DCT

2:24-cv-03558

MiMedx Group Inc v. Surgenex LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-03558, D. Ariz., 12/16/2024
  • Venue Allegations: Venue is alleged to be proper in the District of Arizona because Defendant Surgenex is incorporated in Arizona and maintains its principal place of business there.
  • Core Dispute: Plaintiff alleges that Defendant’s placental tissue allograft products infringe nine patents related to methods of preparing, processing, and configuring tissue grafts derived from human placenta.
  • Technical Context: The technology involves processing human placental tissues, such as the amnion and chorion layers, into dehydrated, shelf-stable biological grafts for use in advanced wound care and other medical applications.
  • Key Procedural History: The complaint indicates that several of the asserted patents belong to two main patent families that share substantially the same specification, suggesting that claim construction and infringement analysis for patents within a family may involve overlapping issues. No prior litigation between the parties or administrative challenges to the patents are mentioned.

Case Timeline

Date Event
2006-08-17 Earliest Priority Date (’494, ’253, ’259, ’839, ’449 Patents)
2007-09-07 Earliest Priority Date (’701, ’174, ’137, ’697 Patents)
2012-12-04 U.S. Patent No. 8,323,701 Issued
2014-04-29 U.S. Patent No. 8,709,494 Issued
2017-02-21 U.S. Patent No. 9,572,839 Issued
2017-10-17 U.S. Patent No. 9,789,137 Issued
2018-05-01 U.S. Patent No. 9,956,253 Issued
2019-09-10 U.S. Patent No. 10,406,259 Issued
2020-12-29 U.S. Patent No. 10,874,697 Issued
2022-11-22 U.S. Patent No. 11,504,449 Issued
2023-09-12 U.S. Patent No. 11,752,174 Issued
2024-12-16 Complaint Filed

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

U.S. Patent No. 8,709,494 - Placental Tissue Grafts

Issued on April 29, 2014 (Compl. ¶22).

The Invention Explained

  • Problem Addressed: The patent addresses a need for improved and standardized procedures for harvesting, processing, and preparing human placental tissue (amnion and/or chorion) for use in surgical grafting procedures ('259 Patent, col. 2:13-16).
  • The Patented Solution: The invention provides methods for processing placental tissue by separating the amnion and chorion layers, cleaning them, and laminating them together to form a multi-layered graft that is then dehydrated ('259 Patent, col. 2:56-65, col. 3:45-50). This process is designed to be gentle to preserve the tissue's biological properties while creating a durable, easy-to-handle product (Compl. ¶50).
  • Technical Importance: The patented solution yields grafts that can be stored at room temperature for extended periods, eliminating the need for refrigeration or freezing and simplifying logistics for medical use ('259 Patent, col. 2:63-65).

Key Claims at a Glance

  • The complaint asserts at least independent claim 9 (Compl. ¶128).
  • Essential elements of claim 9 include:
    • A dehydrated, laminated, placental tissue graft.
    • The graft is a laminate comprising two or more separated and washed layers.
    • The layers are selected from amnion and/or chorion.
    • The layers are directly laminated to each other.
    • At least one of the layers is an amnion layer which retains an epithelial cellular layer.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,956,253 - Placental Tissue Grafts

Issued on May 1, 2018 (Compl. ¶24).

The Invention Explained

  • Problem Addressed: As a member of the same patent family as the '494 Patent, this patent addresses the same need for improved methods of preparing placental tissue for surgical grafting (Compl. ¶56; '259 Patent, col. 2:13-16).
  • The Patented Solution: The invention describes tissue grafts with specific multi-layer constructions derived from separated and washed amnion and chorion layers ('259 Patent, col. 2:36-39, col. 6:56-7:9). The patent provides more specific structural definitions for the layers, detailing the constituent parts of the amnion layer (epithelial layer, basement membrane, compact layer, and fibroblast layer) ('253 Patent, Claim 7).
  • Technical Importance: This approach creates shelf-stable, multi-layer allografts with defined biological structures intended to provide a matrix for cellular migration and promote healing (Compl. ¶48; '259 Patent, col. 2:63-65).

