Court Opinion

ID: 9405400
Source: CourtListenerOpinion
Date Created: 2023-06-28 15:07:48.416532+00
Date Added: 2024-06-11T17:20:21.914222
License: Public Domain

Case: 22-1732   Document: 46     Page: 1   Filed: 06/28/2023

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                 ______________________

                   FLEUR TEHRANI,
                      Appellant

                            v.

          HAMILTON TECHNOLOGIES LLC,
                      Appellee
               ______________________

                       2022-1732
                 ______________________

     Appeal from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in No. IPR2020-
 01199.
                  ______________________

                 Decided: June 28, 2023
                 ______________________

     MARK ROBERT KENDRICK, Kendrick Intellectual Prop-
 erty Law, Sherman Oaks, CA, argued for appellant.

    PATRICK C. KEANE, Buchanan Ingersoll & Rooney PC,
 Alexandria, VA, argued for appellee. Also represented by
 MATTHEW L. FEDOWITZ, Washington, DC; RALPH GEORGE
 FISCHER, Pittsburgh, PA.
                 ______________________

     Before REYNA, STOLL, and STARK, Circuit Judges.
Case: 22-1732     Document: 46      Page: 2   Filed: 06/28/2023

 2                    TEHRANI   v. HAMILTON TECHNOLOGIES LLC

 STARK, Circuit Judge.
     Dr. Fleur Tehrani invented and owns U.S. Patent No.
 7,802,571 (the “’571 patent”). Hamilton Technologies LLC
 (“Hamilton”), a licensee of another of Dr. Tehrani’s patents,
 petitioned for inter partes review (“IPR”) of the ’571 patent.
 The Patent and Trial Appeal Board (“Board”) instituted an
 IPR and ultimately concluded that claims 1-6, 9-12, 29-33,
 and 41 of the ’571 patent were invalid as obvious. Hamil-
 ton Techs. LLC v. Tehrani, IPR2020-01199, 2021 WL
 6339598 (P.T.A.B. 2021), J.A. 1-69. Dr. Tehrani sought Di-
 rector review, which was denied. She then timely ap-
 pealed. We have jurisdiction pursuant to 28 U.S.C.
 § 1295(a)(4)(A). We affirm.
                                I
     The ’571 patent, entitled “Method and Apparatus for
 Controlling a Ventilator,” relates to “a method and appa-
 ratus for controlling a ventilator based on the measured
 levels of oxygen of the patient on the ventilator, as well as
 other physical conditions of the patient.” ’571 patent 1:20-
 23. The method and apparatus includes a “first means”
 comprising “a programmable microprocessor” controlled by
 “a software algorithm” that operates on input data, such as
 respiratory mechanics, pressure-volume data, and the pa-
 tient’s measured carbon dioxide levels, to provide “digital
 output data to control the ventilator and the gas mixer of
 the ventilator.” Id. at 2:43-54. The software algorithm in-
 cludes a proportional, integral, derivative (“PID”) control
 program which “is designed to automatically adjust” the
 fraction of inspired oxygen in a patient’s inspiratory gas
 (“FIO2”) and the patient’s Positive End-Expiratory Pressure
 (“PEEP”) “based on at least the measured oxygen levels of
 the patient.” Id. at 2:54-57. “The processing means detects
 hazardous conditions based on the input data and/or arti-
 facts, replaces and/or corrects the measurement artifacts,
 and instructs generation of appropriate warning signals.”
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 TEHRANI   v. HAMILTON TECHNOLOGIES LLC                      3

