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 .
Information Disclosure Statement
The information disclosure statement filed 6/22/2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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.
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.
Claim(s) 1-3, 6-13, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machamer et al. (U.S. Pub. No. 2018/0140310 A1, hereinafter “Machamer”) in view of Silva et al. (U.S. Pub. No. 2021/0338293 A1, hereinafter “Silva”) and in view of Gordon et al. (U.S. Pub. No. 2011/0282347 A1, hereinafter “Gordon”).
Machamer discloses, regarding claim 1, a retrograde femoral intramedullary nail system (530, see Figs. 1-5) for stabilizing femoral fractures (see para. [0004]), comprising: an elongate body (502) having a distal region (e.g. region near 501) having a distal end (e.g. end near 501), a central region (e.g. region between region near 501 and 503) extending proximally from the distal region (see Fig. 1), a proximal region (e.g. region near 503) having a proximal end (e.g. end near 503) and extending proximally from the central region and a length between the distal and proximal ends (see Fig. 1), the proximal end adapted to be inserted through a femur and the elongate body defining a central longitudinal axis (see Fig. 1, see para. [0022]); a cannulation from the distal end into the distal region of the elongate body (see para. [0022] “elongate tubular rod” and “hollow”), wherein the distal end of the cannulation is threaded (see para. [0028] “threaded coupling”); first and second transverse through-holes (510, 512, see Fig. 1, see para. [0024]) each defining an axis passing through the central longitudinal axis (see Fig. 2); third and fourth transverse through holes (511 and 513, or 515 and 516, see Fig. 1, see para. [0024]) each defining an axis passing through the central longitudinal axis and circumferentially offset from the first and second transverse through-holes (see Figs. 1-2, see para. [0024]); and an insertion handle (540, see Fig. 5) adapted to be releasably attached to the distal end of the distal region (via 544, see para. [0028] “threaded coupling”).
Regarding claim 3, wherein the axis of the third and fourth through holes (515 and 516) is offset by less than 90 degrees relative to the central longitudinal axis (see para. [0025] “45°-60°).
Regarding claim 6, wherein the axis of at least one of the third and fourth through holes (515 and 516) is at an oblique angle from the central longitudinal axis of the elongate body (see para. [0025] “oblique”).
Regarding claim 7, wherein the oblique angle is configured to have a trajectory towards a posterior condyle of the femur when the nail is positioned within the intramedullary canal of the femur (see para. [0017]).
Regarding claim 8, wherein the nail has a proximal bend of 5° to 10° between the distal region and the proximal region (see Fig. 1, see para. [0022] “approximately 10º”).
Regarding claim 9, wherein the nail has a radius of curvature extending to the proximal end of the elongate body (see Fig. 1, see para. [0022]).
Regarding claim 10, wherein the proximal bend begins proximally from the distal region of the elongate body (see Fig. 1).
Regarding claim 11, wherein the distal region of the elongate body has a larger cross-sectional diameter than the central region of the elongate body (see Fig. 4).
Machamer discloses, regarding 12, a retrograde femoral intramedullary nail system (530, see Figs. 1-5) for stabilizing femoral fractures (see para. [0004]), comprising: an elongate body (502) having a distal region (e.g. region near 501) having a distal end (e.g. end near 501), a central region (e.g. region between region near 501 and 503) extending proximally from the distal region (see Fig. 1), a proximal region (e.g. region near 503) having a proximal end (e.g. end near 503) and extending proximally from the central region and a length between the distal and proximal ends (see Fig. 1), the proximal end adapted to be inserted through a femur and the elongate body defining a central longitudinal axis (see Fig. 1, see para. [0022]); a cannulation from the distal end into the distal region of the elongate body (see para. [0022] “elongate tubular rod” and “hollow”), wherein the distal end of the cannulation is threaded (see para. [0028] “threaded coupling”); first, second and third transverse through-holes (511, 513, 518) each defining an axis passing through the central longitudinal axis and being parallel to each other (see Figs. 1 and 3-4, and paras. [0025]-[0025] “ML opening”); fourth and fifth transverse through holes (510 and 512 or 515 and 516) each defining an axis passing through the central longitudinal axis and circumferentially offset from the first to third transverse through-holes (see Figs. 1-2, see para. [0024]), wherein all of the transverse through holes in the distal region are adapted to receive a femoral nail for stabilizing the femoral fractures (see para. [0024] “create a fixed angle construct with the locking screw” and “treat highly unstable fractures”); and an insertion handle (540, see Fig. 5) adapted to be releasably attached to the distal end of the distal region (via 544, see para. [0028] “threaded coupling”).
