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) 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Gray is no longer relied upon to disclose or teach the claimed “valve sleeve” or “vent” limitations contested in Applicant’s submitted arguments.
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.
Claim(s) 14-18 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolenberg (US 2020/0146858 A1) in view of Gray (US 2015/0216533 A1) (previously of record).
Regarding claim 14, Wolenberg discloses:
A method of embolization, comprising:
(a) providing a catheter (catheter 10, see Fig. 1A) including a balloon device (portion of the catheter comprising balloon 22b, see Fig. 1A) disposed on a distal end of the catheter (see Fig. 1A);
wherein the balloon device includes:
a cannula (distal end 16, see Fig. 1A) secured to the distal end of the catheter (see Fig. 1A), the cannula including an inflation port (inflation port 34, see Fig. 1B), a tubular balloon (balloon 22b, see Fig. 1A) disposed on the cannula (see Fig. 1B), and a valve sleeve (balloon 22a, see Fig. 1A) disposed between the tubular balloon and the cannula (see Figs. 1A-1B), the valve sleeve including a vent forming a hole on the valve sleeve (openings 29, see Para. [0043]-[0045]);
wherein the inflation port and the hole are offset from one another by an axial distance relative to a center axis of the cannula (see Fig. 1B showing wherein the openings 29 are axially offset from inflation ports 34);
(b) inserting the balloon device and the catheter into vasculature of a patient and locating the balloon device in or near a target location (see Para. [0025]);
(c) introducing a fluid through the catheter, such that the fluid travels along the axial distance between the outer surface of the cannula and the inner surface of the valve sleeve and into the tubular balloon, thereby inflating the tubular balloon at the target location (see Para. [0042]).
However, Wolenberg does not expressly disclose:
Wherein the balloon device is detachable from the proximal catheter shaft body;
(d) sealing the balloon device during inflation such that the fluid becomes trapped inside the inflated detachable balloon device;
(e) detaching the catheter from the cannula; and
(f) withdrawing the catheter from the vasculature while leaving the detached cannula and inflated tubular balloon at or near the target location inside the vasculature.
In the same field of endeavor, namely balloon catheter devices disposed within blood vessels, Gray teaches wherein a balloon catheter device (see Fig. 1) comprising a catheter body (catheter 10, see Fig. 1) and a distal cannula (tubular member 52, see Figs. 3-5) detachably connected thereto (see Para. [0028] and [0039]) and a plurality of inflation ports disposed along the distal cannula (inflation ports 60, see Figs. 3 and 6B and Para. [0038]-[0040]) in communication with an overlying balloon (balloon 32, see Fig. 3 and Para. [0038]-[0040]) and a plurality of sealing members (flaps 64 disposed on annular member 68, see Fig. 6B and Para. [0039]-[0040]) disposed over each of the plurality of inflation ports and configured to seal the balloon during the inflation process by opening during immediate fluid ingress into the balloon while closing and sealing each inflation port in the absence of an immediate inflation media, remaining closed to prevent fluid from leaking out from the balloon (see Para. [0039]-0040]), wherein the distal cannula is detachable from the proximal catheter shaft to be left in a desired location within the vasculature while the proximal catheter body is withdrawn (see Para. [0028] and [0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Wolenberg to have the distal portion thereof be detachable from the proximal catheter, as taught and suggested by Gray, to allow the balloon device to be left in a desired location for further procedures (as mentioned in Wolenberg Para. [0023]) while the proximal catheter body may be withdrawn from the vasculature (see Gray Para. [0028] and [0039]); wherein the valve sleeve inner balloon (22a) be modified to include a plurality of flaps covering each of the tubular inflation ports to form a seal over each inflation port when not providing inflation media to the balloons to prevent fluid from leaking out from the balloon devices (see Gray Para. [0039]-[0040]).
Regarding claim 15, the combination of Wolenberg and Gray disclose the method of claim 14, Wolenberg further discloses wherein the cannula includes a first axial lumen (inflation lumen 18a, see Fig. 1B and Para. [0027]) and second axial lumen (lumen 18b, see Fig. 1B and Para. [0028]).
