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 § 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.
Claims 1-7 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.
Claim 1 recites the limitation "the plurality of angled distal faces" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the plurality of angled distal faces” will be interpreted as “the at least one angled distal face” as previously disclosed in line 3 of claim 1.
Appropriate corrections are required.
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.
Claims 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al. (U.S. Publication No.2013/0304070 A1; hereinafter “Nelson”).
Regarding claim 1, Nelson discloses an angled bone punch for dynamic bone compression (see the embodiment of Figure 29), comprising: a shaft having a longitudinal axis (514), a proximal end (near reference numeral 594 in Figure 29), and a distal end (near reference numeral 508 in Figure 39); and at least one angled distal face located at the distal end (see distally located cutting head 746), wherein the at least one angled distal face forms an angle of less than about 60 degrees with the longitudinal axis (see proximal tapered top surface portion 748 in Figure 37C), and wherein the at least one angled distal face terminates in a most distal line at a most distal end of the shaft (Figure 37C).
Regarding claim 2, Nelson further discloses wherein the at least one angled distal face includes a convex surface, a concave surface, a planar surface, or a combination thereof (see annotated Figures 37A-37C below).
Regarding claim 3, Nelson further discloses wherein the at least one angled distal face (748) directs compression of bone in a bone hole in a region of the bone facing the at least one angled distal face (para.0172).
Regarding claim 4, Nelson further discloses wherein the at least one angled distal face (748) engages the region of the bone hole and compacts the bone (para.0172).
Regarding claims 5-7, Nelson further discloses wherein the region of the bone has a first bone density, and wherein another region of the bone not facing the at least one angled distal face has a second bone density, wherein the first bone density is greater than the second bone density. It is noted that the region of the bone is merely part of the functional recitation “wherein the at least one angled distal face directs compression of bone in a bone hole in a region of the bone” and Nelson’s surface portion 748 is capable of compressing bone in a bone hole that has a greater density than surrounding bone (para.0172: “Leading cutting edge 750 may be tapered at a steeper angle than the surface portion 748 to provide a sharpened chisel-like point 752 at the distal edge of cutting head 740”).
Regarding claim 8, Nelson discloses an angled bone punch for dynamic bone compression (see the embodiment of Figure 29), comprising: a shaft having a longitudinal axis (514), a proximal end (near reference numeral 594 in Figure 29), and a distal end (near reference numeral 508 in Figure 39); and at least one angled distal face located at the distal end (see proximal tapered top surface portion 748 in Figure 37C), wherein at least one angled distal face forms an angle of less than about 60 degrees with the longitudinal axis (Figure 37C), and wherein the at least one angled distal face converges into a most distal point at a most distal end of the shaft (Figure 37C).
Regarding claim 9, Nelson further discloses wherein the at least one angled distal face consists of two planar surfaces converging into the most distal point (748 and 750).
Regarding claim 10, Nelson further discloses wherein the at least one angled distal face consists of a planar surface (748) and a convex surface (sides of 748, as shown in annotated Figure 37B below) converging into the most distal point.
Regarding claim 11, Nelson further discloses wherein the at least one angled distal face (748) consists of a concave or convex surface terminating into a flat surface at the most distal point (see convex and concave surfaces in annotated Figure 37B below).
Regarding claim 12, Nelson further discloses wherein the at least one angled distal face (748) directs compression of bone in a bone hole in a region of the bone facing the at least one angled distal face (para.0172: “Leading cutting edge 750 may be tapered at a steeper angle than the surface portion 748 to provide a sharpened chisel-like point 752 at the distal edge of cutting head 740”).
Regarding claim 13, Nelson discloses a surgical kit for dynamic bone compression, comprising: an angled bone punch (see the embodiment of Figure 29) having a shaft with a longitudinal axis (514), a proximal end (near reference numeral 594 in Figure 29), and a distal end (near reference numeral 508 in Figure 39); and at least one angled distal surface located at the distal end (see proximal tapered top surface portion 748 in Figure 37C), wherein the at least one angled distal surface forms an angle of less than about 60 degrees with the longitudinal axis of the shaft (Figure 37C); and an open cannula guide having a "sled-like" configuration (516).
Regarding claims 14 and 15, Nelson further discloses wherein the open cannula guide (516) is configured to be inserted into a bone hole to assist in delivery and direction of bone material, such as bone chips, bone particles, or DMB, into the bone hole (Figure 29).
Regarding claim 16, Nelson further discloses wherein at least one of the angled bone punch and the open cannula guide is disposable (shaft 514 and cannula 516 are able to be disposed, or thrown away).
Regarding claim 17, Nelson further discloses an obturator (hub 520).
Regarding claim 18, Nelson further discloses at least one cutting instrument (cutting head 600).
Regarding claim 19, Nelson further discloses at least one fixation device (bearings 690).
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Allowable Subject Matter
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 20 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 13 and claim 19 from which claim 20 depends from. In particular, none of the cited references teach or suggest wherein the at least one fixation device is a soft suture anchor comprising a flexible tubular sleeve or sheath and a plurality of flexible strands extending through a passage of the flexible tubular sleeve or sheath, as required by claim 20.
Conclusion
The prior art made of record and not relied upon but considered pertinent to applicant's disclosure has been listed in the PTO-892 Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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