Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 12
`Entered: July 16, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`RESMED LIMITED, RESMED INC. AND RESMED CORP.,
`Petitioner,
`
`v.
`
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner.
`
`
`Case IPR2019-00179
`Patent 9,333,315 B2
`
`
`
`
`Before THOMAS L. GIANNETTI, JAMES J. MAYBERRY,
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`MAYBERRY, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`Tel: 571-272-7822
`
`Paper 12
`Entered: July 16, 2019
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`RESMED LIMITED, RESMED INC. AND RESMED CORP.,
`Petitioner,
`
`v.
`
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner.
`
`
`Case IPR2019-00179
`Patent 9,333,315 B2
`
`
`
`
`Before THOMAS L. GIANNETTI, JAMES J. MAYBERRY,
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`MAYBERRY, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`Case IPR2019-00179
`Patent 9,333,315 B2
`
`
`I. INTRODUCTION
`Petitioner, ResMed Limited, ResMed Inc., and ResMed Corp.
`(“ResMed”), filed a Petition (Paper 1, “Pet.”) requesting inter partes review
`of claims 1–19 (the “Challenged Claims”) of U.S. Patent No. 9,333,315 B2
`(Ex. 1003, the “’315 patent”). Pet. 1. Patent Owner, Fisher & Paykel
`Healthcare Limited (“Fisher”), filed a Preliminary Response (“Prelim.
`Resp.”) to the Petition. Paper 11. We have jurisdiction under 35 U.S.C.
`§ 314. See also 37 C.F.R. § 42.4(a) (permitting the Board to render
`institution decisions on behalf of the Director).
`To institute an inter partes review, we must determine that the
`information presented in the Petition shows “a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, upon
`considering the present record, we determine that ResMed has not
`established a reasonable likelihood that it would prevail with respect to at
`least one of the Challenged Claims. Accordingly, we deny the Petition.
`A. Related Matters
`The parties indicate that the ’315 patent has been asserted at the
`International Trade Commission. See Pet. 1. The procedural history at the
`International Trade Commission is not relevant to our analysis here.
`The parties also state that related patents are asserted in Fisher &
`Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv-02068-GPC-
`WVG (S.D. Cal.). Pet. 1; Paper 5, 1.
`B. The ’315 Patent
`The ’315 patent, titled “Breathing Assistance Apparatus,” issued
`May 10, 2016 from an application filed September 4, 2015. Ex. 1003, [54],
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`[45], [22]. The application that matured into the ’315 patent claims priority
`to a foreign application filed February 23, 2004. Id. at [30]. The ’315 patent
`relates “to apparatuses for treating sleep [apnea].” Id. at 1:15–16. Figure 9
`of the ’315 patent is reproduced below.
`
`
`Figure 9 “is a perspective view of a fourth embodiment of a nasal cannula.”
`Id. at 3:30–31. Nasal cannula 60 includes three main components: prong
`part 61, body part 62, and ball jointed connector 63. Id. at 6:48–51.
`
`Prong part 61 has two nasal prongs 64 and 65 shaped for placement
`inside a user’s nares. Ex. 1003, 6:52–54. Prongs 64 and 65 are substantially
`oval tubular members that allow for a passage of gases and are integrally
`molded with tubular body 66 in a flexible material such as rubber or
`thermoplastic elastomers. Id. at 6:59–64. Each of prongs 64 and 65 has a
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`flange (flanges 73 and 74, respectively) disposed about its circumference at
`a position on the prong such that each of the flanges rests against the outside
`of each of the patient’s nares. Id. at 7:12–15.
`
`Body part 62 is a tubular passageway in which prong part 61 is
`connected at one end. Ex. 1003, 7:29–31. Ball joint 69 extends from
`connector 63 and slots into a complementary shaped (partial sphere) socket
`end 70 on body part 62. Id. at 7:31–33. Body part 62 has headgear
`extensions 72 and 731 that extend out from body part 70. Id. at 8:31–33.
`Extensions 72 and 73 include channels 77 and 78, respectively, formed in
`the extensions, that are capable of receiving ends 80 and 81 of headgear
`strap 79. Id. at 8:33–35. Strap ends 80 and 81 in use are threaded through
`apertures (preferably two) and extend into and are held in channels 77 and
`78. Id. at 8:35–37.
`Figures 10 and 11 of the ’315 patent are reproduced below.
