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 .
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 12 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.
Claim 12 recites the limitation "the device or system of claim 1" in line 3. Claim 1 is directed to a device not a system. There is insufficient antecedent basis for this limitation in the claim.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al (U.S. Patent Application Publication Number: US 2019/0030328 A1, hereinafter “Stewart”) in view of Pacetti et al (U.S. Patent Application Publication Number: US 2014/0276360 A1, hereinafter “Pacetti”).
Regarding claim 1, Stewart teaches a device (e.g. Fig. 1) for intraluminal administration of a therapeutic agent within a circulatory vessel (e.g. Fig. 4-10, [0079]: a pulmonary vein when the expandable element 30 is positioned in contact with a pulmonary vein ostium), the device comprising:
a first array of positive electrodes, a second array of negative electrodes (e.g. Figs. 5- 21, [0075], [0079], [0080], Note: an electrode is a piece of metal, electrodes can be configured to be positive or negative), and an expandable substrate comprising an outer surface (i.e. balloon e.g. 30 Fig.4-21, [0109]), wherein:
a. the first array and the second array are attached to the outer surface of the expandable substrate in an array configuration electrode (e.g. Figs 5- 21, [0075], [0079], [0080];
c. the expandable substrate is configured to reversibly reposition from a collapsed configuration to an expanded configuration, wherein the collapsed configuration is configured to facilitate insertion of the device into a circulatory vessel, and the expanded configuration is configured to compress the outer surface against a luminal wall of the circulatory vessel (e.g. Fig.1 [0058]-[0061] [0079]: at least a portion of each electrodes 18 may be configured to be in contact with, for example, a circumference of tissue surrounding a pulmonary vein when the expandable element 30 is positioned in contact with a pulmonary vein ostium.); and
d. the first array and second array are configured to induce at least one electric field within the luminal wall when a voltage is applied between the positive electrodes of the first array and the negative electrodes of the second array when the expandable substrate is positioned in the expanded configuration (e.g. [0079]: at least a portion of each electrodes 18 may be configured to be in contact with, for example, a circumference of tissue surrounding a pulmonary vein when the expandable element 30 is positioned in contact with a pulmonary vein ostium, and at least a portion of at least some of the plurality of electrodes 18 may be configured to be in contact with a tissue wall (such as a wall of a chamber of a heart) when a lateral surface of the expandable element 30 is positioned to be in contact with the tissue wall).
Stewart teaches the device is used for reversible electroporation (e.g. [0073] and that reversible electroporation may be used to transfer agents, including genetic material and other large or small molecules including but not limited to therapeutic agents, into targeted cells (e.g. [0068]) but does not specifically teach b. a therapeutic agent coated over at least a portion of the outer surface of the expandable substrate.
In a similar field of endeavor, Pacetti teaches a catheter for intraluminal delivery of a therapeutic agent to a subject comprising a balloon with a coating including a therapeutic agent on an outer surface of the balloon (e.g. [0033], [0038], [0042],[0044]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the balloon in the teachings of Stewart to include a therapeutic agent coating as taught by Pacetti in order to provide the predictable results of promoting rapid and specific drug release from the balloon coating to the vessel lumen.
Regarding claim 2, Stewart in view of Pacetti teaches the claimed invention as discussed above and Stewart teaches that the at least one electric field induced by the first and second arrays is sufficient to cause electroporation of a cellular membrane of the luminal wall (e.g. Abstract, [0006], [0068]).
Regarding claim 3, Stewart in view of Pacetti teaches the claimed invention as discussed above and Stewart teaches the array configuration is selected from at least one of a longitudinal pattern, a horizontal pattern, an oblique pattern, a spiral pattern, an auxetic pattern, and any combination thereof (e.g. Figs. 4-21).
Regarding claim 4, Stewart in view of Pacetti teaches the claimed invention as discussed above and Stewart teaches that at least a portion of the first array of positive electrodes, the second array of negative electrodes, or any combination thereof protrudes outward from the outer surface of the expandable substrate (e.g. Fig.4, [0064]: One or more electrodes 18 may be adhered to, mounted to, affixed to, or otherwise disposed or coupled to the spline(s)).
Regarding claim 5, Stewart in view of Pacetti teaches the claimed invention as discussed above and Stewart teaches the outer surface of the expandable substrate is compliant or non-compliant when the expandable substrate is positioned in the expanded configuration (e.g. [0064]: thin flexible membranes or ballon or inflatable element).
Regarding claim 6, Stewart in view of Pacetti teaches the claimed invention as discussed above and Stewart teaches the expandable substrate is selected from an angioplasty balloon, an expandable stent, and any combination thereof (e.g. [0064]: thin flexible membranes or ballon or inflatable element).
