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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. AND
`RESMED CORP.,
`Petitioners,
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`v.
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`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner.
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`Case IPR2019-00179
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`U.S. Patent No. 9,333,315
`Issue Date: May 10, 2016
`Title: Breathing Assistance Apparatus
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`PETITION FOR INTER PARTES REVIEW
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`TABLE OF CONTENTS
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`I. MANDATORY NOTICES UNDER 37 C.F.R § 42.8(a)(1) ......................... 1
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`A.
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`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) .......................... 1
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`B.
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`Related Matters Under 37 C.F.R. § 42.8(b)(2) ................................... 1
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`C.
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`Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ................ 1
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`D.
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`Service Information ........................................................................... 2
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`II.
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`PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................ 2
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`III. REQUIREMENTS FOR IPR ....................................................................... 3
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`A. Grounds for Standing Under 37 C.F.R. § 42.104(a) ........................... 3
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`B.
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`Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested ........... 3
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`IV. SUMMARY OF THE ’315 PATENT .......................................................... 4
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`A.
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`Brief Description ............................................................................... 4
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`B.
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`Prosecution History of the ’315 Patent ............................................... 4
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`C.
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`The Critical Date of the Claims of the ’315 Patent ............................. 5
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`V.
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`Claim Construction Under 37 C.F.R. §§ 42.104(b)(3).................................. 6
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`A.
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`“Tube” ............................................................................................... 7
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`B.
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`POSITA ............................................................................................. 7
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`VI. GROUND 1: CLAIMS 1, 4-14, 16-19 ARE OBVIOUS UNDER 35 USC
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`103 BASED ON GUNARATNAM ............................................................. 8
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`VII. GROUND 2: CLAIMS 2, 15 ARE OBVIOUS UNDER 35 USC 103
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`BASED ON GUNARATNAM IN VIEW OF HO ......................................37
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`i
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`VIII. GROUND 3: CLAIMS 6-7, 9-14, 16-18 ARE OBVIOUS UNDER 35 USC
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`103 BASED ON THOMLINSON IN VIEW OF GUNARATNAM............39
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`IX. GROUND 4: CLAIMS 1, 3-5, 8, 19 ARE OBVIOUS UNDER 35 USC 103
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`BASED ON THOMLINSON IN VIEW OF GUNARATNAM AND
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`MADAUS ...................................................................................................59
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`X. GROUND 5: CLAIM 2 IS OBVIOUS UNDER 35 USC 103 BASED ON
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`THOMLINSON IN VIEW OF GUNARATNAM, MADAUS AND HO ....67
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`XI. GROUND 6: CLAIM 15 IS OBVIOUS UNDER 35 USC 103 BASED ON
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`THOMLINSON IN VIEW OF GUNARATNAM AND HO .......................68
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`XII. HO PROVISIONAL APPLICATION.........................................................68
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`ii
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`RMD1001: U.S. Patent No. 9,974,914 (“the ’914 patent”)
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`EXHIBITS
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`RMD1002: Prosecution History of the ’914 Patent (“Prosecution History”)
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`RMD1003: U.S. Patent No. 9,333,315 (“the ’315 patent”)
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`RMD1004: Prosecution History of the ’315 Patent (“Prosecution History”)
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`RMD1005: U.S. Patent No. 9,539,405 (“the ’405 patent”)
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`RMD1006: Prosecution History of the ’405 Patent (“Prosecution History”)
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`RMD1007: New Zealand Patent Application 531332
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`RMD1008: New Zealand Patent Application 534606
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`RMD1009: Declaration of Anthony Michael Ging
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`RMD1010: U.S. Pat. Pub. No. 2005/0011524 (“Thomlinson”)
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`RMD1011: U.S. Pat. Pub. No. 2004/0226566 (“Gunaratnam”)
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`RMD1012: RESERVED
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`RMD1013: U.S. Patent No. 7,357,136 (“Ho”)
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`RMD1014: RESERVED
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`RMD1015: RESERVED
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`RMD1016: RESERVED
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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”)
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`iii
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`RMD1019: McGraw-Hill Dictionary of Scientific and Technical Terms, Sixth
`Edition (2003), p.2200 (“tube”).
