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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/02/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 27 and 33, the new matter is "a handle body configured for being translated between the distal-most position and the proximal-most position" and a "slide mechanism [that] may be axially translated along a longitudinal axis to tension the pull wire for articulating the distal member end."
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24, 30, 31 and any claim(s) depending therefrom are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 24 and 30, the limitation "wherein the actuator is configured for being axially translated along a longitudinal axis relative to the actuator" is indefinite because it appears to be self-referential.
For the purpose of examination, the limitation will be interpreted to mean "the actuator is configured for being axially translated along a longitudinal axis relative to the frame".
Regarding claim 31, the limitation "the combined axial device" lacks antecedent basis in the claim. For the purpose of examination, the limitation will be interpreted to mean "the combined axial translation/articulation actuator").
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, 6-13 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]),
wherein the control assembly is configured for preventing the articulable member end from being translated distal to the distal catheter end (i.e., when the inner articulating member distal end is proximal to the distal catheter end, the control assembly prevents further movement unless the user takes action to operate one or both of the carriages to control the relative positions of the articulatable member and the distal catheter end).
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 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]),
wherein the control assembly is configured for preventing the articulable member end from being translated distal to the distal catheter end (i.e., when the inner articulating member distal end is proximal to the distal catheter end, the control assembly prevents further movement unless the user takes action to operate one or both of the carriages to control the relative positions of the articulatable member and the distal catheter end).
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 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 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]).
Claims 1, 10, 23-26, 28-32 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horie et al (U.S. Pub. 2010/0305517 A1, hereinafter "Horie").
Regarding claim 1, Horie discloses an intravascular device, comprising:
an elongated outer catheter body 2 (see Fig. 11(a)) 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 3 (see Fig. 11(a)) 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 manually operated handheld control assembly 7/8/9/10 (see Fig. 11(a)) directly mechanically coupled to the proximal catheter end and the proximal member end, the control assembly configured for articulating the distal member end (by rotating the inner part 9 relative to the outer part 8 in a first direction) and for distally translating the outer member catheter body in a distal direction over the inner articulating member (by rotating the inner part 9 relative to the outer part 8 in the direction opposite to the first direction),
such that the distal catheter end distally extends past the articulatable distal member end, wherein the control assembly is configured for preventing the articulatable distal member end from being translated distal to the distal catheter end (see Fig. 11(a)), illustrating the position of the control assembly indicating the maximum distance that the inner articulating member can move distally relative to the outer elongated catheter body 2, along with the distal end 3a of the inner articulating member 3 not extending distally beyond the distal end of the outer elongated catheter body 2).
Regarding claim 10, Horie discloses an intravascular device, comprising:
an elongated inner articulating member 3 slidably disposed within the inner lumen of an outer catheter body 2 having a proximal catheter end, a distal catheter end, and an inner lumen extending between the proximal catheter end and the distal catheter end, the inner articulating member having a proximal member end and an articulatable distal member end; and
a manually operated handheld control assembly 7/8/9/10 directly mechanically coupled to the proximal catheter end and the proximal member end, the control assembly configured for articulating the distal member end (by rotating the inner part 9 relative to the outer part 8 in a first direction) and for distally translating the outer catheter body in a distal direction over the inner articulating member (by rotating the inner part 9 relative to the outer part 8 in a second opposite direction), such that the distal catheter end distally extends past the articulatable distal member end (see Fig. 11(a), illustrating the position of the control assembly indicating the maximum distance that the inner articulating member can move distally relative to the outer elongated catheter body 2, along with the distal end 3a of the inner articulating member 3 not extending distally beyond the distal end of the outer elongated catheter body 2).
Regarding claim 23, Horie discloses that the control assembly comprises an actuator 7/8/10 (see Fig. 11(a)) affixed to the proximal member end (via nut 10), the actuator being configured for being translated between a distal-most position (shown in Fig. 11(a)), whereby the distal catheter end distally extends past the articulatable distal member end a first distance, and a proximal-most position (see Fig. 11(b)), whereby the distal catheter end distally extends past the articulatable distal member end a second distance greater than the first distance.
Regarding claim 24, Horie discloses a frame, e.g., 7 (see Fig. 11(a)) affixed to the proximal catheter end, wherein the actuator is configured for being axially translated along a longitudinal axis relative to the frame (via movement between parts 8 and 9, as shown in Figs. 11(a) and 11(b)).
Regarding claim 25, Horie discloses that the actuator is a combined axial translation/articulation actuator configured for articulating the distal member end and for distally translating the outer member catheter body in a distal direction over the inner articulating member (see Figs. 11(a) and 11(b); the actuator extends the distal member a particular distance which causes articulation of the distal member end; further, moving the entire handle along with the actuator causes the outer member catheter body to be moved distally).
Regarding claim 26, Horie discloses that the combined axial translation/articulation actuator comprises a housing 9 (see Fig. 12(a)) configured for being translated between the distal-most position and the proximal-most position, a pinion collar 8 (see Fig. 12(a)) rotatably slidable about the housing, and a linear gear 9a (see Fig. 12(a)) affixed to a proximal end of a pull wire 5 (see Fig. 11(a)) operably connected to the distal member end, wherein the pinion collar threadedly engages the linear gear, such that rotation of the pinion collar about the housing tensions the pull wire for articulating the distal member end (the pull wire and distal member end are both articulated by rotation of the pinion collar about the housing).
