Dr. Fleur Tehrani, PhD, PE

Patent Trials and Appeals Board

Dec 28, 2021

IPR2020-01199 (P.T.A.B. Dec. 28, 2021)

Trials@uspto.gov Paper 57
571-272-7822 Entered: December 28, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

HAMILTON TECHNOLOGIES LLC,
Petitioner,
v.
FLEUR TEHRANI,
Patent Owner.

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Patent 7,802,571 B2

Before JOSIAH C. COCKS, KEVIN W. CHERRY, and
JAMIE T. WISZ, Administrative Patent Judges.
CHERRY, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
35 U.S.C. § 318(a)
Denying-In-Part, Granting-In-Part, and Dismissing-In-Part Petitioner’s
Motion to Exclude
Denying-In-Part and Dismissing-In-Part Patent Owner’s
Motion to Exclude
37 C.F.R. § 42.64(c)

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I. INTRODUCTION
A. Background and Summary
Hamilton Technologies LLC (“Petitioner”) filed a Petition (Paper 2,
“Pet.”) seeking inter partes review of claims 1‒6, 9‒12, 29‒33, and 41 of
U.S. Patent No. 7,802,571 B2 (Ex. 1001, “the ’571 patent”). Petitioner
supported the Petition with the Declaration of Richard Imbruce. Ex. 1002.
Fleur Tehrani (“Patent Owner”) filed a Preliminary Response. Paper 5
(“Prelim. Resp.”).
On January 6, 2021, based on the record before us at the time, we
instituted an inter partes review of all challenged claims on all grounds
alleged. Paper 6 (“Institution Decision” or “Inst. Dec.”).
Patent Owner filed a Request for Rehearing of our Institution
Decision. Paper 9. We denied Patent Owner’s Request for Rehearing on
March 5, 2021. Paper 17 (“Reh’g Dec.”).
Patent Owner filed a Response in opposition to the Petition (Paper 19,
“PO Resp.”). Petitioner filed a Reply in support of the Petition (Paper 25,
“Reply”). Patent Owner also filed a Sur-Reply in response to Petitioner’s
Reply. Paper 28 (“Sur-Reply”).
Petitioner filed a motion to exclude evidence. Paper 35 (“Pet. Mot.”).
Patent Owner filed an opposition. Paper 37 (“PO Opp.”). Petitioner filed a
Reply. Paper 40 (“Pet. Mot. Reply”). Patent Owner also filed a motion to
exclude evidence. Paper 33 (“PO Mot.”). Petitioner filed an opposition.
Paper 37 (“Pet. Opp.”). Patent Owner filed a reply. Paper 41 (“PO Mot.
Reply”).
Both parties requested an Oral Hearing. See Paper 32. A transcript of
the Oral Hearing is entered in the record. Paper 53 (“Tr.”).
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We have jurisdiction under 35 U.S.C. § 6. The evidentiary standard is
a preponderance of the evidence. See 35 U.S.C. § 316(e) (2018); 37 C.F.R.
§ 42.1(d) (2020). This Final Written Decision is issued pursuant to
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.

B. Real Parties in Interest
Hamilton Technologies LLC identifies itself and its affiliated
subsidiaries, including Hamilton Holding Medical Corporation, Hamilton
Company, Hamilton Medical AG, Hamilton Medial Inc., and Hamilton
Bonaduz AG, as the real parties in interest. Pet. 1. Dr. Fleur T. Tehrani,
Ph.D., P.E., identifies herself as the real party in interest. Paper 4, 1.

C. Related Matters
Petitioner identifies that GB 2 423 721 B, which claims priority to the
’571 patent, is the subject of an ongoing UK civil action: Fleur Tehrani v.
Hamilton Bonaduz AG et al., High Court of Justice, Business and Property
Courts of England and Wales, Intellectual Property List (ChD), Intellectual
Property Enterprise Court, Claim IP-2019-000196, Issue date 29 November
2019. Pet. 1. Patent Owner also lists the ongoing UK litigation, and states
that there are no related judicial or administrative matters in the U.S.
Paper 4, 1.
D. The ’571 Patent
The ’571 patent, titled “Method and Apparatus For Controlling a
Ventilator,” issued September 28, 2010, from U.S. Application
No. 10/935,446, filed September 7, 2004, and claims the benefit of priority
to U.S. Provisional Application No. 60/481,693, filed November 21, 2003.
Ex. 1001, (54), (45), (21), (22), (60). The ’571 patent relates to “a method
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and apparatus 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.” See id. at 1:20–23. Specifically, the ’571 patent describes a
method and apparatus to control Positive End-Expiratory Pressure (“PEEP”)
and the concentration of oxygen in a patient’s inspiratory gas, or the fraction
of inspired gas (“FIO2” or “FIO2”) to improve the oxygenation of patients
during ventilator therapy. Id. at 2:25‒27, 3:52‒59.
We reproduce Figure 1 from the ’571 patent below.

Figure 1 depicts a block diagram of a mechanical ventilator and the
control apparatus of the claimed invention. Ex. 1001, 3:26–28. Digital
processor 10 includes a programmable controller coupled to receive
outputs 12, 14, and 16 of A/D converters 18, 20, and 22. Id. at 3:67‒4:2.
The A/D converters receive inputs 24, 26, and 28 from oxygen sensor 30,
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carbon dioxide sensor 32, and lung mechanics calculator and PV monitor 34.
Id. at 4:5‒9. Inputs 40 and 42 for sensors 30 and 32 come from the patient,
and input 36 for monitor 34 comes from mechanical ventilator 56. Id. at
4:16‒18, 22‒24. Outputs 44 from digital processor 10 are applied to signal
generator circuit 46. Signal generator circuit 46 sends alarm instruction
signals 52 to alarm circuit 54, control signals 48 to mechanical ventilator 56,
and control signals 50 to mixer regulator circuit 58.1 Id. at 4:26‒36. Control
signals 48 include signals to control PEEP, breathing frequency, tidal
volume, and adjustment of the I:E ratio of the patient. Id. at 4:32‒34.
Control signals 50 include signals to control mixer 62 to adjust FIO2. Id. at
4:34‒36.
The ’571 patent describes that digital processor 10 has a software
algorithm that automatically controls PEEP and FIO2 according to the method
shown in the flow chart of Figures 3a‒3i. Id. at 7:34‒41. The desired set
point for arterial partial pressure of oxygen is defined and the initial values
of FIO2 and PEEP are set. Id. at 7:47‒53, Fig. 3a, steps 200, 202, 204. Then,
a time parameter (e.g., TP) for PEEP adjustment is defined and initially set
to zero and another parameter, AP, for PEEP adjustment is defined to
control whether PEEP is controlled manually or automatically. Id. at 8:4‒
14, Fig. 3a, steps 206, 208. In the next step, threshold values for arterial
hemoglobin oxygen saturation (SpO2) are defined for the specific patient. Id.
at 8:15‒17, Fig. 3a, step 210. A loop indicator is defined and a first loop is
started. Id. at 8:23‒25, Fig. 3a, step 212. The patient’s SpO2 data is read
from one of the input ports, and the arterial partial pressure of oxygen is

1 A schematic diagram of signal generator circuit 46 and alarm circuit 54 for
use in the invention is shown in Figure 4 of the ’571 patent. Ex. 1001, 3:38‒
40, 12:4‒22.
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calculated from the SpO2 data. Id. at 8:26‒41, Fig. 3a, steps 214, 216. The
calculated partial pressure of oxygen, PaO2, is compared with a minimum
acceptable value to detect artifacts in the measurement of SpO2. Id. at 8:42‒
45, Fig. 3b, step 218. If the calculated PaO2 is found to be less than the
minimum acceptable value, then an artifact is assumed, an alarm is
generated, the SpO2 data is discarded and the previous value of PaO2 in
memory is resumed. Id. at 8:45‒49, Fig. 3b, steps 220, 222. If the
calculated PaO2 is found to be greater than or equal to the minimum
acceptable value, its value is accepted. Id. at 8:50‒52.
In the next steps, FIO2 is automatically controlled. Ex. 1001, 8:53‒
10:15, Figs. 3c-3e. The ’571 patent describes this process of automatic
control of FIO2 as using two different mechanisms: (1) a rapid stepwise
control scheme2 which responds instantly to fast declines in SpO2, and (2) a
more finely controlled PID algorithm3 that provides fine control of FIO2 in
the absence of sharp hazardous declines in SpO2. Id. at 10:16‒23. The
stepwise controller has three loops, each with its defined minimum and
maximum SpO2 threshold levels. Id. at 10:23‒26. The controller switches
from PID control to the rapid stepwise algorithm only if rapid declines in
SpO2 are detected. Id. at 10:28‒30. Once in the stepwise mode, the
controller continuously checks SpO2, and if it rises, the controller reduces FIO2
to minimize the exposure of the patient to high and toxic levels of FIO2. Id.
at 10:30‒33.

2 The rapid stepwise control scheme is shown in Figures 3c‒3e and
described in the ’571 patent in column 8, line 53 through column 9, line 33.
3 The PID control algorithm is shown in Figure 3f and described in the ’571
patent in column 9, line 33 through column 10, line 15.
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After the required FIO2 is determined, the procedure of adjusting PEEP
begins with calculating the ratio of PEEP/FIO2. Ex. 1001, 10:43‒45, Fig. 3g,
step 282. If the control parameter AP was set for automatic control of
PEEP, then an automatic PEEP adjustment control loop is started. Id. at
10:61‒64, Fig. 3g, step 284, Fig. 3h, step 294.
In performing the automatic PEEP adjustments, the PEEP/FIO2 value
is kept within a clinically acceptable range. Ex. 1001, 11:48‒49. If the
PEEP/FIO2 value is too low, PEEP is increased by a fixed increment (e.g., 2
cm H2O). Id. at 11:50‒51, 10:64‒11:18, Fig. 3h, steps 296, 298, 300, 302,
Fig. 3i, steps 304, 306. If the PEEP/FIO2 value is within the acceptable range
and SpO2 is low, then PEEP is increased by a fixed increment (e.g., 2 cm
H2O) to improve patient’s oxygenation. Id. at 11:51‒54, 11:37‒47, Fig. 3i,
step 320. On the other hand, if the PEEP/FIO2 value increases beyond a
maximum defined value, the program reduces PEEP in fixed amounts (e.g.,
2 cm H2O). Id. at 11:54‒56, 11:19‒34, Fig. 3i, steps 308, 310, 312, 314,
316. In any case, the interval between two successive PEEP adjustments is
at least equal to a fixed period (e.g., 240 seconds), to allow for the changes
in PEEP to have an observable and measurable impact on the patient’s
oxygenation. Id. at 11:56‒60.
E. Illustrative Claims
The Petition challenges claims 1‒6, 9‒12, 29‒33, and 41. Of these,
claims 1 and 29 are independent. Claim 1, which is illustrative of the
subject matter at issue, is directed to an apparatus and is 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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required concentration of oxygen in inspiratory gas
of the patient (FIO2) and positive end-expiratory pressure
(PEEP) for a next breath of the patient;
wherein FIO2 is determined to reduce the difference
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 ventilator
automatically control PEEP, and FIO2, for a next breath of the
patient.
Ex. 1001, 12:49‒13:3. Independent claim 29 is directed to a method for
automatically controlling a ventilator comprising steps similar to the
functions recited in claim 1. Id. at 15:15‒31.

F. Evidence
The following references form the basis of the grounds presented in
the Petition:
References Date Exhibit
No.
Carmichael, L.C. et al., “Diagnosis and Therapy of
Acute Respiratory Distress Syndrome in Adults: An
International Survey,” J. of Critical Care, Vol. 11,
No. 1 (March 1996), pp. 9‒18 (“Carmichael”)
March,
1996
1004
US 5,388,575 (“Taube”) Feb. 14,
1995
1005
US 4,986,268 (“Tehrani ’268”) Jan. 22,
1991
1006
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Brower, R.G., M.D. et al., “Ventilation with Lower
Tidal Volumes as Compared with Traditional Tidal
Volumes for Acute Lung Injury and the Acute
Respiratory Distress Syndrome,” The New England
J. of Med., Vol. 342, No. 18 (May 4, 2000), pp.
1301‒08 (“ARDSNET”).
May 4,
2000
1007
US 6,148,814 (“Clemmer”) Nov. 21,
2000
1008
Waisel, D.B. et al., “PEFIOS: An Expert
Closed-Loop Oxygenation Algorithm,” MEDINFO
’95 Proceedings of the Eighth World Congress of
Medical Informatics, pp. 1132‒36 (“Waisel”)
1995 1011
Anderson, J.R. et al., “A Closed-Loop Controller for
Mechanical Ventilation of Patients with ARDS,”
Technical Papers, Proceedings of the 39th Annual
Rocky Mountain Bioengineering Symposium & 39th
Int’l ISA Biomedical Sciences Instrumentation
Symposium, Vol. 38, Presented at Copper Mountain,
Colorado, April 12‒14, 2002, pp. 289‒94
(“Anderson”)
April 12‒
14, 2002
1013
Rossi, A. et al., “Intrinsic positive end-expiratory
pressure (PEEPi),” Intensive Care Med (1995)
21:522‒536 (“Rossi”)
1995 1015
For each of the above-listed publications, Petitioner provides evidence
to show “the authenticity of the documents” and “when and how each of
these documents was disseminated or otherwise made available to the extent
that persons interested and ordinarily skilled in the subject matter or art,
exercising reasonable diligence, could have located the documents.”
Declaration of Sylvia D. Hall-Ellis, Ph.D. (Ex. 1017), ¶ 12 (describing scope
of the declaration), ¶¶ 51‒68, 77‒84, 94‒110 (discussing above-listed
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references). Patent Owner has not challenged the prior art status of any of
the cited references.4 PO Resp., passim.
Petitioner also relies on the Declaration of Richard Imbruce
(Ex. 1002) as evidence of the state of the art, the knowledge of one having
ordinary skill in the art, and the anticipation and obviousness of the
challenged claims based on the grounds presented in the Petition. Patent
Owner supported its Preliminary Response with the Declaration of Fleur T.
Tehrani (Ex. 2002) in rebuttal. Patent Owner supported its Patent Owner
Response with the Second Declaration of Dr. Fleur Tehrani, dated March 31,
2021 (Ex. 2010).5 Petitioner supported the Reply with a second Declaration
of Richard Imbruce (Ex. 1029). Petitioner also submitted with its Reply the