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`RMD1020: Public Exhibit No. 29 in 337-TA-1136 (excerpt, pp.41-43).
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`RMD1021: U.S. Provisional Application Serial No. 60/496,059 (“Ho Provisional
`Application”).
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`iv
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`I. MANDATORY NOTICES UNDER 37 C.F.R § 42.8(a)(1)
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`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
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`ResMed Limited, ResMed Inc. and ResMed Corp. (collectively,
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`“Petitioners” or “ResMed”) are the real parties-in-interest, and petition for Inter
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`Partes Review (“IPR”) under 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42 of claims
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`1-19 (“the Challenged Claims”) of U.S. Patent No. 9,333,315 (“the ’315 patent”)
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`assigned to Fisher & Paykel Healthcare Limited (“Patent Owner”).
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`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
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`Three related patents, U.S. Patent 9,333,315; U.S. Patent 9,539,405; and
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`U.S. Patent 9,974,914 are the subject of the following lawsuit that may affect or be
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`affected by a decision in this proceeding: In the Matter of Obstructive Sleep Apnea
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`Treatment Mask Systems and Components Thereof, Inv. No 337-TA-1136, filed
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`with the U.S. International Trade Commission on September 7, 2018. ResMed
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`Corp. is currently a defendant in an earlier litigation in the Southern District of
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`California involving other patents assigned to Patent Owner. See Fisher & Paykel
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`Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv-02068-GPC-WVG (S.D.
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`Cal.). Petitioners and Patent Owner are currently involved in several IPRs before
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`the Board related to the other patents involved in that earlier litigation, but neither
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`the earlier litigation nor the earlier IPRs involve the three patents identified above.
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`C. Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
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`Petitioners provide the following designation of counsel.
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`1
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`Lead Counsel
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`Backup counsel
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`Edward H. Sikorski
`(USPTO Reg. No. 39,478)
`Ed.Sikorski@dlapiper.com
`DLA Piper LLP (US)
`401 B Street, Suite 1700
`San Diego, California 92101-4297
`Tel.: (619) 699-2645
`Fax: (619) 764-6645
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`Tiffany Miller
`(USPTO Reg. No. 52,032)
`Tiffany.Miller@dlapiper.com
`DLA Piper LLP (US)
`401 B Street, Suite 1700
`San Diego, California 92101-4297
`Tel.: (619) 699-3445
`Fax: (619) 764-6445
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`James M. Heintz
`(USPTO Reg. No. 41,828)
`James.Heintz@dlapiper.com
`DLA Piper LLP (US)
`One Fountain Square, Suite 300
`Reston, Virginia 20190-5602
`Tel.: (703) 773-4148
`Fax: (703) 773-5008
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`D.
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`Service Information
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`Papers concerning this matter should be served to the addresses of all
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`counsel listed above. Petitioners consent to electronic service by email above.
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`II.
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`PAYMENT OF FEES – 37 C.F.R. § 42.103
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`The Patent and Trademark Office is authorized to charge Deposit Account
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`No. 07-1896 for the fee set in 37 C.F.R. § 42.15(a) for this Petition and any
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`additional fees, referencing Attorney Docket 358054-000081. This Petition
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`requests review of 19 claims which should incur $32,900.
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`2
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`III. REQUIREMENTS FOR IPR
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`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
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`Petitioners certify that the ’315 patent is available for IPR and Petitioners are
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`not barred or estopped from requesting IPR.
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`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
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`Petitioners request IPR of the Challenged Claims on the grounds listed
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`below. A declaration from Mr. Anthony Ging accompanies this Petition.
