PTAB

IPR2018-00268

Acclarent, Inc. v. Albritton, IV, Ford

1. Case Identification

2. Patent Overview

  • Title: Guide Catheter System and Method
  • Brief Description: The ’412 patent relates to a guide catheter apparatus and method for use in surgical procedures. The system features a handle that allows an operator to control the guide catheter's position with several fingers of one hand while simultaneously manipulating a working device and controlling suction with the thumb and index finger of the same hand.

3. Grounds for Unpatentability

Ground 1: Claims 8 and 11-13 are obvious over Ressemann in view of Goldfarb

  • Prior Art Relied Upon: Ressemann (Application # 2007/0250105) and Goldfarb (Patent 8,747,389).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Ressemann, which was not cited during prosecution, teaches a sinus treatment device with a handle designed for single-handed operation. This device allows a physician to grasp the handle with their fingers to control a guide catheter while simultaneously using their thumb to manipulate a working device (a wire guide), thus teaching the core single-hand manipulation method of claim 8. However, Ressemann does not disclose suction. Petitioner asserted that Goldfarb, an analogous art reference, remedies this deficiency by teaching a similar sinusitis device that incorporates a thumb/finger hole in its handle specifically to control suction.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine Goldfarb's well-known suction feature with Ressemann's device to achieve the critical benefit of maintaining a clear surgical field in sinus surgery. Because both references emphasize the advantage of single-handed operation, a POSITA would be motivated to integrate suction control directly into the handle, as taught by Goldfarb, rather than using a separate suction tool that would require a second hand. The combination represents a simple substitution of one known element for another to obtain predictable results.
    • Expectation of Success: Petitioner contended that adding a known suction control mechanism to a similar surgical device was a predictable solution with a high expectation of success.
    • Key Aspects: The argument for obviousness of the dependent claims rested on the same combination, with Goldfarb’s thumb hole providing the "second opening" for controlling suction as recited in claims 11-13.

Ground 2: Claims 8-13 are obvious over Makower in view of Jones

  • Prior Art Relied Upon: Makower (Application # 2006/0063973) and Jones (Patent 4,915,691).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Makower teaches a pistol-grip surgical hand tool for single-handed use in sinus procedures, which involves controlling a guide catheter's position while manipulating a working device (e.g., a balloon catheter). Makower also expressly suggests that its devices may include an arrangement for suction but does not specify the control mechanism. Petitioner argued that Jones, another reference not cited during prosecution, explicitly teaches a single-handed medical aspirator with a pistol-grip handle and a "thumb control hole" designed to allow a user to vary suction with the same hand holding the device.
    • Motivation to Combine: A POSITA seeking to implement the suction feature suggested by Makower would have been motivated to incorporate the specific, well-known, single-hand control method taught by Jones. Jones was presented as solving the exact problem of freeing an operator's second hand, making it a logical and advantageous modification for Makower's single-handed device.
    • Expectation of Success: The combination of a standard thumb control port from Jones with a device like Makower's that already contemplates suction was argued to be a routine and predictable design choice.
    • Key Aspects: Petitioner argued Makower’s pistol-grip design and other disclosed embodiments inherently teach the angular and pivoting handle limitations of dependent claims 9 and 10. The combination with Jones's thumb port was argued to teach the suction-related limitations of claims 11-13.

4. Key Claim Construction Positions

  • "formed to allow": Petitioner argued this term should be construed broadly as "capable of." The petition contended that this is consistent with its functional and permissive use throughout the claims and specification, which describe the function of the handle without linking the term to any specific, required structure.
  • "manipulating the working device with a thumb and index finger": Petitioner proposed construing this phrase to mean "using one of the thumb and index finger to move the working device while the other one of the thumb and index finger provides oppositional force and stabilizing force." Petitioner asserted this construction is derived from the Patent Owner's own arguments in related district court litigation, which it argued constitute a binding judicial admission.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that instituting review would not be redundant with a co-pending inter partes review (IPR) (IPR2017-00498). The petition asserted that it challenges a different group of claims (method claims 8-13, versus device claims in the other IPR) and relies on different grounds and combinations of prior art. It emphasized that key references like Ressemann and Jones were not cited during the original prosecution, presenting new questions of patentability.

6. Relief Requested

  • Petitioner requests the institution of an inter partes review and the cancellation of claims 8-13 of Patent 9,011,412 as unpatentable under 35 U.S.C. §103.