Regarding claim 28, Horie discloses a rotational actuator 9 (see Fig. 12(a)) affixed to the proximal catheter end, wherein the rotational actuator is configured for being rotated about a longitudinal axis for rotating the outer catheter body about the longitudinal axis (the actuator 9 is freely rotatable around the longitudinal axis, thus permitting rotation of the outer catheter body about the longitudinal axis as well).
Regarding claim 29, Horie discloses that control assembly comprises an actuator 7/8/10 (see Fig. 11(a)) affixed to the proximal member end (via nut 10), the actuator being configured for being translated between a distal-most position (shown in Fig. 11(a)), whereby the distal catheter end distally extends past the articulatable distal member end a first distance, and a proximal-most position (see Fig. 11(b)), whereby the distal catheter end distally extends past the articulatable distal member end a second distance greater than the first distance.
Regarding claim 30, Horie discloses a frame, e.g., 7 (see Fig. 11(a)) affixed to the proximal catheter end, wherein the actuator is configured for being axially translated along a longitudinal axis relative to the frame (via movement between parts 8 and 9, as shown in Figs. 11(a) and 11(b)).
Regarding claim 31, Horie discloses that the actuator is a combined axial translation/articulation actuator configured for articulating the distal member end and for distally translating the outer member catheter body in a distal direction over the inner articulating member (see Figs. 11(a) and 11(b); the actuator extends the distal member a particular distance which causes articulation of the distal member end; further, moving the entire handle along with the actuator causes the outer member catheter body to be moved distally).
Regarding claim 32, Horie discloses that the combined axial translation/articulation actuator comprises a housing 9 (see Fig. 12(a)) configured for being translated between the distal-most position and the proximal-most position, a pinion collar 8 (see Fig. 12(a)) rotatably slidable about the housing, and a linear gear 9a (see Fig. 12(a)) affixed to a proximal end of a pull wire 5 (see Fig. 11(a)) operably connected to the distal member end, wherein the pinion collar threadedly engages the linear gear, such that rotation of the pinion collar about the housing tensions the pull wire for articulating the distal member end (the pull wire and distal member end are both articulated by rotation of the pinion collar about the housing).
Regarding claim 34, Horie discloses a rotational actuator 9 (see Fig. 12(a)) affixed to the proximal catheter end, wherein the rotational actuator is configured for being rotated about a longitudinal axis for rotating the outer catheter body about the longitudinal axis (the actuator 9 is freely rotatable around the longitudinal axis, thus permitting rotation of the outer catheter body about the longitudinal axis as well).
Claims 1, 10, 23, 25, 28, 29, 31 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ormsby et al (U.S. Pub. 2003/0114844 A1, hereinafter "Ormsby").
Regarding claim 1, Ormsby discloses an intravascular device, comprising:
an elongated outer catheter body 120 (see Fig. 1A) having a proximal catheter end 130 (see Fig. 1A), a distal catheter end 120 (see Fig. 1A), and an inner lumen 150 (see Fig. 3A) extending between the proximal catheter end and the distal catheter end;
an elongated inner articulating member 190 or 180 (see Fig. 3A) slidably disposed within the inner lumen of the outer catheter body (see Figs. 4A-4B illustrating the ability of 190 or 180 to slide 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 manually operated handheld control assembly (housed within chassis 160; see Fig. 1A) directly mechanically coupled to the proximal catheter end and the proximal member end, the control assembly configured for articulating the distal member end (by movement of a thumb slide 200 shown in Figs. 1A and 2A; and see para [0053], disclosing the direct coupling of 180 and/or 190 to the thumb slide 200), and for distally translating the outer member catheter body in a distal direction over the inner articulating member (by movement of the slide 200 in the directions indicate by the large arrows in Figs. 1A, 1B, 2A and 2B; see also para [0053] disclosing such movement),
such that the distal catheter end distally extends past the articulatable distal member end (see Fig. 3A) wherein the control assembly is configured for preventing the articulatable distal member end from being translated distal to the distal catheter end (the distal catheter end is closed, as shown in Figs. 3A, 3B).
Regarding claim 10, Ormsby discloses an intravascular device, comprising:
an elongated inner articulating member 190 or 180 (see Fig. 3A) slidably disposed within the inner lumen of an outer catheter body 120 (see Fig. 2A) having a proximal catheter end, a distal catheter end, and an inner lumen extending between the proximal catheter end and the distal catheter end, the inner articulating member having a proximal member end and an articulatable distal member end; and
a manually operated handheld control assembly (housed within chassis 160; see Fig. 1A) directly mechanically coupled to the proximal catheter end and the proximal member end, the control assembly configured for articulating the distal member end ((by movement of a thumb slide 200 shown in Figs. 1A and 2A; and see para [0053], disclosing the direct coupling of 180 and/or 190 to the thumb slide 200), and for distally translating the outer catheter body in a distal direction over the inner articulating member (by movement of the slide 200 in the directions indicate by the large arrows in Figs. 1A, 1B, 2A and 2B; see also para [0053] disclosing such movement),
such that the distal catheter end distally extends past the articulatable distal member end (see Fig. 3A).