Regarding claim 13, wherein the axis of the fourth and fifth through holes (515 and 516) is offset by less than 90 degrees relative to the central longitudinal axis (see para. [0025] “45°-60°).
Regarding claim 16, wherein the axis of at least one of the fourth and fifth through holes (515 and 516) is at an oblique angle from the central longitudinal axis of the elongate body (see para. [0025] “oblique”).
Regarding claim 17, wherein the oblique angle is configured to have a trajectory towards a posterior condyle of the femur when the nail is positioned within the intramedullary canal of the femur (see para. [0017]).
Regarding claim 18, wherein the nail has a proximal bend of 5° to 10° between the distal region and the proximal region (see Fig. 1, see para. [0022] “approximately 10º”).
Regarding claim 19, wherein the nail has a radius of curvature extending to the proximal end of the elongate body (see Fig. 1, see para. [0022]).
Regarding claim 20, wherein the proximal bend begins proximally from the distal region of the elongate body (see Fig. 1).
Machamer discloses where the through-holes are threaded (see para. [0024] “two-start thread 514”). Machamer however fails to explicitly disclose, regarding claim 1, wherein the first and second transverse through-holes each have a four-start threaded opening; and wherein the distal region of the elongate body has a larger cross-sectional diameter than the central region of the elongate body; regarding claim 2, wherein all of the first, second, third and fourth through-holes have a four-start threaded opening; regarding claim 12, wherein all of the transverse through holes in the distal region have a four-start threaded opening; and wherein the distal end has a first diameter, the central region has a second diameter, and the proximal region has a third diameter, and wherein the first diameter is larger than the second diameter and the elongate body includes a tapered region that tapers down from the first diameter to the second diameter.
Silva discloses an orthopedic fixation device (10, see Fig. 1), wherein the threaded openings (see paras. [0012] and [0036]) have a four-start thread (see paras. [0012] and [0036]) in order to enable the bone anchors to be more easily oriented and engaged in the screw holes as well as being secured with fewer turns (see para. [0040]).
Gordon discloses an intramedullary nail (20’, see Fig. 6), with a distal region / end (22), a central region (24) and a proximal end / region (26), wherein the distal region of the elongate body has a larger cross-sectional diameter than the central region of the elongate body (see Fig. 6, see para. [0041]), wherein the distal end (22) has a first diameter (see annotated Fig. 6 below), the central region (24) has a second diameter (see annotated Fig. 6 below), and the proximal region (26) has a third diameter (see annotated Fig. 6 below), and wherein the first diameter is larger than the second diameter and the elongate body includes a tapered region (N) that tapers down from the first diameter to the second diameter (see Fig. 6, see para. [0041]) in order to enable the nail to have a smaller diameter, while still providing insertion stability (see para. [0041]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the through-holes in Machamer to be threaded with four-start threads in view of Silva in order to enable the bone anchors to be more easily oriented and engaged in the screw holes as well as being secured with fewer turns. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify wherein the distal region of the elongate body in Machamer to have a larger cross-sectional diameter than the central region of the elongate body and to modify the first diameter of the distal region, the second diameter of the central region, and the third diameter of the proximal region in Machamer so that the first diameter is larger than the second diameter and the elongate body includes a tapered region that tapers down from the first diameter to the second diameter in view of Gordon in order to enable the nail to have a smaller diameter, while still providing insertion stability.
Claim(s) 4-5, 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machamer in view of Silva and in view of Gordon, as applied to claim 1 above.
Machamer in view of Silva and in view of Gordon discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 4, wherein an opening of at least one of the first and second through holes is positioned 54mm from the distal end of the elongate body; regarding claim 5, wherein an opening of the other one of the first and second through holes is positioned 8mm from the distal end of the elongate body; regarding claim 14, wherein an opening of at least one of the first, second and third through holes is positioned 54mm from the distal end of the elongate body; and regarding claim 15, wherein an opening of another other one of the first, second and third through holes is positioned 8mm from the distal end of the elongate body.
