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 Amendment
The amendment filed December 08, 2025 has been entered. Claims 1-3, 5-10, 12-17, and 21 remain pending in the application. Claims 4, 11, and 18-20 have been cancelled.
Claim Objections
Claim 13 is objected to because of the following informalities: there is a lack of antecedent basis for “the formed opening” in lines 15-16 and for “the same side of the second longitudinal side surface of said catheter hub” in line 28-29. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 13-17 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 13, the limitation “said cutting edges cut a surface of a vein or artery to form an opening in said vein or artery until said inwardly curved distal surface contacts the surface of the vein or artery, and then the inwardly curved distal surface slides through the formed opening without further cutting the vein or artery” in lines 13-16 positively recites and claims a human organism (“a surface of a vein or artery to form an opening in said vein or artery”). It is suggested to amend this limitation to “said cutting edges configured to cut a surface of a vein or artery to form an opening in said vein or artery until said inwardly curved distal surface contacts the surface of the vein or artery, and then the inwardly curved distal surface is configured to slide through the formed opening without further cutting the vein or artery”, or similar.
Claims 14-17 are rejected for being dependent upon claim 13.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Galgano et al. (US 2016/0045715) in view of Baldwin et al. (USPN 3090384) in view of Sasaki (US 2011/0295152) and in further view of Kinast et al. (US 2006/0276759).
Regarding claim 1, Galgano discloses a method of introducing a needle (needle 40) into a vein (vein 11) or artery of a patient (Figures 3A, 4A, 5A, 6) comprising the steps of:
providing a catheter (catheter 30) and a needle (needle 40), said needle having a body with a proximal end (proximal end 42) and a distal end (distal end 41) extending from a distal end of said catheter (Figure 1A), a first longitudinal side surface and a second longitudinal side surface opposite said first longitudinal side surface (Figure 1B), said distal end having a first bevel (sharp beveled edge 41) extending between said first longitudinal side surface and second longitudinal side surface to define cutting edges at a distal tip (Figure 1B);
orienting said needle at a first angle (“starting with the position shown in FIG. 3A, the user could visually direct distal needle end 41 towards a peripheral vein of a patient. As indicated in FIG. 3A, a typical angle of attack can be around 45 degrees” [0100]) where the distal tip contacts an outer surface of the vein or artery at an angle to pierce the vein or artery before said first bevel contacts the vein or artery;
applying a substantially linear insertion force to said needle to pierce a wall of the vein or artery (Figure 3A; “Distal end 41 of needle 40…is then directed to a desired entry point at the patient's skin. It has been found that moving needle 40 forward into the skin at approximately a 45.degree. angle can be beneficial.” [0099], wherein the distal tip of the needle would contact the vein or artery before the bevel), and then orienting the needle at a second inclined angle relative to the longitudinal dimension of the vein or artery that is less than said first angle and introducing said needle into a lumen of the vein or artery (Figure 4A; “Once in that position, handle 20 can be dropped to a shallower entry angle (perhaps approximately 20.degree.-30.degree. relative to the skin or to vein 11. The angle can be dropped if initial vein puncture is successful after visual confirmation in flash chamber 25/19.” [0099]), wherein said second inclined angle (Figure 4A) is smaller than said first inclined angle (Figure 3A).
Galgano fails to explicitly disclose said distal end having a first bevel at an angle of about 16-22°, said second longitudinal side of the needle having an inwardly curved distal surface extending from an outer peripheral surface of said body to said distal tip, said curved distal surface having a second reverse bevel and a third reverse bevel converging to said distal tip at an angle of about 75-85° and forming an inclined cutting edge extending between said distal tip and said curved distal surface of said outer peripheral surface of the needle, and forming cutting edges between said first bevel and said second reverse bevel, and between said first bevel and said third reverse bevel, and where said cutting edges and tip are spaced radially inward with respect to the curved distal surface and said outer peripheral surface of the needle, said method comprising piercing the vein or artery where the inclined cutting edge and curved surface face outwardly from a skin surface and contact a distal surface of the insertion site; the first angle is greater than the angle of the first bevel, where said bevel faces an outer surface of the vein or artery; applying the substantially linear insertion force to said needle to pierce the wall of the vein or artery with the cutting edges until the curved surface contacts the wall of the vein or artery; and the second angle is less than the angle of the first bevel, and introducing said needle into the lumen of the vein or artery with said bevel surface facing an inner surface of said vein or artery in a location opposite an insertion site by said needle, and said curved surface contacts the vein or artery and guides said needle into the vein or artery without further cutting the vein or artery.
Baldwin teaches a needle (needle 10’) having a distal end (Figure 5), said distal end having a first bevel (front face 17’) extending between a first longitudinal side surface and second longitudinal side surface to define cutting edges (cutting edges 18’) at a distal tip (tip 19’), said second longitudinal side having a distal surface having a second reverse bevel (left side face 15’) and a third reverse bevel (right side face 15’) converging to said distal tip (Figures 5-8) and forming a cutting edge (back edge 16’) extending between said distal tip and said distal surface of an outer peripheral surface of the needle (Figure 5), and forming cutting edges (cutting edges 18') between said first bevel and said second reverse bevel, and between said first bevel and said third reverse bevel (Figures 5-8).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the needle utilized in the method of Galgano to include second and third reverse bevels forming a cutting edge extending between the distal tip and a distal surface of the needle and forming cutting edges between the first bevel and reverse bevels based on the teachings of Baldwin to ensure that the needle requires a relative low penetration force that is less likely to cause pain upon insertion into the body (Baldwin [Col 1, line 40-42]).
Modified Galgano fails to explicitly disclose said distal end having a first bevel at an angle of about 16-22°, said second longitudinal side of the needle having an inwardly curved distal surface extending from an outer peripheral surface of said body to said distal tip, said second reverse bevel and a third reverse bevel converging to said distal tip at an angle of about 75-85° and forming an inclined cutting edge, and where said cutting edges and tip are spaced radially inward with respect to the curved distal surface and said outer peripheral surface of the needle, said method comprising piercing the vein or artery where the inclined cutting edge and curved surface face outwardly from a skin surface and contact a distal surface of the insertion site; the first angle is greater than the angle of the first bevel, where said bevel faces an outer surface of the vein or artery; applying the substantially linear insertion force to said needle to pierce the wall of the vein or artery with the cutting edges until the curved surface contacts the wall of the vein or artery; and the second angle is less than the angle of the first bevel, and introducing said needle into the lumen of the vein or artery with said bevel surface facing an inner surface of said vein or artery in a location opposite an insertion site by said needle, and said curved surface contacts the vein or artery and guides said needle into the vein or artery without further cutting the vein or artery.
