`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`EXTREMITY MEDICAL, LLC, a New Jersey
`limited liability company,
`
`
`
`Plaintiff,
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`
`
`C.A. No.
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`JURY TRIAL DEMANDED
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`)
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`))))))))
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`)
`)
`)
`)
`)
`)
`
`v.
`
`
`NEXTREMITY SOLUTIONS, INC., a
`Delaware corporation,
`
`ZIMMER BIOMET HOLDINGS, INC., a
`Delaware corporation, and
`
`ZIMMER, INC., a Delaware corporation,
`
`
`
`
`Defendants.
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`COMPLAINT
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`Plaintiff Extremity Medical, LLC (“Extremity Medical” or “Plaintiff”), for its Complaint
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`against Defendants Nextremity Solutions, Inc. (“Nextremity”), Zimmer Biomet Holdings, Inc.
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`(“Zimmer Biomet”), and Zimmer, Inc. (“Zimmer”), (collectively, “Defendants”), hereby alleges
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`as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a civil action for patent infringement of U.S. Patent No. 8,303,589 (“the
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`’589 Patent”) in violation of the patent laws of the United States, 35 U.S.C. § 1, et seq., arising
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`from Defendants’ unauthorized manufacture, use, offer to sell, sale and/or importing into or in the
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`United States its InCore Lapidus System (“the Infringing System”).
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`THE PARTIES
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`2.
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`Extremity Medical is a limited liability company formed in the State of New Jersey
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`and having its principal place of business at 300 Interpace Parkway, Suite 410, Parsippany, NJ
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`07054.
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 2 of 15 PageID #: 2
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`3.
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`Upon information and belief, Nextremity is a corporation organized under the laws
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`of the State of Delaware and has its principal place of business at 1195 Polk Drive, Warsaw,
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`Indiana 46582.
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`4.
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`Upon information and belief, Zimmer Biomet is a corporation organized under the
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`laws of the State of Delaware and has its principal place of business at 345 East Main Street,
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`Warsaw, Indiana 46580.
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`5.
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`Upon information and belief, Zimmer is a corporation organized under the laws of
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`the State of Delaware and has its principal place of business at 345 East Main Street, Warsaw,
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`Indiana 46580.
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`JURISDICTION AND VENUE
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`6.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
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`1338(a) because this is an action arising under the patent laws of the United States, 35 U.S.C. § 1,
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`et seq.
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`7.
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`This Court has personal jurisdiction over Defendants because, upon information
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`and belief, each Defendant: (a) was incorporated in the state of Delaware, (b) transacts business in
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`Delaware through the sale of products from and/or into Delaware and therefore has substantial and
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`continuous contacts within this judicial district; and (c) has committed, and continues to commit,
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`tortious acts within the state of Delaware giving rise to this action. In short, each Defendant has
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`purposely availed itself of the privileges and benefits of the laws of the State of Delaware, each
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`Defendant derives benefits from its presence in this Judicial District, and each Defendant should
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`reasonably expect its actions to have consequences within this Judicial District.
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`8.
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`Venue is proper under 28 U.S.C. §§ 1391(b), 1391(c) and/or 1400(b).
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`2
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 3 of 15 PageID #: 3
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`THE PATENT-IN-SUIT
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`9.
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`On November 6, 2012, U.S. Patent No. 8,303,589, entitled “Fixation System, an
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`Intramedullary Fixation Assembly and Method Of Use”, was duly and legally issued by the United
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`States Patent and Trademark Office (“USPTO”). A true and correct copy of the ’589 Patent is
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`attached hereto as Exhibit A. The ’589 Patent is valid, enforceable and currently in full force and
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`effect.
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`10.
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`Plaintiff is the owner and assignee of all rights, title, and interest in the ’589 Patent,
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`including the full and exclusive right to bring this action and enforce the ’589 Patent against
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`infringers, and the right to recover damages for all relevant time periods, including for past
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`infringement.
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`11.
