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 Amendment
This office action is responsive to the amendment filed on 08/26/2025. As directed by the amendment: claims 1, 16, and 17 have been amended and claims 8, 10, 11, and 15 have been cancelled. Thus, claims 1-7, 9, 12-14, and 16-17 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 7-8, filed 08/26/2025, have been fully considered and they are persuasive.
The applicant has amended claim 1 to additionally recite: “the first balloon having a first shaft extending proximally therefrom and a guidewire configured to slidably extend through the lumen of the first balloon… the second balloon having a second shaft extending proximally therefrom; a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom, each of the first shaft, second shaft and third shaft being fluidly connected to an inflation line configured for inflating and collapsing the first ballon, second ballon and third ballon, respectively”.
The applicant has amended claims 16 and 17 similarly.
The applicant argues the cited prior art of record does not explicitly teach the balloon device having triple balloons with respective triple sheaths connected to an inflation/collapse lines. The examiner agrees that the combined prior art of Lary, Schaeffer, Jang, and Franano does not explicitly disclose three separate shafts each connected to an inflation/collapse lines.
However, upon further consideration, a new ground(s) of rejection is made in view of Lary, Schaeffer, Jang, Franano, and Kokish et al (US 6485500 B1), herein referenced to as “Kokish”.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the an endovascular occlusion device with a first balloon, second balloon, third balloon, and a inflatable plug. The figures do not show a device with three balloons and an inflatable plug. must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-7, 9, 12-14, and 16-17 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.
In regards to claim 1, the subject matter includes three balloons and an inflatable plug. The embodiments shown in the application do not have more than three inflatable elements. Hence it is not clear how a fourth ballon or inflatable element would be arranged alongside the three other inflatable elements. Specifically the new claim language of “ a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom” does not have written description support along with the inflatable plug (see applicant’s Figs. 2-8D for the three balloons without an inflatable plug and Figs. 8-13B for two balloons with an inflatable plug).
Claims 2-7, 9, and 12-14 are rejected as being dependent on claim 1.
In regards to claim 16, the subject matter includes three balloons and an inflatable plug. The embodiments shown in the application do not have more than three inflatable elements. Hence it is not clear how a fourth ballon or inflatable element would be arranged alongside the three other inflatable elements. Specifically the new claim language of “ a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom” does not have written description support along with the inflatable plug (see applicant’s Figs. 2-8D for the three balloons without an inflatable plug and Figs. 8-13B for two balloons with an inflatable plug).
In regards to claim 17, the subject matter includes three balloons and an inflatable plug. The embodiments shown in the application do not have more than three inflatable elements. Hence it is not clear how a fourth ballon or inflatable element would be arranged alongside the three other inflatable elements. Specifically the new claim language of “ a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom” does not have written description support along with the inflatable plug (see applicant’s Figs. 2-8D for the three balloons without an inflatable plug and Figs. 8-13B for two balloons with an inflatable plug).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-9, 13-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lary (US 6506180 B1), herein referenced to as “Lary” in view of Schaeffer et al (US 20110137245 A1), herein referenced to as “Schaeffer”, Jang (US 4763654 A), herein referenced to as “Jang”, Franano et (US 20160030050 A1), herein referenced to as “Franano”, and Kokish et al (US 6485500 B1), herein referenced to as “Kokish”.
Claim 1
Lary discloses: An endovascular occlusion device (see Figs. 13-14, in the state showing in Fig. 13, the device occludes blood flow) comprising: a second balloon 16 (see Figs. 13-14, col. 4, lines 54-63) having a distal end distal end of 16, a proximal end proximal end of 16, and a lumen 30 (see Figs. 13-14, col. 5, lines 25-29) extending therebetween, and having a deflated state and an inflated state (see col. 5, lines 1-30, the perfusion sleeve 16 is expandable through its inflation lumen), wherein the second balloon 16 in the inflated state is configured to permit blood to flow through the lumen of the second balloon (see Fig. 14, the lumen allows blood to flow through 30), the second balloon 16 having a second shaft 39 (see Figs. 13-14, col. 5, lines 1-15) extending proximally 39 extends proximally from 16 therefrom; and an inflatable plug 60 (see Figs. 13-14, col. 9, lines 1-12) having a distal end distal end of 60 and a proximal end proximal end of 60, the inflatable plug 60 being coaxial with the second balloon 16 (see Figs. 13-14, 60 is coaxial with 16) and having a deflated state and an inflated state (see col. 9, lines 1-12, 60 is an expandable balloon, hence it has a deflated and inflated state), wherein the inflatable plug, while in the inflated state, is configured to form a seal with the second balloon and modulates blood flow in a patient artery through the second balloon (see Fig. 13, while 60 is within the lumen 30 of 16 it controls blow flow by stopping it, as blood flowed is established when 60 is moved out of 16 as shown in Fig. 14).
