Xodus Medical Inc v. Allen Medical Systems Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Xodus Medical, Inc. (Pennsylvania), Alessio Pigazzi (California), and Glenn Keilar (California)
  • Defendant: Allen Medical Systems, Inc. (Massachusetts)
  • Plaintiff’s Counsel: The Webb Law Firm
• Case Identification: 1:18-cv-11098, W.D. Pa., 05/04/2017
• Venue Allegations: Plaintiff alleges venue is proper in the Western District of Pennsylvania because Defendant has committed and continues to commit acts of infringement within the district.
• Core Dispute: Plaintiffs allege that Defendant’s Allen® Steep Trend Pad infringes a patent related to viscoelastic foam pads used to secure patients on operating tables during inclined surgical procedures.
• Technical Context: The technology addresses the need to safely position patients in steep-angle orientations, such as the Trendelenburg position common in robotic and laparoscopic surgeries, by preventing slippage and minimizing pressure-related injuries.
• Key Procedural History: The complaint states that Plaintiff Xodus Medical, Inc. is the exclusive licensee of the patent-in-suit, which is owned by co-plaintiffs and inventors Pigazzi and Keilar. Notably, the patent-in-suit, U.S. Patent No. 8,511,314, has survived two separate ex parte reexamination proceedings where the U.S. Patent and Trademark Office confirmed the patentability of the original claims. The complaint was filed after the first reexamination certificate was issued.

Case Timeline

Date	Event
2012-06-01	'314 Patent Priority Date (Provisional App. 61/654,339)
2013-08-20	'314 Patent Issue Date
2017-04-25	'314 Patent C1 Reexamination Certificate Issued
2017-05-04	Complaint Filing Date
2018-03-12	'314 Patent C2 Reexamination Certificate 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"

• Patent Identification: 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 securing a patient on an operating table when it is tilted at a steep angle, as required for procedures like abdominal or gynecological surgery in the "Trendelenburg position" ('314 Patent, col. 1:45-54). Such tilting can cause undesirable patient movement, disrupting the procedure, and can also create concentrated pressure points on the body that may lead to nerve or tissue damage ('314 Patent, col. 2:1-9).
• The Patented Solution: The invention is a patient support arrangement centered on a viscoelastic foam pad. This pad is designed to deform under the patient's weight, creating an impression that provides a "substantial portion of the holding forces" to prevent sliding ('314 Patent, col. 17:19-24). The foam is characterized by a "rate of recovery sufficiently slow to maintain a depression," which, in combination with the material's frictional properties and pressure-distributing nature, helps to securely and safely hold the patient in place ('314 Patent, col. 5:1-13, col. 17:35-38).
• Technical Importance: The technology provides an alternative or supplement to traditional straps for patient securement, which is particularly relevant for the steep angles used in modern minimally invasive and robotic surgeries ('314 Patent, col. 5:53-6:4).

Key Claims at a Glance

• The complaint asserts infringement of at least independent claim 1 ('314 Patent, col. 17:10-44; Compl. ¶14).
• The essential elements of independent claim 1 include:
  • A patient support arrangement comprising a pad configured for a tiltable medical table.
  • The pad has a length sufficient to support a patient's torso from the thighs to the shoulders.
  • The pad comprises a deformable material.
  • The material is configured to be deformed by the patient's torso to form a depression, which provides a "substantial portion of the holding forces" when the table is tilted.
  • The material has a "rate of recovery sufficiently slow" to maintain the depression for a desired time after a change in force.
  • The pad is configured to distribute pressure forces to minimize injury.
• The complaint's reference to "one or more claims" suggests a reservation of the right to assert additional claims, including dependent claims (Compl. ¶12).

III. The Accused Instrumentality

Product Identification

• The complaint identifies the accused instrumentality as the "Allen® Steep Trend Pad" (Compl. ¶12).

