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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/03/2026 has been entered.
Claims 1, 3, 4 and 6 remain pending.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 14 change “mates” to –mate--. Appropriate correction is required.
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.
Claims 1, 3, 4 and 6 are 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 1 recites the limitation "the compression screw" in line 15. There is insufficient antecedent basis for this limitation in the claim. Claim 1 previously recites "at least three associated screws" and "an associated screw in the proximal compression hole," but never recites a "compression screw." It is unclear whether "the compression screw" is intended to refer to the previously recited "associated screw in the proximal compression hole," to one of the "at least three associated screws" generally, or to a further, fourth screw. For purposes of examination, "the compression screw" is interpreted as the previously recited associated screw received in the proximal compression hole.
Additionally, claim 1 includes the recitation of "the axis of the screws" (line 8), and "the mating diameter” (lines 8-9). Neither "the axis of the screws" nor "the mating diameter" has antecedent basis. It is further unclear whether "the screws" refers collectively to all of the at least three associated screws (which would require a single axis common to several screws extending through holes at different angles, and a geometric impossibility on the disclosed device) or to the individual screw associated with each compression hole.
Claim 1 first recites "at least three through holes comprising a distal screw hole, an intermediate screw hole, and a proximal compression hole," identifying exactly one hole as a compression hole. Claim 1, line 7 then recites "wherein two of the through holes are compression holes." It is unclear which of the previously recited holes is the second compression hole, or whether the second compression hole is an additional, unrecited hole. The metes and bounds of the claim cannot be determined.
Claim 1, line 10 recites "a drive insert that has external threads," and then recites (line 13) that the drive insert "comprises an assembly having a sleeve with a torque driving recess and external threads that mates with internal threads within the central chamber." It is unclear whether the second recitation refers to the same external threads or to an additional set of threads.
Claim 1, lines 14-15, recites "a cap that does not engage the threads," it is unclear whether "the threads" refers to the internal threads of the central chamber, the external threads of the drive insert, or both.
Claims 3, 4 and 6 are rejected as depending from, and incorporating the deficiencies of, claim 1.
Claim Rejections - 35 USC § 103
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 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 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grady et al. (US 2012/0330313 A1) in view of Garlock et al. (US 2017/0296241 A1).
Grady et al. disclose an intramedullary nail system (see Fig. 1, element 10) comprising: an intramedullary nail (1) and at least three associated screws (see Fig. 1, elements 6, 7); wherein the nail includes an elongated nail body member having a central chamber extending along a long axis having internal threads (see Fig. 2, element 44) and at least three through holes (see Fig. 2, elements 50P, 195, 95, 90; see Fig. 1, element 50D) comprising a distal screw hole, an intermediate screw hole, and a proximal compression hole, each of which extend at an angle to the long axis; wherein two of the through holes are compression holes which have a cross sectional configuration taken along the axis of the screws having a dimension that is greater than the mating diameter of an associated screw so as to form an ovoid compression hole. Grady discloses two elongated slots: slot 95 in nail shaft 1S, which aligns with slot 90 in anchoring sleeve 2 to define slot-shaped transverse screw passage 99, and proximal dynamization slot 195. Each slot is elongated along the nail's long axis relative to the diameter of the received bone screw 6, "such that when a bone screw 6 extends through the slot-shaped passage 99, the anchoring sleeve 2 and the nail shaft 1S have a desired amount of freedom to move axially relative to the bone screw," thereby "allowing the nail system to compress the bone(s) being treated" (FIGS. 2, 3, 5). Grady et al. further disclose a drive insert that has external threads, the drive insert positioned in the central chamber such that the drive insert can be rotated to drive an associated screw in the proximal compression hole (see Fig. 2, element 70 - element 70 threadingly mounted inside internally threaded section 44 of nail shaft 1S (FIGS. 2, 4, 11a–11b) and "can be advanced through the hollow internally threaded section against the screw 6 that is mounted within slot passage 99," and "advancing the element 70 against the bone screw 6 pulls the first end PE of the nail shaft toward the bone screw 6 to provide bone compression," compressing the tibia, talus and calcaneus for fusion).
