DCT

1:24-cv-10527

Versah LLC v. Hiossen Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-10527, D.N.J., 03/12/2025
  • Venue Allegations: Venue in the District of New Jersey is based on Defendant Hiossen Inc. having its headquarters in Englewood Cliffs, New Jersey.
  • Core Dispute: Plaintiffs allege that Defendants’ “Bone Compaction Kit,” a set of dental surgical tools, infringes three patents related to methods for preparing a patient's jawbone for a dental implant.
  • Technical Context: The technology, termed "osseodensification," concerns surgical burs and methods for expanding and densifying bone to create a stable site for a dental implant, aiming to be less traumatic than traditional methods.
  • Key Procedural History: Plaintiffs allege sending a demand letter to Defendants on October 3, 2024, and receiving a response on November 1, 2024, that denied infringement and asserted the patents were invalid. This pre-suit notice forms the basis for the willfulness allegations.

Case Timeline

Date Event
2011-03-23 Priority Date for ’783, ’593, and ’253 Patents
2015-05-05 ’783 Patent Issue Date
2015-05-12 ’253 Patent Issue Date
2016-12-27 ’593 Patent Issue Date
2024-09 Alleged Accused Product Launch
2024-10-03 Plaintiffs sent demand letter to Defendants
2024-11-01 Defendants responded to demand letter
2025-03-12 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,022,783 - Fluted Osteotome and Surgical Method for Use (Issued May 5, 2015)

The Invention Explained

  • Problem Addressed: The patent describes prior art methods for preparing a bone site (an osteotomy) for a dental implant as either being overly traumatic (e.g., using a surgical mallet) or lacking sufficient surgeon control. Specifically, motor-driven "expander screw taps" inexorably link the tool's rotation speed to the rate of bone expansion, limiting a surgeon's ability to make real-time adjustments based on bone condition (’783 Patent, col. 2:36-54; col. 3:15-24).
  • The Patented Solution: The invention is a surgical method that uses a fluted, tapered osteotome rotated at high speed. Instead of cutting bone, the tool's "burnishing edges" use a combination of rotational force and downward pressure applied by the surgeon to plastically deform and compact the bone, thereby expanding the osteotomy. This de-links the rotation rate from the expansion rate, granting the surgeon greater control to adjust pressure and speed independently (’783 Patent, Abstract; col. 3:40-52).
  • Technical Importance: This approach suggests a method to prepare an implant site that is less traumatic for the patient while providing the surgeon with more nuanced control over the procedure, potentially improving outcomes in varying bone densities (’783 Patent, col. 3:5-16).

Key Claims at a Glance

  • The complaint asserts independent method claim 15 (Compl. ¶42).
  • The essential elements of Claim 15 include:
    • Providing an osteotome with a tapered working end and a plurality of burnishing edges.
    • Positioning the working end over an osteotomy.
    • Progressively advancing the working end into the osteotomy by continuously rotating it at speeds greater than 200 RPM.
    • Simultaneously "axially reciprocating" the burnishing edges into and out of contact with the interior surface of the osteotomy.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,526,593 - Fluted Osteotome and Surgical Method for Use (Issued December 27, 2016)

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the '’783 Patent, this patent addresses the same technical problems of trauma and lack of surgical control associated with prior art osteotomy preparation techniques (’593 Patent, col. 1:11-15; col. 2:40-56).
  • The Patented Solution: The method described also uses a high-speed rotating dental bur with a tapered end and extending blades to expand an osteotomy. The expansion occurs in a "frustoconically expanding manner" as the blades sweep against the bone. A key element specified in the asserted claim is the concurrent irrigation of the site during the pushing step, which is a common practice for managing heat and clearing debris in dental surgery (’593 Patent, Abstract; col. 12:25-40).
  • Technical Importance: The explicit inclusion of concurrent irrigation addresses a practical aspect of the surgical procedure aimed at preventing thermal damage to the bone, a critical factor for successful implant integration (’593 Patent, col. 7:12-16).

