DCT

2:20-cv-07396

NovaPlast Corp v. Inplant LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:20-cv-07396, D.N.J., 06/17/2020
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because both Defendants are organized under New Jersey law and maintain their principal places of business in the state.
  • Core Dispute: Plaintiff alleges that Defendants’ surgical funnels, used for inserting prosthetic implants, infringe a patent related to a delivery device with an adjustable, pre-formed sizing mechanism.
  • Technical Context: The technology concerns sterile medical devices designed to facilitate "no-touch" insertion of deformable implants, such as breast implants, through surgical incisions smaller than the implant itself.
  • Key Procedural History: The complaint alleges that Plaintiff sent Defendants a letter on September 26, 2018, notifying them of the '213 patent's imminent issuance and providing a copy of the claims. It further alleges that after Plaintiff sent a cease and desist letter concerning Accused Product 1, Defendants developed and began selling Accused Product 2 as a purported design-around.

Case Timeline

Date Event
2015-12-29 ’213 Patent Priority Date
After 2015-12-29 Accused Product 1 first made publicly available
2018-09-26 Plaintiff allegedly sent pre-issuance notice letter to Defendants
2018-10-23 ’213 Patent Issued
2020-06-17 Complaint Filed

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

U.S. Patent No. 10,105,213 - "Prosthetic implant delivery device and method," issued October 23, 2018 (’213 Patent)

The Invention Explained

  • Problem Addressed: The patent's background describes challenges with existing methods for inserting prosthetic implants, which can be time-consuming and risk damaging or contaminating the implant. Specifically, it notes that prior art funnels require a surgeon to manually cut the tip to the desired size, an imprecise process that can lead to waste if an error is made. (’213 Patent, col. 1:32-41, 1:56-62).
  • The Patented Solution: The invention is a delivery device with a flexible, elongated body that has a closed proximal end and an openable distal end. The key feature is a set of selectable fasteners along the edges of a longitudinal opening at the distal end. By engaging a specific fastener, a surgeon can form a distal opening of a predetermined, desired size without the need for cutting, thereby creating a more efficient and reliable system. (’213 Patent, Abstract; col. 2:25-31). The patent illustrates this with various fastener types, including zip-type channels and shoulders. (’213 Patent, Fig. 1).
  • Technical Importance: The claimed invention aims to provide a "touchless" implant delivery method that combines ease of use with an integrated, non-destructive sizing mechanism, which could reduce surgical time and the risk of implant damage. (’213 Patent, col. 5:35-41).

Key Claims at a Glance

  • The complaint asserts "one or more claims" without specifying them (Compl. ¶45). The following analysis focuses on Independent Claim 1, as corrected by the Certificate of Correction.
  • The essential elements of Claim 1 are:
    • a flexible elongated member defining a proximal end and a distal end,
    • the proximal end formed opposite the distal end and defining a closed end,
    • the distal end defining a longitudinal opening;
    • the distal end including a first longitudinal edge and a second longitudinal edge...further defining the longitudinal opening,
    • at least one first fastener formed on the elongated member adjacent the first longitudinal edge,
    • and a second fastener formed on the elongated member adjacent the second longitudinal edge;
    • the second fastener adapted to matingly engage with the at least first fastener and to close the longitudinal opening,
    • whereby a predetermined size distal opening is formed based on the engagement of the second fastener with the at least one first fastener,
    • the distal opening sized to allow the prosthetic implant to be urged therethrough.
  • The complaint does not explicitly reserve the right to assert dependent claims, but infringement is alleged for "one or more claims." (Compl. ¶45).

III. The Accused Instrumentality

Product Identification

The complaint identifies two accused products: "Accused Product 1" and "Accused Product 2," both sold under the brand name "iNPLANT Funnel." (Compl. ¶5-6).

Functionality and Market Context

  • The accused products are described as flexible, cone-shaped surgical funnels for breast augmentation procedures. (Compl. ¶5, ¶25).
  • Accused Product 1 is alleged to have a flexible body with a closed proximal end and a distal end with a longitudinal opening defined by two edges. The complaint alleges it has "at least one first fastener" and a "second fastener" that matingly engage to close the opening and form a "predetermined size distal opening." (Compl. ¶26-27). A product instruction sheet for this product, attached as Exhibit 4, shows a feature called the "Glide Track" for closing the funnel and instructs users to "Cut the tip of the funnel to the desired size." (Compl. Ex. 4, p. 39).
  • Accused Product 2 is described as a design-around, manufactured with a closed distal end that has a perforation. (Compl. ¶21, ¶29). The complaint alleges that once this perforated portion is removed by the user, the product has the same allegedly infringing features as Accused Product 1. (Compl. ¶30). Instructions for Accused Product 2, provided as Exhibit 5, depict the step of removing the "perforated tab" to open the funnel's tip. (Compl. Ex. 5, p. 42).