Machamer discloses wherein at least one of the through holes is positioned 57 mm from the distal end of the elongate body (see para. [0025]) and wherein at least one of the through holes is positioned 14-20 mm from the distal end of the elongate body (see para. [0025]). And further teaches that eh opening locations are not limited to the described distances that they may be positioned at different locations depending on the anatomy of the bone (see para. [0025]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the opening positioned at 57 mm to be positioned 54 mm from the distal end and the opening positioned 14-20 mm to be positioned 8 mm from the distal end, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Response to Arguments
Applicant’s arguments with respect to the amendment to claim 1 “wherein the distal region of the elongate body has a larger cross-sectional diameter than the central region of the elongate body” and with respect to claim 12, “a distal end with a first diameter, a central region with a second diameter”, “a proximal region with a third diameter”, and “wherein the first diameter is larger than the second diameter and the elongate body includes a tapered region that tapers down from the first diameter to the second diameter” 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, e.g. relies on new reference Gordon et al. (U.S. Pub. No. 2011/0282347 A1, hereinafter “Gordon”) to teach these limitations.
Applicant's arguments filed 4/28/2026, with respect to the combination of Machamer in view of Silva in the rejection of claims 1-20 have been fully considered but they are not persuasive.
The Applicant asserts that it would not have been obvious to one having ordinary skill in the art at the time the invention was made to modify the two start thread of Machamer with the four start thread of claim 1, since Machamer states that “fixed angled constructs are used to treat highly unstable fractures. In unstable fractures or in patients with poor bone quality, it is imperative that the surgeon has an ability to stabilize the lateral translation of the nail relative to the screw. This is often referred to as an interference fit. To achieve interference fit with a locking screw, the threaded holes includes threads with a two-start thread. The threaded two- start holes in the nail itself is an advantage over current interference holes because it is easy to manufacture and requires no additional steps or special techniques on the part of the surgeon." (see para. [0024]). The Applicant further asserts that Machamer is specifically teaching away from four start threads since increasing the number of starts decreases the ability to sustain axial loads which leads to a decrease in the ability to stabilize the lateral translation of the nail relative to the screw. Also, a four-start thread has less "self-locking" capability and is more likely to loosen under the repetitive physiological stresses of a healing limb which undermines Machamer's goal of achieving an interference fit with a locking screw. Finally, four start holes are more complicated to manufacture than two start holes which teaches away from Machamer's disclosure relating to the ease of manufacture of a two start hole.
The Office respectfully disagrees. With regard to the Applicant’s arguments that “Machamer is specifically teaching away from four start threads since increasing the number of starts decreases the ability to sustain axial loads which leads to a decrease in the ability to stabilize the lateral translation of the nail relative to the screw” and that “a four-start thread has less "self-locking" capability and is more likely to loosen under the repetitive physiological stresses of a healing limb”, and that “four start holes are more complicated to manufacture than two start holes which teaches away from Machamer's disclosure relating to the ease of manufacture of a two start hole” these arguments are not explicitly disclosed in the Machamer reference, and therefore the Office does not consider Machamer to teach away from four start holes. Rather, Machamers disclosure in paragraph [0024] points to an advantage of having two thread starts in an interference fit with a locking screw and threaded hole, over the prior art, having a single thread start. Machamer does not teach away from having additional thread starts, nor does Machamers disclosure of the two start thread being easy to manufacture and requiring no additional steps over traditional single start threads teach away from having additional thread starts or teach that addition thread starts increases the cost to manufacture. In addition, similar to Machamer disclosure of fixed angle constructs, the threaded screw holes (32,34, and 36) of Silva are disclosed as receiving a bone anchor along a predetermined and fixed axial trajectory (see para. [0031]), e.g. fixed angle constructs. Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the threaded holes in Machamer to include additional thread starts in view of Silva, since Silva teaches having additional thread starts, e.g. a four-start thread (see paras. [0012] and [0036]) enables the bone anchors to be more easily oriented (see para. [0040]) along their predetermined and fixed axial trajectory (see para. [0031]) and engaged in the screw holes as well as being secured with fewer turns (see para. [0040]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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