DETAILED ACTION
A complete action on the merits of claims 1-18 follows below.
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 .
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 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5, 9-14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Halavee (US Patent No. 6,324,257) in view of Schultheis (US Pub. No. 2021/0307828).
Regarding Claim 1, Halavee teaches a system for tissue ablation (Figs. 2-3), the system comprising:
a probe 11, configured to be inserted into a cavity of an organ of a patient; an expandable capsule 12 fitted at a distal end of the probe (Fig. 3) and configured to be expanded within the cavity (Col. 6, ll. 29-33 and Col. 9, ll. 8-15); a voltage discharge device (combination of high voltage power supply and x-ray head in Figs. 2-3, 5A-9C), which is fitted inside the expandable capsule (Fig. 3) and is configured to create plasma by electrical excitation of a gas that fills a capsule 7 (Col. 4, ll. 16-20, Col. 6, ll. 34-Col. 7, ll. 14 and Figs. 9A-C), the plasma emitting X-rays, so as to ablate tissue in the cavity using the X-rays (Col. 3, ll. 4-40, Col. 8, ll. 6-26 and Col. 9, ll. 34-54); and a generator 1 (Fig. 2), which is wired to the voltage discharge device to apply electrical signals that electrically excite the plasma (Col. 3, ll. 53-Col. 4, ll. 47 and Col. 5, ll. 51-Col. 6, ll. 16); however, does not teach the balloon is expanded by being filled with a gas and the plasma is created by electrical excitation of the gas that fills the balloon.
In the same field of invention, Schultheis teaches “balloon fluid 132 can be a liquid or a gas. Exemplary balloon fluids 132 suitable for use herein can include, but are not limited to one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases, such as carbon dioxide, and the like” in [0045] and further teaches creating a plasma within the balloon “the catheter systems of the present invention utilize an energy source, e.g., a light source such as a laser source or another suitable energy source, which provides energy that is guided by an energy guide, e.g., a light guide, to create a localized plasma in a balloon fluid within a balloon interior of an inflatable balloon of the catheter. As such, the energy guide can sometimes be referred to as, or can be said to incorporate a “plasma generator” at or near a guide distal end of the energy guide that is positioned within the balloon interior” in [0029]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use the same fluid source to supply a gas configured to be used to create the plasma and also inflate the balloon of Halavee in order to use a single fluid source (as it appears in Fig. 2) to inflate the balloon and create plasma by the same gas.
Regarding Claim 2, Halavee teaches wherein the expandable capsule is an expandable balloon 12 (Col. 6, ll. 29-33).
Regarding Claim 3, Halavee teaches wherein the voltage discharge device comprises a pair of electrodes (8/9 in Figs. 2-3 or 30a/30b in Figs. 9A-C Col. 9, ll. 34-54).
Regarding Claim 4, Halavee teaches wherein the electrodes are arranged in a linear geometry (8/9 in Figs. 2-5D).
Regarding Claim 5, Halavee teaches wherein the electrodes are arranged in a concentric geometry (30a/30b in Figs. 9A-9C).
Regarding Claim 9, Halavee in view of Schultheis teaches wherein the gas inside the expandable capsule is filled to a sub-atmospheric pressure ([0043] of Schultheis).
Regarding Claim 10, Halavee teaches a method for tissue ablation (Figs. 2-3), the method comprising:
inserting a probe 11 into a cavity of an organ of a patient (Col. 6, ll. 29-33 and Col. 9, ll. 8-15), the probe comprising an expandable capsule 12 fitted at a distal end thereof (Fig. 3); filling the expandable capsule; and using a voltage discharge device (combination of high voltage power supply and x-ray head in Figs. 2-3, 5A-9C) fitted inside the expandable capsule (Fig. 3), creating plasma by electrical excitation of the gas that fills [the expandable] a capsule 7 (Col. 4, ll. 16-20, Col. 6, ll. 34-Col. 7, ll. 14 and Figs. 9A-C), the plasma emitting X-rays, so as to ablate tissue in the cavity using the X-rays (Col. 3, ll. 4-Col. 4, ll. 47, Col. 8, ll. 6-26 and Col. 9, ll. 34-54);
however, does not teach the balloon is expanded by being filled with a gas and the plasma is created by electrical excitation of the gas that fills the balloon.
In the same field of invention, Schultheis teaches “balloon fluid 132 can be a liquid or a gas. Exemplary balloon fluids 132 suitable for use herein can include, but are not limited to one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases, such as carbon dioxide, and the like” in [0045] and further teaches creating a plasma within the balloon “the catheter systems of the present invention utilize an energy source, e.g., a light source such as a laser source or another suitable energy source, which provides energy that is guided by an energy guide, e.g., a light guide, to create a localized plasma in a balloon fluid within a balloon interior of an inflatable balloon of the catheter. As such, the energy guide can sometimes be referred to as, or can be said to incorporate a “plasma generator” at or near a guide distal end of the energy guide that is positioned within the balloon interior” in [0029]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use the same fluid source to supply a gas configured to be used to create the plasma and also inflate the balloon of Halavee in order to use a single fluid source (as it appears in Fig. 2) to inflate the balloon and create plasma by the same gas.