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`Ground
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`Claims
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`Basis
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`References
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`1
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`2
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`3
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`4
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`5
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`6
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`1, 4-14, 16-19
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`§103 Gunaratnam
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`2, 15
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`§103 Gunaratnam in view of Ho
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`6-7, 9-14, 16-18
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`§103 Thomlinson in view of Gunaratnam
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`1, 3-5, 8, 19
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`§103 Thomlinson in view of Gunaratnam
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`and Madaus
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`2
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`§103 Thomlinson in view of Gunaratnam,
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`Madaus and Ho
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`15
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`§103 Thomlinson in view of Gunaratnam
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`and Ho
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`3
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`IV. SUMMARY OF THE ’315 PATENT
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`A. Brief Description
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`The ’315 patent describes nasal cannula for delivery of positive pressure
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`gases to a patient for respiratory treatment (e.g., continuous positive airway
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`pressure (CPAP) therapy). RMD1003, Abstract, 1:14-16, 1:29-30, 4:10-30,
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`FIG. 1. The nasal cannula includes “three main components: a prong part 61, body
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`part 62 and ball jointed connector 63.” Id., 6:50-51. Figures 9, 11 are pertinent:
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`RMD1003, FIG. 11. Body part 62 further includes a pair of headgear extensions
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`72,73 that extend from the sides and configured to connect with a headgear
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`arrangement to secure the nasal cannula to the patient’s face. Id., 8:26-43. The
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`’315 patent describes and claims certain detail about prong part 61, body part 62,
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`and the headgear assembly including extensions and straps.
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`B.
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`Prosecution History of the ’315 Patent
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`The application for the ’315 patent was filed with a “Request for First
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`Action Interview (Full Pilot Program).” RMD1004, 250. The Office obliged with
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`4
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`a “First Action Interview Pilot Program Pre-Interview Communication”
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`(RMD1004, 144-153), primarily identifying obviousness-type rejections for all 19
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`pending claims based on Stenzler (U.S. 2003/0200970A1), Wilkie (US 7,201,169),
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`Piljay (US 4,437,462), Chadran (US 2006/0124131A1) and Thomlinson (US
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`2005/011524A1). RMD1004, 145-147. In January and again February 2016,
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`applicant submitted a proposed amendment to each of the three independent
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`claims, as well as drawings and arguments to be discussed during an interview
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`with the Examiner on February 6, 2016. RMD1004, 106-140. Applicant’s
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`submission also stated that the claims were directed to the embodiment of Figures
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`9-11. RMD1004, 86, 107, 111, 131. During the interview, the Examiner only
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`discussed Stenzler, Wilkie and Piljay and noted that “further proposed
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`amendments” (not specified) were discussed. RMD1004, 104. On March 9, 2016,
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`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, and a subsequent
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`Terminal Disclaimer was filed and accepted in September 2018. RMD1004, 1-5.
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`C. The Critical Date of the Claims of the ’315 Patent
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`The ’315 patent claims priority to a pair of New Zealand patent applications
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`filed February 23, 2004, and August 6, 2004, respectively. RMD1003, Cover
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`5
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`Page; RMD1007 (Feb. 2004 application); RMD1008 (Aug. 2004 application).
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`However, each Challenged Claim requires at least one feature first disclosed in the
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`second New Zealand application filed August 6, 2004, making that the earliest
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`priority date to which the challenged claims are entitled (the “Critical Date”).
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`Specifically, independent claims 1, 6 and l7 each recite a “headgear
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`extension” corresponding to the extension(s) 72,73 of Figure 9, supra (there are
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`two “73” in the figure; the relevant one is near numeral 79). Only the second New
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`Zealand application discloses that structure. See RMD1008, depicting new Figures
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`9-16 first introduced in August 2004.
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`V. Claim Construction Under 37 C.F.R. §§ 42.104(b)(3)
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`For the purposes of IPR only, Petitioners submit that the terms of the ’315
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`patent are to be given their broadest reasonable interpretation (“BRI”) as
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`understood by a person of ordinary skill in the art at the time of the alleged
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`invention (a “POSITA”) in view of the patent’s specification. 37 C.F.R.
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`§42.100(b).1 For purposes of this IPR only, Petitioners submit that all claim terms
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`should be given their plain meaning under the BRI standard. Wellman, Inc. v.
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`Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need
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`1 The Office recently proposed a future change from the BRI standard to a standard
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`applied in District Courts. See 83 Fed. Reg. 21221 (May 9, 2018).
