`tneufeld@neufeldmarks.com
`EVA WONG, State Bar No. 235356
`ewong@neufeldmarks.com
`NEUFELD MARKS
` A Professional Corporation
`360 East Second Street, Suite 703
`Los Angeles, California 90012
`Telephone: (213) 625-2625
`Facsimile:
`(213) 625-2650
`
`JOSEPH G. BURGESS (pro hac vice)
`BURGESS LAW OFFICE, PLLC
`691 N. Squirrel Rd., Suite 245
`Auburn Hills, MI 48326
`Telephone: (248) 364-0200
`Facsimile:
`(248) 364-9604
`Email: jburgess@burgessiplaw.com
`
`Attorneys for Plaintiff/
`Counter-Defendant ADVANCED
`ORTHOPAEDIC SOLUTIONS, INC.
`
`
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA, WESTERN DIVISION
`Case No. 2:14-cv-06354-ODW-MAN
`ADVANCED ORTHOPAEDIC
`
`SOLUTIONS, INC., a California
`ADVANCED ORTHOPAEDIC
`corporation,
`SOLUTIONS, INC.’S
`
`INFRINGEMENT CONTENTIONS
`
`Plaintiff/
`Counter-Defendant,
`
`vs.
`
`BIOMET, INC., an Indiana corporation,
`
`Defendant/
`Counterclaimant, and
`
`ZIMMER BIOMET HOLDINGS, INC,
`an Indiana corporation,
`
`Defendant/
`Counterclaimant.
`
`
`
`
`
`
` /
`
`
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`ZIMMER 1040
`Page 1
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`
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`
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`Plaintiff Advanced Orthopedic Solutions, Inc. (AOS) serves these Infringement
`
`Contentions Infringement Contentions on Defendants Biomet, Inc. (Biomet) and
`
`Zimmer Biomet Holdings, Inc. (Zimmer Biomet) pursuant to Patent L.R. 3-1.
`
`
`
`AOS asserts claims 1-10 of United States Patent No. 8,702,707 B2 (‘707
`
`Patent) against Biomet and Zimmer Biomet’s AFFiXUS Hip Fracture Nail. AOS’
`
`identification of the Biomet and Zimmer Biomet’s AFFiXUS Hip Fracture Nail
`
`includes all models with other designations that are functionally and/or operationally
`
`insubstantially different from the AFFiXUS Hip Fracture Nail. Each element of claims
`
`1-10 of the ‘707 Patent is literally present and/or present under the doctrine of
`
`equivalents in Biomet and Zimmer Biomet’s infringing AFFiXUS Hip Fracture Nail.
`
`
`
`Attached, as Exhibit A, is a chart illustrating where each element of claims 1-10
`
`of the ‘707 Patent is found in Biomet and Zimmer Biomet’s infringing AFFiXUS Hip
`
`Fracture Nail (and any similar models). The AFFiXUS Hip Fracture Nail Surgical
`
`Technique brochure referenced in Exhibit A is attached as Exhibit C.
`
`
`
`The ‘707 Patent claims priority to U.S. Non-Provisional Application No.
`
`11/078,750, filed on March 11, 2005, which claims the benefit of U.S. Provisional
`
`Application No. 60/552,229, filed March 11, 2004. Asserted claims 1-10 are entitled
`
`to a priority date of March 11, 2004.
`
`
`
`Any allegation of willful infringement is based on Biomet’s knowledge and
`
`notice of the '707 Patent and Biomet’s infringement of the ‘707 Patent since at least
`
`the filing and service of the Complaint; and Zimmer Biomet’s knowledge and notice
`
`
`2
`ADVANCED ORTHOPAEDIC SOLUTIONS, INC. INFRINGEMENT CONTENTIONS
`
`
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`ZIMMER 1040
`Page 2
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`
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`of the '707 Patent and Zimmer Biomet’s infringement of the ‘707 Patent since at least
`
`the filing and service of the First Amended Complaint. Despite this knowledge,
`
`Biomet and Zimmer Biomet continue to infringe.
