DCT

1:18-cv-00146

LifeNet Health v. Surgalign SP

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I. Executive Summary and Procedural Information

  • Parties & Counsel:

  • Case Identification: 3:18-cv-00817, M.D. Fla., 06/27/2018

  • Venue Allegations: Venue is alleged to be proper in the Middle District of Florida because Defendant RTI Surgical, Inc. maintains a regular and established place of business in the district.

  • Core Dispute: Plaintiff alleges that Defendant’s soft tissue and bone graft products infringe five U.S. patents related to technologies for preserving and constructing bio-implantable tissues for surgical use.

  • Technical Context: The technology domain is bio-implantable tissue grafts, a field critical for surgical reconstruction, spinal fusion, and wound management, where product stability and biocompatibility are paramount.

  • Key Procedural History: The complaint alleges that U.S. Patent No. 6,569,200 was the subject of prior litigation against LifeCell Corporation, which resulted in a jury verdict finding the patent valid and infringed, a verdict that was subsequently upheld by the U.S. Court of Appeals for the Federal Circuit. Plaintiff alleges Defendant had knowledge of this litigation.

Case Timeline

Date Event
1998-06-30 Earliest Priority Date ('200', '420', '986' Patents)
1999-01-05 Earliest Priority Date ('158', '532' Patents)
2002-10-01 '158 Patent Issued
2003-05-27 '200 Patent Issued
2008-01-01 Alleged first use of Puros-S2, AlloQuent-S, CeSpace, Cornerstone ASR products
2010-01-01 Plaintiff launched Oracell® dermal implant using '200 patent family technology
2011-01-01 Alleged first use of Capistrano product
2012-05-22 '532 Patent Issued
2013-03-05 Defendant's FDA 510(k) summary for Fortiva filed
2013-09-06 Plaintiff filed suit against LifeCell Corporation regarding the '200 Patent
2017-02-28 '420 Patent Issued
2017-03-07 '986 Patent Issued
2018-06-27 Complaint Filing Date

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

U.S. Patent No. 6,569,200 - "Plasticized Soft Tissue Grafts, and Methods of Making and Using Same"

  • Patent Identification: U.S. Patent No. 6,569,200, "Plasticized Soft Tissue Grafts, and Methods of Making and Using Same," issued May 27, 2003.

The Invention Explained

  • Problem Addressed: The patent addresses the problem that conventional methods of preserving biological tissues, such as freeze-drying, result in products that are brittle, require time-consuming rehydration before surgical use, and may have compromised biomechanical properties ('200 Patent, col. 3:46-51).
  • The Patented Solution: The invention proposes replacing the water within the molecular structure of bone or soft tissue with one or more "plasticizers," such as glycerol ('200 Patent, col. 5:1-9; Abstract). This process allows the tissue to be dehydrated for storage at ambient temperatures without becoming brittle, thereby creating a graft that is ready for immediate implantation without significant preparation in the operating room ('200 Patent, Abstract).
  • Technical Importance: This approach aimed to improve the logistical efficiency and mechanical reliability of allograft tissues by eliminating the need for special storage conditions (e.g., freezing) and pre-operative rehydration steps (Compl. ¶21).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 7, as well as dependent claims 2-4 and 8 (Compl. ¶105).
  • Independent Claim 1 (Product Claim): A plasticized soft tissue graft suitable for transplantation into a human, comprising:
    • a cleaned soft tissue graft having an internal matrix; and
    • one or more plasticizers contained in said internal matrix;
    • wherein said one or more plasticizers are not removed from said internal matrix of said plasticized soft tissue graft prior to transplantation into a human.
  • Independent Claim 7 (Method Claim): A method for producing a plasticized soft tissue graft suitable for transplantation into a human, comprising:
    • impregnating a cleaned, soft tissue graft with one or more plasticizers to produce a plasticized soft tissue graft;
    • wherein said one or more plasticizers are not removed from an internal matrix of the plasticized soft tissue graft prior to transplantation into a human.

U.S. Patent No. 9,579,420 - "Plasticized Bone and Soft Tissue Grafts and Methods of Making and Using Same"

  • Patent Identification: U.S. Patent No. 9,579,420, "Plasticized Bone and Soft Tissue Grafts and Methods of Making and Using Same," issued February 28, 2017.

