Filed: October 12, 2016 Filed on behalf of: Fisher & Paykel Healthcare Limited By: Brenton R. Babcock Benjamin J. Everton KNOBBE, MARTENS, OLSON & BEAR, LLP 2040 Main Street, 14th Floor Irvine, CA 92614 Tel.: (949) 760-0404 Fax: (949) 760-9502 Email: [email protected]UNITED STATES PATENT AND TRADEMARK OFFICE __________________________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________________________________ FISHER & PAYKEL HEALTHCARE LIMITED, Petitioner v. RESMED LIMITED, Patent Owner Case No. IPR2017-00062 U.S. Patent No. 9,119,931 PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,119,931
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Filed: October 12, 2016 Filed on behalf of:
Fisher & Paykel Healthcare Limited By: Brenton R. Babcock
Benjamin J. Everton KNOBBE, MARTENS, OLSON & BEAR, LLP 2040 Main Street, 14th Floor Irvine, CA 92614 Tel.: (949) 760-0404 Fax: (949) 760-9502 Email: [email protected]
UNITED STATES PATENT AND TRADEMARK OFFICE __________________________________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________________________________
FISHER & PAYKEL HEALTHCARE LIMITED, Petitioner
v.
RESMED LIMITED, Patent Owner
Case No. IPR2017-00062 U.S. Patent No. 9,119,931
PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,119,931
TABLE OF CONTENTS Page No.
i
I. INTRODUCTION ........................................................................................... 1
II. THIS PETITION IS NOT REDUNDANT UNDER 35 U.S.C. § 325(D) .............................................................................................................. 5
III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(A)(1) ........................ 7
A. Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) .................................... 7
B. Related Matters Under 37 C.F.R. § 42.8(b)(2) ..................................... 7
C. Lead and Back-up Counsel Under 37 C.F.R. § 42.8(b)(3) ................... 8
D. Service Information Under 37 C.F.R. § 42.8(b)(4) ............................... 9
IV. REQUIREMENTS FOR REVIEW UNDER 37 C.F.R. § 42.104 .................. 9
A. Grounds for Standing (37 C.F.R. § 42.104(a)) ..................................... 9
B. Statement of Relief Requested Under 37 C.F.R. §§ 42.104(b)(1)–(2) ............................................................................... 9
1. Prior Art ...................................................................................... 9
a. WO 2007/041751 (“D’Souza”) (Ex. 1102) .................... 10
b. Ultra Mirage Full Face Mask Brochure (“Ultra Mirage”) (Ex. 1103 at 6–7) ............................................. 11
c. U.S. Publication No. 2007/0044804 (“Matula-II”) (Ex. 1105) ................................................................ 12
d. FlexiFit Series, HC 431 Full Face Mask, Instructions for Use (“FlexiFit”) (Ex. 1106 at 9–10) ............................................................................... 12
e. U.S. 6,412,488 (“Barnett”) (Ex. 1107) ........................... 14
f. U.S. Publication No. 2004/0226566 (“Gunaratnam-II”) (Ex. 1110) ........................................ 14
TABLE OF CONTENTS (continued)
Page No.
ii
g. U.S. 6,851,425 (“Jaffre”) (Ex. 1112) .............................. 14
C. Claim Construction (37 C.F.R. § 42.104(b)(3)) .................................. 16
V. THE ’931 PATENT ....................................................................................... 16
A. Example Embodiments ....................................................................... 16
B. Summary of the Prosecution History of the ’931 Patent .................... 19
VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 20
VII. THE CHALLENGED CLAIMS OF THE ’931 PATENT ARE UNPATENTABLE ........................................................................................ 21
A. Legal Standard for Obviousness ......................................................... 21
B. Ground #1: Claims 57, 58, 61, 65, 68, 69, 71, 77–79 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, and Matula-II ........................................................... 22
1. Overview of D’Souza (Ex. 1102) ............................................. 22
2. Overview of Ultra Mirage (Ex. 1103) ...................................... 23
3. Overview of Barnett (Ex. 1107)................................................ 24
4. Overview of Matula-II (Ex. 1105) ............................................ 25
5. Potential Differences from the Prior Art ................................... 26
a. “a pair of upper headgear connectors” ........................... 28
b. “elbow” ........................................................................... 30
c. “removably snap-fit” ...................................................... 32
d. “protruding vent” ............................................................ 34
TABLE OF CONTENTS (continued)
Page No.
iii
e. “one or more folds” ........................................................ 35
f. “plurality of snap fingers” .............................................. 38
g. “each of the shroud module and the frame comprise polycarbonate” ................................................ 40
6. Reasons to Combine ................................................................. 40
C. Ground #2: Claim 60 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, and FlexiFit ................................................................................................ 43
1. Overview of FlexiFit (Ex. 1106) ............................................... 43
2. Potential Differences from the Prior Art ................................... 45
a. “each upper headgear connector includes a slot” ................................................................................. 45
3. Reasons to Combine ................................................................. 46
D. Ground #3: Claims 62–64 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, FlexiFit, and Gunaratnam-II ................................................................ 47
1. Overview of Gunaratnam-II (Ex. 1110) ................................... 47
2. Potential Differences from the Prior Art ................................... 48
a. “headgear” ...................................................................... 48
b. “upper straps provide padding” ...................................... 50
c. “rear straps and the top straps form a closed loop”................................................................................ 52
3. Reasons to Combine ................................................................. 52
TABLE OF CONTENTS (continued)
Page No.
iv
E. Ground #4: Claims 43, 48–50, and 70 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, and Matula-II .............................................................. 54
1. Overview of Jaffre (Ex. 1112) .................................................. 54
2. Potential Differences from Prior Art ........................................ 55
a. “the elbow including a swivel” ....................................... 56
b. “anti-asphyxia valve” ..................................................... 57
3. Reasons to Combine ................................................................. 58
F. Ground #5: Claims 46, 51, and 53–56 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II, and Gunaratnam-II .................................... 58
1. Potential Differences from the Prior Art and Reasons to Combine .................................................................................... 58
VIII. CLAIM CHART ............................................................................................ 59
IX. SECONDARY CONSIDERATIONS ........................................................... 95
TABLE OF AUTHORITIES Page No(s).
v
ABS Global Inc. v. XY, LLC, IPR2014-01161, Paper No. 9 (PTAB January 13, 2015) .................................... 7
In re Cuozzo Speed Techs., LLC, 793 F.3d 1268 (Fed. Cir. 2015), aff’d, 136 S. Ct. 2131 (2016) .......................... 16
EMC Corp. v. Personalweb Techs., LLC, IPR2013-00084, Paper No. 64 (PTAB May 15, 2014) ................................ 12, 13
Graham v. John Deere Co., 383 U.S. 1 (1966) ....................................................... 21
KSR Int’l v. Teleflex Inc., 550 U.S. 398 (2007) ....................................................................21, 40, 43, 54, 59
Leapfrog Enters. Inc. v. Fisher-Price, Inc., 485 F.3d 1157 (Fed. Cir. 2007) .......................................................................... 95
Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 95
Sony Corp. v. Raytheon Co., IPR2016-00209, Paper No. 12 (PTAB March 19, 2016) .................................... 6
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
Exhibit List, Page 1
EXHIBIT LIST
Exhibit No. Description
1101 U.S. Patent No. 9,119,931
1102 PCT Publication No. WO 2007/041751 (D’Souza)
1103 Affidavit of Christopher Butler, Ultra Mirage Brochure (Ultra Mirage), dated September 6, 2016
1104 U.S. Patent No. 7,827,990 (Melidis)
1105 U.S. Publication No. 2007/0044804 (Matula-II)
1106 Affidavit of Christopher Butler, FlexiFit Instructions (FlexiFit), dated September 6, 2016
1107 U.S. Patent No. 6,412,488 (Barnett)
1108 U.S. Patent No. 6,631,718 (Lovell)
1109 PCT Publication No. WO 2007/045008 (Worboys)
1110 U.S. Publication No. 2004/0226566 (Gunaratnam-II)
1111 U.S. Publication No. 2004/0182398 (Sprinkle)
1112 U.S. Patent No. 6,851,425 (Jaffre)
1113 Declaration of Jason Eaton, P.E.
1114 Excerpts from the File History of U.S. Patent No. 9,119,931
1115 Malloy, Robert A., Plastic Part Design for Injection Molding: An Introduction, pp. 336–345 (Hanser Gardner Publications, Inc. 1994) (Malloy)
1116 Declaration of Fiona Cresswell, dated September 21, 2016
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
Exhibit List, Page 2
Exhibit No. Description
1117 Complaint of ResMed Ltd, ResMed Inc., and ResMed Corp. Under Section 337 of the Tariff Act of 1930, as amended, Investigation No. 337-TA-1022
1118 Answer of ResMed Corp. to Complaint for Patent Infringement and Counterclaims, Fisher &Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv-02068-DMS-WVG (S.D. Cal.)
