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 .
Response to Arguments
Amendment dated June 12, 2026 has overcome all outstanding issues other than the non-statutory double patenting rejection of claims 1-16. Please direct attention to rejection below.
Allowable Subject Matter
Claims 1-16 and 18-21 are allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter: Most relevant prior art including 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.
Most relevant prior art including U.S. Patent Pub. No. 2016/0166242 to Krishnan discloses a method of accessing a pericardial cavity of a patient with an introducer sheath. The method comprises inserting the introducer sheath into the inferior vena cava of the patient, the introducer sheath having a balloon in a deflated condition, moving the introducer sheath into the heart of the patient, passing the sheath through a wall of the heart to the pericardial cavity so that the balloon is within the pericardial cavity, inflating the balloon within the pericardial cavity, and engaging the balloon with tissue of the wall of the heart that faces the pericardial cavity.
The prior art fails to teach or disclose, however, wherein the introducer sheath has a curved medial portion and a linear distal portion, the linear distal portion including an indented portion around the entire circumference and a balloon in a deflated condition within the indented portion, wherein the inflating does not enlarge a hole through the right atrial appendage through which the sheath passes, passing an implant through the lumen and out of the opening at the distal end of the introducer sheath.
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 1-8 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.
Claims 9-16 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 a method of accessing a pericardial cavity of a patient via a right atrial appendage of the patient with an introducer sheath. The method comprises moving the introducer sheath to the right atrium of the heart of the patient to a position adjacent the right atrial appendage, the introducer sheath having a curved medial portion and a linear distal portion, the linear distal portion including an indented portion around the entire circumference and a balloon in a deflated condition within the indented portion so that no part of the balloon extends beyond a maximum outer diameter of the linear distal portion or outside of the indented portion, passing the sheath through the right atrial appendage to the pericardial cavity so that the indented portion is within the pericardial cavity; inflating the balloon within the pericardial cavity, wherein the inflating does not enlarge a hole through the right atrial appendage through which the sheath passes; and engaging the balloon with tissue of the right atrial appendage that faces the pericardial cavity.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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