4 Patent Owner does make certain challenges to the admissibility of the
references that we address in discussing Patent Owner’s Motion to Exclude.
See infra IV.
5 The Tehrani Declaration and Second Tehrani Declaration both include two
appendices that provide claim charts comparing the challenged claims to the
disclosures in the prior art references relied on in the Petition. Ex. 2002,
App. 1, App. 2; Ex. 2010, App. 1, App. 2. The Patent Owner Response
attempts to incorporate by reference the arguments from these appendices.
E.g., PO Resp. 56, 65, 72. The AIA trial rules impose word limits for
preliminary responses and prohibit incorporating arguments by reference
from one document into another. 37 C.F.R. §§ 42.24(b)(1), 42.6(a)(3). We
informed Patent Owner that we would not consider such incorporation by
reference in our Institution Decision and our Rehearing Decision. See Inst.
Dec. 9 n.4; Reh’g Dec. 3–5. Patent Owner has repeated this error. As
explained in our Consolidated Trial Practice Guide (CTPG) (Nov. 2019),
https://www.uspto.gov/TrialPracticeGuideConsolidated, “parties that
incorporate expert testimony by reference in their petitions, motions, or
replies without providing explanation of such testimony risk having the
testimony not considered by the Board.” CTPG, 35‒36 (citing Cisco
Systems, Inc. v. C-Cation Techs., LLC, IPR2014-00454, Paper 12 (PTAB
Aug. 29, 2014) (informative)). We do not consider these appendices in
reaching this Decision.
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Declaration of Dr. Jeffrey R. Anderson, P.E. (Ex. 1028). Patent Owner filed
two declarations with its Sur-Reply: the Third Declaration of Dr. Fleur
Tehrani (Ex. 2022) and the Declaration of Dr. James H. Roum (Ex. 2026).

G. Prior Art and Asserted Grounds
Petitioner asserts that the challenged claims are unpatentable on the
following grounds:
Claims Challenged 35 U.S.C. § References/Basis
1, 2, 5, 6, 11, 29, 31‒33, 41 102(b) Carmichael
1, 2, 5, 6, 11, 29, 31‒33, 41 103(a) Carmichael (as evidenced by ARDSNET and Waisel)6
1‒6, 9‒12, 29‒33, 41 103(a) Carmichael, Anderson, Tehrani ’268, Rossi
1‒6, 9‒12, 29‒33, 41 103(a) Taube, Carmichael, ARDSNET, Clemmer, Rossi

II. UNPATENTABILITY ANALYSIS
A. Legal Standards
Petitioner’s first asserted ground of unpatentability is based on
anticipation under 35 U.S.C. § 102(b). “A claim is anticipated only if each
and every element as set forth in the claim is found, either expressly or
inherently described, in a single prior art reference.” Verdegaal Bros., Inc.
v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). To establish
anticipation, “all of the elements and limitations of the claim must be shown

6 Petitioner provides this obviousness ground as an alternative to the
anticipation ground based on Carmichael. See, e.g., Pet. 35‒38. We list it as
a separate ground because it is based on a different statutory provision than
the anticipation ground.
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in a single prior reference, arranged as in the claim.” Karsten Mfg. Corp. v.
Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001).
Petitioner’s remaining asserted grounds of unpatentability are based
on obviousness under 35 U.S.C. § 103.
Section 103(a) forbids issuance of a patent when “the differences
between the subject matter sought to be patented and the prior art
are such that the subject matter as a whole would have been
obvious at the time the invention was made to a person having
ordinary skill in the art to which said subject matter pertains.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of
obviousness is resolved on the basis of underlying factual determinations,
including: (1) the scope and content of the prior art; (2) any differences
between the claimed subject matter and the prior art; (3) the level of ordinary
skill in the art; and (4) when available, objective evidence, such as
commercial success, long felt but unsolved needs, and failure of others.7
Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
“[O]bviousness must be determined in light of all the facts, and . . . a
given course of action often has simultaneous advantages and disadvantages,
and this does not necessarily obviate motivation to combine” teachings from
multiple references. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165
(Fed. Cir. 2006) (emphasis added); see also PAR Pharm., Inc. v. TWI
Pharms., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014) (“The presence or
absence of a motivation to combine references in an obviousness
determination is a pure question of fact.”).

7 The Patent Owner does not direct us to any objective evidence of non-
obviousness in the current record.
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B. Level of Ordinary Skill in the Art
The level of skill in the art is “a prism or lens” through which we view
the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d
1350, 1355 (Fed. Cir. 2001). Petitioner contends that a person having
ordinary skill in the art of the ’571 patent would be:
(i) a medically trained physician or clinician specializing in
treating respiratory failure issues with at least five years of
practical clinical ventilator experience treating such conditions;
or (ii) a Master’s degree in Electrical Engineering or a related
field and about five years of practical experience with developing
ventilators for clinical patient treatment; or (iii) a Bachelor’s
degree in Electrical Engineering or a related field and about 10
years of practical experience with developing ventilators for
clinical patient treatment.
Pet. 20‒21 (referencing Ex. 1002 ¶¶ 71‒72). Petitioner proposes that “[a]
higher level of education or specific skill might compensate less experience,
and vice versa.” Id. at 21.
Patent Owner does not present an opposing view of the level of skill
of the hypothetical person having ordinary skill in the art of the ’571 patent.
See PO Resp. passim.
For the purposes of this Decision, we apply Petitioner’s definition of
the level of ordinary skill in the art. We determine that this definition is
consistent with the prior art of record and the skill reflected in the
Specification of the ’571 patent, based on our review of the record.

C. Weight to Give Dr. Imbruce’s Testimony
Patent Owner argues that we should disregard the testimony of
Petitioner’s Declarant. See PO Resp. 75–77; Sur-Reply 14–15. Patent
Owner asserts that we should disregard Dr. Imbruce’s testimony because he
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did “not identify[] that certain references had technically erroneous
disclosures,” he “was not forthcoming in his deposition,” he “did not
identify in his CV that he had been an expert witness in prior matters.” Id.
Patent Owner located a case where his testimony had been excluded. Id.
Patent Owner also argues that his testimony is unreliable because he testified
that the claim term “for a next breath” was arbitrary and meaningless. Id.
We do not agree with Patent Owner that Dr. Imbruce’s testimony
should be disregarded. With respect to Patent Owner’s contentions about
“technically erroneous disclosures” and the construction of “for a next
breath,” those are really about Patent Owner’s disagreements about those
matters, not whether Dr. Imbruce was attempting to mislead the Board.
Disagreement between the experts is not a basis for disregarding testimony.
We have also reviewed the entirety of Dr. Imbruce’s deposition, and, in
particular, the various parts identified by Patent Owner. PO Resp. 76–77.
And, contrary to Patent Owner’s assertions, we found Dr. Imbruce gave
detailed answers in response to Patent Owner’s questions. We found Dr.
Imbruce’s testimony to be adequate. See, e.g., Ex. 2016, 107:11–115:8
(discussion of Anderson references, explaining the similarities of the
references, but declining to vouch for data he has not seen or collected);
115:9–116:6 (FDA permission, offering to confirm what reference said
about FDA approval, but attorney moving on to other questions). Thus, we
do not find Dr. Imbruce’s behavior during cross examination as a reason to
give no weight to the entirety of his testimony.
As for Patent Owner’s complaint about the disclosure of his prior
testimony, Patent Owner does not point us to any requirement that such
testimony be disclosed. Moreover, Patent Owner was free to inquire of
Dr. Imbruce on the topic, and did. See Ex. 2016, 13:14–17:19.
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Patent Owner focuses on the exclusion of Dr. Imbruce’s testimony in
Smith v. Terumo Cardiovascular Sys. Corp. (Ex. 2017), but we do not find it
informative about the weight we should give Dr. Imbruce’s testimony in this
case. The Terumo case dealt with failure analysis of a different device, and
the court in Terumo excluded Dr. Imbruce’s testimony because he was not
an expert in failure analysis of such devices and applied a methodology that
the party had abandoned, not whether he was knowledgeable about
automated ventilators, the subject matter of this case. See Ex. 2017, 12–13.
Indeed, the court explained
Dr. Imbruce may have the knowledge to describe the general
physiology of oxygenation. Dr. Imbruce may have the
knowledge regarding the various medical devices he invented.
But Dr. Imbruce does not have the knowledge to do a failure
analysis and make the very specific determination that a Terumo
System 1 heart-lung bypass machine failed due to software issues
that had never been identified by the manufacturer or—from the
available information—any other user of the System. . . .
Id. at 11.
Patent Owner also asserts that Dr. Imbruce’s background does not
match with the technology. Sur-Reply 15. As we explain below in response
to Patent Owner’s motion to exclude, there need not be a perfect match
between the expert’s qualifications and the patent at issue. See SEB S.A. v.
Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). It is not
necessary for Dr. Imbruce to demonstrate that he spent the bulk of his career
personally designing mechanical ventilators. Indeed, to testify as an expert
under Federal Rule of Evidence 702, a person need not be one of ordinary
skill, but may be “qualified in the pertinent art.” See B/E Aerospace, Inc. v.
MAG Aerospace Indus. LLC, IPR2014-01513, Paper 104 at 13–14 (PTAB
March 18, 2016) (Final Written Decision) (declining to exclude the
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testimony of expert witness that lacked hands-on experience with the
claimed subject matter). We agree with Petitioner that Dr. Imbruce’s
lengthy experience, including: a) developing ventilator devices and work on
a portable oxygen generator to provide emergency care to patients
undergoing respiratory distress (Ex. 1003, Rapid Oxygen Company work;
Ex. 2016, 10:23–12:22); (b) “developing clinical protocols for new
modalities in artificial ventilation” in the relevant 2003–2009 time period of
the patent at issue in this IPR; (c) “laboratory and clinical research funded by
DOD developing oxygen delivery therapies to treat hemorrhagic shock in
wounded soldiers” in the 2009–2016 time period (Ex. 1003); and (d)
ongoing design and use of ventilators, provides him sufficient experience
and knowledge of the claimed subject matter for his opinion to remain of
record. Ex. 1003; Ex. 2016, 10:23–12:22.
Instead of disregarding Dr. Imbruce’s testimony in its entirety, we
evaluate each of his assertions on their own, in light of the explanation
offered, his answers on the specific topics under cross examination, and the
other evidence of record.

D. Claim Construction
In inter partes reviews, we interpret a claim “using the same claim
construction standard that would be used to construe the claim in a civil
action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under this
standard, we construe the claim “in accordance with the ordinary and
customary meaning of such claim as understood by one of ordinary skill in
the art and the prosecution history pertaining to the patent.” Id.
Petitioner offers express constructions for nine claim terms. Pet. 22‒
27. Patent Owner offers express constructions for five claim terms. PO
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Resp. 11‒13. Included in each party’s initial claim construction briefing are
proposed constructions for the means-plus-function claim terms “first
means” and “second means” recited in claim 1. Pet. 22‒23; Prelim.
Resp. 12‒13.
In our Institution Decision, we determined that only the claim terms
“first means” and “second means” required construction. Inst. Dec. 25–27.
Neither party disputes those constructions and we maintain and adopt them
for the purposes of this Decision.
We determine that, for purposes of this decision, no other terms
require express construction. See Nidec Motor Corp. v. Zhongshan Broad
Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only
construe terms ‘that are in controversy, and only to the extent necessary to
resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g,
Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).