The Invention Explained

  • Problem Addressed: Similar to the '200 patent, this patent addresses the problem that dehydrated tissues can become brittle and that rehydration may not fully restore their natural mechanical properties, potentially leading to graft failure ('420 Patent, col. 3:1-4).
  • The Patented Solution: The invention describes a plasticized tissue graft where water is replaced by plasticizers, with a specific focus on ensuring that the "native orientation of the collagen fibers is maintained" ('420 Patent, Claim 1). This preservation of the underlying collagen structure is intended to ensure the graft retains biomechanical properties similar to natural, hydrated tissue ('420 Patent, col. 4:10-24).
  • Technical Importance: The invention emphasizes the preservation of the tissue's micro-architecture during plasticization, which is critical for load-bearing grafts that must withstand mechanical stress upon implantation (Compl. ¶¶ 22, 64).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 16, among numerous dependent claims (Compl. ¶108).
  • Independent Claim 1 (Product Claim): A plasticized soft tissue graft suitable for transplantation into a human, comprising:
    • a cleaned soft tissue graft having an internal matrix and comprising collagen fibers, wherein the native orientation of the collagen fibers is maintained in the plasticized soft tissue graft; and
    • one or more plasticizers contained in said internal matrix.
  • Independent Claim 16 (Method Claim): A method for producing a plasticized soft tissue graft, comprising:
    • impregnating a cleaned soft tissue graft with one or more plasticizers to produce a plasticized soft tissue graft;
    • wherein the cleaned soft tissue graft comprises collagen fibers, and the orientation of the collagen fibers is not altered by the step of impregnating, such that the native orientation of the collagen fibers is maintained in the plasticized soft tissue graft.

U.S. Patent No. 9,585,986 - "Plasticized Bone and Soft Tissue Grafts and Methods of Making and Using Same"

  • Patent Identification: U.S. Patent No. 9,585,986, "Plasticized Bone and Soft Tissue Grafts and Methods of Making and Using Same," issued March 7, 2017.
  • Technology Synopsis: The patent is part of the same family as the '200 and '420 patents and is also directed to plasticized tissue grafts that can be stored without special conditions and implanted without pre-operative rehydration (Compl. ¶35). The asserted claim focuses on a soft tissue graft obtained from a donor where cellular elements are substantially removed and a plasticizer is contained within the tissue, resulting in mechanical properties similar to natural soft tissue (Compl. ¶67).
  • Asserted Claims: The complaint asserts at least claim 11 (Compl. ¶111).
  • Accused Features: The accused product is Defendant's Fortiva soft tissue graft (Compl. ¶¶ 67, 111).

U.S. Patent No. 6,458,158 - "Composite Bone Graft, Method of Making and Using Same"

  • Patent Identification: U.S. Patent No. 6,458,158, "Composite Bone Graft, Method of Making and Using Same," issued October 1, 2002.
  • Technology Synopsis: This patent is directed to a composite bone graft constructed from multiple discrete bone portions, such as cortical and cancellous bone, that are mechanically connected to form a single graft unit ('158 Patent, Abstract). The invention aims to create larger or stronger bone grafts than might be available from a single piece of donor bone, using biocompatible connectors like bone pins instead of adhesives to hold the components together ('158 Patent, col. 2:11-19).
  • Asserted Claims: The complaint asserts at least claims 1 and 2 (Compl. ¶114).
  • Accused Features: The accused features are found in Defendant's "Infringing Bone Products," including the Capistrano, Puros-S2, AlloQuent, CeSpace, Cornerstone ASR, and Elemax products (Compl. ¶¶ 68-103, 114). The complaint includes a picture of the Capistrano product, describing it as a system machined from cortical and cancellous allograft bone (Compl. ¶¶ 69, 70).

U.S. Patent No. 8,182,532 - "Composite Bone Graft, Method of Making and Using Same"

  • Patent Identification: U.S. Patent No. 8,182,532, "Composite Bone Graft, Method of Making and Using Same," issued May 22, 2012.
  • Technology Synopsis: This patent is also directed to composite bone grafts, with a focus on a "load-bearing composite spinal bone graft" ('532 Patent, Claim 12). The claims describe a structure with multiple bone portions, osteoconductive substances disposed between them, and non-adhesive mechanical connectors, where the graft has "textured surfaces configured to contact a portion of the host bone" to improve stability after implantation ('532 Patent, Abstract; Claim 12).
  • Asserted Claims: The complaint asserts at least claim 12 (Compl. ¶117).
  • Accused Features: The accused features are found in Defendant's "Infringing Bone Products" (Compl. ¶¶ 68-103, 117). The complaint alleges, for example, that the Puros-S2 product is a cervical implant machined from cortical and cancellous bone that provides an "osteoconductive lattice for bony in-growth" (Compl. ¶75), and includes a picture of its structure (Compl. ¶76).

