DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed August 05, 2025 has been entered. Claims 66-80 and 86-87 remain pending in the application. Claims 81-85 have been cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Final Office Action mailed May 05, 2025.
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.
Claims 66-69, 71, 75, 77-80, and 86-87 are rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. (US 2011/0291407) in view of Balzum et al. (US 2003/0028127) in further view of Chambers (USPN 7867219) in further view of Ebata et al. (WO 2014/199519 – with reference to the provided English Translation NPL Document U provided 05/05/25) in view of Abt et al. (US 2014/0025045).
Regarding claim 66, McDermott discloses a catheter (Figure 1; “tubular members are used in the medical field in medical devices. One application of tubular members is as a component of a system for delivery of medical devices to locations within the human body such as within any lumen of the body. For example, the tubes may be used to deliver medical devices within the vasculature, the biliary system, the esophagus or the gastro-intestinal tract.” [0005]) comprising:
a first tubular module (first tube 10 and locking pieces 16 connected via interface 20: “The first locking piece 16 is welded at an interface 20 to the first tube 10 where the tube 10 and locking piece 16 contact one another.” [0026]) and a second tubular module (second tube 12 and second locking pieces 18 connected via interface 22: “The second locking piece 18 is welded at an interface 22 to the second tube 12 where the tube 12 and locking piece 18 contact one another.” [0026]) directly coupled to the first tubular module by a joint (tube joint 14; “The tubes 10 and 12 are connected at a tube joint 14 that includes a first locking piece 16 of the same material as the first tube 10 or of a material readily welded to the first tube 10 and a second locking piece 18 of the same material as the second tube 12 or of a material readily welded to the second tube 12.” [0025]; Figure 1), the joint comprising:
(a) at least one connector (side extensions 36 of locking pieces 16) on the first tubular module (first tube 10 and locking pieces 16; “the locking pieces each have a base portion 34 and two side extensions 36 and an end recess 38.” [0029]) and at least one acceptor (end faces 42 of second tube 12) positioned on the second tubular module (second tube 12 and locking pieces 18; Figure 1),
wherein the at least one connector and at least one acceptor are level with inner and outer surfaces of the first tubular module and the second tubular module when coupled together to define a continuous lumen with a uniform diameter therethrough (Figures 3A-3C; “join two tubes of the same diameter and same wall thickness end to end without deforming the tubes, without changing the wall thickness, without increasing the outside diameter or decreasing the inside diameter” [0039]), and
wherein the at least one connector prevents the first and second tubular modules from rotating circumferentially at the joint (see all of [0027]); and
(b) at least one stabilizing element (projection 44 of first tube 10) positioned on the first tubular module (first tube 10 and locking pieces 16), wherein the stabilizing element is a part of the first tubular module (Figure 2A; “The tubes 10 and 12 each include a base recess 40, an end face 42 and a projection 44” [0030]),
wherein the at least one stabilizing element is level with inner and outer surfaces of the first tubular module and the second tubular module when coupled together (Figures 3A-3C; “join two tubes of the same diameter and same wall thickness end to end without deforming the tubes, without changing the wall thickness, without increasing the outside diameter or decreasing the inside diameter” [0039]),
wherein the at least one stabilizing element (projection 44) prevents the first and second tubular modules from pivoting with respect to each other (“The locking piece 18 is not welded to the tube 10 but is constrained from moving in the x and y directions by the angles of the radial mating surfaces between it and the parts 44 and 16. The locking piece 18 cannot move radially outwards or inwards due to the angles of the radial mating surfaces between it and parts 16 and the part 44.” [0037]; and see all of [0027]),
wherein the stabilizing element (connector 44) has a different shape than the at least one connector (side extensions 36; Figures 1-3C wherein side extensions 36 and projections 44 each have different dimensions and therefore have different shapes) and the stabilizing element (connector 44) has a rectangular shape (Figure 2A),
wherein a distal end of the first tubular module (first tube 10) has a circumference (Figure 1).