Key Claims at a Glance

  • The complaint asserts at least independent claim 7 (Compl. ¶141).
  • Essential elements of claim 7 include:
    • A dehydrated, laminated placental tissue graft which is a laminate of two washed layers.
    • A first layer is an amnion layer consisting of an epithelial cellular layer, a basement membrane, a compact layer, and a fibroblast cellular layer.
    • A second layer is selected from (i) a specific type of amnion layer, (ii) a second specific type of amnion layer, or (iii) a chorion layer.
    • The first and second layers are dehydrated and laminated to each other.
    • The layers were separated prior to being laminated.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,406,259 - Placental Tissue Grafts and Improved Methods of Preparing and Using the Same

Issued September 10, 2019 (Compl. ¶26).

  • Technology Synopsis: Belonging to the same family as the '494 Patent, this patent is directed to a packaged placental tissue graft. The claims add limitations related to the packaging, such as requiring a sealed, deoxygenated container, and a specified shelf-life of at least five years at room temperature (Compl. ¶57, ¶153).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶153).
  • Accused Features: The PelloGraft®, SurGraft XT®, and SurGraft TL® products, particularly their packaging and shelf-life characteristics, are accused of infringement (Compl. ¶152).

U.S. Patent No. 9,572,839 - Placental Tissue Grafts and Methods of Preparing and Using the Same

Issued February 21, 2017 (Compl. ¶28).

  • Technology Synopsis: This patent, also in the '494 patent family, is directed to a laminated graft made of multiple chorion layers. It claims a dehydrated graft consisting of a first and second chorion tissue layer laminated together, where at least one of the layers is not decellularized (Compl. ¶58, ¶166).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶166).
  • Accused Features: The ArdeoGraft® product, which the complaint alleges comprises two layers of chorion, is accused of infringement (Compl. ¶165, ¶168).

U.S. Patent No. 11,504,449 - Placental Tissue Grafts and Methods of Preparing and Using the Same

Issued November 22, 2022 (Compl. ¶30).

  • Technology Synopsis: This patent is in the '494 family and covers a packaged, multi-layer chorion graft. The claims add limitations requiring that the graft was contacted with an antibiotic prior to dehydration and has a shelf-life of at least five years when stored at room temperature (Compl. ¶59, ¶177).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶177).
  • Accused Features: The ArdeoGraft® product and its associated processing and packaging are accused of infringement (Compl. ¶176, ¶179).

U.S. Patent No. 11,752,174 - Placental Tissue Grafts and Improved Methods of Preparing and Using the Same

Issued September 12, 2023 (Compl. ¶32).

  • Technology Synopsis: This patent is in the same family as the '701 Patent and is directed to a tissue graft that comprises a plurality of holes (i.e., is "vented"). The claims cover a graft with a first membrane of amnion laminated to at least one additional membrane, where the resulting graft contains multiple holes (Compl. ¶66, ¶188).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶188).
  • Accused Features: "Vented" versions of the PelloGraft® and SurGraft XT® products are accused of infringement (Compl. ¶187, ¶190-191).

U.S. Patent No. 8,323,701 - Placental Tissue Grafts

Issued December 4, 2012 (Compl. ¶34).

  • Technology Synopsis: This patent is directed to a tissue graft where the amnion's epithelial layer has been substantially removed to expose the underlying basement membrane. This modification is intended to allow host cells to more readily interact with bioactive factors in the basement membrane (Compl. ¶63-64, ¶200). The complaint pleads infringement of this patent in the alternative (Compl. ¶199).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶200).
  • Accused Features: To the extent their manufacturing process removes the epithelial layer, the PelloGraft®, SurGraft XT®, and SurGraft TL® products are accused of infringement (Compl. ¶199, ¶201-203).

U.S. Patent No. 9,789,137 - Placental Tissue Grafts and Improved Methods of Preparing and Using the Same

Issued October 17, 2017 (Compl. ¶36).

  • Technology Synopsis: A member of the '701 patent family, this patent claims a laminated graft with a modified amnion layer (exposed basement membrane) and adds the negative limitation that the layers are "not held in together with a suture" (Compl. ¶68, ¶211).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶211).
  • Accused Features: Pleading in the alternative, the complaint accuses PelloGraft®, SurGraft XT®, and SurGraft TL® products to the extent they are made with a process that removes the epithelial layer and are not sutured (Compl. ¶210, ¶212-214).

U.S. Patent No. 10,874,697 - Placental Tissue Grafts and Improved Methods of Preparing and Using the Same

Issued December 29, 2020 (Compl. ¶38).