Lary does not explicitly disclose: a first balloon having a distal end, a proximal end, and a lumen extending therebetween, the first balloon having a deflated state and an inflated state, wherein the first balloon in the inflated state is configured to contact an inner wall of a vasculature, the first balloon having a first shaft extending proximally therefrom and a guidewire configured to slidably extend through the lumen of the first balloon; a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom, each of the first shaft, second shaft and third shaft being fluidly connected to an inflation line configured for inflating and collapsing the first ballon, second ballon and third ballon, respectively; the second balloon being coaxial with the first balloon and is configured to contact an inner wall of the lumen of the first balloon; the inflatable plug being coaxial with the first balloon; the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface converging radially towards the distal end at a distal angle greater than the proximal angle, wherein at least a portion of the inflatable plug is positioned outside of the distal end of the second balloon and the proximal end of the inflatable plug is juxtaposed with the distal end of the second balloon.
However, Schaeffer in a similar field of invention teaches an endovascular balloon catheter (see Figs. 1-5B) with a second balloon 44 (see Fig. 3A) having an inflated and deflated state (see [0040]). Schaeffer further teaches: a first balloon 42 (see Fig. 3A, [0040]) having a distal end distal end of 42, a proximal end proximal end of 42, and a lumen 242 (see Fig. 3A, [0048]) extending therebetween, the first balloon 44 having a deflated state and an inflated state (see [0041], balloon can be inflated), wherein the first balloon 44 in the inflated state is configured to contact an inner wall of a vasculature (see [0041], 44 can be expanded to expand a stenosis in a body vessel such as a coronary artery, preferably the inner balloon 44 is inflated until the outer balloon 42 contacts a portion of a body vessel wall), the first balloon 42 having a first shaft 212 (see Fig. 3, [0065]) extending proximally therefrom and a guidewire wire guide ([0055]) configured to slidably extend through the lumen 226 (see Fig. 3A, [0055], a lumen of 42) of the first balloon 42; the second balloon 44 being coaxial with the first balloon and is configured to contact an inner wall of the lumen of the first balloon (see [0041], 44 inflates which puts pressure on 42 to contact a portion of a body vessel wall).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lary to incorporate the teachings of Schaeffer and have the endovascular occlusion device further comprise a first balloon that is coaxial with the second balloon and the first balloon having a first shaft extending proximally therefrom and a guidewire configured to slidably extend through the lumen of the first balloon. Motivation for such can be found in Schaeffer as this allows for finer control of the pressure of the balloon on surrounding tissue as the pressure is dispersed through the outer (first balloon) and originating from the second balloon. Furthermore, the outer balloon can be perforated to administer a therapeutic agent and/or diagnostic agent and does not require to have its own pressure inflating mechanism (see [0041]). The guide wire and the lumen through which it extends facilities changing out the first balloon catheter assembly for other medical devices such as a stent-deployment catheter (see [0055])
The combination of Lary and Schaeffer further teaches: the inflatable plug being coaxial with the first balloon (as modified the inflatable plug of Lary is within the second balloon and coaxial and when modified by Schaeffer to have a first balloon over the second balloon, the inflatable plug will remain coaxial and within both the first and second balloons).
The combination of Lary and Schaeffer does not explicitly teach: the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface radially converging towards the distal end at a distal angle greater than the proximal angle, wherein at least a portion of the inflatable plug is positioned outside of the distal end of the second balloon and the proximal end of the inflatable plug is juxtaposed with the distal end of the second balloon.
However, Jang in a similar field of invention teaches an endovascular occlusion device 10 (see Fig. 1) with a second balloon 20 (see Fig. 1) with a distal end (see annotated Fig. 1 below) and inflatable plug 16 (see Fig. 1) with a proximal end (see annotated Fig. 1 below) and a distal end (see annotated Fig. 1 below). Jung further teaches: wherein at least a portion distal portion of 16 extending out of 20 (see Fig. 1) of the inflatable plug 16 is positioned outside of the distal end (see annotated Fig. 1 below) of the second balloon 20 and the proximal end (see annotated Fig. 1 below) of the inflatable plug 16 is juxtaposed with the distal end (see annotated Fig. 1 below) of the second balloon 20.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lary and Schaeffer to incorporate the teachings of Jang and have an endovascular device with at least a portion of the inflatable plug is positioned outside of the distal end of the second balloon and the proximal end of the inflatable plug is juxtaposed with the distal end of the second balloon. Motivation for such can be found in Jang as having slight overlap between the balloons without being tandem allows more balloons in a smaller amount of space without full overlap while eliminating dead space between balloons (see col. 11, lines 16-23).
The combination of Lary, Schaeffer, and Jang does not explicitly teach: the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface radially converging towards the distal end at a distal angle greater than the proximal angle.
However, Franano in a similar field of invention teaches an endovascular device (see Figs. 8U and 18F) that is an inflatable plug 170G (see Fig. 8U and 18F, [0011], expandable body is a balloon/plug) with a distal end 118 (see Fig. 8U) and a proximal end 116 (see Fig. 8U). Franano further teaches: the inflatable plug 170G having a tapered distal surface 172G (see Fig. 8U, [0190]) juxtaposed therewith, a tapered proximal surface 174G (see Fig. 8U, [0190]) juxtaposed therewith, the proximal surface 174G diverging radially outwardly (see annotated Fig. 8U below, 174G diverges radially outward, as the diameter grows along the diverging surface) from the proximal end 116 at a proximal angle, the distal surface 172G radially converging (see annotated Fig. 8U below) towards the distal end 118 at a distal angle (see annotated Fig. 8U below) greater than the proximal angle (see annotated Fig. 8U below).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inflatable plug of the combination of Lary, Schaeffer, and Jang to incorporate the teachings of Franano and teach the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface radially converging towards the distal end at a distal angle greater than the proximal angle. Motivation for such can be found in Franano as this shape, which creates a frustoconical configuration permits the body to make contact and seal the perpendicular surfaces of the blood vessels at the opening of a bifurcation aneurysm (see [0190]).
