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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ResMed Limited, ResMed Inc., ResMed Corp.,
`Petitioners
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`v.
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`Fisher & Paykel Healthcare Limited,
`Patent Owner
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`Case IPR2019-000179
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`U.S. Patent 9,333,315
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`DECLARATION OF ANTHONY MICHAEL GING
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`Page 1
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`RMD
`EXHIBIT 1009 - PAGE 1
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`TABLE OF CONTENTS
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`
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`INTRODUCTION AND BACKGROUND .......................................................4
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`QUALIFICATIONS ..........................................................................................5
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`MATERIALS CONSIDERED...........................................................................9
`
`PERSON OF ORDINARY SKILL IN THE ART ............................................ 11
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`INTERPRETATION OF THE PATENT CLAIMS AT ISSUE ........................ 12
`
`BACKGROUND OF THE THREE RELATED PATENTS ............................. 14
`’914 Patent Overview (RMD1001) ..................................................................... 14
`
`Prosecution History of ’914 Patent (RMD1002) ................................................. 16
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`’315 Patent Overview (RMD1003) ..................................................................... 18
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`Prosecution History of ’315 Patent (RMD1004) ................................................. 19
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`’405 Patent Overview (RMD1005) ..................................................................... 19
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`Prosecution History of ’405 Patent (RMD1006) ................................................. 20
`
`SUMMARY OF CITED REFERENCES ......................................................... 21
`Thomlinson (Ex. 1004) ...................................................................................... 21
`
`Gunaratnam (RMD1011) ................................................................................... 30
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`Madaus (RMD1018) .......................................................................................... 33
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`Ho (RMD1013) .................................................................................................. 34
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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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`A.
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`B.
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`C.
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`D.
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`ANALYSIS OF GUNARATNAM (claims ADDRESSED IN SEQUENCE: 6-
`14, 16-19, 1, 4-5) ................................................................................. 35
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`ANALYSIS GUNARATNAM IN VIEW OF HO (’315 – claimS 2, 15) .......... 67
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`ANALYSIS THOMLINSON IN VIEW OF GUNARATNAM (’315 - claims 6-
`7, 9-14, 16-18) ..................................................................................... 70
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`ANALYSIS THOMLINSON IN VIEW OF GUNARATNAM AND MADAUS
`(’315 – claims 1, 3-5, 8, 19) ................................................................. 94
`
`ANALYSIS Thomlinson in view of GUNARATNAM and HO (’315 – claim,
`15), and THOMLINSON IN VIEW OF GUNARATNAM, MADAUS
`AND HO (’315 – CLAIM 2) .............................................................. 103
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`SUPPORT FOR GUNARATNAM IN EARLIER FILED PROVISIONAL
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`Page 2
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`EXHIBIT 1009 - PAGE 2
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`APPLICATION ................................................................................. 105
`Support for Gunaratnam RMD1011 within U.S. Provisional Application Serial
`
`A.
`
`No. 60/529,696 (“Gunaratnam Provisional Application”; RMD1017) .......................... 105
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`SUPPORT FOR HO IN EARLIER FILED PROVISIONAL APPLICATION
` .......................................................................................................... 109
`Support for Ho RMD1013 within U.S. Provisional Application Serial No.
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`B.
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`60/496,059 (“Ho Provisional Application”; RMD1021) ............................................... 109
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`LEGAL STANDARDS ................................................................................. 113
`Claim Interpretation ......................................................................................... 113
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`Anticipation ..................................................................................................... 114
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`Obviousness ..................................................................................................... 114
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`A.
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`B.
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`C.
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`ADDITIONAL REMARKS .......................................................................... 118
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`Page 3
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`I, Anthony Michael Ging, of Christchurch, New Zealand, declare that:
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`INTRODUCTION AND BACKGROUND
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`1.
`
`I have reviewed the specification, including the claims, of U.S. Patent
`
`No. 9,974,914 (“the ’914 patent,” Ex. RMD1001); U.S. Patent No. 9,333,315 (“the
`
`’315 patent,” Ex. RMD1003); and U.S. Patent No. 9,539,405 (“the ’405 patent, Ex.
`
`RMD1005).
`
`2.
