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
Applicant’s election without traverse of single-shaft fastener species a1 (Fig. 1A) and tool species a (Fig. 3A) in the reply filed on May 27, 2026 is acknowledged. Claims 1-6, 8, 11, 13-16 and 18 have been examined on the merits and claims 81-82, 84, 87, 98, 104, and 106-107 have been withdrawn from further consideration because they are directed to non-elected invention.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12447004.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claims of the present application and the patented claim is that the patented claim includes more elements and is thus more specific. Thus, the invention of the patented claim is in effect a “species” of the “generic” invention of the claims of the present application. It has been held that the generic invention is “anticipated” by the “species.” See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claims of the present application are anticipated by the patented claim, it is not patentably distinct from the patented claim.
Claims 2-6, 8, 11 and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12447004 in view of Sander et al. (US 5720753).
The patented claim discloses all elements of the claimed invention except for the features recited in claims 2-6, 8, 11, 13 and 14-15.
The missing features are disclosed by Sander et al. as features provided on fasteners for soft tissue fixation to provide bioresorbability where required and to enable firm fixation.
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the materials and features, as taught by Sander et al., in the patented claims to enable firm fixation.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12447004 in view of Sander et al. (US 5713903).
The patented claim discloses an internal passage but does not explicitly disclose a second inner transverse dimension at the shaft distal end to be smaller than a first inner transverse dimension at the shaft proximal end.
Sander et al. disclose a bore or internal passage 104’ with a second inner transverse dimension smaller at a shaft distal end than a first inner transverse dimension at the shaft proximal end (Figs. 7A, 7B and 8) wherein the internal passage configuration enables engagement of an anchor pin with the fastener and prevents the pin from sliding distally of the pin (col. 4, lines 35-45).
It would have been obvious to one of ordinary skill in the art to have provided a bore with the configuration of Sander et al. in the fastener of the patented claim to enable retention of a pin with the fastener.
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) 1-4, 6, 8, 11 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torrie et al. (US 5380334).
Regarding claims 1 and 2, Torrie et al. disclose a soft-tissue fastener (4, Fig. 2) for coupling an implant to soft tissue, the soft-tissue fastener including: an elongated shaft having a shaft length extending from a shaft proximal end to a shaft distal end, and an internal surface defining an internal passage 12 extending along the shaft length; an enlarged head 18 coupled to the proximal end of the shaft, the enlarged head having a proximal side and a distal side; a plurality of outriggers 14 each extending from the enlarged head in a direction away from the internal passage to an outrigger distal end (Fig. 2); and a plurality of barbs (15, Fig. 2) each extending along a portion of the shaft length, each of the barbs having a leading edge and trailing edge spaced from the shaft proximal end, the leading edge of each barb being disposed between the trailing edge of that barb and the shaft distal end, where the trailing edge of a second one of the barbs is closer to the shaft proximal end than is the trailing edge of a first one of the barbs (barbs 15 are distributed on the outer circumference of the shaft wherein the trailing edge is the base of the barb, Fig. 2); where the shaft, head, outriggers, and barbs are defined by a unitary piece of polymer and the polymer is bioabsorbable (col. 5, lines 25-67, cols. 6-7 and col. 8, lines 1-38).
Regarding claim 3, the trailing edge of a third one of the barbs is closer to the shaft proximal end than is the trailing edge of the second one of the barbs (see marked up Fig. 2 on the following page).
Regarding claim 4, the plurality of barbs are disposed at equiangular intervals around the cross-sectional perimeter of the shaft (Fig. 3A).
Regarding claim 6, as illustrated in Fig. 2, at least one of the barbs that lies between the outriggers is interpreted to be not radially aligned with any of the outriggers.
Regarding claim 8, at least a portion of the leading edge of the first one of the barbs is disposed at first barb angle relative to the central, longitudinal axis of the shaft; at least a portion of the leading edge of the second one of the barbs is disposed
at a second barb angle relative to the central, longitudinal axis of the shaft, and the
second barb angle is smaller than the first barb angle; and at least a portion of the leading edge of the third one of the barbs is disposed at a third barb angle relative to the central, longitudinal axis of the shaft, and the third barb angle is smaller than the second barb angle (Fig. 2, barbs 15 are positioned at an angle relative to the longitudinal axis of the shaft.
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Regarding claim 11, an outer surface of the shaft defines a tapered section having an first outer transverse dimension at the shaft distal end and tapering toward the shaft proximal end to a second outer transverse dimension that is larger
than the first outer transverse dimension, and the tapered section of the shaft tapers at a first taper angle relative to a central, longitudinal axis of the shaft, and the first taper angle is substantially equal to the first barb angle (wherein 16 is interpreted to be the first barb, Fig. 2).
Regarding claim 13, the inner surface and the outer surface define an edge (defined by the anchor tip, Figs. 2-3) at the shaft distal end.
Regarding claim 14, each of the outrigger 14 distal end is, when measured parallel to a central, longitudinal axis of the shaft, closer to the shaft distal end and is at least a portion of the distal side of the head of the shaft (Fig. 2).