 Id. at 2:60-63. The subsequent output data is then trans-
 mitted through the second means “to a Signal Generator
 which is equipped with converters and/or other electronic
 components to generate the control and appropriate warn-
 ing signals,” which are then supplied to the ventilator or a
 mixer regulator unit to adjust the concentration of oxygen.
 Id. at 3:5-17.
      Figures 3a-i of the ’571 patent show a flowchart de-
 scribing the software algorithm’s process. The first loop
 begins after establishing initial values of FIO2 and PEEP,
 desired set points for arterial partial pressure of oxygen,
 threshold values for arterial hemoglobin oxygen saturation
 (“SpO2”), and a loop indicator. Id. at 7:47-8:25. The pa-
 tient’s SpO2 data is input and used to calculate the arterial
 partial pressure of oxygen, which is then compared to a
 minimum acceptable value. Id. at 8:26-44. If the value is
 greater than or equal to the minimum acceptable value, the
 value is accepted; otherwise, an alarm is generated. Id. at
 8:45-52. The subsequent steps control FIO2, either with a
 rapid stepwise control scheme for fast declines in SpO2 or a
 finely controlled PID algorithm. Id. at 10:16-23. After FIO2
 is determined, the protocol then calculates the ratio of
 PEEP/FIO2. Id. at 10:43-45. If the ratio is not within a clin-
 ically acceptable range, the PEEP is increased or decreased
 by a fixed increment over a fixed period, followed by obser-
 vation and measure of any change in PEEP on the patient’s
 oxygenation. Id. at 11:48-60.
     Of the challenged claims, claims 1 and 29 are independ-
 ent. Claim 1, which is directed to an apparatus, is illustra-
 tive and reproduced below:
     1. An apparatus for automatically controlling a
     ventilator comprising:
       first means for processing data indicative of at
       least a measured oxygen level of a patient, and
       for providing output data indicative of:
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 4                    TEHRANI   v. HAMILTON TECHNOLOGIES LLC

       required concentration of oxygen in inspiratory
       gas of the patient (FIO2) and positive end-expira-
       tory pressure (PEEP) for a next breath of the pa-
       tient;
       wherein FIO2 is determined to reduce the differ-
       ence between the measured oxygen level of the
       patient and a desired value;
       wherein PEEP is determined to keep a ratio of
       PEEP/FIO2 within a prescribed range and, while
       keeping the ratio within the prescribed range, to
       keep the measured oxygen level of the patient
       above a predefined value; and
       second means, operatively coupled to the first
       means, for providing control signals, based on
       the output data provided by the first means, to
       the ventilator;
       wherein the control signals provided to the ven-
       tilator automatically control PEEP, and FIO2, for
       a next breath of the patient.
 Id. at 12:49-13:3. Claim 29 is directed to a method for au-
 tomatically controlling a ventilator with steps like those re-
 cited in claim 1. Id. at 15:15-31.
                                II
     The Board concluded that the claims were invalid as
 obvious on two grounds: (1) a combination of Carmichael,
 Anderson, Dr. Tehrani’s U.S. Patent No. 4,986,268 (the
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 TEHRANI   v. HAMILTON TECHNOLOGIES LLC                    5

 “’268 patent”), and Rossi, 1 and (2) a combination of Taube,
 Carmichael, ARDSNET, Clemmer, and Rossi. 2
    Dr. Tehrani raises a dozen issues on appeal. None has
 merit and only a few warrant discussion.
     Dr. Tehrani argues that the Board should not have
 credited Hamilton’s expert, Dr. Richard Imbruce, because
 he is “a) not a respiratory therapist, b) none of his listed
 patents [are] on mechanical ventilation, and c) he was dis-
 qualified in another case for offering expert testimony on a
 subject he was not familiar with.” Appellant’s Br. at 34.
 Dr. Tehrani also claims that Dr. Imbruce is not a person
 having ordinary skill in the art. Id. at 35. We review the
 Board’s determinations as to what weight to accord expert
 testimony for abuse of discretion. See Shoes by Firebug
 LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362,
 1372 (Fed. Cir. 2020).

    1    Laurence C. Carmichael et al., Diagnosis and Ther-
 apy of Acute Respiratory Distress Syndrome in Adults: An
 International Survey, 11 J. Critical Care 9 (March 1996)
 (“Carmichael”); Jeffrey R. Anderson & Thomas D. East., A
 Closed-Loop Controller for Mechanical Ventilation of Pa-
 tients with ARDS, 38 Biomedical Scis. Instrumentation
 Symposium 289 (2002) (“Anderson”); A. Rossi, Intrinsic
 Positive End-Expiratory Pressure (PEEPi), 21 Intensive
 Care Med. 522 (1995) (“Rossi”).

