DCT
1:19-cv-01092
Rex Medical LP v. Covidien LP
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Rex Medical, LP. (Pennsylvania)
- Defendant: Medtronic, PLC (Ireland) and Covidien, LP (Delaware)
- Plaintiff’s Counsel: Farnan LLP
- Case Identification: 1:19-cv-01092, D. Del., 06/13/2019
- Venue Allegations: Venue is alleged to be proper as Defendant Medtronic is a foreign corporation subject to suit in any judicial district, and Defendant Covidien is a Delaware limited partnership residing in the district.
- Core Dispute: Plaintiff alleges that Defendants’ Endo GIA™ line of surgical staplers infringes two patents related to apparatus and methods for resecting and stapling tissue.
- Technical Context: The technology concerns surgical stapling devices used in minimally invasive procedures, a critical segment of the medical device market focused on reducing patient trauma and recovery time.
- Key Procedural History: The complaint alleges Defendants had pre-suit knowledge of the ’650 Patent via notice letters sent in September and November 2016. Notably, after the complaint was filed, U.S. Patent No. 9,439,650 was subject to an Inter Partes Review (IPR2020-00152), which concluded with the U.S. Patent and Trademark Office confirming the patentability of all asserted dependent claims (6, 19, and 21) but cancelling the underlying independent claims on which they depend (claims 4 and 13).
Case Timeline
| Date | Event |
|---|---|
| 2001-01-31 | Priority Date for ’650 and ’892 Patents |
| 2011-01-01 | Accused Endo GIA™ Curved Tip & Black Reloads Introduced (approx.) |
| 2012-01-01 | Accused Endo GIA™ 30mm & Radial Reloads Introduced (approx.) |
| 2014-01-01 | Accused Endo GIA™ Reinforced Reload Introduced (approx.) |
| 2016-09-13 | ’650 Patent Issued |
| 2016-09-13 | Plaintiff provides notice of ’650 Patent to Defendant Covidien |
| 2016-11-16 | Plaintiff provides notice of ’650 Patent to Defendant Medtronic |
| 2018-11-27 | ’892 Patent Issued |
| 2019-06-13 | Complaint Filed |
| 2019-11-19 | IPR filed against ’650 Patent |
| 2022-05-10 | IPR Certificate issued for ’650 Patent |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,439,650 - "Apparatus and Method for Resectioning Gastro-Esophageal Tissue"
- Issued: September 13, 2016.
The Invention Explained
- Problem Addressed: The patent describes the challenge in surgical resections (the removal of tissue) of needing to simultaneously cut the targeted tissue while also sealing the remaining tissue to prevent it from being left open and exposed (Compl. ¶25). Prior endoscopic staplers offered a limited range of motion, complicating such procedures ('650 Patent, col. 1:40-45).
- The Patented Solution: The invention is a surgical stapling apparatus, often used with an endoscope, featuring a pair of movable jaws for clamping tissue. One jaw holds staples and the other acts as an anvil to form them. A central inventive concept is a "beam" that engages both jaws "from within" to maintain their alignment and spacing as it travels from the proximal to the distal end, pushing and firing staples along the way ('650 Patent, col. 8:30-37; Compl. ¶66). This design enables simultaneous cutting and stapling in a single motion.
- Technical Importance: This technology aims to improve the efficiency and safety of minimally invasive surgeries by combining the cutting and sealing steps into a single, controlled action (Compl. ¶27).
Key Claims at a Glance
- The complaint asserts dependent claims 6, 19, and 21 (Compl. ¶64).
- Asserted claim 6 depends from independent claim 4, which claims an apparatus with:
- A first and second movable jaw.
- A staple carrying portion with slots on the first jaw and an anvil surface on the second.
- A gear or cable to move the jaws into alignment.
- A staple pusher to move staples from the cartridge.
- A "beam" configured to engage the jaws "from within" to maintain alignment and distance while tissue is stapled.
- Asserted claims 19 and 21 depend from independent claim 13, which claims an apparatus with:
- A head portion with first and second jaws.
- The first jaw defining a cavity for staples and slots.
- A "beam" with end portions connected by a central web, configured to clamp and align the jaws "from therewithin" as it moves distally along a channel.
- A control handle and a shaft coupling the handle to the head.
U.S. Patent No. 10,136,892 - "Apparatus and Method for Resectioning Gastro-Esophageal Tissue"
- Issued: November 27, 2018.
The Invention Explained
- Problem Addressed: Similar to its parent '650 Patent, the '892 Patent addresses the need for precise, multi-function tools for minimally invasive resections ('892 Patent, col. 1:32-35).