1119 U.S. Provisional Application No. 61/064,406
1120 U.S. Provisional Application No. 61/071,893
1121 U.S. Provisional Application No. 61/136,617
1122 PCT Publication No. WO 2007/147088 (Matula-I)
1123 U.S. Patent No. 6,796,308 (Gunaratnam-I)
1124 PCT Publication No. WO 2005/123166 (Frater)
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
1
Pursuant to 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.100 et seq., Petitioner
earliest possible priority date for at least Claims 46, 51, 53–56, and 65 of the ’931
Patent is the filing date of the parent application of the ’931 Patent, U.S.
Application No. 12/736,024 (now U.S. 8,550,084), filed as PCT Application No.
PCT/AU2009/000241 on February 27, 2009.
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
11
Additionally, at least the first and second provisional applications did not
disclose the shroud module including a retaining portion positioned rearwardly of
the front opening. Ex. 1119; Ex. 1120; Ex. 1113 ¶ 31. Thus, the earliest possible
priority date for at least Claims 57, 58, 60–65, 68–71, and 77–79 is the filing date
of the third provisional application, U.S. Provisional Application No. 61/136,617,
on September 19, 2008.
Because D’Souza published more than one year before September 19, 2008,
D’Souza is prior art under 35 U.S.C. § 102(b) for the Challenged Claims.1
b. Ultra Mirage Full Face Mask Brochure (“Ultra Mirage”)
(Ex. 1103 at 6–7)
Ultra Mirage was publicly available on ResMed’s website at least by
September 1, 2006 and various pages bear the copyright dates of 2004 and 2005.
Ex. 1103 at 7; Ex. 1113 ¶ 50. The Internet Archive Wayback Machine shows that
the public had access to a ResMed webpage containing links to Ultra Mirage by at
least September 1, 2006. Ex. 1103 at 8. The authenticity of Ultra Mirage is
established by the accompanying affidavit of Christopher Butler, attaching Ultra
Mirage and testifying as to how the Wayback Machine works and its reliability.
1 Reference to 35 U.S.C. §§ 102 and 103 throughout this Petition are to the pre-
AIA versions of these statutes, which are applicable to the ’931 Patent.
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
12
Ex. 1103 at 1–2; see also EMC Corp. v. Personalweb Techs., LLC, IPR2013-
00084, Paper No. 64 at 45 (PTAB May 15, 2014).
The prior art status of Ultra Mirage is further supported by the declaration of
Jason Eaton, P.E. (Ex. 1113), explaining that a person of skill in the art would have
kept informed about CPAP products on the market and would have visited the
websites of well-known companies providing CPAP products, such as ResMed.
Ex. 1113 ¶¶ 48–50.
Because Ultra Mirage was available to the public more than one year before
the earliest possible priority date of the ’931 Patent, Ultra Mirage is prior art under
35 U.S.C. § 102(b).
c. U.S. Publication No. 2007/0044804 (“Matula-II”) (Ex. 1105)
Matula-II published on March 1, 2007. Ex. 1105 at 1. Because Matula-II
published more than one year before the earliest possible priority date of the ’931
Patent, it is prior art under 35 U.S.C. § 102(b).
d. FlexiFit Series, HC 431 Full Face Mask, Instructions for
Use (“FlexiFit”) (Ex. 1106 at 9–10)
FlexiFit was publicly available by at least October 16, 2006. Ex. 1113 ¶ 51;
Ex. 1106 at 5, 8, 11. The authenticity of FlexiFit is established by the
accompanying affidavit of Christopher Butler, attaching FlexiFit and testifying as
to how the Wayback Machine works and its reliability. Ex. 1106 at 1–2; see EMC
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
13
Corp., Paper No. 64 at 45. The Wayback Machine shows that the public had
access to a Fisher & Paykel webpage containing links to FlexiFit by at least
October 16, 2006. Ex. 1106 at 5, 8, 11.
The authenticity and public availability of FlexiFit is further supported by
Fiona Cresswell, testifying to personal knowledge that the documents are authentic
and were available. Ex. 1116 at 1–4; see EMC Corp., Paper No. 64 at 45. Ms.
Cresswell, a Fisher & Paykel employee, confirmed that: (1) Fisher & Paykel made
.PDF files of the most recent marketing materials and instructions for use (“IFUs”)
for its products available for public download by visitors to the website through
hyperlinks on the product webpages; (2) she has personally directed customers,
potential customers, business partners, alliances, and others to Fisher & Paykel’s
website when they asked for additional information; and (3) she has personal
knowledge of and recognizes FlexiFit and confirms that the document control
number and revision letter published thereon indicate that these IFUs were
uploaded to the webpage before October 2006 and were the current revision as of
April 6, 2005. Ex. 1116 at 1–4.
The prior art status of FlexiFit is further supported by the declaration of
Jason Eaton, P.E. (Ex. 1113), explaining that a person of skill in the art would have
kept informed about CPAP products on the market and would have visited the
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
14
websites of well-known companies providing CPAP products, such as Fisher &
Paykel. Ex. 1113 ¶¶ 48–50.
Because FlexiFit was available to the public more than one year before the
earliest possible priority date of the ’931 Patent, FlexiFit is prior art under
35 U.S.C. § 102(b).
e. U.S. 6,412,488 (“Barnett”) (Ex. 1107)
Barnett issued on July 2, 2002. Ex. 1107 at 1. Because Barnett issued more
than one year before the earliest possible priority date of the ’931 Patent, it is prior
art under 35 U.S.C. § 102(b).
f. U.S. Publication No. 2004/0226566 (“Gunaratnam-II”) (Ex.
1110)
Gunaratnam-II published on November 18, 2004. Ex. 1110 at 1. Because
Gunaratnam-II published more than one year before the earliest possible priority
date of the ’931 Patent, it is prior art under 35 U.S.C. § 102(b).
g. U.S. 6,851,425 (“Jaffre”) (Ex. 1112)
Jaffre issued on February 8, 2005. Ex. 1112 at 1. Because Jaffre issued as a
patent more than one year before the earliest possible priority date of the ’931
Patent, it is prior art under 35 U.S.C. § 102(b).
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
15
2. Grounds
Fisher & Paykel requests inter partes review of Claims 43, 46, 48–51, 53–
58, 60–65, 68–71, and 77–79 of the ’931 Patent. Because ResMed claimed a
laundry list of many well-known features in its many lengthy patent claims, this
petition necessarily includes several different prior art references that disclose
those various common features. The grounds below are not overlapping in that
each challenged claim of the ‘931 patent is subject to only one ground of
unpatentability.
Ground #1. Claims 57, 58, 61, 65, 68, 69, 71, and 77–79 would have been
obvious over D’Souza in view of Ultra Mirage, Barnett, and Matula-II under
35 U.S.C. § 103.
Ground #2. Claim 60 would have been obvious over D’Souza in view of
Ultra Mirage, Barnett, Matula-II, and FlexiFit under 35 U.S.C. § 103.
Ground #3. Claims 62–64 would have been obvious over D’Souza in view
of Ultra Mirage, Barnett, Matula-II, FlexiFit, and Gunaratnam-II under
35 U.S.C. § 103.
Ground #4. Claims 43, 48–50, and 70 would have been obvious over
D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, and Matula-II under
35 U.S.C. § 103.
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
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Ground #5. Claims 46, 51, and 53–56 would have been obvious over
D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II, and
Gunaratnam-II under 35 U.S.C. § 103.
C. Claim Construction (37 C.F.R. § 42.104(b)(3))
The claims of the ’931 Patent should be accorded their “broadest reasonable
construction” in light of the specification of the ’931 Patent.2
37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79
(Fed. Cir. 2015), aff’d, 136 S. Ct. 2131 (2016). All terms have their ordinary and
customary meaning in light of the specification, as commonly understood by those
of ordinary skill in the art at the time of the invention. In re Translogic Tech., 504
F.3d 1249, 1257 (Fed. Cir. 2007).
V. THE ’931 PATENT
A. Example Embodiments
The ’931 Patent discloses a CPAP mask system 1010 having a frame 1040
that supports a cushion 1060 and attaches to the shroud 1020, as illustrated in Fig.
3 on the next page. Ex. 1101 at col. 6:51–54; Figs. 1–5. The frame 1040 defines a
breathing chamber and includes an opening 1046 that communicates with the 2 Petitioner’s position regarding the scope of the claims should not be taken as an
assertion regarding the appropriate claim scope in other adjudicative forums where
a different standard of claim construction and/or claim interpretation may apply.
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
17
elbow 1070. Id. at col. 6:60–65. The frame 1040 includes a vent arrangement
1076 for gas washout. Id. at 65-66. The shroud 1020 is structured to removably
attach to headgear and includes a vent receiving hole 1021 to accommodate the
vent arrangement 1076 that protrudes from the frame 1040. Id. at col. 7:9–23. The
bottom of the shroud 1020 includes an elbow hole 1032 to allow access for the
elbow 1070 to the frame 1040. Id. at col. 7:23–25.
Upper headgear connectors 1024 extend from each side of the top portion of
the shroud and lower headgear connectors 1025 extend from each side of the lower
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
18
portion. Id. at col. 7:28–30. Each lower headgear connector 1025 includes a clip
receptacle 1031 at the free end of the arm that interlocks with a headgear clip on a
headgear strap. Id. at col. 8:29–32.
