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 an opening (188) between an electrode and balloon (left side of the device in fig. 5) and an electrode between an opening (192) and the balloon (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 specific reason for either arrangement (electrode between balloon and opening vs. opening between balloon and electrode) other than blood bypass, they are considered functionally equivalent (MPEP 2144.06) for the purpose of bypassing blood. It is noted that “an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious” (MPEP 2144.06(II)). Further, 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)) where a person of ordinary skill in the art (who is a “person of ordinary creativity, not an automation” MPEP 2141.03(I)) would recognize Kauphusman only discloses only two arrangements of opening/electrode for a total of only four possible combinations of arrangements relative to the balloon: both sides having the opening between the electrode and the balloon, both sides having the electrode between the opening and the balloon, and one side having one of those arrangements and the other side having the other arrangement. Thus, both arrangements are identified and predictable solutions, and there is a reasonable expectation that either arrangement, in any of the four combinations, will allow blood to bypass the balloon. 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 for bypassing blood and because it would be obvious to try any of the four combinations of opening/electrode/balloon arrangements, including the electrodes being positioned between the balloon and the openings, 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. The electrodes could be connected to any energy source and any fluid including blood could be passed through the lumen. Further, the electrodes of Demarais as modified are capable of being supplied with some energy parameters while the electrodes are immersed in some hypothetical media within a hypothetical wall having some dimensions which would result a reduction of the “peak electric field intensity” by over 50% at some hypothetical point on the wall. More specifically, this limitation occurs in the context of a hypothetical initial value (i.e. a reduction of 50% relative to what), a hypothetical medium, a hypothetical distance between the wall and the catheter shaft, and hypothetical electrical parameters. Thus, Demarais as modified to include the blood bypass, having the structural limitations recited in the claim, is also capable of performing the functional limitation based on various combinations of the unclaimed aspects directly relevant to the function. For example, the blood bypass results in over 50% reduction of a peak field intensity relative to a hypothetical peak intensity more than double the actual peak field intensity. A value double the actual value will always exist, such that the actual value is always a reduction by over 50% of some value. Alternatively, if the blood bypass results in over 50% reduction of a peak field intensity at a wall where that peak intensity is some value small enough without the blood bypass such that including the blood bypass causes the peak intensity at the wall to go to zero, resulting in a reduction of 100%, that blood bypass will meet the functional limitation. Once again, it will always be true that there exists a field strength value close to zero at a wall, depending on various parameters including the distance between the wall and shaft, such that a reduction in that value results in the value becoming zero, so the analysis applies to all systems with a blood bypass having the structure claimed. Whether this wall is millimeters or centimeters (“adjacent”) from the shaft is irrelevant, as is whether the field intensity is in nanovolts/nanometer or kilovolts/centimeter or some other value, as the claim does not recite any language that would require the wall to be at a given distance from the shaft or that any specific field intensity is in view. Interpreting the claims as extremely broad is the alternative to interpreting the claims to be indefinite and potentially lacking support in the written description. The claims recite a staggering range of possibilities, and while breadth is not indefiniteness, in this case the claim language raises serious questions about where the boundaries of the claim reside and in fact whether the specification supports this breadth. Applicant claims blood bypass that causes a more than 50%-100% reduction in field peak field intensity at a wall adjacent to a shaft for all initial field intensity values, for all electrical parameters that produce an electric field, for every dimension of blood bypass, electrodes and balloon catheter (length, width, height, thickness, spacing, etc.), for every medium between the shaft and the wall and for every distance between the shaft and the wall. And yet, Applicant provides one single example, a reduction in a catheter with a blood bypass relative to a catheter that does not have a blood bypass from about 1200 v/cm to about 500 v/cm ([0050]). First, this is a reduction of approximately 60% such that there is dubious support for the range of over 50%-100% if the claims are understood to require specific structural elements beyond those actually recited. In fact, the specification provides no discussion a percentage decrease at all, Applicant appears to simply infer the over 50%-100% range from the single example noted above, which only discloses a range if “approximately” is understood to produce a range (which does not even then produce the claimed range). Second, the specification discusses some limited operational parameters, but the claims do not. Therefore, the claimed invention must exist at all operational parameters. That is, the claimed invention must produce a more than 50% reduction in electric field intensity regardless of which value or range of values the system produces and/or is operated within. There is no support in the specification for this staggeringly comprehensive reduction in electric field intensity at every possible combination of unclaimed parameters, even the narrower range of unclaimed parameters likely to be present in electroporation of renal nerves. These issues are rendered moot by broadly interpreting the claims to simply require structure that is able to perform such a field intensity reduction under some conditions, including some combination of the variables discussed above.
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 as discussed above with respect to claim 1 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, including electrodes with 1mm width and 5 mm spacing as taught by Roy, that would produce the predictable result of a functional medical device.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Demarais and Kauphusman, further in view of Sugimoto (US 2013/0296853).
Regarding claim 6, the apparatus of Demarais does not disclose the diameter of the balloon. However, this dimension is 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 in diameter ([0041]). 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 of 3-6 mm as taught by Sugimoto, to produce the predictable result of a balloon catheter that can be used to treat tissue in a desired manner.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Demarais and Kauphusman, further in view of Demarais (US 2006/0142801), hereinafter Demarais2.
Regarding claim 7, the apparatus of Demarais does not disclose separation of the electrodes. However, this dimension is common in the art and there is no evidence that they produce an unexpected result. Demarais2 discloses a very similar system and teaches the edge-to-edge separation of the electrodes is 10 mm ([0045], fig. 5). 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 an electrode spacing of 10 mm as taught by Demarais 2, 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.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Demarais, Kauphusman and Dann, further in view of Sugimoto.
Regarding claim 26, the apparatus of Demarais does not disclose the diameter of the balloon. However, this dimension is 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 in diameter ([0041]). 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 of 3-6 mm as taught by Sugimoto, to produce the predictable result of a balloon catheter that can be used to treat tissue in a desired manner.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Demarais and Kauphusman, further in view of Demarais2.
Regarding claim 27, the apparatus of Demarais does not disclose separation of the electrodes. However, this dimension is common in the art and there is no evidence that they produce an unexpected result. Demarais2 discloses a very similar system and teaches the edge-to-edge separation of the electrodes is 10 mm ([0045], fig. 5). 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 an electrode spacing of 10 mm as taught by Demarais2, 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 regarding claims 7 and 27 in view of Sugimoto were persuasive and so the rejections have been rewritten (although they could have simply been withdrawn). Applicant’s arguments regarding claims 1 and 21, which are essentially identical to those presented in previous responses, are not persuasive for the reasons discussed at length in previous Actions. However, to place the application in the best condition for appeal, the rejections have been reworded for clarity.
Conclusion
Applicant's amendments (filed 23 January 2026) necessitated the new ground(s) of rejection presented in this Office action (relative to the previous Non-Final Rejection). 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 DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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