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 3/13/2025 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 § 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(s) 14-15 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 14 recites the limitation "the first, second and third through holes" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It appears that claim 14 should be amended to depend from claim 12 instead of claim 1 in order to have sufficient antecedent basis for the limitation of the third through hole; and for the purpose of compact prosecution, has been examined below under this assumption.
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”).
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; 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.
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]).
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.
Claim(s) 4-5, 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Machamer in view of Silva, as applied to claim 1 above.
Machamer in view of Silva 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose intramedullary nail insertion devices:
PNG
media_image1.png
172
606
media_image1.png
Greyscale
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773