CR Bard v. Angiodynamics

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: C. R. Bard, Inc. (New Jersey)
  • Defendant: AngioDynamics, Inc. (Delaware)
  • Plaintiff’s Counsel: Dorsey & Whitney LLP; Kirkland & Ellis, LLP
• Case Identification: 2:12-cv-00035, D. Utah, 09/17/2012
• Venue Allegations: Plaintiff alleges venue is proper because Defendant makes, sells, and/or uses the accused medical products within the judicial district.
• Core Dispute: Plaintiff alleges that Defendant’s implantable port products infringe patents related to systems and methods for identifying such ports after they have been implanted in a patient.
• Technical Context: The dispute concerns implantable vascular access ports, which are medical devices used for long-term delivery of substances into the bloodstream, and features that allow clinicians to identify a port's specific characteristics (e.g., suitability for power injection) non-invasively via imaging or palpation.
• Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of U.S. Patent No. *7,947,022* because it was cited by a U.S. Patent and Trademark Office examiner during the prosecution of a design patent application assigned to Defendant. The complaint also alleges knowledge of all three asserted patents based on the filing date of the original complaint in this action.

Case Timeline

Date	Event
2005-03-04	Priority Date for ’022, ’302, and ’615 Patents
2010-08-31	U.S. Patent No. *7,785,302* Issues
2011-05-24	U.S. Patent No. 7,947,022 Issues
2011-06-14	U.S. Patent No. *7,959,615* Issues
2011-07-27	Alleged Date of Defendant's Knowledge of ’022 Patent via PTO Action
2012-01-11	Original Complaint Filed
2012-09-17	First Amended Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,947,022 - "Access Port Identification Systems and Methods"

The Invention Explained

• Problem Addressed: The patent describes the difficulty in determining the specific model, style, or design of a medical access port once it has been subcutaneously implanted, noting that such uncertainty can be undesirable. (’302 Patent, col. 1:47-54).
• The Patented Solution: The invention is an implantable access port that includes an identification feature observable through imaging technology after implantation. This feature comprises "one or more alphanumeric characters" that identify the port as being "power-injectable," allowing clinicians to confirm this capability non-invasively via X-ray. (’022 Patent, Abstract; ’022 Patent, cl. 1). The shared specification provides an example of the alphanumeric characters "CT" etched into a disk on the bottom of the port. (’302 Patent, col. 11:51-67, Fig. 52B).
• Technical Importance: This technology aims to enhance patient safety by providing a reliable, non-invasive method for clinicians to verify an implanted port's suitability for specific procedures, such as high-pressure power injection of contrast media for CT scans. (’302 Patent, col. 3:49-54).

Key Claims at a Glance

The complaint asserts infringement of one or more unspecified claims of the ’022 patent (Compl. ¶11). Independent claim 1 is representative and includes the following essential elements:

• An access port for providing subcutaneous access to a patient, comprising: a body defining a fluid cavity accessible by inserting a needle through a septum; and
• at least one radiopaque identification feature of the access port observable via imaging technology subsequent to subcutaneous implantation of the access port,
• the at least one radiopaque identification feature including one or more alphanumeric characters identifying the access port as a power-injectable port.

The complaint does not specify any dependent claims but may reserve the right to assert them later in the litigation.

U.S. Patent No. 7,785,302 - "Access Port Identification Systems and Methods"

The Invention Explained

• Problem Addressed: The patent addresses the same technical problem as the ’022 Patent: the difficulty of identifying the specific characteristics of an access port after it has been implanted. (’302 Patent, col. 1:47-54).
• The Patented Solution: The invention is a venous access port assembly whose housing base includes "radiopaque alphanumeric characters." These characters are designed to convey to a practitioner, upon viewing an X-ray taken after implantation, that the port is "power injectable." (’302 Patent, cl. 1). The specification illustrates this concept with figures showing the letters "CT" on the bottom of the port housing. (’302 Patent, Fig. 52B).
• Technical Importance: By integrating a clear, radiographically visible indicator of power-injection capability, the invention provides a direct method for clinicians to avoid potentially dangerous misuse of ports not designed for high-pressure injections. (’302 Patent, col. 3:49-54).

