DCT
2:22-cv-12513
Versah LLC v. HaeNaem Co Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Versah, LLC, and Huwais IP Holding LLC (Michigan)
- Defendant: HaeNaem Co. Ltd. (Republic of Korea)
- Plaintiff’s Counsel: Carlson, Gaskey & Olds, P.C.
- Case Identification: 2:22-cv-12513, E.D. Mich., 10/19/2022
- Venue Allegations: Venue is alleged to be proper because the defendant is a foreign company not incorporated in any U.S. state, and thus may be sued in any judicial district.
- Core Dispute: Plaintiffs allege that Defendant’s dental bur kits infringe seven U.S. patents related to rotary osteotomes used for preparing bone to receive dental implants, a procedure Plaintiffs term "Osseodensification."
- Technical Context: The technology concerns specialized dental drill bits (burs) designed to compact and densify bone tissue while creating a hole (osteotomy) for an implant, rather than simply excavating and removing bone.
- Key Procedural History: The complaint alleges that Plaintiffs sent a cease-and-desist letter approximately one month prior to filing suit, and that in response, Defendant admitted to having prior knowledge of "most patents owned by Versah," a fact that may be central to Plaintiffs' claims of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2011-03-23 | Earliest Priority Date for ’783, ’253, ’593, ’312, ’639 Patents |
| 2012-11-19 | Priority Date for ’621 Patent |
| 2014-04-01 | Versah founded |
| 2015-05-05 | ’783 Patent Issued |
| 2015-05-12 | ’253 Patent Issued |
| 2016-01-14 | Priority Date for ’548 Patent |
| 2016-12-27 | ’593 Patent Issued |
| 2017-08-22 | ’312 Patent Issued |
| 2018-08-07 | ’621 Patent Issued |
| 2020-02-25 | ’639 Patent Issued |
| 2021-04-20 | ’548 Patent Issued |
| 2022-09-13 | Plaintiffs sent cease-and-desist letter to Defendant |
| 2022-10-19 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,039,621 - "Autografting Osteotome"
The Invention Explained
- Problem Addressed: The patent describes prior art methods for preparing bone for implants as being either overly traumatic (e.g., using a surgical mallet) or providing limited surgical control, as with screw-type expanders where the rate of bone expansion is inexorably linked to the tool's rotation speed (Compl. ¶11; ’621 Patent, col. 1:46-2:16, 3:1-12). These methods do not optimally prepare the bone to integrate with the implant ('621 Patent, col. 3:21-34).
- The Patented Solution: The invention is a rotary osteotome (a specialized drill bit) designed to be operated in a "non-cutting" or "burnishing" direction. The tool's geometry, including specifically shaped flutes, lands, and lips at its tip, is configured to grind bone material and then compact it laterally into the walls of the osteotomy, a process termed "auto-grafting" (’621 Patent, col. 4:13-34, 5:11-16). This action simultaneously generates an "opposing axial reaction force"—a push-back felt by the surgeon—which decouples the tool's rotation speed from the rate of bone expansion, thereby providing enhanced tactile control (’621 Patent, col. 4:5-12).
- Technical Importance: This approach allows a surgeon to prepare an implant site in a less traumatic manner while simultaneously increasing the density of the surrounding bone, which may improve implant stability and promote faster healing (Compl. ¶15).
Key Claims at a Glance
- The complaint asserts independent claim 1 ('621 Patent, col. 24:14-25:1).
- Claim 1 requires, among other elements:
- A rotary osteotome with a shank and a conically tapered body.
- Helically spiraling flutes and lands with working edges configured to "radially displace surrounding bone material through compaction" when rotated in a "non-cutting direction."
- An apical end with at least one "grinding lip" having a specific geometry of first and second trailing flanks and a relief pocket.
- A configuration of the lip and lands that generates an "opposing axial reaction force" when advanced into an osteotomy.
- A configuration of the flutes to receive and "upwardly channel bone debris" for "auto-grafting" and "repatriation into the surrounding bone material."
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 10,980,548 - "Autografting Tool With Enhanced Flute Profile and Methods of Use"
The Invention Explained
- Problem Addressed: Like the '621 patent, this patent addresses the drawbacks of traditional bone-excavating drills, which can lead to poor implant stability, and seeks to improve upon the "osseodensification" technique (Compl. ¶14; ’548 Patent, col. 1:41-56).