As shown in Fig. 9 above, the headgear 1090 includes a pair of upper and
lower straps 1092, 1094. The upper and lower straps 1092, 1094 can be removably
attached to the upper and lower headgear connectors 1024, 1025. Id. at col. 10:41–
45. The free end of each strap can include a Velcro® tab that allows adjustment of
the length of the straps. Id. at col. 10:45–49. Upper straps 1092 split into top
straps 1096 that pass over the top of the patient’s head and can be connected by a
buckle (not shown). Id. at col. 10:52–59.
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
19
As shown in Figs. 11 and 14 above, the shroud can be connected to the
frame by a lower retaining mechanism at the opening of the shroud 1132. Id. at
col. 18:48–53. The opening 1132 of the shroud 1120 includes snap fingers 1145(1)
that resiliently deflect and engage the collar 1149 to removably retain the shroud
1120 to the frame 1140. Id. at col. 18:62–67.
B. Summary of the Prosecution History of the ’931 Patent
The ’931 Patent was originally filed as U.S. Application No. 14/447,673 on
July 31, 2014.
On December 8, 2014, the Examiner issued a rejection of all pending claims
based on U.S. Publication No. 2006/0272646 (“Ho”) in view of other prior art
references. Ex. 1114 at 244–255. The Examiner also rejected all of the pending
claims on the ground of nonstatutory double patenting. Id. at 252–254. None of
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
20
those pending claims are being challenged in this petition, but in response, the
Applicant added Claim 22–33 (of which Claim 30 corresponds to issued Claim
43). Id. at 320–324.
On February 3, 2015, the Examiner issued a final rejection of almost all of
the pending claims based on U.S. Publication No. 2006/0042629 (“Geist”) in view
of other prior art references. Id. at 343–361. The Examiner also indicated that
Claims 29 and 33 would be allowable if rewritten in independent form. Id. at 359.
With respect to Claim 30 (now Claim 43), applicant argued against the
combination of cited references. Id. at 449–450. Applicant also added Claims 34–
83, which recite different permutations of the previously pending claims. Id. at
436–446. The Examiner issued a notice of allowability on July 15, 2015. Id. at
465–472.
VI. LEVEL OF ORDINARY SKILL IN THE ART
A person having ordinary skill in the field at the time of the purported
invention of the ’931 Patent would have at least a bachelor’s degree in mechanical
engineering, biomedical engineering or other similar type of engineering degree
combined with at least two years of experience in the field of masks, respiratory
D’Souza does not expressly disclose upper headgear connectors, but Ultra
Mirage teaches a shroud having a forehead support with upper and lower headgear
connectors, as shown on the next page. Ex. 1103 at 6. As explained in the
Reasons to Combine below, a skilled artisan at the time of the invention would
have been motivated to provide upper headgear connectors as taught by Ultra
Mirage to the forehead support of D’Souza. Ex. 1113 ¶ 63; see § VII(B)(6), infra.
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
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Additionally, to the extent the removability of the headgear in D’Souza is
unclear, Ultra Mirage discloses this feature as shown above. Ex. 1103 at 6. Ultra
Mirage discloses, “Quick release headgear clips: top and bottom allows mask to be
removed without resetting the headgear and provides convenience and safety.” Id.
b. “elbow”
Claim 57 includes “a rotatable elbow directly attached to the shroud.” Claim
61 depends from Claim 57 and further includes, “the elbow is adapted to be
connected to an air delivery tube that delivers breathable gas to the patient.”
D’Souza discloses mask assemblies for use with a flow generator and
adapted to engage an elbow, but does not expressly disclose a rotatable elbow
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
31
directly attached to the shroud or the elbow being connected to an air delivery tube.
Ex. 1102 ¶¶ 3 & 100. However, as taught by Ultra Mirage and shown below, it
was well-known at the time of the invention to include a 360° rotating elbow on a
CPAP mask to provide control over a tubing system. Ex. 1103 at 6; Ex. 1113 ¶ 66.
Additionally, as shown in Figs. 1A–1B (below), Barnett discloses an elbow
36 that is mounted to the shroud 34 and freely rotates over a range of 360° in
direction A. Ex. 1107 at col. 3:52–57. As explained in the Reasons to Combine
below, a person of skill in the art at the time of the invention would have been
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
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motivated to attach the elbow directly to the shroud as taught by Barnett while
allowing 360° rotation of the elbow module. Ex. 1113 ¶ 67; see § VII(B)(6), infra.
c. “removably snap-fit”
Claim 57 includes “the shroud module and the cushion module are
structured and arranged to be removably snap-fit attached to one another by
moving the shroud module and the cushion module towards one another along the
longitudinal axis,” and “the shroud module includes a retaining portion positioned
rearwardly of the front opening, towards the frame, and structured to snap fit with
the cushion module.”
D’Souza expressly discloses that the shroud and frame are adapted to
removably interlock, and a person of skill would understand that this assembly
comprises a removable snap-fit with elastic deformation and a release into the
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
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interlocked position. Ex. 1102 ¶¶ 96 & 100; Ex. 1113 ¶¶ 69–70. As shown in Fig.
8 of D’Souza (below), the collar 440 passes through the retaining portion 448 and
removably interlocks with the retaining portion 448 in a snap-fit manner. Ex. 1113
¶ 70.
To the extent D’Souza provides insufficient teachings for a snap-fit, such
removable snap-fit arrangements were common and well-known in CPAP masks.
Ex. 1113 ¶¶ 69–72. For example, Matula-II teaches a plurality of snap fingers 48
that facilitate elastic deformation to mechanically and removably couple the seal
member 38 to the faceplate 36. Ex. 1105 ¶ 53. Based on the teachings of Matula-
II, a skilled artisan would have been motivated to incorporate such snap fingers
into the removable interlocking arrangement of D’Souza. Ex. 1113 ¶¶ 71–72; see
§ VII(B)(6), infra.
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
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d. “protruding vent”
Claim 65 depends from Claim 57 and further includes “the frame includes a
protruding vent arrangement having a plurality of gas washout holes, wherein the
shroud module includes an upper opening to accommodate said protruding vent
arrangement.” As shown in Figs. 7–8 of D’Souza (below), when the mask
assembly 410 is assembled, the top portion 431 (nasal bridge region) of the frame
414 protrudes through the opening (between the elongated frame members 450) in
the shroud 412. Ex. 1102 ¶ 101.
D’Souza does not expressly disclose a vent on the protrusion. However,
vents positioned in the region of the D’Souza protrusion (nasal bridge region) were
common in prior art CPAP masks. Ex. 1113 ¶ 74. For example, as shown below,
Ultra Mirage teaches an air vent positioned in the nasal bridge region of the mask
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
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assembly to provide CO2 washout and minimize noise output. Ex. 1103 at 6. As
explained in the Reasons to Combine, a skilled artisan at the time of the invention
would have been motivated to provide the vent of Ultra Mirage in the same nasal
bridge region of D’Souza, and thus on the protruding portion of D’Souza. Ex.
1113 ¶¶ 74, 90; see § VII(B)(6), infra.
e. “one or more folds”
Claim 68 depends from Claim 57 and further includes “a nasal bridge
portion of the cushion includes one or more folds to provide in use a higher level
of adaptability or flexibility to the nasal bridge region of the cushion module
Fisher & Paykel Healthcare Petition – IPR of U.S. Pat. 9,119,931
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relative to another region of the cushion module.” D’Souza does not expressly
disclose a fold, but as shown below, Matula-II discloses a fold 106 in the nasal
bridge portion of the cushion 38 to provide “the desired degree of flexibility.” Ex.
1105 ¶ 66.
Claim 68 also includes “each of said one or more folds comprises adjacent
first side walls interconnected by a second side wall.” The ’931 Patent shows each
fold having adjacent first side walls 52(1) interconnected by a second side wall
52(2), as illustrated on the next page in the annotated Fig. 32-3. Ex. 1101 at col.
14:40–42.
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As shown in Fig. 4 below, Matula-II teaches a similar fold 106 having first
side walls interconnected by a second side wall. Ex. 1113 ¶ 77.
First side walls
Second side wall
Second side wall
First side wall First side wall
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f. “plurality of snap fingers”
Claim 69 depends from Claim 57 and further includes “the retaining portion
of the shroud includes a plurality of snap fingers structured to engage the collar
with a snap-fit.”
As shown in Fig. 7 of D’Souza (below), the frame 414 has a collar 440
surrounding the opening 418. Ex. 1102 ¶ 98. The shroud 412 includes a retaining
portion 448 structured to engage and interlock with the collar 440. Id. ¶ 101.
As explained above, because the assembly of the interlocking portions of the
D’Souza shroud and frame requires elastic deformation of one or both components
for the larger diameter collar 440 to pass through the smaller diameter retaining
portion 448, the resulting interlocking is a snap-fit. Ex. 1102 ¶¶ 98 & 100; Ex.
1113 ¶ 81. As shown in Fig. 8 of D’Souza (above), the collar 440 snaps into
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interlocked position on the front edge of the retaining portion 448. Ex. 1113 ¶ 81.