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`6
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`only be construed to the extent necessary to resolve the controversy.”). Petitioners
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`expressly reserve the right to take different claim construction positions in other
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`forums or situations where claim construction standards are different, or to the
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`extent constructions proposed herein do not resolve whatever controversies will
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`exist at that time. Moreover, Petitioners believe certain claims of the challenged
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`patent are deficient under 35 U.S.C. § 112.
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`A.
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`“Tube”
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`Patent Owner has taken the position that the term “tube” in claims 1, 8 and
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`19 can encompass ostensibly a textile sleeve. RMD1020 (from Public Ex.29 in the
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`above-identified Related Matter, 337-TA-1136). Accordingly, Petitioners have
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`included, in the instant IPR challenges, prior art U.S. Pat. Pub. 2004/0025882A1
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`(“Madaus”) under the premise that its textile sleeve falls within the BRI of the term
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`“tube.” Petitioners also provide a dictionary definition for the Board’s
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`consideration (RMD1019) of the BRI (“long cylindrical body with a hollow center
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`used especially to convey fluid.”).
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`B.
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`POSITA
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`Petitioners submit a POSITA in 2004 would have had at least a bachelor’s
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`degree in industrial design, mechanical engineering, biomedical engineering, or
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`similar technical field, with at least two years of relevant product design
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`experience. An increase in experience could compensate for less education, and an
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`7
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`increase in education could likewise compensate for less experience. (RMD1009
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`(Ging Decl.), ¶¶20-21.)
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`VI. GROUND 1: CLAIMS 1, 4-14, 16-19 ARE OBVIOUS UNDER 35 USC
`103 BASED ON GUNARATNAM
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`Gunaratnam (RMD1011) was filed February 20, 2004 (before the August 6,
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`2004 Critical Date of the ’315 patent), and published November 18, 2004.
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`Gunaratnam is prior art under 35 U.S.C. § 102(e). Gunaratnam was not mentioned
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`in the examiner’s correspondence with patent applicant.
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`The obvious and predictable modifications to Gunaratnam demonstrate that
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`claims 1, 4-14, 16-19 were unpatentable. The analysis below begins with
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`independent claims 6 and 17 together, the latter being generally a shorter version
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`of claim 6. The analysis then addresses independent claim 1.
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`[6.P] A mask assembly for delivering positive airway pressure to a user, the
`mask comprising:
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`[17.P] A mask assembly for delivering positive airway pressure to a user, the
`mask comprising:
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`If the preamble is deemed a limiting element of claim 6 (or 17), Gunaratnam
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`discloses it. POSITA would have found at least three embodiments relevant to the
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`claimed mask assembly: a first embodiment (e.g., FIGS. 1-8), a second
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`embodiment (e.g., FIGS. 25-31), and a third embodiment he generally identifies as
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`his “seventh” embodiment (“FIGS. 108-113 [which] includes headgear 602 and
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`cushion assembly 604, each of which is substantially similar to the headgear and
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`8
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`cushion assembly shown, e.g., in FIGS. 60 and 61, respectively.”). Each
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`embodiment of his “nasal assembly [is] used for treatment, e.g., of Sleep
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`Disordered Breathing (SDB) with Continuous Positive Airway Presure (CPAP) or
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`Non-invasive Positive Pressure Ventilation (NPPV).” RMD1011, [0002]. The
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`nasal interface is a mask for delivering positive airway pressure to a user.
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`RMD1009, ¶¶47,66.
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`[6.1] a rigid mask body comprising a central portion, an outer surface having at
`least a curved portion;
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`[17.1] a rigid mask body;
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`Gunaratnam discloses this element in each of the three embodiments
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`identified above. Each embodiment includes a rigid mask body, e.g., frame 16 in
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`Figures 1-4, frame 216 in Figures 26-29, and frame 516 in Figures 60-61, formed
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`of “rigid … polymeric material.” RMD1011, [0178]; see also [0238, “the frame
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`216 adds rigidity to the relatively flexible nozzle assembly 218.”)]. To the extent
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`any embodiment is deemed not to use a rigid mask body, Gunaratnam instructs that
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`“[e]ach illustrated main embodiment includes features that may be used with
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`and/or in the other embodiments, as would be apparent to those of ordinary skill in
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`the art.” RMD1011, [0175]. POSITA would have found it obvious to use
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`Gunaratnam’s suggested rigid polymeric material in each of these three
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`embodiments to achieve the rigidity Gunaratnam desires, and to enable connection
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`9
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`of the flexible nozzle assembly to which each mask body attaches. RMD1009,
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`¶¶48,67.