`
`In this declaration I provide my independent analysis of the ’315
`
`patent in light of the materials cited below and my knowledge and experience in
`
`this field during the relevant time frame. I have been asked to consider what one
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`of ordinary skill in the art at the time of the invention of the ’315 patent (a
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`“POSITA”; refer to ¶¶20-21) would have understood from the specification,
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`including scientific and technical knowledge related to the patents. I have also
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`been asked to consider whether certain references disclose or render obvious the
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`inventions described by claims 1-19 of the ’315 patent.
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`3. My findings, as explained below, are based on my study, experience,
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`and background in the fields discussed below, informed by my education in
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`Product Design, and my extensive experience in the fields of medical devices and
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`respiratory therapy. I have also relied on my review and analysis of the prior art,
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`information provided to me, and information I have independently reviewed.
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`4.
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`I am being compensated for my independent analysis as an expert
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`with respect to this inter partes review proceeding, but my compensation is not
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`contingent in any way on the content of my analysis or the outcome of this
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`proceeding. I have no financial interest in Petitioner (Resmed) and I have no
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`financial interest in the challenged patent.
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`QUALIFICATIONS
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`5.
`
`From 1991 to 1994, I studied Industrial Design at the University of
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`New South Wales. I received my Bachelor of Industrial Design degree from the
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`University of New South Wales in 1994, with minors in Commerce and
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`Mechanical Engineering.
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`6.
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`From approximately June 1995 to December 1998, I worked for ASP
`
`Plastic in a product design and development role, which involved taking an initial
`
`concept of a safety storage/disposal container for hypodermic-needles to reduce
`
`needle related injuries, and turning that into a commercial product. I was
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`responsible for all aspects of the process to get the product coming off the
`
`production line. The product was intended to be fixed in different locations and to
`
`be used by intravenous drug users and, to a smaller degree, diabetics. My job
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`required an understanding of the end product’s usability to enable effective product
`
`design. For instance, it was necessary to consider how user factors such as a
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`medical condition or addiction could affect how someone used the product. For
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`example, intravenous drug users may have comprehension or dexterity issues
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`arising from their addictions which impair their ability to access needles from the
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`container. I learned that it is important to consider limitations like these as part of
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`the product design process to improve the ultimate product and that this is
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`especially true of medical devices which may be used in high stress environments
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`(such as hospitals) or by impaired users (such as the drug users mentioned above).
`
`7.
`
`From approximately July 2001 to July 2004, I was employed by
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`ResMed Limited. My initial job title was Systems Engineer, however, I also took
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`on a Team Leader role for several projects. In these roles, I designed and
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`developed several different patient interface products for the treatment of sleep
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`disordered breathing.
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`8.
`
`For example, I worked as an engineer at ResMed designing
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`components for an upgrade of ResMed’s Mirage full face patient interface, which
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`was later marketed as the Full Face II. This involved designing an adjustable clip-
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`on forehead support to improve the stability of the mask in use, and was intended
`
`as a solution to improve the stability of the mask before a new mask could be
`
`designed and released.
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`9.
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`Also during my experience at ResMed, I work with the design team to
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`develop a number of elements of the Ultra Mirage Nasal mask, particularly around
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`a snap on elbow cover.
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`10.
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`I was also involved in the design and engineering work for ResMed’s
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`Vista nasal mask. For this project, I was the Team Leader for the product and was
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`involved for the entirety of the project. For this design, my design team was
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`awarded the annual company prize for innovation.
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`11. Additionally, my engineering experience includes working on
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`ResMed’s disposable full face mask. Again, I was the Team Leader for
`
`development of this product and involved for the entirety of the project.
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`12.
`
`I also worked on the engineering team for ResMed’s Activa nasal
`
`mask. As part of this experience, I was involved with improving the usability of
`
`features, such as the rotating elbow.
`
`13.
`
`It may also be relevant that, while I did not suffer from a medical
`
`condition that required CPAP treatment during my work at ResMed, my
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`engineering and design experience included personal experiences with wearing
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`several different types of masks while I slept. This research and analysis
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`experience gave me a better understanding of the way patients would use these
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`masks, and the likely problems which may be experienced by those users.
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`14. From approximately October 2005 to November 2006, I worked for
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`Ritract Limited as a Project Engineer developing a safety syringe to reduce needle
`
`injuries. My role at Ritract involved overseeing the process of taking an idea from
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`a broad concept to a market ready product, and I gained personal experience on the
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`challenges of taking a broad concept that may be embodied in a patent
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`specification and transforming that into a commercial product.
