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 6, 2025 has been entered. Claims 1-20 and 22-29 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/602,469, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In particular the earlier application at least fails to provide support for the plurality of inactive segments. Accordingly, claims 3-11 and 16-20 are not entitled to the benefit of the earlier application.
This application repeats a substantial portion of prior Application No. 16/602,469, filed October 11, 2019, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq.
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 1-20 and 22-29 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.
There is insufficient support in the disclosure for the limitations “the elongate tubular member is devoid of any individual connected links embedded in a wall of a catheter which interconnect via a movable engagement of a recessed and tapered region” (lines 8-10 of claim 1 and lines 8-10 of claim 16).
The specification broadly discloses “The plurality of pull wires correspond in number to the plurality of active segments such that each active segment is connected to a single pull wire, whereby applying an axial force to each pull wire causes deflection of a corresponding active segment”, “the plurality of pull wires may include a first pull wire that is connected to the first active segment and a second pull wire that is connected to the second active segment” at respective first and second connection points, “the body may include an outer wall and a plurality of channels that extend through the outer wall in generally parallel relation to the working lumen…the plurality of channels may correspond in number to the plurality of pull wires such that each channel receives a single pull wire.” The disclosure fails to recite how the pull wires are connected to the active segments. Furthermore, the disclosure fails to recite something that conveys to a skilled artisan that the inventor intended the exclusion, such as a discussion of disadvantages or alternatives.
Any negative limitation or exclusionary proviso must have basis in the original disclosure. The mere absence of a positive recitation is not basis for an exclusion. See MPEP 2173.05(i).
Claims 2-15 and 22-23 are rejected due to their dependency on claim 1. Claims 17-20 and 24-29 are rejected due to their dependency on claim 16.
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.
Claim(s) 1-4 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boury (US 5,916,147, hereinafter “Boury”) in view of Sheps et al. (US 2014/0309661, hereinafter Sheps).
Regarding claim 1, Boury discloses the invention substantially as claimed including a medical device (Figs 1A-1B) for establishing trans-radial access to a target site in a blood vessel (col 4, ln 6-20 – length of catheter varied as necessary for a desired procedure, and thus fully capable of being positioned to establish trans-radial access to a target site in a blood vessel), the medical device comprising:
a body (generally shown by outer member 10) including: a proximal end hole (20); a distal end hole (14) positioned opposite to the proximal end hole, wherein the body is configured as an elongate tubular member having an outer wall and an inner wall extending continuously from the proximal end hole to the distal end hole;
a working lumen (12) extending through the body from the proximal end hole to the distal end hole (col 3, ln 59-col 4, ln 5); and
a deflectable region having a plurality of active segments (36A, 36B, 36C, and 36D defined by nodes 32A, 32B, 32C, and 32D) that are deflectable to reconfigure the medical device between a first configuration (Fig 1A), in which the body is generally linear, and a second configuration (Fig 1B), in which the body is non-linear; and
a plurality of pull wires (34) corresponding in number to the plurality of active segments (separate control wire for each node) such that each active segment is connected to a single pull wire, whereby applying an axial force to each pull wire causes deflection of a corresponding active segment (col 5, ln 6-16 and 40-48; col 6, ln 8-19).
However, Boury fails to disclose the elongate tubular member is devoid of any individual connected links embedded in a wall of a catheter which interconnect via a movable engagement of a recessed and tapered region. Boury teaches the steerable catheter has an outer wall extending continuously between a proximal end and a distal end hole such that the catheter is devoid of any links (“The catheter 10 is generally tubular in shape and desirably includes at least one lumen 12” — col 3, In 61-62; “The catheter extends from a proximal end 20 to a distal end 14.” —col 3, In 66-67. It is noted catheter 10 includes the outer body that is generally tubular in shape which is devoid of any links. However, links 40 are located within the body. Thus the “catheter” is interpreted as the outer body, wherein the inner links and the pull wires are located within the catheter.) Sheps discloses a similar steerable catheter (340) having an outer wall extending continuously between a proximal end and a distal end hole such that the catheter is devoid of any links (Figs 11A-B) with multiple steering segments defined by pull rings (343, 345) connected to steering or pulley wires (344a,b and 342a,b) (para [0276-0279]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boury such that the catheter was composed of a shapeable material as taught by Sheps and was devoid of any individual links embedded in a wall of the catheter which interconnect via a movable engagement of a recessed and tapered movement. Substitution of one known element for another element providing the same function to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention.
