DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 13 and 21 are objected to because of the following informalities:
Regarding claims 13 and 21, the limitation “apposition” appears to be a typographical error that should be corrected to –a position--.
Appropriate correction is required.
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.
Claims 10 and 20 are 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.
Claims 10 and 20 recite the limitation "the longitudinal axis" in lines 3 and 4 of each claim. There is insufficient antecedent basis for this limitation in the claim. It is also unclear whether this longitudinal axis is an axis of the entire system or a particular element of the claimed system. Further clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 2-13 and 15-21 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Bloom et al. (US 2013/0085493, filed September 30, 2011).
Regarding claim 2, Bloom discloses an energy delivery system for delivering energy to tissue (“Electrosurgical balloons and catheter assemblies employing electrosurgical balloons as electrode tips are presented.” [0009]), the energy delivery system comprising:
an elongate catheter member defining a longitudinal axis and dimensioned for passage within a blood vessel (catheter assembly 100 in e.g., Fig. 1 and corresponding description; also see [0047]);
a treatment member mounted to the elongate catheter member (balloon electrode tip 120 in e.g., Fig. 1 and corresponding description), the treatment member comprising:
an inner inflation element (inner balloon body 272 in Figs. 5-7 and corresponding descriptions), and
an outer inflation element (outer balloon body 222 in Figs. 5-7 and corresponding descriptions) surrounding the inner inflation element, the outer inflation element comprising an electrode configured to deliver electrical energy (“Outer balloon body 222 has an exterior surface 224 (on which one or more electrodes are disposed, not shown) and an interior chamber 222a within which is disposed inner balloon body 272.” [0063]) to at least nerve tissue associated with the blood vessel to cause at least partial denervation thereof (“Embodiments of the electrosurgical balloon described herein can be used for many procedures, including percutaneous treatment of aneurysms, treatment of mitral valve regurgitation by tightening the annulus around the mitral valve, treatments in the upper and lower gastrointestinal tract (GI) (including, e.g., bleeding varices, ulcers, caustic poisons, Crohn's disease), diverticulosis, varicose veins, sympathetic nerves (e.g., renal denervation by RF ablation), tumors, gene and stem cell therapies, and other surgical procedures in which treatment can include vessel sealing/coagulation, tissue shrinkage, and/or tissue ablation.” [0041]);
a source of a first fluid (“Inner catheter 130 can have a lumen communicating with openings 136. The lumen forms a fluid channel for supplying fluid from a fluid source at a proximal end of inner catheter 130 to fluid outlet openings 136.” [0044]; also see [0036]); and
a source of a second fluid (“where balloon body 122 is attached to outer catheter 110, fluid can be supplied into balloon body 122 via a fluid supply lumen in outer catheter 110. Fluid supply from outer catheter 110 (not shown) can be an alternative to or in addition to dispensing fluid from inner catheter 130 via openings 136.” [0045]), the second fluid different from the first fluid (“The fluid can be a gas (e.g., air) or a liquid (e.g., saline). In some embodiments, the outer balloon is configured to be inflated with a liquid, and the inner balloon is configured to be inflated with a gas.” [0037]);
wherein the energy delivery system comprises a first configuration in which the source of the first fluid is fluidly connected with the inner inflation element (“Inner catheter 130 and throat 273 can have a fluid-tight sealing engagement at attachment portion 278b (see FIG. 6), thereby permitting fluid dispensed from outlets in inner catheter 130 (such as outlet openings 136, see FIGS. 1 and 2) to fill interior chamber 272a of inner balloon body 272 and inflate inner balloon body 272.” [0063]), and
wherein the energy delivery system comprises a second configuration in which the source of the second fluid is fluidly connected with the outer inflation element (“The proximal end of outer balloon body 222 is attached to distal end portion of 114 of outer catheter 110 (similar to earlier-described balloon body 122 of catheter assembly 100) [...] fluid can be dispensed into chamber 222a of outer balloon body 222 from outlets provided in outer catheter 110.” [0063]).
