DCT
7:21-cv-00727
Xodus Medical Inc v. Mullen
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Xodus Medical Inc. (Pennsylvania), Alessio Pigazzi (California), and Glenn Keilar (California)
- Defendant: Mark Mullen and Keenan Mullen (South Carolina)
- Plaintiff’s Counsel: Turner, Padget, Graham & Laney, P.A. (with The Webb Law Firm as Of Counsel)
- Case Identification: 7:21-cv-00727, D.S.C., 03/12/2021
- Venue Allegations: Venue is asserted based on the Defendants’ residence in the District of South Carolina and their commission of alleged acts of infringement within the district.
- Core Dispute: Plaintiffs allege that Defendants’ SurgyPad product infringes three patents related to patient support arrangements used on tiltable medical tables.
- Technical Context: The technology addresses the need to safely secure patients during surgical procedures on inclined operating tables (e.g., the Trendelenburg position) by using a deformable pad that prevents sliding while also minimizing the risk of pressure-related injuries.
- Key Procedural History: Plaintiffs Alessio Pigazzi and Glenn Keilar are the owners of the patents-in-suit, with Xodus Medical Inc. acting as the exclusive licensee. All three asserted patents have undergone ex parte reexamination proceedings at the USPTO, and in each case, the patentability of the original claims was confirmed, with additional claims also being found patentable. This history may strengthen the presumption of validity for the asserted claims.
Case Timeline
| Date | Event |
|---|---|
| 2012-01-10 | Earliest Priority Date for ’314, ’720, and ’876 Patents |
| 2013-06-18 | U.S. Patent No. 8,464,720 ('720 Patent) Issues |
| 2013-08-20 | U.S. Patent No. 8,511,314 ('314 Patent) Issues |
| 2015-10-20 | U.S. Patent No. 9,161,876 ('876 Patent) Issues |
| 2021-03-12 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,511,314 - “Method of Securing a Patient Onto an Operating Table When the Patient is in the Trendelenburg Position and Apparatus Therefor Including a Kit,” Issued August 20, 2013 (’314 Patent)
The Invention Explained
- Problem Addressed: The patent describes the challenge of securing a patient on a surgical table that is tilted at an angle, such as in the Trendelenburg position for abdominal or gynecological operations. Without proper support, a patient can slide, disrupting the procedure, and may suffer nerve or tissue damage from concentrated pressure forces. (’314 Patent, col. 2:40-49, col. 2:5-13).
- The Patented Solution: The invention is a patient support arrangement featuring a pad made of a deformable, viscoelastic material. When a patient is placed on the pad, their body weight creates an impression. The material is designed to have a "rate of recovery sufficiently slow" to maintain this depression, which provides a significant portion of the force needed to hold the patient in place on the tilted table. The pad also distributes pressure across the patient's torso to minimize injury. (’314 Patent, Abstract; col. 2:64-col. 3:1).
- Technical Importance: This technology offers a method for securing patients that relies on the material properties of the pad itself, potentially reducing the need for straps or other restraints that can cause localized pressure points and related injuries. (’314 Patent, col. 2:8-13).
Key Claims at a Glance
- The complaint asserts independent claims 1 (an apparatus) and 23 (a method) (Compl. ¶¶ 38-39).
- Independent Claim 1 requires, in part:
- A pad configured for a tiltable medical table, long enough to support the patient's torso.
- The pad comprising a deformable material.
- The material configured to form a depression from the patient's torso that provides a "substantial portion of the holding forces."
- The material having a "rate of recovery sufficiently slow" to maintain the depression.
- The pad being configured to distribute pressure forces to minimize injuries.
- The complaint reserves the right to assert various dependent claims (Compl. ¶ 19).
U.S. Patent No. 8,464,720 - “Method of Securing a Patient Onto an Operating Table When the Patient is in the Trendelenburg Position and Apparatus Therefor Including a Kit,” Issued June 18, 2013 (’720 Patent)
The Invention Explained
- Problem Addressed: This patent addresses a similar problem to the ’314 Patent but places greater emphasis on an integrated system for patient positioning, particularly in Trendelenburg and lithotomy positions, which are common in robotic surgery. The problems include unwanted patient movement, pressure injuries, and potential contamination in the operating room. (’720 Patent, col. 1:40-49, col. 2:8-13).
- The Patented Solution: The invention is a method using a system that includes a single-use viscoelastic pad, a lift sheet, body straps, and securing straps. The pad is defined by properties like "sufficient thickness and viscosity" to prevent the patient from "bottoming out" on the hard table surface. The integrated lift sheet allows medical staff to reposition the patient without dragging them across the pad, which could otherwise negate the holding effect of the depression. (’720 Patent, Abstract; col. 4:26-33, col. 17:11-30).
- Technical Importance: The invention describes a comprehensive, single-use system that combines patient stabilization, pressure injury prevention, and ease of repositioning, addressing multiple clinical needs in a single integrated solution. (’720 Patent, col. 5:48-col. 6:4).