- The Patented Solution: This invention refines the rotary osteotome design by introducing a "stopper section" on the body and specifying flute geometries that have a "negative rake angle" even in the cutting direction (’548 Patent, Abstract). This configuration enables the tool to create a "densifying crust" on the wall of the osteotomy even while operating in a cutting mode, a function aided by hydrodynamic pressure from irrigation fluid that is trapped by the stopper section (’548 Patent, col. 3:56-61, 4:24-34).
- Technical Importance: The invention provides a tool with enhanced versatility, allowing for bone densification benefits even when a cutting operation is necessary, and leverages fluid dynamics to assist in a less traumatic procedure (’548 Patent, col. 23:3-10).
Key Claims at a Glance
- The complaint asserts independent claim 1 ('548 Patent, col. 33:13-34:2).
- Claim 1 requires, among other elements:
- A rotary osteotome operable in a cutting and a reverse densifying direction.
- A body with helically spiraling flutes, where each flute has a "cutting face" defining a "rake angle" and a "densifying face" defining a "heel-side angle."
- A "stopper section" on the body located between the flutes and the shank.
- A land between each pair of flutes with a working edge.
- A requirement that for each cutting face, "at least a portion of the associated said rake angle is a negative rake angle" measured in the cutting direction.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 9,022,783 - "Fluted Osteotome and Surgical Method for Use"
- Technology Synopsis: This patent describes a surgical method for expanding an initial osteotomy to receive a dental implant. The method involves providing a rotary osteotome with a tapered working end and longitudinally extending burnishing edges and using it with continuous high-speed rotation to enlarge the osteotomy without cutting into the surrounding bone (’783 Patent, Abstract).
- Asserted Claims: Claims 1 and 15 (Compl. ¶76).
- Accused Features: The complaint alleges inducement of infringement by instructing users of the HaeNaem Bur Kits to perform the claimed surgical method (Compl. ¶62, 76).
U.S. Patent No. 9,028,253 - "Fluted Osteotome and Surgical Method for Use"
- Technology Synopsis: This patent covers a surgical method for enlarging an osteotomy by progressively advancing a tapered working end of an osteotome while continuously rotating it at speeds greater than 200 RPM. The method includes axially reciprocating the burnishing edges into and out of contact with the interior surface of the osteotomy (’253 Patent, Abstract).
- Asserted Claims: Claim 1 (Compl. ¶79).
- Accused Features: The complaint alleges inducement by instructing users of the HaeNaem Bur Kits to perform the claimed surgical method, including the "bouncing-pumping motion" shown in Defendant's marketing (Compl. ¶¶63, 79; p. 11, Fig.).
U.S. Patent No. 9,526,593 - "Fluted Osteotome and Surgical Method for Use"
- Technology Synopsis: This patent describes a low-impact surgical method for expanding an osteotomy using high-speed rotation of a rotary osteotome. The method involves "axially bouncing" the rotating working end within the osteotomy to cause progressive plastic deformation of the bone interior surface (’593 Patent, Abstract).
- Asserted Claims: Claim 4 (Compl. ¶82).
- Accused Features: The complaint alleges inducement by instructing users of the HaeNaem Bur Kits to perform the claimed method of "axially bouncing" the tool (Compl. ¶¶64, 82).
U.S. Patent No. 9,737,312 - "Fluted Osteotome and Surgical Method for Use"
- Technology Synopsis: This patent discloses a surgical method using a dental bur with longitudinally extending blades. The method involves pushing a rotating tapered working end into an osteotomy so that expansion occurs in a "frustoconically expanding manner as the blades sweep against the interior surface" (’312 Patent, Abstract).
- Asserted Claims: Claims 1, 8, 13, and 14 (Compl. ¶85).
- Accused Features: The complaint alleges inducement by instructing users of the HaeNaem Bur Kits to perform the claimed surgical method (Compl. ¶¶65, 85).
U.S. Patent No. 10,568,639 - "Fluted Osteotome and Surgical Method for Use"
- Technology Synopsis: This patent describes a surgical method for enlarging an osteotomy using a bone expander tool with longitudinally extending blades. The method includes rotating the tool at high speed while concurrently pushing and axially reciprocating the blades to incrementally plastically deform the bone (’639 Patent, Abstract).
- Asserted Claims: Claim 1 (Compl. ¶91).
- Accused Features: The complaint alleges inducement by instructing users of the HaeNaem Bur Kits to perform the claimed method involving reciprocation of the blades (Compl. ¶¶66, 91).
III. The Accused Instrumentality
Product Identification
- The HaeNaem Bur Kit and the Total HaeNaem Bur Kit (Compl. ¶43).
