Spectrum Solutions LLC v. DNA Genotek Inc

1. Case Identification

• Case #: IPR2023-01424
• Patent #: 11,536,632
• Filed: September 15, 2023
• Petitioner(s): Spectrum Solutions L.L.C.
• Patent Owner(s): DNA Genotek Inc.
• Challenged Claims: 1-16 and 18-20

2. Patent Overview

• Title: Biological Sample Collection System
• Brief Description: The ’632 patent discloses biological sample collection systems comprising a sample collection vessel, a cap containing a reagent, and a movable annular valve. When the cap is connected to the vessel, the valve actuates to release the reagent into the vessel to mix with the sample.

3. Grounds for Unpatentability

Ground 1: Obviousness over Plante and Cho - Claims 1-4, 6-16, and 18-20 are obvious over Plante in view of Cho

• Prior Art Relied Upon: Plante (Application # 2012/0325721) and Cho (International Publication No. WO 2005/051775).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Plante disclosed a biological sample collection system with nearly every element of claim 1, including a collection vessel and a cap with a sealed reagent reservoir. However, Plante used a knife within the vessel to pierce a membrane on the cap to release the reagent. Petitioner asserted that Cho disclosed the missing element: a movable annular valve, comprising cooperating inner and outer cylinders that move relative to each other to open a vent and release a stored additive from a cap into a container. The combination of Plante's system with Cho's valve mechanism allegedly rendered the claims obvious.
  • Motivation to Combine (for §103 grounds): Petitioner presented four primary motivations for a Person of Ordinary Skill in the Art (POSA) to combine the references. A POSA would combine them to: (1) improve safety by replacing Plante's hazardous knife with Cho's safer annular valve, consistent with industry guidance like the Needlestick Safety and Prevention Act; (2) reduce manufacturing cost and complexity by avoiding the difficulty of molding sharp plastic features; (3) improve functionality by allowing the cap to fully seal the vessel before the reagent is released, unlike Plante's design; and (4) perform a simple substitution of one known reagent release mechanism (pierceable membrane) for another (annular valve) to achieve predictable results.
  • Expectation of Success (for §103 grounds): A POSA would have had a reasonable expectation of success because both references are in the same field of storing and mixing substances from a cap into a container, and adapting Cho's cap to fit Plante's vessel would have been a routine design modification.

Ground 2: Anticipation by Ueda - Claims 1-8, 10-16, and 18-20 are anticipated by Ueda

• Prior Art Relied Upon: Ueda (Certified Translation of Japanese Application # 2010-213660).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner contended that Ueda, as a single reference, anticipated every limitation of independent claim 1 and the challenged dependent claims. Ueda was argued to disclose a biological sample container system comprising a container body (vessel) and a cap holding a second material (reagent). Critically, the cap in Ueda included a movable annular valve—formed by an outer cylindrical member (first cylinder) and an inner mixture-holding member (second cylinder)—that releases the reagent into the vessel. Petitioner mapped how screwing Ueda's cap onto the container body caused the second cylinder to slide relative to the first, unblocking communication passages (vents) and allowing the reagent to flow into the sample collection reservoir, thereby teaching the claimed open and closed configurations and relative movement.

• Additional Grounds: Petitioner asserted additional obviousness challenges for specific claims, including claim 5 as obvious over Plante, Cho, and Patterson (Application # 2006/0260959); claim 5 as obvious over Ueda and Patterson; and claim 9 as obvious over Ueda and Williams (Patent 4,761,379). These grounds argued for modifying the primary combinations with known press-fit connections (Patterson) or attachable funnels (Williams).

4. Key Claim Construction Positions

• "Annular Valve": Petitioner noted that in related district court litigation involving the ’646 patent, this term was construed as "ring shaped valve" over the Patent Owner's proposed construction of a "valve with two cylinders." Petitioner argued the claims are unpatentable under any reasonable construction but highlighted that Cho's valve is a "ring shaped valve" consistent with the court's construction.
• "Biological Sample": In the same related litigation, this term was construed as "biological sample containing cells." Petitioner asserted that the claims are unpatentable regardless of this construction, as the prior art discloses collection of samples like saliva, which are known to contain cells.

5. Arguments Regarding Discretionary Denial

• Arguments against §325(d) Denial: Petitioner argued that discretionary denial would be improper because this was the first petition challenging the ’632 patent. Furthermore, the primary prior art references relied upon in the petition (Plante, Cho, Ueda, Patterson, Williams) were not applied by the Examiner during the original prosecution.
• Arguments against §314(a) Denial (Fintiv): Petitioner contended that none of the Fintiv factors supported discretionary denial. It was emphasized that the Patent Owner has not asserted the ’632 patent against the Petitioner, and there is no parallel litigation involving this specific patent, making the Fintiv analysis inapplicable or weigh heavily against denial.

6. Relief Requested

• Petitioner requested the institution of an inter partes review (IPR) and the cancellation of claims 1-16 and 18-20 of the ’632 patent as unpatentable.