1:16-cv-00323
Procter & Gamble Co v. MS Intl Enterprises LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:- Plaintiff: The Procter & Gamble Company (Ohio)
- Defendant: Onuge Personal Care (Guangzhou) Co., Ltd. (People's Republic of China) and MS International Enterprises LLC (New York)
- Plaintiff’s Counsel: Jones Day
 
- Case Identification: 1:16-cv-00323, S.D. Ohio, 02/18/2016
- Venue Allegations: Plaintiff alleges venue is proper because Defendants transact business in the district, have supplied allegedly infringing tooth whitening strips into the district, and derive substantial revenue from sales in the district through distributors and national online retailers.
- Core Dispute: Plaintiff alleges that Defendants’ tooth whitening strip products infringe two patents related to a flexible delivery system for oral care substances, and that the products' packaging infringes Plaintiff's registered trademarks and trade dress for its Crest Whitestrips products.
- Technical Context: The technology concerns at-home cosmetic tooth whitening systems that use a thin, flexible strip of material to apply a chemical agent directly onto the teeth for a sustained period.
- Key Procedural History: The complaint notes that Plaintiff has previously successfully enforced the patents-in-suit against other manufacturers of infringing tooth whitening strips, which may be relevant to Defendants’ knowledge and the question of willfulness.
Case Timeline
| Date | Event | 
|---|---|
| 1997-06-06 | Earliest Priority Date for '453 Patent and '017 Patent | 
| 1999-04-06 | U.S. Patent No. 5,891,453 Issues | 
| 1999-04-13 | U.S. Patent No. 5,894,017 Issues | 
| 2016-02-18 | Complaint Filed | 
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,891,453, “Delivery System For A Tooth Whitener Using A Strip Of Material Having Low Flexural Stiffness,” issued April 6, 1999
The Invention Explained
- Problem Addressed: The patent describes prior tooth whitening methods, such as professionally fitted or generic "one size fits all" trays, as being bulky, uncomfortable, ill-fitting, and requiring large volumes of whitening gel that could leak into the mouth (’453 Patent, col. 2:5-24).
- The Patented Solution: The invention proposes a disposable, unobtrusive delivery system comprising a thin, flexible strip of material coated with a viscous tooth whitening substance. The strip is designed to be highly conformable to the user's teeth without permanent deformation, and the whitening substance itself provides the tackiness needed to hold the strip in place, protecting the active ingredient from erosion by saliva (’453 Patent, Abstract; col. 3:1-24).
- Technical Importance: This approach enabled the creation of a user-friendly, at-home tooth whitening product that was more comfortable and discreet than the tray-based systems that preceded it (Compl. ¶¶ 16, 19).
Key Claims at a Glance
- The complaint asserts dependent claims 2-3, 6-9, 11, and 18, which rely on independent claim 1 (Compl. ¶¶ 94, 100).
- Independent Claim 1 requires:- A strip of flexible material with sufficient flexibility to form a curved shape on a plurality of teeth, being readily conformable to tooth surfaces and interstitial spaces without permanent deformation.
- A tooth whitening substance applied to the strip that, when placed on teeth, contacts the surface to provide an active agent and also provides adhesive attachment to hold the system in place.
 
U.S. Patent No. 5,894,017, “Delivery System For An Oral Care Substance Using A Strip Of Material Having Low Flexural Stiffness,” issued April 13, 1999
The Invention Explained
- Problem Addressed: As with the '453 patent, the background highlights the drawbacks of existing oral care delivery systems like rigid trays, noting they can cause gum irritation and are often apparent to others (’017 Patent, col. 2:8-15).
- The Patented Solution: The invention claims a delivery system for a general "oral care substance" (not limited to whiteners) using a strip of material with a specifically defined low "flexural stiffness." This property allows the strip to drape over and conform to the teeth and adjoining soft tissue with minimal force, held in place by an applied substance that provides both the active ingredient and adhesive attachment (’017 Patent, Abstract; col. 3:5-15).
- Technical Importance: This patent broadens the flexible strip delivery concept to a wider range of oral care applications beyond whitening, defining a specific physical parameter (flexural stiffness) for the strip material (Compl. ¶12).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2-3 and 7 (Compl. ¶¶ 106, 112).
- Independent Claim 1 requires:- A strip of material having a flexural stiffness of less than about 50 grams/centimeter, which is readily conformable to a tooth and its adjoining soft tissue without permanent deformation.
- An oral care substance applied to the strip that contacts the tooth surface to provide an active and provides adhesive attachment to hold the system in place.
 
