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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 6-10, and 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2001/0051815 A1 to Esplin (Esplin).
Regarding at least claim 1
Esplin teaches an apparatus and method for repairing severed or unattached soft tissue of the body, such as tendons, typically includes an anchor for engaging the soft tissue and a securement mechanism designed to securely attach the anchor to the soft tissue and to abut the soft tissue against a surface (abstract).
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Esplin meets the limitations of a repair device system for fixating soft tissue to bone (abstract), comprising:
a carrier member (anchor; 12b) having an elongated structure (paragraph 0017 discloses that the anchor may comprise a plate formed to have a longitudinal direction as shown in fig. 1) with multiple slots (paragraph 0017 discloses a plurality of apertures configured to receive sutures therethrough; fig. 1 defined therein, the carrier member extending to define a longitudinal length (fig. 1 shows that the carrier member/anchor extends to define a longitudinal length);
and at least one anchor (securement mechanism; 18a), the at least one anchor being separate and discrete from the carrier member (the anchor/securement mechanism is a separate and discrete component from the carrier member/anchor), the at least one anchor including at least two legs extending from a base (fig. 16a shows two legs extending from the base of the anchor) such that the at least two legs are configured to be moveable from a straight position to a curled position (fig. 16b shows that the securing mechanism/anchor extends through the tissue; 14 and is movable from a straight position to a curled position), the base (see annotated fig. 16a above) of the at least one anchor extending to define an elongated length (the base defines an elongated length from one aperture to the other; fig. 16a), the at least one anchor sized and configured to extend through the soft tissue (fig. 16b shows that the securement mechanism/anchor extends through the soft tissue; 14) and along the slots defined in the carrier member (figs. 16a and b show that the securement mechanism/anchor extends along slots/apertures) such that the elongated length of the base is oriented to be substantially perpendicular relative to the longitudinal length of the carrier member (fig. 16a shows that the length of the base of the securement mechanism; 18a is substantially perpendicular relative to the longitudinal length of the carrier member/anchor; 12b) so that, upon the at least two legs of the at least one anchor being moved to the curled position, the at least two legs of the at least one anchor extend through the slots defined in the carrier member so as to curl and couple to the carrier member and the soft tissue (annotated fig. 16b above shows that upon the legs of the anchor being moved to the curled position, the legs extend through the apertures/slots in the carrier member so as to curl and couple the carrier member and the soft tissue; 14).
Regarding at least claim 2
Esplin teaches the repair device system of claim 1, wherein the carrier member comprises a bone coupling portion, the bone coupling portion being adjacent one end of the carrier member (paragraph 0025 discloses that the repair may abut a soft tissue against a dissimilar tissue, such as a bone).
Regarding at least claim 3
Esplin teaches the repair device system of claim 2, further comprising a bone anchor, the bone anchor configured to be coupled to the bone coupling portion and configured to be secured to the bone (a second securement mechanism, such as 18b, is construed to be a bone anchor configured to be coupled to the bone coupling portion and secured to the bone when the repair abuts a soft tissue against a bone as disclosed in paragraph 0025).
Regarding at least claim 4
Esplin teaches the repair device system of claim 1, wherein the at least one anchor comprises a u- shaped configuration (fig. 16 shows a u-shaped configuration of the securement mechanism; 18a).
Regarding at least claim 6
Esplin teaches the repair device system of claim 1, wherein the carrier member is a flat monolithic structure (the carrier member/anchor is formed as a plate which is a flat monolithic structure).
Regarding at least claim 7
Esplin teaches the repair device system of claim 1, wherein the carrier member extends with a flat multi-cellular structure (the carrier member/anchor is formed as a plate with apertures and is therefore construed to extend with a flat multi-cellular structure).
Regarding at least claim 8
Esplin teaches the repair device system of claim 1, wherein the slots defined in the carrier member comprise at least one of holes and notches extending through opposing surfaces of the carrier member (the slots of Esplin are apertures which are holes extending through opposing surfaces of the carrier member/anchor; 12b).