E. Ground 1: Claims 1, 2, 5, 6, 11, 29, 31‒33, and 41 as Anticipated by
Carmichael
Petitioner contends that Carmichael anticipates independent claims 1
and 29, and claims 2, 5, 6, 11, 31‒33, and 41, which depend from claim 1 or
claim 29. In the subsections below, we discuss the scope and content of
Carmichael and the asserted anticipation of independent claims 1 and 29.
1. Carmichael
Carmichael is a publication reporting the results from a questionnaire
sent to 3,164 physician members of the American Thoracic Society Critical
Care Assembly asking the members’ opinions regarding factors important in
diagnosis and treatment of adult respiratory distress syndrome (ARDS).
Ex. 1004, 9 (first col.). The data from the 31% of responding physicians
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was collected and reported. Id. The survey included questions about modes
of mechanical ventilation used for treatment and how physicians apply
PEEP at various levels of arterial oxygenation. Id. at 10 (first col.), 17‒18
(questionnaire questions). The survey results showed that the initial
treatment of patients with ARDS was most commonly accomplished using
volume-cycled ventilation in the assist/control mode. Id. at 9 (first & second
cols.), 11 (first col.) (disclosing, with reference to Figure 2, that
assist/control was the favored ventilator mode). The survey results also
showed that “[o]n average, oxygen toxicity was thought to begin at an F[i]O2
between 0.5 and 0.6,” and that “modest levels of [PEEP] were used in
incremental fashion as F[i]O2 requirements increased.” Id. at 9 (second
col.), 11 (second col.) (referencing Figure 4 showing level of FIO2 at which
oxygen toxicity begins), 12 (second col.) (referencing Figure 7 showing the
maximum PEEP used at various levels of FIO2 before increasing to the next
higher level of FIO2). Carmichael also discloses that conventional teaching
in the 1970s was that “a PaO2 > 60 mmHg was desirable and should be
achieved through the use of increased FiO2s and incremental application of
PEEP.” Id. at 13 (bottom of second col.) ‒ 14 (top of first col.). Carmichael
discloses that in the early 1990s it was recognized that peak inspiratory
pressures could induce lung injury and this understanding engendered
interest in limiting peak inspiratory pressure. Id. at 14 (first col.).
Carmichael reports that “[t]o many, the ‘best PEEP’ is the least PEEP at
which hemoglobin-oxygen saturation is considered adequate on nontoxic
concentrations of inspired oxygen.” Id. at 14 (second col.).
2. Analysis of Claim 1
Petitioner asserts that Carmichael discloses an apparatus for
automatically controlling a ventilator that includes the claimed “first means”
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for processing data indicative of at least a measured oxygen level of a
patient, and for providing data indicative of FIO2 and PEEP for a next breath
of the patient. Pet. 29‒34. Specifically, Petitioner asserts that Carmichael’s
disclosed assist control mode uses the measured arterial oxygen level to
provide data indicative of FIO2 and PEEP for a patient’s next breath. Id. at
31 (referencing Ex. 1004, 11‒12, Fig. 7). Petitioner asserts that Carmichael
teaches a desirable PaO2 level achieved through the use of increased FIO2 and
incremental applications of PEEP, teaching a level of PEEP that would not
be exceeded before increasing to the next higher FIO2. Id. (referencing
Ex. 1004, 12, 13‒14).
Patent Owner argues that Carmichael discloses survey results “based
on intermittent, manual, trial and error adjustment of FIO2 and PEEP.” PO
Resp. 29. Patent Owner argues that “in Carmichael, the FIO2 value is kept
constant with PEEP being manually and incrementally increased to some
maximum level before the next change in FIO2” but in the ’571 patent, “FIO2
is continuously determined based on the patient’s measured oxygen level.”
Id. at 29–30 (emphasis omitted). In other words, Patent Owner argues that
in Carmichael’s trial-and-error system, “[n]o difference between a measured
and desired oxygen level of a patient is defined and reduced as required by
the claims of the patent. . . .” Id.
In our Institution Decision, we determined Petitioner had not shown a
reasonable likelihood that Carmichael anticipates the challenged claims
because it lacked adequate disclosure of the apparatus claimed. Inst.
Dec. 29–30. In particular, we preliminarily found that “Carmichael lacks
details as to the specific manner in which the assist control mode was being
used to control PEEP and FIO2 levels” and whether Carmichael’s disclosure
“necessarily entails adjustments to FIO2 and PEEP.” Inst. Dec. 30.
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Petitioner argues that we should reconsider our initial finding because
a qualified POSITA with hands-on clinical experience would have
recognized Carmichael as necessarily disclosing determined adjustments of
PEEP and FIO2 in providing control/data signals to “automatically control
PEEP and FIO2 for a next breath of the patient.” Pet. Reply 6. However,
Petitioner states it “will focus on Ground 2 evidence of record,” which
supports a finding that Carmichael anticipates. Id.
We agree with Patent Owner that Carmichael lacks adequate
disclosure to anticipate the apparatus of claim 1. Specifically, because
Carmichael focuses on the result of physician surveys, and not on the
description of a ventilation system per se, Carmichael lacks details as to the
specific manner in which the assist control mode was being used to control
PEEP and FIO2 levels. Specifically, we cannot discern that Carmichael’s
discussion of an assist control mode for mechanical ventilation necessarily
entails adjustments to FIO2 and PEEP “for a next breath of the patient” as
recited in claim 1. As explained by Patent Owner, it is possible that the
parameters of PEEP and FIO2 could have been set manually by the physician
and/or could have been updated only periodically during treatment. See,
e.g., PO Resp. 25‒26. Thus, Petitioner has not shown by a preponderance of
evidence that Carmichael anticipates claim 1, or claims 2, 5, 6, and 11 that
depend from claim 1.
3. Analysis of Claim 29
Independent method claim 29 recites the step of determining required
FIO2 and PEEP for a patient and providing data signals indicative of the
required FIO2 and PEEP “for a next breath of the patient.” Ex. 1001, 15:19‒
30. Petitioner relies on the same findings as to the disclosure of Carmichael
as discussed above in the analysis of claim 1. Pet. 41‒43. For the same
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reasons discussed above, Petitioner has not shown by preponderance of the
evidence that Carmichael anticipates claim 29, or claims 31‒33 and 41 that
depend from claim 29.

F. Ground 3: Claims 1‒6, 9‒12, 29‒33, and 41 as Unpatentable over
Carmichael, Anderson, Tehrani ’268, and Rossi
Petitioner contends that the combination of Carmichael and Anderson
renders obvious the subject matter of independent claims 1 and 29 and
claims 2, 30, and 41, which depend from claim 1 or claim 29.8 Petitioner
contends that the combination of Carmichael, Anderson, and Tehrani ’268
renders obvious the subject matter of dependent claims 3‒6, 11, 12, and 31‒
33, and that the combination of Carmichael, Anderson, and Rossi renders
obvious the subject matter of dependent claims 9 and 10. In the subsections
below, we discuss the scope and content of the prior art and any differences
between the claimed subject matter and the prior art.
1. Carmichael
A general discussion of Carmichael’s disclosure is provided above in
Section III.E.1.
2. Anderson
Anderson is a technical paper of The Instrumentation, Systems, and
Automation Society (ISA), presented at the Proceedings of the 39th Annual
Rocky Mountain Bioengineering Symposium and 39th Annual International
ISA Biomedical Sciences Instrumentation Symposium. Ex. 1013. Anderson
is a report describing a “closed-loop control system based on

8 Petitioner relies on only Carmichael and Anderson for claims 1, 2, 29–33,
and 41. Tehrani ’268 is added for claims 3–6, 11, and 12. Rossi is added for
claims 9 and 10.
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well-established protocols to systematically maintain appropriate levels of
[PEEP] and [FiO2] in patients with [ARDS].” Id. at 289.
Anderson describes that the system consists of an in-dwelling arterial
oxygenation (PaO2) sensor coupled to a computer that continuously controls
FiO2 and PEEP settings on a Hamilton Amadeus ventilator. Ex. 1013, 289;
see also id. at 290, Fig. 1. Anderson acknowledges that “when high
concentrations of inspired oxygen or high airway pressures become
necessary in a very ill patient, the ventilator itself may further damage the
patient’s lungs.” Id. at 290. Anderson states that “[t]he implemented
protocols provide continuous closed-loop control of oxygenation and a
balance between patient need and minimal therapy.” Id. at 289.
Specifically, “[t]he controller is based on a traditional proportional-integral-
derivative (PID) approach. . . to control, or maintain, the patient’s PaO2
level at a target value.” Id. The controller also uses “non-linear and
adaptive characteristics that allow the system to respond more aggressively
to ‘threatening’ levels of PaO2.” Id.
Anderson illustrates the basic elements of the closed-loop controller,
in Figure 2 of Anderson, which is reproduced below:
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Ex. 1013, 291. Figure 2 of Anderson depicts “the look up tables or the
decision mechanism, the FiO2 and PEEP PID controllers that calculate the
amount of therapy adjustment, and the adaptive overall gain term.” Id.
Anderson describes that the look up tables “contain the logic used to
dictate changes in therapy based on the patient’s current level of PaO2 and
the current PEEP and FiO2 settings.” Ex. 1013, 291. Anderson shows five
logic tables corresponding to different levels of patient blood oxygenation
(i.e., supersatisfactory, satisfactory, acceptable, marginal, and threatening)
having physician-defined thresholds for each level. Id. at 291, Fig. 3.
Anderson also discloses equations that “describe the discrete recursive form
of the PID controller used to calculate the appropriate change in oxygenation
therapy.” Id. at 291 (equation #1 and equation #2). This PID controller uses
gain to provide “more aggressive response to hypoxemia and a more
conservative response to PaO2 above the desired goal.” Id. at 292, Fig. 2
(showing graph of adaptive gain).
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3. Tehrani ’268
Tehrani ’268 is a U.S. patent titled “Method and Apparatus for
Controlling an Artificial Respirator.” Ex. 1006, [54]. The patent relates to a
method and apparatus for controlling a respirator based on the measured
levels of carbon dioxide and oxygen of a patient on the respirator, as well as
other physical conditions of the patient. Id. at 1:14‒18. The patent
describes a programmable microcomputer that uses the measured levels of
carbon dioxide and oxygen of the patient to provide digital output data
representing the amount and optimum frequency of ventilation required for
the next breath. Id. at 2:2‒7. Figure 1 of Tehrani ’268 is reproduced below.