D’Souza does not expressly disclose a plurality of snap fingers, but such snap
fingers were common in prior art CPAP masks. Id. ¶ 82. For example, as shown
in Fig. 4 and the partial view of Fig. 5 (below), Matula-II discloses a “pair of
prongs 48” structured to mechanically couple the seal member 38 to the faceplate
36. Ex. 1105 ¶ 53. Because the faceplate 36 of Matula-II is semi-rigid, the snap-
fingers 48 deflect radially inward and elastically recover to mechanically couple
the seal member 38 to the faceplate 36 with a snap-fit. Id. ¶ 51; Ex. 1113 ¶ 82.
FIG. 4 FIG. 5 (PARTIAL)
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g. “each of the shroud module and the frame comprise
polycarbonate”
Claim 71 depends from Claim 57 and further includes “each of the shroud
module and the frame comprise polycarbonate and the cushion comprises
silicone.” D’Souza discloses a cushion 416 constructed of liquid silicone rubber
and a frame 414 constructed of polycarbonate. Ex. 1102 ¶¶ 97–98. D’Souza
further discloses the shroud being formed of plastic, but does not expressly
disclose that the plastic is polycarbonate. Id. ¶ 100. However, it was common at
the time of the invention to construct CPAP components, including the shroud,
from polycarbonate. Ex. 1113 ¶ 84.
6. Reasons to Combine
Based on the teachings of the prior art, a person of skill in the art at the time
of the invention would have been motivated to provide each of the features
discussed above. See supra § VII(B)(5); see also KSR, 550 U.S. at 419. Such
modifications would have been mere combinations of familiar elements according
to known methods that do no more than yield predictable results. KSR, 550 U.S. at
416. Because D’Souza, Ultra Mirage, Barnett, and Matula-II all teach CPAP
masks for the treatment of sleep disordered breathing, the features taught in Ultra
Mirage, Barnett, and Matula-II would have been readily compatible with and easily
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incorporated into the mask of D’Souza with a reasonable expectation of success.
Ex. 1113 ¶ 85.
A person of skill in the art at the time of the invention would have been
motivated to provide removable headgear straps to the mask assembly of D’Souza
to enable quick and easy mask fitting and removal (e.g., for cleaning or
replacement). Ex. 1103 at 6; Ex. 1113 ¶ 86. Additionally, a skilled artisan would
have known to add upper headgear connectors as taught by Ultra Mirage to the
forehead support of D’Souza to secure the upper portion of the mask and to
stabilize the mask assembly. Ex. 1113 ¶ 86.
As explained above with respect to Ultra Mirage, it was well-known at the
time of the invention to provide an elbow that is rotatable over a 360° range to
provide control over the tubing. Ex. 1103 at 6; Ex. 1113 ¶¶ 87–88. The rotatable
elbow would allow the wearer to position the tubing to provide the most
convenient, comfortable, and low force mask connection. Ex. 1113 ¶ 87.
Additionally, a skilled artisan would have been motivated to directly attach
the elbow to the shroud as taught in Barnett to make it easier to detach the elbow
without affecting the engagement of the mask components. Id. ¶ 89. Attaching the
elbow directly to the shroud instead of the frame would have also provided more
design flexibility. Id. A skilled artisan would have understood that it would be
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easier to attach the elbow to a shroud than a component of the breathing chamber
because the breathing chamber requires an air tight seal. Id.
A skilled artisan would have also known to modify D’Souza to include a
vent as taught by Ultra Mirage for CO2 washout. Ex. 1103 at 6; Ex. 1113 ¶¶ 90–
91. A skilled artisan would have recognized the benefits in positioning the vent on
the protruding portion of the frame to minimize noise output. Ex. 1103 at 6; Ex.
1113 ¶ 90. Additionally, a person of skill would have been motivated to place the
vent in the nasal bridge region to minimize dead space and because air from the
inlet would flow by the patient’s nose and exit the vent to flush exhaled air
effectively and minimize re-breathing of exhaled air. Ex. 1113 ¶ 90.
Additionally, a skilled artisan would have known to incorporate the folds
taught by Matula-II with the D’Souza cushion to provide a higher degree of
flexibility in the delicate nose bridge region compared to other regions. Ex. 1105
¶ 66; Ex. 1113 ¶ 92.
To the extent D’Souza provides insufficient teachings for a removable snap-
fit between the shroud and the cushion module, a person of skill in the art at the
time of the invention would have been motivated to modify the retaining portion of
D’Souza to include the plurality of snap fingers to make it easier to join the shroud
to the cushion module. Ex. 1113 ¶¶ 93–94. Based on the teachings of Matula-II, a
skilled artisan would have understood that it would be advantageous to provide a
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plurality of snap-fit fingers on the retaining portion of D’Souza to facilitate
repeated insertion of the collar 440 through the rigid retaining portion 448 without
destroying the parts. Id. Although the Matula-II snap fingers are on the elbow,
incorporating such snap fingers in the retaining portion of D’Souza would have
involved a simple substitution of one known feature for another to obtain
predictable results and achieve the same purpose of providing a removable
mechanical interlock between the shroud and the cushion module. See KSR, 550
U.S. at 416; Ex. 1102 ¶ 96.
Further, it was well-known at the time of the invention to construct CPAP
mask components, including the shroud, from polycarbonate to provide good
mechanical properties of strength, rigidity, and toughness to support the headgear.
Ex. 1113 ¶ 95. Polycarbonate CPAP components can also be cleaned, disinfected,
and/or sterilized by most commonly used methods. Id.
C. Ground #2: Claim 60 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, and FlexiFit
1. Overview of FlexiFit (Ex. 1106)
FlexiFit was not submitted during the prosecution of the ’931 Patent. Ex.
1101 at 1–12.
As shown below, FlexiFit shows headgear (K) removably coupleable to
mask base (A). Ex. 1106 at 10 (“FITTING YOUR MASK”). The headgear (K)
has upper horizontal straps and lower horizontal straps. Id. The upper horizontal
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straps split to form a pair of top crown straps and rear straps that form a closed
loop. Id. The headgear straps have Velcro® tabs. Id. at 10 (“ASSEMBLING
YOUR MASK”).
Lower Horizontal
Straps
Upper Horizontal
Straps
Top Crown Straps Closed Loop
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As shown in Figs. 3–5 of FlexiFit (below), the upper horizontal straps attach
to corresponding slots in the mask base (A). Id. at 10 (“ASSEMBLING YOUR
MASK”). The lower headgear straps are secured to headgear clips (H), which
attach to GliderTM strap (E). The upper and lower horizontal straps and top crown
straps can be re-adjusted to prevent leaks between the mask and the user. Id. at 10
(“FITTING YOUR MASK”).
2. Potential Differences from the Prior Art
a. “each upper headgear connector includes a slot”
Claim 60 depends from Claim 57 and further includes “each upper headgear
connector includes a slot adapted to receive a respective headgear strap in use,”
and “each lower headgear connector is adapted to be removably interlocked with a
headgear clip associated with a respective headgear strap.” As explained above,
the combination of D’Souza and Ultra Mirage teaches a mask assembly with upper
headgear connectors. See supra § VII(B)(5)(a). D’Souza does not expressly
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disclose upper headgear connector slots, and Ultra Mirage shows the slots on
headgear clips. However, as shown on the previous page in Fig. 3, FlexiFit
discloses attaching top horizontal straps to corresponding slots in the Mask Base.
Ex. 1106 at 10 (“ASSEMBLING YOUR MASK”); Ex. 1113 ¶ 97.
D’Souza discloses lower headgear connectors adapted to engage clips, but to
the extent D’Souza provides insufficient teachings for the removability of the clips,
Ultra Mirage and FlexiFit both disclose removable lower headgear clips. Ex. 1102
¶ 100; Ex. 1103 at 6; Ex. 1106 at 10 (“FITTING YOUR MASK”).
3. Reasons to Combine
A person of skill in the art at the time of the invention would have been
motivated to combine the features of D’Souza, Ultra Mirage, Barnett, Matula-II,
and FlexiFit to arrive at the claimed mask systems of Claim 60 for at least the
reasons provided above. Ex. 1113 ¶ 100; see supra §§ VII(B)(6).
Additionally, a person of skill in the art would have been motivated to
provide the combination of upper headgear connectors having slots and lower
headgear connectors adapted to engage headgear clips as taught by FlexiFit. Ex.
1106 at 10; Ex. 1113 ¶ 101. When headgear is pulled over a user’s head, the lower
headgear straps undergo tension, making it difficult to properly position or remove
the lower headgear straps. Ex. 1113 ¶ 101. At the time of the invention, a skilled
artisan would have been motivated to provide lower headgear clips with removable
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clips as taught by FlexiFit, so that the user would not have to force the lower
headgear straps over his/her head. Id. Since upper headgear straps do not undergo
as much tension as the lower headgear straps when positioning the mask assembly,
a skilled artisan would have known that a simpler design option would have been
to provide upper headgear connectors with slots as taught by FlexiFit and that such
an alternative arrangement would simplify manufacturing and reduce parts. Id.
