Hamilton Technologies LLC v. Tehrani PhD Pe DR Fleur

1. Case Identification

• Case #: IPR2020-01199
• Patent #: 7,802,571
• Filed: July 10, 2020
• Petitioner(s): Hamilton Technologies LLC
• Patent Owner(s): Fleur Tehrani
• Challenged Claims: 1-6, 9-12, 29-33, and 41

2. Patent Overview

• Title: Apparatus and Method for Controlling a Ventilator
• Brief Description: The ’571 patent describes a method and apparatus for automatically controlling a mechanical ventilator. The claimed invention involves measuring a patient's oxygen level, determining the required fraction of inspired oxygen (FIO2) to reach a desired oxygen level, and then adjusting the positive end-expiratory pressure (PEEP) to maintain a PEEP/FIO2 ratio within a prescribed range while keeping the patient's oxygen level above a predefined value.

3. Grounds for Unpatentability

Ground 1: Anticipation or Obviousness over Carmichael - Claims 1-2, 5-6, 11, 29, 31-33, and 41 are anticipated or, in the alternative, obvious over Carmichael, as evidenced by [ARDSNET](https://ai-lab.exparte.com/case/ptab/IPR2020-01199/doc/1007) and Waisel '95.

• Prior Art Relied Upon: Carmichael (a 1996 journal article), ARDSNET (a 2000 journal article), and Waisel '95 (a 1995 conference proceeding).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Carmichael, a survey of physician-conducted treatment protocols for Acute Respiratory Distress Syndrome (ARDS), taught every element of the challenged claims. Carmichael allegedly disclosed a protocol where clinicians first set an FIO2 level to achieve a desired patient oxygen saturation (e.g., >60 mmHg PaO2) and then incrementally adjusted PEEP within a prescribed min/max range, thereby maintaining a PEEP/FIO2 ratio within a prescribed range. Petitioner asserted that ARDSNET corroborated Carmichael's protocol, and Waisel '95 demonstrated that contemporaneous automated, closed-loop ventilators (the "first means" and "second means" of claim 1) were known and available to implement such protocols.
  • Motivation to Combine (for §103 grounds): In the alternative obviousness argument, Petitioner contended a person of ordinary skill in the art (POSITA) would have been motivated to implement the well-understood ARDS treatment protocol from Carmichael using a known automated ventilator system like that described in Waisel '95 to achieve predictable, routine control of patient oxygenation.
  • Expectation of Success (for §103 grounds): A POSITA would have had a high expectation of success because it involved applying a known clinical protocol to a known type of automated medical device for its intended purpose.

Ground 2: Obviousness over Carmichael, Anderson, Tehrani, and Rossi - Claims 1-6, 9-12, 29-33, and 41 are obvious over Carmichael in view of [Anderson](https://ai-lab.exparte.com/case/ptab/IPR2020-01199/doc/1013), [Tehrani ’268](https://ai-lab.exparte.com/case/ptab/IPR2020-01199/doc/1006), and [Rossi](https://ai-lab.exparte.com/case/ptab/IPR2020-01199/doc/1015).

• Prior Art Relied Upon: Carmichael (1996 journal article), Anderson (a 2002 journal article), Tehrani ’268 (Patent 4,986,268), and Rossi (a 1995 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground used Carmichael for the base treatment protocol, as in Ground 1. Anderson was introduced to provide a specific, detailed architecture for an automated, closed-loop ventilator (a Macintosh computer controlling a Hamilton Amadeus ventilator) capable of continuously controlling FIO2 and PEEP to maintain a target PaO2 level. Tehrani ’268, an earlier patent by the same inventor as the ’571 patent, was added to teach the alarm and artifact detection features recited in dependent claims 3, 4, and 12. Rossi was added to teach the concept of monitoring intrinsic PEEP (PEEPi), as recited in dependent claims 9 and 10.
  • Motivation to Combine (for §103 grounds): A POSITA would combine Carmichael's clinical protocol with Anderson's automated system to achieve systematic and reliable ventilator control. It would have been obvious to further incorporate the well-known alarm and artifact-detection features from Tehrani ’268 as a routine safety measure and to include monitoring of PEEPi from Rossi to ensure the total PEEP remained within clinically safe limits.
  • Expectation of Success (for §103 grounds): Success would be expected as the combination involved automating a known therapy using a known controller architecture and adding conventional safety and monitoring features to improve patient outcomes.

Ground 3: Obviousness over Taube, Carmichael/ARDSNET, Clemmer, and Rossi - Claims 1-6, 9-12, 29-33, and 41 are obvious over Taube in view of Carmichael/ARDSNET, Clemmer, and Rossi.

• Prior Art Relied Upon: Taube (Patent 5,388,575), Carmichael/ARDSNET (journal articles), Clemmer (Patent 6,148,814), and Rossi (journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground began with Taube as the primary reference, which disclosed an automated, closed-loop ventilator for adaptive control of PEEP and FIO2 to maintain a desired oxygen level. Petitioner argued the Patent Owner mischaracterized Taube during prosecution. The combination involved modifying Taube’s system to implement the specific PEEP/FIO2 ratio protocol from Carmichael/ARDSNET. Clemmer was cited as evidence that programming various treatment protocols into an automated ventilator was a routine and well-understood practice. Rossi was again cited for the PEEPi limitations.
  • Motivation to combine (for §103 grounds): A POSITA would be motivated to improve the clinical utility of Taube’s automated ventilator by implementing the more specific and clinically validated PEEP/FIO2 ratio protocol from Carmichael. Clemmer demonstrated that such a modification was a routine, predictable application of known programming techniques.
  • Expectation of Success (for §103 grounds): Implementing a known treatment protocol on an existing automated ventilator platform was a common and predictable path for improving ventilator performance and patient care.

4. Key Claim Construction Positions

• "first means" and "second means" (claim 1): Petitioner proposed these means-plus-function terms correspond to an automated ventilator's processor controlled by a software algorithm (first means) and its associated signal generator (second means), as disclosed in the specification and the incorporated Tehrani ’268 patent.
• "PEEP is determined to keep a ratio of PEEP/FIO2 within a prescribed range" (claim 1): Petitioner argued this phrase must be construed to mean that PEEP is determined after FIO2 is determined. This construction was based on the patent specification and file history and was critical to Petitioner's argument that prior art protocols, which set FIO2 first, met this limitation.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that institution was warranted under 35 U.S.C. §325(d) because the petition presented new, non-cumulative prior art and arguments that were not before the Examiner during prosecution. Specifically, Petitioner contended that the Examiner allowed the claims based on a material mischaracterization of the Taube reference by the Patent Owner and a failure to consider key art like Carmichael and Anderson, which directly teach the allegedly novel PEEP/FIO2 ratio control method.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-6, 9-12, 29-33, and 41 of Patent 7,802,571 as unpatentable.