`
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`
`
`1 Figure 9 of the ’315 patent and the corresponding description in the text
`uses reference numeral 73 to refer to two distinct structures: (1) flange 73
`and (2) headgear extension 73.
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`Figure 10 depicts “a side view of the nasal cannula of F[igure] 9” and
`Figure 11 depicts “an exploded perspective view of the nasal cannula of
`F[igure] 9.” Ex. 1003, 3:32–34. As best seen in Figure 11 of the ’315
`patent, each headgear extension has a dogleg shape and is attached to body
`part 62 at opposite sides where body 66 of prong part 61 interfaces body
`part 62, that is, on a distal side of the prong part. As seen in Figure 10, each
`headgear extension is attached near the horizontal centerline (not shown) of
`body 62.
`
`C. Challenged Claims
`Of the Challenged Claims, claims 1, 6, and 17 are independent claims.
`Claim 17 is reproduced below.
`17. A mask assembly for delivering positive airway pressure
`to a user, the mask comprising:
`
`a rigid mask body;
`
`an inspiratory conduit connected to the rigid mask body;
`
`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;
`
`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
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`proximally toward a user in use, the first head gear 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
`
`a second headgear extension having a distal end connected
`to the rigid mask body on the 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, 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.
`Ex. 1003, 11:24–12:20.
`
`D. The Applied References
`ResMed’s asserted grounds of unpatentability for the Challenged
`Claims rely on the following four references:
`Ex. 1010
`Jan. 20, 2005
`Thomlinson
`US 2005/0011524 A1
`Nov. 18, 2004 Ex. 1011
`Gunaratnam
`US 2004/0226566 A1
`Apr. 15, 2008
`Ex. 1013
`Ho
`US 7,357,136 B2
`Feb. 12, 2004
`Ex. 1018
`Madaus
`US 2004/0025882 A1
`ResMed also relies on the declaration testimony of Mr. Anthony M.
`Ging. See Ex. 1009.
`E. Asserted Grounds of Unpatentability
`ResMed asserts six grounds of unpatentability: (1) claims 1, 4–14, 16–
`19 are unpatentable under 35 U.S.C. § 103 over Gunaratnam alone;
`(2) claims 2 and 15 are unpatentable under 35 U.S.C. § 103 over
`Gunaratnam and Ho; (3) claims 6–7, 9–14, and 16–18 are unpatentable
`under 35 U.S.C. § 103 over Thomlinson and Gunaratnam; (4) claims 1, 3–5,
`8, and 19 are unpatentable under 35 U.S.C. § 103 over Thomlinson,
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`Gunaratnam, and Madaus; (5) claim 2 is unpatentable under 35 U.S.C. § 103
`over Thomlinson, Gunaratnam, Madaus, and Ho; and (6) claim 15 is
`unpatentable under 35 U.S.C. § 103 over Thomlinson, Gunaratnam, and Ho.
`Pet. 3.
`
`F. Overview of the Applied References
`We provide a brief summary of the applied references below.
`1. Gunaratnam
`Gunaratnam, titled “Nasal Assembly,” published November 18, 2004,
`from an application filed February 20, 2004. Ex. 1011, [54], [43], [22].
`Gunaratnam “relates to a nasal assembly used for treatment, e.g., of Sleep
`Disordered Breathing (SDB) with Continuous Positive Airway Pressure
`(CPAP) or Non-invasive Positive Pressure Ventilation (NPPV).” Id. ¶ 2.
`ResMed directs us to three distinct embodiments disclosed in
`Gunaratnam: (1) a first embodiment of Figures 1–8; (2) a second
`embodiment of Figures 25–31; and (3) a third embodiment of Figures 108–
`113. Pet. 8.
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`a. Gunaratnam’s first embodiment
`We reproduce Gunaratnam’s Figure 1 below.
`
`
`
`
`
`Figure 1 depicts “a perspective view” of part of Gunaratnam’s nasal
`assembly. Ex. 1011 ¶ 29. Gunaratnam’s nasal assembly 10 is structured to
`deliver breathable gas to nasal passages 12 of a patient’s nose 14. Id. ¶ 177.
`Nasal assembly 10 includes frame 16 and nozzle assembly 18 that may be
`permanently or removably connected to frame 16. Id.
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`b. Gunaratnam’s second embodiment
`We reproduce Gunaratnam’s Figures 25–27 below.
