DETAILED ACTION
This office action is responsive to the amendment filed June 8, 2026. Claim 22 was amended; claim 23 was canceled; and claim 36 was newly presented. Claims 1-4, 6, 21, 22, and 24-36 are pending, though claims 21, 22, and 24-33 were previously withdrawn from consideration.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 .
Response to Arguments
Applicant's arguments filed June 8, 2026, have been fully considered but they are not persuasive.
The arguments are related to the rejection of claims 1-4, 6, 34, and 35 under 35 USC 103 in view of Niver et al. (US 2025/0387147) and Chang (US 2009/0129889).
The argument states that the combination of Chang and Niver is improper since one with ordinary skill in the art would not have been motivated to modify Niver’s system to incorporate portions of Chang’s system due to the devices being related to distinct fields of use.
Examiner agrees that Niver’s and Chang’s devices are taught being used in different spaces, but disagrees, ultimately, that Niver’s portion 169 and Chang’s portion 2/3 do not relate to the same problem – namely, a solution for driving a threaded component into another structure. The rejection identifies that Chang’s arrangement, when applied to the Niver device, functions to improve alignment between the driver and driven-part, and increases surface area between driver and driven-part in order to prevent stripping between the portions.
The argument states that one would not have made the modification to Niver, since such is a more complex system. Examiner disagrees due the advantages of alignment and prevented stripping that the modified arrangement accomplishes.
The rejection of record is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 36 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Examiner studies the disclosure for the newly added limitations “free of any tapering”; and “uniform diameter”. Such terms are not in the disclosure. Therefore, Examiner is of the position that such can only be disclosed insomuch as can be ascertained from the figures.
Examiner disagrees that there is sufficient teaching to meet either of the limitations in question. For instance:
Examiner studies figure 2; the enlarged portion demonstrates a screw tip having tapered teeth at the tip, thereof.
Further studying figure 2, examiner is of the position that portions of the proximal end which include threads are not of a uniform diameter with portions which do not include the thread.
Further studying figure 2, examiner is of the position that the final turn of thread in the proximal portion (see e.g. fig. 3) both tapers back to the rigid body 108, and is not of a uniform diameter at this transition portion.
Therefore, new claim 36 is considered to contain new matter.
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, and 34-35 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, 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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/DAVID W BATES/Primary Examiner, Art Unit 3799
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