Regarding at least claim 9
Esplin also meets the limitations of a repair device system for fixating soft tissue (abstract), the repair device system comprising: an elongated flat carrier member (12b) extending to define a longitudinal length (fig. 16a), the elongated flat carrier member including slots (apertures) defined therein; and at least one anchor (securement mechanism; 18a) being separate and discrete from the elongated flat carrier member (securement mechanism/anchor is a separate and discrete component from the carrier member; 12b), the at least one anchor including two legs extending from a base (the anchor; 18b has two legs that extend from a base, as shown in annotated fig. 16a above) such that the two legs are configured to be moveable from a straight position to a curled position (annotated fig. 16b above shows that the legs are movable as claimed), the base of the at least one anchor defining an elongated length, the at least one anchor sized and configured to extend through and along the slots defined in the carrier member and extend through the soft tissue such that the elongated length of the base is oriented to be substantially perpendicular relative to the longitudinal length of the carrier member (fig. 16b shows that the length of the base of the securement mechanism is substantially perpendicular to the length of the carrier member) so that, upon the two legs of the at least one anchor being moved to the curled position, the two legs of the at least one anchor extend through the slots of the carrier member so as to couple the carrier member to the soft tissue (annotated fig. 16b above shows that upon the legs of the anchor being moved to the curled position, the legs extend through the apertures/slots in the carrier member so as to curl and couple the carrier member and the soft tissue; 14).
Regarding at least claim 10
Esplin teaches the repair device system of claim 9, wherein the at least one anchor comprises a u- shaped configuration (fig. 16 shows a u-shaped configuration of the securement mechanism; 18a).
Regarding at least claim 12
Esplin teaches the repair device system of claim 9, further comprising an elongated flat second carrier member (12d) that is separate and discrete relative to the elongated flat carrier member (12b), the at least one anchor (18a) sized and configured to couple the elongated flat second carrier member to the soft tissue and the elongated flat carrier member (fig. 16b shows that the carrier members are coupled to the soft tissue with the securement mechanism/anchor).
Regarding at least claim 13
Esplin teaches the repair device system of claim 9, wherein the elongated flat carrier member is a monolithic structure (the carrier member/anchor is formed as a plate which is a flat monolithic structure).
Regarding at least claim 14
Esplin teaches the repair device system of claim 9, wherein the elongated flat carrier member extends with multi-cellular structure (the carrier member/anchor is formed as a plate with apertures and is therefore construed to extend with a flat multi-cellular structure).
Regarding at least claim 15
Esplin teaches the repair device system of claim 9, wherein the slots defined in the elongated flat carrier member comprise at least one of holes and notches extending through opposing surfaces of the elongated flat carrier member (the apertures defined in the carrier member; 12b are holes extending through opposing surfaces thereof).
Regarding at least claim 16
Esplin teaches the repair device system of claim 9, wherein the elongated flat carrier member comprises a bone coupling portion, the bone coupling portion being adjacent one end of the elongated flat carrier member (paragraph 0025 discloses that the repair may abut a soft tissue against a dissimilar tissue, such as a bone).
Regarding at least claim 17
Esplin teaches the repair device system of claim 16, further comprising a bone anchor, the bone anchor configured to be coupled to the bone coupling portion and configured to be secured to bone (a second securement mechanism, such as 18b, is construed to be a bone anchor configured to be coupled to the bone coupling portion and secured to the bone when the repair abuts a soft tissue against a bone as disclosed in paragraph 0025).
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(s) 5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esplin in view of US Patent Application Publication No. 2004/0030354 A1 to Leung et al. (Leung).
Regarding at least claim 5
Esplin teaches the repair device system of claim 1, wherein the at least one anchor comprises a u- shaped structure (fig. 16b shows that the securement mechanism/anchor comprises a u-shaped structure). However, Esplin does not teach that the u-shaped structure is with a middle tine.
Leung teaches a suture anchor with sutures extending from the anchor member (abstract). Each suture has a sharp pointed end for penetrating the tissue and a plurality of barbs which permit movement of the sutures through the tissue in one direction of movement of the pointed end and prevent movement of the sutures relative to the tissue in the opposite direction (abstract and fig. 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor/securement mechanism of Esplin, which is a suture, to include barbs such that the u-shaped structure is with a middle tine, in order to prevent movement of the structure relative to the tissue in at least one direction, as taught by Leung.
Regarding at least claim 11
Esplin teaches the repair device system of claim 9, wherein the at least one anchor extends with two legs (fig. 16a shows that the securement mechanism/anchor extends with two legs). However, Esplin does not teach a tine therebetween.