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`Figure 25 “is a partial perspective view” of a second embodiment of
`Gunaratnam’s nasal assembly mounted to a patient’s head and engaged with
`nasal passages of the patient. Ex. 1011 ¶ 53. Figure 26 is “a partial front
`perspective view” (Id. ¶ 54) and Figure 27 is “a cross-sectional view” of the
`nasal assembly of Figure 25 (Id. ¶ 55). Nasal assembly 210 includes
`frame 216 and nozzle assembly 218 that is removably connected to frame
`216. Id. ¶ 236. Headgear assembly 220 is removably attached to frame 216
`to maintain frame 216 and nozzle assembly 218 in a desired adjusted
`position on the patient’s face. Id. Headgear assembly 220 and inlet conduits
`274 are removably attached to frame 216 by an inlet conduit and headgear
`connection assembly 222. Id. Connection assembly 222 includes first
`connector portions 224 provided by frame 216 and second connector
`portions 226 adapted to be removably coupled with first connector
`portions 224. Id. Second connector portions 226 are removably connected
`to headgear assembly 220 and inlet conduits 274. Id.
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`c. Gunaratnam’s third embodiment
`We reproduce Gunaratnam’s Figures 108 and 109 below.
`
`
`
`
`Figure 108 is “a perspective view” (Ex. 1011 ¶ 160) and Figure 109 is “an
`isometric view” of a third embodiment of Gunaratnam’s nasal assembly 120
`(Id. ¶ 163). Gunaratnam’s mask assembly 600 includes headgear 602
`designed to capture the crown of the patient’s head and cushion
`assembly 604. Id. ¶ 376. Yokes provide stability to the sides and retain at
`least a partial portion of the basic shape of headgear, which facilitates
`donning of the headgear. Id. Yoke 608 includes yoke ring 610 and the
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`cushion assembly may be adjustably rotated with respect to headgear 602, to
`a position which best fits the patient. Id. ¶ 379.
`2. Thomlinson
`Thomlinson, titled “Nasal Interface Apparatus,” published January 20,
`2005, from an application filed July 9, 2004. Ex. 1010, [54], [43], [22].
`Thomlinson is directed to “devices used to deliver positive airway pressure
`to a patient for the treatment of sleep apnea.” Id. ¶ 2. We reproduce
`Thomlinson’s Figures 37 and 38, below.
`
`Figures 37 and 38 depict an assembled ventilation system including a nasal
`interface and a strap system. Id. ¶ 327. The nasal interface includes nasal
`prongs 10 and 12, exhalation ports 22, tubing 90, and locking tabs 38 that
`releasably engage strap attachment plate 92. Id. ¶ 207. We reproduce
`Thomlinson’s Figure 30, below.
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`Figure 30 shows Thomlinson’s locking tabs 38 for releasably engaging strap
`attachment plate 92. Id. ¶ 305. Strap attachment plate 92 includes one or
`more openings 136 for receiving one or more locking tabs 38, and includes
`one or more strap connections 120 for receiving strap system 102. Id. ¶ 306.
`3. Madaus
`
`Madaus, titled “Holding Device for a Respiratory Mask,” published
`February 12, 2004, from an application filed June 22, 2001. Ex. 1018, [54],
`[43], [22]. Madaus is directed to “a holding device for a respiratory mask, as
`it may for instance be used in the field of sleep medicine for fixing a nasal
`mask to the face of a patient.” Id. ¶ 1.
`4. Ho
`
`Ho, titled “Patient Interface Assembly and System Using Same,”
`issued April 15, 2008, from an application filed August 13, 2004. Ex. 1013,
`[54], [45], [22]. Ho is directed to “a patient interface assembly, a system for
`supplying a flow of gas to a patient that incorporates such an assembly, and
`to a patient interface device and a headgear for use in such an assembly” Id.
`at 1:16–20.
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`II. ANALYSIS
`A. Level of Ordinary Skill in the Art
`The level of skill in the art is “a prism or lens” through which we view
`the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d
`1350, 1355 (Fed. Cir. 2001). ResMed asserts that one of ordinary skill in the
`art “had at least a bachelor’s degree in industrial design, mechanical
`engineering, biomedical engineering, or similar technical field, with at least
`two years of relevant product design experience” although “[a]n increase in
`experience could compensate for less education, and an increase in
`education could likewise compensate for less experience.” Pet. 7–8 (citing
`Ex. 1009 ¶¶ 20–21). Fisher does not dispute this characterization nor does it
`provide its own characterization of the level of ordinary skill in the art.