`
`
`
` AOS asserts claims 6-11, 13-15, 19-20 of United States Patent No. 8,092,454
`
`B2 (‘454 Patent) against Biomet and Zimmer Biomet’s AFFiXUS Hip Fracture Nail.
`
`AOS’ identification of the AFFiXUS Hip Fracture Nail includes all models with other
`
`designations that are functionally and/or operationally insubstantially different from
`
`the AFFiXUS Hip Fracture Nail. Each element of claims 6-11, 13-15, and 19-20 of
`
`the ‘454 Patent is literally present and/or present under the doctrine of equivalents in
`
`Biomet and Zimmer Biomet’s infringing AFFiXUS Hip Fracture Nail.
`
`
`
`Attached, as Exhibit B, is a chart illustrating where each element of claims 6-
`
`11, 13-15, and 19-20 of the ‘454 Patent is found in Biomet and Zimmer Biomet’s
`
`infringing AFFiXUS Hip Fracture Nail (and any similar models). The AFFiXUS Hip
`
`Fracture Nail Surgical Technique brochure referenced in Exhibit B is attached as
`
`Exhibit C.
`
`
`
`The ‘454 Patent claims priority to U.S. Provisional Application No. 60/552,229,
`
`filed March 11, 2004. Asserted claims 6-11, 13-15, 19-20 are entitled to a priority date
`
`of March 11, 2004.
`
`
`
`Any allegation of willful infringement is based on Biomet and Zimmer
`
`Biomet’s knowledge and notice of the '454 Patent and Biomet and Zimmer Biomet’s
`
`infringement of the ‘454 Patent since at least the filing and service of the First
`
`
`3
`ADVANCED ORTHOPAEDIC SOLUTIONS, INC. INFRINGEMENT CONTENTIONS
`
`
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`ZIMMER 1040
`Page 3
`
`
`
`
`
`Amended Complaint. Despite this knowledge, Biomet and Zimmer Biomet continue
`
`Respectfully submitted,
`
`Burgess Law Office, PLLC
`
`/s/ Joseph G Burgess
`JOSEPH G. BURGESS (pro hac vice)
`BURGESS LAW OFFICE, PLLC
`691 N. Squirrel Rd., Suite 245
`Auburn Hills, MI 48326
`Telephone: (248) 364-0200
`Facsimile:
`(248) 364-9604
`Email: jburgess@burgessiplaw.com
`
`
`
`TIMOTHY L. NEUFELD, State Bar
`No. 66980
`EVA WONG, State Bar No. 235356
`NEUFELD MARKS
`360 E Second Street, Suite 703
`Los Angeles, CA 90012
`Telephone: (213) 625-2625
`Facsimile: (213) 625-2650
`Email: tneufeld@neufeldmarks.com
`Email: ewong@neufeldmarks.com
`
`
`
`Attorneys for Plaintiff/Counter-
`Defendant ADVANCED
`ORTHOPAEDIC SOLUTIONS, INC.
`
`
`to infringe.
