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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/1/2026 has been entered.
Response to Arguments
Applicant's arguments filed 4/1/2026 with regards to the 35 USC 103 rejection of claim 14 under Wolenberg (US 2020/0146858 A1) (previously of record) in view of Gray (US 2015/0216533 A1) (previously of record) have been fully considered but they are not persuasive.
Regarding claim 14, Applicant contends that none of either Wolenberg or Gray expressly disclose the amended limitations of “the valve sleeve fits tightly against the cannula over the inflation port when the balloon is inflated” on the grounds that the “valve sleeve” (i.e., balloon 22a) of Wolenberg is configured to expand and “loosely flow” about the tubular member during inflation and thus is not “tightly fitted” against the cannula during or post-inflation. Applicant additionally contends that the disclose of Gray does not remedy this deficiency. The Examiner respectfully disagrees in light of the currently applied claim language. The cited limitations are viewed to require the balloon be tightly fitted to the cannula, once inflated, while being disposed over the inflation port(s). The Examiner contends that Wolenberg discloses these amended limitations in Figs. 1A-1B and Para. [0029]-[0030] mentioning wherein the proximal and distal ends of balloon 22a are secured to the distal portion 16 of the catheter 10 such that no inflation media is permitted to leak into the external biological environment during inflation or use and is thus understood to constitute a “tight connection” to the distal end of the catheter while being over the inflation port(s) which are disposed within the internal space of the balloon 22a.
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, 21-26 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolenberg (US 2020/0146858 A1) (previously of record) 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 portion 16 of catheter 10 upon which balloons 22a and 22b are disposed, see Fig. 1A) secured to the distal end of the catheter (see Fig. 1A showing wherein distal end portion 16 is secured to the distal end of the catheter main body 10), the cannula including an inflation port (inflation port 34A, see Fig. 1B and Para. [0042]), 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 showing wherein balloon 22a is disposed between balloon 22b and the distal end portion 16 of the catheter 10; see also Para. [0032]), 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 34A);
(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] mentioning wherein inflation media enters balloon 22a through inflation port(s) 34A before entering balloon 22b through opening(s) 29; as the two ports are axially offset from one another, combined with fluid’s tendency to disperse within an open space to achieve equilibrium, the inflation fluid is understood to travel along an axial distance between the outer surface of the distal end portion of the catheter and an inner surface of balloon22a before entering balloon 22b);
wherein the valve sleeve fits tightly against the cannula over the inflation port when the balloon is inflated (see Para. [0029]-[0030] mentioning wherein the proximal and distal ends of balloon 22a are secured to the distal portion 16 of the catheter 10 such that no inflation media is permitted to leak into the external biological environment during inflation or use and is thus understood to constitute a “tight connection” to the distal end of the catheter and over the inflation port which is disposed within the internal space of the balloon 22a).
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:
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 end portion (16) thereof be detachable from the proximal portion of the 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]); in making such a combination, one would further modify the valve sleeve inner balloon (22a) 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] mentioning wherein inflation is introduced, via inflation port(s) 34A, into the lumen of balloon 22a before moving through openings 29 into the outer balloon 22b; the inflation media would move axially along a length of the inner balloon before moving through openings 29 due to the dispersing qualities of inflation fluid to achieve equilibrium);
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 via a compressive force, especially when abutting against portions of the vasculature that radially compress against the balloon against the valve sleeve during inflation).
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 angularly and 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 angularly and 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).
Regarding claim 22, 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 portion 16 of catheter 10 upon which balloons 22a and 22b are disposed, see Fig. 1A) secured to the distal end of the catheter (see Fig. 1A showing wherein distal end portion 16 is secured to the distal end of the catheter main body 10), the cannula including an inflation port (inflation port 34A, see Fig. 1B and Para. [0042]);
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 showing wherein balloon 22a is disposed between balloon 22b and the distal end portion 16 of the catheter 10; see also Para. [0032]), 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 axially 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 34A);
(b) introducing a fluid through the catheter, such that the fluid travels along the axial distance between an outer surface of the cannula and an inner surface of the valve sleeve and into the tubular balloon, thereby inflating the tubular balloon at the target location (see Para. [0042] mentioning wherein inflation media enters balloon 22a through inflation port(s) 34A before entering balloon 22b through opening(s) 29; as the two ports are axially offset from one another, combined with fluid’s tendency to disperse within an open space to achieve equilibrium, the inflation fluid is understood to travel along an axial distance between the outer surface of the distal end portion of the catheter and an inner surface of balloon22a before entering balloon 22b);
wherein the valve sleeve fits tightly against the cannula over the inflation port when the balloon is inflated (Para. [0029]-[0030] mentioning wherein the proximal and distal ends of balloon 22a are secured to the distal portion 16 of the catheter 10 such that no inflation media is permitted to leak into the external biological environment during inflation and is thus understood to constitute a “tight connection” to the distal end of the catheter and over the inflation port which is disposed within the internal space of the balloon 22a).
However, Wolenberg does not expressly disclose:
Wherein the balloon device is detachable from the proximal catheter shaft body; and
(c) sealing the detachable balloon device during inflation such that the fluid becomes trapped inside the inflated detachable balloon device; and
(d) detaching the catheter from the cannula.
