DETAILED ACTION
Applicant’s amendments and remarks, filed November 5, 2025, are a fully acknowledged by the Examiner. Currently, claims 1-2, 4-8 and 21-22 are pending with claims 3 and 9-20 cancelled, claims 21 and 22 newly added, and claims 1, 4 and 6 amended. Applicant’s amendments to claim 4 has obviated the previously-filed rejection of claims 4 and 8 under 35 U.S.C. 112(b). The following is a complete response to the November 5, 2025 communication.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-8, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Maor et al. (US Pat. Pub. 2009/0248012 A1) further in view of Nance et al. (US Pat. Pub. 2008/0243081 A1).
Regarding claim 1, Maor provides for an ablation device, comprising a sheath (15), a balloon attached to the sheath and being expandable 35) and an electrode located on an outer surface of the sheath (one of 25/27),wherein the balloon is located longitudinally adjacent to the electrode (at least a portion of 25/27 is located longitudinally adjacent to 35 as in figure 2).
While Moar displays arrangements when the sheath (15) is curved (see figure 1A) and further contemplates various arrangements for achieving the device including “a medical device including a guidewire and balloon catheter” and “a steerable balloon catheter” in paragraph [0078], Moar fails to specifically contemplate that a portion of the sheath where the electrode is located is curved longitudinally when no external force is applied to the sheath.
Nance discloses a similar device as that of Moar for advancing a sheath with an expandable portion such as a balloon thereon (see figures 2, 12, 15 and 16). Nance further provides for the ability to sheath the device through a desired bend within the body to access a portion of the body with the steering provided by an active steering arrangement like that set forth in [0078] of Moar, or for such to be provided by a naturally curved sheath and a straight guidewire inserted therein (see [0021] providing for “curved catheter and straight guidewire”).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have provided the sheath of Moar with a pre-shaped bend in a natural state along the length of the sheath at its distal end including portions proximal and distal to the balloon that corresponds to a desired location of treatment and for the use of a steering guidewire that deviates the sheath from its curved shape so as to guide the sheath to a location of treatment in view of the teaching of Nance. Moar readily contemplates various manners of accomplishing the steering of its sheath to a target location in paragraph [0078] with the arrangement in Nance representing a known alternative in the each that would be equally suitable to provide for the requisite guiding/curving of the sheath to access the target location.
Regarding claim 2, Maor provides that the sheath has a distal end and a proximal end (15 has a proximal end and a distal end), and wherein the electrode is located to a distal end side of the balloon (each of 25/27 extend from a proximal end side of 35 to a distal end side of 35 as in figure 2).
Regarding claim 4, Maor provides that the sheath has a proximal end and a distal end (15 has a proximal end and a distal end as shown throughout), and wherein the electrode includes a first electrode portion located to the distal end side of the balloon (a first portion of one of 25/27 is located distal to 35 as in figure 2), and a second electrode portion is located to a proximal end side of the balloon (a second portion of one of 25/27 is located proximal to 35 as in figure 2).
Regarding claim 5, Maor provides that the sheath has a distal end and a proximal end (15 has a proximal end and a distal end), and wherein the electrode is located to a proximal end side of the balloon (each of 25/27 extend from a proximal end side of 35 to a distal end side of 35 as in figure 2).
Regarding claim 6, in view of the combination with Nance in the rejection of claims 11/5 above, the combined arrangement provides that the sheath includes a first curved portion located proximal to the balloon and a second curved portion located proximal to the first curved portion, wherein, when no external force is applied to the sheath, the first curved portion and the second curved portion are each curved longitudinally (with such being provided by the combination including the curved sheath in the natural state in the rejection of claim 1 above; the longitudinal curving would be by virtue of such being curved along a length of the sheath both proximal and distal to the balloon, and particularly for the above limitations with the curve being proximal to the balloon), and wherein the electrode is located between the balloon and the first curved portion (via the one of 25/27 being located between the first curved portion defined above and the balloon 35).
Regarding claims 7 and 8, Maor provides that the electrode is further located on an outer surface of the balloon (see figure 2 with each of 25/27 located on the outer surface of 35).
Regarding claim 21, in view of the combination with Nance in the rejection of claims 1/5/6 above, the combined arrangement provides that when no external force is applied to the sheath, a curvature of the first curved portion corresponds to a curvature of a cystic duct and a curvature of the second curved portion corresponds to a curvature of a common bile duct and a branch portion toward the cystic duct. The Examiner is of the position that the limitations of a) a curvature of a cystic duct and b) a curvature of a common bile duct and a branch portion toward the cystic duct are broad recitations and that the curvature provided as in the rejection of claim 1 in light of the teaching of Nance would result in curves that generally correspond to some manner of curvature found at each of the locations within the body. To this end, the Examiner notes that Nance readily contemplates the use of curvature ranging from 20 degrees to 120 degrees (see [0009], [0021], [0026], and [0124]).
Regarding claim 22, in view of the combination with Nance in the rejection of claims 1/5/6 above, the combined arrangement provides the first curved portion and the second curved portion are non-overlapping (such is by virtue of the first curve being proximal to the balloon and the second curve being proximal to the first curve along the length of the sheath 15).
Response to Arguments
Applicant’s arguments, see pages 6-11 of the Remarks filed November 5, 2025, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Maor (US Pat. Pub. 2009/0248012) have been fully considered and are persuasive. The Examiner notes that Maor, as provisionally agreed to in the November 3, 2025 interview, fails to provide that its sheath at 15 provides for the limitation of “when no external force is applied to the sheath, a portion of the sheath where the electrode is located is curved longitudinally”. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1, 2, 4-8, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Maor et al. (US Pat. Pub. 2009/0248012 A1) further in view of Nance et al. (US Pat. Pub. 2008/0243081 A1).
The Examiner is of the position that the newly cited Nance reference readily cures the noted deficiencies in Maor for at least the reasoning set forth in the rejections above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794