Figure 1 is a block diagram of an artificial respirator and control
apparatus. Ex. 1006, 2:35‒37. The apparatus disclosed in Tehrani ’268
includes A/D converters 18, 20 “coupled to the outputs 26 and 28 of an
oxygen sensor 32 and a carbon dioxide sensor 30, respectively.” Id. at 2:64‒
67. Tehrani ’268 also discloses D/A converters 50 and 52 for control signals
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generated by the ventilator computer to be sent to analog components. Id. at
2:23‒24. Tehrani ’268 teaches that ventilators use measured values
“supplied via the A/D converters” so that “they can also be monitored
continuously.” Id. at 3:8‒11.
Tehrani ’268 also describes that the apparatus calculates the pressures
of oxygen and carbon dioxide in the patient’s arterial blood, and compares
these values to upper and lower alarm limits to generate an alarm if either
pressure is outside of the specified range. Id. at 8:5‒34.
4. Rossi
Rossi is a review article published in Intensive Care Medicine.
Ex. 1015. Rossi describes that alveolar pressure can remain positive
throughout expiration without PEEP set by the ventilator whenever the time
available to breathe out is shorter than the time required to decompress the
lungs to the elastic equilibrium volume of the total respiratory system. Id. at
522 (first col.). Rossi describes that this phenomenon has been termed
“intrinsic PEEP [] owing to its similarity and contrast with PEEP set by the
ventilator.” Id. (first and second columns). Rossi describes that in assisted
modes of mechanical ventilation, intrinsic PEEP (or PEEPi) should be
measured routinely. Id. at 530 (first col.).
5. Analysis of Claim 1
Petitioner relies on Carmichael to disclose automated ventilators
operating in assist control mode to provide prescribed ARDS treatment
protocols. Pet. 46. Petitioner acknowledges that Carmichael does not
disclose the ventilator architectures in detail. Id. Petitioner relies on
Anderson to show a closed-loop control system using an oxygenation sensor
and a computer to continuously control FIO2 and PEEP settings on a
Hamilton Amadeus ventilator based on a traditional PID approach to control,
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or maintain, the patient’s oxygen level at a target value. Id. at 46‒47 (citing
Ex. 1013, 289 (Abstract), 290, Fig. 1; Ex. 1002 ¶¶ 264‒275). Petitioner
asserts that a person of ordinary skill in the art would have been expected to
implement Carmichael’s disclosed PEEP/FIO2 treatment protocol on an
automated ventilator, as disclosed by Anderson, to “systematically maintain
appropriate levels of [PEEP] and [FIO2].” Id. at 47 (quoting Ex. 1013, 289).
Petitioner asserts that operation of Anderson’s ventilator according to
Carmichael’s treatment protocol of “determining PEEP, after determining
[FIO2], to keep a calculated ratio of PEEP/[FIO2] within a prescribed range
would have been predictable and routine ventilator operation.” Id. at 47‒48
(referencing Ex. 1002 ¶¶ 273‒275).
Petitioner has shown by a preponderance of the evidence that
Carmichael discloses it was known in the art at the time of the invention to
use volume-cycled ventilation in the assist/control mode to implement
treatment protocols for treatment of ARDS patients through automatic
control of a ventilator. Pet. 29‒30; Ex. 1004, 9 (first & second cols.), 11
(first col.); Ex. 1002 ¶¶ 119‒123. Petitioner has shown that Carmichael
discloses a treatment protocol of increased FIO2 and incremental application
of PEEP at the FIO2 level to achieve a desired oxygen saturation level.
Pet. 30‒31; Ex. 1004, 11 (second col.) (referencing Figure 4 showing level
of FIO2 at which oxygen toxicity begins), 12 (second col.) (referencing
Figure 7 showing the maximum PEEP used at various levels of FIO2 before
increasing to the next higher level of FIO2), 13 (bottom of second col.), 14
(top of first col.) (conventional teaching was that “a PaO2 > 60 mmHg was
desirable and should be achieved through the use of increased FiO2s and
incremental application of PEEP”); Ex. 1002 ¶¶ 124‒127. Petitioner has
shown that Carmichael discloses “[t]oo [sic] many, the ‘best PEEP’ is the
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least PEEP at which hemoglobin-oxygen saturation is considered adequate
on nontoxic concentrations of inspired oxygen.” Id. at 14 (second col.).
Thus, Petitioner has shown that Carmichael discloses a relationship between
FIO2 and PEEP used to achieve a desired oxygen saturation. Petitioner also
has shown that Carmichael’s treatment protocol determines FIO2 to reduce
the difference between the measured oxygen level of the patient and a
desired value. Pet. 32; Ex. 1004, 13‒14 (describing selection of FIO2 to
achieve a desired oxygen saturation (PaO2 > 60 mmHG)); Ex. 1002 ¶ 136.
Petitioner has also shown that Anderson discloses a closed-loop
automated ventilator and control system for continuous control of PEEP and
FIO2 based on oxygen saturation. Pet. 46‒47. Petitioner has shown that the
treatment protocol disclosed in Carmichael, as implemented, with a
reasonable expectation of success, on the closed-loop continuous control
system of Anderson, would include the claimed first means (or equivalents
thereof) for determining PEEP and FIO2 in the manner claimed and the
claimed second means (or equivalents thereof) for providing signals to
control the ventilator by automatically controlling PEEP and FIO2 for a next
breath of the patient. Pet. 46‒48; Pet. Reply 18–19 (citing Ex. 1002 ¶¶ 147,
274, 275, 290).
As to Carmichael, Patent Owner argues that the main outputs of the
ventilator are set manually by an operator by trial and error and are not
automatically controlled. PO Resp. 23‒27 (citing Ex. 2007, 2012). Exhibit
2007, cited by Patent Owner, is a 1992 paper presented during a conference
on the “Essentials of Mechanical Ventilators.” Ex. 2007, 1026. This paper
describes that “Assist/control ventilation (A/C) is a mode of ventilator
operation in which mandatory breaths are delivered at a set [frequency],
pressure or volume, and inspiratory flow. Between machine-initiated
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breaths, the patient can trigger the ventilator and receive a mandatory breath
at the volume or pressure set on the ventilator.” Id. at 1032. Exhibit 2012,
which is cited by Patent Owner, is an article from “RT Magazine,” dated
February 7, 2007. Ex. 2012, 1. Exhibit 2012, to the extent it has any weight
as it is from long after the filing of the challenged patent, provides a similar
understanding. Ex. 2012, 2 (“ACMV still delivers a set tidal volume at a set
respiratory rate, but also responds to a patient’s inspiration.”). We disagree
with Patent Owner’s premise that an apparatus “for automatically controlling
a ventilator” must provide automatic control of some of the outputs “for a
next breath of the patient.” PO Resp. 26, 58–59. The preamble of the
challenged independent claims, which is where Carmichael is cited by itself
for disclosing automatic control of a ventilator, does not recite “for a next
breath of the patient.” Ex. 1001, 12:48‒49, 15:15‒16. Petitioner relies on
the combination of the references where the claim does recite “for a next
breath of a patient. See Pet. 46–48. Indeed, the Specification of the ’571
patent describes a clinician manually setting the initial values and allows for
manual control of PEEP in the preferred embodiment of the invention. Id. at
7:67–8:2, 8:10–14, 10:16–65, 11:48–49, 12:23–28. Thus, Patent Owner’s
argument that “[a]n automatic ventilator cannot have manually set outputs
that are adjusted intermittently by an operator” is inconsistent with the
description in the challenged patent. See PO Resp. 58. Our finding that
Carmichael discloses automatic control of a ventilator is based on our
understanding that Carmichael discloses a ventilator that allows an operator
to select a desired PEEP and FIO2, and the ventilator controls the output to
deliver machine initiated breaths at these desired values. Ex. 1002 ¶¶ 122,
123. This understanding is supported by Petitioner’s evidence and is
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consistent with the description of “assist/control ventilation” provided in
Patent Owner’s Exhibit 2007.
Further, this ground is based on the modification of Carmichael’s
assist control ventilator with Anderson’s automated ventilator architecture to
provide automated control for a next breath of the patient. Pet. 46‒48. The
record contains extensive evidence that highly sophisticated microprocessor-
controlled ventilator systems capable of very high gas outputs, complex
monitoring were known in the art at the time of the invention. See Ex. 1011
(Waisel), 1132 (§ 2), 1134 (§ 2.3); Ex. 1013 (Anderson); Ex. 1006 (Tehrani
’268). Thus, Patent Owner’s separate attack on Carmichael is simply not
persuasive when the Petition relies on the combination of references.
Patent Owner also argues that Carmichael fails to disclose that PEEP
is determined to keep a ratio of PEEP/FIO2 within a prescribed range. PO
Resp. 27–30. As discussed above, Petitioner has shown that Carmichael
disclosed it was known in the art to select PEEP based on the level of FIO2
and to avoid exceeding a maximum PEEP for a certain FIO2 by moving to
next higher level of FIO2 when the PEEP reaches the maximum level.
Ex. 1004, 12, Fig. 7. Figure 7 of Carmichael shows that the maximum level
of acceptable PEEP increased as the FIO2 level increased. Id. Petitioner
describes, and we find persuasive, how this disclosed protocol selects PEEP
to maintain a ratio of PEEP/FIO2 within a certain range. Pet. 32‒33.
Patent Owner argues that “[b]y trial and error adjustment, FIO2 is not
determined to reduce the difference between the measured oxygen level of a
patient and a desired value as required in the Patent.” PO Resp. 27 (“There
is no mechanism in place to reduce such difference systematically”). As
discussed above, Petitioner has shown that Carmichael discloses adjusting
FIO2 to reach a desired oxygen level. See Ex. 1002 ¶¶ 129–135. Patent
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Owner’s arguments about trial-and-error are beside the point. Importantly,
even if clinicians in Carmichael reached their preferred treatment by trial-
and-error, Carmichael reports this preferred treatment, which a person of
ordinary skill would have been motivated to implement in the automated
system of Anderson with a reasonable expectation of success. See Ex. 1002
¶¶ 267–275. We find sufficient evidence and reasoning that one having
ordinary skill in the art, implementing such a protocol to adjust FIO2 to reach
a desired oxygen level, as taught in Carmichael, in the automated system of
Anderson, would have been led to adjust FIO2 to minimize the difference
between the measured and desired oxygen levels.
As to Anderson, Patent Owner also argues that Anderson’s disclosure
of a look up table to control PEEP and FIO2 suggests discrete pairs for
intermittent adjustments of the two variables, while Anderson’s
“Proportional-Integral-Derivative (PID) controllers are designed to control
the output continuously and based on error signals.” PO Resp. 35, 62.
Patent Owner argues that these two techniques are contradictory means of
adjusting PEEP and FIO2. Id. at 36. We disagree that Anderson is internally
inconsistent. Anderson discloses that the look up tables shown in Figure 3
contain the logic used to dictate if changes in therapy are needed “based on
the patient’s current level of PaO2 and the current PEEP and FiO2 settings.”
Ex. 1013, 291. Thus, these logic tables are used to determine whether a
change in PEEP and/or a change in FIO2 is necessary. Id. at Fig. 3 (showing
indicators of “B” when both PEEP and FIO2 are to be changed, an “F” if only
FIO2 is to be changed, a “P” if only PEEP is to be changed, and “N” if neither
is to be changed); Ex. 1028 ¶¶ 16–18; Ex. 1029 ¶¶ 6, 7, 11. Anderson
discloses that the look up tables contain “logic used to dictate changes in
therapy based on the patient’s current level of PaO2 and the current PEEP
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and FiO2 settings.” Ex. 1013, 291. Different “tables correspond to different
levels of patient blood oxygenation.” Id. PID equations then control FIO2
and PEEP settings. Ex. 1013, 291–292, eqs.1–2, Fig. 4. Anderson does not
disclose using these look up tables to determine the amount of the change to
either or both of these parameters. Rather, Anderson uses equations to
calculate the appropriate changes. Id. at 291 (eq. #1, eq. #2), Fig. 2
(describing using the FIO2 and PEEP PID controllers to determine the amount
of change needed); Pet. Reply 16 (showing annotated version of Figure 7 of
Anderson showing FiO2 being adjusted while PEEP is maintained and then
both being adjusted later).
We further note the similarity of Anderson’s use of Lookup Tables to
the Loop Indicators (LIs) of the ’571 Patent, which operate in conjunction
with PID control. Pet. Reply 16. As Petitioner explains, a selected look up
table (LUT) of Anderson defines logic to apply PID control of PEEP and
FIO2. Id. A selected loop indicator of the ’571 Patent does the same.
Ex. 1001, 8:23–25; Figs. 3a–3h: steps 212, 224–226, 252.
Patent Owner further argues that the equations disclosed in Anderson
for PID control “are erroneous.” PO Resp. 37. Patent Owner points to
Anderson’s disclosure that the equations are for the “discrete recursive form
of the PID controller.” Id. (citing Ex. 1013, 291). Patent Owner then argues
that “[t]he parameters of a discretized PID are functions of the sampling
interval and are not constant,” citing “equation 8-52 on page 312 of Exhibit
2013.” Id. We have reviewed Exhibit 2013, and fail to see on its face, and
Patent Owner does not provide adequate explanation, exactly how it
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supports Patent Owner’s assertions.9 Patent Owner further argues that
“discretized PID is not applicable to the subject of Anderson.” Id. Again,
Patent Owner does not cite to any evidence in its Patent Owner Response to
support these arguments, nor does Patent Owner provide in its Patent Owner
Response any explanation for the basis of these assertions.10 In contrast, Dr.
Anderson confirms in his testimony that the equations are accurate.
Ex. 1028 ¶ 15. We find this testimony consistent with the disclosure of
Anderson and give it significant weight.
Patent Owner seeks to have us infer that Anderson’s system did not
use any PID control, despite Anderson’s explicit disclosure of PID
controllers, because the clinical results reported in Anderson are identical to
results in the 1994 Anderson paper (Ex. 2008) published eight years earlier.
PO Resp. 37–40, 60–62. Patent Owner asserts that this earlier article
describes that the system “is ‘protocol’ based as stated in the paper (meaning
it used a look up table) and it does not use any PID controller.” Id. at 40.
Patent Owner argues that because Anderson’s results are the same as the
1994 paper (Ex. 2008), it appears the authors used only a look up table for
both articles. Id.; Ex. 2010 ¶¶ 84–87. Patent Owner bases this contention on
an interpretation of the sentence “A system was designed based on these
protocols which provides continuous closed-loop control of oxygenation.”
Ex. 2008, A188; Ex. 2010 ¶¶ 83–87, 141–150.

9 Dr. Tehrani makes identical allegations in her declaration. Ex. 2010 ¶ 83.
However, no additional explanation is provided in that paragraph. Id.
10 Although not cited in the Patent Owner Response, Patent Owner provides
similar assertions in her declaration without any further explanation or
reasoning to explain the basis for these assertions. Ex. 2010 ¶ 83. We
decline to give weight to this unsupported testimony.
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We decline to ignore Anderson’s explicit teaching of use of PID
controllers to determine the amount of change needed for continuous
adjustment of PEEP and FIO2. We also decline to infer that the mention in
the 1994 Anderson paper to the use of “protocols” to design its closed-loop
system necessarily means that the earlier system in the 1994 Anderson paper
was based solely on look up tables. Ex. 2008 (“A system was designed
based on these protocols which provides continuous closed-loop control of
oxygenation”). The 1994 Anderson paper is silent as to the particular logic
used in its software to provide the control of PEEP and FIO2. Id. The natural
reading of Anderson’s discussion of “protocols” is that a treatment protocol
was developed by clinicians and the system was designed “based on” that
“protocol,” and nothing more. Ex. 2008, A188. This conclusion is further
supported by the testimony of Dr. Anderson. See Ex. 1028 ¶¶ 3–5.
Dr. Anderson acknowledges that the data included in the two papers is the
same, and explains that the “protocols” discussed are the treatment protocols
developed by some of the co-authors, not the architecture of the system.
Ex. 1028 ¶¶ 7, 8. This testimony and our reading is consistent with the two
papers when they are read together. The 1994 Andersen paper (Exhibit
2008) is a brief synopsis of the work in progress, less than a half a page
long. It provides minimal details regarding the architecture of the system.
See generally Ex. 2008. The Anderson reference (Exhibit 1013) is a lengthy
detailed description of the work. See generally Ex. 1013. We note that
Exhibit 1013 contains a similar description of the design criteria to Exhibit
2008: “We have designed a system based on well-established protocols for
management of mechanical ventilation that provides continuous loop control
of oxygenation and a balance between patient need and minimal therapy.”
Ex. 1013, 290. Thus, Exhibit 1013 is consistent with Exhibit 2008.
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Patent Owner’s reading of these two papers—where Exhibit 2008’s
use of the word “protocol” must mean that the system used look up tables
and, therefore, Exhibit 1013 is a falsified article—is unreasonable, takes the
word “protocol” as it is used in Exhibit 2008 entirely out of context, ignores
the more natural reading of the two papers together, and goes against Dr.
Anderson’s unimpeached and well-explained testimony. Patent Owner’s
accusations are serious ones, but are based on nothing more than conjecture
and suspicions. We find Patent Owner’s contentions unsupported and
against the great weight of the evidence. Thus, we disagree with Patent
Owner that Anderson should be disregarded.
Patent Owner contends that experiments, such as Anderson’s, require
FDA approval, but Anderson does not “provide the essential and required
information about an FDA permission to conduct its claimed closed-loop
clinical experiments.” PO Resp. 40–41. Patent Owner’s argument is not
persuasive. Patent Owner points to no evidence that any article about a
study must discuss FDA permission specifically. See id. And there is no
requirement that a party submit an FDA number to the Board to show
something is prior art. See 35 U.S.C. § 102. Anderson explicitly discloses
clinical compliance of trials conducted in Salt Lake City, Utah, where
“Informed consent was obtained from 2 ARDS patients in the Shock/Trauma
ICU at LDS Hospital for a clinical trial.” Ex. 1013, 292. Dr. Anderson’s
testimony confirms that the proper approvals were obtained for the trial.
Ex. 1028 ¶¶ 5–14, 19–22. Patent Owner cites FDA documents apparently
from 2006—long after the trial discussed in Anderson took place.
Exs. 2014, 2015. However, even if we consider these documents from long
after the trial, at most, all these FDA documents suggest is that FDA
permission must be obtained for such clinical trials. Id. Patent Owner fails
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to point out any requirement that any paper describing such clinical trials
must explicitly discuss FDA approval of the study they are describing. See
PO Resp. 40–41; Sur-Reply 30–31. Thus, Patent Owner’s conclusion that
no clinical trial actually took place because the article does not contain
evidence of FDA permission is completely speculative, wholly without
evidentiary support, and against the entire weight of the evidence in the
record.
Finally, Patent Owner argues that Anderson’s use of a PID controller
would result in constant changing to PEEP that would be hazardous to a
patient, which is why no commercial ventilator has used a PID controller to
control PEEP. PO Resp. 41. Patent Owner does not cite to any evidence in
its Patent Owner Response to support this assertion.11 Patent Owner does

