Trademark Trial and Appeal Board Electronic Filing System. https://estta.uspto.gov
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`ESTTA Tracking number:
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`ESTTA1217035
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`Filing date:
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`06/22/2022
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Proceeding no.
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`92079989
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`Party
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`Correspondence
`address
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`Submission
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`Filer's name
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`Filer's email
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`Signature
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`Date
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`Plaintiff
`Fusion Orthopedics, LLC
`
`ANTHONY M. VERNA III
`VERNA LAW, P.C.
`80 THEODORE FREMD AVE.
`RYE, NY 10580
`UNITED STATES
`Primary email: anthony@vernalaw.com
`No phone number provided
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`Motion to Suspend for Civil Action
`
`Anthony M. Verna III
`
`anthony@vernalaw.com
`
`/s Anthony M. Verna III s/
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`06/22/2022
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`Attachments
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`motion to suspend pending civil proceeding - Fusion.pdf(5103971 bytes )
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`

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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`
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`Fusion Orthopedics, LLC
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`Plaintiff,
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`vs.
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`
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`Treace Medical Concepts, Inc.
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`
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`Defendant
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`Cancellation No.:
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`MOTION TO SUSPEND OPPOSITION
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`Pursuant to 37 CFR §2.117(a) and Rule 510.02 of the Trademark Trial and Appeal Board
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`Manual of Procedure (“TBMP”), Fusion Orthopedics, LLChereby moves to suspend the above-
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`captioned cancellation proceeding (the “Cancellation Proceeding”) pending final disposition of
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`the case captioned Treace Medical Concepts, Inc., vs. Fusion Orthopedics, LLC, Case No. 2:22-
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`cv-00490, filed in the United States District Court for the District of Virginia (“Federal Civil
`
`Action”), commenced on March 29, 2022.
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`Copies of the Complaint and the Answer in the Federal Civil Action are attached for the
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`Board’s reference as Exhibit 1 and 2, respectively.
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`This suspension is requested on the basis that the decision in the Federal Civil Action will
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`have significant bearing on the instant Cancellation Proceeding. The issues necessarily decided
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`by the district court in resolving the Federal Civil Action will affect all pending trademark issues
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`involved in the Opposition Proceeding. The Federal Civil Action will clarify the rights of the
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`parties, in all of marks that are the subject of the trademark applications and registrations that are
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`Motion to Suspend – Fusion
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`Page 1 of 5
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`

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`the subject of the Opposition Proceeding on both the Plaintiff and Defendant sides of the instant
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`opposition.
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`To the extent that a civil action in a federal district court involves issues in common with
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`those in a proceeding before the Board, the decision of the federal district court is often binding
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`upon the Board while the decision of the Board is not binding upon the court. TBMP §
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`510.02(a), at n.2 (citing New Orleans Louisiana Saints LLC v. Who Dat? Inc., 99 USPQ2d 1550,
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`1552 (TTAB 2011). Thus, suspension of the pending Opposition Proceeding will promote
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`judicial economy and the conservation of resources.
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`Respectfully submitted,
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`Dated this June 22, 2022
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`
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`
`
`
`
`/s Anthony M. Verna III /s
`Anthony M. Verna III, Esq.
`Verna Law, P.C.
`80 Theodore Fremd Dr.
`Rye, NY 10580
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`Motion to Suspend – Fusion
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`Page 2 of 5
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`IN THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`
`Fusion Orthopedics, LLC
`
`Plaintiff,
`
`vs.
`
`
`
`
`
`Treace Medical Concepts, Inc.
`
`
`
`Defendant
`
`Cancellation No.:
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
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`
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that on this 22nd day of June 2022, a copy of the foregoing
`Motion was served via First Class mail on the following representative:
`
`John Pickerill
`Fredrikson & Byron, P.A.
`200 South 6th Street, Suite 4000
`Minneapolis, MN 55402
`
`
`
`Respectfully submitted,
`
`Dated this June 22, 2022
`
`/s Anthony M. Verna III /s
`Anthony M. Verna III, Esq.
`Verna Law, P.C.
`80 Theodore Fremd Dr.
`Rye, NY 10580
`
`
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`Motion to Suspend – Fusion
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`Page 3 of 5
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`EXHIBIT 1
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`Motion to Suspend – Fusion
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`Page 4 of 5
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`

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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 1 of 58
`
`
`
`Eric M. Fraser, 027241
`Phillip W. Londen, 032488
`OSBORN MALEDON, P.A.
