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 . 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.
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 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais (US 2010/0191112) in view of Kauphusman (US 2010/0292687).
Regarding claims 1 and 8, Demarais discloses an apparatus with a flexible catheter shaft (302, fig. 4A) with an electrically insulating, collapsible/expandable balloon (304, [0044]) and ring electrodes on either side of the balloon (306a and 306b). Demarais does not include a lumen or related structures, or the balloon material. Kauphusman discloses a catheter with electrodes on either side of a balloon and teaches that a lumen through the shaft that holds the balloon may be provided with openings (188, 192), either between the electrode and balloon (left side of the device in fig. 5) or distal to the balloon and electrode (right side of the device in fig. 5), to allow blood to flow past the balloon when it is inflated in a body lumen ([0027]). Since Kauphusman does not disclose a reason for either arrangement (electrode/opening/balloon vs. balloon/electrode/opening) they are considered functionally equivalent (MPEP 2144.06), where there are only four possible combinations of the opening/electrode arrangements: both sides having the proximal side arrangement, both sides having the distal side arrangement and one side having one and the other side having the other of the proximal and distal arrangements. It has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, is an obvious modification (MPEP 2141(III)). Further, Kauphusman discloses the balloon can be made of polyurethane as is common in the art ([0018]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the apparatus of Demarais to include a balloon made of polyurethane as taught by Kauphusman, to produce the predictable result of a ballon having desired mechanical, electrical and/or thermal properties. Further, it would have been obvious to one of ordinary skill in the art to modify the apparatus of Demarais to include a blood bypass lumen such as taught by Kauphusman to allow blood to bypass the balloon including using any combination of the opening/electrode arrangements taught by Kauphusman, including the electrodes being positioned between the balloon and the openings, both because the arrangements are functionally equivalent and because it would be obvious to try any of the four combinations of opening/electrode arrangements with expectation that all of them will produce the predictable result of allowing blood to bypass the balloon. The claims use a significant amount of functional language (“configured to”) directed to how the apparatus can be operated. For example, the claims recite that the electrode pair is configured to be used for irreversible electroporation and that the lumen is configured to provide a blood path. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, the electrodes of Demarais as modified are capable of being supplied with some hypothetical energy parameters while the electrodes are immersed in some hypothetical media within a hypothetical “vessel” having some dimensions which would result a reduction of the “peak electric field intensity” by over 50% at some hypothetical point on a wall of the hypothetical vessel, at least in part due to the electrical communication through the openings. Further, the electrodes could be connected to any energy source and any fluid including blood could be passed through the lumen.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais and Kauphusman, further in view of Stewart (US 2013/0030425).
Regarding claims 2 and 3, Demarais discloses the electrodes are bipolar and thus must be provided with independent leads ([0046]), but does not disclose whether the leads are insulated to a certain degree. The fact that Demarais does not discuss the leads at all suggests the details are a matter for a person of ordinary skill in the art to determine. Further, Demarais does note that the electrodes can be used to deliver electroporation energy to the renal artery, where such energy is known to have relatively high voltages ([0040]). A person of ordinary skill in the art would be able to create a functional medical device, such as, for example, a device that does not break due to poor insulation. Stewart discloses an ablation catheter which uses electroporation and teaches that the generator can apply pulses in the range of 500-1000 volts ([0048]). Therefore, before the application was filed, it would have been obvious to further modify the device of Demarais to use an insulation of the leads that is able to withstand any commonly known voltages associated with electroporation, including at least 500 V as taught by Stewart, that would produce the predictable result of a device that can be used to provide electroporation energy without self-destruction.
Claims 4, 21, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais and Kauphusman, further in view of Dann (US 6,223,085).
Regarding claims 4, 21, and 28, Demarais as modified discloses all the limitations but does not disclose an inflation lumen inside the shaft, distinct from the bypass lumen, presumably because a person of ordinary skill in the art would know how to create a functional balloon catheter which does not involve filling the balloon with blood. However, in the interest of compact prosecution, Dann shows a balloon catheter with a bypass (fig. 9B) and shows that the bypass lumen (210) and a balloon inflation lumen (54) are distinct lumens within the catheter. Therefore, before the application was filed, it would have been obvious to further modify the device of Demarais to include an inflation lumen fluidically isolated from the bypass lumen as taught by Dann to produce the predictable result of allowing blood to bypass an inflatable balloon while allowing the balloon to be inflated with a fluid.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais and Kauphusman, further in view of Roy (US 2012/0116200).
