DCT
1:24-cv-02745
Nanjing 3H Medical Products Co Ltd v. KT Health LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Nanjing 3H Medical Products Co., Ltd. (P.R. China)
- Defendant: KT Health, LLC (Delaware)
- Plaintiff’s Counsel: Pequignot + Myers
- Case Identification: 1:24-cv-02745, D. Md., 09/23/2024
- Venue Allegations: Venue is based on Defendant’s business activities in Maryland, which include advertising, selling products to Maryland residents, conducting demonstration seminars, and storing accused products in an Amazon warehouse located in Baltimore.
- Core Dispute: Plaintiff seeks a declaratory judgment that its kinesiology tape products do not infringe Defendant's utility and design patents, and further that those patents are invalid and unenforceable, following Defendant’s patent infringement complaints submitted to Amazon.com.
- Technical Context: The technology involves pre-cut, elastic therapeutic kinesiology tape, a product used in sports medicine and physical therapy to provide support and alleviate pain from injuries.
- Key Procedural History: This action was precipitated by Defendant KT Health filing an infringement complaint with Amazon.com around June 18, 2024, targeting Plaintiff 3H Medical’s products for allegedly infringing U.S. Design Patent No. D962,344. The complaint alleges a prior business relationship where 3H Medical developed and manufactured products for KT Health’s founder. The core of the case rests on allegations that KT Health’s patents are invalid due to statutory bars (prior public use and sale) and functionality, and are unenforceable due to inequitable conduct (failure to disclose material prior art and misidentification of inventors).
Case Timeline
| Date | Event |
|---|---|
| 2008-11-11 | Alleged first public use and distribution of product samples |
| 2008-11-25 | Earliest priority date claimed by '115 and '571 Patents |
| 2009-01-20 | KT Health website allegedly goes live, constituting public disclosure |
| 2009-04-18 | "Intro to KT Tape" YouTube video published by KT Health |
| 2013-12-19 | Priority date for '697 Patent |
| 2016-04-12 | U.S. Patent No. 9,308,115 issues |
| 2020-04-14 | U.S. Patent No. 10,617,571 issues |
| 2020-08-31 | Priority date for '944 Patent |
| 2021-04-13 | U.S. Patent No. 10,973,697 issues |
| 2022-04-05 | Priority date for '344 Patent |
| 2022-04-05 | U.S. Design Patent No. D947,944 issues |
| 2022-08-30 | U.S. Design Patent No. D962,344 issues |
| 2022-08-30 | Priority date for '400 and '420 Patents |
| 2023-06-06 | U.S. Design Patent No. D988,400 issues |
| 2024-01-16 | U.S. Design Patent No. D1,011,420 issues |
| 2024-06-18 | KT Health files infringement complaint with Amazon.com |
| 2024-09-23 | Complaint for Declaratory Judgment filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Design Patent No. D962,344 - "Roll of Pre-Cut Strips of Kinesiology Tape," Issued August 30, 2022
The Invention Explained
- Problem Addressed: Design patents protect ornamental appearance, not functional solutions. The complaint does not allege the design itself solves a problem, but rather that its features are dictated by function (Compl. ¶74).
- The Patented Solution: The patent claims the ornamental design for a roll of pre-cut kinesiology tape. The claimed design, illustrated in the patent’s figures, consists of an elongated strip of tape with rounded ends and a constricted, "waist"-like area between adjacent segments, shown partially unspooled from a roll (D’962,344 Patent, Fig. 1). The complaint includes an image of this patented design to support its invalidity arguments (Compl. ¶62, p. 21).
Key Claims at a Glance
- As a design patent, the '344 Patent contains a single claim: "The ornamental design for a roll of pre-cut strips of kinesiology tape, as shown and described" (D’962,344 Patent, Claim).
U.S. Patent No. 9,308,115 - "Body-Adhesive Kinesiology Tape," Issued April 12, 2016
The Invention Explained
- Problem Addressed: The patent's background describes issues with conventional kinesiology tape sold in continuous rolls, which requires users to custom-cut strips. This process can be difficult, requires sharp scissors, and often results in sharp corners that can fray, snag on clothing, or cause discomfort ('115 Patent, col. 1:48-68).
- The Patented Solution: The invention provides pre-cut, ready-to-use strips of kinesiology tape on a roll with a backing material, eliminating the need for custom cutting ('115 Patent, col. 2:4-6). Key features include rounded corners to prevent fraying and improve comfort, and a specific adhesive pattern to ensure adhesion while allowing the skin to breathe ('115 Patent, col. 4:11-22).
- Technical Importance: This approach makes kinesiology tape more accessible and user-friendly for consumers who may not have the tools or expertise to properly prepare tape from a continuous roll ('115 Patent, col. 2:12-24).