`2929 North Central Avenue, Suite 2100
`Phoenix, Arizona 85012
`
`(602) 640-9000
`efraser@omlaw.com
`plonden@omlaw.com
`
`Todd G. Miller (pro hac vice to be filed)
`Oliver J. Richards (pro hac vice to be filed)
`FISH & RICHARDSON P.C.
`12860 El Camino Real, Suite 400
`San Diego, California 92130
`(858) 678-5070
`miller@fr.com
`ojr@fr.com
`
`Frank E. Scherkenbach (pro hac vice to be filed)
`FISH & RICHARDSON P.C.
`One Marina Park Drive
`Boston, Massachusetts 02210-1878
`(617) 542-5070
`scherkenbach@fr.com
`
`Attorneys for Plaintiff
`
`UNITED STATES DISTRICT COURT
`
`DISTRICT OF ARIZONA
`
`Treace Medical Concepts, Inc.,
`
`
`Plaintiff,
`vs.
`
`
`Fusion Orthopedics, LLC,
`
`
`Defendant.
`
`
`
`
` No.
`
`COMPLAINT FOR PATENT
`INFRINGEMENT, TRADEMARK
`INFRINGEMENT, UNFAIR
`COMPETITION AND COPYRIGHT
`INFRINGEMENT
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 2 of 58
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`
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`Plaintiff, Treace Medical Concepts, Inc. (“Treace Medical”), by its attorneys,
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`brings this Complaint against defendants Fusion Orthopedics, LLC (“Fusion”). Treace
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`Medical alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a civil action arising out of Fusion’s: (a) patent infringement in
`
`violation of the Patent Laws of the United States, 35 U.S.C. §§ 271 and 281-285; (b)
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`trademark infringement under 15 U.S.C. § 1114(a); (c) federal unfair competition; (d)
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`common law trademark infringement and unfair competition, and (e) federal copyright
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`infringement under 17 U.S.C. § 101, et seq.
`
`THE PARTIES
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`2.
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`Treace Medical is a Delaware corporation having its principal place of
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`business at 203 Fort Wade Rd., Suite 150, Ponte Vedra, Florida, 32081.
`
`3.
`
`On information and belief, Fusion is an Arizona limited liability company
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`having its principal place of business at 4135 S. Power Rd., Ste. 118, Mesa, Arizona,
`
`85212.
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`JURISDICTION AND VENUE
`
`4.
`
`This Court has subject matter jurisdiction over Treace Medical’s patent
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`infringement claims under 28 U.S.C. § 1331 and 1338(a).
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`5.
`
`This Court has subject matter jurisdiction over Treace Medical’s federal
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`trademark infringement claim under 15 U.S.C. § 1121(a), and under 28 U.S.C. §§ 1331
`
`and 1338.
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`6.
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`This Court has subject matter jurisdiction over Treace Medical’s common
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`law trademark and unfair competition claims under 15 U.S.C. § 1121(a) and under 28
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`U.S.C. §§ 1331 and 1338(b).
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`7.
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`This Court has subject matter jurisdiction over Treace Medical's federal
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`copyright infringement claim under 28 U.S.C. §§ 1331 and 1338(a).
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 3 of 58
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`
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`8.
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`This Court has personal jurisdiction over Fusion because Fusion is an
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`Arizona limited liability company and has a registered agent for service of process in this
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`state.
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`9.
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`On information and belief, Fusion is doing business in this judicial district
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`and has committed one or more of the acts complained of in this judicial district, providing
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`additional bases for the Court’s exercise of personal jurisdiction over Fusion.
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`10. Venue is proper in this district under 28 U.S.C. §§ 1391(b), (c), and 1400(a)
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`and (b).
`
`FACTUAL BACKGROUND
`
`Treace Medical’s Revolutionary LAPIPLASTY® 3D Bunion Correction™
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`11.
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`Treace Medical is the world’s leading designer, developer and manufacturer
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`of surgical instruments and surgical methods focused on the management of bunion
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`deformities and related midfoot correction through its Lapiplasty® 3D Bunion
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`Correction™ procedure. Bunions are the most commonly encountered forefoot problems.
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`Recognizable as a bump on the side of the big toe, bunions are not merely a cosmetic
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`issue. They are a deformity that can result in painful disability.
