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 without traverse of Group II, Species 2, Species a, and Species II in the reply filed on 07/20/2026 is acknowledged. Claims 10, 11 and 16-25 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 10, 11, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 and 19 of U.S. Patent No. 12,137,941 B2 in view of Whiteside et al. (U.S. 5,501,688).
Claim 15 of the patent discloses the invention of claim 10 of the application except for explicitly disclosing said medical cable having a closed loop at at least one of its ends.
Whiteside discloses a surgical wire having ends preformed into loops which can be hooked with instruments to aid in manipulation (see Background; Figs. 5-7; claim 14) in the same field 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 include a closed loop at at least one end of the cable, as taught by Whiteside, in order to allow the cable end to be hooked with an instrument to aid in routing the cable through the bone segments.
Regarding claim 11, see patent claims 16 and 19 (the element for redirecting the cable is a fulcrum pin or screw attached to the fixed bone segment and configured to extend within its intramedullary canal).
Regarding claim 16, see patent claim 17 (two cable pulling devices hold opposite ends of a same cable), with loops at both ends as taught by Whiteside (see claim 14).
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 18-20, 24 and 25 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 24 recites that the lead wires "extend from the main body for at least 70 mm." The original disclosure describes a lead wire extending "for at least 40 mm, ideally for at least 90 mm," and "at most 200 mm, ideally at most 150 mm" (see par. 0015), and a length "between 90 mm and 150 mm" (see par. 0057). A lower limit of 70 mm is not disclosed, and the open-ended range "at least 70 mm" is not supported by the disclosed ranges or examples.
Claim 18 recites "two lead wires of the medical cable defining a closed loop are provided at both the first end and the second end." It is unclear whether the two lead wires together define a single closed loop, or whether one lead wire at each end defines its own closed loop. It is also unclear whether the "two lead wires" include the "at least one lead wire" of claim 17, and how they relate to "the closed loop" of claims 10 and 17. For examination, the limitation is interpreted as a lead wire at each of the first and second ends, each defining a respective closed loop, one of which is the at least one lead wire of claim 17 (see Fig. 3, elements 92, 98; par. 0057). Claims 19, 20, and 25 are rejected for depending from claim 18.
Claim 24 recites "said two lead wires forming the closed loop." Under claim 18, two closed loops may be present, so it is unclear which closed loop is referenced, or whether the two lead wires together form one loop. For examination, claim 24 is interpreted as each lead wire, forming its respective closed loop, extending from the main body by the claimed length.
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) 10, 11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dankai et al. (CN 108498149 A) in view of Whiteside et al. (U.S. 5,501,688).
Concerning claim 10, Wu discloses an orthopedic bone transport system (see Fig. 1), comprising: an external fixation frame (see Fig. 1, element 4) adapted to be solidly attached to at least a fixed bone segment (i.e., the bone transport receiving end of the long bone, into which Schanz nails 2, 6 are percutaneously placed); at least a cable pulling device (3, i.e., a capstan with turntable 32 rotated about axis 31) adapted to be fixed on said external fixation frame (capstan 3 is mounted on cable seat 4); and at least a medical cable (1) adapted to be secured to a transport bone segment (i.e., the osteotomized active bone block) and to be wound on said cable pulling device (end 12 is attached to turntable 32, which winds cable 1 in a single direction).
Dankai et al. fail to explicitly disclose said medical cable having a closed loop at at least one of its ends.
Whiteside discloses surgical wires whose ends are preformed into loops which can be hooked with instruments to aid in manipulation, wherein a looped end is placed in a notch of a hook and the hook is withdrawn to draw the wire around the bone (see Background; Figs. 5-7; claim 14, "a wire having looped ends"), in the same field 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 include a closed loop at at least one end of the medical cable of Dankai, as taught by Whiteside, in order to allow the cable end to be hooked with an instrument to aid in manipulating and routing the cable, e.g., through the hollow slideway of Schanz nail 2 and along the medullary cavity to the transport bone segment.
Concerning claim 11, further comprising a balance screw or pin (2, i.e., the special Schanz nail) adapted to be anchored to at least a fixed bone segment (Schanz nail 2 is placed percutaneously into the receiving-end bone) to redirect the medical cable within an intramedullary canal of said bone segment (cable 1 enters the hollow slideway of Schanz nail 2 at external opening 22 and exits at internal opening 21 into the medullary cavity, then extends along the medullary cavity to the transport segment; see Figs. 1-3).
Concerning claim 16, wherein the medical cable has closed loops at both its opposite ends (Whiteside, both ends of the wire are looped; see claim 14, "slipping the other looped end of said wire about said hook"). The motivation of claim 10 applies equally to both ends, since each end of the cable of Dankai must be routed (one to the transport segment, one through Schanz nail 2 to capstan 3).
