DCT
1:23-cv-04614
Cross Innovations LLC v. Wiesner
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Cross Innovations, LLC (Wyoming)
- Defendant: Juan Felipe Velez Wiesner (Colombia); Wiesner Healthcare Innovation LLC (Delaware); Wiesner Healthcare SAS (Colombia)
- Plaintiff’s Counsel: Dan B Law PLLC
- Case Identification: 1:23-cv-04614, S.D.N.Y., 05/30/2023
- Venue Allegations: Venue is alleged based on Defendants' establishment of regular distribution channels, including appointing Amazon.com as a distributor, to advertise and sell products to individuals located in the Southern District of New York.
- Core Dispute: Plaintiff seeks a declaratory judgment that its medical device does not infringe Defendant's patent related to external male incontinence clamps, and further alleges the patent is invalid and unenforceable, alongside claims of false advertising and unfair competition by the Defendants.
- Technical Context: The technology involves external mechanical clamps designed to manage male urinary incontinence by occluding the urethra, aiming to improve upon prior solutions that were often uncomfortable or unhygienic.
- Key Procedural History: This declaratory judgment action was filed after Defendants allegedly submitted an intellectual property infringement claim to Amazon.com on May 15, 2023, accusing Plaintiff's product of infringing U.S. Patent No. 11,642,205. The complaint notes this followed a similar, prior infringement claim regarding a parent patent, U.S. Patent No. 10,624,728, which was allegedly withdrawn. The complaint also contains significant allegations of inequitable conduct, asserting that the inventor failed to disclose his own prior product sales and other prior art to the USPTO during prosecution.
Case Timeline
| Date | Event |
|---|---|
| 2012-02-01 | Mr. Wiesner allegedly begins selling the WIESNER Incontinence Clamp in the U.S. |
| 2013-09-01 | WIESNER Incontinence Clamp allegedly offered for sale on Amazon.com. |
| 2014-01-01 | "Advertising Images" of the WIESNER clamp allegedly disclosed to the public. |
| 2015-04-24 | Defendant Wiesner Healthcare Innovation LLC is created. |
| 2016-08-31 | Priority Date for '728 and '205 Patents (App. No. 15/253,051 filed). |
| 2020-03-05 | Application for '205 Patent filed (as continuation of '051 application). |
| 2020-04-21 | U.S. Patent No. 10,624,728 Issues. |
| 2020-08-13 | Defendant allegedly submits infringement claim to Amazon re: '728 Patent. |
| 2023-05-09 | U.S. Patent No. 11,642,205 Issues. |
| 2023-05-15 | Defendant allegedly submits infringement claim to Amazon re: '205 Patent. |
| 2023-05-30 | Complaint for Declaratory Judgment filed. |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,642,205 - "External Male Incontinence Clamp" (issued May 9, 2023)
The Invention Explained
- Problem Addressed: The patent describes prior art incontinence solutions, such as adult diapers, as "bulky, retain the moisture, and are embarrassing" ('205 Patent, col. 1:20-22). Existing clamps are described as often being uncomfortable, ineffective due to poor anatomical fit, and unhygienic because they use foam pads that collect urine or materials that cause slippage ('205 Patent, col. 1:23-34).
- The Patented Solution: The invention is a hinged clamp with an upper and lower arm designed to encircle the penis. The key innovation appears to be a system of guides that are coupled to the inner surfaces of the clamp arms to better "adapt the user anatomy in shape and size" ('205 Patent, col. 2:22-23). Specifically, the lower guide is described as having a protrusion to apply pressure to the urethra while allowing blood circulation, and in some embodiments, the guides are removable and interchangeable ('205 Patent, col. 2:40-54, 2:55-59).
- Technical Importance: The claimed design seeks to provide a more effective, comfortable, and customizable fit for users, addressing issues of hygiene and secure positioning common in earlier devices ('205 Patent, col. 1:35-40).
Key Claims at a Glance
- The complaint seeks a declaratory judgment of non-infringement of the independent claims of the '205 patent (Compl. ¶51). The independent claims are 1, 9, and 18.
- Independent Claim 1 (representative elements):
- An upper and a lower clamp arm "dimensioned to partially encircle a penis of a user."
- A hinge connecting the first ends of the clamp arms.
- An "upper guide" with a "curved concave-inner surface, a convex outer surface," and an "upper attachment."
- An "upper padding" attached to cover the upper guide, "exclusive of the upper attachment."
- A "removable lower guide" with a middle portion comprising a "protrusion oriented towards the upper clamp arm" and a "lower attachment for removably coupling" it.
- A "lower padding" shaped as a cover to be secured over the removable lower guide, "exclusive of the lower attachment."
- Independent Claim 9 (representative elements):
- An upper and a lower clamp arm, a hinge, and a connector.
- An "upper guide" with an "upper attachment."
- A "removable lower guide" having a "convex outer face" and a "concave inner face."
- A "lower padding" shaped as a cover for the removable lower guide.
- Plaintiff seeks a declaration that it does not infringe "any claim" of the patent (Compl. ¶56).
III. The Accused Instrumentality
Product Identification
- The LUNDERG Confidence Clamp (Compl. ¶2).
Functionality and Market Context
- The LUNDERG Confidence Clamp is described as a medical product for male patients with urinary incontinence that is sold on Amazon.com (Compl. ¶2). The complaint alleges that the product's design differs materially from the patented invention. Specifically, the complaint alleges that the LUNDERG clamp's "top stabilizer is not removable and therefore cannot have the claimed upper attachment" (Compl. ¶52). It further alleges the product does not have a "removable lower guide comprising a concave inner face" as recited in Claim 9 (Compl. ¶53). An image provided in the complaint shows the accused LUNDERG clamp disassembled in its packaging, illustrating its constituent parts (Compl. p. 9).
