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, 12, 14 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samson et al. (Samson: Pub. No. 2004/0143312).
Regarding claim 1, Samson discloses a method of operating a medical device, the method comprising: positioning a distal end of a medical device at a target area (vasculature), the medical device including a first lumen 103 or 107 and a second lumen 105, wherein the first lumen is in fluid communication with a distal end of the medical device (pars. 0009 and 0054: heat exchanging medium/fluid), and wherein a distal portion of the medical device includes side ports 109; supplying fluid through the first lumen (delivery lumen for fluid exchange); and applying suction through the second lumen (return lumen; par. 0096: suction applied).
Regarding claim 2, see claim 8 (laser ablation) as well as par. 0010.
Regarding patentably indistinct claim 12, note the comments above with respect to similarly worded limitations.
Regarding claim 14, see Figs. 1 and 2 (distal end of second lumen), as well as par. 0054 which discloses the recited fluid isolation.
Regarding claim 15, see Fig. 6 showing both a distal front face (the face applied to the targeted tissue) including a plurality of first openings (those plurality of openings allowing fluid flow in direction 90) and a side opening defining fluid flow in direction 84).
Claim(s) 1-3, 12, 14, 16 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hasson (Pat. No. 5,129,896).
Regarding claim 1, Hasson discloses a method of operating a medical device, the method comprising: positioning a distal end of a medical device at a target area (targeted tissue), the medical device including a first lumen (the lumen created within sleeve 18) and a second lumen 62, wherein the first lumen is in fluid communication with a distal end of the medical device (see Fig. 1), and wherein a distal portion of the medical device includes side ports 58; supplying fluid through the first lumen (through space 50); and applying suction through the second lumen (vacuum source pulling fluid and debris into opening 64 in direction 66).
Regarding claim 3, Hasson shows the insertion of the laser fiber within a conduit/channel of a laser fiber holder 32 (see Fig. 3). The conduit includes a first proximal hole and a second distal hole opposite the first proximal hole (i.e., the channel/lumen of the holder includes diametrically opposed holes in order to allow the laser fiber to be inserted therethrough). A proximal portion of the holder (male portion 34) extends circumferentially around the conduit/channel/lumen as seen in Fig. 3 to form the first proximal hole. The proximal portion is considered to be removably coupled to a distalmost end of the first lumen by virtue of its threaded connection.
Regarding claim 12, note the comments made above in the rejection of related limitations in claim 1.
Regarding claim 16, Hasson discloses a method of operating a medical device, comprising: positioning a distal end of a medical device at a target area (targeted tissue), the medical device including a first lumen (the lumen created within sleeve 18) and a second lumen 62, wherein the first lumen is in fluid communication with a first opening at a distal end of the medical device; inserting a laser fiber 16 in the first lumen and extending the laser fiber through a laser fiber holder 32 and through the first opening (see Fig. 3), and initiating the laser fiber (inherently required for intended therapy).
While it is not explicitly stated that the laser fiber holder is removably coupled to a portion of the medical device defining the first opening, the mechanism is attached through a threaded connector (see text abridging cols. 4 and 5). A threaded connector is considered to inherently permit removable coupling by virtue of the fact that such connectors may be selectively operated in either a tightening or loosening direction.
Regarding claim 20, cup-shaped wall portion 26, which may be considered a part of the laser fiber holder, is considered to be tapered inwardly towards the distal aperture.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9-11, 13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassan ‘896 in view of Kassab et al. (Pub. No. 2010/0160719).
Regarding claims 9 and 13, while Hassan does not disclose the recited recess, Kassab discloses in a related device that injection apertures may be positioned within grooves/recesses to prevent or minimize tissue adhesion and/or contact with one or more of the apertures (par. 0172). Artisans desiring to prevent or minimize tissue adhesion and/or contact with the one or more apertures, would have considered such a feature to be a matter of obvious design.
Regarding claim 10, the first and second lumens are defined by an outer wall of tube 14. The lumens are fluidically isolated from each other along the length of the sleeve 18.
Regarding claims 11 and 19, Hassan discloses a plurality of side ports 58 that may be obliquely angled to produce a more random fluid shower (col. 5, lines 44-58). It would have been obvious to angle at least a plurality of the ports toward the distal working end of the medical device in order to better cool the laser and handle the debris nearest the targeted region. Regarding the use of a recess, note the comments above in the rejection of claim 9. Artisans desiring to improve cooling, debris handling and prevent or minimize tissue adhesion and/or contact with the one or more apertures, would have considered such a feature to be a matter of obvious design.
Allowable Subject Matter
Claims 4-8, 17 and 18 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.
Regarding claim 4, there is no suggestion in the prior art to modify the laser fiber holder of Hassan to include the recited tapered shape.
Regarding claim 5, there is no suggestion in the prior art to include a third hold in the radial surface of the laser holder conduit. A similar comment applies to claim 17.
Regarding claims 7 and 18, there is no teaching in the art of record for the recited transitioning step. Such a feature allows the laser holder to be entirely disposed within the first lumen upon insertion into the patient’s body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
June 27, 2026
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