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 action is responsive to the amendments filed on May 27, 2026.
Claims 1, 4, 21, and 26 have been amended.
Claims 31-32 and 36 are cancelled.
Claims 37-41 have been added.
Thus, claims 1-6, 12, 14, 16-18, 20-22, 24-26 and 37-41 are presently pending in this application.
In view of the amendment to claim 21, the previous rejection under 35 U.S.C. §112(b) is withdrawn.
Response to Arguments
Applicant's arguments filed May 27, 2026 have been fully considered but they are not persuasive as to the rejections set forth below.
Regarding claim 1, Applicant has amended the claim to further specify that the catheter is configured to selectively inflate or deflate the first, second, and third balloons independently of each other and that the first balloon has a length longer than that of the second and third balloons.
These amendments have been fully considered and are addressed in the new 35 U.S.C. §103 rejection below, which relies on Kokish (US Patent No. 6485500), hereinafter, Kokish, as the primary reference in view of Gerrans (US Patent No. 10864323), hereinafter, Gerrans, as a secondary reference.
The previous 35 U.S.C. §102 rejection of claim 1 (and claims dependent thereon) is withdrawn and replaced with this 35 U.S.C. §103 rejection.
Regarding claim 4, Applicant has amended the claim to further specify that the catheter body has a second port configured over the second portion of the catheter body and a third port configured over the third portion of the catheter body, wherein the second and third balloons are configured to be selectively inflated or deflated using the second and third ports.
These amendments have been fully considered and are addressed in the new 35 U.S.C. §103 rejection below, which relies on Kokish (US Patent No. 6,485,500), hereinafter, Kokish, as the primary reference in view of Gerrans (US Patent No. 10,864,323), hereinafter, Gerrans, as a secondary reference.
The previous 35 U.S.C. §102 rejection of claim 4 (and claims dependent thereon) is withdrawn and replaced with this 35 U.S.C. §103 rejection.
Claim 26 is rejected under 35 U.S.C. §102 over Kokish, as previously applied.
Clarification of Examiner’s position: Applicant’s amendment was limited to a typographical correction and did not alter the claim scope. Kokish’s proximal (second) and distal (third) balloon configuration allows for a partial seal when the proximal balloon is only partially inflated. A partially inflated compliant or semi-compliant balloon, as disclosed by Kokish, can contact the vessel wall sufficiently to create a partial barrier while still permitting continued distal blood flow/perfusion. This is particularly advantageous for lesions near the distal end of arteries or veins to balance treatment with perfusion needs. Applicant’s arguments have been considered but are not persuasive.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 26 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kokish.
Regarding claim 26, Kokish discloses a multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) used for treatment of lesions that occur near the distal end (distal end 314 in fig. 13) of the arteries or veins, comprising:
an elongated catheter body (blocking balloon catheter 312 in fig. 13) having a tip (leading portion of elongated catheter body 312 in fig. 13),
a proximal end (proximal end 316 in fig. 13), and a distal end (distal end 314 in fig. 13);
a first balloon (inflatable/angioplasty balloon 330 in fig. 13) with a predefined shape and size attached over a first portion (longitudinal region of elongated catheter body 312 over which the first balloon 330 is mounted in fig. 13) of the elongated catheter body (blocking balloon catheter 312 in fig. 13);
a second balloon (proximal inflatable balloon 334 in fig. 13) with a predefined shape and size attached over a second portion (longitudinal regions of elongated catheter body 312 over which the second balloon 334 is mounted) of the catheter body (blocking balloon catheter 312 in fig. 13) at the proximal end (proximal end 316 in fig. 13) thereof;
wherein, the first balloon (inflatable/angioplasty balloon 330 in fig. 13), the second balloon (proximal inflatable balloon 334 in fig. 13) are selectively inflated or deflated to perform at least one of: a procedure for widening a selected section or a point of occurrence of lesion of a blood vessel in order to allow an improved blood flow therethrough, a procedure for delivery of one or more treatment therapeutic agents within the selected section of the blood vessel, and a procedure for deployment of a stent within the selected section or lesion section of the vessel to ensure the selected section of the blood vessel remain open once it is opened by inflating the first balloon (inflatable/angioplasty balloon 330 in fig. 13) of the balloon catheter (Col. 20, Lines 34-49);
wherein, the second balloon (proximal inflatable balloon 334 in fig. 13) when inflated within the selected section of the blood vessel form a partial seal to allow continued partial blood supply distally at the end of the blood vessel (Col. 20, Lines 34-37); and
wherein, the first balloon (inflatable/angioplasty balloon 330 in fig. 13) when inflated for widening the selected section or lesion of the blood vessel pushes and comes in at least partial contact with interior sides of the selected section or selected lesion of the vessel (Col. 20, Lines 37-39).