Key Claims at a Glance
- The complaint asserts invalidity and unenforceability of the patent and references independent claims 1 and 6, and dependent claim 9 (Compl. ¶¶77, 78, 81).
- The essential elements of asserted independent claim 1 are:
- A body-adhesive kinesiology tape comprising individual strips where a user need not cut the tape before use.
- The tape comprises a strip of pre-cut, tear-resistant, and resiliently elastic woven fibers.
- An adhesive is applied to the tape's surface in a "step frequency pattern" including a "modified sine wave pattern."
- A backing material covers the adhesive to protect it from drying until use.
- The complaint reserves the right to challenge other claims.
Multi-Patent Capsules
- U.S. Design Patent No. D947,944, "Roll of Pre-Cut Strips of Tape," Issued April 5, 2022:
- Technology Synopsis: This patent claims an ornamental design for a roll of pre-cut tape, similar to the '344 Patent. The design features pre-cut strips with a "waist" and rounded corners, shown on a roll (D'947,944 Patent, Fig. 1).
- Asserted Claims: One design claim.
- Accused Features: The complaint alleges the '944 Patent is invalid for the same reasons as the '344 Patent, namely that its claimed design is functional and anticipated by prior art (Compl. ¶¶71, 80, 84).
- U.S. Design Patent No. D988,400, "Roll of Pre-Cut Strips of Kinesiology Tape," Issued June 6, 2023:
- Technology Synopsis: This patent claims an ornamental design for a roll of pre-cut tape. The design features are similar to those in the '344 and '944 patents.
- Asserted Claims: One design claim.
- Accused Features: The complaint alleges the '400 Patent is invalid due to functionality and anticipation by prior art (Compl. ¶¶71, 80, 84).
- U.S. Design Patent No. D1,011,420, "Roll of Pre-Cut Strips of Kinesiology Tape," Issued January 16, 2024:
- Technology Synopsis: This patent claims an ornamental design for a roll of pre-cut tape, with features similar to the other asserted design patents.
- Asserted Claims: One design claim.
- Accused Features: The complaint alleges the '420 Patent is invalid due to functionality and anticipation by prior art (Compl. ¶¶71, 80, 84).
- U.S. Patent No. 10,617,571, "Pre-Cut Strips of Kinesiology Tape," Issued April 14, 2020:
- Technology Synopsis: This utility patent is directed to pre-cut strips of kinesiology tape on a roll, describing features such as rounded corners and a backing material that can be torn to dispense individual strips.
- Asserted Claims: The complaint seeks a declaration of invalidity and unenforceability for all claims (Compl. ¶¶86, 90).
- Accused Features: The complaint alleges the '571 Patent is invalid for incorrect inventorship and anticipation by prior public use and other prior art (Compl. ¶¶72, 73).
- U.S. Patent No. 10,973,697, "Pre-Cut Strips of Kinesiology Tape," Issued April 13, 2021:
- Technology Synopsis: This utility patent, related to the '571 Patent, is also directed to pre-cut strips of kinesiology tape with similar functional features.
- Asserted Claims: The complaint seeks a declaration of invalidity and unenforceability for all claims (Compl. ¶¶86, 90).
- Accused Features: The complaint alleges the '697 Patent is invalid for incorrect inventorship and anticipation by prior public use and other prior art (Compl. ¶¶72, 73).
III. The Accused Instrumentality
Product Identification
- The products are 3H Medical’s kinesiology tape products, sold on Amazon.com and identified by various Amazon Standard Identification Numbers (ASINs) that were removed following KT Health’s infringement notice (Compl. ¶¶54-55).
Functionality and Market Context
- The complaint states that KT Health's takedown notice characterized 3H Medical's products as "direct copies of KT Health, LLCs patented product" (Compl. ¶53). The complaint presents visual evidence, such as a screenshot from a 2011 KT Health video, to allege that the design claimed in the '344 Patent was publicly disclosed by KT Health itself more than a decade before the patent's filing date (Compl. ¶64, p. 22). Further visuals compare prior art products directly to the patented design, asserting they are identical in configuration (Compl. ¶68). A side-by-side comparison shows a close-up of a 2017 prior art product next to an excerpt from Figure 1 of the '344 patent to demonstrate their similarity (Compl. ¶69, p. 26).
IV. Analysis of Infringement Allegations
As this is a complaint for declaratory judgment of non-infringement and invalidity, it does not contain a traditional infringement claim chart. Instead, it presents arguments and evidence for why the patents-in-suit are invalid. A central argument is that the asserted design patents are invalid for claiming a primarily functional design, an argument supported by KT Health's own utility patents. The table below summarizes this functionality argument by mapping ornamental features from the '344 design patent to their alleged functional purposes described in the '115 utility patent.
