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 .
Claim Objections
Claim 1 objected to because of the following informalities: Claim 1 recites “in proximal-distal direction” in line 7 which should read “in a proximal-distal direction”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 12 is 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.
Claim 12 recites the limitation "the second handle" in in line 1. There is insufficient antecedent basis for this limitation in the claim.
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. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 1, U.S. Patent No. 12,121,461 B2 claims a method for delivering a prosthetic heart valve to a heart of a patient using a catheter system (catheter system configured to deliver a prosthetic heart valve; claim 1, lines 1-3), the method comprising: inserting an introducer comprising a sheath into the patient (claim 1, line 14); a delivery catheter configured to deliver the prosthetic heart valve and having a proximal end and a distal end (claim 1, lines 2-4), the distal end comprising a tip that includes a first sleeve movable relative to a second sleeve in proximal-distal direction, a middle section configured to be uncovered when the first sleeve is in a proximal-most position with respect to the second sleeve, and a holder disposed in the second sleeve, the second sleeve positioned proximal to the first sleeve and the first sleeve having an open end facing in a proximal direction (claim 1, lines 4-13); manipulating an integrated handle to cause a steering catheter to deflect to steer the delivery catheter (the integrated handle configured to control movement of the steering catheter configured to be deflected to steer the delivery catheter; claim 1, lines 15-16, 20-23), the integrated handle comprising a delivery handle portion and a steering handle portion comprising a housing, the housing of the steering handle portion sized and configured to receive the delivery handle portion, the integrated handle configured to control movement of the delivery catheter and the steering catheter, independently (claim 1, lines 17-23); and causing an actuator movably coupled to the delivery handle portion and configured to move with respect to the delivery handle portion to move to manipulate the first sleeve relative to the second sleeve and the holder while the delivery handle portion is received by the housing of the steering handle portion (claim 1, lines 24-29), wherein the steering catheter is fixedly connected to the steering handle portion and the delivery catheter is fixedly connected to the delivery handle portion (claim 1, lines 30-32), and wherein the steering catheter and the delivery catheter are selectively coaxially and rotationally independently movable (claim 1, lines 33-35).
U.S. Patent No. 12,121,461 B2 fails to explicitly claim advancing a delivery catheter and a steering catheter in the introducer.
However, Zhang teaches a method for delivering a prosthetic heart valve (valve prosthesis) to a heart of a patient using a catheter system (implantation device 600; Figs. 23, 24A-H), the method comprising: inserting an introducer (introducer 134) comprising a sheath into a patient (Fig. 23; [0287); and advancing a delivery catheter (including at least first sheath 620, second sheath 610, and control cable 655; Figs. 24A-24F) and a steering member (guidewire 601; Figs. 24A-24F) in the introducer (Figs. 23, 24A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of U.S. Patent No. 12,121,461 B2 to advance the delivery catheter and the steering catheter in the introducer in light of the teachings of Zhang in order to provide an access path to the treatment site.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 2, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the steering catheter comprises a control wire configured to deflect the steering catheter to steer the delivery catheter (claim 2, lines 1-3).
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 3, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the sheath is extendable through a vascular duct and comprises a crimping section (claim 3, lines 1-3).
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 4, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the first sleeve is configured to secure a distal end of the prosthetic heart valve to the delivery catheter and the second sleeve is configured to secure a proximal end of the prosthetic heart valve to the delivery catheter, and wherein at least a portion of the prosthetic heart valve is disposed in the middle section of the tip and not covered by the first sleeve or the second sleeve prior to movement of the first sleeve during deployment of the prosthetic heart valve (claim 4, lines 1-10).
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 5, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein a diameter of the prosthetic heart valve varies over a length of the prosthetic heart valve when the prosthetic heart valve is secured to the delivery catheter (claim 5, lines 1-4).
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 6, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein an inner diameter of the sheath is less than 24 French (claim 8, lines 1-2).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 7, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the sheath has a pre-shaped, curved configuration (claim 9, lines 1-2).
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 8, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the sheath comprises a flexible polymer, a hydrophilic coating, a PTFE liner, coil reinforcement, braid reinforcement, or a combination thereof (claim 10, lines 1-4).
