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 the Claims
Claims 17-20 are cancelled. Claims 21-22 are newly added. Claims 1-16 and 21-22 are currently pending. Claims 1, 6, 9, 12, and 14 are currently amended. Claims 1-16 and 21-22 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/11/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC § 102 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 Therefore, the rejection has been withdrawn.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 Waitz et al (US 5688246 A; hereafter Waitz).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 8, 14, and 16 is/are rejected under 35 U.S.C. 103 as being obvious over Shelverton (US 20190160255 A1) in view of Waitz et al (US 5688246 A; hereafter Waitz).
Regarding claim 1, Shelverton discloses a catheter assembly, comprising: a catheter hub (hub 220, fig. 5a, [0092]), comprising a distal end, a proximal end, and a catheter hub lumen extending through the distal end of the catheter hub and the proximal end of the catheter hub (see fig. 8b which shows needle 820 extending through the hub 220; therefore hub 220 must have a lumen);
a catheter (catheter 500, fig. 5a, [0092]) extending from the distal end of the catheter hub (see fig. 5a), wherein the catheter comprises:
a catheter tube (first portion 514, fig. 7, [0096]) comprising a distal end (distal end 512, fig. 5a, [0092]), a proximal end (proximate end 511, fig. 5a, [0092]), a tubular wall (wall 515.1, fig. 5B, [0093]) forming a catheter tube lumen (space surrounded by inner surface 517, fig. 5B, [0093]), the catheter tube lumen extending through the distal end of the catheter tube and the proximal end of the catheter tube ([0096] blood or other fluid F may be drawn into the catheter by way of inflow 604 through the plurality of openings 530 provided in the second portion 516 whereby it is sucked into the solid first portion 514 and drawn up into the syringe 700; Examiner notes that since fluid flows through the catheter tube portions 514 and 516, the catheter tube must have a lumen); and
a fluid-permeable section (second portion 516; fig. 7, [0095] In the second portion 516, the fluid is permitted to exit the body uniformly around the circumference of the body) extending from the distal end of the catheter tube (first portion 514, see fig. 5a), wherein the fluid-permeable section (516) comprises a mesh or a coil ([0092] circumferential wall 515 of the second portion 516 of the catheter body is formed in a web, mesh or lattice like structure 540); and
an introducer needle (needle 810, fig. 8a, [0098]) extending through the catheter tube and the fluid-permeable section (see fig. 8b).
Shelverton is silent to wherein the distal end of the catheter tube comprises a beveled surface formed by an oblique cut through the tubular wall such that the distal end of the catheter tube defines an obliquely oriented opening into the catheter tube lumen.
Waitz, in the art of cannula, teaches wherein the distal end of the catheter tube (microcannula 12, col. 6 ln. 61-col. 7 ln. 6, fig. 3) comprises a beveled surface (beveled leading edge 16, fig. 6b, col. 6 ln. 61-col. 7 ln. 6) (col. 6 ln. 61-col. 7 ln. 6, The beveled leading edge 16 of the microcannula comes into contact with the outside of the blood vessel 18 outer wall slightly displacing the wall of the blood vessel and stretching the hole punctured in the blood vessel wall.), formed by an oblique cut through the tubular wall (see fig. 2 below which shows oblique cut, at 25 degrees, through the tubular wall of the catheter tube) such that the distal end of the catheter tube defines an obliquely oriented opening into the catheter tube lumen (see annotated fig. 2 below).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the distal end of the catheter tube 514 of Shelverton to include a bevel as taught by Waitz, since both references deal with insertion into the vasculature. One would have been motivated to make the modification because, as noted by Waitz (col. 6 ln. 61-col. 7 ln. 6) the leading edge 16 of the microcannula slightly displaces the wall of the blood vessel. The gradual introduction of the more solid portion of the catheter of Shelverton would allow for a gradual displacement of the skin and blood vessel wall of a patient, helping to decrease pain and damage to the area which may arise from a blunter transition to the catheter tube.
Regarding claim 8, Shelverton as modified discloses the catheter assembly of claim 1, as described above, including wherein the distal end of the catheter tube comprises a bevel (see bevel in Waitz fig. 2, see 103 rejection of claim 1 above).