Regarding Claim 11, Halavee teaches wherein the expandable capsule is an expandable balloon 12 (Col. 6, ll. 29-33).
Regarding Claim 12, Halavee teaches wherein the voltage discharge device comprises a pair of electrodes (8/9 in Figs. 2-3 or 30a/30b in Figs. 9A-C Col. 9, ll. 34-54).
Regarding Claim 13, Halavee teaches wherein the electrodes are arranged in a linear geometry (8/9 in Figs. 2-5D).
Regarding Claim 14, Halavee teaches wherein the electrodes are arranged in a concentric geometry (30a/30b in Figs. 9A-9C).
Regarding Claim 18, Halavee in view of Schultheis teaches wherein the gas inside the expandable capsule is filled to a sub-atmospheric pressure ([0043] of Schultheis).
Claims 1-5, 9-14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schultheis in view of Halavee.
Regarding Claim 1, Schultheis teaches a system for tissue [ablation] (tissue treatment by disrupting calcification at the treatment site by the steps of generating energy with an energy source to electrodes positioned within a balloon and creating vascular lesions, abstract, [0028] and [0034]-[0036]), the system comprising:
a probe 110 (Fig. 1), configured to be inserted into a cavity of an organ of a patient ([0035]); an expandable capsule (balloon 104) fitted at a distal end of the probe and configured to be expanded within the cavity and to be filled with a gas ([0045]); a voltage discharge device, which is fitted inside the expandable capsule and is configured to create plasma by electrical excitation of the gas that fills the expandable capsule; and a generator, which is wired to the voltage discharge device to apply electrical signals that electrically excite the plasma ([0013]-[0017], [0029]-[0030], [0039]-[0040]);
however, does not teach the plasma emitting X-rays, so as to ablate tissue in the cavity using the X-rays as claimed.
In the same field of invention, Halavee teaches “A very high intensity x-ray pulse is achieved due to the unique geometry in which the electrons are accelerated toward a control elongated anode in the device. Furthermore, the device of the present invention may utilize the method of direct conversion of light into x-ray radiation, providing a radiotherapeutical device with no need for accelerating an electron beam and with no need for electric conductors, thereby greatly simplifying its operation” in Col. 3, ll. 4-23 and “a method for the generation of x-rays in situ in the human body, comprising locating the x-ray source of the device, preferably by inserting it into a body cavity, such as a blood vessel, at a treated area, and according to one embodiment activating the light source and, according to another embodiment, concurrently activating the power supply. This method is useful in a wide range of brachytherapy procedures and the x-ray source may be inserted into body cavities via a catheter in combination with medical procedure instrumentality, such as balloons or stents” in Col. 4, ll. 37-47.
Since Schultheis teaches “the energy guide can include an electrode pair including spaced apart electrodes that extend into the balloon interior; and pulses of high voltage from the energy source can be applied to the electrodes and form an electrical arc across the electrodes” [0017] to create plasma within the balloon, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add the electrodes in such a manner as to allow a very high intensity x-ray pulse to be achieved by the unique geometry in which the electrons are accelerated toward a control elongated anode in the device to ablate tissue as Halavee teaches in order to use the device in a variety of treatment procedures such as the use of x-ray in tissue ablation.
Regarding Claim 2, Schultheis teaches wherein the expandable capsule is an expandable balloon 104 ([0036]).
Regarding Claim 3, Schultheis teaches wherein the voltage discharge device comprises a pair of electrodes ([0017], [0040], 158/160 [0087] Fig. 1, 258/260 [0096] Fig. 2, 358/360 [0104] Fig. 3, also 8/9 in Figs. 2-3 or 30a/30b in Figs. 9A-C Col. 9, ll. 34-54 of Halavee).
Regarding Claim 4, Schultheis in view of Halavee teaches wherein the electrodes are arranged in a linear geometry (8/9 in Figs. 2-5D of Halavee).
Regarding Claim 5, Schultheis in view of Halavee teaches wherein the electrodes are arranged in a concentric geometry (30a/30b in Figs. 9A-9C of Halavee).
Regarding Claim 9, Schultheis teaches wherein the gas inside the expandable capsule is filled to a sub-atmospheric pressure ([0043]).
