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 § 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 1, 3-18, and 20 are 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 1 recites the first steering cable is 180 degrees from both the first return cable and the second steering cable. Claim 20 recites the second steering cable is 180 degrees from both the second return cable and the first steering cable. It is not clear how one component can be 180 degrees from two different components around the circumference of a ring. For purposes of the rejection the first return and steering cables are taken to be 180 degrees from each other and the second return and steering cables are taken to be 180 degrees from each other. Claim 20 recites in the second to last line recites “the second control member” however, this is believed to be “the third control member.”
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.
Claim(s) 1, 3-11, 14-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shia et al. (US 2022/0126060 A1) in view of Shaolian et al. (US 2024/0316318 A1).
With regard to claim 1, Shia et al. teach a medical device delivery system comprising: a steering catheter including: a first steering ring having a proximal end, a distal end, an outer surface, an inner surface, a wall defined between the outer surface and inner surface, and a central lumen defined by the inner surface along a longitudinal direction (Fig. 2C member 140); a plurality of apertures positioned in the wall of the first steering ring, the plurality of apertures positioned at spaced distances around a circumference of the first steering ring (Fig. 2C members 151-159); a first steering cable passing through a first aperture of the plurality of apertures (Figs. 2B and 2C member 115 passing through 151); a first return cable passing through a second aperture of the plurality of apertures, wherein the first return cable is positioned at an offset from a position that is 180 degrees from the first steering cable (Figs. 2B and 2C member 115 passing through 156); a second steering cable passing through a third aperture of the plurality of apertures, wherein the first steering cable is positioned about 180 degrees from the second steering cable (Figs. 2B and 2C member 115 passing through 153, degree position not considered as rejected under 112 above); a second return cable passing through a fourth aperture of the plurality of apertures, wherein the second return cable is positioned at an offset from a position that is 180 degrees from the second steering cable (Figs. 2B and 2C member 115 passing through 158); and a handle operably coupled to a proximal end of the steering catheter (Fig. 1B member 5). Shia et al. teach member 5 may include one or more dials to control the bending of the steerable section ([0063], exemplary Fig. 1B member 52) but do not explicitly disclose two handles which rotate to control the first and second steering and return cables. However, Shaolin et al. teach steering knobs may be connected to actuation elements connected to wires to control pulling and pushing of opposing actuation wires ([0245]-[0246], Figs. 23-26). This is beneficial for assisting the operator in straightening a curved portion for steering and redirecting the catheter ([0246]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the plurality of dials as disclosed by Shia et al. coupled to opposing steering elements as in Shaolin et al. as the bidirectional movement is beneficial for assisting the operator in straightening a curved portion for steering and redirecting the catheter. This would yield the same predictable result of steering the catheter.
With regard to claims 3, 4, and 16, see Figs. 2B and 2C members 115 passing through 152 and 157, as combined above these would be connected to a third control member.
With regard to claims 5-8, see Fig. 2C member 130, some members 115 continue through 130 through additional holes which may be diametrically opposed.
With regard to claims 9-11, and 17, see Fig. 2C member 120, some members 115 continue through 120. The first dial may control wires connected to the first ring, the second dial may control wires connected to the second ring, and the third dial may control wires connected to the third ring. If the offset angle were not found to be as recited one of ordinary skill in the art further would be able to select the number and placement of cables as needed for desired bending control.
With regard to claims 14, 15, and 18, see Fig. 1 member 3 sections corresponding to the various rings, the hyoptube may be laser cut with various liners ([0069]).
With regard to claim 20, Shia et al. teach a medical device delivery system comprising: a steering catheter including: a first steering ring having a proximal end, a distal end, an outer surface, an inner surface, a wall defined between the outer surface and inner surface, and a central lumen defined by the inner surface along a longitudinal direction (Fig. 2C member 140); a plurality of apertures positioned in the wall of the first steering ring, the plurality of apertures positioned at spaced distances around a circumference of the first steering ring (Fig. 2C members 151-159); a second steering ring, the second steering ring spaced apart from the first steering ring in a longitudinal direction and including a proximal end, a distal end, an outer surface, an inner surface, a wall defined between the outer surface and inner surface, a central lumen defined by the inner surface along a longitudinal direction, and a plurality of apertures positioned in the wall at spaced distances around a circumference of the second steering ring (Fig. 2C member 130); a third steering ring, the third steering ring spaced apart from the first steering ring and the second steering ring in a longitudinal direction and including a proximal end, a distal end, an outer surface, an inner surface, a wall defined between the outer surface and inner surface, a central lumen defined by the inner surface along a longitudinal direction, and a plurality of apertures positioned in the wall at spaced distances around a circumference of the third steering ring (Fig. 2C member 120); a first steering cable passing through a first aperture of the plurality of apertures, wherein the first steering cable extends through a first aperture of the third steering ring and the first return cable extends through a second aperture of the third steering ring (Figs. 2B and 2C one of wires 115 extending through 140, 130, and 120); a first return cable passing through a second aperture of the plurality of apertures (Figs. 2B and 2C another of members 115 extending through 140, 130, and 120); a second steering cable passing through a third aperture of the plurality of apertures, wherein the first steering cable is positioned about 180 degrees from the second steering cable (Figs. 2B and 2C another of members 115 extending through 140 across from the first steering cable); a second return cable passing through a fourth aperture of the plurality of apertures (Figs. 2B and 2C another of members 115 extending through 140); a third steering cable passing through a fifth aperture of the plurality of apertures of the first steering ring and a third return cable passing through a sixth aperture of the plurality of apertures (Figs. 2B and 2C another of members 115 extending through 140); and a handle operably coupled to a proximal end of the steering catheter (Fig. 1B member 5). Shia et al. teach member 5 may include one or more dials to control the bending of the steerable section ([0063], exemplary Fig. 1B member 52) but do not explicitly disclose two handles which rotate to control the first and second steering and return cables. However, Shaolin et al. teach steering knobs may be connected to actuation elements connected to wires to control pulling and pushing of opposing actuation wires ([0245]-[0246], Figs. 23-26). This is beneficial for assisting the operator in straightening a curved portion for steering and redirecting the catheter ([0246]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the plurality of dials as disclosed by Shia et al. coupled to opposing steering elements as in Shaolin et al. as the bidirectional movement is beneficial for assisting the operator in straightening a curved portion for steering and redirecting the catheter. This would yield the same predictable result of steering the catheter.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shia et al. (US 2022/0126060 A1) and Shaolian et al. (US 2024/0316318 A1) as applied to claim 9 above, and further in view of von Oepen et al. (US 2020/0155804 A1).
With regard to claims 12 and 13, Shia et al. teach a device substantially as claimed but do not disclose the steering cables to be paired. However, von Oepen et al. teach pairing cables (Fig.1 19A pairs 822 routed through steps 824) which reduces the need to rely on welding or adhesive to attach cables ([0112]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use paired cables and apertures separated by steps in Shia et al. as von Oepen et al. teach this is beneficial for reducing the need to rely on welding or adhesive to attach cables. One of ordinary skill in the art further would be able to select the number and placement of cables as needed for desired bending control.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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