As previously noted, Kokish’s proximal (second) balloon 334 is capable of forming a partial seal when only partially inflated. At intermediate pressures, the compliant or semi-compliant balloon can achieve sufficient wall contact to create a partial barrier while still allowing continued distal blood flow/perfusion.
See also figs. 16 and 17 and the accompanying disclosure (col. 22, lines 15-50), which further illustrate the catheter’s ability to permit blood perfusion through the distal end (e.g., once the guidewire is retracted). This capability supports use for lesions near the distal end of arteries or veins, where maintaining some distal perfusion is often desirable.
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.
Claims 1-2, 4-5, 12, 16, 18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kokish in view of Gerrans.
Regarding claim 1, Kokish discloses:
A multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13), comprising:
an elongated catheter body (blocking balloon catheter 312 in fig. 13) having a tip (leading portion of elongated catheter body 312 in fig. 13),
a proximal end (proximal end 316 in fig. 13), and a distal end (distal end 314 in fig. 13);
a first balloon (inflatable/angioplasty balloon 330 in fig. 13) with a predefined shape and size attached over a first portion (longitudinal region of elongated catheter body 312 over which the first balloon 330 is mounted in fig. 13) of the elongated catheter body (blocking balloon catheter 312 in fig. 13); and
a second balloon (proximal inflatable balloon 334 in fig. 13), and a third balloon (distal inflatable balloon 324 in fig. 13) with predefined shapes and sizes attached over a second portion and a third portion of the catheter body (longitudinal regions of elongated catheter body 312 over which the second balloon 334 and third balloon 324 are mounted) on either side of the first balloon (inflatable/angioplasty balloon 330 in fig. 13) at the proximal end (proximal end 316 in fig. 13), and the distal end (distal end 314 in fig. 13) of the catheter body (blocking balloon catheter 312 in fig. 13) respectively (Col. 20, Lines 29-34);
wherein, the catheter is configured to selectively inflate or deflate the first balloon (inflatable/angioplasty balloon 330 in fig. 13), the second balloon (proximal inflatable balloon 334 in fig. 13), and the third balloon (distal inflatable balloon 324 in fig. 13) to perform at least one of: a procedure for widening a selected section or a point of occurrence of lesion of a blood vessel in order to allow an improved blood flow therethrough, a procedure for delivery of one or more treatment therapeutic agents within the selected section of the blood vessel, and a procedure for deployment of a stent or implant within the selected section of the vessel (Col. 20, Lines 34-49);
wherein, the second balloon (proximal inflatable balloon 334 in fig. 13) and the third balloon (distal inflatable balloon 324 in fig. 13) when inflated within the selected section of the blood vessel form a sealed region (Col. 20, Lines 34-37) extending in between the points of contact of the second balloon (proximal inflatable balloon 334 in fig. 13) and the third balloons (distal inflatable balloon 324 in fig. 13) with the blood vessel;
wherein, the first balloon (inflatable/angioplasty balloon 330 in fig. 13) when inflated for widening the selected section or lesion of the blood vessel pushes and comes in at least partial contact with interior sides (Col. 20, Lines 34-37) of the selected section of the vessel; and
Kokish does not, however, explicitly disclose that the catheter is configured to inflate or deflate the first, second, and third balloons independently of each other. Neither does Kokish disclose that the first balloon has a length along an axis of the elongated catheter body in a direction from the proximal end to the distal end, which is longer than a length of the second balloon and longer than a length of the third balloon.