Functionality and Market Context
- The accused products are kits containing multiple dental burs of varying sizes, used sequentially to prepare and expand osteotomies for dental implants (Compl. p. 10, Fig.). Defendant's marketing materials and instructional videos, provided in English and available in the U.S., allegedly promote the use of the burs for "Osseodensification," a term coined by Plaintiffs (Compl. ¶13; p. 11, Fig.). This image from the complaint shows the Defendant's marketing materials using Plaintiffs' proprietary term "Osseodensification" (Compl. p. 11, Fig.). The instructions allegedly direct surgeons to use a "bouncing-pumping motion" with "copious irrigation" while rotating the burs, which Plaintiffs contend is a method covered by their patents (Compl. ¶64; p. 11, Fig.). The products are allegedly sold in the U.S. through distributors and are marketed as a "special export" product by Defendant (Compl. ¶¶47, 51, 53).
IV. Analysis of Infringement Allegations
10,039,621 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a rotary osteotome configured to be turned continuously in one direction at high speed to enlarge an osteotomy... the osteotome including: a shank... a body joined to said shank, said body having a conically tapered profile | The HaeNaem Bur Kits include at least one rotary osteotome with a shank and a conically tapered body. | ¶60 | col. 9:50-10:2 |
| a plurality of helically spiraling flutes disposed about said body, a plurality of lands... each said land having a working edge helically twisting... in a direction that turns away from the non-cutting direction | The accused osteotomes have helically spiraling flutes, lands, and twisting working edges. | ¶60 | col. 11:20-41 |
| said working edges configured to radially displace surrounding bone material through compaction when said osteotome is pushed into an osteotomy while being rotated in the high-speed non-cutting direction | The accused osteotomes are alleged to have working edges that displace bone via compaction when rotated in the non-cutting direction. | ¶60 | col. 24:31-36 |
| said apical end including at least one lip... a radially outer portion of said grinding lip configured to grind bone material... said grinding lip having a generally planar first trailing flank... a second trailing flank... a relief pocket | The accused osteotomes have an apical end with a grinding lip and associated flank and pocket geometry. | ¶60 | col. 10:16-67 |
| at least one of said lip and said lands configured to generate an opposing axial reaction force | The accused osteotomes are alleged to be configured to generate an opposing axial reaction force. | ¶60 | col. 13:21-14:5 |
| an equal number of a plurality of said flutes opening directly into each said second trailing flank and said relief pocket... to receive and then upwardly channel bone debris | The flutes of the accused osteotomes are alleged to open into the trailing flank and relief pocket to channel debris. | ¶60 | col. 17:15-21 |
| said working edges further configured to auto-grafting the bone debris particles channeled upwardly through said flutes for repatriation into the surrounding bone material. | The accused osteotomes are alleged to be configured to auto-graft bone debris back into the surrounding bone material. | ¶60 | col. 17:1-5 |
Identified Points of Contention
- Scope Questions: The complaint alleges the accused products perform "Osseodensification." A question may arise whether this marketing term, used by the Defendant, is coextensive with the functional limitations of the patent claims, such as "auto-grafting" and generating an "opposing axial reaction force."
- Technical Questions: A central evidentiary question will be whether the specific geometry of the HaeNaem burs, when rotated in a non-cutting direction, actually generates a measurable "opposing axial reaction force" as required by the claim. The analysis will also question whether the accused burs are merely compacting bone laterally or if they perform the more specific "auto-grafting" function of channeling debris up the flutes for "repatriation."
10,980,548 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A rotary osteotome operable in a cutting direction and a reverse densifying direction, the osteotome including a shank... a body extending from said shank... having an apical end | The HaeNaem Bur Kits include at least one rotary osteotome operable in a cutting and a reverse densifying direction, with a shank and body. | ¶61 | col. 9:9-14 |
| a plurality of helically spiraling flutes disposed about said body, each said flute having a cutting face on one side thereof defining a rake angle and a densifying face on the other side thereof defining a heel-side angle | The accused osteotomes have helically spiraling flutes with a cutting face and a densifying face. | ¶61 | col. 11:57-62 |
| for each said densifying face the associated said heel-side angle is a positive angle measured in the cutting direction | The heel-side angle of the densifying face of the accused osteotomes is alleged to be positive. | ¶61 | col. 11:63-65 |
| a stopper section of said body disposed between said flutes and said shank | The accused osteotomes are alleged to have a stopper section between the flutes and the shank. | ¶61 | col. 12:3-5 |
| a land formed between each adjacent pair of flutes, each said land having a working edge along said cutting face | The accused osteotomes have lands formed between flutes with a working edge. | ¶61 | col. 12:6-9 |
| for each said cutting face at least a portion of the associated said rake angle is a negative rake angle measured in the cutting direction. | The rake angle of the cutting face of the accused osteotomes is alleged to be negative. | ¶61 | col. 12:12-15 |
Identified Points of Contention
- Scope Questions: The term "stopper section" is a key structural limitation. The dispute will question what physical feature on the accused burs constitutes this element and whether it performs the functions attributed to it in the patent specification, such as plugging the osteotomy to build hydraulic pressure. This image from the complaint shows the accused bur kit, where the presence of a "stopper section" may be disputed (Compl. p. 10, Fig.).
