DCT
1:19-cv-00525
P Tech LLC v. Intuitive Surgical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: P Tech, LLC (Florida)
- Defendant: Intuitive Surgical, Inc. (Delaware)
- Plaintiff’s Counsel: Rogowski Law LLC
- Case Identification: 1:19-cv-00525, D. Del., 10/02/2019
- Venue Allegations: Venue is based on Defendant's incorporation in the state of Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s da Vinci Surgical System, when used with its EndoWrist and SureForm surgical staplers, infringes three patents related to robotic surgical fastening systems and methods.
- Technical Context: The technology concerns robotic-assisted surgical systems that apply fasteners, such as staples, to internal body tissues, a field characterized by a need for high precision and safety.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with notice of U.S. Patent Nos. 9,149,281 and 9,192,395 prior to filing suit, and notice of U.S. Patent No. 10,368,953 in August 2019. Subsequent to the filing of this complaint, Inter Partes Review (IPR) proceedings at the U.S. Patent and Trademark Office resulted in the cancellation of all asserted independent claims across all three patents-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2002-03-20 | Earliest Priority Date for ’281, ’395, and ’953 Patents |
| 2015-10-06 | U.S. Patent No. 9,149,281 Issues |
| 2015-11-24 | U.S. Patent No. 9,192,395 Issues |
| 2019-08-06 | U.S. Patent No. 10,368,953 Issues |
| 2019-08-22 | Plaintiff sends letter to Defendant re: ’953 Patent |
| 2019-10-02 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,149,281 - "Robotic System for Engaging a Fastener With Body Tissue"
The Invention Explained
- Problem Addressed: The complaint contextualizes the invention as addressing an "increasing number of adverse events associated with surgical staplers for internal use," such as misfiring, difficulty in firing, and stapler failure, which can reduce patient safety (Compl. ¶¶ 17-18).
- The Patented Solution: The patent describes a robotic surgical system designed to provide enhanced control and safety when applying a fastener to body tissue. The system comprises a robotic mechanism with an "adaptive arm," a surgeon-operated interface, and a computer that controls the mechanism ('281 Patent, Fig. 1). A central feature of the invention is that the computer actively "limits" the magnitude of the forces (both axial and transverse) that the robotic arm can apply to the fastener, which is intended to ensure safe and precise operation ('281 Patent, col. 2:9-15).
- Technical Importance: The claimed integration of computer-limited force feedback into a robotic fastening system is presented as a way to "ensure safe and precise stapling and thus prevent the occurrence" of adverse events common with manual or less sophisticated staplers (Compl. ¶19).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶72).
- The essential elements of independent claim 1 are:
- A robotic mechanism including an adaptive arm, configured to position a fastener and having first and second force transmitting portions to apply axial and/or transverse force to the fastener.
- A computer configured to control the robotic mechanism.
- An adaptive arm interface coupled to the adaptive arm and the computer, configured to operate the computer.
- Wherein a magnitude of the at least one axial and transverse force applied to the fastener is limited by the computer.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 9,192,395 - "Robotic Fastening System"
The Invention Explained
- Problem Addressed: The technology addresses the same general problem as the ’281 Patent: ensuring the safe and accurate application of surgical staples in robotic procedures (Compl. ¶¶ 17-19).
- The Patented Solution: This patent claims a more specific robotic system that integrates several components. It requires not only a robotic mechanism for positioning a staple and a fastening member to apply force, but also explicitly includes either a position sensor or a force measurement device to provide feedback on the stapling process ('395 Patent, col. 2:16-20). Crucially, the system also claims "a tissue retractor assembly coupled to the robotic mechanism" which includes a cannula to facilitate instrument insertion ('395 Patent, col. 2:21-25).
- Technical Importance: By claiming a system that combines the robotic fastening mechanism with integrated sensing and a coupled cannula, the invention aims to provide a more complete, self-contained solution for performing minimally invasive stapling procedures (Compl. ¶19).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶¶ 89, 91).
- The essential elements of independent claim 1 are:
- A robotic mechanism including an adaptive arm configured to position a staple.
- A robotic arm interface configured to operate the adaptive arm.
- A staple having first and second legs.
- A fastening member with force transmitting portions configured to move the staple legs toward each other.
- At least one of a position sensor or a force measurement device to indicate staple movement or resistance.
- A tissue retractor assembly coupled to the robotic mechanism, where the assembly includes a cannula.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 10,368,953 - "Robotic System for Fastening Layers of Body Tissue Together and Method Thereof"
Technology Synopsis
This patent claims a method for fastening body tissue using a robotic system. The method involves applying force to the tissue, using a sensor to generate a "fastening signal" that indicates the tissue is suitable for fastening, receiving and processing that signal with a computer to confirm suitability, and only then fastening the tissue with a fastener applied by the robot (Compl. ¶14). This creates a closed-loop, feedback-driven process intended to enhance safety (Compl. ¶19).