The combination of Lary, Schaeffer, Jang, and Franano does not explicitly teach: a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom, each of the first shaft, second shaft and third shaft being fluidly connected to an inflation line configured for inflating and collapsing the first ballon, second ballon and third ballon.
However, Kokish in a similar field of invention teaches an endovascular occlusion device (see Fig. 4) with a first balloon 51 (see Fig. 3) with a first shaft the shaft that contains lumen 64 (see Fig. 3) and a second balloon 46 (see Fig. 4) with a lumen the lumen of 46 with a second shaft the shaft that contains lumen 48 (see Fig. 2). Kokish further teaches: a third balloon 40 (see Figs. 1-4, col. 10, lines 10-20) having a distal end distal end of 40 (see Figs. 1-4), a proximal end proximal end of 40 (see Figs. 1-4), and a lumen the lumen of 40 extending therebetween, the third balloon 40 being coaxial with the second balloon 46 and having a deflated state and an inflated state (see col. 10, lines 10-20, the balloon is inflatable, hence it has a deflated and inflated state), the third balloon 40 having a third shaft 38 (see Figs. 1-4, col. 10, lines 5-23) extending proximally therefrom, each of the first shaft the shaft that contains lumen 64, second shaft the shaft that contains lumen 48 and third shaft 38 being fluidly connected to an inflation line inflation fluid lumen (see col. 10, lines 47-54, col. 10, lines 18-20, col. 11, lines 9-14) configured for inflating and collapsing the first ballon 51, second ballon 46 and third ballon 40 (see col. 10, lines 47-54, col. 10, lines 18-20, col. 11, lines 9-14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lary, Schaeffer, Jang, and Franano to incorporate the teachings of Kokish and teach an endovascular occlusion device with a third balloon and the first, second, and third balloon having their own shafts connected to an inflation line for inflating and collapsing the balloons separately. Motivation for such can be found in Kokish as this allows for individual inflation of the balloons to provide different functions such as clearing emboli, stenting, and balloon angioplasty of blood vessels (see col. 9, lines 64-67 and col. 10, lines 1-5).
The language, " wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lary, Schaeffer, Jang, Franano, and Kokish meets the structural limitations of the claim, and is capable of inflating the third balloon to contact the inner wall of the lumen of a second balloon, as with shafts separately connected to each of the balloons, they can be positioned in relation to one another to allow the third balloon to inflate within the second balloon.
Claim 2
The combination of Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 1, see 103 rejection above. Lary further discloses: the second balloon and the inflatable plug are constructed from a non-compliant material (see col. 5, ll 35-40, the balloons are disclosed to be constructed of PET, which the applicant discloses as either a compliant or non-compliant material, see [0058] of applicant’s PGPUB). Schaeffer further teaches: the first balloon is constructed from a compliant material (see [0066], PET, the applicant discloses as either a compliant or non-compliant material, see [0058] of applicant’s PGPUB).
Claim 3
The combination of Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 1, see 103 rejection above. Lary further discloses: wherein the distal end distal end of 60 of the inflatable plug 60 forms the seal with the proximal end proximal end of 16 of the second balloon 16 (see Fig. 13, the distal/proximal end of 60 is sized to prevent blood flow/to contact the inner lumen of 16, so when the distal end of 60 is at the proximal end of 16, it prevents blood flow).
Claim 4
The combination of Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 1, see 103 rejection above. Lary further discloses: wherein the proximal end proximal end of 60 of the inflatable 60 plug forms the seal with the distal end proximal end of 16 of the second balloon 16 (see Fig. 13, the distal/proximal end of 60 is sized to prevent blood flow/to contact the inner lumen of 16, so when the proximal end of 60 is at the distal end of 16, it prevents blood flow).
Claim 5
The combination of Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 1, see 103 rejection above. Lary further discloses: further comprising: a handle 7 (see Fig. 1, col. 4, lines 56-63) operably coupled to the second balloon 16 and the inflatable plug 60.
Lary does not explicitly disclose: the handle operably coupled to the first balloon.
However, Schaeffer in a similar field of invention teaches an endovascular balloon catheter (see Figs. 1-5B) with a second balloon 44 (see Fig. 3A) having an inflated and deflated state (see [0040]) and a handle 20 (see Fig. 1). Schaeffer further teaches: the handle 20 operably coupled to the first balloon 44 (see Fig. 1, [0040]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lary, Schaeffer, Jang, and Franano to further incorporate the teachings of Schaeffer and have the handle of Lary operably coupled to the first balloon. Motivation for such can be found in Schaeffer as these are conventional fittings in order to control and manipulate balloon catheters (see [0040]).
