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 .
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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Claims 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,263,107. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a method for treating a bifurcated vessel comprising providing first and second delivery catheters having first and second expandable members, respectively, a first stent having a side hole disposed over the first expandable member and wherein a portion of the second elongate shaft of the second delivery catheter is disposed under the first stent, radially expanding a first portion of the first expandable member to expand a corresponding first portion of the first stent while maintaining a second portion of the first stent in a crimped configuration, radially contracting the first portion of the first expandable member to form a gap, and slidably moving the second elongate shaft relative to the first elongate shaft through the gap and side hole while the second portion of the first stent remains crimped. The difference between claims of the instant application and the claims of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,364,356. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a method for treating a bifurcated vessel comprising providing first and second delivery catheters having first and second expandable members, respectively, a first stent having a side hole disposed over the first expandable member and wherein a portion of the second elongate shaft of the second delivery catheter is disposed under the first stent, radially expanding a first portion of the first expandable member to expand a corresponding first portion of the first stent while maintaining a second portion of the first stent in a crimped configuration, radially contracting the first portion of the first expandable member to form a gap, and slidably moving the second elongate shaft relative to the first elongate shaft through the gap and side hole while the second portion of the first stent remains crimped. The difference between claims of the instant application and the claims of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Allowable Subject Matter
Claims 1-19 are allowed.
Claims 20-22 would be allowable if rewritten or amended to overcome the rejection(s) on the ground of nonstatutory double patenting or if a terminal disclaimer is filed.
The following is an examiner’s statement of reasons for allowance:
Regarding claims 1-19, the prior art fails to teach and/or disclose a method for treating a bifurcated vessel comprising first and second delivery catheters with first and second expandable members, respectively, for delivering first stent having a side hole therethrough and a second stent, as claimed, particularly wherein a proximal portion of the second expandable member is disposed under a proximal portion of the first stent and a distal portion of the second expandable member is disposed under the second stent, and comprising the steps of: “partially radially expanding the second expandable member to expand only the proximal portion of the first stent while maintaining a distal portion of the first stent crimped to the first expandable member”, “forming a gap between an inside surface of the proximal portion of the first stent and an outer surface of the second elongate shaft”, “slidably moving the second elongate shaft under the first stent and through the side hole while the distal portion of the first stent remains crimped to the first delivery catheter”, and “expanding the second stent into engagement with a portion of the bifurcated vessel”. See for example Figures 50A-C and para [0189-0191] of the specification as filed.
Of the closest prior art, Hilaire et al. (US 2005/0085845) disclose a system for treating a bifurcated vessel and teach first and second delivery catheters (102, 104) having first and second respective expandable members (130, 132) for delivering an expandable stent (170), wherein the stent is disposed over the first expandable member (130) of the first catheter, the stent has a side hole (172) through which the second delivery catheter (104) passes through (Figs 3-4; para [0075-0078]). However, Hilaire teaches the first expandable (130) member is first inflated to expand and seat the main portion of the stent (170) within the vessel, the first expandable member is deflated, and subsequently the second expandable member (132) is inflated to expand the side opening (172), or alternatively, the expandable members are simultaneously expanded (Figs 3-4; para [0075-0078]). In an alternative embodiment (Figs 5 and 10-13; para [0079-0080, 0091-0095]), Hilaire teaches a second stent (178) disposed on the second expandable member (132). However, in this embodiment, the second expandable member (132) is disposed proximally of the first stent and second expandable member does not have a proximal portion disposed under a proximal portion of the first stent (170) as claimed. Hilaire fails to disclose the partial radial expansion of the second expandable member to radially expand only the proximal portion of the first stent without radially expanding a second stent, while a distal portion of the first stent remains crimped to the first expandable member, and wherein the partial radial expansion of the second radial member forms a gap between an inside surface of the proximal portion of the first stent and an outer surface of the second catheter thereby permitting relative slidable movement, in combination with the other claimed features.
