DCT

1:19-cv-02315

Wilson Wolf Mfg Corp v. Brammer Bio LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-02315, D. Del., 12/20/2019
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation with a registered agent in the district, and therefore "resides" there for purposes of venue statutes.
  • Core Dispute: Plaintiff alleges that Defendant’s use of the Corning HYPERStack cell culture device for contract development and manufacturing services infringes three patents related to methods and devices for efficiently culturing cells using gas permeable materials.
  • Technical Context: The technology concerns devices for growing biological cells in a laboratory setting, a critical process for scientific research, diagnostics, and the commercial production of biopharmaceuticals and gene therapies.
  • Key Procedural History: The complaint does not mention any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history related to the patents-in-suit.

Case Timeline

Date Event
2003-10-08 Priority Date for U.S. Patent No. 9,441,192
2003-10-08 Priority Date for U.S. Patent No. 8,697,443
2006-12-07 Priority Date for U.S. Patent No. 9,732,317
2014-04-15 U.S. Patent No. 8,697,443 Issues
2016-09-13 U.S. Patent No. 9,441,192 Issues
2017-08-15 U.S. Patent No. 9,732,317 Issues
2018-07-01 Date of Brammer Bio presentation allegedly listing the HYPERStack as part of its platform
2019-12-20 Complaint Filed

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

U.S. Patent No. 9,441,192 - "Cell culture methods and devices utilizing gas permeable materials"

The Invention Explained

  • Problem Addressed: The patent's background describes conventional cell culture devices, such as flasks, as inefficient because they rely on a gas-liquid interface for oxygenation (Compl. ¶¶ 12-14). This requires keeping the liquid nutrient medium at a very shallow depth (e.g., 2-3 mm), which wastes the majority of the flask's volume, necessitates frequent medium changes, and increases labor costs and contamination risks (’192 Patent, col. 2:3-32).
  • The Patented Solution: The invention proposes a method using a cell culture device where at least a portion of the device itself is made of a gas permeable material, allowing cells to receive oxygen from the ambient environment outside the container (’192 Patent, col. 1:19-24). This innovation eliminates the need for a large internal gas "headspace" and, crucially, allows the liquid medium to be maintained at a height "elevated beyond 2.0 cm," far deeper than conventionally practiced, leading to more efficient, scalable, and less labor-intensive cell culturing (Compl. ¶ 18; ’192 Patent, Abstract).
  • Technical Importance: This approach challenged the conventional wisdom that limited medium depth, enabling the design of more compact, high-volume static cell culture devices that could support more cells for longer periods in a given footprint (Compl. ¶ 19).

Key Claims at a Glance

  • The complaint asserts independent claim 1 ('192 Patent, col. 45:57-46:13).
  • Essential elements of claim 1 include:
    • Adding medium and animal cells into a static cell culture device that is not compartmentalized by a semi-permeable membrane.
    • The device is comprised at least in part of a non-porous gas permeable material, and ambient gas is in contact with that material.
    • Placing the device in a suitable cell culture location.
    • Orienting the device so at least a portion of the cells reside upon the gas permeable material.
    • The uppermost location of the medium is elevated beyond 2.0 cm from the lowermost location of the medium.
    • The device is in a state of static cell culture.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 9,732,317 - "Highly efficient gas permeable devices and methods for culturing cells"

The Invention Explained

  • Problem Addressed: The patent addresses the inefficiency of scaling up adherent cell cultures (cells that must attach to a surface to grow) (’317 Patent, col. 13:1-10). Traditional flasks offer limited surface area, and while multi-shelved flasks increase surface area, they still rely on an inefficient gas-liquid interface for each shelf, making the devices bulky and sub-optimal (’317 Patent, col. 13:11-34).
  • The Patented Solution: The invention is a static cell growth apparatus comprising a housing that defines a "plurality of gas permeable shelves" stacked one above the other (’317 Patent, col. 31:7-20). By making the shelves themselves gas permeable, the device eliminates the need for a gas-liquid interface between each layer, allowing the shelves to be stacked more compactly. The invention also describes a manifold to connect the culture spaces for fluid transfer and "projections" to maintain a gas space between the outside of the shelves for oxygenation (’317 Patent, Abstract).
  • Technical Importance: This design allows for a significant increase in cell growth surface area within a given device volume, improving the space efficiency of large-scale adherent cell culture compared to traditional multi-shelved flasks (Compl. ¶ 19).

