BMC Medical Co. Ltd.v.null

Patent Trial and Appeal Board

Jan 20, 2016

13100783 (P.T.A.B. Jan. 20, 2016)

Trials@uspto.gov Paper 25
Tel. 571-272-7822 Entered: January 20, 2016

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

BMC MEDICAL CO. LTD., 3B PRODUCTS, L.L.C., and
3B MEDICAL INC.,
Petitioner,

v.

RESMED LIMITED,
Patent Owner.
_______________

Case IPR2014-01363
Patent RE 44,453 E
_______________

Before MEREDITH C. PETRAVICK, BARRY L. GROSSMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

Opinion for the Board filed by Administrative Patent Judge PAULRAJ.

Opinion Dissenting-in-Part filed by Administrative Patent Judge
PETRAVICK.

FINAL WRITTEN DECISION
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73

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I. BACKGROUND
BMC Medical Co. Ltd., 3B Products, L.L.C., and 3B Medical Inc.
(collectively “Petitioner”) filed a Petition for inter partes review of claims
9–19, 23–36, 40, and 63 of U.S. Patent No. RE 44,453 E (Ex. 1001, “the
’453 patent”) pursuant to 35 U.S.C. §§ 311–319 and 37 C.F.R. §§ 42.1–
42.123. Paper 2 (“Pet.”). ResMed Limited (“Patent Owner”) filed a
Preliminary Response. Paper 6. Taking into account the Petition and Patent
Owner’s Preliminary Response, we determined that there was a reasonable
likelihood that challenged claims 9–19, 23–36, 40, and 63 are unpatentable.
Pursuant to 35 U.S.C. § 314, we instituted inter partes review, on January
21, 2015, as to claims 9–19, 23–36, 40, and 63 of the ’453 patent. Paper 7
(“Dec.”).
After institution, Patent Owner filed a Patent Owner Response (Paper
12, “PO Resp.”). Petitioner filed a reply to the Patent Owner Response.
Paper 13 (“Pet. Reply”). Additionally, Petitioner filed a Motion to Exclude
Evidence (Paper 14), to which Patent Owner filed an Opposition (Paper 18).
Petitioner filed a Reply in Support of its Motion to Exclude (Paper 20).
A hearing was held on September 16, 2015, a transcript of which
appears in the record. Record of Oral Hearing, Paper 24 (“Tr.”).
We have jurisdiction under 35 U.S.C. § 6(c). This decision is a final
written decision under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 as to the
patentability of the challenged claims. For the reasons discussed below, we
determine that Petitioner has shown by a preponderance of the evidence that
claims 9–19, 25–36, 40, and 63 are unpatentable. Petitioner’s Motion to
Exclude Evidence is dismissed as moot.

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A. Related Proceedings
In addition to this proceeding, we have instituted an inter partes
review of claims 1–7 of the ’453 patent based on a separate petition filed by
the same Petitioner. See Case IPR2014-01196, Decision on Institution of
Inter Partes Review (PTAB Jan. 21, 2015) (Paper 7).
A separate petition for inter partes review challenging claims 1–7 of
the ’453 patent was filed by Apex Medical Corp. in Case IPR2014-00551.
That proceeding was terminated based on settlement prior to our decision on
institution. See Case IPR2014-00551, Judgment (PTAB Sept. 12, 2014)
(Paper 11).
The ’453 patent is a reissue of U.S. Patent No. 7,614,398 (“the ’398
patent”). Claims 8–98 were added in the reissue.
The ’398 patent was initially asserted in an investigation before the
U.S. International Trade Commission (ITC), In the Matter of Certain Sleep-
Disordered Breathing Treatment Systems and Components Thereof, ITC
Investigation No. 337-TA-890, but was later substituted with the ’453
patent. Pet. 2; Ex. 1007; Ex. 1022. Patent Owner has also asserted the ’398
patent in ResMed Inc. v. BMC Medical Co., Ltd., et al., 313-cv-01246 (S.D.
Cal), and ResMed Inc. et al v. Apex Medical Corporation et al., 8:13-cv-
00498 (C.D. Cal), which have been stayed pending the outcome of the ITC
investigation and the Board’s inter partes review. Pet. 2; Ex. 1008; Ex.
1009.
B. The ’453 Patent
The ’453 patent relates to a humidifier for use with a continuous
positive airway pressure (CPAP) device. Ex. 1001, 1:25–28. As the ’453
patent explains, humidification of air delivered to CPAP patients may
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increase comfort. Id. at 1:31–33. To this end, manufacturers often supply
humidifiers which may be attached in the air circuit between the blower
outlet and the patient interface of a CPAP device. Id. at 1:33–35.
In describing the prior art, the ’453 patent explains that “[t]ypically,
the blower and humidifier are separate components connected via a flexible
conduit” wherein “[a]n air delivery conduit connects the humidifier outlet to
a patient interface mask,” or “[a]lternatively, the blower and humidifier may
be rigidly-connected together” wherein “[a]ir from the blower outlet passes
into the humidifier inlet where it is humidified and then passes to the air
delivery conduit.” Id. at 1:40–46. However, “[a] potential problem with
either arrangement is that if the humidifier is tilted relative to its normal
orientation, water may run or spill from the humidifier into the blower outlet
which may damage the electrical circuits of the blower and potentially cause
infection control problems.” Id. at 1:46–50.
The ’453 patent seeks to address this problem with the humidifier
embodiments disclosed therein. For example, one embodiment of a
humidifier in a non-working, upright orientation is shown in Figure 10,
reproduced below:
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Figure 10 shows a humidifier 30 for a CPAP apparatus that “is rotated to an
angle about 90° from the working upright orientation, such that a side 80
thereof corresponding to the side of the humidifier 30 adjacent the inlet 32,
is oriented below a side 82 thereof corresponding to the side of the
humidifier 30 adjacent the outlet 34.” Id. at 8:29–34. “Because the raised
portion 48 of the gasket 38 increases the volume of the second chamber 76,
the body of liquid 78 remains only in the second chamber 76 and the level
81 of the liquid body 78 remains below the first aperture 50. Thus, the liquid
will not exit through the inlet 32.” Id. at 8:34–38.
The ’453 patent contemplates that the humidifier “may be used as a
retrofit or add-on component for a CPAP apparatus.” Id. at 9:25–26. To
facilitate this usage, the ’453 patent also discloses the use of “a connecting
structure 100 that is configured to connect between the CPAP apparatus and
humidifier 30.” Id. at 9:26–29. In certain embodiments illustrated in the
patent, “the connecting structure 100 includes a housing 102, which provides
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a generally horizontally extending receptacle 104 within which the
humidifier 30 may be disposed. The housing 102 provides a base portion
106 that is configured to support the humidifier 310 thereon and a retaining
portion 108 configured to secure the humidifier 30 in position.” Id. at 9:30–
35.
C. Illustrative Claims
The challenged claims of the ’453 patent were added during the
reissue proceeding. Reissued claims 9, 23, and 25 of the ’453 patent are
illustrative, and reproduced below:
9. A humidifier for humidifying a flow of
breathable gas to be delivered to a patient, the
humidifier comprising:
a humidifier body configured to retain a body
of liquid having a predetermined maximum
volume, the humidifier body comprising:
a first chamber having a first chamber inlet
configured to receive the flow of breathable gas,
and
a second chamber in communication with the
first chamber through a passage, the second
chamber being structured to contain a
predetermined maximum volume of liquid when
the humidifier body is in a normal upright,
operating position, the second chamber comprising
a second chamber outlet configured to deliver the
flow of breathable gas with added humidity,
wherein the first chamber, the second chamber,
and the passage are arranged such that when liquid
is contained in the second chamber in the upright,
normal operating position, the possibility of liquid
flowing from the second chamber through the
passage is reduced or prevented, and liquid that
flows from the second chamber and through the
passage is collected in the first chamber such that
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liquid is discouraged or prevented from spilling
back from the first chamber inlet when the
humidifier body is inadvertently rotated from the
upright, normal operating position to a non-upright
position.

