UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ResMed Inc., ResMed Corp., and ResMed Limited
`Petitioners
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`v.
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`Fisher & Paykel Healthcare Limited
`Patent Owner
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`Patent No. 8,443,807
`IPR Nos. 2016-1726 & 2016-1734
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`DECLARATION OF JOHN IZUCHUKWU, Ph.D., P.E.
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`1
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`RMD 1008
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
`TABLE OF CONTENTS
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`Page
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`I. 
`
`II. 
`
`ASSIGNMENT ................................................................................................ 1 
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`QUALIFICATIONS ........................................................................................ 1 
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`III.  LEGAL STANDARDS ................................................................................... 4 
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`IV.  PERSON OF ORDINARY SKILL IN THE ART .......................................... 8 
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`V.  MATERIALS CONSIDERED ........................................................................ 9 
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`VI.  BACKGROUND OF THE ’807 PATENT ................................................... 11 
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`A. 
`
`B. 
`
`Subject Matter Overview .................................................................... 11 
`
`File History of the ’807 Patent ............................................................ 14 
`
`VII.  CLAIM CONSTRUCTIONS ........................................................................ 20 
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`VIII.  DISCUSSION OF PROPOSED GROUNDS OF UNPATENTABILITY ... 25 
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`A. 
`
`Teachings of the Prior Art References ................................................ 25 
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` 
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` 
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` 
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` 
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`Overview of Gunaratnam ......................................................... 25 
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`Overview of Ging ...................................................................... 28 
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`Overview of McAuley ............................................................... 31 
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`Overview of Lovell.................................................................... 33 
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`B. 
`
`Ground 1: Gunaratnam in view of Ging ............................................. 35 
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`  Motivation to Combine Gunaratnam and Ging as Proposed by
`Petitioners .................................................................................. 35 
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` 
`
` 
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`Claim Chart Showing Corresponding Disclosure In
`Gunaratnam And Ging For Each Element of Claims 1-8, 17-21,
`And 24-27 Of The ’807 Patent.................................................. 37 
`
`Supplemental Analysis Of Individual Claim Limitations ........ 80 
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
`TABLE OF CONTENTS (cont’d)
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`Page
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`a) 
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`b) 
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`c) 
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`d) 
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`e) 
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`f) 
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`g) 
`
`h) 
`
`i) 
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`j) 
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`k) 
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`l) 
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`Claim Limitations 1.2 and 1.3 ................................................... 80 
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`Claim Limitation 1.4 ................................................................. 85 
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`Claim Limitation 1.5 ................................................................. 86 
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`Claim Limitation 1.6 ................................................................. 91 
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`Claim Limitation 1.8 ................................................................. 92 
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`Claim Limitation 1.9 ................................................................. 93 
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`Claim Limitation 1.12 ............................................................... 95 
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`Claim Limitation 1.15 ............................................................... 96 
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`Claim Limitation 1.16 ............................................................... 99 
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`Claim 2 ...................................................................................... 99 
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`Claim 3 ....................................................................................102 
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`Claim 4 ....................................................................................104 
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`m) 
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`Claim 5 ....................................................................................107 
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`n) 
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`o) 
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`p) 
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`q) 
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`r) 
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`s) 
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`t) 
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`u) 
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`Claim 6 ....................................................................................108 
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`Claim 7 ....................................................................................110 
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`Claim Limitations 8.3, 8.5 ......................................................111 
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`Claim Limitation 8.4 ...............................................................116 
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`Claim Limitations 8.7, 8.8 ......................................................118 
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`Claim Limitation 8.9 ...............................................................120 
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`Claim Limitation 8.10 .............................................................121 
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`Claim Limitation 8.12 .............................................................123 
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`ii
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
`TABLE OF CONTENTS (cont’d)
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`Page
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`v) 
`
`w) 
`
`x) 
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`y) 
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`z) 
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`Claim Limitation 8.13 .............................................................124 
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`Claim Limitation 8.14 .............................................................126 
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`Claim Limitation 8.15 .............................................................131 
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`Claim Limitations 8.17, 8.19 ..................................................132 
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`Claim Limitation 8.23 .............................................................134 
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`aa) 
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`Claim Limitation 8.25 .............................................................136 
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`bb)  Claim Limitations 8.32, 8.33 ..................................................138 
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`cc) 
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`Claim 17 ..................................................................................140 
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`dd)  Claims 18, 19 ..........................................................................143 
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`ee) 
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`ff) 
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`Claims 20, 21 ..........................................................................144 
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`Claims 24, 25 ..........................................................................145 
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`gg)  Claims 26, 27 ..........................................................................149 
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`C. 
