1:15-cv-00654
DermaFocus LLC v. Ulthera Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: DermaFocus LLC (Delaware)
- Defendant: Ulthera, Inc. (Delaware)
- Plaintiff’s Counsel: Farnan LLP (Of Counsel: Dovel & Luner, LLP)
- Case Identification: 1:15-cv-00654, D. Del., 07/29/2015
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation, is allegedly responsible for acts of infringement in the district, and has delivered or caused its products to be delivered or used in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Ulthera System for non-invasive skin treatment infringes a patent related to the therapeutic application of focused ultrasound to rejuvenate skin.
- Technical Context: The lawsuit concerns the field of non-ablative dermatological treatments, which use energy sources like ultrasound to stimulate subsurface skin layers to reduce wrinkles without damaging the outer skin surface.
- Key Procedural History: The complaint alleges Defendant has known of the patent-in-suit since at least February 2005. Notably, after the complaint was filed, the patent-in-suit was subject to an inter partes review (IPR) proceeding (IPR2016-01459), which concluded with a certificate confirming all claims (1-18) as patentable. This post-grant challenge and its outcome may significantly strengthen the patent’s presumption of validity and create estoppel against certain invalidity defenses.
Case Timeline
| Date | Event |
|---|---|
| 1997-12-29 | ’559 Patent Priority Date |
| 2000-09-05 | ’559 Patent Issue Date |
| 2005-02-09 | Alleged date of Defendant's first knowledge of the patent |
| 2009-09-01 | Alleged start date of infringing activity ("at least") |
| 2015-07-29 | Complaint Filing Date |
| 2016-07-19 | IPR Proceeding (IPR2016-01459) Filed |
| 2019-10-02 | IPR Certificate Issued Confirming Patentability of Claims |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,113,559 - "Method and Apparatus for Therapeutic Treatment of Skin with Ultrasound"
The Invention Explained
- Problem Addressed: The patent describes prior art methods for reducing skin wrinkles—such as laser ablation, chemical peels, and dermabrasion—as problematic because they cause significant damage to the epidermis (the outer layer of skin), leading to pain, risk of infection, and prolonged recovery periods (’559 Patent, col. 1:36-51).
- The Patented Solution: The invention proposes a method and apparatus that applies a focused ultrasound beam to selectively target the underlying dermis layer of the skin. By delivering controlled energy to the dermis, the method aims to "stimulate or irritate" it, triggering a biological response that synthesizes new connective tissue over time, which in turn smooths the outer skin without substantially damaging the protective epidermis layer (’559 Patent, Abstract; col. 2:6-12).
- Technical Importance: The technology offered a non-ablative approach to skin rejuvenation, seeking to provide the benefits of wrinkle reduction while avoiding the undesirable side effects associated with treatments that damage the skin surface (’559 Patent, col. 2:1-4).
Key Claims at a Glance
- The complaint asserts infringement of "at least one claim" of the ’559 Patent without specifying which claims will be asserted (’559 Patent, Compl. ¶11). The analysis below focuses on independent method claim 1 as a representative claim.
- Independent Claim 1:
- identifying a region of skin to be treated;
- focusing ultrasound energy in a dermis layer of the region of skin; and
- depositing energy in the dermis layer sufficient to heat tissue within the layer to a temperature ranging from about 47° C. to about 75° C. to stimulate or irritate a dermis layer... so as to cause a change in the dermis layer... that results in a change in a smoothness of an epidermis layer of the skin.
- The complaint implicitly reserves the right to assert other claims, including dependent claims.
III. The Accused Instrumentality
Product Identification
The "Ulthera System" and associated products and services for "non-invasive lifting and tightening of the skin using focused ultrasound technology" (Compl. ¶11).
Functionality and Market Context
The complaint alleges that the Ulthera System functions by performing the steps of the patented method (Compl. ¶12). Specifically, it is alleged to be "specifically created to perform operations that align with the claimed elements," including "focusing ultrasound energy in a dermis layer" and "depositing energy... sufficient to heat tissue within the layer to a temperature ranging from about 47° C. to about 75° C." (Compl. ¶13). The complaint does not provide further technical details on the system's operation or its market position beyond identifying its general function.
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint does not contain a claim chart. The following table summarizes the infringement allegations for Claim 1 based on the narrative text of the complaint.
