Trials@uspto.gov
`571-272-7822
`
`
`Paper No. 26
`
`Entered: May 11, 2018
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FISHER & PAYKEL HEALTHCARE LIMITED
`Petitioner,
`
`v.
`
`RESMED LIMITED,
`Patent Owner.
`____________
`
`Case IPR2017-00340
`Patent 8,950,404 B2
`____________
`
`
`
`
`
`
`Before BARRY L. GROSSMAN, BEVERLY M. BUNTING, and
`JAMES J. MAYBERRY, Administrative Patent Judges.
`
`MAYBERRY, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
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`IPR2017-00340
`Patent 8,950,404 B2
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`I. INTRODUCTION
`Petitioner, Fisher & Paykel Healthcare Ltd. (“Fisher”), filed a Petition
`(Paper 1, “Pet.”) requesting inter partes review of claims 1–66 (the
`“Challenged Claims”) of U.S. Patent No. 8,950,404 B2 (Ex. 1001, the
`“’404 patent”). Patent Owner, ResMed Ltd. (“ResMed”), filed a Preliminary
`Patent Owner Response to the Petition. Paper 6 (“Prelim. Resp.”). We
`initially instituted trial on claims 1–8, 13–20, 22–36, 40–46, 48–55, and 59–
`65. Paper 8, 52 (“Dec. on Inst.”).
`After we instituted trial, ResMed filed a Patent Owner Response.
`Paper 17 (“PO Resp.”). Fisher filed a Reply to ResMed’s Patent Owner
`Response. Paper 19 (“Reply”). Oral hearing was conducted for this
`proceeding on January 23, 2018 and the record contains a transcript of the
`hearing. Paper 23 (“Tr.”).
`On May 3, 2018, we supplemented our Decision on Institution to
`include in the trial claims 9–12, 21, 37–39, 47, 56–58, and 66 so as to
`institute trial on all Challenged Claims and all grounds. See Paper 25, 3; see
`also SAS Inst., Inc. v. Iancu, 2018 WL 1914661, at *10 (U.S. Apr. 24, 2018)
`(“Because everything in the statute before us confirms that SAS is entitled to
`a final written decision addressing all of the claims it has challenged and
`nothing suggests we lack the power to say so, the judgment of the Federal
`Circuit is reversed and the case is remanded for further proceedings
`consistent with this opinion.”). During a conference call to discuss the
`impact of the SAS Inst., Inc. decision on this proceeding, Fisher and ResMed
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`indicated that no briefing was desired in this proceeding. See Ex. 1027, 25
`(providing a transcript of the conference call).1
`Fisher relies on the Declaration testimony of Mr. Richard Lordo. Ex.
`1013. ResMed relies on the Declaration testimony of Mr. Geoffrey Sleeper.
`Ex. 2004.
`The Board has jurisdiction under 35 U.S.C. § 6. This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`For the reasons that follow, we conclude that Fisher has established, by a
`preponderance of the evidence, that claims 1, 2, 5–7, 13, 14, 16–19, 22–32,
`34, 35, 40, 42–46, 48–51, 53, 54, 59, and 61–65 of the ’404 patent are
`unpatentable. We further conclude that Fisher has not established, by a
`preponderance of the evidence, that claims 3, 4, 8–12, 15, 20, 21, 33, 36–39,
`41, 47, 52, 55–58, 60, and 66 of the ’404 patent are unpatentable.
`A. Related Matters
`Fisher indicates that the ’404 patent is involved in district court
`litigation in the Southern District of California, in a case styled Fisher &
`Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv-02068-DMS-
`WVG (S.D. Cal.). Pet. 6; see also Paper 4, 2 (identifying the litigation).