11 We note that Patent Owner’s argument that continuous changing of PEEP
is “against the method of the patent” is directly in tension with Patent
Owner’s proposed construction of “for a next breath of the patient.” PO
Resp. 11–12, 42. For claim construction, Patent Owner argues that “[t]he
term “for a next breath of the patient” simply means “for a patient’s breath
immediately following in time” or simply “the next breathing cycle of the
patient” as evident from the claims and the entire patent specification.” Id.
at 12. However, with respect to Anderson and Taube, Patent Owner argues
that adjusting FIO2 is required, but adjusting PEEP breath-by-breath is
forbidden. Indeed, Patent Owner asserts that the Specification discloses
only adjusting PEEP after a 240 second delay. See PO Resp. 41 (“In the
Patent, PEEP is determined (i.e., decided upon) every fraction of a second
(e.g., every 0.75 seconds as shown in Figure 3h) and for a next breath of the
patient, but it is not ‘changed’ until a fixed period (e.g., 240 seconds) has
passed since the last ‘change’ in PEEP.”). The challenged claims make no
distinction between FIO2 and PEEP, but instead recite automatically
controlling both of them “for a next breath of a patient.” See, e.g., Ex. 1001,
13:1–3 (“wherein the control signals provided to the ventilator automatically
control PEEP, and FIO2, for a next breath of the patient” (emphasis added)).
Without meaningful explanation, Patent Owner would have “for a next
breath of the patient” mean different things for different parts of the same
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cite to its declarant’s testimony on this point, but the declaration cites no
other evidence to support the factual contentions underlying this opinion.
Ex. 2010 ¶ 92. Thus, we give this testimony little weight. Anderson
discloses that its clinical results showed that the system disclosed in
Anderson was safe for control of PEEP and FIO2 in the patients on which it
was tested. Ex. 1013, 293. Dr. Anderson provides similar testimony as to
the safety and efficacy of the system. Ex. 1028 ¶¶ 7–14. Thus, we find that
the preponderance of the evidence in this record does not support Patent
Owner’s contentions.
Moreover, even if Patent Owner were correct regarding this
contention about adjusting PEEP, “just because better alternatives exist in
the prior art does not mean that an inferior combination is inapt for
obviousness purposes.” In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012)
(citing In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)). Patent Owner fails
to explain how PID control would be outside the scope of the language of
the claims. Instead, Patent Owner agreed that PID control was within the
meaning of “determining” and “calculating.” See PO Resp. 13; Ex. 1027,
116:25–117:3.
As to the combination, Patent Owner argues that Anderson’s alleged
system would be rendered inoperable if combined with Carmichael’s manual
setting of parameters. PO Resp. 73‒75. This argument misstates
Petitioner’s proposed combination. Petitioner does not propose to modify

limitation. We do not need to resolve this tension between the proposed
claim construction and these admissions regarding the disclosure of the
challenged patent, because we determine that regardless of whether we adopt
Patent Owner’s or Petitioner’s claim construction, Grounds 3 and 4 meet this
limitation.
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Anderson’s automated ventilator control system to use manual controls.
Rather, Petitioner proposes 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 patients. Pet. 47–48. “The test
for obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference,” In re Keller,
642 F.2d at 425; see also In re Mouttet, 686 F.3d at 1332 (citing In re Keller,
642 F.2d at 425), but rather whether “a skilled artisan would have been
motivated to combine the teachings of the prior art references to achieve the
claimed invention,” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed.
Cir. 2007). “A person of ordinary skill is also a person of ordinary
creativity, not an automaton.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
421 (2007). Anderson itself describes that existing treatment protocols were
used to design the system. Ex. 1013, 290. This goal is reflected in other
references in this art in the record as well. See, e.g., Ex. 1011, 1133 (noting
the goal of “mimic[ing] how expert clinicians care for patients”).
Patent Owner also asserts that the Petitioner never specifically
addresses how Anderson determines FIO2 and PEEP “for a next breath of the
patient.” PO Resp. 62. Petitioner describes, with reference to Figure 1 of
Anderson, that Anderson’s “computer constantly reads important
information from both the PaO2 monitor and Ventilator via RS232 serial
ports” and uses this information “to calculate new values of PEEP and FiO2
that are subsequently transmitted to the ventilator for proper adjustments in
patient therapy.” Pet. 47 (citing Ex. 1002 ¶¶ 271‒272; Ex. 1013, 290).
Petitioner’s declarant, Dr. Imbruce, explains in the cited paragraphs that the
closed-loop adaptive controller of Anderson’s Figure 2 “continuously
controls FiO2 and PEEP.” Ex. 1002 ¶ 272 (citing Ex. 1013, 291).
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Carmichael’s protocol targets a desired PaO2 level “through the use of
increased FiO2s [sic] and incremental application of PEEP” while keeping
PEEP to a value within a range of zero to 25 cmH2O for a given FIO2 value.
Ex. 1004, 13–14; Ex. 1002 ¶ 147. We understand Petitioner, in its
contentions that the computer “constantly reads” information from the
patient and “continuously controls FiO2 and PEEP,” to address the
requirement that the system determines FIO2 and PEEP “for a next breath of
the patient” in view of Carmichael’s teachings.
For these reasons, Petitioner has demonstrated by a preponderance of
the evidence that claim 1 would have been obvious based on the combined
teachings of Carmichael and Anderson.
6. Analysis of Claim 29
Petitioner relies on the same findings and combination of Carmichael
and Anderson to challenge method claim 29 as presented for its challenge to
claim 1. Pet. 57‒58. Patent Owner does not present separate arguments for
claim 29. See PO Resp. 10, 11, 27, 29, 35–43, 56–65, 72‒75 (presenting the
same arguments for claims 1 and 29). We have reviewed Petitioner’s
evidence and arguments for claim 29, and find them sufficient. See Pet. 57–
58. Thus, for the same reasons discussed above in our analysis of claim 1,
Petitioner has shown by a preponderance of the evidence that claim 29
would have been obvious based on the combined teachings of Carmichael
and Anderson.
7. Analysis of Claims 2‒6, 9‒12, 30‒33, and 41
Claims 2‒6, 9‒12, 30‒33, and 41 all depend directly or indirectly
from claim 1 or claim 29. We have reviewed Petitioner’s cited evidence and
explanation regarding why the combination of Carmichael and Anderson,
either by itself, or further combined with Tehrani ’268 and Rossi, renders
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obvious the subject matter of these dependent claims and find the evidence
and reasoning sufficient to show by a preponderance of the evidence that
these claims are unpatentable. Although Patent Owner discusses
Tehrani ’268 in its Patent Owner Response, Patent Owner does not address
or contest Petitioner’s reliance on Tehrani ’268 for its disclosure of an A/D
converter or a D/A converter (claim 5, 10, 31). PO Resp. 54‒55 (arguing
only that Tehrani ’268 does not disclose certain subject matter of claims 1
and 29 and does not disclose the features of unchallenged claim 14). Patent
Owner argues that Petitioner’s reliance on Tehrani ’268 for teaching an
alarm unit (claims 3, 4, 11, 12) is misplaced. PO Resp. 55. We disagree.
Petitioner has shown persuasively that the combined teachings of
Carmichael, Anderson, and Tehrani ’268 would have rendered the subject
matter of these claims obvious. Pet. 48‒50; Ex. 1002 ¶¶ 277‒295
(demonstrating that it was well-known in the art of automated control for a
ventilator computer to detect an artifact and generate an alarm output).
Further, although Patent Owner discusses Rossi in its Patent Owner
Response, Patent Owner does not contest Petitioner’s reliance on Rossi for
its disclosure of measurement of PEEPi (claims 9, 10, 30). PO Resp. 53‒54
(arguing that Rossi individually does not describe any system to control a
ventilator or to control PEEP, and not presenting arguments against Rossi in
combination with the teachings of Carmichael and Anderson).
Patent Owner raises no other arguments regarding these claims other
than those considered above with respect to claim 1. We determine that
Petitioner has shown by a preponderance of the evidence that the combined
teachings of Carmichael, Anderson, Tehrani ’268, and Rossi render obvious
claims 2‒6, 9‒12, 30‒33, and 41.
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G. Ground 4: Claims 1‒6, 9‒12, 29‒33, and 41 as Unpatentable over
Taube, Carmichael, as evidenced by ARDSNET, Clemmer, and Rossi
Petitioner contends that the combination of Taube, Carmichael, as
evidenced by ARDSNET, Clemmer, and Rossi renders obvious independent
claims 1 and 29, and claims 2‒6, 9‒12, 30‒33, and 41, which depend from
claim 1 or claim 29. In the subsections below, we discuss the scope and
content of the prior art and any differences between the claimed subject
matter and the prior art.
1. Taube
Taube is a U.S. patent titled, “Adaptive Controller for Automatic
Ventilators.” Ex. 1005. Taube describes automatic controls for positive
pressure ventilation systems. Id. at 1:6‒8. Specifically, Taube’s system is
intended to make more automatic the control of inspiratory ventilation time
(Tinsp), PEEP, and FIO2. Id. at 1:25‒30. Taube discloses using a pulse
oximeter to determine hemoglobin saturation and of the patient’s blood to
calculate the partial pressure of arterial oxygen (PaO2), which is used to
regulate Tinsp, PEEP, and FIO2. Id. at 1:31‒37. Taube describes, “[t]he
control mechanism is derived from the known relationship between the
preset level of Tinsp, PEEP, minimum required FiO2 delivered to the patient,
and predetermined lung function dynamics in order to maintain a desirable
PaO2.” Id. at 1:37‒41.
Taube describes prior art devices for controlling the oxygen content of
blood by controlling breathing parameters, and using an optical oximeter and
a temporary oxygen deficient mixture to prevent super saturation. Id. at
1:62‒2:66. Taube describes using sensed hemoglobin saturation to
concurrently and adaptively control FIO2, Tinsp, and PEEP from a ventilator
to address “the patient’s changing need for increasing and decreasing of
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blood oxygenation.” Id. at 2:67‒3:7. Taube’s system automatically
provides “the highest oxygen saturation in the blood” while maintaining the
highest possible Tinsp, the lowest possible PEEP, and the lowest possible
FIO2 delivered to the patient. Id. at 3:15‒29.
Figure 1 of Taube is shown below.

Figure 1 of Taube is a diagrammatic view of the automatic ventilator
control system. Ex. 1005, 3:64‒65. Figure 1 shows optical sensor 28 placed
on the finger of patient 20. Id. at 4:17. Pulse oximeter 30 is connected to
sensor 28 and computer 36. Id. at 4:18‒24. The outputs from computer 36
pass through D/A converter 40 to ventilator 44. Id. at 4:24‒26.
Taube discloses the control program with reference to Figure 3, which
is reproduced below.
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Figure 3 is a flow diagram showing the operation of Taube’s system.
Ex. 1005, 3:67‒68. Taube describes that computer 36 receives a
hemoglobin saturation signal from pulse oximeter 30 and calculates a partial
pressure of arterial oxygen (PaO2) value for patient 20. Id. at 5:16‒18.
According to Taube, “The computer then determines modification values of
Tinsp, PEEP, and FiO2 from the calculated PaO2.” Id. at 5:19‒21. After the
modification values are determined, the “computer then determines the
proportional, differential, and integral gain coefficients to develop control
signals to the ventilator” and “sends control signals to the ventilator for the
modification of Tinsp, PEEP, and FiO2 values.” Id. at 5:22‒27. Taube then
describes that “[t]he patient then breath[e]s in through a breathing tube the
positive air pressure at the modified Tinsp, PEEP, and FiO2 values.” Id. at
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5:28‒30. Taube explains that “[t]he values of Tinsp, PEEP, and FiO2 are
chosen by the computer to maintain a desired level of the patient’s blood
oxygen level.” Id. at 5:30‒33.
2. Carmichael
A general discussion of Carmichael’s disclosure is provided above in
Section II.E.1.
3. ARDSNET
ARDSNET is an article published in The New England Journal of
Medicine reporting on the results of a trial to determine whether ventilation
with lower tidal volumes would improve the clinical outcomes in patients
with acute lung injury and ARDS. Ex. 1007, 1301 (Background). The
article provides a table summarizing the ventilator procedures used during
the trial. Id. at 1303 (Table 1). The table shows that the trial treated two
groups of patients, a first group receiving traditional tidal volumes and a
second group receiving lower tidal volumes. Id. Both groups were treated
with a “volume assist-control” ventilator and using an oxygenation goal of
PaO2 of 55‒80 mm Hg or SpO2 of 88‒95%. Id. The Table lists a range of
“allowable combinations of [FIO2] and PEEP” that includes FIO2 of 0.3 to 1.0
and PEEP of 5 to 24 cm of water. Id. ARDSNET describes that various
data were recorded “in four hours before the ventilator settings were
changed on day 0” and that data “were recorded between 6 and 10 a.m. on
days 1, 2, 3, 4, 7, 14, 21, and 28.” Id. at 1303.
4. Clemmer
Clemmer is a U.S. patent titled, “Method and System for Patient
Monitoring and Respiratory Assistance Control Through Mechanical
Ventilation by the Use of Deterministic Protocols.” Ex. 1008, [54].
Clemmer describes its objective as generating executable instructions for
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patient care which takes into account a large number of parameters of patient
conditions and ventilation. Id. at [57]. “Patient data are processed according
to a set of protocols which contain rules for patient care decisions arranged
in a logical sequence to generate detailed, executable instructions for patient
care.” Id. The data can be acquired and the patient care instructions can be
carried out automatically, and instructions are updated when new data is
acquired. Id. Specifically, Clemmer describes monitoring and controlling a
patient’s oxygenation while being treated through mechanical ventilation by
controlling the patient’s oxygen partial pressure by adjusting PEEP and
FiO2. Id. at 5:65‒6:1. Clemmer describes various protocols for generating
patient care instructions. Id. at Figs. 2‒18B.
5. Rossi
A general discussion of Rossi’s disclosure is provided above in
Section II.F.4.
6. Analysis of Claim 1
Petitioner relies on Taube to disclose automated control of a ventilator
to adjust PEEP and FIO2. Pet. 61. Petitioner maps Taube’s ventilation
system to the first means and second means of claim 1. Id. at 61‒63 (citing
Ex. 1005, 1:25‒30, 1:37‒41, 4:30‒50, 5:8‒6:15, Fig. 1; Ex. 1002 ¶¶ 409‒
412). Petitioner acknowledges that Taube does not explicitly discuss a
desired value for a hemoglobin saturation setpoint. Id. at 64.
Petitioner asserts that Carmichael discloses a desired setpoint of
“oxygen saturations of 86% to 90%” and discloses monitoring a patient’s
measured oxygen saturation level and increasing FIO2 and incremental
application of PEEP to bring the patient’s oxygen saturation closer to the
setpoint. Pet. 64 (citing Ex. 1004, 13‒14; Ex. 1002 ¶¶ 413‒418). Petitioner
asserts that a person of ordinary skill in the art would have been motivated to
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modify Taube’s ventilator system control to keep the PEEP/FIO2 ratio within
a prescribed range, as disclosed by Carmichael, “to ensure that mechanical
ventilation would improve important clinical outcomes in patients by
keeping the patient’s hemoglobin saturation closer to the desired ‘oxygen
saturations of 86% to 90%’ [] while avoiding an application of PEEP that
could be higher than a permissible maximum value.” Id. at 64‒65 (citing
Ex. 1004, 12‒14; Ex. 1002 ¶¶ 419‒430).
Petitioner relies on Clemmer as “evidence of the skill level in the art
for programming an automated ventilator with any of a variety of treatment
protocols” and to show that modifying Taube’s system to use Carmichael’s
treatment protocols would have involved “known programming techniques
and constituted a predictable, expected result.” Pet. 66. On review of the
entire record, Petitioner has shown by a preponderance of the evidence that
claim 1 would have been obvious over the combination of Taube,
Carmichael, as evidenced by ARDSNET, Clemmer, and Rossi.
Pointing to Figure 3 of Taube, Patent Owner argues that Taube differs
from claim 1 because in Taube, if PaO2 increases (i.e., an improvement in
oxygenation), then the levels of FIO2, PEEP, and Tinsp are increased. PO
Resp. 49; see also id. at 50‒51; Sur-Reply 28–29. Patent Owner argues that
Taube’s control algorithm is against clinical practice, in which levels of
PEEP and FIO2 are increased if the oxygen level decreases. Id. Patent
Owner’s characterization of Taube’s Figure 3 appears overly simplistic.
When Figure 3 is considered in combination with the accompanying
description, Taube teaches that the computer chooses the values of the
parameters (FIO2, PEEP, Tinsp) “to maintain a desired level of the patient’s
blood oxygen level.” Ex. 1005, 5:30–33. Taube also recognizes, discussing
the prior art, the problem of oversaturation. Ex. 1005, 2:14–20. We agree
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with Dr. Imbruce, and give substantial weight to his testimony, that Patent
Owner’s reading of Taube is unreasonable and contrary to Taube’s own
disclosure. See Ex. 1029 ¶¶ 13–19. Thus, we do not understand Taube to
disclose in Figure 3 a system that continues to increase PEEP and FIO2 levels
as the patient’s oxygen levels increase.12
Patent Owner acknowledges that Taube’s Figure 3 shows adjustment
of PEEP, FIO2 and Tinsp by PID control, but argues that “[a]s described with
regard to Anderson, the output of a PID controller changes continuously
with time and cannot be used to safely adjust PEEP whose effect on patient’s
oxygenation is not instantaneous.” PO Resp. 49. Patent Owner contends
that “[u]sing PID controllers to adjust PEEP automatically can be quite
hazardous to patients, has not been done in any commercial ventilators, and
is not used in any of the embodiments of the Patent,” and “[f]or this reason
alone, the PTAB should not rely on Taube’s disclosure.” Id. Patent Owner
does not provide adequate evidentiary support for this argument.13