Key Claims at a Glance

  • The complaint asserts independent claim 6 (’317 Patent, col. 31:7-32).
  • Essential elements of claim 6 include:
    • A static cell growth apparatus comprising a liquid impermeable housing.
    • The housing defining a plurality of gas permeable shelves, each with an inside and outside surface.
    • Each shelf's inside surface having an opposing surface that defines a culture space.
    • The culture spaces are located one above the other when the shelves are in a horizontal position.
    • A manifold that connects the culture spaces.
    • Projections that make contact with the outside surface of each shelf while leaving a portion of that surface in contact with ambient gas.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 8,697,443 - "Cell culture methods and devices utilizing gas permeable materials"

  • Patent Identification: U.S. Patent No. 8,697,443, "Cell culture methods and devices utilizing gas permeable materials", issued April 15, 2014 (Compl. ¶ 24).
  • Technology Synopsis: The patent describes a method for culturing cells in a device containing at least two growth surfaces ("scaffolds") and composed of gas permeable material (’443 Patent, Abstract). The method involves adding enough liquid medium to prevent a gas-liquid interface from forming directly above at least one scaffold, thereby enabling a more compact and efficient multi-layered cell culture system compared to traditional devices that require headspace for each layer (’443 Patent, col. 45:4-13).
  • Asserted Claims: Independent claim 26 (Compl. ¶ 25).
  • Accused Features: The complaint alleges infringement through the use of the Corning HYPERStack device, identifying its multiple shelves as the claimed "scaffolds" and its fluid handling system as the "access port." The infringement theory focuses on the method of adding sufficient liquid medium to fill the spaces between the shelves, thereby preventing the formation of a gas-liquid interface above each growth surface (Compl. ¶ 30, pp. 14-15).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the use of the Corning HYPERStack cell culture device by Brammer Bio (Compl. ¶ 27).

Functionality and Market Context

  • The complaint alleges that Brammer Bio is a contract development and manufacturing organization (CDMO) that uses the HYPERStack device as a "flat stock" platform to develop cell culture processes and to grow cells and viral vectors for clients, particularly in the field of gene therapy (Compl. ¶¶ 26-27). The HYPERStack is described as a "multiple-shelf device that uses gas-permeable material to oxygenate cells" and is filled with liquid medium during use (Compl. ¶ 27). The complaint references a diagram showing the HYPERStack's layered structure, consisting of a "Gas Permeable Layer" upon which cells reside, a "Growth Media" layer, an opposing "Plastic Layer," and an "Air Space" below the gas permeable layer for gas exchange (Compl. ¶ 28, p. 11).
  • The complaint alleges the HYPERStack is part of Brammer Bio's "Full-range of production platforms" and is used as an "upstream manufacturing platform for anchorage dependent cells" (Compl. ¶ 26).

IV. Analysis of Infringement Allegations

‘192 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
adding medium and animal cells into a static cell culture device In use, medium and animal cells are added to the HYPERStack, which is a static cell culture device. ¶28, p. 10 col. 22:50-54
that is not compartmentalized by a semi-permeable membrane, The HYPERStack does not have a semi-permeable membrane. ¶28, p. 10 col. 18:60-63
at least a portion of said cell culture device is comprised at least in part of a nonporous gas permeable material, The HYPERStack vessels function via a gas permeable material that allows gas exchange. The complaint provides a diagram identifying a "Gas Permeable Layer." ¶28, p. 10-11 col. 22:21-27
wherein said cell culture device is oriented in a position such that at least a portion of said cells reside upon at least a portion of said gas permeable material, The HYPERStack is placed in an incubator such that at least some cells reside on the gas permeable material. The complaint includes a diagram showing cells residing on the gas permeable layer. ¶28, p. 11 col. 22:10-15
the uppermost location of said medium is elevated beyond 2.0 cm from the lowermost location of said medium, The uppermost location of the medium is alleged to be elevated more than 2.0 cm from the lowermost location, with the complaint stating this "can be seen in the picture above, from which the dimensions of the device filled with medium can be appreciated." ¶28, p. 11 col. 23:42-44
and said device is in a state of static cell culture. The HYPERStack is cultured in a static state. ¶28, p. 11 col. 1:52-54
  • Identified Points of Contention:
    • Evidentiary Question: What evidence does the complaint provide to support the quantitative limitation that the medium is "elevated beyond 2.0 cm"? The allegation relies on a reader's ability to "appreciate" the dimensions from a product photograph, which may become a point of factual dispute regarding whether the accused method meets this claim element (Compl. ¶ 28, p. 11).
    • Scope Questions: Does Brammer Bio's "use" of the HYPERStack constitute performing all steps of the claimed method? The claim is a method claim, and the analysis will require showing that the defendant's actions meet each step of the process.