Claim 6
The combination of Lary Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 3, see 103 rejection above. Lary further discloses: further comprising: a sheath 12 (see Fig. 1, col. 4, lines 56-63) having a proximal end proximal end of 12, a distal end distal end of 12, and a lumen (see col. 4, lines 56-63, multi-luminal) extending therebetween, the proximal end proximal end of 12 of the sheath 12 being operably coupled to a handle 7 (see Fig. 1, col. 4, lines 56-63) and the distal end distal end of 12 of the sheath 12 being operably coupled to the second balloon 16 and the inflatable plug 60 (see Fig. 1, lines 56-63).
Lary does not explicitly disclose: the sheath being operably coupled to the first balloon.
However, Schaeffer in a similar field of invention teaches an endovascular balloon catheter (see Figs. 1-5B) with a second balloon 44 (see Fig. 3A) having a inflated and deflated state (see [0040]) and a sheath 30 (see Fig. 1). Schaeffer further teaches: the sheath 30 being operably coupled to the first balloon 44 (see Fig. 1, [0040]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lary, Schaeffer, Jang, and Franano to further incorporate the teachings of Schaeffer and have the sheath of Lary operably coupled to the first balloon. Motivation for such can be found in Schaeffer as these are conventional fittings in order to control and manipulate balloon catheters (see [0040]).
Claim 7
The combination of Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 6, see 103 rejection above. Lary further discloses: wherein the sheath 12 includes a plurality of lumens (see col. 4, lines 56-63, multi-luminal).
Claim 8
The combination of Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 1, see 103 rejection above. Larry does not explicitly disclose: further comprising: a guide wire configured to extend through a lumen of the first balloon.
However, Schaeffer in a similar field of invention teaches an endovascular balloon catheter (see Figs. 1-5B) with a first balloon 42 and lumen 242 of the first balloon 42. Schaeffer further teaches: further comprising: a guide wire 50 (see Fig. 1, [0040]) configured to extend through the lumen 242 (the lumen 242 includes the space occupied by the second balloon 44 and further in, see 112b rejection above) of the first balloon 42.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lary, Schaeffer, Jang, and Franano to further incorporate the teachings of Schaeffer and have the occlusive device further comprise a guide wire configured to extend through the lumen of the first balloon. Motivation for such can be found in Schaeffer as these are conventional fittings in order to control and manipulate balloon catheters (see [0040]).
Claim 9
The combination of Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 1, see 103 rejection above. Larry further discloses: further comprising: a delivery sheath 12 (see Fig. 1, col. 4, lines 56-63) configured to surround and receive the second balloon 16 and the inflatable plug 60 (see Fig. 1, col. 4, lines 56-63, multi-luminal, see also col. 5, lines 61-63). The combination of Larry and Schaeffer further teaches: the delivery sheath 12 (Lary) is configured to surround and receive the first balloon (as combined the balloons are contained within 12).
Claim 13
The combination of Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 1, see 103 rejection above. Lary further discloses: wherein the lumen 30 of the second balloon 16 has a width the width of 30.
The combination of Lary, Schaeffer, Jang, and Franano does not explicitly teach: and the inflatable plug is inflatable to a size wherein a portion of the inflatable plug has a width that is greater than the width of the lumen of the second balloon.
However, Kokish in a similar field of invention teaches an endovascular occlusion device (see Fig. 4) with a second balloon 46 (see Fig. 4) with a lumen the lumen of 46 having a width the width of the lumen of 46 and an inflatable plug 40 (see Fig. 4). Kokish further teaches: the inflatable plug 40 is inflatable to a size wherein a portion a distal or proximal portion of 40 of the inflatable plug 40 has a width the width of 40 that is greater than the width of the lumen the width of 46 of the second balloon 46 (see Fig. 4, the width of 40 is greater than the lumen width of 46).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lary, Schaeffer, Jang, and Franano to incorporate the teachings of Kokish and have the inflatable plug is inflatable to a size wherein a portion of the inflatable plug has a width that is greater than the width of the lumen of the second balloon. Motivation for such can be found in Kokish as the inflatable plug can then also serve as an anchor while manipulating the balloon to an optimal position for treatment (see col. 10, lines 10-15, 25-30, 42-2-54, and 55-65).
Claim 14
The combination of Lary, Schaeffer, Jang, Franano, and Kokish teaches: the endovascular occlusion device of claim 3, see 103 rejection above. Larry further discloses: wherein at least a portion proximal end of 60 of the inflatable plug 60 is positioned outside (see Fig. 13) of the proximal end proximal end of 16 of the second balloon 19.
Claim 16
Lary discloses: An endovascular occlusion device (see Figs. 13-14, in the state showing in Fig. 13, the device occludes blood flow) comprising: a second balloon 16 (see Figs. 13-14, col. 4, lines 54-63) having a distal end distal end of 16, a proximal end proximal end of 16, and a lumen 30 (see Figs. 13-14, col. 5, lines 25-29) extending therebetween, and having a deflated state and an inflated state (see col. 5, lines 1-30, the perfusion sleeve 16 is expandable through its inflation lumen), wherein the second balloon 16 in the inflated state is configured while permitting blood to flow through the lumen of the second balloon (see Fig. 14, the lumen allows blood to flow through 30) the second balloon 16 having a second shaft 39 (see Figs. 13-14, col. 5, lines 1-15) extending proximally 39 extends proximally from 16 therefrom; and an inflatable plug 60 (see Figs. 13-14, col. 9, lines 1-12) having a distal end distal end of 60 and a proximal end proximal end of 60, the inflatable plug 60 being coaxial with the second balloon 16 (see Figs. 13-14, 60 is coaxial with 16) and having a deflated state and an inflated state (see col. 9, lines 1-12, 60 is an expandable balloon, hence it has a deflated and inflated state), wherein the inflatable plug, while in the inflated state, is configured to form a seal with the second balloon to adjust flow restriction only through the second balloon (see Fig. 13, while 60 is within the lumen 30 of 16 it controls blood flow by stopping it, as blood flowed is established when 60 is moved out of 16 as shown in Fig. 14).
