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 . Claims 1-20 are pending and examined below.
Response to Arguments
Applicant's arguments filed 08/15/2025 have been fully considered but they are not persuasive.
In regards to independent claims 1, 12, and 18 (pages 6-8), the applicant argue that the prior art, Rincon, does not teach "the pin assembly being distally moveable relative to the core member to disengage from the lock apertures." Applicant argues that Rincom discloses that "the wire holder is configured to move proximally, thereby retracting the engagement wires from the distal receiver and eyelets and that the examiner’s interpretation of the orientation of the proximal and distal direction is inconsistent with the prior art’s disclosure. The examiner respectfully disagree. Proximal and distal terms are relative terms in the art. Applicant discloses in the specification that “the term "distal" can denote a location or direction that is away from a point of interest, such as a control unit or region of the delivery system that will be used to deliver a valve prosthesis to a native valve annulus. Additionally, the term "proximal" can denote a location or direction that is closer to a point of interest, such as a control unit or region of the delivery system that will be used to deliver a valve prosthesis” [0308]. Although the applicant and the prior art uses the terms “proximal” & “distal” differently, they are place holder. The orientation of Rincon can be renamed to be consistent with the proximal and distal terminology used or defined by applicant. All components and structures of the claimed invention are disclosed by the prior art, Rincon. Therefore, the applicant’s argument is not sufficient to overcome the rejection of record and the claims remains rejected.
Claim Rejections - 35 USC § 103
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) 1-5, 7, and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rincon (US 20100324647 A1) in view of Olson et al. (US 20120022633 A1) hereinafter, Olson.
Regarding claim 1, Rincon teaches a delivery system (¶0072, Rincon) for delivering a valve prosthesis, the delivery system comprising:
a core member (inner member hypotube 700, Fig. 8) extending longitudinally (Fig. 8);
a lock component (wire guide 706, Fig. 8) fixedly coupled to the core member (inner member hypotube 700, Fig. 8),
the lock component (wire guide 706, Fig. 8) comprising a plurality of lock apertures (holes 718, Fig. 8); and
a pin assembly (wire holder 702, Fig. 8) slidably coupled to the core member (inner member hypotube 700, Fig. 8) and
movable relative to the lock component (wire guide 706, Fig. 8), wherein
the pin assembly (wire holder 702, Fig. 8) comprises a plurality of pins (engagement wires 704, Fig. 8) extending proximally through a plurality of connection apertures (eyelets 802, Fig. 7) of the valve prosthesis (stent-graft 800, Fig. 7) and
through the plurality of lock apertures (holes 718, Fig. 8) to engage the valve prosthesis (stent-graft 800, Fig. 7) to the delivery system (stent-graft delivery system, ¶0072, Rincon),
the pin assembly (wire holder 702, Fig. 8) being distally moveable relative to the core member (inner member hypotube 700, Fig. 8) to disengage from the lock apertures (holes 718, Fig. 8).
Rincon does not teach a valve prosthesis. However, Olson teaches a prosthetic heart valve (abstract, Olson)
teaches a delivery system (delivery system 6300, Fig. 63, Olson) for delivering a valve prosthesis (prosthetic valve 6370, Fig. 67, Olson).
It would have been obvious to one of ordinary skill in the pertinent art before the effective filing date of the claimed invention to modify the teachings of Rincon with the above teachings of Olson in order to frictionally secure native leaflets of a patient's heart valve against an exterior surface of a prosthetic valve when the patient's heart valve has been replaced by the prosthetic valve (¶0014, Olson).
Regarding claim 2, Rincon teaches
wherein the pin assembly (wire holder 702, Fig. 8) comprises a tubular component (tubular configuration, 0072) coupled thereto and extending proximally beyond the lock component (wire guide 706, Fig. 8).
Regarding claim 3, Rincon teaches
wherein the pin assembly (wire holder 702, Fig. 8) comprises an annular component (wire holder 702 is annular in shape, Fig. 8) at least partially surrounding the core member (inner member hypotube 700, Fig. 8), wherein
the plurality of pins (engagement wires 704, Fig. 8) extends proximally from the annular component (wire holder 702 is annular in shape, Fig. 8).