23. An apparatus for supplying breathable gas
under pressure, comprising:
a blower to generate a flow of pressurized
breathable gas;
the humidifier according to claim 9 structured
to reduce risk of or prevent spillback of liquid
from the humidifier to the blower;
a connecting structure configured to connect
between the blower and the humidifier and allow
communication of an outlet of the blower with the
first chamber inlet of the humidifier; and
an air delivery conduit in communication with
output from the humidifier.

25. A humidifier assembly for a CPAP
apparatus, comprising:
a humidifier that defines a reservoir for a body
of liquid, and a fluid passage between an inlet
provided at a rear side of the humidifier and an
outlet of the humidifier for exposure of a flow of
breathable gas from the CPAP apparatus to the
body of liquid, the humidifier comprising
a base configured to retain the body of liquid
therein and including a heat conducting material,
and
a top cover that covers the base, the top cover
including the outlet; and
a connecting structure configured to connect
between the CPAP apparatus and humidifier and
allow communication of an outlet of the CPAP
apparatus with the inlet of the humidifier, the
connecting structure comprising a housing, the
housing providing a generally horizontal, open
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receptacle within which the humidifier may be
removably disposed by generally horizontally
inserting the humidifier within and pulling it out of
the receptacle, the housing comprising a base
portion forming a lower surface of the receptacle
and configured to support the humidifier thereon, a
heating element positioned on the lower surface
and in thermal contact with the heat conducting
material of the base when the humidifier is
disposed in the receptacle, and a retaining portion
positioned adjacent the top cover of the humidifier
and being spaced above the base portion, the
retaining portion being configured to assist in
retaining the humidifier in the generally horizontal
receptacle.

D. Grounds for Unpatentability
We instituted inter partes review of the ’453 patent based upon the
following grounds of unpatentability:
A. Anticipation of claims 9–19, 40, and 63 by Wilson;1
B. Obviousness of claims 23 and 24 over Wilson and Dobson;2
C. Anticipation of claims 25–27 by HumidAire;3
D. Obviousness of claim 28 Over HumidAire and Helot;4
E. Obviousness of claims 29–31 Over HumidAire, Helot, and
Maeda;5
F. Obviousness of claim 32 Over HumidAire, Usry,6 and Prime; 7

1 U.S. Pat. No. 1,085,833, iss. Feb. 3, 1914 (Ex. 1002).
2 U.S. Pat. No. 5,673,687, iss. Oct. 7, 1997 (Ex. 1019).
3 Instruction Manual for Sullivan® HumidAire Humidifier, 1998 (Ex. 1003).
4 U.S. Pat. No. 6,185,095 B1, iss. Feb. 6, 2001 (Ex. 1023).
5 U.S. Pat. No. 5,870,283, iss. Feb. 9, 1999 (Ex. 1013).
6 U.S. Pat. No. 4,588,425, iss. May 13, 1986 (Ex. 1017).
7 PCT Publication No. WO 00/21602, pub. Apr. 20, 2000 (Ex. 1018).
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G. Obviousness of Claim 33 Over HumidAire, Helot, Maeda, and
Usry; and
H. Obviousness of Claims 34–36 Over HumidAire, Helot, Maeda,
Usry, and Glynn.8
Dec. 19.
II. DISCUSSION
A. Claim Construction
In an inter partes review, claim terms in an unexpired patent are
interpreted according to their broadest reasonable construction in light of the
specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14,
2012). Claim terms are given their ordinary and customary meaning, as
would be understood by one of ordinary skill in the art in the context of the
entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
Cir. 2007).
1. “Humidifier”
We determined, in our Decition to Institute, that that the preamble
recitations of “humidifier” in all the challenged claims are merely statements
of intended use and did not require any specific structure. Dec. 7. Although
Patent Owner’s counsel indicated during the oral hearing that the term
“humidifier” should be construed as “a device for regulating the amount of
water vapor in a specific container or area” (Tr. 40:24–41:6), Patent Owner
has not presented any any additional evidence or argument in its Patent
Owner Response that would justify modification of our initial claim
construction. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,

8 U.S. Pat. No. 2,780,708, iss. Feb. 5, 1957 (Ex. 1024).
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48,768 (Aug. 14, 2012) (parties are not permitted to raise new arguments at
oral hearing). There is no intrinsic evidence identified in support of Patent
Owner’s proposed construction. Nor does Patent Owner’s construction
impose any particular structural requirements for a “humidifier.”
Accordingly, we maintain our determination that “humidifier” is not
accorded patentable weight, beyond requiring that the prior-art structure be
capable of the claimed use. See In re Schreiber, 128 F.3d 1473, 1477 (Fed.
Cir. 1997).
2. “Connecting structure configured to connect between the
CPAP apparatus and humidifier and allow communication of
an outlet of the CPAP apparatus with the inlet of the
humidifier”