’559 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| identifying a region of skin to be treated; | The complaint alleges that "medical personnel implementing the Ulthera System" directly infringe the patent, which necessarily involves identifying a region of skin for treatment (Compl. ¶12). | ¶12 | col. 10:23 |
| focusing ultrasound energy in a dermis layer of the region of skin; | The Ulthera System is alleged to be specifically created to perform operations including "focusing ultrasound energy in a dermis layer of the region of skin" (Compl. ¶13). | ¶13 | col. 10:24-25 |
| and depositing energy in the dermis layer sufficient to heat tissue within the layer to a temperature ranging from about 47° C. to about 75° C. to stimulate or irritate a dermis layer... so as to cause a change... in a smoothness of an epidermis layer of the skin. | The Ulthera System is alleged to perform the operation of "depositing energy in the dermis layer sufficient to heat tissue within the layer to a temperature ranging from about 47° C. to about 75°C., etc." to achieve the claimed result (Compl. ¶13). | ¶13 | col. 10:26-34 |
Identified Points of Contention
- Technical Questions: A primary question is what evidence exists to support the allegation that the Ulthera System operates within the specific temperature range of "about 47° C. to about 75° C." (Compl. ¶13). The complaint asserts this as a fact but provides no supporting documentation, such as technical manuals or marketing materials, raising the question of how this operational parameter will be proven.
- Scope Questions: The complaint's infringement theory relies on allegations that mirror the patent’s claim language. The dispute may focus on whether the actual mechanism of action of the Ulthera System constitutes the claimed "stimulate or irritate" function, or if it operates via a different biological or physical principle not covered by the patent's claims as properly construed.
V. Key Claim Terms for Construction
The Term
"sufficient to heat tissue within the layer to a temperature ranging from about 47° C. to about 75° C."
Context and Importance
This limitation is the core of the claimed method, defining the specific physical conditions for achieving the therapeutic effect. The infringement analysis will likely depend on whether the accused system's operational temperatures fall within this range. Practitioners may focus on this term because the use of "about" introduces ambiguity, and the numerical boundaries are critical for distinguishing the invention from prior art.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification discusses a trade-off, noting that at "approximately 47° C., it takes several tens of seconds to denature a small fraction of the proteins," whereas at "73° C., the same... are denatured in several tens of microseconds" (’559 Patent, col. 8:47-53). A party could argue this context supports a flexible reading of the range and the word "about."
- Evidence for a Narrower Interpretation: The specification explicitly states that the required energy "is typically that required to raise the temperature of the dermis layer to somewhere is the range of 47° C. to 75° C." (’559 Patent, col. 8:38-41). A party could argue this "typical" range is a defining characteristic intended to distinguish the invention's "gentle" stimulation from higher-power prior art (’559 Patent, col. 3:51-61).
VI. Other Allegations
Indirect Infringement
The complaint alleges both induced and contributory infringement. Inducement is based on Defendant allegedly providing "instructions, product documentation, and customer support" that instruct medical personnel to use the Ulthera System in an infringing manner (Compl. ¶12). Contributory infringement is based on allegations that Defendant supplies components of the Ulthera System that are "especially made and adapted for use in the infringing" method, are "not a staple of commerce," and are not suitable for "substantial non-infringing use" (Compl. ¶13).
Willful Infringement
Willfulness is alleged based on Defendant’s purported knowledge of the ’559 Patent since "at least February 9, 2005" and its subsequent disregard of an "objectively high likelihood" that its actions constituted infringement (Compl. ¶14).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of operational proof: what evidence will emerge to substantiate the complaint’s allegation that the accused Ulthera System heats dermal tissue to the specific temperature range of "about 47° C. to about 75° C.," a highly technical fact that is asserted but not evidenced in the pleading?
- A key legal question will concern claim scope: how will the court construe the functional limitation "to stimulate or irritate" the dermis? Will the term be limited to the specific mechanisms of hyperthermia and cavitation detailed in the patent's specification, or will it be interpreted more broadly to cover any application of focused ultrasound that results in new connective tissue synthesis?
- The most significant procedural issue will be the impact of the IPR: given that all claims of the ’559 Patent were confirmed as patentable in an IPR proceeding filed after this lawsuit began, to what extent will the defendant be estopped from challenging the patent’s validity on grounds that were or reasonably could have been raised in that review, potentially focusing the litigation almost exclusively on infringement?