Key Claims at a Glance
- The complaint asserts independent claims 1, 6, and 10, all of which are method claims (Compl. ¶¶ 67-69).
- Independent Claim 1 requires, in part, a method using a system with a lift sheet, body straps, and a single-use pad, and includes steps for:
- Placing and securing the pad and straps on the operating table.
- Laying the lift sheet over the pad.
- Placing the patient on the lift sheet and pad, thereby deforming the pad.
- Adjusting the table to the Trendelenburg position.
- Lifting the patient with the lift sheet for repositioning.
- The complaint reserves the right to assert various dependent claims (Compl. ¶¶ 22-23).
Multi-Patent Capsule: U.S. Patent No. 9,161,876 - “Method of Securing a Patient Onto an Operating Table When the Patient is in the Trendelenburg Position and Apparatus Therefor Including a Kit,” Issued October 20, 2015 (’876 Patent)
Technology Synopsis
- The ’876 patent claims a patient support arrangement configured to support a patient's body on a tiltable medical table. The core technology, similar to the ’314 Patent, involves a "pad arrangement" made of a deformable material that forms a depression to hold the patient in place through both friction and the physical contour, while also distributing pressure to minimize injury. (’876 Patent, Abstract; col. 31:31-32:1).
Asserted Claims
- Independent claims 1 (an apparatus) and 17 (a method) are asserted (Compl. ¶¶ 98-99).
Accused Features
- The complaint alleges that the SurgyPad product constitutes the claimed "pad arrangement" and possesses the necessary properties of a deformable material with a slow rate of recovery to infringe the patent (Compl. ¶¶ 100-102).
III. The Accused Instrumentality
Product Identification
- The accused product is identified as the "SurgyPad" (Compl. ¶ 18).
Functionality and Market Context
- The complaint alleges the SurgyPad is a pad made from a "viscoelastic material" or a "high-density, water-wicking foam pad" (Compl. ¶¶ 33, 41). It is marketed for use in positioning and holding patients on medical tables that can be tilted, such as for the Trendelenburg and Reverse Trendelenburg positions (Compl. ¶ 34). The complaint asserts that when a patient is placed on the SurgyPad, the pad deforms to create a depression that provides holding forces, and that the pad has a slow rate of recovery to maintain this depression (Compl. ¶¶ 41-42).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'314 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A patient support arrangement comprising: a pad configured to be placed on a tiltable medical procedure table; | The SurgyPad is alleged to be a patient support arrangement comprising a pad configured for placement on a tiltable table (Compl. ¶ 40). | ¶40 | col. 3:36-39 |
| said pad having a length sufficient to extend from about at least the thighs of a patient to about at least the shoulders of a patient to support the torso of a patient placed on said pad; | The SurgyPad is alleged to have a length sufficient to support a patient's torso from the thighs to the shoulders (Compl. ¶ 40). | ¶40 | col. 3:36-41 |
| said pad comprising a deformable material; | The SurgyPad is alleged to be made from a deformable material, specifically a "high-density, water-wicking foam pad" (Compl. ¶ 41). | ¶41 | col. 2:64-65 |
| said deformable material being configured to be deformable by the torso of a patient to form a depression in said pad, which depression provides a substantial portion of the holding forces which hold a patient generally in a desired position... | The SurgyPad's foam material is alleged to deform under a patient's torso, creating a depression that provides a substantial portion of the holding force (Compl. ¶ 41). | ¶41 | col. 5:4-10 |
| said deformable material has a rate of recovery sufficiently slow to maintain a depression in said pad for a desired period of time upon a change in a depression-generating force on said pad; and | The SurgyPad is alleged "upon information and belief" to have a rate of recovery slow enough to maintain the depression for a desired period (Compl. ¶ 42). | ¶42 | col. 2:25-36 |
| said pad is configured to distribute pressure forces across a substantial portion of the torso of a patient in contact with said pad to minimize injuries generated by concentration of pressure forces... | The SurgyPad is alleged "upon information and belief" to distribute pressure forces across the patient's torso to prevent injuries (Compl. ¶ 42). | ¶42 | col. 2:5-13 |
'720 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of minimizing injuries ... by using a single-use Trendelenburg patient support system comprising: a lift sheet ... body straps ... a single-use, viscoelastic Trendelenburg pad ... and securing straps... | The complaint alleges the SurgyPad is for use in a method with a support system that includes these components (Compl. ¶ 70). | ¶70 | col. 17:11-30 |
| said method comprising the steps of: A) placing a longitudinal edge of said single-use, viscoelastic Trendelenburg pad adjacent and in alignment with a longitudinal edge of a surgical operating table... | The complaint alleges the SurgyPad is sold for performing this placement step (Compl. ¶ 71). | ¶71 | col. 14:15-20 |
| D) attaching said securing straps to said surgical operating table rails; | The complaint alleges the SurgyPad is sold for performing the step of attaching securing straps to the table rails (Compl. ¶ 71). | ¶71 | col. 14:26-28 |
| F) laying a patient in a supine position on said lift sheet and said single-use, viscoelastic Trendelenburg pad ... and thereby deforming said single-use, viscoelastic Trendelenburg pad, which said...pad comprises: sufficient thickness and viscosity to sufficiently cushion the body of said patient... | The complaint alleges the SurgyPad is sold for use in this step and that "upon information and belief," it has sufficient thickness and viscosity to cushion the patient and minimize bottoming out (Compl. ¶¶ 71-72). | ¶¶71-72 | col. 15:2-15 |
| G) lifting said lift sheet and thereby lifting said patient up and off said single-use, viscoelastic Trendelenburg pad to reposition said patient as or if needed; | The complaint alleges the SurgyPad is sold for performing this repositioning step (Compl. ¶ 73). | ¶73 | col. 4:30-33 |
Identified Points of Contention
- Evidentiary Questions: The complaint's allegations regarding the specific physical properties of the SurgyPad (e.g., rate of recovery, coefficient of friction, ball rebound, density) are made "upon information and belief" and largely recite claim language (Compl. ¶¶ 42, 50-51). A primary point of contention will be whether discovery and testing can substantiate that the accused product actually meets these specific, often quantitative, claim limitations.
