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 .
Response to Arguments
Applicant's arguments (for the rejection relying upon Sinnott, Figs 23-25) fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Fig 25 of Sinnott clearly shows the distal portion is non-cannulated.
Applicant’s arguments with respect to claim(s) 1, 8 in view of Liu and Sinnott (Fig 1) 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.
Election/Restrictions
Claims 9, 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse (of Group I Species A (Figs 8) in the reply filed on 4/7/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “112” has been used to designate both a “hole” (Fig 1) and a dimension (fig 4). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1, 4, 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sinnott US 2017/0112552.
Regarding Claim 1, Sinnott discloses an intramedullary nail (#600, Fig 22-25) comprising a proximal portion, a shaft, and a distal portion (see Fig below), the distal portion being threaded (see Fig below, paragraph 82) and the intramedullary nail including plural transverse holes (only one hole #14 is shown, see paragraph 72 where there can be a plurality of transverse holes #14), wherein the distal portion is non-cannulated (Fig 25).
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Sinnott does not disclose the proximal portion is also threaded.
Sinnott discloses another similar embodiment of an intramedullary nail (#100, Fig 1) comprising a proximal portion (#108), a shaft (#118), and a distal portion (#104), both a proximal portion (#122, paragraph 61) and the distal portion (#112, paragraph 56) being threaded (Fig 1, paragraph 56, 61) and the intramedullary nail including plural transverse holes (“one or more transverse holes..” end of paragraph 61), the proximal portion threads (#122) providing proximal fixation of the nail (paragraph 61).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the proximal portion of Sinnott to include threads in view of another embodiment of Sinnott above because provides additional proximal fixation of the nail.
Regarding Claim 4, Sinnott as modified discloses the distal portion having a staggered configuration (Fig 22-25 in Sinnot where the distal portion is staggered between threaded areas having a larger diameter than the smooth root surface with a smaller diameter).
Regarding Claim 6, Sinnott as modified discloses a first set of holes positioned for syndesmotic securement (see Fig below, paragraph 82 in Sinnott) and a second set of holes positioned for distal securement (see Fig below), each of the first set of holes being spaced apart along an axis of the intramedullary nail (see Fig below, spaced along a longitudinal axis of the nail), each of the first set of holes having an axis, the axes of the first set of holes being generally parallel to one another (see Fig below, see also Fig 25 and paragraph 82 in Sinnott), each of the second set of holes being spaced apart along an axis of the intramedullary nail (see Fig below) and the second set of holes being disposed relatively proximally to the second set of holes (in the orientation as seen in Fig 23-25 the second set of holes are proximal to the first set of holes).
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Regarding Claim 7, Sinnott as modified discloses at least one hole of the second set of holes having an axis that is generally parallel to the axes of the first set of holes (see Fig below, Fig 24-25 in Sinnott) and at least one hole of the second set of holes having an axis that is not generally parallel to the axes of the first set of holes (see Fig below, Fig 24-25 in Sinnott).
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Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sinnott US 2017/0112552 in view of Liu US 2020/0405329.
Sinnott as modified discloses the claimed invention as discussed above but does not disclose, the distal threaded portion being tapered.
Lieu discloses an intramedullary nail (#12, Fig 3) comprising a proximal portion, a shaft, and a distal portion (see Fig below), both a proximal portion and the distal portion being threaded (see Fig below, paragraph 75) and the intramedullary nail including plural transverse holes (only one hole #14 is shown, see paragraph 72 where there can be a plurality of transverse holes #14), the distal threaded portion being tapered (as seen in Fig 3) to provide a leading end of the nail into the intramedullary canal (Fig 1a, paragraph 48, 75).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the distal threaded portion of Sinnott to be tapered in view of Lieu above to provide a leading end of the nail as it is threaded into the bone.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sinnott US 2017/0112552 in view of Whipple US 2015/0196336.
Sinnott discloses the claimed invention as discussed above but does not disclose an interrupted distal thread.
Whipple discloses a threaded fastener (Fig 1-2) with having a distal groove (#41) that provides an interrupted distal thread (as seen in Fig 1-2), the distal groove allows for removal of bone chips as the fastener is implanted (paragraph 27).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Sinnott to include a distal groove such that it provides an interrupted distal thread in view of Whipple above so that bone chips are able to be removed as the nail is implanted.
Claims 8, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sinnott US 2017/0112552 in view of Liu US 20200405329.