`B. The ’404 Patent
`The ’404 patent, titled “Headgear for Masks,” issued February 10,
`2015, with claims 1–66. Ex. 1001, (54), (45), 23:14–28:53. The ’404 patent
`is generally directed “to headgear . . . for use in holding a mask in position
`on a patient’s face, the mask being used for treatment, e.g., of Sleep
`Disordered Breathing (SDB) with Continuous Positive Airway Pressure
`
`
`1 The parties confirmed that they did not desire briefing to address the added
`claims in this proceeding in an email to the Board dated May 9, 2018.
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`(CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV).” Id. at
`1:16–21. Figures 1 and 6 of the ’404 patent depict embodiments of the ’404
`patent’s headgear and are reproduced below.
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`Figure 1 depicts “a side view of headgear in position on a patient’s
`head according to an embodiment of the” ’404 patent and Figure 6 depicts “a
`rear perspective view of headgear in position on a patient’s head according
`to another embodiment of the” ’404 patent. Ex. 1001, 4:9–10, 4:26–28. In
`the embodiment of Figure 1, mask 10 is connected to upper side strap 20 and
`lower side strap 30. Id. at 8:9–12. Top strap 40 is configured to pass over
`the top of a wearer’s head and attach to the top ends of two opposing
`rigidizers 60, with rear strap 50 interconnecting the lower ends of opposing
`rigidizers 60. Id. at 8:12–18. Rigidizers of the ’404 patent are “constructed
`of a rigid or semi-rigid material that . . . add rigidity to the headgear . . . .
`[The rigidizers] . . . resist or prevent stretching of the headgear in the
`lengthwise direction of the rigidizer [and] [t]he rigidizers may be
`substantially inextensible.” Id. at 7:36–39.
`The headgear of the embodiment of Figure 6 includes upper side strap
`620 and lower side strap 630 attached to mask 10. Ex. 1001, 10:5–9.
`Rigidizer 660 is substantially circular or oval in shape, with an arc removed
`at the lower portion of rigidizer 660 to allow the size of the shape to be
`adjusted. Id. at 10:1–4. In the embodiments of Figures 1 and 6, straps 20,
`30, 620, and 630 include VELCRO® tabs “to engage the remainder of the
`strap to secure the strap in place and allow” mask 10 to be adjusted. Id. at
`15:35–39.
`Figures 14C and 14G are reproduced below:
`
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`Figures 14C and 14G depict “cross-sectional views showing
`alternative rigidizer configurations.” Ex. 1001, 16:58–59. In the
`embodiment depicted in Figure 14C, “the rigidizer may include a semi-rigid
`molded component 980 that is covered in fabric 981, e.g., two pieces of
`fabric joined by stitching.” Id. at 17:21–23. The embodiment depicted in
`Figure 14G includes fabric layers 1381 around rigidizer 1380, with the
`fabric layers joined together at abutting ends, with the joint offset from the
`flat surface of the layers. See id., Fig. 14G. “The fabric outer layers may be
`heat sealed together, stitched, ultrasonically cut, CNC knife cut, or otherwise
`joined.” Id. at 17:44–46.
`
`C. Challenged Claims
`Claims 1, 29, and 48 of the Challenged Claims are independent.
`Claim 29 differs from claim 1 by requiring a rear portion that (1)
`circumscribes the rear of a wearer’s head, (2) includes material that is
`relatively inextensible, and (3) is joined to upper and lower straps by stitched
`joins. Claim 48 is similar to claim 29. These claims are reproduced below:
`1. A headgear system for holding a respiratory mask in a
`position on a face of a patient to enhance a mask seal with the
`patient’s face, the headgear system including a plurality of straps
`providing a four-point arrangement for attachment with the
`respiratory mask, said plurality of straps comprising:
`at least one upper strap configured to extend above the
`patient’s ears in use;
`at least one lower strap configured to extend below the
`patient’s ears in use; and
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`a rear portion,
`wherein at least one strap of said plurality of straps is
`constructed from a laminate having at least a first fabric layer and
`a second fabric layer, said first fabric layer being constructed and
`arranged to be located on a patient-contacting side in use, and
`said second fabric layer being constructed and arranged to be
`located on a non patient-contacting side in use and further
`wherein said first fabric layer and said second fabric layer are
`joined at a joint configured to be positioned away from the
`patient’s face when in use and wherein said at least one strap of
`said plurality of straps has a first rounded lateral edge when
`viewed in cross-section, and
`wherein the joint is positioned at approximately a center
`or middle of the first rounded lateral edge when viewed in cross
`section.
