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 .
Election/Restrictions
Applicant's election with traverse of group I species 1 in the reply filed on 11/10/2025 is acknowledged. The traversal is on the ground(s) that the figures are part of a single kit. This is not found persuasive because while the specification discloses nails provided in kits paragraph 40-48 clearly state that figures 13A-20 are “alternative embodiments” to figure 1 such they would not be including in the kit but alternative to the kit. The applicant does not argue the restriction between groups.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15 and 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/10/2025.
Claim Objections
Applicant is advised that should claim 11 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by James et al. (US Pub 2005/0055024).
With respect to claim 1, James discloses an intramedullary fibula nail kit (see figures 4-6 and 11-12, paragraph 8, combination of devices can be included), comprising: an intramedullary fibula nail (fig 4, 100) including a proximal portion (see fig 4 below and fig 5) configured to be positioned within a medullary canal of a fibula, and a distal portion (see fig 4 below and FIG 6) configured to be positioned within the medullary canal of the fibula, wherein the distal portion defines a non-cylindrical geometry (see fig 6 below). With respect to claim 2, James discloses wherein: the proximal portion is cylindrically shaped (fig 5) ;the distal portion defines a first maximum (see fig 6 below) width in a medial-lateral plane and a second maximum width (see fig 6 below) in an anterior-posterior plane; the second maximum width is larger than the first maximum width (see fig 6 below); and the second maximum width is larger (see figs 4-6 below) than a maximum diameter (fig 5) of the proximal portion. With respect to claim 3, James discloses, wherein: the distal portion includes a neck portion (see fig 4 and 12 below) which tapers (fig 4) to the proximal portion when the intramedullary fibula nail is implanted. With respect to claim 4, James discloses wherein: the proximal portion defines a proximal portion longitudinal axis (see fig 4 below); the distal portion defines a distal portion longitudinal axis (see fig 4 below); andthe distal portion longitudinal axis is not aligned with the proximal portion longitudinal axis in the anterior-posterior plane when the intramedullary fibula nail is implanted (see fig 9 below). With respect to claim 8, James discloses the intramedullary fibula nail further including: at least one serrated anchoring structure (fig 12, 142 or fig 11, 144) configured to anchor the intramedullary fibula nail, wherein the proximal portion defines a proximal portion longitudinal axis; the at least one serrated anchoring structure defines at least one activated anchoring longitudinal axis: and the at least one activated anchoring longitudinal axis is parallel to the proximal portion longitudinal axis (the serrated surface is located on the surface parallel to the axis).
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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.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over James et al. (US pub 2005/0055024) in view of Fallin et al. (US Patent 10,136,929).
With respect to claims 5 and 6, James discloses the claimed invention except for further comprising: at least one threaded anchoring structure configured to anchor the intramedullary fibula nail, wherein the proximal portion defines a proximal portion longitudinal axis; the at least one threaded anchoring structure defines an activated anchoring longitudinal axis: and the activated anchoring longitudinal axis is parallel to the proximal portion longitudinal axis, wherein: the activated anchoring longitudinal axis is coaxial with the proximal portion longitudinal axis; and the proximal portion is configured to slidingly engage the distal portion.
Fallin discloses at least one threaded anchoring structure (fig 43 threads on 274) configured to anchor the intramedullary fibula nail, wherein the proximal portion defines a proximal portion longitudinal axis (axis of 250); the at least one threaded anchoring structure defines an activated anchoring longitudinal axis: and the activated anchoring longitudinal axis is parallel (aligns with the axis) to the proximal portion longitudinal axis, wherein: the activated anchoring longitudinal axis is coaxial (fig 42) with the proximal portion longitudinal axis; and the proximal portion is configured to slidingly (274 slides onto 272) engage the distal portion (fig 42, 272) to aid in stabilizing the bone (col. 1, ll. 47-49).
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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 device of James to include further comprising: at least one threaded anchoring structure configured to anchor the intramedullary fibula nail, wherein the proximal portion defines a proximal portion longitudinal axis; the at least one threaded anchoring structure defines an activated anchoring longitudinal axis: and the activated anchoring longitudinal axis is parallel to the proximal portion longitudinal axis, wherein: the activated anchoring longitudinal axis is coaxial with the proximal portion longitudinal axis; and the proximal portion is configured to slidingly engage the distal portion in view of Fallin in order to aid in stabilizing the bone.
