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 Amendments
The Amendment filed 10/17/2025 has been entered.
Claim 9 has been cancelled.
Claims 1-8 and 10-20 remain pending in the application.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dubrul et al. (U.S. Patent Pub. 20140188127), and further in view of Fischell et al. (U.S. Patent Pub. 20190255297), hereinafter Fischell.
Regarding claim 1, Dubrul discloses a probe assembly (assembly 94; see FIG. 16) comprising:
a probe housing (dilator 46, see FIG. 11);
a probe (wire 10) that extends within the probe housing, the probe having a dynamically expandable distal end (expandable element 16); and
a probe actuator (grip 26, see FIG. 1) that is configured to advance the probe (wire 10) from a proximal position to a distal position (the Examiner notes guide wire 10 is shown passing through lumen 42 in FIG. 5. The initial position of the wire can be considered a proximal position, with the furthest insertion point being considered the distal position.), the probe actuator also being configured to expand the dynamically expandable distal end (“FIG. 6 illustrates expandable element 16 placed in a radially expanded state by pulling on deployment grip 26”, [0097]). However, Dubrul does not expressly state wherein the probe actuator is a rotational probe actuator.
Fischell teaches a guide catheter extension system (Abstract) comprising a rotational probe actuator (“By manipulating the inner and/or outer member pusher(s) 42 and/or 46, a surgeon actuates a required linear and/or rotational displacement of the inner member 36 with regard to the “sheath” 70 of the outer member 40 (as will be detailed in further paragraphs), to advance or retract, the interconnection unit 50 to or from the guide catheter 11 by displacing the inner member 36 relative to the outer member 40, as required by the procedure performed.”, [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the actuator of Dubrul to be rotational. Doing so allows for advancement or retraction of the catheters inner member, as taught by Fischell (see [0103]).
Regarding claim 2, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 1, and Dubrul further teaches wherein the probe comprises a core segment (inner guide wire 14), a braided segment (braided expandable element 16) and a displacement segment (outer guide wire 12).
Regarding claim 3, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 2, and Dubrul further teaches wherein the braided segment forms the dynamically expandable distal end (braided expandable element 16; see FIGS. 1-2).
Regarding claim 4, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 3, and Dubrul further teaches wherein the probe actuator (grip 26) moves the displacement segment relative to the core segment to expand the braided segment (“Thus movement of the core and shell relative to one another moves the braided element from a radially retracted position, which is useful for insertion through the catheter to a radially expanded position”, [0093]).
Regarding claim 5, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 2, and Dubrul further teaches wherein:
a proximal end of the core segment is coupled to the probe actuator (“proximal end 24 of inner guide wire 14 has a deployment grip 26 secured thereto”, [0091]) and a distal end of the core segment is coupled to a distal end of the braided segment (“distal end 22 secured to the distal end 24 of inner guide wire 14”, [0091]); and
a proximal end of the displacement segment (outer guide wire 12) is coupled to the probe actuator (grip 26; the Examiner notes proximal end of guide wire 12 is secured to engagement sleeve 34 which is further secured to 26) and a distal end of the displacement segment is coupled to a proximal end of the braided segment (the Examiner notes distal end of guide wire 12 can be seen coupled to the proximal end of expandable element 16 in FIG. 1).
Regarding claim 6, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 5, and Dubrul further teaches wherein the probe actuator expands the dynamically expandable distal end by moving the displacement segment relative to the core segment (“Thus movement of the core and shell relative to one another moves the braided element from a radially retracted position, which is useful for insertion through the catheter to a radially expanded position”, [0093]).
Regarding claim 7, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 6, and Dubrul further teaches wherein the probe actuator expands the dynamically expandable distal end by moving the proximal end of the displacement segment distally relative to the proximal end of the core segment (see FIG. 2; “Relative movement between the outer and inner guide wires 12, 14 can be restricted by a guide wire lock 31. Guide wire lock 31 includes a kink 32 in inner guide wire 14 along region 30 and a kink engagement sleeve 34 slidably mounted on region 30 of inner guide wire 14. Kink engagement sleeve 34 may be secured to outer guide wire 12 or not. A suggested in FIG. 2, pulling on inner guide wire deployment grip 26 to separate proximal ends 24, 28, while maintaining kink engagement sleeve 34 adjacent to proximal end 28 of outer guide wire 12, causes kink 32 to move within the deformable kink engagement sleeve 34”, [0091]).