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`12. Bunions often progress to the point of requiring surgical intervention. For
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`decades, traditional bunion surgery produced mixed results. With traditional bunion
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`surgery techniques, the relevant bones of the foot were cut, reshaped and the cosmetic
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`bump addressed. These traditional techniques, however, did not restore the foot’s natural
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`biomechanical structure.
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`13.
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`In 2015, Treace Medical introduced surgeons to a better way to surgically
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`treat bunions. Treace Medical’s novel methods led to greatly improved patient outcomes
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`and caused a paradigm shift in the way surgeons performed bunion surgery. Treace
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`Medical’s patented surgical methods seek to restore the natural biomechanical structure of
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`the foot by restoring the tri-planar alignment of the patient’s big toe, or more specifically,
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`the relative orientation of the medial cuneiform and first metatarsal bones and the
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 4 of 58
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`
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`cuneiform-metatarsal joint. Treace Medical’s procedure allows patients to walk in a
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`surgical boot within days of the surgery.
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`14. A simplified comparison of traditional bunion surgery with Treace Medical’s
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`LAPIPLASTY® 3D Bunion Correction™ surgical procedure is shown below:
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`15.
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`The bones of the foot most relevant to this case are the first metatarsal and
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`the medial cuneiform. The first metatarsal and medial cuneiform bones (highlighted in
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`yellow in the figure below) and the joint (cuneiform-metatarsal joint) between them are the
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`general focus of bunion surgery using Treace Medical’s patented methods.
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 5 of 58
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`16.
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`Treace Medical’s LAPIPLASTY® 3D Bunion Correction™ corrects the
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`alignment of the first metatarsal in three planes: the transverse plane (right to left direction
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`in the figure below), the sagittal plane (into and out of the page in the figure below) and
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`the frontal plane (the big toe is rotated clockwise when viewed end on by the surgeon).
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 6 of 58
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`17.
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`Treace Medical’s LAPIPLASTY® 3D Bunion Correction™ allows the
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`patient to quickly return to weight-bearing use (in a boot) of the treated foot (see below).
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`
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`18.
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`The surgical methods claimed by the Treace Medical patents asserted in this
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`case include the steps, generally, of preparing or cutting the end of a bone, aligning the
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`bones, compressing the ends of the bones together, inserting a fulcrum between bones, and
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`fixing the bones in an aligned position.
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 7 of 58
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`19.
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`Treace Medical’s surgical method has received extensive industry praise. As
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`a result, surgeons have increasingly chosen to change the way they treat bunions, moving
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`away from traditional surgical methods to Treace Medical’s LAPIPLASTY® 3D Bunion
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`Correction™.
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`20. Unfortunately, along with praise and the commercial success of Treace
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`Medical’s LAPIPLASTY® 3D Bunion Correction™, have come copyists like Fusion,
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`seeking to capitalize on Treace Medical’s pioneering technology, Treace Medical’s
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`impressive clinical data and Treace Medical’s commercial achievements for their own
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`financial gain. Fusion has infringed Treace Medical’s patent, trademark and copyright
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`rights.
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`Fusion’s Infringing LapiLock 4D Bunion Correction System and Method
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`21.
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`Fusion has an internet website at www.fusionorthopedics.com. On that
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`website, Fusion promotes its LapiLock 4D Bunion Correction System to both patients and
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`surgeons. For example at, https://lapilockbunionsurgery.com/?radius=25, Fusion promotes
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`its LapiLock 4D Bunion Correction and implant options to patients and provides a patient-
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`directed video describing its LapiLock 4D Bunion Correction Surgery.
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 8 of 58
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`
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`22. While the above excerpt from Fusion’s website states that LapiLock 4D
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`Correction System is FDA cleared, there is no record of a clearance of this system in the
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`FDA’s 510(k) database (see below).
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`
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`23. While the above except from Fusion’s website also states that the LapiLock
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`4D Correction System is patent pending, there are no published patent applications
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`available on the United States Patent and Trademark Office’s (“USPTO”) website
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`assigned to Fusion that describe or claim Fusion’s LapiLock 4D Correction System or the
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`method of its use.
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 9 of 58
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`24.
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`Fusion’s internet website also invites prospective patients to “FIND A
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`DOCTOR”. By pressing the “FIND A DOCTOR” button, the prospective patient is able
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`to select from doctors in the greater Phoenix area at the link
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`https://lapilockbunionsurgery.com/find-a-bunion-surgery-doctor/?radius=25
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`25.