Patent Owner asserts that the phrase “connecting structure configured
to connect between the CPAP apparatus and humidifier and allow
communication of an outlet of the CPAP apparatus with the inlet of the
humidifier,” which is recited in claim 25, should be construed to require a
“structure that connects a CPAP apparatus and a standalone humidifier to
form an integrated assembly in which the outlet of the CPAP apparatus is
allowed to communicate with the inlet of the humidifier without an
intermediate hose which must be separately connected to the CPAP outlet
and humidifier inlet.” PO Resp. 7. Patent Owner asserts that, in order to
establish communication between the CPAP outlet and humidifier inlet, “no
intervening hose would be present in the circuit between a CPAP and a
standalone humidifier.” Id. at 7–8.
In support of its proposed construction, Patent Owner points out that
“[e]very embodiment of the ’453 specification that includes a connecting
structure also relates to integrated assemblies of CPAP and humidifier
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devices.” Id. at 8. Patent Owner further points to statements in the ’415
patent indicating that a blower and humidifier rigidly connected together is
an alternative to a blower and humidifier connected via a flexible conduit,
and that one aspect of the invention is “to provide a humidifier that is
capable of directly connecting to a CPAP apparatus,” while another aspect
of the invention is to “provide a humidifier that has an inlet that is directly
connectable with a CPAP apparatus to effectively eliminate a supply tube.”
Id. at 10 (citing Ex. 1001, 1:40–44, 57–61). Patent Owner further points to
arguments and amendments made during the prosecution of both the original
’398 patent and the ’453 reissue where the applicants allegedly distinguished
prior art structures with a “standalone humidifier.” Id. at 12–15.
Petitioner argues that neither the specification of the ’453 patent nor
the prosecution history requires that the connecting structure in claim 25
lack an intermediate hose separately connected to the CPAP outlet and
humidifier inlet. Pet. Reply 2–4. We agree with Petitioner.
The specification acknowledges that prior-art blower and humidifier
combinations included both those connected via a flexible air delivery
conduit as well as those connected rigidly. Ex. 1001, 1:40-44. There is
nothing in the claim language that would distinguish between these two
types of structures. Moreover, we find that the portions of the specification
cited by Patent Owner referring to “aspects” of the invention where the
humidifier is directly connected to the CPAP appatus refer to only certain
embodiments of the invention, but do not otherwise limit the claimed
“connecting structure.” Although the preferred embodiments taught in the
’453 patent utilize rigid connecting structures rather than a flexible hose, the
claims are not so limited. The Federal Circuit has “expressly rejected the
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contention that if a patent describes only a single embodiment, the claims of
the patent must be construed as being limited to that embodiment.” Liebel–
Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004).
Furthermore, we do not find that applicants clearly disclaimed connecting
structures utilizing a flexible hose during prosecution. Rather, applicants
only argued that the “casing 28” in the structure of the prior art Grant
reference did not meet the “connecting structure” requirement, but did not
otherwise disavow the use of a connecting hose. Ex. 1011 (‘398 File
History), 49-50.
We further note that claim 23 of the ’453 patent also recites “a
connecting structure configured to connect between the blower and the
humidifier and allow communication of an outlet of the blower with the first
chamber inlet of the humidifier.” Although the language used is slightly
different, we find no reason to distinguish the connecting structure of claim
25 from the structure of claim 23.
Accordingly, under a broadest reasonable interpretation, we decline to
construe the claimed “connecting structure” to exclude the use of an
intermediate hose.
3. “generally horizontal, open receptacle within which [a]
humidifier may be removably disposed by generally
horizontally inserting the humidifier within and pulling it
out of the receptacle”

Patent Owner also asserts that the phrase “generally horizontal, open
receptacle within which [a] humidifier may be removably disposed by
generally horizontally inserting the humidifier within and pulling it out of
the receptacle” in claim 25 should be construed to require that
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the connecting structure housing has a generally horizontally
extending opening that receives the humidifier and provides a
resting place in which the humidifier is disposed, wherein the
horizontal opening also is configured such that the humidifier is
both inserted into the generally horizontally extending opening
and pulled out of that opening by way of predominantly
horizontal motion.