Regarding claim 3, Bloom further discloses the elongate catheter member defining a first lumen (“Inner catheter 130 can have a lumen” [0044]; also see e.g., Figs. 1, 5 and corresponding descriptions) and a second lumen (“Outer catheter 110 has an elongated body 112 with a lumen 116.” [0044]; also see e.g., Fig. 1 and corresponding description), wherein in the first configuration, the first lumen fluidically connects the source of the first fluid with the inner inflation element (“Inner catheter 130 and throat 273 can have a fluid-tight sealing engagement at attachment portion 278b (see FIG. 6), thereby permitting fluid dispensed from outlets in inner catheter 130 (such as outlet openings 136, see FIGS. 1 and 2) to fill interior chamber 272a of inner balloon body 272 and inflate inner balloon body 272.” [0063]), and in the second configuration, the second lumen fluidically connects the source of the second fluid and the outer inflation element (“The proximal end of outer balloon body 222 is attached to distal end portion of 114 of outer catheter 110 (similar to earlier-described balloon body 122 of catheter assembly 100) [...] fluid can be dispensed into chamber 222a of outer balloon body 222 from outlets provided in outer catheter 110.” [0063]).
Regarding claim 4, Bloom further discloses wherein the outer inflation element defines a plurality of apertures configured to permit passage of at least the second fluid therethrough (“the outer balloon can be selectively inflated with fluid from a fluid source and has weeping holes for dispensing the fluid to the pair of electrodes as earlier described” [0037]).
Regarding claim 5, Bloom further discloses wherein the inner inflation element defines a fully enclosed volume (interior chamber 272a of inner balloon body 272 in Fig. 6 and corresponding description).
Regarding claim 6, Bloom further discloses wherein the inner inflation element does not define any apertures (“An inner balloon body can provide balloon electrode tip 120 with a double-wall construction that is more resistant to displacement. The inner balloon body can serve as a support for electrode tip 120 to enhance the stability of balloon body 122 and help ensure that the exposed electrode portions of electrodes 156a and 156b on distal portion 162 can be steadily placed in contact with target tissue. The outer balloon body 122 can be adjustably inflated with fluid to vary its shape or internal pressure to control fluid flow rate from weeping holes 126, vary the distance between electrodes and/or achieve desired electrode contact on tissue surfaces. In some embodiments, the inner balloon body can always be filled with fluid once deployed (without adjustment).” [0061]).
Regarding claim 7, Bloom further discloses wherein the inner inflation element and the outer inflation element are fluidically isolated from each other (“inner balloon body 272 and outer balloon body 222 are independently inflatable” [0063]).
Regarding claim 8, Bloom further discloses wherein the inner inflation element is enclosed within a volume defined by the outer inflation element (“Outer balloon body 222 has an exterior surface 224 (on which one or more electrodes are disposed, not shown) and an interior chamber 222a within which is disposed inner balloon body 272.” [0063]).
Regarding claim 9, Bloom further discloses wherein the inner inflation element and the outer inflation element are coaxial (see outer balloon body 222 and inner balloon body 272 in Fig. 5, reproduced below, and corresponding description).
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Regarding claim 10, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Bloom further discloses wherein in an expanded configuration of each of the inner inflation element and the outer inflation element: the inner inflation element is expanded a first distance from the longitudinal axis, and the outer inflation element is expanded a second distance from the longitudinal axis that is greater than or equal to than the first distance (see Fig. 5 and corresponding description).
Regarding claim 11, Bloom further discloses wherein the energy delivery system is configurable such that the first configuration and the second configuration simultaneously exist (“catheter assembly 200 can be provided with fluid outlet opening(s) (such as outlet openings 136) in inner catheter 130 for dispensing fluid to inflate inner balloon body 272, and fluid outlet opening(s) in inner or outer catheters 130 and 110 for inflating outer balloon body 222” [0065]).
Regarding claim 12, Bloom further discloses wherein the energy delivery system comprises a third configuration in which the source of the first fluid is fluidly connected with the outer inflation element (“Fluid can be dispensed from outlets in inner catheter 130 (such as outlet openings 136, see FIGS. 1 and 2) into chamber 222a of outer balloon body 222 [...] Alternatively, fluid can be dispensed into chamber 222a of outer balloon body 222 from fluid inflating chamber 272a of inner balloon body (e.g., via fluid outlet holes provided in inner balloon body 272).” [0063]; also see “fluid outlet opening(s) in inner or outer catheters 130 and 110 for inflating outer balloon body 222” [0065]).