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` The ’589 Patent discloses, inter alia, bone fixation systems comprising
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`intramedullary fixation assemblies for treating and fixating deteriorated, damaged and/or fractured
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`bones, such as bones in the human foot. For example, assemblies disclosed in the ’589 Patent may
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`be used to restore the arch in a human foot by coupling the assembly to the medullary canals of
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`the first metatarsal, medial cuneiform, navicular and/or talus bones in the foot.
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`12.
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`An exemplary figure, Figure 18, from the ’589 Patent is provided below:
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`3
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 4 of 15 PageID #: 4
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`FACTUAL BACKGROUND
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`
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`13.
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`Extremity Medical was founded in 2008 by Matthew Lyons. Mr. Lyons graduated
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`from Syracuse University in 1986 with a Bachelor of Science in Mechanical Engineering,
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`specializing in biomechanics. Mr. Lyons has over 30 years of experience in the medical device
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`industry and is named as inventor on numerous patents directed to orthopedics and medical
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`devices.
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`14.
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`Extremity Medical is a global medical engineering company, dedicated to creating
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`innovative solutions for the challenges that extremity surgeons face. Extremity Medical develops
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`next-generation products for fusion, fixation and motion-preserving systems for the upper and
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`lower extremities of the human body, including the hands and feet. Plaintiff proudly manufactures
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`its products in the United States, and sells and promotes them throughout the United States and
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`worldwide.
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`4
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 5 of 15 PageID #: 5
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`15.
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`Extremity Medical has invested substantial time and resources into the research,
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`design and development of its products, and secures intellectual property rights to protect them.
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`The company has obtained 39 patents in the United States, Australia, Canada, the European Union,
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`and Japan, and currently has seven additional patent applications pending.
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`16.
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`On November 23, 2021, Extremity Medical, by its counsel, sent a letter to
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`Defendants Nextremity and Zimmer Biomet. The letters explained that Extremity Medical has
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`obtained over 20 patents on its inventions in the United States, and several others in foreign
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`countries. The letters further explained that the ’589 Patent is owned by Extremity Medical, and
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`that the Infringing System contains all of the elements recited in Claim 59 of the ’589 Patent, and
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`is therefore infringing at least this claim.
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`17.
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`On December 15, 2021 and January 14, 2022, Defendants Nextremity and Zimmer
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`Biomet sent letters to Extremity Medical, confirming receipt of Extremity Medical’s November
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`23, 2021 letter and acknowledging the notice provided by Extremity Medical regarding the ’589
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`Patent.
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`18.
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`The Infringing System includes at least: (1) an “InCore Post”, (2) a “Targeting
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`Guide,” and (3) a screw. Below are annotated images of the Infringing System. The images
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`(without annotations) are depicted on the cover and page 3 of product materials for the Infringing
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`System, identified on Nextremity’s website and Zimmer Biomet’s website as the “InCore®
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`Lapidus System Surgical Technique” Guide (the “Surgical Guide”). A copy of the Surgical Guide
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`is attached hereto as Exhibit B. The Surgical Guide is available for download from Defendants’
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`websites (See https://www.nextremity.com/portfolio-items/incore-lapidus-system/ and
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`https://www.zimmerbiomet.com/en/products-and-solutions/specialties/foot-and-ankle/incore-
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`lapidus-system.html#07-education).
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`5
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 6 of 15 PageID #: 6
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`Targeting Guide
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`InCore Post
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`Exhibit B at 3;
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`InCore Post
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`screw
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`Exhibit B, cover.
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`6
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 7 of 15 PageID #: 7
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`CLAIMS FOR RELIEF
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`FIRST CLAIM FOR RELIEF
`(INFRINGEMENT OF THE ’589 PATENT)
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`19.
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`Plaintiff hereby incorporates by reference paragraphs 1-18 as if fully set forth
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`herein.
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`20.
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`Defendants have infringed and continue to infringe, either literally or under the
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`doctrine of equivalents, at least Claim 59 of the ’589 Patent in violation of 35 U.S.C. § 271(a) by
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`making, using, offering for sale, selling and/or importing into or in the United States the Infringing
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`System, without a license or permission from Plaintiff.