Regarding claim 14, Shelverton discloses the catheter assembly of claim 1, wherein a distal end of the fluid-permeable section (516, fig. 7) comprises an annular ring (tip portion 513, fig. 5a shows that a cross section of the tip portion 513 forms an annular ring, [0092]).
Regarding claim 16, Shelverton discloses the catheter assembly of claim 1, as described above. Shelverton further discloses wherein the fluid-permeable section (516, fig. 7) comprises the mesh ([0092] circumferential wall 515 of the second portion 516 of the catheter body is formed in a web, mesh or lattice like structure 540).
Claim(s) 2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelverton modified by Waitz, and further in view of Altman et al (US 20020177772 A1; hereafter Altman).
Regarding claim 2, Shelverton modified by Waitz discloses the catheter assembly of claim 1, as described above.
Shelverton modified by Waitz is silent to wherein the catheter tube is over-molded with the mesh or the coil.
Altman, in the art of catheters, teaches wherein the catheter tube (catheter body 1502, fig. 15a, [0110]) is over-molded ([0110] Braided catheter body 1502 is bonded to the bendable region through standard catheter joining techniques such as an overmolded lap joint.) with the mesh or the coil (bendable tube 1504 with a coil 1506, fig. 15a, [0110]) ([0110] deflecting region of the guide catheter 1530 comprises a flexible and easily bendable tube 1504 with a coil 1506 disposed coaxially within the tube shown in cross section in FIG. 15a).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to form the connection between the catheter tube and the mesh of Shelverton by overmolding as taught by Altman, since both references deal with catheters. One would have been motivated to make the modification because, as noted by Altman [0110], overmolding is a “standard catheter joining technique”, implying that the technique is well known and reliable, thus removing the risks associated with using a less known attachment method which may not be as thoroughly understood by technicians in the art.
Regarding claim 6, Shelverton modified by Waitz and Altman discloses the catheter assembly of claim 2, as described above, including wherein the mesh or the coil (Shelverton: [0092] circumferential wall 515 of the second portion 516 of the catheter body is formed in a web, mesh or lattice like structure 540; Altman: bendable region) extends along a partial length of the catheter tube (Shelverton: first portion 514, fig. 7, [0096]; Altman: catheter body) such that a proximal end of the mesh or the coil is spaced apart from the proximal end of the catheter tube (Altman: [0110] catheter body is bonded to the bendable region through standard catheter joining techniques such as an overmolded lap joint.)
Note that a lap joint involves overlapping the ends of two pieces which are joined together. As described in the rejection of claim 2 above, the catheter tube and the mesh of Shelverton are arranged in an overmolded lap joint as taught by Altman, thus they must partially overlap.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shelverton modified by Waitz and Altman, and further in view of Kennelly et al (US 20150174364 A1; hereafter Kennelly).
Regarding claim 3, Shelverton discloses the catheter assembly of claim 2, as described above. Shelverton further discloses wherein part of the catheter (516, fig. 7) is constructed of a polymer material ([0093] As most clearly illustrated in FIG. 5B, both the inner surface 517 and outer surface 518 of the wall 515.1 of the first portion 514 have an applied micro-texture or roughness to reduce the smoothness of the polymer surfaces of the body.).
Kennelly, directed to a catheter, teaches wherein the fluid-permeable section (soft tip elongated tubing 18, fig. 3 shows multiple holes, [0043]) is constructed of a polymer material ([0043] the elongated tubing may be made from PTFE)
Shelverton discloses the claimed invention except for wherein the fluid-permeable section is constructed of a polymer material. It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the fluid-permeable section of Shelverton to be constructed of a polymer, as taught by Kennelly [0043], since both references deal with catheters, and 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. (See MPEP 2144.07.) One would have been motivated to make the modification because, as noted by Kennelly [0048], “being made from the polymeric materials disclosed above, the catheters are compatible for human use, do not affect the potency of the medicaments used therewith, and are viewable under ultrasound.”.
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Shelverton modified by Waitz and Altman, as applied to claim 2 above, and further in view of Sharrock (US-4368730-A; hereafter Sharrock).
Regarding claim 4, Shelverton as modified discloses the catheter assembly of claim 2, as described above.
Shelverton as modified is silent to wherein the fluid-permeable section is constructed of metal.
