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 .
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “healthier” in claim 21 is a relative term which renders the claim indefinite. The term “healthier” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 1-2, 4-5, 12, 16, 18, 20-21, 26, 31, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kokish (US Patent No. 6,485,500), hereinafter, Kokish.
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);
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 first balloon (inflatable/angioplasty balloon 330 in fig. 13), the second balloon (proximal inflatable balloon 334 in fig. 13), the third balloon (distal inflatable balloon 324 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 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 balloon (distal inflatable balloon 324 in fig. 13) with the blood vessel; 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 (Col. 20, Lines 34-37) of the selected section of the vessel.
Regarding claim 2, 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, 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 selectively inflated or deflated using a second port (distal opening of lumen 178 in fig. 9) and a third port (distal opening of lumen 165 in fig. 9) configured over the second portion and the third portion (longitudinal regions of elongated catheter body 152 over which the second balloon 174 and third balloon 164 are mounted in fig. 9) of the catheter body (blocking balloon catheter 152 in fig. 9) respectively.
Regarding claim 5, 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, 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, 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, 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, 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 relatively healthier vessel segments (as in claim 21), using the same balloons and shaft portions without any difference in structure.
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).
Regarding claim 31, Kokish discloses a multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) used for treatment of microvasculature, comprising:
an elongated catheter body (blocking balloon catheter 312 in fig. 13) having a tip (leading portion of elongated catheter body (312)),
a proximal end (proximal end 316 in fig. 13), and a distal end (distal end 314 in fig. 13);
a balloon (inflatable/angioplasty balloon 330 in fig. 13) with a predefined shape and size attached over a portion of the catheter body (blocking balloon catheter 312 in fig. 13) at an end;
wherein, the balloon is 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); and
wherein, the balloon when inflated for widening the selected section or lesion of the blood vessel and delivery of the one or more treatment therapeutic agents within the selected section 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).
Regarding claim 36, the functional language has been carefully considered but is 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 1. Since the first, second, and third balloons (angioplasty 330, proximal 334 , and distal 324 inflatable balloons in fig. 13) of claim 36 have the same structure as those in claim 1, 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 recited function, as the claimed sequence – first inflating the first balloon (angioplasty inflatable balloon 330 in fig. 13) to widen a selected section or lesion, then inflating the second and third balloons (proximal 334 and distal 324 inflatable balloons in fig. 13) on either side to create a sealed region, then deflating the first balloon (angioplasty inflatable balloon 330 in fig. 13) before delivering therapeutic agents through at least one port (ports 326 in fig. 13) – is determined by how one chooses to operate the same three-balloon catheter, not by any structural difference in catheter construction.
A person of ordinary skill in the art would understand that this structure permits inflating and deflating the balloons, and delivering agents through the ports, in any desired order based on the selected section or lesion and procedural strategy.
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.
Claims 3, 6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kokish 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 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, 24-25, 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kokish 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).
Regarding claim 32, modified Kokish discloses the multifunctional balloon catheter (triple balloon emboli protection system 310 in fig. 13) of claim 31 further comprising one or more electrodes (Hawkins, electrodes 22, 24 in figs. 2,4) 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 and powered by a power source (Hawkins, voltage pulse generator 30 in figs. 2,4).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783