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 with respect to claim(s) 1-3 and 5-9 have been considered but are moot because the new ground of rejection over Pal et al. 2008/0039728 in view of Summers et al. US 5431673.
Applicant argues Summer discloses a retractable tether or deflector wire 154, but fails to disclose wherein the retractable tether is located “within an interior of the catheter” or “attached to a location within an interior of the catheter on the distal portion” as amended.
However, Summers et al. teaches a catheter device (figure 1) comprising a mechanism wherein the mechanism includes a retractable tether 154 attached to a location on the distal portion 150 (figures 8, 9, column 7, lines 56-59; pull on wire 154). Summer discloses the tether on the exterior (shown in figures 8, 9) or alternatively wherein the deflector wire or tether may extend through a lumen formed in the body of the catheter 12 (column 7, lines 51-52). Therefore, the amendment fails to overcome the prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 3 and 6 discloses wherein the mechanism includes a moveable plunger causing the waveguide to protrude outward from the window in a curved manner. However, claim 1 was amended to include the mechanism including a retractable tether causing the waveguide to protrude outward. The specification and drawings fail to disclose a device comprising both the retractable tether and a plunger in the same embodiment.
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, 5, 6, 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pal et al. 2008/0039728 in view of Summers et al. US 5431673.
Regarding claims 1 and 5, Pal et al. discloses a medical device (system 100, figure 1, paragraph 0081), comprising:(a) a catheter 102 comprising an end-effector (figure 1, region 3), wherein the end-effector further comprises: (i) a proximal portion 140 (figure 3, paragraph 0089); and (ii) a flexible distal portion (paragraph 0098, distal end may be of various flexibility along the length), wherein the distal portion further includes a window formed therein (aperture 110, figure 3); and (b) a flexible ultrasonic waveguide 112 disposed within the end-effector (figure 3, paragraph 0110), wherein the waveguide includes an active zone that extends through the window (wire portion 122 within aperture 110, figures 1, 3); and (c) a mechanism for bending the waveguide, bending the distal portion, or bending both the waveguide and the distal portion (horn 176 for vibrating wire waveguide 112, paragraph 0104; flexible wire 122 bows outward through 110, paragraph 0110), (d) wherein the mechanism permits desired positioning of the waveguide within a lumen (paragraph 0110, wire bows outward to increase efficacy of treatment and positioning relative to the blood vessel wall), but fails to disclose wherein the mechanism includes a retractable tether attached to a location within an interior catheter on the distal portion, wherein retracting the tether causes the distal portion to bow downward, wherein retracting the tether causes the distal portion to bow upward and causes the waveguide to protrude outward from the window in a curved manner.
Summers et al. teaches a catheter device (figure 1) comprising a mechanism wherein the mechanism includes a retractable tether 154 attached to a location on the distal portion 150 (figures 8, 9, column 7, lines 56-59; pull on wire 154), wherein the deflector wire or tether may extend through a lumen formed in the body of the catheter 12 (column 7, lines 51-52), wherein retracting the tether causes the distal portion to bow downward (figure 9, column 7, lines 56-59), wherein retracting the tether causes the distal portion to bow upward (may rotate catheter 180 degrees to result in bowing upward or downward within the vessel) causes the cutter to protrude outward in a curved manner (figure 9, column 7, lines 58-59). Examiner notes the combination would result in the waveguide of Pal extending through the window in a curved manner.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Pal et al. with a mechanism includes a retractable tether attached to a location on the distal portion within the catheter, wherein retracting the tether causes the distal portion to bow downward, and causes the waveguide to protrude outward from the window in a curved manner, as taught by Summers et al., and known in the art to provide a mechanism or retractable tether for bending the waveguide outward in a curved manner for controlled placement within vessel.
Regarding claims 3 and 6, Pal et al. discloses a device essentially as claimed as discussed above, but fails to disclose wherein mechanism includes a moveable plunger attached to a proximal end of the waveguide, wherein depressing the plunger causes the waveguide to protrude outward from the window in a curved manner, or lifting the plunger causes the distal portion to bend downward in a curved manner.