Gerrans teaches a catheter is configured to inflate or deflate the first, second, and third balloons independently of each other (middle balloon 58 is independently inflated in figs. 3A-3B and repeatedly inflated and deflated according to treatment application; col. 9, lines 53-56; proximal and distal balloons may be inflated in sequence or simultaneously to create a fluidly isolated chamber between the balloons; col. 7, lines 32-35).
Gerrans also teaches that the first balloon has a length along an axis of the elongated catheter body in a direction from the proximal end to the distal end, which is longer than a length of the second balloon and longer than a length of the third balloon (middle balloon 58 is shown with a length longer than that of proximal balloon 54 and distal balloon 56 in figs. 3A-3C).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the multifunctional balloon catheter of Kokish so that the first, second, and third balloons are configured to be selectively inflated or deflated independently of each other, as taught by Gerrans, so that the first (middle) balloon can adequately expand the treatment area before blocking off the treatment area using the second (proximal) and third (distal) balloons, thus enhancing the efficacy of the treatment at the lesion site and to provide more flexible operation during stenting and localized drug delivery procedures.
It would have been further obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the length of the first (middle) balloon of Kokish to be longer than the second (proximal) and third (distal) balloons, as shown by Gerrans, in order to adequately span the lesion site and provide more effective coverage of the selected lesion section while the proximal and distal balloons create the sealed treatment area.
Regarding claim 2, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 150 in fig. 9) of claim 1, wherein the elongated catheter body (blocking balloon catheter 152 in fig. 9) includes a first port (distal opening of lumen 172 in fig. 9) located on the first portion (longitudinal region of elongated catheter body (152) over which the first balloon (170) is mounted in fig. 9) for selectively inflating or deflating the first balloon (inflatable/angioplasty balloon 170 in fig. 9) within the selected section of the blood vessel when the medical procedure is carried out to dilate a lesion.
Regarding claim 4, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 150 in fig. 9) of claim 1, wherein the second balloon (proximal inflatable balloon 174 in fig. 9), and the third balloon (distal inflatable balloon 164 in fig. 9) are configured to be selectively inflated or deflated using the second port (distal opening of lumen 178 in fig. 9) and the third port (distal opening of lumen 165 in fig. 9) respectively.
Kokish fails, however, to explicitly disclose that the catheter body has a second port configured over the second portion of the catheter body and a third port configured over the third portion of the catheter body.
Gerrans teaches that the catheter body has a second port configured over the second portion of the catheter body and a third port configured over the third portion of the catheter body (ports are configured over both the second and third portions of the catheter body in figs. 3A-3B; col. 9; lines 3-16).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the catheter of Kokish to include a dedicated second port over the second portion and a third port over the third portion of the catheter body, as taught by Gerrans, in order to enable reliable, independent, and selective inflation/deflation of the proximal and distal balloons and maintaining a sealed treatment area for therapeutic agent delivery.
Regarding claim 5, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 4, wherein the inflation of the second balloon (proximal inflatable balloon 334 in fig. 13) and the third balloon (distal inflatable balloon 324 in fig. 13) form a seal at their points of contact with the selected section of the blood vessel (Col. 20, Lines 34-37).
Regarding claim 12, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 1, wherein the first balloon (inflatable/angioplasty balloon 330 in fig. 13) is made up of non-compliant or semi- compliant materials capable of expanding to a specific diameter and exerting a high pressure onto the walls of the blood vessel, wherein the non-compliant or semi- compliant materials are selected from the group consisting of polyester, nylon, polyurethane, and silicon (Col. 12, Lines 18-23).
Regarding claim 16, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 1 further comprising at least one port (ports 326 in fig. 13) located either on one side or both the sides of the first balloon (inflatable/angioplasty balloon 330 in fig. 13) for delivery and extraction of one or more treatment therapeutic agents within the selected section of the blood vessel during or after the medical procedures (Col. 20, Lines 2-5).
Regarding claim 18, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 1, wherein the first balloon (inflatable/angioplasty balloon 330 in fig. 13) is further configured to carry the stent (Col 20, Lines 37-44 and claim 34) deployable at the selected section or the point of occurrence of lesion by inflating the first balloon (inflatable/angioplasty balloon 330 in fig. 13).
