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, see page 2, filed 01/27/2026, with respect to the rejection(s) of claim(s) 1 and 28 under Vale have been fully considered and are persuasive. The examiner agrees that Vale fails to disclose “wherein, where at least a portion of the at least one protrusion and the inner surface of the outer catheter are in contact, no plane transverse to a longitudinal axis of the inner catheter has a full 360-degree friction fit between the at least one protrusion and the inner surface of the outer catheter” as required by claims 1 and 28. Therefore, the rejection has been withdrawn. Independent claim 28 is in condition for allowance since Vale is the closest prior art that discloses a chevon shaped seal, but fails to disclose or suggest the required limitation above. However, upon further consideration, a new ground(s) of rejection is made over Look et al. (US 20170100142) in view of Voda (US 5354271) and evidenced by Shipp (US 20190282221) for the rection of claim 1.
Claim Objections
Claims 1, 21-23, 33, and 35 are objected to because of the following informalities:
Claim 1, line 10: “an inner surface of the outer surface” which should recite “the inner surface of the outer surface”.
Claim 1, lines 17 and 19: “the at least one protrusion” which should recite “the at least one annular protrusion”.
Claim 21 (line 2) and claim 22 (line 2): “the second plane” which should recite “a plane”.
Claim 23 (line 2), claim 33 (line 2), and claim 35 (line 2): "a longitudinal axis of the inner catheter" which should recite "the longitudinal axis of the inner catheter".
Appropriate correction is required.
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) 1, 21-23 and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Look et al. (US 20170100142) [hereinafter Look] in view of Voda (US 5354271) and evidenced by Shipp (US 20190282221).
Regarding claim 1, Look discloses a sealed neurovascular extendable catheter (Figs. 1-2, para. 0094) comprising:
an outer catheter 108 having a proximal end 144 (see Fig. 3, para. 0095) and a distal end 120 (Fig. 1, para. 0094);
an inner catheter 106 having a proximal end 118 and a distal end 116 and extendable through the outer catheter 108 such that the distal end 116 of the inner catheter 106 is configured to extend beyond the distal end 120 of the outer catheter 108 (Fig. 4, para. 0094: “The thrombectomy catheter 106 comprises a distal tube 114 which is configured to be extendable out of the inner lumen 110 of the guiding catheter 108, such that a distal end 116 of the distal tube 114 can be advanced a desired length into the blood vessel 102 so that it can be placed adjacent the target area 112”);
an annular gap G (best shown in Fig. 11) between an outer surface of the inner catheter 106 and an inner surface of the outer catheter 108 (para. 0098: “The thin-walled construction of the distal tube 114 allows a finite gap G between the distal tube 114 and the inner lumen 110 of the guiding catheter 108, while still maintaining a relatively large lumen 130 in the distal tube 114”); and
a seal 124 positioned on the outer surface of the inner catheter 106 (Fig. 4, para. 0095: “A sealing member 124 is carried by the proximal end 118 of the distal tube 114, and may comprise, for example, an annular seal attached to an outer cylindrical surface 122 of the distal tube 114”), the seal 124 configured to fluidly seal at least a portion of a length of the annular gap G formed between the outer surface of the inner catheter 106 and an inner surface of the outer catheter 108 (para. 0095: “The sealing member 124 is configured to seal off an annulus 142 between the distal tube 114 and an inner surface 123 defined by the inner lumen 110 of the guiding catheter 108 so that an extended lumen 128 is created, at least when a negative pressure gradient is placed between the proximal end 144 (FIGS. 4 and 6) of the guiding catheter 108 and the distal end 116 of the distal tube 114”),
the seal 124 comprising at least one annular protrusion (para. 0122: “the sealing member 124 may be an inflatable balloon, whose diameter and/or inflation pressure may be controlled”) extending around a circumference of the inner catheter (para. 0095: “A sealing member 124…may comprise, for example, an annular seal attached to an outer cylindrical surface 122 of the distal tube 114”) and a thickness configured to allow axial translation of the inner catheter 106 relative to the outer catheter (para. 0103: “the sealing member 124 may be an inflatable balloon, whose diameter and/or inflation pressure may be controlled” such that the thickness of the seal 124 may be varied to allow axial translation. This is supported by para. 0103: “. In some embodiments, the outer diameter may be in close clearance relation to the inner diameter of the guiding catheter 108. In some embodiments, the outer diameter may be in a non-touching relation to the inner diameter of the guiding catheter 108. In some embodiments, there may me multiple features, having a combination of these relationships (rubbing, touching, etc.)” and para. 0081 which discloses another seal capable of being expanded and collapsed: “The benefit of having a distally facing lip 166 whose maximum outer diameter is smaller than the inner diameter of the inner lumen 110 of the guiding catheter 108 (when not activated by pressure), is that during tracking of the thrombectomy catheter 106, when the vacuum source 146 is not being applied, there is no seal between the distally facing lip 166 and the inner wall 168 of the guiding catheter 108, and thus there is less axial friction, thus making it easier to track and slide the thrombectomy catheter freely (longitudinal translation), providing both low axial resistance to motion (less drag), and high precision of motion (better “feel”).