Lary does not explicitly disclose: a first balloon having a distal end, a proximal end, and a lumen extending therebetween, the first balloon having a deflated state and an inflated state, wherein the first balloon in the inflated state is configured to contact an inner wall of a vasculature, the first balloon having a first shaft extending proximally therefrom and a guidewire configured to slidably extend through the lumen of the first balloon; a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom, each of the first shaft, second shaft and third shaft being fluidly connected to an inflation line configured for inflating and collapsing the first ballon, second ballon and third ballon, respectively; the second balloon being coaxial with the first balloon and is configured to contact an inner wall of the lumen of the first balloon; the inflatable plug being coaxial with the first balloon; the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface converging radially towards the distal end at a distal angle greater than the proximal angle, wherein at least a portion of the inflatable plug is positioned outside of the distal end of the second balloon and the proximal end of the inflatable plug is juxtaposed with the distal end of the second balloon.
However, Schaeffer in a similar field of invention teaches an endovascular balloon catheter (see Figs. 1-5B) with a second balloon 44 (see Fig. 3A) having an inflated and deflated state (see [0040]). Schaeffer further teaches: a first balloon 42 (see Fig. 3A, [0040]) having a distal end distal end of 42, a proximal end proximal end of 42, and a lumen 242 (see Fig. 3A, [0048]) extending therebetween, the first balloon 44 having a deflated state and an inflated state (see [0041], balloon can be inflated), wherein the first balloon 44 in the inflated state is configured to contact an inner wall of a vasculature (see [0041], 44 can be expanded to expand a stenosis in a body vessel such as a coronary artery, preferably the inner balloon 44 is inflated until the outer balloon 42 contacts a portion of a body vessel wall) the first balloon 42 having a first shaft 212 (see Fig. 3, [0065]) extending proximally therefrom and a guidewire wire guide ([0055]) configured to slidably extend through the lumen 226 (see Fig. 3A, [0055], a lumen of 42) of the first balloon 42; the second balloon 44 being coaxial with the first balloon and is configured to contact an inner wall of the lumen of the first balloon (see [0041], 44 inflates which puts pressure on 42 to contact a portion of a body vessel wall).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lary to incorporate the teachings of Schaeffer and have the endovascular occlusion device further comprise a first balloon that is coaxial with the second balloon. Motivation for such can be found in Schaeffer as this allows for finer control of the pressure of the balloon on surrounding tissue as the pressure is dispersed through the outer (first balloon) and originating from the second balloon and a guidewire configured to slidably extend through the lumen of the first balloon. Furthermore, the outer balloon can be perforated to administer a therapeutic agent and/or diagnostic agent and does not require to have its own pressure inflating mechanism (see [0041]). The guide wire and the lumen through which it extends facilities changing out the first balloon catheter assembly for other medical devices such as a stent-deployment catheter (see [0055]).
The combination of Lary and Schaeffer further teaches: the inflatable plug being coaxial with the first balloon (as modified the inflatable plug of Lary is within the second balloon and coaxial and when modified by Schaeffer to have a first balloon over the second balloon, the inflatable plug will remain coaxial and within both the first and second balloons) and to adjust flow restriction through the first balloon and the second balloon (as modified the plug will stop blood flow of the second balloon, and since the second balloon is within the first balloon, the blood flow will be stopped between both first and second balloons).
The combination of Lary and Schaeffer does not explicitly teach: the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface radially converging towards the distal end at a distal angle greater than the proximal angle, wherein at least a portion of the inflatable plug is positioned outside of the distal end of the second balloon and the proximal end of the inflatable plug is juxtaposed with the distal end of the second balloon.
However, Jang in a similar field of invention teaches an endovascular occlusion device 10 (see Fig. 1) with a second balloon 20 (see Fig. 1) with a distal end (see annotated Fig. 1 below) and inflatable plug 16 (see Fig. 1) with a proximal end (see annotated Fig. 1 below) and a distal end (see annotated Fig. 1 below). Jung further teaches: wherein at least a portion distal portion of 16 extending out of 20 (see Fig. 1) of the inflatable plug 16 is positioned outside of the distal end (see annotated Fig. 1 below) of the second balloon 20 and the proximal end (see annotated Fig. 1 below) of the inflatable plug 16 is juxtaposed with the distal end (see annotated Fig. 1 below) of the second balloon 20.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lary and Schaeffer to incorporate the teachings of Jang and have an endovascular device with at least a portion of the inflatable plug is positioned outside of the distal end of the second balloon and the proximal end of the inflatable plug is juxtaposed with the distal end of the second balloon. Motivation for such can be found in Jang as having slight overlap between the balloons without being tandem allows more balloons in a smaller amount of space without full overlap while eliminating dead space between balloons (see col. 11, lines 16-23).
