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 amendment filed June 2, 2026 has been entered. Applicant’s amendments
to the Specification and specifically the Abstract of the Disclosure, has overcome each and
every objection and rejection previously set forth in the Non-Final Office Action
mailed 04/30/2026.
Response to Amendment
Applicant's arguments filed 06/02/2026 have been fully considered but they are not persuasive.
In response to applicant's argument on pages 8-9 that “Nothing in Jentzen discloses providing the claimed tension and stabilization to a procedural catheter or use of a bifurcated catheter for allowing access to a procedural catheter at a procedural site in a lower extremity for a procedure” a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, the structures taught by Jentzen, specifically Fig 8 showing the bifurcatde catheter system, provide stabilization and resist tension throughout the catheter allowing access to a patient’s extremities.
In response to applicant’s argument, found on page 12, that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Chobotov does teach using a snare knot for rapid exchange of elements. The applicant merely alleges that the motivation/teaching supplied does not match the teaching/motivation instant application. Similarly, applicant’s arguments allude to the concept that Chobotov is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Chobotov is art of the same endeavor, delivering medical modalities to the interior of the vasculature of patients while allowing the device operator to maintain wire strain using a knot/snare configuration in the wire.
Rejections detailed below are updated to reflect the claim amendments and maintained.
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.
Claim 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jentzen et al. US 2012/0016454A1, herein referred to as Jentzen, in view of Bourang et al. US 20110282427 A1, herein referred to as Bourang.
Regarding claim 17, Jentzen discloses a system for providing tension and stabilization to a procedural catheter, the system comprising:
a bifurcated catheter (Jentzen Fig 8, 240) having a proximal end and a distal end (Jenetzen Fig 8), the bifurcated catheter configured to be inserted via a contralateral arterial access (capable of claimed configuration);
the stabilization wire (Jentzen Fig 8, 2,4) comprising two sections (Jentzen Fig 8, stabilization lumens 240’ 240’’),
a proximal section configured to attach to a wall of the bifurcated catheter (Jentzen [0037]), and a distal section configured to exit via the side hole (capable of claimed configuration);
a snare access sheath (Jentzen Fig 5, sheath 140) configured to have a snare catheter comprising a snare wire inserted therethrough (Jentzen Fig 5, guidewire 110; [0025]), the snare access sheath configured for an ipsilateral arterial access (Jentzen teaches being used for bilaterial procedures, cover claimed limitation see [0030]; Also, Jentzen is capable of claimed configuration);
the snare wire configured to snare a distal end of the stabilization wire (capable of claimed configuration) and externalize (externalize as defined in the instant application is meant to mean applying tensile force to push, see [0013]; Jentzen teaches forces applied to wire during use [0030]) and lock ([0030] Jentzen teaches a control knob as used by operator for multiple securing steps) the stabilization wire outside the ipsilateral arterial access ([0031-0037] capable of claimed limitation);
the proximal end of the bifurcated (Jentzen teaches being used for bilaterial procedures, cover claimed limitation see [0030-0037]; Also, Jentzen is capable of claimed configuration); wherein the locked bifurcated sheath and the locked stabilization wire together provide access (capable of claimed limitation), tension and stabilization to a procedural catheter and instruments used for a lower extremity intervention procedure (capable of claimed limitation).
Jentzen fails to explicitly disclose the bifurcated catheter having a side hole between 1 to 4 centimeters (cm) from the distal end; the stabilization wire configured to extend for 8 to 14 cm beyond the side hole.
Bourang teaches the bifurcated catheter (device of Fig 37) having a side hole (Annotated Fig 37 below; [0088] Bourang teaches an exchange port between 1-30 cm. While Bourang does not teach the specific range, the claimed ranges are within the ranges taught by Bourang) between 1 to 4 centimeters (cm) from the distal end (Fig 37); the stabilization wire (Bourang Fig 27, guidewire 50) configured to extend for 8 to 14 cm beyond the side hole (Bourang [0089] Bourang teaches an exchange port expanding past 5-32 centers past port. While Bourang does not teach the specific range, the claimed ranges are within the ranges taught by Bourang).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Jentzen to incorporate the bifurcated catheter having a side hole between 1 to 4 centimeters (cm) from the distal end; the stabilization wire configured to extend for 8 to 14 cm beyond the side hole, as taught and suggested by Bourang In order to allow rapid exchange of catheters during surgery (Bourang [0088]).
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Regarding claim 18, Jentzen/Bourang discloses the invention substantially as claimed and as discussed above with respect to claim 17 teaches wherein when the stabilization wire is snared and externalized it is configured to provide a pull-force to guide the bifurcated catheter through the tortuous vasculature of the lower extremity ([0003] Jentzen teaches femoral entry; BRI of a pull-force is meet, see [0050]).
Regarding claim 19, Jentzen/Bourang discloses the invention substantially as claimed and as discussed above with respect to claim 17 teaches wherein a push-pull force using the stabilization wire (Jentzen [0030]) and the bifurcated catheter enable easy access for the procedural catheter and instruments to the site of the lower extremity intervention procedure (Jentzen [0003]).
Regarding claim 20, Jentzen/Bourang discloses the invention substantially as claimed and as discussed above with respect to claim 17 teaches wherein the stabilization wire locked outside the ipsilateral arterial access (capable of claimed limitation) is configured to provide stabilization to the bifurcated catheter ([0030 Jenetzen teaches controlling system with a knob]) and the procedural catheter during the lower extremity intervention procedure (Jentzen [0003]).
Claim 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jentzen in view of Bourang, further in view of Chobotov US 20100016943 A1, herein referred to as Chobotov.
