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 . Claims 1-19 & 21 are pending and examined below.
Specification
The disclosure is objected to because of the following informalities:
Page 6 lines 29-30 of the specification recites “...serves as a guidewire 17 lumen.” It is unclear if reference character “17” is referring to a guidewire or a guidewire lumen.
Page 8 lines 2-4, “outer catheter tube” has been referenced to as 16 and 14.
Appropriate correction is required.
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 11-19 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 11 recites the limitation “a stent” in line 3. It is unclear of this is the same or different stent from line 1. For the purpose of examination, they are regarded as the same.
All dependent claims are likewise rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8, 10-14, 16-19, & 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colgan et al. (US 20030040789 A1) hereinafter, Colgan.
Regarding claim 1, Colgan teaches
a catheter (340, Fig. 19A) for stent delivery comprising:
(a) an elongated catheter body (body of 340, Fig. 19A) having an outer catheter tube (352, Fig. 19A) surrounding an inner catheter tube (342, Fig. 19A);
(b) a stent holder (see annotated Fig. 19A below) for holding a stent (10, Fig. 19A) within said outer catheter tube (352, Fig. 19A) at a portion proximally adjacent to a distal portion (portion by 346, Fig. 19A);
(c) a first mechanism for advancing said stent forward into said distal portion (344, Fig. 19A); and
(d) a second mechanism (354, Fig. 19A) for pulling back said outer catheter tube to thereby deploy said stent (outer sheath is moved toward the handle, ¶0149).
Regarding claim 2, Colgan teaches
wherein said distal portion is more elastic than said portion proximally adjacent to said distal portion of said elongated catheter body (material at the distal end being selected for a higher flexibility, crease resistance and with a lower durometer, and the first portion is a material/blend chosen for higher stiffness, crush-strength and having relative high durometer, ¶0163).
Regarding claim 3, Colgan teaches
wherein said inner catheter tube (342, Fig. 19A) includes a guidewire lumen (lumen inside 342. Fig. 19B).
Regarding claim 5, Colgan teaches
further comprising a nose cone (346, Fig. 19A) attached to a distal end of said elongated catheter body (body of 340, Fig. 19A).
Regarding claim 6, Colgan teaches
wherein said stent (10, Fig. 19A) is advanced forward against said nose cone (346, Fig. 19A).
Regarding claim 7, Colgan teaches
wherein pulling back said outer catheter tube (outer sheath is moved toward the handle, ¶0149) to thereby deploy said stent disengages it from said stent holder (with the outer sheath moved proximally, the stent 10 is able to self expand into proper position, ¶0142).
Regarding claim 8, Colgan teaches
wherein said distal portion is 20-80 mm in length (1-50 cm, ¶0131). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
Regarding claim 10, Colgan teaches
further comprising a handle (handle portion of 344, Fig. 19A) for activating said first and said second mechanism.
Regarding claim 11, Colgan teaches
a method of delivering a stent (10, Fig. 19A) through a tortuous blood vessel (artery, vessel or other desired location, ¶0142) comprising:
(a) advancing a catheter (340, Fig. 19A) through the tortuous blood vessel, said catheter carrying a stent (10, Fig. 19A) within a portion proximally adjacent to a distal portion (portion by 346, Fig. 19A);
(b) advancing said stent (10, Fig. 19A) forward into said distal portion (advanced axially and distally until the distal radiopaque marker 60 is positioned axially at a location, ¶0103); and
(c) deploying said stent (with the outer sheath moved proximally, the stent 10 is able to self expand into proper position, ¶0142).
Regarding claim 12, Colgan teaches
wherein said distal portion is more elastic than said portion proximally adjacent to said distal portion of said elongated catheter body (material at the distal end being selected for a higher flexibility, crease resistance and with a lower durometer, and the first portion is a material/blend chosen for higher stiffness, crush-strength and having relative high durometer, ¶0163).
Regarding claim 13, Colgan teaches
wherein said catheter (340, Fig. 19A) includes an elongated catheter body (body of 340, Fig. 19A) having an outer catheter tube (352, Fig. 19A) surrounding an inner catheter tube (342, Fig. 19A).
Regarding claim 14, Colgan teaches
wherein said inner catheter tube includes a guidewire lumen (lumen inside 342. Fig. 19B).
Regarding claim 16, Colgan teaches
wherein said elongated catheter body further comprising a nose cone (346, Fig. 19A) attached to a distal end thereof.
Regarding claim 17, Colgan teaches
wherein said stent (10, Fig. 19A) is advanced forward against said nose cone (346, Fig. 19A).
Regarding claim 18, Colgan teaches
wherein (d) is carried out by pulling back said outer catheter tube (outer sheath is moved toward the handle, ¶0149).
Regarding claim 19, Colgan teaches
wherein said distal portion is 20-80 mm in length (1-50 cm, ¶0131), or wherein said distal portion has an elasticity of 170-513 mPa. It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
Regarding claim 21, Colgan teaches
a stent (10, Fig. 2A) comprising a tubular braid (46, Fig, 2A) having exposed wire ends (42, Fig. 2A), wherein each of said ends includes a ball-like protrusion (250, Fig. 4C, weld ball, ¶0082).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 4 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colgan in view of Gupta (US 20200129317 A1).
Regarding claim 4, Colgan teaches
wherein said guidewire lumen extends from a first opening (opening at 346, Figs. 19A-B, Colgan) at a distal tip (346, Fig. 19A, Colgan) of said elongated catheter body.
Colgan does not teach wherein said guidewire lumen extends from a first opening of said elongated catheter body to a second opening at a side wall of said outer catheter tube. However, Gupta teaches intravascular delivery system (abstract, Gupta)
wherein said guidewire lumen (28, Fig. 3B, Gupta) extends from a first opening at a distal tip (opening at 32, Fig. 1, Gupta) of said elongated catheter body to a second opening (30, Fig. 1, Gupta) at a side wall of said outer catheter tube.
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 teachings of Colgan by incorporating the teaching above as taught by Gupta in order to permit the delivery of a therapeutic delivery catheter along the guidewire to a target site in a blood vessel (¶0075, Gupta).
Regarding claim 15, Colgan teaches
wherein said guidewire lumen extends from a first opening (opening at 346, Figs. 19A-B, Colgan) at a distal tip (346, Fig. 19A, Colgan) of said elongated catheter body.
Colgan does not teach wherein said guidewire lumen extends from a first opening of said elongated catheter body to a second opening at a side wall of said outer catheter tube. However, Gupta teaches
wherein said guidewire lumen (28, Fig. 3B, Gupta) extends from a first opening at a distal tip (opening at 32, Fig. 1, Gupta) of said elongated catheter body to a second opening (30, Fig. 1, Gupta) at a side wall of said outer catheter tube.
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 teachings of Colgan by incorporating the teaching above as taught by Gupta in order to permit the delivery of a therapeutic delivery catheter along the guidewire to a target site in a blood vessel (¶0075, Gupta).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colgan in view of Tamir (US 20230270547 A1).
Regarding claim 9, Colgan does not teach wherein said distal portion has an elasticity of 170-513 mPa. However, Tamir teaches an introducer sheath system (abstract, Tamir)
wherein said distal portion has an elasticity of 170-513 mPa (400 MPa or greater, ¶0187, Tamir). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
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 teachings of Colgan by incorporating the teaching above as taught by Tamir in order to facilitate passage of the prosthetic device through the lumen (¶0187, Tamir).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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