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 Arguments
The current office action is a second non-final rejection to provide appropriate mapping of prior art Rahdert, et al., US 20060252984 A1 to the limitations.
Applicant’s arguments in Applicant’s responses filed 08/11/2026 with respect to the rejection of claims 45-49, 51, 54, 58, 63-64 under 35 U.S.C. 102(a)(1) and claims 50, 52-53, 55-57, 59-62, and 65-66 under 35 U.S.C. 103, have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejections are made in view of newly found prior art Houser, et al., US 20010051809 A1.
Specifically, Houser teaches a graft deployment system which includes a tissue dilator and a needle for perforating tissue, mounted coaxially within the dilator. Intralumenal systems further include a catheter for containing the dilator (abstract), the dilator including dilator magnets disposed at a distal end (fig. 25). The system also includes a guide wire and [0075] indicates that The dilator magnets are used in conjunction with a guide wire 209 advanced beyond a stenosed lesion 210 within a vessel 212. The guide wire is formed of metal, and to further enhance magnetic attraction may incorporate a magnet 214 of opposite polarity to the dilator magnet. Magnetic positioning facilitates placing bypass grafts through tortuous vessels or over long distances beyond the lesion. Alternatively, known imaging techniques can be used to locate the dilator magnets.
The teachings of Hause have been combined with the teachings of Rahdert, et al., US 20060252984 A1 to arrive at the claimed invention.
Therefore, the claims stand rejected.
Withdrawn Claim Objections
The objection made to claim 57 is hereby withdrawn in view of Applicant’s amendments filed 08/11/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 45-49, 51, 54, 58, 63-64, and 66-67 are rejected under 35 U.S.C. 103 as being unpatentable over Rahdert, et al., US 20060252984 A1 in view of Houser, et al., US 20010051809 A1.
Regarding claim 45, Rahdert discloses a sleeve device for facilitating advancement of a catheter device through a bodily wall ([0183] discloses use of introducer sheath for vascular access), the sleeve device comprising:
a flexible tubular sleeve having a main lumen for advancement of a distal portion of the catheter device therethrough ([0183] the introducer sheaths provide access for the great cardiac vein (GCV) catheter 40 and left atrium (LA) catheter 60. By providing access, the passage implies that the sheaths include a lumen for advancing the catheters therethrough);
a dilator removably advanced through the main lumen of the flexible tubular sleeve, the dilator having a main lumen ([0185]-[0186]); and
a magnet assembly ([0187] discloses a magnetic or ferromagnetic head 42 positioned on the distal end of the GCV catheter shaft 45) rotatably coupled to a distal portion of the dilator ([0186]-[0187]) and comprising at least one magnet ([0187]).
Rahdert fails to teach wherein the magnet is configured to magnetically attract to a guidewire advanced through the bodily wall and wherein the magnet assembly is configured to magnetically couple to an external surface of the guidewire.
However, within the same field of endeavor, Houser teaches a graft deployment system which includes a tissue dilator and a needle for perforating tissue, mounted coaxially within the dilator. Intralumenal systems further include a catheter for containing the dilator (abstract), the dilator including dilator magnets disposed at a distal end (fig. 25). Houser further teaches wherein the magnet is configured to magnetically attract to a guidewire advanced through the bodily wall [0075] and wherein the magnet assembly is configured to magnetically couple to an external surface of the guidewire by disclosing in [0075] that the dilator magnets are used in conjunction with a guide wire 209 advanced beyond a stenosed lesion 210 within a vessel 212. The guide wire is formed of metal, and to further enhance magnetic attraction may incorporate a magnet 214 of opposite polarity to the dilator magnet. Magnetic positioning facilitates placing bypass grafts through tortuous vessels or over long distances beyond the lesion. Alternatively, known imaging techniques can be used to locate the dilator magnets.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Rahdert, wherein the magnet is configured to magnetically attract to a guidewire advanced through the bodily wall and wherein the magnet assembly is configured to magnetically couple to an external surface of the guidewire, as taught by Houser, to improve positioning of the dilator and the guidewire [0075].
Regarding claim 46, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert further teaches wherein the catheter device comprises an intracardiac echocardiography (ICE) catheter ([0184]).
Regarding claim 47, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert further teaches wherein the magnet assembly is rotatable within the main lumen of the dilator when advanced therethrough ([0187], [0224]).
Regarding claim 48, Rahdert in view of Houser teaches all the limitations of claim 47 above.
Rahdert further teaches wherein rotation of the magnet assembly re-orients a pole of the at least one magnet ([0177]).