12 Even assuming that Patent Owner was correct, i.e., that Taube disclosed a
device that would administer a therapy that a person of ordinary skill would
immediately recognize was fatal to the patient, such disclosure would not
disqualify Taube as prior art. To begin with, nothing in the claims requires a
particular level of efficacy or a treatment result. Moreover, under an
obviousness analysis, a reference need not work to qualify as prior art; “it
qualifies as prior art, regardless, for whatever is disclosed therein.” Amgen
Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1357 (Fed. Cir. 2003).
“Even if a reference discloses an inoperative device, it is prior art for all that
it teaches.” Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547,
1551 (Fed. Cir. 1989).
13 The only evidence in the record that seems to support this argument is in
Dr. Tehrani’s Declaration. See Ex. 2010 ¶ 92. However, Dr. Tehrani
provides no citations to support the factual contentions underlying this
argument, and the record contains two prior art references—Taube and
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Moreover, even if Patent Owner were correct, “just because better
alternatives exist in the prior art does not mean that an inferior combination
is inapt for obviousness purposes.” In re Mouttet, 686 F.3d at 1334 (citing
In re Gurley, 27 F.3d at 553). Patent Owner fails to explain how PID
control would be outside the scope of the language of the claims. Instead,
Patent Owner agreed that PID control was within the meaning of
“determining” and “calculating.” See PO Resp. 13; Ex. 1027, 116:25–117:3.
Patent Owner also argues that in Taube, FIO2 is not determined to
reduce the difference between measured oxygen level and desired level and
PEEP is not controlled to keep ratio of PEEP/FIO2 within a prescribed range.
PO Resp. 51–52. Petitioner relies on Carmichael,14 however, for the
specifications of the PEEP and FIO2 control, and relies on Clemmer to show
that it would have been a matter of routine programming to implement
Carmichael’s control of PEEP and FIO2 in Taube’s automated ventilator
control system. See Pet. 66.
As to Clemmer, Patent Owner argues that Clemmer’s “protocols”
provide for manual adjustment of treatment parameters by physicians, and
the adjustments are made several hours apart. PO Resp. 52 (citing Ex. 1008,
26:39‒42). Patent Owner also argues that Clemmer does not use a PID
control system or closed-loop feedback control. Id. at 53, 67.
We disagree with Patent Owner’s assertion that Clemmer’s protocols
require manual adjustment. For instance, Clemmer discusses, with reference
to Figure 4, an alternative with continuous monitoring and adjustment.

Anderson—that do describe PID control of PEEP. Thus, we give this
testimony little weight.
14 We addressed above, in our analysis of the other grounds, the scope and
content of Carmichael.
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Ex. 1008, 18:53‒63. Moreover, Clemmer teaches that “patient instructions
can be carried out automatically” and the control programming instructions
of the “inventive system therefore accomplished closed loop control of
ventilation.” Ex. 1008, Abstract, 5:2–3, 9:3–4. Further, whether Clemmer
discloses PID control or closed-loop feedback control is not relevant to the
asserted ground, which relies on Taube for disclosing these features.
Pet. 61‒63.
As to the combination, Patent Owner argues that “Carmichael is all
about manual adjustments of PEEP and FIO2 several hours apart,” and
“Taube claims continuous PID control of PEEP and FIO2.” PO Resp. 69.
Patent Owner contends that “combining any of Carmichael, ARDSNET or
Clemmer’s manual adjustments of parameters would render Taube’s PID
automatic control of PEEP and FIO2 system inoperable and thus Taube
would not operate on the same principles.” Id. at 74. This argument
misstates Petitioner’s proposed combination. Petitioner does not propose to
modify Taube’s automated ventilator control system to use manual
adjustments. Rather, Petitioner proposes that it would have been obvious to
employ Taube’s automated system to implement Carmichael’s treatment
protocol for adjustment of PEEP and FIO2 in ARDS patients, using routine
programming, as evidenced by Clemmer. Pet. 65–66.
Patent Owner contends that “[n]ot only it is impossible to combine
these systems, but a desired oxygen level is not definable in Taube, because
“Taube maximizes the patient’s oxygen level if that level increases.” Id. at
69. However, as we explained above, supra pp. 45–47, this argument is
based on Patent Owner’s unreasonable interpretation of Taube. See
Ex. 1029 ¶¶ 13–19. Moreover, Petitioner proposes to modify Taube’s
treatment regime to implement the treatment regime of Carmichael. Patent
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Owner never addresses that combination.15 We have reviewed Petitioner’s
evidence and find it persuasive that such a combination would have been
obvious to a person of ordinary skill at the time of the invention. See
Pet. 60–66; Ex. 1002 ¶¶ 419–438.
For these reasons, Petitioner has demonstrated, by a preponderance of
the evidence, the unpatentability of claim 1, under 35 U.S.C. § 103(a), based
on the combined teachings of Taube, Carmichael, as evidenced by
ARDSNET, Clemmer, and Rossi.
7. Analysis of Claim 29
Petitioner relies on the same findings and combination of Taube,
Carmichael, as evidenced by ARDSNET, Clemmer, Rossi to challenge
method claim 29 as presented for its challenge to claim 1. Pet. 70‒72.
Patent Owner does not present separate arguments for claim 29. See PO
Resp. 30‒33, 51‒54 (presenting the same arguments for claims 1 and 29).
We have reviewed Petitioner’s evidence and arguments for claim 29, and
find them sufficient. See Pet. 70–72. Thus, for the same reasons discussed
above in our analysis of claim 1, Petitioner has shown by a preponderance of
the evidence that claim 29 would have been obvious based on the combined
teachings of Taube, Carmichael, and Clemmer.

15 Patent Owner also argues that we failed to take into account the
Examiner’s consideration of Taube during prosecution. See PO Resp. 47,
67. However, we discussed at length the Examiner’s consideration of Taube
in our Institution Decision, and we found that the Examiner materially erred
in the consideration of Taube. Inst. Dec. 11–22 (explaining the material
errors in the Examiner’s consideration of Taube). Therefore, we do not find
the Examiner’s prior consideration of Taube to be entitled to any weight in
determining whether the challenged claims are patentable over the
combination of Taube, Carmichael, ARDSNET, Clemmer, and Rossi.
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8. Analysis of Claims 2‒6, 9‒12, 30‒33 and 41
Claims 2‒6, 9‒12, 30‒33, and 41 all depend directly or indirectly
from claim 1 or claim 29. We have reviewed Petitioner’s cited evidence and
explanation regarding why the combination of Taube, Carmichael, as
evidenced by ARDSNET, Clemmer, and Rossi, renders obvious the subject
matter of these dependent claims and find the evidence and reasoning
sufficient to show by a preponderance of the evidence that these claims are
also unpatentable as obvious. Although Patent Owner discusses Rossi in its
Patent Owner Response, Patent Owner does not contest Petitioner’s reliance
on Rossi for its disclosure of measurement of PEEPi (claims 9, 10, 30). PO
Resp. 53‒54 (arguing that Rossi individually does not describe any system
to control a ventilator or to control PEEP, and not presenting arguments
against Rossi in combination with the teachings of Taube, Carmichael, and
Clemmer).
Patent Owner raises no other arguments regarding these claims other
than those considered above with respect to claim 1. We determine that
Petitioner has shown by a preponderance of the evidence that Taube,
Carmichael, Clemmer, and Rossi renders obvious claims 2‒6, 9‒12, 30‒33,
and 41.
H. Remaining Grounds
Having determined that Petitioner establishes by a preponderance of
the evidence that the subject matter of claims 1‒6, 9‒12, 29‒33, 41 would
have been obvious over the combination of Carmichael, Anderson, Tehrani
’268, and Rossi and the combination of Taube, Carmichael, as evidenced by
ARDSNET, Clemmer, and Rossi, we do not address Petitioner’s additional
ground of obviousness based on Carmichael (as evidenced by ARDSNET
and Waisel) challenging claims 1, 2, 5, 6, 11, 29, 31‒33, 41 (Ground 2). See
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SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018) (holding a petitioner “is
entitled to a final written decision addressing all of the claims it has
challenged”); Boston Sci. Scimed, Inc. v. Cook Grp. Inc., 809 F. App’x 984,
990 (Fed. Cir. 2020) (nonprecedential) (“We agree that the Board need not
address [alternative grounds] that are not necessary to the resolution of the
proceeding.”).

III. PETITIONER’S MOTION TO EXCLUDE
Petitioner seeks to exclude Exhibits 2009, 2012, 2013, 2014, 2015,
2018, 2022, 2024, 2025, 2026, and 2027. We grant-in-part, deny-in-part,
and dismiss-as-moot-in-part Petitioner’s Motion to Exclude.

