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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/15/2025 has been entered.
Acknowledgment
Claims 41, 55-56, 58, 64-65, 67, 70 are amended and filed on 7/15/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 58-73 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 58 recites the limitation "a central longitudinal axis" in line 13. It is unclear if it is referring to the limitation in line 3 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the line 3 of claim 58.
Claim 59 recites the limitation "a traverse plane" in line 2. It is unclear if it is referring to the limitation in line 13 of claim 58 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the line 13 of claim 58.
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) 58-63, 71-72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishida et al. (WO 2018169032A1 using US. 20190381282A1) (“Ishida”) in view of Fecht et al. (US 4617019) (“Fecht ”).
Re claim 58, Ishida discloses a vascular access kit (Figs. 1-18, ¶0032) comprising:(a) a vascular access catheter (12) comprising: an elongated tubular catheter body (34) enclosing a lumen (13, lumen of 12 for the needle 16, Fig. 3) defining a central longitudinal axis (axis of 13), wherein the catheter body includes a catheter tip 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 38, Fig. 3); and (b) an access needle (16) comprising a hollow needle body (44, ¶0071) and a beveled tip ending with a distal sharp needle edge (¶0078, 16a, Annotated Fig. 2a of Ishida); wherein the vascular access catheter is configured to accommodate the access needle (16, Fig. 3) through the lumen and the opening (Fig. 3); and it is further discloses a front edge portion (top half of 38), inclined edge portion (lower 38b at PC, 40B, Fig. 2a), but it fails to specifically discloses that the distal edge includes a front edge portion comprising a flat front surface in longitudinal cross section forming the distal tip of the catheter, the flat front surface extending in a traverse plane that is substationally perpendicular to a central longitudinal axis of the catheter body, the flat front surface spanning a top portion of the opening and an inclined edge portion spanning a bottom portion of the opening and inclining proximally away from the front edge portion, relative to the central longitudinal axis of the catheter body; wherein the inclined edge portion of the opening merges with the flat edge portion and is at least partially convexly curved in longitudinal cross section relative to the central longitudinal axis of the catheter body, and wherein the inclined edge portion includes or merges with a sliding surface extending proximally along a bottom portion of the tubular catheter body, and wherein the sliding surface comprises one or more of a groove, a slit, a weakened portion, or a flattened portion configured to deform radially inward to facilitate the vascular access catheter sliding along an inner wall of a blood vessel without damaging the inner wall of the blood vessel when the vascular access catheter is introduced into the blood vessel over the access needle.
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Annotated Fig. 2a of Ishida
However, Fecht discloses a catheter (12, Fig. 1-6, abstract) that can be used in vessel with a flexible tip (60, Col. 4, lines 1-36) and the tip has the distal edge includes a front edge portion comprising a flat front surface (49) in longitudinal cross section forming the distal tip of the catheter (perpendicular to axes 64 , Fig. 6), the flat front surface extending in a traverse plane that is substationally perpendicular to a central longitudinal axis of the catheter body (64), the flat front surface spanning a top portion of the opening (end of the lumen 31 close to 42, Fig. 6) and an inclined edge portion (56, 58, 48, 46, 50, 54) spanning a bottom portion of the opening and inclining proximally away from the front edge portion (Figs, 5-6), relative to the central longitudinal axis of the catheter body (Fig. 5-6, Col. 4, lines 1-36); wherein the inclined edge portion of the opening merges with the flat edge portion and is at least partially convexly curved in longitudinal cross section relative to the central longitudinal axis of the catheter body (Fig. 6), and wherein the inclined edge portion includes or merges with a sliding surface extending ( surface from 54 to 42 includes 50, 46, 48, 72, 52, 44) proximally along a bottom portion of the tubular catheter body (Fig, 5-6), and wherein the sliding surface comprises one or more of a groove, a slit, a weakened portion, or a flattened portion (weekend portion, 70, 44) configured to deform radially inward (capable to deform inwardly) to facilitate the vascular access catheter sliding along an inner wall of a blood vessel without damaging the inner wall of the blood vessel when the vascular access catheter is introduced into the blood vessel over the access needle (Col. 2, lines 8-35).
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 catheter of Ishida so that the distal edge includes a front edge portion comprising a flat front surface in longitudinal cross section forming the distal tip of the catheter, the flat front surface extending in a traverse plane that is substationally perpendicular to a central longitudinal axis of the catheter body, the flat front surface spanning a top portion of the opening and an inclined edge portion spanning a bottom portion of the opening and inclining proximally away from the front edge portion, relative to the central longitudinal axis of the catheter body; wherein the inclined edge portion of the opening merges with the flat edge portion and is at least partially convexly curved in longitudinal cross section relative to the central longitudinal axis of the catheter body, and wherein the inclined edge portion includes or merges with a sliding surface extending proximally along a bottom portion of the tubular catheter body, and wherein the sliding surface comprises one or more of a groove, a slit, a weakened portion, or a flattened portion configured to deform radially inward to facilitate the vascular access catheter sliding along an inner wall of a blood vessel without damaging the inner wall of the blood vessel when the vascular access catheter is introduced into the blood vessel over the access needle as taught by Fecht for the purpose of providing a catheter with an end that can be laterally compressed and inserted into an incision of a patient from the exterior of the patient with minimal traumatic effect (Fecht , Col. 2, lines 1-20).