Regarding claim 49, Rahdert in view of Houser teaches all the limitations of claim 47 above.
Rahdert further teaches wherein the sleeve is advanceable along a guidewire ([0183]), and wherein rotation of the magnet assembly results in movement of the magnets along the circumflex of an outside surface of the guidewire ([0187]).
Regarding claim 51, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert further teaches wherein the at least one magnet comprises a plurality of discrete magnetic elements (magnetic head 42 of fig. 37A and B and magnetic head 62 of fig. 38).
Regarding claim 54, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert further teaches wherein the distal magnet assembly is at least partially radiopaque or echogenic ([0179]).
Regarding claim 58, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert further teaches wherein the sleeve device comprises a proximal end and the proximal end is coupled with a hub ([0176]).
Regarding claim 63, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert further teaches wherein the at least one magnet is cylinder shaped (see fig. 38 for the magnetic head 62 assuming a cylindrical shape).
Regarding claim 64, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert further teaches wherein the at least one magnet is magnetized along a longitudinal axis of the at least one magnet (see fig. 38 for the orientation of the magnet head 62 and [0177] discusses the polarization of the magnet head).
Regarding claim 66, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert teaches a system for facilitating advancement of a catheter device through a bodily wall, the system comprising the sleeve device of any one of claim 45 and the guidewire ([0173], [0174]).
Regarding claim 67, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert fails to teach wherein the magnet assembly is configured to magnetically dock with the guidewire without the guidewire extending through any lumen of the dilator or flexible tubular sleeve.
However, Houser further teaches wherein the magnet assembly is configured to magnetically dock with the guidewire without the guidewire extending through any lumen of the dilator or flexible tubular sleeve (see reproduced fig. 25 below and [0075]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Rahdert, wherein the magnet assembly is configured to magnetically dock with the guidewire without the guidewire extending through any lumen of the dilator or flexible tubular sleeve, as taught by Houser, to improve positioning of the dilator and the guidewire [0075].
Claims 50, 55, and 59-62 are rejected under 35 U.S.C. 103 as being unpatentable over Rahdert in view of Houser, as applied to claim 47 above, and further in view of Wilson, et al., US 20100022948 A1.
Regarding claim 50, Rahdert in view of Houser teaches all the limitations of claim 47 above.
Rahdert in view of Houser fails to teach a steering knob coupled to a proximal end of the dilator to rotate one or more of the dilator or the magnet assembly.
However, within the same field of endeavor, Rahdert teaches a catheter according to one embodiment may be configured to extend through a transseptal puncture site, a left atrium, and into a left ventricle. The catheter may comprise a shaft defining at least one lumen configured to receive at least one of an implant and/or a dilator, a first steerable actuator coupled to the shaft at a position on the shaft substantially corresponding to the annulus of the mitral valve when the distal end of the shaft is disposed within the left ventricle, and a handle assembly coupled to a proximal end of the shaft (see abstract). The catheter further includes a dilator 34b of [0060] that includes a steering knob (knob 116 of reproduced fig. 13A below) coupled to a proximal end of the dilator to rotate one or more of the dilator or the magnet assembly ([0061] discloses that the defecting wire 106 may be coupled to the handle assembly 102 such that the distal tip 98a may be bent as desired. According to one embodiment, the handle assembly 102 may include at least one knob, slider or the like 115 coupled to the defecting wire 106 such that actuation of the knob 115 may result in movement of the distal tip 98a. For example, the knob 115 may be coupled to the defecting wire 106 and may pull the defecting wire 106 generally towards the handle assembly 102 causing the distal tip 98a to bend to one side).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert to include a steering knob coupled to a proximal end of the dilator to rotate one or more of the dilator or the magnet assembly, as taught by Wilson, providing an improved ability of the steerable catheter to be inserted over the dilator through the tortuous pathway of the transseptal route to the left ventricle ([0097]), while also improving the general control of the dilator as it is advanced over a guide wire the transseptal route to the left atrium ([0098]).
Regarding claim 55, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert in view of Houser fails to teach wherein the dilator comprises a tapered distal tip.
However, Wilson further teaches wherein the dilator comprises a tapered distal tip (see figs. 13A and 13B for the tapered distal end 109 of the dilator).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert wherein the dilator comprises a tapered distal tip, as taught by Wilson, providing an improved ability of the steerable catheter to be inserted over the dilator through the tortuous pathway of the transseptal route to the left ventricle ([0097]), while also improving the general control of the dilator as it is advanced over a guide wire the transseptal route to the left atrium ([0098]).