`
`Ground 2: Gunaratnam in view of Ging and McAuley .....................149 
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`D.  Ground 3: Lovell in view of Gunaratnam .........................................152 
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`  Motivation to Combine Lovell and Gunaratnam as Proposed by
`Petitioners ................................................................................152 
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` 
`
` 
`
`a) 
`
`b) 
`
`Claim Chart Showing Corresponding Disclosure in Lovell and
`Gunaratnam For Each Element of Claims 1-8, 17-21, and 25-27
`of the ’807 Patent ....................................................................153 
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`Supplemental Analysis Of Individual Claim Limitations ......182 
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`Limitations 1.3-1.4 ..................................................................182 
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`Limitation 1.6 ..........................................................................183 
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`iii
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
`TABLE OF CONTENTS (cont’d)
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`Page
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`c) 
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`d) 
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`e) 
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`f) 
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`g) 
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`h) 
`
`i) 
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`j) 
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`k) 
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`l) 
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`Limitation 1.8 ..........................................................................185 
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`Limitation 1.10 ........................................................................186 
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`Limitations 1.11-1.17 ..............................................................187 
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`Claim 2 ....................................................................................188 
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`Claim 3 ....................................................................................190 
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`Claim 4 ....................................................................................191 
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`Claim 5 ....................................................................................191 
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`Claim 6 ....................................................................................192 
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`Claim 7 ....................................................................................194 
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`Claim Limitation 8.4 ...............................................................194 
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`m) 
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`Claim Limitations 8.5, 8.6 ......................................................195 
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`n) 
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`o) 
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`p) 
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`q) 
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`r) 
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`s) 
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`t) 
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`u) 
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`v) 
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`Claim Limitations 8.7, 8.8 ......................................................196 
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`Claim Limitation 8.12 .............................................................200 
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`Claim Limitation 8.15 .............................................................202 
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`Claim Limitations 8.16-8.18 ...................................................203 
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`Claim Limitation 8.24 .............................................................204 
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`Claim Limitation 8.25 .............................................................206 
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`Claim Limitations 8.27-8.34 ...................................................207 
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`Claim 17 ..................................................................................208 
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`Claims 18-21 ...........................................................................210 
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`w) 
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`Claims 24-27 ...........................................................................212 
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`iv
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`5
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
`TABLE OF CONTENTS (cont’d)
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`Page
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`IX.  CONCLUSION ............................................................................................217 
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`v
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`6
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`I, John Izuchukwu, of University City, Missouri declare that:
`
`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`I.
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`ASSIGNMENT
`1.
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`I have been retained on behalf of ResMed Inc., ResMed Corp., and
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`ResMed Limited (“ResMed”). I understand that ResMed is requesting that the
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`Patent Trial and Appeal Board (“PTAB” or “Board”) institute inter partes review
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`(“IPR”) proceedings of U.S. Patent No. 8,443,807 (“the ’807 patent”) (RMD1001).
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`2.
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`I have been asked to opine on the subject of the validity of the claims
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`of the ’807 patent in light of the grounds of rejection at issue in ResMed’s inter
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`partes review Petitions.
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`3.
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`My findings, as explained below, are based on my study, experience,
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`and background in the fields discussed below. I have also relied on my review and
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`analysis of the prior art, information provided to me in connection with this case,
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`and information I have independently reviewed.
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`4.