- The Patented Solution: The patent describes a more structurally defined stapling apparatus. It explicitly claims a "first adjustment assembly" for "gross movement" of the jaws and a "second adjustment assembly" including a "beam" for "fine movement" to maintain a fixed distance ('892 Patent, col. 7:60-67). The beam is detailed as having a central web with a cutting blade and upper/lower portions, where at least one portion is a "generally flat plate orthogonally attached" to the web, and the entire assembly is "coplanar" with a channel in the jaws ('892 Patent, col. 8:13-24).
- Technical Importance: This invention provides a refined mechanical framework for a surgical stapler that integrates clamping, stapling, and cutting functions with a high degree of structural specificity, intended for precise endoscopic use (Compl. ¶27-¶29).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 5 (Compl. ¶103).
- Independent Claim 1 elements include:
- A head with movable first and second jaws.
- A "first adjustment assembly" for "gross movement".
- A "second adjustment assembly" with a "beam" for "fine movement".
- The beam has a central web with a cutting blade and is coupled to a pusher.
- At least one beam portion is a "generally flat plate orthogonally attached" to the web and engages a jaw "entirely from within".
- The pusher and web are "coplanar" with a channel in the jaws.
- Independent Claim 5 elements include:
- A head portion with movable jaws.
- A "beam" with upper/lower portions, a central web, and a cutting blade on its leading edge.
- The beam is configured to clamp and align the jaws "at least partially from within".
- A pusher is operatively coupled to the beam.
- At least one beam portion is "orthogonally attached" to the web, and the pusher is "coplanar" with the web and the channel.
III. The Accused Instrumentality
Product Identification
- The complaint identifies Defendants’ "Endo GIA™" brand of surgical stapling devices, including the Endo GIA™ 30 mm Reload, Curved Tip Reload, Black Reload, Radial Reload, and Reinforced Reload, all featuring "Tri-Staple™ Technology" (Compl. ¶39, ¶59). These reloadable cartridges are used with stapling systems like the Signia™ and iDrive™ (Compl. ¶40). The "30 mm Product" is presented as a representative example of the "Accused Products" (Compl. ¶61).
Functionality and Market Context
- The Accused Products are described as surgical tissue stapling devices for use in both minimally invasive and open resection surgeries (Compl. ¶43, ¶57). The complaint alleges they are used to simultaneously cut and staple tissue (Compl. ¶27).
- A key technical feature highlighted in Defendants’ own marketing materials and cited in the complaint is the "stronger fixed anvil and I-beam incorporated into" the staplers (Compl. ¶76). This "I-beam" is central to the infringement allegations. The complaint provides a still from a marketing video showing the "Stronger I-Beam Profile" of the accused device (Compl. p. 24, ¶77).
IV. Analysis of Infringement Allegations
’650 Patent Infringement Allegations
(based on representative independent claim 4)
| Claim Element (from Independent Claim 4) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a first jaw and a second jaw, at least one of the first jaw and the second jaw being movable with respect to the other... | The accused 30 mm Product has two jaws, at least one of which is movable to clamp tissue. A complaint visual shows the jaws in open and closed positions. (Compl. p. 15, ¶71) | ¶71 | col. 3:5-15 |
| a staple carrying portion of the first jaw defining slots through which staples are configured to pass; | The first jaw of the accused product contains a staple-carrying portion with slots for staples. The complaint includes a close-up image showing these slots. (Compl. p. 17) | ¶72 | col. 3:5-7 |
| an anvil surface defined on the second jaw opposing the first jaw; | The second jaw of the accused product has an opposing anvil surface to form the staples. A marketing image labels this the "SLIMMER FIXED ANVIL." (Compl. p. 18, ¶73) | ¶73 | col. 3:7-8 |
| a beam configured to engage the first and second jaws from within the first and second jaws while tissue is stapled... | The accused product's advertised "I-beam" is alleged to engage channels within both jaws to maintain alignment and distance during firing. A complaint visual illustrates this engagement. (Compl. p. 24, ¶77) | ¶76-77 | col. 8:30-37 |
’892 Patent Infringement Allegations
(based on representative independent claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a first adjustment assembly configured for gross movement of the first jaw or the second jaw; | The complaint alleges the accused product has an assembly for gross jaw movement, showing images of the device being positioned on tissue. (Compl. p. 44, ¶109) | ¶109 | col. 7:60-61 |
| a second adjustment assembly including a beam configured for fine movement...wherein the beam...includes a central web portion including a cutting blade... | The accused product’s "I-beam" is alleged to be this second assembly, providing fine movement and including a cutting blade. A graphic shows the "Stronger I-Beam Profile." (Compl. p. 44, ¶110) | ¶110-111 | col. 7:62-67 |
| a handle having one or more actuators configured to move at least one of the first jaw...and to actuate the stapling assembly; | The accused stapling systems include a handle with actuators for clamping and firing. The complaint shows images of the handle. (Compl. p. 48, ¶113) | ¶113 | col. 8:7-12 |
| at least one of the upper beam portion and the lower beam portion is a generally flat plate orthogonally attached to an end of the central web portion... | The complaint alleges the I-beam has this structure, providing a marketing image with highlighting to show the orthogonal plates. (Compl. p. 50, ¶115) | ¶115 | col. 8:13-19 |
| the pusher and the central web portion are coplanar with a channel defined in a tissue contacting surface of each of the first jaw and the second jaw... | The I-beam is alleged to travel within a channel in the jaws, coplanar with the pusher. A visual from a marketing video shows the beam moving within this channel. (Compl. p. 51, ¶116) | ¶116 | col. 8:20-24 |
- Identified Points of Contention:
- Scope Questions: A central dispute may revolve around whether the accused product's single "I-beam" mechanism can satisfy the '892 Patent's requirement for two distinct assemblies: a "first adjustment assembly" for "gross movement" and a "second" for "fine movement." The defense could argue the accused device does not have two structurally separate assemblies as claimed.