McDermott fails to explicitly teach wherein the at least one connector includes a circular locking section connected to the first tubular module by a stem section and the at least one acceptor comprises a circular portion to receive the circular locking section, wherein a distal end of the first tubular module has a crown comprising a plurality of curvilinear elements, wherein the curvilinear elements form a sinusoidal-shaped wave around a full circumference of the distal end of the first tubular module, and further comprising tip that is attached to the curvilinear elements, wherein the tip is made from one or more alloys.
Balzum teaches a guidewire (Figures 7-9) comprising a first tubular module (second wire 304) and a second tubular module (first wire 302) coupled to the first tubular module by a joint (first end portion 322 and second end portion 321), the joint comprising at least one connector (struts 334) on the first tubular module (Figure 7) and at least one acceptor (apertures 350) on the second tubular module (first wire 302; Figure 7), wherein the at least one connector includes a circular locking section (enlarged portion 340; Figure 7) connected to the first tubular module (second wire 304) by a stem section (proximal portion 336; Figure 7) and the at least one acceptor comprises a circular portion (apertures 350; Figure 7) to receive the circular locking section (Figure 9), further comprising a tip (distal tip 128) attached to a distal end of the first tubular module (“First wire 102 also includes a distal tip 128 fixed to body member 106 proximate second end 119.” [0043]; Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter of McDermott to the at least one connector includes a circular locking section connected to the first tubular module by a stem section and the at least one acceptor comprises a circular portion to receive the circular locking section based on the teachings of Balzum to provide a secure, selective attachment between tubular modules and joint in a manner that provides a level and smooth outer surface (Balzum [0004], [0091]; Figure 9) and to further modify the catheter of McDermott to include a tip attached to a distal end of the first tubular module based on the teachings of Balzum to assist in guiding the catheter (Balzum [0043-0044]; Figure 1).
Modified McDermott fails to explicitly teach a distal end of the first tubular module has a crown comprising a plurality of curvilinear elements, wherein the curvilinear elements form a sinusoidal-shaped wave around a full circumference of the distal end of the first tubular module, and the tip is attached to the curvilinear elements, wherein the tip is made from one or more alloys.
Chambers teaches a catheter (catheter 20) comprising a first tubular module (distal section 22) and a second tubular module (intermediate section 23), wherein a tip (distal tip section 63; “The distal section has a soft flexible pre-formed tip having a curvature of ninety degrees or greater and shape retention properties (ability to retain curved shape).” [Col 2, lines 58-61]) is attached to a distal end of the first tubular module (Figure 1A), wherein the tip is made from one or more alloys (“The distal section 22 is shown in close up in FIG. 1A and illustrates an important feature of the present invention, a pre-formed distal tip 63 having shape retention…The distal section 22 can be constructed of any material suitable and known in the art such as a…braided metal (such as Nitinol).” [Col 5, line 59 – Col 6, line 5]; “the pre-formed distal tip 63 can further include a wire having shape memory characteristics or braided metal.” [Col 6, lines 20-21], wherein Nitinol is an alloy of nickel and titanium).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter of McDermott to have a tip made from one or more alloys attached to the first tubular module based on the teachings of Chambers to provide the distal end of the catheter with angular adjustability in order to aim and direct the catheter into branched vasculature using a material that provides both flexibility and shape retention (Chambers [Col 2, lines 31-43] and [Col 6, lines 1-6]).
Modified McDermott fails to explicitly teach a distal end of the first tubular module has a crown comprising a plurality of curvilinear elements, wherein the curvilinear elements form a sinusoidal-shaped wave around a full circumference of the distal end of the first tubular module, and the tip is attached to the curvilinear elements.
Ebata teaches a catheter (catheter 10B) comprising a first tubular module (shaft 12), wherein a distal end of the first tubular module (tip portion 20b) has a crown (base 34a) comprising a plurality of elements (plurality of projecting portions 34; Figures 6A-6B), and wherein the elements form a wave (Figure 6A) around a full circumference of the distal end of the first tubular module (Figures 6A-6B), and further comprising a tip (soft tip 14) that is attached to the plurality of elements (Figure 6B).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the distal end of the first tubular member of McDermott to have a crown comprising a plurality of elements forming a wave around the full circumference of the distal end of the first tubular module and the tip attached to the plurality of elements based on the teachings of Ebata to facilitate attachment between the first tubular module and the tip of the catheter by increasing the surface area of a coupling surface to increase the coupling strength between the first tubular module and the tip (Ebata [Page 8, Paragraph 2]).