`Prelim Resp. 9.
`We preliminarily adopt ResMed’s asserted level of ordinary skill
`solely to determine whether there is a reasonable likelihood that ResMed
`would prevail with respect to at least one of the claims challenged in the
`Petition.
`
`B. Claim Construction
`The claim construction standard to be employed in an inter partes
`review recently changed. See Changes to the Claim Construction Standard
`for Interpreting Claims in Trial Proceedings Before the Patent Trial and
`Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (to be codified at 37
`C.F.R. § 42). That new standard, however, applies only to proceedings in
`which the petition is filed on or after November 13, 2018. The Petition in
`this proceeding was accorded a filing date of November 7, 2018, and we
`therefore apply the broadest reasonable interpretation standard that was in
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`effect at that time. See Paper 8; 37 C.F.R. § 42.100(b) (2018). Under the
`broadest reasonable interpretation standard, claim terms are given their
`ordinary and customary meaning, as would be understood by one of ordinary
`skill in the art in the context of the entire disclosure. In re Translogic Tech.,
`Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Also, we are careful not to read
`a particular embodiment appearing in the written description into the claim.
`See In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (“[L]imitations
`are not to be read into the claims from the specification.”).
`ResMed proposes a construction for the term “tube.” Pet. 7. Fisher
`does not dispute ResMed’s interpretation. Prelim Resp. 9. As will be
`evident from our analysis below, we need not reach a construction of the
`term “tube.” See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
`803 (Fed. Cir. 1999) (construing explicitly only those claim terms in
`controversy and only to the extent necessary to resolve the controversy).
`C. Asserted Grounds of Unpatentability
`ResMed’s grounds of unpatentability are based on obviousness. See
`Pet. 3. A patent claim is unpatentable as obvious “if the differences between
`the subject matter sought to be patented and the prior art are such that the
`subject matter as a whole would have been obvious at the time the invention
`was made to a person having ordinary skill in the art to which said subject
`matter pertains.” 35 U.S.C. § 103(a) (2011). The question of obviousness is
`resolved on the basis of underlying factual determinations, including:
`(1) the scope and content of the prior art; (2) any differences between the
`claimed subject matter and the prior art; (3) the level of ordinary skill in the
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`art;2 and (4) when available, secondary considerations, such as commercial
`success, long felt but unsolved needs, and failure of others.3 See Graham v.
`John Deere Co., 383 U.S. 1, 17–18 (1966). We address these factual
`determinations below.
`1. Claims 1, 4–14, and 16–19 as allegedly unpatentable over Gunaratnam
`ResMed asserts that claims 1, 4–14, and 16–19 are unpatentable under
`35 U.S.C. § 103 over Gunaratnam alone. Pet. 3.
`a. Independent claims 1, 6, and 17.
`In relevant part, independent claim 1 requires a “first headgear
`extension having a distal end connected to the left peripheral side of the rigid
`mask body on a distal side of the prong part at a location spaced from a
`user in use.” Ex. 1003, 9:6–9 (emphasis added) (the “first headgear
`extension” limitation of claim 14). Independent claims 6 and 17 recite a
`similar limitation. See id. at 10:7–9, 12:1–3. ResMed contends that the
`mask configurations in three of Gunaratnam’s embodiments disclose the
`“first headgear extension” limitations of claims 1, 6, and 17. Pet. 12–15
`(addressing the “first headgear extension” limitations of claims 6 and 17
`together), 36 (addressing the “first headgear extension” limitation of claim 1
`and referencing the analysis for claim 6).
`
`With respect to Gunaratnam’s first embodiment, ResMed contends
`that connector 26 corresponds to the recited first headgear extension.
`Pet. 12–13. ResMed contends that connector 26 is L-shaped, with its
`
`2 We addressed the level of ordinary skill in the art in Section II.B., supra.
`3 Fisher does not present any evidence concerning secondary considerations
`at this stage of the proceeding.
`4 The quoted language represents a portion of the entire first headgear
`extension limitation of claim 1.
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`proximal end (side 62) disposed towards the user. ResMed states that “[o]n
`each side of the mask body, connector 26 has a first/front side 60 (a ‘distal
`side’ according to the claim) connected to the mask body on a distal side of
`the prong part.” Id. at 13. ResMed adds that “the connector is on a distal
`side of the prong part 18, when considered in a lateral direction, and on the
`distal side of the prong part 18 when considered in a direction away from the
`user.” Id. ResMed directs us to Gunaratnam’s Figures 1 and 11, which we
`reproduce below, in support of its contentions.
