DCT
2:18-cv-04169
Becon Medical Ltd v. Bartlett
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Becon Medical, Ltd. (Arizona) and Henry Stephenson Byrd, MD (Texas)
- Defendant: Scott P. Bartlett, MD (Pennsylvania) and TalexMedical, LLC (Pennsylvania)
- Plaintiff’s Counsel: Saul Ewing Arnstein & Lehr LLP; McDonald Hopkins, PLC
- Case Identification: 2:18-cv-04169, E.D. Pa., 11/14/2018
- Venue Allegations: Venue is alleged to be proper as Defendants reside in the district, have a principal place of business in the district, and have committed alleged acts of infringement in the district.
- Core Dispute: Plaintiffs allege that Defendants’ "InfantEar" ear molding system infringes two patents directed to non-surgical devices for correcting ear deformities in infants.
- Technical Context: The technology involves non-surgical, external devices that apply gentle, continuous pressure to reshape an infant’s ear cartilage while it is still pliable, thereby correcting congenital deformities.
- Key Procedural History: The complaint alleges that Defendant Dr. Bartlett is a former medical resident of the inventor, Dr. Byrd, and a former customer who received training on Plaintiffs' patented "EarWell" system before founding a competing company. The complaint also alleges that a patent application filed by Defendants cites the patents-in-suit. Subsequent to the filing of this complaint, Inter Partes Review (IPR) proceedings resulted in the cancellation of the specific independent claims asserted in this complaint for both patents-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2009-02-10 | Priority Date for ’942 and ’277 Patents |
| 2011-11-29 | Dr. Bartlett allegedly first ordered Plaintiff's product |
| 2012-05-01 | U.S. Patent No. 8,167,942 Issues |
| 2013-01-01 | Dr. Bartlett allegedly began purchasing only "retractors" |
| 2014-10-07 | U.S. Patent No. 8,852,277 Issues |
| 2017-01-01 | Dr. Bartlett allegedly stopped all purchases and founded TalexMedical |
| 2018-11-14 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,167,942 - Ear Molding Device for Correcting Misshaped Ears, Issued May 1, 2012
The Invention Explained
- Problem Addressed: The patent addresses the high incidence of congenital ear deformities in newborns, such as "prominent ear," "lop ear," and "Stahl's ear," which result from malformations of the ear's cartilage framework (Compl. ¶13; ’942 Patent, col. 1:26-48).
- The Patented Solution: The invention is a non-surgical molding device that reshapes an infant's ear. It comprises "one or more braces" that support a "scaphal mold." This assembly is designed to fit over the outer rim of the ear (the helix), holding it in a "substantially correct anatomical shape" and guiding its growth to conform to the space created by the device (’942 Patent, Abstract; col. 2:4-10).
- Technical Importance: The device provides a non-invasive method for correcting ear deformities during the neonatal period, when the ear cartilage is highly malleable and responsive to external molding forces (’942 Patent, col. 1:56-58).
Key Claims at a Glance
- The complaint asserts independent Claim 1 as an illustrative example of infringement (Compl. ¶40).
- Essential elements of Claim 1 include:
- A molding device for a human ear comprising:
- one or more braces; and
- a scaphal mold supported by the one or more braces;
- wherein the components are "constructed to retain" the helix and helical rim within a defined space, "maintain a substantially correct anatomical shape," and "mold the helix and helical rim during their growth."
- A 2023 Inter Partes Review Certificate indicates that Claim 1 has been cancelled (’942 Patent, IPR Certificate p. 2). The complaint does not explicitly reserve rights to assert other claims but makes general allegations of infringement of "one or more claims" (Compl. ¶27).
U.S. Patent No. 8,852,277 - Ear Molding Device for Correcting Misshaped Ears, Issued October 7, 2014
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem of correcting congenital ear deformities as its parent, the ’942 Patent (’277 Patent, col. 1:24-64).