Regarding claim 2, wherein the plurality of active segments are spaced axially along a longitudinal axis of the body (Figs 1A-1B).
Regarding claim 3, wherein the body further includes a plurality of inactive segments (proximal length 22 and distal length 16; col 3, ln 66-col 4, ln 5).
Regarding claim 4, wherein the body is configured such that the plurality of active segments (36A, 36B, 36C, and 36D defined by nodes 32A, 32B, 32C, and 32D) and the plurality of inactive segments (proximal length 22 and distal length 16) are arranged in a staggered pattern along the longitudinal axis (Figs 1A-1B).
Regarding claim 22, wherein deflection of the body is provided solely by the plurality of wires (34) (col 5, ln 6-16 and 40-48; col 6, ln 8-19 – steering controlled by pullwires without another external active input).
Claim(s) 5-11, 16-20, 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boury (US 5,916,147) and Sheps (US 2014/0309661), as applied to claim 4 above, further in view of Gibson et al. (US 2008/0139999, hereinafter “Gibson”).
Regarding claims 5 and 23, Boury teaches the body at least includes a plurality of inactive segments (proximal length 22 and distal length 16; col 3, ln 66-col 4, ln 5) and a plurality of active segments (36A, 36B, 36C, and 36D defined by nodes 32A, 32B, 32C, and 32D) with at least a first inactive segment (proximal length 22); a first active segment located distally of the first inactive segment (at least one of active segments 36A, 36B, 36C, and 36D); a second inactive segment located distally of the first active segment (distal length 16). However, Boury fails to teach the particular staggered arrangement with a first inactive segment; a first active segment located distally of the first inactive segment; a second inactive segment located distally of the first active segment; and a second active segment located distally of the second inactive segment. Gibson teaches a similar a steerable catheter having a body with a plurality of active segments (bending segments 56, 58) and a plurality of inactive segments (transition segments 48, 49), wherein the active and inactive segments are arranged in a staggered pattern including a first inactive segment (49); a first active segment (58) located distally of the first inactive segment; a second inactive segment (48) located distally of the first active segment; and a second active segment (56) located distally of the second inactive segment (Fig 9; para [0060, 0071-0072]). Gibson teaches adding inactive segments between active segments in this staggered pattern “can be helpful in improving the reliability and ease of deflecting a bending segment” (para [0071]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Boury such that the body comprised a first inactive segment; a first active segment located distally of the first inactive segment; a second inactive segment located distally of the first active segment; and a second active segment located distally of the second inactive segment for the purpose of improving the reliability and ease of deflecting a bending segment, as taught by Gibson.
Regarding claim 6, Boury teaches wherein the plurality of pull wires (34A-D) includes: a first pull wire (34A) connected to the first active segment (36A defined by node 32A); and a second pull wire (34B) connected to the second active segment (36B defined by node 32B) (separate control wire for each node; col 5, ln 6-16 and 40-48; col 6, ln 8-19).