Sasaki teaches a method of introducing a needle (incision needle 1) into a vein (Figures 5-8) comprising the steps of: providing a needle (incision needle 1, embodiment of Figure 15) have a distal end (Figure 15) having a first bevel (angled end face 20) at an angle of 16-22° (“the tip of incision needle 1 has angled end face 20, which is angled with respect to central axis A of the needle. This inclination angle B (shown in FIG. 3) is preferably about 5.degree. to 21.degree.” [0121]) defining a distal tip (pointed extremity 21; Figure 15), a second longitudinal side (reverse surface 30) of the needle having an inwardly curved distal surface (see annotated Figure 15 below) extending from an outer peripheral surface of the body of the needle to said distal tip (Figure 15), said curved distal surface having a second reverse bevel and a third reverse bevel (reverse cutting faces 31) converging to said distal tip (Figure 15, and Figure 13, for example) and forming an inclined edge (edge where reverse cutting faces 31 meet each other and pointed extremity 21; Figure 13 for example) extending between said distal tip and said curved distal surface of said outer peripheral surface of the needle (Figure 15, and Figure 13, for example), forming cutting edges (at cutting face 22) between said first bevel and said second reverse bevel and between said first bevel and said third reverse bevel (Figure 15), and where said cutting edges and tip are spaced radially inward with respect to the curved distal surface and said outer peripheral surface of the needle (Figure 15; “Pointed extremity 21 is bent towards central axis A of the needle. This bend may be a curve or a bend” [0121]), said method comprising piercing the vein where the inclined cutting edge (where reverse cutting faces 31 meet each other and pointed extremity 21; Figure 13 for example) and curved surface (see annotated Figure 15) face outwardly from a skin surface (Figure 5) and contact a distal surface of the insertion site (Figure 6); orienting said needle at a first angle that is greater than the angle of the first bevel (first angle as provided by Galgano above: “moving needle 40 forward into the skin at approximately a 45° angle” [0099], wherein 45° is greater than the angle of the first bevel of 5-21° as taught by Sasaki) where said first bevel (angled end face 20) faces an outer surface of the vein (blood vessel 101) and the distal tip (pointed extremity 21) contacts an outer surface of the vein at an angle to pierce the vein (Figure 5-6) before said first bevel (angled end face 20) contacts the vein (Figure 5); applying a substantially linear insertion force to said needle to pierce the wall of the vein or artery with the cutting edges until the curved surface contacts the wall of the vein or artery (Figures 5-6; “the angle between pointed extremity 21 and the surface of shunt blood vessel 101 can be adequately secured when incision needle 1 is used to puncture shunt blood vessel 101 with angled end face 20 facing down and pointed extremity 21 on top. Thus, shunt blood vessel 101 can be punctured accurately with incision needle 1 even in so-called upside-down puncturing with pointed extremity 21 on top.” [0129]); and orienting the needle at a second inclined angle relative to the longitudinal dimension of the vein that is less than the angle of the first bevel (second inclined angle as provided by Galgano above: “Once in that position, handle 20 can be dropped to a shallower entry angle (perhaps approximately 20°-30° relative to the skin or to vein 11.” [0099], wherein 20° is less than at least a part of the range of the angle of the first bevel of 5-21° as taught by Sasaki) and introducing said needle into a lumen of the vein with said first bevel surface facing an inner surface of said vein in a location opposite an insertion site by said needle (Figure 8), wherein said curved surface contacts the vein or artery (Figure 6) and guides said needle into the vein or artery without further cutting the vein or artery (“damage to the skin and shunt blood vessel wall can be controlled and the needle can be inserted smoothly with little pain because the tip of the protruding part is rounded with a radius of 200 .mu.m or more.” [0057]; see all of [0126]; “smooth upside-down puncturing by incision needle 1 with pointed extremity 21 on top is possible because cutting face 22 is formed on angled end face 20 from pointed extremity 21 to the middle of angled face 20a of angled end face 20.” [0131]; Figures 6-8).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the needle utilized in the method of Galgano as modified by Baldwin to include the first bevel is formed at an angle of 16-22°, a second longitudinal side of the needle having an inwardly curved distal surface having a second and third reverse bevels forming an inclined cutting edge, and where said cutting edges and tip are spaced radially inward with respect to the curved distal surface and said outer peripheral surface of the needle and to modify the method of Galgano to include that the first angle, as provided by Galgano, is greater than the angle of the first bevel, where said bevel faces an outer surface of the vein or artery; the second angle, as provided by Galgano, is less than the angle of the first bevel, and introducing said needle into the lumen of the vein or artery with said bevel surface facing an inner surface of said vein or artery in a location opposite an insertion site by said needle by applying a substantially linear insertion force to said needle to pierce the wall of the vein or artery with the cutting edges until the curved surface contacts the wall of the vein or artery, and said curved surface contacts the vein or artery and guides said needle into the vein or artery without further cutting the vein or artery based on the teachings of Sasaki to allow for accurate and smooth introduction of the needle into the blood vessel without causing unnecessary damage to the vessel walls (Sasaki [0129-0131]).
Modified Galgano fails to explicitly disclose said second reverse bevel and a third reverse bevel converging to said distal tip at an angle of about 75-85°.
Kinast teaches a needle (needle 1) having a first bevel (surface 18; Figure 2) extending between first and second longitudinal side surfaces to define edges (outer edges 19) at a distal tip (tip 9, Figure 5), said second longitudinal side having an inwardly curved distal surface (Figure 1; “the tip 4 is bent suitably from a position 17 located at the periphery of the needle (see FIG. 6), where the tip has a position 17 depicted by dot-dashed lines in a lower part of the needle 1, in the direction towards (upwards in FIG. 6) a position in which the tip occupies substantially the center of a cross section of the needle.” [0051]), said curved distal surface having second and third reverse bevels (left and right side of penetrating tip 4 formed by grinding underside 20; “the tip 4 may first be ground, for example it may be provided with a so-called back bevel cut” [0052]) converging to said distal tip an angle of 75-85° (“Preferably, the pointed end 3 is provided with a first grind angle, i.e. a tip angle .alpha., in the interval 50 to 100.degree….Preferably, the pointed end 3 is further provided with a second grind angle .beta. in the interval 50 to 140.degree.” [0053]; Figures 9 and 10, wherein angle alpha is the angle which the cutting edges are relative to each other and angle beta is the angle which the reverse bevel surfaces are relative to each other, each including the range of 75-85°) and forming an inclined edge (edge formed between back bevel cuts forming tip 4; Figures 1 and 10) extending between said distal tip and said curved distal surface of said outer peripheral surface of the needle (Figure 1), and where said edges and tip are spaced radially inward with respect to the curved distal surface and said outer peripheral surface of the needle (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the needle utilized in the method of Galgano to include that the second and third reverse bevels converging to said distal tip at an angle of about 75-85° based on the teachings of Kinast to provide the distal tip of the needle with a point shaped tip that can penetrate the skin (Kinast [0053]).
Regarding claim 3, modified Galgano teaches the method of claim 1, further comprising orienting said first bevel with respect to a longitudinal dimension of the vein or artery to promote angular movement from said first position to said second position during insertion (“moving needle 40 forward into the skin at approximately a 45.degree. angle can be beneficial. Once in that position, handle 20 can be dropped to a shallower entry angle (perhaps approximately 20.degree.-30.degree. relative to the skin or to vein 11” [0099]; Figures 3A and 4A).
Regarding claim 5, modified Galgano teaches the method of claim 1, further comprising inserting said distal tip into a lumen of the vein or artery in a position spaced from an inner wall surface of the vein or artery opposite the insertion site and pointing in a direction substantially parallel to the longitudinal dimension of the vein or artery (Figure 4A, wherein the axis of the bevel 41 and the opening of the lumen of the needle 40 is substantially parallel to the axis of the vein).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Galgano et al. (US 2016/0045715) in view of Baldwin et al. (USPN 3090384) in view of Sasaki (US 2011/0295152) and in further view of Kinast et al. (US 2006/0276759) as applied to claim 1 above, and further in view of Chang (USPN 6524277).
