Xodus Medical Inc v. Prime Medical LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Xodus Medical Inc. (Pennsylvania), Alessio Pigazzi (California), and Glenn Keilar (California)
  • Defendant: Prime Medical LLC (Tennessee) and Symmetry Surgical Inc. (Tennessee)
  • Plaintiff’s Counsel: The Webb Law Firm
• Case Identification: 3:18-cv-00413, W.D. Pa., 09/18/2013
• Venue Allegations: Venue is alleged on the basis that Defendants have committed acts of patent infringement within the Western District of Pennsylvania.
• Core Dispute: Plaintiffs allege that Defendants infringe two patents related to viscoelastic foam pads used to secure patients on an operating table when placed in a steep, head-down (Trendelenburg) position.
• Technical Context: The technology addresses the clinical need to prevent patients from sliding during surgical procedures that require significant tilting of the operating table, a common requirement in modern robotic and minimally invasive surgery.
• Key Procedural History: The complaint notes that Plaintiff Xodus Medical is the exclusive licensee of the patents-in-suit, which are owned by the inventor co-plaintiffs. Notably, both asserted patents have survived multiple ex parte reexamination proceedings at the U.S. Patent and Trademark Office, a fact which may be presented to suggest the patents’ validity over prior art.

Case Timeline

Date	Event
2012-01-10	’720 Patent Priority Date
2012-06-01	’314 Patent Priority Date
2013-06-18	U.S. Patent No. 8,464,720 Issued
2013-08-20	U.S. Patent No. 8,511,314 Issued
2013-09-18	Complaint Filing Date
2017-04-14	’720 Patent Reexamination Certificate (C1) Issued
2017-04-25	’314 Patent Reexamination Certificate (C1) Issued
2018-03-07	’720 Patent Reexamination Certificate (C2) Issued
2018-03-12	’314 Patent Reexamination Certificate (C2) Issued

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

The Invention Explained

• Problem Addressed: The patent describes the challenge of safely positioning a patient for medical procedures, such as robotic surgery, that require the operating table to be steeply inclined in the Trendelenburg (head-down) position. This incline creates a risk of the patient sliding or shifting, which could disrupt the surgery, and can also create concentrated pressure points on the body that lead to nerve damage, such as brachial plexopathy (’314 Patent, col. 1:40-59; col. 2:8-13).
• The Patented Solution: The invention is a patient support arrangement centered on a pad made of a deformable, viscoelastic material. When a patient lies on the pad, their body weight creates an impression or depression. The material is designed to have a slow recovery rate, meaning the depression is maintained for a period of time. This depression, combined with the material's frictional properties, helps hold the patient securely in place, preventing sliding while also distributing pressure more evenly across the body to minimize injury (’314 Patent, Abstract; col. 17:10-38).
• Technical Importance: This technology facilitates the use of steep Trendelenburg positioning, which provides surgeons with better access and visualization, particularly in laparoscopic and robotic-assisted abdominal and gynecological surgeries (’314 Patent, col. 1:46-52).

Key Claims at a Glance

• The complaint asserts infringement of one or more unspecified claims (Compl. ¶12). Independent claim 1 is a representative apparatus claim.
• The essential elements of independent claim 1 include:
  • A patient support arrangement comprising a pad for a tiltable medical table.
  • The pad has a length sufficient to support the patient’s torso from at least the thighs to the shoulders.
  • The pad comprises a "deformable material" that forms a "depression" from the patient's torso, which provides a "substantial portion of the holding forces."
  • The deformable material has a "rate of recovery sufficiently slow to maintain a depression."
  • The pad is configured to "distribute pressure forces" to minimize injury.
• The complaint implicitly reserves the right to assert other independent or dependent claims.

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

The Invention Explained

• Problem Addressed: The patent addresses the same technical problem as the ’314 Patent: preventing patient movement and pressure-related injuries during surgical procedures in the Trendelenburg position (’720 Patent, col. 1:40-45).
• The Patented Solution: This patent claims a specific multi-step method for using a patient support system that includes a viscoelastic pad. The method details a sequence of actions, including placing the pad and a lift sheet, positioning the patient, attaching straps to the table rails, placing the patient's legs in stirrups (lithotomy position), and then tilting the table. The method relies on the pad deforming to create a cavity that helps hold the patient securely once the table is inclined (’720 Patent, Abstract; col. 4:15-40).
• Technical Importance: The claimed method provides a systematic process intended to ensure patient safety and stability, which is critical for the success of complex procedures like robotic surgery performed in steep Trendelenburg (’720 Patent, col. 5:53-col. 6:6).