The combination of Lary, Schaeffer, and Jang does not explicitly teach: the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface radially converging towards the distal end at a distal angle greater than the proximal angle.
However, Franano in a similar field of invention teaches an endovascular device (see Figs. 8U and 18F) that is an inflatable plug 170G (see Fig. 8U and 18F, [0011], expandable body is a balloon/plug) with a distal end 118 (see Fig. 8U) and a proximal end 116 (see Fig. 8U). Franano further teaches: the inflatable plug 170G having a tapered distal surface 172G (see Fig. 8U, [0190]) juxtaposed therewith, a tapered proximal surface 174G (see Fig. 8U, [0190]) juxtaposed therewith, the proximal surface 174G diverging radially outwardly (see annotated Fig. 8U below, 174G diverges radially outward, as the diameter grows along the diverging surface) from the proximal end 116 at a proximal angle, the distal surface 172G radially converging (see annotated Fig. 8U below) towards the distal end 118 at a distal angle (see annotated Fig. 8U below) greater than the proximal angle (see annotated Fig. 8U below).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inflatable plug of the combination of Lary, Schaeffer, and Jang to incorporate the teachings of Franano and teach the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface radially converging towards the distal end at a distal angle greater than the proximal angle. Motivation for such can be found in Franano as this shape, which creates a frustoconical configuration permits the body to make contact and seal the perpendicular surfaces of the blood vessels at the opening of a bifurcation aneurysm (see [0190]).
The combination of Lary, Schaeffer, Jang, and Franano does not explicitly teach: a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom, each of the first shaft, second shaft and third shaft being fluidly connected to an inflation line configured for inflating and collapsing the first ballon, second ballon and third ballon.
However, Kokish in a similar field of invention teaches an endovascular occlusion device (see Fig. 4) with a first balloon 51 (see Fig. 3) with a first shaft the shaft that contains lumen 64 (see Fig. 3) and a second balloon 46 (see Fig. 4) with a lumen the lumen of 46 with a second shaft the shaft that contains lumen 48 (see Fig. 2). Kokish further teaches: a third balloon 40 (see Figs. 1-4, col. 10, lines 10-20) having a distal end distal end of 40 (see Figs. 1-4), a proximal end proximal end of 40 (see Figs. 1-4), and a lumen the lumen of 40 extending therebetween, the third balloon 40 being coaxial with the second balloon 46 and having a deflated state and an inflated state (see col. 10, lines 10-20, the balloon is inflatable, hence it has a deflated and inflated state), the third balloon 40 having a third shaft 38 (see Figs. 1-4, col. 10, lines 5-23) extending proximally therefrom, each of the first shaft the shaft that contains lumen 64, second shaft the shaft that contains lumen 48 and third shaft 38 being fluidly connected to an inflation line inflation fluid lumen (see col. 10, lines 47-54, col. 10, lines 18-20, col. 11, lines 9-14) configured for inflating and collapsing the first ballon 51, second ballon 46 and third ballon 40 (see col. 10, lines 47-54, col. 10, lines 18-20, col. 11, lines 9-14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lary, Schaeffer, Jang, and Franano to incorporate the teachings of Kokish and teach an endovascular occlusion device with a third balloon and the first, second, and third balloon having their own shafts connected to an inflation line for inflating and collapsing the balloons separately. Motivation for such can be found in Kokish as this allows for individual inflation of the balloons to provide different functions such as clearing emboli, stenting, and balloon angioplasty of blood vessels (see col. 9, lines 64-67 and col. 10, lines 1-5).
The language, " wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lary, Schaeffer, Jang, Franano, and Kokish meets the structural limitations of the claim, and is capable of inflating the third balloon to contact the inner wall of the lumen of a second balloon, as with shafts separately connected to each of the balloons, they can be positioned in relation to one another to allow the third balloon to inflate within the second balloon.
Claim 17
Lary discloses: An endovascular occlusion device (see Figs. 13-14, in the state showing in Fig. 13, the device occludes blood flow) comprising: a second balloon 16 (see Figs. 13-14, col. 4, lines 54-63) having a distal end distal end of 16, a proximal end proximal end of 16, and a lumen 30 (see Figs. 13-14, col. 5, lines 25-29) extending therebetween, and having a deflated state and an inflated state (see col. 5, lines 1-30, the perfusion sleeve 16 is expandable through its inflation lumen), wherein the second balloon 16 in the inflated state is configured while permitting blood to flow through the lumen of the second balloon (see Fig. 14, the lumen allows blood to flow through 30); and an inflatable plug 60 (see Figs. 13-14, col. 9, lines 1-12) having a distal end distal end of 60 and a proximal end proximal end of 60, the inflatable plug 60 being coaxial with the second balloon 16 (see Figs. 13-14, 60 is coaxial with 16) and having a deflated state and an inflated state (see col. 9, lines 1-12, 60 is an expandable balloon, hence it has a deflated and inflated state), wherein the inflatable plug, while in the inflated state, is configured to restrict blow flow through the second balloon (see Fig. 13, while 60 is within the lumen 30 of 16 it controls blow flow by stopping it, as blood flowed is established when 60 is moved out of 16 as shown in Fig. 14).