Regarding claim 2, modified Galgano teaches the method of claim 1, the needle providing a blood flashback passage (passage to flash chamber [0065]; Figure 1B).
Modified Galgano fails to explicitly teach wherein said second side surface of said needle has a notch defining a blood flashback passage between said needle and said catheter, and where said notch is oriented on a side opposite said first bevel.
Chang teaches a method of introducing a needle into a vein of a patient (Figure 5) comprising the steps of providing a needle (needle 120) having a first bevel surface extending between a first and second longitudinal surface to define a distal tip at the second side surface (Figure 1), wherein said second side surface of said needle has a notch (aperture 132) defining a blood flashback passage between said needle and said catheter (tube 110; “The blood enters aperture(s) 132 located on a side of needle 120. Aperture 132 provides an early indication of the blood flashback. The blood continues to travel through an annular space defined by needle 120 and tube 110. The blood then flows into hub 105 and through needle holder 107 and collects in a flashback chamber.” [Col 3, line 1]), and where said notch is oriented on a side opposite said first bevel (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the blood flashback passage of Galgano to be defined by a notch oriented on a side opposite said first bevel based on the teachings of Chang to provide early indication of blood flashback and therefore early indication of proper needle placement (Chang [Col 3, line 2]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Galgano et al. (US 2016/0045715) in view of Baldwin et al. (USPN 3090384) in view of Sasaki (US 2011/0295152) in view of Kinast et al. (US 2006/0276759) as applied to claim 1 above, and further in view of Ibragimov (US 2015/0305769) in further view of Wiley (US 2010/0137804).
Regarding claim 21, modified Galgano teaches the method of claim 1, wherein said catheter (catheter 30) includes a catheter hub (hub 36) with a first side and a second side opposite said first side (Figure 3A), said method further comprising advancing said catheter over said needle (Figure 6).
Modified Galgano fails to explicitly teach a push tab on a first side, orienting said catheter relative to said needle where said first bevel faces outwardly from said second side of said catheter hub, said method further comprising advancing said catheter over said needle whereby said tip and said inclined cutting edge do not contact an inner surface of said catheter.
Ibragimov teaches a method of introducing a needle and catheter into a vein or artery of a patient (Figures 5a-5d and 6) comprising the steps of: providing a catheter (sheath 150/250) and a needle (needle 130/230), said needle having a first longitudinal side surface and a second longitudinal side surface and a first bevel (beveled tip 120/220) extending between said first and second longitudinal surfaces (Figure 6), wherein said catheter includes a catheter hub (sheath hub 282) with a first side and a second side opposite said first side (Figure 6), and a push tab on a first side (Figure 6; “sheath hub 282, which in turn may be equipped with a protrusion allowing the sheath to be disengaged from the needle hub 240 and slidingly moved along the needle 230 when inserting into the target vessel.” [0056]), orienting said catheter relative to said needle where said first bevel faces outwardly from said second side of said catheter hub, the method further comprising advancing said catheter over said needle (Figure 5b; “When the tip 120 is rotated about ½ of a turn (see FIG. 5b), the flat edge of the bevel aligns generally parallel with the vessel wall 12…Following step 2 of the method of rotating the hollow needle 130 by about ½ of a turn, the procedure may be continued to the step of advancing the sheath 150 into the vessel 10 as seen in FIG. 5c and further to needle removal as seen in FIG. 5d.” [0051-0052]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Galgano to include that the first side of the catheter hub includes a push tab and orienting said catheter relative to said needle where said first bevel faces outwardly from said second side of said catheter hub based on the teachings of Ibragimov to allow the catheter to be easily disengaged from the needle hub and advanced in a manner that limits damage to the posterior wall of the vessel and provides increased support for advancement of the catheter into the vessel (Ibragimov [0051], [0056]).
Modified Galgano fails to explicitly teach said method further comprising advancing said catheter over said needle whereby said tip and said inclined cutting edge do not contact an inner surface of said catheter.
Wiley teaches a method of introducing a needle and catheter (needle and catheter arrangement 400) into a vein or artery comprising the steps of: providing a catheter (catheter 410) and a needle (needle 300), said needle having a first bevel (first side 330), a distal tip (sharp point 362), and an inwardly curved distal surface (slopping/curving heel 340); the method further comprising advancing said catheter over said needle whereby said tip and said inwardly curved distal surface do not contact an inner surface of said catheter (Figures 12-15, wherein catheter 410 is advanced into the vessel without contacting tip 362 or heel 340 because they is spaced radially inward).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Galgano to include advancing said catheter over said needle whereby said tip and said inclined cutting edge on said inwardly curved distal surface, as provided by Kinast, do not contact an inner surface of said catheter based on the teachings of Wiley to facilitate advancement of the catheter into the vessel in a manner that prevents damage to the vessel walls or catheter (Wiley [0043-0046]).
Claims 6-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Galgano et al. (US 2016/0045715) in view of Baldwin et al. (USPN 3090384)1 in view of Sasaki (US 2011/0295152), and in further view of Chang (USPN 6524277) and in further view of Ibragimov (US 2015/0305769) in further view of Wiley (US 2010/0137804).
Regarding claim 6, Galgano discloses introducing a catheter (catheter 30) into a vein (vein 11) or artery of a patient (Figures 3A, 4A, 5A, 6) comprising the steps of:
positioning a catheter (catheter 30) and needle (needle 40) at a first inclined angle with respect to a longitudinal dimension of the vein or artery (Figure 3A; “starting with the position shown in FIG. 3A, the user could visually direct distal needle end 41 towards a peripheral vein of a patient. As indicated in FIG. 3A, a typical angle of attack can be around 45 degrees” [0100]), said catheter having a catheter hub (hub 36) with a first side and a second side opposite said first side (Figure 3A), said needle having a body with a proximal end (open proximal end 42), a distal end (distal end 41), a first longitudinal side surface and a second longitudinal side surface opposite said first longitudinal side surface (Figure 1C), said distal end having a first bevel (sharp beveled edge 41) extending between said first longitudinal side surface and said second longitudinal side surface to define a first cutting edge (left side of bevel edge 41) and a second cutting edge (right side of beveled edge 41) converging to a distal tip at said second longitudinal side surface (Figure 1C), said needle defining a blood flashback passage between a lumen of said needle and said catheter ([0099]), and a guide wire (guide wire 60) extending though said needle (Figure 3E);
piercing the vein or artery at said first inclined angle where said distal tip penetrates a surface of the vein or artery at said first inclined angle (“Distal end 41 of needle 40, fixed in the end of handle 20, is then directed to a desired entry point at the patient's skin. It has been found that moving needle 40 forward into the skin at approximately a 45.degree. angle can be beneficial.” [0099]; Figure 3A); and
inserting said needle and catheter through an insertion site into a lumen of the vein or artery at a second angle (“Once in that position, handle 20 can be dropped to a shallower entry angle (perhaps approximately 20.degree.-30.degree. relative to the skin or to vein 11. The angle can be dropped if initial vein puncture is successful after visual confirmation in flash chamber 25/19. This can be beneficial for subsequent deployment of HSC tube 50 and guide wire 60 via sliders 15 and 16.” [0099]; Figure 4A);
wherein the first bevel (sharp beveled edge 41) is inclined relative to the first longitudinal surface at a first bevel angle (Figures 1A and 3H).