Modified McDermott in view of Ebata fails to explicitly teach the plurality of elements of the crown are a plurality of curvilinear elements that form a sinusoidal-shaped wave.
Abt teaches a catheter (instrument 10) having a first tubular module (elongate portion 100) wherein a distal end of the first tubular module has a crown (interlocking features 119) comprising a plurality of curvilinear elements (deep grooves 200 and shallow grooves 202; Figure 1D) forming a sinusoidal-shaped wave (“the shallow grooves 202 may be in the form of arc-shaped recesses” [0032]; Figure 1D showing that each arc forms at least a portion of a sinusoidal shaped wave), further comprising a tip (soft tip 130) that is attached to the curvilinear elements (Figure 1A; [0028]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the crown comprising elements forming a triangular wave around the full circumference of the distal end of the first tubular module of McDermott as modified by Ebata to include that the elements are curvilinear elements and therefor forming a sinusoidal-shaped wave based on the teachings of Abt to further increase the surface area of the distal end of the first tubular module in order to facilitate a secure and stable connection between the distal end of the first tubular module and an attachable tip (Abt [0028]).
Regarding claim 67, modified McDermott teaches the catheter of claim 66.
Modified McDermott fails to explicitly disclose the at least one connector includes a cantilever joint.
Balzum teaches a guidewire (Figures 7-9) comprising a first tubular module (second wire 304) and a second tubular module (first wire 302) coupled to the first tubular module by a joint (first end portion 322 and second end portion 321), the joint comprising at least one connector (struts 334) on the first tubular module (Figure 7), wherein the at least one connector includes a cantilever joint (Figures 8-9; “Struts 334 of second wire 304 deflect outwardly as they ride upon an outer surface of tapered portion 358…The generally enlarged portion 340 of each strut 334 of second wire 304 is disposed within a cavity 354 defined by body member 306 of first wire 302.” [0054-0055]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the at least one connector of the catheter of McDermott to include a cantilever joint based on the teachings of Balzum to provide a secure attachment between tubular modules and joint in a manner that provides a level and smooth outer surface (Balzum [0091]).
Regarding claim 68, modified McDermott teaches the catheter of claim 66, wherein the at least one stabilizing element (projection 44) does not include a cantilever joint (“FIG. 2B shows a step in the method of joining the tubes 10 and 12. The locking pieces 16 and 18 are positioned together in an interlocked configuration. The side extensions 36 of the locking pieces 16 are abutted against the base portions 34 of two adjoining locking pieces 18. Similarly, the side extensions 36 of the locking pieces 18 are abutting against the base portions 34 of two adjoining locking pieces 16.” [0033]).
Regarding claim 69, modified McDermott teaches the catheter of claim 66, wherein the second tubular module is formed from Nitinol (“one of the tubes is of a steel alloy and the other tube is of a nickel titanium alloy, also referred to as nitinol” [0036]).
Regarding claim 71, modified McDermott teaches the catheter of claim 66, wherein at least a portion of the joint is enclosed with a tubular cover (“It is foreseeable that a wrap, coating or fastening may be applied to the locking pieces to hold them in position” [0033]).
Regarding claim 75, modified McDermott teaches the catheter of claim 66, wherein at least a portion of the continuous lumen is coated with a lining (“The tubes may be lined, coated on interior and/or exterior surfaces” [0057]).
Regarding claim 77, modified McDermott teaches McDermott teaches the catheter of claim 66, wherein at least one edge of the connector (edges of side extensions 36 of locking pieces 16) and acceptor (edges of end faces 42 of second tube 12) are beveled at an angle ranging between about 5° to 90° (Figures 3B-3C wherein the bevel angle of the locking pieces 16 and 18 relative to the tubes 10 and 12 is approximately 90°).