Summers et al. teaches a catheter device (figure 1) comprising a mechanism including a moveable plunger (slide 78) attached to a proximal end of the cutter housing 14 (figure 9, coupled to the wire 154, column 7, lines 47-48), wherein depressing the plunger causes the cutter housing 14 to bend outward in a curved manner (figure 9, column 7, lines 56-65), lifting the plunger causes the distal portion to bend downward in a curved manner (moving plunger 78 back and forth causes the distal portion of cutter to bend, figure 9; rotating the catheter 180 degrees would result in a bend downward within the vessel; column 5, lines 25-29; column 7, lines 45-48) to control the lateral displacement of the cutter 14 against the blood vessel wall (column 5, lines 34-45). Examiner notes the combination would result in the waveguide of Pal extending through the window in a curved manner.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Pal et al. with a mechanism including a movable plunger attached to a proximal end of the waveguide, as taught by Summers et al. and known in the art to provide a mechanism for bending the waveguide outward in a curved manner for controlled placement within vessel.
Regarding claim 8, Pal et al. discloses wherein the active zone of the waveguide is configured to emit ultrasonic energy in radial manner (figure 4C, paragraph 0108).
Regarding claim 9, Pal et al. discloses wherein the device is configured to dissolve thrombi, disrupt and clear atherosclerosis, cut organic tissue, or coagulate organic tissue (occluded region breaks apart, paragraph 0108).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pal et al. 2008/0039728 in view of Summers et al. US 5431673, as discussed above, and further in view of Shturman US 5,554,163.
Regarding claim 2, Pal et al. discloses the device essentially as claimed as discussed above, but fails to disclose further comprising:(a) a first length of flexible tubing inserted into and extending outward from a proximal first wall of the window; and (b) a second length of flexible tubing inserted into and extending outward from a distal second wall of the window, (c) wherein the waveguide extends through both the first and second lengths of flexible tubing.
Shturman teaches a catheter device (figure 1) comprising; a first length of flexible tubing inserted into and extending outward from a proximal first wall of the window (proximal segment of shaft 50 inserted into aperture 16, figures 1, 3, column 6) ; and (b) a second length of flexible tubing inserted into and extending outward from a distal second wall of the window (distal segment of shaft 50 extending through aperture 16, figures 1, 3), (c) wherein the waveguide extends through both the first and second lengths of flexible tubing (wire 30 extends through tubing shaft 50, figure 3, column 7, lines 23-36; for controlled placement of the device and abrasive portion 54 against tissue).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Pal et al. with a first length of flexible tubing inserted into and extending outward from a proximal first wall of the window; and a second length of flexible tubing inserted into and extending outward from a distal second wall of the window, wherein the waveguide extends through both the first and second lengths of flexible tubing, as taught by Shturman, to control placement of the wire guide and abrasive portion for engaging tissue.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pal et al. 2008/0039728 in view of Summers et al. US 5431673, as discussed above, and further in view of Ju et al. US 5725513.
Regarding claim 7, Pal et al. discloses wherein the catheter is an elongated polymeric tubular structure (paragraph 0098), but fails to disclose the structure comprises: (a) an inner lubricious layer disposed within the elongated polymeric tubular structure; (b) a middle reinforcement layer located outside of the inner lubricious layer; and (c) an outer polymer layer located outside of the middle reinforcement layer.
Ju et al. teaches a catheter comprising an elongated polymeric tubular structure comprising: an elongated polymeric tubular structure (a) an inner lubricious layer 28 disposed within the elongated polymeric tubular structure (figure 2, column 4, lines 24-26); (b) a middle reinforcement layer 30 located outside of the inner lubricious layer (sleeve 30, figure 2, column 4, lines 33-35); and (c) an outer polymer layer 32 located outside of the middle reinforcement layer (column 5, lines 3-7), the structure resulting in the desired outer diameter and characteristics (column 5,m lines 34).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Pal et al. with a catheter structure comprising (a) an inner lubricious layer disposed within the elongated polymeric tubular structure; (b) a middle reinforcement layer located outside of the inner lubricious layer; and (c) an outer polymer layer located outside of the middle reinforcement layer, as taught by Ju et al. to provide a catheter structure having the desired diameter and characteristics and stiffness.
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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