Because D’Souza, Ultra Mirage, Barnett, Matula-II, and FlexiFit all teach
similar CPAP masks for the treatment of sleep disordered breathing, the features
taught in Ultra Mirage, Barnett, Matula-II, and FlexiFit would have been readily
compatible with and easily incorporated into the mask of D’Souza with a
reasonable expectation of success. Ex. 1113 ¶ 100.
D. Ground #3: Claims 62–64 would have been obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, FlexiFit, and Gunaratnam-II
1. Overview of Gunaratnam-II (Ex. 1110)
The Examiner cited Gunaratnam-II during prosecution, but for a different
feature and as a secondary reference. Ex. 1101 at 6; Ex. 1114 at 358–359.
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Gunaratnam-II discloses nasal assemblies having headgear. Ex. 1110 at
Abstract. As shown in Fig. 135 (above), Gunaratnam-II discloses headgear having
a pair of top straps and rear straps. Id. at Fig. 135. The top straps are removably
and adjustably coupled with a buckle. Id. ¶ 316.
2. Potential Differences from the Prior Art
a. “headgear”
As detailed in the Claim Chart below, Claim 62 depends from Claim 57 and
recites various headgear features.
As explained above, the combination of D’Souza and Ultra Mirage teaches
headgear connectors adapted to removably attach to respective headgear straps and
upper and lower headgear connectors. See supra § VII(B)(5)(a). D’Souza and
Ultra Mirage do not expressly disclose the specific headgear configuration recited
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in Claim 62, but as shown in the annotated figure below, FlexiFit teaches headgear
(K) having the above-mentioned features. Ex. 1106 at 10 (“FITTING YOUR
MASK” & “ASSEMBLING YOUR MASK”).
FlexiFit discloses adjustable upper and lower headgear straps, top crown
straps configured to pass over the top of the patient’s head, and rear straps adapted
to pass behind the patient’s head. Id. at 10 (“ASSEMBLING YOUR MASK”). As
shown in the figure below, the upper straps split to form the pair of top crown
straps and the pair of rear straps. Id.
Additionally, FlexiFit discloses Velcro® tabs on the straps. Id. at 10
(“FITTING YOUR MASK”). To the extent there is insufficient teaching that the
Velcro® tabs are positioned at the free ends of the straps, such positioning would
Top Crown Straps
Rear Straps
Lower Straps
Upper Straps
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have been obvious to a person of skill in the art and typical for headgear straps in
prior art. Ex. 1113 ¶ 106.
Gunaratnam-II also discloses a pair of top straps removably and adjustably
threaded through a buckle, as shown in Fig. 135 (below). Ex. 1110 ¶ 316 & Fig.
135; Ex. 1113 ¶ 107. Gunaratnam-II discloses that each top strap is wrapped
around a respective cross-bar associated with the buckle. Ex. 1110 ¶ 316.
b. “upper straps provide padding”
Claim 63 includes “the upper straps provide padding to the respective
headgear connectors of the shroud module on the patient’s face in use.”
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As shown in Figs. 2 and 3 (below), FlexiFit teaches flexible headgear straps.
Ex. 1106 at 10.
Additionally, as shown below, FlexiFit shows that a portion of each upper
strap of headgear (K) is sufficiently flexible to extend across the patient-facing side
of the upper headgear connector of the mask frame (A) and loop through the upper
headgear connector, and around to the outside-facing side of the mask frame (A).
Id. A person of skill in the art would have recognized that the flexible headgear
strap between the upper headgear connector and the user’s face provides padding.
Ex. 1113 ¶ 110.
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c. “rear straps and the top straps form a closed loop”
Claim 64 includes “the rear straps and the top straps form a closed loop to
encircle a rear portion of the patient’s head when in use.” As shown below,
FlexiFit teaches the rear straps and the top straps forming a closed loop. Ex. 1106
at 10; Ex. 1113 ¶ 111.
3. Reasons to Combine
A person of skill in the art at the time of the invention would have been
motivated to combine the features of D’Souza, Ultra Mirage, Barnett, Matula-II,
FlexiFit, and Gunaratnam-II to arrive at the claimed mask systems of Claims 62–
Closed Loop
Top Crown Straps
Rear Straps
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64 for at least the reasons provided above. Ex. 1113 ¶ 112; see supra §§ VII(B)(6),
VII(C)(3).
Further, D’Souza and Ultra Mirage disclose CPAP mask assemblies adapted
to engage headgear, and FlexiFit and Gunaratnam-II disclose headgear. Ex. 1113
¶¶ 113–114. As explained above, FlexiFit teaches each of the headgear features
recited in Claims 60–64. As shown in the annotated drawings below, the mask
assembly of D’Souza as modified by Ultra Mirage teaches a mask assembly with
upper and lower connectors that would be compatible with the upper and lower
straps of the FlexiFit headgear. Id. ¶ 113.
FlexiFit (partial) D’Souza (rotated) Ultra Mirage
A person of skill in the art would have recognized the benefits of using the
FlexiFit headgear in connection with upper headgear connectors. Doing so would
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provide padding between the upper headgear connectors and the user’s face to
provide comfort, without increasing the number of components. Id. ¶¶ 110, 114.
Further, a skilled artisan at the time of the invention would have been motivated to
provide a headgear configuration with a rear loop, as taught by FlexiFit, to stabilize
the upper and lower straps, while minimizing the total amount of material required
for the headgear. Id. ¶ 114. A skilled artisan would have also known to join the
top crown straps of the FlexiFit headgear using a buckle as taught by Gunaratnam-
II to allow for adjustment and to maintain the straps in a desired position. Ex.
1110 ¶ 316; Ex. 1113 ¶ 115.
These modifications would have been a mere combination of familiar
elements according to known methods that does no more than yield predictable
results. KSR, 550 U.S. at 416.
E. Ground #4: Claims 43, 48–50, and 70 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, and Matula-II
1. Overview of Jaffre (Ex. 1112)
Jaffre was submitted during the prosecution of the ’931 Patent, but was not
cited by the Examiner. Ex. 1101 at 5.
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Jaffree discloses CPAP devices having an exhaust port assembly. Ex. 1112
at col. 1 at 13–33. As shown in Figs. 8–9 (above), the exhaust port assembly 62
includes an auxiliary opening 88 with a valve member 68. Id. at col. 10:11–14.
When the pressure system is functioning properly, a cantilevered member 90 of the
valve member 68 flexes to block the opening 88 (see Fig. 8). Id. at col. 10:14–17.
If the pressure of the gas in the interior 92 is not greater than ambient atmosphere,
cantilever member 90 returns to its normal position and unblocks auxiliary opening
88 so that the patient has access to ambient atmosphere (see Fig. 9). Id. at col.
10:23–28.
2. Potential Differences from Prior Art
As detailed in the Claim Chart below, D’Souza discloses nearly all of the
limitations of Claims 43, 48–50, and 70. Any differences were well-known at the
time of the invention and taught by other prior art CPAP masks. Ex. 1113 ¶ 117.
For example, as discussed above with respect to Claims 57, 60–62, and 65, the
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combination of D’Souza, Ultra Mirage, FlexiFit, Barnett, and Matula-II teaches
most of the features of Claims 43, 48–50, and 70. See supra §§ VII(B)–VII(D).
a. “the elbow including a swivel”
Claim 43 further includes “the elbow including a swivel adapted to connect
to an air delivery tube.” D’Souza discloses an elbow adapted to engage the mask,
but does not expressly disclose the elbow including a swivel. Ex. 1102 ¶ 100.
However, as shown below, Ultra Mirage does.
Ultra Mirage specifically discloses a 360° rotating elbow having a “[q]uick
release swivel [that] allows easy disconnection from tubing.” Ex. 1103 at 6.
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b. “anti-asphyxia valve”
Claim 43 includes “the elbow including an anti-asphyxia valve (AAV) and a
port that is selectively closed by a flap portion of the AAV.” Claim 70 depends
from Claim 57 and further incudes “the elbow includes an anti-asphyxia valve and
wherein the anti-asphyxia valve includes a flap portion adapted to selectively close
a port provided in the elbow.”
D’Souza discloses a mask assembly adapted to engage an elbow and Ultra
Mirage discloses a safety valve in the elbow, but Ultra Mirage does not expressly
disclose that the valve includes a flap portion. Ex. 1102 ¶ 100; Ex. 1103 at 6.
However, such valve assemblies in CPAP elbows were well-known prior to the
’931 Patent. Ex. 1113 ¶ 121. As shown in Figs. 8–9 of Jaffre (below), the valve
has a flap portion 68 that selectively closes port 88. Ex. 1112 at col. 10:14–28.
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3. Reasons to Combine
A person of skill in the art at the time of the invention would have been
motivated to combine the features of D’Souza, Ultra Mirage, FlexiFit, Barnett,
Jaffre, and Matula-II to arrive at the claimed mask features of 43, 48–50, and 70
for at least the reasons provided above. Ex. 1113 ¶ 122; see supra §§ VII(B)(6),
VII(C)(3), VII(D)(3).
Based on the teachings of Ultra Mirage, a person of skill in the art would
have been further motivated to provide an elbow with a swivel to facilitate easy
adjustment and disconnection from tubing. Ex. 1103 at 6; Ex. 1113 ¶ 123.