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`21.
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`Upon information and belief, Defendants have also infringed and continue to
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`infringe at least Claim 59 of the ’589 Patent in violation of 35 U.S.C. § 271(b) by inducing vendors,
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`customers and others to make, use, sell, or offer for sale within the United States, systems that
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`practice inventions of the ’589 Patent with knowledge of and intent that such vendors, customers
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`and others infringe the ’589 Patent. Defendants have intentionally caused, urged, encouraged, or
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`aided in the actions—including the direct infringement of the ‘589 Patent—that induced
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`infringement of the ’589 Patent by vendors, customers and others. Upon information and belief,
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`such intentional actions include, for example, inducing Defendants’ customers to infringe the ’589
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`Patent by making available on their website surgical guides that teach surgeons how to assemble
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`and use the Infringing System. As a result of Defendants’ conduct, Defendants have induced and
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`are inducing such vendors, customers and others to make or use systems, such as the Infringing
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`System, to infringe at least Claim 59 of the ’589 Patent. Additionally and in the alternative,
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`Defendants have induced and are inducing their vendors, customers and others to implement and
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`utilize parts of the Infringing System to infringe at least Claim 59 of the ’589 Patent. Defendants
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`7
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 8 of 15 PageID #: 8
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`have engaged and are engaging in this conduct while aware of the ’589 Patent and with the intent
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`to infringe, at least as of the filing of the Complaint.
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`22.
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`Upon information and belief, with knowledge of the ’589 Patent, Defendants have
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`also contributed to the infringement of the ’589 Patent by offering for sale or selling within the
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`United States or importing into the United States the InCore Post, which constitutes a material part
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`of the Infringing System. Defendants know the InCore Post is especially made or especially
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`adapted for use in the Infringing System, and that the InCore Post is not a staple article or
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`commodity of commerce suitable for substantial noninfringing use. By contributing to the use of
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`the Infringing System by their vendors, customers and others, Defendants have been indirectly
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`infringing under 35 U.S.C. § 271(c) one or more claims of the ’589 Patent, either literally or under
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`the doctrine of equivalents.
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`23.
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`Claim 59 of the ’589 Patent recites: “[a] fixation system for compressing bone,
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`comprising” certain elements. The Infringing System is a fixation system for compressing bone.
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`Below is an annotated image of the InCore Post and screw of the Infringing System:
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`InCore Post
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`screw
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`8
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 9 of 15 PageID #: 9
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`See Exhibit B, cover. Below is an image of the Targeting Guide and InCore Post of the Infringing
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`System:
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`
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`See Exhibit B at 2; see also id. at 1 (“Targeting Guide includes built-in Compression-Distraction
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`Fixture providing compression parallel to the long axis of the first metatarsal”).
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`24.
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`Claim 59 further recites: “a first screw member comprising a head portion and a
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`first shaft extending along a first longitudinal axis . . . .” The screw of the Infringing System is a
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`first screw member comprising a head portion and a first shaft extending along a first longitudinal
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`axis. An annotated image of a screw of the Infringing System is shown below.
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`
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`screw
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`head portion
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`See Exhibit B at 1.
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`first shaft
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`
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`first longitudinal axis
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`
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`25.
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`Claim 59 further recites: “a second member comprising a second shaft extending
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`along a second longitudinal axis and a bore extending through said second shaft along a bore axis
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`. . . .” The InCore Post of the Infringing System is a second member comprising a second shaft
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`9
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 10 of 15 PageID #: 10
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`extending along a second longitudinal axis and a bore extending through said second shaft along
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`a bore axis. An annotated image of the InCore Post of the Infringing System is shown below:
`InCore Post
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`
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`second shaft
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`bore
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`bore axis
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`
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`second longitudinal axis
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`See Exhibit B at 1.
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`
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`26.