Regarding claim 13, Bloom further discloses wherein when the elongate catheter member and the treatment member are positioned within the blood vessel, the treatment member is configured such that inflation of the inner inflation element causes the outer inflation element and the electrode to maintain apposition with a wall of the blood vessel (“The inner balloon can be used for support and keeping the electrodes on the outer balloon in place during tissue treatment, while the outer balloon can be controlled to vary the inflation amount and pressure so as to control the amount of fluid that weeps, the surface area contact, and the distance between bipolar electrodes.” [0037]).
Regarding claim 15, Bloom discloses an energy delivery system for delivering energy to tissue (“Electrosurgical balloons and catheter assemblies employing electrosurgical balloons as electrode tips are presented.” [0009]), the energy delivery system comprising:
an elongate catheter member defining a longitudinal axis and dimensioned for passage within a blood vessel (catheter assembly 100 in e.g., Fig. 1 and corresponding description; also see [0047]);
a treatment member mounted to the elongate catheter member (balloon electrode tip 120 in e.g., Fig. 1 and corresponding description), the treatment member comprising:
an inner inflation element (inner balloon body 272 in Figs. 5-7 and corresponding descriptions) defining a fully enclosed volume (interior chamber 272a of inner balloon body 272 in Fig. 6 and corresponding description),
an outer inflation element (outer balloon body 222 in Figs. 5-7 and corresponding descriptions) surrounding the inner inflation element (“Outer balloon body 222 has [...] an interior chamber 222a within which is disposed inner balloon body 272.” [0063]), the outer inflation element defining a plurality of apertures (“the outer balloon can be selectively inflated with fluid from a fluid source and has weeping holes for dispensing the fluid to the pair of electrodes as earlier described” [0037]; also see weeping holes 126 in e.g., Fig. 1 and corresponding description),
an electrode mounted on the outer inflation element, the electrode configured to deliver electrical energy (“Outer balloon body 222 has an exterior surface 224 (on which one or more electrodes are disposed, not shown)” [0063]) to at least nerve tissue associated with the blood vessel to cause at least partial denervation thereof (“Embodiments of the electrosurgical balloon described herein can be used for many procedures, including percutaneous treatment of aneurysms, treatment of mitral valve regurgitation by tightening the annulus around the mitral valve, treatments in the upper and lower gastrointestinal tract (GI) (including, e.g., bleeding varices, ulcers, caustic poisons, Crohn's disease), diverticulosis, varicose veins, sympathetic nerves (e.g., renal denervation by RF ablation), tumors, gene and stem cell therapies, and other surgical procedures in which treatment can include vessel sealing/coagulation, tissue shrinkage, and/or tissue ablation.” [0041]);
a source of a first fluid (“Inner catheter 130 can have a lumen communicating with openings 136. The lumen forms a fluid channel for supplying fluid from a fluid source at a proximal end of inner catheter 130 to fluid outlet openings 136.” [0044]; also see [0036]); and
a source of a second fluid (“where balloon body 122 is attached to outer catheter 110, fluid can be supplied into balloon body 122 via a fluid supply lumen in outer catheter 110. Fluid supply from outer catheter 110 (not shown) can be an alternative to or in addition to dispensing fluid from inner catheter 130 via openings 136.” [0045]), the second fluid different from the first fluid (“The fluid can be a gas (e.g., air) or a liquid (e.g., saline). In some embodiments, the outer balloon is configured to be inflated with a liquid, and the inner balloon is configured to be inflated with a gas.” [0037]);
wherein the energy delivery system comprises a first configuration in which the source of the first fluid is fluidly connected with the inner inflation element (“Inner catheter 130 and throat 273 can have a fluid-tight sealing engagement at attachment portion 278b (see FIG. 6), thereby permitting fluid dispensed from outlets in inner catheter 130 (such as outlet openings 136, see FIGS. 1 and 2) to fill interior chamber 272a of inner balloon body 272 and inflate inner balloon body 272.” [0063]), and
wherein the energy delivery system comprises a second configuration in which the source of the second fluid is fluidly connected with the outer inflation element (“The proximal end of outer balloon body 222 is attached to distal end portion of 114 of outer catheter 110 (similar to earlier-described balloon body 122 of catheter assembly 100) [...] fluid can be dispensed into chamber 222a of outer balloon body 222 from outlets provided in outer catheter 110.” [0063]).