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`Treace Medical has spent considerable amounts of money educating
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`surgeons about the benefits of LAPIPLASTY® 3D Bunion Correction™ over traditional
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`bunion surgery and on training surgeons in how to correctly perform LAPIPLASTY® 3D
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`Bunion Correction™. Treace Medical sponsors cadaver labs and other educational
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`seminars where surgeons can learn from and practice LAPIPLASTY® 3D Bunion
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`Correction™ with experienced LAPIPLASTY® 3D Bunion Correction™ surgeons before
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`they perform this surgery on their own.
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`26. On information and belief, Fusion targeted surgeons who are trained in
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`performing LAPIPLASTY® 3D Bunion Correction™ as customers for its LapiLock 4D
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`Correction System. By targeting trained LAPIPLASTY® 3D Bunion Correction™
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`surgeons, Fusion avoids the substantial cost inherent in converting surgeons who perform
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`traditional bunion surgery to a new technique and then ensuring that these surgeons
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`perform the new technique correctly. Fusion’s efforts to target surgeons trained in
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`performing LAPIPLASTY® 3D Bunion Correction™ have been most pronounced in
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`Arizona and Utah. Fusion identifies fourteen (14) LAPIPLASTY® 3D Bunion
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`Correction™ trained surgeons from these states at its “FIND A DOCTOR” link.
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 10 of 58
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`
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`27. On information and belief, Fusion has also been hiring and attempting to hire
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`sales representatives who represent Treace Medical and have been trained by Treace
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`Medical to understand and sell Treace Medical’s LAPIPLASTY® 3D Bunion
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`Correction™, to promote Fusion’s LapiLock 4D Bunion Correction, instead, to Treace
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`Medical’s customers and potential customers.
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`28.
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`Fusion’s internet website also includes a “Surgeon Portal” at
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`https://lapilockbunionsurgery.com/surgeons/ where surgeons can download a current
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`version of the “LAPILOCK SURGICAL TECHNIQUE” document (“LapiLock
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`Brochure”) or watch a video demonstrating and explaining the LapiLock 4D Bunion
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`Correction System and method of use titled DTP003 Rev 3 Surgical Technique Video
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`(“LapiLock Video”) or “Learn More About LapiLock 4D Bunion Correction” by
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`submitting their contact information.
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`29.
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`Fusion has used and is using and is offering to sell and selling technology
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`that Treace developed over the past eight years at great expense. Treace Medical's
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`LAPIPLASTY® 3D Bunion Correction™ has been refined and tested over that time to
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`deliver optimum surgical results for patients. On information and belief, Fusion’s
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`LapiLock 4D Bunion Correction has been subject to little or no clinical testing.
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 11 of 58
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`
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`30. On information and belief, surgeons led to believe that Fusion’s LapiLock
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`4D Bunion Correction will produce the consistently positive results that they achieve with
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`Treace Medical’s LAPIPLASTY® 3D Bunion Correction™ have instead experienced
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`inconsistent results with Fusion’s LapiLock 4D Bunion Correction, including failure of
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`bones to fuse post-surgery.
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`31. On information and belief, patients experiencing poor outcomes with
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`Fusion’s LapiLock 4D Bunion Correction are unlikely to distinguish between Fusion’s
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`surgical method and system and Treace Medical’s surgical method and system. On
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`information and belief, these patients are, however, likely to tell their friends and
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`colleagues about their dissatisfaction with the “latest” surgical technique for treating
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`bunions. On information and belief, this bad “word of mouth” taints Treace Medical’s
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`LAPIPLASTY® 3D Bunion Correction™ in the minds of prospective patients. On
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`information and belief, this bad “word of mouth” can also cause prospective patients who
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`would otherwise be helped through surgery with Treace Medical’s LAPIPLASTY® 3D
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`Bunion Correction™ to unnecessarily forego care and endure great pain and ongoing
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`disfigurement.
