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 .
Response to Amendment
The objections to claim 1 is withdrawn in light of the amendments.
Response to Arguments
Applicant’s arguments filed on 03/27/2026 have been fully considered but they are not persuasive.
Regarding the claim rejection of claim 1, applicant’s argument is not persuasive. Applicant argues that there is no motivation in Radl to provide a projection, in order to prevent excessive pressure from being applied to the balloon and that the projection would be an inhibiting factor and teach away from the present application, this is not persuasive. The rejection of claim 1 does not rely on the projection for the pressure-related purposes described in the Applicant’s disclosure. Rather, the rejection relies on known structural arrangements of a projection engaging a corresponding concavity to limit relative movement between components. Therefore, even if Applicant attributes a different purpose or benefit to the projection, this does not negate the obviousness of using the same structure for the movement-limiting function relied upon in the rejection.
Applicant’s argument that the elongated ridge or annular configuration of Kornberg’s projection results in inferior operability is not persuasive because applicant has not provided sufficient evidence or technical reasoning to support this conclusion.
Applicant’s argument that the configuration of Kornberg’s projection is not structurally simple as the projection of the present application is not persuasive because applicant has not provided sufficient evidence or technical reasoning to support this conclusion.
Applicant’s argument that Kornberg does not teach a single, approximately hemispherical projection since Kornberg teaches elongated ridges or an annular projection is not persuasive since Kornberg does teach a single, approximately hemispherical projection, please see rejection below.
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.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Radl et al. (US Pub No. 20190105057 A1, herein, Radl) in view of Kornberg (US Patent No. 4969877 A).
Regarding claim 1, Radl discloses a balloon catheter system comprising:
a balloon catheter (22, 40 – Fig.1) having a balloon (54 – Fig.1) placed in a front end region;
a cock (26 – Fig.1) being detachably connected with a back end of the balloon catheter (Fig.1); and
a syringe (24 – Fig.1) being detachably attached to the cock, the syringe inflating and deflating the balloon of the balloon catheter (“inflating and deflating the balloon” – Para [0068]), the syringe having a cylindrical barrel with an inner periphery (58 – Fig.1), and a plunger (60 – Fig.1) being slidably placed in a longitudinal direction of the barrel, the plunger being provided with a circular plate (64 – Fig.1) in a back end side of the cylindrical barrel;
the limitation, “wherein the balloon catheter system is used to assist insertion and/or removal of an OTW (Over The Wire) catheter by inflating the balloon of the balloon catheter inserted in a guiding catheter and biasing and fixing a guide wire to an inner periphery of the guiding catheter” is interpreted to be a functional limitation. (The balloon catheter system of Radl is capable of performing this function since the system comprises all the elements provided above, which can be used to assist insertion and/or removal of an OTW),
wherein the plunger is slid to the back end side of the cylindrical barrel and moved to a first position to allow a necessary amount of a balloon inflation medium to be introduced in the cylindrical barrel to inflate the balloon and fix the guide wire (Para [0068]),
the plunger is slid to a front end side of the barrel in a state in which the syringe containing the balloon inflation medium is connected with the balloon catheter to introduce the balloon inflation medium for inflating the balloon (“the inflation liquid can be introduced or injected from the syringe… thereby fully inflate the interior of the balloon ” - Para [0069]), and
a negative pressure is applied by pulling the plunger to deflate the balloon, (“the plunger of the syringe can be retracted to withdraw the sterile saline from the interior of the balloon” – Para [0081]).
However, Radl does not expressly disclose the syringe comprising a single, approximately hemispherical projection, wherein the plunger is slid to the back end side of the cylindrical barrel and moved to the first position in which the circular contacts the projection, and wherein the circular concavity is positioned to connect to the projection by sliding the plunger toward a back end side of the cylindrical barrel further than a first position.
Kornberg teaches a syringe (10 – Fig.5) comprising a single, approximately hemispherical projection (48 – Fig.7, “continuous…ridge” – Col.8, lines 47-48, is a single approximately hemispherical projection) provided on the inner periphery, a circular concavity (54 – Fig.7) configured to connect to the projection (Fig.5), wherein a plunger (34 – Fig.5) is slid to a back end side of the cylindrical barrel and moved to a first position in which the circular plate (40 – Fig.7) contacts the projection (Col.10, lines 4-12), and wherein the circular concavity is positioned to connect to the projection by sliding the plunger toward a back end side of the cylindrical barrel further than a first position (Fig.5, Col.10, lines 4-12).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the syringe of Radl to comprise a single, approximately hemispherical projection and a circular concavity on the plunger that contacts the projection by sliding the plunger as taught by Kornberg since Kornberg teaches that the projections serve as a plunger lock to stop the piston from moving any further, allowing for precise adjustments and ensuring a safe locking mechanism which would allow the device of Radl to prevent unintended axial movement of the plunger during handling and when unused, while still permitting deliberate advancement during use. The resulting structure of Radl would be capable of performing the function of the plunger being locked until the balloon inflation medium is removed in a state in which a negative pressure is applied by pulling the plunger to a second position after the guide wire is biased and fixed to an inner periphery of the guiding catheter, the second position being in a back end side further than the first position since the catheter system of Radl, as modified, comprises all the elements provided above, which can be used to for this function.
Regarding claim 2, Radl discloses a balloon catheter system as recited above comprising a syringe, but Radl does not expressly disclose wherein a circular concavity is disconnected from a projection by moving the plunger backward or forward.
Kornberg teaches wherein a circular concavity (54– Fig.7) is disconnected from a projection (48 – Fig.7) by moving the plunger (34 – Fig.5) backward or forward (Col.9, lines 52-68, Col.10, lines 1-12).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the syringe of Radl to comprise a circular concavity that is disconnected from a projection by moving the plunger as taught by Kornberg since Kornberg teaches that a plunger moving backwards and forwards to disconnect from the projection is a well-known locking mechanism such as the snap-fit engagement.
Regarding claim 3, Radl discloses a balloon catheter system as recited above, the limitation “wherein the balloon catheter is a trapping balloon catheter” is interpreted to be a functional limitation (The balloon catheter system of Radl, is capable of performing this function since this system comprises the elements recited above, which can function as a trapping balloon catheter).
Regarding claim 4, Radl discloses a balloon catheter system as recited above, but Radl does not expressly disclose a projection with a height of 1.4 to 1.6 mm, and the circular concavity with a depth of 3 to 5mm.
Kornberg teaches a projection (48 – Fig.7) with a height and a circular concavity (54 – Fig.7) with a depth. It is evident that Kornberg recognizes that the projection and concavity need to be sized specifically to form a releasable locking engagement configured to permit connection and disconnection between the components. Therefore, one of the ordinary skill in the art would have understood that the height of the projection and the depth of the concavity would be selected to provide the desired balance between retention and ease of release, and routine optimization of such dimensions to achieve the known releasable locking function.
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the syringe of Radl to comprise a projection with a height and a circular concavity with a depth as taught by Kornberg since Kornberg teaches that the projections serve as a plunger lock to stop the piston from moving any further, allowing for precise adjustments and ensuring a safe locking mechanism.
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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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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