (side ports 22, 23, and 25) extending through a side wall of the catheter proximal a distal end of the catheter (see FIG. 7).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the aperture of Camrud to be a side aperture of the lumen, the side aperture extending through a side wall of the catheter proximal a distal end of the catheter. Doing so would provide a hole sizable to receive a needle (see [0031]).
Regarding claim 2, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 1, and Kraus further teaches wherein: the catheter tube includes:
a first section (see number 33) having a first outer diameter (diameters of lumens 35 and 36);
a second section (see 30 in FIG. 3) having a second outer diameter larger than the first outer diameter; and
a transition section (member 41) extending between the first section and the second section (See FIG. 3), the transition section is configured to transition the first outer diameter to the second outer diameter, and
the first section is disposed distal the second section (See FIG. 3).
Regarding claim 3, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 2, and Camrud further teaches wherein the aperture (slot 40) is disposed along the transition section (The Examiner notes tubular member attached to hub 100 into needle 20 can be considered the transition section in Camrud, akin to the tubular member 30 in FIG. 3 of Kraus).
Regarding claim 4, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 1, and Camrud further teaches wherein the blade (projection 34) includes a sharp edge (edges 35, 36, and 37) directed toward the distal end of the skin nicking device (see FIG. 3).
Regarding claim 5, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 1, and Camrud further teaches wherein the skin nicking device (needle 20 and projection 34) includes a skin nicking device body (body of 30) extending along the catheter tube.
Regarding claim 6, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 5, and Camrud further teaches wherein the device body (number 33) extends proximally along the catheter tube and proximally along one of the two or more extension legs (lumens 32) such that a proximal end of the device exits the one of the two or more extension legs (see FIG. 3). However, Kraus does not expressly state wherein this device body is a skin nicking device body.
Camrud teaches a hollow medical needle for medical applications (see [0002]) having a skin nicking device (needle 20 with projection 34) body.
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 body of Kraus to be a skin nicking device body. Doing so provides percutaneous or surgical routes of a vein or artery for catheterization, as taught by Camrud (see [0003]).
Regarding claim 7, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 5, and Camrud further teaches wherein the skin nicking device body is rigid from the proximal end to the distal end (The Examiner notes Camrud [0044] teaches that needle 20 and member 30 are tubular members made of suitable material like stainless steel. The Examiner is of the position this is sufficient disclosure to teach or suggest rigidity of the device body from a proximal to distal end).
Regarding claim 8, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 5, and Camrud further teaches wherein the skin nicking device body includes one or more rigid portions and one or more flexible portions (The Examiner notes Camrud [0044] teaches that needle 20 and member 30 are tubular members made of suitable material like stainless steel. The Examiner is of the position this is sufficient disclosure to teach or suggest rigidity or flexibility of the device body based on chosen material).
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to change the material of the device body to be a flexible or rigid material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 8, and Camrud further teaches wherein a distal portion of the skin nicking device body is flexible and a proximal portion of the skin nicking device body is rigid (The Examiner notes Camrud [0044] teaches that needle 20 and member 30 are tubular members made of suitable material like stainless steel. The Examiner is of the position this is sufficient disclosure to teach or suggest rigidity or flexibility of the device body based on chosen material).
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to change the material of the device body to be a flexible or rigid material in the distal or proximal ends, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 10, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 1, and Camrud further teaches wherein the skin nicking device (needle 20 with projection 34) is positionable within the lumen between: a distal position, where the blade protrudes from the aperture; and a proximal position, where the blade is disposed within the lumen proximal the aperture (see first and second positions of [0061]; see FIGS. 13-14).
Regarding claim 11, Kraus in view of Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 1, and Camrud further teaches wherein the skin nicking device is rotatable (needle 20 with projection 34) within the lumen between: a first orientation, where the blade is directed radially inward; and a second orientation, where the blade is directed radially outward, thereby enabling the blade to nick the skin (see first and second positions of [0061]; see FIGS. 13-14).
Claims 21-26 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 Mitchell et al. (U.S. Patent Pub. 20160220786), hereinafter Mitchell.
