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 the Device species of Figs. 24A-24D and the Proximal End Section species of Figs. 23A-23F in the reply filed on July 31, 2026 is acknowledged.
Claims 33-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of Device (the elected species of Figs. 24A-24D does not include longitudinal apertures on the elongate body wherein each elongate member of a plurality of elongate members passes through a respective longitudinal aperture as recited in claim 33), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 31, 2026.
Applicant's election with traverse of the Distal End species of Disk Shape 3110 in the reply filed on July 31, 2026 is acknowledged. The traversal is on the ground(s) that Disks 3102 and 3104 are the same disk in different configurations. This is found persuasive and thus, the election of species requirement with respect to the Distal End species is being considered in view of both Disks 3102 and 3104 being grouped as a single species.
Claims 43-56 have been examined.
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 43-50 and 53-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al. (US 2010/0023010 A1).
Claim 43. Nelson discloses a bone fixation device, comprising:
an elongate body (body portion 114’) comprising a tubular sidewall defining a lumen (occupied by drive member 128’, shuttle 710, and tension wire 716) therethrough, wherein the sidewall includes a plurality of spaced apart, circumferentially extending slots (gaps 414);
an elongate member (drive member 128’ exclusive of enlarged head, shuttle 710, and tension wire 716) disposed within the lumen and configured to translate axially within the lumen (see para. 0101);
a proximal interface (enlarged head of drive member 128’) at a proximal end portion of the elongate body and configured to receive a torque transmission device (via socket 130, which is labeled in Fig. 7B); and
a distal interface (region with grippers 108 located at the lower end of body portion 114’ as shown in Fig. 9) at a distal end portion of the elongate body, wherein the distal interface includes an articulable structure (gripper 108) that is moveable between a radially collapsed state for insertion of the fixation device into a bone and a radially expanded state for anchoring the fixation device in the bone (see para. 0081),
wherein the fixation device is configured to be positioned in a flexible state along a curved path within an intramedullary space of a bone and transitioned to a curved, rigid state (see para. 0100) (Figs. 4, 8A-8C, and 9).
Claim 44. Nelson discloses wherein the elongate member has a proximal end portion operably coupled to the proximal interface (see Figs. 8B-8C) (Figs. 4, 8A-8C, and 9).
Claim 45. Nelson discloses wherein the elongate member has a distal end portion operably coupled to the distal interface (see para. 0081) (Figs. 4, 8A-8C, and 9).
Claim 46. Nelson discloses wherein the elongate member has a circular cross-section (see Figs. 8B-8C; see also Fig. 8D) (Figs. 4, 8A-8C, and 9).
Claim 47. Nelson discloses wherein the elongate member includes circumferential threads (see para. 0099) (Figs. 4, 8A-8C, and 9).
Claim 48. Nelson discloses wherein the proximal interface has a recess (socket 130, which is labeled in Fig. 7B) configured to receive the torque transmission device (Figs. 4, 8A-8C, and 9).
Claim 49. Nelson discloses wherein the proximal interface has a flange (the enlarged head of drive member 128’ acts as a flange) (Figs. 4, 8A-8C, and 9).
Claim 50. Nelson discloses wherein the proximal interface is a separate component that is attached to the tubular sidewall (the proximal interface is a separate component from the tubular sidewall) (Figs. 4, 8A-8C, and 9).
Claim 53. Nelson discloses wherein the slots extend through an entire thickness of the tubular sidewall (see Fig. 8B) (Figs. 4, 8A-8C, and 9).
Claim 54. Nelson discloses wherein the articulable structure is configured to move between the radially collapsed state and the radially expanded state by movement of the one or more elongate members (see paras. 0100-0101) (Figs. 4, 8A-8C, and 9).
Claim 55. Nelson discloses wherein the elongate body comprises stainless steel (see para. 0129) (Figs. 4, 8A-8C, and 9).
Claim 56. Nelson discloses wherein the elongate body comprises titanium (see para. 0129) (Figs. 4, 8A-8C, and 9).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 51 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2010/0023010 A1) in view of Nelson et al. (US 2006/0264952 A1; hereinafter referred to as “Nelson ‘952”).
Nelson fails to disclose wherein when the elongate body is curved, a width of at least one slot on an inside of the curve is narrowed and a width of at least one slot on the outside of the curve is widened (claim 51) and wherein the slots are arranged in pairs with each slot of a pair being axially and circumferentially offset from the other slot of the pair (claim 52).
Nelson ‘952 teaches a fixation device comprising: an elongate body (sleeve 850) comprising a tubular sidewall including a plurality of spaced apart, circumferentially extending slots (c-cuts 852A) for providing flexibility to the elongate body (see para. 0092), wherein a width of each slot is substantially constant along the circumferential length of the slot when the elongate body is in a straight, flexible state (see Figs. 8C-8D), and wherein the slots are arranged in pairs with each slot of a pair being axially and circumferentially offset from the other slot of the pair (see Figs. 8B-8C) (Figs. 8A-8D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixation device of Nelson by substituting the slot configuration of Nelson ‘952 for that of Nelson as such is a simple substitution of one slot configuration for another and would allow the fixation device to be used in a variety of long bones of a patient. In view of such a modification, because the width of each slot of Nelson ‘952 is substantially constant along the circumferential length of the slot, it would have been obvious that when the elongate body is curved, a width of at least one slot on an inside of the curve is narrowed and a width of at least one slot on the outside of the curve is widened (claim 51). Also in view of such a modification, it would have been obvious that the slots are arranged in pairs with each slot of a pair being axially and circumferentially offset from the other slot of the pair (claim 52).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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