III. The Accused Instrumentality

Product Identification

  • The complaint accuses two categories of products:
    1. The "Infringing Soft Tissue Product," identified as Fortiva™ (Compl. ¶¶ 11, 49).
    2. The "Infringing Bone Products," identified as Capistrano, Puros-S2, AlloQuent-S, CeSpace, Cornerstone ASR, and Elemax (Compl. ¶12).

Functionality and Market Context

  • Fortiva™: The complaint describes Fortiva as a porcine (pig) dermis tissue product processed via "meticulous cleaning and solvent dehydration" (Compl. ¶¶ 11, 53). It is supplied "pre-hydrated in water," is sterilized, and is marketed as "ready for immediate use without extra preparation (i.e., no rinsing, no soaking, etc.)" (Compl. ¶52). The complaint alleges that in its FDA 510(k) filing, RTI represented Fortiva as "substantially equivalent" to Strattice®, a product previously found by a jury to infringe the '200 patent (Compl. ¶50). A table from the FDA filing compares the "Proposed Device" (Fortiva) to the "Predicate Device" (Strattice) across characteristics including intended use, material, and design (Compl. ¶56).
  • Infringing Bone Products: These products are generally described as allograft spacer systems for spinal applications, constructed from cortical and cancellous bone (Compl. ¶¶ 12, 69, 75, 81, 87, 93, 99). They are designed to provide structural support and act as an "osteoconductive scaffold" to promote new bone growth (Compl. ¶¶ 69, 81). The complaint includes several images depicting the composite structures of these products, such as the AlloQuent graft, which is shown to have a "Cortical component for strength" and a "Cancellous component for bony ingrowth" (Compl. ¶82).

IV. Analysis of Infringement Allegations

'200 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a plasticized soft tissue graft suitable for transplantation into a human Fortiva is alleged to be a plasticized soft tissue graft suitable for transplantation, based on its characteristics and alleged equivalence to a predicate device previously found to infringe. ¶58 col. 13:10-11
comprising: a cleaned soft tissue graft having an internal matrix Fortiva is described as a processed porcine dermal tissue that undergoes a "meticulous cleaning" process and comprises an "extracellular collagen matrix." ¶¶ 52, 53, 59 col. 13:12-13
and one or more plasticizers contained in said internal matrix The complaint alleges on information and belief that Fortiva contains plasticizers because it is stored hydrated and is ready for immediate use without extra preparation like rinsing or soaking. ¶¶ 59, 60 col. 13:14-15
wherein said one or more plasticizers are not removed from said internal matrix of said plasticized soft tissue graft prior to transplantation into a human Fortiva is described in its Instructions for Use as "ready for immediate use without extra preparation (i.e., no rinsing, no soaking, etc.)." ¶¶ 52, 60 col. 13:15-18
  • Identified Points of Contention:
    • Scope Questions: A primary question will be the definition of "plasticizer." The complaint alleges Fortiva contains a plasticizer based on its functional properties (ready-to-use, no rehydration needed) and its alleged equivalence to an infringing product, rather than by identifying a specific chemical component in Fortiva as the plasticizer (Compl. ¶¶ 59-60). The patent, however, describes the invention as replacing water with plasticizers like glycerol, raising the question of whether the water in which Fortiva is "pre-hydrated" can itself be considered the claimed "plasticizer" ('200 Patent, Abstract; Compl. ¶52).
    • Technical Questions: A key evidentiary question will be what substance, if any, within the Fortiva product performs the function of a "plasticizer" as described in the patent. The dispute may turn on whether Fortiva's "solvent dehydration" process followed by storage in water achieves the same technical result through the same mechanism as the claimed invention (Compl. ¶53).