`
`
`Pet. 13. Figure 1 depicts “a perspective view” of part of Gunaratnam’s nasal
`assembly and Figure 11 depicts “a perspective view of . . . an inlet conduit
`and headgear connector assembly adapted to be used with the nasal
`assembly shown in F[igure] 1.” Ex. 1011 ¶¶ 29, 39.
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`With respect to Gunaratnam’s second embodiment, ResMed contends
`that connector portion 226 corresponds to the recited first headgear
`extension. Pet. 13. ResMed contends that “first connector portion 226
`connects (at its ‘distal end’ 260) to the rigid mask 216 at a location that is on
`a distal side, both laterally and away from the user, of the nozzle
`assembly 218.” Id. at 13–14. ResMed adds that connector portion 226
`“connects at a location spaced from the user in use, and its L-shape disposes
`its opposite/rear end 262 (the claimed ‘proximal end’) proximally toward the
`user in use.” Id. at 14. ResMed relies on Gunaratnam’s Figures 26, 27, 32,
`33, and 36, which we reproduce below, to support its contentions.
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`Figure 26 depicts “a partial front perspective view of the nasal assembly”
`and Figure 27 depicts “a cross-sectional view of the nasal assembly shown
`in” Gunaratnam’s Figure 25. Ex. 1011 ¶¶ 54, 55. Figure 32 depicts “a
`perspective view illustrating an embodiment of an inlet conduit and
`headgear connector assembly of the nasal assembly” and Figure 33 depicts
`“a rear perspective view of the inlet conduit and headgear connector
`assembly shown in” Gunaratnam’s Figure 25. Id. ¶¶ 60, 61. Figure 36
`depicts “a side view illustrating the routing of the inlet conduits of the nasal
`assembly shown in” Gunaratnam’s Figure 25. Id. ¶ 64.
`Fisher presents three arguments as to why connector portions 26 and
`226 of Gunaratnam’s first and second embodiments do not satisfy the
`requirements of the first headgear extension limitation of claims 1, 6, and 17.
`Prelim. Resp. 13–21. We need address only one of these arguments, as we
`find it persuasive.
`Fisher argues that connector portions 26 and 226 do not connect to
`Gunaratnam’s mask frame as recited in the claims, as it does not connect on
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`the distal side of the prong part nor does it connect at a location spaced from
`a user in use. Prelim. Resp. 18, 19. Fisher argues that the Petition merely
`states that the connection is on the distal side of the prong part and does not
`provide any additional explanation as to how connector portions 26 and 226
`satisfy the claim requirements. Id. at 19. Fisher explains that connector
`portions 26 and 226 include circular connection structures that connect to
`circular structures 24 and 224 on frame 16 and 216, respectively. Id. Fisher
`adds that “Gunaratnam specifically requires this type of large, circular
`connection structure to allow the frame (and thus the nasal assembly) to
`rotate/adjust relative to the second connector portions 26/226 to facilitate
`positioning of the nasal assembly in a customized position.” Id. (referencing
`Ex. 1011 ¶¶ 179, 240; Ex. 2001 ¶ 45). Fisher argues that this type of
`connection results in a connection location that is not on the distal side of the
`prong part and that is adjacent to the user’s face when the mask is in use. Id.
`We agree with Fisher that the Petition fails to explain adequately how
`connector portions 26 and 226 are connected to the mask body on a distal
`side of the prong part as required by the first headgear extension limitation
`of claim 1. The Petition states that connector portions 26 and 226 are
`connected to the mask body on a distal side of the prong part, without further
`explanation. See Pet. 13–14. Mr. Ging’s declaration does not add any
`explanation either. See Ex. 1009 ¶ 51. Instead, both the Petition and
`Mr. Ging’s declaration state that connector portions 26 and 226 are
`connected to the mask body on a distal side of the prong part “when
`considered in a lateral direction” and “when considered in a direction away
`from the user,” without defining what constitutes the distal side of the prong
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`part or how being connected in a lateral direction satisfies the claim
`requirement. See Pet. 13–14, Ex. 1009 ¶ 51.