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 9, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the delivery catheter comprises a holding tube, and the prosthetic heart valve is secured to the delivery catheter by the holding tube (claim 6, lines 1-4).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 10, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein a distal end or a proximal end of the prosthetic heart valve comprises a male connector, and the delivery catheter comprises a female connector complimentary to the male connector of the prosthetic heart valve (claim 7, lines 1-5).
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 11, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the delivery handle portion comprises a first handle configured to control movement of the delivery catheter and the steering handle portion comprises a second handle configured to control movement of the steering catheter (claim 11, lines 1-5).
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 12, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the second handle of the steering catheter comprises a second actuator to deflect a shaft of the delivery catheter from a relaxed configuration into a curved configuration (claim 12, lines 1-4).
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 13, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the steering catheter, the delivery catheter, and the sheath are circumferentially independently movable when the steering catheter and the delivery catheter are simultaneously disposed in the sheath (claim 13, lines 1-5).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12,121,461 B2 in view of Zhang (US 2010/0249918 A1).
Regarding claim 14, U.S. Patent No. 12,121,461 B2 modified claims the invention above, and U.S. Patent No. 12,121,461 B2 further claims wherein the delivery catheter and the steering catheter are simultaneously introducible into the sheath (claim 14, lines 1-3).
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 12,121,461 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 15, U.S. Patent No. 12,121,461 B2 claims a method for delivering a prosthetic heart valve to a heart of a patient using a catheter system (catheter system comprising a delivery catheter configured to deliver a prosthetic heart valve; claim 15, lines 1-2), the method comprising: inserting an introducer comprising a sheath and a crimping section proximal to a sheath into the patient, the crimping section having an inner diameter that decreases in a distal direction (claim 15, lines 13-15); advancing a delivery catheter and a steering catheter in the introducer (the steering catheter and the delivery catheter are simultaneously introducible into the introducer; claim 15, lines 30-32), the delivery catheter configured to deliver the prosthetic heart valve and having a proximal end and a distal end (claim 15, lines 2-4), the distal end comprising a tip that includes a first sleeve movable relative to a second sleeve in a proximal-distal direction (claim 15, lines 4-6), and a holder disposed in the second sleeve (claim 15, lines 9-10), the second sleeve positioned proximal to the first sleeve and the first sleeve having an open end facing in a proximal direction (claim 15, lines 7-9), manipulating an integrated handle to cause a steering catheter to deflect to steer the delivery catheter (the integrated handle configured to control movement of the delivery catheter and the steering catheter and the steering catheter configured to be deflected to steer the delivery catheter; claim 15, lines 11-12, 21-23), the integrated handle comprising a delivery handle portion fixedly connected to the delivery catheter and a steering handle portion comprising a housing fixedly connected to the steering catheter (claim 15, lines 16-19), the housing of the steering handle portion sized and configured to receive the delivery handle portion, and the integrated handle configured to control movement of the delivery catheter and the steering catheter, independently (claim 15, lines 19-23); and causing an actuator movably coupled to the delivery handle portion and configured to move with respect to the delivery handle portion to move to manipulate the first sleeve relative to the second sleeve and the holder while the delivery handle portion is received by the housing of the steering handle portion (claim 15, lines 24-29), wherein the delivery catheter and the steering catheter are simultaneously introducible into the crimping section of the introducer (claim 15, lines 30-32); and wherein the steering catheter, the delivery catheter, and the sheath are rotationally independently movable when the steering catheter and the delivery catheter are simultaneously disposed in the sheath (claim 15, lines 33-36).
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 12,121,461 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 16, U.S. Patent No. 12,121,461 B2 claims wherein a middle section of the tip is uncovered when the first sleeve is in a proximal-most position with respect to the second sleeve (claim 16, lines 1-4).
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,121,461 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 17, U.S. Patent No. 12,121,461 B2 claims wherein the first sleeve secures a distal end of the prosthetic heart valve to the delivery catheter and the second sleeve secures a proximal end of the prosthetic heart valve to the delivery catheter, and wherein at least a portion of the prosthetic heart valve is disposed in the middle section of the tip (claim 17, lines 2-7).
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 12,121,461 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 18, U.S. Patent No. 12,121,461 B2 claims wherein at least one of the distal end or the proximal end of the prosthetic heart valve comprises a first connector, and the delivery catheter comprises a second connector complimentary to the first connector (claim 18, lines 1-5).
