PTAB

IPR2018-01097

HyperBranch Medical Technology, Inc. v. Confluent Surgical, Inc.

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1. Case Identification

2. Patent Overview

  • Title: Silicone Spray Tip
  • Brief Description: The ’483 patent is directed to an applicator assembly for mixing and spraying dual-component bioadhesives. The invention describes a spray tip assembly with a multi-chambered design, including an internal mixing chamber that contains an insert with a recess on its distal end to create turbulence and promote mixing.

3. Grounds for Unpatentability

Ground I: Claims 19 and 21 are obvious over Spero in view of Haber

  • Prior Art Relied Upon: Spero (Application # 2003/0069537) and Haber (Patent # 5,341,993).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Spero disclosed a laparoscopic spray device for multiple component materials that teaches every element of independent claim 19 except for a recess formed in the distal end of the tip's insert. Spero’s device included sources for two components, a manifold (interface member 12), an elongated shaft with dual lumens (elongated body 14), and a tip assembly with an insert (spray regulator 104). Petitioner asserted that Haber supplied the missing limitation by disclosing a spray nozzle with a substantially cylindrical swirl atomizer insert (atomizer 40) that has recesses (ring channel 64 and spoke channels 66) on its distal end.
    • Motivation to Combine: Petitioner argued a person of ordinary skill in the art (POSITA) would have been motivated to modify Spero’s device by replacing its simple insert with Haber's recessed swirl atomizer insert. The stated purpose was to improve the mixing and atomization of the bioadhesive components, as Spero's smooth-ended insert was a suboptimal design for creating the desired turbulent, swirling flow. Spero itself acknowledged that spray tip characteristics could be modified, suggesting the interchangeability of such components.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success because the modification involved the simple substitution of one known element for another to obtain the predictable benefits of a swirl atomizer. The components were physically compatible and served analogous functions in similar medical spray applications, requiring only routine skill to implement. Dependent claim 21 was argued to be obvious as Haber’s recesses were explicitly configured to create turbulence.

Ground II: Claims 19 and 21 are obvious over Spero in view of Kitabayashi

  • Prior Art Relied Upon: Spero (Application # 2003/0069537) and Kitabayashi (Japanese Utility Model Publication No. 3-32959).
  • Core Argument for this Ground:
    • Prior Art Mapping: The argument relied on the same mapping of Spero as in Ground I. Kitabayashi was asserted to teach the missing element: an improved spray nozzle mechanism containing a columnar insert (piece 3) with a recess (centered recess 32 and cut grooves 34) on its distal end. Kitabayashi's insert was specifically designed to form a turbulent, swirling flow for creating a fine mist.
    • Motivation to Combine: The motivation was analogous to that for combining Spero and Haber. A POSITA would have sought to improve the suboptimal mixing in Spero by incorporating the well-understood swirl atomizer geometry taught by Kitabayashi. This modification addressed the known objective of achieving more effective mixing and atomization in dual-component applicators.
    • Expectation of Success: Success was predictable as it involved applying a known technique (using a swirl-inducing insert) to a known device (Spero's applicator) to achieve a well-known result (enhanced mixing and atomization). The modification would have required little to no change to Spero's mixing chamber.

Ground IV: Claims 19 and 21 are obvious over Capozzi

  • Prior Art Relied Upon: Capozzi (Patent # 5,116,315).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued Capozzi, by itself, rendered the claims obvious. Capozzi disclosed a biological syringe system for delivering a two-part mixed composition as a spray, teaching a system with component sources (syringes), a manifold, an elongated shaft (conical nose 58), and a multi-chambered tip assembly with an insert (cylindrical extension 77). Critically, Capozzi’s swirl-inducing recesses (channels 118) were located on the interior wall of the nozzle body, adjacent to the insert, rather than on the insert's distal end itself.
    • Motivation to Combine (for Obviousness): Petitioner contended that it would have been an obvious design choice for a POSITA to relocate the swirl-inducing recesses from the nozzle wall onto the distal end of the insert. A POSITA would have recognized that the function—inducing a swirling flow—would be the same regardless of which of the two adjoining surfaces contained the channels. This modification was presented as a routine design choice between two known, functionally equivalent options, which a POSA might make to simplify molding or accommodate different materials.

Ground VI: Claims 19 and 21 are anticipated by Voegele

  • Prior Art Relied Upon: Voegele (Application # 2008/0121657).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued Voegele disclosed each and every element of the challenged claims. Voegele described a surgical device for dispensing dual-component adhesive, including: sources of components (chambers 272), a manifold (funnel 290 with divider 266), an elongated shaft (shaft 291), and a tip assembly (tip 294). The tip assembly was shown to have a first chamber receiving the shaft, a second chamber configured to receive an insert (mixer 293), and a final chamber. Voegele’s mixer 293 was described as a substantially cylindrical insert with a recess on its distal end, explicitly configured to create turbulence by causing the component fluids to impinge on each other before exiting.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 19 and 21 as obvious over Spero in view of Green (Patent 3,112,074) and over Dodge (Patent 7,037,289) in view of Haber, but relied on similar theories of modifying a primary system with a known recessed insert design.

4. Key Claim Construction Positions

  • “manifold”: Petitioner proposed the construction “a connector with fluid passages.” This broad construction was important for mapping prior art components that serve as an interface between the syringes and the delivery shaft, such as Spero’s “interface member 12” and Capozzi’s “manifold 14,” to the claimed element.
  • “elongated shaft”: Petitioner proposed the construction “a body with a circular or substantially circular cross-section and a length to width ratio (i.e., aspect ratio) greater than 1.” This construction was based on the patent's figures and dictionary definitions and was key to mapping prior art structures like Spero's "elongated body 14" and Capozzi's "forward nose 58" to the claims.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 19 and 21 of Patent 8,033,483 as unpatentable.