DETAILED ACTION
Claims 7 and 22 are amended. Claims 15-18 and 20 are canceled. A complete action on the merits of pending claims 7-8, 10-14, and 22-24 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to Applicant’s amendments made on 02/06/2026 which are entered. With regards to the claim objection and 35 USC 112(a) rejections documented in the Non-Final Office Action sent on 11/28/2025 they’re withdrawn given the cancellation of the relevant claims.
Claim Objections
Claims 11 and 22 are objected to because of the following informalities:
The claim 11 number is provided at the end of claim 10. It should match or be listed alongside the claim 11 recitation.
Claim 22, the “wherein” clause on line 6 of the claim should include a colon such that it reads “wherein:”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claim(s) 7-8, 10-14, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 6,120,480 A), in view of Neoh (US 2014/0046357 A1).
Regarding claim 7, Zhang discloses, catheter introducers. Zhang teaches, a catheter (Figure 2, dilator (12); Col. 5, line 32-35) comprising:
a hollow shaft (Figure 2, elongate tubular shaft (32); Col. 5, line 56-59), and
a distal tip (Figures 2 and 8-10, distal end/arrowhead (20); Col. 5, line 37-39) connected to a distal end of the hollow shaft (As seen in Figures 2 and 8-10, distal end/arrowhead (20) is indeed connected to a distal end of shaft (32), given that it is the distal end of shaft (32)), wherein:
an outer diameter (Figure 10, outer radius (54); Col. 6, line 47-51; Where diameter (d) = 2 * radius (r)) of the distal tip (arrowhead (20)) in a direction perpendicular to an axial direction of the hollow shaft (As seen in Figure 10 and described in Col. 6, line 44-55, the diameter is indeed taken in a direction perpendicular to an axial direction of shaft (32)) is largest at an enlarged diameter portion (Figures 8-10, proximal taper (50); Col. 6, line 5-12 and Col. 6, line 47-55) of the distal tip positioned between a distal end of the distal tip and the distal end of the hollow shaft (As seen in Figures 8-10, proximal taper (50) is indeed situated between the distal end of arrowhead (20) and the distal end of shaft (32)),
the outer diameter of the distal tip (2 * outer radius (54)) at the enlarged diameter portion (proximal taper (50)) is larger than an outer diameter of the distal end of the hollow shaft (Figure 10, inner radius (52); Col. 6, line 47-55; Where diameter (d) = 2 * radius (r)),
an outer peripheral edge of the distal tip is connected to an outer peripheral edge of the distal end of the hollow shaft to form a continuously flush outer peripheral surface (Col. 8, line 22-Col. 9, line 2, discloses the manufacturing method of the dilator, the arrowhead is formed of the same tube as the overall dilator, as such they are one structure and indeed their peripheral edges would be connected to form a continuously flush outer peripheral surface as seen in Figures 8-10),
the hollow shaft (shaft (32)) is configured to receive a guide wire (Col. 5, line 56-59), and
the outer diameter of the distal tip and the outer diameter of the distal end of the hollow shaft are configured to reduce contact resistance when advancing the catheter through a lesion (Col. 6, line 23-26, “…the tissue is not exposed to an abrupt, larger diameter shoulder that might increase the resistance to insertion as well as patient discomfort and tissue trauma.” Col. 8, line 18-21, “By maintaining the outer diameter of the end face 62 of the sheath very close to, if not identical, to that of the arrowhead, the risk of the distal end of the sheath becoming caught on tissue is significantly reduced.” Col. 12, line 3-4, “…improve the ease with which the introducer sheath can be advanced through tissue…” and Col. 4, line 7-31. The enlarged-diameter proximal taper (50) on the distal tip combined with the smaller outer diameter of the hollow shaft (32) and the continuously flush surface eliminates abrupt radial steps/shoulders that would otherwise increase frictional contact resistance or cause catching when advancing percutaneously through tissue).
Zhang fails to teach, the distal tip formed of metal and an outer periphery of the distal tip is metal.