Regarding claim 20, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 1, wherein the first balloon (inflatable/angioplasty balloon 330 in fig. 13) is sized to substantially cover the length of the selected section or lesion of the blood vessel while the second balloon (proximal inflatable balloon 334 in fig. 13) and the third balloon (distal inflatable balloon 324 in fig. 13) remain aligned within or at a proximal edge and within or at a distal edge of the selected section or lesion of the blood vessel (Col. 20, Lines 2-34).
Regarding claim 21, the functional language has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the first, second, and third balloons (angioplasty 330, proximal 334 ,and distal 324 inflatable balloons in fig. 13) of claim 20. Since the first, second, and third balloons (angioplasty 330, proximal 334, and distal 324 inflatable balloons in fig. 13) of claim 21 have the same structure as those in claim 20, they are able to be used in the same manner as set forth in the claim.
In the instant case, the structure of Kokish is capable of performing the function, as this depends on the particular selected section or lesion and the choice of where along that section to position the second and third balloons (proximal 334 and distal 324 inflatable balloons in fig. 13), rather than any difference in catheter structure. A person of ordinary skill in the art would understand that the same three-balloon catheter of Kokish can be positioned such that the second and third balloons (proximal 334 and distal 324 inflatable balloons in fig. 13) lie either at the proximal and distal lesion edges (as in claim 20) or slightly away from those edges in other vessel segments (as in claim 21), using the same balloons and shaft portions without any difference in structure.
Claims 3, 6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kokish in view of Gerrans, as applied to claim 1 above, and further in view of Shulze (US Patent No. 6,056,721), hereinafter, Shulze.
Regarding claim 3, Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 1, wherein the first portion (longitudinal region of elongated catheter body 312 over which the first balloon 330 is mounted in fig. 13) of the elongated catheter body (blocking balloon catheter 312 in fig. 13) has a first balloon (inflatable/angioplasty balloon 330 in fig. 13) attached, but Kokish fails to disclose the first balloon (inflatable/angioplasty balloon 330 in fig. 13) comprising a pair of radiopaque marker bands.
Shulze teaches a pair of radiopaque marker bands (locator markers 57 in fig. 3) placed about the elongated catheter body adjacent to the first balloon (catheter body 20 adjacent to second balloon 50 in fig. 3) (Col. 8, Lines 1-12).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the first balloon of Kokish to include radiopaque marker bands as taught by Shulze in order to ensure accurate visualization and positioning of the balloon catheter.
Regarding claim 6, Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 4, wherein each of the second portion and the third portion of the catheter body (blocking balloon catheter 312 in fig. 13) have a second balloon and third balloon (proximal 334 and distal 324 inflatable balloons in fig. 13) attached thereon, but Kokish fails to disclose that the second and third balloon (proximal 334 and distal 324 inflatable balloons in fig. 13) further comprise a first pair of radiopaque marker bands and a second pair of radiopaque marker bands respectively configured at either ends of the second balloon and third balloon (proximal 334 and distal 324 inflatable balloons in fig. 13).
Shulze teaches a radiopaque marker band (locator marker 45 in fig. 3) under/adjacent to (first balloon 46 in fig. 3) and a pair of radiopaque marker bands (locator markers 57 in fig. 3) at the proximal and distal shoulders of the first balloon (balloon 50 in fig. 3). Applying Shulze’s teaching of proximal and distal locator markers to each of Kokish’s balloon regions, including the second and third balloons, would have represented applying a known technique to a known device ready for improvement to yield predictable results, as set forth in MPEP §2143(I)(D).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the second and third balloons of Kokish to include radiopaque markers as taught by Shulze in order to ensure accurate visualization and positioning of the balloon catheter.
Regarding claim 14, Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 1, but Kokish fails to disclose that the second balloon and the third balloon (proximal 334 and distal 324 inflatable balloons in fig. 13) are made up of semi-compliant or compliant materials, wherein the semi-compliant or compliant materials are selected from the group consisting of polyurethane, silicon, ethylene-vinyl acetate, polyvinyl chloride (PVC), olefin copolymers or homopolymers, polyethylenes, polyurethanes, crosslinked low density polyethylenes (PETs), highly irradiated linear low density polyethylene (LDPE), acrylonitrile polymers and copolymers, acrylonitrile blends, and ionomer resins.