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`RMD1011, FIGS. 1-4, 28-29, 60; [0118], [0315]-[0317], [0375]-[0379], [0396],
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`[0398], FIGS. 108-109, 80, 117, 119, 120, 122.
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`[6.2] an inspiratory conduit connected to the rigid mask body;
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`[17.2] an inspiratory conduit connected to the rigid mask body;
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`Gunaratnam discloses this element in each of the three embodiments
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`identified above. Conduit 72 in Figures 9-12, conduit 274 in Figures 32-36, and
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`delivery air tube 606, 612 in Figures 108-109 are connected to their respective
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`10
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`rigid masks and to air supply conduits to receive breathable air for the user.
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`RMD1011, [0198], [0242], [0377], [0385]-[0388]. RMD1009, ¶¶49,68. The
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`inspiratory conduits are shown and described in FIGS. 13-14, 36-37, 108-109.
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`[6.3] a prong part comprising a hollow body and first and second nasal prongs
`extending from the hollow body, the hollow body removably connected to
`the mask body;
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`[17.3] a prong part comprising a hollow body and first and second nasal prongs
`extending from the hollow body, the hollow body removably connected to
`the mask body;
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`Gunaratnam discloses this element in each of the three embodiments
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`identified above. In his first and second embodiments “nozzle assembly 18 is
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`removably attached to the frame 16 with a snap, e.g., snap-fit, push-pin fit, or
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`stretch over fit, which allows for simple assembly.” RMD1011, [0186]; see [0240
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`(“when nozzle assembly 218 is attached to the frame 216….”)]. The nozzle
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`assembly is preferably silicone. RMD2011, [0191]-[0192]. The nozzles can be
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`nasal prongs. RMD1011, [0189]. Figure 6 shows the nozzle assembly in cross
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`section, depicting it as a single piece with two nasal nozzles (at 50, 58) extending
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`from a hollow body (near numeral 52). The second embodiment in Figure 25
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`shows a more cylindrical shape to the hollow body. Moreover, Gunaratnam
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`instructs that “[e]ach illustrated main embodiment includes features that may be
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`used with and/or in the other embodiments, as would be apparent to those of
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`ordinary skill in the art.” RMD1011, [0175].
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`11
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`The third identified embodiment, FIGS. 108-113, uses nozzle assembly 518 of
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`FIGS. 60-61 which is cylindrical somewhat like FIG. 25 but its hollow body has
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`free ends that are joined by a clip 530 when connected to the mask frame.
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`RMD1011, [0291]-[0298]. RMD1009, ¶¶50,69.
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`[6.4] a first headgear extension having a distal end connected to the rigid mask
`body on a distal side of the prong part at a location spaced from a user in
`use, and a proximal end disposed proximally toward a user in use,
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`[17.4] a first headgear extension having a distal end connected to the rigid mask
`body on a distal side of the prong part at a location spaced from a user in
`use, and a proximal end disposed proximally toward a user in use,
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`Gunaratnam discloses this element in each of the three embodiments
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`identified above. In embodiment 1, two connectors 26 are connected to the rigid
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`12
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`mask body; one connector is the claimed “first headgear extension” and the other is
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`the claimed “second headgear extension” recited as the next claim element below.
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`On each side of the mask body, connector 26 has a first/front side 60 (a “distal
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`side” according to the claim) connected to the mask body on a distal side of the
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`prong part - note in Figure 1 that the connector is on a distal side of the prong part
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`18, when considered in a lateral direction, and on the distal side of the prong part
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`18 when considered in a direction away from the user). RMD1011, Fig. 1. The
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`same figure shows the distal side of connector 26 is at a location spaced from the
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`user in use; it also shows that its L-shape disposes the opposite/rear side 62
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`(“proximal end”) of connector 26 proximally toward the user in use:
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`RMD1011, Fig 1.