A. Untimely Exhibits (Exhibits 2022, 2024–2026)
Under 37 C.F.R. § 42.23(b), a “sur-reply may only respond to
arguments raised in the corresponding reply and may not be accompanied by
new evidence other than deposition transcripts of the cross-examination of
any reply witness.” 37 C.F.R. § 42.23(b). The Consolidated Trial Practice
Guide states that a “sur-reply may not be accompanied by new evidence
other than deposition transcripts of the cross-examination of any reply
witness.” CTPG, at 73.
Patent Owner filed two declarations with its Sur-Reply: the Third
Declaration of Dr. Fleur Tehrani (Ex. 2022) and the Declaration of Dr.
James H. Roum (Ex. 2026). Patent Owner contends that these exhibits were
necessary because Petitioner’s Reply contained new arguments and was, in
effect, “a brand-new Petition based on new declarations and evidence.” PO
Opp. 3. In particular, Patent Owner contends that Petitioner’s construction
of “for a next breath” was new and required new evidence to respond. Id.
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at 4. As for Exhibit 2026, Patent Owner argues that Dr. Roum’s declaration
is necessary to “prevent Petitioner from misleading the Board.” Id. at 5. In
particular, Patent Owner asserts that Dr. Roum’s declaration is necessary to
respond to Dr. Anderson’s and Dr. Imbruce’s testimony “regarding the
alleged clinical trials in Anderson having been conducted in accordance with
a hospital Internal Review Board (IRB) regulations and the FDA rules.” Id.
at 5–6.
We agree with Petitioner that Exhibits 2022 and 2026 are untimely
and should be excluded. Rule 42.23(b) and the Consolidated Trial Practice
Guide are clear that such declarations cannot be filed with a sur-reply.
There is no automatic “responding to new arguments” exception to that
prohibition. As the Consolidated Trial Practice Guide explains, the proper
course if new arguments were presented in the Reply would be to seek
authorization to file a motion to strike. CTPG, 80–81. Patent Owner did not
do that. Regardless, our rules do not permit a party to file exhibits without
authorization. 37 C.F.R. § 42.7(a) (forbidding filings not authorized);
§ 42.23(b) (forbidding new evidence other than deposition transcripts with a
sur-reply). Our rules only authorize limited exhibits that may be filed with a
sur-reply. See 37 C.F.R. § 42.23(b). Patent Owner did not seek
authorization to file these additional exhibits.
Moreover, we disagree with Patent Owner that the interests of justice
support allowing these declarations. First, Patent Owner’s contention that
Petitioner’s challenge to Dr. Tehrani’s credentials requires a response is not
persuasive. Petitioners routinely challenge the credentials of experts. Dr.
Tehrani has testified at length about her credentials in her first two
declarations and has provided a curriculum vitae and other materials that
will allow us to assess them. Dr. Tehrani was also allowed to testify to her
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credentials in her deposition and her counsel could have asked her additional
questions on re-direct. We see no need for additional testimony from either
Dr. Tehrani or Dr. Roum on that matter. Second, as for the disputes
regarding the Anderson reference, we explained above why Patent Owner’s
arguments about FDA authorization and the intricacies of clinical trials were
not persuasive. Patent Owner’s new testimony simply repeats the same
assertions and does not add anything new that would change that conclusion.
Therefore, that testimony is also unnecessary. Finally, with respect to the
alleged new claim construction, we disagree with Patent Owner that the
claim construction is new or that additional expert testimony on the claim
construction that was already thoroughly discussed in Patent Owner’s prior
declarations will add any further illumination to this subject. Moreover, we
have found that the claim constructions make no difference to the result on
Grounds 3 and 4, which also render this testimony unnecessary.
Accordingly, because they were filed in violation of our rules and the
interests of justice do not support excusing that violation, we grant
Petitioner’s Motion to Exclude Exhibits 2022 and 2026.
In addition to the declarations discussed above, Patent Owner also
filed Exhibits 2024 and 2025 with its Sur-Reply. Exhibit 2024 is an article
entitled “What You Need to Know About Brain Oxygen Deprivation,”
which was published in 2021. Ex. 2024. Patent Owner cited Exhibit 2024
to address how the term “oxygen deprivation” would have been understood
at the time of the invention of the ’571 patent. Sur-Reply 15. Patent Owner
argues that this article is necessary to address the “next breath” dispute. PO
Opp. 13–14. Exhibit 2025 is a definition of “trial and error” from the
Merriam-Webster Online Dictionary. Patent Owner argues that this exhibit
is necessary to respond to alleged new arguments in the Reply. Id. at 14.
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We agree with Petitioner that these exhibits are also untimely and
should be excluded. We are also not persuaded that the interests of justice
require us to allow these exhibits. With respect to Exhibit 2024, we fail to
see why an article on oxygen deprivation, at a very general level, is
necessary for this proceeding given that there seems to be no dispute about
the need to prevent oxygen deprivation. As for Exhibit 2025, we do not
believe that a dictionary definition of the common expression “trial and
error,” a term not found in the claims of the ’571 patent, is necessary for this
proceeding. Accordingly, because they are untimely and the interests of
justice would not be served by allowing them to be admitted, we grant
Petitioner’s Motion to Exclude Exhibits 2024 and 2025.

B. Exhibits 2009, 2018, and 2027
Exhibit 2009 is The Opinion of the United Kingdom Intellectual
Property on Infringement of the GB2423721 Patent, Opinion#09/18, issued
on June 6, 2018. Ex. 2009, 1. Exhibit 2018 is several pages from the
textbook Mechanical Ventilation by Neil R. MacIntyre and Richard D.
Branson. Exhibit 2027 purports to be an email between an employee of the
UK Intellectual Property Office and Dr. Tehrani. Ex. 2027, 1. Petitioner
argues that these exhibits should be excluded. Pet. Mot. 3–5, 9–10, 12; Pet.
Opp. 10–11. We did not rely on Exhibits 2009, 2018, and 2027 in reaching
our decision in this case because Patent Owner does not cite them in making
any arguments regarding patentability or, as to Exhibit 2018, which as with
Exhibit 2007 and 2012 discusses assist/control mode ventilation, they are
cumulative of other exhibits discussed. Therefore, we dismiss Petitioner’s
Motion to Exclude Exhibits 2009, 2018, and 2027 as moot.

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C. Exhibits 2012–2015
Exhibit 2012 is purportedly a website entitled “Ventilation Modes and
Monitoring.” Ex. 2012. Exhibit 2013 appears to be portions of a chapter of
a book entitled “Digital Control System Analysis & Design,” by Charles L.
Phillips et al. Ex. 2013, 1. Exhibit 2014 is an information sheet from the
U.S. FDA’s website. Ex. 2014, 1. Exhibit 2015 is an Investigational Device
Exemption (IDE) form printed from the U.S. FDA’s website. Petitioner
argues that these exhibits are irrelevant and should be excluded under Fed.
R. Evid. 401–403. Pet. Mot. 4–5. Petitioner also contends that Exhibits
2012, 2014, and 2015 should be excluded under Fed. R. Evid. 901–902.
Here, Patent Owner does rely on these exhibits to support its
arguments. We find this sufficient to clear the very low bar of relevance.
See United States v. Whittington, 455 F.3d 736, 739 (6th Cir. 2006) (“[T]he
district court correctly noted that the relevance threshold is very low under
Rule 401.”) (internal quotation marks omitted). As for Fed. R. Evid. 403,
assuming that it applies in these non-jury proceedings, Schultz v. Butcher, 24
F.3d 626, 632 (4th Cir. 1994) (finding court should not exclude evidence
under Rule 403 in non-jury trial on grounds of unfair prejudice), we find that
Petitioner’s arguments deal not with prejudice, but rather, the weight we
should give the evidence.
As for authentication, documents are authenticated by evidence
“sufficient to support a finding that the item is what the proponent claims it
is.” Fed. R. Evid. 901(a). Authenticity is, therefore, not an especially high
hurdle for a party to overcome. See United States v. Patterson, 277 F.3d
709, 713 (4th Cir. 2002); see also United States v. Ceballos, 789 F.3d 607,
617–18 (5th Cir. 2015) (noting “low” burden for authentication); United
States v. Isiwele, 635 F.3d 196, 200 (5th Cir. 2011) (noting flaws in
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authentication go to weight not admissibility). Patent Owner’s counsel has
offered a declaration attesting to the accuracy of these documents. See
Ex. 2019 ¶¶ 3–5. We find this testimony sufficient to clear the low bar for
authentication. Accordingly, we deny Petitioner’s Motion to Exclude
Exhibits 2012–2015.
D. Summary
Accordingly, for the reasons above, we grant Petitioner’s Motion to
Exclude Exhibits 2022, 2024–2026, dismiss-as-moot Petitioner’s Motion to
Exclude Exhibits 2009, 2018, and 2027, and deny Petitioner’s Motion to
Exclude Exhibits 2012–2015.

IV. PATENT OWNER’S MOTION TO EXCLUDE
Patent Owner moves to exclude Exhibits 1002, 1005, 1011, 1013,
1023, 1024, 1025, 1026, 1028, and 1029. We consider each of these exhibits
in turn. For the following reasons, we deny-in-part and dismiss-as-moot-in-
part Patent Owner’s Motion to Exclude.

A. Exhibit 1002
Exhibit 1002 is the First Declaration of Dr. Richard Imbruce. Patent
Owner argues that Dr. Imbruce’s experience is distant from the ’571 patent
and not up to date. PO Mot. 3–4. Patent Owner contends that “Exhibit 1002
presents numerous incorrect, and totally unsubstantiated allegations about
the prior art and the Patent.” Id. at 4. Patent Owner asserts that “Dr.
Imbruce, has offered expert testimony on matters outside his knowledge in
the past. The Patent Owner brought to the attention of the Board that
Dr. Imbruce had to be disqualified in another case (Ex. 2017) (POR, 75-77),
because he had offered incorrect testimony not within his expertise as
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admitted by the Petitioner (PRPOR at 23).” Id. at 5. Patent Owner also
argues that Dr. Imbruce failed to bring “to the attention of the Board that two
of the Petitioner’s alleged prior art, Ex. 1011 and Ex. 1013, both non-
reviewed papers, do not present true data as explained by the Patent Owner.”
Id. Patent Owner submits that “Ex. 1002 is a large collection of flawed and
unsubstantiated allegations that has caused an unjustified institution in this
case.” Id. at 6. Patent Owner “requests the exclusion of this evidence
because it is totally misleading and prejudicial (FRE 401-403), is not based
on sufficient facts or data and the expert has not reliably applied the
principles and methods to the facts of the case (FRE 702) and is not based on
evidence (FRE 901).” Id.
Petitioner opposes, pointing to the relevant experience in Dr.
Imbruce’s curriculum vitae and that the experiences he testified about in his
deposition. Pet. Opp. 1 (citing Ex. 1003; Ex. 2016, 10:23–12:22).
Patent Owner’s arguments go to the weight we should give Dr.
Imbruce’s testimony, not its admissibility. See Microfinancial, Inc. v.
Premier Holidays Int’l., 385 F.3d 72, 81 (1st Cir. 2004) (“When the factual
underpinning of an expert’s opinion is weak, it is a matter affecting the
weight and credibility of the testimony—a question to be resolved by the
[factfinder].”). The prior case where Dr. Imbruce’s testimony was excluded
(Ex. 2017) involved a very narrow and specialized area (failure analysis of a
particular specialized medical device—a heart-lung machine). Patent
Owner’s arguments do not persuade us that we should exclude Dr.
Imbruce’s testimony. There need not be a perfect match between the
expert’s qualifications and the patent at issue. See SEB S.A., 594 F.3d at
1373. It is not necessary for Dr. Imbruce to demonstrate that he spent the
bulk of his career personally designing mechanical ventilators. Indeed, to
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testify as an expert under Fed. Rule Evid. 702, a person need not be one of
ordinary skill, but may be “qualified in the pertinent art.” See B/E
Aerospace, Inc. v. MAG Aerospace Indus. LLC, Paper 104 at 13–14 (Final
Written Decision) (declining to exclude the testimony of expert witness that
lacked hands-on experience with the claimed subject matter). We agree with
Petitioner that Dr. Imbruce’s lengthy experience, including a) developing
ventilator devices and work on a portable oxygen generator to provide
emergency care to patients undergoing respiratory distress (Ex. 1003, Rapid
Oxygen Company work; Ex. 2016, 10:23–12:22); (b) “developing clinical
protocols for new modalities in artificial ventilation” in the relevant 2003–
2009 time period of the patent at issue in this IPR; (c) “laboratory and
clinical research funded by DOD developing oxygen delivery therapies to
treat hemorrhagic shock in wounded soldiers” in the 2009–2016 time period
(Ex. 1003); and (d) ongoing design and use of ventilators, provides him
sufficient experience and knowledge of the claimed subject matter for his
opinion to remain of record. Ex. 1003; Ex. 2016, 10:23–12:22.
Moreover, “[t]he policy considerations for excluding expert
testimony, such as those implemented by the gatekeeping framework
established by the Supreme Court in Daubert v. Merrell Dow Pharm., Inc.,
509 U.S. 579 (1993), are less compelling in bench proceedings such as inter
partes reviews than in jury trials.” Nestle Healthcare Nutrition, Inc. v.
Steuben Foods, Inc., IPR2015-00249, Paper 76 at 23 (PTAB June 2, 2016).
To be sure, we take into account the qualifications of an expert witness—and
any shortcomings revealed through cross-examination—when evaluating the
weight to be given that witness’s testimony. But the wholesale exclusion of
a witness’s declarations is rarely called for in a proceeding before the Board.
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We have considered Dr. Imbruce’s qualifications in determining the weight
to be given his testimony.
Patent Owner’s other objections are without merit. Fed. R. Evid. 901
has no application here—there is no doubt that Dr. Imbruce’s declaration is
authentic. Nor can there any doubt that it is relevant under Fed. R.
Evid. 401. See Whittington, 455 F.3d at 739 (“[T]he district court correctly
noted that the relevance threshold is very low under Rule 401.”) (internal
quotation marks omitted). As for Fed. R. Evid. 403, assuming that it applies
in these non-jury proceedings, Schultz, 24 F.3d at 632 (finding court should
not exclude evidence under Rule 403 in non-jury trial on grounds of unfair
prejudice), we find that Patent Owner’s arguments deal not with prejudice,
but rather, the weight we should give the testimony. Accordingly, we deny
Patent Owner’s Motion to Exclude Exhibit 1002.