Regarding Claim 8, Sinnott as modified discloses a system (Fig 80 in Sinnott) comprising the intramedullary nail of claim 1 (#600, see rejection for claim 1 above), a driver (#1302, Fig 35, 78-80), and a placement jig (#1306, Fig 35, 80), the placement jig comprising a keyed driver opening (see Fig below) and a plurality of holes (see Fig below), the driver comprising a keyed portion that may be accommodated within the keyed driver opening (see Fig below, Fig 80) and engageable with said intramedullary nail (Fig 80), and the placement jig further comprising a plurality of openings (see Fig below), at least some of the openings positioned for alignment with respective holes in said intramedullary nail when said keyed portion of said driver is positioned within said keyed driver opening and when said driver is in engagement with said nail (see Figs below, Fig 80, paragraph 150).
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Sinnott does not disclose the system is part of a kit.
Liu discloses an intramedullary nail (#12), a driver (#50) and a placement jig (#30) packaged in a sterilized kit (paragraph 82).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the system of Sinnott to be packaged in a kit in view of Liu so that the nail, driver and jig are packaged in a sterile kit ready for use.
Regarding Claim 10, Sinnott as modified discloses a transverse screw (“screw” paragraph 82 and as seen in Fig 81 in Sinnott below).
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Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sinnott US 2017/0112552 in view of Krause US 2011/0144703.
Sinnott as modified discloses wherein the distal portion has a major diameter (Fig 24, diameter of the outer threads of the distal portion) and a minor diameter (root diameter of the threads, Fig 24), the minor diameter of the distal portion having a proximal zone, a distal zone, and an intermediate zone, the intermediate zone disposed between the proximal zone and the distal zone, wherein the minor diameter is constant throughout the proximal zone and the distal zone (see Fig below all the zones has a constant minor diameter) but does not disclose the minor diameter is tapered throughout the intermediate zone.
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Krause discloses a threaded screw (Fig 13) a major diameter (diameter of the outer threads, Fig 13) and a minor diameter (Fig 13, root diameter of the threads, T1, T2, T3), the minor diameter of the distal portion having a proximal zone (at T3 fig 13), a distal zone (at T1 Fig 13), and an intermediate zone (middle section that includes T2, Fig 13), the intermediate zone disposed between the proximal zone and the distal zone (Fig 13), wherein the minor diameter (T1, T3) is constant throughout the proximal zone and the distal zone (paragraph 84), and wherein the minor diameter is tapered throughout the intermediate zone (paragraph 84 where it tapers inward from T1 to T2 and then outward from T2 to T3), where this configuration reduces torque required to advance the screw (paragraph 84).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to have the minor diameter of Sinnott to be tapered throughout the intermediate zone in view of Krause above because this configuration reduces torque required to advance the nail.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sinnott US 2017/0112552 in view of Buckley US 3,079,968.
Sinnott as modified discloses the distal portion has a major diameter (outer diameter of the threads, Fig 24 below) and a minor diameter (root diameter of the threads, see Fig 24), the minor diameter of the distal portion having a most proximal end (see Fig below), a distalmost portion (see Fig below), and an intermediate portion (see Fig below), the intermediate portion disposed between the most proximal end and the distalmost portion (see Fig below), wherein the minor diameter is constant throughout the most proximal end (see Fig below, the dotted line represents where the most proximal end is located and the minor diameter along the dotted line is constant) the minor diameter along the dotted line at the proximal post end is constant) and the distalmost portion (see Fig below, the dotted line represents where the distalmost portion is located and the minor diameter along the dotted line is constant) but does not disclose wherein the minor diameter is thicker throughout the intermediate portion.
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Buckley, in the same field of endeavor as threaded screws and pertinent to the problem of providing threads to a screw (Fig 5, see Fig below), discloses a screw having a major diameter (diameter of the threads, see Fig 5 below) and a minor diameter (root diameter, see Fig 5 below), the minor diameter of the distal portion having a most proximal end, a distalmost portion, and an intermediate portion (see Fig below), the intermediate portion disposed between the most proximal end and the distalmost portion (see Fig below), wherein the minor diameter is constant throughout the most proximal end (see Fig below, the dotted line represents where the most proximal end is located and the minor diameter along the dotted line is constant) the minor diameter along the dotted line at the proximal post end is constant) and the distalmost portion (see Fig below, the dotted line represents where the distalmost portion is located and the minor diameter along the dotted line is constant) and wherein the minor diameter is thicker throughout the intermediate portion (see Fig below, Col 3 lines 15-21) that allows for easier driving of the screw.
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the intermediate portion of Sinnott to be thicker in view of Buckley above because this allows for easier driving of the screw.
Conclusion
See PTO-892 where Hasenbohler (Fig 3), Zucherman (Fig 1a), Anderson (Fig 1a) show various thread configurations.
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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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, the examiner’s supervisor, Eduardo Robert can be reached 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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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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