Regarding claim 4, Rincon teaches
wherein the annular component (wire holder 702 is annular in shape, Fig. 8) of the pin assembly (wire holder 702, Fig. 8) comprises a cylindrical piston member (right side portion of wire holder 702, Fig. 8).
Regarding claim 5, Rincon teaches
wherein the piston member (right side portion of wire holder 702, Fig. 8) comprises opposing proximal and distal plates (Fig. 8), the proximal plate comprising at least one aperture (holes 716, Fig. 8) through which at least one pin (engagement wires 704, Fig. 8) extends, wherein a portion of the at least one pin (engagement wires 704, Fig. 8) is interposed and engaged between the proximal and distal plates (Fig. 8).
Regarding claim 7, Rincon teaches
wherein the annular component (wire holder 702 is annular in shape, Fig. 8) comprises a disc shape, a cylindrical shape, or a torus shape (wire holder 702 is annular in shape, Fig. 8).
Regarding claim 12, Rincon teaches a delivery system (¶0072) for delivering a valve prosthesis, the system comprising:
a core member (inner member hypotube 700, Fig. 8) having a proximal end portion (left side of Fig. 8), a distal end portion (right side of Fig. 8), and a longitudinal axis extending between the proximal and distal end portions (Fig. 8); and
an engagement mechanism (Fig. 8) coupled to the distal end portion of the core member (inner member hypotube 700, Fig. 8) for releasably engaging the valve prosthesis (stent-graft 800, Fig. 7), the engagement mechanism comprising:
a pin assembly (wire holder 702, Fig. 8) coupled to and movable along the core member (inner member hypotube 700, Fig. 8),
the pin assembly (wire holder 702, Fig. 8) comprising an annular component (wire holder 702 is annular in shape, Fig. 8) and at least one pin (engagement wires 704, Fig. 8) coupled to the annular component (wire holder 702 is annular in shape, Fig. 8) and extending in a direction away from the distal end portion (Fig. 8),
the at least one pin (engagement wires 704, Fig. 8) being radially spaced apart from the core member (inner member hypotube 700, Fig. 8); and
a lock component (wire guide 706, Fig. 8) fixedly coupled to the core member (inner member hypotube 700, Fig. 8) proximal to the annular component (wire holder 702 is annular in shape, Fig. 8),
the lock component (wire guide 706, Fig. 8) comprising at least one lock aperture (holes 718, Fig. 8) configured to permit the at least one pin (engagement wires 704, Fig. 8) to extend therethrough,
the lock component (wire guide 706, Fig. 8) and the pin assembly (wire holder 702, Fig. 8) collectively forming an engagement region (Fig. 7) therebetween for engaging a portion of the valve prosthesis (stent-graft 800, Fig. 7), wherein
the pin assembly (wire holder 702, Fig. 8) is slidable distally relative to the lock component (wire guide 706, Fig. 8) to distally advance the at least one pin (engagement wires 704, Fig. 8) out of the engagement region (Fig. 7) to disengage the pin assembly (wire holder 702, Fig. 8) from the portion of the valve prosthesis (stent-graft 800, Fig. 7).
Rincon does not teach a valve prosthesis. However, Olson teaches a prosthetic heart valve (abstract, Olson)
teaches a delivery system (delivery system 6300, Fig. 63) for delivering a valve prosthesis (prosthetic valve 6370, Fig. 67).
It would have been obvious to one of ordinary skill in the pertinent art before the effective filing date of the claimed invention to modify the teachings of Rincon with the above teachings of Olson in order to frictionally secure native leaflets of a patient's heart valve against an exterior surface of a prosthetic valve when the patient's heart valve has been replaced by the prosthetic valve (¶0014, Olson).
Regarding claim 13, Rincon teaches
wherein the pin assembly (wire holder 702, Fig. 8) comprises a plurality of pins (engagement wires 704, Fig. 8) and the lock component (wire guide 706, Fig. 8) comprises a plurality of lock apertures (holes 718, Fig. 8) each corresponding to one of the plurality of pins (engagement wires 704, Fig. 8).