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over James et al. (US pub 2005/0055024) in view of Emilio et all. (US Patent 5,814,047).
With respect to claims 5 and 7, James discloses the claimed invention except for further comprising: at least one threaded anchoring structure configured to anchor the intramedullary fibula nail, wherein the proximal portion defines a proximal portion longitudinal axis; the at least one threaded anchoring structure defines an activated anchoring longitudinal axis: and the activated anchoring longitudinal axis is parallel to the proximal portion longitudinal axis wherein: the activated anchoring longitudinal axis is not coaxial with the proximal portion longitudinal axis; and the at least one threaded anchoring structure is configured to extend outwardly from the distal portion.
Emilio discloses at least one threaded anchoring structure (fig 12, 131) configured to anchor the intramedullary fibula nail, wherein the proximal portion defines a proximal portion (see fig 12 below) longitudinal axis; the at least one threaded anchoring structure defines an activated anchoring longitudinal axis (see fig 12 below): and the activated anchoring longitudinal axis is parallel (see fig 12 below) to the proximal portion longitudinal axis wherein: the activated anchoring longitudinal axis is not coaxial (see fig 12 below parallel but not coaxial) with the proximal portion longitudinal axis; and the at least one threaded anchoring structure is configured to extend outwardly from the distal portion (fig 12) to fix the nail in the bone cavity (abstract).
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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 device of James to include further comprising: at least one threaded anchoring structure configured to anchor the intramedullary fibula nail, wherein the proximal portion defines a proximal portion longitudinal axis; the at least one threaded anchoring structure defines an activated anchoring longitudinal axis: and the activated anchoring longitudinal axis is parallel to the proximal portion longitudinal axis wherein: the activated anchoring longitudinal axis is not coaxial with the proximal portion longitudinal axis; and the at least one threaded anchoring structure is configured to extend outwardly from the distal portion in view of Emilio in order to fix the nail in the bone cavity.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over James et al. (US pub 2005/0055024) in view of Walker (US Patent 4,457,301).
With respect to claim 9, James discloses the claimed invention except for further comprising: at least one rod configured to extend outwardly from the distal portion and to support the at least one serrated anchoring structure.
Walker discloses further comprising :at least one rod (fig 9, 11)configured to extend outwardly from the distal portion (extends from the distal end to the proximal end) and to support the at least one serrated anchoring structure (fig 9, 23) to allow for a precise fit and sufficient stability in the bone (col. 1, ll. 30-35).
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 device of James to include at least one rod configured to extend outwardly from the distal portion and to support the at least one serrated anchoring structure in view of Walker in order to allow for a precise fit and sufficient stability in the bone.
Claim(s) 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over James et al. (US pub 2005/0055024) in view of Saravia et al. (US Pub 2011/0144645).
With respect to claim 10, James discloses the claimed invention except for the intramedullary fibula nail further including: at least one suture activated anchoring structure; and an activation suture operably connected to the at least one suture activated anchoring structure.
Saravia discloses the intramedullary fibula nail (see figures 1C and D below) further including: at least one suture activated anchoring structure (fig 1, 110, 110’); and an activation suture (fig 1, 160)operably connected to the at least one suture activated anchoring structure to grip the inside of the bone (paragraph 77). With respect to claims 11 and 12, Saravia discloses wherein: the activation suture is operably connected to the at least one suture activated anchoring structure through a wedge component (fig 1, 150). With respect to claim 13, Saravia discloses wherein: the at least one suture activated anchoring structure is pivotably connected to the proximal portion through at least one pivot pin (see fig 1 below). With respect to claim 14, Saravia discloses wherein: the at least one suture activated anchoring structure comprises two suture activated anchoring structures (fig 1, 110, 110’), each of the two suture activated anchoring structures pivotably connected to the proximal portion through a respective one of the at least one pivot pin (fig 1c below).
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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 device of James to include the intramedullary fibula nail further including: at least one suture activated anchoring structure; and an activation suture operably connected to the at least one suture activated anchoring structure in view of Saravia in order to grip the inside of the bone.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over James in view of Saravia as applied to claim 14 above, and further in view of Voor et al. (US Patent 11,207,081).