Neoh discloses, a dilator for enlarging an opening through a body tissue. Neoh teaches, a dilator/catheter (Figures 1-8, dilator (100)) may be made from any suitable material known in the art such as metal, where the shaft (Figures 1-8, shaft portion (110)) and the dilator tip (Figures 1-8, dilator tip (130)) may be made from the same material (Paragraph [0038]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the material that forms the dilator of Zhang such that it is formed of metal as taught by Neoh, such that the outer periphery of the distal tip is also metal, as both references and the claimed invention are directed to flexible, tube-like devices, designed for navigating tubular structures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material that forms the dilator of Zhang such that it is formed of metal as taught by Neoh, such that the outer periphery of the distal tip is also metal, as such a modification would have been predictable, namely, metal is a suitable material known in the art (Paragraph [0038] of Neoh).
Regarding claim 8, Zhang teaches, an outer peripheral surface of the distal tip (surface of distal end/arrowhead (20) seen in Figures 8-10).
Zhang fails to teach, a protruding portion formed on the outer peripheral surface of the distal tip, wherein the protruding portion extends spirally in a longitudinal direction and protrudes radially outward from the outer peripheral surface.
Neoh teaches, a protruding portion (Figure 3, projections (140)) formed on the outer peripheral surface (Figure 3, outer surface (138)) of the distal tip (dilator tip (130)), wherein the protruding portion extends spirally in a longitudinal direction and protrudes radially outward from the outer peripheral surface (Figure 3; Paragraph [0032]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer peripheral surface of the distal tip of Zhang such that it comprises a protruding portion formed on the outer peripheral surface of the distal tip, wherein the protruding portion extends spirally in a longitudinal direction and protrudes radially outward from the outer peripheral surface as taught by Neoh, as both references and the claimed invention are directed to flexible, tube-like devices, designed for navigating tubular structures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer peripheral surface of the distal tip of Zhang such that it comprises a protruding portion formed on the outer peripheral surface of the distal tip, wherein the protruding portion extends spirally in a longitudinal direction and protrudes radially outward from the outer peripheral surface as taught by Neoh, as such a modification would have been predictable, namely, such a pattern may aid in passing the dilator tip through an opening in a body tissue by twisting the dilator tip (Paragraph [0033] of Neoh).
Regarding claim 10, modified Zhang teaches, wherein a pitch of the protruding portion increases toward the distal end of the distal tip (Paragraph [0032] of Neoh discloses, “The longitudinal distance between adjacent turns of the spiral pattern may be referred to as the pitch of the spiral pattern. The spiral pattern may have any suitable pitch… the pitch may increase… in a proximal to distal longitudinal direction between the proximal end 132 and the distal end 134.”).
Regarding claim 11, Zhang further teaches, wherein an outer peripheral surface of the distal tip (surface of distal end/arrowhead (20) seen in Figures 8-10) in a region sandwiching the enlarged diameter portion is a curved surface having an inclination gradually changing in a longitudinal sectional view of the catheter (The enlarged diameter portion of distal end/arrowhead (20) is specifically at outer radius (54) (see Figure 10) of proximal taper (50) and as disclosed/described/shown in Figures 8-10 and Col. 6, line 5-12 and Col. 6, line 44-55, the region sandwiching the enlarged diameter portion, distal taper (48) and proximal taper (50) are indeed a curved surface having an inclination gradually changing in a longitudinal sectional view of the dilator (12)).
Regarding claim 12, Zhang teaches, an outer peripheral surface of the distal tip (surface of distal end/arrowhead (20) seen in Figures 8-10), the enlarged diameter portion (proximal taper (50)), and the distal end of the hollow shaft (shaft (32)).
Zhang fails to explicitly teach, wherein the outer peripheral surface of the distal tip is outwardly convex between the enlarged diameter portion and the distal end of the hollow shaft in a longitudinal sectional view of the catheter.
Neoh teaches, an outer peripheral surface of the distal tip (outer surface (138)) is outwardly convex between the proximal end of the dilator tip (Figure 1, proximal end (132) which is situated at the distal end of shaft (110)) and the distal end of the dilator tip (Figure 1, distal end (134)) in a longitudinal sectional view of the catheter (dilator (12)) (Paragraph [0026] states, “In another example, the nonlinear taper may be a convex taper in which the outer surface 138 may be curved outward away from the longitudinal axis of the dilator tip 130.”).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer peripheral surface of the distal tip of Zhang such that it is outwardly convex between the enlarged diameter portion and the distal end of the hollow shaft in a longitudinal sectional view of the catheter as taught by Neoh, as both references and the claimed invention are directed to flexible, tube-like devices, designed for navigating tubular structures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer peripheral surface of the distal tip of Zhang such that it is outwardly convex between the enlarged diameter portion and the distal end of the hollow shaft in a longitudinal sectional view of the catheter as taught by Neoh, as such a modification would have been predictable, namely, aid in passing the dilator/distal tip through an opening in a body tissue to enlarge the opening (Paragraph [0026] of Neoh).