Regarding claim 16, Bloom further discloses wherein the inner inflation element does not define any apertures (“An inner balloon body can provide balloon electrode tip 120 with a double-wall construction that is more resistant to displacement. The inner balloon body can serve as a support for electrode tip 120 to enhance the stability of balloon body 122 and help ensure that the exposed electrode portions of electrodes 156a and 156b on distal portion 162 can be steadily placed in contact with target tissue. The outer balloon body 122 can be adjustably inflated with fluid to vary its shape or internal pressure to control fluid flow rate from weeping holes 126, vary the distance between electrodes and/or achieve desired electrode contact on tissue surfaces. In some embodiments, the inner balloon body can always be filled with fluid once deployed (without adjustment).” [0061]).
Regarding claim 17, Bloom further discloses wherein the inner inflation element and the outer inflation element are fluidically isolated from each other (“inner balloon body 272 and outer balloon body 222 are independently inflatable” [0063]).
Regarding claim 18, Bloom further discloses wherein the inner inflation element is enclosed within a volume defined by the outer inflation element (“Outer balloon body 222 has an exterior surface 224 (on which one or more electrodes are disposed, not shown) and an interior chamber 222a within which is disposed inner balloon body 272.” [0063]).
Regarding claim 19, Bloom further discloses wherein the inner inflation element and the outer inflation element are coaxial (see outer balloon body 222 and inner balloon body 272 in Fig. 5, reproduced below, and corresponding description).
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Regarding claim 20, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Bloom further discloses wherein in an expanded configuration of each of the inner inflation element and the outer inflation element: the inner inflation element is expanded a first distance from the longitudinal axis, and the outer inflation element is expanded a second distance from the longitudinal axis that is greater than or equal to than the first distance (see Fig. 5 and corresponding description).
Regarding claim 21, Bloom further discloses wherein when the elongate catheter member and the treatment member are positioned within the blood vessel, the treatment member is configured such that inflation of the inner inflation element causes the outer inflation element and the electrode to maintain apposition with a wall of the blood vessel (“The inner balloon can be used for support and keeping the electrodes on the outer balloon in place during tissue treatment, while the outer balloon can be controlled to vary the inflation amount and pressure so as to control the amount of fluid that weeps, the surface area contact, and the distance between bipolar electrodes.” [0037]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith (US 2011/0319809, December 29, 2011).
Regarding claim 14, Bloom further discloses wherein the first fluid is an irrigation fluid (“the fluid used to inflate the balloon is a conductive fluid (e.g., saline)” [0033]).
Bloom fails to disclose and wherein the second fluid is an anesthetic solution. Although Bloom does disclose the delivery of drugs from a drug source to the treatment site (“in addition to weeping holes, drug delivery holes can be provided in the balloon for delivery of drugs from a drug source to the treatment site. Thus, both electrosurgical and pharmaceutical-based therapies can be applied to the treatment site using the electrosurgical balloon.” [0035]).
However, Smith teaches, in the same field of endeavor, (“As the anesthetic fluid is delivered to the infusion balloon 430, the infusion balloon 430 changes from the un-expanded state (FIG. 4A) to the intermediate expanded state (FIG. 4B). At the intermediate expanded state, the force exerted by the needle 428 against the vein 456 can stretch the vein 456, as seen in FIG. 4B. FIG. 4C illustrates the expanded state of the infusion balloon 430 where the force exerted by the needle 428 has punctured the vein 456. Once the vein 456 is punctured, the anesthetic fluid can be delivered to the perivenous location via the chamber 432, which is in fluid communication with the needle 428.” [0046]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Blom with wherein the second fluid is an anesthetic solution as taught by Smith in order to provide pain relief during a procedure ([0021] of Smith).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-W, F 9am-5pm EST.
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/A.A./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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