- The Patented Solution: This patent claims a more comprehensive system. It includes the molding device from the ’942 patent, but adds an external "cradle" that surrounds the ear. This cradle has a base section that adheres to the skin behind the ear and a "releasably engageable" cover. This two-part cradle creates a secure compartment that holds the inner molding device in a stable position against the ear (’277 Patent, Abstract; col. 2:21-36).
- Technical Importance: The cradle system provides a stable external anchor for the molding components, which may improve the consistency of the corrective forces and protect the device from being dislodged (’277 Patent, col. 6:1-4).
Key Claims at a Glance
- The complaint asserts independent Claim 1 as an illustrative example of infringement (Compl. ¶51).
- Essential elements of Claim 1 include:
- A molding system for a human ear comprising:
- A "cradle" with a "base section" defining an opening for the ear and a "cover releasably engageable with the base section."
- An "ear molding device" (comprising braces and a scaphal mold) positioned within the cradle, which is "adapted to retain" the helix and helical rim and "maintain a substantially correct anatomical shape."
- A 2023 Inter Partes Review Certificate indicates that Claim 1 has been cancelled (’277 Patent, IPR Certificate p. 2). The complaint makes general allegations of infringement of "one or more claims" (Compl. ¶50).
III. The Accused Instrumentality
Product Identification
- The "InfantEar" non-surgical ear molding system (Compl. ¶27).
Functionality and Market Context
- The complaint alleges the InfantEar system is a direct competitor to Plaintiffs' EarWell™ system (Compl. ¶21). Based on allegations and visual evidence, the system includes a conformer or molding piece that is placed on the infant's ear to reshape the cartilage, as well as a larger assembly that surrounds the ear (Compl. ¶¶ 40, 51). A screenshot from an instructional video shows a "Step 6: Select conformers" stage in the application process (Compl. ¶40, p. 7). The product is allegedly sold online and through direct sales calls to Plaintiffs' own customers (Compl. ¶34).
IV. Analysis of Infringement Allegations
’942 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A molding device for a human ear...comprising: one or more braces; and a scaphal mold supported by the one or more braces... | The InfantEar molding device, referred to as a "conformer," is alleged to include a "Mold" and one or more "Brace" components. | ¶40 | col. 2:4-6 |
| wherein the one or more braces and the scaphal mold are constructed to retain the helix and helical rim within a space defined between the one or more braces and the scaphal mold... | The complaint alleges the accused device is constructed to retain the helix and helical rim within the space defined by the device's components. | ¶40 | col. 2:6-9 |
| and further constructed to maintain a substantially correct anatomical shape of the helix and the helical rim... | The complaint alleges the device is constructed to maintain a correct anatomical shape. A video still is provided to support this allegation. | ¶40 | col. 2:9-10 |
| wherein the scaphal mold and one or more braces are constructed to mold the helix and helical rim during their growth such that the growth...conforms to the space between the scaphal mold and the one or more braces. | The complaint alleges the device is constructed to mold the ear during growth so that it conforms to the space created by the device's components. | ¶40 | col. 10:29-34 |
- Identified Points of Contention:
- Claim Viability: A threshold issue is that asserted Claim 1, along with most other claims of the patent, was cancelled in a 2023 IPR proceeding. The complaint was filed in 2018, before this cancellation. The viability of this count is therefore a primary question for the court.
- Scope Questions: The term "constructed to" appears repeatedly. The dispute may focus on whether the accused device has a specific structure that inherently achieves the claimed functions (retaining, maintaining, molding) or if it is a general structure that is merely capable of being used to do so.