PO Resp. 17. Relying upon the Random House Webster’s Dictionary,
Patent Owner argues that “[t]he appropriate definition for ‘generally’ in the
context of this phrase is ‘with respect to the larger part; for the most part: a
generally accurate interpretation of the facts.’” Id. at 18 (citing Ex. 2011,
795). As such, Patent Owner argues that “the words ‘generally horizontal’
requires that the receptacle be arranged for a humidifier to be inserted into
the receptacle, or removed from the receptacle, in a predominantly
horizontal manner,” i.e., a “side-loading” humidifier. Id. at 18, 24. As
further support, Patent Owner points to the embodiments illustrated in
Figures 14 and 15 as showing a “connecting structure 100 [that] includes a
housing 102, which provides a generally horizontally extending receptacle
104 within which the humidifier 30 may be disposed.” Id. at 19 (citing Ex.
1001, 9:29–34)
We are unpersuaded by Patent Owner’s arguments. The specification
does not define “generally horizontal” as “predominantly horizontal,” nor do
we find any basis to limit the claims to the “side-loading” humidifiers
described with respect to the the embodiments of Figures 14 and 15. In the
context of the claims, the term “generally” is more akin to the modifier
“about,” and is thus intended to convey less precision when ascertaining
whether the “open receptacle” and/or the act of inserting the humidifier is
horizontal. See Ex. 2011, 795 (defining “generally” as “1. usually;
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commonly, ordinarily: He generally comes home at noon. 2. with respect to
the larger part; for the most part: a generally accurate interpration of the
facts. . . .”). Accordingly, we find nothing in the intrinsic evidence to
suggest that a “generally horizontal, open receptacle” requires that the
humidifier be inserted or received into the receptacle at any particular angle
(e.g., 90 degrees). See also Tr. 59:15–61:6 (Patent Owner’s counsel
declining to identify particular angle of insertion that qualifies as “generally
horizontal.”) Furthermore, as we indicated in our Decision to Institute, the
recitation “may be removably disposed” in this phrase indicates merely that
the housing must be capable of allowing for a generally horizontal insertion
and removal of the humidifier. Dec. 14. No particular structure is required
to achieve this capability.
We therefore decline to adopt Patent Owner’s construction for this
phrase, and otherwise apply the broadest reasonable interpretation of the
claim language in our analysis.
4. Other Claim Terms
We determine that no express claim construction for any other term is
required for purposes of this decision.
B. Anticipation of Claims 9–19, 40, and 63 by Wilson
Wilson, an early patent issued in 1914, discloses a vaporizing inhaler
for delivering medication. Ex. 1002, 1:8–10. Wilson’s Figures 1, 2, and 3
are reproduced below.
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Figures 1 and 2 show top and elevation views, respectively, of a
vaporizing inhaler in an upright position, and Figure 3 shows an elevation
view of the vaporizing inhaler in a tilted position. As shown in Wilson’s
Figure 2, the device includes container C, which contains a quantity of
liquid, an air inlet duct a, which communicates with container C by air inlet
port a1 and draws in air from outside through exterior port a2. Id. at 1:40–52.
There is also an inhalation nozzle I, which communicates with container C
by vapor exhaust port i1. Wilson’s Figure 1 indicates the relative positions
of the inlets. In use, air sucked into the device is pulled over the liquid,
which impregnates the air with medicinal vapor. Id. at 1:75–78. Fig. 3
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illustrates an alternate mode of use, in which the device is tilted in order to
pull air through the liquid. Id. at 1:70–74. When the device is tilted, the
liquid is caught in air inlet duct a to prevent spillage. Id. at 1:54–61.
Petitioner argues that Wilson discloses all limitations of claims 9–19,
40, and 63 in the claimed arrangements. Pet. 8–12; 12–26 (chart). Patent
Owner has not directed any arguments to this anticipation challenge. As we
indicated in our Scheduling Order, “any arguments for patentability not
raised in the [Patent Owner’s] response will be deemed waived.” Paper 8, 5.
Upon consideration of the arguments and evidence made of record in this
proceeding, we determine that Petitioner has demonstrated by a
preponderance of the evidence that Wilson anticipates claims 9–19, 40, and
63.
C. Obviousness of Claims 23 and 24 over Wilson and Dobson
Claim 23 recites an “apparatus for supplying breathable gas under
pressure,” comprising a blower, “the humidifier according to claim 9
structured to reduce risk of or prevent spillback of liquid from the humidifier
to the blower,” a connecting structure, and an air delivery conduit. Claim 24
depends from claim 23, and further requires a “patient interface connected to
the air delivery conduit.”
Petitioner contends that these claims are rendered obvious by the
combination of Wilson and Dobson. As discussed above, Petitioner has
demonstrated—without dispute from Patent Owner—that Wilson teaches the
humidifier of claim 9. Petitioner contends that the other features of the
apparatus of claims 23 and 24 are satisfied by Dobson. Pet. 27–28. In
particular, Dobson discloses an apparatus for supplying breathable gas under
pressure, comprising a ventilator 1 with a variable speed fan 3 to generate a
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flow of pressurized breathable gas to a humidifier 2. Ex. 1019, 3:9-20, Figs.
1–3. Dobson also discloses a seal member 44’ configured to connect
between the ventilator 1/variable speed fan 3 and the humidifier 2 and allow
communication of an air outlet 7 of the ventilator 1/ variable speed fan 3
with an air inlet 44 of the humidifier 2. Id. at 6:11–39, Fig. 16. Further, as
shown in Fig. 1, Dobson discloses an air delivery conduit in communication
with an output 48 from the humidifier 2, and a patient interface connected to
the air delivery conduit. Id. 1019 at 4:52–54 and Figs. 1–3 (“the air A then
flows around the divider 46 and exits through the outlet 48 and onto the
patient”).
Petitioner contends that it would have been obvious for one of
ordinary skill in the art to implement the inhaler of Wilson with Dobson’s
apparatus for supplying breathable gas under pressure. Pet. 28. More
particularly, Petitioner asserts:
It also would have been obvious to one of ordinary skill in the
art to implement the inhaler of Wilson with a seal member 44’
configured to connect between the blower 1/variable speed fan
3 and the inhaler and allow communication of the air outlet 7 of
the blower 1 with the exterior inlet port a2 of the inhaler;
resulting in reducing risk of or preventing spillback of liquid
from the exterior inlet port a2 of the inhaler to the blower
1/variable speed fan 3. Further, it would have been obvious to
one of ordinary skill in the art to implement the inhaler of
Wilson with an air delivery conduit, connected to a patient
interface, in communication with output from the exhaust
nozzle i of Wilson.

Id. at 28–29.

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Petitioner asserts that a person of ordinary skill in the art would have
been motivated to combine the structures of Wilson and Dobson “in order to
provide an automated means by which to provide pressurized air to the
inhaler for the treatment of various diseases.” Id. at 29. For example,
Petitioner asserts that this would be beneficial to patients who “have shallow
breathing and lack sufficient energy to produce and inhale adequate
pressurized air through the inhaler.” Id. Furthermore, according to
Petitioner, the combination would “ensure an optimum and effective
delivery of the humidified air to the patient after exiting the inhaler” such
that “the patient could simply lay in bed and allow the air delivery conduit
and patient interface to help deliver the humidified air with or without the
addition of medication.” Id. at 30. Petitioner also contends that “such a
modification of Wilson would constitute no more than an obvious design
choice.” Id.
We find that Petitioner has not demonstrated a sufficient basis to
combine the structures of Dobson and Wilson to arrive at the apparatus of
claims 23 and 24. We begin with the recognition that the devices taught by
Wilson and Dobson are designed for fundamentally different purposes.
“[C]ombinations that change the ‘basic principles under which the [prior art]
was designed to operate,’ . . . or that render the prior art ‘inoperable for its
intended purpose,’ . . . may fail to support a conclusion of obviousness.”
Plas-Pak Indus., Inc. v. Sulzer Mixpac AG, 600 F. App'x 755, 758 (Fed. Cir.
2015) (citing In re Gordon, 733 F.2d 900, 902 (Fed.Cir.1984); In re Ratti,
270 F.2d 810, 813 (1959)). Wilson’s inhaler is designed to deliver
medication when held to the patient’s mouth manually in one of two ways:
1) by holding the inhaler upright as indicated in Fig. 2, “the air and vapor
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may be withdrawn through the inhalation nozzle i, from above the surface of
the medicated fluid in the container C, without having passed the air through
said fluid;” or 2) “by tilting the inhaler as indicated in Fig. 3, the exhaust
through the inhalation nozzle will cause the inflow of air through the duct a,
to pass through the medicated liquid before it can be inhaled.” See Ex.
1002, 2:64–74. It is therefore apparent that Wilson’s device is designed for
a conscious patient who can control the amount of medication to be inhaled
by tilting the device accordingly. By contrast, Dobson’s apparatus is
designed for use on a patient who is sleeping or is otherwise unconscious of
his or her breathing, as shown for example in Fig. 1 of Dobson. Contrary to
the rationale supplied by Petitioner, there is an insufficient basis on this
record to conclude that Wilson’s inhaler could be used properly in its
intended manner by patients who are “sick, weak and barely able to get out
of bed” and have “shallow breathing and lack sufficient energy to produce
and inhale adequate pressurized air through an inhaler.” Pet. 29. For
example, Petitioner has not demonstrated how such a patient would be able
to tilt Wilson’s inhaler in order to control the amount of medication
delivered when the device is connected to the blower 1/variable speed fan 3
taught by Dobson.
Additionally, we find that Dobson teaches away from the type of
bottle arrangement used for Wilson’s inhaler. A reference teaches away
from a claimed invention when a person of ordinary skill, “upon reading the
reference, would be discouraged from following the path set out in the
reference, or would be led in a direction divergent from the path that was
taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). In
this case, Dobson teaches:
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Early humidifying arrangements were simply bottles filled with
water with air inlets and outlets. Later arrangements became
more sophisticated but still presented many of the same
fundamental problems as the earlier bottle ones.
More specifically, prior humidifying units as typified by
the early bottle arrangements are somewhat clumsy to use and
difficult to clean.