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`I am being compensated for my work as an expert on this matter, but
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`my compensation is not contingent in any way on the content of my opinions or the
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`outcome of this proceeding.
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`II. QUALIFICATIONS
`5.
`I am a Professional Engineer with more than thirty years of
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`experience in medical device technologies, and mechanical and industrial
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`engineering. I have attached my curriculum vitae at the conclusion of this
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`1
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`declaration as Appendix A for a fuller overview of my experience and expertise.
`
`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`The following paragraphs summarize some pertinent aspects of the C.V.
`
`6.
`
`In 1980, I received a Bachelor’s of Science degree in Industrial and
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`Mechanical Engineering from the University of Portland in Oregon. Then in 1984,
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`I was awarded a Master’s of Science degree in Mechanical Engineering from the
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`University of Portland. In 1994, I received a Ph.D. in Industrial and Mechanical
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`Engineering from Northeastern University. Later, in 2002, I received an MBA
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`from the Kellogg School of Management at Northwestern University. I am also
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`registered as a Professional Engineer in the State of Missouri.
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`7.
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` I currently serve as the Chief Executive Officer (CEO) and Chief
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`Technical Officer (CTO) of Core Devices Inc., a medical device company that I
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`founded in 2001. In these roles, I have been intimately involved in the
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`development of medical device technologies as well as the development and
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`growth of the business itself. Among other things, I led the design and
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`development of an oxygen conserving device, a conformal oxygen system for
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`persons with respiratory disability, and a backpack-able field anesthesia machine.
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`8.
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`From 1998-2001, I was employed by Nellcor Puritan Bennett (later
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`Covidien, and now Medtronic) where I held the position of Senior Director of
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`Global Research & Development and Engineering. During this time, I oversaw the
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`development of diagnostic and therapeutic devices for respiratory care, including
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`devices for the treatment of sleep apnea disorders and chronic obstructive
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`pulmonary disease (COPD). We brought to market more than a dozen new
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`products, including several CPAP machines, and bi-level ventilators for respiratory
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`support, sleep masks, a spirometer for the diagnosis of respiratory disorders, an
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`oxygen conserving device, an oxygen concentrator, and a high efficiency liquid
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`oxygen system.
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`9.
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`Before joining Nellcor Puritan Bennett, I worked in research and
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`development at Ethicon Endo-Surgery, Inc. from 1994-1998. Our R&D efforts at
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`Ethicon were primarily focused on endoscopic surgical devices. I also worked for
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`more than a decade (1983-1994) at Digital Equipment Corporation in the areas of
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`manufacturing and automation technologies. I am a named inventor on 19 patents.
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`I regularly serve as an adjunct professor at colleges and universities in the areas of
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`medical device, mechanical, and industrial engineering, and have authored or co-
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`authored more than two dozen publications.
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`10.
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`I am listed in Marquis “Who’s Who in Science and Engineering,”
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`“Who’s Who in the World,” and “Who’s Who in America.” I am also a former
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`member of the Board of Directors of the Rankin Jordan Pediatric Hospital in St.
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`Louis, Missouri.
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`
`III. LEGAL STANDARDS
`11.
`In preparing my analysis, I have applied the legal standards described
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`below, which were provided to me by counsel for the Petitioners.
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`12.
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`It is my understanding that assessing the validity of a U.S. patent
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`based on a prior art analysis requires two essential steps. First, one must construe
`
`the terms of the patent claims to understand what meaning one of ordinary skill in
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`the art would have given the terms as of the effective priority date(s) of the claims.
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`Second, after the claim terms have been construed, one may then assess validity by
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`comparing a patent clam to the “prior art.” For the purpose of my independent
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`analysis herein, I have assumed that each of the references applied in the Petitions
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`constitutes prior art.
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`13.