`
`15. Part of my role with Ritract was to evaluate the effectiveness of the
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`product and determine if the basic concepts described in a patent specification
`
`would actually work. My work included a careful analysis of features described in
`
`a patent specification to determine how such structures will interact and/or perform
`
`in an actual commercial product.
`
`16. From approximately September 2010 to September 2012, I worked for
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`Talbot Technologies as a Project Manager. Talbot Technologies is a third-party
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`injection molding company which manufactures products for its clients. However,
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`Talbot Technologies also offers design advice and services for its clients as part of
`
`manufacturing components for them. While I was employed at Talbot
`
`Technologies I provided some design advice to improve manufacturability of parts
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`of CPAP humidifiers and blowers, including blower housings and impellors; those
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`parts were being manufactured by Talbot Technologies for Fisher & Paykel
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`Healthcare Limited.
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`17.
`
`I have not been an employee of ResMed for more than a decade, and I
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`have not been employed by the above-mentioned manufacturer for Fisher & Paykel
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`Healthcare Limited for more than five years. Instead, I am currently employed as
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`Project Engineer by Cavotec MoorMaster Limited in Christchurch, New Zealand.
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`18. Based upon my knowledge and experience in these fields, I am aware
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`of the needs confronting, and the known solutions available to, mask designers in
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`the field of respiratory therapy—from the early 2000s until the present. I am aware
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`of the conventional design options that were available to a POSITA. My analysis
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`set forth in this declaration is informed by my experience with medical devices and
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`respiratory therapy. Based on my above-described experiences in medical devices
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`and respiratory therapy, I believe that I am considered an expert in at least the field
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`of respiratory therapy, including the design and development of respiratory
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`interfaces, such as CPAP masks. Also, based on my experiences, I understand and
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`know of the capabilities of a POSITA, including during the time of invention, and I
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`participated in organizations and worked closely with many such persons of skill
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`during that time frame.
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`MATERIALS CONSIDERED
`
`19.
`
`In preparing this declaration, I have considered the claims,
`
`specification, and prosecution history of the ’914 patent. I have considered the
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`claims, specification, and prosecution history of the ’315 patent; I have considered
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`the claims, specification, and prosecution history of the ’405 patent. As part of my
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`analysis for this Declaration, I have considered my own knowledge and
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`experience, including my work and experience with medical devices and
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`respiratory therapy, and my experience in working with others involved with
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`medical devices and respiratory therapy. Some additional materials that I have
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`reviewed in preparing this declaration include the following documents:
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`
`
` RMD1001: U.S. Patent No. 9,974,914 (“the ’914 patent”)
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` RMD1002: Prosecution History of the ’914 Patent (“Prosecution
`
`History”)
`
` RMD1003: U.S. Patent No. 9,333,315 (“the ’315 patent”)
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` RMD1004: Prosecution History of the ’315 Patent (“Prosecution
`
`History”)
`
` RMD1005: U.S. Patent No. 9,529,405 (“the ’405 patent”)
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` RMD1006: Prosecution History of the ’405 Patent (“Prosecution
`
`History”)
`
` RMD1007: New Zealand Patent Application 531332
`
` RMD1008: New Zealand Patent Application 534606
`
` RMD1009: (will be this Declaration of Anthony Michael Ging)
`
` RMD1010: U.S. Pat. Pub. No. 2005/0011524 (“Thomlinson”)
`
` RMD1011: U.S. Pat. Pub. No. 2004/0226566 (“Gunaratnam”)
`
` RMD1012: U.S. Pat. No. 6,478,026 (“Wood”)
`
` RMD1013: U.S. Patent No. 7,357,136 (“Ho”)
`
` RMD1014: U.S. Pat. Pub. No. 2005/0028822 (“Sleeper”)
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` RMD1015: U.S. Pat. No. 7,658,189 (“Davidson”)
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`EXHIBIT 1009 - PAGE 10
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` RMD1016: U.S. Provisional Application Serial No. 60/493,515
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`(“Sleeper Provisional Application”)
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` RMD1017: U.S. Provisional Application Serial No. 60/529,696
`
`(“Gunaratnam Provisional Application”)
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` RMD1018: U.S. Pat. Pub. No. 2004/0025882A1 (“Madaus”)
`
`issued as U.S. Pat. No. 7,562,658 (“Madaus”)
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` RMD1019: McGraw-Hill Dictionary of Scientific and Technical
`
`Terms, Sixth Edition (2003), p.2200 (“tube”).