Ex. 1019, 1:15–22. The solution for this problem that is proposed in Dobson
is to use a humidifier that “has a completely separable top and bottom,”
which is not the type of arrangement taught in Wilson. Id. at 1:39–41.
Petitioner acknowledges that Wilson’s inhaler is the type of early
humidifying arrangement mentioned as prior art in Dobson, but does not
otherwise address Dobson’s criticism and discouragement of using such a
bottle arrangement. Pet. 27; Pet. Reply 9–12.
Finally, we find that Petitioner has not explained adequately the
specific design considerations that are necessary to implement that apparatus
taught by Dobson with Wilson’s inhaler. Rather, Petitioner asserts generally
that “a modification of Wilson would constitute no more than an obvious
design choice,” and “applying the blower providing pressurized breathable
gas, air delivery conduit, and patient interface of Dobson to the inhaler of
Wilson would have done nothing more than combine familiar elements
according to known methods.” Pet. 30. However, a “design choice”
rationale for obviousness is “precluded where the claimed structure and the
function it performs are different from the prior art.” In re Chu, 66 F.3d 292,
299 (Fed. Cir. 1995) (citing In re Gal, 980 F.2d 717 (Fed. Cir. 1992)). The
evidence of record shows that the inhalation of medication using Wilson’s
inhaler functions differently from the supplying of humidified air to a patient
using Dobson’s apparatus. For example, while Dobson’s humidifier consists
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of a large-area, shallow tub of water for the blown air to pass over the water,
the inhaler of Wilson, when tilted, would require the air coming in through
the inlet port a2 to pass through the medicated liquid in order to be
withdrawn through the inhalation nozzle i. See Ex. 1002, Fig. 3; Ex. 1019,
Fig. 3. There is no evidentiary basis to conclude that Dobson’s blower 1/
variable speed fan 3 could function in that manner when connected to the
inlet port a2 of Wilson’s inhaler. See Pet. 28–29. As noted by Patent
Owner, at least three design considerations must be taken into account to
ensure that sufficient humidity is added to the pressurized air flow in a
CPAP apparatus: 1) “the humidifier should provide sufficient water surface
area that would be needed to generate the amount of evaporation required to
achieve a desired humidity level;” 2) “the humidifier should provide
sufficient storage capacity for at least the volume of water that would be
needed for a full therapy session” (i.e., 6–8 hours for a night of CPAP
therapy); and 3) “the structure of the humidifier should be adapted so that
the pressurized air flow from the gas supply apparatus flows substantially
over the entire surface of the water, rather than jetting across a portion of the
surface area.” Pet. 33 (citing Ex. 2008 (Declaration of John Izuchukwu,
Ph.D., P.E.), ¶ 128). Petitioner, however, does not address any of these
design considerations in its analysis.
We therefore determine that Petitioner has not demonstrated by a
preponderance of the evidence the obviousness of claims 23 and 24 based on
a combination of Wilson and Dobson.
D. Anticipation of Claims 25–27 by HumidAire
Petitioner contends that the instruction manual for the Sullivan
HumidAire, an earlier CPAP humidifier model sold by Patent Owner,
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anticipates claims 25–27 of the ’453 patent. Ex. 1003 (“HumidAire”).9
Patent Owner does not dispute that HumidAire qualifies as prior art under 25
U.S.C. § 102(b). See Ex. 1012, 1410.
The HumidAire instructions teach a CPAP humidifier, as shown in the
annotated Figure below:

Ex. 1003, 2. The illustration above shows a front view of the Sullivan
HumidAire humidifier with its various components labeled. According to
the instructions, the HumidAire includes a water chamber (circled) that may
be filled with water either through one of the first or second connector pipes
or by removing the lid and filling the chamber base with water until it is

9 During the oral hearing for this proceeding, both Patent Owner and
Petitioner sought to make arguments with respect to the physical Sullivan
HumidAire device or photographs thereof. See, e.g., Tr. 56:7–24, 64:1–24.
However, consistent with the statutory requirement in 35 U.S.C. § 311(b)
that the scope of an inter partes review is limited to challenges “on the basis
of prior art consisting of patents or printed publications,” our consideration
of this anticipation challenge is limited to the actual teachings of the
HumidAire instruction manual rather than the device itself or any
photographs thereof.

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approximately 2/3 full. Id. at 3. Once filled with water, the water chamber
is positioned over a heater plate within a circular recessed portion (labeled
“concavity” in the illustration above) of the HumidAire housing. Id. One
end of a “short tube” and one end of a “long tube” are each connected to the
connector pipes, wherein the free end of the short tub is connected to a “flow
generator” (i.e., a CPAP apparatus) while the free end of the long tube is
connected to the patient’s mask. Id. at 3–4.
Petitioner has included claim charts showing how each of the
limitations of claims 25–27 are taught by HumidAire. See Pet. 34–40 (claim
chart). Patent Owner makes two arguments with respect to claim 25
regarding this challenge, neither of which we find persuasive.
First, Patent Owner argues that HumidAire does not anticipate claim
25 because it fails to expressly or inherently disclose a “connecting structure
configured to connect between the CPAP apparatus and humidifier and
allow communication of an outlet of the CPAP apparatus with the inlet of
the humidifier.” PO Resp. 48–49. More particularly, Patent Owner asserts
that “HumidAire does not anticipate claim 25 because it lacks the claimed
connecting structure that excludes hose-type connections between the
humidifier inlet and the CPAP outlet.” Id. at 48 (emphasis removed). We
disagree. As noted above, we decline to construe the claimed “connecting
structure” to exclude the use of an intermediate hose. Accordingly, the
“short tube” used to connect the HumidAire to the CPAP apparatus may be
properly considered as part of the claimed “connecting structure.”
Second, Patent Owner argues that “HumidAire does not anticipate
claim 25 because it lacks a generally horizontal receptacle,” and that
Petitioner “offers no evidence to show that HumidAire’s water chamber can
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be ‘removably disposed by generally horizontally inserting the humidifier
within and pulling it out of the receptacle.’” Id. at 52–59. Again, we
disagree. With respect to the requirement for a “generally horizontal
receptacle,” we find this to be taught by the illustrations included with the
HumidAire instructions showing a circular recessed portion that is designed
to receiver the water chamber. There is no basis to conclude that this
recessed portion constitutes a “verticle” receptacle, rather than a “generally
horizontal” receptacle as required. Furthermore, with respect to the
requirement that “the humidifier may be removably disposed by generally
horizontally inserting the humidifier within and pulling it out of the
receptacle,” the HumidAire instructions also illustrate this capability, as
shown in this Figure:

Ex. 1003, 3. In the illustration above, the presence of the arrow pointing to
the right along with the instructions “[r]emove the water chamber” shows
plainly that the water chamber may be inserted into and out of the
HumidAire housing and receptacle in a generally horizontal fashion. We
find this to hold true even assuming that the water chamber must be inserted
or removed at an angle within the circular recessed portion (receptacle)
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contained in the HumidAire housing. As noted in our claim construction
discussion above, the term “generally horizontal” does not require any
particular angle of insertion into or removal from the receptacle.
We therefore determine that Petitioner has shown by a preponderance
of the evidence that HumidAire anticipates claims 25–27.
E. Obviousness of Claim 28 Over HumidAire and Helot
Claim 28 recites “[a] humidifier assembly according to claim 2 7,
further comprising a retaining mechanism to secure the connecting structure
to the CPAP apparatus.” With respect to this claim, Petitioner asserts that it
would have been obvious to one of ordinary skill in the art to implement
HumidAire with a retaining mechanism to secure the flow generator or
CPAP on top of the HumidAire housing. Pet. 40–41. Petitioner further
relies upon the teachings of Helot (Ex. 1023) for this limitation, and asserts
that “[o]ne of ordinary skill in the art would have been motivated to
implement the retaining mechanism of Helot to prevent the CPAP from
falling off the top of the HumidAire housing.” Id. at 41
Other than the arguments with respect to independent claim 25
discussed above, Patent Owner does not direct any additional arguments to
this obviousness challenge. Upon consideration of the arguments and
evidence made of record in this proceeding, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claim 28 is
unpatentable for obviousness over HumidAire and Helot.
F. Obviousness of Claims 29–31 Over HumidAire, Helot, and Maeda
Claim 29 recites “[a] humidifier assembly according to claim 28,
wherein the retaining mechanism comprises a resiliently biased locking
member configured to releasably engage a projection of the CPAP
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apparatus.” Claim 30 recites “[a] humidifier assembly according to claim
29, further comprising a release member coupled to the resiliently biased
locking member to move the resiliently biased locking member out of
engagement with the projection of the CPAP apparatus.” Claim 31 recites
“[a] humidifier assembly according to claim 30, wherein the release member
is provided in the base portion of the housing.” Petitioner relies upon
HumidAire combined with the teachings of Helot and Maeda (Ex. 1013) for
these limitations. Pet. 47–49. Petitioner asserts that “[a]t the very least, one
of ordinary skill in the art would have been motivated to implement the
projection of Maeda to improve the connection between the flow generator
or CP AP and the HumidAire housing,” and that “[b]y implementing the
projection in the opening of Maeda in the aperture or slot of Helot, the
connection between the engagement members 36 of docking station 22 with
corresponding apertures or slots of the computer 24 could be better secured.”
Id. at 47.
Other than the arguments with respect to independent claim 25
discussed above, Patent Owner does not direct any additional arguments to
this obviousness challenge. Upon consideration of the arguments and
evidence made of record in this proceeding, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claims 29–31 are
unpatentable for obviousness over HumidAire, Helot, and Maeda.
G. Obviousness of Claim 32 Over HumidAire, Usry, and Prime
Claim 32 recites “[a] humidifier assembly according to claim 25,
wherein the heat conducting material of the base of the humidifier is
provided in an opening in a bottom wall of the base of the humidifier.” With
respect to this claim, Petitioner relies upon HumidAire combined with the
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teachings of Usry (Ex. 1017) and Prime (Ex. 1018). Pet. 49–52. According
to Petitioner, “[i]t would have been obvious to one of ordinary skill in the art
to have modified the base of the water chamber of the [HumidAire]
Instructions to incorporate heat conductive material panel of [Usry] in an
opening in a bottom wall of the base of the water chamber such that the heat
conductive material is positioned next to the heater plate.” Id. at 50. As a
rationale to combine these teachings, Petitioner asserts that “only having the
heat conductive material in an opening in a bottom portion of the base of the
water chamber would increase the ability of the water chamber to retain heat
for cost effective operation.” Id. Based on Prime’s teaching of the
advantages of reducing the amount of heat conductive material in a
humidifier, Petitioner further asserts that it would have been obvious “to
modify the water chamber base of the Instructions to incorporate the flat cup
26 of [Usry], instead of making the entire base of the water chamber out of a
heat conductive material” because “[t]his modification would have improved
the heat retention at noted in Prime.” Id. at 51. Petitioner asserts that
“[s]uch a modification of the water chamber base of the Instructions to
include flat cup 26 of [Usry], as suggested by Prime, would have been an
obvious combination of familiar elements to yield predictable results.” Id.
Other than the arguments with respect to independent claim 25
discussed above, Patent Owner does not direct any additional arguments to
this obviousness challenge. Upon consideration of the arguments and
evidence made of record in this proceeding, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claim 32 is
unpatentable for obviousness over HumidAire, Usry, and Prime.
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H. Obviousness of Claim 33 Over HumidAire, Helot, Maeda, and
Usry
Claim 33 recites “[a] humidifier assembly according to claim 31,
wherein the heating element is upwardly biased into engagement with the
heat conducting material.” With respect to this claim, Petitioner relies upon
HumidAire, combined with the teachings of Helot, Maeda, and Usry. Pet.
52–54. As a rationale for combining the references, Petitioner cites “the
advantages of increasing the thermal contact between the heater plate and
heat conducting material discussed in [Usry]” as reason why it would have
been obvious to “modify the upwardly positioned heater plate of the
[HumidAire] Instructions to include the spring-loaded heater plate of [Usry],
so as to be upwardly biased into engagement with the heat conducting
material of the water chamber base.” Id. at 53–54.
Other than the arguments with respect to independent claim 25
discussed above, Patent Owner does not direct any additional arguments to
this obviousness challenge. Upon consideration of the arguments and
evidence made of record in this proceeding, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claim 33 is
unpatentable for obviousness over HumidAire, Helot, Maeda, and Usry.
I. Obviousness of Claims 34–36 Over HumidAire, Helot, Maeda,
Usry, and Glynn