III. The Accused Instrumentality
Product Identification
The "Dr. Brody's One Smile," "Bright White," and "Healthy White" tooth whitening strip products (collectively, the "Accused Products") (Compl. ¶¶ 48, 61, 73).
Functionality and Market Context
The Accused Products are at-home tooth whitening kits consisting of disposable strips for applying a whitening agent to teeth (Compl. ¶¶ 48, 55). They are manufactured by Defendant Onuge and distributed by Defendant MSI through various channels, including discount retailers and major online platforms (Compl. ¶¶ 5, 55). The complaint alleges the products are "slavish copies" of Plaintiff's commercially successful Crest Whitestrips products and are sold in packaging designed to mimic the Crest trade dress (Compl. ¶96). The complaint provides an image of the "Dr. Brody's One Smile" packaging, which describes the contents as "30 TEETH WHITENING STRIPS" in a "DENTAL WHITENING KIT" (Compl. ¶55).
IV. Analysis of Infringement Allegations
The complaint does not include a claim chart. The following tables summarize the infringement theory for the lead independent claim of each patent based on the complaint's narrative allegations.
'453 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation | 
|---|---|---|---|
| a. a strip of flexible material having a sufficient flexibility to form a curved shape on a plurality of teeth, said strip of material being readily conformable to tooth surfaces...without permanent deformation... | The Accused Products are "tooth whitening strip products" that inherently include a strip of material designed to be applied to the user's teeth (Compl. ¶55). | ¶¶ 48, 55, 94 | col. 6:46-54 | 
| b. a tooth whitening substance applied to said strip of material such that when said delivery system is placed on a surface of said teeth, said substance contacts said surface providing an active...and...providing adhesive attachment... | The Accused Products are sold as kits containing strips with a whitening agent, and the packaging includes instructions for applying them to teeth (Compl. ¶56). | ¶¶ 56, 81, 94 | col. 7:38-46 | 
- Identified Points of Contention:- Technical Question: A factual dispute may arise over whether the whitening gel on the Accused Products provides the "adhesive attachment" required by the claim, or if its tackiness is merely an incidental property of a viscous gel that does not perform the claimed function of holding the strip in place.
- Scope Question: The complaint does not provide test data for the physical properties of the accused strips. A central question will be whether the accused strips are "readily conformable" and avoid "permanent deformation" in a manner consistent with the patent's teachings.
 
'017 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation | 
|---|---|---|---|
| a. a strip of material having a flexural stiffness less than about 50 grams/centimeter as measured on a Handle-O-Meter per ASTM test method D2923-95, said strip of material being readily conformable without permanent deformation... | The Accused Products contain a strip alleged to be a "slavish copy" of Plaintiff's commercial product, which embodies the patented technology (Compl. ¶108). | ¶¶ 106, 108, 112 | col. 5:62-6:4 | 
| b. an oral care substance applied to said strip of material such that when said delivery system is placed on a surface of said tooth...said substance contacts said surface providing an active...and...providing adhesive attachment... | The Accused Products are whitening kits, a type of oral care product, that contain a substance applied to the strip to be delivered to the teeth (Compl. ¶55). | ¶¶ 55, 106, 112 | col. 5:13-24 | 
- Identified Points of Contention:- Evidentiary Question: The core of the infringement case for the ’017 patent will likely depend on factual evidence. The critical question is whether the accused strips possess a "flexural stiffness less than about 50 grams/centimeter" when measured according to the specific ASTM standard recited in the claim. This will likely be a subject of expert testing and testimony.
- Scope Question: The use of the word "about" in the "flexural stiffness" limitation raises a question of scope. The court may need to determine how much, if any, deviation from the 50 grams/centimeter value is permissible under this term.
 
