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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 9, 2025 has been entered.
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.
Claims 1-4, 6, 7, 10-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WO 2022/010062 A1) in view of Hoya Technosurgical (JP 7154369 B1).
Claim 1. Kim discloses a lag screw assembly comprising:
a lag screw (lag screw 100) including:
a shank (see Fig. 3 inset) extending from a proximal end (see Fig. 3 inset) to a distal end (see Fig. 3 inset) along a longitudinal axis, the shank having an outer surface, and the shank having a threaded portion (screw portion 110) at the distal end;
a groove (one of grooves 101) formed in the shank and open to the outer surface, the groove extending along the shank between the proximal and distal ends (see Figs. 3 and 4),
wherein at least a portion of the groove defines a path that extends around and along the longitudinal axis on the outer surface (see Figs. 3 and 4); and
a blade (superelastic member 200) having a head (connecting rod 210) and a leg (one of pins 211) extending therefrom for slidably engaging the groove (Figs. 3-6).
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Claim 2. Kim discloses wherein the groove extends along the shank in a helical path (see Figs. 3 and 4) (Figs. 3-6).
Claim 3. Kim discloses wherein the leg of the blade is adapted to extend along the shank in the helical path (see Fig. 4) (Figs. 3-6).
Claim 4. Kim discloses wherein the groove extends into the threaded portion of the shank (see Fig. 3) (Figs. 3-6).
Claim 6. Kim discloses wherein a depth of the groove varies along a length of the shank (see Fig. 5, which shows that the proximal end of groove 101 is deep enough to fully seat pin 211; see abstract, which states that superelastic member 200 prevents rotation of lag screw 100 relative to nail 20, which indicates that superelastic member 200 must not be fully seated within groove 101 of lag screw 100 at that location in order to engage nail 20) (Figs. 3-6).
Claim 7. Kim discloses wherein the groove defines a first depth (see Fig. 4) at the threaded portion of the shank and a second depth (see Fig. 5, which shows that the proximal end of groove 101 is deep enough to fully seat pin 211) at a non-threaded portion (see Fig. 3 inset on pg. 5 above) of the shank, the second depth being greater than the first depth (Figs. 3-6).
Claim 10. Kim discloses wherein the lag screw includes a recess (see Fig. 5 inset) at the proximal end for engaging a tool (Figs. 3-6).
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Claim 11. Kim discloses wherein the groove extends from the proximal end of the shank to the distal end of the shank (see Figs. 3 and 4) (Figs. 3-6).
Claim 12. Kim discloses wherein an outer diameter of the head substantially corresponds in size to an outer diameter of the screw shank (see Fig. 5) (Figs. 3-6).
Claim 13. Kim discloses wherein at least a portion of the leg is adapted to follow the path defined by the groove as the portion of the leg extends along the shank (see Fig. 4) (Figs. 3-6).
Claim 14. Kim discloses wherein the groove formed in the shank is a first groove (one of grooves 101), and the lag screw includes a second groove (other of grooves 101) formed in the shank and open to the outer surface, the second groove extending along the shank between the proximal end and the distal end (see Figs. 3 and 4) (Figs. 3-6).
Claim 15. Kim discloses wherein at least a portion of one of the first groove and the second groove has a depth substantially equal to a thickness of the blade (see Fig. 5, which shows that the portion of grooves 101 adjacent the proximal end of lag screw 100 has a depth substantially equal to a thickness of the blade) (Figs. 3-6).
Claim 16. Kim discloses wherein the first and second grooves extend into the threaded portion (see Fig. 3) (Figs. 3-6).
Claim 17. Kim discloses a fixation assembly for fixation of a bone, comprising:
an intramedullary nail (nail 20) defining a bore (bore that receives lag screw 100) therethrough; and
the lag screw assembly of claim 1 (see claim 1 above) configured to extend through the bore of the intramedullary nail (Figs. 3-6).
Claim 19. Kim discloses a lag screw assembly comprising:
a lag screw (lag screw 100) including:
a shank (see Fig. 3 inset on pg. 5 above) extending from a proximal end (see Fig. 3 inset on pg. 5 above) to a distal end (see Fig. 3 inset on pg. 5 above) along a longitudinal axis, the shank having an outer surface, and the shank having a threaded portion (screw portion 110) at the distal end;
a groove (one of grooves 101) formed in the shank and open to the outer surface, the groove extending along the shank between the proximal and distal ends (see Figs. 3 and 4),
wherein at least a portion of the groove defines a helical path on the outer surface (see Figs. 3 and 4); and
a blade (superelastic member 200) having a head (connecting rod 210) and a leg (one of pins 211) extending along a length therefrom for slidably engaging the groove,
wherein the leg has a thickness defined in the radial direction (Figs. 3-6).
