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
Examiner acknowledges the reply filed 10/16/2025. Claims 1, 10, 17, 18, 19 and 20 were amended. Claims 21 and 22 were newly added. Claims 4 and 13 are canceled. The amendment was accompanied by Remarks, the contents of which are addressed in the Response to Arguments section of this Office action.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-13 and 15-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stahler et al (U.S. Pub. 2008/0243064 A1, hereinafter “Stahler”).
Regarding claim 1, Stahler discloses an intravascular device, comprising:
an elongated outer catheter body 39 (see Fig. 5A) having a proximal catheter end, a distal catheter end, and an inner lumen extending between the proximal catheter end and the distal catheter end;
an elongated inner articulating member 37 (see Fig. 5A) slidably disposed within the inner lumen of the outer catheter body (see para [0093]), the inner articulating member having a proximal member end and an articulatable distal member end (shown in detail in Fig. 48A) ; and
a manually operated handheld control assembly (combination of portions 3 and 15, that include carriages 67 and 69; this assembly can be manually operated and held with the hand; see Fig. 1, showing a user 17 manually controlling the control assembly 15 and 3 from a workstation 5) directly mechanically coupled to the proximal catheter end and the proximal member end (elongated catheter body 39 is attached at its proximal end to the carriage 69, while the elongated inner articulating member is attached at its proximal member end to the carriage 67), the control assembly configured for articulating the distal member end and for distally translating the outer catheter body in a distal direction over the inner articulating member, such that the distal catheter end distally extends past the articulatable distal member end (as shown in Fig. 5F, the carriages are configured to slide relative to one another, as indicated by the two-headed arrows, in order to manipulate the axial positions of the elongated catheter body 39 and the elongated inner articulating member, permitting the outer catheter body 39 to translate over the inner articulating member 37 so that the distal end of the outer catheter body extends past the articulatable distal member; see Fig. 5F, for example, showing the inner articulating member distal end completely within the distal catheter end; and see paras [0093]-[0096]).
Regarding claim 2 and 3, Stahler discloses that the control assembly is configured for articulating the distal member end of the inner articulating member 37 into a single-curve planar shape (as per claim 2) or a multi-curve shape (as per claim 3) (the inner articulating member 37 can be controlled, for example, by control elements 405 in the form of pull wires, that extend from the distal member end of the inner articulating member 37 to the portion 3 of the control assembly (see para [0240]); these control wires are able to manipulate the distal end of the catheter into either a single-curve planar shape as shown in Fig. 48A, or into a multi-curve shape by additionally bending the tool 41 in the directions indicated by the two-headed curved arrows in Fig. 48A).
Regarding claim 6, Stahler discloses that the distal catheter end has one or more infusion openings (see Fig. 6C, showing tubing 111 that can be used for the injection or removal of fluids; the fluid is understood to be transportable from the tubing 111 to an opening at the distal catheter end).
Regarding claim 7, Stahler discloses that the distal catheter end includes a distal wire tip (see para [0093], disclosing that motors within the instrument driver 15 can be activated to control bending of the distal end of the elongated outer catheter body 39; this bending can occur by activating pull wires within the elongated outer catheter body 39 (see para [0101])).
Regarding claim 8, Stahler does not explicitly disclose that the distal catheter end is configured for being inserted into a branch of an aortic arch of a human; however, this limitation appears to constitute intended use of the distal catheter end that does not impart a structural limitation to the distal catheter end; Stahler discloses that the device can be used to enhance the positioning of controllable surgical instruments in small vascular spaces (see paras [0004]-[0008]) and so a skilled artisan would conclude that the distal catheter end in Stahler would be capable of insertion into a branch of an aortic arch of a human.
Regarding claim 9, Stahler discloses at least one pull wire 171-173 (see Figs. 11A-11B) operably connected between the distal member end and the control assembly, wherein the control assembly is configured for articulating the distal member end by tensioning the at least one pull wire (see para [0117]).