Additionally, a person of skill in the art would have been motivated to
provide the anti-asphyxia valve of Jaffre to the D’Souza elbow to allow patients to
breathe fresh air when the flow generator does not provide flow. Ex. 1103 at 6;
Ex. 1109 ¶ 106; Ex. 1113 ¶ 124. A skilled artisan would understand that an anti-
asphyxia valve using a flap is advantageous because the flap easily moves by
airflow and pressure. Ex. 1113 ¶ 125.
F. Ground #5: Claims 46, 51, and 53–56 would have been obvious over D’Souza in view of Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II, and Gunaratnam-II
1. Potential Differences from the Prior Art and Reasons to Combine
As detailed in the Claim Chart below, D’Souza discloses nearly all of the
limitations of Claims 46, 51, and 53–56. Any differences were well-known at the
time of the invention and taught by other prior art CPAP masks. Ex. 1113 ¶ 126.
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For example, as discussed above with respect to Claims 43, 62, 63, 65, and 69, the
combination of Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II, and Gunaratnam-
II teach the potentially different features. See supra §§ VII(B)–VII(E). A person
of skill in the art at the time of the invention would have been motivated to
combine the features of D’Souza, Ultra Mirage, FlexiFit, Barnett, Jaffre, Matula-II,
and Gunaratnam-II to arrive at the claimed mask features of Claims 46, 51, and
53–56 for at least the reasons provided above. Id. ¶ 127; see supra §§ VII(B)(6),
VII(C)(3), VII(D)(3); VII(E)(3). Additionally, combining these features would
have been a mere combination of familiar elements according to known methods
that does no more than yield predictable results. KSR, 550 U.S. at 416.
VIII. CLAIM CHART
’931 Patent Prior Art 43. A mask system for delivery of a supply of air at positive pressure to a patient's airway, the mask system comprising:
D’Souza: “[M]ask assembl[ies] for use with blowers and flow generators in the treatment of sleep disordered breathing (SDB) . . . . [P]atient interface is held in a sealing position by headgear so as to enable a supply of air at positive pressure to be delivered to the patient's airways.” Ex. 1102 ¶ 3.
[A] a cushion module comprising a frame defining a
breathing chamber configured to receive the positive pressure air, and
a cushion to form a seal with the patient's face in a nasal bridge
D’Souza: “[F]rame 414 and a cushion 416 are . . . interlocked to provide a cushion/frame sub-assembly 430. . . . [C]ushion 416 is constructed of liquid silicone rubber (LSR).” Ex. 1102 ¶ 97. “[F]rame 414 includes an upper wall that provides an opening 418 for communicating with an inlet conduit. . . . A side wall 420 extends from the upper wall . . . . [F]rame 414 is constructed of polycarbonate.” Id. ¶ 98.
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region, a cheek region and a lower lip/chin region of the patient's face,
wherein the cushion is constructed of a first, relatively soft, elastomeric material and the frame is constructed of a second material that is more rigid than the cushion,
“[C]ushion provides a seal around the patient's nose and mouth to enable the delivery of breathable gas to the patient's nose and mouth.” Id. ¶ 81.
[B] the frame including a washout vent,
Ultra Mirage: “Air vent provides excellent CO2 washout and minimal noise output.” Ex. 1103 at 6.
[C] the frame including an opening;
D’Souza: “[A]nnular elbow connection seal 448 interlocks with the annular wall 440.” Ex. 1102 ¶ 101.
[D] headgear to maintain the mask
D’Souza: “[P]atient interface is held in a sealing position by headgear.” Ex. 1102 ¶ 3.
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system in a desired position on the patient's face, the headgear comprising a pair of upper headgear straps each configured to extend above a respective one of the patient's ears in use and a pair of lower headgear straps each configured to extend below a respective one of the patient's ears in use,
“[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446 adapted to be engaged with clips provided to straps of a headgear assembly (not shown).” Id. ¶ 100. Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.
FlexiFit: “Gently adjust the Top Horizontal straps then the Lower Horizontal straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”). “[A]ttach the four straps in to the corresponding slots in the Mask Base and the GliderTM strap (E).” Id. at 10 (“ASSEMBLING YOUR MASK”).
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[E] wherein a free end of each of the upper headgear straps and the lower headgear straps includes a hook tab structured to engage a remainder of the respective upper headgear strap and respective lower
FlexiFit: “Gently adjust the Top Horizontal straps then the Lower Horizontal straps . . . . If leaks occur . . . tighten the top horizontal straps. . . . If leaks occur . . . tighten the lower horizontal straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”). “[A]ttach the four straps in to the corresponding slots in the Mask Base and the GliderTM strap (E). This can be done without undoing the Velcro® Tabs by sliding the Headgear into the slots.” Id. at 10 (“ASSEMBLING
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headgear strap to secure the upper and lower straps in place in a length adjustable manner,
YOUR MASK”).
[F] wherein the headgear includes a pair of top straps and a pair of rear straps, each said top strap being configured to extend from generally above a respective ear of the patient such that the top straps cross over the top of the patient's head in use, the rear straps being adapted to pass behind the patient's head in use, and
FlexiFit: “Gently adjust . . . Top Crown straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”).
[G] wherein the rear straps and the top straps together at least partly form a closed loop to encircle a rear portion of the patient's head when
FlexiFit: Ex. 1106 at 10.
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in use;
[H] a shroud module including headgear connectors adapted to removably attach to the headgear,
D’Souza: “[S]keleton frame 412 includes . . . lower headgear clip receptacles 446 adapted to be engaged with clips provided to straps of the headgear assembly (not shown).” Ex. 1102 ¶ 100.
Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.
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[I] wherein the headgear connectors include two upper connectors associated with the upper headgear straps,
D’Souza: “[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446.” Ex. 1102 ¶ 100.
Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.
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[J] the shroud module having an opening of circular shape, and two lower connectors associated with the lower headgear straps,
D’Souza: “[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446 . . . .” Ex. 1102 ¶ 100. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440 of the cushion/frame sub-assembly 430. Id. ¶ 101, Fig. 7.
Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.
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[K] each said upper headgear connector including a slot or receiving hole adapted to receive one of the upper headgear straps,
D’Souza: “[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446.” Ex. 1102 ¶ 100.
Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.
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FlexiFit: “[A]ttach the four straps in to the corresponding slots in the Mask Base.” Ex. 1106 at 10 (“ASSEMBLING THE MASK”).
[L] wherein the shroud module and the frame of the cushion module are configured to be removably snap-fit
D’Souza: “[S]keleton frame 412 that is adapted to removably interlock with a cushion/frame sub-assembly 430.” Ex. 1102 ¶ 96. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440 . . . upper support member 444 interlocks with a top portion 431 . .
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attached to one another in a non-rotatable manner by pushing the shroud module towards the frame along a longitudinal axis of both the opening of the frame and the opening of the shroud;
. and the elongated frame members 450 interlock with respective protrusions 442.” Id. ¶ 101.
Matula-II: “Coupling member 46 includes a pair of prongs 48 that define a channel 50 to receive the wall of the faceplate and the end of seal member 38.” Ex. 1105 ¶ 53.
[M] and an elbow rotatably attached to and carried by the shroud module or the frame of the cushion module, the
D’Souza: “[S]keleton frame 412 includes . . . an annular elbow connection seal 448 adapted to engage an inlet conduit, e.g., elbow.” Ex. 1102 ¶ 100. Ultra Mirage: “360° rotating elbow provides control
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elbow being configured to deliver the positive pressure air to the breathing chamber,
over tubing system.” Ex. 1103 at 6.
Barnett: “[C]onduit coupling member 36 is preferably rotateably mounted on a second side of collar 34 . . . so that conduit coupling member 36 freely rotates over a range of 360°.” Ex. 1107 at col. 3:52–57; see also id. at col. 8:66—col. 9:43. “Conduit coupling portion 88 attaches conduit coupling member 36 to a patient circuit 92, . . . which carries a flow of breathing gas generated by a flow generating device 94 . . . to nose receiving cavity 42.” Ex. 1107 at col. 8:49–54.
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[N] the elbow including a swivel adapted to connect to an air delivery tube,
Ultra Mirage: “360° rotating elbow provides control over tubing system.” Ex. 1103 at 6. “Quick release swivel allows easy disconnection from tubing.” Id.
[O] the elbow including Ultra Mirage: “Safety valve allows patient to breathe
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an anti-asphyxia valve (AAV) and a port that is selectively closed by a flap portion of the AAV.
fresh air when flow generator does not provide flow.” Ex. 1103 at 6. Jaffre: “During normal use, where the pressure support system is functioning properly, a cantilever member 90 of valve member 68 flexes, as shown to FIG. 8, to block auxiliary opening 88. . . . If, however, the pressure of the gas in interior 92 is not greater than ambient atmosphere, cantilever member 90 returns to its normal, undeflected position shown in FIG. 9 and unblocks auxiliary opening 88 so that the patient has access to the ambient atmosphere as indicated by arrow H.” Ex. 1112 at col. 10:14–28.
46. The mask system of claim 43, wherein: [A] the elbow is rotatably attached the shroud module,
See supra Claim 43[M].