Regarding claim 21, Camrud discloses a catheter placement device (needle 20 with projection 34), comprising: an elongate body (body of needle 20) defining a proximal end and a distal end; a blade (projection 34) fixedly attached to the elongate body at the distal end (see FIG. 3) the blade including a sharp edge (edges 35, 36, 37) configured to nick a skin of a patient adjacent an insertion site of a catheter to enlarge the insertion site, wherein: the catheter placement device is configured for placement within a lumen of the catheter (“needle 20 of the invention attached to a hub assembly 100. The hub assembly may be helpful when handling and positioning the needle. The hub assembly may also be useful in a catheterization or other procedure involving needle 20 when additional devices must be inserted into or positioned relative to the needle.”, [0057]), and the blade is configured to protrude from an aperture (opening of bevel face 31) of the lumen (see FIG. 3). However, Camrud does not expressly state a side aperture of the lumen, the side aperture extending through a side wall of the catheter proximal a distal end of the catheter.
Mitchell teaches an integrated catheter assembly for rapid vascular insertion (Abstract) comprising a side aperture (side ports 22, 23, and 25) of the lumen, the side aperture extending through a side wall of the catheter proximal a distal end of the catheter (see FIG. 7).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the aperture of Camrud to be a side aperture of the lumen, the side aperture extending through a side wall of the catheter proximal a distal end of the catheter. Doing so would provide a hole sizable to receive a needle (see [0031]).
Regarding claim 22, Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 21, and Camrud further teaches wherein the sharp edge (edges 35, 36, 37) of the blade (projection 34) is directed distally (see FIG. 3).
Regarding claim 23, Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 21, and Camrud further teaches wherein: the elongate body (body of needle 20) includes a lateral slot (slit 40) extending proximally away from the distal end, and the sharp edge is positioned at a bottom of the lateral slot (see FIGS. 13-14).
Regarding claim 24, Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 21, and Camrud further teaches wherein the elongate body (body of needle 20) includes a flexible (The Examiner notes Camrud [0044] teaches that needle 20 and member 30 are tubular members made of suitable material. The Examiner is of the position this is sufficient disclosure to teach or suggest flexibility of the device body based on chosen material. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.) distal portion having a preformed curved shape (the Examiner notes the bevel face 31 has a curved shaped perimeter).
Regarding claim 25, Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 24, and Camrud further teaches wherein the curved shape includes a 180-degree bend (see bevel face 31 in FIG. 14).
Regarding claim 26, Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 24, and Camrud further teaches wherein the sharp edge (edges 35, 36, 37) extends along an outside surface of the curved shape (see bevel face 31 in FIG. 14).
Claim 27 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 Mitchell et al. (U.S. Patent Pub. 20160220786), hereinafter Mitchell, in further view of Bliss et al. (US Patent Pub 20110118769), hereinafter Bliss.
Regarding claim 27, Camrud in view of Mitchell teaches the claimed invention as discussed above concerning the rejection of claim 21, and Camrud further teaches wherein the elongate body includes a longitudinal slit (slot 40) extending proximally away from the distal end (See FIG. 14), the longitudinal slit defining a first distal portion and a second distal portion (see portions on either side of slot 40), the sharp edge directed inward toward the second distal portion (see FIG. 3). However, Camrud in view of Mitchell does not expressly state, wherein the first distal portion is flexible and includes a preformed curved shape such that the first flexible distal portion curves away from the second distal portion.
Bliss teaches a medical cutting tool for treating aortic septal dissections (Abstract) wherein the first flexible distal portion (flexible displacement elements 43) includes a preformed curved shape such that the first flexible distal portion curves away from the second distal portion (tips 49; see FIG. 16).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the device of Camrud in view of Mitchell to have the first distal portion be flexible and include a preformed curved shape such that the first flexible distal portion curves away from the second distal portion. Doing so allows displacement of cutting elements, as taught by Bliss (see [0124-0125]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 8/07/2026, with respect to the rejection(s) of claim(s) 1-11 under 35 U.S.C. 103 to Kraus (US Patent No. 5578009) in further view of Camrud (US 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 Kraus (US Patent No. 5578009) in further view of Camrud (US Patent Pub. 20020177864) in further view of Mitchell (U.S. Patent Pub. 20160220786).
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
9/17/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights