The present invention is directed to a bone plating system for fracture fixation, and in particular to a system including a bone plate having plate holes for both locking and non-locking screws.
The clinical success of plate and screw systems for internal fixation of fractures is well-documented. However, treatment of certain fractures, such as peri-articular fractures, which require a fixed angular relationship between the bone plate and screws, remains problematic. Fixed angle devices for treatment of these fractures are available and include the Dynamic Condylar Screw System commercially available from Synthes (USA) of Paoli, Pa. and a wide variety of blade plates. All of these devices require a high level of surgical skill, suitable bone quantity and quality, and a fracture pattern compatible with the device.
In cases in which these requirements are not satisfied, e.g. severely comminuted bone or missing bone segments, conventional bone plate and screw systems must be used. Although these conventional systems are particularly well-suited to promoting healing of the fracture by compressing the fracture ends together and drawing the bone into close apposition with other fragments and the bone plate, the angular relationships between the plate and screws are not fixed and can change postoperatively. This can lead to mal-alignment and poor clinical results.
The primary mechanism for the change in angular relationship is related to energy storage. As previously noted, threading a bone screw into bone compresses the bone against the plate. The compression results in high strain in the bone, and, consequently, energy storage. With the dynamic loading resulting from physiological conditions, loosening of the plate and screw and loss of the stored energy can result.
Securing the screws to the plate provides a fixed angle relationship between the plate and screw and reduces the incidence of loosening. One method of securing the screw to the plate involves the use of so-called “locking screws.” A locking screw has threading on an outer surface of its head that mates with corresponding threading on the surface of a plate hole to lock the screw to the plate. Bone plates having threaded holes for accommodating locking screws are known. For example, German Patent Application No. 43 43 117 discloses a bone plate with threaded holes for locking screws. As the relationship between the locking screws and the plate is fixed, locking screws provide a high resistance to shear or torsional forces. However, locking screws have a limited capability to compress bone fragments.
In summary, conventional bone screws, i.e. screws that are not secured to a plate so that a fixed angular relationship between the plate and screw is maintained (hereinafter “non-locking screws”) effectively compress bone fragments, but possess a low resistance to shear force that can lead to loosening of the screw. Locking screws have a high resistance to shear force that ensure stability at the bone screw/plate hole interface, but possess a limited ability to compress bone fragments. Thus, a bone plating system that combines non-locking screws with locking screws would be ideal for certain clinical situations.
U.S. Pat. No. 5,601,553 discloses a locking plate and bone screw. The plate has a plurality of threaded plate holes for receiving locking screws. The plate also has non-threaded plate holes for receiving temporary screws that keep the plate in place while the locking screws are inserted. After the locking screws are inserted, the temporary screws are removed. Thus, the long term benefits of combining non-locking screws with locking screws are not obtained. U.S. Pat. No. 5,709,686 discloses a bone plate with partially threaded plate holes. The partially threaded holes allow either non-locking or locking screws to be used. Because the plate holes are only partially threaded, the locking screws used may not be able to maintain the fixed angular relationship between the screws and plate under physiological loads. Specifically, the locking screws within the plate are only partially captivated and thus only partially surrounded by threads. Under high stress and loading conditions, the locking plate hole may distort and allow the fixed angular relationship between the locking screw and plate to change. This can result in loss of fixation or loss of established intraoperative plate orientation. Additionally, because of the plate hole geometry, translation of the plate with the non-locking screws is limited to one direction only. This may be a disadvantage in reduction and manipulation of fragments.
Thus, there exists a need for an improved bone plating system that overcomes the deficiencies of the prior art.
The bone plating system for fixation of bone according to the present invention includes a bone plate having an upper surface, a bone-contacting surface, at least one first hole passing through the upper and bone-contacting surfaces and having a thread, and at least one second hole passing through the upper and bone-contacting surfaces. The bone plating system also includes a first screw having a shaft with a thread for engaging bone and a head with a thread configured and dimensioned to mate with the thread of the first hole, and a second screw having a shaft with a thread for engaging bone and a head. The first and second screws remain seated in their respective holes for substantially as long as the bone plate is implanted. Preferably, the bone plate includes a plurality of first and second holes, and a corresponding plurality of first and second screws are provided.
In order to facilitate insertion, the first and second screws can be a self-tapping screws. These screws can also be self-drilling screws. Additionally, the first and second screws can be cannulated for insertion of a guide wire to guide screw placement. The first plate hole can have a substantially conical shape with a double-lead thread.
In one embodiment, the bone plate has a trapezoidal shaped cross section in regions between the first and second plate holes for minimizing contact between bone and the bone-contacting surface. Additionally, at least one of the second plate holes is longitudinally elongated and has an edge inclined at an angle to the upper surface toward the bone-contacting surface for displacing the bone plate when engaged by the head of a second bone screw.
In an exemplary embodiment, the bone plate includes a head portion configured and dimensioned to conform to a metaphysis of a bone and a shaft portion configured and dimensioned to conform to a diaphysis of a bone. The head portion has only first plate holes and the shaft portion has both first and second plate holes. In one embodiment, the head portion has a curved surface, includes an anterior fork substantially parallel to an anterior side of the shaft portion, and includes a posterior fork extending out from a posterior side of the shaft portion. In another embodiment, the head portion flares outward from the shaft portion and is curved, tapered, and twisted. The head portion can also be provided with suture holes from suture anchoring of the bone plate.
The method for fracture fixation of bone according to the present invention comprises the steps of reducing the fracture to bring bone fragments in close apposition; compressing a bone plate against the bone with at least one first fastener to hold the fracture reduction; and securing at least one second fastener at a fixed angular relationship to the bone plate. The first fasteners are inserted before the second fasteners and both the first and second fasteners remain in bone for substantially as long as the bone plate is implanted.
The bone plating system according to the present invention includes a bone plate, non-locking screws, and locking screws.
First plate holes 36 are preferably conical in shape. As shown in
As seen best in
Bone-contacting surface 34 on bone plate 30 can be shaped to minimize contact with bone. Limiting contact between the bone plate and bone has a number of biological and mechanical advantages including reduced damage to blood supply and easier plate removal. Providing bone plate 30 with a trapezoidal cross section (
By combining locking screws and non-locking screws on the same bone plate, the present invention provides a novel mixed fixation. With the non-locking screws, fracture reduction is held by friction between the bone plate and bone. This friction is generated by tightening the non-locking screws in bone. However, micromotion between the non-locking screws and bone leads to bone resorption, and loss of reduction. Additionally, insertion of the non-locking screws requires bone to withstand the stresses of tightening of the screws. This results in high stress in bone surrounding the non-locking screws. Ordinarily, the high stress can cause the non-locking screw threads to strip (threads in bone fail in shear) and/or creep in bone (since bone is a viscoelastic material). Either one of these phenomenon also results in loss of reduction.
By adding at least one locking screw, loss of reduction is minimized or eliminated by the present invention. Specifically, by securing the locking screws to the bone plate and not the bone, the effect of the viscoelastic behavior of bone is reduced, the threads do not strip, and micromotion is prevented. The attachment between the locking screws and bone plate is a high strength connection in which the locking screw must cut sideways through bone to fail.
As management of certain peri-articular fractures typically involves insertion of screws at various angles with respect to the bone plate and it is highly desirable to maintain the initial angular relationships between the individual screws and the bone plate, the bone plating system according to the present invention is particularly well-suited for these clinical applications.
Bone plate 50 has an upper surface 52 and a bone-contacting surface 54. Bone plate 50 has a plurality of threaded plate holes 56a, 56b, 56c (collectively referred to as threaded plate holes 56) for receiving locking screws 20 and a plurality of non-threaded plate holes 58 for receiving non-locking screws 10. Each of threaded and non-threaded plate holes 56, 58 passes through upper 52 and bone-contacting surfaces 54. As was the case for bone plate 30, the thread on threaded plate holes 56 mates with threaded head 22 of locking screw 20 to secure locking screw 20 to bone plate 50 at a temporally fixed angular orientation and insertion of non-locking screws 10 in non-threaded plate holes 58 draws the bone toward bone-contacting surface 54 to compress the bone.
Bone plate 50 includes a head portion 60 configured and dimensioned to conform to the metaphysis of the distal femur and a shaft portion 62 configured and dimensioned to conform to a diaphysis of a bone. As best seen in
The non-threaded plate holes 58 are preferably dynamic compression unit (DCU) screw holes substantially similar to second plate holes 38. Shaft portion 62 has both threaded plate holes 56a and non-threaded plate holes 58 so that both locking and non-locking screws can be used in shaft portion 62. The ability to use locking screws in shaft portion 62 is particularly useful when the far cortex of part of the diaphysis is missing or severely damaged since fixation with non-locking screws is problematic because of the condition of the far cortex. As best seen in
In contrast to shaft portion 62, head portion 60 contains only threaded holes 56. Specifically, threaded plate holes 56b that surround a centrally located threaded plate hole 56c. Threaded plate hole 56c has a larger diameter than threaded plate holes 56b to accommodate a locking screw with a larger diameter, e.g. threaded plate hole 56b have a diameter of 5.0 mm and threaded plate hole 56c has a diameter of 7.3 mm.
Bone plate 80 includes a head portion 90 configured and dimensioned to conform to the metaphysis of the lateral proximal tibia and a shaft portion 92 configured and dimensioned to conform to a diaphysis of the lateral proximal tibia. As seen in
The non-threaded plate holes 88 are preferably dynamic compression unit (DCU) screw holes substantially similar to second plate holes 38. Shaft portion 92 has both threaded plate holes 86a and non-threaded plate holes 88 so that both locking and non-locking screws can be used in shaft portion 92. The ability to use locking screws in shaft portion 92 is particularly useful when the far cortex of part of the diaphysis is missing or severely damaged since fixation with non-locking screws is problematic because of the condition of the far cortex. As best seen in
In similar fashion to shaft portion 92, head portion 90 contains threaded holes 86 and non-threaded holes 88. Head portion 90 features threaded plate holes 86b and 86c. Holes 86b and 86c have a diameter of 5.0 mm and are oriented as shown in
While it is apparent that the illustrative embodiments of the invention herein disclosed fulfill the objectives stated above, it will be appreciated that numerous modifications and other embodiments may be devised by those skilled in the art. For example, for some fractures only one first plate hole and one second plate hole are needed, although at least two of each is advantageous. Furthermore, additional plate holes without screws can be present in the plate, if desired to allow the surgeon further flexibility in use. Therefore, it will be understood that the appended claims are intended to cover all such modifications and embodiments which come within the spirit and scope of the present invention.
This application is a continuation of U.S. patent application Ser. No. 10/665,431, filed on Sep. 22, 2003, now U.S. Pat. No. 7,341,589, which is a continuation of U.S. application Ser. No. 09/660,287, filed on Sep. 12, 2000, now U.S. Pat. No. 6,623,486, which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 60/153,239, filed on Sep. 13, 1999.
Number | Name | Date | Kind |
---|---|---|---|
1105105 | Sherman | Jul 1914 | A |
2352297 | Wales | Jun 1944 | A |
2526959 | Lorenzo | Oct 1950 | A |
3463148 | Treace | Aug 1969 | A |
3534731 | Muller | Oct 1970 | A |
3552389 | Allgower et al. | Jan 1971 | A |
3630261 | Gley | Dec 1971 | A |
3668972 | Allgower et al. | Jun 1972 | A |
3716050 | Johnston | Feb 1973 | A |
3779240 | Kondo | Dec 1973 | A |
3842825 | Wagner | Oct 1974 | A |
RE28841 | Allgower et al. | Jun 1976 | E |
4219015 | Steinemann | Aug 1980 | A |
4388921 | Sutter | Jun 1983 | A |
4408601 | Wenk | Oct 1983 | A |
RE31628 | Allgower et al. | Jul 1984 | E |
4484570 | Sutter et al. | Nov 1984 | A |
4493317 | Klaue | Jan 1985 | A |
4513744 | Klaue | Apr 1985 | A |
4537185 | Stednitz | Aug 1985 | A |
4565193 | Streli | Jan 1986 | A |
4683878 | Carter | Aug 1987 | A |
4838252 | Klaue | Jun 1989 | A |
4867144 | Karas et al. | Sep 1989 | A |
4905680 | Tunc | Mar 1990 | A |
4927421 | Goble et al. | May 1990 | A |
4957497 | Hoogland et al. | Sep 1990 | A |
4988350 | Herzberg | Jan 1991 | A |
5002544 | Klaue et al. | Mar 1991 | A |
5006120 | Carter | Apr 1991 | A |
5013313 | Surer | May 1991 | A |
5041114 | Chapman et al. | Aug 1991 | A |
5053036 | Perren et al. | Oct 1991 | A |
5085660 | Lin | Feb 1992 | A |
5129901 | Decoste | Jul 1992 | A |
5139497 | Tilghman et al. | Aug 1992 | A |
5151103 | Tepic et al. | Sep 1992 | A |
5190544 | Chapman et al. | Mar 1993 | A |
5197966 | Sommerkamp | Mar 1993 | A |
5269784 | Mast | Dec 1993 | A |
5275601 | Gogolewski et al. | Jan 1994 | A |
5304180 | Slocum | Apr 1994 | A |
5324290 | Zdeblick et al. | Jun 1994 | A |
5364398 | Chapman et al. | Nov 1994 | A |
5364399 | Lowery et al. | Nov 1994 | A |
5429641 | Gotfried | Jul 1995 | A |
5514138 | McCarthy | May 1996 | A |
5520690 | Errico et al. | May 1996 | A |
5522902 | Yuan et al. | Jun 1996 | A |
5571109 | Bertagnoli | Nov 1996 | A |
5591168 | Judet et al. | Jan 1997 | A |
5601553 | Trebing et al. | Feb 1997 | A |
5607428 | Lin | Mar 1997 | A |
5655089 | Bucci | Aug 1997 | A |
5674222 | Berger | Oct 1997 | A |
5702399 | Kilpela et al. | Dec 1997 | A |
5709686 | Talos et al. | Jan 1998 | A |
5718705 | Sammarco | Feb 1998 | A |
5735853 | Olerud | Apr 1998 | A |
5741258 | Klaue et al. | Apr 1998 | A |
5749872 | Kyle et al. | May 1998 | A |
5772662 | Chapman et al. | Jun 1998 | A |
5810823 | Klaue et al. | Sep 1998 | A |
5938664 | Winquist et al. | Aug 1999 | A |
5954722 | Bono | Sep 1999 | A |
5968047 | Reed | Oct 1999 | A |
5976141 | Haag et al. | Nov 1999 | A |
6022352 | Vandewalle | Feb 2000 | A |
6059785 | Schavan | May 2000 | A |
6096040 | Esser | Aug 2000 | A |
6129730 | Bono et al. | Oct 2000 | A |
6183475 | Lester et al. | Feb 2001 | B1 |
6206881 | Frigg et al. | Mar 2001 | B1 |
6228085 | Theken et al. | May 2001 | B1 |
6235033 | Brace et al. | May 2001 | B1 |
6306136 | Baccelli | Oct 2001 | B1 |
6322562 | Wolter | Nov 2001 | B1 |
6364882 | Orbay | Apr 2002 | B1 |
6440135 | Orbay et al. | Aug 2002 | B2 |
6454770 | Klaue | Sep 2002 | B1 |
6468278 | Mückter | Oct 2002 | B1 |
6527776 | Michelson | Mar 2003 | B1 |
6575975 | Brace et al. | Jun 2003 | B2 |
D479331 | Pike et al. | Sep 2003 | S |
6623486 | Weaver et al. | Sep 2003 | B1 |
6666868 | Fallin | Dec 2003 | B2 |
6669701 | Steiner et al. | Dec 2003 | B2 |
7128744 | Weaver et al. | Oct 2006 | B2 |
7341589 | Weaver et al. | Mar 2008 | B2 |
20020013587 | Winquist et al. | Jan 2002 | A1 |
20040111089 | Stevens et al. | Jun 2004 | A1 |
20040215198 | Marnay et al. | Oct 2004 | A1 |
20080132960 | Weaver et al. | Jun 2008 | A1 |
Number | Date | Country |
---|---|---|
2047521 | Jan 1992 | CA |
611147 | May 1979 | CH |
29 33 637 | Apr 1980 | DE |
43 41 980 | Jun 1995 | DE |
43 43 117 | Jun 1995 | DE |
4438264 | Mar 1996 | DE |
196 29 011 | Jan 1998 | DE |
93 21 544 | Oct 1999 | DE |
0 207 884 | Jan 1987 | EP |
1 468 655 | Oct 2004 | EP |
742 618 | Mar 1933 | FR |
2233973 | Jan 1975 | FR |
2405062 | May 1979 | FR |
2405705 | May 1979 | FR |
2405706 | May 1979 | FR |
2496429 | May 1979 | FR |
2 739 151 | Mar 1997 | FR |
1279626 | Dec 1986 | SU |
WO 9625892 | Aug 1996 | WO |
WO 9709000 | Mar 1997 | WO |
WO 9925266 | May 1999 | WO |
WO 9944529 | Sep 1999 | WO |
WO 0053110 | Sep 2000 | WO |
WO 0053111 | Sep 2000 | WO |
Entry |
---|
Ace Symmetry™ Titanium Upper Extremity Plates, Ace Medical Company. |
35 U.S.C. §282 Notice in the Pennsylvania Action, dated Oct. 10, 2008 (Ex. 40). |
4.5 mm Cannulated Screw Technique Guide, published 1995 (Synthes) [SNI-0259703-714] (Ex. 21). |
510(k) Disclosure K961413, Aug. 7, 1996 (Synthes) (“K961413”) [SNI-0259751] (Ex. 35). |
510(k) Disclosure K961421, Jun. 26, 1996 (Synthes) (“K961421”) [SNI-0258396] (Ex. 36). |
510(k) Disclosure K962616, Sep. 3, 1996 (Synthes) (“K962616”) [SNI-0258397] (Ex. 37). |
510(k) Disclosure K963798, Nov. 27, 1996 (Synthes) (“K963798”) [SNI-0258398] (Ex. 38). |
510(k) Disclosure K982732, Oct. 8, 1998 (Synthes) (“K982732”) [SNI-0259741-744] (Ex. 39). |
AO/ASIF Instruments and Implants, A Technical Manual, Springer-Verlog, 1994 [SNI0287857-859] (the “AO-ASIF Manual”) (Ex. 44). |
Bolhofner, et al., “The Results of Open Reduction and Internal Fixation of Distal Femur Fractures Using a Biologic (Indirect) Reduction Technique,” J. of Orthopaedic Trauma, 1996, vol. 10, No. 6, 372-377. |
Claim Construction Order in Pennsylvania Action, dated Feb. 4, 2008 (Dkt. 101) (Ex. 3). |
Collins Instruments de Chirurgie, published 1935, as illustrated at http://www.litos.com/pages/winkelstabilitaet—e.html (Sep. 26, 2007) (“Collin Catalog”) [SNI-0258552-556] (Ex. 20). |
Court Order denying Synthes' Motion for Reconsideration of Claim Construction for the '486 Patent in the Pennsylvania Action, dated Jun. 30, 2008 (Dkt. 118) (Ex. 13). |
Declaration of Clifford H. Turen, M.D. In Support of Synthes' Opposition to Smith & Nephew's Motion for Partial Summary Judgment of Invalidity of Method Claims 10-12 of U.S. Patent No. 6,623,486 (with Exhibits 1-4), dated Sep. 29, 2008 (Dkt. 161) (Ex. 69). |
Declaration of Robert A. King in Support of their Motion for Partial Summary Judgment of Invalidity of Claims 10-12 of U.S. Patent No. 6,623,486 (without exhibits), dated Sep. 10, 2008 (Dkt. 133) (Ex. 66). |
Dr. Marsh's Jul. 26, 2008 Deposition transcript in the Pennsylvania Action (Ex. 52). |
Dr. Parsons Aug. 7, 2008 deposition transcript in the Pennsylvania Action (Ex. 58). |
Dr. Turen's Aug. 15, 2008 deposition transcript in the Pennsylvania Action (Ex. 61). |
Expert Report of John F. Witherspoon, (without exhibits) in the Pennsylvania Action, dated Apr. 9, 2008 (Ex. 73). |
Gautier, E., et al., “Porosity and Remodelling of Plated Bone After Internal Fixation: Result of Stress Shielding of Vascular Damage?”, Biomaterials and Biomechanics 1983, Elsevier Science Publishers B.V. 1984 (“Gautier”) [SNI-0257388-393] (Ex. 27). |
Haas, N.P., et al., “LISS—Less Invasive Stabilization System—A New Internal Fixator for Distal Femur Fractures,” OP J., vol. 13(3), pp. 340-344, Georg Thieme Verlag, Dec. 1997 (original in German, translation to English attached with certification). |
Initial Expert Report of J. Lawrence Marsh, M.D., Apr. 9, 2008 (with Exhibits 1-2 and Appendices A-L), dated Apr. 9, 2008 (Ex. 41). |
Joint submission setting forth agreed claim construction in the Pennsylvania Action, dated Jul. 31, 2007 (Dkt. 76) (Ex. 9). |
Kassab, et al., “Patients Treated for Nonunions with Plate and Screw Fixation and Adjunctive Locking Nuts,” Clinical Orthopaedics and Related Research, 1998, 347, 86-92. |
Kolodziej, P., et al. “Biomechanical Evaluation of the Schuhli Nut,” Clinical Orthopaedics and Related Research, No. 347, pp. 79-85, Lippencott-Raven Publishers, Feb. 1988 (“Kolodziej”) [SNI-0256042-048] (Ex. 28). |
Koval, k., et al., “Distal Femoral Fixation: A Biomechanical Comparison of the Standard Condylar Buttress Plate, a Locked Buttress Plate, and the 95-Degree Blade Plate,” J. of Orthopaedic Trauma, vol. 11(7), pp. 521-524, Lippencott-Raven Publishers, Oct. 1997. |
Koval, k., et al., “Distal Femoral Fixation: A Biomechanical Comparison of the Standard Condylar Buttress Plate, a Locked Buttress Plate, and the 95-Degree Blade Plate,” J. of Orthopaedic Trauma, vol. 11(7), pp. 521-524, Lippencott-Raven Publishers, Oct. 1997, on-line color version of article. |
Krettek, C., LISS: Less Invasive Stabilization System, AO Dialogue, vol. 12(1), Jun. 1999 (“Krettek”) [SNI-0255846-874] (Ex. 29). |
Krettek, C., “LISS: Less Invasive Stabilization System,” (Electronic Supplement), AO Dialogue, vol. 12(1) Jun. 1999 (“Krettek Supp.”) [SNI-0258498-499] (Ex. 30). |
Less Invasive Stabilization System LISS Surgical Technique Proximal Tibia, (“Draft LISS Guide”) [SNI-0256558-568] (Ex. 22). |
Manual of Internal Fixation, Techniques Recommended by the AO-ASIG Group, Springer-Verlag, 1991, 200-251. |
Mr. Van Horn's Jul. 15, 2008 deposition transcript in the Pennsylvania Action (Ex. 78). |
Ms. Truman's Jul. 24, 2008 deposition transcript in the Pennsylvania Action (Ex. 81). |
Perren, et al., “The Limited Contact Dynamic Compression Plate (LC-DCP),” Arch. Orthopaedic & Trauma Surg., 1990, vol. 109, 304-310. |
Perren, S., et al., “Early Temporary Porosis of Bone Induced by Internal Fixation Implants,” Clinical Orthopaedics and Related Research, No. 232, Jul. 1988 (“Perren”) [SNI-0259074-086] (Ex. 32) Perren, S., et al., “Early Temporary Porosis of Bone Induced by Internal Fixation Implants,” Clinical Orthopaedics and Related Research, No. 232, Jul. 1988 (“Perren”) [SNI-0259074-086] (Ex. 32). |
Photographs of sample LC-DCP Condylar Buttress Plate (“CBP”) [SYN-PHY-0000001] (Ex. 42). |
Photographs of the Bolhofner Distal Femur Plating System (Bolhofner DFPS) (Ex. 76). |
Photographs of the Pi plate marked as Little Deposition Exhibit 84 SYN-PHY-0000012) (Ex. 75). |
Pure Titanium Implants Catalog, published Dec. 1993 (Synthes) (“PTI”) [SNI0259670-673] (Ex. 23). |
Rebuttal Expert Report of Charles E. Van Horn (without Exhibits), dated May 12, 2008 (Ex. 77). |
Rebuttal Expert Report of Clifford H. Turen, M.D., (with Exhibit 1), dated May 14, 2008 (Ex. 59). |
Rebuttal Expert Report of Eric R. Gozna, M.D., P.Eng., (with Exhibit 1), dated May 13, 2008 (Ex. 56). |
Rebuttal Expert Report of Mari Truman, P.E., (with Exhibit 2), dated May 14, 2008 (Ex. 79). |
Rebuttal Expert Report of Russell Parsons, Ph.D., (with Exhibit 1), dated Jul. 15, 2008 (Ex 57). |
Ring, D., et al,“A New Plate for Internal Fixation of the Distal Radius,”vol. IX, issue I, Jun. 1996 [SNI-0254971-973] (Ex. 53). |
Ring, D., et al. “Prospective Multicenter Trial of a Plate for Distal Fixation of Distal Radius Fractures,” J. of Hand Surgery, vol. 22a(5), pp. 777-784, Sep. 1997 [SNl0258321-328] (Ex. 48). |
Schandelmaier, P., et al., Distal Femur Fractures and LISS Stabilization Injury, Int. J. Care Injured, vol. 32, Suppl. 3, [SYN-0048236-244] (“Schandelmaier Article”) (Ex. 80). |
Schmoker, The Locking Reconstruction Plate 2.4-3.2, originally published in Swiss Dent 17, 1996. |
Schuhli Technique Guide, published by Synthes, 1995. |
Schuhli Technique Guide 1998, (Synthes) (“Schuhli Guide”) [SNI-0259719-737] (Ex. 26). |
Second Supplement to Apr. 9, 2008 Expert Report of David Seligson, M.D., dated Sep. 3, 2008 (Ex. 54). |
Second Supplement to Apr. 9, 2008 Expert Report of J. Lawrence Marsh (with Exhibit 1), dated Sep. 3, 2008 (Ex. 49). |
Smith & Nephew's Amended Answer in the Pennsylvania Action (without Exhibits A-S ) in the Pennsylvania Action, dated Aug. 7, 2007 (Dkt. 78) (Ex. 71). |
Smith & Nephew's Memorandum in Support of its Motion for Partial Summary Judgment of Invalidity of Claims 10-12 of the '486 patent, dated Sep. 10, 2008 (Dkt. 130) (Ex. 64). |
Smith & Nephew's Memorandum in Support of Motion for Leave to file Amended Answer in the Pennsylvania Action, dated Aug. 7, 2007 (Dkt. 77) (Ex. 70). |
Synthes 1997 Catalog, published by Synthes, Mar. 1997. |
Declaration of J. Lawrence Marsh, M.D. dated Jun. 3, 2010. |
Declaration of J. Lawrence Marsh, M.D. dated Nov. 22, 2010. |
Declaration of J. Lawrence Marsh, M.D. dated Jun. 25, 2010. |
Declaration of Dr. Seligson in Support of Smith & Nephew's Motion for Partial Summary Judgment of Invalidity of Claims 10-12 of U.S. Patent No. 6,623,486 dated Sep. 9, 2008 (with Exhibit 1, pp. 16-66 dated Sep. 10, 2008). (Dkt. 132) (Ex. 65). |
Declaration of J. Russell Parsons, Ph.D. In Support of Synthes Opposition to Smith & Nephew's Motion for Partial Summary Judgment of Invalidity of Method Claims 10-12 of U.S. Patent No. 6,623,486 dated Sep. 26, 2008 (with Exhibits 1-4, pp. 19-105 dated Sep. 29, 2008). (Dkt. 160) (Ex. 68). |
Docket sheet for the U.S. District Court Southern District of California (San Diego) Civil Action—3:07-cv-00309-L—AJB dated Feb. 14, 2007. (Ex. 1). |
Docket sheet for the United States District Court Eastern District of Pennsylvania (Philadelphia) Civil Action—2:03-cv-0084 dated Jan. 7, 2003. (CDJ) (Ex. 4). |
Luthi, U., et al., “Kontackflache zwischen Osteosyntheseplatte und Knochen,” Aktuel. Traumatol. 10:131-136, 1980 (“Luthi”) [SNI-0258572-577] (Ex. 31), with English Abstract. |
Smith & Nephew's Opening Claim Construction Brief (without exhibits) for the Pennsylvania Action, dated Mar. 16, 2007 (Dkt. 53) (Ex. 6). |
Smith & Nephew's Opposition to Synthes' Motion for Reconsideration of Claim Construction for the '486 Patent in the Pennsylvania Action, dated Mar. 4, 2008 (Dkt. 108) (Ex. 11). |
Smith & Nephew's Responses and Objections to Plaintiffs Fourth Set of Interrogatories Nos. 15-16, dated May 21, 2008 (Ex. 55). |
Smith & Nephew's Responsive Claim Construction Brief (without exhibits) for the Pennsylvania Action, dated Apr. 20, 2007 (Dkt. 60) (Ex. 8). |
Smith & Nephew's Third Supplemental Response to Interrogatories Nos. 4, 5, 6, 8 and 9; Second Supplemental Responses to Interrogatories Nos. 1, 2, 3, 10, 11 and 12; and First Supplemental Responses to Interrogatories Nos. 13, 15 and 17 (with Smith & Nephew Exhibit 1 thereto), dated Aug. 11, 2008 (Ex. 14). |
Smith and Nephew's Opposition to Synthes Motion for Summary Judgment of No Invalidity Based on K982222 (including Opposition Memorandum, Statement of Undisputed Facts, K. Doyle Declaration with Exhibits A-F and R. King's Declaration with Exhibits A-D), dated Sep. 29, 2008 (Dkt. 154) (Ex. 63). |
Stay Order in Pennsylvania Action, dated Jul. 13, 2009 (Dkt. 184) (Ex. 2). |
Summary of Safety and Effectiveness Information [510(k) Summary], K982222, Jul. 29, 1998. |
Supplement to Apr. 9, 2008 Expert Report of J. Lawrence Marsh in the Pennsylvania Action (with Exhibit 1), dated May 14, 2008 (Ex. 46). |
Supplement to Apr. 9, 2008 Expert Report of John F. Witherspoon (without exhibits), dated May 14, 2008 (Ex. 74). |
Supplemental Expert Report of Clifford H. Turen, M.D., May 2009 (with Exhibit 1), dated Aug. 8, 2008(Ex.60). |
Surgical Instruments Catalog, Collin & Co., 1935 (original in French, translation to English of pp. 392-397 attached with certification). |
Sutter, F., et al., “Titanplasma-beschichtetes Hohlschrauben- und Rekonstructions-platten-System (THRP) zur Oberbriickung von Kieferdefekten,” Chirurg No. 55, pp. 741-748, 1984 [SNI-0006164-171], and translation thereof [SNI-0006152-163] (Ex. 33). |
Synthes Opposition to Smith & Nephew's Motion for Summary Judgment of Invalidity of Claims 10-12 of the '486 Patent, dated Sep. 29, 2008 (Dkt. 159) (Ex. 67). |
Synthes Titanium Modular Hand System, 1996. |
Synthes' 1996 Titanium Modular Hand System brochure (the “Hand System Brochure”) [SNI-0290287-294] (Ex. 47). |
Synthes' Opening Claim Construction Brief (without supporting declaration and attached exhibits but including Appendix A & B) for the Pennsylvania Action, dated Mar. 16, 2007 (Dkt. 54) (Ex. 5). |
Synthes' Reply to Smith & Nephew's Opposition to Synthes Motion for Reconsideration of Claim Construction for the '486 patent in the Pennsylvania Action, dated Mar. 14, 2008 (Dkt.109) (Ex. 12). |
Synthes' Responsive Claim Construction Brief (without exhibits) for the Pennsylvania Action, dated Apr. 20, 2007 (Dkt. 61) (Ex. 7). |
Synthes' Summary Judgment Motion of No Invalidity Based on K982222 Summary including supporting memorandum, and declarations of A. Silversti and B. Liu (with supporting exhibits), dated Sep. 10, 2008 (Dkt. 136) (Ex. 62). |
Synthes' Supporting Memorandum for Reconsideration of Claim Construction (without supporting Declaration) in the Pennsylvania Action, dated Feb. 19, 2008 (Dkt. 104) (Ex.10). |
Technique Guide, Less Invasive Stabilization (LISS), Oct. 2003 (Ex. 72). |
The 1998 Schuhli Guide (SYN-0066081-099) (Ex. 50). |
The Distal Radius Plate Instrument and Implant Set Technique Guide, (Synthes) (“1998 Radius Plate Guide”) [SNI-0259855-872] (Ex. 24). |
The Distal Radius Plate Instrument and Implant Set Technique Guide, (Synthes) (“1999 Radius Plate Guide”) [SNI-0259653-668] (Ex. 25). |
The Locking Reconstruction Plate Technique Guide, published by Synthes, 1997. |
The Titanium Distal Radius Plate Technique Guide, [SNI-0276598-609] (the “DRP Guide”) published by Synthes in 1996 (Ex. 45). |
The Titanium Distal Radius Plate Technique Guide, published by Synthes, 1997. |
Update, Titanium LC-DCP Condylar Buttress Plate, Jun. 15, 1995 (Synthes) [SNI-0287861] (“the LC-DCP update”) (Ex. 43). |
Vattolo, M., Thesis, “The Effect of Grooves in Osteosynthesis Plates on the Restructuring of the Corticalis,” Laboratory for Experimental Surgery, Swiss Research Institute, 1986 (original in German, translation to English attached with Certification). |
Zimmer Advertisement, J. of Orthopaedic Trauma, vol. 12, No. 5, Jun.-Jul. 1998. |
Marsh Exhibit 1, Curriculum Vitae, Dec. 2006, pp. 1-34. |
Marsh Exhibit B, The Titanium Distal Radious Plate Technique Guide, Synthes USA, 1997. |
Marsh Exhibit C, Universelle Rekonstruktionsplatte URP 2.4-3.2 (UniRecon®), Swiss Dent, 17, 1996, pp. 19-25. |
Marsh Exhibit D, Schmoker, Roland, “The Locking Reconstruction Plate 2.4-3.2”, Swiss Dent, 17,4, 1996, pp. 1-6. |
Marsh Exhibit E, Bolhofner et al, “The Results of Open Reduction and Internal Fixation of Distal Femur Fractures Using a Biologic (Indirect) Reduction Technique”, Journal of Orthopaedic Trauma, 10, 6, 1996, pp. 372-377. |
Marsh Exhibit 1, Affidavit of Christopher Butler dated Aug. 24, 2010. |
Marsh Exhibit A, Releasable 510(k) Search, Aug. 7, 2000, http://web.archive.org/web/19970615015534/www.fda.gov/egi-bin/htmlscript?510k.hts+showcat-OR. |
Marsh Exhibit A, Initial Expert Report of J. Lawrence Marsh, MD, Civil Action No. 03-0084, dated Apr. 9, 2008, pp. 1-181. |
Marsh Exhibit B, Supplement to Apr. 9, 2008 Expert Report of J. Lawrence Marsh, MD, Civil Action No. 03-0084, dated May 14, 2008 , pp. 1-19. |
Marsh Exhibit C, Declaration of J. Lawrence Marsh, MD., in support of Smith & Nephew's, Inc's Motion for Partial Summary Judgement of Invalidity of Claims 10-12 of US Patent No. 6,623,486, dated Sep. 9, 2008, pp. 1-20. |
Smith & Nephew, Inc. v. Rea, Federal Circuit Opinion dated Jul. 9, 2013, 18 pages. |
Number | Date | Country | |
---|---|---|---|
20050080421 A1 | Apr 2005 | US |
Number | Date | Country | |
---|---|---|---|
60153239 | Sep 1999 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 10665431 | Sep 2003 | US |
Child | 10923566 | US | |
Parent | 09660287 | Sep 2000 | US |
Child | 10665431 | US |