Regarding claim 7, Boury teaches the degree of curvature of the first and second active segments (36A, 36B) can be controlled by the tension placed on the associated control wire (34) (col 8, ln 12-26) and Fig 1B shows the first active segment and the second active segment are each configured to define a bend that lies substantially within a range of approximately 0 degrees to approximately 270 degrees. Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that the first active segment and the second active segment are each configured to define a bend that lies substantially within a range of approximately 0 degrees to approximately 270 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 8, Boury teaches the degree of curvature of the first and second active segments (36A, 36B) can be controlled by the tension placed on the associated control wire (34) (col 8, ln 12-26) and Fig 1B shows the first active segment is configured to define a first bend that lies substantially within a range of approximately 0 degrees to approximately 270 degrees. Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that the first active segment was configured to define a first bend that lies substantially within a range of approximately 0 degrees to approximately 270 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 9, Boury teaches the degree of curvature of the first and second active segments (36A, 36B) can be controlled by the tension placed on the associated control wire (34) (col 8, ln 12-26) and Fig 1B shows the second active segment is configured to define a second bend that lies substantially within a range of approximately 0 degrees to approximately 180 degrees. Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that the second active segment was configured to define a second bend that lies substantially within a range of approximately 0 degrees to approximately 180 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 10 and 11, wherein the first pull wire (34) is connected to the first active segment (36A) such that, upon deflection, the first active segment defines a first bend that curves in a first direction and wherein the second pull wire (34) is connected to the second active segment (36B) such that, upon deflection, the second active segment defines a second bend that curves in a second direction that is generally different to the first direction (Fig 1B; col 4, ln 61-col 5, ln 4).
Regarding claims 16 and 25, Boury discloses the invention substantially as claimed including, a medical device (Figs 1A-1B) for establishing trans-radial access to a target site in a blood vessel (col 4, ln 6-20 – length of catheter varied as necessary for a desired procedure, and thus fully capable of being positioned to establish trans-radial access to a target site in a blood vessel), the medical device comprising:
a body (10) defining a longitudinal axis and including:
a proximal end hole (20);
a distal end hole (14) positioned opposite the proximal end hole, wherein the body is configured as an elongate tubular member extending continuously from the proximal end hole to the distal end hole (“The catheter 10 is generally tubular in shape and desirably includes at least one lumen 12” – col 3, ln 61-62; “The catheter extends from a proximal end 20 to a distal end 14.” – col 3, ln 66-67).
a plurality of active segments (36A, 36B, 36C, and 36D defined by nodes 32A, 32B, 32C, and 32D) that are deflectable to reconfigure the medical device between a generally linear configuration (Fig 1A) and a non-linear configuration (Fig 1B) (col 5, ln 6-16 and 40-48; col 6, ln 8-19); and a plurality of inactive segments (proximal length 22 and distal length 16; col 3, ln 66-col 4, ln 5), wherein the body is configured such that the plurality of active segments and the plurality of inactive segments are arranged in a staggered pattern along the longitudinal axis (Figs 1A-B); and
a plurality of pull wires (34) that are connected to the plurality of active segments (36A, 36B, 36C, and 36D) such that each active segment is deflectable via an axial force applied to a corresponding pull wire (col 5, ln 6-16 and 40-48; col 6, ln 8-19).
Boury teaches the degree of curvature of the active segments can be controlled by the tension placed on the associated control wire (34) (col 8, ln 12-26) and Fig 1B shows the at least one active segment configured to define a bend greater than approximately 90 degrees upon deflection. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the Boury such that each active segment is configured to define a bend greater than approximately 90 degrees upon deflection, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, as discussed above Boury teaches the body at least includes a plurality of inactive segments (proximal length 22 and distal length 16; col 3, ln 66-col 4, ln 5) and a plurality of active segments (36A, 36B, 36C, and 36D defined by nodes 32A, 32B, 32C, and 32D) with at least a first inactive segment (proximal length 22); a first active segment located distally of the first inactive segment (at least one of active segments 36A, 36B, 36C, and 36D); a second inactive segment located distally of the first active segment (distal length 16). However, Boury fails to teach the particular staggered arrangement with at least one of the inactive segments positioned between the active segments. Gibson teaches a similar a steerable catheter having a body with a plurality of active segments (bending segments 56, 58) and a plurality of inactive segments (transition segments 48, 49), wherein the active and inactive segments are arranged in a staggered pattern including a first inactive segment (49); a first active segment (58) located distally of the first inactive segment; a second inactive segment (48) located distally of the first active segment; and a second active segment (56) located distally of the second inactive segment (Fig 9; para [0060, 0071-0072]). Gibson teaches adding inactive segments between active segments in this staggered pattern “can be helpful in improving the reliability and ease of deflecting a bending segment” (para [0071]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Boury such that at least one inactive segment was positioned between the active segments for the purpose of improving the reliability and ease of deflecting a bending segment, as taught by Gibson.
