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 .
Acknowledgment
Claim 1 is amended and filed on 11/6/2025.
Claim 5 is canceled.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-10, 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishida et al. (US. 20190381282A1) (“Ishida”) in view of Southern (US. 6712797B1).
Re Claim 1, Ishida discloses a vascular access catheter (Figs. 1-18, ¶0032), comprising: an elongated tubular catheter body (34 body of 12) enclosing a lumen (13 lumen for the needle, Fig. 3), the catheter body has a plane of symmetry coinciding with a median plane (a median plane of the catheter that cross the catheter longitudinally at longitudinal axis of 12 in Fig. 1 to give the cross half section as shown in Fig. 3) and includes a catheter tip ( tip of the 38b) ending with a catheter distal end (38) and comprising a distal edge at the catheter distal end surrounding an opening opened to the lumen (edge of 38b), the distal edge includes: (a) a pair of lateral leading edges located at opposing sides of the median plane (a portion of the edge of 38 that is right to the median plane and a portion of the edge of 38 that is left to the median plane), (b) a bottom edge portion extending between and below the lateral leading edges and spanning a bottom portion of the opening (a portion of the edge at the bottom of 38b), and (c) a top edge portion extending between and above the lateral leading edges and spanning a top portion of the opening (a top portion of the edge 38b); wherein the lateral leading edges are configured to penetrate through an aperture in a bodily tissue (Fig. 5, as 38 is inserted inside the skin tissue S, it is capable to expand the aperture as the diameter of the tip is increases), and further disclose that lateral leading edges are gradually expand the aperture downwardly in parallel to the median plane, when the catheter tip is pushed distally through the aperture( as the catheter and the needle are inserted in the tissue “S”, and due to the increasing in the diameter of the distal portion of the catheter from the tip of the catheter, it leads to further increase the diameter of the aperture in the tissue in order to insert the catheter, Fig. 5), but it fails to disclose that each of the lateral leading edges is curved downwardly and proximally from a respective front portion of the distal edge, and to gradually expand the aperture downwardly in parallel to the median plane, when the catheter tip is pushed distally through the aperture; and wherein the lateral leading edges extend distally beyond the bottom edge portion and the top edge portion to penetrate through the aperture before either of the bottom edge portion or the top edge portion penetrate through the aperture when pushed through the aperture at an acute angle relative to an outer surface of the bodily tissue.
However, Southern discloses insertion device can be used in soft tissue such as skin (abstract,, Fig. 5a ) and the catheter (14 Fig. 5a-5b) and wherein the catheter has a tip (20), the tip comprises a top edge wherein each of the lateral leading edges (Annotated Fig. 5a of Southern) is curved downwardly and proximally from a respective front portion of the distal edge (Annotated Fig. 5a of Southern), and to gradually expand the aperture downwardly in parallel to the median plane (Annotated Fig. 5a of Southern), when the catheter tip is pushed distally through the aperture (Annotated Fig. 5a of Southern, as the catheter is inserted as in Fig. 25, the front edge penetrate the tissue before the bottom edge and increases the a aperture of the tissue as the diameter increases along the distal portion starting from the tip ) and wherein the lateral leading edges extend distally beyond the bottom edge portion and the top edge portion (Annotated Fig. 5a of Southern ) to penetrate through the aperture before either of the bottom edge portion or the top edge portion penetrate through the aperture when pushed through the aperture at an acute angle relative to an outer surface of the bodily tissue ( lateral edge enter the tissue’s opening before the top and bottom edges).
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Annotated Fig. 5a of Southern
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the tip of the catheter of Ishida so that each of the lateral leading edges is curved downwardly and proximally from a respective front portion of the distal edge, and to gradually expand the aperture downwardly in parallel to the median plane, when the catheter tip is pushed distally through the aperture; and wherein the lateral leading edges extend distally beyond the bottom edge portion and the top edge portion to penetrate through the aperture before either of the bottom edge portion or the top edge portion penetrate through the aperture when pushed through the aperture at an acute angle relative to an outer surface of the bodily tissue as taught by Southern for the purpose of decreasing the potential for adherence to the blood wall and block (Southern, Co. 2, lines 5-15).
Re Claim 2, Ishida discloses wherein the bodily tissue is a skin tissue (“S”, ¶0084) and the catheter tip is configured to pass through the aperture into a blood vessel (50) over an access needle after the aperture is formed by the access needle (needle 16, ¶0084).