Galgano fails to explicitly teach said first side of the said catheter hub having a push tab, said second longitudinal side surface having an inwardly curved distal surface converging to said distal tip and extending between said second longitudinal side surface and said distal tip, said distal tip and cutting edges spaced radially inward from an outer peripheral surface of said needle, said second longitudinal side having a notch defining a blood flashback passage between a lumen of said needle and said catheter, and where said notch is oriented opposite said first bevel, and wherein said needle has a second reverse bevel and a third reverse bevel converging with said first bevel to form said first cutting edge between said first bevel and said second reverse bevel, and to form said second cutting edge between said first bevel and said third reverse bevel, said second reverse bevel and third reverse bevel converging to form an inclined cutting edge extending from said distal tip toward said curved distal surface and said outer surface of said needle in a direction opposite said first bevel and facing toward said second side of said needle and outwardly from said second side of said catheter hub, and the said cutting edges are spaced radially inward with respect to said outer peripheral surface; the method further comprising piercing the vein or artery at said first inclined angle where said distal tip penetrates and the first and second cutting edges cut a surface of the vein or artery at said first inclined angle where said first bevel surface faces the vein or artery and said inwardly curved distal surface faces outward with respect to the vein or artery and outwardly from said first side of said catheter hub until the curved surface contacts the surface of the vein or artery; and then inserting said needle and catheter into a lumen of the vein or artery at an second angle where said first bevel surface faces an inner wall surface of the vein or artery at a location opposite a point of penetration of said needle and catheter and said curved surface passes through the insertion site without further cutting the vein or artery to promote orientation of said distal tip toward an axis of the lumen, and advancing said catheter over said needle where said tip does not contact an inner surface of said catheter; wherein the first inclined angle is greater than the first bevel angle, and the second angle is less than the first bevel angle.
Baldwin teaches a needle (needle 10’) having a distal end (Figure 5), said distal end having a first bevel (front face 17’) extending between a first longitudinal side surface and second longitudinal side surface to define a first cutting edge and a second cutting edge (cutting edges 18’) converging to a distal tip (tip 19’; Figure 5) at second longitudinal side surface, and wherein said needle has a second reverse bevel (left side face 15’) and a third reverse bevel (right side face 15’) converging with said first bevel to form said first cutting edge between said first bevel and said second reverse bevel (left cutting edge 18’; Figures 5-8), and to form said second cutting edge between said first bevel and said third reverse bevel (right cutting edge 18’; Figures 5-8), said second reverse bevel and said third reverse bevel converging to form a cutting edge (back edge 16’) extending from said distal tip toward said distal surface and an outer surface of said needle in a direction opposite said first bevel and facing toward said second side of said needle (Figure 5).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the needle utilized in the method of Galgano to include second and third reverse bevels converging with the first bevel to form first and second cutting edges and the reverse bevels converging to form a cutting edge based on the teachings of Baldwin to ensure that the needle requires a relative low penetration force that is less likely to cause pain upon insertion into the body (Baldwin [Col 1, line 40-42]).
Modified Galgano fails to explicitly teach said first side of the said catheter hub having a push tab, said second longitudinal side surface having an inwardly curved distal surface converging to said distal tip and extending between said second longitudinal side surface and said distal tip, said distal tip and cutting edges spaced radially inward from an outer peripheral surface of said needle, said second longitudinal side having a notch defining a blood flashback passage between a lumen of said needle and said catheter, and where said notch is oriented opposite said first bevel, said second reverse bevel and third reverse bevel converging to form an inclined cutting edge extending from said distal tip toward said curved distal surface and said outer surface of said needle in a direction opposite said first bevel and facing toward said second side of said needle and outwardly from said second side of said catheter hub, and the said cutting edges are spaced radially inward with respect to said outer peripheral surface; the method further comprising piercing the vein or artery at said first inclined angle where said distal tip penetrates and the first and second cutting edges cut a surface of the vein or artery at said first inclined angle where said first bevel surface faces the vein or artery and said inwardly curved distal surface faces outward with respect to the vein or artery and outwardly from said first side of said catheter hub until the curved surface contacts the surface of the vein or artery; and then inserting said needle and catheter into a lumen of the vein or artery at a second angle where said first bevel surface faces an inner wall surface of the vein or artery at a location opposite a point of penetration of said needle and catheter and said curved surface passes through the insertion site without further cutting the vein or artery to promote orientation of said distal tip toward an axis of the lumen, and advancing said catheter over said needle where said tip does not contact an inner surface of said catheter; wherein the first inclined angle is greater than the first bevel angle, and the second angle is less than the first bevel angle.
Sasaki teaches a method of introducing a catheter (tube 10) into a vein (Figures 5-8) comprising the steps of: positioning a catheter (tube 10) and a needle (incision needle 1, embodiment of Figure 15) at a first angle with respect to the vein (Figure 5), said catheter having a catheter hub (connecting part 11) having a first side (Figure 1, side facing into page) and a second side opposite the first side (Figure 1, side facing out of page), said needle having a first bevel (angled end face 20 and cutting face 22) defining first and second cutting edges (edges between cutting face 22 and reverse cutting faces 31) converging to a distal tip (pointed extremity 21; Figure 21) at a second longitudinal side surface (reverse surface 30), said second longitudinal side surface having an inwardly curved distal surface (see annotated Figure 15 above) converging to a distal tip (pointed extremity 21; Figure 15) and extending between said second longitudinal side surface and said distal tip (Figure 15), said distal tip and cutting edges spaced radially inward from an outer peripheral surface of said needle (Figure 15; “Pointed extremity 21 is bent towards central axis A of the needle. This bend may be a curve or a bend” [0121]), and wherein said needle has a second reverse bevel and a third reverse bevel (reverse cutting faces 31) converging with said first bevel to form said first and second cutting edges (Figure 15, and Figure 13, for example), said second reverse bevel and said third reverse bevel converging to form an inclined edge (edge where reverse cutting faces 31 meet each other and pointed extremity 21; Figure 13 for example) extending from said distal tip toward said curved distal surface and an outer surface of the needle in a direction opposite said firs bevel and facing toward said second side of said needle and outwardly from said second side of said catheter hub (Figures 1, 3, and 15), and wherein said cutting edges are space radially inward with respect to said outer peripheral surface (Figure 15); the method comprising piercing the vein at said first inclined angle where said distal tip penetrates and the first and second cutting edges cut a surface of the vein or artery at said first inclined angle where said first bevel surface (end face 20 and cutting face 22) faces the vein and said inwardly curved distal surface (see annotated Figure 15) faces outward with respect to the vein and outwardly from said first side of said catheter hub until the curved surface contacts the surface of the vein or artery (Figures 5-6; “Next, as shown in FIG. 5, incision needle 1 is disposed with pointed extremity 21 on top and angled end face 20 facing down, or in other words with angled end face 20 facing skin 100, and inserted at a specific angle from diagonally above the surface of skin 100. Incision needle 1 is thus inserted from skin 100 under the skin towards shunt blood vessel 101, forming puncture route 102. When pointed extremity 21 of incision needle 1 reaches the surface of shunt blood vessel 101 as shown in FIG. 6, it opens puncture hole 101a to form a incision, and