Finally, Boury fails to disclose the elongate tubular member is devoid of any individual connected links embedded in a wall of a catheter which interconnect via a movable engagement of a recessed and tapered region. Boury teaches the steerable catheter has an outer wall extending continuously between a proximal end and a distal end hole such that the catheter is devoid of any links (“The catheter 10 is generally tubular in shape and desirably includes at least one lumen 12” — col 3, In 61-62; “The catheter extends from a proximal end 20 to a distal end 14.” —col 3, In 66-67. It is noted catheter 10 includes the outer body that is generally tubular in shape which is devoid of any links. However, links 40 are located within the body. Thus the “catheter” is interpreted as the outer body, wherein the inner links and the pull wires are located within the catheter.) Sheps discloses a similar steerable catheter (340) having an outer wall extending continuously between a proximal end and a distal end hole such that the catheter is devoid of any links (Figs 11A-B) with multiple steering segments defined by pull rings (343, 345) connected to steering or pulley wires (344a,b and 342a,b) (para [0276-0279]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Boury such that the catheter was composed of a shapeable material as taught by Sheps and was devoid of any individual links embedded in a wall of the catheter which interconnect via a movable engagement of a recessed and tapered movement. Substitution of one known element for another element providing the same function to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention.
Regarding claim 17, Boury teaches wherein the plurality of pull wires (34) includes first and second pull wires connected to one of the plurality of active segments at respective first and second connection points located at different radial positions relative to each other to facilitate deflection of the body in generally different first and second directions (Fig 1B; col 4, ln 61-col 5, ln 4).
Regarding claim 18, Boury teaches the degree of curvature of the active segments can be controlled by the tension placed on the associated control wire (34) (col 8, ln 12-26) and Fig 1B shows the at least one active segment configured to define a bend greater than approximately 90 degrees upon deflection. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the Boury such that each active segment was configured to define a bend between approximately 90 degrees and approximately 270 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 19, as discussed above, Boury teaches the body at least includes a plurality of inactive segments (proximal length 22 and distal length 16; col 3, ln 66-col 4, ln 5) and a plurality of active segments (36A, 36B, 36C, and 36D defined by nodes 32A, 32B, 32C, and 32D) with at least a first inactive segment (proximal length 22); a first active segment located distally of the first inactive segment (at least one of active segments 36A, 36B, 36C, and 36D); a second inactive segment located distally of the first active segment (distal length 16). However, Boury fails to teach the particular arrangement with a first inactive segment; a first active segment located distally of the first inactive segment; a second inactive segment located distally of the first active segment; and a second active segment located distally of the second inactive segment. Gibson teaches a similar a steerable catheter having a body with a plurality of active segments (bending segments 56, 58) and a plurality of inactive segments (transition segments 48, 49), wherein the active and inactive segments are arranged in a staggered pattern including a first inactive segment (49); a first active segment (58) located distally of the first inactive segment; a second inactive segment (48) located distally of the first active segment; and a second active segment (56) located distally of the second inactive segment (Fig 9; para [0060, 0071-0072]). Gibson teaches adding inactive segments between active segments in this staggered pattern “can be helpful in improving the reliability and ease of deflecting a bending segment” (para [0071]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boury such that the body comprised a first inactive segment; a first active segment located distally of the first inactive segment; a second inactive segment located distally of the first active segment; and a second active segment located distally of the second inactive segment for the purpose of improving the reliability and ease of deflecting a bending segment, as taught by Gibson.
Regarding claim 20, Boury teaches the degree of curvature of the active segments can be controlled by the tension placed on the associated control wire (34) (col 8, ln 12-26) and Fig 1B shows the at least one active segment configured to define a bend greater than approximately 90 degrees upon deflection. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that first active segment was configured to define a first bend that lies substantially within a range of approximately 90 degrees to approximately 270 degrees and the second active segment was configured to define a second bend that lies substantially within a range of approximately 90 degrees to approximately 180 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 24, wherein deflection of the body is provided solely by the plurality of wires (34) (col 5, ln 6-16 and 40-48; col 6, ln 8-19 – steering controlled by pullwires without another external active input).