Kim fails to disclose wherein at least a portion of the leg protrudes farther in a radial direction than an outer diameter of the threaded portion, wherein a first portion of the leg protrudes farther from the groove in the radial direction than a second portion of the leg (claim 1), wherein when the blade is coupled to the shank, a portion of the blade corresponding to the threaded portion extends outwardly from at least one of the first and second grooves in the threaded portion a distance greater than a root diameter of a thread of the threaded portion (claim 16), wherein at least a portion of the leg positioned within a portion of the groove defined in the threaded portion protrudes radially beyond an outer diameter of the threaded portion, and wherein the thickness varies along the length of the leg (claim 19).
Hoya teaches a lag screw (lag screw 200) including a shank (shaft portion 221) having a threaded portion (engaging portion 211) at a distal end and grooves (grooves 250, each of which includes groove 251 and groove 252) formed in the shank and extending into the threaded portion, and a blade (blade body 300) having a head (blade support portion 302) and legs (blades 301) for slidably engaging the grooves, wherein the depth of the grooves decreases extending toward the distal end (see para. 0049) such that at least a portion of the legs positioned within the grooves at the threaded portion adjacent the distal end protrudes radially beyond an outer diameter of the threaded portion (see para. 0049; see also Figs. 6A-6B) and a first portion of the leg (portion adjacent reference character 2522 as shown in Fig. 6A) protrudes farther from the groove in the radial direction (the portion of blade 301c located within groove 250 is located above the dotted line in Fig. 6A and thus the portion protruding from the groove in the radial direction is located below the dotted line) than a second portion of the leg (portion adjacent reference character 301c as shown in Fig. 6A) in order to enable the legs to function as a wedge to increase the rotation suppression force (see para. 0051), and wherein the legs are tapered at their distal ends (see Fig. 6A, which shows the free end of blades 301b and 301c tapering) such that the thickness varies along the length of the leg (Figs. 1-6B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Kim such that the depth of the groove(s) decreases extending toward the distal end, wherein at least a portion of the leg protrudes farther in a radial direction than an outer diameter of the threaded portion, wherein a first portion of the leg protrudes farther from the groove in the radial direction than a second portion of the leg (claim 1), wherein when the blade is coupled to the shank, a portion of the blade corresponding to the threaded portion extends outwardly from at least one of the first and second grooves in the threaded portion a distance greater than a root diameter of a thread of the threaded portion (claim 16), and wherein at least a portion of the leg positioned within a portion of the groove defined in the threaded portion protrudes radially beyond an outer diameter of the threaded portion (claim 19), as suggested by Hoya, in order to enable the legs to function as a wedge to increase the rotation suppression force. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Kim such that the leg is tapered at its distal end such that the thickness varies along the length of the leg (claim 19), as suggested by Hoya, as such a configuration would allow for easier insertion into and through bone.
Claims 5, 9, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WO 2022/010062 A1) in view of Hoya Technosurgical (JP 7154369 B1) as applied to claims 1, 8, and 17 above, and further in view of Aschmann (US 2006/0084999 A1).
Claim 5. Kim discloses wherein the leg is integral with the head of the blade, and wherein the head of the blade is adapted to be fastened to the proximal end of the shank with a fastener (cap 300) (Figs. 3-6).
Claim 9. Kim discloses wherein the fastener is a screw (see Fig. 5, which shows that cap 300 includes threads) configured to be threadably coupled to the proximal end of the shank (see Fig. 5) (Figs. 3-6).
Claim 18. Kim discloses wherein the bore defined by the intramedullary nail is substantially cylindrical (see Fig. 6), sized to receive the lag screw (see Fig. 6), wherein the leg is protruding from a circumference of the shank when coupled to the shank (see abstract, which states that superelastic member 200 prevents rotation of lag screw 100 relative to nail 20, which indicates that superelastic member 200 must not be fully seated within groove 101 of lag screw 100 at that location in order to engage nail 20) (Figs. 3-6).
Kim and Hoya fail to teach wherein the head of the blade is an annular cylindrical portion and the leg is integral with the annular cylindrical portion (claim 5), wherein the screw is configured to be threadably coupled to the head of the blade (claim 9), and wherein the bore includes at least a groove configured to receive the leg of the blade therethrough (claim 18).
