DETAILED ACTION
This office action is responsive to the amendment of January 7, 2026. By that amendment, claim 32 was amended. Claims 32-55 are pending.
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 with respect to claim(s) 32-55 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. The newly presented rejection is necessitated by the amendments to the claims of January 7, 2026.
Claim Rejections - 35 USC § 102
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) 32-42, 44-48, 50, and 52-55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Labitzke (DE 3835682 A1). (Previously cited on prior Notice of References, form 892)
Examiner is referring to the original document, and a Clarivate Analytics translation of the document, attached, hereto.
Regarding claim 32, Labitzke teaches an intramedullary nail as at fig. 3 comprising:
a sheath element 2 extending in a longitudinal direction and having a proximal end (down in fig. 3), a distal end (up), and a substantially cylindrical interior (inside of 2),
wherein an external contour of the sheath element, viewed perpendicularly to the longitudinal direction, comprises an elongate spring element (coil spring), which is wound in a helical shape starting from the proximal end and with respect to the longitudinal direction, and
wherein an extension of the external contour of the sheath element is reducible by tensioning the elongate spring element in a winding direction and is increasable by detensioning the elongate spring element counter to the winding direction (inherent to the structure of a helical spring; discussed in paragraph of reference prior to claims); and
a substantially rod-shaped nail core 4 insertable into the interior through the proximal end of the sheath element 2,
wherein the rod-shaped nail core 4 consists of a solid material (“elastically deformable wire”) and has a circular cross- section (wires, or ‘bundles of wires’ as described are known to have circular cross-section), and
wherein the sheath element and the rod-shaped nail core are two separate parts.
Regarding claim 33, the sheath element has the shape of a hollow cylinder (as laid out in fig. 2, the sheath 2 can be seen to be cylindrical in some cases).
Regarding claim 34, the external contour of the sheath element is the wound spring element as seen in the figures.
Regarding claims 35 and 36, the spring element of 2 is wound in form of a three-dimensional coil as seen in fig. 3.
Regarding claim 37, there is a gap between adjacent windings of the spring element as seen in fig. 3.
Regarding claim 38, the spring element is a wire (final paragraph of the document before the claims).
Regarding claim 39, the sheath element 2 is, when its external contour is expanded, braceable against an inner wall of an elongate hollow body to be stabilized (R).
Regarding claims 40-42, the sheath element 2 comprises two elongate spring elements, which are arranged one above the other, and which are each wound in a helical shape with respect to the longitudinal direction of the sheath element (see discussion of nested and multi-start coil spring elements).
Regarding claim 44, the nail core 4 is insertable from an outside into the sheath element 2 which itself is already inserted into a hollow body to be stabilized, or which itself is already implanted in a bone – there is no reason 4 cannot be inserted in such a manner).
Regarding claim 45, the nail core 4 is elastically bendable (elastically deformable wire).
Regarding claim 46, the nail core 4 is capable of being inserted into the sheath element 2, which comprises a bend (at each wind of the spring).
Regarding claim 47, the proximal end of the sheath element 2 comprises a substantially axial aperture configured for insertion of the nail core 4 as seen in the figures.
Regarding claims 48 and 50, the proximal end of the sheath element 2 comprises a nail head – an end of the device will be referred to as a ‘head’ thereof. A length of the core “correlates” with an axial extension of the spring element and the nail head. (Examiner notes that “correlates” as used in this case is essentially non-limiting).
Regarding claim 52, the distal end of the nail core 4 comprises a rounded tip (at least in the final wind of the coil).
Regarding claim 53, the proximal end of the nail core is capable of being fixed in the proximal end of the sheath element (as by changing diameter of the coil; or by use of device 3 for fixing).
Regarding claim 54, the proximal end of the nail core 4 is widened with respect to another radial extension of the nail core (e.g. at the sharpened distal tip).
Regarding claim 55, a diameter of the sheath element 2 is reducible to a diameter of the nail core 4 by tensioning the spring element.
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.
Claim(s) 43, 49 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Labitzke in view of Zielsdorf (US 2006/0142764 A1).
Regarding claim 43, the limitations of claim 40 were taught by Labitzke, as above. However, Labitzke did not teach the two spring elements wound in opposite directions.
Zielsdorf teaches an IM rod with a sheath 1 and a core 2, the sheath 1 seen at fig. 5. The sheath 1 is arranged as a double-helix of opposite directions 3/4. Different portions of the two windings 3/4 can be designated as the two spring elements.
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the Labitzke spring 2 to have the form of the Zielsdorf spring of 1. One would have done so in order to provide Labitzke with additional interconnections which stabilize the entire device (Zielsdorf, [0037]).
Regarding claims 49 and 51, the limitations of claims 48 and 32 were taught by Labitzke, as above. However, Labitzke did not teach the nail head including a sleeve (or endcap) which is rotatable about a longitudinal axis and which is connected to an origin or an end of a spring element.
Zielsdorf teaches an IM rod with a sheath 1 and a core 2, the sheath 1 as at fig. 5. The sheath 1 includes a nail head 8 (which can also be referred to as an endcap) which is formed as a sleeve as at fig. 2. The sleeve is rotatable about a longitudinal axis by use of tool recess 11. The sleeve is connected to an end of the sheath 1 as at fig. 5.
It would have been obvious to one with ordinary skill in the art at the time of the invention to provide Labitzke’s sheath 2 with a head 8 of Zielsdorf including a tool recess. One would have done so in order to permit use of a tool to assist in insertion assembly and deployment of the Labitzke device (Zielsdorf [0040]).
Conclusion
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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