Leung teaches a suture anchor with sutures extending from the anchor member (abstract). Each suture has a sharp pointed end for penetrating the tissue and a plurality of barbs which permit movement of the sutures through the tissue in one direction of movement of the pointed end and prevent movement of the sutures relative to the tissue in the opposite direction (abstract and fig. 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor/securement mechanism of Esplin, which is a suture, to include barbs such that a tine extends between the two legs, in order to prevent movement of the structure relative to the tissue in at least one direction, as taught by Leung.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,701,218 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, the patent claims also recite a repair device system for fixating soft tissue to bone, comprising: a carrier member having an elongated structure with multiple slots defined therein, the carrier member extending to define a longitudinal length; and at least one anchor, the at least one anchor being separate and discrete from the carrier member, the at least one anchor including at least two legs extending from a base such that the at least two legs are configured to be moveable from a straight position to a curled position, the base of the at least one anchor extending to define an elongated length, the at least one anchor sized and configured to extend through the soft tissue and along the slots defined in the carrier member such that the elongated length of the base is oriented to be substantially perpendicular relative to the longitudinal length of the carrier member so that, upon the at least two legs of the at least one anchor being moved to the curled position, the at least two legs of the at least one anchor extend through the slots defined in the carrier member so as to curl and couple to the carrier member and the soft tissue (see patent claims 1 and 8).
Regarding claim 2, the patent claims also recite the repair device system of claim 1, wherein the carrier member comprises a bone coupling portion, the bone coupling portion being adjacent one end of the carrier member (see patent claim 2).
Regarding claim 3, the patent claims also recite the repair device system of claim 2, further comprising a bone anchor, the bone anchor configured to be coupled to the bone coupling portion and configured to be secured to the bone (see patent claim 3).
Regarding claim 4, the patent claims also recite the repair device system of claim 1, wherein the at least one anchor comprises a u- shaped configuration (see patent claim 4).
Regarding claim 5, the patent claims also recite the repair device system of claim 1, wherein the at least one anchor comprises a u- shaped structure with a middle tine (see patent claim 10).
Regarding claim 6, the patent claims also recite the repair device system of claim 1, wherein the carrier member is a flat monolithic structure (see patent claim 5).
Regarding claim 7, the patent claims also recite the repair device system of claim 1, wherein the carrier member extends with a flat multi-cellular structure (see patent claim 6).
Regarding claim 8, the patent claims also recite the repair device system of claim 1, wherein the slots defined in the carrier member comprise at least one of holes and notches extending through opposing surfaces of the carrier member (see patent claim 7).
Regarding claim 9, the patent claims also recite a repair device system for fixating soft tissue, the repair device system comprising: an elongated flat carrier member extending to define a longitudinal length, the elongated flat carrier member including slots defined therein; and at least one anchor being separate and discrete from the elongated flat carrier member, the at least one anchor including two legs extending from a base such that the two legs are configured to be moveable from a straight position to a curled position, the base of the at least one anchor defining an elongated length, the at least one anchor sized and configured to extend through and along the slots defined in the carrier member and extend through the soft tissue such that the elongated length of the base is oriented to be substantially perpendicular relative to the longitudinal length of the carrier member so that, upon the two legs of the at least one anchor being moved to the curled position, the two legs of the at least one anchor extend through the slots of the carrier member so as to couple the carrier member to the soft tissue (see patent claim 8).
Regarding claim 10, the patent claims also recite the repair device system of claim 9, wherein the at least one anchor comprises a u- shaped configuration (see patent claim 9).
Regarding claim 11, the patent claims also recite the repair device system of claim 9, wherein the at last one anchor extends with the two legs and a tine therebetween (see patent claim 10).
Regarding claim 12, the patent claims also recite the repair device system of claim 9, further comprising an elongated flat second carrier member that is separate and discrete relative to the elongated flat carrier member, the at least one anchor sized and configured to couple the elongated flat second carrier member to the soft tissue and the elongated flat carrier member (see patent claims 8 and 11).
Regarding claim 13, the patent claims also recite the repair device system of claim 9, wherein the elongated flat carrier member is a monolithic structure (see patent claim 12).
Regarding claim 14, the patent claims also recite the repair device system of claim 9, wherein the elongated flat carrier member extends with multi-cellular structure (see patent claim 13).
Regarding claim 15, the patent claims also recite the repair device system of claim 9, wherein the slots defined in the elongated flat carrier member comprise at least one of holes and notches extending through opposing surfaces of the elongated flat carrier member (see patent claim 14).
Regarding claim 16, the patent claims also recite the repair device system of claim 9, wherein the elongated flat carrier member comprises a bone coupling portion, the bone coupling portion being adjacent one end of the elongated flat carrier member (see patent claim 15).
Regarding claim 17, the patent claims also recite the repair device system of claim 16, further comprising a bone anchor, the bone anchor configured to be coupled to the bone coupling portion and configured to be secured to bone (see patent claim 16).
Conclusion
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/M.A.H/ Examiner, Art Unit 3774
/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774
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