- Technical Questions: The complaint relies heavily on marketing animations. A technical question is whether these animations accurately depict the mechanical interactions required by the claims. For instance, what evidence demonstrates that the accused beam engages the jaws "entirely from within" ('892 Patent) or that its components are "coplanar" with the jaw channel in the precise manner claimed?
V. Key Claim Terms for Construction
The Term: "beam"
- Context and Importance: This term is central to all asserted claims. The complaint alleges Defendants' "I-beam" is the claimed "beam". The construction of this term, particularly its structural relationship to the jaws, will be critical for infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification of the '650 Patent refers to the structure more generally as a "translating clamping member" (e.g., '650 Patent, col. 3:65-67), which may support a broader, more functional definition not limited to a specific shape.
- Evidence for a Narrower Interpretation: The patents depict specific embodiments, such as the "I-beam member 70" in Figure 14 of both patents. Defendants may argue that the term "beam" should be construed as limited to this disclosed I-shaped structure and its equivalents.
The Term: "from within the first and second jaws" ('650 Patent) / "entirely from within" ('892 Patent)
- Context and Importance: This phrase dictates the spatial interaction between the beam and the jaws, a core aspect of the invention's stability mechanism. The complaint's visuals show the accused I-beam fitting into open channels on the jaw surfaces (Compl. p. 24, ¶77).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Plaintiff may argue "from within" should be interpreted functionally to mean any engagement that is not purely external, including fitting into the channels shown in the accused product, as this achieves the claimed alignment function.
- Evidence for a Narrower Interpretation: The language could be interpreted more strictly to mean the beam is substantially enclosed by the main body of the jaws, not merely sliding in an external track or channel. The figures, such as Figure 15 in the '650 Patent, show the I-beam (70) situated between the structural components of the jaws.
VI. Other Allegations
- Indirect Infringement: The complaint alleges Defendants induce infringement by providing instruction manuals, training videos, and product support that direct and encourage medical professionals to use the Accused Products in a manner that performs the patented methods (Compl. ¶97, ¶127). The complaint cites Defendants' "Surgical Stapling Product Training & Support" webpages as evidence (Compl. ¶54).
- Willful Infringement: The willfulness allegation for the '650 Patent is based on alleged pre-suit knowledge, citing notice letters sent to Covidien on September 13, 2016, and to Medtronic on November 16, 2016 (Compl. ¶96, ¶98). For the later-issued '892 Patent, the allegation is based on knowledge "since at least the date of filing this complaint" (Compl. ¶126).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of structural interpretation: Can the single, integrated "I-beam" mechanism of the accused Endo GIA™ products be mapped onto the '892 Patent’s language requiring two distinct systems—a "first adjustment assembly for gross movement" and a "second adjustment assembly for fine movement"—or does this represent a fundamental structural and functional distinction?
- A second core issue will be the definitional scope of relational terms. Can the phrase "from within," as used in the patents, be construed to cover an I-beam that travels in open channels on the jaw surfaces, as depicted in the complaint's evidence, or does it require a more enclosed spatial relationship?
- A key procedural question will be the legal effect of the IPR proceeding on the '650 Patent. While the asserted dependent claims (6, 19, 21) survived, the cancellation of the independent claims (4, 13) from which they depend may create complex arguments regarding claim scope and validity, potentially focusing the dispute on the specific limitations added by the surviving dependent claims.