Lary does not explicitly disclose: a first balloon having a distal end, a proximal end, and a lumen extending therebetween, the first balloon having a deflated state and an inflated state, wherein the first balloon in the inflated state is configured to contact an inner wall of a vasculature the first balloon having a first shaft extending proximally therefrom and a guidewire configured to slidably extend through the lumen of the first balloon;; a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom, each of the first shaft, second shaft and third shaft being fluidly connected to an inflation line configured for inflating and collapsing the first ballon, second ballon and third ballon, respectively; the second balloon being coaxial with the first balloon and is configured to contact an inner wall of the lumen of the first balloon; the inflatable plug being coaxial with the first balloon; the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface converging radially towards the distal end at a distal angle greater than the proximal angle, wherein at least a portion of the inflatable plug is positioned outside of the distal end of the second balloon and the proximal end of the inflatable plug is juxtaposed with the distal end of the second balloon.
However, Schaeffer in a similar field of invention teaches an endovascular balloon catheter (see Figs. 1-5B) with a second balloon 44 (see Fig. 3A) having a inflated and deflated state (see [0040]). Schaeffer further teaches: a first balloon 42 (see Fig. 3A, [0040]) having a distal end distal end of 42, a proximal end proximal end of 42, and a lumen 242 (see Fig. 3A, [0048]) extending therebetween, the first balloon 44 having a deflated state and an inflated state (see [0041], balloon can be inflated), wherein the first balloon 44 in the inflated state is configured to contact an inner wall of a vasculature (see [0041], 44 can be expanded to expand a stenosis in a body vessel such as a coronary artery, preferably the inner balloon 44 is inflated until the outer balloon 42 contacts a portion of a body vessel wall); the first balloon 42 having a first shaft 212 (see Fig. 3, [0065]) extending proximally therefrom and a guidewire wire guide ([0055]) configured to slidably extend through the lumen 226 (see Fig. 3A, [0055], a lumen of 42) of the first balloon 42; the second balloon 44 being coaxial with the first balloon and is configured to contact an inner wall of the lumen of the first balloon (see [0041], 44 inflates which puts pressure on 42 to contact a portion of a body vessel wall).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lary to incorporate the teachings of Schaeffer and have the endovascular occlusion device further comprise a first balloon that is coaxial with the second balloon. Motivation for such can be found in Schaeffer as this allows for finer control of the pressure of the balloon on surrounding tissue as the pressure is dispersed through the outer (first balloon) and originating from the second balloon and a guidewire configured to slidably extend through the lumen of the first balloon. Furthermore, the outer balloon can be perforated to administer a therapeutic agent and/or diagnostic agent and does not require to have its own pressure inflating mechanism (see [0041]). The guide wire and the lumen through which it extends facilities changing out the first balloon catheter assembly for other medical devices such as a stent-deployment catheter (see [0055]).
The combination of Lary and Schaeffer further teaches: the inflatable plug being coaxial with the first balloon (as modified the inflatable plug of Lary is within the second balloon and coaxial and when modified by Schaeffer to have a first balloon over the second balloon, the inflatable plug will remain coaxial and within both the first and second balloons).
The combination of Lary and Schaeffer does not explicitly teach: the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface radially converging towards the distal end at a distal angle greater than the proximal angle, wherein at least a portion of the inflatable plug is positioned outside of the distal end of the second balloon and the proximal end of the inflatable plug is juxtaposed with the distal end of the second balloon.
However, Jang in a similar field of invention teaches an endovascular occlusion device 10 (see Fig. 1) with a second balloon 20 (see Fig. 1) with a distal end (see annotated Fig. 1 below) and inflatable plug 16 (see Fig. 1) with a proximal end (see annotated Fig. 1 below) and a distal end (see annotated Fig. 1 below). Jung further teaches: wherein at least a portion distal portion of 16 extending out of 20 (see Fig. 1) of the inflatable plug 16 is positioned outside of the distal end (see annotated Fig. 1 below) of the second balloon 20 and the proximal end (see annotated Fig. 1 below) of the inflatable plug 16 is juxtaposed with the distal end (see annotated Fig. 1 below) of the second balloon 20.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lary and Schaeffer to incorporate the teachings of Jang and have an endovascular device with at least a portion of the inflatable plug is positioned outside of the distal end of the second balloon and the proximal end of the inflatable plug is juxtaposed with the distal end of the second balloon. Motivation for such can be found in Jang as having slight overlap between the balloons without being tandem allows more balloons in a smaller amount of space without full overlap while eliminating dead space between balloons (see col. 11, lines 16-23).
The combination of Lary, Schaeffer, and Jang does not explicitly teach: the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface radially converging towards the distal end at a distal angle greater than the proximal angle.
