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 1-10, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rayes et al. (US 20140214034 A1) (hereon referred to as Reyes).
Regarding claim 1, Reyes teaches a telescopic intramedullary nail (300) for the treatment of fractures or deformations of long bones, such as for example in the case of osteogenesis imperfecta or pseudoarthrosis (see Figs. 19-21), comprising:
a hollow stem (302); and
a rod (304) telescopically coupled inside said hollow stem (see Fig. 21);
wherein said hollow stem (302) comprises, at a free distal end (end near 310), an anchor tip (310) configured to be internally fixed inside a distal portion of a long bone of a patient (see Para. [0066]), without protruding from said long bone (see Fig. 21A); and
wherein said rod (304) comprises a free proximal end (318) arranged to be fixed to a proximal site of said long bone (see Para. [0069]).
Regarding claim 2, Reyes teaches the telescopic intramedullary nail according to claim 1, wherein said rod (304) comprises, at the proximal end (318), a terminal head (316) arranged to externally abut against a proximal cortical of said long bone (see Para. [0069]).
Regarding claim 3, Reyes teaches the telescopic intramedullary nail according to claim 2, wherein said terminal head (316) is integrally formed with the rest of the rod (see Para. [0069]).
Regarding claim 4, Reyes teaches the telescopic intramedullary nail according to claim 2, wherein said rod (304) comprises, in a position which is adjacent to the terminal head (316), a cylindrical portion (see labelled diagram of Fig. 21 below) with a diameter which is greater than an internal diameter of the hollow stem (see labelled diagram of Fig. 21 below).
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Regarding claim 5, Reyes teaches the telescopic intramedullary nail according to claim 2, wherein said terminal head (316) comprises a conical thread (defined at self-tapping feature 318 see Para. [0069]) which connects to a cylindrical thread provided on a first proximal section of the rod (defined at non-self-tapping section 316 see Para. [0069]).
Regarding claim 6, Reyes teaches the telescopic intramedullary nail according to claim 1, wherein said hollow stem (302) comprises, at a proximal end (near 308) thereof, coupling means (322) for an insertion tool and/or for an extraction tool of said hollow stem (see Para. [0067]).
Regarding claim 7, Reyes teaches the telescopic intramedullary nail according to claim 6, wherein said coupling means (322) are arranged at an insertion mouth (324) of the rod (304) and comprise an internal thread in said insertion mouth (324).
Regarding claim 9, Reyes teaches the telescopic intramedullary nail according to claim 1, wherein said anchor tip (316) has a thread (see Para. [0069]) shaped and configured to screw in the epiphysis (see Para. [0069]).
Regarding claim 10, Reyes teaches the telescopic intramedullary nail according to claim 7, wherein a screwing direction of the thread of the anchor tip (316) is opposite to that of the internal thread of said coupling means of the hollow stem (See Para. [0067]).
Regarding claim 12, Reyes teaches the telescopic intramedullary nail according to claim 1, wherein said anchor tip is cannulated (see Fig. 21).
Regarding claim 13, Reyes teaches a kit comprising a telescopic intramedullary nail according to claim 1 and at least one removal tool (10) comprising a stem (11) and a boring portion arranged to be coupled (see Para. [0072]), by means of a threaded tip (see Para. [0059]) with a left-handed thread (see Para. [0067]), to coupling means arranged at an end of the hollow stem (see Para. [0067]).
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khmyzov et al. (WO 2024162942 A1) (hereon referred to as Khmyzov).
Regarding claim 16, Khmyzov teaches a telescopic intramedullary nail (see Fig. 10) for treatment of fractures or deformations of long bones (see P. 4, Para. 2), such as for example in the case of osteogenesis imperfecta or pseudoarthrosis, comprising:
a hollow stem (2); and
a rod (23) telescopically coupled inside said hollow stem (2);
wherein said hollow stem (2) comprises, at a free distal end (see labelled diagram of Fig. 10 below), an anchor tip (1) configured to be internally fixed inside a distal portion of a long bone of a patient, without protruding from said long bone (see P. 11, Para. 4-8; also note that this is an apparatus claim, not a method claim, therefore requiring only that the device is capable of satisfying this functional limitation);
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wherein said rod (23) comprises a free proximal end (see labelled diagram of Fig. 10 below) arranged to be fixed to a proximal site of said long bone (note this is a functional recitation, satisfied by the devices capability to be implanted accordingly);
wherein said rod (23) comprises, at the proximal end (see labelled diagram of Fig. 10 below), a terminal head (15) arranged to externally abut against a proximal cortical of said long bone (note that this is a functional recitation, satisfied by the devices design to pass through cortical long bone, also noting that the density and size of bone in question is not specified); and
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wherein said terminal head (15) comprises a threaded outer surface (self-tapping thread described in P. 11, Para. 4) having a conical taper with a diameter that increases toward a head end (see Fig. 10).