Regarding claim 13, Zhang teaches, an outer peripheral surface of the distal tip (surface of distal end/arrowhead (20) seen in Figures 8-10) and the enlarged diameter portion (proximal taper (50)).
Zhang fails to teach, wherein a slit is formed in the outer peripheral surface of the distal tip at a position distal to the enlarged diameter portion.
Neoh teaches, a slit (Figure 7, groove (160)) is formed in the outer peripheral surface (outer surface (138)) of the distal tip (dilator tip (130)) at a position distal to an enlarged diameter portion (Figure 7, proximal end (132) of dilator tip (130)) (Figure 7; Paragraph [0037]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer peripheral surface of the distal tip of Zhang such that a slit is formed in the outer peripheral surface of the distal tip at a position distal to the enlarged diameter portion as taught by Neoh, as both references and the claimed invention are directed to flexible, tube-like devices, designed for navigating tubular structures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer peripheral surface of the distal tip of Zhang such that a slit is formed in the outer peripheral surface of the distal tip at a position distal to the enlarged diameter portion as taught by Neoh, as such a modification would have been predictable, namely, the groove/slit reduces the surface area of the distal tip which may engage a body tissue, where the reduced contact area between the tip and the tissue may reduce the force required to pass the tip through the opening in the body tissue and/or reduce the pain and/or discomfort which may be experienced by the patient (Paragraph [0037] of Neoh).
Regarding claim 14, Zhang teaches, an outer peripheral surface of the distal tip (surface of distal end/arrowhead (20) seen in Figures 8-10), the enlarged diameter portion (proximal taper (50)), and the distal end of the hollow shaft (shaft (32)).
Zhang fails to explicitly teach, wherein the outer peripheral surface of the distal tip is radially concave from the enlarged diameter portion to the distal end of the hollow shaft in a longitudinal sectional view of the catheter.
Neoh teaches, an outer peripheral surface of the distal tip (outer surface (138)) is radially concave between the proximal end of the dilator tip (proximal end (132) which is situated at the distal end of shaft (110)) and the distal end of the dilator tip (distal end (134)) in a longitudinal sectional view of the catheter (dilator (12)) (Paragraphs [0025]-[0026] describe a concave taper of the outer surface (138) of dilator tip (130)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer peripheral surface of the distal tip of Zhang such that it is radially concave from the enlarged diameter portion to the distal end of the hollow shaft in a longitudinal sectional view of the catheter as taught by Neoh, as both references and the claimed invention are directed to flexible, tube-like devices, designed for navigating tubular structures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer peripheral surface of the distal tip of Zhang such that it is radially concave from the enlarged diameter portion to the distal end of the hollow shaft in a longitudinal sectional view of the catheter as taught by Neoh, as such a modification would have been predictable, namely, aid in passing the dilator/distal tip through an opening in a body tissue to enlarge the opening (Paragraph [0026] of Neoh).