enters shunt blood vessel 101 with pointed extremity 21 first.” [0126]), and inserting said needle and catheter through an insertion side into a lumen of the vein at a second angle where said first bevel surface faces an inner wall surface of the vein at a location opposite a point of penetration of said needle and catheter (Figure 8) and said curved surface passes through the insertion site without further cutting the vein or artery to promote orientation of said distal tip toward an axis of the lumen (“damage to the skin and shunt blood vessel wall can be controlled and the needle can be inserted smoothly with little pain because the tip of the protruding part is rounded with a radius of 200 .mu.m or more.” [0057], see all of [0126]; “smooth upside-down puncturing by incision needle 1 with pointed extremity 21 on top is possible because cutting face 22 is formed on angled end face 20 from pointed extremity 21 to the middle of angled face 20a of angled end face 20.” [0131]; Figures 6-8); wherein the first bevel (angled end face 20) is inclined relative to the first longitudinal surface at a first bevel angle (“the tip of incision needle 1 has angled end face 20, which is angled with respect to central axis A of the needle. This inclination angle B (shown in FIG. 3) is preferably about 5.degree. to 21.degree.” [0121]), the first inclined angle is greater than the first bevel angle (first angle as provided by Galgano above: “moving needle 40 forward into the skin at approximately a 45° angle” [0099], wherein 45° is greater than the first bevel angle of 5-21° as taught by Sasaki), and the second angle is less than the first bevel angle (second inclined angle as provided by Galgano above: “Once in that position, handle 20 can be dropped to a shallower entry angle (perhaps approximately 20°-30° relative to the skin or to vein 11.” [0099], wherein 20° is less than at least a part of the range of the first bevel angle of 5-21° as taught by Sasaki).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the needle utilized in the method of Galgano as modified by Baldwin to include a second longitudinal side of the needle having an inwardly curved distal surface having a second and third reverse bevels forming an inclined cutting edge, and where said cutting edges and tip are spaced radially inward with respect to the curved distal surface and said outer peripheral surface of the needle and to modify the method of Galgano to include piercing the vein or artery at said first inclined angle where said distal tip penetrates and the first and second cutting edges cut a surface of the vein or artery at said first inclined angle where said first bevel faces the vein or artery and said curved distal surfaces faces outward with respect to the vein or artery until the curved surface contacts the surface of the vein or artery, inserting said needle and catheter into a lumen of the vein or artery at a second angle where said first bevel faces an inner wall surface of the vein or artery at a location opposite a point of penetration of said needle and catheter and said curved surface passes through the insertion site without further cutting the venin or artery, and orienting said first bevel surface toward an inner surface of said opposing wall surface of the vein or artery at a location opposite the point of entry of said needle into the vein, wherein the first inclined angle, as provided by Galgano, is greater than the first bevel angle, and the second angle, as provided by Galgano, is less than the first bevel angle based on the teachings of Sasaki to allow for accurate and smooth introduction of the needle into the blood vessel without causing unnecessary damage to the vessel walls (Sasaki [0129-0131]).
Modified Galgano fails to explicitly teach said first side of said catheter hub having a push tab, said second longitudinal side of said needle having a notch defining a blood flashback passage between a lumen of said needle and said catheter, and where said notch is oriented opposite said first bevel, and advancing said catheter over said needle where said tip does not contact an inner surface of said catheter.
Chang teaches a method of introducing a catheter into a vein of a patient (Figure 5) comprising the steps of providing a needle (needle 120) having a first bevel extending between a first and second longitudinal surface to define a distal tip at the second side surface (Figure 1), said second longitudinal side surface having a notch (aperture 132) defining a blood flashback passage between a lumen of said needle and said catheter (tube 110; “The blood enters aperture(s) 132 located on a side of needle 120. Aperture 132 provides an early indication of the blood flashback. The blood continues to travel through an annular space defined by needle 120 and tube 110. The blood then flows into hub 105 and through needle holder 107 and collects in a flashback chamber.” [Col 3, line 1]), and where said notch is oriented opposite said first bevel (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the blood flashback passage utilized in the method of Galgano to be defined by a notch oriented on a side opposite said first bevel based on the teachings of Chang to provide early indication of blood flashback and therefore early indication of proper needle placement (Chang [Col 3, line 2]).
Modified Galgano fails to explicitly teach said first side of said catheter hub having a push tab, and advancing said catheter over said needle where said tip does not contact an inner surface of said catheter.
Ibragimov teaches a method of introducing a needle and catheter into a vein or artery of a patient (Figures 5a-5d and 6) comprising the steps of: positioning a catheter (sheath 150/250) and a needle (needle 130/230), said catheter includes a catheter hub (sheath hub 282) with a first side having a push tab (Figure 6; “sheath hub 282, which in turn may be equipped with a protrusion allowing the sheath to be disengaged from the needle hub 240 and slidingly moved along the needle 230 when inserting into the target vessel.” [0056]) and a second side opposite said first side (Figure 6).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Galgano to include that the first side of the catheter hub includes a push tab based on the teachings of Ibragimov to allow the catheter to be easily disengaged from the needle hub and advanced into the vessel (Ibragimov [0056]).
Modified Galgano fails to explicitly teach advancing said catheter over said needle where said tip does not contact an inner surface of said catheter.
Wiley teaches a method of introducing a needle and catheter (needle and catheter arrangement 400) into a vein or artery comprising the steps of: positioning a catheter (catheter 410) and a needle (needle 300), said needle having a first bevel (first side 330), a distal tip (sharp point 362), and an inwardly curved distal surface (slopping/curving heel 340); the method further comprising advancing said catheter over said needle where said tip does not contact an inner surface of said catheter (Figures 12-15, wherein catheter 410 is advanced into the vessel without contacting tip 362 because the tip is spaced radially inward).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Galgano to include advancing said catheter over said needle where said tip does not contact an inner surface of said catheter based on the teachings of Wiley to facilitate advancement of the catheter into the vessel in a manner that prevents damage to the vessel walls or catheter (Wiley [0043-0046]).
Regarding claim 7, modified Galgano teaches the method of claim 6, further comprising orienting said first bevel with respect to said longitudinal dimension of the vein or artery at said inclined angle to promote angular movement from said first orientation to said second orientation during said insertion step (“moving needle 40 forward into the skin at approximately a 45.degree. angle can be beneficial. Once in that position, handle 20 can be dropped to a shallower entry angle (perhaps approximately 20.degree.-30.degree. relative to the skin or to vein 11” [0099]; Figures 3A and 4A).
Regarding claim 8, modified Galgano teaches the method of claim 6.
Modified Galgano fails to explicitly teach orienting said first bevel toward an inner surface of said opposing wall surface of the vein or artery at a location opposite the point of entry of said needle into the vein or artery.
Sasaki teaches a method of introducing a catheter (tube 10) into a vein (Figures 5-8) comprising the steps of: positioning a catheter (tube 10) and a needle (incision needle 1, see embodiment of Figure 15) at a first angle with respect to the vein (Figure 5), the method further comprising orienting said first bevel (angled end face 20) toward an inner surface of said opposing wall surface of the vein at a location opposite the point of entry of said needle into the vein (Figure 8).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Galgano to include orienting said first bevel surface toward an inner surface of said opposing wall surface of the vein or artery at a location opposite the point of entry of said needle into the vein based on the teachings of Sasaki to allow for accurate and smooth introduction of the needle into the vein (Sasaki [0129-0131]).