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`In embodiment 2, connector portion 226 (a respectively claimed “headgear
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`extension”) is on each side of the rigid mask 216. Like the first embodiment, the
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`first connector portion 226 connects (at its “distal end” 260) to the rigid mask 216
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`13
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`
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`at a location that is on a distal side, both laterally and away from the user, of the
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`nozzle assembly 218. It also connects at a location spaced from the user in use,
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`and its L-shape disposes its opposite/rear end 262 (the claimed “proximal end”)
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`proximally toward the user in use.
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`RMD1011, Figs. 26-27; see also Fig. 36. For the third embodiment in Figures
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`108-110, each headgear yoke 608 attaches (on its “distal end”) via ring 610 on a
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`side of the body of the nasal cannula body, and extends laterally outward and
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`upward from the body. Id., FIGS. 108-109. Each yoke is a claimed headgear
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`extension; Figure 110 shows the extension’s distal end connected to the rigid mask,
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`e.g., near numeral 616, which is on a distal side (laterally and away from the user)
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`of the nozzle assembly (“prong part” 617). The connection location is also spaced
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`from the user during use. The L-shape disposes the opposite, proximal side of
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`each yoke proximally toward the user during use. RMD1009, ¶¶51,70.
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`14
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`905
`
`Headgear Straps 904
`
`Second Headgear
`Extension
`(Right Yoke 608)
`
`sou —/
`
`12D '
`\612*
`El]?
`
`First Headgear
`Extension
`(Left Yoke 608)
`
`822
`
`
`
`Second Headgear
`Extension
`
`(Right Yoke 608)
`
`First Headgear
`Extension
`(Left Yoke 608)
`
`
`
`
`309
`
`FIG.
`
`|08
`
`
`
`.
`
`|09
`
`
`
`
`
`o “
`
`.‘\‘L‘““
`
`o '
`
`
`
`15
`15
`
`
`
`
`
`[6.5] the first headgear extension comprising a first portion and a second
`portion, the first portion of the first headgear extension comprising the
`distal end of the first headgear extension and extending at least along a
`first lateral direction extending laterally away from the rigid mask body
`and beyond an outer periphery of the prong part, the second portion of the
`first headgear extension extending from the first portion, along a second
`direction extending more proximally toward the user than the first
`direction in use;
`
`[17.5] the first headgear extension extending from the rigid mask body, at least
`along a first lateral direction extending laterally away from the rigid mask
`body and beyond an outer periphery of the prong part and along a second
`direction extending more proximally toward the user than the first
`direction in use; and
`
`Gunaratnam discloses this element in each of the three embodiments
`
`identified above. In each embodiment, a connector or yoke (headgear extension)
`
`has an L-shape with a first portion starting at its “distal end’s” connection to the
`
`rigid mask body, and extending at least along a first (left) lateral direction laterally
`
`away from the rigid mask body, and beyond an outer periphery of the nozzle
`
`assembly (prong part). The second portion extends from the connector or yoke’s
`
`elbow area more proximally toward the user than the first (left) direction in use.
`
`RMD1011, see figures shown above. RMD1009, ¶¶52,71.
`
`16
`
`
`
`
`
`[6.6] a second headgear extension having a distal end connected to the rigid
`mask body on a distal side of the prong part at a location spaced from a
`user in use, and a proximal end disposed proximally toward a user in use,
`
`[17.6] a second headgear extension having a distal end connected to the rigid
`mask body on a distal side of the prong part at a location spaced from a
`user in use, and a proximal end disposed proximally toward a user in use,
`
`Gunaratnam’s second headgear extension is the mirror-image of the first
`
`headgear extension (connector 26, 226 or yoke 608) disclosed in the three
`
`aforementioned embodiments, and analyzed in [6.4]/[17.4] above. RMD1011,
`
`figures shown above. RMD1009, ¶¶53,72.
