DETAILED ACTION
This is the first office action on the merits in this application. The claims of February 12, 2025, are under consideration. Claims 1-20 are pending.
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
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) 14-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arai et al. (US 2013/0178901 A1).
Regarding claim 14, Arai teaches an orthopedic method comprising:
(a) inserting a shaft of a bone peg 20 into a hole in a bone (see e.g. fig. 34) such that a head 21 of the bone peg extends upwardly away from the hole in the bone (as shown in fig. 5, it is clear that portion 21 will not pass into the hole);
(b) wherein the bone peg is cannulated 27 to be capable of receiving and guiding a guide pin.
Regarding claim 15, when the shaft of the bone peg is inserted in the hole in the bone, the head 21 of the bone peg provides a visual indication of a trajectory of the hole in the bone (by permitting one to view the head 21).
Regarding claim 16, when the bone peg is inserted in the hole in the bone, the bone peg provides a visual indication of the hole in the bone when the bone is imaged using a surgical imaging system (inferred imaging system; depends on what type of imaging system is used).
Regarding claim 17, after inserting the bone peg 20 in the hole in the bone, temporarily securing at least one suture to the head of the bone peg (any suture attached to 20 is considered attached to the head 21 since 21 is monolithic with the rest of 20; for example, suture 110 as at fig. 22).
Regarding claim 18, after inserting the bone peg 20 in the hole in the bone, using the head 21 of the bone peg to tension at least one suture (see e.g. fig. 24; tightening the fastener; application of force at the head end, etc.).
Regarding claim 19, using the head of the bone peg to tension the at least one suture comprises rotating the bone peg 20 while it is inserted in the hole in the bone such that the at least one suture winds around the head of the bone peg (such as through interference with bone tunnel).
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) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wetzler et al. (US 7,575,578 B2) in view of Arai et al. (US 2013/0178901 A1).
Regarding claim 1, Wetzler teaches an orthopedic method as best seen at figs. 1, 2, 4 and 5, comprising:
(a) inserting a guide pin 50 into a bone (see fig. 5; col. ), wherein insertion of the guide pin 50 is guided by and passes through a cannulation 46 in a bone peg 44 that is inserted in the cannula 42 of a cutting guide 10 positioned on the bone 90 as in fig. 5, the bone peg 44 comprising a shaft and a head as seen in the figures;
(b) after insertion of the guide pin 50 into the bone 90, removing the bone peg 44 from the cutting guide 10 as in fig. 5;
(c) after removal of the bone peg 44, positioning a cannulated cutter (cannulated drill, col. 5, lines 37-41) over the guide pin 50, and using the cannulated cutter to form a hole in the bone (bone tunnel), wherein the guide pin 50 guides the formation of the hole in the bone by the cannulated cutter;
(d) after forming the hole in the bone, removing the cannulated cutter from the hole (considered inherent at some point during the procedure).
Wetzler fails to teach after removing the cannulated cutter from the hole, inserting the shaft of the bone peg into the hole in the bone such that the head of the bone peg extends upwardly away from the hole in the bone. However, Wetzler does teach that his bone tunnel is formed in order to permit correction of damaged ligaments (col. 1, lines 35-40; col. 2, lines 8-13).
Arai teaches a cannulated, threaded, bone peg 20. The bone peg includes a head at portion 21 which is not designed to be inserted into a bone, and a shaft distal thereto. The peg 20 is taught being be implanted into a bone tunnel for purposes of use during ligament reconstruction surgery [0060], [0069]. It is clear from the Arai design that the end 21 would extend upwardly away from the hole in the bone.
It would have been obvious to one with ordinary skill in the art at the time of the invention to replace the plug 44 of Wetzler with the plug 20 of Arai. Such would have required modifying the Arai cannula 42 to accommodate the Arai plug. One would have done so as a matter of selection of a device which would function equivalently to the Wetzler plug 44 during guidance portions of the procedure, but simply has a different configuration. Such would also have reduced the number of parts required for a ligament reconstruction surgery since the substituted plug could then also be used as a ligament retention by an interference screw.
Regarding claim 2, an outer diameter of the shaft of the bone peg is approximately the same as an inner diameter of the hole in the bone (as modified to make 42 accommodate the substituted peg).
Regarding claim 3, both the cutting guide 10 and the guide pin 50 guides the formation of the hole in the bone by the cannulated cutter (cannulated drill, col. 5, lines 37-41).
Regarding claim 4, in the proposed modification, the shaft of the Arai bone peg 20 is inserted into the hole in the bone after the cutting guide is removed from the bone.
Regarding claim 5, the bone peg 20 remains inserted in the hole in the bone after the guide pin 50 is removed from the bone (such as when the replacement ligament is being retained).
Regarding claim 6, when the bone peg 20 is inserted in the hole in the bone 90, the head 21 of the bone peg provides a visual indication of a trajectory of the hole in the bone (by viewing 21 relative to the bone).
Regarding claim 7, when the bone peg 20 is inserted in the hole in the bone 90, the bone peg 20 is capable of providing a visual indication of the hole in the bone 90 when the bone is imaged using a surgical imaging system (depending on what type of inferred imaging system is used).
Regarding claim 8, when the bone peg 20 is inserted in the hole in the bone, the bone peg provides a visual indication of a position, a trajectory, and a depth of the hole in the bone when the bone is imaged using the surgical imaging system (Depending on what type of inferred imaging system is used).
Regarding claim 9, when the bone peg 20 is inserted in the hole in the bone, the head 21 of the bone peg resists soft tissue from moving over the hole in the bone 90 (by obstructing entrance to the hole).
Regarding claim 10, after inserting the bone peg 20 in the hole in the bone 90, temporarily securing at least one suture to the head of the bone peg (any suture coupled to 20 is considered coupled to the head, thereof, since 20 is a monolithic structure).
Regarding claim 11, after inserting the bone peg 20 in the hole in the bone 90, using the head 21 of the bone peg 20 to tension at least one suture (considered inherent as 20 is taught to function as an interference fastener for the suture).
Regarding claim 12, using the head of the bone peg to tension the at least one suture comprises rotating the bone peg while it is inserted in the hole in the bone such that the at least one suture winds around the head of the bone peg (during installation of the threaded body, rotation occurs; threading motion achieved by application of force at the head; the suture retained by 20 will wrap around some portion of 20 to accomplish retention).
Regarding claim 13, after inserting the bone peg in the hole in the bone, it would have been obvious to remove the bone peg from the hole in the bone and install a fastener in the hole in the bone. Examiner is of the position that inserting a different interference screw in the hole is a matter of selection of an appropriately sized/shaped component based on patient anatomy, or simply insertion of a duplicate structure in event, for example, the first was damaged. A second interference screw can be referred to as a ‘fastener’ in absence of any other limitations defining structure of the fastener. Duplication of parts or a method step is an obvious modification of a prior art reference.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai et al. (US 2013/0178901 A1).
Regarding claim 20, after inserting the bone peg 20 in the hole in the bone, it would have been obvious to remove the bone peg from the hole in the bone and install a fastener in the hole in the bone. Examiner is of the position that inserting a different interference screw in the hole is a matter of selection of an appropriately sized/shaped component based on patient anatomy, or simply insertion of a duplicate structure in event, for example, the first was damaged. A second interference screw can be referred to as a ‘fastener’ in absence of any other limitations defining structure of the fastener. Duplication of parts or a method step is an obvious modification of a prior art reference.
Conclusion
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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