IV. Analysis of Infringement Allegations
The complaint seeks a declaratory judgment of non-infringement. The following table summarizes Plaintiff's key allegations of how its product fails to meet the limitations of a representative independent claim.
'205 Patent Infringement Allegations (Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an upper guide dimensioned to span a majority of the arcuate inner surface of the upper clamp arm... comprising a curved concave-inner surface, a convex outer surface, and an upper attachment... | The LUNDERG clamp allegedly does not possess a removable "upper guide." The complaint states its "top stabilizer is not removable" and therefore lacks the claimed "upper attachment" and does not have the claimed surface curvatures. | ¶52 | col. 4:8-15 |
| an upper padding attached to cover the upper guide, exclusive of the upper attachment | As the LUNDERG clamp allegedly lacks the claimed "upper guide" and "upper attachment," it cannot meet this limitation. | ¶52 | col. 4:14-16 |
| a removable lower guide dimensioned to span a majority of the arcuate inner surface of the lower clamp arm... and a lower attachment for removably coupling the removable lower guide with the lower clamp arm | The complaint alleges the LUNDERG clamp does not possess the "removable lower guide" as claimed. It specifically disputes having the "concave inner face" feature recited in the related independent Claim 9. | ¶53 | col. 4:17-25 |
| a lower padding shaped as a cover that is sized to be secured over the removable lower guide, exclusive of the lower attachment | As the LUNDERG clamp allegedly lacks the claimed "removable lower guide," it cannot meet this limitation regarding a padding that covers it. | ¶53 | col. 4:26-29 |
- Identified Points of Contention:
- Scope Questions: A central issue may be whether the term "upper guide" requires a component that is structurally separate and attachable, or if it can read on an integrated feature like the accused product's "top stabilizer." The complaint's focus on the stabilizer not being "removable" suggests this will be a key area of dispute (Compl. ¶52).
- Technical Questions: The dispute will likely involve a direct structural comparison. A key question is whether the accused product's lower component embodies the specific features of the claimed "removable lower guide," including its method of attachment and its surface geometry (e.g., the "protrusion" of Claim 1 or the "concave inner face" of Claim 9) (Compl. ¶52-53).
V. Key Claim Terms for Construction
The Term: "upper guide"
Context and Importance: This term is critical because the Plaintiff's primary non-infringement argument is that its product's "top stabilizer" is not an "upper guide" because it is not removable and lacks the claimed attachment mechanism (Compl. ¶52). The construction of this term may resolve the infringement question for claims reciting this element.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The abstract of the '205 patent states an upper guide is "coupled" to the inner surface of the upper clamp arm, a term that does not inherently require removability ('205 Patent, Abstract).
- Evidence for a Narrower Interpretation: The specification, incorporated by reference from the parent application, describes an embodiment where "the upper guide 24 and the lower guide 26 are releasably attached" and states, "Since the upper and lower guides 24, 26 may be removable, a user may replace the guides..." ('728 Patent, col. 2:53-58). This language may support an interpretation that a "guide" must be a replaceable component.
The Term: "removable lower guide"
Context and Importance: Plaintiff explicitly denies that its product possesses a "removable lower guide" with the claimed features (Compl. ¶53). The definition of what constitutes "removable" and the specific structural features of the guide are central to this dispute.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Claim 1 recites a "lower attachment for removably coupling" the guide, which could be interpreted broadly to cover any non-permanent means of connection ('205 Patent, col. 4:23-25).
- Evidence for a Narrower Interpretation: The specification describes a specific mechanism for attachment: "The lower clamp guide 26 includes a ridge releasably retained within the slot 20" ('205 Patent, col. 2:63-65). A party could argue that "removable" should be construed in light of this disclosed embodiment.
VI. Other Allegations
- Unenforceability (Inequitable Conduct): The complaint alleges that the '205 patent is unenforceable due to "infectious unenforceability" stemming from alleged inequitable conduct during the prosecution of its parent patent, '728 (Compl. ¶59). The core allegation is that the inventor intentionally withheld material prior art from the USPTO with an intent to deceive, including: (1) his own commercial sales of the WIESNER clamp beginning in 2012, more than one year before the 2016 priority date; (2) public "Advertising Images" from 2014; and (3) a similar prior art product, the "BioDerm Kind Klamp" (Compl. ¶58, 61).
- False Advertising and Unfair Competition: Plaintiff alleges Defendants engaged in false advertising under the Lanham Act by making literally false claims, including that their product is "FDA approved" when it is not registered with the FDA (Compl. ¶67-69) and that it has served "millions of patients" when the number is allegedly closer to tens of thousands (Compl. ¶65-66). The complaint also alleges Defendants marketed a product under the name "Virth Healthcare," which is not an existing legal entity (Compl. ¶71-72).
VII. Analyst’s Conclusion: Key Questions for the Case
- A threshold issue will be one of enforceability and validity: can the plaintiff prove by clear and convincing evidence that the inventor withheld material prior art—including his own alleged pre-filing commercial sales—from the USPTO with an intent to deceive, potentially rendering the '205 patent unenforceable due to inequitable conduct or invalid under the on-sale bar?
- A central infringement question will be one of claim construction: does the term "guide," as used in the patent, require a physically separate and replaceable component, as suggested by certain embodiments in the specification? The answer may determine whether the accused product's integrated features fall outside the scope of the claims.
- Separate from the patent issues, the case presents a significant factual dispute regarding commercial conduct: can the plaintiff demonstrate that the defendants' marketing claims about FDA approval and patient numbers are literally false, which could lead to an injunction and damages under federal and state unfair competition laws?