Regarding claim 14, Rincon teaches
wherein the pin assembly (wire holder 702, Fig. 8) comprises a tubular component (tubular configuration, 0072) coupled thereto and extending proximally beyond the lock component (wire guide 706, Fig. 8).
Regarding claim 15, Rincon teaches
wherein the annular component (wire holder 702 is annular in shape, Fig. 8) at least partially surrounds the core member (inner member hypotube 700, Fig. 8), and the at least one pin (engagement wires 704, Fig. 8) extends proximally from the annular component (wire holder 702 is annular in shape, Fig. 8).
Regarding claim 16, Rincon teaches
wherein the annular component (wire holder 702 is annular in shape, Fig. 8) of the pin assembly (wire holder 702, Fig. 8) comprises a cylindrical piston member (round component on wire holder 702, Fig. 8).
Regarding claim 17, Rincon teaches
wherein the piston member (right side portion of wire holder 702, Fig. 8) comprises opposing proximal and distal plates (Fig. 8), the proximal plate comprising at least one aperture (holes 716, Fig. 8) through which the at least one pin (engagement wires 704, Fig. 8) extends, wherein a portion of the at least one pin (engagement wires 704, Fig. 8) is interposed and engaged between the proximal and distal plates (Fig. 7).
Regarding claim 18, Rincon teaches a delivery system (¶0072, Rincon), the system comprising:
the valve anchor (stent-graft 800, Fig. 7) comprises a plurality of rounded base portions (intersections 314, Fig. 5) and
a plurality of anchoring legs (struts 312, Fig. 5) interconnected with and alternatingly interposed between the plurality of rounded base (intersections 314, Fig. 5), wherein
each of the anchoring legs (struts 312, Fig. 5) has a proximal end joined to a rounded base portion (intersections 314, Fig. 5) and a distal end having a connection aperture (eyelets 802, Fig. 9);
a core member (inner member hypotube 700, Fig. 8) having a proximal end portion (left side of Fig. 8), a distal end portion (right side of Fig. 8), and a longitudinal axis extending between the proximal and distal end portions (Fig. 8); and
an engagement mechanism (Fig. 8) coupled to the distal end portion of the core member (inner member hypotube 700, Fig. 8) for releasably engaging the valve prosthesis (stent-graft 800, Fig. 7), the engagement mechanism comprising:
a pin assembly (wire holder 702, Fig. 8) coupled to and movable along the core member (inner member hypotube 700, Fig. 8),
the pin assembly (wire holder 702, Fig. 8) comprising an annular component (wire holder 702 is annular in shape, Fig. 8) and at least one pin (engagement wires 704, Fig. 8) coupled to the annular component (wire holder 702 is annular in shape, Fig. 8) and extending in a direction away from the distal end portion (Fig. 8), the at least one pin being radially spaced apart from the core member (Fig. 8); and
a lock component (wire guide 706, Fig. 8) fixedly coupled to the core member (inner member hypotube 700, Fig. 8) proximal to the annular component (wire holder 702 is annular in shape, Fig. 8),
the lock component (wire guide 706, Fig. 8) comprising at least one lock aperture (holes 718, Fig. 8) configured to permit the at least one pin (engagement wires 704, Fig. 8) to extend therethrough,
the lock component (wire guide 706, Fig. 8) and the pin assembly (wire holder 702, Fig. 8) collectively forming an engagement region (Fig. 7) therebetween for engaging the connection aperture (eyelets 802, Fig. 9) of each of the anchoring legs, wherein
the pin assembly (wire holder 702, Fig. 8) is slidable distally relative to the core member (inner member hypotube 700, Fig. 8) and the lock component (wire guide 706, Fig. 8) to distally advance the at least one pin (engagement wires 704, Fig. 8) out of the engagement region to disengage the pin assembly (wire holder 702, Fig. 8) from the portion of the valve prosthesis (stent-graft 800, Fig. 7).
Rincon does not teach a valve prosthesis. However, Olson teaches
a valve prosthesis (prosthetic valve 6370, Fig. 67) comprising a valve anchor (stent 10, Fig. 63) and a support frame (cover 9804, Fig. 98) movably coupled to the valve anchor (stent 10, Fig. 63).