Regarding claims 59 and 60, Rahdert in view of Houser teaches all the limitations of claim 58 above.
Rahdert in view of Houser fails to teach wherein the hub includes a flush port; and wherein the hub includes a hemostatic seal.
However, Wilson further teaches wherein the hub includes a flush port; and wherein the hub includes a hemostatic seal ([0062] states that [0062] The handle assembly 102 may also optionally include one or more valves or fittings. For example, the handle assembly 102 may include a fitting 111 (such as, but not limited to, a Luer lock fitting or the like) configured to allow the lumen 97 to be flushed. The handle assembly 102 may also optionally include a valve 112 (such as, but not limited to, a hemostasis valve) configured to seal with the delivery guide wire 30 (not shown)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert wherein the hub includes a flush port; and wherein the hub includes a hemostatic seal, as taught by Wilson, providing an improved ability of the steerable catheter to be inserted over the dilator through the tortuous pathway of the transseptal route to the left ventricle ([0097]), while also improving the general control of the dilator as it is advanced over a guide wire the transseptal route to the left atrium ([0098]).
Regarding claim 61, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert in view of Houser fails to teach wherein the diameter of the main lumen of the flexible tubular sleeve is between 1 and 7 mm.
However, Wilson further teaches wherein the diameter of the main lumen of the flexible tubular sleeve is between 1 and 7 mm ([0062] states that [0062] The handle assembly 102 may also optionally include one or more valves or fittings. For example, the handle assembly 102 may include a fitting 111 (such as, but not limited to, a Luer lock fitting or the like) configured to allow the lumen 97 to be flushed. The handle assembly 102 may also optionally include a valve 112 (such as, but not limited to, a hemostasis valve) configured to seal with the delivery guide wire 30 (not shown)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert wherein the diameter of the main lumen of the flexible tubular sleeve is between 1 and 7 mm, as taught by Wilson, providing an improved ability of the steerable catheter to be inserted over the dilator through the tortuous pathway of the transseptal route to the left ventricle ([0097]), while also improving the general control of the dilator as it is advanced over a guide wire the transseptal route to the left atrium ([0098]).
Regarding claim 62, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert in view of Houser fails to teach wherein the distal portion of the dilator is malleable to adjust a bend radius of said distal portion.
However, Wilson further teaches wherein the distal portion of the dilator is malleable to adjust a bend radius of said distal portion ([0060] discloses that The dilator 34 may include a deflectable tip 98a configured to allow the user to bend the distal region 109 of the dilator 34b).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert, wherein the distal portion of the dilator is malleable to adjust a bend radius of said distal portion, as taught by Wilson, providing an improved ability of the steerable catheter to be inserted over the dilator through the tortuous pathway of the transseptal route to the left ventricle ([0097]), while also improving the general control of the dilator as it is advanced over a guide wire the transseptal route to the left atrium ([0098]).
Claims 52-53, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Rahdert in view of Houser, as applied to claim 51 above, and further in view of Golden, et al., US 5902238 A.
Regarding claim 52, Rahdert in view of Houser teaches all the limitations of claim 51 above.
Rahdert in view of Houser fails to teach wherein the magnet assembly comprises a flexible shaft and the plurality of discrete magnetic elements are arranged in series along the flexible shaft.
However, within the same field of endeavor, Golden teaches A medical tube, apparatus and method for locating the medical tube within the body of a patient. The medical tube has a permanent magnet associated therewith and is capable of being located by a detection apparatus which senses the static magnetic field strength gradient generated by the magnet associated with the medical tube and indicates the value of the gradient to the user (see abstract). Golden then teaches that the medical tube 100 wherein the magnet assembly comprises a flexible shaft (col. 12, lines 1-7) and the plurality of discrete magnetic elements are arranged in series along the flexible shaft (col. 11, lines 45-60).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert wherein the magnet assembly comprises a flexible shaft and the plurality of discrete magnetic elements are arranged in series along the flexible shaft, as taught by Golden, to provide accurate navigation of the endoscope or catheter to the region of interest (col. 2, lines 33-42).
Regarding claim 53, Rahdert in view of Houser and Golden teaches all the limitations of claim 52 above.
Rahdert in view of Houser fails to teach wherein the distal magnet assembly further comprises at least one support spring for the flexible shaft.
However, Golden further teaches wherein the distal magnet assembly further comprises at least one support spring for the flexible shaft (see reproduced figs. 12A-12C) .