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`Treace Medical Requested Fusion Discontinue its Improper Activities
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`32. On February 16, 2022, Mr. John Treace, the Chief Executive Officer and
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`Founder of Treace Medical and a co-inventor of the ’590 Patent, sent a letter to Mr. Adam
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`Cundiff, the Chief Executive Officer of Fusion. Mr. Treace’s letter attached a copy of the
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`’590 Patent and a detailed claim chart explaining, with citation to the LapiLock Brochure
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`and LapiLock Video, how Fusion’s LapiLock 4D Bunion Correction infringed the claims
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`of Treace Medical’s ’590 Patent. Mr. Treace’s letter also explained that Fusion’s use of
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`the mark LapiLock 4D Bunion Correction infringed Treace Medical’s registered trademark
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`LAPIPLASTY and 3D BUNION CORRECTION mark and was likely to cause
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`confusion—confusion that could lead Treace Medical’s customers and potential customers
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`to mistakenly believe that Fusion’s LapiLock 4D Bunion Correction is manufactured by
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`Treace Medical, distributed by Treace Medical, associated or connected with Treace
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 12 of 58
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`Medical, or had the sponsorship, endorsement or approval of Treace Medical. Mr. Treace
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`asked that Fusion confirm, no later than March 2, 2022, that it would:
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`1. Stop making, using, importing, offering for sale, and selling in the
`United States the devices used with [Fusion’s] LapiLock;
`2. Stop inducing infringement of [Treace Medical’s] patents by removing
`all materials describing LapiLock from its own websites and all
`affiliated websites;
`3. Stop distributing all printed and electronic literature related to
`LapiLock;
`4. Stop all other activities that describe or encourage the performance of
`[Treace Medical’s] patented methods using Fusion products;
`5. Stop using the LAPILOCK mark, “4D Bunion Correction” language
`and all other confusingly similar themes, text and illustrations;
`6. Produce to Treace [Medical, Fusion’s relevant] sales information for the
`LapiLock system and components; and
`7. Produce to Treace [Medical] all existing LapiLock inventory, training
`supplies, kits, loaners, demonstration products, related devices and
`promotional literature (or certify to Treace [Medical] in writing that the
`same have been destroyed).
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`33. On February 17, 2022, Mr. Sam Rocereta, representing himself as General
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`Counsel for Fusion, acknowledged receipt of Mr. Treace’s letter and responded, copying
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`Adam Cundiff, Nathan Peterson (Fusion’s President and Co-Founder) and Jason Graff
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`(Fusion’s Patent attorney) as follows:
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`John,
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` I
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` am in receipt of your February 16th, 2022 correspondence addressed to Mr.
`Cundiff. I write as attorney for Fusion Orthopedics and if you are
`represented by an attorney, please put me in touch with them.
`
`
`Fusion appreciates the positions outlined in the correspondence. To be clear,
`Fusion respects all intellectual property rights and would never infringe on
`anyone’s intellectual property rights intentionally.
`
`
`Generally, Fusion's position is contrary to the allegations in the
`correspondence. After cursory review, Fusion disagrees with your
`assessment that the Lapilock product infringes with the two ‘590 patent
`independent claims. Perhaps most concerning of the ‘590 patent claims is the
`probability that well known prior art existed before your earliest priority
`date. Intellectual property counsel is further assessing your allegations,
`claims, patent enforceability, and demands, as well as our pending patents.
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 13 of 58
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`Congratulations on your remarkable success with TMCI. As you envision
`productive conversations, or opportunities for our companies to work
`together, always feel free to reach out.
`
`Kind regards,
`
`34. On February 18, 2022, Mr. Treace sent the following e-mail to Mr. Rocereta,
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`copying Adam Cundiff, Nathan Peterson and Jason Graff:
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`Hi Sam,
`
`
`Thank you for reaching out and for your kind words about the remarkable
`success that Treace continues to enjoy. As you can imagine, our success has
`been the result of years of hard work by the entire Treace team.
`
`
`As a co-inventor of the ’590 patent, I am curious about the views you
`express on infringement and validity. Could you please explain why Fusion
`believes that its LapiLock system and method does not infringe the two
`independent claims of the ’590 patent? Similarly, could you please identify
`the “well known prior art” that you refer to in your letter. I would very much
`enjoy reviewing that art.
`
`I appreciate your prompt response to my previous letter and hope that you
`will provide the requested information just as quickly.
`
`Best regards,
`
`35. On February 18, 2022, Mr. Rocereta responded to Mr. Treace, copying
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`Adam Cundiff, Nathan Peterson and Jason Graff, as follows:
`
`John,
`
`I’ve calendared your request for the week of the 28th. I’m unavailable some
`of the next week due to Presidents Day.