Claim 34 recites “[a] humidifier assembly according to claim 33,
wherein the heating element is a resistance heater.” Claim 35 recites “[a]
humidifier assembly according to claim 34, further comprising a seal
between the heat conducting material and the bottom wall.” Claim 36
recites “[a] humidifier assembly according to claim 35, wherein the
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connecting structure includes contact elements that communicate with a
power supply, a controller, and/or sensors within the CPAP apparatus.”
Petitioner relies upon HumidAire combined with the teachings of Helot,
Maeda, Usry, and Glynn (Ex. 1024) for these limitations. Pet. 54–59.
Petitioner asserts that the HumidAire’s “ heater plate must be a resistance
heater because it operates on electricity, which creates heat through
resistance,” but “[t]o the extent the Board finds otherwise, the use of a heater
plate that uses a resistance heater is obvious in view of the teachings of
Glynn.” Id. at 55. Petitioner further asserts that the the use of a seal between
the heat conducting material and the wall in the bottom of the base would
have been an obvious combination of familiar elements according to known
methods, as taught by Usry, and “including a seal would prevent the leakage
of water from the water chamber.” Id. at 56. Additionally, Petitioner asserts
that the use of contact elements that communicate with a power supply of a
CPAP apparatus would have been an obvious combination of familiar
elements according to known methods, as taught by Helot, and “would
enable power to be directed to the flow generator or CPAP through the
HumidAire housing so that the flow generator or CPAP need not be
manually plugged in before use.” Id. at 57.
Other than the arguments with respect to independent claim 25
discussed above, Patent Owner does not direct any additional arguments to
this obviousness challenge. Upon consideration of the arguments and
evidence made of record in this proceeding, we determine that Petitioner has
demonstrated by a preponderance of the evidence that claims 34–36 are
unpatentable for obviousness over HumidAire, Helot, Maeda, Usry, and
Glynn.
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III. PETITIONER’S MOTION TO EXCLUDE EVIDENCE
Petitioner moves to exclude certain portions of the Declarations
submitted by Patent Owner (Ex. 2008; Ex. 2009), as well as Exhibits 2012–
2018. Paper 14. Because our decision does not rely on any of the
challenged portions of these exhibits, we dismiss Petitioner’s Motion to
Exclude Evidence as moot.
IV. CONCLUSION
We conclude that Petitioner has demonstrated by a preponderance of the
evidence that claims 9–19, 40, and 63 are anticipated by Wilson, that claims
25–27 are anticipated by HumidAire, that claim 28 is rendered obvious by
HumidAire and Helot, that claims 29–31 are rendered obvious by
HumidAire, Helot, and Maeda, that claim 32 is rendered obvious by
HumidAire, Usry, and Prime, that claim 33 is rendered obvious by
HumidAire, Helot, Maeda, and Usry, and that claims 34–36 are rendered
obvious by HumidAire, Helot, Maeda, Usry, and Glynn.
This is a final written decision of the Board under 35 U.S.C. § 318(a).
Parties to the proceeding seeking judicial review of this decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.
V. ORDER
Accordingly, it is
ORDERED that claims 9–19, 25–36, 40, and 63 of U.S. Patent RE
44,453 E are held to be unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude Evidence is
dismissed as moot;
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FURTHER ORDERED that because this is a Final Written Decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

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PETRAVICK, Administrative Patent Judge, joining-in-part and dissenting-
in-part
I join the majority opinion holding that claims 9–19, 25–36, 40, and
63 of the ’453 are unpatentable, but I respectfully dissent from the majority
regarding the patentablilty of claims 23 and 24. I determine that Petitioner
establishes by a preponderance of the evidence that claims 23 and 24 are
unpatentable over Wilson and Dobson.
A. Petitioner’s Contentions
Petitioner contends that claims 23 and 24 would have been
obvious to one of ordinary skill in the art based upon two alternative
arguments to combine Wilson and Dobson. Petitioner first argues that
“[i]t would have been obvious to one of ordinary skill in the art to
implement the inhaler of Wilson with the apparatus for supplying
breathable gas under pressure of Dobson.” Pet. 28. Under this theory,
the resulting combination would be Dobson’s ventilator system with
the humidifier replaced by Wilson’s inhaler.
Petitioner, however, alternatively argues that it would have
been obvious to one of ordinary skill in the art to modify the inhaler of
Wilson to include a blower as in Dobson, “to provide an automated
means by which to provide pressurized air to the inhaler for the
treatment of various diseases” because “in many cases, patients are
sick, weak, and barely able to get out of bed” or “may also have
shallow breathing and lack sufficient energy to produce and inhale
adequate pressurized air through the inhaler.” Pet. 29 (citing Ex. 1004
¶ 94). Petitioner further reasons that it would have been obvious to
one of ordinary skill in the art to modify the inhaler of Wilson to
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include “the air delivery conduit, connected to a patient interface of
Dobson, to the inhaler of Wilson . . . to ensure an optimum and
effective delivery of the humidified air to the patient after exiting the
inhaler.” Pet. 30 (citing Ex. 1004 ¶ 95). Under this alternate theory,
the resulting combination would be Wilson’s inhaler with a connected
blower and air deliver conduit with a patient interface.
I am persuaded by Petitioner’s alternate combination that claims 23
and 24 are unpatentable over Wilson and Dobson.
B. Analysis
Claims 23 and 24 are reproduced below.
23. An apparatus for supplying breathable gas under pressure,
comprising:
a blower to generate a flow of pressurized breathable gas;
the humidifier according to claim 9 structured to reduce
risk of or prevent spillback of liquid from the humidifier to the
blower;
a connecting structure configured to connect between the
blower and the humidifier and allow communication of an
outlet of the blower with the first chamber inlet of the
humidifier; and
an air delivery conduit in communication with output
from the humidifier.