Regarding claim 15, the plurality of outriggers 14 are disposed at equiangular intervals around the head (Fig. 2).
Claim(s) 1-6, 8, 11 and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sander et al. (US 5720753).
Regarding claims 1 and 2, Sander et al. disclose a soft-tissue fastener (100, Fig. 1) for coupling an implant to soft tissue, the soft-tissue fastener including: an elongated shaft (112, 114, Fig. 1) having a shaft length extending from a shaft proximal end to a shaft distal end, and an internal surface defining an internal passage 104 extending along the shaft length; an enlarged head 101 coupled to the proximal end of the shaft, the enlarged head having a proximal side and a distal side; a plurality of outriggers 110 each extending from the enlarged head in a direction away from the internal passage to an outrigger distal end (angled edges extend away from the distal end, Figs. 1 and 2); and a plurality of barbs (116, Fig. 2) each extending along a portion of the shaft length, each of the barbs having a leading edge and trailing edge spaced from the shaft proximal end, the leading edge of each barb being disposed between the trailing edge of that barb and the shaft distal end, where the trailing edge of a second one of the barbs is closer to the shaft proximal end than is the trailing edge of a first one of the barbs (first barb is closest to the shaft distal end) are distributed on the outer circumference of the shaft wherein the trailing edge is the base of the barb, Fig. 1); where the shaft, head, outriggers, and barbs are defined by a unitary piece of polymer and the polymer is bioabsorbable (col. 3, lines 8-67, col. 4 and col. 5, lines 1-63).
Regarding claim 3, the trailing edge of a third one of the barbs is closer to the shaft proximal end than is the trailing edge of the second one of the barbs.
Regarding claim 4, the plurality of barbs are disposed at equiangular intervals around the cross-sectional perimeter of the shaft (Fig. 3).
Regarding claim 5, the plurality of barbs consists of three barbs (116, Fig. 1).
Regarding claim 11, an outer surface of the shaft defines a tapered section having an first outer transverse dimension at the shaft distal end and tapering toward the shaft proximal end to a second outer transverse dimension that is larger
than the first outer transverse dimension, and the tapered section of the shaft tapers at a first taper angle relative to a central, longitudinal axis of the shaft, and the first taper angle is substantially equal to the first barb angle (Fig. 1).
Regarding claim 13, the inner surface and the outer surface define an edge (defined by the anchor tip, Figs. 1-2) at the shaft distal end.
Regarding claim 14, each of the outrigger 14 distal end is, when measured parallel to a central, longitudinal axis of the shaft, closer to the shaft distal end and is at least a portion of the distal side of the head of the shaft (Figs. 1 and 2).
Regarding claim 15, the plurality of outriggers 110 are disposed at equiangular intervals around the head (Fig. 3).
Regarding claim 16, Sander et al. disclose a plurality of outriggers 116 which includes any number greater than 1, including 4.
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Torrie et al. (US 5380334) in view of Wenstrom et al. (US 5984927).
Torrie et al. disclose 3 outriggers in a front view and assuming symmetrical placement there appear to be 4 outriggers (Fig. 2).
It is well known to provide one or more spikes 38 extending downwardly from the head of a soft tissue fastener, as evidenced by Wenstrom et al. (Fig. 4 and col. 2, lines 61-67 and col. 3, lines 1-2).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided four outriggers, as suggested by Torrie et al., and taught by Wenstrom et al. to firmly engage tissue and hold it in place.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Torrie et al. (US 5380334) in view of Sander et al. (US 5713903).
Torrie et al. disclose an anchor bore or passage 12 but do not explicitly disclose a second inner transverse dimension at the shaft distal end to be smaller than a first inner transverse dimension at the shaft proximal end.
Sander et al. disclose a bore or internal passage 104’ with a second inner transverse dimension smaller at a shaft distal end than a first inner transverse dimension at the shaft proximal end (Figs. 7A, 7B and 8) wherein the internal passage configuration enables engagement of an anchor pin with the fastener and prevents the pin from sliding distally of the pin (col. 4, lines 35-45).
It would have been obvious to one of ordinary skill in the art to have provided a bore with the configuration of Sander et al. in the Torrie et al. fastener to enable retention of a pin with the fastener.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sander et al. (US 5720753) in view of Sander et al. (US 5713903).
Sander et al. disclose an anchor bore or passage 12 but do not explicitly disclose a second inner transverse dimension at the shaft distal end to be smaller than a first inner transverse dimension at the shaft proximal end.
Sander et al. disclose a bore or internal passage 104’ with a second inner transverse dimension smaller at a shaft distal end than a first inner transverse dimension at the shaft proximal end (Figs. 7A, 7B and 8) wherein the internal passage configuration enables engagement of an anchor pin with the fastener and prevents the pin from sliding distally of the pin (col. 4, lines 35-45).
It would have been obvious to one of ordinary skill in the art to have provided a bore with the configuration of Sander et al. in the Sander et al. fastener to enable retention of a pin within the fastener.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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August 6, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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