B. Exhibit 1005
Patent Owner argues that we should exclude the Taube patent under
Federal Rules of Evidence 401–403. PO Mot. 6. In particular, Patent
Owner argues that it was “raised by the Examiner” and “was fully responded
to before the Patent was allowed” and “cannot be combined with any manual
chart or table” and is “detrimental” and “[a] Patent describing a detrimental
method should not be used at any trial because it is misleading, irrelevant to
the facts and prejudicial.” Id.
We agree with Petitioner that Patent Owner’s arguments fail to
provide any basis for excluding evidence under Federal Rules of Evidence
401–403. See Pet. Opp. 2, 4–6. Federal Rule of Evidence 401 provides that
evidence is relevant if it “has any tendency to make a fact more or less
probable than it would be without the evidence” and “the fact is of
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consequence in determining the action.” Fed. R. Evid. 401; Fed. R. Evid.
402 (“Relevant evidence is admissible”). Courts have characterized the
relevance threshold as being “very low.” United States v. White, 692 F.3d
235, 246 (2d Cir. 2012) (quoting United States v. Al-Moayad, 545 F.3d 139,
176 (2d Cir. 2008)). The fact that Taube was considered by the Examiner
does not negate its relevance or admissibility. Similarly, the argument about
whether Taube can be combined goes to the merits of the combination, not
the admissibility of the evidence, because although the combination might
not be obvious, the evidence would still be relevant. Finally, Patent Owner’s
arguments that Taube is not relevant because of the the alleged detrimental
nature of Taube—i.e., that Taube allegedly discloses a device that will
increase and decrease oxygen levels in a way that is harmful (see supra pp.
45–46) are also unpersuasive. See PO Mot. 6; PO Reply 2. Under an
obviousness analysis, a reference need not work to qualify as prior art; “it
qualifies as prior art, regardless, for whatever is disclosed therein.” Amgen
Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1357 (Fed. Cir. 2003).
“Even if a reference discloses an inoperative device, it is prior art for all that
it teaches.” Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547,
1551 (Fed. Cir. 1989). Thus, even if Patent Owner’s arguments regarding
the operation of Taube were correct, which as we explain above they are not,
see supra pp. 45–46, it would not be basis for excluding Exhibit 1005.
Instead, we find that Exhibit 1005 easily clears the very low threshold of
relevance.
Patent Owner’s argument that Federal Rule of Evidence 403 compels
exclusion is equally unavailing. PO Mot. 6; PO Reply 2. Rule 403 has
limited applicability, if any, to bench trials like this proceeding. See, e.g.,
Schultz, 24 F.3d at 632 (holding that “in the context of a bench trial,
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evidence should not be excluded under 403” because the court can “hear
relevant evidence, weigh its probative value and reject any improper
inferences”). In the end, Patent Owner’s arguments simply go to the weight
the evidence should be given and not its admissibility. Accordingly, we
deny Patent Owner’s Motion to Exclude Exhibit 1005.

C. Exhibit 1011
Patent Owner argues that Exhibit 1011, Waisel, should be excluded
because it “does not present true data” and it is “misleading, presents
unreliable data, is irrelevant to the facts and prejudicial.” PO Mot. 7; PO
Reply 2–3. Again, even if Patent Owner’s assertions are correct, under an
obviousness analysis, a reference need not work to qualify as prior art; “it
qualifies as prior art, regardless, for whatever is disclosed therein.” Amgen,
314 F.3d at 1357. Moreover, Patent Owner’s assertions that Waisel does not
present true data are based on speculation and are not persuasive. In
addition, as we explained above, Patent Owner’s contentions that Waisel
cannot be considered because it does not disclose an FDA Investigational
Device Exception is not persuasive. See supra pp. 34–35 (explaining with
respect to Anderson why similar contentions were not persuasive). Patent
Owner also argues Waisel should be excluded under Federal Rule of
Evidence 702 (PO Mot. 7), but that rule relates to expert testimony, which
this prior art reference is not. Finally, we find that Petitioner has provided
more than sufficient evidence to authenticate Waisel (see Ex. 1017 ¶¶ 77–
84, 120), so Patent Owner’s authentication objection (PO Mot. 7) is not
persuasive. Accordingly, for similar reasons as we articulated for Exhibit
1005, we deny Patent Owner’s Motion to Exclude Exhibit 1011.

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D. Exhibit 1013
Patent Owner argues that Exhibit 1013, the Anderson reference,
should be excluded “because it presents misleading and unreliable data, is
irrelevant to the facts and prejudicial ((FRE 401-403), is not based on
reliable facts and data (FRE 702), and is not based on evidence (FRE 901).”
PO Mot. 8. For the reasons stated above for Exhibits 1005 and 1011, these
arguments with respect to Federal Rules of Evidence 401–403 and 702 are
not persuasive. As for Patent Owner’s objection under Federal Rule of
Evidence 901, Petitioner has provided more than sufficient evidence that
Exhibit 1013 is what it purports to be, i.e., a copy of the Anderson reference.
See, e.g., Ex.1017 ¶¶ 94–101, 120; Ex. 1028 ¶¶ 3–5. Accordingly, we deny
Patent Owner’s Motion to Exclude Exhibit 1013.

E. Exhibits 1023–1025
Patent Owner seeks to exclude Exhibits 1023–1025, which are three
exhibits relating to the Terumo Advanced Perfusion System. See Exs. 1023–
1025. Patent Owner’s declarant was questioned on these exhibits at her
deposition, but neither party cites or discusses these exhibits. We did not
rely on these exhibits in reaching our decision, so we dismiss Patent
Owner’s Motion to Exclude Exhibits 1023–1025 as moot.

F. Exhibit 1026
Exhibit 1026 s a United Kingdom Intellectual Property Office UK
IPO Opinion dated March 19, 2021, regarding invalidity of a UK Patent No.
GB 2423721, a parallel UK patent to the US Patent at issue in this
proceeding. Patent Owner argues that we should exclude Exhibit 1026
because it is “a non-binding, non-final opinion from another jurisdiction that
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is presently under review and thus is completely irrelevant to the facts and
prejudicial (FRE 401–403) is not based on evidence (FRE 901), and was
relied upon for the first time in Petitioner’s Reply.” PO Mot. 2. We did not
rely on Exhibit 1026 in reaching our decision in this case. Therefore, we
dismiss Patent Owner’s Motion to Exclude Exhibit 1026 as moot.

G. Exhibit 1028
Patent Owner argues that Exhibit 1028, the Declaration of Dr. Jeffrey
R. Anderson, P.E., should be excluded because “it is irrelevant to the facts
and prejudicial (FRE 401 – 403), is inadmissible hearsay (FRE 801), is not
based on sufficient facts or data (FRE 702), is not based on substantiated
evidence (FRE 901), and was relied upon for the first time in Petitioner’s
Reply.” PO Mot. 13–14. None of these arguments is persuasive. First,
Federal Rule of Evidence 702 does not apply because Dr. Anderson is not
offered as an expert witness, but instead as a fact witness based on his first-
hand knowledge. See Pet. Opp. 8. Second, Patent Owner provides no
explanation of how Dr. Anderson’s testimony is hearsay (under Federal Rule
of Evidence 801) or how it is not authentic under Federal Rule of Evidence
901. See id.; PO Mot. Reply 5. Federal Rule of Evidence 801(c) defines
“hearsay” as “a statement that: (1) the declarant does not make while
testifying at the current trial or hearing; and (2) a party offers in evidence to
prove the truth of the matter asserted in the statement.” Here, Dr.
Anderson’s declaration is testimony offered in the current trial, and is,
therefore, by definition not hearsay. Thus, Patent Owner’s blanket hearsay
objection against the entire declaration is without merit. As for Federal Rule
Evidence 901, that rule deals with authentication. See Fed. R. Evid. 901.
There is no dispute that Dr. Anderson’s declaration is what it purports to
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be—i.e., the declaration of Dr. Jeffrey Anderson. A Rule 901 objection has
no place here. To the extent that Patent Owner means Federal Rule of
Evidence 602, which requires that a witness have personal knowledge in
order to testify as a fact witness, Dr. Anderson, as one of the named authors
of the paper in question has shown that he has the requisite personal
knowledge to testify. See Ex. 1028 ¶¶ 3–22 (explaining his personal
knowledge of the events on which he testifies).
Finally, Patent Owner’s arguments regarding relevance (Fed. R. Evid.
401), prejudice (Fed. R. Evid. 403), and the alleged lateness of the exhibit
are not persuasive. Patent Owner argued extensively in the Patent Owner
Response with supporting testimony in her First and Second Declarations
and in the Patent Owner Response that Dr. Anderson’s paper was false and
the reported trial never occurred. See PO Resp. 37–41, 60–63. Petitioner
was entitled to respond in its Reply to the arguments that Patent Owner
made. See 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments
raised in the corresponding opposition, patent owner preliminary response,
patent owner response, or decision on institution.”). Our rules allow that
response to be supported by new evidence. See id. (only limiting the
evidence that may be filed with a sur-reply). We find that Dr. Anderson’s
testimony is not new, but is directly responsive to Patent Owner’s own
arguments and accusations of misrepresentation attributed to Dr. Anderson
and his co-authors. Thus, we agree with Petitioner that Dr. Anderson’s
testimony is relevant and timely. As for Patent Owner’s prejudice argument,
Patent Owner does not offer a credible explanation as to any prejudice that
arises from Dr. Anderson’s testimony that seeks to refute the argument made
by Patent Owner that Dr. Anderson misrepresented data in his 1994 paper.
Accordingly, we deny Patent Owner’s Motion to Exclude Exhibit 1028.
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H. Exhibit 1029
Patent Owner seeks to exclude Exhibit 1029, the Second Declaration
of Dr. Richard Imbruce. PO Mot. Exclude 14. Patent Owner argues that
“Dr. Imbruce makes numerous unsubstantiated and incorrect allegations in
this declaration and therefore, Ex. 1029 is irrelevant and prejudicial (FRE
401-403).” Id. Patent Owner further contends that Dr. Imbruce’s second
declaration should be excluded because it relies on other exhibits Patent
Owner has sought to exclude. Id. Patent Owner also argues that “Dr.
Imbruce even signs his name as RRT (i.e., Registered Respiratory Therapist)
despite that he has not practiced respiratory therapy or renewed his RT
certificate for 40 years.” Id.
Patent Owner additionally seeks to exclude Exhibit 1029 because
Patent Owner contends that “Petitioner is requesting a new claim
construction for ‘a next breath of the patient,’ and is providing new
arguments on Waisel.” Id. Patent Owner requests that Exhibit 1029 be
excluded in its entirety, or alternatively, that the portions of Exhibit 1029
referring to the new claim construction be excluded, which appear to be
paragraphs 22–28 of Exhibit 1029. Id.
Petitioner responds that Dr. Imbruce’s testimony does not offer a new
claim construction, but seeks to respond to Patent Owner’s arguments and
the Institution Decision’s preliminary findings regarding Waisel. Pet.
Opp. 9–10. Thus, Petitioner contends that the testimony is proper.
We agree with Petitioner that Patent Owner’s request to exclude
Exhibit 1029 should be denied. To begin with, an expert may rely on
otherwise inadmissible evidence in forming his or her opinion. Thus, even if
Dr. Imbruce relied on some exhibits that are inadmissible, it would not
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necessarily warrant excluding his testimony. See Fed. R. Evid. 703.
Moreover, as we found above, Patent Owner’s objections to the exhibits
relied on by Dr. Imbruce are without merit, so we find unavailing the
argument that Dr. Imbruce relied on excluded evidence. Furthermore, Patent
Owner’s arguments concerning Dr. Imbruce’s title and experience go to the
weight we should give Dr. Imbruce’s testimony, not its admissibility. See
Microfinancial, Inc., 385 F.3d at 81 (“When the factual underpinning of an
expert’s opinion is weak, it is a matter affecting the weight and credibility of
the testimony—a question to be resolved by the [factfinder].”). Patent
Owner was free to cross examine Dr. Imbruce on these points, which it has.
Finally, as for the allegedly new arguments, we begin by noting that a
motion to exclude is not the proper vehicle to seek to strike new arguments.
See CTPG, at 79 (“Nor should a motion to exclude address arguments or
evidence that a party believes exceeds the proper scope of reply or sur-
reply.”). In any event, the allegedly new arguments in paragraphs 20–28 are
not a basis for excluding the entirety of Exhibit 1029. As for paragraphs 20–
28, we have reviewed them and agree with Petitioner that they are not new
arguments, but instead, respond directly to the Decision to Institute and the
arguments Patent Owner has made in this proceeding. Accordingly, we
deny Patent Owner’s Motion to Exclude Exhibit 1029.

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V. CONCLUSION16
After considering all the evidence and arguments presently before us,
we determine Petitioner has established by a preponderance of the evidence
that the challenged claims are unpatentable.
In summary,
Claim(s)
35
U.S.C.
§ Reference(s)/Basis
Claim(s)
Shown
Unpatentable
Claim(s) Not
Shown
Unpatentable
1, 2, 5, 6,
11, 29,
31‒33, 41
102 Carmichael 1, 2, 5, 6, 11, 29, 31–33, 41
1, 2, 5, 6,
11, 29,
31‒33, 41
103(a)
Carmichael (as
evidenced by
ARDSNET and
Waisel)17

1‒6, 9‒12,
29‒33, 41 103(a)
Carmichael,
Anderson,
Tehrani ’268,
Rossi
1‒6, 9‒12,
29‒33, 41

16 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
17 This ground was not reached. See supra § II.H.
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Claim(s)
35
U.S.C.
§ Reference(s)/Basis
Claim(s)
Shown
Unpatentable
Claim(s) Not
Shown
Unpatentable
1‒6, 9‒12,
29‒33, 41 103(a)
Taube,
Carmichael,
ARDSNET,
Clemmer, Rossi
1‒6, 9‒12,
29‒33, 41
Overall Outcome 1‒6, 9‒12, 29‒33, 41

We grant-in-part, deny-in-part, and dismiss-as-moot-in-part
Petitioner’s Motion to Exclude. We deny-in-part and dismiss-as-moot-in-
part Patent Owner’s Motion to Exclude.

VI. ORDER
For the reasons given, it is:
ORDERED, that Petitioner has shown based on a preponderance of
evidence, that claims 1‒6, 9‒12, 29‒33, and 41 of U.S. Patent 7,613,649 B2
are unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude is
granted-in-part, denied-in-part, and dismissed-as-moot-in-part;
FURTHER ORDERED that Patent Owner’s Motion to Exclude is
denied-in-part and dismissed-in-part; and
FURTHER ORDERED because this is a final written decision, the
parties to this proceeding seeking judicial review of our Decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

IPR2020-01199
Patent 7,802,571 B2
69
FOR PETITIONER:
Patrick C. Keane
Ralph G. Fischer
Matthew L. Fedowitz
BUCHANAN INGERSOLL & ROONEY PC
patrick.keane@bipc.com
ralph.fischer@bipc.com
matthew.fedowitz@bipc.com

FOR PATENT OWNER:
Mark Kendrick
KENDRICK INTELLECTUAL PROPERTY LAW
mkendrick852001@gmail.com