DCT
1:18-cv-00303
WH Wall Family Holdings v. Celonova Biosciences Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: W. H. WALL FAMILY HOLDINGS, LLLP (Georgia)
- Defendant: Celonova Biosciences, Inc. (Delaware)
- Plaintiff’s Counsel: Munsch Hardt Kopf & Harr, P.C.
- Case Identification: 1:18-cv-00303, W.D. Tex., 01/22/2019
- Venue Allegations: Plaintiff alleges venue is proper in the Western District of Texas because Defendant has a regular and established place of business in San Antonio and has committed acts of infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s COBRA PzF NanoCoated Coronary Stent System infringes a patent related to angioplasty stents designed to prevent arterial restenosis.
- Technical Context: The technology involves implantable medical devices known as stents, which provide a mechanical scaffold to hold a blood vessel open following an angioplasty procedure.
- Key Procedural History: The complaint notes that prosecution of the asserted patent was delayed due to "litigation and appeal of an interference action" and the application being misplaced by the USPTO. The complaint also alleges Defendant had pre-suit knowledge of the patent via a notice letter dated October 26, 2017.
Case Timeline
| Date | Event |
|---|---|
| 1984-10-15 | Alleged conception date of the invention |
| 1987-12-08 | '475 Patent priority date (filing date) |
| 2005-12-13 | '475 Patent issue date |
| 2012-12-01 | Defendant received CE Mark for Accused Product (approx. date) |
| 2017-02-21 | Defendant received FDA approval for Accused Product in the U.S. |
| 2017-10-26 | Plaintiff sent notice letter to Defendant regarding the '475 Patent |
| 2019-01-22 | First Amended Complaint filing date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,974,475 - "Angioplasty Stent," issued December 13, 2005.
The Invention Explained
- Problem Addressed: The patent addresses the problem of restenosis, where an artery narrows again after a balloon angioplasty procedure, requiring the procedure to be repeated (’475 Patent, col. 1:8-10). The patent also notes that prior art stents, often made of woven wire, lacked longitudinal flexibility, limiting their use to straight sections of vessels (’475 Patent, col. 1:28-30).
- The Patented Solution: The invention is a prosthesis, or stent, designed to be placed in a blood vessel to mechanically maintain an opening (’475 Patent, col. 1:36-41). It is described as a "sleeve" that can be delivered in a collapsed state via a catheter and then expanded at the target site. The patent discloses that the sleeve walls should have openings to promote tissue growth ("epithelialization"), which helps embed and secure the stent in the vessel wall (’475 Patent, Abstract; col. 3:55-59).
- Technical Importance: The technology provides a mechanical support to counteract the arterial wall's tendency to collapse or narrow after angioplasty, a common clinical problem (’475 Patent, col. 1:4-10).
Key Claims at a Glance
- The complaint asserts independent method claim 30 (’475 Patent, col. 9:46-67).
- The essential elements of Claim 30 are:
- providing a sleeve formed in a mesh and a coating applied to the mesh
- the sleeve defining a plurality of openings for tissue growth
- providing a catheter
- mounting the sleeve in a collapsed position on the catheter
- inserting the catheter and sleeve into a lumen of the body
- carrying the sleeve to a target position
- radially expanding the sleeve at the position
- radially expanding the lumen in response
- withdrawing the catheter
- promoting epithelialization of the lumen about the sleeve
- retarding re-stenosis of the lumen with the sleeve
- The complaint reserves the right to assert other claims, but does not specify them (Compl. ¶14, ¶21).
III. The Accused Instrumentality
Product Identification
- The COBRA PzF NanoCoated Coronary Stent System (“Accused Product”) (Compl. ¶15).
Functionality and Market Context
- The Accused Product is a stent system intended for use in percutaneous transluminal coronary angioplasty (Compl. ¶16). It is described as a sleeve formed in a mesh made from cobalt chromium alloy (Compl. ¶17). A key feature is its "Polyzene-F nanocoating" (Compl. ¶17). The complaint includes a diagram specifying the stent's strut material and the nanocoating's thickness (Compl. p. 7). This diagram, sourced by the Plaintiff, indicates the cobalt chromium alloy struts are 71 µm thick and coated with a Polyzene-F layer of ≤0.05 µm (Compl. p. 7). The product is deployed via a catheter, expanded in the artery, and left in place after the catheter is withdrawn, where it allegedly "promotes epithelialization and retards re-stenosis" (Compl. ¶18).
- The complaint alleges the product received a CE Mark for distribution outside the U.S. in December 2012 and FDA approval for U.S. distribution on February 21, 2017 (Compl. ¶20).