Shulze teaches forming balloon catheters (balloon 46 in fig. 3) from silicon and even polyurethane (Col. 6, Line 64 – Col. 7, Line 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the second and third balloons of Kokish from known compliant or semi-compliant balloon materials such as polyurethane or silicon as taught by Shulze in order to achieve a desired combination of high-pressure capability and controlled expansion at the lesion site.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kokish in view of Gerrans, as applied to claims 1 and 16 above, and further in view of Ingber (US Publication No. 2015/0147276), hereinafter, Ingber.
Regarding claim 17, Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 16, but Kokish fails to disclose one or more treatment therapeutic agents which comprise medications, biologically active agents, anti-platelets, anticoagulants, antithrombotic and fibrolytic agents, anti-inflammatory agents, antibodies deliverable in a solution form either individually, or as a combination or in conjunction with nanoparticles including lipid, gold, carbon.
Ingber teaches nanoparticle compositions for vascular therapy in which therapeutic agents such as anticoagulant agents, antithrombotic agents, fibrolytic agents, anti-inflammatory agents, and antibodies are carried and delivered to vascular lesions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select, for delivery by Kokish’s catheter system, therapeutic agents such as anticoagulant agents, antithrombotic agents, fibrolytic agents, anti-inflammatory agents, and antibodies, and to formulate them in a solution in conjunction with known nanoparticle carriers including lipid-based nanocarriers as taught by Ingber, in order to achieve targeted, localized treatment of vascular lesions.
Claims 22 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kokish in view of Gerrans, as applied to claim 1 above, and further in view of Hawkins (US Patent No. 9,180,280), hereinafter, Hawkins.
Regarding claim 22, Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 1, but Kokish fails to disclose the catheter further comprising one or more electrodes attached or located in close proximity to the first portion (longitudinal region of elongated catheter body 312 over which the first balloon 330 is mounted in fig. 13) of the catheter body (blocking balloon catheter 312 in fig. 13) and powered by a power source, wherein the power source delivers a stream of pulses to the one or more electrodes to create a stream of waves or vibrations within the first balloon (inflatable/angioplasty balloon 330 in fig. 13) that migrate towards the selected section or lesion section of the blood vessel.
Hawkins teaches one or more electrodes (electrodes 22, 24 in figs. 2,4) positioned within the balloon region of the catheter and a power source (voltage pulse generator 30 in figs. 2,4) that delivers a stream of high-voltage pulses to those electrodes to create a series of sound waves or ultrasonic waves (shock waves 28 in fig. 4) within the balloon that travel through the balloon fluid to the calcified lesion region of the blood vessel (Col. 3, Lines 46-55).
Regarding claim 24, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 22, wherein the stream of waves (shock waves 28 in fig. 4) or pulses that lead to continuous vibration or drilling effect on the lesion section of the blood vessel (Col. 3, Lines 46-55).
Regarding claim 25, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 22, wherein the waves comprising at least mechanical waves including sound waves or ultrasonic waves or pressure waves (shock waves 28 in fig. 4) capable of propagating through air, fluid, and solids; or electromagnetic waves capable of propagating through air, fluid, solid material or vacuum (Col. 3, Lines 46-55).
Claims 37-41 are rejected under 35 U.S.C. 103 as being unpatentable over Kokish in view of Gerrans, as applied to claim 1 above, and further in view of Forman (US Publication No. 2004/0215140), hereinafter, Forman.
Regarding claim 37, modified Kokish discloses a method of using the multifunctional balloon catheter of claim 1, the method comprising: inserting the catheter into a blood vessel; inflating the first balloon to widen a selected section or a point of occurrence of lesion of the blood vessel (Kokish: middle balloon with an inflation fluid to place a stent, or to perform an angioplasty procedure; col. 20, lines 37-39).
Kokish fails, however, to disclose inflation of the first ballon while the second balloon and the third balloon remain in a non-inflated state;
inflating the second balloon and the third balloon on either side of the first balloon to create respective seals between their points of contact with the blood vessel; deflating the first balloon to create a contiguous sealed region between the first balloon and the second balloon; and
at the same time as deflating the first balloon, or after deflating the first balloon, delivering one or more treatment therapeutic agents to the contiguous sealed region through at least one port located at one or both sides of the first balloon.