`We hope you have a great weekend.
`
`Kind regards,
`
`36. On March 2, 2022, Mr. Rocereta sent an e-mail to Mr. Treace, copying
`
`Adam Cundiff, Nathan Peterson and Jason Graff stating:
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 14 of 58
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`John,
`
`Fusion has made recent adjustments in their literature to better reflect the
`distinct differences in the two systems. Your intellectual property attorneys can
`analyze and advise you on why the LapiLock system does not infringe on the
`two ‘590 independent claims.
`
`Regarding the independent literature, with which you have an interest, we will
`provide the literature at the appropriate time should it be necessary for us to go
`forward with an inter partes review proceeding on the ‘590 patent.
`
`As always, should an opportunity arise for our companies to work together in a
`productive way, feel free to reach out.
`
`Kind regards,
`
`37.
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`Fusion’s website at https://lapilockbunionsurgery.com/wp-
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`content/uploads/2022/02/STG015_LapiLock_2.pdf did indeed direct the viewer to a new
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`version of the LapiLock Brochure. The new brochure is entitled “STG015_LapiLock_2”.
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`The previous brochure at this location was entitled “STG015_LapiLock_4D Brochure-
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`c.pdf”. Fusion made minor changes, such as replacing the word “fulcrum” in the previous
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`version of the brochure with the word “spacers” at three locations and removing the word
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`“bunion” in the mark “LapiLock 4D Bunion Correction”. However, elsewhere on Fusion’s
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`website, LapiLock 4D Bunion Correction remains in use. Fusion made minor changes to
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`the described surgical procedure. Specifically, Fusion's literature now instructs surgeons
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`to remove the fulcrum (now “spacer”) prior to correction of the intermetatarsal angle
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`(“IMA”) and then replace the fulcrum after the IMA is corrected, whereas Fusion
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`previously instructed LapiLock surgeons to leave the fulcrum in place while correcting the
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`IMA. On information and belief, if this change were to be followed by surgeons, it would
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`likely lead to reduced surgical efficacy and adverse outcomes for patients.
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`38. Whether and to what extent Fusion will ensure that this “new” surgical
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`procedure will be taught or followed by either new or existing surgeon users of Fusion’s
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`products and surgical procedure is unknown, but unlikely.
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 15 of 58
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`39. On March 15, 2022, Mr. Treace responded to Mr. Rocereta copying Adam
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`Cundiff, Nathan Peterson and Jason Graff stating:
`
`Sam,
`
`I appreciate your response. Unfortunately, you did not sufficiently address
`any of the concerns raised in my letter. In fact, your response raises even
`more questions and concerns.
`
`
`First, Fusion’s literature changes are tacit acknowledgement that it has
`infringed on Treace Medical’s intellectual property rights. My concern –
`which remains and is now further validated by your response – is that Fusion
`has infringed and may still be infringing Treace Medical’s ‘590 patent.
`
`
`Second, the changes Fusion made to its literature do nothing to remediate the
`harm caused to Treace Medical nor do they stop surgeons trained and
`instructed under Fusion’s prior literature from continuing to perform the prior
`technique, as trained and instructed by Fusion. Consequently, the changes
`made by Fusion are insufficient to cure the past and continued harm to
`Treace Medical’s proprietary rights.
`
`
`Third, I question the sincerity of the changes made to Fusion’s literature.
`Specifically, Fusion’s literature now instructs surgeons who use LapiLock to
`remove the fulcrum (which Fusion renamed “spacer” in its revised literature)
`prior to correction of the intermetatarsal angle (“IMA”) whereas Fusion
`previously instructed LapiLock surgeons to leave the fulcrum in place while
`correcting the IMA. I believe that Fusion made this change solely as an
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`attempt to evade clear culpability for infringement of Treace Medical’s ‘590
`patent because – if the change is actually followed by surgeons – it will
`obviously lead to poor surgical efficacy and adverse outcomes for patients.
`This also negatively affects Treace Medical’s solid reputation with patients
`who may not appreciate that their surgeon is using similarly named and
`described surgical equipment and techniques that are not affiliated with
`Treace Medical. We therefore believe that Fusion continues to instruct and/or
`train surgeons who use LapiLock to leave the fulcrum in place while
`correcting the IMA despite the changes made to its literature to now do the
`opposite.