Aschmann teaches an assembly comprising: a lag screw (neck screw 10a) including a groove (one of slots 13a) formed in a shank (see Fig. 1); a blade (locking element 16a) having a head (collar 17a) and a leg (one of prongs 18a), wherein the head of the blade is an annular cylindrical portion (collar 17a) and the leg is integral with the annular cylindrical portion; a screw (screw 20) configured to be threadably coupled to the head of the blade and a proximal end (end with tapped hole 14) of the shank of the lag screw to fasten the blade to the lag screw (see para. 0026; see Fig. 4); and an intramedullary nail (nail 1a) having a bore (borehole 7a) therethrough, wherein the bore includes at least a groove (one of grooves 8a) configured to receive the leg of the blade therethrough; wherein the interaction between the lag screw, blade, and intramedullary nail rotationally secures the lag screw relative to the intramedullary nail (see para. 0013) (Figs. 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the assembly of Kim such that the head of the blade is an annular cylindrical portion and the leg is integral with the annular cylindrical portion (claim 5), the screw is configured to be threadably coupled to the head of the blade (claim 9), and the bore includes at least a groove configured to receive the leg of the blade therethrough (claim 18), as suggested by Aschmann, as the configuration of the head and the screw is a simple substitution of one means for securing the blade to the lag screw for another and the bore with the groove provides means to rotationally secure the lag screw relative to the intramedullary nail.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WO 2022/010062 A1) in view of Hoya Technosurgical (JP 7154369 B1), Shaver et al. (US 2007/0123878 A1), and Walker (US 4,457,301 A).
Claim 20. Kim discloses an assembly for fixation of a bone, comprising:
a lag screw (lag screw 100) including:
a shank (see Fig. 3 inset on pg. 4 above) extending from a proximal end (see Fig. 3 inset on pg. 4 above) to a distal end (see Fig. 3 inset on pg. 4 above) along a longitudinal axis, the shank having an outer surface, and the shank having a threaded portion (screw portion 110) at the distal end;
a groove (one of grooves 101) formed in the shank and open to the outer surface, the groove extending along the shank between the proximal and distal ends (see Figs. 3 and 4),
wherein at least a portion of the groove defines a helical path on the outer surface (see Figs. 3 and 4); and
a blade (superelastic member 200) having a head (connecting rod 210) and a leg (one of pins 211) extending along a length therefrom for slidably engaging the groove,
wherein the leg has a thickness defined in the radial direction (Figs. 3-6).
Kim fails to disclose wherein the assembly, which includes the lag screw and the blade, is part of a kit, wherein at least a portion of the blade corresponding to the threaded portion of the shank protrudes radially beyond an outer diameter of the threaded portion, and wherein a portion of the leg is convex along the length in a direction of the thickness (claim 20).
Shaver teaches that components of an assembly, including a lag screw (bone screw 30) and an intramedullary nail (rod 24), are provided in a kit that also includes tools and instructions, wherein the contents of the kit are packaged to maintain sterility of the contents (see para. 0048) (Fig. 1).
Hoya teaches a lag screw (lag screw 200) including a shank (shaft portion 221) having a threaded portion (engaging portion 211) at a distal end and a groove (groove 250, which includes groove 251 and groove 252) formed in the shank and extending into the threaded portion, and a blade (blade body 300) having a head (blade support portion 302) and a leg (blade 301) for slidably engaging the groove, wherein the depth of the groove decreases extending toward the distal end (see para. 0049) such that at least a portion of the leg positioned within the groove at the threaded portion adjacent the distal end protrudes radially beyond an outer diameter of the threaded portion (see para. 0049; see also Figs. 6A-6B) in order to enable the leg to function as a wedge to increase the rotation suppression force (see para. 0051) (Figs. 1-6B).
Walker teaches that a leg (pin 11) has a rounded tip (end 12) such that the tip is convex along its length in a direction of the thickness (see Fig. 1), wherein the leg is inserted through and along a groove (groove 14) formed in a shank (core 13) (Figs. 1, 2, and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Kim such that the assembly, which includes the lag screw and the blade, is part of a kit (claim 20), as suggested by Shaver, as a kit can also include an intramedullary nail, tools, and instructions and be packaged to maintain sterility of the contents. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Kim such that the depth of the groove decreases extending toward the distal end, wherein at least a portion of the blade corresponding to the threaded portion of the shank protrudes radially beyond an outer diameter of the threaded portion (claim 20), as suggested by Hoya, in order to enable the leg to function as a wedge to increase the rotation suppression force. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Kim such that the leg is rounded at its distal end such that a portion of the leg is convex along the length in a direction of the thickness (claim 20), as suggested by Walker, as such a configuration would allow for easier insertion into the groove in the shank and into and through bone.
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Note that the Examiner is interpreting “an indentation” as an area of decreased thickness bookended by areas of increased thickness. Thus, the Examiner is not interpreting “an indentation” as merely a taper, such as that shown at the free ends of blades 301b and 301c of Hoya.
Response to Arguments
The Examiner notes that Applicant has not presented any arguments regarding the prior art applied in the previous rejection but merely made a conclusory statement that none of the prior art teaches the new limitations introduced into claims 1, 19, and 20 (see pg. 7). The Examiner disagrees (see the rejections above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773