`As can be seen in Gunaratnam’s Figure 1, connector portion 26
`connects to frame 16 at a location that is not on the distal side of nozzle
`assembly 18, but is instead spaced slightly apart from nozzle assembly 18
`(the alleged prong part) and lateral to nozzle assembly 18. See Ex. 1011,
`Fig. 1. Similarly, Gunaratnam’s Figures 25–33 show connector portion 226
`with ribs 240 that fit inside connector portion 224 of the mask body. See,
`e.g., Ex. 1011, Figs. 25–27 (showing connector portion 226 inserted into
`opening in frame 216 (the alleged mask body)), Figs. 28–29 (showing
`connector opening 224 on frame 216), Figs. 32–33 (showing ribs 240). That
`is, the connection point is on the mask body, laterally removed from the
`alleged prong part.
`Claims 1, 6, and 17 are generally picture claims, at least with respect
`to the headgear extension limitations, which recite the structure for the
`headgear extensions depicted in Figure 9 of the ’315 patent. Compare
`Ex. 1003, 8:50–9:49, 9:66–10:42, 11:24–12:20, with Fig. 9. Figure 9 shows
`headgear extension 72 connected to body part 62 at a point where the distal
`end of prong part 61 connects with body part 62. Given the narrow drafting
`of the headgear extension limitations, we interpret the phrase “connected to
`the left peripheral side of the rigid mask body on a distal side of the prong
`part” of claim 1 (and similar limitations in claims 6 and 17) to require the
`connection point to be actually on the distal side of the prong part, rather
`than merely close to the distal side of the prong part.
`Fisher also explains that connector portions 26 and 226 do not satisfy
`the requirement that the headgear extension be attached to the mask body at
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`a location spaced from the user in use. Prelim. Resp. 19. Fisher argues that,
`given the large circular connections between the mask body and connector
`portions 26 and 226, at least part of the connection location is next to the
`patient’s face when the mask is in use. Id. Fisher adds, with respect to the
`first embodiment, Gunaratnam expressly discloses that connector portion 26
`follows the contour of the user’s face, which would include the part of
`connector portion 26 connected to frame 16. Id. at 19–20 (referencing
`Ex. 2001 ¶ 46).
`We agree with Fisher on this point as well. As seen in Gunaratnam’s
`Figures 1 and 25, the location where connectors 26 and 226 connect to
`frame 16 and 216 are adjacent to the user’s face when the mask is in use.
`See Ex. 1011, Figs. 1, 25. Because the connections are cylindrical in shape
`to match the barrel shape of Gunaratnam’s mask, at least a portion of the
`outer surface of the cylinder is adjacent to the user’s face, and not spaced
`from it.
`With respect to Gunaratnam’s third embodiment, ResMed contends
`that “each headgear yoke 608 attaches (on its ‘distal end’) via ring 610 on a
`side of the body of the nasal cannula body, and extends laterally outward
`and upward from the body.” Pet. 14. ResMed contends that Gunaratnam’s
`“Figure 110 shows the extension’s distal end connected to the rigid mask,
`e.g., near numeral 616, which is on a distal side (laterally and away from the
`user) of the nozzle assembly (‘prong part’ 617).” Id. ResMed adds that
`“[t]he connection location is also spaced from the user during use.” Id. We
`reproduce Gunaratnam’s Figure 110, below.
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`Figure 110 depicts a “cross-sectional view of a portion of a nasal assembly.”
`Ex. 1011 ¶ 164.
`Fisher argues that yoke 608 “fails to disclose the claimed headgear
`extension limitations for many of the same reasons” as for the first two
`embodiments, discussed above. Prelim. Resp. 21. Fisher argues that
`yoke 608 attaches to frame 616 (the alleged mask body) on the lateral ends
`of frame 616 through a ring structure, not on the distal side of the prong part
`(allegedly nozzle assembly 617). Id. at 23.
`Fisher also argues that yoke 608 is not connected at a location away
`from the user, because the connection is a ring, with at least a portion of the
`ring abutting the user’s face when in use. Id. Fisher argues that the Petition
`merely offers a conclusory statement that this limitation is met. Id.
`We agree with Fisher that the Petition fails to explain adequately how
`yoke 608 attaches to frame 616 on a distal side of nozzle assembly 617 at a
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`location away from the user when in use. Yoke 608 connects through
`ring 610 to frame 616 near the sides of nozzle assembly 617. See Ex. 1011,
`Fig. 108–110, 110B. We reproduce Gunaratnam’s Figure 110B, below.