Vardi et al. (US 6,325,826) discloses a system for treating a bifurcated vessel (Figs 13A-H; col 11, ln 26 – col 12, ln 4) comprising first delivery catheters (400) with a first expandable members (402) having a first stent (100) disposed thereon and a second guidewire (GW2) extending through the side opening (102) of the first stent (Fig 13B). The proximal portion of the first expandable member is first inflated to expand only the proximal portion of the first stent (Fig 13C) to form a gap and allow a sheath (404) of a second catheter to be advanced over the second guidewire while a distal portion of the first stent remains crimped to the first expandable member. However, Vardi fails to disclose partial radial expansion of the second expandable member to radially expand only the proximal portion of the first stent without radially expanding a second stent, while a distal portion of the first stent remains crimped to the first expandable member, and wherein the partial radial expansion of the second radial member forms a gap between an inside surface of the proximal portion of the first stent and an outer surface of the second catheter thereby permitting relative slidable movement, in combination with the other claimed features.
Additional prior art of note that teach systems for treating a bifurcated vessels include: Dibie (US 2010/0222861) - Figs 5A-F, Jennings et al. (US 2009/0299454) – Figs 1-5, and Krever et al. (US 2007/0219611) – Fig 5B. However, similar to the above art, Dibie, Jennings, and Krever each fail to disclose the partial radial expansion of the second expandable member to radially expand only the proximal portion of the first stent without radially expanding a second stent, while a distal portion of the first stent remains crimped to the first expandable member, and wherein the partial radial expansion of the second radial member forms a gap between an inside surface of the proximal portion of the first stent and an outer surface of the second catheter thereby permitting relative slidable movement, in combination with the other claimed features.
Regarding claims 20-21, the prior art fails to teach or disclose a method for treating a bifurcated vessel, as claimed, particularly the steps of (1) radially expanding a first portion of the extended length first expandable member of the first delivery catheter to expand a corresponding first portion of the first stent while maintaining a second portion of the first stent in a crimped configuration, (2) radially contracting the first portion of the extended length first expandable member to form a gap between an inside surface of the expanded portion of the first stent and the outer surfaces of the first and second elongate shafts while maintaining the second portion of the first stent crimped, and (3) slidably moving the second elongate shaft relative to the first elongate shaft and through the gap and through the side hole in the first stent while the second portion of the first stent remains crimped.
Of the closest prior art, Vardi (US 6,325,826) discloses a method of treating a bifurcation (Figs 13A-H; col 11, lines 26-67) comprising the steps of radially expanding only a first portion of a first expandable member to expand only a first portion of a first stent disposed over the first expandable member while a second portion of the stent remains crimped to the first elongate shaft (Figs 13A-C) and slidably moving a second elongate shaft relative to the first elongate shaft under a portion of the first stent to pass through a side hole in the first stent while a second portion of the first stent remains crimped to the first delivery catheter thereby preventing movement of the first stent relative to the first delivery catheter. In particular, Vardi teaches partial expansion of the first balloon provides a partial opening for advancing the second elongate member (col 11, lines 49-55). However, Vardi fails to positively teach the additional method step of radially contracting the first expandable member to form a gap while maintaining the second portion of the first stent crimped and before slidably moving the second elongate shaft relative to the first elongate shaft through the side hole in the first stent, as claimed.
Hilaire (US 2005/0085845) additionally teaches a similar method of treating a bifurcation (Figs 10-13; para [0091-0095]) comprising the steps of (1) radially expanding a first expandable member to expand a first stent disposed over the first expandable member (Fig 11), (2) radially contracting the first expandable member to form a gap between an inside surface of the first stent and an outer surface of the first elongate shaft and an outer surface of the second elongate shaft, and (3) slidably moving the second elongate shaft relative to the first elongate shaft under a portion of the first stent to pass through a side hole in the first stent. However, Hilaire teaches expanding the entire first expandable member to expand the entire length of the first stent prior to collapsing the first expandable member, forming the gap, and slidably moving the second elongate shaft through the side hole in the first stent. Hilaire fails to teach a portion of the first stent remains crimped to the first delivery catheter, as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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
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