Regarding claims 5 and 7, Demarais does not disclose ring electrodes of a certain diameter or spacing. However, the fact that Demarais has not provided the specific dimensions of the electrodes which ring the catheter is an indication that such parameters are a matter for a person of ordinary skill in the art to determine. Roy discloses a catheter that uses ring electrodes and teaches the electrodes can have a 1 mm width and can be spaced about 5 mm apart ([0035]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the apparatus of Demarais to have any commonly known type, dimensions and spacing of electrodes such as taught by Roy that would produce the predictable result of a functional medical device.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais and Kauphusman, further in view of Sugimoto (US 2013/0296853).
Regarding claims 6 and 7, the apparatus of Demarais does not disclose the diameter of the balloon or the edge-to-edge separation of the electrodes. However, these dimensions are common in the art and there is no evidence that they produce an unexpected result. Sugimoto discloses a balloon catheter and teaches the balloon can be 3-6mm and have a length from 8-30mm. The electrodes of Demarais are on either side of the balloon such that the minimum edge-to-edge separation is “about” the length of the balloon. Therefore, before the application was filed, it would have been obvious to further modify the apparatus of Demarais to have any commonly known dimensions, including a balloon diameter or length as taught by Sugimoto, where the minimum electrode separation is a function of balloon length, to produce the predictable result of a balloon catheter that can be used to treat tissue in a desired manner.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais, Kauphusman and Dann, further in view of Stewart.
Regarding claims 22 and 23, Demarais discloses the electrodes are bipolar and thus must be provided with independent leads ([0046]), but does not disclose whether the leads are insulated to a certain degree. The fact that Demarais does not discuss the leads at all suggests the details are a matter for a person of ordinary skill in the art to determine. Further, Demarais does note that the electrodes can be used to deliver electroporation energy to the renal artery, where such energy is known to have relatively high voltages ([0040]). A person of ordinary skill in the art would be able to create a functional medical device, such as, for example, a device that does not break due to poor insulation. Stewart discloses an ablation catheter which uses electroporation and teaches that the generator can apply pulses in the range of 500-1000 volts ([0048]). Therefore, before the application was filed, it would have been obvious to further modify the device of Demarais to use an insulation of the leads that is able to withstand any commonly known voltages associated with electroporation, including at least 500 V as taught by Stewart, that would produce the predictable result of a device that can be used to provide electroporation energy without self-destruction.
Claims 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais, Kauphusman and Dan, further in view of Roy.
Regarding claims 25 and 27, Demarais does not disclose ring electrodes of a certain diameter or spacing. However, the fact that Demarais has not provided the specific dimensions of the electrodes which ring the catheter is an indication that such parameters are a matter for a person of ordinary skill in the art to determine. Roy discloses a catheter that uses ring electrodes and teaches the electrodes can have a 1 mm width and can be spaced about 5 mm apart ([0035]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the apparatus of Demarais to have any commonly known type, dimensions and spacing of electrodes such as taught by Roy that would produce the predictable result of a functional medical device.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais, Kauphusman and Dann, further in view of Sugimoto.
Regarding claims 26 and 27, the apparatus of Demarais does not disclose the diameter of the balloon or the edge-to-edge separation of the electrodes. However, these dimensions are common in the art and there is no evidence that they produce an unexpected result. Sugimoto discloses a balloon catheter and teaches the balloon can be 3-6mm and have a length from 8-30mm. The electrodes of Demarais are on either side of the balloon such that the minimum edge-to-edge separation is “about” the length of the balloon. Therefore, before the application was filed, it would have been obvious to further modify the apparatus of Demarais to have any commonly known dimensions, including a balloon diameter or length as taught by Sugimoto, where the minimum electrode separation is a function of balloon length, to produce the predictable result of a balloon catheter that can be used to treat tissue in a desired manner.
Response to Arguments
Applicant's arguments filed 19 May 2025 have been fully considered but they are not persuasive. Applicant has added only functional language to the claims that does not meaningly change the structure previously recited. The claims are directed to an apparatus inserted into the body, not a system that includes an apparatus and an irreversible electroporation generator, nor a method of treating renal arteries with irreversible electroporation using a given apparatus. As discussed above, the references when modified are capable of all the recited functional limitations. Applicant’s other adjacent arguments are unpersuasive. The arguments about the exact location of one side of the lumen are unpersuasive for reasons discussed in previous Actions, where there is no evidence that moving the location of one opening a few millimeters “would not efficiently remove heat.” In fact, Kauphusman does not associate the exact location of the opening relative to the electrodes with what makes heat removal possible. The efficiency of heat removal is only associated with blood flow in general. Further, even if the claims include positive recitation of an irreversible electroporation generator, Applicant is factually incorrect about the nature of Demarais. Specifically, that reference in fact contemplates irreversible electroporation as an ablation modality ([0023], see also [0009] and [0042]). Further, Demarais explicitly discloses that blood can be used to mitigate thermal effects from ablation (abstract, [0033]), such that the blood bypass disclosed by Kauphusman is directly relevant to the apparatus disclosed by Demarais.
Conclusion
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.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794