Regarding claim 22, Zhang teaches, a catheter (Figure 2, dilator (12); Col. 5, line 32-35) comprising:
a hollow shaft (Figure 2, elongate tubular shaft (32); Col. 5, line 56-59), and
a distal tip (Figures 2 and 8-10, distal end/arrowhead (20); Col. 5, line 37-39) connected to a distal end of the hollow shaft (As seen in Figures 2 and 8-10, distal end/arrowhead (20) is indeed connected to a distal end of shaft (32), given that it is the distal end of shaft (32)); and
an outer peripheral surface of the distal tip (surface of distal end/arrowhead (20) seen in Figures 8-10);
wherein:
an outer diameter (Figure 10, outer radius (54); Col. 6, line 47-51; Where diameter (d) = 2 * radius (r)) of the distal tip (arrowhead (20)) in a direction perpendicular to an axial direction of the hollow shaft (As seen in Figure 10 and described in Col. 6, line 44-55, the diameter is indeed taken in a direction perpendicular to an axial direction of shaft (32)) is largest at an enlarged diameter portion (Figures 8-10, proximal taper (50); Col. 6, line 5-12 and Col. 6, line 47-55) of the distal tip positioned between a distal end of the distal tip and the distal end of the hollow shaft (As seen in Figures 8-10, proximal taper (50) is indeed situated between the distal end of arrowhead (20) and the distal end of shaft (32)),
the outer diameter of the distal tip (2 * outer radius (54)) at the enlarged diameter portion (proximal taper (50)) is larger than an outer diameter of the distal end of the hollow shaft (Figure 10, inner radius (52); Col. 6, line 47-55; Where diameter (d) = 2 * radius (r)),
an outer peripheral edge of the distal tip is connected to an outer peripheral edge of the distal end of the hollow shaft to form a continuously flush outer peripheral surface (Col. 8, line 22-Col. 9, line 2, discloses the manufacturing method of the dilator, the arrowhead is formed of the same tube as the overall dilator, as such they are one structure and indeed their peripheral edges would be connected to form a continuously flush outer peripheral surface as seen in Figures 8-10), and
the outer diameter of the distal tip and the outer diameter of the distal end of the hollow shaft are configured to reduce contact resistance when advancing the catheter through a lesion (Col. 6, line 23-26, “…the tissue is not exposed to an abrupt, larger diameter shoulder that might increase the resistance to insertion as well as patient discomfort and tissue trauma.” Col. 8, line 18-21, “By maintaining the outer diameter of the end face 62 of the sheath very close to, if not identical, to that of the arrowhead, the risk of the distal end of the sheath becoming caught on tissue is significantly reduced.” Col. 12, line 3-4, “…improve the ease with which the introducer sheath can be advanced through tissue…” and Col. 4, line 7-31. The enlarged-diameter proximal taper (50) on the distal tip combined with the smaller outer diameter of the hollow shaft (32) and the continuously flush surface eliminates abrupt radial steps/shoulders that would otherwise increase frictional contact resistance or cause catching when advancing percutaneously through tissue).
Zhang fails to teach, the distal tip formed of metal and an outer periphery of the distal metal tip is metal; a protruding portion formed on an outer peripheral surface of the distal tip, wherein the protruding portion extends spirally in a longitudinal direction and protrudes radially outward from the outer peripheral surface; wherein the outer peripheral surface of the distal tip is radially concave from the enlarged diameter portion to the distal end of the hollow shaft in a longitudinal sectional view of the catheter; and a slit is formed in the outer peripheral surface of the distal tip at a position distal to the enlarged diameter portion.
Neoh teaches, a dilator/catheter (Figures 1-8, dilator (100)) may be made from any suitable material known in the art such as metal, where the shaft (Figures 1-8, shaft portion (110)) and the dilator tip (Figures 1-8, dilator tip (130)) may be made from the same material (Paragraph [0038]). Neoh further teaches, a protruding portion (Figure 3, projections (140)) formed on an outer peripheral surface (Figure 3, outer surface (138)) of the distal tip (dilator tip (130)), wherein the protruding portion extends spirally in a longitudinal direction and protrudes radially outward from the outer peripheral surface (Figure 3; Paragraph [0032]); wherein the outer peripheral surface of the distal tip (outer surface (138)) is radially concave between the proximal end of the dilator tip (proximal end (132) which is situated at the distal end of shaft (110)) and the distal end of the dilator tip (distal end (134)) in a longitudinal sectional view of the catheter (dilator (12)) (Paragraphs [0025]-[0026] describe a concave taper of the outer surface (138) of dilator tip (130)); and a slit (Figure 7, groove (160)) is formed in the outer peripheral surface (outer surface (138)) of the distal tip (dilator tip (130)) at a position distal to an enlarged diameter portion (Figure 7, proximal end (132) of dilator tip (130)) (Figure 7; Paragraph [0037]) (Paragraph [0048], discloses in part, “In one example, the dilator tip 130 may include surface features (e.g., projections 140, indentations 150, and/or grooves 160), which may be arranged in a spiral pattern as described above.”).