[B] the upper headgear straps provide padding to the respective headgear connectors of the shroud on the
FlexiFit: Ex. 1106 at 10.
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patient's face in use,
[C] the frame includes a protruding vent arrangement having a plurality of holes, wherein the shroud module includes a first opening to accommodate said protruding vent arrangement,
D’Souza: “[S]keleton frame 412 is engaged with the cushion/frame sub-assembly 430 such that . . . upper support member 444 interlocks with a top portion 431 . . . and the elongated frame members 450 interlock with respective protrusions 442.” Ex. 1102 ¶ 101.
Ultra Mirage: “Air vent provides excellent CO2 washout and minimal noise output.” Ex. 1103 at 6.
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[D] further wherein the shroud module includes a second opening to accommodate the elbow,
See supra Claim 43[M].
[E] the frame includes an opening and the frame further includes a collar surrounding said opening, and wherein the shroud module includes a retaining portion with one or more rearward extending snap fingers structured to engage the collar with a snap-fit, and
D’Souza: “[A]nnular wall 440 surrounds the opening 418 [of the frame 414].” Ex. 1102 ¶ 98. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440.” Id. ¶ 101.
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Matula-II: “Coupling member 46 includes a pair of prongs 48 that define a channel 50 to receive the wall of the faceplate and the end of seal member 38.” Ex. 1105 ¶ 53.
[F] the top straps are connected together with a buckle allowing independent adjustment of each of the top straps.
FlexiFit: “Gently adjust the . . . Top Crown straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”).
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Gunaratnam-II: “[H]eadgear buckle 570 includes a first locking portion 571 and a second locking portion 572. The first locking portion 571 is adapted to be removably and adjustably coupled with one of the upper straps 598 . . . and the second locking portion 572 is adapted to be removably and adjustably coupled with the other of the upper straps 598 . . . . Each of the upper straps 598 may be wrapped around the cross-bar of the associated locking portion 571, 572.” Ex. 1110 ¶ 316, Fig. 135.
48. The mask system of D’Souza: “[F]rame 414 is constructed of
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claim 43, wherein the frame is semi-rigid or rigid.
polycarbonate.” Ex. 1102 ¶ 98.
49. The mask system of claim 48, wherein the frame is rigid.
D’Souza: “[F]rame 414 is constructed of polycarbonate.” Ex. 1102 ¶ 98.
50. A system for treating a patient with sleep disordered breathing, comprising: the mask system of
claim 43; and a flow generator to
generate a supply of air at positive pressure to be delivered to the mask system, wherein
the air delivery tube is configured to deliver the supply of air from the flow generator to the mask system.
See supra Claim 43. D’Souza: “[M]ask assembl[ies] for use with blowers and flow generators in the treatment of sleep disordered breathing (SDB) . . . . [P]atient interface is held in a sealing position by headgear so as to enable a supply of air at positive pressure to be delivered to the patient's airways.” Ex. 1102 ¶ 3. “[C]ushion provides a seal . . . to enable the delivery of breathable gas to the patient's nose and mouth.” Id. ¶ 81. Ultra Mirage: “360° rotating elbow provides control over tubing system.” Ex. 1103 at 6. “Quick release swivel allows easy disconnection from tubing.” Id.
51. A mask system for See supra Claim 43, preamble.
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delivery of a supply of air at positive pressure to a patient's airway, the mask system comprising: a cushion module comprising a frame defining a
breathing chamber configured to receive the positive pressure air, and
a cushion to form a seal with the patient's face in a nasal bridge region, a cheek region and a lower lip/chin region of the patient's face,
wherein the cushion is constructed of a first, relatively soft, elastomeric material and the frame is constructed of a second material that is more rigid than the cushion,
See supra Claim 43[A].
the frame including a washout vent;
See supra Claim 43[B].
headgear to maintain the mask system in a desired position on the patient's face, the headgear comprising a pair of upper headgear straps each configured to extend above a respective one of the patient's ears in use and
See supra Claim 43[D].
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a pair of lower headgear straps each configured to extend below a respective one of the patient's ears in use, wherein a free end of each of the upper headgear straps and the lower headgear straps includes a hook tab structured to engage a remainder of the respective upper headgear strap and respective lower headgear strap to secure the upper and lower straps in place in a length adjustable manner,
See supra Claim 43[E].
wherein the headgear includes a pair of top straps and a pair of rear straps, each said top strap being configured to extend from generally above a respective ear of the patient such that the top straps cross over the top of the patient's head in use, the rear straps being adapted to pass behind the patient's head in use, and
See supra Claim 43[F].
wherein the rear straps and the top straps together at least partly form a closed loop to encircle a rear portion of the patient's head when
See supra Claim 43[G].
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in use; a shroud module including headgear connectors adapted to removably attach to the headgear,
See supra Claim 43[H].
wherein the headgear connectors include two upper connectors associated with the upper headgear straps and two lower connectors associated with the lower headgear straps,
See supra Claim 43[I] & 43[J].
each said upper headgear connector including a slot or receiving hole adapted to receive one of the upper headgear straps,
See supra Claim 43[K].
wherein the shroud module and the frame of the cushion module are configured to be removably snap-fit attached to one another in a non-rotatable manner;
See supra Claim 43[L].
and an elbow rotatably attached to and carried by the shroud module or the frame of the cushion module, the elbow being configured to deliver the positive pressure air to the breathing chamber,
See supra Claim 43[M].
the elbow including a swivel adapted to connect to an air
See supra Claim 43[N].
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delivery tube, the elbow including an anti-asphyxia valve (AAV) and a port that is selectively closed by a flap portion of the AAV;
See supra Claim 43[O].
the elbow is rotatably attached the shroud module,
the upper headgear straps provide padding to the respective headgear connectors of the shroud on the patient's face in use,
the frame includes a protruding vent arrangement having a plurality of holes, wherein the shroud module includes a first opening to accommodate said protruding vent arrangement,
further wherein the shroud module includes a second opening to accommodate the elbow,
the frame includes a frame opening and the frame further includes a collar surrounding said frame opening, and wherein the shroud module includes a retaining
See supra Claim 46.
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portion with one or more rearward extending snap fingers structured to engage the collar with a snap-fit, and
the top straps are connected together with a buckle allowing independent adjustment of each of the top straps.
53. The mask system of claim 51, wherein the second shroud opening and the frame opening are aligned along a common longitudinal axis, and wherein the shroud and the frame are removably snap-fit attached to one another by moving the shroud and the frame towards one another along the longitudinal axis.
See supra Claim 43[L].
54. The mask system of claim 51, wherein the frame is semi-rigid or rigid.
See supra Claim 48.
55. The mask system of claim 54, wherein the frame is rigid.
See supra Claim 49.
56. A system for treating a patient with sleep disordered breathing, comprising: the mask system of
claim 51; and a flow generator to
See supra Claims 50 & 51.
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generate a supply of air at positive pressure to be delivered to the mask system, wherein
the air delivery tube is configured to deliver the supply of air from the flow generator to the mask system.
57. A mask system for treating a patient with sleep disordered breathing with a supply of air at positive pressure, comprising:
See supra Claim 50.
headgear including headgear straps;
D’Souza: “[P]atient interface is held in a sealing position by headgear.” Ex. 1102 ¶ 3. “[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446 adapted to be engaged with clips provided to straps of a headgear assembly (not shown).” Ex. Id. ¶ 100.
a shroud module having a pair of upper headgear connectors and a pair of lower headgear connectors adapted to removably attach to the respective headgear straps of the headgear,
See supra Claim 43[I] & 43[J]. Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.
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the shroud module having a front opening;
See supra Claim 43[J].
a rotatable elbow directly attached to the shroud; and
See supra Claim 43[M].
a cushion module, the cushion module comprising a frame defining a
breathing chamber, the frame having a frame opening leading to the breathing chamber; and
a cushion to form a seal with the patient's face,
wherein the cushion comprises a first, relatively soft, elastomeric material and the frame comprises a second material that is more
See supra Claim 43[A]. D’Souza: “[F]rame 414 includes an upper wall that provides an opening 418 for communicating with an inlet conduit. . . . A side wall 420 extends from the upper wall.” Ex. 1102 ¶ 98.
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rigid than the cushion; wherein: the front opening of the shroud module and the frame opening of the frame are aligned along a common longitudinal axis, and wherein the shroud module and the cushion module are structured and arranged to be removably snap-fit attached to one another by moving the shroud module and the cushion module towards one another along the longitudinal axis,
See supra Claim 43[L].
and the shroud module includes a retaining portion positioned rearwardly of the front opening, towards the frame, and structured to snap fit with the cushion module.
D’Souza: “[S]keleton frame 412 that is adapted to removably interlock with a cushion/frame sub-assembly 430.” Ex. 1102 ¶ 96. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440 of the cushion/frame sub-assembly 430. Id. ¶ 101, Fig. 7.
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Matula-II: “Coupling member 46 includes a pair of prongs 48 that define a channel 50 to receive the wall of the faceplate and the end of seal member 38.” Ex. 1105 ¶ 53.
