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 .
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.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,925,045 in view of Alkhatib (US 2010/0191326).
Regarding the application claim 1, the patent claim 1 recites: a system for performing a therapeutic procedure on a defective heart valve (patent claim 1, lines 1-2), the system comprising: a prosthetic heart valve including a stent frame and a valve structure coupled to the stent frame, the stent frame having a radially compressed condition and a radially expanded condition (patent claim 1, lines 3-6); and a delivery device comprising: a capsule configured to maintain the stent frame in the radially compressed condition (patent claim 1, lines 16-18 and 22-24); an inner shaft disposed within the capsule (patent claim 1, lines 9-10 and 22-24); a valve retainer coupled to the inner shaft (patent claim 1, lines 11-12); and a tether (patent claim 1, lines 19-20); wherein the system is configured to transition between: a delivery state in which the prosthetic heart valve is maintained over the inner shaft in the radially compressed condition by the capsule (patent claim 1, lines 22-24) and the tether is connected to the stent frame (patent claim 1, lines 24-25); a partial deployment state in which the capsule is withdrawn from the prosthetic heart valve and the tether remains engaged with the stent frame and the stent frame expands toward the expanded condition with a portion of the stent frame connected to the delivery device via the tether (patent claim 1, lines 27-33); and a full deployment state in which the plurality of tethers are released from the stent frame (patent claim 1, lines 44-45).
The patent claim 1 fails to recite that the tether is a plurality of tethers.
However, Alkhatib discloses securing a frame of the prosthetic heart valve to a delivery device using a plurality of tethers as described below.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Alkhatib to have modified the method of the patent claim 1 to use a plurality of tethers as claimed in order to provide additional securement of the prosthetic heart valve to the delivery device.
The patent claim 1 fails to recite that the stent frame is enabled to expand to the radially expanded condition in the full deployment state upon release of the tethers as claimed.
Alkhatib discloses expanding prosthetic heart valve to a radially expanded condition when transitioning a prosthetic heart valve to a full deployment state upon release of tethers in order to secure the prosthetic heart valve to a deployment site (¶[0070]; also see 35 U.S.C. 102 rejection below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Alkhatib to have allowed the stent to radially expand upon release of the tethers in order to better secure the prosthetic heart valve to a deployment site.
Claims 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 10-12, respectively, of U.S. Patent No. 10,869,761 in view of Alkhatib (US 2010/0191326).
Regarding the application claim 14, the patent claim 1 recites: a method of performing a therapeutic procedure on a defective heart valve of a patient (patent claim 1, lines 1-2), the method comprising: delivering a system in a delivery state through the patient's vasculature to a location of the defective heart valve (patent claim 1, lines 3 and 15-17), the system including a prosthetic heart valve loaded into a delivery device (patent claim 1, lines 3-4), the prosthetic heart valve including a stent frame and a valve structure coupled to the stent frame (patent claim 1, lines 5-6), the delivery device including an inner shaft, an outer sheath forming a capsule, and a tethers coupling the prosthetic heart valve device to the delivery device (patent claim 1, lines 9-13); transitioning the system to a partial deployment state by proximally retracting the capsule from the prosthetic heart valve, the partial deployment state including the prosthetic heart valve expanding from the compressed condition toward a natural, expanded condition and remaining connected to the delivery device via the tether (patent claim 1, lines 19-24); altering tension in the plurality of tethers to enable a corresponding region of the stent frame to expand toward the expanded condition (patent claim 1, lines 25-27); transitioning the system to a full deployment state, including transitioning the stent frame to the expanded condition, by releasing the tether from the stent frame (patent claim 1, lines 8-9).
The patent claim 1 fails to recite that the tether is a plurality of tethers.
However, Alkhatib discloses securing a frame of the prosthetic heart valve to a delivery device using a plurality of tethers as described below.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Alkhatib to have modified the method of the patent claim 1 to use a plurality of tethers as claimed in order to provide additional securement of the prosthetic heart valve to the delivery device.
The patent claim 1 fails to recite that the stent frame is expanded in the full deployment state as claimed.
Alkhatib discloses expanding a stent frame (210) when transitioning a prosthetic heart valve to a full deployment state in order to secure the prosthetic heart valve to a deployment site (¶[0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Alkhatib to have expanded the frame of the patent claim 1 when transitioning into the full deployment state as claimed in order to better secure the prosthetic heart valve to a deployment site.
Regarding the application claims 15-20, the patent claims 2-4 and 10-12 recite the limitations as claimed, respectively.
Claim Rejections - 35 USC § 102
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, 7 and 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alkhatib (US 2010/0191326).