  • Technology Synopsis: Also in the '701 patent family, this patent claims a graft with a modified amnion layer (exposed basement membrane) that also comprises a plurality of holes (Compl. ¶69, ¶222).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶222).
  • Accused Features: Pleading in the alternative, the complaint accuses "vented" versions of PelloGraft® and SurGraft XT® to the extent their manufacturing process removes the epithelial layer (Compl. ¶221, ¶223-224).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Surgenex's PelloGraft®, ArdeoGraft®, SurGraft XT®, and SurGraft TL® placental tissue-based products (Compl. ¶70).

Functionality and Market Context

The complaint alleges these are allografts derived from human placental tissue for use in wound care and other medical applications (Compl. ¶71, ¶88). Surgenex allegedly processes the tissue at an on-site facility, which includes a clean room space (Compl. ¶72). A provided screenshot shows the interior of the "Surgenex Processing Facility" (Compl. p. 14). The general process is alleged to involve donor screening, tissue acquisition, cleaning and processing using "proprietary methods," sterilization via irradiation, and ambient temperature storage (Compl. ¶75). The complaint includes a flowchart from a product flyer detailing Surgenex's nine-step "Our Process" from birth collection to application (Compl. p. 15). Surgenex allegedly markets its process as involving "[m]inimal manipulation to retain the native biomechanical structure" and "exhaustive post-processing rinsing" (Compl. ¶80, ¶93). The products are allegedly dehydrated or lyophilized and have a five-year shelf life (Compl. ¶82, ¶86).

IV. Analysis of Infringement Allegations

'494 Patent Infringement Allegations

Claim Element (from Independent Claim 9) Alleged Infringing Functionality Complaint Citation Patent Citation
A dehydrated, laminated, placental tissue graft which is a laminate The accused PelloGraft®, SurGraft XT®, and SurGraft TL® products are placental tissue grafts that are dehydrated and laminated to form multi-layer structures. ¶90, ¶94, ¶95, ¶107, ¶111, ¶112, ¶119, ¶120 col. 3:45-50
comprising two or more separated and washed layers which layers are selected from amnion and/or chorion The products are comprised of two or more layers of amnion and/or chorion. During processing, the native amnion and chorion layers are allegedly separated from each other and are cleaned and washed. ¶90, ¶91, ¶92, ¶107, ¶108, ¶109, ¶115, ¶116, ¶117 col. 6:49-55
wherein the layers are directly laminated to each other Adjacent amnion and/or chorion layers in the accused products are allegedly laminated directly to each other to form the final graft product. ¶95, ¶112, ¶120 col. 3:45-50
and at least one of said layers is an amnion layer which retains an epithelial cellular layer. Based on Surgenex’s marketing of a process with "[m]inimal manipulation," it is alleged on information and belief that the amnion layers in the accused products retain their native epithelial cellular layer. ¶93, ¶110, ¶118, ¶130, ¶131, ¶132 col. 6:15-19

'253 Patent Infringement Allegations

Claim Element (from Independent Claim 7) Alleged Infringing Functionality Complaint Citation Patent Citation
A dehydrated, laminated placental tissue graft which is a laminate consisting of two washed layers The accused PelloGraft® and SurGraft XT® products are dehydrated, laminated grafts made of two washed layers of placental tissue. ¶90, ¶92, ¶94, ¶107, ¶109, ¶111 col. 3:45-50
wherein a first of said layers is an amnion layer which consists of an epithelial cellular layer, a basement membrane, a compact layer, and a fibroblast cellular layer Based on the alleged retention of the native tissue structure through "minimal manipulation," the amnion layer in the accused products is alleged to consist of these constituent layers. ¶93, ¶110, ¶143, ¶144 col. 1:40-43
and a second of said layers is... (iii) chorion The PelloGraft® product comprises a layer of amnion and a layer of chorion. ¶90, ¶143 col. 2:36-39
wherein the first and second layers are dehydrated and laminated to each other The layers of the accused products are dehydrated and directly laminated to each other. ¶90, ¶94, ¶95, ¶107, ¶111, ¶112 col. 3:45-50
and wherein the layers were separated prior to being laminated to each other. The amnion and chorion layers are allegedly separated from each other during processing before being laminated together. ¶91, ¶108, ¶143, ¶144 col. 6:49-55

