DCT
0:20-cv-00700
Corning Inc v. Wilson Wolf Mfg Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Corning Incorporated (New York)
- Defendant: Wilson Wolf Manufacturing Corporation and John R. Wilson (Minnesota)
- Plaintiff’s Counsel: Fredrikson and Byron, P.A. (with Winston & Strawn LLP and Barnes & Thornburg LLP Of Counsel)
- Case Identification: 0:20-cv-00700, D. Minn., 02/19/2021
- Venue Allegations: Plaintiff alleges venue is proper in the District of Minnesota because Defendant Wilson Wolf resides in the district and a substantial part of the events giving rise to the action occurred there.
- Core Dispute: Plaintiff Corning seeks a declaratory judgment that its HYPERStack® cell culture products do not infringe Defendants’ patents, and that those patents are invalid and unenforceable due to inequitable conduct before the U.S. Patent and Trademark Office and claim preclusion from prior litigation.
- Technical Context: The technology relates to devices for culturing cells in vitro, a foundational process in biopharmaceutical research and manufacturing for producing therapeutics like gene therapies.
- Key Procedural History: The complaint alleges an extensive and contentious history between the parties. This includes a prior Minnesota litigation where infringement claims on related Wilson Wolf patents (’426 and ’427 Patents) were dismissed with prejudice. It also references a PTAB interference proceeding where a related Wilson Wolf patent (’044 Patent) was invalidated. Based on these events and alleged misconduct during patent prosecution, the complaint asserts claims of unenforceability, invalidity, and claim preclusion.
Case Timeline
| Date | Event |
|---|---|
| 2003-10-08 | Priority Date: U.S. Provisional Application No. 60/509,651 (’192 and ’443 Patents) |
| 2006-12-07 | Priority Date: U.S. Provisional Application No. 60/873,347 (’317 Patent) |
| 2013-01-01 | Wilson Wolf sues Corning in the "Minnesota Litigation" over related patents (approx. date) |
| 2014-04-15 | Issue Date: U.S. Patent No. 8,697,443 |
| 2015-03-17 | Minnesota District Court dismisses Wilson Wolf's patent infringement claims with prejudice |
| 2016-09-13 | Issue Date: U.S. Patent No. 9,441,192 |
| 2017-08-15 | Issue Date: U.S. Patent No. 9,732,317 |
| 2019-12-20 | Wilson Wolf sues Corning customers Brammer Bio and Sarepta for patent infringement |
| 2020-01-13 | Wilson Wolf sues Corning customer Children's Hospital for patent infringement |
| 2021-02-19 | Complaint Filing Date |
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 describes limitations in conventional cell culture devices, which rely on a gas/liquid interface for oxygenation. This limits the height of the culture medium to about 3 mm, creating inefficiencies in labor, space, and cost, and increasing contamination risk during frequent media exchanges (’192 Patent, col. 1:19-2:18).
- The Patented Solution: The invention proposes using gas-permeable materials for the device housing itself, which eliminates the sole reliance on a gas/liquid interface and allows for an increased height of the culture medium (’192 Patent, col. 3:9-14). This approach is intended to permit more cells to be cultured in a device of the same footprint and to reduce handling frequency (’192 Patent, col. 3:15-20). Figure 5 illustrates a static culture vessel with a lower gas-permeable membrane and a significant medium height.
- Technical Importance: By enabling greater medium height and volume in a static culture device, the invention aims to improve the efficiency and scalability of cell culture processes beyond what was possible with traditional flasks and plates.
Key Claims at a Glance
- The complaint’s infringement analysis focuses on independent claim 1 (Compl. Ex. E, pp. 10-11).
- Claim 1 of the ’192 Patent recites a method with the following essential elements:
- A method of culturing cells comprising:
- adding medium and animal cells into a static cell culture device that is not compartmentalized by a semi-permeable membrane;
- at least a portion of the device is comprised of a nonporous gas permeable material;
- ambient gas is in contact with at least a portion of the gas permeable material;
- placing the device in a location with ambient gas suitable for animal cell culture;
- the device is oriented so at least a portion of the cells reside upon the gas permeable material;
- the uppermost location of said medium is elevated beyond 2.0 cm from the lowermost location of said medium;
- the device is in a state of static cell culture.
- The complaint indicates that Wilson Wolf also asserted claims 8, 18, and 25 (Compl. ¶178-179).
U.S. Patent No. 8,697,443 - Cell culture methods and devices utilizing gas permeable materials
The Invention Explained
- Problem Addressed: The ’443 Patent, which shares its specification with the ’192 Patent, addresses the surface area deficiency of traditional flasks for adherent cell culture (’443 Patent, col. 13:5-9). Multi-shelved flasks improve surface area but require a gas/liquid interface for each shelf, making them sub-optimal in efficiency (’443 Patent, col. 13:30-36).