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the material that forms the dilator of Zhang such that it is formed of metal as taught by Neoh, such that the outer periphery of the distal tip is also metal, and to further modify the outer peripheral surface of the distal tip of Zhang such that it comprises both a protruding portion formed on the outer peripheral surface of the distal tip, wherein the protruding portion extends spirally in the longitudinal direction and protrudes radially outward from the outer peripheral surface and a slit formed in the outer peripheral surface of the distal tip at a position distal to the enlarged diameter portion as taught by Neoh, and to also have the outer peripheral surface of the distal tip be radially concave from the enlarged diameter portion to the distal end of the hollow shaft in the longitudinal sectional view of the catheter as also taught by Neoh, as both references and the claimed invention are directed to flexible, tube-like devices, designed for navigating tubular structures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material that forms the dilator of Zhang such that it is formed of metal as taught by Neoh, such that the outer periphery of the distal tip is also metal, and to further modify the outer peripheral surface of the distal tip of Zhang such that it comprises both a protruding portion formed on the outer peripheral surface of the distal tip, wherein the protruding portion extends spirally in the longitudinal direction and protrudes radially outward from the outer peripheral surface and a slit formed in the outer peripheral surface of the distal tip at a position distal to the enlarged diameter portion as taught by Neoh, and to also have the outer peripheral surface of the distal tip be radially concave from the enlarged diameter portion to the distal end of the hollow shaft in the longitudinal sectional view of the catheter as also taught by Neoh, as such a modification would have been predictable, namely, metal is a suitable material known in the art (Paragraph [0038] of Neoh). Furthermore, such a protruding portion pattern may aid in passing the dilator tip through an opening in a body tissue by twisting the dilator tip, while the groove/slit reduces the surface area of the distal tip which may engage a body tissue, where the reduced contact area between the tip and the tissue may reduce the force required to pass the tip through the opening in the body tissue and/or reduce the pain and/or discomfort which may be experienced by the patient (Paragraphs [0033] & [0037] of Neoh), and lastly a radially concave outer peripheral surface of the distal tip aids in passing the dilator/distal tip through an opening in a body tissue to enlarge the opening (Paragraph [0026] of Neoh).
Regarding claim 23, Zhang further teaches, wherein the outer peripheral surface of the distal tip (surface of distal end/arrowhead (20) seen in Figures 8-10) in a region sandwiching the enlarged diameter portion is a curved surface having an inclination gradually changing in the longitudinal sectional view of the catheter (The enlarged diameter portion of distal end/arrowhead (20) is specifically at outer radius (54) (see Figure 10) of proximal taper (50) and as disclosed/described/shown in Figures 8-10 and Col. 6, line 5-12 and Col. 6, line 44-55, the region sandwiching the enlarged diameter portion, distal taper (48) and proximal taper (50) are indeed a curved surface having an inclination gradually changing in a longitudinal sectional view of the dilator (12)).
Regarding claim 24, Zhang teaches, the outer peripheral surface of the distal tip (surface of distal end/arrowhead (20) seen in Figures 8-10), the enlarged diameter portion (proximal taper (50)), and the distal end of the hollow shaft (shaft (32)).
Zhang fails to explicitly teach, wherein the outer peripheral surface of the distal tip is outwardly convex between the enlarged diameter portion and the distal end of the hollow shaft in the longitudinal sectional view of the catheter.
Neoh teaches, the outer peripheral surface of the distal tip (outer surface (138)) is outwardly convex between the proximal end of the dilator tip (Figure 1, proximal end (132) which is situated at the distal end of shaft (110)) and the distal end of the dilator tip (Figure 1, distal end (134)) in the longitudinal sectional view of the catheter (dilator (12)) (Paragraph [0026] states, “In another example, the nonlinear taper may be a convex taper in which the outer surface 138 may be curved outward away from the longitudinal axis of the dilator tip 130.”).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer peripheral surface of the distal tip of Zhang such that it is outwardly convex between the enlarged diameter portion and the distal end of the hollow shaft in the longitudinal sectional view of the catheter as taught by Neoh, as both references and the claimed invention are directed to flexible, tube-like devices, designed for navigating tubular structures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer peripheral surface of the distal tip of Zhang such that it is outwardly convex between the enlarged diameter portion and the distal end of the hollow shaft in the longitudinal sectional view of the catheter as taught by Neoh, as such a modification would have been predictable, namely, aid in passing the dilator/distal tip through an opening in a body tissue to enlarge the opening (Paragraph [0026] of Neoh).
Response to Arguments
Applicant’s arguments with respect to claim(s) 7 and 22 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.
See updated rejections above.
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.
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/O.N./Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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