`
`I understand that the ’807 patent has not expired. As such, I have
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`been informed that the “broadest reasonable interpretation” standard of
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`construction applies in these proceedings. Under this standard, claims are to be
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`interpreted according to their broadest reasonable construction in light of the
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`specification as it would be interpreted by one of ordinary skill in the art as of the
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`time of the respective claims of the ’807 patent. I understand that under the
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`broadest reasonable interpretation, words of the claim are given their plain
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`meaning, unless such meaning is inconsistent with the specification. The plain
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`meaning of a term means the ordinary and customary meaning given to the term by
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`those of ordinary skill in the art at the time of the invention. I have been informed
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`that the broadest reasonable interpretation standard that applies in inter partes
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`review proceedings involving unexpired patents is different than the standard
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`applied by courts and in some other forums in which issued patents are litigated.
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`14.
`
`I understand that the teaching of the prior art is viewed through the
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`eyes of a person of ordinary skill in the art at the time the invention was made. To
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`assess the level of ordinary skill in the art, I understand that one can consider the
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`types of problems encountered in the art, the prior solutions to those problems
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`found in prior art references, the rapidity with which innovations are made, the
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`sophistication of the technology, and the level of education of active workers in the
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`field. My opinion as to what constitutes a relevant person of ordinary skill in the
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`art is set forth further below.
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`15.
`
`I understand that a patent claim is invalid as obvious if the subject
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`matter “as a whole” of the claimed invention would have been obvious to a person
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`of ordinary skill in the field at the time the invention was made. In determining the
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`differences between a prior art reference (or a proposed combination of prior art
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`references) and the claims, the question of obviousness is not whether the
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`differences themselves would have been obvious, but whether the claimed
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`invention as a whole would have been obvious.
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`I understand that a patent claim composed of several elements is not
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`
`16.
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`proved obvious merely by demonstrating that each of its elements was
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`independently known in the prior art. In evaluating whether any claim of the ’807
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`patent would have been obvious, I have further considered and set forth articulated
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`reasons that would have prompted a person of ordinary skill in the field to combine
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`the elements or concepts from the prior art in the same way as in the claimed
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`invention.
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`17.
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`I understand that there is no single way to define the line between true
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`inventiveness on one hand (which is patentable) and the application of common
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`sense and ordinary skill to solve a problem on the other hand (which is not
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`patentable). For example, market forces or other design incentives may be what
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`produced a change, rather than true inventiveness. It is my understanding that the
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`decision-maker may consider whether the change was merely the predictable result
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`of using prior art elements according to their known functions, or whether it was
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`the result of true inventiveness. And, the decision-maker may also consider
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`whether there is some teaching or suggestion in the prior art to make the
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`modification or combination of elements recited in the claim at issue. Also, the
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`decision-maker may consider whether the innovation applies a known technique
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`that had been used to improve a similar device or method in a similar way. The
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`decision-maker may also consider whether the claimed invention would have been
`6
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`obvious to try, meaning that the claimed innovation was one of a relatively small
`
`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`number of possible approaches to the problem with a reasonable expectation of
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`success by those skilled in the art. I understand that the decision-maker must be
`
`careful not to determine obviousness using the benefit of hindsight, and that the
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`decision-maker should consider obviousness from the position of a person of
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`ordinary skill in the relevant field at the time the claimed invention was made.
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`18.
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`I understand that in order to determine whether a patent claim is
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`obvious, one is to make certain factual findings regarding the claimed invention
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`and the prior art. Specifically, I understand that the following factors are to be
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`evaluated to determine whether a claim is obvious: (1) the scope and content of the
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`prior art; (2) the difference or differences, if any, between the claim of the patent
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`and the prior art; (3) the level of ordinary skill in the art at the time the claimed
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`invention was made; and (4) the objective indicia of non-obviousness, also known
`
`as “secondary considerations.”
`
`19.
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`I understand that the secondary considerations include:
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`(1) commercial success of a product due to the merits of the claimed
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`invention;
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`(2) a long felt need for the solution provided by the claimed invention;
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`(3) unsuccessful attempts by others to find the solution provided by the
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`claimed invention;
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`(4) copying of the claimed invention by others;
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`(5) unexpected and superior results from the claimed invention;
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`(6) acceptance by others of the claimed invention as shown by praise from
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`others in the field or from the licensing of the claimed invention;
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`(7) teaching away from the conventional wisdom in the art at the time of the
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`invention;
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` (8) independent invention of the claimed invention by others before or at
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`about the same time as the named inventor thought of it; and
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`(9) other evidence tending to show obviousness.