Key Claims at a Glance

The complaint asserts infringement of one or more unspecified claims of the ’302 patent (Compl. ¶24). Independent claim 1 is representative and includes the following essential elements:

• A venous access port assembly for implantation into a patient, comprising: a housing having a discharge port, a needle-penetrable septum, and a cap...retaining the septum securely...
• the housing having a housing base defining a bottom wall of at least one reservoir, and an outwardly facing bottom surface,
• the housing base including radiopaque alphanumeric characters that convey to a practitioner that the venous access port assembly is power injectable when an X-ray of the patient is taken after implantation.

The complaint does not specify any dependent claims but may reserve the right to assert them later in the litigation.

U.S. Patent No. 7,959,615 - "Access Port Identification Systems and Methods"

Technology Synopsis

This patent addresses the same problem of post-implantation identification but proposes a solution based on the port's physical shape. The invention is an access port with a body that includes at least one concave side surface, which can be perceived by palpation to identify the port's characteristics, such as being power-injectable. (’615 Patent, cl. 1; ’302 Patent, col. 3:15-24).

Asserted Claims

The complaint asserts infringement of one or more unspecified claims of the ’615 patent; independent claims 1 and 8 are representative. (Compl. ¶37).

Accused Features

The complaint alleges that the accused products "include concave sides that provide a way to identify Defendant's Smart Port port products." (Compl. ¶45).

III. The Accused Instrumentality

Product Identification

Defendant's "implantable port products including, for example, Smart Port port products." (Compl. ¶11).

Functionality and Market Context

• The accused products are described as implantable ports "intended to facilitate frequent blood sampling or the delivery of medications, nutritions [sic], blood products and power injection of contrast media for imaging." (Compl. ¶17, ¶30).
• Plaintiff alleges Defendant markets these products as "identifiable under X-ray or scout scan through visualization of the CT markings located on the bottom of the port." (Compl. ¶19, ¶32).
• For certain products, Plaintiff alleges they "include concave sides that provide a way to identify Defendant's Smart Port port products." (Compl. ¶45).
• The complaint alleges Defendant sells these products throughout the United States but provides no specific information regarding market share or commercial significance. (Compl. ¶2).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

7,947,022 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a body defining a fluid cavity accessible by inserting a needle through a septum	The accused Smart Port products are implantable ports used for fluid delivery and blood sampling via needle access through a septum.	¶17	col. 3:35-45
at least one radiopaque identification feature of the access port observable via imaging technology subsequent to subcutaneous implantation	Defendant's Smart Port products are marketed as "identifiable under X-ray or scout scan" via markings on the bottom of the port.	¶19	col. 11:21-31
the at least one radiopaque identification feature including one or more alphanumeric characters identifying the access port as a power-injectable port	The accused products allegedly have "CT markings" and are intended for "power injection," which the markings allegedly serve to identify.	¶17, ¶19	col. 11:51-67

Identified Points of Contention

• Scope Questions: A central question may be whether the accused "CT markings," as implemented on the Defendant's products, meet the claim limitation of "one or more alphanumeric characters." The analysis may turn on whether a stylized logo or symbol is considered "alphanumeric."
• Technical Questions: The complaint's allegations rely on Defendant's marketing materials. A key factual question will be what evidence demonstrates that the accused markings are "radiopaque" and function to identify the port as "power-injectable" in the manner required by the claim.