`
`////
`
`DATED: September 2, 2015
`
`
`
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`ADVANCED ORTHOPAEDIC SOLUTIONS, INC. INFRINGEMENT CONTENTIONS
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`ZIMMER 1040
`Page 4
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`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a true and correct copy of the foregoing ADVANCED
`
`ORTHOPAEDIC SOLUTIONS, INC.’S INFRINGEMENT CONTENTIONS was
`
`served upon counsel of record electronically on September 2, 2015 as follows:
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`1 2 3 4 5 6 7 8 9
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`
`Nimalka R. Wickramasekera
`(State Bar No. 268518)
`nimalka.wickramasekera@kirkland.com
`KIRKLAND & ELLIS LLP
`333 South Hope Street
`Los Angeles, California 90071
`Telephone: (213) 680-8400
`Facsimile: (213) 680-8500
`
`Bryan S. Hales (pro hac vice)
`bryan.hales@kirkland.com
`Eric D. Hayes (pro hac vice)
`eric.hayes@kirkland.com
`KIRKLAND & ELLIS LLP
`300 North LaSalle Street
`Chicago, Illinois 60654
`Telephone: (312) 862-2000
`Facsimile: (312) 862-2200
`
`Attorneys for Defendants/Counterclaimants BIOMET, INC. and ZIMMER
`BIOMET HOLDINGS, INC.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Joseph G Burgess
`JOSEPH G. BURGESS (pro hac vice)
`BURGESS LAW OFFICE, PLLC
`691 N. Squirrel Rd., Suite 245
`Auburn Hills, MI 48326
`
`
`
`
`
`
`5
`ADVANCED ORTHOPAEDIC SOLUTIONS, INC. INFRINGEMENT CONTENTIONS
`
`
`
`ZIMMER 1040
`Page 5
`
`
`
`
`
`EXHIBIT A
`
`
`
`
`
`ZIMMER 1040
`Page 6
`
`
`
`ADVANCED ORTHOPAEDIC SOLUTIONS, INC.’S INFRINGEMENT CONTENTIONS
`
`EXHIBIT A
`
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a).
`
`“The AFFIXUS Hip Fracture Nail System is intended to treat stable and unstable proximal fractures
`of the femur. . . .” (Exhibit B, AFFiXUS Hip Fracture Nail, Surgical Technique Brochure pp. 7,
`hereafter “Brochure”.)
`
`
`
`U.S. Patent No. 8,702,707
`— Claim 1
`
`
`1. A fixation instrument for
`treating a bone fracture
`comprising:
`
`
`
`Page 1 of 24
`
`ZIMMER 1040
`Page 7
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. The AFFIXUS nail is a nail member, having a longitudinal axis with a distal
`end and a proximal end. Brochure, pp.7 – Figure 1, “AFFIXUS Hip Fracture Nail Short — (180 mm)
`and AFFIXUS Hip Fracture Nail Long — (260 – 460 mm).”
`
`Illustrated below are Figures 22A and 22B, Brochure, pp. 19 with annotations identifying the structure
`of the AFFIXUS Nail corresponding to the claim element.
`
`
`
`a nail member, having a
`longitudinal axis, a distal
`end and a proximal end,
`said proximal end having a
`transverse aperture
`extending therethrough and
`said nail member having a
`chamber located in said
`proximal end;
`
`
`
`Page 2 of 24
`
`
`
`ZIMMER 1040
`Page 8
`
`
`
`a bone screw, having a
`threaded portion, said bone
`screw extending through
`said aperture;
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`
`
`
`
`Page 3 of 24
`
`ZIMMER 1040
`Page 9
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`an insert having a
`longitudinal axis, a distal
`end, a proximal end and a
`passageway extending
`longitudinally through said
`insert from said proximal
`end to said distal end, said
`insert having a retaining
`member located on said
`proximal end of said insert,
`said insert positioned and
`constrained against rotation
`about said longitudinal axis
`of said insert within said
`chamber;
`
`
`
`
`
`Page 4 of 24
`
`ZIMMER 1040
`Page 10
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. “The set screw is pre-loaded in the nail.” Brochure, pp. 19 – Fig. 22A. Nail is
`inserted “by hand over the 3mm ball nose guide wire into the medullary canal.” Brochure, pp. 14. In
`order to insert the nail over the wire the “pre-loaded “ set screw, see Figure 22B below must h ave a
`longitudinal passageway extending therethrough.