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`20.
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`I have been informed that, in order to establish a secondary
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`consideration, the evidence must demonstrate a nexus between that secondary
`
`consideration and the claimed invention.
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`IV. PERSON OF ORDINARY SKILL IN THE ART
`21.
`It is my opinion that a person of ordinary skill in the art at the time of
`
`the effective filing dates of the applications that led to the ’807 patent would have
`
`had a bachelor’s degree in mechanical engineering, biomedical engineering, or a
`
`related discipline, and at least five years of relevant product design experience in
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`the field of medical devices or respiratory therapy, or an equivalent advanced
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`education. My opinions are thus based on the perspective of a person of ordinary
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`skill in the art having this level of knowledge and skill at the time of the effective
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`filing dates of the applications that led to the ’807 patent.
`
`22.
`
`I understand that the ’807 patent claims priority to a pair of New
`
`Zealand patent applications that were filed on July 14, 2006, and November 6,
`
`2006, respectively. I have been instructed by counsel for the Petitioners to apply
`
`the perspective of a person of ordinary skill in the art from the time leading up to
`
`the July and November 2006 filing dates of the New Zealand application. My
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`analysis in this declaration is based on the perspective of one of ordinary skill in
`
`the art during this timeframe (as early as July 2006).
`
`V. MATERIALS CONSIDERED
`23.
`In preparing this declaration, I have considered the claims,
`
`specification, and prosecution history of the ’807 patent. I have also read and
`
`considered ResMed’s Petitions for inter partes review of the ’807 patent, the
`
`various documents referenced in my declaration, and additional background
`
`materials. Among the materials that I have reviewed in preparing this declaration
`
`are:
`
` U.S. Patent No. 8,443,807 to McAuley et al. (RMD1001, “the ’807 Patent”)
`
` U.S. Patent Application Publication No. 2004/0226566 to Gunaratnam et
`
`al. (RMD1004, “Gunaratnam”)
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` U.S. Patent Application Publication No. 2003/0196658 to Ging et al.
`
`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`(RMD1005, “Ging”)
`
` U.S. Patent No. 6,691,707 to Gunaratnam et al. (RMD1007, “the ’707
`
`patent” or “Gunaratnam II”)
`
` File History of U.S. Patent No. 8,443,807 to McAuley et al. (RMD1009)
`
`(selected portions)
`
` U.S. Patent No. 7,219,669 to Lovell et al. (“Lovell”) (RMD1012)
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` Merriam-Webster’s Collegiate Dictionary, Eleventh Edition (2004)
`
`(selected portions) (RMD1014)
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` U.S. Patent 4,676,241 to Webb (RMD1016)
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` PCT Publication No. WO 2004/022147 to Drew (RMD1018)
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` U.S. Patent 4,782,832 to Trimble (RMD1019)
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` U.S. Patent 6,431,172 to Bordewick (RMD1020)
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` U.S. Patent 6,192,886 to Rudolph (RMD1021)
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` U.S. Patent 6,581,594 to Drew (RMD1022)
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` Mirage Vista User’s Guide (RMD1024)
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` PCT Pub. WO 2005/079726 to McAuley et al. (“McAuley”) (RMD1034)
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` U.S. Patent No. 7,178,528 (“Lau”) (RMD1037)
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`10
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` WeddingBands.com – Men’s Wedding Ring Shopping Page (Retrieved
`
`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
`
`October 16, 2015 from
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`http://www.weddingbands.com/ProductPop_wedding_bands_metal/48214
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`W.html?gclid=Cj0KEQjwwIKxBRDKhOz7ytT30vkBEiQAT1NaPTkynkzziab
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`Z7rGCksELV_JfZn_nYKjW7Cfog4tma3MaAixf8P8HAQ) (RMD 1038)
`
` HomeDepot.com – Ring Nut Sales Page (Retrieved October 16, 2015 from
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`http://www.homedepot.com/p/Everbilt-1-2-in-Galvanized-Hex-Nut-
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`804076/204647893) (RMD1039)
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` ResMed Origins Brochure (Retrieved April 17, 2016 from
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`http://www.resmed.com/us/dam/documents/articles/resmed-origins.pdf)
`
`(RMD1040)
`
`VI. BACKGROUND OF THE ’807 PATENT
`A.
