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 of Species A (Claims 1-8) in the reply filed on 3/12/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 9-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/12/26.
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 7 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 7 is rejected as indefinite for the recitation of “a fifth fastener” in line 1. Claim 1 from which it depends only recites three fasteners therefore, it is unclear how there can be a fifth fastener without mention of a fourth.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zander et al (US Patent Pub. 20240156499A1).
Zander recites a bone stabilization system. Specifically in regards to claim 1, Zander recites a bone plate (10) configured to be positioned against an exterior surface of a long bone, the bone plate (10) having a plurality of fastener openings (15,14,19,16,20) defined therethrough (Fig. 3, Para. [0033]); an intramedullary nail (70) configured to extend through a medullary canal of the long bone, the intramedullary nail (70) defining a plurality of holes (73,74) therethrough (Fig. 1; and Para. [0031]); a first fastener (52 or 56) configured to extend through one of the fastener openings (14 or 15) in the bone plate (10) and through one of the holes (73 or 74) in the intramedullary nail (70) and into the bone, thereby interlocking the bone plate (10) and the intramedullary nail (70) together (Fig. 5 and Para, [0050]); a second fastener (59 or 58) configured to extend through one of the fastener openings (19 or 20) in the bone plate (10) and directly into the bone without passing through the intramedullary nail (70) (Fig. 5, Para. [0053]); and a third fastener (locking screws shown in Fig. 17) configured to extend through one of the holes in the intramedullary nail (70) and directly into the bone without passing through the bone plate (10) (Fig. 17, Para. [0048]).
In regards to claim 2, Zander recites wherein the first fastener (52 or 56) includes a locking screw that threads into both the bone plate (10) and the intramedullary nail (70), a locking screw that threads into the bone plate only, a headed or headless locking screw that threads into the nail only, or a non-locking screw that does not lock to the bone plate or the intramedullary nail (Fig. 5 and 14).
In regards to claim 3, Zander recites wherein the second fastener (59 or 58) includes a plate locking screw configured to secure one end of the bone plate into epiphysis of the bone (Fig. 5).
In regards to claim 4, Zander recites a fourth fastener (59 or 58) configured to extend through one of the fastener openings (19 or 20) in the bone plate (10), around the intramedullary nail (70), and directly into bone without passing through the intramedullary nail (70) (Fig. 1-2 or 5).
In regards to claim 5, Zander recites wherein the fourth fastener (59 or 58) includes a plate locking screw configured to secure the bone plate into diaphysis of the bone (Fig. 1-2 or 5).
In regards to claim 6, Zander recites wherein the fourth fastener (59 or 58) is part of a pair of fasteners positioned on opposite sides of the intramedullary nail (70) (Fig. 1-2 or 5).
In regards to claim 7, Zander recites a fifth fastener configured to extend through one of the fastener openings (16) in the bone plate (10) and into the neck and head of the long bone (Fig. 3; and Para. [0061]).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zander.
Zander recites a bone stabilization system comprises a bone plate and an intramedullary nail wherein a first fastener passes through both the plate and nail, a second nail passes only through the plate and into the bone, and a third fastener passes only through the nail and into the bone. In regards to claim 8, Zander recites wherein the first fastener (52 or 56) is part of one set of fasteners configured for interlocking a distal end of the bone plate (10) and the intramedullary nail (70) (Fig. 5 and 14), and wherein a fastener for interlocking a proximal end of the bone plate (10) and intramedullary nail (10) (Zander recites that a proximal bore is then drilled in the bone either over or after removal of the k-wire, with the bore extending through proximal plate hole 16 and proximal nail hole 75 and a third fastener is inserted through proximal plate hole 16 and into the proximal bore and proximal nail hole 75.) (Fig. 3, and Para. [0061]). However, the reference is silent as to a second set of fasteners configured for interlocking a proximal end of the bone plate and intramedullary nail. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the drilling into the proximal end of the plate (10) and nail (70) of Zander so that there’s be two anchors at the proximal end instead of one, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775