`
`a locking ring, having a
`longitudinal passageway
`extending therethrough,
`said locking ring including
`a lower surface having an
`engagement portion, said
`locking ring received in
`said chamber and said
`engagement portion
`engaging said retaining
`member of said insert to
`attach said locking ring to
`said insert, said locking
`ring operative to secure
`said insert within said
`chamber; and
`
`
`
`
`
`
`Page 5 of 24
`
`ZIMMER 1040
`Page 11
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. “[T]he set screw contacts the lag screw in one of the four lag screw grooves
`(Figure 22A & 22B).” Brochure, pp. 19. Figure 22B shows the “Cross section of set screw engaging
`lag screw.” “[T]he set screw contacts the lag screw in one of the four lag screw grooves.” Brochure,
`pp. 19. The set screw has properly engaged the lag screw if the lag screw will not rotate. Brochure, pp.
`19.
`
`said bone screw having a
`longitudinal axis and
`having a plurality of
`longitudinally extending
`grooves, said grooves
`extending substantially
`parallel to said longitudinal
`axis of said bone screw on
`an outer surface of said
`bone screw wherein at least
`a portion of said distal end
`of said insert is received in
`one of said grooves to
`resist rotation of said bone
`screw within said aperture.
`
`
`
`
`
`
`Page 6 of 24
`
`
`
`ZIMMER 1040
`Page 12
`
`
`
`U.S. Patent No. 8,702,707
`— Claim 2
`2. A fixation instrument for
`treating a bone fracture as
`set forth in claim 1
`including:
`said aperture extending at
`an angle through the
`proximal end of the nail
`member; and
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a).
`See elements set forth above regarding Claim 1.
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. The AFFIXUS nail has a neck shaft angle or angle of proximal targeting of
`130°. Brochure, pp. 12, 27.
`
`
`
`
`
`Page 7 of 24
`
`ZIMMER 1040
`Page 13
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. As illustrated below the portion of the set screw engaging the bone screw
`extends at substantially the same angle as the aperture.
`
`said distal end of said
`insert includes a locking
`projection, said locking
`projection having a portion
`thereof that extends at an
`angle substantially the
`same as the angle of said
`aperture, wherein said
`portion of said locking
`projection that extends at
`an angle substantially the
`same as the angle of said
`aperture extends into and is
`located in one of said
`grooves of said bone
`screw.
`
`
`
`
`
`
`Page 8 of 24
`
`ZIMMER 1040
`Page 14
`
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents. See elements set forth
`above regarding Claim 1.
`
`U.S. Patent No. 8,702,707
`— Claim 3
`3. A fixation instrument for
`treating a bone fracture as
`set forth in claim 1
`including said insert having
`a locating member
`configured to be received
`by a corresponding channel
`extending longitudinally on
`an inner surface of
`chamber, said locating
`member operative to
`constrain said insert from
`rotation within said
`chamber.
`
`
`
`
`
`
`Page 9 of 24
`
`ZIMMER 1040
`Page 15
`
`
`
`U.S. Patent No. 8,702,707
`— Claim 4
`4. A fixation instrument for
`treating a bone fracture as
`set forth in claim 1
`including:
`said chamber having an
`inner surface and a
`plurality of threads located
`on said inner surface; and
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents.See elements set forth above
`regarding Claim 1.
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`Page 10 of 24
`
`ZIMMER 1040
`Page 16
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`said locking ring having an
`outer surface and a
`plurality of threads located
`on said outer surface,
`wherein said threads
`located on said locking
`ring engage said threads on
`said inner surface of said
`chamber.
`
`
`
`
`
`Page 11 of 24
`
`ZIMMER 1040
`Page 17
`
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents.
`See elements set forth above regarding Claim 1. As illustrated below, the engagement portion of the
`locking ring and the retaining member of the insert are configured such that the locking ring remains
`attached to the insert and rotates about the longitudinal axis of the insert.
`
`U.S. Patent No. 8,702,707
`— Claim 5
`5. A fixation instrument for
`treating a bone fracture as
`set forth in claim 1
`including said engagement
`portion and said retaining
`member configured such
`that when said engagement
`portion engages said
`retaining member said
`locking ring may rotate
`about said longitudinal axis
`of said insert while
`remaining attached to said
`insert.