`
` RMD1020: FPH infringement contentions against Resmed P10
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`CPAP interface product (excerpt for “flexible tube” element from
`
`public exhibit #29).
`
` RMD1021: U.S. Provisional Application Serial No. 60/496,059
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`(“Ho Provisional Application”).
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`
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`
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`PERSON OF ORDINARY SKILL IN THE ART
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`20.
`
`I understand that the teaching of the prior art is viewed through the
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`eyes of a POSITA. To assess the level of ordinary skill in the art, I understand that
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`one can consider the types of problems encountered in the art, the prior solutions to
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`those problems found in prior art references, the speed with which innovations
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`were made at that time, the sophistication of the technology, and the level of
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`education of active workers in the field.
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`21. Based upon my knowledge and experience in this area, a POSITA
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`would have had at least a bachelor’s degree in industrial design, mechanical
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`engineering, biomedical engineering, or a similar technical field, with at least two
`
`years of relevant product design experience. An increase in experience could
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`compensate for less education, and an increase in education could likewise
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`compensate for less experience. I believe the same definition of POSITA would
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`apply to each of these patents, and I believe I qualify as a POSITA for each of
`
`them. My analysis is thus based on the perspective of a POSITA having this level
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`of knowledge and skill at the relevant time of the invention. For purposes of my
`
`analysis, I have been informed that the Critical Date for the ’914, ’315 and ’405
`
`patents is the August 6, 2004 timeframe, and I have applied this timeframe as
`
`being the relevant time for the perspective of a POSITA. My analysis, however,
`
`regarding the background knowledge and definition of a POSITA and the known
`
`benefits of prior art mask features (as articulated below in this Declaration) would
`
`be correct even if the date of invention for any of these patents was earlier in 2004.
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`INTERPRETATION OF THE PATENT CLAIMS AT ISSUE
`
`22.
`
`I understand that, for purposes of my analysis in this inter partes
`
`review proceeding, the terms appearing in the patent claims should be interpreted
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`according to their “broadest reasonable construction in light of the specification of
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`the patent in which it appears.” 37 C.F.R. § 42.100(b). In that regard, I understand
`
`that the best indicator of claim meaning is its usage in the context of the patent
`
`specification as understood by a POSITA. I further understand that the words of
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`the claims should be given their plain meaning under the broadest reasonable
`
`interpretation standard, unless that meaning is inconsistent with the patent
`
`specification or the patent’s history of examination before the Patent Office (for
`
`example, where the applicant explicitly acted as a lexicographer to provide a clear
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`and unambiguous definition of a term in the patent specification, or where the
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`applicant provided an explicit disclaimer/disavowal of a particular claim scope).
`
`23.
`
`I also understand that the words of the claims should be interpreted as
`
`they would have been interpreted by a POSITA at the time the invention was made
`
`(not today). For purposes of my analysis here, I have used the August 6, 2004,
`
`filing date of NZ Patent Application 534606, to which each of the ’914, ’315 and
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`’405 patent claims priority and for which I have been informed is the Critical Date
`
`for the claims at issue, as the date of invention for the ’914, ’315 and ’405 patents.
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`Without exception, however, my analysis of the plain meaning of the recited claim
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`elements (under the broadest reasonable interpretation standard) in this Declaration
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`would be correct if the date of invention was anywhere within the early-to-mid-
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`2000s. My understanding of the Critical Date (August 6, 2004) for each patent is
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`based on the lack of any disclosure in the other, earlier New Zealand application of
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`(1) a segment on the prong part “inwardly curving toward an interior of the prong
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`part body” as claimed in the ’914 patent; (2) a pair of headgear extensions shown
`
`in Figures 9-11 and claimed in the ’914, ’315 and ’405 patents.
`
`24.