Asserted Claims
Independent claim 6 (Compl. ¶¶ 106, 108).
Accused Features
The complaint alleges that Defendant's systems infringe by executing this method, specifically through the use of its "SmartClamp" and "SmartFire" technologies, which allegedly generate and process signals related to tissue properties before and during stapling (Compl. ¶¶ 63-69).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is the da Vinci® Surgical System, including the da Vinci X, da Vinci Xi, and da Vinci SP models, when used in combination with Intuitive’s EndoWrist Staplers and SureForm Staplers (Compl. ¶¶ 20, 24, 31). The system is comprised of a patient cart with adaptive arms, a vision cart, and a surgeon console (Compl. ¶22). A representative image of the patient cart depicts its four adaptive arms used to manipulate surgical instruments (Compl. ¶25).
Functionality and Market Context
The da Vinci System is a robotic-assisted surgical platform that allows a surgeon to operate through small incisions from a console (Compl. ¶20). The accused staplers attach to the system's adaptive arms to deliver surgical staples (Compl. ¶32). The complaint focuses on two key technologies: "SmartClamp," which allegedly provides feedback and "detects whether the jaws of the stapler can adequately close on the tissue," and "SmartFire," which allegedly "measures tissue compression before and during the firing of the stapler" to avoid excessive clamp force (Compl. ¶¶ 37, 42-43). The complaint alleges these computer-controlled features are central to the infringement (Compl. ¶¶ 36, 41).
IV. Analysis of Infringement Allegations
’281 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a robotic mechanism including an adaptive arm...the robotic mechanism having first and second force transmitting portions configured to apply...force relative to the fastener | The da Vinci patient cart includes adaptive arms that position the EndoWrist/SureForm Staplers. The staplers include a "wedge-shaped sliding mechanism" and an "anvil" that apply axial and transverse forces to form the staples. | ¶¶ 23, 34, 50-51, 54 | col. 2:2-8 |
| a computer configured to control the robotic mechanism | A computer within the da Vinci System controls the movement of the adaptive arms and the force applied by the staplers. | ¶¶ 23, 36, 41 | col. 2:9-10 |
| an adaptive arm interface coupled to the adaptive arm and the computer, the adaptive arm interface configured to operate the computer | The da Vinci Surgeon Console allows the surgeon to operate and control the patient cart's adaptive arms and attached instruments. An image of the console is provided in the complaint. | ¶¶ 27-28 | col. 2:11-13 |
| wherein a magnitude of the at least one axial force and transverse force applied to the fastener is limited by the computer | The "SmartClamp" technology allegedly stops clamping if tissue is too thick, and the "SmartFire" technology allegedly uses an algorithm to avoid "excessive clamp force," thereby limiting the applied force. | ¶¶ 36-38, 41-43, 53 | col. 2:13-15 |
- Identified Points of Contention:
- Scope Questions: A central question for construction would be the meaning of "limited by the computer." The dispute may focus on whether the accused system's algorithmic "control" and "monitoring" of force (Compl. ¶¶ 42-43) meets the specific claim requirement of a "limit," which could be construed as a hard stop or a predefined maximum threshold.
- Technical Questions: Evidence would be needed to determine if the "SmartClamp" and "SmartFire" technologies actually function to impose a force "limit" as claimed, or if they merely regulate force or provide feedback to the surgeon without imposing a computer-enforced maximum.
’395 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a robotic mechanism including an adaptive arm configured to position a staple relative to a body portion of a patient | The da Vinci patient cart includes adaptive arms that are configured to position the attached EndoWrist or SureForm stapler. | ¶¶ 23, 34 | col. 2:2-5 |
| a robotic arm interface configured to operate the adaptive arm of the robotic mechanism | The da Vinci Surgeon Console is the interface used by the surgeon to operate the adaptive arms. | ¶¶ 27-28 | col. 2:6-8 |
| a fastening member...having first and second force transmitting portions...configured to secure the body portion with the staple | The staplers are the fastening member, and their internal mechanisms, such as the wedge-shaped slider and anvil, are the force transmitting portions that form the staple legs. A diagram shows the "Wedge Shaped Slider Mechanism." | ¶¶ 50-51, 54, 56, p. 13 | col. 2:10-15 |
| at least one of a position sensor...and a force measurement device configured to indicate a resistance required to move the staple | The da Vinci System is alleged to include a "force measurement device" that indicates resistance, specifically citing the "SmartFire" technology which "measures tissue compression" and generates a "clamping force signal." | ¶¶ 42, 59-60 | col. 2:16-20 |
| a tissue retractor assembly coupled to the robotic mechanism, the tissue retractor assembly including a cannula | The complaint alleges that both the EndoWrist and SureForm Staplers are "adapted to be inserted through a cannula into the working space inside the patient." | ¶45 | col. 2:21-25 |
- Identified Points of Contention:
- Scope Questions: The primary dispute may center on the "tissue retractor assembly coupled to the robotic mechanism" limitation. The question is whether the use of a standard surgical cannula—through which the robotic stapler is passed—satisfies the requirement that the cannula be part of an "assembly" that is "coupled to" the robotic mechanism.
