DCT

1:24-cv-10527

Versah LLC v. Hiossen Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-10527, D.N.J., 11/15/2024
  • Venue Allegations: Venue is based on Defendant Hiossen Inc. operating a place of business in Englewood, New Jersey.
  • Core Dispute: Plaintiffs allege that Defendants’ "Bone Compaction Kit" infringes three patents related to specialized dental osteotomes and surgical methods that expand and densify bone for implant placement.
  • Technical Context: The technology concerns dental surgical instruments designed to prepare a patient's jawbone for an implant by compacting and preserving existing bone tissue, a procedure Plaintiffs term "osseodensification," rather than by excavating it.
  • Key Procedural History: The complaint notes that on October 3, 2024, Plaintiffs’ counsel sent a demand letter to Defendants alleging infringement. On November 1, 2024, Defendants’ counsel responded, denying infringement and asserting the patents-in-suit are invalid. This exchange establishes Defendants' pre-suit knowledge of the patents and the infringement allegations.

Case Timeline

Date Event
2011-03-23 Priority Date for ’783, ’593, and ’253 Patents
2015-05-05 U.S. Patent No. 9,022,783 Issues
2015-05-12 U.S. Patent No. 9,028,253 Issues
2016-12-27 U.S. Patent No. 9,526,593 Issues
2024-10-03 Plaintiffs send demand letter to Defendants
2024-11-01 Defendants respond to demand letter, denying infringement
2024-11-15 Complaint Filed

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’s background describes prior art methods for preparing a dental implant site as either traumatic (e.g., using a mallet), which can lead to complications, or inefficient. Motor-driven expander screw taps, for example, have a fixed relationship between rotation speed and bone expansion rate, limiting surgeon control and often requiring numerous, time-consuming steps (Compl. ¶10; ’783 Patent, col. 2:36-col. 3:24).
  • The Patented Solution: The invention is a fluted, tapered osteotome tool and method designed to expand and densify bone rather than cut it. The tool features "burnishing edges" with a large negative rake angle that, when rotated and pushed into the bone, create a compression wave that plastically deforms and compacts the bone tissue with minimal removal of material (’783 Patent, Abstract; col. 5:45-65). This approach "de-links" the tool's rotation rate from the rate of bone expansion, affording the surgeon greater control over the procedure (’783 Patent, col. 4:15-24).
  • Technical Importance: This technique of bone compaction, which Plaintiffs call "osseodensification," was developed to preserve healthy bone, increase bone density at the implant site to improve stability, and reduce trauma to the patient compared to conventional drilling or hammering methods (Compl. ¶¶10, 13).

Key Claims at a Glance

  • The complaint asserts at least independent method claim 15 (Compl. ¶33).
  • The essential elements of claim 15 are:
    • Providing an osteotome with a tapered working end and a plurality of "burnishing edges".
    • Positioning the working end over an osteotomy (a hole in the bone).
    • Progressively advancing the working end into the osteotomy by continuously rotating it at speeds "greater than 200 RPM" while "axially reciprocating" the burnishing edges into and out of contact with the bone surface.

U.S. Patent No. 9,526,593 - “Fluted Osteotome and Surgical Method for Use,” issued December 27, 2016

The Invention Explained

  • Problem Addressed: The patent addresses the same limitations of prior art osteotomy techniques as the ’783 patent: the traumatic nature of mallet-driven tools and the lack of independent control over expansion rate in motor-driven screw taps (’593 Patent, col. 2:36-col. 3:24).
  • The Patented Solution: The invention describes a surgical method using a "dental bur" with a tapered working end and extending blades. As with the ’783 patent, the core concept is the simultaneous rotation and pushing of the tool to expand the osteotomy via compression and plastic deformation of the surrounding bone, rather than by cutting (’593 Patent, col. 4:46-67). The claims specifically contemplate a multi-step procedure using a series of progressively larger osteotomes to achieve a desired final osteotomy width (’593 Patent, col. 9:16-col. 10:60).
  • Technical Importance: The method provides a systematic approach for using the novel bone-compacting technology to prepare implant sites of varying sizes, while aiming to improve bone quality and implant stability (Compl. ¶¶12-13).

Key Claims at a Glance

  • The complaint asserts at least independent method claim 4 (Compl. ¶44).
  • The essential elements of claim 4 are:
    • Providing a "dental bur" with a tapered working end and a plurality of longitudinally extending "blades".
    • Positioning the bur to enter an osteotomy.
    • Rotating the bur at "high speed".
    • "Pushing" the bur into the osteotomy concurrently with rotation so expansion occurs as the blades sweep against the interior surface.
    • "Irrigating" the osteotomy concurrently with the pushing step.