24. An apparatus according to claim 23, further comprising:
a patient interface connected to the air delivery conduit.
As discussed above in the majority opinion, we determine that a
preponderance of the evidence establishes that Wilson describes the
humidifier of claim 9, and Patent Owner does not contest such. See
Pet 12–16; Tr. 26–27.
Unlike the majority, however, I determine that a preponderance
of the evidence establishes that it would have been obvious to one of
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ordinary skill in the art to modify Wilson’s inhaler to include a blower
to generate a flow of pressurized breathable gas, to structure the
humidifier to reduce risk of or prevent spillback of liquid from the
humidifier to the blower, and to provide a connecting structure to
connect the outlet of the blower to the inlet of the humidifier, as
taught by Dobson.
Wilson discloses that its inhaler is used to treat diseases of the
throat or nasal passages by inhaling medicated volatile fluids. Ex.
1002, 1:8–12. As discussed in the majority opinion above, Wilson’s
inhaler may be used in an upright position or a tilted position to
change the amount of medication impregnated into the air. Id. at
1:24–30, 66–99. Wilson discloses that it is desirable to prevent the
fluid from overflowing into the inhaler’s inlet. Id. at 1:55–60.
Regardless of whether Wilson’s inhaler is used in an upright position
or a tilted position, users must be able to inhale sufficiently to
adequately pull air into the air inlet duct and out the vapor exhaust
port. See id. 1:15–31, 66–96; Figs. 2–3.
Petitioner’s declarant Mr. Steve Bordewick testifies that “[i]n
many cases, patients are sick, weak, and barely able to get out of bed”
and “may also have shallow breathing and lack sufficient energy to
produce and inhale adequate pressurized air through the inhaler.” Ex.
1004 ¶ 94.
Dobson discloses early humidifiers that are similar to Wilson’s
inhaler. See Ex. 1019, 1:15–16 (disclosing bottle type humidifiers).
Dobson discloses that these humidifiers are “commonly connected to
[a] ventilator or other respiratory device by a flexible hose.” Id. at
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1:13–15, 22–24. Dobson also discloses an embodiment of an
apparatus that has a ventilator with a connected fan that generates an
air flow through a humidifier to deliver humidified air to patient. Ex.
1009, 3:12–17, Fig. 1. Dobson does not limit its teachings to the
disclosed ventilator embodiment, but suggests that a ventilator could
be “any and all respiratory devices (including respirators) for
generating air flow for use by a patient.” Ex. 1019, 6:55–64.
The ’435 patent similarly discloses that manufacturers of non-
invasive positive pressure ventilation apparatus or CPAP apparatus
“often supply humidifiers which many be attached in the air circuit
between the blower outlet and the patient interface.” Ex. 1001, 1:29–
35.
Given this evidence, I am persuaded that it would have been
obvious to one of ordinary skill in the art to modify Wilson’s inhaler
to include a blower to generate a flow of pressurized breathable gas,
to structure the humidifier to reduce risk of or prevent spillback of
liquid from the humidifier to the blower, and to provide a connecting
structure to connect the outlet of the blower to the inlet of the
humidifier as taught by Dobson. Such a modification is desirable
because it helps diseased users produce an adequate air flow through
the inhaler. See Ex. 1004 ¶¶ 94, 96.
In addition, I am persuaded by a preponderance of the evidence
that it would have been obvious to one of ordinary skill in the art to
modify Wilson’s inhaler to include an air delivery conduit with a
patient interface. Dobson depicts the use of an air delivery conduit
with a mask. Ex. 1019, Fig. 1. The ’435 patent similarly discloses
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that non-invasive positive pressure ventilation or CPAP apparatus
“typically comprises a blower whose output is connected to a patient
interface, such as a mask, via an air delivery conduit.” Ex. 1001,
1:29–31. Petitioner’s declarant Mr. Bordewick testifies that such a
modification would “ensure an optimum and effective delivery of the
humidified air to the patient after exiting the inhaler.” Ex. 1004 ¶¶ 95,
96.
Given this evidence, I am persuaded that it would have been
obvious to one of ordinary skill in the art to modify Wilson’s inhaler
to include an air delivery conduit with a patient interface to facilitate
delivery of medication impregnated air to the patient.
I determine that Petitioner establishes by a preponderance of the
evidence that claims 23 and 24 are unpatentable over Wilson and
Dobson.
C. Patent Owner’s Arguments
With respect to Petitioner’s alternate combination, Patent
Owner argues that Petitioner’s alternate combination is unsupported
by sufficient evidence. PO Resp. 38–40 (citing Ex. 2008 ¶¶ 137–
139). For the reasons discussed above, however, I determine that the
disclosures of Wilson and Dobson and the testimony of Petitioner’s
declarant Mr. Bordewick sufficiently supports Petitioner’s alternate
combination.
Patent Owner also argues that Mr. Bordewick is not qualified to
testify because he is not a medical professional but an engineer. PO
Resp. 39. Patent Owner’s argument, however, does not account for
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the fact that Mr. Bordewick’s engineering experience includes
designing and developing CPAP masks. Ex. 1004 ¶¶ 12–14.
With respect to Petitioner’s first combination, Patent Owner
makes multiple arguments as to why Petitioner’s first combination
would not have been obvious to one of ordinary skill in the art. PO
Resp. 31–38, 40–45. For example, Patent Owner argues that
implementing Wilson’s inhaler in the Dobson’s ventilator system
would create practical problems because Wilson’s inhaler would not
provide adequate humidity for Dobson’s clinical system (id. at 31–
35), that Petitioner does not provide adequate evidence to establish
how Wilson’s inhaler could be incorporated into Dobson’s ventilator
(id. at 40), and that Dobson teaches away from incorporating Wilson’s
inhaler into Dobson’s ventilator (id. at 44).
Each of these arguments are directed to whether Wilson’s
inhaler could be bodily incorporated into Dobson’s ventilator.
However, “[t]he test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the structure of
the primary reference. . . . Rather, the test is what the combined
teachings of those references would have suggested to those of
ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA
1981); see also In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983)
(“[I]t is not necessary that the inventions of the references be
physically combinable to render obvious the invention under
review.”); In re Nievelt, 482 F.2d 965, 968 (CCPA 1973)
(“Combining the teachings of references does not involve an ability to
combine their specific structures.”).
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Regardless, in the Petitioner’s alternate combination, Wilson’s
inhaler is not being bodily incorporated into Dobson’s ventilator. In
Petitioner’s alternate combination, Wilson’s inhaler is being modified
to include a blower to generate a flow of pressurized breathable gas,
to structure the humidifier to reduce risk of or prevent spillback of
liquid from the humidifier to the blower, to provide a connecting
structure to connect the outlet of the blower to the inlet of the
humidifier; and to include an air delivery conduit with a patient
interface. Pet. 29–31.
D. Conclusion
I determine that Petitioner establishes by a preponderance of the
evidence that claims 23 and 34 are unpatentable over Wilson and Dobson.

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For PETITIONER:

E. Robert Yoches
Joshua L. Goldberg
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
Bob.yoches@finnegan.com
Joshua.goldberg@finnegan.com

For PATENT OWNER:

Stephen R. Schaefer
Michael Kane
Timothy W. Riffe
FISH & RICHARDSON, P.C.
Schaefer@fr.com
IPR36784-0032IP2@fr.com
Riffe@fr.com