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert wherein the distal magnet assembly further comprises at least one support spring for the flexible shaft, as taught by Golden, to provide accurate navigation of the endoscope or catheter to the region of interest (col. 2, lines 33-42).
Regarding claim 65, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert in view of Houser fails to teach wherein the poles of the at least one magnet are oriented transverse to a longitudinal axis of the dilator when the dilator is in a neutral configuration.
However, Golden further teaches wherein the poles of the at least one magnet are oriented transverse to a longitudinal axis of the dilator when the dilator is in a neutral configuration (col. 10, lines 29-31).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert, wherein the poles of the at least one magnet are oriented transverse to a longitudinal axis of the dilator when the dilator is in a neutral configuration, as taught by Golden, to provide accurate navigation of the endoscope or catheter to the region of interest (col. 2, lines 33-42).
Claims 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Rahdert in view of Houser, as applied to claim 45 above, and further in view of Hayakawa, et al., US 20200023168 A1.
Regarding claim 56, Rahdert in view of Houser teaches all the limitations of claim 45 above.
Rahdert in view of Houser fails to teach wherein the flexible tubular sleeve is at least partially made of a polymer material.
However, within the same field of endeavor, Hayakawa teaches a guide wire, a medical device, and a medical method are able to achieve satisfactory workability and while ensuring safety by preventing a puncture needle portion from performing erroneous puncture. A guide wire for guiding a dilator to be inserted into a living body includes a shaft portion, a puncture portion fixed to a distal portion of the shaft portion, and whose distal side includes a needle portion for forming a hole in a biological tissue, and a deformable deformation portion fixed to the shaft portion or the puncture portion (see abstract). Hayakawa teaches wherein the flexible tubular sleeve is at least partially made of a polymer material, with [0076] disclosing that a configuration material of the dilator 40 is preferably a flexible material. For example, it is possible to preferably use polyolefin such as polyethylene and polypropylene, polyamide, polyester such as polyethylene terephthalate, fluorine-based polymer such as polytetrafluoroethylene (PTFE) and ethylene-tetrafluoroethylene copolymer (ETFE), polyether ether ketone (PEEK), or polyimide, a shape memory alloy, or metal such as stainless steel, tantalum, titanium, platinum, gold, and tungsten. In addition, the dilator 40 may contain the X-ray contrast material or the ultrasound contrast material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert, wherein the flexible tubular sleeve is at least partially made of a polymer material, as taught by Hayakawa, as such modification would improve safety of the procedure by prevent erroneous punctures to healthy tissues ([0111], [0128]).
Regarding claim 57, Rahdert in view of Houser teaches all the limitations of claim 56 above.
Rahdert in view of Houser fails to teach wherein the flexible tubular sleeve is at least partially made of a polymer material; and wherein the polymer material is one or more of high-density polyethylene (HDPE), low-density polyethylene (LDPE), polytetrafluoroethylene (PTFE), polyethylene pyrolysis (PEP), polyether ether ketone (PEEK), or polyether block amide (Pebax).
However, within the same field of endeavor, Hayakawa teaches a guide wire, a medical device, and a medical method are able to achieve satisfactory workability and while ensuring safety by preventing a puncture needle portion from performing erroneous puncture. A guide wire for guiding a dilator to be inserted into a living body includes a shaft portion, a puncture portion fixed to a distal portion of the shaft portion, and whose distal side includes a needle portion for forming a hole in a biological tissue, and a deformable deformation portion fixed to the shaft portion or the puncture portion (see abstract). Hayakawa teaches wherein the flexible tubular sleeve is at least partially made of a polymer material; and wherein the polymer material is one or more of HDPE, LDPE, PTFE, PEP, PEEK, or Pebax, with [0076] disclosing that a configuration material of the dilator 40 is preferably a flexible material. For example, it is possible to preferably use polyolefin such as polyethylene and polypropylene, polyamide, polyester such as polyethylene terephthalate, fluorine-based polymer such as polytetrafluoroethylene (PTFE) and ethylene-tetrafluoroethylene copolymer (ETFE), polyether ether ketone (PEEK), or polyimide, a shape memory alloy, or metal such as stainless steel, tantalum, titanium, platinum, gold, and tungsten. In addition, the dilator 40 may contain the X-ray contrast material or the ultrasound contrast material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Rahdert, wherein the polymer material is one or more of HDPE, LDPE, PTFE, PEP, PEEK, or Pebax, as taught by Hayakawa, as such modification would improve safety of the procedure by prevent erroneous punctures to healthy tissues ([0111], [0128]).
Conclusion
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/FAROUK A BRUCE/ Examiner, Art Unit 3797
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