However, Franano in a similar field of invention teaches an endovascular device (see Figs. 8U and 18F) that is an inflatable plug 170G (see Fig. 8U and 18F, [0011], expandable body is a balloon/plug) with a distal end 118 (see Fig. 8U) and a proximal end 116 (see Fig. 8U). Franano further teaches: the inflatable plug 170G having a tapered distal surface 172G (see Fig. 8U, [0190]) juxtaposed therewith, a tapered proximal surface 174G (see Fig. 8U, [0190]) juxtaposed therewith, the proximal surface 174G diverging radially outwardly (see annotated Fig. 8U below, 174G diverges radially outward, as the diameter grows along the diverging surface) from the proximal end 116 at a proximal angle, the distal surface 172G radially converging (see annotated Fig. 8U below) towards the distal end 118 at a distal angle (see annotated Fig. 8U below) greater than the proximal angle (see annotated Fig. 8U below).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inflatable plug of the combination of Lary, Schaeffer, and Jang to incorporate the teachings of Franano and teach the inflatable plug having a tapered distal surface juxtaposed therewith, a tapered proximal surface juxtaposed therewith, the proximal surface diverging radially outwardly from the proximal end at a proximal angle, the distal surface radially converging towards the distal end at a distal angle greater than the proximal angle. Motivation for such can be found in Franano as this shape, which creates a frustoconical configuration permits the body to make contact and seal the perpendicular surfaces of the blood vessels at the opening of a bifurcation aneurysm (see [0190]).
The combination of Lary, Schaeffer, Jang, and Franano does not explicitly teach: a third balloon having a distal end, a proximal end, and a lumen extending therebetween, the third balloon being coaxial with the second balloon and having a deflated state and an inflated state, wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon, the third balloon having a third shaft extending proximally therefrom, each of the first shaft, second shaft and third shaft being fluidly connected to an inflation line configured for inflating and collapsing the first ballon, second ballon and third ballon.
However, Kokish in a similar field of invention teaches an endovascular occlusion device (see Fig. 4) with a first balloon 51 (see Fig. 3) with a first shaft the shaft that contains lumen 64 (see Fig. 3) and a second balloon 46 (see Fig. 4) with a lumen the lumen of 46 with a second shaft the shaft that contains lumen 48 (see Fig. 2). Kokish further teaches: a third balloon 40 (see Figs. 1-4, col. 10, lines 10-20) having a distal end distal end of 40 (see Figs. 1-4), a proximal end proximal end of 40 (see Figs. 1-4), and a lumen the lumen of 40 extending therebetween, the third balloon 40 being coaxial with the second balloon 46 and having a deflated state and an inflated state (see col. 10, lines 10-20, the balloon is inflatable, hence it has a deflated and inflated state), the third balloon 40 having a third shaft 38 (see Figs. 1-4, col. 10, lines 5-23) extending proximally therefrom, each of the first shaft the shaft that contains lumen 64, second shaft the shaft that contains lumen 48 and third shaft 38 being fluidly connected to an inflation line inflation fluid lumen (see col. 10, lines 47-54, col. 10, lines 18-20, col. 11, lines 9-14) configured for inflating and collapsing the first ballon 51, second ballon 46 and third ballon 40 (see col. 10, lines 47-54, col. 10, lines 18-20, col. 11, lines 9-14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lary, Schaeffer, Jang, and Franano to incorporate the teachings of Kokish and teach an endovascular occlusion device with a third balloon and the first, second, and third balloon having their own shafts connected to an inflation line for inflating and collapsing the balloons separately. Motivation for such can be found in Kokish as this allows for individual inflation of the balloons to provide different functions such as clearing emboli, stenting, and balloon angioplasty of blood vessels (see col. 9, lines 64-67 and col. 10, lines 1-5).
The language, " wherein the third balloon in the inflated state is configured to contact an inner wall of the lumen of the second balloon while permitting blood to flow through the lumen of the third balloon," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lary, Schaeffer, Jang, Franano, and Kokish meets the structural limitations of the claim, and is capable of inflating the third balloon to contact the inner wall of the lumen of a second balloon, as with shafts separately connected to each of the balloons, they can be positioned in relation to one another to allow the third balloon to inflate within the second balloon.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lary in view of Schaeffer, Jang, Franano, and Kokish as applied to claim 1 above, and further in view of Rocha-Singh (US 20170266421 A1), herein referenced to as “Rocha-Singh”.
Claim 12
The combination of Lary, Schaeffer, Jang, and Franano teaches: the endovascular occlusion device of claim 1, see 103 rejection above. Lary further discloses: said second balloon 16 has a length the length of 16 between its proximal and distal ends proximal and distal ends of 16. Schaeffer further teaches: wherein the first balloon 42 has a length the length of 42 between its proximal and distal ends proximal and distal ends of 42.
The combination of Lary, Schaeffer, Jang, and Franano does not explicitly teach: the length of the first and second balloons are substantially the same.
However, Rocha-Singh in a similar field of invention teaches an endovascular occlusion device (see Fig. 2B) with a first balloon 30 and a second balloon 31 with both having lengths the lengths of 30 and 31 respectively. Rocha-Singh further teaches: the length the lengths of 30 and 31 respectively of the first 30 and second balloons 31 are substantially the same (see Fig. 2B, [0045] 30 and 31 are affixed to shoulders 36 and 37, hence they have the same length).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lary, Schaeffer, Jang, and Franano to incorporate the teachings of Rocha-Singh and have the length of the first and second balloons be substantially the same. Motivation for such can be found in Rocha-Singh as a device with an overall conformed size will make it easier to navigate and position when radiopaque markers are placed at the conformed lengths (see [0048]).
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.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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