- The Patented Solution: The invention integrates traditional attachment surfaces ("scaffolds") into a gas-permeable device, eliminating the need for a gas/liquid interface and allowing the scaffolds to be stacked more compactly (’443 Patent, col. 14:36-41; col. 28:26-34). This configuration is intended to provide a large surface area for adherent cells in a space-efficient format. Figure 13 shows an embodiment with numerous stacked scaffolds (120D) inside a device with a gas-permeable wall (200) (’443 Patent, col. 30:41-43).
- Technical Importance: This approach seeks to combine the high surface area of multi-layered systems with the improved gas exchange of gas-permeable materials, enabling high-density adherent cell culture in a static, scalable device.
Key Claims at a Glance
- The complaint’s infringement analysis focuses on independent claim 1 (Compl. at 30).
- Claim 1 of the ’443 Patent recites a method with the following essential elements:
- A method of culturing cells in a cell culture device comprised at least in part of a gas permeable material and including at least one access port and including at least two scaffolds, the method comprising:
- adding cells and a volume of liquid medium into said cell culture device;
- orienting said cell culture device into an inoculation position such that said scaffolds reside at different elevations within said cell culture device.
- The complaint also indicates Wilson Wolf asserted claim 26 (Compl. ¶199).
U.S. Patent No. 9,732,317 - Highly efficient gas permeable devices and methods for culturing cells
Technology Synopsis
The ’317 Patent describes cell culture devices with multiple gas-permeable shelves that are vertically stacked (’317 Patent, Abstract). The design aims to create uniform culture conditions across the shelves and improve space efficiency for large-scale cell culture by, for example, using projections to create space for ambient gas to contact each shelf (’317 Patent, col. 2:38-48).
Asserted Claims
Claims 1-9 are referenced in the complaint's invalidity and unenforceability arguments (Compl. ¶¶231-232, 113).
Accused Features
The complaint alleges that Defendants have accused the general use of Corning's HYPERStack® cell culture device by its customers of infringing the ’317 patent (Compl. ¶¶1, 25).
III. The Accused Instrumentality
Product Identification
The Corning HYPERStack® cell culture vessel (Compl. ¶13).
Functionality and Market Context
- The complaint describes the HYPERStack® as an efficient and scalable vessel specifically designed for adherent cell culture applications (Compl. ¶13). A key feature is its use of gas-permeable film technology to provide oxygen to the cells, which eliminates the need for a gas-liquid "headspace" within the culture chamber (Compl. p. 27, claim chart). The device consists of multiple stacked layers ("Stackettes") connected by a liquid manifold, creating a closed system for fluid manipulations (Compl. p. 29, claim chart). The complaint includes a photograph showing a laboratory-scale HYPERStack® unit (Compl. p. 5).
- The complaint alleges the HYPERStack® is used by contract manufacturing organizations and biopharmaceutical companies for developing and commercializing gene therapies (Compl. ¶¶19-22).
IV. Analysis of Infringement Allegations
The following charts summarize allegations made by Defendant Wilson Wolf in lawsuits against Corning's customers, as reproduced in Corning's Declaratory Judgment complaint (Compl. ¶72).
’192 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a method of culturing cells comprising: adding medium and animal cells into a static cell culture device | The HYPERStack is a static device used to culture cells by adding medium and cells. | ¶72; p. 27 | col. 46:40-42 |
| 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 which allows gas exchange to occur. | ¶72; p. 27 | col. 46:45-48 |
| ambient gas is in contact with at least a portion of said gas permeable material, and | The device has air spaces beneath each culture chamber which are open to the atmosphere. | ¶72; p. 27 | col. 46:49-51 |
| 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 cells reside on the gas permeable material. The complaint includes a diagram illustrating cells on a gas permeable layer (Compl. p. 28). | ¶72; p. 28 | col. 46:55-58 |
| the uppermost location of said medium is elevated beyond 2.0 cm from the lowermost location of said medium, | The uppermost location of medium is elevated more than 2.0 cm from the lowermost location. This is allegedly shown in a photograph depicting the HYPERStack device being placed in an incubator (Compl. p. 28). | ¶72; p. 28 | col. 46:52-54 |
’443 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of culturing cells in a cell culture device comprised at least in part of a gas permeable material | The HYPERStack is a cell culture device comprised of gas permeable film. The "Stackette" is the individual cell culture compartment. | ¶72; p. 29 | col. 44:60-62 |
| and including at least one access port and including at least two scaffolds, the method comprising: | The HYPERStack has a liquid handling tubing port and at least two scaffolds (the "Stackette" layers). | ¶72; p. 29 | col. 44:63-65 |
| b) orienting said cell culture device into an inoculation position such that said scaffolds reside at different elevations within said cell culture device. | The device is oriented so the scaffolds reside one above the other. A diagram illustrates the layered structure (Compl. p. 29). | ¶72; p. 29 | col. 45:3-6 |
| a manifold that connects the culture spaces | A Liquid Manifold connects each of the stackette layers together within a HYPERStack module. | ¶72; p. 30 | col. 45:12-13 |
Identified Points of Contention
- Scope Questions: The complaint raises the question of whether the term "scaffolds" as used in the ’443 Patent reads on the gas-permeable film layers of the HYPERStack® (Compl. ¶199). Corning also disputes that its device meets the "not compartmentalized by a semi-permeable membrane" limitation of the ’192 Patent (Compl. ¶178).