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 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Reyes as applied to claim 1 above and further in view of Duggal et al. (US 20230301646 A1) (hereon referred to as Duggal).
Reyes teaches an intramedullary nail for the treatment of fractures as outlined in the rejection of claim 1 above, however fails to teach wherein said anchor tip is not threaded but has a transverse through hole for insertion of an anchor pin (claim 11), further comprising a drill bit comprising a stem provided with progressive length indices in order to identify during a boring step a length of the components of the telescopic intramedullary nail to be implanted (claim 14).
Duggal teaches an intramedullary nail (400), wherein the nail comprises an anchor tip (600), wherein the ankle tip has a non-threaded end section but comprises a through hole (406) for the reception of a pin (405, see Para. [0134]). Duggal also teaches a drill (100) and a drill bit (see Para. [0180]) with progressive sizes in order to bore the hole prior to the insertion of the intramedullary nail (see Para. [0180]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor tip of Reyes to be non-threaded and comprise a pin as taught by Duggal, as this would enable better compression and reduction of fracture as compared to other methods (see Paras. [0108] and [0111]), and further to modify the intramedullary nail of Reyes to include a drill bit as taught by Duggal, wherein the drill bit comprises several length indexes in order to accommodate the intramedullary nail during the drilling step (see para. [0180]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Reyes as applied to claim 1 above and further in view of Epperly et al. (US 20130041414 A1) (hereon referred to as Epperly).
Reyes teaches an intramedullary nail for the treatment of fractures as outlined in the rejection of claim 1 above, however fails to teach further comprising a left-handed tension rod comprising a stem provided with a left-handed threaded tip; and a right-handed tension rod comprising a stem provided with a right-handed threaded tip.
Epperly teaches an intramedullary bone nail (10) for treatment of fractures, wherein the device comprises a left-handed tension rod (632) with a left-handed threaded tip (see Para. [0146]); and a right-handed tension rod (508) with a right-handed threaded tip (see Para. [0146]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intramedullary nail of Reyes to have a left-handed tension rod comprising a stem provided with a left-handed threaded tip; and a right-handed tension rod comprising a stem provided with a right-handed threaded tip, as taught by Epperly, as this would enable removal of the nail when the necessary threads are locked out (see Para. [0146]).
Allowable Subject Matter
Claim 8 is allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 8. In particular, none of the cited references teach or suggest “wherein said coupling means further comprise a crenelated end profile comprising a plurality of circumferentially spaced radial slots defining corresponding drive tabs at said insertion mouth” as required by claim 8.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive.
Applicant claims that the device of Rayes is not an intramedullary nail, further declaring that the nail of Rayes does not have the specific dimensional or anatomical characteristics required. Applicant does not go on to support this with any clear evidence as to what characteristics would be required for an intramedullary nail. Not only does applicant not specify clear requirements for the strength and size of an intramedullary nail, applicant further fails to acknowledge that such metrics would be highly variable based on the medullary canal in question; age, size, and species are all elements that would dramatically change the physical requirements of said nail.
Applicant goes on to argue that in order to implant such a nail into a medullary cavity, one would have to fully re-design the nail. The office once again disagrees with this assertion. It is again noted that the size and shape of the medullary cavity in question has not been established by the claim. It is therefore unreasonable to speculate about the lack of compatibility between the nail and such an ambiguous medullary cavity.
Finally, applicant argues that Para. [0006] of Rayes, which discloses an existing telescopic intramedullary nail, indicates mutual exclusivity with the device of Rayes. There is nothing in this paragraph that supports this claim by applicant; rather, Rayes uses this example only to state the perceived benefit of telescoping fixation methods in young patients.
In light of the office's position regarding independent claim 1, applicant's arguments pertaining to the 103 rejections are moot. See the updated rejection above with regards to remaining independent claims 8 and 16.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
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