Regarding claim 10, Stahler discloses an intravascular device, comprising:
an elongated inner articulating member 37 (see Fig. 5A) slidably disposed within the inner lumen of the outer catheter body 39 (see Fig. 5A) having a proximal catheter end, a distal catheter end, and an inner lumen extending between the proximal catheter end and the distal catheter end (see para [0093]), the inner articulating member having a proximal member end and an articulatable distal member end (shown in detail in Fig. 48A); and
a manually operated handheld control assembly (combination of portions 3 and 15, that include carriages 67 and 69; this assembly can be manually operated and held with the hand; see Fig. 1, showing a user 17 manually controlling the control assembly 15 and 3 from a workstation 5) directly mechanically coupled to the proximal catheter end and the proximal member end (elongated catheter body 39 is attached at its proximal end to the carriage 67, while the elongated inner articulating member is attached at its proximal member end to the carriage 69), the control assembly configured for articulating the distal member end and for distally translating the outer catheter body in a distal direction over the inner articulating member, such that the distal catheter end distally extends past the articulatable distal member end (as shown in Fig. 5F, the carriages are configured to slide relative to one another, as indicated by the two-headed arrows, in order to manipulate the axial positions of the elongated catheter body 39 and the elongated inner articulating member, permitting the outer catheter body 39 to translate over the inner articulating member 37 so that the distal end of the outer catheter body extends past the articulatable distal member; see Fig. 5F, for example, showing the inner articulating member distal end completely within the distal catheter end; and see paras [0093]-[0096]).
Regarding claim 11 and 12, Stahler discloses that the control assembly is configured for articulating the distal member end of the inner articulating member 37 into a single-curve planar shape (as per claim 11) or a multi-curve shape (as per claim 12) (the inner articulating member 37 can be controlled, for example, by control elements 405 in the form of pull wires, that extend from the distal member end of the inner articulating member 37 to the portion 3 of the control assembly (see para [0240]); these control wires are able to manipulate the distal end of the catheter into either a single-curve planar shape as shown in Fig. 48A, or into a multi-curve shape by additionally bending the tool 41 in the directions indicated by the two-headed curved arrows in Fig. 48A).
Regarding claim 13, Stahler discloses that control assembly is a manually operated control assembly (see Fig. 1, showing a user 17 manually controlling the control assembly 15 and 3 from a workstation 5).
Regarding claim 15, Stahler does not explicitly disclose that the distal catheter end is configured for being inserted into a branch of an aortic arch of a human; however, this limitation appears to constitute intended use of the distal catheter end that does not impart a structural limitation to the distal catheter end; Stahler discloses that the device can be used to enhance the positioning of controllable surgical instruments in small vascular spaces (see paras [0004]-[0008]) and so a skilled artisan would conclude that the distal catheter end in Stahler would be capable of insertion into a branch of an aortic arch of a human.
Regarding claim 16, Stahler discloses at least one pull wire 171-173 (see Figs. 11A-11B) operably connected between the distal member end and the control assembly, wherein the control assembly is configured for articulating the distal member end by tensioning the at least one pull wire (see para [0117]).
Regarding claim 17, Stahler discloses that the control assembly is configured for distally translating the outer catheter body over the inner articulating member distally over the inner articulating member (as described above with respect to claim 10), while maintaining the inner articulating member still as the distal catheter end distally extends past the articulatable distal member end (the outer catheter body 39 can be moved forward relative to the inner articulating member 37, or the inner articulating member 37 can be moved backward relative to the outer body catheter 39, in order to completely retract the tip of the inner articulating member 37 into the outer body catheter 39; this may be useful, for instance, when retracting the inner articulating member 37 from the patient entirely, as disclosed in para [0093]).
Regarding claim 18, Stahler discloses that the control assembly comprises an actuator (such as a motor system; see para [0098]) configured for being manipulated to distally translate the outer catheter body over the inner articulating member.
Regarding claim 19, Stahler discloses that the control assembly is configured for distally translating the outer catheter body in the distal direction over the inner articulating member, while maintaining the inner articulating member still as distal catheter end distally extends past the articulatable distal member end (the outer catheter body 39 can be moved forward relative to the inner articulating member 37, or the inner articulating member 37 can be moved backward relative to the outer body catheter 39, in order to completely retract the tip of the inner articulating member 37 into the outer body catheter 39; this may be useful, for instance, when retracting the inner articulating member 37 from the patient entirely, as disclosed in para [0093]).
Regarding claim 20, Stahler discloses that a handle assembly, e.g., 15, comprises an actuator (such as a motor system; see para [0098]) configured for being manipulated to distally translate the outer catheter body over the inner articulating member.
Regarding claims 21 and 22, Stahler discloses that the control assembly comprise an actuator to which the at least one pull wire is directly connected, and configured for being manipulated to articulate the distal member end by tensioning the at least one pull wire (see para [0126], disclosing that the wires are routed back to a catheter splayer and associated control knobs; these knobs can pull the wires to tension them so that they are pulled downwardly and cause the movement shown in Figs. 11A-11B).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Stahler in view of Wallace et al (U.S. Pub. 2009/00228020 A1, hereinafter “Wallace”).