- Technical Questions: Infringement will depend on precise geometric measurements. A key factual question will be whether the cutting faces of the HaeNaem burs have a "negative rake angle" and whether the densifying faces have a "positive... heel-side angle," as measured according to the definitions and conventions of the patent.
V. Key Claim Terms for Construction
The Term: "opposing axial reaction force" ('621 Patent, Claim 1)
- Context and Importance: This functional language is a cornerstone of the '621 patent's asserted novelty, distinguishing it from prior art tools where the surgeon's control is limited. Practitioners may focus on this term because proving that the accused burs are "configured to generate" this specific force is essential for Plaintiffs to establish infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the force functionally as a "push-back phenomenon" that "gives the surgeon enhanced control" and "effectively decouples the rotation of the tool to the rate of expansion in the bone" ('621 Patent, col. 4:8-12). This could support an interpretation covering any tool geometry that produces this tactile, control-enhancing effect.
- Evidence for a Narrower Interpretation: The patent explicitly links the generation of this force to "at least one of the lip and the lands" ('621 Patent, col. 4:6-7) and the interaction of the working edges with the bone when rotated in the burnishing direction, which creates a "large negative rake angle" ('621 Patent, col. 13:13-17). This may support a narrower construction limited to the specific geometries disclosed that are responsible for the effect.
The Term: "stopper section" ('548 Patent, Claim 1)
- Context and Importance: This is a key structural element of Claim 1 of the '548 Patent. The presence or absence of a structure on the accused burs that meets the definition of a "stopper section" will be a critical, and potentially dispositive, point of the infringement analysis.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language is structurally simple, defining the term merely by its location: "disposed between said flutes and said shank" ('548 Patent, col. 34:5-6). This could support a reading on any non-fluted portion of the tool's body in that location.
- Evidence for a Narrower Interpretation: The abstract states the stopper section "plugs the hole when a certain depth is reached," which enables hydraulic pressure to build (’548 Patent, Abstract). Defendant may argue this functional language requires a structure specifically sized and shaped to create a seal-like effect, potentially narrowing the term's scope beyond just any feature located between the flutes and shank. This instructional diagram from the complaint showing a "bounce pumping" motion may be relevant to the function of the alleged "stopper section" (Compl. p. 12, Fig.).
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement for all asserted patents except for the initial direct infringement counts on the '621 and '548 patents. The allegations are based on Defendant's marketing materials, website, English-language instructions for use, and YouTube videos, which allegedly instruct U.S. surgeons to use the HaeNaem Bur Kits in a manner that performs the steps of the patented methods (Compl. ¶¶62-67, 76, 79, 82, 85, 88, 91, 94).
- Willful Infringement: Willfulness is alleged based on both pre-suit and post-suit knowledge. The complaint alleges Defendant had pre-suit knowledge based on a response to a cease-and-desist letter, in which Defendant allegedly "admitted... it already had knowledge of 'most patents owned by Versah' before receiving" the letter (Compl. ¶58). The complaint further alleges that Defendant has knowingly continued its infringing activities after receiving the notice letter (Compl. ¶59).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of functional performance: Can Plaintiffs prove, likely through expert testing and testimony, that the specific geometry of the HaeNaem burs performs the key functions required by the claims? This includes demonstrating the generation of a measurable "opposing axial reaction force" ('621 patent) and the formation of a "densifying crust" while in a cutting mode ('548 patent).
- A key legal question will be one of claim scope: How will the court construe the term "stopper section" ('548 patent)? The case may turn on whether the court adopts a purely structural definition based on location or a narrower functional definition requiring the ability to "plug" an osteotomy to build hydraulic pressure.
- A critical question for damages will be willfulness: Does the defendant's alleged admission of pre-suit knowledge of the plaintiff's patent portfolio meet the standard for willful infringement? If infringement is found, this allegation could significantly increase the potential damages award.