Grady et al. do not expressly disclose that the drive insert comprises an assembly having a sleeve with a torque driving recess and external threads that mates with the internal threads within the central chamber, and a cap that does not engage the threads and which engages the compression screw. Grady's internal compression screw 70 is a unitary threaded member that bears directly against bone screw 6.
Garlock et al. disclose a drive insert (see Fig. 17, element 710) comprising an assembly having a sleeve with a torque driving recess, and external threads that mate with internal thread within a central chamber and a cap (722) that does not engage the threads and which engages a compression screw in the same field of endeavor for the purpose of applying compression to a locking screw seated in an oblong slot. Specifically, Garlock teaches that element 710 threads into opening 718 of IM nail 700, wherein "element 710 can include al thread which pushes element 722 against an interconnecting screw 720 that may be placed through an oblong, dynamization slot 708" (FIGS. 17–21). Element 722 bears on the compression screw without itself engaging the threads. Garlock further teaches that "element 710 can be used in all types of IM nails."
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Grady's unitary internal compression screw to be a two-piece assembly comprising a threaded, torque-driven sleeve and a separate non-threaded thrust cap bearing on the bone screw, as taught by Garlock. The motivation to do so is provided by Garlock's express teaching that its dynamic cap-and-plunger arrangement is applicable to "all types of IM nails and such arthrodesis devices," and by the well-recognized advantages of a rotationally decoupled thrust member. Separating the driven, threaded element from the element that contacts the bone screw prevents the applied driving torque from being transmitted to the bone screw (which could back the screw out), and allows the thrust face to seat squarely against the screw regardless of the rotational position of the threaded member. Such a substitution is a simple substitution of one known compression-transmitting structure for another to obtain predictable results. Providing a torque driving recess in the threaded sleeve is also obvious, as Grady's internal compression screw 70 must be rotated in situ through the cannulation and therefore requires a driving feature.
Regarding claim 4, Grady et al. disclose that at least one through hole is a distal hole (see Fig. 3, element 50D) along the long axis and has a round cross-sectional configuration and has an associated screw to anchor the nail body member in the associated bone. Hole 50D adjacent the distal end DE, is configured to receive a bone screw 6.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grady et al. (US 2012/0330313 A1) in view of Garlock et al. (US 2017/0296241 A1) as applied to claim 1 above, further in view of Brigido (US 2011/0054473 A1).
Grady et al. in view of Garlock et al. disclose the invention substantially as described above. However, Grady et al. in view of Garlock et al. do not explicitly disclose a screwdriver which extends into the central chamber, the screwdriver having a tip configured to selectively engage the drive insert.
Brigido discloses a tibiotalocalcaneal arthrodesis nail 12 having a drive insert 18 (see Fig. 7) that is rotated to compress the arthrodesis site, and a screwdriver 24 (see Fig. 16) having a tip 184 configured to selectively engage the drive insert (see par. 0040) i.e., the driver extends into an internal bore of the nail to selectively engage the driver insert.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the Grady/Garlock system with a screwdriver extending into the central chamber and having a tip configured to selectively engage the drive insert, as taught by Brigido, in order to transmit rotational torque to the internal compression member from outside the patient after the nail has been implanted, so that the amount of compression across the fusion site can be set or later adjusted under the surgeon’s direct control. This is the use of a known technique (a mating driver tip and drive socket) to improve a similar device in the same way.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grady et al. (US 2012/0330313 A1) in view of Garlock et al. (US 2017/0296241 A1) as applied to claim 1 above, further in view of Elghazaly et al. (U.S. 8,157,802 B2).
Grady et al. in view of Garlock et al. disclose the invention substantially as described above. However, Grady et al. in view of Garlock et al. do not explicitly disclose an outrigger which is external to but connected to the nail during surgery to provide a drill guide to direct placement of the screws.
Elghazaly et al. disclose an intramedullary nail system (see Fig. 6) comprising an outrigger (500) which is external to but connected to the nail during surgery to provide a drill guide for placement of the screws in the same filed of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Grady et al. in view of Garlock et al. to include an outrigger, as disclosed by Elghazaly et al., in order to precisely place the screws within the intramedullary nail openings. Besides greater accuracy, other benefits of an outrigger include reduced radiation exposure as use of a fluoroscope is not necessary, decreased operative time, and simplified distal locking.
Response to Arguments
Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
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.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
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