`
`
`
`Page 12 of 24
`
`
`
`ZIMMER 1040
`Page 18
`
`
`
`U.S. Patent No. 8,702,707
`— Claim 6
`6. A fixation instrument for
`treating a bone fracture
`comprising:
`
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents.
` “The AFFIXUS Hip Fracture Nail System is intended to treat stable and unstable proximal fractures
`of the femur. . . .” (Exhibit B, AFFiXUS Hip Fracture Nail, Surgical Technique Brochure pp. 7,
`hereafter “Brochure”.)
`
`
`Page 13 of 24
`
`ZIMMER 1040
`Page 19
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. The AFFIXUS nail is a nail member, having a longitudinal axis with a distal
`end and a proximal end. Brochure, pp.7 – Figure 1, “AFFIXUS Hip Fracture Nail Short — (180 mm)
`and AFFIXUS Hip Fracture Nail Long — (260 – 460 mm).” The AFFIXUS nail has a neck shaft
`angle or angle of proximal targeting of 130°. Brochure, pp. 12, 27. Illustrated below are Figures 22A
`and 22B, Brochure, pp. 19 with annotations identifying the structure of the AFFIXUS Nail
`corresponding to the claim element.
`
`a nail member having a
`longitudinal axis, a distal
`end and a proximal end,
`said proximal end having
`an aperture extending
`therethrough at an angle
`with respect to said
`longitudinal axis of said
`nail member, said nail
`member having a chamber
`located in said proximal
`end, said chamber having
`an inner surface and a
`plurality of threads located
`on said inner surface;
`
`Page 14 of 24
`
`ZIMMER 1040
`Page 20
`
`
`
`a bone screw having a
`threaded portion, said bone
`screw extending through
`said aperture;
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`
`
`
`
`
`
`Page 15 of 24
`
`ZIMMER 1040
`Page 21
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`an insert, said insert having
`a longitudinal axis, a distal
`end, a proximal end and a
`passageway extending
`longitudinally through said
`insert from said proximal
`end to said distal end, said
`insert having a lower
`surface, said insert
`positioned within said
`chamber;
`
`
`
`
`
`Page 16 of 24
`
`ZIMMER 1040
`Page 22
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. “The set screw is pre-loaded in the nail.” Brochure, pp. 19 – Fig. 22A. Nail is
`inserted “by hand over the 3mm ball nose guide wire into the medullary canal.” Brochure, pp. 14. In
`order to insert the nail over the wire the “pre-loaded “ set screw, see Figure 22B below must have a
`longitudinal passageway extending therethrough. As illustrated below, the engagement portion of the
`locking ring and the retaining member of the insert are configured such that the locking ring remains
`attached to the insert and rotates about the longitudinal axis of the insert.
`
`a locking ring having a
`longitudinal passageway
`extending therethrough
`and an outer surface, a
`plurality of threads located
`on said outer surface,
`wherein said threads
`located on said outer
`surface of said locking
`ring engage said threads on
`said inner surface of said
`chamber, said locking ring
`rotatably connected to said
`insert; and
`
`
`
`Page 17 of 24
`
`
`
`ZIMMER 1040
`Page 23
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`
`said bone screw having a
`longitudinal axis and
`having a plurality of
`longitudinally extending
`grooves, said grooves
`extending substantially
`parallel to said longitudinal
`axis of said bone screw on
`an outer surface of said
`bone screw wherein at least
`a portion of said distal end
`of said insert is located in
`one of said grooves to
`resist rotation of said bone
`screw within said aperture.
`
`
`
`
`
`Page 18 of 24
`
`ZIMMER 1040
`Page 24
`
`
`
`U.S. Patent No. 8,702,707
`— Claim 7
`7. A fixation instrument for
`treating a bone fracture as
`set forth in claim 6
`including:
`said locking ring having a
`downwardly projecting
`finger having a lip; and
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is present literally and/or under the
`Doctrine of Equivalents.