Regarding claim 5, it is noted that Stahler does not appear to disclose that the control assembly is releasably coupled to the proximal catheter end.
Wallace discloses an intravascular device, comprising:
an elongated outer catheter body 8 (see Figs. 11A-11E) having a proximal catheter end, a distal catheter end, and an inner lumen extending between the proximal catheter end and the distal catheter end;
an elongated inner articulating member 6 (see Figs. 11A-11E) slidably disposed within the inner lumen of the outer catheter body, the inner articulating member having a proximal member end and an articulatable distal member end, and
a control assembly 54 (see Figs. 11A-11E); see Fig. 5A) mechanically coupled to the proximal catheter end and the proximal member end, the control assembly configured for distally translating the outer catheter body and the inner catheter body (see para [0030]), and the control assembly is releasably coupled to the proximal catheter end (see para [0030]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Stahler, so that the control assembly is releasably coupled to the proximal catheter end, as taught in Wallace, in case it is necessary to gain access to the proximal catheter end, for instance to remove a blockage or to replace the catheter, with a reasonable expectation of success.
Regarding claim 14, it is noted that Stahler does not appear to disclose that the control assembly is configured for being releasably coupled to the proximal catheter end.
Wallace discloses an intravascular device, comprising:
an elongated outer catheter body 8 (see Figs. 11A-11E) having a proximal catheter end, a distal catheter end, and an inner lumen extending between the proximal catheter end and the distal catheter end;
an elongated inner articulating member 6 (see Figs. 11A-11E) slidably disposed within the inner lumen of the outer catheter body, the inner articulating member having a proximal member end and an articulatable distal member end, and
a control assembly 54 (see Figs. 11A-11E); see Fig. 5A) mechanically coupled to the proximal catheter end and the proximal member end, the control assembly configured for distally translating the outer catheter body and the inner catheter body (see para [0030]), and the control assembly is releasably coupled to the proximal catheter end (see para [0030]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Stahler, so that the control assembly is releasably coupled to the proximal catheter end, as taught in Wallace, in case it is necessary to gain access to the proximal catheter end, for instance to remove a blockage or to replace the catheter, with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered.
Claim Rejections - 35 U.S.C. §112(b)
Claims 18 and 20 were amended. The §112(b) rejection has been withdrawn.
Claim Rejections - 35 U.S.C. §112(d)
Claim 10 was amended. The §112(d) rejection has been withdrawn.
Claim Rejections - 35 U.S.C. §102
Applicant argued that “none of the user interface devices on the workstation 5 of the Stahler device constitute a ‘manually operated control assembly,’ but rather are simply manually operated devices as part of a robotic control assembly” (Remarks, pg. 6).
This argument is not found persuasive because the control assembly of Stahler can be manually operated, e.g., Fig. 1 shows a user 17 manually controlling the control assembly 15 and 3 from a workstation 5. Additionally, the term “operated” has been interpreted reasonably broadly to cover any activity aspect of operation, such as manually moving the control assembly through the use of a mounting brace 13 and/or a control lever 57 (see Fig. 4A). Applicant has not limited the claim term “operated” to refer to a specific movement of the components of the control system.
Moreover, it can be seen from Fig. 1A that the control assembly is sized in such relation to a human operator or patient to permit it to be held by an operator or patient’s hand. Aside from holding the control assembly, Applicant has not limited the specific actions or functions intended to be performed by a hand.
Applicant also argued that Stahler does not disclose that the assembly is directly mechanically coupled to the proximal catheter end. However, the elongated catheter body 39 is directly attached at its proximal end to the carriage 69 of the control assembly (see para [0094], referring to the elongated catheter body being “mounted on” the carriage 69; and see also Figs. 6C and 6D, showing the proximal end of the catheter body 39 extending partially within the carriage 69 with a proximal tip being provided for the insertion/attachment of another catheter device or valve 111).
Claim Rejections - 35 U.S.C. §103
Applicant argued that claims 5, 10-12 and 14-20 are patentable based on their dependence from claims 1 and 10. See response, above.
New Claims
Applicant argued that claims 21 and 22 are patentable based on their dependence from claims 1 and 10. . See response, above.
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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 01/05/2025