Look further discloses that the seal 124 is oriented perpendicular to the longitudinal axis of the inner catheter 106 relative to the outer catheter 104 (see Figs. 11 and 15 for example; however, all of Look’s seal embodiments are oriented perpendicularly). However, Look fails to disclose that the seal may have an angled orientation such that the seal comprises a proximal edge comprising a proximal tip pointing in a proximal direction and a distal edge comprising a distal tip pointing in a distal direction; wherein, where at least a portion of the at least one protrusion and the inner surface of the outer catheter are in contact, no plane transverse to a longitudinal axis of the inner catheter has a full 360-degree friction fit between the at least one protrusion and the inner surface of the outer catheter.
Voda in the same field of endeavor of annular expandable seals teaches that it is known in the art to orient an annular inflatable sealing balloon 46 disposed on a tubular member 36 at an acute angle 50 relative to a longitudinal axis 44 of the tubular member (see Fig. 5, col. 4 lines 34-39: “The vascular sheath apparatus 28 includes an annular inflatable sealing balloon 46 disposed about the sheath 36 and expandable radially outward beyond the outer surface 42 of sheath 36. As best seen in FIG. 5, the sealing balloon 46 lies in a plane 48 oriented at an acute angle 50 to the longitudinal axis 44 of sheath 36”) as a known orientation in the art of seals. Due to the orientation of the seal, the seal comprises a proximal edge comprising a proximal tip pointing in a proximal direction and a distal edge comprising a distal tip pointing in a distal direction (see annotated Fig. 5 of Voda below).
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Annotated Fig. 5 of Voda
The combination of Look and Voda would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that changing the angular orientation of the inflatable seal, as taught by Voda, would still allow the seal of Look engage the inner lumen of the outer catheter and thereby seal the space between the inner catheter and the outer catheter as intended by Look (para. 0095 of Look); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination of Look and Voda would also result in a product wherein, where at least a portion of the at least one protrusion and the inner surface of the outer catheter are in contact, no plane transverse to the longitudinal axis of the inner catheter has a full 360-degree friction fit between the at least one protrusion and the inner surface of the outer catheter due to the angled orientation of the seal, as taught by Voda. This is evidenced by Shipp which teaches that having an angled sealing element 22 that contacts the inner surface of a tubular member 100 would result in no plane transverse to the longitudinal axis of the inner catheter having the full 360-degree friction fit as claimed (see Fig. 6, para. 0074 of Shipp).
Regarding claim 21, modified Look discloses wherein the distal edge lies on a second plane that is inclined relative to the longitudinal axis of the inner catheter (see annotated Fig. 5 [1] of Voda below).
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Annotated Fig. 5 [1] of Voda
Regarding claim 22, modified Look discloses wherein the second plane resides at an angle within a range of from about 20 to about 50 degrees from the longitudinal axis (col. 4 lines 39-40 of Voda: “Angle 50 is preferably in the range of 30 degrees to 60 degrees”).
Regarding claim 23, modified Look discloses wherein the proximal edge lies on a plane (interpreted as the second plane shown above in Fig. 5 [1] of Voda) that is inclined relative to a longitudinal axis of the inner catheter (see annotated Fig. 5 [1] of Voda above).
Regarding claim 40, modified Look discloses wherein the at least one annular protrusion comprises a uniform thickness (The examiner notes that an inflatable balloon seal, as shown in Voda, has a uniform thickness along it’s entire surface such that a cross-section of the balloon perpendicular to the longitudinal axis would result in a circle).
Regarding claim 41, modified Look discloses wherein the at least one annular protrusion comprises a variable thickness (The examiner notes that an inflatable balloon seal, as shown in Voda, has a variable thickness due to the rounded edge of the balloon such that the thickness tapers from a center of the balloon to an outer edge of the balloon).
Regarding claim 42, modified Look discloses wherein the at least one annular protrusion is at least partially hollow (see Fig. 15 of Lookfor example which illustrates an annular protrusion being partially hollow to allow the inner catheter to be disposed therethrough, para. 0078: “an annular seal attached to an outer cylindrical surface 122 of the distal tube 114”).
Allowable Subject Matter
Claims 28-35 are allowed.
Claim 39 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. Regarding claim 39, modified Look fails to disclose or suggest “wherein the at least one annular protrusion comprises a chevron-shaped protrusion”. As stated in the previous action, Vale teaches a chevron-shaped protrusion (see Fig. 13c of Vale). However, Vale’s chevron-shaped seal is an annular lip such that a plane transverse to a longitudinal axis of the inner catheter would have a full 360-degree friction fit between the seal and the inner surface of the outer catheter (para. 0092 of Vale).
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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