'420 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a plasticized soft tissue graft... comprising: a cleaned soft tissue graft having an internal matrix and comprising collagen fibers Fortiva is described as a processed porcine dermal tissue comprising an "extracellular collagen matrix." ¶¶ 52, 63, 64 col. 13:58-61
wherein the native orientation of the collagen fibers is maintained in the plasticized soft tissue graft The complaint alleges this is met because Fortiva's cleaning process "gently removes unwanted materials" and the product is alleged to have the same technological characteristics as the predicate device Strattice. ¶¶ 64, 66 col. 13:62-64
and one or more plasticizers contained in said internal matrix As with the '200 patent, the complaint alleges on information and belief that Fortiva contains plasticizers based on its functional characteristics. ¶63 col. 13:65-66
  • Identified Points of Contention:
    • Scope Questions: In addition to the "plasticizer" term discussed for the '200 patent, a central question will be the scope of the phrase "native orientation of the collagen fibers is maintained." The parties may dispute the degree of structural alteration permitted by this limitation.
    • Technical Questions: An evidentiary question will be whether RTI's "Tutoplast® tissue sterilization process," which includes "solvent dehydration," in fact maintains the "native orientation" of the collagen fibers as required by the claim (Compl. ¶53). Analysis of the accused product's microstructure may be required to resolve this factual question.

V. Key Claim Terms for Construction

  • The Term: "plasticizer" (from the '200 and '420 patents)

    • Context and Importance: The presence of a "plasticizer" is a core limitation of the asserted claims against Fortiva. The definition of this term is critical, as the complaint does not identify a specific ingredient in Fortiva as a plasticizer but infers its presence from the product's characteristics.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent defines a plasticizer functionally as any biocompatible compound "which are soluble in water and can easily displace/replace water at the molecular level" ('200 Patent, col. 8:1-4). This functional language could support a broader reading.
      • Evidence for a Narrower Interpretation: The patent's abstract states that the "invention replaces water... with one or more plasticizers," suggesting a distinction between the two ('200 Patent, Abstract). The specification provides a list of exemplary plasticizers, including glycerol and other polyols, which may suggest the term is limited to such non-water chemical agents ('200 Patent, col. 8:36-50).

  • The Term: "native orientation of the collagen fibers is maintained" (from the '420 patent)

    • Context and Importance: This term is central to distinguishing the '420 patent and is a key technical limitation for the infringement allegation. Practitioners may focus on this term because the complaint's support for this element rests on general descriptions of a "gentle" cleaning process, which will require factual evidence to substantiate (Compl. ¶¶ 64, 66).
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification does not appear to provide a quantitative metric for how much deviation from the "native" state is permissible, which may support an interpretation that allows for some minor, inevitable alteration during processing.
      • Evidence for a Narrower Interpretation: The patent's emphasis on achieving material properties that "approximate those properties present in normal hydrated tissue" suggests that the term requires a high degree of structural fidelity, sufficient to preserve the tissue's original biomechanical function ('420 Patent, Abstract).

VI. Other Allegations

Willful Infringement

The complaint alleges that Defendant RTI had knowledge of the '200 patent "at least by virtue of the '200 patent litigation" against LifeCell Corporation, in which the patent was found valid and infringed (Compl. ¶48). This allegation of pre-suit knowledge of the patent and a prior infringement verdict forms the basis for a claim of willful infringement regarding the '200 patent. The complaint does not contain similar specific allegations of pre-suit knowledge for the '420, '986, '158, or '532 patents.

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

  • A core issue will be one of definitional scope: can the term "plasticizer," as used in the context of an invention that replaces water in tissue, be construed to read on a product that is supplied "pre-hydrated in water"? The resolution of this question will be fundamental to the infringement analysis for the '200, '420, and '986 patents.
  • A key evidentiary question will be one of structural and compositional identity: does the Fortiva product contain a substance that meets the definition of a "plasticizer," and do its collagen fibers retain their "native orientation" after processing? For the accused bone grafts, the analysis will turn on a detailed, element-by-element comparison of their physical construction—including the arrangement of cortical and cancellous bone, the use of mechanical pins, and the presence of textured surfaces—with the specific limitations of the '158 and '532 patent claims.
  • A central question for damages will be one of willfulness: does the allegation that RTI knew of the prior successful litigation involving the '200 patent support a finding that any infringement of that patent was willful, potentially leading to enhanced damages?