D'344 Patent Invalidity Allegations (Functionality)
| Ornamental Feature (from D'344 Patent) | Alleged Functional Purpose (from '115 Patent) | Complaint Citation | Patent Citation ('115) |
|---|---|---|---|
| Pre-cut strips of body-adhesive kinesiology tape in which a user need not cut the tape before using | This configuration is described as an improvement that allows for "multiple useful conformations without the need for custom cutting and fitting." | ¶76 | col. 2:4-6 |
| Rounded corners on the ends of the tape strips | The specification describes rounded corners as preventing fraying, reducing the chance of accidental detachment, and providing more comfort to the user. | ¶82 | col. 4:11-22 |
| The constricted "waist" area between adjacent tape strips | This feature is part of the backing material that is torn to separate individual strips, a functional aspect of dispensing the product without tearing the tape itself. | ¶79 | col. 6:22-30 |
- Identified Points of Contention:
- Functionality Doctrine: A primary legal question is whether the ornamental design claimed in the '344 Patent (and related design patents) is dictated by its function. The complaint argues that because the '115 Patent extols the functional benefits of the same features (e.g., rounded corners, pre-cut strips), the design is not ornamental and the design patents may be invalid under 35 U.S.C. §171 (Compl. ¶¶74, 83).
- Statutory Bars: A key factual question is whether KT Health's own alleged public disclosures, sales, and demonstrations of the product design, starting as early as November 2008, constitute a statutory bar that would invalidate the design patents, whose earliest priority date is in 2020 (Compl. ¶¶61, 63). The complaint provides a screenshot from what it identifies as a 2009 YouTube video published by KT Health as evidence of this prior public disclosure (Compl. ¶64, p. 22).
V. Key Claim Terms for Construction
The Term: "ornamental design" ('344 Patent, Claim)
- Context and Importance: The determination of whether the claimed features are "ornamental" versus "primarily functional" is dispositive for the validity of the design patents. Practitioners may focus on this term because the complaint's core argument is that the design's appearance is dictated by its utility, thereby making it ineligible for design patent protection.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader (Ornamental) Interpretation: A party defending the patent might argue that while the features have functions, the specific aesthetic combination of the rounded corners, the particular curve of the "waist," and the overall proportions create a distinct visual impression that is not required by the function and is therefore ornamental.
- Evidence for a Narrower (Functional) Interpretation: The complaint points directly to the '115 Patent's specification, which describes the functional advantages of the pre-cut strips and rounded corners, as evidence that the design is functional (Compl. ¶¶76, 82). The complaint also alleges there is "only a finite number of ways...to design kinesiology tape," suggesting a lack of alternative designs, which would support a finding of functionality (Compl. ¶83).
The Term: "rounded corners" ('115 Patent, dependent claim 9)
- Context and Importance: The interpretation of this term is critical to the functionality analysis. If "rounded corners" are construed as a purely functional element in the utility patent, it strengthens the argument that the same feature cannot be the basis for a valid ornamental design in the '344 Patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain meaning of the term is not limited in the claims, suggesting it could cover any corner that is not a sharp angle.
- Evidence for a Narrower Interpretation: The '115 Patent specification explicitly discloses three distinct functions for rounded corners: preventing fraying, reducing accidental detachment by avoiding snags, and providing user comfort ('115 Patent, col. 4:11-22). A court may construe the term in light of these disclosed utilitarian purposes.
VI. Other Allegations
- Unenforceability (Inequitable Conduct): The complaint alleges that KT Health and its named inventor committed inequitable conduct before the USPTO. This is based on allegations of knowingly failing to disclose material prior art, specifically KT Health's own prior sales and public uses of the patented designs which allegedly occurred more than one year before the applications' effective filing dates (Compl. ¶¶47-49, 70-71). The complaint further alleges that KT Health intentionally failed to name the correct inventors, asserting that employees of 3H Medical conceived of key features during the product development process (Compl. ¶¶50, 72). These allegations of withholding material information and misrepresenting inventorship, if proven to have been done with an intent to deceive, could render the patents unenforceable.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of patent eligibility: is the design claimed in the '344 Patent and its family primarily functional? The case may turn on whether the court finds that the visual appearance of the tape is dictated by the utilitarian advantages described in KT Health's own '115 utility patent, potentially invalidating the design patents.
- A key evidentiary question will be one of timing and disclosure: did KT Health’s alleged public use and sales of the kinesiology tape design beginning in 2008 create a statutory bar to the design patents filed over a decade later? The resolution will depend on factual evidence regarding the nature and timing of these alleged events and whether they were intentionally withheld from the USPTO.
- A foundational question will be one of inventorship and ownership: were employees of Plaintiff 3H Medical the true inventors or co-inventors of the patented technology, as the complaint alleges? This will require an inquiry into the facts of the early collaboration between the parties and could, if proven, lead to a correction of inventorship and a potential shift in ownership rights.