In the same field of endeavor, namely balloon catheter devices disposed within blood vessels, Gray teaches:
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 end portion (16) thereof be detachable from the proximal portion of the 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]); in making such a combination, one would further modify the valve sleeve inner balloon (22a) 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 23, the combination of Wolenberg and Gray disclose the method of claim 22, Wolenberg further discloses wherein the cannula includes a first axial lumen and a second axial lumen (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 24, the combination of Wolenberg and Gray disclose the method of claim 22, 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 25, the combination of Wolenberg and Gray disclose the method of claim 22, Wolenberg further discloses:
wherein introducing the fluid through the catheter includes:
the valve sleeve expanding to permit the fluid to travel, along the axial distance, inside a local plenum formed between the valve sleeve and the cannula (see Para. [0027] and [0043] mentioning wherein inflation is introduced, via inflation port(s) 34A, into the lumen of balloon 22a before moving through openings 29 into the outer balloon 22b; the inflation media would move axially along a length of the inner balloon before moving through openings 29 due to the dispersing qualities of inflation fluid to achieve equilibrium); and
the fluid passing through the vent into the tubular balloon (see Para. [0043]).
Regarding claim 26, the combination of Wolenberg and Gray disclose the method of claim 22, 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 via a compressive force, especially when abutting against portions of the vasculature that radially compress against the balloon against the valve sleeve during inflation).
Regarding claim 28, the combination of Wolenberg and Gray disclose the method of claim 22, 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 angularly and 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 angularly and 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 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolenberg (US 2020/0146858 A1) (previously of record) 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).
Regarding claim 27, the combination of Wolenberg and Gray discloses all of the limitations of the method of claim 22.
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).
Allowable Subject Matter
Claims 29-33 are allowed.
Regarding claim 29, 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 detachable balloon device includes:
a cannula (distal end portion 16 of catheter 10 upon which balloons 22a and 22b are disposed, see Fig. 1A) secured to the distal end of the catheter (see Fig. 1A showing wherein distal end portion 16 is secured to the distal end of the catheter main body 10), the cannula including:
an inflation port (inflation port 34A, see Fig. 1B and Para. [0042]);
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 showing wherein balloon 22a is disposed between balloon 22b and the distal end portion 16 of the catheter 10; see also Para. [0032]), 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 axially 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 34A);
(b) introducing a fluid through the catheter, such that the fluid travels along the axial distance between an outer surface of the cannula and an inner surface of the valve sleeve and into the tubular balloon, thereby inflating the tubular balloon at the target location (see Para. [0042] mentioning wherein inflation media enters balloon 22a through inflation port(s) 34A before entering balloon 22b through opening(s) 29; as the two ports are axially offset from one another, combined with fluid’s tendency to disperse within an open space to achieve equilibrium, the inflation fluid is understood to travel along an axial distance between the outer surface of the distal end portion of the catheter and an inner surface of balloon22a before entering balloon 22b);
wherein the valve sleeve fits tightly against the cannula over the inflation port when the tubular balloon is inflated (Para. [0029]-[0030] mentioning wherein the proximal and distal ends of balloon 22a are secured to the distal portion 16 of the catheter 10 such that no inflation media is permitted to leak into the external biological environment during inflation and is thus understood to constitute a “tight connection” to the distal end of the catheter and over the inflation port).
However, Wolenberg does not expressly disclose:
Wherein the balloon device is detachable from the proximal catheter shaft body;
wherein the valve sleeve presses against the cannula forming a seal over the inflation port in response to a positive pressure within the inflated balloon;
(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
In the same field of endeavor, namely balloon catheter devices disposed within blood vessels, Gray teaches:
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 end portion (16) thereof be detachable from the proximal portion of the 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]); in making such a combination, one would further modify the valve sleeve inner balloon (22a) 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]).
However, none of either Wolenberg or Gray expressly disclose:
Wherein the valve sleeve presses against the cannula forming a seal over the inflation port in response to a positive pressure within the inflated balloon.
It would not 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, as modified by Gray to perform these cited limitations as the valve sleeve (balloon 22a) of Wolenberg is connected to the distal end of the catheter body as points both proximal and distal to the inflation port (34A) as shown in Figs. 1A-1B and thus is not inherently “sealed” against the inflation port. Further, the valve sleeve of Wolenberg is configured to inflate such that the portion of the valve sleeve axially aligned with the inflation port inflates and expands away from the inflation port during use (shown in Figs. 1A-1B) and would thus not be capable of sealing against the inflation port when inflated. As inflation fluid is configured to pass between the two balloons (22a and 22b) of Wolenberg via ports (29), fluid would constantly be shifting between the two balloons during navigation and use of the device as various parts of the vascular space press against the exterior surfaces of the balloons. Should the inflation port(s) be sealed once the balloons are inflated, it would not be immediately apparent to one of ordinary skill in the art if the device of Wolenberg would functional properly without excess undue experimentation.
Claims 30-33 are additionally viewed to be allowable over the prior art due to their dependency from and further modification of claim 29.
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 2010/0266219 A1 to Frimerman, US 2003/0055398 A1 to Imran, US 8435225 B2 to Courney, and US 2021/0330346 A1 to Frimerman all disclose occluding balloon catheters having some sort of sleeve mechanism for controlling inflation into the outer balloon device.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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