Regarding claims 7 and 8, Stewart in view of Pacetti teaches the claimed invention as discussed above except for the therapeutic agent comprising a charged compound and the at least one electric field induced by the first and second arrays is sufficient to cause electroporation of the cellular membrane of the luminal wall and electrophoresis to facilitate the intraluminal administration of the therapeutic agent (e.g. [0016]: a charged moiety such as a micelle, nanoparticle or liposome is employed to encapsulate the therapeutic agent, [0022], [0033], [0045]: electric current provides an electromotive force which repels electrostatically charged molecules and/or moieties from the balloon to the vessel wall.) and the therapeutic agent being an encapsulated agent that is configured to release in response to a release factor selected from stretching, heating, changes to pH, releasing of a cofactor, photoactivation, irradiation, application of electrical fields of variable strength and frequency, and any combination thereof (e.g. [0016]: a charged moiety such as a micelle, nanoparticle or liposome is employed to encapsulate the therapeutic agent, [0022],[0033], [0045]: electric current provides an electromotive force which repels electrostatically charged molecules and/or moieties from the balloon to the vessel wall.). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the therapeutic agent coating teachings of Stewart in view of Pacetti to be encapsulated by charged moieties therapeutic agent as taught by Pacetti in order to provide the predictable results of promoting rapid and specific drug release from the balloon coating to the vessel lumen.
Regarding claim 9, Stewart in view of Pacetti teaches the claimed invention as discussed above and Stewart teaches a power source (i.e. energy generator e.g. Abstract, 14 Fig.1, [0057]: electroporation energy generator 14 including an energy control, delivering, and monitoring system through a device electrode distribution system 16) including an energy control, delivering, and monitoring system operatively coupled to the first array of positive electrodes and to the second array of negative electrodes, and a controller operatively coupled to the power source, wherein: a. the power source is configured to apply the voltage between the positive electrodes of the first array and the negative electrodes of the second array; and b. the controller is configured to operate the power source at a predetermined variable strength and frequency, the predetermined strength and frequency configured to induce electroporation, electrophoresis, or any combination within the luminal wall of the circulatory vessel (e.g. [0015], [0021],[0065],[0070], Fig.1,[0097]).
Regarding claim 10, Stewart in view of Pacetti teaches a system for intraluminal administration of a therapeutic agent within a circulatory vessel, comprising the device of claim 1 (as discussed above) and Stewart further teaches a power source (i.e. energy generator e.g. Abstract, 14 Fig.1, [0057]: electroporation energy generator 14 including an energy control, delivering, and monitoring system through a device electrode distribution system 16 ) operatively coupled to the first array of positive electrodes and to the second array of negative electrodes, and a controller operatively coupled to the power source, wherein: a. the power source is configured to apply a voltage between the positive electrodes of the first array and the negative electrodes of the second array; and b. the controller is configured to operate the power source at a predetermined variable voltage strength and frequency, the predetermined variable strength and frequency configured to induce electroporation, electrophoresis, or any combination thereof within the luminal wall of the circulatory vessel (e.g. [0015], [0021],[0065],[0070], Fig.1,[0097]).
Regarding claim 11, Stewart in view of Pacetti teaches a method for intraluminal administration of a therapeutic agent within a circulatory vessel, the method comprising:
a. providing the device or system of claim 1 (as discussed above);
b. positioning the expandable substrate in the collapsed configuration within a lumen of the circulatory vessel (e.g. Fig. 4-10, [0079]: a pulmonary vein when the expandable element 30 is positioned in contact with a pulmonary vein ostium);
c. repositioning the expandable substrate into the expanded configuration to press the positive electrodes of the first array, the negative electrodes of the second array, and the amount of the therapeutic agent against the luminal lining of the circulatory vessel(e.g. Fig.1 [0058]-[0061], [0079] at least a portion of each electrodes 18 may be configured to be in contact with, for example, a circumference of tissue surrounding a pulmonary vein when the expandable element 30 is positioned in contact with a pulmonary vein ostium.); and
d. operating the power source to apply a voltage to the positive electrodes of the first array and the negative electrodes of the second array and to induce at least one electric field within the luminal wall, the at least one electric field configured to induce electroporation, electrophoresis, or any combination thereof within the luminal wall of the circulatory vessel, wherein the induced electroporation, electrophoresis, or any combination thereof facilitate the intraluminal administration of the therapeutic agent(e.g. [0015], [0021],[0065],[0070], Fig.1,[0097]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al (U.S. Patent Application Publication Number: US 2019/0030328 A1, hereinafter “Stewart”) in view of Pacetti et al (U.S. Patent Application Publication Number: US 2014/0276360 A1, hereinafter “Pacetti”) and further in view of Scott et al (U.S. Patent Application Publication Number: US 2004/0220511 A1, hereinafter “Scott”).
Regarding claim 12, Stewart in view of Pacetti teaches the claimed invention as discussed above and Stewart teaches delivering the device 12 into the tissue region via a sheath (e.g. [0058]) and states that it may also be removed (e.g. [0073]), however they do not specifically teach a. repositioning the expandable substrate into the collapsed configuration; and b. removing the expandable substrate in the collapsed configuration from within the lumen of the circulatory vessel.
In a similar field of endeavor, Scott teaches a catheter with an expandable distal end for delivering one or more medicaments and also teaches a means for controlling or manipulating the expandable distal end to expand and contract into various configurations (e.g. abstract) and repositioning the expandable substrate into the collapsed configuration (e.g. [0084]: lowest configuration,[0085] and removing the expandable substrate in the collapsed configuration from within the lumen of the circulatory vessel (e.g.[0091], [0092]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Stewart in view of Pacetti and insert the device and remove it from the lumen as taught by Scott in order to provide the predictable results of easily and safely inserting and removing the device into and from the target tissue.
Conclusion
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792