`Subject Matter Overview
`24.
`
`The ’807 patent (RMD1001) is titled “Breathing Assistance
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`Apparatus,” and generally describes devices that “provide[] a nasal interface for
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`the supply of respiratory gases,” such as for the treatment of obstructive sleep
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`apnea. RMD1001 at 1:10-33.
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`25. Obstructive sleep apnea (OSA) is a sleep disorder in which a person’s
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`airway closes during sleep, resulting in “repeated sequences of snoring, breathing
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`difficulty, lack of breathing, waking with a start and then returning to sleep.” Id. at
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`11
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`17
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`1:24-33. One way to treat OSA is to deliver a pressurized flow of gas to a patient’s
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`airway during sleep to help keep the airway open. This treatment is called
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`continuous positive airway pressure (“CPAP”) as would have been well
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`understood by one of ordinary skill in the art at the time of the ’807 patent.
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`Notably, one of ResMed’s founders, Dr. Colin Sullivan, is widely recognized as a
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`pioneer in CPAP technology, and was the first to apply CPAP to treat OSA. See
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`ResMed Origins (RMD1040) at pp. 2, 9-13.
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`26. A CPAP system generally includes a flow generator (e.g., a blower)
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`that generates pressurized air. Id. at 1:45-49. Tubing and a mask deliver the
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`pressurized air to the patient’s nasal passages or mouth. See id. at 4:43-5:24, Fig.
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`1. Headgear may help keep the mask on the patients face. Id. at 1:47-49.
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`27.
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`The ’807 patent refers to the tubing, mask, and headgear together as a
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`“patient interface.” The ’807 patent relates to specific features of a patient
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`interface, which the patent contends were useful to overcome disadvantages in the
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`prior art. RMD1001 at 1:15-40, 2:58-60. Namely, the ’807 patent states that
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`“[c]onventional nasal masks used for administrating CPAP treatment are []
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`considered uncomfortable and cumbersome” and can also “be noisy due to air
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`leaks,” resulting in reduced patient compliance with prescribed treatment. Id. at
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`2:23-32. The ’807 patent claims at issue here relate particularly to patient
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`interfaces with “nasal-pillow”-type masks, in which small cushions (i.e., nasal
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`pillows) deliver pressurized air to a patients nares (e.g., nostrils).
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`28.
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`Figures 2 and 3 illustrate a preferred embodiment of a patient
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`interface that generally depicts the features of the claims. The patient interface
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`includes a headgear assembly 21; a mask assembly including mask body 23 with
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`nasal pillows 24 and 25 and mask base 22; and an air delivery tube 31 having an
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`elbow connector 30 and connector end 46 for rotatably connecting to the front of
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`the mask assembly:
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`Side
`strap 37
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`Top
`strap 35
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`Headgear assembly 21
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`Back strap 36
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`Mask body 23, having
`nasal pillows 24, 25
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`Side
`strap 38
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`Elbow
`connector 30
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`Mask base 22
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`Curved and
`Elongate Member 34
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`29. As shown in Figures 2 and 3 above, the headgear assembly 21
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`includes a curved and elongate member 34, to which a pair of side straps 37 and 38
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`are attached. Together, the side straps 37 and 38, along with a back strap 36 and
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`top strap 35, secure the mask to the patient’s head. RMD1001 at 6:57-7:3. The
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`curved and elongate member 34 includes a central section 42 that receives a hard
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`mask base 22 having a ring-like opening. Id. at 6:19-45, 7:46-55. On a distal side
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`of the mask base 22 is a channel 45 that receives a lip of the mask body 23, which
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`is generally flexible and softer than the base 22. Id. The connector end 46 of the
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`tube assembly (of elbow connector 30) then fits into a proximal side of the mask
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`base 22, and allows the tube assembly to swivel relative to the mask base 22. Id. at
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`6:38-45.
