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 .
Detailed Action
This is in response to the non-provisional application filed 11/01/2023.
Allowable Subject Matter
Claim 7 is 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 following is a statement of reasons for the indication of allowable subject matter: Claim 7 recites wherein the at least one peripheral lumen extends along a first linear path in the proximal-most section, and a second linear path in the distal-most section.
The Office agrees the art of record fails to teach or suggest these features.
Claim Rejections - 35 USC § 102
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) 1-6, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipate by U.S. Patent Publication Number 2020/0383740 (HYODO et al.)
Regarding claims 1-6, 9 HYODO et al. discloses as shown in Figures 1, 3, 4D, 9 an interventional tool, comprising: a delivery catheter defining a central lumen (center lumen 13, see paragraph [0073]) and a plurality of peripheral lumens (lumens 12, see paragraph [0072]) , at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter; see paragraph [0062] and claim 1; and at least one line (one of wires 10, see paragraph [0075]) disposed within the at least one of the plurality of peripheral lumens, the at least one line being capable of actuating a medical device, wherein the plurality of peripheral lumens comprises two peripheral lumens equally spaced from one another and the at least one line comprises two lines, wherein each of the two peripheral lumens extends along a corresponding helical path, wherein the helical path is confined to a bendable section of the delivery catheter, wherein the helical path extends along an entire length of the delivery catheter, wherein the delivery catheter includes a proximal-most section, a bendable section and a distal-most section, the helical path of the at least one peripheral lumen being disposed within the bendable section, wherein the helical path of the at least one peripheral lumen forms more than one full revolution. See paragraph [0065].
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.
Claim(s) 8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2020/0383740 (HYODO et al.)
Regarding claim 8, Hyodo et al. fails to disclose wherein the helical path of the at least one peripheral lumen has a pitch of between 1 revolution per inch and 2 revolutions per inch.
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 interventional tool disclosed by Hyodo et al. such that the helical path of the at least one peripheral lumen has a pitch of between 1 revolution per inch and 2 revolutions per inch as a matter of engineering design choice.
Applicant has not disclosed that the pitch being between 1 revolution per inch and 2 revolutions per inch apart provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0074]. One of ordinary skill in the art, furthermore, would have expected Hyodo et al.’s pitch, and applicant’s invention, to perform equally well with either configuration because both spacing dimensions would perform the same function of guiding a wire through the catheter equally well given the relative dimensions disclosed.
Regarding claim 10, Hyodo et al. fails to wherein the helical path of the at least one peripheral lumen forms more than five full revolutions.
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 interventional tool disclosed by Hyodo et al. such that the helical path of the at least one peripheral lumen forms more than five full revolutions as a matter of engineering design choice.
Applicant has not disclosed that the helical path of the at least one peripheral lumen forming more than five full revolutions provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraphs [0072], [0074]. One of ordinary skill in the art, furthermore, would have expected Hyodo et al.’s revolutions, and applicant’s invention, to perform equally well with either configuration because both spacing dimensions would perform the same function of guiding a wire through the catheter equally well given the relative dimensions disclosed.
Claim(s) 1, 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0257883 (Basude et al.) in view of U.S. Patent Publication Number 2020/0383740 (HYODO et al.)
Regarding claim 1, Basude et al. discloses as shown in Figures 20, 21, 23 an interventional tool, comprising: a delivery catheter (shaft 302, see paragraph [110]) defining a central lumen (lumen holding 326, see Figures 21, 23) and a plurality of peripheral lumens (lumens 342, 340, see paragraphs [0112], [0113]); and at least one line (lines 90, see paragraph [0083]) disposed within the at least one of the plurality of peripheral lumens, the at least one line being configured to actuate a medical device.
Basude et al. fails to disclose at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter.
Hyodo et al., from the same field of endeavor teaches a similar interventional tool as shown in Figures 1, 3, 4D, 9 where a plurality of peripheral lumens (lumens 12, see paragraph [0072]) , at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter, for the purpose of configuring the friction between the wires and the inner surfaces of the lumens to not greatly change depending on the forms in which the inserted portion is bent. see paragraphs [0062], [0069]. and claim 1.
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 interventional tool disclosed by Basude such that at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter in order to configure the friction between the wires and the inner surfaces of the lumens to not greatly change depending on the forms in which the inserted portion is bent, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 11-16, Basude discloses a system comprising: the interventional tool of claim 1; and a medical device (fixation device 14, see paragraph [0082]) comprising two arms (leg 68, see paragraph [0079]) and two proximal elements (proximal elements 16, see paragraph [0066]), at least one of the proximal elements being coupled to the at least one line of the interventional tool, wherein the at least one line comprises two lines, each of the two lines being coupled to a selected one of the two proximal elements, wherein the two lines comprise wires, wherein the two lines are configured to actuate the two proximal elements to move them with respect to the two arms, wherein the medical device is a fixation device, wherein the medical device is a mitral clip.
Regarding claims 17, 18, 20 Basude et al. discloses as shown in Figures 20, 21, 23 a method of actuating a medical device, comprising: providing an interventional tool including a delivery catheter (shaft 302, see paragraph [110]) defining a central lumen (lumen holding 326, see Figures 21, 23) and a plurality of peripheral lumens (lumens 342, 340, see paragraphs [0112], [0113]), at least one line disposed within the at least one of the plurality of peripheral lumens; and pulling the at least one line (lines 90, see paragraph [0083]) to actuate a medical device (fixation device 14, see paragraph [0082]), wherein the medical device comprises two arms (leg 68, see paragraph [0079]) and two proximal elements (proximal elements 16, see paragraph [0066]), and wherein pulling the at least one line comprises moving a first of the two proximal elements with the at least one line, wherein the plurality of peripheral lumens comprises two peripheral lumens equally spaced from one another, and wherein pulling the at least one line comprises passing the at least one line through one of the two peripheral lumens. See paragraph [0092].
Basude et al. fails to disclose at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter
Hyodo et al., from the same field of endeavor teaches a similar interventional tool as shown in Figures 1, 3, 4D, 9 where a plurality of peripheral lumens (lumens 12, see paragraph [0072]) , at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter, for the purpose of configuring the friction between the wires and the inner surfaces of the lumens to not greatly change depending on the forms in which the inserted portion is bent. see paragraphs [0062], [0069]. and claim 1.
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 method disclosed by Basude such that at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter in order to configure the friction between the wires and the inner surfaces of the lumens to not greatly change depending on the forms in which the inserted portion is bent, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 19, Basude discloses wherein the medical device comprises two arms and two proximal elements, wherein the at least one line comprises two lines. See paragraph [0083]
Basude fails to disclose wherein pulling the at least one line comprises moving each of the two proximal elements independently.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Basude such that wherein pulling the at least one line comprises moving each of the two proximal elements independently as obvious to try because it represents choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Lines can only be moved in tandem or independently. It necessarily follows that pulling the at least one line comprises moving each of the two proximal elements independently represents choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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