Re Claim 3, Ishida discloses the catheter is configured for gradually stretching the skin tissue while expanding the aperture for reducing pain associated with catheter penetration through skin into a blood vessel over a needle (¶0084, Fig. 5, the catheter and the needle 16 are capable for stretching the skin tissue while expanding the aperture as the catheter/needle enter the skin with taper diameter and increases from, the tip).
Re Claim 4, the modified Ishida discloses wherein the bottom edge portion and/or the top edge portion is curved generally proximally (Annotated Fig. 5a of Southern).
Re Claim 6, the modified Ishida discloses wherein each of the lateral leading edges is curved upwardly and proximally from the respective front portion of the distal edge (Annotated Fig. 5a of Southern).
Re Claim 7, the modified Ishida discloses wherein the lumen is cylindrical along a portion of the catheter body proximally to the catheter tip (Fig.5, Ishida, above 38) and tapers along a portion of the catheter tip (38, Ishida).
Re Claim 8, the modified Ishida discloses wherein radius of curvature of each of the lateral leading edges is smallest adjacent to the respective front portion and/or greatest adjacent to the bottom edge portion (Annotated Fig. 5a of Southern).
Re Claim 9, the modified Ishida discloses wherein radius of curvature of each of the lateral leading edges gradually increases between the respective front portion and the bottom edge portion (see the Annotated Fig. 5a of Southern).
Re Claim 10, Ishida discloses wherein the bottom edge portion includes or merges with a sliding surface (lower than 38, Fig. 4-5), the sliding surface is at least partially parallel, or inclined at a shallow angle, to the bottom edge portion ( have shallow angle with lower edge) .
Re Claim 12, Ishida discloses wherein the sliding surface is at least partially curved (Fig. 4-5).
Re Claim 13, the modified Ishida discloses vascular access kit, comprising: the vascular access catheter according to claim 1( see the rejection of claim 1); and an access needle comprising a beveled tip ending with a distal sharp needle edge ( needle 16 with beveled edge 16b, 16c, Fig. 2b).
Re Claim 14, the modified Ishida discloses comprising coupling means (Ishida, 22) configured to fixedly connect the catheter body to the access needle (Ishida, ¶0081), wherein the beveled tip protrudes distally from the lumen through the opening (Ishida, Fig. 1), such that a plane of symmetry of the access needle coincides with the median plane (Ishida, a median plane of the catheter is the same the median plane to the needle that cross the catheter/needle longitudinally at longitudinal axis of 12 in Fig. 1 to give the cross half section as shown in Fig. 3) and the beveled tip (Ishida, 16b) is inclined distally and downwardly towards the distal sharp needle edge from a top needle end (left side of the needle) extending through the opening top portion to a bottom needle end (Ishida, 16c) extending through the opening bottom portion (Ishida, Fig. 3).
Re Claim 15, the modified Ishida discloses wherein the catheter is configured to accommodate the access needle through the lumen and the opening in at least two configurations comprising a tissue-penetration configuration (Ishida, Fig. 3) wherein the beveled tip fully extends from the lumen distally to the catheter distal end (Ishida, Fig. 3), and a safety configuration (Ishida, Fig. 5) wherein the beveled tip fully resides within the lumen proximally to the catheter distal end (Ishida, Fig. 5).
Re Claim 16, the modified Ishida discloses a method for inserting a catheter into a blood vessel using the kit of claim 13 (see the rejection of claim 13), the method comprising: providing the vascular access catheter connected to the access needle (Ishida, a catheter 12 and a needle 16, Fig. 1-5), wherein the beveled tip protrudes distally from the lumen through the opening (Fig. 3), such that a plane of symmetry of the access needle coincides with the median plane (Ishida, a median plane of the catheter is the same the median plane to the needle that cross the catheter/needle longitudinally at longitudinal axis of 12 in Fig. 1 to give the cross half section as shown in Fig. 3) and the beveled tip is inclined distally and downwardly towards the distal sharp needle edge (16a) from a top needle end (left end of 16b) extending through the opening top portion to a bottom needle end extending through the opening bottom portion (Ishida, 16c); forming an aperture in a skin tissue ( Ishida, Fig. 5 in opening in the skin “S”) covering the blood vessel with the beveled tip ( Ishida, just before penetrating the vessel 50); pushing the catheter body through the aperture at an acute angle relative to an outer surface of the skin tissue (Ishida, Fig. 5), thereby expanding the aperture sideways perpendicularly to the median plane with the pair of lateral leading edges (left and right edges 38b, Fig. 3, Ishida) and further disclose that the aperture will expand as the catheter/ and the needle further pushed due to increasing the diameter of the portion 38b from the tip to 34), but it fails to disclose that after the lateral leading edges followed by gradually expanding the aperture downwardly in parallel to the median plane until the bottom edge portion penetrates through the aperture.