`
`
`Figure 110B depicts a “partial enlarged cross-sectional view of the right
`hand side of F[igure] 110.” Id. ¶ 167. As can be seen from Figure 110B,
`yoke 608 ends at ring 110, which fits into sealing ring 614, which connects
`to first connection portion 618. First connection portion is part of
`frame 618. This connection is at a lateral side of the body of the mask. The
`connection point is not on the distal side of the alleged prong part. Also, as
`seen in Figure 110B, at least a portion of the connection point is not spaced
`away from the user when in use. The circular nature of the connection
`places a portion of the connection adjacent to the user’s face.
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`Accordingly, we determine that the Petition fails to demonstrate
`adequately that Gunaratnam’s first, second, or third embodiments satisfy the
`requirements of the “first headgear extension” limitations of claims 1, 6, and
`17. Also, ResMed does not contend that it would have been obvious to
`locate the connection point for the alleged headgear extensions on the distal
`end of the prong part for any of the three embodiments. As such, we
`determine that the information in the Petition does not demonstrate a
`reasonable likelihood that independent claims 1, 6, and 17 are unpatentable
`under 35 U.S.C. § 103 over Gunaratnam.
`b. Dependent claims 4, 5, and 7–14, 16, 18, and 19.
`Claims 4, 5, 7–14, 16, 18, and 19 ultimately depend from one of
`independent claims 1, 6, or 17. For the reasons discussed above, we
`determine that the information in the Petition does not demonstrate a
`reasonable likelihood that dependent claims 4, 5, 7–14, 16, 18, and 19 are
`unpatentable under 35 U.S.C. § 103 over Gunaratnam.
`2. Claims 2 and 15 as allegedly unpatentable over Gunaratnam and Ho
`ResMed asserts that claims 2 and 15 are unpatentable under 35 U.S.C.
`§ 103 over Gunaratnam and Ho. Pet. 3. Claim 2 depends from independent
`claim 1 and claim 15 depends from independent claim 6. ResMed does not
`contend that Ho remedies the deficiencies we identified in our analysis of
`independent claims 1 and 6, above. See Pet. 38 (describing how the
`combination of Gunaratnam and Ho discloses the subject matter of claims 2
`and 15, but not further addressing claims 1 and 6).
`Accordingly, for the reasons discussed above in connection with our
`analysis of claims 1 and 6, we determine that the information in the Petition
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`does not demonstrate a reasonable likelihood that dependent claims 2 and 15
`are unpatentable under 35 U.S.C. § 103 over Gunaratnam and Ho.
`3. Claims 6, 7, 9–14, and 16–18 as allegedly unpatentable over Thomlinson
`and Gunaratnam
`ResMed asserts that claims 6, 7, 9–14, and 16–18 are unpatentable
`under 35 U.S.C. § 103 over Thomlinson and Gunaratnam. Pet. 3.
`a. Independent claims 6 and 17.
`In relevant part, independent claim 6 requires 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.” Ex. 1003,
`10:7–9 (emphasis added) (the “first headgear extension” limitation of
`claim 65). Independent claim 17 recites a similar requirement. See id. at
`12:1–3. ResMed contends that Thomlinson, as modified by Gunaratnam,
`discloses the subject matter of the first headgear extension limitations of
`claims 6 and 17. Pet. 42–47.
`We reproduce Thomlinson’s Figure 30, as annotated by ResMed,
`below.
`
`
`5 The quoted language represents a portion of the entire first headgear
`extension limitation of claim 6.
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`Pet. 43. Figure 30 depicts “an assembled view of one embodiment” of
`Thomlinson’s nasal interface, annotated to show strap attachment plate 92 in
`green. Ex. 1010 ¶ 131. Strap attachment plate 92 includes an opening to
`receive locking tab 38 and openings 120 to receive straps from a headgear.
`Id. ¶ 306. Locking tab 38 releasably engages strap attachment plate 92. Id.
`¶ 203.
`ResMed contends that it would have been obvious to modify
`Thomlinson’s nasal mask to include yokes 608 from Gunaratnam’s third
`embodiment, discussed above in connection with our analysis of claims 1, 6,
`and 17 over Gunaratnam. Pet. 46. Specifically, ResMed contends that it
`would have been obvious to replace strap attachment plate 92 with a
`structure that would attach the yokes to Thomlinson’s mask body at tab 38.
`Id.
`
`ResMe
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