`
`[6.7] the second headgear extension comprising a first portion and a second
`portion, the first portion of the second headgear extension comprising the
`distal end of the second headgear extension and extending at least along a
`third lateral direction extending laterally away from the rigid mask body
`and beyond the outer periphery of the prong part, the second portion of the
`second headgear extension along a fourth direction more proximally
`toward the user than the third direction in use; and
`
`[17.7] the second headgear extension extending from the rigid mask body at least
`along a third lateral direction extending laterally away from the rigid
`mask body and beyond the outer periphery of the prong part and along a
`fourth direction more proximally toward the user than the third direction
`in use.
`
`Gunaratnam’s second headgear extension is the mirror-image of the first
`
`headgear extension (connector 26, 226 or yoke 608) disclosed in the three
`
`aforementioned embodiments, and analyzed in [6.5]/[17.5] above. The claimed
`
`“third direction” is a right-hand direction (generally opposite the “first direction);
`
`the fourth direction mirrors the second direction. RMD1011, figures shown above.
`
`RMD1009, ¶¶54,73.
`
`17
`
`
`
`
`
`[6.8] a headgear strap connected to the first headgear extension at a first
`location between the distal end and the proximal ends of the first headgear
`extension and connected to the second headgear extension at a second
`location disposed between the proximal and distal ends of the second
`headgear extension.
`
`[18] The mask assembly of claim 17 additionally comprising a headgear strap
`connected to the first headgear extension at a first location between the
`distal end and the proximal ends of the first headgear extension and
`connected to the second headgear extension at a second location disposed
`between the proximal and distal ends of the second headgear extension.
`
`Gunaratnam discloses this element in each of the three embodiments
`
`identified above. In embodiment 1, Figure 18 shows a strap 92 whose “reduced
`
`width [connects] around the cross-bar 70” of the first and second headgear
`
`extensions. RMD1011, FIG. 18, [0209]-[0210]. Embodiment 2 illustrates in
`
`Figure 37 a headgear strap incorporating an air conduit and having a piece 296
`
`similarly engaging a respective crossbar 270 of the first and second headgear
`
`extensions. RMD1011, [0245]-[0250]. In these embodiments, each crossbar 70
`
`(i.e., the “first location” and “second location”) is between the distal end and
`
`proximal end of the first (left) and second (right) headgear extensions 26, 226,
`
`thereby making the location of the strap-extension connection between the
`
`proximal and distal ends of the extension. RMD1011, FIGs. 1, 9-12, 25-27,32-33,
`
`37. RMD1009, ¶¶55,74.
`
`18
`
`
`
`
`
`In the third identified embodiment, headgear strap 904, 906 (in orange
`
`
`
`
`
`annotation below) connects to each green-annotated yoke (headgear extension) at a
`
`location between the two ends of the yoke. RMD1011, FIG. 108. In the magnified
`
`view below, POSITA would understand the two pieces to be connected by
`
`stitching where they overlap, thus locating their connections at an area between the
`
`distal and proximal ends of each yoke. RMD1011, [0398] (“…yoke [608] and
`
`headgear could be formed of one piece, instead of using stitching” (emphasis
`
`added). “Sewn” overlap is also shown in FIG. 60. RMD1009, ¶¶55,74.
`
`19
`
`
`
`
`
`Second Headgear
`Extension
`(Right Yoke 608)
`
`600 —/
`
`2
`
`f 9“
`
`Headgearstraps 904
`
`Second Headgear
`
`Extension
`First Headgear
`
`
`Extension
`(Left Yoke 608)
`
`First Headgear
`Extension
`(Left Yoke 608)
`
`(Right Yoke 608)
`
`
`FIG.
`
`IDS
`
`609
`
`
`
`
`
`
`
`
`
`
`20
`20
`
`
`
`
`
`[7] The mask assembly of claim 6, wherein the first portion of the first
`headgear extension is shorter than the second portion of the first headgear
`extension and the first portion of the second headgear extension is shorter
`than the second portion of the second headgear extension.