Sharrock, directed to a catheter, teaches wherein the fluid-permeable section (portion of flexible wire-wound coil assembly 2 and core 4 not leak-proofed, col. 3 ln. 45-56; remaining flexible portion not leak-proofed noted in col. 4 ln. 34-45; see fig. 5) is constructed of metal (Detailed Description: col. 3 ln. 45-56, “core 4 of stainless steel”; Summary of Invention: col. 2 ln. 13-16 “the wire-wound catheter and the core, which may also be made of stainless steel wire”; Abstract: “stainless steel catheter assembly”).
Shelverton as modified discloses the claimed invention except for the material. It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the fluid-permeable section of Shelverton to be formed of a metal as taught by Sharrock since both references deal with catheters with a permeable distal section, and 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. (See MPEP 2144.07.) One would have been motivated to make the modification because metal provides stability and steerability to the catheter device, and stainless steel can be sterilized and is thus well suited to medical purposes.
Regarding claim 5, Shelverton as modified discloses the catheter assembly of claim 2, as described above.
Shelverton as modified is silent to wherein the mesh or the coil extends along an entire length of the catheter tube.
Sharrock, directed to a catheter, teaches wherein the mesh or the coil (wire-wound coil assembly 2 and core 4 not leak-proofed, col. 3 ln. 45-56, fig. 4) extends along an entire length of the catheter tube (section of catheter leak-proofed with plastic, see annotated fig. 4 below; col. 4 ln. 16-22, “the approximately six to nine centimeters of helical coil at the proximal end of the assembly near the coupling fitting may be provided with a plastic material, such as teflon or a silicon material, to prevent fluid leakages through the interstices of the helical coils”).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Shelverton to have the mesh forming Shelverton’s fluid permeable section to overlap with the entirety of the catheter tube, as taught by Sharrock which has the coil that forms the fluid permeable section of Sharrock extending past the fluid permeable section to the base of the catheter, where it meets the fitting 41 as shown above in fig. 4 of Sharrock, since both references deal with catheters with fluid permeable sections. One would have been motivated to make the modification because having the coil/mesh extend along the length of the catheter ensures that the fluid permeable section is firmly bonded to the catheter tube section of the catheter, since the coil/mesh forming the fluid permeable section is integrally bonded with the catheter tube itself, as taught by Sharrock. This arrangement ensures that the fluid permeable section is not easily detached from the catheter tube.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelverton as modified by Waitz and further in view of Anand et al (US 20180104459 A1; hereafter Anand).
Regarding claim 7, Shelverton as modified discloses the catheter assembly of claim 1, as described above.
Shelverton as modified is silent to wherein the fluid-permeable section is formed of a same material as the catheter tube.
Anand, in the field of catheters, teaches wherein the fluid-permeable section (distal portion 411 with auxiliary holes 402 and 404, fig. 4b, [0135]) is formed of a same material as the catheter tube (catheter main body 407, fig. 4b, [0135]) ([0135] catheter main body 407 is formed of silicone and distal portion 411 is formed through silicone overmolding).
Shelverton as modified discloses the claimed invention except for the material. It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the fluid-permeable section and catheter tube of Shelverton to be formed of a same material as taught by Anand since both references deal with catheters with a distal section having multiple holes, and 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. (See MPEP 2144.07.) One would have been motivated to make the modification because using the same material for both sections simplifies the construction process and ensures good bonding between the sections during overmolding.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelverton as modified by Waitz and further in view of Amin et al (AU 2017444936 A1; hereafter Amin). Text reference is made to the FOR document corresponding to Amin included with the previous Office Action.
Regarding claim 9, Shelverton modified by Waitz discloses the catheter assembly of claim 8, as described above. Shelverton further discloses wherein a distal end of the introducer needle (introducer 810, fig. 8b, [0098]) comprises another bevel (bevel 815, fig. 8b, [0098]).
Shelverton modified by Waitz is silent to the bevel of the catheter tube facing in an opposite direction as the another bevel of the introducer needle.