Key Claims at a Glance

  • The complaint asserts independent method claim 4 (Compl. ¶59).
  • The essential elements of Claim 4 include:
    • Providing a dental bur with a tapered working end and a plurality of longitudinally extending blades.
    • Positioning the working end to enter an osteotomy.
    • Rotating the working end at high speed.
    • Pushing the working end into the osteotomy concurrently with rotation, causing the osteotomy to expand.
    • "Irrigating the osteotomy concurrently with said pushing step."
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,028,253 - Fluted Osteotome and Surgical Method for Use (Issued May 12, 2015)

The Invention Explained

  • Technology Synopsis: This patent describes a "low-impact" surgical method for expanding an osteotomy using a rotary osteotome with burnishing edges. The inventive method centers on "axially bouncing" the rotating tool within the osteotomy. This motion causes the burnishing edges to lap against and then separate from the bone surface in deepening movements, resulting in progressive plastic deformation of the bone (’253 Patent, Abstract; col. 16:20-40).

Key Claims at a Glance

  • Asserted Claims: Independent method claim 1 is asserted (Compl. ¶78).
  • Accused Features: The complaint alleges that Defendants' instructions for the Bone Compaction Kit to "move the hand piece up and down vertically" during use constitutes the claimed "axially bouncing" of the rotating working end (Compl. ¶¶ 79, 83).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' "Bone Compaction Kit," which contains surgical drill bits or burs (the "Infringing Burs") (Compl. ¶¶ 23, 35).

Functionality and Market Context

  • The complaint alleges the Bone Compaction Kit is used by dental clinicians to perform osteotomies—the preparation of a patient's jawbone—to receive a dental implant (Compl. ¶43).
  • The kit is marketed and sold by Hiossen in the United States, and the complaint alleges it is manufactured and distributed by Osstem, which is Hiossen's parent company (Compl. ¶¶ 24, 26, 30).
  • The complaint includes a screenshot from Hiossen's e-commerce website showing the "Bone Compaction Kit" offered for sale, depicting a case with numerous color-coded surgical burs (Compl. ¶25).
  • The complaint positions the accused kit as being competitive with Plaintiffs' own Densah® Burs product (Compl. ¶48).

IV. Analysis of Infringement Allegations

'783 Patent Infringement Allegations

Claim Element (from Independent Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation
A surgical method for enlarging an osteotomy to receive a dental implant... The Bone Compaction Kit is used for this purpose as instructed by Defendants. ¶43 col. 1:15-18
providing an osteotome having a tapered working end, the working end including a plurality of burnishing edges, Defendants’ instructions direct users to use burs from the kit that have a tapered working end and burnishing edges that compress bone chips. ¶44 col. 4:1-3
positioning the working end of the osteotome over an open end of an osteotomy... Defendants’ instructions direct users to position the bur over the osteotomy site. ¶45 col. 8:15-18
progressively advancing the working end of the osteotome into the osteotomy by continuously rotating the working end at speeds greater than 200 RPM... Defendants’ user manual allegedly recommends a rotational speed of 800 to 1200 rpm. ¶46 col. 8:45-48
...while axially reciprocating the burnishing edges into and out of contact with the interior surface of the osteotomy. Defendants’ user manual allegedly instructs users that "[w]hen cutting, move the hand piece up and down vertically." ¶46 col. 8:55-65
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether the instruction to "move the hand piece up and down vertically" meets the claim limitation of "axially reciprocating the burnishing edges into and out of contact with the interior surface of the osteotomy." The analysis may focus on whether a general vertical movement necessarily results in the specific "into and out of contact" action required by the claim.
    • Technical Questions: What evidence demonstrates that the edges on the accused burs function as "burnishing edges" that cause plastic deformation, as described in the patent, rather than as cutting edges that remove bone material?

'593 Patent Infringement Allegations

Claim Element (from Independent Claim 4) Alleged Infringing Functionality Complaint Citation Patent Citation
A surgical method for enlarging an osteotomy to receive a dental implant using continuous high-speed rotation of a dental bur... The Bone Compaction Kit is used for this purpose via high-speed rotation of its burs. ¶60 col. 12:25-27
providing a dental bur having a tapered working end, the working end having a plurality of longitudinally extending blades; Defendants’ instructions direct users to use burs from the kit with a tapered working end and blades that create bone chips. ¶61 col. 12:28-30
pushing the tapered working end into the osteotomy concurrently with said rotating step so that expansion of the osteotomy occurs in a frustoconically expanding manner... Defendants’ instructions allegedly direct users to move the handpiece "up and down vertically" while cutting. ¶64 col. 12:33-38
...and irrigating the osteotomy concurrently with said pushing step. The complaint alleges on information and belief that users are instructed to do this, or that it is normal practice for this type of procedure. ¶65 col. 12:39-40
  • Identified Points of Contention:
    • Scope Questions: Does the accused method's expansion occur "in a frustoconically expanding manner as the blades sweep against the interior surface," and what level of proof is required to show this specific mode of action?
    • Evidentiary Questions: The complaint alleges the "irrigating... concurrently" step based on "information and belief" that it is "normal practice" (Compl. ¶65). This raises the question of whether Defendants’ instructions or the product's inherent functionality directly teach this step, or if Plaintiffs will need to rely on extrinsic evidence of standard medical procedure.