Regarding claim 1, the combination of Jentzen/Bourange discloses the invention substantially as claimed and as discussed above with respect to claim 17 teaches, and additionally teaches:
a system comprising: a bifurcated catheter (Jenzen Fig 8, 240) comprising a proximal end and a distal end (JentzenFig 8); the bifurcated catheter (Bourang Device of Fig 37) further comprising a side hole (Bourang Annotated Fig 37, hole above) near the distal end (Bourange [0088]);
a stabilization wire (Jentzen Fig 8, 2, 4) attached to a wall of the bifurcated catheter, the stabilization wire (Jentzen Fig 8, 2 and 4) configured to emerge and extend from the side hole (capable of claimed configuration);
wherein a distal end of the stabilization wire is configured to extend beyond the distal end of the bifurcated catheter (Jenzten ([0032]);
a snare access sheath (Jentzen Fig 5, sheath 140) configured to have a snare catheter comprising a snare wire inserted therethrough (Jentzen Fig 5, guidewire 110; [0025]); wherein the stabilization wire is configured to be pulled to guide the bifurcated catheter (Jentzen [0030-0037] capable of claimed configuration);
wherein the distal end of the snared stabilization wire is configured to be pulled and externalized by the snare wire to lock the distal end of the stabilization wire at a first location (Jentzen [0031-0037] capable of claimed limitation);
and wherein the proximal end of the bifurcated catheter is configured to be locked at a second percutaneous location outside the vasculature to enable application of tension and provide stabilization to the bifurcated catheter (Jentzen [0030-0037] Capable of claimed limitation).
Jentzen/Bourang fails to disclose wherein the snare wire is configured to snare a distal end of the stabilization wire using a snare knot.
But Chobotov teaches wherein the snare wire (Chobotov Fig 20E, wire 1024) is configured to snare a distal end of the stabilization wire using a snare knot (Chobotov Fig 20E, loop 1081’ [0237], loop meets definition of knot).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Jentzen/Bourang to incorporate wherein the snare wire is configured to snare a distal end of the stabilization wire using a snare knot, as taught and suggested by Chobotov in order to constrain a wire (Chobotov [00237]).
Regarding claim 2, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the side hole is at a distance between 1 and 3 cm from the distal end of the bifurcated catheter (While Bourang does not teach the specific range, the claimed ranges are within the ranges taught by Bourang [0056]; Since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)).
Regarding claim 3, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the stabilization wire (Jentzen Fig 8, 4) comprises two sections (Jentzen Fig 8, stabilization lumens 240’ 240’’), a first section fixed to the wall of the bifurcated catheter and a second section that is outside the side hole of the bifurcated catheter (Jentzen Fig 8).
Regarding claim 4, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 3 teaches wherein the first section of the stabilization wire is configured be within the bifurcated catheter and to have a rectangular cross section (Jentzen Fig 5; Chobotov teaches ribbon-like wire [0231], spefically rectangular).
Regarding claim 5, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 3 teaches wherein the second section of the stabilization wire is configured to have a circular cross section (Chobotov teaches circular wire [0231]).
Regarding claim 6, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 3 teaches wherein the second section of the stabilization wire is configured to extend 8 to 14 cm beyond the side hole ([0089] Bourang teaches an exchange port expanding past 5-32 cm past port. While Bourang does not teach the specific range, the claimed ranges are within the ranges taught by
Bourang).
Regarding claim 7, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 3 teaches wherein the second section of the stabilization wire extends beyond the distal end of the bifurcated catheter (Jentzen Fig 8).
Regarding claim 8, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the bifurcated catheter is configured for access into the vasculature via a percutaneous contralateral access (Jentzen [0003]).
Regarding claim 9, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 8 teaches wherein the second location is outside the percutaneous contralateral access to the vasculature (Jentzen [0003]).
Regarding claim 10, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the distal end of the bifurcated catheter comprises a radio opaque band to enable guiding the distal end of the bifurcated catheter (Chobotov teaches using radio opaque material [0020]).
Regarding claim 11, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 8 teaches wherein the snare catheter is configured for an access into the vasculature via an ipsilateral percutaneous access (Jentzen [0003] teaches access as claimed).
Regarding claim 12, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 8 teaches wherein the first location where the snare wire is externalized and locked is outside the ipsilateral percutaneous access to the vasculature (“externalize” as defined in the instant application is meant to mean applying tensile force to push, see [0013]; Jenetzen teaches forces applied to wire during use [0030]) and lock ([0030] Jentzen teaches a control knob as used by operator for multiple securing steps; Jentzen teaches entering percutaneously [0003]).
Regarding claim 13, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 11 teaches wherein the percutaneous contralateral access and ipsilateral percutaneous access are arterial accesses (Jentzen [0003] capable of claimed limitation).
Regarding claim 14, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the bifurcated catheter is configured to receive a pull force (Jenetzen teaches forces applied to wire during use [0030]; as configured would be under pull force as claimed) from the stabilization wire and a push force from the proximal end of the bifurcated catheter to advance the bifurcated catheter through tortuous vessels to a site of a lower extremity intervention procedure (Jentzen [0003] teaches periphery entry.
Regarding claim 15, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the stabilization wire is configured to apply tension and stabilization to the procedural catheter for access to a procedural location ([0030] Jentzen teaches controlling system with a knob).
Regarding claim 16, Jentzen/Bourang/Chobotov discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the proximal end of the stabilization wire is configured to be affixed to the bifurcated catheter wall from a third location within the bifurcated catheter between the proximal and distal ends of the bifurcated catheter (Chobotov [0010] teaches a plurality of affixation points), with the distal end of the stabilization wire configured to extend from the side hole beyond the distal end of the bifurcated catheter (capable of claimed configuration).
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 Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.F./Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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