DCT

2:24-cv-10527

Versah LLC v. Hiossen Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-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, and Defendant Osstem Implant Company, LTD. importing the accused products into the United States.
  • Core Dispute: Plaintiffs allege that Defendants’ “Bone Compaction Kit” infringes three U.S. patents directed to a surgical method and tool for preparing a jawbone for dental implants through a process termed "osseodensification."
  • Technical Context: The technology concerns specialized surgical burs used in dental implantology to expand and densify bone at an implant site, aiming to improve implant stability while minimizing trauma to the patient.
  • Key Procedural History: The complaint alleges that Plaintiffs’ counsel sent a demand letter to Defendants’ counsel on October 3, 2024, alleging infringement. On November 1, 2024, Defendants’ counsel responded, denying infringement and asserting that the patents-in-suit are invalid. This exchange establishes pre-suit knowledge for the purpose of willfulness allegations.

Case Timeline

Date Event
2011-03-23 Patent Priority Date ('783, '593, & '253 Patents)
2015-05-05 U.S. Patent No. 9,022,783 Issued
2015-05-12 U.S. Patent No. 9,028,253 Issued
2016-12-27 U.S. Patent No. 9,526,593 Issued
2024-10-03 Plaintiff sent demand letter to Defendant
2024-11-01 Defendant responded to demand letter
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 (’783 Patent)

The Invention Explained

  • Problem Addressed: The patent describes prior art methods for preparing a jawbone for a dental implant as being either traumatic to the patient (e.g., using a mallet to drive an osteotome) or providing limited surgical control (e.g., using screw-taps where the rate of bone expansion is inexorably linked to the tool's rotation speed) (Compl. ¶10; ’783 Patent, col. 2:37-54). These methods could lead to bone fractures, patient discomfort, and a lengthy procedure (Compl. ¶10; ’783 Patent, col. 3:1-15).
  • The Patented Solution: The invention is a surgical method using a tapered, fluted osteotome that, when rotated at high speed and pushed into the bone, expands the osteotomy (the prepared hole) with minimal or no removal of bone material (’783 Patent, Abstract). The tool's "burnishing edges" are designed to deform and compact the surrounding bone through plastic deformation, a process Plaintiffs term "osseodensification," which densifies the bone to better support an implant (Compl. ¶¶11-13; ’783 Patent, col. 4:10-24). This approach decouples the tool's rotation speed from the rate of bone expansion, giving the surgeon greater control (’783 Patent, col. 4:16-24).
  • Technical Importance: The described technique offers a method to prepare an implant site that is potentially less traumatic than mallet-driven osteotomes and more controllable than screw-type expanders, while also claiming to improve the quality of the surrounding bone (’783 Patent, col. 4:5-10).

Key Claims at a Glance

  • The complaint asserts at least independent claim 15 (’783 Patent, Compl. ¶33).
  • The essential elements of independent method claim 15 are:
    • Providing an osteotome with a tapered working end that includes a plurality of "burnishing edges."
    • Positioning the working end over an osteotomy.
    • Progressively advancing the working end into the osteotomy by:
      • continuously rotating the working end at speeds greater than 200 RPM, while
      • axially reciprocating (i.e., "bouncing") the burnishing edges into and out of contact with the interior surface of the osteotomy.

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

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the ’783 Patent, the ’593 Patent addresses the same technical problems of trauma and lack of control associated with prior art osteotomy preparation techniques (’593 Patent, col. 2:38-55).
  • The Patented Solution: The patent describes a similar method of using a rotating dental bur with specialized "blades" to expand an osteotomy. The method involves pushing the rotating bur into the bone, causing a "frustoconically expanding" deformation as the blades "sweep against the interior surface" to compact and densify the bone (’593 Patent, col. 12:4-10). The specification, largely shared with the '783 Patent, emphasizes achieving this expansion via plastic deformation rather than by cutting away bone material (’593 Patent, col. 7:30-34).
  • Technical Importance: This patent further refines the claims around the method of using a high-speed rotating tool to achieve controlled bone expansion and densification for implantology.

Key Claims at a Glance

  • The complaint asserts at least independent claim 4 (’593 Patent, Compl. ¶44).
  • The essential elements of independent method claim 4 are:
    • Providing a dental bur with a tapered working end having 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 so that expansion occurs in a "frustoconically expanding manner 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 (’253 Patent)

  • Technology Synopsis: The patent describes a surgical method using a fluted osteotome that expands a bone site for an implant through "burnishing" rather than cutting. The tool's design, featuring flutes with burnishing edges and a tapered end, allows a surgeon to expand bone via plastic deformation by applying downward pressure while the tool rotates at high speed, offering greater control and reducing trauma compared to prior art methods (’253 Patent, Abstract; col. 4:5-24).
  • Asserted Claims: At least independent claim 1 (Compl. ¶55).
  • Accused Features: The "Infringing Burs" within the Defendants' "Bone Compaction Kit" are alleged to infringe when used as instructed to prepare a site for a dental implant (Compl. ¶¶ 55-56).

III. The Accused Instrumentality

Product Identification

  • Defendants’ "Bone Compaction Kit" and the drill bits or "Infringing Burs" contained within it (Compl. ¶¶23, 28).

Functionality and Market Context

  • The complaint alleges that Defendants manufacture, offer to sell, and sell the "Bone Compaction Kit" for use in dental procedures (Compl. ¶¶23-25). The complaint includes a screenshot from Defendant Hiossen’s e-commerce website showing the accused "Bone Compaction Kit," which contains a set of graduated drill burs in a case (Compl. ¶27). The product's name, "Bone Compaction Kit," suggests its intended function is to compact bone, a function central to the "osseodensification" process described in the patents-in-suit. The complaint alleges that analysis of the burs determined they infringe the patents-in-suit (Compl. ¶28).