However, Southern discloses insertion device can be used in soft tissue such as skin (abstract,, Fig. 5a ) and the catheter (14 Fig. 5a-5b) and wherein the catheter has a tip (20), the tip comprises a top edge wherein each of the lateral leading edges (Annotated Fig. 5a of Southern) is curved downwardly and proximally from a respective front portion of the distal edge (Annotated Fig. 5a of Southern), and to gradually expand the aperture downwardly in parallel to the median plane (Annotated Fig. 5a of Southern), when the catheter tip is pushed distally through the aperture (Annotated Fig. 5a of Southern, as the catheter is inserted as in Fig. 25, the front edge penetrate the tissue before the bottom edge and increases the a aperture of the tissue as the diameter increases along the distal portion starting from the tip ) and wherein the lateral leading edges extend distally beyond the bottom edge portion and the top edge portion (Annotated Fig. 5a of Southern ) to penetrate through the aperture before either of the bottom edge portion or the top edge portion penetrate through the aperture when pushed through the aperture at an acute angle relative to an outer surface of the bodily tissue ( lateral edge enter the tissue’s opening before the top and bottom edges).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ishida the lateral leading edges penetrate the aperture is followed by gradually expanding the aperture downwardly in parallel to the median plane until the bottom edge portion penetrates through the aperture as taught by Southern for the purpose of decreasing the potential for adherence to the blood wall and block (Southern, Co. 2, lines 5-15).
Re Claim 17, the modified Ishida discloses the top edge portion penetrates through the aperture following full or partial penetration of the bottom edge portion (the top edge can pentene following full or partial penetration of the bottom edge portion as the entering angle is acute angle, see Fig. of Ishida).
Re Claim 18, the modified Ishida discloses comprising inserting the beveled tip and/or the catheter tip into the blood vessel until visualizing blood drawn from the blood vessel into the access needle and/or the catheter body (Ishida, Fig. 3, ¶0124, wherein the blood will be withdrawn in the blood flashback path 32 to confirm that the needle in the vessel lumen, ¶0008, ¶0095).
Re Claim 19, the modified Ishida discloses wherein the inserting is followed by pushing the catheter body distally related to access needle and removing the access needle from the blood vessel ( Fig.5, Ishida, ¶0102).
Re Claim 20, the modified Ishida discloses wherein the inserting is followed by penetrating across a wall of the blood vessel ( top wall of vessel 50, Fig. 5 Ishida) such that the beveled tip protrudes distally from the blood vessel ( just before pulling back the needle Fig. 5, Ishida), then drawing the beveled tip back into the blood vessel until visualizing blood drawn from the blood vessel into the access needle and/or the catheter body (¶0095, Fig. 5, Ishida), and then pushing the catheter body distally relative to access needle and removing the access needle from the blood vessel (Ishida Fig. 5, ¶0099).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishida in view of Southern and further in view of Layne et al. (US. 20050090852A1) (“Layne”).
Re Claim 11, Ishida fails to disclose wherein the sliding surface forms a shaped area bounded by and between a distal parabola and a proximal parabola, the distal parabola has a smaller focal length than the proximal parabola.
However, Layne discloses insertion device can be used in soft tissue such as skin (abstract, Figs. 42, ¶0089) and wherein the sliding surface forms a shaped area bounded by and between a distal parabola and a proximal parabola, the distal parabola has a smaller focal length than the proximal parabola ( Annotated Fig. 5a of Southern).
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Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the tip of the catheter of Ishida to include a distal parabola and a proximal parabola so that the sliding surface forms a shaped area bounded by and between a distal parabola and a proximal parabola, the distal parabola has a smaller focal length than the proximal parabola as taught by Layne for the purpose of a desired catheter tip shape to inserted in soft tissue and accommodating insertion of the medical device within the catheter during the procedure (Layne, ¶0017, ¶0098).
Response to Arguments
Applicant’s arguments, see remark, filed 11/6/2025, with respect to the rejection(s) of claim(s) 10 under 103 using Layne 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 Ishida in view of Southern.
The applicant argue with regards to the double patenting and newly added limitation is persuasive. The double patient rejection is withdrawn.
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783