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 Objections
Claim 7 is objected to because of the following informalities: the limitation recites “the knob translates the road” in line 2 which is believed should recite “the knob translates the rod” (emphasis added). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “substantially” in claim 1 line 4 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2-27 are rejected as indefinite for depending upon an indefinite claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 16 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In claim 16 at lines 1-2 the limitation recites “the bone anchor is passed through a graft or ligament and into bone, the overhang holds the graft or ligament against the bone”. This limitation cannot be satisfied without the inclusion of the human organism, or the graft, ligament, or bone, therefore, applicant is claiming the graft, ligament, or bone as parts of the invention. Instead, applicant should use “adapted to” or “configured to” language to overcome the 101 rejection.
Claim 18 is also rejected under 35 USC 101 for failing to correct the deficiency of the claim from which it depends.
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, 14-15, 17, 23-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pilgeram et al (US Patent Pub. 20180235746A1).
Pilgeram recites a bone anchor delivery system. Specifically in regards to claim 1, Pilgeram recites a delivery tool (1130) comprising a handle (same as 40 shown in Fig. 3), an elongated shaft (same as 45/33/34, shown in Fig. 4a-4b) extending from the handle, and a first blade (blades of 1130) extending distally from a rod (same as 34, Fig. 4a,4b) extending through the shaft (34 extends into 45 as shown in Fig. 4a-4b) to a sharpened bone-piercing tip (1131); and an implantable bone anchor (1120) disposed upon the blade , the bone anchor (1120) comprising a base (1123/1123’), a stake (body of 1120) extending substantially perpendicular from the base, and an open portion (1127 in Fig. 10B) in the base through which the first blade (blades of 1130) (1130) extends (Fig. 10a-11c and Fig. 3-4b.; and Para. [0048],[0077]-[0080]).
In regards to claim 2, Pilgeram recites wherein the stake (body of 1120, Fig. 10b) is substantially flat, comprising first and second opposed substantially planar surfaces (faces of 1123/1123’); first and second barbed (1123/123’) where the first and second surface meet; and a distal point (1126) (Fig. 10b).
In regards to claim 3, Pilgeram recites wherein a flat side of the first blade (1130) lies against the first substantially planar surface of the stake (body of 1120) of the bone anchor (1120) (Fig. 11c).
In regards to claim 4, Pilgeram recites wherein the open portion (1127) defines a slot (opening passes transverse to the barbs of the anchor 1120) through the base (1123/1123’), wherein a flat side of the slot cooperates with the first substantially planar surface of the stake (body of 1120) to define an essentially flat surface against which the first blade (blades of 1130) (1130) lies (Fig. 11C).
In regards to claim 6, Pilgeram recites wherein the delivery tool (1030/1130) comprises a second blade (blades of 1130) (1130), wherein the first and second blade (blades of 1130) (1130/1130) sit against respective opposed surfaces of the stake of the bone anchor (Fig. 11C).
In regards to claim 14, Pilgeram recites wherein the bone anchor (1130) is made from an absorbable polymer, a bioabsorbable polymer, or a biological metrical (Para. [0042]).
In regards to claim 15, Pilgeram recites wherein the base (1123/1123’) of the bone anchor comprises overhangs that extend away from the stake in multiple directions (The barbs 123/1123’ overhang over the body of the eyelet 1130.) (Fig. 10b).
In regards to claim 17, Pilgeram recites wherein the bone anchor (1120) includes at least two lateral barbs (123/1123’) that protrude in opposed lateral directions, and wherein the first and second blade (blades of 1130) s (1130) puncture or cut into bone in the opposed lateral directions, and/or where the barbs and the blades are not co-planar (Fig. 11c; and Para. [0078]).
In regards to claim 23, Pilgeram recites wherein the bone anchor (1120) comprises at least one sloped face (face leading to 1123) providing a transition between a flat surface of the stake and a proximal-most face of the base (1123) (Fig. 10b).
In regards to claim 24, Pilgeram recites, wherein the sloped face (face leading to 1123)-when a sharpened tip (1131) of the first blade is positioned within a cutaway space defined by the sloped face-guides the bone anchor (1130) into position while the bone anchor (1120) is being loaded onto the delivery tool (1130) (Fig. 11c; and Para. [0078]-[0080]).