- Scope Questions: For the ’720 patent, a dispute may arise over the term "single-use Trendelenburg patient support system." The claims recite a system including a lift sheet and body straps. The infringement analysis will question whether the SurgyPad is sold as part of an integrated kit containing all recited components, or if the sale of the pad alone can support a claim for indirect infringement based on its intended combination with other, separately sourced items.
V. Key Claim Terms for Construction
The Term: "rate of recovery sufficiently slow" (’314 Patent, cl. 1)
- Context and Importance: This term is central to the invention's primary function of holding a patient in place via a maintained depression. Its construction will determine the objective standard for infringement, and it is a likely target for an indefiniteness challenge if found to be purely subjective.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is functional and does not provide a numerical value, suggesting that any rate of recovery that achieves the stated function of maintaining a depression could fall within its scope.
- Evidence for a Narrower Interpretation: The specification (incorporated from the ’720 patent) provides specific, exemplary numerical ranges, such as "in the range of approximately 10-35 seconds for 100 percent recovery" (’720 Patent, col. 2:34-36). A party could argue these examples define the otherwise subjective term, limiting its scope to materials exhibiting similar recovery times.
The Term: "substantial portion of the holding forces" (’314 Patent, cl. 1)
- Context and Importance: This term quantifies the contribution of the pad's depression to overall patient stability. The case may turn on whether this requires the depression to be the primary source of holding force or merely a non-trivial contributor. Practitioners may focus on this term because its ambiguity makes it a prime candidate for dispute.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is not defined with a percentage, which may support a construction that requires only a meaningful or significant contribution, not necessarily a majority of the force.
- Evidence for a Narrower Interpretation: The specification of the related ’720 patent states that the depression "may provide the primary holding for holding a person on the operating table" (’720 Patent, col. 5:50-53). This language could be used to argue that "substantial portion" means a majority (i.e., >50%) of the holding forces.
VI. Other Allegations
Indirect Infringement
- The complaint alleges that Defendants contributorily infringe and induce infringement of the method claims across all three patents (Compl. ¶¶ 21, 24, 27). The allegations are based on Defendants marketing and selling the SurgyPad specifically for use in medical procedures that would require end-users (e.g., hospital staff) to perform the patented methods (Compl. ¶ 34).
Willful Infringement
- The complaint alleges willful infringement for all three patents, asserting that Defendants had "actual knowledge" of the patents and their validity (Compl. ¶¶ 29-32, 60-61, 91-92, 121-122). The alleged basis for this knowledge is Defendants' "prior sales" of Plaintiff Xodus's own commercial embodiment of the patented technology, suggesting pre-suit awareness of the products and the associated intellectual property (Compl. ¶ 28).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of technical proof: can Plaintiffs demonstrate through testing that the accused SurgyPad, described in the complaint as a "high-density, water-wicking foam pad," actually possesses the specific and often quantitative material properties (e.g., "rate of recovery," "coefficient of static friction," "ball rebound") required by the claims, which are currently alleged only "upon information and belief"?
- The case will likely involve a significant dispute over claim scope: can functional terms such as "substantial portion of the holding forces" and "rate of recovery sufficiently slow" be construed with enough objective certainty to be found definite and enforceable, and if so, will their scope be broad enough to read on the accused product's performance?
- A key issue for the ’720 patent will be one of system-level infringement: does liability for the claimed method, which uses a "system" comprising a pad, lift sheet, and straps, require the sale of a single, all-in-one kit, or can indirect infringement be established by the sale of the SurgyPad alone with knowledge of its intended combination with other components by end-users?