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 12,121,461 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 19, U.S. Patent No. 12,121,461 B2 claims wherein the first connector comprises eyelets, and the second connector comprises recesses (claim 19, lines 1-3).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 12,121,461 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 20, U.S. Patent No. 12,121,461 B2 claims wherein a central segment of the prosthetic heart valve is compressed from a first diameter to a second diameter smaller than the first diameter when the delivery catheter passes through the crimping section (claim 20, lines 1-5).
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12,121,461 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 21, U.S. Patent No. 12,121,461 B2 claims wherein a proximal end of the sheath comprises a hemostasis valve (claim 21, lines 1-2).
Prior Art
The closest prior art of record, Zhang (US 2010/0249918 A1), Rosenman et al. (US 2006/0135961 A1), Daum (US 6,572593 B1), and Deem et al. (US 2013/0231735 A1), does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of independent claims 1 and 15, which recite, inter alia “causing an actuator movably coupled to the delivery handle portion and configured to move with respect to the delivery handle portion to move to manipulate the first sleeve relative to the second sleeve and the holder while the delivery handle portion is received by the housing of the steering handle portion”.
Zhang discloses a method for delivering a prosthetic heart valve (support frame 625) to a heart of a patient using a catheter system (implantation device 600; Figs. 24A-24H), the method comprising: inserting an introducer (introducer 134) comprising a sheath into a patient (Fig. 23); advancing a delivery catheter (600) and a steering member (guidewire 601) in the introducer (Figs. 23, 24A), the delivery catheter configured to deliver the prosthetic heart valve and having a proximal end and a distal end (Fig. 24A), the distal end comprising a tip that includes a first sleeve (second sheath 610) movable relative to a second sleeve (first sheath 620) in a proximal-distal direction (Figs. 24A-24H), a middle section (between 610, 620) configured to be uncovered when the first sleeve is in a proximal-most position with respect to the second sleeve (Fig. 24A), wherein the first and second sleeves are movably coupled to a delivery handle (control unit 670) via first and second controller switches ([0288]-[0289]) but fails to disclose a holder within the second sleeve, a steering catheter, and manipulating an integrated handle to cause the steering catheter to deflect to steer the delivery catheter, the integrated handle comprising a delivery handle portion and a steering handle portion comprising a housing, the housing of the steering handle portion sized and configured to receive the delivery handle portion, the integrated handle configured to control movement of the delivery catheter and the steering catheter, independently; and causing an actuator movably coupled to the delivery handle portion and configured to move with respect to the delivery handle portion to move to manipulate the first sleeve relative to the second sleeve and the holder while the delivery handle portion is received by the housing of the steering handle portion, wherein the steering catheter is fixedly connected to the steering handle portion and the delivery catheter is fixedly connected to the delivery handle portion, and wherein the steering catheter and the delivery catheter are selectively coaxially and rotationally independently movable.
Rosenman teaches a steering handle portion (handle 3) in which a device such as that taught by Zhang can be inserted to steer the device at the appropriate treatment site ([0035]). Rosenman is silent to the device being a delivery catheter with a holder as claimed.
Daum teaches an integrated handle (Figs. 6-7) comprising first and second handle portions (cannula handle 51 and catheter handle 56) that can be connected to one another to form a single handle unit (Figs. 6-7) but is silent to actuators on the handle as claimed.
Deem teaches a delivery catheter (catheter 102; Figs. 11-14) for a prosthetic heart valve (prosthetic device 150) with first and second sleeves (distal sheath 270 and proximal sheath 272) and a holder (holder 360) disposed in the second sleeve (272; Figs. 12-14), but fails to disclose the actuator, integrated handle, and/or steering catheter as claimed.
It would not have been obvious to one of ordinary skill in the art to modify Zhang with all of the additional parts of Rosenman, Daum, and/or Deem without a substantially reconstruction and redesign of the elements shown in Zhang. Further, such a modification would fail to result in the method step of causing an actuator movably coupled to the delivery handle portion and configured to move with respect to the delivery handle portion to move to manipulate the first sleeve relative to the second sleeve and the holder while the delivery handle portion is received by the housing of the steering handle portion, as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771