Regarding claim 1, Alkhatib discloses system (Figures 15-20) for performing a therapeutic procedure on a defective heart valve, the system comprising: a prosthetic heart valve (200) including a stent frame (210) and a valve structure (220) coupled to the stent frame, the stent frame having a radially compressed condition (Figures 13 and 16) and a radially expanded condition (Figures 17-20); and a delivery device (10) comprising: a capsule (120) configured to maintain the stent frame in the radially compressed condition (¶[0075]); an inner shaft (50) disposed within the capsule; a valve retainer (140; ¶[0090]; Figure 18) coupled to the inner shaft; and a plurality of tethers (130); wherein the system is configured to transition between: a delivery state in which the prosthetic heart valve is maintained over the inner shaft in the radially compressed condition by the capsule (Figure 13) and the plurality of tethers are connected to the stent frame (via posts 218); a partial deployment state in which the capsule is withdrawn from the prosthetic heart valve and the plurality of tethers remain engaged with the stent frame (Figure 18; ¶[0078]) and the stent frame expands toward the expanded condition with a portion of the stent frame connected to the delivery device via the plurality of tethers; and a full deployment state (Figure 19) in which the plurality of tethers are released from the stent frame to enable the stent frame to expand to the radially expanded condition (¶[0078], [0080]).
Regarding claim 7, each of the tethers extends through a corresponding crown of the stent frame at a distal end of the stent frame (Figure 17; each v-shaped member of section 216 or all of section 216 can be considered as a crown as claimed).
Regarding claim 9, Alkhatib discloses that the stent frame includes a plurality of posts (211) extending from a proximal end of the stent frame, the posts configured to be received by the valve retainer in the delivery state (¶[0090]).
Regarding claim 10, the system further comprises support arms (214) coupled to the stent frame, wherein the support arms are disposed within the capsule in the delivery state.
Regarding claim 11, the system further includes an initial deployment state (¶[0078]) wherein the capsule has been proximally retracted relative to the stent frame past the support arms such that the support arms self-expand (¶[0070], [0075], [0081]) radially outwardly relative to the stent frame.
Regarding claim 12, support arms (214) coupled to the stent frame, wherein the support arms are disposed within the capsule in the delivery state (Figure 16).
Regarding claim 13, the system further includes an initial deployment state wherein the capsule has been proximally retracted relative to the stent frame past the support arms such that the support arms self-expand to radially outwardly relative to the stent frame while the plurality of tethers prevent or impede self-expansion of the stent frame distal of the capsule (¶[0078]).
Regarding claim 14, Alkhatib discloses a method of performing a therapeutic procedure on a defective heart valve of a patient, the method comprising: delivering a system (10) in a delivery state through the patient's vasculature (¶[0004], [0005], [0059]) to a location of the defective heart valve (¶[0060]), the system including a prosthetic heart valve (200) loaded into a delivery device, the prosthetic heart valve including a stent frame (210) and a valve structure (220) coupled to the stent frame, the delivery device including an inner shaft (50), an outer sheath (120) forming a capsule (it encapsulates the heart valve), and a plurality of tethers (130 or 500) coupling the prosthetic heart valve device to the delivery device; transitioning the system to a partial deployment state by proximally retracting the capsule from the prosthetic heart valve, the partial deployment state including the prosthetic heart valve expanding from the compressed condition toward a natural, expanded condition and remaining connected to the delivery device via the plurality of tethers (¶[0078], [0100], [0101]; Figure 17); altering tension in the plurality of tethers to enable a corresponding region of the stent frame to expand toward the expanded condition; transitioning the system to a full deployment state, including transitioning the stent frame to the expanded condition, by releasing the plurality of tethers from the stent frame (¶[0078], [0080]; Figure 20).
Regarding claim 15, prior to the step of transitioning the system to a full deployment state, the method comprises increasing tension in the plurality of tether to partially re-collapse a corresponding region of the stent frame (¶[0078]).
Regarding claim 16, the stent frame is a self-expanding stent frame configured to self-expand from the compressed condition to the expanded condition (¶[0070], [0075], [0081]).
Regarding claim 17, the plurality of tethers (500) are connected to the proximal side of the stent frame in the delivery and partial deployment states (Figure 28).
Regarding claim 18, the delivery device further includes a valve retainer (140; Figure 18) carried by the inner shaft, the valve retainer configured to selectively receive a component of the stent frame (¶[0090]; Figure 22) and forming a capture feature (146; ¶[0091]) configured to selectively maintain the plurality of tethers in the delivery and partial deployment states.
Regarding claim 19, the step of transitioning the system to the partial deployment state includes locating a distal end of the capsule longitudinally between the prosthetic heart valve and the valve retainer (¶[0078]; Figure 17).
Regarding claim 20, the step of transitioning the system to the full deployment state includes locating the distal end of the capsule proximal of the capture feature of the valve retainer (¶[0078]; Figure 20).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib (US 2010/0191326) in view of Hill et al. (US 2008/0319526).
Regarding claim 8, Alkhatib fails to disclose that each of the crowns at the distal end of the stent frame includes an eyelet, and wherein the each of the tethers extends through a corresponding eyelet. Alkhatib discloses that alternative means may be used to secure the prosthetic heart valve to the delivery device (¶[0007]) and that the prosthetic valve may have a variety of different designs (¶[0080]).
Hill et al. disclose a similar system (Figure 5A) for performing a therapeutic procedure on a defective heart valve (Abstract) and further teaches that tethers (406) used to secure a prosthetic valve to a delivery device may extend through eyelets at the distal end of a frame (at 430 in Figure 4 - ¶[0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Hill et al. to have secured the tethers through eyelets on the distal crowns of the frame in order to provide a more secure attachment of the frame and allow controlled release of the distal end of the frame.
Allowable Subject Matter
Claims 2-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771