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 .
Election/Restrictions
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/8/26.
Applicant’s election without traverse of Group II in the reply filed on 5/8/26 is acknowledged.
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 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,058,412.
Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose a method and suture delivery device for delivering a suture through soft tissue, comprising: a first and second needle, a flexible loop member deployed outside of the distalmost tip of the first needle, the second needle intersecting the flexible loop member when in the deployed configuration to allow the flexible loop to grasp a suture, the suture being slidably positioned along the second needle and aligned with the flexible loop member.
Claim 15 is rejected over claim 16 of U.S. Patent No. 11,058,412 as they both disclose a method for puncturing a distal end of a suture delivery device through tissue, the suture delivery device comprising: a first elongated needle extending from a handle, the first elongated needle being hollow and having a proximal, straight section attached to the handle and a distal, curved section with a sharpened distalmost tip; a flexible loop member being movable between a retracted position inside the first elongated needle and a deployed position outside of the distalmost tip of the first elongated needle; a second elongated needle extending from the handle and being movable between a first position outside the loop member and a second position where a distal end of the second needle intersects the loop member when the loop member is in the deployed position, wherein the distal end of the second elongated needle is aligned to allow the loop member to grasp the second elongated needle when the second elongated needle is in the second position; a suture slidably positioned along the second elongated needle for aligning the suture within the loop member; and deploying the flexible loop member from the first elongated needle, the flexible loop member thereby forming the deployed position; advancing the second elongated needle from the first position to the second position such that the distal end of the second needle intersects the loop member; advancing the suture to extend at least substantially through the flexible loop member; and retracting the flexible loop member thereby grasping and securing the suture within the retracted flexible loop member, or conforming around a part of the suture.
Claim 16 is rejected over claim 16 of U.S. Patent No. 11,058,412 which discloses retracting the second elongated needle to the first position.
Claim 17 is rejected over claim 17 of U.S. Patent No. 11,058,412 which discloses wherein puncturing the distal end of the device comprises puncturing the tissue with a distal end of the first elongated needle.
Claim 18 is rejected over claim 18 of U.S. Patent No. 11,058,412 which discloses wherein advancing the second elongated needle into the second position comprises puncturing the tissue with the second elongated needle.
Claim 19 is rejected over claim 19 of U.S. Patent No. 11,058,412 which discloses pulling the device in a proximal direction thereby looping the suture through the tissue to form a part of a stitch.
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.
Claim(s) 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marshall et al. US 2010/0228271.
Regarding claim 15, Marshall et al. discloses a method comprising: puncturing a distal end of a suture delivery device 100 through tissue 5 (figure 10), the suture delivery device comprising:
a first elongated needle 115 extending from a handle (figure 10, at proximal end of device), the first elongated needle being hollow (to receive elongate body 140 and loop 130, figure 9)and having a proximal, straight section attached to the handle and a distal, curved section with a sharpened distalmost tip 120 (shown in figure 10 as a straight needle on the proximal section and distal section, however, other directional orientations are contemplated and may be selected based on a patient’s anatomy, including curved distal sections, for example curved needles with a curved distal section shown in figure 107, paragraph 0084; needles 105 or 115 may be straight, as shown, or curved as desired; paragraph 0097);
a flexible loop member (loop 130 of snare 125, figure 10) being movable between a retracted position inside the first elongated needle (figures 6-9, paragraph 0042) and a deployed position outside of the distalmost tip of the first elongated needle (figure 10, paragraph 0042-0043, snare 125 and loop 130 is advanced out of needle 115 into an extended position);
a second elongated needle 105 extending from the handle (figure 10) and being movable between a first position outside the loop member (figures 7, 9) and a second position where a distal end of the second needle intersects the loop member when the loop member is in the deployed position (figure 10, paragraph 0043), wherein the distal end of the second elongated needle is aligned to allow the loop member to grasp the second elongated needle when the second elongated needle is in the second position (figure 10, loop 130 around needle 105);
a suture 145 slidably positioned along the second elongated needle for aligning the suture within the loop member (figures 10-12, paragraph 0044); and
deploying the flexible loop member 130 from the first elongated needle (figure 10, paragraph 0042), the flexible loop member thereby forming the deployed position (figure 9); advancing the second elongated needle 105 from the first position (figures 7, 9) to the second position such that the distal end of the second needle 105 intersects the loop member 130 (figure 10);
advancing the suture 145 to extend at least substantially through the flexible loop member (figure 10, paragraph 0043); and
retracting the flexible loop member thereby grasping and securing the suture within the retracted flexible loop member (paragraph 0046).
Regarding claim 16, Marshall et al. discloses retracting the second elongated needle 105 to the first position (figure 12, paragraph 0044, needle 105 is withdrawn leaving suture through loop 130 of snare 125).
Regarding claim 17, Marshall et al. discloses wherein puncturing the distal end of the device comprises puncturing the tissue with a distal end of the first elongated needle (figures 5 and 6, distal tip 120 pierces tissue 5, paragraph 0041).
Regarding claim 18, Marshall et al. discloses wherein advancing the second elongated needle into the second position comprises puncturing the tissue with the second elongated needle (figure 5, needle distal tip 110 pierces through tissue 5, paragraph 0040).
Regarding claim 19, Marshall et al. discloses pulling the device in a proximal direction thereby looping the suture through the tissue to form a part of a stitch (figures 15, 16 suture tightened to repair tissue and held with knot, paragraph 0048-0049).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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