`
`Gunaratnam discloses or renders obvious this element in each of the three
`
`embodiments identified above. In the first embodiment (e.g., FIGS. 9-12),
`
`connector 26 has an L-shape whose two portions are generally of equal length. In
`
`the second embodiment (e.g., FIG. 25) the connector 226 appears also to satisfy the
`
`claimed lengths. To the extent these embodiments are deemed not to match the
`
`claimed lengths, POSITA would have found it obvious, based on the desired shape
`
`of the overall interface and the shape of a user’s head, to make the first portion of
`
`connector 26, 226 shorter than its second portion; for example, FIGS. 47B and 48B
`
`show similar connectors matching the claimed length requirements, and
`
`Gunaratnam says “[e]ach illustrated main embodiment includes features that may
`
`be used with an/or in the other embodiments, as would be apparent to those of
`
`ordinary skill in the art.” RMD1011, [0175]. Accordingly, POSITA would have
`
`found it obvious to use length proportions of FIG. 48B for the connectors 26, 226,
`
`in the first two embodiments. RMD1009, ¶56.
`
`21
`
`
`
`
`
`
`
`[8] The mask assembly of claim 6, wherein the headgear strap comprises a
`flexible tube and is connected to the second portion of the first headgear
`extension and the second portion of the second headgear extension.
`
`[19] The mask assembly of claim 18, wherein the headgear strap comprises a
`flexible tube engaged with the first and second headgear extensions.
`
`Gunaratnam discloses or renders obvious this element in the first two
`
`embodiments identified for claim 6 and claim 18. For claim 8, in those
`
`embodiments Gunaratnam’s headgear includes strap pieces (e.g., 96, 296)
`
`“connected to” each extension by mating with respective cross-bars 70, 270 on the
`
`“second portion” of each extension. RMD1011, [0210]. Claim 19, unlike claim 8,
`
`requires the tube itself to “engage” the first and second extensions, and indeed
`
`Gunaratnam’s L-shaped connectors (extensions) engage conduits 74, 274.
`
`Conduits “74, 76 [and 274] provide a single air flow channel” because they join
`
`together (e.g., at connector 284 in Fig. 37) thus forming a single tube that engages
`
`both extensions. RMD2009, ¶75. Claim 19 also requires, from claim 18, the
`
`headgear strap to “connect” to each extension, which is explained supra for claim
`
`22
`
`
`
`
`
`[18] specifically. RMD1009, ¶¶57,75. Note, claim 8 is also met by single tube 74,
`
`274 connecting the extensions at 72, 272.
`
`
`
`
`
`
`
`POSITA would have understood conduits 74/76/274 to be “structured from
`
`any suitable polymeric material such as silicone or a thermoplastic elastomer, such
`
`as Krayton®, for example.” RMD1011, [0204]-[0205]. POSITA would
`
`understand these materials to be flexible, as claimed. RMD1009, ¶¶57,75.
`
`23
`
`
`
`
`
`[9] The mask assembly of claim 6, wherein the first portion of the first
`headgear extension and the first portion of the second headgear
`extensions extend laterally outward distally of a sealing location between
`the prong part and the mask body and the second portion of the first
`headgear extension and the second portion of the second headgear
`extension terminate proximally of the sealing location between the prong
`part and the mask body.
`
`Gunaratnam discloses this element in the first two embodiments identified
`
`for claim 6. In each embodiment, each connector 26, 226 (headgear extension)
`
`extends laterally and outwardly to the left or right, respectively, and distally of the
`
`location where the nozzle assembly 18, 218 (prong part) and the rigid mask body
`
`16, 216 seal together. Moreover, each connector 26, 226 (headgear extension)
`
`terminates proximally of the same sealing location. This proximal location is
`
`evidenced by other embodiments, e.g., FIGs. 107, 107I, where a cushion assembly
`
`794 connects to a tube that extends much more distally of the sealing location, i.e.,
`
`to the rear of the user’s head. RMD1011, FIG. 107, 107-I.. RMD1009, ¶58.
`
`
`
`
`
`
`
`24
`
`
`
`
`
`[10] The mask assembly of claim 6, wherein the headstrap comprises first and
`second ends, the first end extending along first and second opposite sides
`of the second portion of the first headgear extension at the connection to
`the first headgear extension, the second end extending along first and
`second opposite sides of the second portion of the second headgear
`extension at the connection to the second headgear extension.
`
`Gunar
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