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boury (US 5,916,147) and Sheps (US 2014/0309661), as applied to claim 1 above, further in view of Bedell (US 2003/0004460, hereinafter “Bedell”).
Regarding claim 12, Boury teaches “it may be desirable to provide more than one lumen or to subdivide a large lumen into two or more separate lumens, such as in balloon angioplasty” (col 3, ln 63-65). However, Boury fails to specifically further include an inflatable balloon supported on the body proximally of the distal end hole. Bedell discloses a similar steerable catheter with a plurality of pull wires (24, 25) and teaches the catheter further comprises an inflatable balloon (21) supported on the body proximally of the distal end hole (distal end of 16), wherein the inflation source is connected to an inflation lumen (13) to inflate the balloon (Figs 3-4; para [0041-0043, 0045]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Boury such that an inflatable balloon was supported on the body proximally of the distal end hole such that the catheter may be useful in procedures such as balloon angioplasty.
Regarding claim 13, Boury teaches the body includes an outer wall and a plurality of channels (24) extending through the outer wall in generally parallel relation to the working lumen ((col 9, ln 7-27).
Regarding claim 14, Boury teaches the plurality of channels (24) correspond in number to the plurality of pull wires (34) such that each channel receives a single pull wire (col 9, ln 7-27).
Regarding claim 15, the combination of Boury, Sheps and Bedell teach the medical device is configured for connection to an inflation source and at least one of the plurality of channels is configured for communication with the inflation source such that inflation fluid is communicable from the inflation source to the inflatable balloon therethrough (Boury col 3, ln 63-65).
Claim(s) 26-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boury (US 5,916,147), Sheps (US 2014/0309661), and Gibson (US 2008/0139999), as applied to claim 17 above, further in view of Ma (US 2014/0275779, hereinafter “Ma”).
Regarding claim 26, Boury fails to disclose the actuation mechanism for controlling the movement of the pull wires comprises at least one lever as claimed. Ma discloses a similar catheter and teaches the handle assembly (102) includes activation mechanism (410) which “may include one or more levers, slides, triggers, or similar controls, each attached to at least one deflection member, for example a pull wire, cable or other means for communicating motion from first and second members 406, 408 to the distal end of shaft 402” (para [0049]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination to further comprise a handle at a proximal end comprising at least one lever coupled to each pull wire to control movement of the pull wire since levers are well known in the art as a control mechanism for pull wires. In the combination, it is obvious activation of at least one wire results in deflection of at least one deflectable segment since Boury teaches activation of each wire results in deflection of at least one deflectable segment.
Regarding claims 27-29, in the combination deflection of one deflectable segment creates a deflection for the device to bend as desired for a particular use (col 6, ln 62 – col 7, ln 14) and thus is fully capable of creating a deflection for the device to bend from a right subclavian artery, through an innominate artery, and into a right common carotid artery, and deflection of a second deflectable segment creates a deflection for the device to bend from an innominate artery, through an aortic arch, and into a left common carotid artery, or wherein deflection of at least one tertiary deflectable segment creates a deflection for the device to bend from an innominate artery, through an aortic arch, and into a left subclavian artery, or deflection for the device to bend from a right subclavian artery, through an innominate artery, and into a right common carotid artery, and deflection of a second deflectable segment creates a deflection for the device to bend from an innominate artery, through an aortic arch, and into a left subclavian artery. It is noted 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.
Response to Arguments
Applicant’s arguments, see amendment, filed June 6, 2025, with respect to the rejection(s) of claim(s) 1-4 under 35 USC 102(a)(1) as being anticipated by Boury and claims 5-11 and 16-21 under 35 USC 103 as being unpatentable over Boury in view of Gibson, 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 Sheps (US 2014/0309661). Furthermore, new claims 26-29 are further rejected in view of Ma (US 2014/0275779).
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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771