Multi-Patent Capsule: U.S. Patent No. 9,028,253 - “Fluted Osteotome and Surgical Method for Use,” issued May 12, 2015

  • Technology Synopsis: This patent discloses a dual-functionality osteotome and surgical method. The tool is designed to expand an osteotomy by non-cutting "burnishing" when rotated in a first direction, and to expand the osteotomy by cutting and removing bone material when rotated in the opposite direction (’253 Patent, Abstract; col. 4:1-32). This provides the surgeon with the option to either compact or excavate bone using the same instrument.
  • Asserted Claims: At least independent method claim 1 is asserted (Compl. ¶55).
  • Accused Features: The "Infringing Burs" contained within Defendants' "Bone Compaction Kit" are alleged to infringe the patent when used according to Defendants' instructions (Compl. ¶¶55-56).

III. The Accused Instrumentality

Product Identification

  • Defendants' "Bone Compaction Kit," which contains multiple drill bits referred to as the "Infringing Burs" (Compl. ¶¶23, 28).

Functionality and Market Context

  • The complaint alleges the Bone Compaction Kit is sold and used for preparing osteotomies for dental implants (Compl. ¶¶23-25). The product's name itself suggests a function of compacting bone, which aligns with the core "osseodensification" technology described by Plaintiffs (Compl. ¶¶11, 23). The complaint includes a screenshot from Defendants' website showing the accused product, which contains a set of surgical burs of progressively increasing diameters in a case (Compl. ¶27). Plaintiffs allege that this kit is a direct competitor to their own Densah® Bur Kit and that its use by customers, as instructed by Defendants, constitutes infringement (Compl. ¶¶11, 28, 33).

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,022,783 Infringement Allegations

Claim Element (from Independent Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation
providing an osteotome having a tapered working end, the working end including a plurality of burnishing edges The complaint alleges that the "Infringing Burs" in the accused Bone Compaction Kit constitute the claimed osteotome and possess the claimed features of a tapered working end and burnishing edges (Compl. ¶28). ¶28 col. 12:1-4
positioning the working end of the osteotome over an open end of an osteotomy, the osteotomy having an interior surface surrounded by bone The complaint alleges that Defendants instruct customers to perform this step as part of the infringing use of the Bone Compaction Kit (Compl. ¶33). ¶33 col. 12:5-9
progressively advancing the working end... by continuously rotating the working end at speeds greater than 200 RPM while axially reciprocating The complaint alleges that Defendants' instructions for the Bone Compaction Kit direct users to perform a method that meets this limitation, including rotation above 200 RPM and the "bouncing" motion of axial reciprocation (Compl. ¶¶33-34). ¶¶33-34 col. 12:50-54

U.S. Patent No. 9,526,593 Infringement Allegations

Claim Element (from Independent Claim 4) Alleged Infringing Functionality Complaint Citation Patent Citation
providing a dental bur having a tapered working end, the working end having a plurality of longitudinally extending blades The complaint alleges that the "Infringing Burs" are the claimed dental burs and that they have a tapered working end with the claimed blades (Compl. ¶¶28, 45). ¶¶28, 45 col. 11:23-27
positioning the tapered working end of the dental bur so as to enter an osteotomy to be enlarged It is alleged that Defendants' instructions direct customers to position the burs to enter the osteotomy as part of the infringing method (Compl. ¶44). ¶44 col. 11:28-31
rotating the working end of the dental bur at high speed Defendants are alleged to instruct users to rotate the burs at high speed during the procedure (Compl. ¶¶44-45). ¶¶44-45 col. 11:32
pushing the working end into the osteotomy concurrently with said rotating step so that expansion of the osteotomy occurs The complaint alleges that Defendants instruct users to push the rotating burs into the osteotomy to achieve expansion, thereby meeting this limitation (Compl. ¶¶44-45). ¶¶44-45 col. 11:33-37
irrigating the osteotomy concurrently with said pushing step The complaint makes a blanket allegation that the instructed use meets "each limitation" of the claim, which would include concurrent irrigation (Compl. ¶45). ¶45 col. 11:38-39
  • Identified Points of Contention:
    • Scope Questions: A central dispute may arise over the term "burnishing edges" in the ’783 Patent versus "dental bur" and "blades" in the ’593 Patent. The shared patent specification distinguishes the invention's "burnishing" function from prior art "cutters" or "burs" (’783 Patent, col. 2:9-11). This raises the question of whether the accused product, marketed as a "Bone Compaction Kit," performs non-cutting "burnishing" (as required by the ’783 Patent) or if it functions as a conventional cutting bur, and how the court will construe these seemingly conflicting terms used across the patents-in-suit.
    • Technical Questions: The complaint does not provide specific evidence from Defendants' instructions or marketing materials detailing the operational parameters of the accused kit. A key factual question will be what evidence shows that Defendants instruct users to perform the specific "axially reciprocating" (or "bouncing") motion required by claim 15 of the ’783 Patent (’783 Patent, col. 8:54-67). Likewise, evidence will be needed to show that the instructed method for the accused kit includes "irrigating... concurrently" as required by claim 4 of the ’593 Patent.