‘317 Patent Infringement Allegations

Claim Element (from Independent Claim 6) Alleged Infringing Functionality Complaint Citation Patent Citation
a static cell growth apparatus comprising: a liquid impermeable housing, the inside of which is able to contain cells and medium and the outside of which is in contact with ambient gas; The HYPERStack is a static apparatus with a liquid impermeable housing that contains cells and medium. Its exterior is in contact with ambient gas via "air spaces...beneath each culture chamber." ¶29, p. 12 col. 3:55-57
the housing defining a plurality of gas permeable shelves, each having an inside surface and an outside surface; The HYPERStack housing contains multiple gas permeable shelves. The complaint provides a diagram showing a "Gas Permeable Layer" which functions as a shelf. ¶29, p. 12 col. 30:8-10
the inside surface of each shelf having an opposing surface located a distance away and defining a culture space; The inside surface of the gas permeable shelf has an opposing "plastic layer," with a culture space in between for the growth media and cells. ¶29, p. 12 col. 30:11-14
a manifold that connects the culture spaces; A "Liquid Manifold" is alleged to connect each of the layers within the HYPERStack module to allow for a single fluid manipulation. ¶29, p. 13 col. 30:35-37
projections that make contact with the outside surface of each shelf while leaving a portion of the outside surface in contact with ambient gas. The complaint alleges that projections make contact with the outside of each shelf, and provides a photograph purporting to demonstrate the resulting gas space. ¶29, p. 13 col. 25:52-60
  • Identified Points of Contention:
    • Scope Questions: The complaint's evidence for "projections" is a photograph showing paper inserted into a space, demonstrating that a gas space exists (Compl. ¶ 29, p. 13). A central question may be whether the structural features of the HYPERStack that create this space meet the definition of "projections" as understood in the context of the patent, or if they are merely integral contours of the molded shelves.
    • Technical Questions: Does the "Liquid Manifold" of the HYPERStack function as the "manifold that connects the culture spaces" as required by the claim? The analysis may focus on the specific structure and fluidic connection provided by the accused manifold compared to the teachings in the patent.

V. Key Claim Terms for Construction

The Term: "the uppermost location of said medium is elevated beyond 2.0 cm from the lowermost location of said medium" (’192 Patent, Claim 1)

  • Context and Importance: This quantitative limitation is a core element distinguishing the claimed method from prior art that taught very shallow medium depths. The infringement analysis for the ’192 Patent will depend heavily on whether the accused use of the HYPERStack can be proven to meet this specific height requirement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent repeatedly emphasizes moving beyond the conventional 2-3 mm depth, suggesting the key inventive step is the principle of using much deeper medium, not a precise numerical threshold. The specification describes embodiments and results with medium heights of 3.2 cm, 5.6 cm, and up to 20.4 cm, demonstrating the invention is not limited to heights just "beyond 2.0 cm" (’192 Patent, col. 33:46-51).
    • Evidence for a Narrower Interpretation: The claim language recites an explicit numerical threshold ("beyond 2.0 cm"). The patent also states in the summary that an object is to provide devices that "will allow medium to reside at a height of at least 2.0 cm." (’192 Patent, col. 23:42-44). A defendant may argue this establishes 2.0 cm as a clear, required boundary for the claimed method.

The Term: "projections" (’317 Patent, Claim 6)

  • Context and Importance: This term defines the structure responsible for maintaining the critical gas space for oxygenation between the stacked shelves. Whether the structural features of the HYPERStack meet this definition is a likely point of dispute. Practitioners may focus on this term because the complaint's visual evidence suggests these features might be integral parts of the shelf molding rather than distinct add-on components (Compl. ¶ 29, p. 13).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the function of these structures as maintaining a gas space and keeping the shelves substantially horizontal, without narrowly defining their form. It describes a "culture compartment support" that "resides between culture compartments" and can be in the form of "external projections," suggesting a functional rather than a strictly structural definition (’317 Patent, col. 7:38-46).
    • Evidence for a Narrower Interpretation: The patent figures illustrate potential embodiments of supports as distinct structures, such as spacers (Fig. 9B, item 135) or feet (Fig. 9A, item 95A), which could be argued to be different from integral molded ridges or bumps. A defendant may argue that "projections" implies structures that extend out from a baseline surface, rather than being part of the overall shape of the shelf itself.

VI. Other Allegations

  • Indirect Infringement: The prayer for relief seeks an injunction against inducing and contributing to infringement (Compl. p. 17, ¶ 3). However, the complaint's single count for infringement focuses exclusively on allegations of direct infringement by the Defendant (Compl. ¶¶ 33-36). The complaint does not plead specific facts to support the knowledge and intent elements required for claims of induced or contributory infringement.

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

  • A central issue will be one of evidentiary proof: Can Plaintiff produce sufficient factual evidence, beyond a photograph from which dimensions "can be appreciated," to demonstrate that Defendant's use of the HYPERStack meets the quantitative "elevated beyond 2.0 cm" medium height limitation of the ’192 patent?
  • A key question will be one of claim construction: Can the term "projections," as used in the ’317 patent, be construed to cover the integral molded features of the accused HYPERStack shelves that create a gas space, or does the patent require more distinct, separate structures?
  • The case may also turn on a question of technical infringement: Does the accused HYPERStack device, with its multi-layered, gas-permeable design and liquid manifold, embody the specific structural and functional elements of the "plurality of gas permeable shelves," "manifold," and "projections" as claimed in the apparatus of the ’317 patent?