Regarding claim 9, modified Galgano teaches the method of claim 6, further comprising orienting said distal tip at an incline to space said first bevel from said inner surface of said opposing wall of said vein during insertion into the vein or artery (“Once in that position, handle 20 can be dropped to a shallower entry angle (perhaps approximately 20.degree.-30.degree. relative to the skin or to vein 11. The angle can be dropped if initial vein puncture is successful after visual confirmation in flash chamber 25/19. This can be beneficial for subsequent deployment of HSC tube 50 and guide wire 60 via sliders 15 and 16.” [0099]; Figure 4A).
Regarding claim 10, modified Galgano teaches the method of claim 6, further comprising advancing said catheter with respect to said needle into the vein or artery (“as indicated in FIG. 6, the user can manually push, slide, thread or otherwise manipulate the catheter assembly 17 distally. The catheter cannula 30, typically a thin wall flexible tube (such as known in the art), will follow the outside of the needle and then the extended portion of HSC tube 50 and then the extended portion of guide wire 60.” [0107]).
Regarding claim 12, modified Galgano teaches the method of claim 6.
Modified Galgano fails to explicitly teach the method comprising inserting said needle into the patient where the curved distal end portion contacts a surface of the vein or artery at an insertion site and promotes an inward movement of said needle into the vein or artery.
Sasaki teaches a method of introducing a catheter (tube 10) into a vein (Figures 5-8) comprising the steps of: inserting a needle (incision needle 1) into a patient, wherein a curved distal end portion (see annotated Figure 15) contacts a surface of the vein at an insertion site and promotes an inward movement of said needle into the vein (“damage to the skin and shunt blood vessel wall can be controlled and the needle can be inserted smoothly with little pain because the tip of the protruding part is rounded with a radius of 200 .mu.m or more.” [0057], see also [0126]; Figures 6-8).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Galgano to include inserting said needle into the patient where the curved distal end portion contacts a surface of the vein or artery at an insertion site and promotes an inward movement of said needle into the vein based on the teachings of Sasaki to allow for accurate and smooth introduction of the needle into the vein (Sasaki [0129-0131]).
Claims 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Vaillancourt (USPN 4525157) in view of Baldwin et al. (USPN 3090384) in further view of Sasaki (US 2011/0295152) in further view of Kinast et al. (US 2006/0276759) further in view of Ibragimov (US 2015/0305769) in further view of Wiley (US 2010/0137804).
Regarding claim 13, Vaillancourt discloses a catheter assembly (Figure 2) comprising:
a needle (cannula 40) having a needle body having a longitudinal dimension with a proximal end and a distal end, a first longitudinal side surface (back side of cannula 40, Figure 4), a second longitudinal side surface (front side of cannula 40, Figure 4) opposite said first longitudinal side surface (Figures 2 and 4), and a first bevel (needle beveled end 42) extending between said first longitudinal side surface and said second longitudinal side surface to define a distal tip at said second longitudinal side surface (Figure 2),
said first bevel facing outwardly with respect to said first longitudinal side surface of said needle (Figure 2), and said second longitudinal side surface has a notch (aperture 46) defining a blood flashback passage (lumen of cannula 40 through aperture 46 into skirt portion 47; [Col 6, lines 35-44]) opposite said first bevel (Figure 2);
a catheter (catheter 50) positioned on said needle (Figure 2), where said needle is removable from said catheter (“When and with the catheter in place the needle hub 44, the guide wire 62 and bag 66 are separated as in FIG. 4, and these components are now discarded” [Col 7, line 51]); and
a catheter hub (hub 52) receiving said catheter, said catheter hub having a first longitudinal side surface (right side of hub 52; Figure 2) configured for manipulating the catheter assembly by a thumb or finger of a user (Figures 2-4) and a second longitudinal side surface (left side of hub 52; Figure 2) configured without interference from push tabs (Figures 2-4) configured for facing the skin of a patient, and where said first bevel (needle beveled end 42) of said needle faces the same side of the second longitudinal side surface of said catheter hub (Figures 2-4).
Vaillancourt fails to explicitly teach said second longitudinal side surface having an inwardly curved distal surface extending between said distal tip and an outer peripheral surface, a second reverse bevel and a third reverse bevel converging at said distal tip and forming a cutting edge between said second reverse bevel and said first bevel, a cutting edge between said third reverse bevel and said first bevel, and an inclined cutting surface between said second reverse bevel and said third reverse bevel, said cutting edges being oriented radially inward relative to the outer peripheral surface and said inwardly curved distal surface such that said cutting edges cut a surface of a vein or artery to form an opening in said vein or artery until said inwardly curved distal surface contacts the surface of the vein or artery, and then the inwardly curved distal surface slides through the formed opening without further cutting the vein or artery, and said inwardly curved distal surface extending between said second longitudinal side surface and said inclined cutting edge between said second reverse bevel and said third reverse bevel, and said first bevel formed at an angle of 16-22° with respect to the longitudinal dimension of said needle, and said second reverse bevel and third reverse bevel are formed at an angle of 75-85° with respect to each other to form said inclined cutting edge; and said first longitudinal side surface of said catheter hub having a push tab configured for manipulating the catheter assembly by a thumb or finger of a user and wherein said distal tip does not contact an inner surface of said catheter when said catheter is advanced over said distal tip.
Baldwin teaches a needle (needle 10’) having a distal end (Figure 5) and a first bevel (front face 17’) extending between a first longitudinal side surface and second longitudinal side surface to define a distal tip (tip 19’; Figure 5) at said second longitudinal side surface, said first bevel facing outwardly with respect to said first longitudinal side surface (Figure 5), said second longitudinal side surface having a second reverse bevel (left side face 15’) and a third reverse bevel (right side face 15’) converging at said distal tip (Figures 5-8) and forming a cutting edge between said second reverse bevel and said first bevel (left side cutting edge 18’), a cutting edge between said third reverse bevel and said first bevel (right side cutting edge 18’), and a cutting edge (back edge 16’) between said second reverse bevel and said third reverse bevel (Figures 5-8) distal tip and said distal surface of an outer peripheral surface of the needle (Figure 5).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the needle of Vaillancourt to include second and third reverse bevels forming cutting edges between the first bevel and reverse bevels and forming a cutting edge between the reverse bevels based on the teachings of Baldwin to ensure that the needle requires a relative low penetration force that is less likely to cause pain upon insertion into the body (Baldwin [Col 1, line 40-42]).
Modified Vaillancourt fails to explicitly teach said second longitudinal side surface having an inwardly curved distal surface extending between said distal tip and an outer peripheral surface, an inclined cutting surface between said second reverse bevel and said third reverse bevel, said cutting edges being oriented radially inward relative to the outer peripheral surface and said inwardly curved distal surface such that said cutting edges cut a surface of a vein or artery to form an opening in said vein or artery until said inwardly curved distal surface contacts the surface of the vein or artery, and then the inwardly curved distal surface slides through the formed opening without further cutting the vein or artery, and said inwardly curved distal surface extending between said second longitudinal side surface and said inclined cutting edge between said second reverse bevel and said third reverse bevel, and said first bevel formed at an angle of 16-22° with respect to the longitudinal dimension of said needle, and said second reverse bevel and third reverse bevel are formed at an angle of 75-85° with respect to each other to form said inclined cutting edge; and said first longitudinal side surface of said catheter hub having a push tab configured for manipulating the catheter assembly by a thumb or finger of a user and wherein said distal tip does not contact an inner surface of said catheter when said catheter is advanced over said distal tip.