With respect to claim 16, James in view of Saravia discloses a kit including a reamer (fig 19, 302) and a guide sleeve (fig 19, 304) wherein the proximal portion defines a proximal portion longitudinal axis (fig 4 above) but does not specifically disclose a guide reamer including a sleeve coupling portion and at least one side guide channel; a guide sleeve including a central coupling portion configured to non-rotatably couple with the sleeve coupling portion of the guide reamer, the guide sleeve including at least one offset guide channel; and at least one offset reamer, and the at least one offset guide channel and the at least one side guide channel are configured to guide the at least one offset reamer within the guide sleeve and the at least one side guide channel is configured to guide the at least one offset reamer outside of the guide sleeve.
Voor discloses a guide reamer (fig 12, 440) including a sleeve coupling portion(fig 12, 43)) and at least one side guide channel (Fig 12, 460); a guide sleeve (Fig 11, 470) including a central coupling portion configured to non-rotatably couple with the sleeve coupling portion of the guide reamer (fig 11), the guide sleeve including at least one offset guide channel (fig 12, 479); and at least one offset reamer (fig 12, 487), and the at least one offset guide channel and the at least one side guide channel are configured to guide the at least one offset reamer within the guide sleeve and the at least one side guide channel is configured to guide the at least one offset reamer outside of the guide sleeve (fig 11 and 12) to allow for selective shaping of the canal (col. 1, ll. 50-55).
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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 device of James in view of Saravia to include a guide reamer including a sleeve coupling portion and at least one side guide channel; a guide sleeve including a central coupling portion configured to non-rotatably couple with the sleeve coupling portion of the guide reamer, the guide sleeve including at least one offset guide channel; and at least one offset reamer, and the at least one offset guide channel and the at least one side guide channel are configured to guide the at least one offset reamer within the guide sleeve and the at least one side guide channel is configured to guide the at least one offset reamer outside of the guide sleeve in view of Voor in order to allow for selective shaping of the canal.
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over James in view of Saravia in view of Voor as applied to claim 16 above and further in view of Frigg (US patent 5,034,012).
With respect to claim 17, James in view of Saravia in view of Voor discloses the suture is secured by a ratchet (fig 4, 444 of Saravia) to hold the suture in the deployed position (paragraph 78) but does not disclose the suture held by wherein: the distal portion defines a suture cross-over region; the intramedullary fibula nail kit includes a clamping screw; and the clamping screw is configured to clamp the activation suture within the suture cross- over region.
Frigg discloses the suture (fig 6, 14) held by wherein: the distal portion (fig 6, 13) defines a suture cross-over region (Fig 6. 6); the intramedullary fibula nail kit includes a clamping screw (Fig 6, 2); and the clamping screw is configured to clamp the activation suture within the suture cross- over region (fig 8) to hold the suture in the deployed position (col. 3, ll. 33-40).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute Ratchet of James in view of Saravia in view of Voor with the distal portion defines a suture cross-over region; the intramedullary fibula nail kit includes a clamping screw; and the clamping screw is configured to clamp the activation suture within the suture cross- over region in view of Frigg because the ratchet and the distal portion defines a suture cross-over region; the intramedullary fibula nail kit includes a clamping screw; and the clamping screw is configured to clamp the activation suture within the suture cross- over region are mere functional equivalents, and because such a substitution of one for the other would have achieved the same predicable result of holding the suture in the deployed position.
With respect to claim 18, James in view of Saravia in view of Voor and in view of Frigg discloses further comprising :a plurality of screws (fig 21, 202 and 204 of James), wherein the distal portion includes a plurality of elongated screw holes (fig 21, 118, 132), and the plurality of screws and the plurality of elongated screw holes are configured to provide a syndesmosis fixation (fig 1) but does not specifically disclose the angle of between 10 and 50 degrees. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have the angle of between 10 and 50 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20170143390 A1 discloses a nail with a deployable serrated anchor
US 20060015101 A1 discloses a nail with a non-cylindrical geometry
US 20180296258 A1 discloses a nail with an anchoring structure
US 20210153917 A1 discloses a nail with an offset distal and proximal portions and a support rod
US 20210128205 A1 discloses a nail with a non-cylindrical geometry and offset distal and proximal portions
US 20200305938 A1 discloses a nail with kits with different anchor features
US 20130116693 A1 discloses a nail with an anchoring structure
US 5908423 A discloses a nail with an anchoring structure and a reamer
US 7655009 B2 discloses a nail with a non-cylindrical geometry and offset distal and proximal portions
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm 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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/S.J.C/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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