Claims 17-21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Dankai et al. (CN 108498149 A) in view of Whiteside et al. (U.S. 5,501,688), and further in view of Huebner (U.S. 2006/0106391 A1).
Concerning claim 17, Wu discloses the medical cable comprises: a flexible main body (1, i.e., the titanium cable, which is wound on turntable 32) having an external cable diameter, the main body having a first end (the end fixed to the transport segment by screw 13) and a second end (12). Whiteside teaches the closed loop, as set forth for claim 10.
Dankai et al. and Whiteside fail to explicitly disclose at least one lead wire extending from the first end or the second end of the main body, the lead wire having a wire diameter and being more flexible than the main body, the wire diameter being less than one half of the external cable diameter, said lead wire defining the closed loop.
Huebner discloses a bone fixation wire having a loop manipulation feature at either or both ends, which may be formed separately from the elongate body, may have a different composition than the body, and is then secured to the body; the loop at the threading end may be flexible so that it can be flattened to fit through apertures (see par. 0029). Huebner further discloses longitudinally arrayed segments of different flexibility, wherein a relatively more flexible segment may have a smaller diameter than a relatively less flexible segment (see pars. 0032; 0043), in the same field 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 form the closed loop of Dankai, as modified by Whiteside, from a separate, more flexible, smaller-diameter lead wire secured to and extending from the end of the main body, as taught by Huebner, in order to allow the loop to flatten and pass through narrow apertures while the main body retains the strength needed to transport the bone segment.
As to the wire diameter being less than one half of the external cable diameter, Huebner teaches the more flexible segment may have a smaller diameter. The relative diameter is a result-effective variable: a smaller lead wire gives greater flexibility. It would have been obvious to optimize the ratio to less than one half through routine experimentation. Applicant describes the ratio as preferred and has not shown criticality.
Concerning claim 18, wherein two lead wires of the medical cable defining a closed loop are provided at both the first end and the second end (as interpreted above; Huebner, the loop may be at either or both ends; Whiteside, both ends looped, see claim 14). Providing the lead wire loop of claim 17 at each end is a mere duplication of parts for the same purpose.
Concerning claim 19, wherein the first end of the medical cable is visibly distinguishable from the second end of the medical cable (Huebner, segments of the wire may be marked with a visible coating, band, dot, alphanumeric character, or colored indicium to facilitate identification of regions of the wire (see par. 0033); a coating may have a color distinct from the core(see par. 0037)). It would have been obvious to mark the first and second ends differently, as taught by Huebner, in order to allow the surgeon to identify and distinguish the respective ends of the cable during routing.
Concerning claim 20, wherein the first end and the second end are distinguishable because of a different marking or a difference in color in the main body or in the lead wires respectively attached thereto (Huebner, colored indicium or distinct-color coating, see par. 0033; motivation as in claim 19).
Concerning claim 21, wherein the wire diameter is less than one third of the external cable diameter (result-effective variable optimized through routine experimentation, as set forth for claim 17).
Concerning claim 24, wherein said two lead wires forming the closed loop of the medical cable extend from the main body for at least 70 mm. It is noted that the length of the lead wire loop is a result-effective variable. The loop must be capable of being reached and engaged by a hook through the bone bores while limiting excess material. It would have been obvious to optimize the length to at least 70 mm through routine experimentation.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Dankai et al. (CN 108498149 A) in view of Whiteside et al. (U.S. 5,501,688) and Huebner (U.S. 2006/0106391 A1), and further in view of Burke (U.S. 5,997,542).
Concerning claim 22, Dankai, Whiteside, and Huebner disclose the invention of claim 17 but fail to explicitly disclose the main body of the medical cable is formed of a plurality of strands, each strand having a plurality of strand wires. Burke discloses a surgical cable (46) including seven bundles (50) of strands (48), each bundle including seven strands, with a diameter of about 0.9-2.0 mm (see Fig. 9), in the same field 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 form the titanium cable of Dankai with a multi-bundle, multi-strand construction, as taught by Burke, in order to provide a cable flexible enough to be guided around bone and wound on the capstan, as Burke teaches cable constructions are more flexible than solid wire of the same size.
Concerning claim 23, wherein the strand wires and the lead wire of the medical cable are made of different materials (Burke, strands of stainless steel, titanium, or cobalt chrome; Huebner, the loop feature may have a different composition than the wire body, and segments may be of different materials such as stainless steel and nickel titanium alloy or plastics). It would have been obvious to form the lead wire of a different material than the strand wires, as taught by Huebner, in order to give the loop greater flexibility than the load-bearing main body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited art relates to cable-based bone transport systems: Venturini et al. (U.S. 2023/0200854 A1) discloses a reel-type cable pulling device mounted to an external fixation ring, with a cable looped around a transport segment and redirected about a fulcrum screw; Muschler et al. (U.S. 5,429,638) discloses a traction cable attached to a bone segment and pulled through a sheath along the intramedullary canal.
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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