Forman teaches inflation of a first (middle) ballon while the second balloon and the third balloon remain in a non-inflated state (Forman: balloons 20/22/24 have independent inflation control, any one or any combination of the balloons can be inflated according to the desired outcome; para [0044]);
inflating the second balloon and the third balloon on either side of the first balloon to create respective seals between their points of contact with the blood vessel; deflating the first balloon to create a contiguous sealed region between the first balloon and the second balloon (Forman: balloons 20/22/24 have independent inflation control, any one or any combination of the balloons can be inflated according to the desired outcome; para [0044]);
and Gerrans teaches at the same time as deflating the first balloon, or after deflating the first balloon, delivering one or more treatment therapeutic agents to the contiguous sealed region (Gerrans: delivery of therapeutic agents is adjusted at the same time as the middle balloon in inflated or deflated in fig. 3C; col. 9, lines 52-62) through at least one port located at one or both sides of the first balloon (Gerrans: therapeutic agents delivered to fluidly isolated chamber 62 via ports 60 positioned on the catheter between proximal and distal balloons 54 and 56 in figs. 3A-3C; col. 9, lines 3-13).
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 method of using the multifunctional balloon catheter of Kokish to perform the claimed sequence of steps. Kokish teaches the overall method of inserting the catheter into a blood vessel and using the first (middle), second (proximal), and third (distal) balloons to widen a lesion, deliver agents, and/or deploy a stent. Forman teaches independent inflation control of multiple balloons on a single catheter, such that any one balloon or any combination of the balloons can be inflated according to desired outcome of procedure, including inflating a first (middle) balloon while the second and third balloons remain in a non-inflated state. Gerrans further teaches a multi-balloon system in which therapeutic agents are delivered at the same time as (during) inflation or deflation of the first (middle) balloon, with continuous adjustment of agent delivery as the middle balloon is inflated and deflated to modulate pressure in the chamber and delivery occurring through ports located on one or both sides of the first (middle) balloon within the fluidly isolated chamber.
One of ordinary skill in the art would have been motivated to modify Kokish to (1) inflate the first (middle) balloon while the second (proximal) and third (distal) balloons remain non-inflated, (2) subsequently inflate the second and third balloons to create seals, (3) deflate the first (middle) balloon to create a contiguous sealed region, and (4) deliver therapeutic agents at the same time as or after deflating the first (middle) balloon through the side ports, at taught by Forman’s flexible balloon control and Gerrans’ dynamic pressure modulation and port configuration. The combination yields predictable results with improved procedural control, reduced risk, and more effective localized treatment.
Regarding claim 38, modified Kokish discloses the method of claim 37, wherein the first balloon and second balloon are inflated simultaneously (Forman: balloons 20/22/24 have independent inflation control, any one or any combination of the balloons can be inflated according to the desired outcome; para [0044]).
Regarding claim 39, modified Kokish discloses the method of claim 37, wherein the one or more treatment therapeutic agents are delivered at the same time as deflating the first balloon (Gerrans: delivery of therapeutic agents is adjusted at the same time as the middle balloon in inflated or deflated in fig. 3C; col. 9, lines 52-62).
Regarding claim 40, modified Kokish discloses the method of claim 37, wherein the one or more treatment therapeutic agents are delivered to the sealed region through a port located between the first balloon and the second balloon and a port located between the second balloon and the third balloon (Gerrans: therapeutic agents delivered to fluidly isolated chamber 62 via ports 60 positioned on the catheter between proximal and distal balloons 54 and 56 in figs. 3A-3C; col. 9, lines 3-13).
Regarding claim 41, modified Kokish discloses the method of claim 37, comprising removing the treatment agent from the contiguous sealed region before deflating the second and third balloons (Kokish: pressure of inflation fluid can be increased to create a pressure differential between proximal and distal inflation balloons which caused inflation fluid to jet or stream out of balloon perforations to dislodge and carry emboli from isolated portion of blood vessel to exit through the open evacuation lumen as shown in figs. 3 and 11; col. 17, lines 5-17 and col. 17, line 46 – col. 18, line 7).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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