`See elements forth above regarding Claim 6.
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`Page 19 of 24
`
`ZIMMER 1040
`Page 25
`
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`said insert having an
`inwardly extending flange
`whereby said flange
`cooperates with said lip to
`rotatably secured the
`locking ring to the insert.
`
`
`
`
`
`
`Page 20 of 24
`
`ZIMMER 1040
`Page 26
`
`
`
`U.S. Patent No. 8,702,707
`— Claim 8
`8. A fixation instrument for
`treating a bone fracture as
`set forth in claim 7
`including:
`said chamber having a
`groove extending along a
`side wall of said chamber;
`and
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). See elements set forth above regarding Claim 7.
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`Page 21 of 24
`
`ZIMMER 1040
`Page 27
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`said insert including a
`locating member extending
`radially outward from a
`body of said insert, said
`locating member
`cooperating with said
`groove whereby said insert
`moves in said chamber in a
`longitudinal direction and
`is constrained against
`rotation by the locating
`member.
`
`
`
`
`
`Page 22 of 24
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`ZIMMER 1040
`Page 28
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`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents.
`See elements set forth above regarding Claim 8.
`
`U.S. Patent No. 8,702,707
`— Claim 9
`9. A fixation instrument for
`treating a bone fracture as
`set forth in claim 8
`including said insert having
`an overall outer diameter
`less than an inner diameter
`of said chamber formed by
`said threads on said inner
`surface of said chamber.
`
`
`
`
`
`
`Page 23 of 24
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`ZIMMER 1040
`Page 29
`
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents.
`See elements set forth above regarding Claim 8. As illustrated below the portion of the set screw
`engaging the bone screw extends at substantially the same angle as the aperture.
`
`
`U.S. Patent No. 8,702,707
`— Claim 10
`10. A fixation instrument
`for treating a bone fracture
`as set forth in claim 8
`wherein said portion of
`said lower surface
`engaging said grooves in
`said locking screw extends
`at an angle substantially
`the same as the angle of
`said aperture.
`
`
`
`Page 24 of 24
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`ZIMMER 1040
`Page 30
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`
`
`
`
`EXHIBIT B
`
`
`
`
`
`ZIMMER 1040
`Page 31
`
`
`
`EXHIBIT B
`
`ADVANCED ORTHOPAEDIC SOLUTIONS, INC.’S INFRINGEMENT CONTENTIONS
`U.S. Patent No. 8,092,454
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a).
`
`“The AFFIXUS Hip Fracture Nail System is intended to treat stable and unstable proximal fractures
`of the femur. . . .” (Exhibit C, AFFiXUS Hip Fracture Nail, Surgical Technique Brochure pp. 7,
`hereafter “Brochure”.)
`
`
`
`U.S. Patent No. 8,092,454
`— Claim 6
`
`
`1. A fixation instrument for
`treating a bone fracture
`comprising:
`
`
`
`Page 1 of 31
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`ZIMMER 1040
`Page 32
`
`
`
`a nail member, said nail
`member having a
`longitudinal axis, a distal
`end and a proximal end,
`said proximal end having
`an aperture extending
`therethrough and said nail
`member having a chamber
`located in said proximal
`end;
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. The AFFIXUS nail is a nail member, having a longitudinal axis with a distal
`end and a proximal end. Brochure, pp.7 – Figure 1, “AFFIXUS Hip Fracture Nail Short — (180 mm)
`and AFFIXUS Hip Fracture Nail Long — (260 – 460 mm).” Illustrated below are Figures 22A and
`22B, Brochure, pp. 19 with annotations identifying the structure of the AFFIXUS Nail corresponding
`to the claim element.