Amin, in the art of catheters, teaches wherein the distal end of the catheter tube (distal end 14 of catheter body 20, fig. 5, pg. 16 ln. 15-32) comprises a bevel (beveled end 33, fig. 5, see also fig. 7a-d, pg. 18 ln. 13-19 ), and
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wherein the bevel of the catheter tube faces in an opposite direction as the another bevel of the introducer needle (see annotated fig. 5 above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further include the relative positioning of the bevel of the introducer needle and the bevel of the catheter tube facing in opposite directions, as taught by Amin fig. 5, since both references deal with catheters. One would have been motivated to make the modification because having the bevels facing opposite directions ensures that during insertion stress to the entrance hole is not all placed on one portion of the skin/vessel wall since the gradual widening of the insertion needle and catheter tube, due to their opposing bevels, allows for gradual displacement of the skin and blood vessel wall in multiple areas instead of just one, thus helping to avoid damaging one area too much.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shelverton modified by Waitz and further in view of Kennelly.
Regarding claim 10, Shelverton as modified discloses the catheter assembly of claim 1, as described above.
Shelverton as modified is silent to wherein the fluid-permeable section is constructed of a different material than the catheter tube.
Kennelly, directed to a catheter, teaches wherein the fluid-permeable section (soft tip elongated tubing 18, fig. 3 shows multiple holes, [0043]) is constructed of a different material than the catheter tube (elongated tube 4, fig. 5, [0043]) ([0043] As disclosed above, elongated tube 4 may be made from…polyether block amide (PEBA)…and may have a durometer… preferably between 50-80 Durometer Shore D. The soft tip elongated tubing 18 may also be made of a plastics material such as nylon and other similar material as the elongate tube but may have a range of … preferably between 0-30 Durometer Shore D (or 0-100 Durometer Shore A).).
Shelverton as modified discloses the claimed invention except for wherein the fluid-permeable section is constructed of a different material than the catheter tube. It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the fluid-permeable section of Shelverton to be constructed of a different material than the catheter tube, as taught by Kennelly [0043], since both references deal with catheters, and 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. (See MPEP 2144.07.) One would have been motivated to make the modification because the different portions of the catheter device have different purposes. For instance, a lower durometer, or softer plastic may be used at a distal end of a catheter to lower the risk of damage to internal tissues, while a higher durometer, or stiffer plastic may be used at a proximal portion of the catheter to aid in transmission of longitudinal and rotational force along the length of the catheter.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelverton modified by Waitz and further in view of Sheridan (US-3612050-A; hereafter Sheridan).
Regarding claim 11, Shelverton as modified discloses the catheter assembly of claim 1, as described above, including the distal section of the catheter being a fluid-permeable section (second portion 516; fig. 7, [0095] In the second portion 516, the fluid is permitted to exit the body uniformly around the circumference of the body).
Shelverton as modified is silent to wherein the fluid-permeable section comprises a plurality of clip features and an outer surface of the introducer needle comprises a plurality of corresponding clip features, wherein the plurality of clip features and the plurality of corresponding clip features contact each other and are configured to prevent a distal end of the fluid-permeable section from moving proximal to the plurality of corresponding clip features.
Sheridan, directed to an intravascular catheter, teaches wherein the distal section (cannula distal end portion 82 and tapered tip 84, fig. 10, col. 4 ln. 54-60) comprises a plurality of clip features (see process described in col. 4 ln. 40-53, using dilating liquid also used in col. 4 ln. 54-60, cannula distal end portion 82 and tapered tip 84 conform to the grooves 80 of trocar 78) and an outer surface (wall 76 of the trocar 78, fig. 10, col. 4 ln. 54-60) of the introducer needle (trocar 78, fig. 10, col. 4 ln. 54-60) comprises a plurality of corresponding clip features (grooves 80, fig. 10, col. 4 ln. 54-60), wherein the plurality of clip features and the plurality of corresponding clip features contact each other and are configured to prevent a distal end of the fluid-permeable section from moving proximal to the plurality of corresponding clip features (Note similar dilating process noted for fig. 10 is earlier described in reference to fig. 9: col. 4 ln. 40-53, volatile organic liquid and then placed upon the trocar so the dilated portion 70 overlays the roughened trocar surface 68. When the dilating liquid evaporates, the cannula end portion 70 and tip 72 shrink around the trocar and create a firm blending of the cannula tip to the trocar. This creates good holding and prevents push back of the flexible cannula on the trocar which the skin and vascular wall of the patient are pierced upon insertion of the catheter assembly.)