Functionality and Market Context

• The complaint alleges that Defendant Allen Medical Systems, Inc. manufactures, sells, and/or offers to sell the accused product (Compl. ¶14). The complaint does not, however, provide any specific technical details regarding the composition, material properties, or method of operation of the Allen® Steep Trend Pad. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the accused product infringes at least claim 1 of the '314 patent but does not contain element-by-element infringement allegations or a claim chart exhibit (Compl. ¶14). The infringement theory is therefore presented in a conclusory manner. The following table maps the elements of claim 1 to the general 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 complaint alleges the "Allen® Steep Trend Pad" is a patient support pad for use on operating tables.	¶12, ¶14	col. 17:10-12
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 complaint does not provide specific details on the dimensions or intended placement of the accused product.	¶12, ¶14	col. 17:13-17
said pad comprising a deformable material; 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...	The complaint does not specify the material of the accused product or how it generates holding forces.	¶12, ¶14	col. 17:18-24
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 complaint does not provide evidence regarding the material properties or recovery rate of the accused product.	¶12, ¶14	col. 17:35-38
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 complaint does not provide details on the pressure distribution characteristics of the accused product.	¶12, ¶14	col. 17:39-44

Identified Points of Contention

• Technical Questions: Given the lack of detail in the complaint, a central question will be one of evidence: what are the actual material properties of the "Allen® Steep Trend Pad"? The case will likely require expert testing and testimony to determine if the accused product's material has a "rate of recovery sufficiently slow" and other physical characteristics (e.g., coefficient of friction, indentation force) that fall within the scope of the claims.
• Scope Questions: The analysis will raise questions about the meaning of claim terms of degree. For example, what quantum of force constitutes a "substantial portion of the holding forces," and how is that measured relative to other forces like friction?

V. Key Claim Terms for Construction

• The Term: "deformable material has a rate of recovery sufficiently slow to maintain a depression"

  • Context and Importance: This functional language is at the core of the claimed invention, distinguishing it from simple foam cushions. The entire infringement analysis may depend on whether the accused product's material meets this functional limitation. Practitioners may focus on this term because it links a material property ("rate of recovery") to a specific function ("maintain a depression").
  • Intrinsic Evidence for a Broader Interpretation: The claim language itself is functional, suggesting that any material performing the function could infringe, regardless of its specific composition.
  • Intrinsic Evidence for a Narrower Interpretation: The specification provides specific, quantitative examples of recovery rates, such as "2-10 seconds for approximately 50 percent to 80 percent recovery" ('314 Patent, col. 2:26-29). A party may argue that these examples should inform, if not limit, the meaning of "sufficiently slow."

• The Term: "depression provides a substantial portion of the holding forces"

  • Context and Importance: This term of degree is critical for proving infringement, as it requires quantifying the source of the patient-holding effect. The dispute will be over what percentage or contribution level qualifies as "substantial."
  • Intrinsic Evidence for a Broader Interpretation: The patent states the holding ability is a "combination of the coefficient of friction ... and the holding ability of the impression made by the patient" ('314 Patent, col. 5:3-7), which may support an interpretation where "substantial" does not require the depression to be the majority or primary source of the force, but merely a significant, non-trivial contributor.
  • Intrinsic Evidence for a Narrower Interpretation: The claim language distinguishes the "depression" as the source of the holding force. A party could argue that to be "substantial," this depression-based force must be the primary mechanism holding the patient, as opposed to friction, which is a property of many surfaces.

VI. Other Allegations

• Indirect Infringement: The complaint includes a conclusory allegation of contributory and induced infringement (Compl. ¶271). It does not, however, plead specific facts to support the knowledge and intent elements, such as referencing defendant's marketing materials or user instructions that would encourage an infringing use.
• Willful Infringement: The complaint alleges that Defendant's infringement is "willful and wanton" and seeks treble damages (Compl. ¶15, D). The complaint does not allege any facts indicating pre-suit knowledge of the patent by the Defendant. The basis for willfulness may therefore depend on establishing knowledge from the date the complaint was served.

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

• A central issue will be one of evidentiary proof: given the complaint's lack of technical detail, the case will depend heavily on discovery and expert testimony to establish the actual physical and material properties of the accused "Allen® Steep Trend Pad." Does the product, in operation, exhibit the slow-recovery viscoelastic behavior that is a cornerstone of the asserted patent claim?
• The outcome will also hinge on a question of definitional scope: how will the court construe the key functional limitations in Claim 1, such as "rate of recovery sufficiently slow" and "substantial portion of the holding forces"? Whether the court adopts broader functional definitions or narrower interpretations tied to the specification's quantitative examples will likely be dispositive.
• A further question relates to willfulness and damages: can the plaintiffs leverage the patent's survival of two ex parte reexaminations to argue that any defense of invalidity is objectively unreasonable, thereby strengthening their claim for willful infringement and potential enhanced damages?