`
`I have been asked by counsel to assume that, under the U.S. Patent
`
`and Trademark Office’s Patent Trials and Appeal Board’s “broadest reasonable
`
`interpretation” standard, the term “flexible tube” appearing in claims 1 (RMD1003,
`
`9:36), 8 (RMD1003, 10:48), and 19 (RMD1003, 12:28) encompasses a textile
`
`sleeve capable of housing a flat reinforcement such as plastic. Counsel has
`
`provided me with an excerpt (RMD1020) from FPH’s infringement contentions
`
`from a dispute against Resmed in the U.S. International Trade Commission, which
`
`counsel identified as 337-TA-1136. This excerpt indicates that FPH believes a
`
`fabric strap is encompassed by the term “tube” in the ’315 patent.
`
`BACKGROUND OF THE THREE RELATED PATENTS
`
`A. ’914 Patent Overview (RMD1001)
`
`25. The ’914 patent describes “a nasal cannula [that] is shaped to fit
`
`within a user’s nares” to deliver positive pressure gases to a patient for respiratory
`
`therapy, such as continuous positive airway pressure (CPAP) therapy. RMD1003,
`
`Abstract, 1:14-17, 1:29-30, 4:21-42, FIG. 1. The ’914 patent explains the nasal
`
`cannula includes “three main components: a prong part 61, body part 62 and ball
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`jointed connector 63.” Id., 6:47-51. Figure 11 (reproduced below) illustrates an
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`example of these components:
`
`
`
`
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`RMD1001, FIG. 11. The prong part 61 includes a pair of nasal prongs configured
`
`to “to follow the contours of the human nares” and create a seal with internal
`
`surfaces of the user’s nares to “maintain the prongs within the user's nares” when
`
`in use. RMD1001, 5:9-11; 5:33-45; 7:3-5. The ’914 patent describes that the nasal
`
`cannula’s body part 62 includes a pair of headgear extensions 72, 73 on the sides
`
`that are connected to headgear worn by a patient to secure the nasal cannula to the
`
`patient’s face. Id., 8:49-65. The ’914 patent includes other figures that depict
`
`certain details regarding the geometry of the nasal prongs 64, 65 on prong part 61
`
`and the shape of body part 62, and of the headgear extensions, which are the focus
`
`of the claims, as discussed below in the Prosecution History section.
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`B. Prosecution History of ’914 Patent (RMD1002)
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`26. The ’914 patent was initially allowed after one Office Action.
`
`RMD1002, 245, 321-332. To arrive at the allowance, Patent Owner amended the
`
`independent claims to require that the geometry of the “prong part body” have an
`
`outer surface that includes a “curved segment” along a portion “facing toward a
`
`user’s face in use.” RMD1002, 277-291, 316-318. Patent Owner discussed these
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`amendments with the Examiner in an interview, during which Patent Owner was
`
`warned that that the amendments may cause Thomlinson (U.S. Pub.
`
`2005/0011524; RMD1004) to be applied to the claims. RMD1002, 301 (stating
`
`that “Thomlinson . . . appears to disclose a platform 58 that joins the nasal prongs
`
`10 and 12” and “a rejection under Thomlinson (an intervening reference) could be
`
`permissible”). Patent Owner addressed the Examiner’s assertions regarding
`
`Thomlinson’s “platform 58” structure of FIG. 9 in its Office Action Response,
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`following which the Office allowed the application. RMD1002, 286-289, 245.
`
`27. After this first Allowance, Patent Owner filed a Request for
`
`Continued Examination (RCE) that added new dependent claims corresponding to
`
`issued Claims 15-28 of the ’914 patent. RMD1002, 214-238. In response to the
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`RCE, the Office issued another Office Action. RMD1002, 90-113. In response to
`
`the Office Action, Patent Owner amended the independent claims to incorporate
`
`the subject matter of then pending dependent claim 4, which was identified in the
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`list of rejected claims (RMD1002, 91) but was not included in the substantive prior
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`art rejections. RMD1002, 65-79. In particular, the independent claims were
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`amended to further require that “the two prongs are angled toward each other and
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`toward the central axis, the two prongs having a first side adjacent the curved
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`segment and a second side adjacent the second portion, the first sides of the two
`
`prongs being disposed further apart than the second sides of the two prongs.”
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`RMD1002, 66-68 (emphasis added). In the Office Action Response, Patent Owner
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`specifically identified this subject matter in its annotation Figure 12 from the ’914
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`patent, as reproduced below:
`
`RMD1002, 73 (annotating RMD1001, Fig. 12); generally id., 65-79 (Patent
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`Owner’s Response). In simple terms, and as described in the ’914 patent
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`specification, “the prongs are … angled in the same manner as a human's nares.