Identified Points of Contention

  • Factual Question: A central point of contention may be the factual condition of the epithelial cell layer on the amnion in Surgenex’s final products. The complaint alleges infringement of the '494 patent family by asserting this layer is "retained" based on Surgenex's "minimal manipulation" marketing claims (Compl. ¶93, ¶130). However, the complaint also pleads in the alternative that Surgenex infringes the '701 patent family "to the extent Surgenex's manufacturing process substantially removes the amnion's epithelial layer" (Compl. ¶199, ¶210). This highlights a fundamental, and potentially case-dispositive, technical question about what Surgenex's process actually does to the tissue.
  • Scope Questions: Another question may be whether Surgenex's proprietary cleaning and processing methods (Compl. ¶79) constitute "washing" as understood in the patent. Similarly, the infringement allegations for packaged products rely on an inference that a five-year shelf life necessitates a "sealed, deoxygenated container," which may raise a dispute over both the facts of Surgenex's packaging and the scope of the claim term (Compl. ¶155). The product flyer for PelloGraft®, which shows the product held by forceps, provides no information on its final sealed packaging (Compl. p. 18).

V. Key Claim Terms for Construction

  • "retains an epithelial cellular layer" (from '494 Patent, Claim 9)

    • Context and Importance: The presence or absence of this layer appears to be a critical technical distinction between the two asserted patent families and thus central to the infringement analysis. Plaintiff alleges infringement of patents requiring retention of this layer, while simultaneously alleging infringement of other patents that require its substantial removal. The construction of "retains" (e.g., does it mean 100% retention, substantial retention, or merely incidental, non-zero retention?) will be pivotal.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification's repeated emphasis on "gentle" and "careful" processing to avoid damaging the tissue could support an interpretation where any process that is not intentionally destructive "retains" the layer, even if some cells are lost (Compl. ¶50; '259 Patent, col. 6:15-19).
      • Evidence for a Narrower Interpretation: The specification of the related '701 patent family explicitly teaches "substantially remov[ing]" the epithelium layer to achieve the technical goal of exposing the basement membrane (Compl. ¶63). The contrast between the explicit "removal" in one patent family and "retention" in another may suggest that "retains" implies keeping the layer substantially intact and functional.

  • "deoxygenated container" (from '259 Patent, Claim 1)

    • Context and Importance: This term is a key limitation in the packaging-related claims. The complaint does not allege direct observation of a deoxygenation process but infers its presence from the product's five-year shelf life (Compl. ¶155). Practitioners may focus on this term because its definition will determine what level of proof is required to show infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification states, "[t]o the extent possible, oxygen is removed from the inner pouch before it is sealed" ('259 Patent, col. 9:66-67). The qualifying phrase "to the extent possible" could support a broader construction that does not require a complete absence of oxygen, but merely an active step to reduce it.
      • Evidence for a Narrower Interpretation: A defendant might argue that "deoxygenated" implies a specific, measurable low level of oxygen that is not met, or that the term is indefinite without such a specification. The patent does not appear to provide a quantitative threshold for "deoxygenated."

VI. Other Allegations

Indirect Infringement

The complaint does not provide sufficient detail for analysis of indirect infringement. The infringement counts make a general reference to 35 U.S.C. § 271 but do not plead specific facts to support the knowledge and intent elements required for induced infringement or the elements of contributory infringement.

Willful Infringement

Willfulness is alleged for all asserted patents. The primary basis alleged is knowledge of MiMedx's patent portfolio, including at least the '494 Patent (Compl. ¶134, ¶146, ¶159). The complaint also alleges constructive knowledge based on Plaintiff's product labeling and reference to its patent portfolio on its corporate website, in accordance with patent marking statutes (Compl. ¶123).

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

  • A core issue will be one of technical fact-finding: what is the actual physical state of the epithelial cellular layer in Surgenex's accused allografts? The plaintiff's assertion of infringement of two distinct patent families—one requiring retention of this layer and one requiring its removal—places this technical question at the center of the dispute and suggests the outcome may depend heavily on expert testimony and evidence from discovery concerning Surgenex's proprietary manufacturing process.
  • A second key evidentiary question will be one of inferential proof: can infringement of packaging limitations, such as the requirement for a "deoxygenated container," be established by inference from a product's marketed shelf-life? The court will need to determine whether the complaint's allegations, made on "information and belief," are sufficient and whether circumstantial evidence can satisfy the patent's specific claim language.