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the tip portion 513 of the fluid permeable section 516, see Shelverton fig. 7, of Shelverton to include the conformation to grooves on the introducer needle, as taught by Sheridan, since both references deal with catheters inserted into the vasculature. One would have been motivated to make the modification because engagement between the tip portion 513 of Shelverton and grooves on the introducer needle would ensure that the needle and distal tip portion did not slip relative to each other during insertion into the vein, and make it easy to keep track of the needle tip.
Regarding claim 12, Shelverton as modified discloses the catheter assembly of claim 11, as described above, including wherein each of the plurality of corresponding clip features comprises a groove (Sheridan: grooves 80, fig. 10, col. 4 ln. 54-60), wherein each of the plurality of clip features comprises a protrusion (Sheridan: see process described in col. 4 ln. 40-53, using dilating liquid also used in col. 4 ln. 54-60, cannula distal end portion 82 and tapered tip 84 conform to the grooves 80 of trocar 78).
Shelverton as modified discloses all limitations of the claimed invention except wherein the plurality of clip features comprises a groove, and the plurality of corresponding clip features comprises a protrusion (note opposite relationship described above). It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the grooves on the fluid-permeable section and the protrusions on the introducer needle, thereby reversing the position of the grooves/protrusions, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of preventing unwanted relative movement.
Regarding claim 13, Shelverton as modified discloses the catheter assembly of claim 11, as described above, including wherein the distal end of the fluid-permeable section (Shelverton: 516, fig. 7) comprises an annular ring (Shelverton: tip portion 513, fig. 5a shows that a cross section of the tip portion 513 forms an annular ring, [0092]), wherein the annular ring comprises the plurality of clip features (note 103 rejection of claim 11 above wherein the tip portion 513 of Shelverton is modified by Sheridan to include the plurality of clip features).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shelverton modified by Waitz and further in view of Sharrock.
Regarding claim 15, Shelverton as modified the catheter assembly of claim 1, as described above.
Shelverton as modified is silent to wherein the fluid-permeable section comprises the coil.
Sharrock, directed to a catheter, teaches wherein the fluid-permeable section (remaining flexible portion not leak proofed, noted in col. 4 ln. 34-45; see fig. 5, the fluid permeable section is the coil portion which does not overlap with the tubular extension 5) comprises the coil (catheter helical coil noted in col. 4 ln. 34-45).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the fluid-permeable section of Shelverton to be formed from a coil instead of a mesh, as taught by Sharrock, since both references deal with catheters having permeable distal sections. One would have been motivated to make the modification because a coil provides more natural stability than a mesh, thus making the catheter movement easier to predict and guide.
Claim(s) 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Shelverton modified by Sheridan.
Regarding claim 21, Shelverton discloses a catheter assembly, comprising:
a catheter hub (hub 220, fig. 5a, [0092]), comprising a distal end, a proximal end, and a catheter hub lumen extending through the distal end of the catheter hub and the proximal end of the catheter hub (see fig. 8b which shows needle 820 extending through the hub 220; therefore hub 220 must have a lumen);
a catheter (catheter 500, fig. 5a, [0092]) extending from the distal end of the catheter hub (see fig. 5a), wherein the catheter comprises:
a catheter tube (first portion 514, fig. 7, [0096]) comprising a distal end (distal end 512, fig. 5a, [0092]), a proximal end (proximate end 511, fig. 5a, [0092]), a catheter tube lumen extending through the distal end of the catheter tube and the proximal end of the catheter tube ([0096] blood or other fluid F may be drawn into the catheter by way of inflow 604 through the plurality of openings 530 provided in the second portion 516 whereby it is sucked into the solid first portion 514 and drawn up into the syringe 700; Examiner notes that since fluid flows through the catheter tube portions 514 and 516, the catheter tube must have a lumen); and
a fluid-permeable section (second portion 516; fig. 7, [0095] In the second portion 516, the fluid is permitted to exit the body uniformly around the circumference of the body) extending from the distal end of the catheter tube (first portion 514, see fig. 5a), wherein the fluid-permeable section (516) comprises a mesh or a coil ([0092] circumferential wall 515 of the second portion 516 of the catheter body is formed in a web, mesh or lattice like structure 540), wherein the distal end of the fluid-permeable section (516, fig. 7) comprises an annular ring (tip portion 513, fig. 5a shows that a cross section of the tip portion 513 forms an annular ring, [0092]); and
an introducer needle (needle 810, fig. 8a, [0098]) extending through the catheter tube and the fluid-permeable section (see fig. 8b).