Regarding claim 78, modified McDermott teaches the catheter of claim 66, wherein the at least one stabilizing element (projections 44 of first tube 10) prevents the first and second tubular modules from rotating with respect to each other (“The locking piece 18 is not welded to the tube 10 but is constrained from moving in the x and y directions by the angles of the radial mating surfaces between it and the parts 44 and 16. The locking piece 18 cannot move radially outwards or inwards due to the angles of the radial mating surfaces between it and parts 16 and the part 44.” [0037]; and see all of [0027]).
Regarding claim 79, modified McDermott teaches the catheter of claim 66, wherein the diameter of the continuous lumen is maintained around a central luminal axis when the first or second tubular module form a curvilinear shape (“Bending and other forces are a combination of these forces and are therefore also resisted by the tube joint 14 by the combination of interface surfaces.” [0027]).
Regarding claim 80, modified McDermott teaches the catheter of claim 66, wherein the at least one connector (side extensions 36 of first tube 10) extends from the first tubular module (first tube 10 and first locking pieces 16), wherein the at least one connector has a wall thickness that is the same as a wall thickness of the first tubular module (Figures 3A-3C; “join two tubes of the same diameter and same wall thickness end to end without deforming the tubes, without changing the wall thickness, without increasing the outside diameter or decreasing the inside diameter” [0039]).
Regarding claim 86, modified McDermott teaches the catheter of claim 66.
Modified McDermott fails to explicitly teach wherein the crown comprises 5-20 curvilinear elements.
Ebata teaches a catheter (catheter 10B) comprising a first tubular module (shaft 12), wherein a distal end of the first tubular module (tip portion 20b) has a crown (base 34a) comprising a 5-20 elements (plurality of projecting portions 34; Figures 6A-6B showing approximately 8 projecting portions 34) forming a wave (Figure 6A) around the full circumference of the distal end of the first tubular module (Figures 6A-6B).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the distal end of the first tubular member of McDermott such that the crown comprises 5-20 curvilinear elements based on the teachings of Ebata to facilitate attachment between the first tubular module and a soft tip of the catheter by increasing the surface area of a coupling surface to increase the coupling strength between the first tubular module and the soft tip (Ebata [Page 8, Paragraph 2]).
Regarding claim 87, modified McDermott teaches the catheter of claim 66.
Modified McDermott fails to explicitly teach wherein the alloy comprises Ni-Ti, Cu-Zn, Cu-Zn-X, or Ni-Al, wherein X = Be, Si, Sn, Al, or Ga.
Chambers teaches a catheter (catheter 20) comprising a first tubular module (distal section 22) and a second tubular module (intermediate section 23), wherein a tip (distal tip section 63; “The distal section has a soft flexible pre-formed tip having a curvature of ninety degrees or greater and shape retention properties (ability to retain curved shape).” [Col 2, lines 58-61]) is attached to a distal end of the first tubular module (Figure 1A), wherein the tip is made from one or more alloys comprising Ni-Ti, Cu-Zn, Cu-Zn-X, or Ni-Al, wherein X = Be, Si, Sn, Al, or Ga (“The distal section 22 is shown in close up in FIG. 1A and illustrates an important feature of the present invention, a pre-formed distal tip 63 having shape retention…The distal section 22 can be constructed of any material suitable and known in the art such as a…braided metal (such as Nitinol).” [Col 5, line 59 – Col 6, line 5]; “the pre-formed distal tip 63 can further include a wire having shape memory characteristics or braided metal.” [Col 6, lines 20-21], wherein Nitinol is an alloy of nickel and titanium).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter of McDermott to have a tip made from one or more alloys comprising Ni-Ti attached to the first tubular module based on the teachings of Chambers to provide the distal end of the catheter with angular adjustability in order to aim and direct the catheter into branched vasculature using a material that provides both flexibility and shape retention (Chambers [Col 2, lines 31-43] and [Col 6, lines 1-6]).
Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. (US 2011/0291407) in view of Balzum et al. (US 2003/0028127) in further view of Chambers (USPN 7867219) in further view of Ebata et al. (WO 2014/199519) in view of Abt et al. (US 2014/0025045) as applied in claim 69 above and further in view of Pike et al. (USPN 5695506).