`
`
`
`Page 2 of 31
`
`
`
`ZIMMER 1040
`Page 33
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`an insert adapted to be
`positioned within said
`chamber and having a
`lower surface, said lower
`surface operative to contact
`a bone screw extending
`through said aperture;
`
`Page 3 of 31
`
`
`
`
`
`
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`ZIMMER 1040
`Page 34
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`a locking ring received in
`said chamber and engaging
`said insert, said locking
`ring operative to secure
`said insert within said
`chamber;
`
`
`
`
`
`
`Page 4 of 31
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`ZIMMER 1040
`Page 35
`
`
`
`a locking projection
`located on said lower
`surface of said insert; and
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents
`
`
`Page 5 of 31
`
`
`
`
`
`
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`ZIMMER 1040
`Page 36
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. “[T]he set screw contacts the lag screw in one of the four lag screw grooves
`(Figure 22A & 22B).” Brochure, pp. 19. Figure 22B shows the “Cross section of set screw engaging
`lag screw.” “[T]he set screw contacts the lag screw in one of the four lag screw grooves.” Brochure,
`pp. 19. The set screw has properly engaged the lag screw if the lag screw will not rotate. Brochure, pp.
`19.
`
`said bone screw having a
`longitudinally axis and
`having a plurality of
`longitudinal extending
`grooves, said grooves
`extending substantially
`parallel to said longitudinal
`axis of said bone screw on
`an outer surface of said
`bone screw wherein said
`locking projection is
`located in one of said
`grooves when said lower
`surface contacts said bone
`screw.
`
`
`
`Page 6 of 31
`
`ZIMMER 1040
`Page 37
`
`
`
`U.S. Patent No. 8,092,454
`— Claim 7
`7. A fixation instrument for
`treating a bone fracture as
`set forth in claim 6
`including:
`said aperture extending
`through said nail member
`at an angle with respect to
`the longitudinal axis of
`said nail member; and
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a).
`See elements set forth above regarding Claim 6.
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. The AFFIXUS nail has a neck shaft angle or angle of proximal targeting of
`130°. Brochure, pp. 12, 27.
`
`
`
`
`
`Page 7 of 31
`
`ZIMMER 1040
`Page 38
`
`
`
`said lower surface
`extending at an angle
`substantially the same as
`the angle of said aperture.
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. As illustrated below the portion of the set screw engaging the bone screw
`extends at substantially the same angle as the aperture.
`
`Page 8 of 31
`
`
`
`
`
`
`
`ZIMMER 1040
`Page 39
`
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents. See elements set forth
`above regarding Claim 6. “The set screw is pre-loaded in the nail.” Brochure, pp. 19 – Fig. 22A. Nail
`is inserted “by hand over the 3mm ball nose guide wire into the medullary canal.” Brochure, pp. 14. In
`order to insert the nail over the wire the “pre-loaded “ set screw, see Figure 22B below both the
`locking ring and insert must have a longitudinal passageway extending therethrough.
`
`U.S. Patent No. 8,092,454
`— Claim 8
`8. A fixation instrument for
`treating a bone fracture as
`set forth in claim 6 wherein
`each of said insert and said
`locking ring have
`longitudinal passageways
`extending therethrough,
`wherein said longitudinal
`passageway extending
`through said insert
`terminates at said lower
`surface.
`
`Page 9 of 31
`
`ZIMMER 1040
`Page 40
`
`
`
`U.S. Patent No. 8,092,454
`— Claim 9
`9. A fixation instrument for
`treating a bone fracture as
`set forth in claim 6 wherein
`said locking ring is
`rotatably connected to said
`insert.
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents.
`See elements set forth above regarding Claim 6. As illustrated below, the engagement portion of the
`locking ring and the retaining member of the insert are configured such that the locking ring remains
`attached to the insert and rotates about the longitudinal axis of the insert.
`
`
`
`Page 10 of 31
`
`
`
`ZIMMER 1040
`Page 41
`
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is present under the Doctrine of
`Equivalents. As illustrated, the locking ring has a post portion with an outwardly projecting finger
`corresponding by equivalents to the “inwardly projecting fingers.”