Regarding claim 8, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 6, and Dubrul further teaches wherein the probe actuator expands the dynamically expandable distal end by moving the proximal end of the displacement segment distally and moving the proximal end of the core segment proximally (see FIG. 2; “Relative movement between the outer and inner guide wires 12, 14 can be restricted by a guide wire lock 31. Guide wire lock 31 includes a kink 32 in inner guide wire 14 along region 30 and a kink engagement sleeve 34 slidably mounted on region 30 of inner guide wire 14. Kink engagement sleeve 34 may be secured to outer guide wire 12 or not. A suggested in FIG. 2, pulling on inner guide wire deployment grip 26 to separate proximal ends 24, 28, while maintaining kink engagement sleeve 34 adjacent to proximal end 28 of outer guide wire 12, causes kink 32 to move within the deformable kink engagement sleeve 34”, [0091]).
Regarding claim 10, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 1, and Dubrul further teaches wherein the dynamically expandable distal end comprises a braided segment (braided expandable element 16), and wherein the probe actuator expands the dynamically expandable distal end by shortening the braided segment (see shortened length of braiding segment while segment is in expanded state in FIG. 2).
Regarding claim 11, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 10, and Dubrul further teaches wherein the probe actuator contracts the dynamically expandable distal end by lengthening the braided segment (see FIG. 1; “A suggested in FIG. 2, pulling on inner guide wire deployment grip 26 to separate proximal ends 24, 28, while maintaining kink engagement sleeve 34 adjacent to proximal end 28 of outer guide wire 12, causes kink 32 to move within the deformable kink engagement sleeve 34. The resistance to kink 32 moving within kink engagement sleeve 34 maintains expandable element 16 at the radially contracted condition of FIG. 1 or at any of a range of radially expanded conditions, such as that shown in FIG. 2”, [0091]).
Regarding claim 12, Dubrul discloses a vascular access system comprising:
a catheter adapter (catheter assembly 48) from which a catheter extends distally (catheter 60; see FIGS. 8 and 9); and
a probe assembly (assembly 94; see FIG. 16) that is configured to couple to the catheter adapter, the probe assembly comprising:
a probe housing (lumen 42, see FIG. 4);
a probe (wire 10) that extends within the probe housing, the probe having a core segment (inner guide wire 14), a braided segment (braided expandable element 16) and a displacement segment (outer guide wire 12); and
a probe actuator (grip 26) that is configured to extend the probe (wire 10) distally from the catheter (catheter 60) while the braided segment is in a flow-reducing position (radially contracted condition; see FIG. 1) and to transition the braided segment into an open position (radially expanded condition; see FIG. 2) after the probe is extended distally from the catheter (the Examiner notes [0097] of Dubrul discloses that the expandable element 16 is moved through the catheter distally past the occlusion 40 before it is placed in its expanded state.). However, Dubrul does not expressly state wherein the probe actuator is a rotational probe actuator.
Fischell teaches a guide catheter extension system (Abstract) comprising a rotational probe actuator (“By manipulating the inner and/or outer member pusher(s) 42 and/or 46, a surgeon actuates a required linear and/or rotational displacement of the inner member 36 with regard to the “sheath” 70 of the outer member 40 (as will be detailed in further paragraphs), to advance or retract, the interconnection unit 50 to or from the guide catheter 11 by displacing the inner member 36 relative to the outer member 40, as required by the procedure performed.”, [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the actuator of Dubrul to be rotational. Doing so allows for advancement or retraction of the catheters inner member, as taught by Fischell (see [0103]).