Sasaki teaches a needle (incision needle 1, embodiment of Figure 15) having a first bevel (angled end face 20 and cutting face 22), a second longitudinal side (reverse surface 30) of the needle having an inwardly curved distal surface (see annotated Figure 15 below) extending between a distal tip (pointed extremity 21) and an outer peripheral surface (Figure 15), a second reverse bevel and a third reverse bevel (reverse cutting faces 31) converging at said distal tip (Figure 15, and Figure 13, for example) and forming a cutting edge between each of said second and third reverse bevels and said first bevel (at cutting face 22; Figure 15) and forming an inclined edge (edge where reverse cutting faces 31 meet each other and pointed extremity 21; Figure 13 for example) between said second reverse bevel and said third reverse bevel (Figure 15, and Figure 13, for example), said cutting edges being oriented radially inward relative to the outer peripheral surface and said inwardly curved distal surface (Figure 15; “Pointed extremity 21 is bent towards central axis A of the needle. This bend may be a curve or a bend” [0121]) such that said cutting edges cut a surface of a vein or artery to form an opening in said vein or artery until said inwardly curved distal surface contacts the surface of the vein or artery, and then the inwardly curved distal surface slides through the formed opening without further cutting the vein or artery (Figures 5-8: “Next, as shown in FIG. 5, incision needle 1 is disposed with pointed extremity 21 on top and angled end face 20 facing down, or in other words with angled end face 20 facing skin 100, and inserted at a specific angle from diagonally above the surface of skin 100. Incision needle 1 is thus inserted from skin 100 under the skin towards shunt blood vessel 101, forming puncture route 102. When pointed extremity 21 of incision needle 1 reaches the surface of shunt blood vessel 101 as shown in FIG. 6, it opens puncture hole 101a to form a incision, and enters shunt blood vessel 101 with pointed extremity 21 first. As shown in FIG. 7, puncture hole 101a (incision) splits open in a rough reverse U-shape starting from the far side of the incision relative to horizontal direction component X1 of insertion direction X of the incision needle, and optimal press point 101b is formed on the far side of the puncture hole 101a. Next, as shown in FIG. 8, incision needle 1 is advanced further so that all of angled end face 20 of incision needle 1 is inserted into shunt blood vessel 101.” [0126]; “damage to the skin and shunt blood vessel wall can be controlled and the needle can be inserted smoothly with little pain because the tip of the protruding part is rounded with a radius of 200 .mu.m or more.” [0057]; see also [0131]), and said inwardly curved distal surface extending between said second longitudinal side surface and said inclined cutting edge between said second reverse bevel and said third reverse bevel (Figure 15), and said first bevel formed at an angle of 16-22° with respect to the longitudinal dimension of said needle (“the tip of incision needle 1 has angled end face 20, which is angled with respect to central axis A of the needle. This inclination angle B (shown in FIG. 3) is preferably about 5.degree. to 21.degree.” [0121]) and wherein said second reverse bevel and third reverse bevel (reverse cutting faces 31) are formed at an angle with respect to each other to form an inclined cutting edge (Figure 4).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the needle of Vaillancourt as modified by Baldwin to include an inwardly curve distal surface having a second and third reverse bevels forming an inclined cutting edge oriented radially inward relative to the outer peripheral surface and said inwardly curved distal surface such that said cutting edges cut a surface of a vein or artery to form an opening in said vein or artery until said inwardly curved distal surface contacts the surface of the vein or artery, and then the inwardly curved distal surface slides through the formed opening without further cutting the vein or artery, and said first bevel formed at an angle of 16-22° with respect to the longitudinal dimension of said needle based on the teachings of Sasaki to form a cutting edge that facilitates smooth and accurate insertion of the needle into the blood vessel without causing unnecessary damage to the vessel walls (Sasaki [0121-0122]).
Modified Vaillancourt fails to explicitly teach said second reverse bevel and third reverse bevel are formed at an angle of 75-85° with respect to each other to form said inclined cutting edge; and said first longitudinal side surface of said catheter hub having a push tab configured for manipulating the catheter assembly by a thumb or finger of a user and wherein said distal tip does not contact an inner surface of said catheter when said catheter is advanced over said distal tip.
Kinast teaches a needle (needle 1) having a first bevel (surface 18; Figure 2) extending between first and second longitudinal side surfaces to define a distal tip (tip 9, Figure 5), said second longitudinal side having an inwardly curved distal surface (Figure 1; “the tip 4 is bent suitably from a position 17 located at the periphery of the needle (see FIG. 6), where the tip has a position 17 depicted by dot-dashed lines in a lower part of the needle 1, in the direction towards (upwards in FIG. 6) a position in which the tip occupies substantially the center of a cross section of the needle.” [0051]), and second and third reverse bevels (left and right side of penetrating tip 4 formed by grinding underside 20; “the tip 4 may first be ground, for example it may be provided with a so-called back bevel cut” [0052]) forming an inclined edge (edge formed between back bevel cuts forming tip 4; Figures 1 and 10) , said second reverse bevel and third reverse bevel formed at an angle of 75-85° with respect to each other to form said inclined edge (“Preferably, the pointed end 3 is provided with a first grind angle, i.e. a tip angle .alpha., in the interval 50 to 100.degree….Preferably, the pointed end 3 is further provided with a second grind angle .beta. in the interval 50 to 140.degree.” [0053]; Figures 9 and 10, wherein angle alpha is the angle which the cutting edges are relative to each other and angle beta is the angle which the reverse bevel surfaces are relative to each other, each including the range of 75-85°).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the needle of Vaillancourt to include that the second and third reverse bevels are formed at an angle of about 75-85° based on the teachings of Kinast to provide the distal tip of the needle with a point shaped tip that can penetrate the skin (Kinast [0053]).
Modified Vaillancourt fails to explicitly teach said first longitudinal side surface of said catheter hub having a push tab configured for manipulating the catheter assembly by a thumb or finger of a user and wherein said distal tip does not contact an inner surface of said catheter when said catheter is advanced over said distal tip.
Ibragimov teaches a catheter assembly (device 200) comprising a needle (needle 230) said needle having a first bevel (beveled tip 220) extending between first and second longitudinal surfaces and facing outwardly from said first longitudinal side surface (Figure 6); a catheter (sheath 250) and a catheter hub (sheath hub 282) having a first longitudinal side surface (top surface of hub 282 in Figure 6) with a push tab configured for manipulating the catheter assembly by a thumb or finger of a user (Figure 6; “sheath hub 282, which in turn may be equipped with a protrusion allowing the sheath to be disengaged from the needle hub 240 and slidingly moved along the needle 230 when inserting into the target vessel.” [0056]) and a second longitudinal side surface (bottom surface of hub 282) configured without interference from push tabs for facing the skin of a patient (Figure 6), and where said first bevel of said needle based the same side of the second longitudinal side surface of said catheter hub (Figures 5b-5d showing the bevel of the needle facing the second longitudinal side).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter hub of the catheter assembly of Vaillancourt to include a push tab on the first longitudinal side surface of the catheter hub based on the teachings of Ibragimov to allow the catheter to be easily disengaged from the needle hub and advanced in a manner that limits damage to the posterior wall of the vessel and provides increased support for advancement of the catheter into the vessel (Ibragimov [0051], [0056]).
Modified Vaillancourt fails to explicitly teach wherein said distal tip does not contact an inner surface of said catheter when said catheter is advanced over said distal tip.
