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 .
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Chin et al. (US 2019/0365364 A1) in view of Brenizer et al. (US 2018/0161547 A1).
Regarding claim 1, Chin discloses a method (i.e., as disclosed in paras. [0091]-[0096]; Figs. 18C-18F), comprising: extending a guidewire 10 along a preliminary insertion route within the body (i.e., as shown in Fig. 18C), between a first location 41 on a skin of the subject (i.e., first incision in a skin surface as disclosed by para. [0091]) and a bodily lumen (i.e., through 38), wherein a proximal end of the guidewire is outside the body (i.e., as shown in 18C) and a distal end of the guidewire is inside the bodily lumen (i.e., Fig. 18D); capturing a target portion (i.e. at 12 Fig. 18D) of the guidewire inside the body with a surgical tunneler 21; locally manipulating, folding and/or fixedly deforming the captured guidewire with the surgical tunneler at or near the target portion of the guidewire (i.e. as shown in Fig. 18E, the surgical tunneler manipulates the guidewire 10 and pulls it at 12); pulling the target portion of the guidewire to a second location on the skin (i.e., through 42), remote from the first location (Figs. 18A-18E), thereby rerouting the guidewire such that the guidewire follows a final insertion route within the body between the second location and the bodily lumen (i.e., for example as shown in 18G) and no longer extends along the preliminary insertion route between the first location on the skin of the subject and the bodily lumen (see Fig. 18E reproduced below; i.e., note that under BRI, the primary insertion route is along the initial incision, the rerouting of 10 creates a second route).
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Chin does not directly disclose implanting the access line along the final insertion route.
In the same field of endeavor of guide extension catheters, Brenizer discloses a similar method of advancing a guidewire into a desired position (para. [0021]). Brenizer also discloses implanting the access line (i.e., catheter) along the final insertion route (i.e., para. [0021] discloses creating an insertion route by use of a guidewire and tube member and then delivering a catheter over the guidewire through the tube member into position).
It is obvious to one of ordinary skill in the art to use catheters as access lines over a guidewire in a previously created insertion route for purposes of reducing the number of incisions made into the body and extra ability to push and advance the treating catheter along the insertion route (para. [0021]).
Regarding claim 2, Chin and Brenizer disclose the method according to claim 1. Chin also discloses wherein the capturing follows forming a surgical tunnel by advancing the surgical tunneler from the second location towards the target portion of the guidewire (see Figs. 18B-18D), wherein the pulling includes passing the target portion through the surgical tunnel (i.e., at least by way of passing and being secured to the hook) towards and/or through the second opening (i.e., Figs. 18C-18E).
Regarding claim 3, Chin and Brenizer disclose the method according to claim 1. Chin also discloses fixedly deforming the guidewire using the surgical tunneler to form a local deviated portion at or adjacent to the target portion (i.e., Fig. 18D-18E shows a deviated portion adjacent to the target portion as its pulling at the target portion characterized by the knot, the wire 10 proximal to the knot is curved and travels down the line such that 10 can be pulled back to the surface of the skin) having reduced resistance to bending or folding relative to portions of the guidewire adjacent thereto (i.e., at least since the knot portion is more stiff by having a knot, or being protected from bending by being inside the lumen of 15).
Regarding claim 4, Chin and Brenizer disclose the method according to claim 1. Chin and Brenizer don’t directly disclose wherein the final insertion route is greater in length and/or inclined more gradually relatively to surface of the skin, than the preliminary insertion route.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of inclined more gradually relatively to surface of the skin, than the preliminary insertion route since the only three choices are [1) inclined more gradually relatively to surface of the skin, than the preliminary insertion route, 2) inclined less gradually relatively to surface of the skin, than the preliminary insertion route, or 3) inclined at the same angle relative to surface of the skin, as the preliminary insertion route]. These are the only two options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at inclined more gradually relatively to surface of the skin, than the preliminary insertion route.
Regarding claim 5, Chin and Brenizer disclose the method according to claim 1. Chin also discloses wherein the capturing includes engaging the target portion (i.e., 12) with a guidewire capturing portion (i.e., hook of 21 as shown Fig. 18) of the surgical tunneler and pushing the surgical tunneler distally against the target portion for capturing the target portion with the guidewire capturing portion (i.e., 21 is pushed distally into body cavity and against 10 to contact and engage with 12).
Regarding claim 6, Chin and Brenizer disclose the method according to claim 1. Chin also discloses wherein the pulling includes releasing of bodily tissues from a guidewire capturing portion of the surgical tunneler while holding the target portion with the guidewire capturing portion (i.e., at least since tissues may have been contacted with hook piece while entering 39, but would subsequently be pushed out by engagement with 12 and pulling 21 back through 42).
Regarding claim 7, Chin and Brenizer disclose the method according to claim 1. Chin also discloses wherein the capturing is followed by fastening a guidewire capturing portion of the surgical tunneler onto the target portion (i.e., at least by 12 being engaged with the hook as shown in Fig. 18D).
Response to Arguments
Applicant's arguments filed August 14, 2026 have been fully considered but they are not persuasive.
Applicant’s argument that feature 10 of Chin is a “self-locking strap” rather than a “guidewire” is not persuasive. Although Chin refers to feature 10 as a self-locking strap, the difference in terminology does not establish a structural or functional difference from the guidewire. Rather, Chin’s self-locking strap performs a function similar to the claimed guidewire as it is an elongated member that is introduced through the body along a primary route and then is rerouted by a tool such that it creates a changed route. Accordingly, the fact that Chin has disclosed the element 10 as a “self-locking” strap does not preclude the strap from satisfying the limitation.
Secondly, Applicant argues that Chin does not teach or suggest “pulling the target portion to a second location on the skin, remote from the first location” thereby causing the rerouting of the guidewire such that the guidewire follows a final insertion route within the body between the second location and the bodily lumen and no longer extends along the preliminary insertion route between the first location on the skin of the subject and the bodily lumen is not convincing.
Specifically, Applicant appears to interpret the limitation “no longer extends along the preliminary insertion route” as requiring the entirety of the guidewire to be removed from the insertion route. However, the claim recites “pulling a target portion of the guidewire to the second location, thereby rerouting the guidewire to follow the final insertion route.” As shown in Fig. 18E reproduced above, the preliminary insertion route is along the catheter through the first incision and is pointed downwards (i.e., 41 and body lumen). The final incision route is created such that 10 is captured by 12 and brought through towards 42 to create a new incision route (i.e., 42 and body lumen) such that 10 does not continue along the preliminary incision route. The fact that another portion of the elongated strap may remain within or extend through a portion of the initially established path (i.e., or back through the initial incision as shown in Fig. 18k) does not negate the disclosed rerouting of the target portion since the guidewire no longer extends along the preliminary insertion route.
Regarding Applicant’s argument that the combination of Chin and Brenizer is improper because Chin relates to closure of a tissue defect using a self-locking strap, whereas Brenizer relates to guide extension catheters is unpersuasive. The rejection does not rely on references merely because they are directed to the same medical procedure, but instead their respective teachings concerning the use of the insertion route within the body. As discussed above, Chin teaches manipulating a flexible member (i.e., strap 10) within the body to establish a primary and final insertion route. Brenizer teaches establishing a route by using a guidewire and advancing a catheter over the guidewire (para. [0021]). Thus, Brenizer provides the teaching missing from Chin of utilizing a previously established insertion route to subsequently advance and implant an access line along that route.
Conclusion
THIS ACTION IS MADE FINAL. 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 RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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