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`B.
`30.
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`File History of the ’807 Patent
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`I have reviewed select portions of the ’807 patent’s file history
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`(RMD1009). Based on this review, I understand that the Patent Office mailed an
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`office action in July 2012, which rejected certain of the then-pending claims as
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`being anticipated by Lovell (RMD1012), and which rejected certain other claims as
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`being obvious over Lovell (RMD1012) in view of Gunaratnam (RMD1004). See
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`RMD1009, ’807 File History, pp. 585-590.
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`31.
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` I understand that application claim 38 corresponds to issued claim 1
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`in the ’807 patent, and that application claim 47 corresponds to issued claim 8 in
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`the ’807 patent. In response to the July 2012 office action, the applicant amended
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`claim 38 as shown on page 614 of the file history (RMD1009), and also amended
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`claim 47 as shown on pages 615-616 of the file history (RMD1009).
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`20
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`The amendments to claims 38 and 47 added a number of limitations to
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`32.
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`the claims, but the applicant only specifically addressed two of the added
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`limitations in the arguments. See RMD1009, pp. 620-622.
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`33.
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`Regarding the first argued limitation, the applicant remarked that
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`Lovell does not disclose “an elbow rotatably engaged with the ring such that a
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`portion of the elbow is received within the ring,” as recited in amended claim 38.
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`Id. at p. 620 (“Furthermore, Lovell discloses a ‘conduit elbow 14 that fits onto
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`swivel connector 12.’ Lovell, col. 5, ll. 26-28, Figure 4B. Thus, Lovell fails to
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`teach or suggest a nasal mask having ‘an elbow rotatably engaged with the ring
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`such that a portion of the elbow is received within the ring’ . . . .”) (emphasis in
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`original). To illustrate the applicant’s argument, Figures 1B and 4B of Lovell
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`(RMD1012) are copied and annotated below. As these figures show, Lovell’s
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`assembly included a conduit elbow 14 having an end that fit onto a complementary
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`portion of the swivel connector 12, which the Examiner had identified as
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`disclosing the claimed “ring” structure. See RMD1009, p. 587. In other words,
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`Lovell’s conduit elbow 14 acted as a female connector to receive a portion of the
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`swivel connector 12, and in turn the swivel connector 12 acted as a male connector
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`that fit within the conduit elbow 14. In its argument, the applicant distinguished
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`Lovell by pointing to the amendment that required the elbow to be received within
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`21
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`the ring, rather than “onto” it.
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`34.
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`In my opinion, and based on my knowledge and experience in the
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`field, one of ordinary skill in the art at the time of the ’807 patent would have
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`found the feature of an elbow rotatably engaged with the ring such that a portion of
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`the elbow is received within the ring (as opposed to the elbow fitting onto the
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`ring), to be an obvious modification of Lovell’s design. For example, all that is
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`required to meet this feature of amended claim 38 (issued claim 1) is to switch the
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`configuration of the connection between the swivel elbow connector 12 and the
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`conduit elbow 14 such that the swivel connector 12 serves as the female connector
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`(rather than the male connector) for receiving the conduit elbow 14. The choice of
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`male and female connectors was well-known at the time of the ’807 patent, and
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`their selection would have been an obvious engineering design choice. For
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`instance, one of ordinary skill in the art would have understood that the
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`arrangement of male and female parts often is made based on safety considerations
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`Izuchukwu ’807 Declaration
`Attorney Docket Nos. 36784-0042IP1 / -0042IP2
`IPR Nos. 2016-1726 / -1734
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`and/or the direction of flow