- Technical Questions: A central dispute concerns the ’192 Patent's requirement that the medium be "elevated beyond 2.0 cm". Corning alleges its HYPERStack® device does not meet this limitation (Compl. ¶179). The complaint further suggests a potential mismatch by noting that the patent's exemplary figures (e.g., Fig. 5, Fig. 13) depict devices for suspension or adherent cells, respectively, while the accused HYPERStack® is specifically designed for adherent cells (Compl. ¶¶67, 70), raising the question of whether the patented methods apply to the accused product's distinct application.
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
Corning alleges non-infringement based on its device not meeting this limitation (Compl. ¶179). The definition of how to measure the "uppermost" and "lowermost" locations of the medium in a multi-layered device like the HYPERStack® will be critical to the infringement analysis. Practitioners may focus on this term because the patent's own examples are alleged to show how this height can be satisfied even when scaffolding interrupts the medium (Compl. ¶71).
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification describes a general goal of allowing "an increased height of cell culture medium" to improve efficiency, without limiting how that height is measured in a complex geometry (’192 Patent, col. 1:13-15). The patent also states that in a preferred embodiment, walls should be capable of allowing medium to reside at a height that exceeds that of typical static gas permeable devices, preferably beyond 2.0 cm (’192 Patent, col. 23:40-44).
- Evidence for a Narrower Interpretation: Figure 5, which the complaint identifies as an example satisfying the height requirement, depicts a simple container with an uninterrupted column of liquid medium (Compl. ¶66). This could support an argument that the measurement is intended for a single, continuous body of medium, which may not be present in the multi-layered HYPERStack®.
The Term: "scaffolds" (’443 Patent, Claim 1)
Context and Importance
Corning's non-infringement defense to the ’443 patent is based on its position that the HYPERStack® does not contain "at least two 'scaffolds'" (Compl. ¶199). The case may turn on whether the thin, gas-permeable films that form the layers of the HYPERStack® qualify as "scaffolds" under the patent's definition.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The term "scaffold" is used generally in the specification to refer to structures that provide a surface for cell attachment in three-dimensional culture systems. The patent states the invention integrates "traditional cell support scaffolds" (’443 Patent, col. 1:20).
- Evidence for a Narrower Interpretation: The specification provides a specific example, stating, "In the preferred embodiment, scaffolds 120D have identical material characteristics as those present in traditional tissue culture flasks" (’443 Patent, col. 30:44-46). This could support a narrower construction limiting "scaffolds" to thicker, more rigid structures like polystyrene shelves, potentially excluding the thin films of the HYPERStack®.
VI. Other Allegations
The complaint does not allege indirect or willful infringement by Defendants. Instead, it contains extensive allegations of inequitable conduct by Defendants during the prosecution of the patents-in-suit, which, if proven, could render the patents unenforceable.
- Withholding of Material Information: The complaint alleges that Defendants, during prosecution, possessed but failed to disclose to the PTO test data showing that their invention's purported benefits (e.g., increased medium height) did not apply to, or were detrimental to, the culturing of adherent cells—the very type for which the accused HYPERStack® is designed (Compl. ¶¶76-77, 86).
- Misleading Declarations: The complaint alleges that to overcome a rejection, Defendants submitted a declaration from an expert, Dr. Juan Vera, attesting to the "unexpected results" of the invention, without disclosing to the PTO that Dr. Vera was a paid consultant and collaborator, creating a strong potential for bias (Compl. ¶¶97, 100).
- Failure to Disclose Concurrent Litigation: The complaint alleges that during the prosecution of the application leading to the ’317 patent, Defendants and their attorneys failed to disclose to the patent examiner the existence of a contemporaneous and highly relevant PTAB interference proceeding (the "Corning-Wilson Interference") where the validity of a closely related patent was being challenged with material prior art (Compl. ¶¶119-120, 140).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of enforceability: Did Defendants engage in inequitable conduct by allegedly withholding unfavorable experimental data regarding adherent cells, failing to disclose the paid status of a declarant, and failing to disclose material, concurrent PTAB proceedings to the patent examiner?
- A second issue will be one of definitional scope: Can the term "scaffolds", described in the patent with reference to "traditional tissue culture flasks," be construed to cover the thin, gas-permeable films of the accused HYPERStack®? Similarly, how is the "2.0 cm" medium height limitation of the ’192 patent measured in a multi-layered device where the liquid medium is not a single, uninterrupted column?
- A third issue will be one of preclusion: Does the prior dismissal with prejudice of infringement claims against Corning on related Wilson Wolf patents bar the current infringement suits against Corning's customers under the doctrines of claim preclusion or the Kessler doctrine? This will depend on whether the claims of the patents-in-suit are found to be "patentably indistinct" from those of the previously litigated patents.