Shelverton is silent to wherein the fluid-permeable section comprises a plurality of clip features and an outer surface of the introducer needle comprises a plurality of corresponding clip features.
Sheridan, directed to an intravascular catheter, teaches wherein the distal section (cannula distal end portion 82 and tapered tip 84, fig. 10, col. 4 ln. 54-60) comprises a plurality of clip features (see process described in col. 4 ln. 40-53, using dilating liquid also used in col. 4 ln. 54-60, cannula distal end portion 82 and tapered tip 84 conform to the grooves 80 of trocar 78) and an outer surface (wall 76 of the trocar 78, fig. 10, col. 4 ln. 54-60) of the introducer needle (trocar 78, fig. 10, col. 4 ln. 54-60) comprises a plurality of corresponding clip features (grooves 80, fig. 10, col. 4 ln. 54-60), wherein the plurality of clip features and the plurality of corresponding clip features contact each other and are configured to prevent a distal end of the fluid-permeable section from moving proximal to the plurality of corresponding clip features (Note similar dilating process noted for fig. 10 is earlier described in reference to fig. 9: col. 4 ln. 40-53, volatile organic liquid and then placed upon the trocar so the dilated portion 70 overlays the roughened trocar surface 68. When the dilating liquid evaporates, the cannula end portion 70 and tip 72 shrink around the trocar and create a firm blending of the cannula tip to the trocar. This creates good holding and prevents push back of the flexible cannula on the trocar which the skin and vascular wall of the patient are pierced upon insertion of the catheter assembly.)
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the tip portion 513 of the fluid permeable section 516, see Shelverton fig. 7, of Shelverton to include the conformation to grooves on the introducer needle, as taught by Sheridan, since both references deal with catheters inserted into the vasculature. One would have been motivated to make the modification because engagement between the tip portion 513 of Shelverton and grooves on the introducer needle would ensure that the needle and distal tip portion did not slip relative to each other during insertion into the vein, and make it easy to keep track of the needle tip.
Note that Shelverton modified by Sheridan includes wherein the plurality of clip features (Sheridan: see process described in col. 4 ln. 40-53, using dilating liquid also used in col. 4 ln. 54-60, cannula distal end portion 82 and tapered tip 84 conform to the grooves 80 of trocar 78) are spaced apart around a circumference of the annular ring (Shelverton: tip portion 513, fig. 5a shows that a cross section of the tip portion 513 forms an annular ring, [0092]) (see 103 modification above).
Regarding claim 22, Shelverton as modified discloses the catheter assembly of claim 21, as described above, including wherein each of the plurality of clip features comprises a groove (Sheridan: grooves 80, fig. 10, col. 4 ln. 54-60), wherein each of the plurality of corresponding clip features comprises a protrusion (Sheridan: see process described in col. 4 ln. 40-53, using dilating liquid also used in col. 4 ln. 54-60, cannula distal end portion 82 and tapered tip 84 conform to the grooves 80 of trocar 78).
Shelverton as modified discloses all limitations of the claimed invention except wherein the plurality of clip features comprises a groove, and the plurality of corresponding clip features comprises a protrusion (note opposite relationship described above). It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the grooves on the fluid-permeable section and the protrusions on the introducer needle, thereby reversing the position of the grooves/protrusions, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of preventing unwanted relative movement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sloane (US 5397512 A) - catheter 3 has taper 5 and bevel 6; cannula 1, within catheter 3, has a sharpened point 2; see figs. 1-2, col. 2 ln. 54-col. 3 ln. 2
Cosman (US 20170049514 A1) - many bevel configurations with two bevels; see figs. 12a-y; [0227] Referring to FIGS. 12L and 12M, certain embodiments of a bevel 12303 for an epidural needle 1200 and a bevel 12603 for an epidural stylet 1250
Grayzel (US 4850960 A) - beveled catheter, beveled sheath, face opposite directions in fig. 12, col. 9 ln. 60-col. 10 ln. 2
Waitz (US 5688246 A) - sharpened trochar in beveled cannula, fig. 6B, for example, also see figs. 1-2
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.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 07/23/2026
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