    2    U.S. Patent No. 5,388,575 (“Taube”); The Acute
 Respiratory Distress Syndrome Network, Ventilation with
 Lower Tidal Volumes as Compared with Traditional Tidal
 Volumes for Acute Lung Injury and the Acute Lung Respir-
 atory Distress Syndrome, 342 New England J. Med. 1301
 (2020) (“ARDSNET”); U.S. Patent No. 6,148,814 (“Clem-
 mer”).
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 6                     TEHRANI   v. HAMILTON TECHNOLOGIES LLC

      The Board did not abuse its discretion. As the Board
 explained, Dr. Imbruce has decades of experience with ven-
 tilator devices and portable oxygen generators, including
 developing clinical protocols for new modalities in artificial
 ventilation and oxygen delivery therapies for hemorrhagic
 shock in wounded soldiers. Dr. Imbruce is an inventor on
 two patents related to a portable oxygen generator for
 emergency use, has worked in industry related to oxygen
 delivery and artificial ventilation since 1981, and has at
 least eleven years of clinical experience in pulmonary func-
 tion and respiratory therapy. The Board found Dr. Im-
 bruce’s testimony “adequate,” J.A. 14, and it was free to do
 so.
     Dr. Imbruce is a person of ordinary skill in the art, as
 he is a “clinician specializing in treating respiratory failure
 issues with at least five years of practical clinical ventilator
 experience treating such conditions,” which is one of the
 disjunctive options provided in the agreed-upon definition
 of an ordinary artisan, which the Board adopted. J.A. 13.
 Even assuming there was error in the Board failing to ex-
 pressly find that Dr. Imbruce was a person of ordinary skill
 in the art, such error was harmless, because, as we have
 explained, Dr. Imbruce plainly has the qualifications to
 make him such a person. 3

     3    At oral argument, Dr. Tehrani’s counsel empha-
 sized that Dr. Imbruce’s clinical experience occurred more
 than 40 years ago. Oral Arg. at 9:44-10:29. The Board’s
 definition of a person of ordinary skill in the art imposes no
 restriction as to when the skilled artisan’s clinical experi-
 ence must have occurred. Issues relating to the extent and
 timing of Dr. Imbruce’s clinical experience may affect the
 weight that the Board should choose to give his opinions,
 but those issues do not render his opinions unreliable.
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 TEHRANI   v. HAMILTON TECHNOLOGIES LLC                      7

      Dr. Tehrani also contends that the Board should have
 construed the claim term “for a next breath of the patient”
 as controlling PEEP and FIO2 for “a patient’s breath imme-
 diately following in time” or “the next breathing cycle of the
 patient.” J.A. 35-36 n.11; Appellant’s Br. at 41-43. Hamil-
 ton instead proposed the plain and ordinary meaning as
 not limited to the immediate next breath or breathing cy-
 cle. J.A. 2509-11. “[W]e review the Board’s ultimate claim
 constructions de novo.” Microsoft Corp. v. Proxyconn, Inc.,
 789 F.3d 1292, 1297 (Fed. Cir. 2015), overruled on other
 grounds by Aqua Prods., Inc. v. Matal, 872 F.3d 1290 (Fed.
 Cir. 2017). Here, however, the Board did not actually con-
 strue this claim term. Instead, after noting that Dr. Teh-
 rani’s proposed construction would contradict her
 argument that the specification requires adjusting PEEP
 after a 240-second delay, see ’571 patent 11:56-60, the
 Board determined that the claim limitation was taught in
 the prior art combinations “regardless of whether we adopt
 Patent Owner’s or Petitioner’s claim construction.” J.A.
 35-36 n.11. The Board had substantial evidence for this
 finding. See, e.g., J.A. 1114-15, 1118 (Anderson stating
 “[t]he computer constantly reads important [input] infor-
 mation” to “continuously control[] FiO2 and PEEP” and
 disclosing graph showing changes in FIO2 and PEEP over
 time); J.A. 446 (’268 patent teaching “controlling a respira-
 tor” based on input data and “provid[ing] digital output
 data representing the amount and optimum frequency of
 ventilation required for the next breath”). In combination,
 the prior art teaches that FIO2 and PEEP can be controlled
 for an immediate next breath or a later breath, satisfying
 both parties’ competing constructions.