Regarding claim 23, Ormsby discloses that the control assembly comprises an actuator 200 (see Fig. 1A) affixed to the proximal member end (see para [0053]), the actuator being configured for being translated between a distal-most position (shown in Fig. 1A), whereby the distal catheter end distally extends past the articulatable distal member end a first distance, and a proximal-most position (see Fig. 1B), whereby the distal catheter end distally extends past the articulatable distal member end a second distance greater than the first distance (i.e., in the position shown in Fig. 1B, the articulatable distal member 180 and/or 190 is more proximal than it would be in the position shown in Fig. 1A).
Regarding claim 25, Ormsby discloses that the actuator is a combined axial translation/articulation actuator configured for articulating the distal member end and for distally translating the outer member catheter body in a distal direction over the inner articulating member (see Figs. 1A and 1B; the actuator extends the distal member a particular distance which causes articulation of the distal member end; further, moving the entire handle along with the actuator causes the outer member catheter body to be moved distally).
Regarding claim 28, Ormsby discloses a rotational actuator 220 (see Fig. 2) affixed to the proximal catheter end (see para [0054]), wherein the rotational actuator is configured for being rotated about a longitudinal axis for rotating the outer catheter body about the longitudinal axis (the actuator 220 is freely rotatable around the longitudinal axis, thus permitting rotation of the outer catheter body about the longitudinal axis as well, so long as the rotation of the actuator 220 is accompanied by rotation of the housing 160).
Regarding claim 29, Ormsby discloses that the control assembly comprises an actuator 200 (see Fig. 1A) affixed to the proximal member end (see para [0053]), the actuator being configured for being translated between a distal-most position (shown in Fig. 1A), whereby the distal catheter end distally extends past the articulatable distal member end a first distance, and a proximal-most position (see Fig. 1B), whereby the distal catheter end distally extends past the articulatable distal member end a second distance greater than the first distance (i.e., in the position shown in Fig. 1B, the articulatable distal member 180 and/or 190 is more proximal than it would be in the position shown in Fig. 1A).
Regarding claim 31, Ormsby discloses that the actuator is a combined axial translation/articulation actuator configured for articulating the distal member end and for distally translating the outer member catheter body in a distal direction over the inner articulating member (see Figs. 1A and 1B; the actuator extends the distal member a particular distance which causes articulation of the distal member end; further, moving the entire handle along with the actuator causes the outer member catheter body to be moved distally).
Regarding claim 34, Ormsby discloses a rotational actuator 220 (see Fig. 2) affixed to the proximal catheter end (see para [0054]), wherein the rotational actuator is configured for being rotated about a longitudinal axis for rotating the outer catheter body about the longitudinal axis (the actuator 220 is freely rotatable around the longitudinal axis, thus permitting rotation of the outer catheter body about the longitudinal axis as well, so long as the rotation of the actuator 220 is accompanied by rotation of the housing 160).
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.
Claims 27 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Ormsby in view of Stevens (U.S. Pat. 3,503,385, hereinafter "Stevens").
Regarding claims 27 and 33, it is noted that Ormsby, in the embodiments relied upon in the rejection under 35 U.S.C. 102, does not appear to disclose a handle body configured for being translated between the distal-most position and the proximal-most position, and a slide mechanism to which a pull wire operably connected to the distal member end is affixed, wherein the slide mechanism is slidably disposed on the handle body, such that slide mechanism may be axially translated along a longitudinal axis to tension the pull wire for articulating the distal member end.
Stevens discloses a handle 64 to be moved between a proximalmost position and a distalmost position (see Fig. 2 showing a proximalmost position of a slider mechanism between numbers 64 and 54), and a slide mechanism 57 disposed within the handle, to which a pull wire 20 operably connected a distal member end is affixed, wherein the slide mechanism is slidably disposed on the handle body, such that slide mechanism may be axially translated along a longitudinal axis to tension the pull wire for articulating the distal member end.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Ormsby, in order to incorporate the features taught in Stevens, as a well-known way to ergonomically articulate the distal member end, with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 04/02/2026 have been fully considered.
Claim Rejections - 35 U.S.C. §102
Applicant argued that the control assembly of Stahler does not prevent the distal end of the catheter instrument 37 from being translated distal to the distal end of the flexible sheath instrument 39, as required by claim 1 and 10. (see Remarks, pg. 10).
This argument is not found persuasive because when the inner articulating member distal end is proximal to the distal catheter end, the control assembly prevents further movement unless the user takes action to operate one or both of the carriages to control the relative positions of the articulatable member and the distal catheter end.
Claim Rejections - 35 U.S.C. §103
Applicant argued that the dependent claims are patentable based on their dependence from claims 1 and 10, but did not provide further detail for the argument of patentability.
New Claims
Applicant argued that claims 23-34 are patentable based on their dependence from claims 1 and 10, but did not provide further detail for the argument of patentability.
Conclusion
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 06/29/2026
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