`Ex. 1001, 23:14–38.
`29. A headgear system for holding a respiratory mask in a
`position on a face of a patient to enhance a mask seal with the
`patient’s face, the headgear system including a plurality of straps
`providing a four-point arrangement for attachment with the
`respiratory mask, said plurality of straps comprising:
`at least one upper strap configured to extend above the
`patient’s ear in use, the at least one upper strap including loop
`material and an end with hook material, for adjustable attachment
`to a slot of a forehead support;
`at least one lower strap configured to extend below the
`patient’s ear in use, the at least one lower strap including loop
`material and an end with hook material for adjustable attachment
`to a headgear clip that connects with a lower part of the mask;
`and
`
`a rear strap portion having a rear loop configured and
`dimensioned to circumscribe the rear of the patient’s head, the at
`least one upper strap and the at least one lower strap being
`attached to the rear strap portion via stitched joins, the rear strap
`portion comprising a material that is relatively inextensible
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`compared to a relatively extensible material of the at least one
`upper strap,
`wherein at least one strap of said plurality of straps is
`constructed from a laminate having at least a first layer and a
`second layer, said first layer being constructed and arranged to
`be located on a patient-contacting side in use, and said second
`layer being constructed and arranged to be located on a non
`patient-contacting side in use, and further wherein each of said
`first layer and said second layer forms a part of at least one
`rounded lateral edge of the at least one strap when viewed in
`cross-section.
`Ex. 1001, 24:65–25:28.
`48. A headgear system for holding a respiratory mask in a
`position on a face of a patient to enhance a mask seal with the
`patient’s face, the headgear system including a plurality of straps
`providing a four-point arrangement for attachment with the
`respiratory mask, said plurality of straps comprising:
`a pair of upper straps each configured to extend above the
`patient’s ear in use, each said upper strap including an outwardly
`facing loop material layer and an end with hook material to
`adjustably engage the outwardly facing loop material layer, for
`length-adjustable attachment to a slot of a forehead support;
`a pair of lower straps each configured to extend below the
`patient’s ear in use, each said lower strap including an outwardly
`facing loop material layer and an end with hook material to
`adjustably engage the outwardly facing loop material layer, for
`length-adjustable attachment to a headgear clip that connects
`with a lower part of the mask; and
`a rear strap portion having a rear loop configured and
`dimensioned to circumscribe the rear of the patient’s head, each
`said upper strap and each said lower strap being attached to the
`rear strap portion via stitched joins, the rear strap portion
`comprising a first material with a first extensibility and each said
`upper or lower strap comprising a second material with a second
`extensibility that is different than the first extensibility of the first
`material,
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`wherein each of said upper strap and each said lower strap
`is constructed from at least a patient-contacting fabric material
`layer and a respective said outwardly facing loop material layer,
`each said patient-contacting fabric material
`layer being
`constructed and arranged to engage the patient’s face while in
`use, and further wherein mutual edges of the patient-contacting
`fabric material layer and said outwardly facing loop material
`layer form a joint positioned, as seen in cross-section, at a lateral
`edge of each said upper strap and each said lower strap, each said
`joint being spaced away from the patient’s face in use while the
`patient-contacting fabric material layer contacts the patient’s
`face in use.
`Ex. 1001, 26:37–27:9.
`
`D. The Prior Art
`We instituted trial on the only two grounds of unpatentability raised
`by Petitioner for the Challenged Claims, which rely on the following
`references:
`WO 2004/041341 A1 May 21, 2004
`Amarasinghe
`WO 2008/030831 A2 Mar. 13, 2008
`Ho
`US 3,424,633
`Jan. 28, 1969
`Corrigall
`Dec. on Inst. 52–53, Paper 25, 3.