V. Key Claim Terms for Construction

Term 1: “burnishing edges” (’783 Patent, Claim 15)

  • Context and Importance: This term is the technological core of the ’783 Patent’s asserted claim, defining the mechanism as one of bone compaction through plastic deformation, not cutting. The infringement analysis will depend heavily on whether the accused "Infringing Burs" are found to have "burnishing edges" that operate in the claimed manner.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a general definition of burnishing as "the deformation of a surface due to stressed contact with another object... without actual removal of metal" (’783 Patent, col. 4:50-54). A party could argue this functional definition covers any tool edge that primarily displaces bone rather than cutting and removing it.
    • Evidence for a Narrower Interpretation: The patent strongly links the "burnishing" effect to a specific geometry, namely a "large negative rake angle" (e.g., greater than 60 degrees) on the crest of the tool's flutes, which "applies outward pressure... to create a compression wave" (’783 Patent, col. 5:45-54). A party may argue that to be a "burnishing edge," the accused tool must possess this specific structural characteristic, not just achieve a similar result.

Term 2: “axially reciprocating the burnishing edges into and out of contact” (’783 Patent, Claim 15)

  • Context and Importance: This limitation describes a specific "bouncing" motion that distinguishes the claimed method from a simple, continuous push. Infringement requires proof that the accused method includes this specific action. Practitioners may focus on this term because it requires a specific user action that may not be part of a standard drilling technique.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that any up-and-down movement during the procedure, even if incidental to managing the tool, satisfies the "axially reciprocating" requirement.
    • Evidence for a Narrower Interpretation: The specification describes this motion as a "controlled 'bouncing,' i.e., axially reciprocating, fashion where pressure is applied in short bursts," which allows the surgeon to "continuously monitor progress and make fine corrections and adjustments" (’783 Patent, col. 8:20-25). This suggests an intentional, controlled technique rather than any incidental vertical movement.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents-in-suit. The allegations are based on Defendants making, selling, and importing the Bone Compaction Kit with knowledge of the patents and with the intent that their customers' use of the kit, per Defendants' instructions, would directly infringe the asserted claims (e.g., Compl. ¶¶33, 35-36, 44, 46-47). The complaint further alleges the "Infringing Burs" are a material part of the inventions and have no substantial non-infringing uses (e.g., Compl. ¶¶37-38).
  • Willful Infringement: Willfulness is alleged for all three patents. The complaint pleads that Defendants either intended for their customers to infringe or were "at least willfully blind" to the existence and infringement of the patents (e.g., Compl. ¶¶35, 46, 57). The factual basis for pre-suit knowledge is the demand letter sent on October 3, 2024, and Defendants' subsequent response (Compl. ¶¶30-31).

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

  • A core issue will be one of functional mechanism: Do the accused "Bone Compaction Kit" burs operate by "burnishing"—plastically deforming bone without significant cutting, as described in the patents—or do they function as conventional cutting burs? The resolution will likely depend on a detailed technical analysis of the accused tool's geometry, particularly its rake angles, and the primary effect it has on bone tissue when used as instructed.
  • A related central question will be one of claim construction and scope: How will the court reconcile the patents' own language, which distinguishes the invention's "burnishing osteotome" from prior art "burs," with the fact that asserted claims in the family refer to the inventive tool as both an "osteotome" and a "dental bur"? This determination will be critical to defining the scope of the claims.
  • Finally, a key evidentiary question will be one of instructed use: Can Plaintiffs produce sufficient evidence from Defendants’ user manuals, training materials, or other documents to prove that users are instructed to perform the specific "axially reciprocating" or "bouncing" motion required by claim 15 of the ’783 patent?