’277 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A molding system for a human ear, ... comprising: a cradle comprising: a base section defining an opening dimensioned to accommodate the passage of the ear... | The InfantEar product is alleged to include a cradle with a base section that has an opening for the ear. A screenshot identifies the "Base" and "Opening." | ¶51 | col. 2:21-24 |
| a cover releasably engageable with the base section, wherein the cover, when engaged...defines a compartment between an inner surface of the cover and an inner surface of the base section... | The product is alleged to include a cover that is "releasably attached to base" and that defines a compartment. A screenshot shows this accused feature. | ¶51 | col. 2:26-30 |
| and an ear molding device comprising: one or more braces; and a scaphal mold supported by the one or more braces...adapted to retain the helix and helical rim...and to maintain a substantially correct anatomical shape of the helical rim. | The product is alleged to include an ear molding device (conformer) with braces and a scaphal mold that are adapted to retain and shape the helix and helical rim. A video still is referenced. | ¶51 | col. 2:30-36 |
- Identified Points of Contention:
- Claim Viability: As with the ’942 Patent, asserted Claim 1 of the ’277 Patent was cancelled in a 2023 IPR proceeding, raising a primary question about the viability of this count as pled.
- Technical Questions: A potential dispute concerns the term "releasably engageable." The complaint provides a visual of a cover attached to the base (Compl. ¶51, p. 12). The court may need to determine if this method of attachment meets the definition of "engageable" as contemplated by the patent, which describes various mechanisms like snaps or hook-and-loop fasteners.
V. Key Claim Terms for Construction
Term from ’942 Patent: "constructed to"
- Context and Importance: This term appears in multiple functional limitations of Claim 1. Its construction is critical because it defines the required relationship between the device's physical structure and its intended purpose. Practitioners may focus on this term to dispute whether the accused product's structure is specifically designed to perform the claimed functions or is merely capable of doing so.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's general statements about providing "techniques... for non-surgical correction of misshapen ears" could support a reading where any structure capable of achieving the result meets the limitation (’942 Patent, col. 2:63-64).
- Evidence for a Narrower Interpretation: The detailed description and figures show specific structural arrangements, such as the curvature of the legs and the shape of the scaphal mold, that are explicitly linked to achieving the correct anatomical outcome, suggesting "constructed to" requires a purpose-built design (’942 Patent, col. 7:40-47; FIG. 6A).
Term from ’277 Patent: "releasably engageable"
- Context and Importance: This term defines how the cradle's cover and base connect. The strength and nature of this connection are central to the cradle's function of creating a stable, protective compartment. The dispute will likely center on what level of connection qualifies as "engageable."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification explicitly lists multiple types of connections, including "two or more snaps, or a hinge and one or more snaps, or hook and loop fasteners, or lug and notch, or a latch type mechanism, or any other type of fastening mechanism," which suggests the term is meant to be inclusive of many connection types (’277 Patent, col. 5:22-26).
- Evidence for a Narrower Interpretation: The function of the engagement is to form a "compartment" that provides "additional stability to the ear molding device resisting the traction exerted by the ear," which could suggest a connection that is more secure than simply placing the cover on the base (’277 Patent, col. 2:28-30, col. 8:62-65).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Defendants, with knowledge of the patents, provided "instructions, videos, and otherwise" to encourage infringing use by customers (Compl. ¶45, ¶56). Contributory infringement is based on the allegation that the InfantEar system has no substantial non-infringing use (Compl. ¶46, ¶57).
- Willful Infringement: Willfulness is alleged based on pre-suit knowledge of the patents. The complaint claims this knowledge arises from Defendant Dr. Bartlett's history as a customer and trainee for the patented product, and from the fact that Defendants' own patent application cited the patents-in-suit (Compl. ¶41, ¶52).
VII. Analyst’s Conclusion: Key Questions for the Case
- A dispositive issue for the case as currently pled is one of claim viability: what is the legal effect of the post-filing IPR proceedings that cancelled the only independent claims asserted in the complaint? The court will need to determine if Plaintiffs can maintain these counts or would need to amend the complaint to assert any surviving dependent claims.
- Should the case proceed, a central issue will be one of functional construction: how will the court define terms like "constructed to" and "adapted to"? This will determine whether infringement requires a product specifically engineered for the claimed purpose or if a product that is merely capable of performing the function is sufficient.
- A key evidentiary question will be one of technical operation: what evidence will be required to prove that the accused InfantEar system actually performs the specific molding and shaping functions recited in the claims, such as molding the ear "during their growth" to conform to a specific anatomical space?