IV. Analysis of Infringement Allegations

’213 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a flexible elongated member defining a proximal end and a distal end, the proximal end formed opposite the distal end and defining a closed end, the distal end defining a longitudinal opening; The accused products include a flexible elongated member with a closed proximal end and a distal end with a longitudinal opening. ¶26, ¶29 col. 5:25-30, 5:48-49
the distal end including a first longitudinal edge and a second longitudinal edge...further defining the longitudinal opening, The distal end of the accused products allegedly includes a first and second longitudinal edge defining the opening. ¶27, ¶30 col. 5:28-30
at least one first fastener formed on the elongated member adjacent the first longitudinal edge, and a second fastener formed on the elongated member adjacent the second longitudinal edge; The accused products allegedly have a first fastener and a second fastener formed on the member adjacent to the respective longitudinal edges. ¶27, ¶30 col. 5:58-6:2
the second fastener adapted to matingly engage with the at least first fastener and to close the longitudinal opening, The second fastener on the accused products allegedly "matingly engages with the at least first fastener to close the longitudinal opening." ¶27, ¶30 col. 6:1-2
whereby a predetermined size distal opening is formed based on the engagement of the second fastener with the at least one first fastener, the distal opening sized to allow the prosthetic implant to be urged therethrough. The complaint alleges that engagement of the fasteners forms a "predetermined size distal opening" that is sized to allow the implant to pass through. ¶27, ¶30 col. 6:3-7

Identified Points of Contention

  • Technical Question: A primary dispute may arise from the functionality of the claimed "fastener." The patent positions its invention as an improvement over prior art that requires cutting to size. However, the instructions for Accused Product 1 explicitly direct users to "Cut the tip of the funnel to the desired size," and the instructions for Accused Product 2 state users "may wish to trim the opening." (Compl. Ex. 4, p. 39; Ex. 5, p. 42). This raises the question of whether the accused products form a "predetermined size distal opening...based on the engagement of the...fastener," as the claim requires, or if sizing is accomplished by a separate, conventional cutting step.
  • Scope Questions: For Accused Product 2, which is sold with a perforated tip, a question exists as to whether the seller is directly infringing. The complaint alleges direct infringement. (Compl. ¶51). Defendants may argue that the product as sold does not meet the "longitudinal opening" limitation and that any infringement occurs only after modification by the end-user, thereby shifting the dispute to induced infringement.

V. Key Claim Terms for Construction

  • The Term: "fastener"

    • Context and Importance: The definition of "fastener" is critical because the accused products' "Glide Track" must fall within its scope. More importantly, the function of the fastener is tied to the sizing of the opening, which appears to be a point of direct conflict between the claim language and the accused products' own instructions.
    • Intrinsic Evidence for a Broader Interpretation: The specification discloses numerous embodiments of fasteners, including "zip-type," "snap attaching units," "receiving slots" with "tabs," and "hook and loop enclosure[s]," suggesting the term is not limited to a single structure. (’213 Patent, col. 4:27-38; Figs. 7-10).
    • Intrinsic Evidence for a Narrower Interpretation: The patent consistently describes the purpose of the fastener system as a way to select a "desired size of the distal opening" to avoid the imprecise "cutting a portion of the end of the sleeve" required by the prior art. (’213 Patent, col. 2:25-31; col. 1:56-62). A party could argue that to be a "fastener" under the patent, the structure must not only close the device but also be the primary mechanism for setting the final opening size, a function the accused products' instructions assign to cutting.

  • The Term: "a predetermined size distal opening is formed based on the engagement of the...fastener"

    • Context and Importance: This phrase is the functional core of the asserted claim. The infringement analysis will turn on whether the accused products' "Glide Track" performs this sizing function, or if it merely closes the side of the funnel while sizing is left to a separate cutting step.
    • Intrinsic Evidence for a Broader Interpretation: A plaintiff may argue that engaging the "Glide Track" necessarily results in an opening of a size, and that this size is "predetermined" by the product's geometry, thus satisfying the limitation, regardless of whether a user later chooses to trim it further.
    • Intrinsic Evidence for a Narrower Interpretation: A defendant may argue that this phrase requires the fastener engagement itself to be the causation of the final, clinically-desired opening size. Citing the product's instructions to "Cut the tip...to the desired size" (Compl. Ex. 4, p. 39), they could contend that the opening size is "based on" cutting, not the fastener engagement, placing the products outside the claim scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for Accused Product 2. (Compl. ¶52). This allegation is based on Defendants' instructions for use, which allegedly direct users to remove the perforated distal end, thereby configuring the product in an infringing manner. (Compl. ¶33, ¶37; Ex. 5).
  • Willful Infringement: Willfulness is alleged for both direct and indirect infringement. (Compl. ¶47, ¶53). The allegations are based on Defendants’ alleged pre-suit knowledge of the ’213 Patent, stemming from a notice letter Plaintiff allegedly sent on September 26, 2018—before the patent issued—which included a copy of the patent claims to be issued. (Compl. ¶39-40).

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

  1. A central issue will be one of infringement and claim scope: Can a product whose own instructions direct the user to "cut" or "trim" the tip to achieve a "desired size" be found to infringe a claim that requires a "predetermined size distal opening" to be "formed based on the engagement of the...fastener"? This question forces a confrontation between the physical capabilities of the accused device and its instructed method of use.

  2. A key liability question for Accused Product 2 will be the theory of infringement: Does selling a device with a perforated tip that must be removed by the end-user to create the allegedly infringing "longitudinal opening" constitute direct infringement by the manufacturer, or is the claim limited to induced infringement based on the provided instructions?

  3. The case will likely feature a significant dispute over willfulness: Given the complaint’s allegation that Defendants received pre-issuance notice of the patent’s claims, a critical factual question will be what steps, if any, Defendants took to form a good-faith belief of non-infringement before and after the patent issued, particularly in relation to the development of Accused Product 2 as an alleged design-around.