Regarding claim 70, modified McDermott teaches the catheter of claim 69, wherein the first tubular module is formed from stainless steel (“one of the tubes is of a steel alloy and the other tube is of a nickel titanium alloy, also referred to as nitinol” [0036]).
Modified McDermott fails to explicitly disclose the first tubular module is formed from stainless steel of SAE grade selected from 304, 316, 402, and 440, 17-7 precipitation hardened stainless steel (PH), or Nickel Cobalt Alloy (MP35N).
Pike teaches a catheter (catheter device 40) having a first tubular module (flex tube 60) and a second tubular module (taper end of catheter body 42), wherein the first tubular module is formed from stainless steel of SAE grade 304 (“The flex tube 60 is fabricated from a flexible material such 304 stainless steel.” [Col 6, line 35]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the first tubular module of McDermott to be formed from stainless steel of SAE grade selected from 304 based on the teachings of Pike to ensure that the first tubular module is flexible and able to maintain a desired degree of axial and torsional stiffness (Pike [Col 5, lines 30-37]).
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. (US 2011/0291407) in view of Balzum et al. (US 2003/0028127) in further view of Chambers (USPN 7867219) in further view of Ebata et al. (WO 2014/199519) in view of Abt et al. (US 2014/0025045) as applied in claim 66 above and further in view of Eskuri (USPN 8419658).
Regarding claim 72, modified McDermott teaches the catheter of claim 66.
Modified McDermott fails to explicitly disclose a filament is threaded in a spiral configuration around at least a portion of the first and second tubular modules.
Eskuri teaches a catheter (“any of the tubular members mentioned herein can be incorporated into a catheter shaft.” [Col 13, line 33]) comprising a tubular member (tubular member 20), wherein a filament (thread member 60; “the thread member 60 can be a separate structure that has been extended around and attached to the outer surface 38 of the tube wall 33” [Col 6, line 44]) is threaded in a spiral configuration around at least a portion of the tubular module (Figure 1; “the spiral-shaped pattern of thread member 60” [Col 7, line 9]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter of McDermott to include a filament threaded in a spiral configuration around at least a portion of the first and second tubular modules based on the teachings of Eskuri to aid the catheter in crossing an occlusion by acting in a screw-like manner to draw and pull the catheter through the occlusion (Eskuri [Col 7, lines 8-18] and [Col 13, line 36]).
Claims 73-74 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. (US 2011/0291407) in view of Balzum et al. (US 2003/0028127) in further view of Chambers (USPN 7867219) in further view of Ebata et al. (WO 2014/199519) in view of Abt et al. (US 2014/0025045) as applied in claim 66 above and further in view of Galdonik et al. (US 2006/006649).
Regarding claims 73 and 74, modified McDermott teaches the catheter of claim 66, wherein at least a portion of at least one tubular module is covered with a jacket (“it will be necessary to provide the additional support of a heat-shrink tube over the joined tubes” [0056]).
Modified McDermott fails to explicitly disclose the jacket is a polymer jacket, as required by claim 73; and wherein the polymer jacket is formed from nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (polyethylene terephthalate) or PEEK (polyether ether ketone), as required by claim 74.
Galdonik teaches a catheter (elongate structure 550) comprising a first tubular module (first segment 552) and a second tubular module (second segment 554), wherein at least a portion of at least one tubular module is covered with a polymer jacket (polymer coating 564; Figure 10) formed from nylon or polyether block amide (“The polymer coating can be, for example, polyamides (Nylon), polyurethane, polyester, polyether-block-amide (PEBA, such as Pebax.RTM.) or combinations thereof.” [0059]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the jacket of the catheter of McDermott to be polymer jacket formed from nylon or polyether block amide based on the teachings of Galdonik to increase the strength of the joint while maintaining a constant outer diameter of the catheter at the joint (Galdonik [0058], [0059]).
Regarding claim 76, modified McDermott teaches the catheter of claim 75.
Modified McDermott fails to explicitly disclose the lining is formed from nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (polyethylene terephthalate) or PEEK (polyether ether ketone).
