DETAILED ACTION
This office action is responsive to the amendment filed February 10, 2026, and request for continued examination filed March 13, 2026. Claims 1, 21, 27, and 35 were amended. Claims 1-4, 6, and 21-35 are pending, though claims 21-33 were previously withdrawn from consideration.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 13, 2026, has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6, 34 and 35, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly presented rejections are necessitated by the amendments to the claims of February 10, 2026.
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) 1-4, 6, 34, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niver et al. (US 2025/0387147 A1) in view of Chang (US 2009/0129887 A1). Niver is properly prior art based on the provisional application date, which provisional application includes at least the subject matter of figs. 1-29 of the published non-provisional application.
Regarding claim 1, Niver teaches an apparatus for the approximation of two bones as at fig. 13, comprising:
a nail 100 configured to be disposed within a first bone, the nail comprising a proximal end 107, a distal end 102, and a rigid body;
one or more first threads 108 disposed along the proximal end 107 of the nail;
one or more second threads 104 disposed along the distal end 102 of the nail, the one or more first threads 108 being axially spaced from the one or more second threads 104;
a non-threaded portion 105 of the nail 100 disposed between the one or more first threads 108 and the one or more second threads 104;
one or more first fixation holes 113 disposed in the non-threaded portion 105 of the nail 100, wherein the one or more first fixation holes 113 are proximate and free from engagement with the one or more second threads 104; and
an insertion block 169 (structure attached to 100 in fig. 22) removably attached to the distal end 102 of the nail 100.
Niver fails to teach the insertion block being configured to accommodate both a female torque element and a male torque element. Niver’s structure 169 is essentially a special ‘screwdriver’ (see e.g. fig. 15).
Chang teaches a screw kit including a screw 1 (analogous to the nail in this case), and an insertion block 2/3. The insertion block 2/3 is used as a special screwdriver to drive the screw 1. Insertion block 2/3 is configured to accommodate both a female torque element 111 and a male torque element at the portion of 11 configured as a central penta-lobular ‘post’.
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the driving structure of the nail 100 to be similar to those at 111 on Chang’s screw, and the insertion block 169 to be similar to that of Chang’s driving structures 2/3, sizes being correlated. Such an arrangement provides for improved interlocking between the driver and the screw, ensuring alignment of the driver. Such an arrangement additionally provides additional contact area between the driver and the screw in order to assist with prevention of stripping of the driving structures on the screw and driver during application of torque. The modified arrangement additionally provides for an alignment element 3 which further ensures alignment between screw and driver during use.
Regarding claim 2, Niver teaches a proximal cutting tip disposed at the proximal end 107 of the nail 100 as seen best at fig. 5. The ‘interrupted thread’ design 125 (with flats 122) is known to be a cutting tip design.
Regarding claim 3, the one or more first threads 108 are disposed adjacent to the proximal cutting tip at 107.
Regarding claim 4, the one or more first threads 108 are disposed along the proximal end of the nail 100 such that there is space between the one or more first threads and the proximal cutting tip – portion 108 will be considered to end at the junction between the threads with full form and the threads with flats, which will be considered the cutting tip, as seen best at fig. 4.
Regarding claim 6, the device includes one or more second fixation holes 115 in the nail 100 for fixating the nail to the first bone via one or more inferred second fixation devices (e.g. a screw), the one or more second fixation holes disposed between the one or more first threads 108 and the one or more second threads 104.
Regarding claim 34, the non-threaded portion 105 of the nail 100 comprises: a first proximal end of a first diameter (above necked region in fig. 1); a first distal end of a second diameter larger than the first diameter (below the necked region in fig. 1); and the one or more first fixation holes 113 are disposed in and extend fully through the first distal end of the non-threaded portion 105 of the nail 100.
Regarding claim 35, the male torque element 21 is considered to be a star drive – e.g. a five point star. While the figures demonstrate the female torque element (at the hole in 21) being a five-lobed structure (rather than the claimed hex drive), examiner points to the teaching that the driver has ‘at least one driving facet’ – considered to encompass the claimed hex (six). Selection of five or six driving facets does not materially affect the functionality of the tool for its purpose of driving the screw, and in-fact, would further improve the proposed improvement laid out by examiner, in that such an arrangement provides for increased surface area of contact between the driver and screw to further prevent likelihood of stripping.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799