Regarding claim 13, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 12, and Dubrul further teaches wherein the braided segment has a distal end that is coupled to the core segment and a proximal end that is coupled to the displacement segment (“A braided expandable element 16 has a proximal end 18 secured to the distal end 20 of outer guide wire 12 and a distal end 22 secured to the distal end 24 of inner guide wire 14”, [0091]; see FIG. 1).
Regarding claim 14, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 13, and Dubrul further teaches wherein the core segment has a proximal end that is coupled to the probe actuator (“The proximal end 24 of inner guide wire 14 has a deployment grip 26 secured thereto”, [0091]) and the displacement segment has a proximal end that is coupled to the probe actuator (see proximal end 28 of outer guide 12 coupled to sleeve 34 coupled to grip 26 in FIG. 1).
Regarding claim 15, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 14, and Dubrul further teaches wherein the probe actuator (grip 26) transitions the braided segment into the open position by moving the displacement segment relative to the core segment (“Thus movement of the core and shell relative to one another moves the braided element from a radially retracted position, which is useful for insertion through the catheter to a radially expanded position”, [0093]). .
Regarding claim 16, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 12, and Dubrul further teaches wherein transitioning the braided segment (braided expandable element 16) into the open position comprises shortening the braided segment (see shortened length of braiding segment in FIG. 2).
Regarding claim 17, Dubrul discloses a method for accessing a vasculature (see [0097]) comprising:
accessing a probe assembly (assembly 94; see FIG. 16) that is coupled to a catheter adapter (catheter assembly 48) having a catheter (catheter 60) that is inserted into a patient's vasculature, the probe assembly comprising a probe housing (dilator 46), a probe (wire 10) that extends within the probe housing and a probe actuator (grip 26);
wherein the probe actuator causes a distal end of the probe to extend distally from the catheter (see [0093]); and
after the distal end of the probe extends distally from the catheter, manipulating the probe actuator to cause the distal end of the probe to expand (see [0093]). However, Dubrul does not expressly state wherein the probe actuator is a rotational probe actuator.
Fischell teaches a guide catheter extension system (Abstract) comprising a rotational probe actuator (“By manipulating the inner and/or outer member pusher(s) 42 and/or 46, a surgeon actuates a required linear and/or rotational displacement of the inner member 36 with regard to the “sheath” 70 of the outer member 40 (as will be detailed in further paragraphs), to advance or retract, the interconnection unit 50 to or from the guide catheter 11 by displacing the inner member 36 relative to the outer member 40, as required by the procedure performed.”, [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the actuator of Dubrul to be rotational. Doing so allows for advancement or retraction of the catheters inner member, as taught by Fischell (see [0103]).
Regarding claim 18, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 17, and Dubrul further teaches wherein the probe has a core segment (inner guide wire 14), a braided segment (braided expandable element 16) and a displacement segment (outer guide wire 12).
Regarding claim 19, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 18, and Dubrul further teaches wherein manipulating the probe actuator to cause the distal end of the probe to expand comprises manipulating the probe actuator to cause the displacement segment to move relative to the core segment (“Thus movement of the core and shell relative to one another moves the braided element from a radially retracted position, which is useful for insertion through the catheter to a radially expanded position”, [0093]).
Regarding claim 20, Dubrul in view of Fischell teaches the claimed invention as discussed above concerning the rejection of claim 19, and Dubrul further teaches wherein the braided segment has a distal end that is coupled to the core segment and a proximal end that is coupled to the displacement segment (“A braided expandable element 16 has a proximal end 18 secured to the distal end 20 of outer guide wire 12 and a distal end 22 secured to the distal end 24 of inner guide wire 14”, [0091]; see FIG. 1).
Response to Arguments
Applicant’s arguments, see Remarks pages 7-8, filed 10/17/2025, with respect to the rejection(s) of claim(s) 1-20 under 102(a)(1) to Dubrul (U.S. Patent Pub. 20140188127) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 over Dubrul (U.S. Patent Pub. 20140188127), and further in view of Fischell (U.S. Patent Pub. 20190255297).
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 NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
01/08/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783