Regarding Claim 10, Schultheis teaches a method for tissue [ablation] (tissue treatment by disrupting calcification at the treatment site by the steps of generating energy with an energy source to electrodes positioned within a balloon and creating vascular lesions, abstract, [0028] and [0034]-[0036]), the method comprising:
inserting a probe 110 (Fig. 1) into a cavity of an organ of a patient, the probe comprising an expandable capsule (balloon 104) fitted at a distal end thereof (Fig. 1); filling the expandable capsule with a gas ([0045]); and using a voltage discharge device fitted inside the expandable capsule, creating plasma by electrical excitation of the gas that fills the expandable capsule ([0013]-[0017], [0029]-[0030], [0039]-[0040]);
however, does not teach the plasma emitting X-rays, so as to ablate tissue in the cavity using the X-rays as claimed.
In the same field of invention, Halavee teaches “A very high intensity x-ray pulse is achieved due to the unique geometry in which the electrons are accelerated toward a control elongated anode in the device. Furthermore, the device of the present invention may utilize the method of direct conversion of light into x-ray radiation, providing a radiotherapeutical device with no need for accelerating an electron beam and with no need for electric conductors, thereby greatly simplifying its operation” in Col. 3, ll. 4-23 and “a method for the generation of x-rays in situ in the human body, comprising locating the x-ray source of the device, preferably by inserting it into a body cavity, such as a blood vessel, at a treated area, and according to one embodiment activating the light source and, according to another embodiment, concurrently activating the power supply. This method is useful in a wide range of brachytherapy procedures and the x-ray source may be inserted into body cavities via a catheter in combination with medical procedure instrumentality, such as balloons or stents” in Col. 4, ll. 37-47.
Since Schultheis teaches “the energy guide can include an electrode pair including spaced apart electrodes that extend into the balloon interior; and pulses of high voltage from the energy source can be applied to the electrodes and form an electrical arc across the electrodes” [0017] to create plasma within the balloon, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add the electrodes in such a manner as to allow a very high intensity x-ray pulse to be achieved by the unique geometry in which the electrons are accelerated toward a control elongated anode in the device to ablate tissue as Halavee teaches in order to use the device in a variety of treatment procedures such as the use of x-ray in tissue ablation.
Regarding Claim 11, Schultheis teaches wherein the expandable capsule is an expandable balloon 104 ([0036]).
Regarding Claim 12, Schultheis teaches wherein the voltage discharge device comprises a pair of electrodes ([0017], [0040], 158/160 [0087] Fig. 1, 258/260 [0096] Fig. 2, 358/360 [0104] Fig. 3, also 8/9 in Figs. 2-3 or 30a/30b in Figs. 9A-C Col. 9, ll. 34-54 of Halavee).
Regarding Claim 13, Schultheis in view of Halavee teaches wherein the electrodes are arranged in a linear geometry (8/9 in Figs. 2-5D of Halavee).
Regarding Claim 14, Schultheis in view of Halavee teaches wherein the electrodes are arranged in a concentric geometry (30a/30b in Figs. 9A-9C of Halavee).
Regarding Claim 18, Schultheis teaches wherein the gas inside the expandable capsule is filled to a sub-atmospheric pressure ([0043]).
Claims 6-7 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Halavee in view of Schultheis or Schultheis in view of Halavee as applied above and further in view of Fleming (US Pub. No. 2002/0131554).
Regarding Claims 6-7 and 15-16, Halavee and Schultheis teach the invention as applied above; however, neither alone or in combination teach wherein the gas is krypton, and the X-rays are generated from K-shell transition lines of the krypton plasma and the X-rays are generated from K-shell transition lines of the xenon plasma.
In the same field of invention, Fleming teaches “Another aspect of the invention involves the selection of vapor used within the x-ray tube. The selection of the vapor relates to the particular application. In one example, for a fluorescent x-ray tube designed for irradiating meat up to 10-12 cm thick, 30 keV x-rays are attractive since as much as 80% of the x-ray flux hitting the meat will be absorbed. Accordingly, for this application, xenon, which has a characteristic K x-ray emission at about 30 keV, would be selected as the fill gas for the fluorescent x-ray tube. Several other gases are attractive for other applications. For instance, krypton would be useful, with its 13 keV x-ray emissions, for the irradiation of thinner and/or lower atomic number materials” in [0059].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use different gases such as krypton or xenon, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Halavee in view of Schultheis or Schultheis in view of Halavee in view of Fleming as applied above and further in view of Le Galloudec (US Patent No. 9,269,524).
Regarding Claims 8 and 17, Halavee and Schultheis in view of Fleming teach the invention as applied above including the gas is krypton, and the X-rays are generated from K-shell transition lines of the krypton plasma and the X-rays are generated from K-shell transition lines of the xenon plasma; however, neither alone or in combination teach wherein the gas is argon, and the X-rays are generated from K-shell transition lines of the argon plasma.
In the same field of invention, Vrba teaches “In some embodiments, the fluid is any noble gas (e.g., heavy gas), including but not limited to: helium, neon, argon, krypton, and xenon” in [0240].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a different gas such as argon to create the plasma, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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