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`The prongs 24, 25 are angled toward one another (or toward the vertical axis Y) at
`
`the top 27, 28 of the prongs [near the tip of the nose] and away from one another at
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`the bottom 29, 30 of the prongs” at the base of the nose. RMD1001, col.5, ll.19-
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`24. The Office allowed the application for a second time in response to these
`
`claim amendments, but did not include an explicit statement on the reasons for
`
`allowance. RMD1002, 14-17.
`
`C. ’315 Patent Overview (RMD1003)
`
`28. For purposes of this declaration, the ’315 patent shares the same
`
`disclosure as the ’914 patent. Figures 9 and 11 are pertinent:
`
`The ’315 patent includes figures other than Fig. 11 that depict certain details
`
`regarding the mechanism for attaching the positive airway pressure device to the
`
`user, which are the focus of the claims, as discussed below.
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`D. Prosecution History of ’315 Patent (RMD1004)
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`29. The application for the ’315 patent was filed September 4, 2015,
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`together with a “Request for First Action Interview (Full Pilot Program).”
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`RMD1004, 250. On December 4, 2015, the Office accommodated by sending
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`“First Action Interview Pilot Program Pre-Interview Communication” (RMD1004,
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`144-153), primarily identifying obviousness-type rejections for all 19 pending
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`claims. RMD1004, 145-147. In January and again in February, 2016, applicant
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`submitted a proposed amendment to each of the three independent claims, as well
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`as drawings and arguments to be discussed during an interview with the Examiner
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`on February 6. RMD1004, 106-140. Applicant’s submission also stated that the
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`claims were directed to the embodiment of Figures 9-11 in the application.
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`RMD1004, 86, 107, 111, 131. During the interview, the Examiner discussed
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`additional (non-identified) claim amendments. RMD1004, 104. On March 9,
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`2016, applicant submitted a summary of the interview together with supplemental
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`amendments to each independent claim. RMD1004, 84-100. A Notice of
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`Allowability followed on March 29, 2016, without further statements from the
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`Examiner. RMD1004, 21. The ’315 patent issued May 10, 2016. Very recently,
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`on September 10, 2018, patent owner filed an electronic Terminal Disclaimer over
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`the ’914 patent (RMD1001), which was accepted by the Office. RMD1004, 1-7.
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`E. ’405 Patent Overview (RMD1005)
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`30. For purposes of this declaration, the ’405 patent shares the same
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`disclosure as the ’914 patent. Figure 11 is pertinent and repeated above. The ’415
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`patent includes figures other than Fig. 11 that depict certain details regarding the
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`mechanism for attaching the positive airway pressure device to the user, which are
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`the focus of the claims, as discussed below.
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`F. Prosecution History of ’405 Patent (RMD1006)
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`31. The application for the ’405 patent was filed March 31, 2016, together
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`with a “Request for First Action Interview (Full Pilot Program).” RMD1006, 234.
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`On June 16, 2016, the Office accommodated by sending “First Action Interview
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`Pilot Program Pre-Interview Communication” (RMD1006, 121-137), primarily
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`identifying obviousness-type double patenting issues between then-pending claims
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`1-7 and (1) claims 1-3, 6 and 15 of the ’315 patent (see RMD1006, 110-111) and
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`(2) claims 1 and 3 of then-pending published application U.S. 2016/038705 which
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`would become U.S. Patent 9,550,038 (see RMD1006, 111). The First Action
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`Communication also included objections to the remaining claims 8-20. RMD1006,
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`123. Applicant responded on July 18, 2016, by waiving an interview and
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`amending independent claim 16. RMD1006, 102-117. On September 7, 2016, the
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`appropriate Terminal Disclaimers were filed and accepted. RMD1006, 91-100.
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`Two days later, applicant proposed amendments to thirteen claims (RMD1006, 85-
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`90) that were converted into an Examiner’s Amendment (RMD1006, 67-72). The
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`Examiner provided Reasons for Allowance as well. RMD1006, 71. On October
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`13, 2018, the applicant restarted prosecution by filing a Request for Continued
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`Prosecution together with some 88 prior art references. RMD1006, 44-51. On
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`November 7, 2016, the Examiner allowed the case without further comment.