`
`
`Fourth, you did not address the other concern I raised in my letter, namely
`that Fusion’s use of LAPILOCK is causing consumer confusion with Treace
`Medical’s well-known LAPIPLASTY® mark. I mentioned in my letter that
`both marks are very similar and create a similar overall commercial
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 16 of 58
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`impression. The similarities are particularly striking given Fusion’s use of the
`language “4D Bunion Correction” in connection with LAPILOCK. Treace
`Medical routinely uses the mark 3D Bunion Correction™ in connection with
`its LAPIPLASTY® mark. This stylization and combination of terms
`highlights the likelihood of confusion. In fact, many of the themes,
`illustrations, videos and other materials on Fusion’s LapiLock website are
`very similar to those appearing on Treace Medical’s websites, individually
`and collectively giving the false and misleading impression that Fusion’s
`LapiLock is made by, distributed by, associated with or endorsed by Treace
`Medical. I remain concerned that Fusion’s selection of identifiers for its
`products and procedure was intended to cause hospitals, surgeons, patients
`and the public to confuse those products and procedures with those offered
`by Treace Medical.
`
`
`Finally, as I mentioned in my letter of February 14, it appears that LapiLock
`infringes on multiple Treace Medical patents. The ‘590 patent is merely one
`example. Other Treace Medical patents practiced by Fusion, its LapiLock
`products, and the techniques Fusion trains and instructs surgeons to perform
`include, but are not limited to, United States Patent Nos. 10,561,426;
`10,849,670; 10,888,335; and 10,945,764. I am providing claim charts
`(Exhibits A-D) explaining how Fusion is infringing representative claims of
`these patents. Of course, Fusion’s infringement is not limited to these
`representative claims.
`
`
`Accordingly, I ask that you provide to Treace Medical the following by noon
`(Pacific Time) on March 22, 2022:
`
`(1) Confirmation that Fusion now only instructs and/or trains surgeons –
`through its literature, its training modules, labs, cases, procedures and
`otherwise – to remove the fulcrum (which you now claim to call a
`spacer) prior to correcting the IMA;
`(2) Confirmation that Fusion no longer instructs or trains surgeons –
`through its literature, its training modules, labs, cases, procedures or
`otherwise – to leave the fulcrum in place while correcting the IMA;
`(3) Confirmation that Fusion has provided remedial training and
`instruction to its sales and marketing personnel, including any
`distributors of LapiLock, educating them that the fulcrum cannot be in
`place while correcting the IMA;
`(4) Confirmation that Fusion has provided written notice to all surgeons
`who had previously been instructed and/or trained to leave the fulcrum
`in place while correcting the IMA or who had previously performed
`the LapiLock procedure leaving the fulcrum in place while correcting
`the IMA, that they are required to remove the fulcrum before
`proceeding to correct the IMA;
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`Case 2:22-cv-00490-MTM Document 1 Filed 03/29/22 Page 17 of 58
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`(5) A copy of the written notice and a complete list of all surgeons
`provided with the written notice referenced in (4) above;
`(6) Confirmation that Fusion will immediately stop making, using,
`importing, offering for sale, and selling in the United States the
`devices specifically designed for use in performing any procedure that
`infringes any Treace Medical patent;
`(7) Confirmation that Fusion will immediately stop inducing infringement
`of any and all Treace Medical patents, including the following U.S.
`patents: 10,561,426, 10,849,670, 10,888,335 and 10,945,764, by
`removing all materials from its literature, its own websites and all
`affiliated websites that would induce a surgeon to perform a surgical
`method covered by Treace Medical’s patents;
`(8) Confirmation that Fusion will immediately stop distributing all printed
`and electronic literature that would induce a surgeon to perform a
`surgical method covered by Treace Medical’s patents;
`(9) Confirmation that Fusion will immediately stop all other activities that
`describe or encourage the performance of Treace Medical’s patented
`methods using Fusion products;
`(10) To the extent Fusion refuses to confirm 6-9, a detailed explanation as
`to why Fusion is not practicing the claims of the 10,561,426,
`10,849,670, 10,888,335 and 10,945,764 patents;
`(11) Confirmation that Fusion will immediately stop using the LAPILOCK
`mark and “4D Bunion Correction” language; and
`(12) All existing LapiLock inventory, training supplies, kits, loaners,
`demonstration products, related devices and promotional literature for
`dest