V. Key Claim Terms for Construction
- The Term: "flexural stiffness less than about 50 grams/centimeter" ('017 Patent, Claim 1) - Context and Importance: This quantitative limitation is central to the infringement analysis of the ’017 patent. Its interpretation will define the boundary of the claim, and proving that the Accused Products fall within this boundary is essential for the Plaintiff.
- Intrinsic Evidence for a Broader Interpretation: The patent uses the term "about," which may support an argument that the 50 g/cm value is not an absolute, precise ceiling. The specification's focus on the functional outcome—the ability to "drape over the contoured surfaces of teeth with very little force"—could be cited to argue for a slightly wider numerical range that achieves the same result (’017 Patent, col. 5:62–6:11).
- Intrinsic Evidence for a Narrower Interpretation: The claim explicitly incorporates a specific measurement protocol: "as measured on a Handle-O-Meter per ASTM test method D2923-95" (’017 Patent, Claim 1). Defendants may argue this ties the claim term strictly to results obtained from that precise standard, limiting the scope of "about" and resisting interpretations based on general functionality.
 
- The Term: "adhesive attachment" ('453 Patent, Claim 1; '017 Patent, Claim 1) - Context and Importance: This term defines the mechanism by which the strip is held on the teeth. Whether the "tackiness" of the gel on the Accused Products meets this limitation will be a key point of dispute. Practitioners may focus on this term because it distinguishes the invention from systems that rely purely on mechanical fit.
- Intrinsic Evidence for a Broader Interpretation: The specification describes the attachment as arising from the "viscosity and general tackiness of the substance" (’453 Patent, col. 7:1-3). This could support a broad reading where any substance sticky enough to hold the strip in place for the intended duration meets the limitation.
- Intrinsic Evidence for a Narrower Interpretation: The specification also quantifies the adhesion by referencing a "peel force of from about 1 gram to about 50 grams" required for removal (’453 Patent, col. 7:16-19). This language could support an argument that "adhesive attachment" requires a specific, measurable bond strength, rather than just incidental stickiness from a viscous gel.
 
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement against both Defendants. The factual basis is that Defendants sell the Accused Products with packaging and instructions that direct end-users to apply the strips to their teeth, thereby performing the steps of the patented methods (Compl. ¶¶ 56, 81, 95, 101). Knowledge is alleged based on Defendants' explicit comparisons to P&G's patented Crest products in advertising and P&G's prior public enforcement of the patents against others (Compl. ¶¶ 96, 102, 108).
- Willful Infringement: The complaint alleges willful infringement based on the same facts supporting knowledge. It further alleges that the Accused Products are "slavish copies" of P&G's patent-protected products and trade dress, suggesting Defendants acted with knowledge of and in conscious disregard for P&G's patent rights (Compl. ¶¶ 96, 108).
VII. Analyst’s Conclusion: Key Questions for the Case
- A key evidentiary question will be one of quantitative compliance: Does objective testing of the Accused Products show that their strips have a "flexural stiffness" that falls within the scope of the '017 patent's "less than about 50 grams/centimeter" limitation, as measured by the specified ASTM standard?
- A central issue of claim construction will be one of functional definition: Can the "tackiness" of the whitening gel on the Accused Products be properly characterized as providing the "adhesive attachment" required by the claims, or does this term require a more specific bonding property not present in the accused gel?
- The allegations of both patent and trade dress infringement raise a critical question of intent: Does the evidence of alleged "slavish copying" of P&G's product design and marketing, combined with alleged knowledge of P&G's prior patent enforcement, support a finding of willful infringement that could lead to enhanced damages?