`E. Instituted Grounds of Unpatentability
`We instituted trial, as supplemented by our order of May 3, for the
`Challenged Claims as follows:
`
`Ex. 1002
`Ex. 1003
`Ex. 1004
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`References
`Amarasinghe and Corrigall
`
`Basis2
`35 U.S.C. § 103(a)
`
`Claims Challenged
`1, 5–9, 14, 16, 17, 19,
`21, 27, and 28
`2–4, 10–13, 15, 18,
`20, 22–26, and 29–66
`
`35 U.S.C. § 103(a)
`
`Amarasinghe, Corrigall, and
`Ho
`Dec. on Inst. 52–53, Paper 25, 3.
`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). Fisher asserts that the level of ordinary skill in
`the art to which the ’404 patent pertains is “at least a bachelor’s degree in
`mechanical engineering, biomedical engineering or other similar type of
`engineering degree combined with at least two years of experience in the
`field of masks, respiratory therapy, patient interfaces or relevant product
`design experience.” Pet. 13–14 (citing Ex. 1013 (Decl. of Richard Lordo) ¶
`26).
`
`ResMed’s declarant, Mr. Sleeper, defines the level of ordinary skill in
`the art as “a bachelor’s degree in mechanical engineering, biomedical
`engineering, or a similar technical field, and at least two years of relevant
`product design experience. An increase in experience could compensate for
`less education, and an increase in education could likewise compensate for
`less experience.” Ex. 2002 (Decl. of Geoffrey Sleeper) ¶ 12.
`
`
`2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 296–307 (2011), took effect on September 16, 2012. Because the
`application for the patent at issue in this proceeding has an effective filing
`date before that date, we refer to the pre-AIA versions of the statute.
`
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`Factual indicators of the level of ordinary skill in the art include “the
`various prior art approaches employed, the types of problems encountered in
`the art, the rapidity with which innovations are made, the sophistication of
`the technology involved, and the educational background of those actively
`working in the field.” Jacobson Bros., Inc. v. United States, 512 F.2d 1065,
`1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co., Inc. v. United States,
`702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson
`Bros.).
`We find both parties assert very similar definitions of the level of
`ordinary skill in the art. Both definitions include a degreed engineer with
`two years of experience. Fisher identifies the fields of experience as
`“masks, respiratory therapy, patient interfaces or relevant product design
`experience” and ResMed, through Mr. Sleeper, defines the field of
`experience as “relevant product design experience.” Mr. Sleeper declares
`that additional experience may compensate for less education and additional
`education may compensate for less experience.
`We find, based on our review of the complete record, that the
`evidence of record supports a level of ordinary skill in the art consistent with
`the parties’ definitions—a person having a bachelor’s degree in mechanical
`engineering, biomedical engineering or other similar type of engineering
`degree combined with two years of experience in the field of masks,
`respiratory therapy, patient interfaces, or other relevant product design
`experience. We also find that additional experience may compensate for
`less education and additional education may compensate for less experience.
`Further, we note that our patentability analysis presented below would reach
`
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`the same findings and determinations under either party’s definition of the
`level of ordinary skill in the art.
`B. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are given
`their broadest reasonable construction in light of the specification of the
`patent in which they appear. 37 C.F.R. § 42.100(b). Under the broadest
`reasonable construction 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 if
`the claim language is broader than the embodiment. 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.”).
`In two situations, the proper interpretation of a claim term departs
`from the ordinary and customary meaning, as would be understood by one of
`ordinary skill in the art in the context of the entire disclosure—when the
`patentee acted as its own lexicographer or disavowed certain claim scope.
