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 .
Amendment
This action is in response to the Amendment filed on 6/17/2026.
Claims 1-20 are pending.
Response to Arguments
Applicant's arguments with respect to claims 1-20 have been considered but are not persuasive.
Claim Rejections Under 35 U.S.C. 112
In view of the amendments to claim 12, the rejection has now been withdrawn.
Claim Rejections Under 35 U.S.C. 103 U.S. Patent App. Pub. No. US 2019/0030328 (Stewart) in view of U.S. Patent App. Pub. No. US 2014/0276360 (Pacetti), U.S. Patent App. Pub. No. US 2004/0220511 (Scott).
Independent claim 1 has been amended to now recite in part:
“... the at least one electric field is configured to simultaneously (i) electroporate a cellular membrane of the luminal wall and (ii) deliver the therapeutic agent from the expandable substrate into the luminal wall of the circulatory vessel”.
Applicant argues that no combination of Stewart and Pacetti teaches or suggests the device as recited in amended claim 1 specifically the integrated, simultaneous dual mechanism recited in amended claim 1.
Applicant’s amendments and arguments have been carefully considered and are not persuasive for the following reasons.
First, there is no disclosure in the originally filed specifications that the at least one field is configured to “simultaneously” electroporate a cellular membrane AND deliver the therapeutic agent. There is no support for the limitation “simultaneously”. Second, no specific parameters have been disclosed for the electric field to “simultaneously” electroporate the cellular membrane and deliver the therapeutic agent in the originally field specifications as well as the claims.
Stewart teaches a system and device and method for electroporation of a tissue wall comprising an expandable substrate with positive electrodes and negative electrodes of a first and second array configured to induce an electric field in the wall of the tissue when a voltage is applied between them. Stewart clearly states that the device is used for electroporation (e.g. abstract [0006],[0018], [0109]). While 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]), they do not specifically teach that the expandable substrate comprises a therapeutic agent.
The examiner relied on Pacetti’s teachings for the therapeutic agent on the substrate since Pacetti discloses a drug- coated catheter balloon for delivering a therapeutic agent to the vessel wall (e.g. Abstract, [0012]) and as conceded by the applicant. Pacetti also teaches in [0066] that drug uptake into the vessel wall can be increased by the application of low voltage or current, e.g. via electroporation of the endothelium.
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.
Therefore, the combination of Stewart in view of Pacetti teaches the invention as claimed. The claims do not recite any additional limitations that preclude the combined teachings of the applied prior art and therefore the rejection is maintained.
New claims 13-20 have been addressed in the current office action below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 1 recites that the at least one electric field is configured to simultaneously electroporate a cellular membrane of the luminal wall and deliver the therapeutic agent from the expandable substrate into the luminal wall of the circulatory vessel. There is no disclosure in the originally filed specifications that the at least one field is configured to “simultaneously” electroporate a cellular membrane AND deliver the therapeutic agent. There is no support for the limitation “simultaneously”. No specific parameters have been disclosed for the electric field to “simultaneously” electroporate the cellular membrane and deliver the therapeutic agent in the originally field specifications as well as the claims.
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 and 13-20 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”- PREVIOUSLY CITED) in view of Pacetti et al (U.S. Patent Application Publication Number: US 2014/0276360 A1, hereinafter “Pacetti” - PREVIOUSLY CITED).
Regarding claims 1, 8 and 16-18, 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:
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];
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
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 a therapeutic agent coated over at least a portion of the outer surface of the expandable substrate and wherein the therapeutic agent is an encapsulated agent, wherein the encapsulated agent 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.
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 that is an encapsulated agent is encapsulated with in micelle or liposome or nanoparticle and wherein the encapsulated agent 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 on an outer surface of the balloon (e.g. [0033], [0038], [0042],[0044]) and also teaches that the agents are charged (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 modify the balloon in the teachings of Stewart to include a therapeutic agent coating that is encapsulated 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.
As discussed in the response to arguments section and in view of the rejection, the combination of Stewart in view of Pacetti teaches that the at least one electric field is configured to simultaneously (i) electroporate a cellular membrane of the luminal wall and (ii) deliver the therapeutic agent from the expandable substrate into the luminal wall of the circulatory vessel and also teaches that the therapeutic agent is transported into the luminal wall through tissue that has been electroporated by the at least one electric field ( as claimed in claim 16).