Key Claims at a Glance

• The complaint asserts infringement of one or more unspecified claims (Compl. ¶16). Independent claim 1 is a representative method claim.
• The essential elements of independent claim 1 include:
  • A method using a system comprising a lift sheet, body straps, a single-use viscoelastic pad, and securing straps.
  • The method includes the steps of: (A-D) placing the pad on a surgical table and attaching its straps to the table rails; (E) laying the lift sheet over the pad; (F) laying a patient on the sheet and pad, thereby deforming the pad; (G-J) repositioning the patient and securing their arms and legs; (K) adjusting the table to the Trendelenburg position; and (L) "assisting in substantially holding the body" using the pad, which forms a cavity.
• The complaint implicitly reserves the right to assert other independent or dependent claims.

III. The Accused Instrumentality

Product Identification

• The complaint does not identify any specific accused products, methods, or services by name (Compl. ¶¶12, 16).

Functionality and Market Context

• The complaint does not provide any description of the functionality, operation, or market context of any accused instrumentality.
  No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for analysis of infringement. The pleading makes only broad, conclusory allegations that Defendants infringe by "manufacturing, selling and/or offering to sell products that infringe" the patents-in-suit, without identifying any specific products or mapping any product features to the limitations of the asserted claims (Compl. ¶¶12, 16). Consequently, a claim chart summary cannot be constructed.

• Identified Points of Contention:
  • Factual Questions: A primary issue for discovery will be for Plaintiffs to identify the specific accused products and present evidence demonstrating how those products meet each limitation of the asserted claims.
  • Scope Questions: For the ’314 Patent, a likely point of dispute will be whether an accused product's material possesses a "rate of recovery sufficiently slow" to meet the claim limitation. For the ’720 Patent, a key question will be whether the use of an accused product involves performing all the specific, sequential steps recited in the method claims (e.g., the use of a lift sheet, body straps, and leg stirrups in the manner claimed).
  • Technical Questions: The infringement analysis may turn on empirical testing of an accused product's material properties (e.g., viscosity, rebound, friction) to determine if they fall within the scope of the claims, particularly the more detailed dependent claims.

V. Key Claim Terms for Construction

• Term: "deformable material" (’314 Patent, Claim 1)

• Context and Importance: This term is fundamental to the scope of the apparatus claims. The dispute will center on whether the term is limited to the specific "viscoelastic foam" detailed in the specification or if it can encompass a broader range of materials. Practitioners may focus on this term because its construction could either narrow the claims to a specific type of foam or broaden them to cover other patient support surfaces.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The claim uses the general term "deformable material" without explicitly including the word "viscoelastic."
  • Evidence for a Narrower Interpretation: The specification consistently and repeatedly describes the invention as using "viscoelastic foam" and provides extensive detail on its specific properties, such as recovery rates, compression set, and indentation force deflection (’314 Patent, col. 2:3-65). A defendant may argue that these descriptions define and limit the scope of "deformable material."

• Term: "assisting in substantially holding the body" (’720 Patent, Claim 1)

• Context and Importance: This functional language is central to the method claims, as it defines the required performance of the pad. The construction of "substantially" will be critical. The question is how much holding force the pad itself must contribute, relative to other components like straps, to satisfy this limitation.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The term "assisting" suggests the pad need only contribute to the holding function, not be the sole or primary means of it.
  • Evidence for a Narrower Interpretation: The specification suggests the impression on the pad "may provide the primary holding" for the patient, which could support an argument that the "assisting" must be significant and more than incidental (’720 Patent, col. 5:49-52).

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendants are contributorily infringing and inducing infringement of both patents (Compl. ¶¶12, 16). However, it does not plead any specific facts to support the required elements of knowledge and intent, such as alleging that Defendants' product documentation instructs users to perform the patented methods.
• Willful Infringement: The complaint alleges that Defendants' infringement is "willful and wanton" (Compl. ¶¶13, 17). It does not allege any specific facts to support this claim, such as pre-suit knowledge of the patents or egregious conduct.

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

1. An Evidentiary Question of Infringement: The complaint’s lack of factual specificity is a central feature. A threshold issue will be for Plaintiffs to produce evidence identifying specific accused products and demonstrating, on an element-by-element basis, how those products or their use infringe the asserted claims.

2. A Definitional Question of Claim Scope: The case will likely involve a significant dispute over claim construction. A core question for the court will be whether terms like "deformable material" are limited to the specific viscoelastic foams described in the specification, or if they encompass a wider range of patient support materials. The outcome of this interpretation will be a primary driver of the infringement analysis.

3. A Strategic Question of Patent Strength: How will the successful outcome of multiple ex parte reexaminations for both patents influence the litigation? Plaintiffs may leverage this history to argue for the patents’ robust validity against invalidity challenges, potentially affecting litigation strategy and settlement negotiations.