`See Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343, 1353
`(Fed. Cir. 2016). “The standards for finding lexicography and disavowal are
`‘exacting.’” Id. (emphasis added). “To act as a lexicographer, a patentee
`must ‘clearly set forth a definition of the disputed claim term’ and ‘clearly
`express an intent to redefine the term.’” Id. Disavowal (or disclaimer)
`requires that the patentee make it clear, either in the Specification or in the
`prosecution history, “that the invention does not include a particular
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`feature.” Id. “While such disavowal can occur either explicitly or
`implicitly, it must be clear and unmistakable.” Id. (emphasis added).
`Fisher contends that the terms of the Challenged Claims should be
`“given their ‘broadest reasonable interpretation’ in light of the
`[S]pecification of the ’404 [p]atent” and does not offer any express
`constructions for any term in the Challenged Claims. See Pet. 10. In its
`Patent Owner Response, ResMed proffers express constructions for two
`terms, which we address below. See PO Resp. 9–12. We also address
`certain claim constructions from our Decision on Institution.
`1. “at least one strap of said plurality of straps is constructed from a
`laminate having at least a first fabric layer and a second fabric layer . . .
`wherein said first fabric layer and said second fabric layer are joined at a
`joint configured to be positioned away from the patient’s face when in use”
`Claim 1 requires at least one of the plurality of straps to include a
`“joint configured to be positioned away from the patient’s face when” the
`claimed headgear system is in use. Ex. 1001, 23:24–33. In our Decision on
`Institution, we construed the phrase “at least one strap of said plurality of
`straps is constructed from a laminate having at least a first fabric layer and a
`second fabric layer . . . wherein said first fabric layer and said second fabric
`layer are joined at a joint configured to be positioned away from the
`patient’s face when in use” in claim 1 to be limited to an at least one strap
`that contacts, at some point, a patient’s face when the headgear is in use for
`the purposes of that Decision. Dec. on Inst. 12. Our construction adopted
`the construction proposed by ResMed in its Preliminary Patent Owner
`Response. See id. at 11–12.
`ResMed maintains its position with respect to the construction of this
`claim limitation in its Patent Owner Response. PO Resp. 10–11. Fisher
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`does not dispute our claim construction from the Decision on Institution in
`its Reply. See Reply 13–15. Based on a review of the entire record, we see
`no need to alter our construction, except for one point of emphasis.
`Accordingly, for the reasons provided in our Decision on Institution, we
`interpret the phrase “at least one strap of said plurality of straps is
`constructed from a laminate having at least a first fabric layer and a second
`fabric layer . . . wherein said first fabric layer and said second fabric layer
`are joined at a joint configured to be positioned away from the patient’s face
`when in use” in claim 1 to be limited to an at least one strap that contacts, at
`some point, a patient’s face when the headgear is in use. See Dec. on Inst.
`11–12. We emphasize that the construction includes the phrase “at some
`point,” which means that the strap may include points that do not contact the
`face.
`2. “a substantially circular or oval shape”
`Claims 15, 41, and 60 of the Challenged Claims each requires the rear
`portion of the headgear to engage the back of a wearer’s head in a
`substantially circular or oval shape—the “substantially circular or oval
`shape” limitation. See, e.g., Ex. 1001, 23:63–67 (providing claim 15, which
`depends from claim 1 and further recites “wherein the rear portion is
`configured to engage a back of a patient’s head and extend on either side of
`the patient’s parietal bone behind the patient’s ears and assume, in use, a
`substantially circular or oval shape”).3
`
`
`3 Claim 41 depends from independent claim 29 and claim 60 depends from
`independent claim 48 and each further recites “wherein the rear strap portion
`is configured to engage a back of a patient’s head and extend on either side
`of the patient’s parietal bone behind the patient’s ears and assume, in use, a
`substantially circular or oval shape.” Ex. 1001, 25:66–26:3, 27:53–28:3.