It would have been obvious to one of ordinary skill in the pertinent art before the effective filing date of the claimed invention to modify the teachings of Rincon with the above teachings of Olson in order to frictionally secure native leaflets of a patient's heart valve against an exterior surface of a prosthetic valve when the patient's heart valve has been replaced by the prosthetic valve (¶0014, Olson).
Regarding claim 19, Rincon
wherein the pin assembly (wire holder 702, Fig. 8) comprises a plurality of pins (engagement wires 704, Fig. 8) and the lock component (wire guide 706, Fig. 8) comprises a plurality of lock apertures (holes 718, Fig. 8) each corresponding to one of the plurality of pins (engagement wires 704, Fig. 8).
Regarding claim 20, Rincon
wherein the pin assembly (wire holder 702, Fig. 8) comprises a tubular component (tubular configuration, ¶0072) coupled thereto and extending proximally beyond the lock component (wire guide 706, Fig. 8).
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Claim(s) 6 and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rincon in view of Olson, and further in view of Forster et al. (US 8403981 B2) hereinafter, Forster.
Regarding claim 6, Rincon does not teach the pins is bent. However, Forster teaches prosthetic valve delivery devices (abstract)
wherein a distal end of each of the plurality of pins is bent (pin 130 is offset, Fig. 19D).
It would have been obvious to one of ordinary skill in the pertinent art before the effective filing date of the claimed invention to modify the teachings of Rincon and Olson with the above teachings of Forster in order to offset the deflection and to provide more even wrapping of the valve 30 (col. 17 lines 26-27, Forster).
Regarding claim 8, Rincon does not teach a pusher component. However, Forster teaches
further comprising a pusher component (attachment collar 111, Fig. 3A) slidable along the core member (pin shaft 134, Fig. 3A) and relative to the lock component (pin stabilizer 133, Fig. 3B).
It would have been obvious to one of ordinary skill in the pertinent art before the effective filing date of the claimed invention to modify the teachings of Rincon and Olson with the above teachings of Forster in order to aid the deployment mechanism.
Regarding claim 9, Rincon does not teach a pusher component. However, Forster teaches
wherein the pusher component (attachment collar 111, Fig. 3A) is movable along the core member (pin shaft 134, Fig. 3A) to contact the pin assembly (pin hub 132, Fig. 3B, col. 9 lines 11-14, Forster) and
cause disengagement of the valve prosthesis from the delivery system (col. 12 lines 23-32).
It would have been obvious to one of ordinary skill in the pertinent art before the effective filing date of the claimed invention to modify the teachings of Rincon and Olson with the above teachings of Forster in order to aid the deployment mechanism.
Regarding claim 10, Rincon does not teach a pusher component. However, Forster teaches
wherein the pusher component (attachment collar 111, Fig. 3A) comprises a shaft component (slotted tube 110, Fig. 3) configured to extend through the lock component (pin stabilizer 133, Fig. 3B) to facilitate movement of the pin assembly (pin hub 132, Fig. 3B).
It would have been obvious to one of ordinary skill in the pertinent art before the effective filing date of the claimed invention to modify the teachings of Rincon and Olson with the above teachings of Forster in order to aid the deployment mechanism.
Regarding claim 11, Rincon does not teach a pusher component. However, Forster teaches
wherein the pusher component (attachment collar 111, Fig. 3A) is configured to contact a tubular component (slotted tube 110, Fig. 3) of the pin assembly (pin hub 132, Fig. 3B) to facilitate movement of the pin assembly (pin hub 132, Fig. 3B, col. 11 lines 30-34, Forster).
It would have been obvious to one of ordinary skill in the pertinent art before the effective filing date of the claimed invention to modify the teachings of Rincon and Olson with the above teachings of Forster in order to aid the deployment mechanism.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims of the present application are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,020,226 as detailed below. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are broader than the patented claims and do not include all of the limitations of the patented claims, while the patented claims include all of the limitations of the claims of the present application:
Present Application
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Patent No. 11,020,226
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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.
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774