Re claim 59, the modified Ishida discloses wherein the front edge portion substantially coincides with a transverse plane of the catheter body crossing perpendicularly to the longitudinal axis (Fig. 5-6 of Fecht).
Re claim 60, the modified Ishida discloses wherein the front edge portion spans at least half of a cross section of the catheter body at the distal end parallel to the transverse plane (Fig. 5-6 of Fecht).
Re claim 61, the modified Ishida discloses wherein a radius of curvature of the inclined edge portion is smallest adjacent to the front edge portion and greatest adjacent to a vertex of the inclined edge portion (54 of Fig. 5-6 of Fecht).
Re claim 62, the modified Ishida discloses wherein at least a portion of the sliding surface is inclined to the longitudinal axis (Fig. 5-6 of Fecht).
Re claim 63, Ishida fails to discloses 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, Fecht discloses a catheter (12, Fig. 1-6, abstract) that can be used in vessel with a flexible tip (60, Col. 4, lines 1-36) and wherein the sliding surface forms a shaped area bounded by and between a distal parabola (50) and a proximal parabola (44), the distal parabola has a smaller focal length than the proximal parabola (it is narrower).
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 catheter of Ishida 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 Fecht for the purpose of providing a catheter with an end that can be laterally compressed and inserted into an incision of a patient from the exterior of the patient with minimal traumatic effect (Fecht , Col. 2, lines 1-20).
Re claim 71, the modified Ishida discloses wherein the sliding surface comprises a weakened or flattened portion (weekend area around 46, 48, Fecht).
Re claim 72, the modified Ishida discloses wherein the radius of curvature of the inclined edge portion increases as it inclines proximally away from the front edge portion (at least from 46 to 56 and 58, Fig, 5-6 of Fecht).
Claim(s) 64-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishida in view of Fecht and further in view of Layne et al. (US 20050090852aA) (“Layne”).
Re claim 64, Ishida fails to discloses wherein the sliding surface comprises the groove extending along a bottom end of the catheter tip, proximally from, and opened to, the inclined edge portion.
However, Layne discloses a catheter (Fig. 28, ¶0089) and wherein the sliding surface comprises a groove extending along a bottom end of the catheter tip (groove between the inclined edges), proximally from, and opened to, the inclined edge portion (annotated Fig. 28 of Layne).
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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 catheter of Ishida so that the sliding surface comprises a groove extending along a bottom end of the catheter tip, proximally from, and opened to, the inclined edge portion as taught by Layne for the purpose of accommodated insertion of medical devices such as balloon/ stent through the catheter in a controlled directional manner (Layne, ¶003, ¶004, ¶006, Note, the catheter of Layne can be use in soft tissue see ¶0090, ¶0003).
Re claim 65, Ishida fails to discloses wherein the sliding surface comprises the slit extending along a bottom end of the catheter tip, proximally from, and opened to, the inclined edge portion.
However, Layne discloses a catheter (Fig. 28, ¶0089) and wherein the sliding surface comprises a cut or a slit extending along a bottom end of the catheter tip, proximally from, and opened to, the inclined edge portion tip (groove between the inclined edges, annotated Fig. 28 of Layne).
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 catheter of Ishida so that the sliding surface comprises a cut or a slit extending along a bottom end of the catheter tip, proximally from, and opened to, the inclined edge portion.as taught by Layne for the purpose of accommodated insertion of medical devices such as balloon/ stent through the catheter in a controlled directional manner (Layne, ¶003, ¶004, ¶006, Note, the catheter of Layne can be use in soft tissue see ¶0090, ¶0003).
Allowable Subject Matter
Claims 66-70, 73 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 41-57 are allowed.
The following is an examiner’s statement of reasons for allowance:
Re Claims 41 and 56, a vascular access kit comprising: (a) a vascular access catheter comprising: a catheter tip ending with a catheter distal end and comprising a distal edge ; and (b) an access needle wherein the distal edge includes a front edge portion comprising a flat front surface; and wherein the inclined edge portion of the opening is at least partially convexly curved in longitudinal cross section relative to the central longitudinal axis of the catheter body to form or merge with a sliding surface extending proximally along and from the bottom portion of the opening; and wherein the sliding surface has elastic resistance to inward radial deformation smaller than an opposing top portion of the catheter tip in combination with other claimed structure was not found or rendered obvious by the prior art of record.
In particular, Ishida in view of Fecht and of Layne is the closest prior art of record. Even though Ishida in view of Fecht and of Layne discloses a vascular access kit comprising: (a) a vascular access catheter comprising: a catheter tip ending with a catheter distal end and comprising a distal edge; and (b) an access needle wherein the distal edge includes a front edge portion comprising a flat front surface;, but Ishida in view of Fecht and of Layne fails to disclose wherein the inclined edge portion of the opening is at least partially convexly curved in longitudinal cross section relative to the central longitudinal axis of the catheter body to form or merge with a sliding surface extending proximally along and from the bottom portion of the opening; and wherein the sliding surface has elastic resistance to inward radial deformation smaller than an opposing top portion of the catheter tip.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments, see remark, filed 7/15/2025, with respect to claims 41 and 56 have been fully considered and are persuasive. The 103 rejection of claims 41 and 56 has been withdrawn.
Applicant’s arguments, see remark, filed 7/15/2025 with respect to the rejection(s) of claim(s) 58 under 103 using Ishida and 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 over Ishida in view of Fecht.
Conclusion
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