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 array and the second array 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 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 claim 7, Stewart in view of Pacetti teaches the claimed invention as discussed above and further as discussed above in the response to arguments section, the combination of Stewart in view of Pacetti teaches the at least one electric field induced by the first array and the second array is sufficient to cause electroporation of the cellular membrane of the luminal wall and delivery of the therapeutic agent to facilitate the intraluminal administration of the therapeutic agent.
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: 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 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 13, Stewart in view of Pacetti teaches the claimed invention as discussed above and Stewart teaches the outer surface of the expandable substrate is non-compliant (e.g. [0064], 41 Fig.1: splines) when the expandable substrate is positioned in the expanded configuration.
Regarding claims 14 and 15, Stewart in view of Pacetti teaches the claimed invention as discussed above and Stewart teaches the collapsed configuration is configured to facilitate insertion of the device into the circulatory vessel and the expandable substrate is configured to reversibly reposition from the collapsed configuration to the expanded configuration (e.g.[0058]: the medical device 12 may be a catheter that is deliverable to the tissue region via a sheath or intravascular introducer [0064]: advancement of the lumen 40 within the elongate body 22 may extend the spline(s) 41 and reduce the diameter of the expandable element 30, whereas retraction of the lumen 40 within the elongate body 22 may retract the spline(s) 41 and increase the diameter of the expandable element 30. That is, the spline(s) 41 may be transitionable between a linear, or at least substantially linear, first configuration and an expanded second configuration in which each spline 41 is curvilinear, bowed, or arcuate , [0071]: the expandable element 30 may be expanded or collapsed (in some embodiments, inflated or deflated) and may adjust to the shape of a particular tissue region).
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: 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 the controller is configured to operate the power source at a predetermined variable voltage strength and a frequency, the predetermined variable strength and the frequency configured to induce electroporation, delivery of the therapeutic agent, 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:
providing the device of claim 1 (as discussed above);
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);
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 a 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
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 and delivery of a therapeutic agent within the luminal wall of the circulatory vessel, wherein the simultaneously induced electroporation, and delivery of the therapeutic agent facilitates the intraluminal administration of the therapeutic agent (e.g. [0015], [0021],[0065],[0070], Fig.1,[0097]).
Regarding claims 19 and 20, Stewart in view of Pacetti teaches the claimed invention as discussed above and as discussed in the response to arguments section and in view of the rejection, the combination of Stewart in view of Pacetti teaches that the first array of positive electrodes and the second array of negative electrodes are configured such that the same electrodes that generate the at least one electric field for electroporation also generate the at least one electric field for delivery of the therapeutic agent and that the electroporation and delivery of the therapeutic agent occur during a common application of the voltage between the first array of positive electrodes and the second array of negative electrodes (Note: as discussed above the application does not provide any specific parameter for the electric field and since Stewart teaches a system and device and method for electroporation of a tissue wall comprising an expandable substrate with positive electrodes and negative electrodes of a first and second array configured to induce an electric field in the wall of the tissue when a voltage is applied between them and also 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]) which is modified to include encapsulated therapeutic agent on the expandable substrate as taught by Pacetti, the combination of Stewart in view of Pacetti teaches the first array of positive electrodes and the second array of negative electrodes are configured such that the same electrodes that generate the at least one electric field for electroporation also generate the at least one electric field for delivery of the therapeutic agent and that the electroporation and delivery of the therapeutic agent occur during a common application of the voltage between the first array of positive electrodes and the second array of negative electrodes.
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” - PREVIOUSLY CITED) in view of Pacetti et al (U.S. Patent Application Publication Number: US 2014/0276360 A1, hereinafter “Pacetti” - PREVIOUSLY CITED) and further in view of Scott et al (U.S. Patent Application Publication Number: US 2004/0220511 A1, hereinafter “Scott” - PREVIOUSLY CITED).
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 repositioning the expandable substrate into the collapsed configuration; and 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gruba et al (U.S. Patent Application Publication Number: US 2022/0062632 A1, hereinafter “Gruba”) teaches an expandable electroporation balloon that is used to administer a therapeutic agent into a target tissue (e.g. abstract, [0040]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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