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 .
Allowable Subject Matter
Claims 1-8 are allowable over the prior art.
Claims 10-16 and 18 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.
The following is a statement of reasons for the indication of allowable subject matter: Most relevant prior art U.S. Patent Pub. No. 2007/0255207 to Hangai et al., U.S. Patent Pub. No. 2004/0210240 to Saint., U.S. Patent Pub. No. 2008/0243081 to Nance, and U.S. Patent No. 5,429,605 to Richling disclose an introducer sheath having an inner lubricious layer, an outer hear-settable layer, a coil core extending partially through the sheath, and an adjustable balloon capable of extending at an angle to the longitudinal axis of the sheath. A linear distal portion of the introducer sheath has a circumference around the longitudinal axis, and includes an indented portion around the entire circumference. The balloon has a deflated condition in which the balloon does not extend past either of the edges or the maximum outer diameter of the linear distal portion and an inflated condition in which the balloon extends coaxially past the maximum outer diameter of the linear distal portion around the circumference of the linear distal portion
The prior art fails to teach or disclose, however, the structural relationship including but not limited to wherein the coil core fails to extend into a linear distal portion of the sheath, and wherein the balloon in the inflated condition has a surface facing proximally that is angled with respect to the longitudinal axis at an angle between and including 60 to 90 degrees.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 9 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 12,011,151. This is a statutory double patenting rejection.
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 1-8, 17, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,071,535. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose an introducer sheath for insertion through the right atrial appendage into the pericardial cavity. The introducer sheath comprising an inner lubricious layer defining an internal lumen extending along a longitudinal axis of the sheath from a proximal end to a distal end of the sheath, an outer heat-settable layer surrounding the inner layer and extending from the proximal end to the distal end, a coil core fixed between the inner layer and the outer layer. The linear distal portion has a circumference around the longitudinal axis, and includes an indented portion around the entire circumference, the indented portion having proximal and distal edges an outer diameter less than a maximum outer diameter of the linear distal portion, and further comprising a balloon in the indented portion, the balloon having a deflated condition in which the balloon does not extend past either of the edges or the maximum outer diameter of the linear distal portion and an inflated condition in which the balloon extends coaxially past the maximum outer diameter of the linear distal portion around the circumference of the linear distal portion, and wherein the balloon in the inflated condition has a surface facing proximally that is angled with respect to the longitudinal axis at an angle between and including 60 to 90 degrees.
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 17 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2007/0255207 to Hangai et al. in view of U.S. Patent Pub. No. 2004/0210240 to Saint.
As to Claim 17, Hangai discloses a device combination (Figs. 1-4) for placing a belt in an atrioventricular groove of a patient to treat tricuspid valve regurgitation [0002, 0018]. The device comprises an introducer sheath (2) having a curved medial portion (capable of curve via flexible material described in [0053-0054]) and a linear distal portion (at 4, Figs. 1-4), the linear distal portion including an indented portion (at 5, Figs. 1-4) around the entire circumference (Figs. 1-4) and a balloon (5) in a deflated condition (Fig. 1) within the indented portion so that no part of the balloon extends beyond a maximum outer diameter of the linear distal portion (Fig. 1) or outside of the indented portion Fig. 1).
Hangai discloses the claimed invention except for a belt configured for placement in the atrioventricular groove to treat tricuspid valve regurgitation, the belt being passable through the introducer sheath.
Saint discloses a device combination for placing a belt in an atrioventricular groove of a patient to treat tricuspid valve regurgitation [0010] including a belt (20) configured for placement in the atrioventricular groove to treat tricuspid valve regurgitation [0038-0039], the belt being passable through an introducer sheath (90, [0043]) in order to provide a device and means for delivery to allow tightening of the device around the atrioventricular groove, reducing the radius of curvature to treat tricuspid valve regurgitation [0011].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device combination for placing a belt in an atrioventricular groove of a patient to treat tricuspid valve regurgitation of Hangai with the belt modification of Saint in order to provide a device and means for delivery to allow tightening of the device around the atrioventricular groove, reducing the radius of curvature to treat tricuspid valve regurgitation.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775