`
`U.S. Patent No. 8,092,454
`— Claim 10
`
`10. A fixation instrument
`for treating a bone fracture
`as set forth in claim 9
`wherein said locking ring
`includes a post portion
`having an inwardly
`projecting fingers; and
`
`Page 11 of 31
`
`
`
`ZIMMER 1040
`Page 42
`
`
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is present under the Doctrine of
`Equivalents. As illustrated, the insert includes a retaining member having an inwardly extending lip
`corresponding by equivalents to the “outwardly extending lip,” whereby the outwardly projecting
`finger and inwardly extending lip rotatably secure the locking ring to the insert.
`
`said insert having a
`retaining member located
`on a distal end thereof, said
`retaining member
`including an outwardly
`extending lip when said
`locking finger engages said
`lip to rotatably secure said
`locking ring to said insert.
`
`
`
`
`
`
`Page 12 of 31
`
`ZIMMER 1040
`Page 43
`
`
`
`U.S. Patent No. 8,092,454
`— Claim 11
`11. A fixation instrument
`for treating a bone fracture
`as set forth in claim 6
`including a cap, said cap
`operative to close said
`opening located at said rear
`edge of said nail member.
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents. “Attach the end cap to the 5
`mm end cap hex driver(2112-01-600 or 2112-01-601) and insert into the end of the nail. Tighten the
`end cap by turning clockwise until the end cap fully seats against the top of the nail.” Brochure, pp. 25
`– Fig. 31.
`
`
`
`Page 13 of 31
`
`
`
`
`
`
`
`ZIMMER 1040
`Page 44
`
`
`
`U.S. Patent No. 8,092,454
`— Claim 13
`13. A fixation instrument
`for treating a bone fracture
`comprising:
`
`
`
`AFFiXUS Hip Fracture Nail
`
`Plaintiff asserts infringement under 35 USC 271(a). This element is literally present; if not considered
`literally present this element is present under the Doctrine of Equivalents.
` “The AFFIXUS Hip Fracture Nail System is intended to treat stable and unstable proximal fractures
`of the femur. . . .” (Exhibit C, AFFiXUS Hip Fracture Nail, Surgical Technique Brochure pp. 7,
`hereafter “Brochure”.)
`
`
`Page 14 of 31
`
`ZIMMER 1040
`Page 45
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents. The AFFIXUS nail has a neck shaft angle or angle of proximal targeting of
`130°. Brochure, pp. 12, 27.
`
`
`
`a nail member, said nail
`member having a
`longitudinal axis, a distal
`end and a proximal end,
`said proximal end having
`an aperture extending
`therethrough at an angle
`with respect to the
`longitudinal axis of said
`nail member and said nail
`member having a chamber
`located in said proximal
`end;
`
`
`
`
`
`Page 15 of 31
`
`ZIMMER 1040
`Page 46
`
`
`
`a bone screw;
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`
`
`
`
`
`
`
`
`
`Page 16 of 31
`
`ZIMMER 1040
`Page 47
`
`
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`
`an insert adapted to be
`positioned within said
`chamber, said insert having
`a proximal end and a distal
`end, said distal end
`terminating at said lower
`surface, said lower surface
`extending at an angle
`substantially the same as
`the angle of said aperture
`extending through said nail
`member and engaging said
`bone screw when said bone
`screw extends through said
`aperture;
`
`
`
`Page 17 of 31
`
`
`
`ZIMMER 1040
`Page 48
`
`
`
`a locking ring received in
`said chamber and engaging
`said insert, said locking
`ring operative to secure
`said insert within said
`chamber;
`
`This element is literally present; if not considered literally present this element is present under the
`Doctrine of Equivalents.
`
`
`
`
`
`
`
`
`
`Page 18 of 31
`
`ZIMMER 1040
`Page 49
`
`
`
`said nail member having a
`second aperture extending
`therethrough for rece