Galdonik teaches a catheter (medical device 100) comprising a first tubular module (first segment 552) and a second tubular module (second segment 554) coupled by a joint (Figure 1), wherein at least a portion of the continuous lumen of the tubular modules is coated with a lining (“the inner surface of the tube…can be coated with a friction reducing agent.” [0029]) formed from PTFE (“Suitable friction reducing agents include… polytetrafluoroethylene” [0029]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the lining of the catheter of McDermott to be formed from PTFE based on the teachings of Galdonik to facilitate relative longitudinal motion between an object being delivered through the continuous lumen and the tubular modules (Galdonik [0029]).
Response to Arguments
Applicant’s arguments with respect to claims 66-80 and 86-87 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the language of amended claim 66, the amended claim language as current presented does not require that the tip is made entirely from one or more alloys and the limitation “the tip is made from one more alloys” can be reasonably interpreted as the tip is made at least partially from one or more alloys. Additionally, neither Ebata nor Abt were relied upon for a teaching of a tip made out of an alloy and were not modified to have a tip made from one or more alloys. As detailed above with respect to the rejection of claim 66, Chambers discloses a catheter having a soft tip (distal tip section 63; “The distal section has a soft flexible pre-formed tip having a curvature of ninety degrees or greater and shape retention properties (ability to retain curved shape).” [Col 2, lines 58-61]) made from one or more alloys (“The distal section 22 is shown in close up in FIG. 1A and illustrates an important feature of the present invention, a pre-formed distal tip 63 having shape retention…The distal section 22 can be constructed of any material suitable and known in the art such as a…braided metal (such as Nitinol).” [Col 5, line 59 – Col 6, line 5]; “the pre-formed distal tip 63 can further include a wire having shape memory characteristics or braided metal.” [Col 6, lines 20-21], wherein Nitinol is an alloy of nickel and titanium). It would have been obvious to one having ordinary skill in the art to further modify the catheter of McDermott to have a tip made from one or more alloys attached to the first tubular module based on the teachings of Chambers to provide the distal end of the catheter with angular adjustability in order to aim and direct the catheter into branched vasculature using a material that provides both flexibility and shape retention (Chambers [Col 2, lines 31-43] and [Col 6, lines 1-6]).
Regarding the argument that the combination of prior art does not teach “a plurality of curvilinear elements form a sinusoidal-shaped wave around a full circumference of the distal end of the first tubular module” as required by claim 66 (Remarks, page 7-8), the examiner respectfully disagrees. As detailed above with respect to the rejection of claim 66, Ebata teaches a catheter (10B) comprising a crown (34a) comprising a plurality of elements (34; Figures 6A-6B) forming a wave around a full circumference of the distal end of the first tubular module (Figures 6A-6B) for the purpose of facilitating attachment between the first tubular module and the tip of the catheter by increasing the surface area of a coupling surface to increase the coupling strength between the first tubular module and the tip (Ebata [Page 8, Paragraph 2]); however, Ebata does not explicitly disclose that the plurality of elements of the crown are a plurality of curvilinear elements that form a sinusoidal-shaped wave. Abt teaches a catheter (10) having a crown (119) comprising a plurality of curvilinear elements (deep grooves 200 and shallow grooves 202; Figure 1D) forming a sinusoidal-shaped wave (“the shallow grooves 202 may be in the form of arc-shaped recesses” [0032]; Figure 1D). One having ordinary skill in the art would recognize that if the crown of Ebata having triangular elements forming a triangular wave around a full circumference of the distal end of the tubular module were modified based on the teachings of Abt to instead by curvilinear elements, the resulting wave around the full circumference of the distal end of the first tubular module would be sinusoidal-shaped. Figure 1D of Abt shows that each arc forms at least a portion of a sinusoidal shaped wave. It is therefore maintained that it would have been obvious to modify the crown comprising elements forming a triangular wave around the full circumference of the distal end of the first tubular module of McDermott as modified by Ebata to include that the elements are curvilinear elements and therefor forming a sinusoidal-shaped wave based on the teachings of Abt to further increase the surface area of the distal end of the first tubular module in order to facilitate a secure and stable connection between the distal end of the first tubular module and an attachable tip (Abt [0028]).
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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/LEAH J SWANSON/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783