IV. Analysis of Infringement Allegations

The complaint alleges infringement of method claims, asserting that the "Infringing Burs" meet each limitation of the asserted claims "when used as instructed by Hiossen" (Compl. ¶¶34, 45, 56). However, the complaint does not provide specific factual allegations or evidence, such as excerpts from user manuals or technical documents, to map the functionality of the accused burs to the specific elements of the claims.

’783 Patent 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 Defendants provide the "Infringing Burs," which constitute the claimed osteotome (Compl. ¶33). However, the complaint does not provide sufficient detail to analyze whether the burs possess the claimed "burnishing edges" as distinct from conventional cutting flutes. ¶¶33, 34 col. 6:19-28
positioning the working end of the osteotome over an open end of an osteotomy The complaint does not provide sufficient detail for analysis of this element, but alleges generally that instructed use of the burs for preparing an implant site would constitute performance of this step. ¶34 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 while axially reciprocating the burnishing edges into and out of contact with the interior surface of the osteotomy The complaint does not provide sufficient detail for analysis of this element. It does not allege specific facts regarding the instructed rotational speeds or whether Defendants’ instructions direct users to perform the specific "axially reciprocating" (bouncing) motion required by the claim, as opposed to a continuous downward push. The complaint alleges generally that instructed use of the burs meets this limitation (Compl. ¶34). ¶34 col. 8:46-49, 55-67

Identified Points of Contention

  • Technical Question: A primary technical question is whether the "Infringing Burs" are designed to, and in practice actually do, "burnish" bone (i.e., expand it through plastic deformation with minimal material removal) as described in the patent, or if they are conventional cutting burs that primarily remove bone material. The product name "Bone Compaction Kit" may support the plaintiffs' theory, but the actual physical operation will be determinative.
  • Scope Question: The infringement analysis for the '783 Patent will question whether the instructed use of the accused burs includes the specific "axially reciprocating" (bouncing) motion required by claim 15. If the instructions direct a simple, continuous insertion, it may raise a question of non-infringement of this claim element.

V. Key Claim Terms for Construction

The Term: "burnishing edges" (’783 Patent, Claim 15)

Context and Importance

  • This term is at the heart of the invention's purported distinction from prior art cutting burs. The definition of "burnishing edges" will be critical to determining whether the accused burs, which have fluted edges, fall within the scope of the claims. Practitioners may focus on this term because it appears to be a neologism or a term of art defined by the patentee, and its construction will likely decide the infringement question.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification states that the "burnishing edge 40 is that specific portion of the crest 38 which lies along the major diameter of the tapered working end 28" (’783 Patent, col. 6:22-26). This could support an interpretation where any outermost edge of a flute on a tapered tool qualifies.
  • Evidence for a Narrower Interpretation: The specification links the term to a specific function and geometry, stating that a "large negative rake angle... applies outward pressure at the burnishing edge 40 to create a compression wave" and that the "plowing action of the burnishing edge 40 thus progressively enlarges the osteotomy" (’783 Patent, col. 6:49-52; col. 7:27-30). This suggests a narrower definition requiring a specific non-cutting geometry and function that causes plastic deformation rather than material removal.

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

Context and Importance

  • This "bouncing" motion is a specific action required by the asserted method claim. Whether this limitation is met will depend on the instructions provided by the Defendants and the actions of the end-users. If the accused method does not involve this specific motion, infringement may be avoided.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: A party could argue that any non-continuous downward pressure, including minor adjustments by the surgeon, constitutes "reciprocating." The claim language itself does not specify the amplitude or frequency of the motion.
  • Evidence for a Narrower Interpretation: The specification describes this as a specific, "controlled 'bouncing,' i.e., axially reciprocating, fashion" and a "very controlled technique" used to manage heat and evaluate progress (’783 Patent, col. 7:17-20; col. 8:62-67). This may support a construction requiring a deliberate, repeated in-and-out maneuver, rather than incidental variations in pressure.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement for all three patents. The inducement allegation is based on Defendants allegedly providing instructions for the "Bone Compaction Kit" that direct customers to use the burs in a manner that directly infringes the asserted method claims (Compl. ¶¶33, 44, 55). The contributory infringement allegation is based on the assertion that the "Infringing Burs" are a material part of the invention and have no substantial non-infringing uses (Compl. ¶¶36-38, 47-49, 58-60).

Willful Infringement

  • The complaint alleges that Defendants had knowledge of the patents-in-suit and intended for their customers to infringe, or were willfully blind to the infringement (Compl. ¶¶35, 46, 57). The factual basis for this allegation is the pre-suit notice letter sent by Plaintiffs' counsel on October 3, 2024, and the subsequent response from Defendants' counsel on November 1, 2024, which confirmed receipt and awareness (Compl. ¶¶30-31).

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

  • A core issue will be one of technical mechanism: Do the flutes on the accused "Bone Compaction Kit" burs operate by "burnishing" to compact and displace bone with minimal material removal, as required by the patent claims, or do they function as conventional cutting flutes that primarily excavate bone? The case may depend on expert testimony and evidence regarding the microscopic interaction between the accused burs and bone tissue.
  • A second key question will be one of claim scope and evidentiary proof: How narrowly will the court construe the specific method steps, such as "axially reciprocating" the tool? Furthermore, what evidence will Plaintiffs present during discovery to demonstrate that the instructions provided by Defendants for the accused kit actually direct users to perform each and every step of the claimed methods?
  • A final dispositive question will concern the validity of the "burnishing" concept: Defendants have asserted that the patents are invalid. This raises the question of whether the distinction between the claimed "burnishing" and prior art bone-cutting or expansion techniques is a patentable difference, or if it was obvious to a person of ordinary skill in the art at the time of the invention.