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`RMD1006, 25-29. The ’405 patent issued January 10, 2017. Very recently, on
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`September 10, 2018, patent owner filed an electronic Terminal Disclaimer over the
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`’914 patent (RMD1001), which was accepted by the Office. RMD1006, 1-7.
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`SUMMARY OF CITED REFERENCES
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`A. Thomlinson (Ex. 1004)
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`32. Thomlinson (RMD1010) is a U.S. patent application publication titled
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`“Nasal Interface Apparatus.” Thomlinson purports to be directed to “nasal
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`interfaces suitable for ventilation applications, such as continuous positive airway
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`pressure (CPAP) applications, and bi-level positive airway pressure (BIPAP)
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`applications, and intermittent (non-continuous) positive pressure (IPPB)
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`applications.” RMD1010, [0193]. With any of these possible ventilation
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`applications, Thomlinson’s nasal interface is configured to deliver a pressurized
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`flow of air to a patient, which may be warmed, humidified, and/or enriched with
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`certain gases such as oxygen. RMD1010, [0199] (“[T]he nasal interface can be
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`connected to ventilator apparatus via additional tubing or the like. The ventilator
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`apparatus can be used to provide air, enriched air (22% to 100% Oxygen), or
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`alternative gas mixtures to a patient in need thereof.”), [0325] (“the system may
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`also warm and humidify the delivered air”).
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`33. For example, one embodiment of Thomlinson’s nasal interface is
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`depicted in Figures 10A and 10B. See, e.g., RMD1010, FIGS. 10A-10B, [0216]-
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`[0217] (overview of FIGS. 10A-10B), FIGS. 17A-17H (variations of “distal
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`portion” component from FIGS. 10A-10B), FIGS. 13A-13I (variations of
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`“proximal portion” component from FIGS. 13A-13I). Figure 10A shows the
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`interface as assembled, and Figure 10B shows an exploded view of the assembly:
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`RMD1010, FIGS. 10A-10B.
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`34. The components shown in Figures 10A and 10B were common in
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`nasal ventilation interfaces before the Critical Date of the ’315 patent. These
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`components include a pair of nasal prongs 10 and 12, a proximal portion 14, a
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`distal portion 16, and ventilation ports in the form of nozzles 22 for ventilating
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`carbon dioxide exhaled by the patient during use. RMD1010, FIGS. 10A-10B,
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`[0216]-[0217]. The nasal prongs 10 and 12 are configured to fit within openings
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`60 and 62 of the proximal portion 14, and the proximal portion 14 is configured to
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`seal with the distal portion 16 to create a chamber through which pressurized air
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`flows to the nasal prongs 10 and 12 during inspiratory phases of the patient’s
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`breathing cycle, and through which exhaled air can be exhausted during expiratory
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`phases of the breathing cycle.
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`35. Thomlinson discloses a number of variations of its nasal interface, and
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`these variations would have suggested a number of different predictable design
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`options to a POSITA at the time. See RMD1010, [0329] (“While the invention is
`
`susceptible to various modifications, and alternative forms, specific examples
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`thereof have been shown in the drawings and are herein described in detail. It
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`should be understood, however, that the invention is not to be limited to the
`
`particular forms or methods disclosed.”), [0212] (“[O]ne of skill in the art can
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`readily interchange components and features of different embodiments of the
`
`present invention in light of the teachings set forth herein to arrive at other
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`embodiments. Such interchangeability is within the scope of this disclosure.”).
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`One of the variations described in Thomlinson relates to the prong part of the nasal
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`interface. Although Figures 10A and 10B show the nasal prongs 10 and 12 and the
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`proximal portion 14 as separate components that can be assembled for use,
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`Thomlinson explains that the nasal prongs 10 and 12 and the proximal portion 14
`
`optionally can be “integrally” formed with each other to create a prong part.
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`RMD1010, [0274] (“[N]asal prongs 10 and 12 and proximal portion 14 can be
`
`combined to form part of a nasal interface of the present invention. In another
`
`embodiment, nasal prongs 10 and 12 and proximal portion 14 integral with each
`
`other and form part of a nasal interface of the present invention.”), [0299] (“[I]n
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`one embodiment, proximal portion 14, is integral with or combined with nasal
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`prongs 10 and 12.”), [0300] (“Different components of the invention can be …
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`formed as integral bodies.”). Thomlinson does not sp