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 .
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, 2, 3, 6, 17, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ostrovsky (US PGPub 2009/0192495)
Regarding Claim 1, Ostrovsky teaches a steerable catheter device, comprising:
a shaft (100; Figure 1) having a steerable distal portion (see Figures 1B and 2) comprising a proximal section (see annotated Figure 2 below; Paragraph 0025) and a distal section (56; see annotated Figure 2 below; Paragraph 0025);
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and
a pull wire (104R or 104L; Figures 1-2; Paragraph 0024-0025) extending through the proximal section of the shaft and the distal section (see Figures 1-2),
wherein tension applied to the pull wire (104R or 104L) is effective to flex the proximal section in a primary flexing plane (as described in Paragraph 0024 and shown in Figure 1) and to flex the distal section in a first direction away from the primary flexing plane (as seen in Figure 2 and described in Paragraph 0025).
Regarding Claim 2, Ostrovsky teaches the catheter device of claim 1, wherein: the pull wire is a first pull wire (104R), and the catheter device further comprises a second pull wire (104L) extending through the proximal section and the distal section (Figures 1-2; Paragraph 0025).
Regarding Claim 3, Ostrovsky teaches the catheter device of claim 2, wherein greater tension applied to the second pull wire than the first pull wire is effective to flex the proximal section in the primary flexing plane and flex the distal section in a second direction away from the primary flexing plane, wherein the second direction is different than the first direction (as disclosed in Paragraph 0025 states “As described above, when the right pull wire 104R is pulled 110, the structure 100 bends to the right as shown. However, because the left pull wire 104L is held in place along the left inner surface 101 of the structure, when the left pull wire 104L is subsequently pulled 120, it applies a force 222 along the left inner surface of the structure and, thus, the structure tends to bend to the left. In this way, the pull wires in FIG. 2 can independently control the direction of bending of the tube structure and thus pull wires have superior control characteristics over the pull wires shown FIGS. 1A and 1B” and if the force 222 was not greater, then the distal section would not flex, therefore it’s the examiners position that the tension in the second pull wire is greater than the first”.
Regarding Claim 6, Ostrovsky teaches the catheter device of claim 1, wherein the second direction is along a locus approximating a portion of a surface of a sphere (Figure 2; Paragraph 0025) .
Regarding Claim 17, Ostrovsky teaches a steerable catheter device, comprising:
a shaft (100; Figure 1) having primary flexing section (see annotated Figure 2 below; Paragraph 0025) and a secondary flexing section (56; see annotated Figure 2 below; Paragraph 0025);
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a pull wire (104R or 104L; Figures 1-2; Paragraph 0024-0025) extending through primary flexing section and then through a secondary flexing section of the shaft (see Figures 1-2),
wherein tension applied to the pull wire (104R or 104L) is effective to flex the primary flexing section of the shaft in a first flexing plane (as described in Paragraph 0024 and shown in Figure 1) and to flex the secondary flexing section relative to the primary flexing section in a second flexing plane on a side of the first flexing plane (as seen in Figure 2 and described in Paragraph 0025).
Regarding Claim 18, Ostrovsky teaches the catheter device of claim 17, wherein: the pull wire is a first pull wire (104R), and the steerable catheter device further comprises a second pull wire (104L) (Figures 1-2; Paragraph 0025).
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 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky (US PGPub 2009/0192495) as applied to claim 1 and 2 above, and further in view of Gibson (US PGPub 2011/0270173).
Regarding Claim 4, Ostrovsky teaches the catheter device of claim 2, but is silent on the proximal end of the shaft in the disclosure and thus Ostrovsky fails to disclose wherein:
the shaft comprises a main pull-wire lumen extending through the proximal section and first and second distal pull-wire lumens extending from the main pull-wire lumen,
the distal pull-wire lumens diverge away from each other and then extend parallel to each other through the distal section,
the first pull wire extends through the main pull-wire lumen and the first distal pull-wire lumen, and
the second pull wire extends through the main pull-wire lumen and the second distal pull-wire lumen.