- Technical Questions: The analysis would require determining the nature of the relationship between the cannula used for instrument access and the da Vinci robotic mechanism itself. Is there a structural or control linkage that would support a finding of "coupling," or is the cannula a passive, separate component?
V. Key Claim Terms for Construction
The Term: "limited by the computer" (from ’281 Patent, Claim 1)
Context and Importance: This term is the central feature distinguishing the invention from prior art. Its construction is critical to determining infringement. Practitioners may focus on this term because Defendant is likely to argue that its system's "SmartClamp" and "SmartFire" features "control" or "adjust" force based on an algorithm, but do not impose a "limit" in the sense of a fixed, predetermined maximum ceiling as might be required by the claim.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification of the ’281 patent does not provide a specific definition for "limited," instead repeating the claim language ('281 Patent, col. 2:13-15). The absence of a narrowing definition in the specification may support an interpretation based on the term's plain and ordinary meaning, which could encompass any form of computer-managed force constraint.
- Evidence for a Narrower Interpretation: The patent does not describe any specific limiting algorithm or mechanism. A defendant might argue that in the context of the described invention, the term must imply more than general computer control and requires a specific safety-based cutoff function, which they may contend their product does not have.
The Term: "a tissue retractor assembly coupled to the robotic mechanism, the tissue retractor assembly including a cannula" (from ’395 Patent, Claim 1)
Context and Importance: Infringement of the ’395 patent may depend entirely on whether the accused system meets this limitation. Practitioners may focus on this term because the complaint's allegation relies on the fact that the accused staplers are inserted through a cannula (Compl. ¶45), which may not satisfy the claim's requirement that the cannula be part of an assembly that is "coupled to" the robot.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A broad reading of "coupled" could include functional or operational coupling. Plaintiff may argue that because the robotic stapler cannot function for its intended purpose without being inserted through a cannula, the cannula is necessarily "coupled" to the system in an operational sense.
- Evidence for a Narrower Interpretation: The ’395 patent abstract states "a tissue retractor assembly may be coupled to the robotic mechanism." A defendant could argue that "coupled" requires a direct physical or electromechanical connection, and that a standard, passive access port (cannula) through which an instrument passes is not "coupled to the robotic mechanism" in the manner required by the claim.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement against Intuitive for all three patents. The basis for this allegation is that Intuitive sells the da Vinci Systems and staplers and provides "training, supporting, teaching, directing, and instructing" customers on how to use them in an infringing manner, allegedly with specific intent to cause infringement (Compl. ¶¶ 77-78, 94-95, 111-112). Contributory infringement is also alleged, stating the staplers are a material part of the claimed systems and are not suitable for substantial non-infringing use (Compl. ¶¶ 82-83, 99-100, 116-117).
- Willful Infringement: The complaint alleges willful infringement for all three patents. Willfulness is based on alleged pre-suit knowledge. The complaint states that P Tech "previously sent a copy of the ‘281 patent to Intuitive" and the ‘395 patent to Intuitive (Compl. ¶¶ 81, 98). For the ’953 patent, willfulness is alleged based on a letter sent to Intuitive's counsel on August 22, 2019, which included a copy of the patent and an allegation of infringement (Compl. ¶115).
VII. Analyst’s Conclusion: Key Questions for the Case
While the subsequent cancellation of all asserted claims in IPR proceedings may render these questions moot from a litigation standpoint, the core of the original dispute centered on the following issues:
- A core issue would have been one of definitional scope: does the claim term "limited by the computer" ('281 patent) require a specific hard-stop safety function, or can it be construed more broadly to cover the complex, algorithm-based force "control" and "adjustment" functions of the accused "SmartClamp" and "SmartFire" technologies?
- A second key issue would have been one of structural versus functional coupling: does the phrase "a tissue retractor assembly coupled to the robotic mechanism" ('395 patent) require a direct physical or control linkage, or is it satisfied when a robotic instrument is merely used through a standard, passive surgical cannula that is necessary for the system's operation?
- A central evidentiary question for the method patent ('953 patent) would have been one of functional equivalence: do the accused system's internal sensor signals and processing algorithms perform the specific steps of "generating...a fastening signal indicative of...suitability" and "determining...that the...portions...are suitable," or is there a fundamental mismatch in the logic and operation of the claimed method versus the accused process?