In regards to claim 25, Pilgeram recites a method of anchoring a graft to bone, the method comprising: using a system of claim 1 (see above) to carry the bone anchor (1120) disposed on the blade through an incision to a target site on bone; driving the anchor (1120) and the blade into the bone; retracting the rod (34) in a proximal direction into the shaft to remove the blade from the bone anchor (1120) while the bone anchor (1120) is sitting in the bone; and removing the delivery tool (1120) from the target site and out of the incision (Fig. 16a-16b; and Para.[0032],[0070]-[0071],[0078]-[0083]).
In regards to claim 26, Pilgeram recites wherein the shaft has a bridge that holds the anchor (1120) in the bone during the retracting step (Pilgeram recites that a rod can pass through a cannulation 1147 into pockets 1142/1143 to force barbs out into the bone underneath the cortical layer when the awl is being removed by pulling or during the use of a slap hammer.) (Fig. 11c; and Para. [0080]).
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) 12, 19, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilgeram in view of Beyar (US Patent Pub. 20020050277A1).
Pilgeram recites a bone anchor delivery system comprising a delivery tool with a handle, an elongated shaft, a first blade distally extending from a rod extending through the shaft to a sharpened tip; and an implantable bone anchor disposable on the blade wherein the anchor has a base, a stake, and an open portion through which the blade extends. In regards to claim 12, Pilgeram recites wherein the bone anchor (1120) comprises a pliable material, and wherein the delivery tool comprises first and second blades that prevent the anchor (1120) from deforming during delivery (Para. [0042] and [0078]-[0080]). However, the reference is silent as to the composition of the delivery tool.
Beyar recites a bone anchor delivery system. In regards to claim 12, Beyar discloses the system comprising a delivery tool (810) and an anchor (835), wherein the delivery tool (810) comprise a rigid metal (Fig. 12a-12b; and Para. [0094]). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to modify the delivery tool of Pilgeram to compose to the tool of a rigid material as discussed in Beyar in order to be any suitable material, for example, stainless steel which meets surgical instrument standards (Para. [0094]).
In regards to claims 19, 21-22, Pilgeram discloses a delivery system as disclosed above. However, the reference is silent as to an insertion sleeve.
Beyar recites a bone anchor delivery system. In regards to claim 19, Beyar discloses an insertion sleeve (730) disposed slidably over the shaft, wherein a distal end of the insertion sleeve (730) can be opened by sliding the insertion sleeve in a proximal direction over the elongated shaft (Fig. 29; and Para. [0134]-[0135]). In regards to claim 21, Beyar recites wherein the insertion sleeve (730) comprises an elastic deformable material and a slit separating two portions of a distal tip, wherein the insertion sleeve (730) opens by bending the two portions of the distal elastically away from one another (Fig. 29). In regards to claim 22, Beyar recites wherein retracting the insertion sleeve (730) exposes the bone anchor (726) (Fig. 29). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to modify the delivery system of Pilgeram adding a insertion sleeve in view of Beyar so as not to accidentally damage the patient's tissue (Para. [0097]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pilgeram in view of Domecus et al (US Patent Pub. 20210275290A1).
Pilgeram recites a bone anchor delivery system comprising a delivery tool with a handle, an elongated shaft, a first blade distally extending from a rod extending through the shaft to a sharpened tip; and an implantable bone anchor disposable on the blade wherein the anchor has a base, a stake, and an open portion through which the blade extends. In regards to claim 13, Pilgeram recites wherein the bone anchor (1120) has first and second edges (Fig. 10b). However, the reference is silent as to the anchor having teeth.
Domecus recites an anchor delivery system. Specifically in regards to claim 13, Domecus recites wherein the stake of the bone anchor has a plurality of teeth (Fig. 2g, and Para. [0084]). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to modify the anchor of Pilgeram to have teeth along its edges as discussed in Domecus as taught in order to enhance the frictional resistance of the tip from being pulled out during insertion device removal (e.g., delivery cannula removal) and during anchor deployment (Para. [0084]).
Allowable Subject Matter
Claims 5, 7-11, 20, and 27 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775