Gibson teaches a steerable catheter (abstract) comprising:
a shaft (32; Figures 2A-3C) comprises a main pull-wire lumen (54; Figure 3C) extending through the proximal section and first and second distal pull-wire lumens (50 and 52; Figure 3B) extending from the main pull-wire lumen,
the distal pull-wire lumens (50, 52) diverge away from each other and then extend parallel to each other through the distal section (30; see Figure 3A),
the first pull wire (40) extends through the main pull-wire lumen (54; Figure 3C) and the first distal pull-wire lumen (50; Figure 3B), and
the second pull wire (42) extends through the main pull-wire lumen (54; Figure 3C) and the second distal pull-wire lumen (52; Figure 3B).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the shaft lumens taught by Ostrovsky with lumens as taught by Gibson since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, Gibson teaches that having a proximal main pull wire lumen is an obvious variant of multiple satellite lumens extending to the proximal end (Paragraph 0055) and it’s the Examiner’s position that results of the combination would be predictable and resulted in a product being able to function as intended (Gibson; Paragraph 0055).
Regarding Claim 7, Ostrovsky teaches the catheter device of claim 1, but fails to disclose wherein the distal section has a lower durometer than the proximal section.
Gibson teaches a steerable catheter (abstract) wherein the distal section (56) of the steerable section has a lower durometer (less stiff) than the proximal section (which includes transition 8; 0008, 0044, 0050-0051, 0056)
It would have been obvious to one of ordinary skill in the art before the effective filing of the invention to modify the catheter of Ostrovsky to have a more flexible distal bending segment than the proximal bending segment, for the advantage of providing a structure with sufficient pushability in the proximal portion yet be flexible enough to be manipulated without damaging tissue contacting the distal tip.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky (US PGPub 2009/0192495) and Gibson (US PGPub 2011/0270173) as applied to claim 2 above, and further in view of Bogusky (US PGPub 2015/0374956)
Regarding Claim 5, the combination of references disclosed above teaches the catheter device of claim 2, wherein the first and second distal pull-wire lumens are angularly spaced apart from each other at an angle of less than 180 degrees.
Bogusky teaches a steerable catheter with a single proximal lumen (130; Figure 7C) for housing pull wires (108) that extend to a distal section that has first and second pull wire lumens spaced apart from each other at a angle of less than 180 degrees (Paragraph 0098 discloses an angle of 120 degrees or 90 degrees).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the spacing of the pull wire lumens to be less than 180 degrees by adding more pull wires, as taught by Bogusky, as the advantage of achieving the desired articulation in the distal section (Paragraph 0098; Bogusky).
Allowable Subject Matter
Claims 8-16 are allowed.
The prior art of record fails to disclose:
Regarding Claim 8, Ostrovsky teaches a steerable catheter device, comprising:
a shaft (100; Figures 1-2; Paragraph 0024) having a primary flexing section and a secondary flexing section distally disposed relative to the primary flexing section (see annotated Figure 2 below); and
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first and second pull wires (104L and 104R; Paragraph 0024-0025) extending along a length of the primary flexing section and then extending along a length of the secondary flexing section (See annotated Figure 2 above).
Ostrovsky fails to disclose:
wherein greater tension applied to the first pull wire than the second pull wire is effective to flex the primary flexing section in a first flexing plane and to flex the secondary flexing section in a first direction away from the first flexing plane, and
wherein greater tension applied to the second pull wire than the first pull wire is effective to flex the primary flexing section in the first flexing plane and to flex the secondary flexing section in a second direction away from the first flexing plane.
Claims 9-16 are allowable by dependency to Claim 8.
Claims 19-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record fails to disclose:
Claim 19: the steerable catheter device of claim 18, wherein the side of the flexing plane is a first side, and wherein greater tension is applied to the second pull wire than the first pull wire to flex the primary flexing section of the shaft in the first flexing plane and to flex the secondary flexing section in a third flexing plane on a second side of the first flexing plane.
Claims 20-21 are objected to but allowable by dependency to Claim 19.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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