IV. Analysis of Infringement Allegations
'475 Patent Infringement Allegations
| Claim Element (from Independent Claim 30) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| providing a sleeve formed in a mesh and a coating applied to said mesh and defining a plurality of openings throughout the mesh to allow tissue to grow there through | The Accused Product is a sleeve formed in a mesh of cobalt chromium alloy, coated with Polyzene-F nanocoating, and contains openings for tissue growth. | ¶17 | col. 3:37-59 |
| providing a catheter | The Accused Product is deployed using a catheter. | ¶18 | col. 2:48-55 |
| mounting the sleeve in a radially collapsed position on the catheter | The Accused Product is mounted in a radially collapsed position on the catheter for delivery. | ¶18 | col. 4:6-15 |
| inserting the catheter with the collapsed sleeve mounted thereon into a lumen of the body, carrying the sleeve in its collapsed position with the catheter along the length of the lumen to a position in the lumen where the minimum opening in the lumen is to be maintained | The catheter with the collapsed stent is inserted into the artery and advanced to the location where it is to be expanded. | ¶18 | col. 2:56-61 |
| radially expanding the sleeve in the position of the lumen where the minimum opening in the lumen is to be maintained | The Accused Product is expanded at the appropriate location within the artery. | ¶18 | col. 2:61-65 |
| radially expanding the lumen in response to the radial expansion of the sleeve | After the Accused Product has been expanded in the artery, the catheter is withdrawn. The expansion of the stent expands the lumen. | ¶18 | col. 2:61-65 |
| withdrawing the catheter from the sleeve and from the lumen | After the Accused Product has been expanded in the artery, the catheter is withdrawn. | ¶18 | col. 1:11-13 |
| promoting epithelialization of the lumen about the sleeve and its openings for incorporating the sleeve into the lumen, and | The Accused Product allegedly promotes epithelialization. | ¶18 | col. 3:57-59 |
| retarding re-stenosis of the lumen with the sleeve | The Accused Product allegedly retards re-stenosis of the artery. | ¶18 | col. 1:36-41 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether the term "coating" as described in the patent (e.g., a "plastic material" covering a "woven network") can be read to encompass the "Polyzene-F nanocoating" of the Accused Product. The significant difference in scale (a bulk plastic coating vs. a nanocoating) may be a focus of dispute.
- Technical Questions: Claim 30 includes the functional limitation "promoting epithelialization." The complaint makes a conclusory allegation that the Accused Product performs this function (Compl. ¶18). A key evidentiary question will be what proof exists that the Accused Product’s design, particularly its openings and nanocoating, actually performs this specific biological function as contemplated by the patent.
V. Key Claim Terms for Construction
The Term: "coating"
Context and Importance: This term is critical because the Accused Product's primary distinguishing feature is its "Polyzene-F nanocoating." The dispute will likely center on whether this nanocoating is equivalent to the "coating" described in the patent.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims do not specify the thickness or type of coating, only that it is "applied to said mesh." A party might argue that "coating" should be given its plain and ordinary meaning, which would not exclude a coating at the nanoscale.
- Evidence for a Narrower Interpretation: The specification discusses the coating in the context of a "plastic material" (e.g., polyethylene, polyester) that covers a "woven network" or "filaments" (’475 Patent, col. 3:48-52). A party could argue that this context limits the term "coating" to a bulk material that encapsulates the mesh structure, as depicted in Figure 5, rather than a surface treatment at the nano-level.
The Term: "promoting epithelialization"
Context and Importance: This is a functional limitation that describes a desired biological outcome. Practitioners may focus on this term because infringement will depend on whether the Accused Product is proven to achieve this specific result, not merely that it has openings.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not define a specific mechanism or required level of epithelialization. A party could argue that any design that facilitates tissue ingrowth through the stent's openings meets this limitation.
- Evidence for a Narrower Interpretation: The patent links this function directly to the "plurality of openings" that "promotes epithelialization to promote incorporation of the stent into the vessel wall" (’475 Patent, col. 3:57-59). A party might argue that this requires proof that the openings themselves are the primary driver of this effect, and that the function must rise to the level of "incorporation" into the vessel wall.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement and contribution (Compl. ¶21). The factual basis for inducement appears to be that Defendant sells the Accused Product, which is "intended for use" in a patented method (Compl. ¶16), thereby encouraging surgeons to perform the infringing steps. The basis for contributory infringement is an allegation that the Accused Products "have no suitable non-infringing use" (Compl. ¶22).
- Willful Infringement: Willfulness is alleged based on Defendant having knowledge of the ’475 Patent "at least since Wall informed it of the ’475 Patent through a letter dated October 26, 2017" (Compl. ¶23). This allegation covers conduct occurring after this date.
VII. Analyst’s Conclusion: Key Questions for the Case
A core issue will be one of definitional scope: can the term "coating," which the patent specification describes as a "plastic material" covering a mesh, be construed to read on the "nanocoating" of the Accused Product, or does the patent's disclosure implicitly limit the term to a bulk material?
A key evidentiary question will be one of proving function: what evidence will be required to demonstrate that the Accused Product's design actually performs the claimed function of "promoting epithelialization," and does this function occur in the manner described by the patent?
The case may also raise a prosecution history estoppel question, given the complaint’s reference to an "interference action" during the patent’s long prosecution (’475 Patent, Compl. ¶10). The arguments and claim amendments made during that proceeding, if any, could be relevant to the scope of the asserted claims.