7,785,302 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a housing having a discharge port, a needle-penetrable septum, and a cap...retaining the septum securely...	The accused Smart Port products are implantable ports having the basic structure of a housing, septum, and outlet for fluid delivery.	¶30	col. 3:35-45
the housing base including radiopaque alphanumeric characters	The accused products are alleged to have "CT markings located on the bottom of the port."	¶32	col. 11:51-67
that convey to a practitioner that the venous access port assembly is power injectable when an X-ray of the patient is taken after implantation	The "CT markings" are allegedly visible on an X-ray, and the products are marketed for power injection, suggesting the markings convey this capability.	¶30, ¶32	col. 12:1-10

Identified Points of Contention

• Scope Questions: As with the ’022 Patent, the dispute may focus on the proper construction of "radiopaque alphanumeric characters" and whether the accused "CT markings" fall within that scope.
• Technical Questions: What is the actual construction, material, and radiographic visibility of the "CT markings" on the accused products? The functional language "that conveys to a practitioner" raises the evidentiary question of how these markings are perceived and understood in a clinical setting.

V. Key Claim Terms for Construction

The Term: "radiopaque alphanumeric characters"

(’302 Patent, cl. 1) and "one or more alphanumeric characters" (’022 Patent, cl. 1)

• Context and Importance: The infringement allegations for the ’302 and ’022 patents are predicated on the accused "CT markings" meeting this limitation. The construction of this term is therefore critical to determining infringement. Practitioners may focus on this term because the Defendant could argue its "CT markings" are a stylized logo and not "alphanumeric characters."
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification refers to an "alphanumeric message 122 etched in a disk" and explicitly uses the letters "CT" as the example in Figure 52B, suggesting that common medical abbreviations are contemplated within the term's scope. (’302 Patent, col. 11:59-62, Fig. 52B).
  • Evidence for a Narrower Interpretation: The term "alphanumeric" has a plain meaning that may be argued to exclude purely graphical or stylized logos. A defendant may argue that the specific, distinct letters shown in Figure 52B of the patent limit the scope to standard, non-stylized characters.

The Term: "concave side"

(’615 Patent, cl. 1)

• Context and Importance: The infringement allegation for the ’615 Patent relies on this structural feature. The dispute will likely involve whether the accused product's shape meets this definition and whether that shape functions as an identifier.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The shared specification discloses embodiments with inwardly curving surfaces, such as "concave region 106 of side surface 50," suggesting the term could cover a variety of inwardly curved shapes on the side of the port. (’302 Patent, col. 9:48-56, Fig. 18).
  • Evidence for a Narrower Interpretation: The specification states that an identifiable feature may be "perceived by palpation." (’302 Patent, col. 3:16-17). A party could argue this functional context narrows the term to require a shape with a degree of concavity sufficient to be unambiguously identified by touch, as opposed to being merely a stylistic choice.

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement for all three patents. It asserts that Defendant provides instructional materials, such as "Instructions for Use," that direct medical professionals to use the accused Smart Port products in an infringing manner, specifically for power injection and identification via their markings or shape. (Compl. ¶17-18, ¶30-31, ¶43-44).

Willful Infringement

Willfulness is alleged for all three patents. For the ’022 Patent, the complaint alleges pre-suit knowledge based on a USPTO examiner citing the patent against Defendant's own design patent application on July 27, 2011. (Compl. ¶13). For all asserted patents, knowledge is also alleged as of the filing of the original complaint on January 11, 2012. (Compl. ¶26, ¶39). The complaint alleges that Defendant's infringement continued despite this knowledge. (Compl. ¶21, ¶34, ¶47).

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

• A core issue will be one of definitional scope: can the term "alphanumeric characters," as used in the ’022 and ’302 patents, be construed to cover the "CT markings" on the accused products, or will those markings be deemed a non-alphanumeric logo falling outside the claims?
• A second key issue will involve functionality and form: for the ’615 patent, does the accused product's external shape possess a "concave side" that is structurally and functionally capable of serving as a palpable identifier, as claimed, or is its curvature merely stylistic and incidental?
• A central evidentiary question will be one of technical proof: the complaint relies heavily on Defendant's marketing materials. The case may turn on factual evidence demonstrating how the accused products are actually constructed and how their features—whether radiographic markings or physical shape—are perceived and function in a clinical setting.