Wiley teaches a catheter assembly (needle and catheter arrangement 400) comprising a needle (needle 300) having a first bevel (first side 330), a distal tip (sharp point 362), and an inwardly curved distal surface (slopping/curving heel 340); and a catheter (catheter 410); and a catheter hub (fitting 1210; Figure 12) having a first longitudinal side surface (upper side of fitting 1210; Figure 15) and a second longitudinal side surface (lower side of fitting 1210) configured for facing the skin of a patient (Figure 15), and where said first bevel (first side 330) of said needle faces outwardly with respect to second longitudinal side surface of said catheter hub (Figures 12-15) where said distal tip (sharp point 362) does not contact an inner surface of said catheter when said catheter is advanced over said distal tip (Figures 12-15, wherein catheter 410 is advanced into the vessel without contacting tip 362 because it is spaced radially inward). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter assembly of Vaillancourt to include wherein said distal tip does not contact an inner surface of said catheter when said catheter is advanced over said distal tip to facilitate advancement of the catheter into the vessel in a manner that prevents damage to the vessel walls or catheter (Wiley [0043-0046]).
Regarding claim 14, modified Vaillancourt teaches the catheter assembly of claim 13, wherein said catheter is an IV catheter (“placement of a flexible catheter into the lumen of an artery or vein.” [Abstract]), and where said blood flashback passage (lumen of cannula 40 through aperture 46) in said needle body is in communication with a blood control member (cylindrical skirt portion 47; [Col 6, lines 35-44]), and a guide wire (guide wire 62) extending through said needle (Figures 2-3).
Regarding claim 15, modified Vaillancourt teaches the catheter assembly of claim 14, wherein said blood flashback passage (lumen of cannula 40 through aperture 46 into skirt portion 47; [Col 6, lines 35-44]) extends between said needle body and said catheter (Figure 2).
Regarding claim 16, modified Vaillancourt teaches the catheter assembly of claim 15, wherein said blood flashback passage is in communication with a lumen in said needle body (“hub 44 has a transverse hole or aperture 46 which provides an exit or discharge for blood passing through the hollow needle as and when the needle penetrates the wall of a vessel” [Col 6, line 36]), and where said catheter hub is connected to said blood control member (Figure 2; wherein hub 52 mates with hub 44 having skirt portion 47).
Regarding claim 17, modified Vaillancourt teaches the catheter assembly of claim 14, wherein said needle body includes a lumen forming said blood flashback passage (“hub 44 has a transverse hole or aperture 46 which provides an exit or discharge for blood passing through the hollow needle as and when the needle penetrates the wall of a vessel” [Col 6, line 36]) and where said catheter hub (hub 52) is coupled to a needle hub (hub 44) connected to said blood control member (cylindrical skirt portion 47) for receiving blood from said needle (Figure 2).
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 5-10, 12-17, and 21 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.
Regarding the argument that “Sasaki…lack cutting edges that are spaced radially inward of the curved surface and an outer peripheral surface of the needle body” (Remarks, page 8), the examiner respectfully disagrees. As detailed in the rejections of independent claims 1, 6, and 13 above, Sasaki discloses a needle having an inwardly curved distal surface (see annotated Figure 15 above), said curved distal surface having a second reverse bevel and a third reverse bevel (reverse cutting faces 31) forming an inclined edge (edge where reverse cutting faces 31 meet each other and pointed extremity 21; Figure 13 for example) and cutting edges (at cutting face 22) between said first bevel and said second reverse bevel and between said first bevel and said third reverse bevel (Figure 15), and where said cutting edges and tip are spaced radially inward with respect to the curved distal surface and said outer peripheral surface of the needle (Figure 15; “Pointed extremity 21 is bent towards central axis A of the needle. This bend may be a curve or a bend” [0121]).
Regarding the argument that the cited prior art of record, specifically Sasaki (US 2011/0295152), “fails to teach or suggest first inserting the needle to pierce a wall of a vein or artery with the cutting edges until the curved surface contacts the wall of the vein or artery, and then further inserting the needle with the curved surface contacting the vein or artery and guiding the needle into the vein or artery without further cutting the vein or artery” as required by the amended independent claims (Remarks, page 8 and 10-11), the examiner respectfully disagrees. As detailed above, Sasaki, in at least Figures 5-8, discloses using a needle (1) to pierce a blood vessel using cutting edges until the curved surface contacts the wall of the blood vessel (“Next, as shown in FIG. 5, incision needle 1 is disposed with pointed extremity 21 on top and angled end face 20 facing down, or in other words with angled end face 20 facing skin 100, and inserted at a specific angle from diagonally above the surface of skin 100. Incision needle 1 is thus inserted from skin 100 under the skin towards shunt blood vessel 101, forming puncture route 102. When pointed extremity 21 of incision needle 1 reaches the surface of shunt blood vessel 101 as shown in FIG. 6, it opens puncture hole 101a to form a incision, and enters shunt blood vessel 101 with pointed extremity 21 first.” [0126]), and then further inserting the needle with curved surface contacting the blood vessel (Figure 6) and guiding the needle into the blood vessel without further cutting the blood vessel (“As shown in FIG. 7, puncture hole 101a (incision) splits open in a rough reverse U-shape starting from the far side of the incision relative to horizontal direction component X1 of insertion direction X of the incision needle, and optimal press point 101b is formed on the far side of the puncture hole 101a. Next, as shown in FIG. 8, incision needle 1 is advanced further so that all of angled end face 20 of incision needle 1 is inserted into shunt blood vessel 101.” [0126]; “damage to the skin and shunt blood vessel wall can be controlled and the needle can be inserted smoothly with little pain because the tip of the protruding part is rounded with a radius of 200 .mu.m or more.” [0057]; see also [0131]).
Regarding the argument that “Ibragimov does not suggest orienting the push tab relative to the bevels of the needle in the claimed method” and “Ibragimov specifically teaches inserting the needle where the flat bevel faces away from the patient, and thus, effectively teaches away from the claimed method” (Remarks Page 9), the examiner respectfully disagrees. As detailed above with respect to the rejection of claim 21, Ibragimov teaches a method of introducing a needle and catheter into a vein (Figures 5a-5d and 6) comprising the step of orienting said catheter relative to said needle where said first bevel faces outwardly from said second side of said catheter hub, the method further comprising advancing said catheter over said needle (Figure 5b; [0051-0052]). The claims as currently presented do not require that the first bevel always faces outwardly from said second side of said catheter hub throughout the use of the needle and catheter. Additionally, Galgano in view of Baldwin and Sasaki discloses a method in which the first bevel of the needle is faces the patient. The language of claim 21 as currently presented require “a push tab on a first side” [of a catheter hub]. There is no requirement in the claims that the push tab has any specific orientation relative to the bevel or curved surfaces of the needle. Therefore, it is maintained that it would have been obvious to modify the method of Galgano to include that the first side of the catheter hub includes a push tab and orienting said catheter relative to said needle where said first bevel faces outwardly from said second side of said catheter hub based on the teachings of Ibragimov to allow the catheter to be easily disengaged from the needle hub and advanced in a manner that limits damage to the posterior wall of the vessel and provides increased support for advancement of the catheter into the vessel (Ibragimov [0051], [0056]).
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
1 Baldwin et al. (USPN 3090384) was inadvertently left out of the heading for the rejections of claims 6-10 and 12 int eh previous action. This has been corrected here. The body of the rejection with respect to the teachings of Baldwin has not been changed.