V. Key Claim Terms for Construction

  • The Term: "axially reciprocating" (from ’783 Patent, Claim 15)

    • Context and Importance: This term is critical because it defines the specific motion that distinguishes the claimed method from one of simple rotation and linear advancement. The complaint equates this term with the instruction to "move the hand piece up and down vertically" (Compl. ¶46). The outcome of the infringement analysis for the '’783 patent may depend on whether this general instruction is construed to be the same as the specific functional language of the claim, which requires moving "into and out of contact" with the bone.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the process as a "controlled 'bouncing'" where the surgeon can "lift the burnishing edges 40 away from contact with the surface of the bone to allow air cooling or irrigation" (Compl. '’783 Patent, col. 7:17-21). This could support a reading where any intentional up-and-down motion qualifies.
      • Evidence for a Narrower Interpretation: The claim language itself requires that the reciprocation moves the edges "into and out of contact with the interior surface of the osteotomy." A defendant may argue this requires a specific, repeated disengagement and re-engagement with the bone wall, which is more precise than a generic "up and down" movement that might maintain contact throughout.

  • The Term: "irrigating the osteotomy concurrently with said pushing step" (from ’593 Patent, Claim 4)

    • Context and Importance: This is the final, affirmative step of method claim 4. Infringement requires that this step be performed. Practitioners may focus on this term because the complaint's allegation is not based on an explicit instruction but on "information and belief" that it is "normal practice" (Compl. ¶65). The dispute will likely center on whether inducement can be proven without a direct instruction from the defendant.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification of the parent '’783 patent, incorporated by reference, notes that heat "can be controlled by the surgeon by altering, on-the-fly, the rotation speed and/or pressure and/or irrigation flow," suggesting irrigation is an integral and contemplated part of the overall procedure (’783 Patent, col. 7:14-16).
      • Evidence for a Narrower Interpretation: The claim requires the irrigation to be performed "concurrently with said pushing step." A defendant could argue that even if irrigation is a general part of the overall surgery, the claim requires it to happen at the specific moment the bur is being pushed, and that their instructions do not teach this specific timing.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents. Inducement is primarily based on allegations that Defendants' user manuals, marketing materials, and other instructions direct customers to use the Bone Compaction Kit in a manner that performs the steps of the patented methods (Compl. ¶¶ 40, 57, 76). Contributory infringement is based on allegations that the Infringing Burs are a material part of the invention with no substantial non-infringing uses (Compl. ¶¶ 50-51, 69-70, 87-88).
  • Willful Infringement: The complaint alleges willful infringement based on Defendants' alleged knowledge of the patents. This knowledge is asserted to have arisen from at least the demand letter sent on October 3, 2024, and Defendants' subsequent response (Compl. ¶¶ 37-38). The complaint further alleges that Defendants are sophisticated companies that monitor competitors' patents and knew or should have known their actions constituted infringement (Compl. ¶¶ 48, 67, 85).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of claim construction and scope: can the general instruction to move a dental tool "up and down vertically" be construed to meet the more specific claim limitations of "axially reciprocating the burnishing edges into and out of contact" (’783 patent) and "axially bouncing" (’253 patent)? The case may turn on whether these claim terms import a functional requirement beyond simple vertical movement.
  • A key evidentiary question will be one of proof of inducement: for elements not explicitly detailed in the accused user manual, such as "irrigating... concurrently with said pushing step" (’593 patent), what level of evidence is required to prove that Defendants specifically intended for their customers to perform that claimed step? The analysis will likely focus on the sufficiency of relying on "normal practice" versus a direct instruction.
  • A final question will be technical and functional equivalence: does the operation of the accused burs result in "burnishing" and "plastic deformation" as claimed in the patents, or do they function primarily as cutting instruments? The distinction between compacting existing bone and excavating it is central to the patents' description of the invention.