Regarding claim 16, the combination of Wolenberg and Gray disclose the method of claim 14, Wolenberg, as modified by Gray, further discloses wherein the cannula is detachably secured to the catheter in a friction fit (see Gray Para. [0043] and [0047] mentioning wherein the tubular member is secured to the proximal shaft via frictional forces).
Regarding claim 17, the combination of Wolenberg and Gray disclose the method of claim 14, Wolenberg further discloses wherein introducing a the fluid through the catheter includes: the valve sleeve expanding to permit fluid to travel, along the axial distance, inside a local plenum formed between the valve sleeve and the cannula (see Para. [0027] and [0043]; and the fluid passing through the vent into the tubular balloon (see Para. [0043]).
Regarding claim 18, the combination of Wolenberg and Gray disclose the method of claim 14, Wolenberg further discloses wherein sealing the detachable balloon device during inflation comprises forming a positive pressure inside the tubular balloon that further presses the valve sleeve against the cannula (during and post-inflation, balloon (22b) would apply a radially-inward pressure to the valve sleeve (22a) that would aid in securing the valve sleeve to the cannula body, especially when abutting against portions of the vasculature that radially compress against the balloon).
Regarding claim 21, the combination of Wolenberg and Gray disclose the method of claim 14, Wolenberg further discloses wherein the inflation port and the vent are angularly offset from one-another by an angular distance relative to the center axis of the cannula (see Fig. 1B showing wherein the identified ports 29 and 34 are axially offset from one-another), such that when the fluid is introduced through the catheter, the fluid travels along the angular distance between the outer surface of the cannula and the inner surface of the valve sleeve (as the identified ports 29 and 34 are axially offset from one-another as shown in Fig. 1B, inflation fluid would travel along an axial distance of the valve sleeve between the two ports).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolenberg (US 2020/0146858 A1) in view of Gray (US 2015/0216533 A1) (previously of record), further in view of Williamson (US 2016/0089518 A1) (previously of record) in further view of Tegg (US 2013/0296781 A1) (previously of record).
Regarding claim 20, the combination of Wolenberg and Gray discloses all of the limitations of the method of claim 14.
However, Wolenberg does not expressly disclose manipulating a nickel titanium wire disposed in the catheter, thereby partially deflating the inflated detachable balloon device.
In the same field of endeavor, namely balloon catheters, Williamson teaches a wire (ripcord 360, see Figs. 3A-3B) that attaches to an interior surface of a balloon (balloon 140, see Figs. 3-4, see also Para. [0029]-[0030]) that can be used to rapidly deflate the balloon when actuated (see Para. [0041] and [0044]) which causes rapid, but controlled deflation of the balloon and restores blood flow through the target lumen or valve (see Para. [0044]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter device of Wolenberg to a ripcord within the instrument lumen 18b that attaches to the interior surface of the balloon as taught and suggested by Williamson to, in this case, allow for rapid, faster deflation times that cause deflation of the balloon in a controlled manner that rapidly restores blood flow through the target lumen (see Williamson Para. [0041] and [0044]). Such a modification would facilitate the removal of balloons that may have become stuck and limits the time a procedure restricts blood flow to vital organs (see Williamson Para. [0024]).
However Williamson expressly disclose wherein the wire is a nickel titanium (nitinol) wire.
In the same field of endeavor, namely catheter devices, Tegg teaches wherein wires (pull wires 40 and 42, see Fig. 7) may be comprised of nitinol (see Para. [0060]).
Therefore, 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 ripcord of Williamson, as incorporated into the device of Wolenberg, to be made of nitinol as disclosed by Tegg, since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2017/0056090 A1 to Eum, US 2004/0267338 A1 to Harrison, US 2004/0064093 A1 to Hektner and US 6811559 B2 to Thornton all disclose occluding balloon catheters having some sort of sleeve mechanism for controlling inflation into the outer balloon device.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./ Examiner, Art Unit 3771
/DARWIN P EREZO/ Supervisory Patent Examiner, Art Unit 3771