58. The mask system of claim 57, wherein the shroud module and the cushion module are structured and arranged to be detached from one another by moving the shroud module and the cushion module away from one another along the longitudinal axis.
D’Souza: “[S]keleton frame 412 that is adapted to removably interlock with a cushion/frame sub-assembly 430.” Ex. 1102 ¶ 96.
60. The mask system of claim 57, wherein each
See supra Claim 43[K].
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upper headgear connector includes a slot adapted to receive a respective headgear strap in use; and wherein each lower headgear connector is adapted to be removably interlocked with a headgear clip associated with a respective headgear strap.
D’Souza: “[S]keleton frame 412 includes an upper support member 444 adapted to support a forehead support, lower headgear clip receptacles 446.” Ex. 1102 ¶ 100.
Ultra Mirage: “Quick release headgear clips: top and bottom allows mask to be removed without resetting the headgear and provides convenience and safety.” Ex. 1103 at 6.
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61. The mask system of claim 57, wherein the elbow is adapted to be connected to an air delivery tube that delivers breathable gas to the patient.
See supra Claim 43[N] & 50.
62. The mask system of claim 57, wherein: the headgear includes upper straps and lower straps,
See supra Claim 43[D].
a free end of each of the upper straps and the lower straps includes a hook tab structured to engage a remainder of the respective upper strap and respective lower strap to secure the upper and lower straps in place in a length adjustable manner,
See supra Claim 43[E].
the upper straps split to FlexiFit: “Gently adjust . . . Top Crown straps.” Ex.
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form a pair of top straps and a pair of rear straps,
1106 at 10 (“FITTING YOUR MASK”).
the top straps being connected together by a buckle and configured to pass over the top of the patient's head in use, the rear straps being adapted to pass behind the patient's head in use, and
See supra Claims 43[F] & 46[E].
a free end of each of the top straps has a hook tab threaded through the buckle to engage a remainder of the respective top strap to secure the top straps in place relative to the buckle in a length adjustable manner.
FlexiFit: “Gently adjust the . . . Top Crown straps.” Ex. 1106 at 10 (“FITTING YOUR MASK”). “[A]ttach the four straps in to the corresponding slots in the Mask Base and the GliderTM strap (E). This can be done without undoing the Velcro® Tabs by sliding the Headgear into the slots.” Id. at 10 (“ASSEMBLING YOUR MASK”).
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Gunaratnam-II: “[H]eadgear buckle 570 includes a first locking portion 571 and a second locking portion 572. The first locking portion 571 is adapted to be removably and adjustably coupled with one of the upper straps 598 . . . and the second locking portion 572 is adapted to be removably and adjustably coupled with the other of the upper straps 598 . . . . Each of the upper straps 598 may be wrapped around the cross-bar of the associated locking portion 571, 572.” Ex. 1110 ¶ 316 & Fig. 135.
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63. The mask system of claim 62, wherein the upper straps provide padding to the respective headgear connectors of the shroud module on the patient's face in use.
See supra Claim 46[B].
64. The mask system of claim 62, wherein the rear straps and the top straps form a closed loop to encircle a rear portion of the patient's head when in use.
FlexiFit: Ex. 1106 at 10.
65. The mask system of claim 57, wherein the frame includes a protruding vent arrangement having a plurality of gas washout holes, wherein the shroud module includes an upper opening to accommodate said protruding vent arrangement.
See supra Claim 46[C].
68. The mask system of claim 57, wherein a
Matula-II: “[S]eal member 38 includes at least one pleat 106 (which can also be referred to as a fold or
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nasal bridge portion of the cushion includes one or more folds to provide in use a higher level of adaptability or flexibility to the nasal bridge region of the cushion module relative to another region of the cushion module; and further wherein each of said one or more folds comprises adjacent first side walls interconnected by a second side wall.
gusset) provided at a portion of the seal member so that the seal member has the desired degree of flexibility. In this case, pleats 106 are provided at and upper portion of the seal member so that this portion of the seal member can expand and contract with adjustment of the adjustment mechanism.” Ex. 1105 ¶ 66.
“Pleats 106 are oriented such that the pleat protrudes into chamber 44 with a channel 108 defined on the exterior surface of the seal member.” Id.
69. The mask system of claim 57, wherein the frame includes a collar surrounding said frame opening, and wherein the retaining portion of the shroud includes a plurality of snap fingers structured to engage the collar with a snap-fit.
D’Souza: “[A]nnular wall 440 surrounds the opening 418 [of the frame 414].” Ex. 1102 ¶ 98. “[A]nnular elbow connection seal 448 interlocks with the annular wall 440.” Id. ¶ 100.
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Matula-II: “Coupling member 46 includes a pair of prongs 48 that define a channel 50 to receive the wall of the faceplate and the end of seal member 38.” Ex. 1105 ¶ 53.
70. The mask system of claim 57, wherein the elbow includes an anti-asphyxia valve and wherein the anti-
See supra Claim 43[O].
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asphyxia valve includes a flap portion adapted to selectively close a port provided in the elbow. 71. The mask system of claim 57, wherein each of the shroud module and the frame comprises polycarbonate and the cushion comprises silicone.
D’Souza: “[C]ushion 416 is constructed of liquid silicone rubber (LSR).” Ex. 1102 ¶ 97. “[T]he frame 414 is constructed of polycarbonate.” Id. ¶ 98. “[T]he skeleton frame 412 is formed of plastic.” Id. ¶ 101.
77. The mask system of claim 57, wherein the frame is semi-rigid or rigid.
See supra Claim 48.
78. The mask system of claim 77, wherein the frame is rigid.
See supra Claim 49.
79. A system for treating a patient with sleep disordered breathing, comprising: the mask system of
claim 57; a flow generator to
generate a supply of air at positive pressure to be delivered to the mask system; and
an air delivery tube configured to deliver the supply of air from the flow generator to the mask system.
See supra Claims 50 & 57.
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IX. SECONDARY CONSIDERATIONS
Secondary considerations should be taken into account, but they do not
control the obviousness conclusion. Newell Cos., Inc. v. Kenney Mfg. Co., 864
F.2d 757, 768 (Fed. Cir. 1988). And where a strong prima facie obviousness
showing exists, as here, the Federal Circuit has repeatedly held that even relevant
secondary considerations supported by substantial evidence may not dislodge the
primary conclusion of obviousness. See, e.g., Leapfrog Enters. Inc. v. Fisher-
Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007). For example, evidence of
commercial sales generally would not be sufficient to overcome the strong prima
facie showing of obviousness. Further, there would be no nexus between the
commercial sales and the claims of the ’931 Patent. See, e.g., Wyers v. Master
Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010).
Petitioner is not aware of any secondary considerations that would be
relevant to the obviousness inquiries presented here. Further, Petitioner does not
believe that any potential secondary considerations could outweigh the strong
prima facie case of obviousness. In the event that the Patent Owner puts forth any
allegations regarding secondary considerations of non-obviousness, Petitioner will
address those allegations in due course.
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Respectfully submitted,
KNOBBE, MARTENS, OLSON & BEAR, LLP Dated: October 12, 2016 By: /Brenton R. Babcock/
Brenton R. Babcock (Reg. No. 39,592) Benjamin J. Everton (Reg. No. 60,659) Customer No. 20,995
Attorneys for Petitioner Fisher & Paykel Healthcare Limited
(949) 760-0404
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CERTIFICATE OF TYPE-VOLUME LIMITATIONS
UNDER 37 C.F.R. § 42.24
Pursuant to 37 C.F.R. § 42.24(d), Counsel for Petitioner Fisher & Paykel
Healthcare Limited hereby certifies that this document complies with the type-
volume limitation of 37 C.F.R. § 42.24(a)(1)(i). According to Microsoft Office
Word 2010’s word count, this document contains approximately 13,582 words,
including any statement of material facts to be admitted or denied in support, and
excluding the table of contents, table of authorities, mandatory notices under
§ 42.8, exhibit list, certificate of service or word count, or appendix of exhibits or
claim listing.
Respectfully submitted,
KNOBBE, MARTENS, OLSON & BEAR, LLP Dated: October 12, 2016 By: /Brenton R. Babcock/
Brenton R. Babcock (Reg. No. 39,592) Benjamin J. Everton (Reg. No. 60,659) Customer No. 20,995
Attorneys for Petitioner Fisher & Paykel Healthcare Limited
(949) 760-0404
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CERTIFICATE OF SERVICE
I hereby certify that true and correct copies of the foregoing PETITION
FOR INTER PARTES REVIEW OF U.S. PATENT 9,119,931 and Fisher &
Paykel Healthcare Exhibits 1101-1124 are being served on October 12, 2016, via
FedEx Priority Overnight service on counsel of record for U.S. Patent 9,119,931
patent owner RESMED LIMITED at the address below:
Correspondence Address of Record for U.S. Patent 9,119,931 at the U.S.
Patent and Trademark Office:
Nixon & Vanderhye, PC 901 North Glebe Road, 11th Floor
Arlington, VA 22203
Dated: October 12, 2016 By: /Brenton R. Babcock/
Brenton R. Babcock Registration No. 39,592 Attorney for Petitioner Fisher & Paykel Healthcare Limited