 There is no basis for us to find the Board abused its discre-
 tion in the weight it placed on this witness’ testimony.
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 8                    TEHRANI   v. HAMILTON TECHNOLOGIES LLC

     Most of Dr. Tehrani’s remaining arguments challenge
 the Board’s factual findings, which we review for substan-
 tial evidence. “Obviousness under 35 U.S.C. § 103 is a
 mixed question of law and fact. We review the Board’s ul-
 timate obviousness determination de novo and underlying
 fact-findings for substantial evidence.” Hologic, Inc. v.
 Smith & Nephew, Inc., 884 F.3d 1357, 1361 (Fed. Cir.
 2018). Two examples are sufficient to illustrate the lack of
 merit in Dr. Tehrani’s contentions on appeal.
      Dr. Tehrani argues that Anderson’s use of look up ta-
 bles contradicts the ’571 patent’s PID control and, further,
 that Carmichael does not teach the use of an automatic
 ventilator and a ratio of PEEP/FIO2. Oral Arg. at 5:06-7:18,
 7:48-8:57. Substantial evidence supports the Board’s find-
 ing that “it would have been obvious to employ Anderson’s
 automated system to implement Carmichael's treatment
 protocol for adjustment of PEEP and FIO2 in ARDS [(Acute
 Respiratory Distress Syndrome)] patients.” J.A. 37. As Dr.
 Imbruce explained, the combination of Anderson and Car-
 michael, along with the ’268 patent and Rossi, teaches
 every challenged limitation of the ’571 patent. In particu-
 lar, Anderson teaches a “closed-loop control system,” using
 an oxygenation sensor and computer to use a “traditional
 proportional-integral-derivative (PID) approach” to “con-
 tinuously control[] FIO2 and PEEP settings on a Hamilton
 Amadeus ventilator.” J.A. 1114. Substantial evidence, in-
 cluding Dr. Imbruce’s second declaration, also supports the
 Board’s finding that Anderson’s look-up tables “contain the
 logic used to dictate if changes in therapy are needed ‘based
 on the patient’s current level of PaO2 and current PEEP
 and [FIO2] settings.’” J.A. 30 (quoting J.A. 1116 (Ander-
 son)). Anderson uses “[FIO2] and PEEP PID controllers that
 calculate the amount of therapy adjustment.” J.A. 1116.
 Anderson’s look-up tables serve the same function as the
 ’571 patent’s loop indicators, defining the logic that
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 TEHRANI   v. HAMILTON TECHNOLOGIES LLC                      9

 determines if and when PID controllers change FIO2 and
 PEEP. J.A. 31, 2715; ’571 patent 8:23-25.
     The Board also had substantial evidence to conclude
 that Carmichael teaches a treatment protocol of increasing
 FIO2 and incrementally changing PEEP and using the rela-
 tionship between FIO2 and PEEP to achieve the desired ox-
 ygen saturation level within a prescribed range, as
 depicted below in Carmichael’s Figure 7. J.A. 26-27, 29,
 422 (illustrating maximum acceptable PEEP used at each
 FIO2 level); see also J.A. 215-17 (“Carmichael discloses a de-
 sired oxygen level of a patient ‘should be achieved through
 the use of increased [FIO2] and incremental application of
 PEEP.”) (quoting J.A. 423-24). The slope in Figure 7 indi-
 cates the limits of the relationship between FIO2 and PEEP.
 See Oral Arg. at 14:30-16:19; see also J.A. 29 (“Figure 7 of
 Carmichael shows that the maximum level of acceptable
 PEEP increased as the FIO2 level increased.”).

 J.A. 422 (Carmichael Fig. 7).
      Many of Dr. Tehrani’s arguments are directed to point-
 ing out limitations that are not present in individual prior
 art references, but what matters is what the combination
 of references collectively contain, not what they individu-
 ally contain or lack. See Intel Corp. v. PACT XPP Schweiz
 AG, 61 F.4th 1373, 1380 (Fed. Cir. 2023) (explaining courts
 “‘look to interrelated teachings of multiple patents’”)
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 10                   TEHRANI   v. HAMILTON TECHNOLOGIES LLC

 (quoting KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
 (2007)). Identifying flaws in individual references does not
 defeat Hamilton’s showing that both combinations relied
 on by the Board disclose, collectively, all the limitations of
 the challenged claims.
                              III
    We have considered Dr. Tehrani’s remaining argu-
 ments and find them unpersuasive. For the foregoing rea-
 sons, we affirm.
                         AFFIRMED