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 .
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.
Claims 1, 2, 3, and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giordano et al. (US 20180317982 A1) (hereon referred to as Giordano).
Regarding claim 1, Giordano teaches a tether (20) for an implantable bone device (12), the tether comprising:
a retention portion (41) for holding the implantable bone device (12) in place, wherein the retention portion (41) comprises a recess (44) configured to receive a proximate end of the implantable bone device (see Fig. 10) when the implantable bone device (12) is positioned inside a bone (10) with the proximate end protruding from the bone (see Fig. 10), wherein the recess (44) is closed at the top (see Fig. 8), open at a first end (see labelled diagram of Fig. 8 below) and closed at a second end (see labelled diagram of Fig. 8 below) by a surface (see Para. [0030]), and contoured to approximate or to match a shape of the proximate end of the implantable bone device (see Para. [0026], noting that the closed second end and the proximate end of the implantable bone device are shaped to fit together at least approximately); and
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a fastening portion (30) for affixing the tether (20) to bone (10), wherein the fastening portion (30) comprises one or more through fastener openings (31), wherein each through fastener opening (31) is configured to receive a bone fastener (see Para. [0022]), wherein the fastening portion (30) is adjustable (note that the fastening portion is ovular, making it adjustable as the screw may be adjusted within the bore), and wherein the fastening portion is shaped to be less thick than a height of the retention portion (see Para. [0022]).
Regarding claim 2, Giordano teaches the tether of claim 1, further comprising an implantable bone device (12), wherein the implantable bone device (12) is an intramedullary nail (see Para. [0016]).
Regarding claim 3, Giordano teaches the tether of claim 1, wherein the tether (20) comprises a bone-side contour (24) to approximate a contour of the bone to which it is to be affixed (see Para. [0023]).
Regarding claim 4, Giordano teaches the tether of claim 1, wherein the tether (20) comprises a smooth outside contour (see Fig. 3) to reduce irritation of tissue when implanted (see Para. [0022]).
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Giordano as applied to claim 1 above, and further in view of Hedge et al. (US 20040162558 A1) (hereon referred to as Hedge).
Giordano teaches a tether for an implantable bone device as outlined in the rejection of claim 1 above, however fails to teach the device further comprising one or more bone-side spikes protruding from a bone-side surface of the tether and configured to penetrate the bone when the tether is affixed to the bone.
Hedge teaches a tether (100, see Figs. 1-5) comprising: a retention portion (104) for holding the implantable bone device in place (configured to hold a rod, see Para. [0029]), wherein the retention portion comprises a recess (110) configured to receive a proximate end of the implantable bone device when the implantable bone device is positioned inside a bone with the proximate end protruding from the bone (see Para. [0029]), wherein the recess is open at a first end (156) and closed at a second end (154); and a fastening portion (102) for affixing the tether (100) to bone, further comprising one or more bone-side spikes (112a, 112b) protruding from a bone-side surface (102b) of the tether (100) and configured to penetrate the bone when the tether is affixed to the bone (see Para. [0032]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bone tether of Giordano to further consist of bone spikes as taught by Hedge, as this would enable the plate to better attach to bone and reduce unwanted movement (see Para. [0033]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Giordano as applied to claim 1 above, and further in view of Iott et al. (WO 2005006948 A2) (hereon referred to as Iott).
Giordano teaches a tether for an implantable bone device as outlined in the rejection of claim 1 above, however fails to teach the device further comprising a clamp for manipulating a tether for the implantable bone device, the clamp comprising: two clamp arms joined at their proximal ends or between their proximal and distal ends and configured such that their distal ends can be brought together, wherein the distal ends of the two clamp arms are configured to grip the tether.
Iott teaches a tether (20’, see Fig. 8A) configured to be implanted with a clamp (450), the clamp comprising: two clamp arms (451, 454) joined between their proximal and distal ends (at 453) and configured such that their distal ends can be brought together (see P. 25, ll. 19-34), wherein the distal ends (458, 460) of the two clamp arms are configured to grip the tether (see P. 25, ll. 19-34).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tool of Giordino to be a clamp as taught by Iott, as such a tool would enable better control and manipulation of the device, while only requiring the practitioner to use one hand (see P. 2, ll. 16-21).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Giordano as applied to claim 1 above, and further in view of Chapolini et al. (US 20060111723 A1) (hereon referred to as Chapolini).
Giordano teaches a tether for an implantable bone device as outlined in the rejection of claim 1 above, however fails to teach a keyless chuck for an implantable bone device, the keyless chuck comprising: a receptacle configured to receive a proximal end of the implantable bone device, wherein no key is required to secure the implantable bone device, and wherein the receptacle is configured to rotate the implantable bone device or the implantable bone device tamp when the keyless chuck is rotated.
Chapolini teaches a keyless chuck (see Para. [0048]) for an implantable bone device (note that this is a functional limitation, and the keyless chuck of Chapolini may satisfy this requirement if the two devices are oriented accordingly), the keyless chuck comprising:
a receptacle (distal end of chuck described in Para. [0048]) configured to receive a proximal end of the implantable bone device (note that this is a functional limitation; depending on the relative size of the two devices, such a configuration may be possible), wherein no key is required to secure the implantable bone device (note that the disclosure elaborates on the use of a keyless chuck, see Para. [0048]), and wherein the receptacle is configured to rotate the implantable bone device or the implantable bone device tamp when the keyless chuck is rotated (see Para. [0071]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tether device of Giordano to have the keyless chuck configuration as taught by Chapolini, as this would enable the use of exemplary couplers for drill devices (see Para. [0071] of Chapolini).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Giordano in view of Chapolini as applied to claim 22 above, and further in view of Weinstein et al. (US 20160242771 A1) (hereon referred to as Weinstein).
Giordano teaches a tether for an implantable bone device as outlined in the rejection of claim 1 above, and Chapolini teaches a keyless chuck as outlined in the rejection of claim 22 above, however the combination of the two fails to teach the device further comprising a bone tamp with an impact anvil surface (claim 23), further comprising an implantable bone device tamp, wherein the tamp is detachably engageable with the receptacle (claim 24).
Weinstein teaches a bone tamp with (196) an impact anvil surface (200) (claim 23), further comprising an implantable bone device tamp (196), wherein the tamp is detachably engageable with the receptacle (via 202, see Para. [0075], noting that the distal end of the tamp is configured for engagement with an implant) (claim 24).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable bone device of Giordano to further include a bone tamp with an anvil impact surface as taught by Weinstein, as this would enable punching of the device into bone, improving ease of fixation thereto (see Para. [0071] of Weinstein).
Response to Arguments
Applicant's arguments filed 04/24/2025 have been fully considered but they are not persuasive. Applicant argues that the device of Giordano does not contain a recess "closed at a top, open at a first end, closed at a second end, and contoured to approximate or match a shape of the proximate end of the implantable bone device". For sake of clarity, the office has incorporated a labelled diagram of the first and second ends, as well as the top, in order to better represent the orientation as interpreted herein. As it pertains to the claim amendments, applicant requires that the closed second end "approximate[s]" the proximate end of the implantable bone device. as applicant points to in P. 10 of the arguments filed 02/05/2026, "...the reduced diameter section 44 can be of any shape. Preferably, the end of the intramedullary nail forms an interference fit with reduced diameter section 44". This description is a clear statement as to the configuration of the closed second end and its relationship to the bone device, wherein the two corresponding components are clearly shaped to fit together approximately, if not with a perfect match. The office points also to the advisory action dated 01/23/2026, wherein the office advises that these amendments do not overcome the outstanding rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/H.J.L./Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773