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
Applicant's arguments filed 1/5/2026 have been fully considered but they are not persuasive.
Applicant argues on page 8 that the Rudko reference teaches away from using blades. This is accurate, however the claims as amended and prior to amendment do not recite or require blades. Blades have a specific and narrow meaning. The amendment is specific to a cutting edge. Under broadest reasonable interpretation an edge of any kind, sharpened or not, can be considered an edge. In Rudko figures 7 and 8 the optical fiber, considered to be the cutting tool, is comprised of optical fibers. Rudko discloses that these optical fibers 88 each have a distal end, the distal end of each optical fiber is used to resect the valve tissue (see paragraph 0045). Under broadest reasonable interpretation the distal end of each optical fiber, which contacts the valve tissue, can be considered a cutting edge in that it is resecting tissue. Dictionary.com https://www.dictionary.com/browse/resect defines resection as “surgery to cut out part of (a bone, an organ, or other structure or part)”.
The prior art rejections are not withdrawn.
The drawing objections and the 35 USC § 112 rejections are withdrawn in light of the amendments received.
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.
Claims 1, 2, 4, 5 and 25-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rudko et al. US 2004/0260322.
Regarding claims 1, 4 and 31: Rudko discloses a valve leaflet cutting device 80 (“endovascular tissue removal device”, figures 8A, 8B and 9) comprising; an elongated shaft 81 (“multi-lumen catheter”, figures 8A, 8B and 9) which a lumen 82 (figures 8A, 8B and 9) which extends through the catheter 81, a first expandable structure/balloon
(“lower balloon”, figures 8A, 8B and 9) disposed near a distal end of the elongate shaft; a second expandable structure/balloon 92 (figures 8A, 8B and 9) and a cutting tool 88 (figures 8A, 8B and 9 “optical fiber”, “for ablating tissue”, paragraph 0043) coupled to the elongate shaft 80, wherein the cutting tool comprises a cutting edge (the cutting edge is considered to be the distal end of each optical fiber 88), wherein the first and second expandable structures are axially movable relative to each other (figure 9, paragraph 0046), the two balloons are drawn together in order to place the leaflets between the two ballons, the optical fiber is then used to ablate the leaflets as is seen in figure 15, the dotted line is the ablation line which severs the leaflets 102/104.
Regarding claim 2: Rudko discloses a cover sheath 82 (figure 4, “catheter enclosing an optical fiber or waveguide”, the multi-lumen catheter 81 is within the lumen 82) which is positioned over the elongate shaft/catheter 81, the catheter includes centering structure 98 (figures 8A, 8B and 9) which is coupled to the outermost catheter 82), the balloon 98 has both an inflated and deflated sate (paragraph 0043 and 0044).
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Regarding claim 5: Rudko discloses a proximal end of the cutting tool is operably coupled to an external portion of the elongate shaft proximal to a distal end of the elongate shaft (figure 8A). The proximal end of the cutting tool 88 is attached to the multi-lumen catheter 81 via the hub 84, this would be coupling to an external portion, the external portion which is the hub is also proximal to a distal end of the shaft.
Regarding claims 25-26: Rudko discloses that the first expandable balloon and second expandable balloon overlap 91/92 (figure 5). Asi is seen in figure 5, prior to deployment the first and second balloons are housed together, balloon 91 is operably inside of balloon 92. This is also seen in figures 6-7.
Regarding claims 27-28 and 30: Rudko discloses that the first balloon 100 is attached to the distal end of the catheter (figure 8B), the energy absorption layer 112 is part of the balloon 100 and is associated with the cutting device in that the optical fibers 88 and the energy absorption layer work together.
Regarding claim 32: Rudko discloses that the second balloon 92 is associated with spaced fibers considered to be expandable armatures, and the optical fibers are energy emitting components (figure 8B).
Regarding claim 29: Rudko discloses the claimed invention including the limitations of claim 1. Rudko further discloses a tissue cutter 40 connected to the shaft 44 (figure 3) which is powered by a motor to cut the tissue (paragraph 0040). As is discussed in Rudko the optical fibers are an improvement over the cutting blade to aid in preventing the removal of too much tissue (paragraphs 0041-0043). However, it would have been obvious to one of ordinary skill in the art, based on the Rudko disclosure, to include the cutting blades in place of the optical fibers in that this is known prior art admitted and disclosed by Rudko.
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.
Claims 3 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Rudko et al. US 2004/0260322 in view of Hefer US 2015/0216552.
Regarding claims 3 and 24: Rudko discloses the claimed invention however Rudko does not specifically discloses that the centering structure and/or expandable structure is a stent-like structure. Hefer however teaches of a valve repair and replacement device (title and abstract) which includes a stent-like device mounted over a balloon of a balloon catheter. It therefore would have been obvious to include a stent-like structure, as taught by Hefer, in order to provide a gap which allows for blood to flow (paragraph 0013).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796