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`Claim 59 further recites: “an instrument adapted for coupling said first screw
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`member to said second member . . . .” The Targeting Guide of the Infringing System is an
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`instrument adapted for coupling the screw of the Infringing System to the InCore Post. Annotated
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`images of the Targeting Guide as part of the Infringing System are shown below:
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`10
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 11 of 15 PageID #: 11
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`Targeting Guide
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`See Exhibit B at 3;
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`
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`Targeting Guide
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`
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`See Exhibit B at 9. According to the Surgical Guide, “[s]ighting the holes in the Targeting Guide,
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`alignment can be visualized to ensure proper assembly and left/right foot selection.” Exhibit B at
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`3.
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`11
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 12 of 15 PageID #: 12
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`27.
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`Claim 59 further recites: “wherein said second longitudinal axis and said bore axis
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`define an angle, wherein said first screw member is adapted for coupling to said second member
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`at said angle . . . .” As shown in the following annotated image of the Infringing System, the
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`second longitudinal axis and bore axis of the InCore Post define an angle, and the screw of the
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`Infringing System is adapted for coupling to the InCore Post at that angle:
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`screw
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`bore axis
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`InCore Post
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`angle
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`See Exhibit B, cover.
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`second longitudinal axis
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`
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`28.
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`Claim 59 further recites: “wherein each of said first screw member and said second
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`member is adapted for residing substantially within at least one bone . . . .” As shown in the
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`following annotated image, the InCore Post and screw are adapted for residing substantially within
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`at least one bone:
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`12
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`
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 13 of 15 PageID #: 13
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`InCore Post
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`screw
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`
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`See Exhibit B at 1.
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`Claim 59 further recites: “wherein said second member comprises first and second
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`circumferentially spaced recesses adapted for coupling to said instrument.” As shown in the
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`following annotated image, the InCore Post includes first and second circumferentially spaced
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`recesses adapted for coupling to the Targeting Guide:
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`second recess
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`first recess
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`See Exhibit B at 1;
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`13
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 14 of 15 PageID #: 14
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`Exhibit B at 2.
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`
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`Exhibit B at 2.
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`29.
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`Plaintiff has already been damaged by Defendants’ infringement of the ’589 Patent,
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`has been irreparably harmed by that infringement, and will suffer additional damages and
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`irreparable harm for which there is no adequate remedy at law unless and until such infringing
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`conduct is enjoined pursuant to 35 U.S.C. § 283 and/or the equitable powers of this Court.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff respectfully requests the following relief:
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`A.
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`Entry of a judgment in favor of Plaintiff on all Counts of the Complaint;
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`14
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`Case 1:22-cv-00239-UNA Document 1 Filed 02/25/22 Page 15 of 15 PageID #: 15
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`B.
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`Entry of a judgment that each Defendant has directly and/or indirectly infringed the
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`’589 Patent and that such infringement has been willful;
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`C.
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`Entry of a preliminary and permanent injunction against each Defendant, pursuant
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`to 35 U.S.C. § 283 and/or the equitable powers of this Court, to prevent further direct and/or
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`indirect infringement of the ’589 Patent;
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`D.
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`An award of damages, in an amount to be determined, adequate to compensate
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`Plaintiff for the infringement that has occurred, pursuant to 35 U.S.C. § 284;
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`E.
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`An Order requiring each Defendant to pay Plaintiff its costs and attorneys’ fees in
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`this action pursuant to 35 U.S.C. § 285 and/or other applicable laws;
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`F.
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`Such other and further relief as the Court may deem just and proper.
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`JURY DEMAND
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`Plaintiff hereby demands a trial by jury of all issues so triable.
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`ASHBY & GEDDES
`
`/s/ Andrew C. Mayo
`____________________________
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, Delaware 19899
`(302) 654-1888
`amayo@ashbygeddes.com
`
`Attorneys for Plaintiff Extremity Medical, LLC
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`Of Counsel:
`
`Michael J. Zinna
`David G. Lindenbaum
`KELLEY DRYE & WARREN LLP
`One Jefferson Road
`2nd Floor
`Parsippany, NJ 07054
`(973) 503-5900
`
`Dated: February 25, 2022
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`15
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