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`Both parties agree that the “substantially circular or oval shape”
`limitation should be given its plain and ordinary meaning, although the
`parties dispute what that meaning is. ResMed contends that the plain and
`ordinary meaning of the term “is that in use, the rear portion of the headgear
`forms a loop having an oval, i.e., ellipsoidal, shape or a substantially circular
`shape.” PO Resp. 12. We adopted ResMed’s definition in our Decision on
`Institution. Dec. on Inst. 12–13. ResMed maintains its proffered
`construction in its Patent Owner Response. PO Resp. 12.
`Fisher contends that we should clarify our construction, as Fisher
`argues that ResMed’s wording of the plain and ordinary meaning distorts
`that meaning. Reply 21. Specifically, Fisher argues that ResMed
`improperly narrows the term “oval” to mean ellipsoid. Id. at 20. Fisher also
`argues that the word “substantially” in the claims should modify both
`“circular” and “oval.” Id. at 21; See Tr. 26:20–23 (“And I think because [the
`claim] says substantially circular and substantially oval, you can look at the
`opening and say, yeah, that’s substantially oval, even by ResMed’s own
`dictionaries.”) (emphasis added).
`To clarify our construction, we determine that the “substantially
`circular or oval shape” limitation should be given its plain and ordinary
`meaning. As we describe in greater detail below, we further determine that
`meaning to be as the words of the claim require—the rear portion of the
`headgear, in use, assumes a substantially circular shape or an oval shape.
`The word “substantially” modifies the word “circular,” but not the word
`“oval,” while “shape” is the noun which is modified by the adjectives
`“substantially circular” and “oval.”
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`Also, “oval” is not limited to the exact geometric shape of an
`ellipsoid. Instead, the word “oval,” means “resembling the shape of an egg.”
`See, e.g., MERRIAM-WEBSTER ONLINE DICT., available at
`https://www.merriam-webster.com/dictionary/oval (last visited Apr. 12,
`2018) (defining the adjective “oval” as “having the shape of an egg” also
`“broadly elliptical”). In other words, an oval shape is not a precise ellipse,4
`but is, substantially, or broadly, elliptical, and thus the term does not require
`exacting geometric precision, unlike the shape implicated by the term
`circular. Thus, the word “oval” itself encompasses the variability concept
`conveyed by the term “substantially.”
`The plain reading of the claim language supports our construction.
`See, e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en
`banc) (“[T]he context in which a term is used in the [claim at issue] can be
`highly instructive.”). First, the word “substantially” modifies “circular” but
`not “oval.” Second, the language of the claim uses the more general term
`“oval,” not ellipse or ellipsoid.
`The language of other claims informs our construction. See Phillips,
`415 F.3d at 1314 (“Other claims of the patent in question . . . can also be
`valuable sources of enlightenment as to the meaning of a claim term.”). In
`each and every claim limitation that recites the “substantially circular or oval
`
`
`4 We also note that an ellipsoid is a three-dimensional shape, while an oval
`and circle, shapes recited in the “substantially circular or oval shape”
`limitation, are two-dimensional. See, e.g., MERRIAM-WEBSTER ONLINE
`DICT., available at https://www.merriam-webster.com/dictionary/ellipsoid
`(last visited April 12, 2018) (defining “ellipsoid” as “a surface all plane
`sections of which are ellipses or circles”). An ellipse is the two-dimensional
`representation of an ellipsoid.
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`shape” limitation, the word “substantially” modifies the word “circular” only
`and the word “oval” is used in each occurrence of the limitation. See Ex.
`1001, 23:63–67 (providing claim 10), 24:16–21 (claim 15), 25:48–52 (claim
`37), 25:66–26:3 (claim 41), 27:35–39 (claim 56), 27:53–28:3 (claim 60).
`The Specification does not provide an express definition of this claim
`term, but the disclosure is consistent with our construction. The
`Specification uses the phrase “substantially circular or oval shape” in
`describing the embodiment of Figures 6 and 7. See Ex. 1001, 10:1–4. This
`single use of the phrase substantially circular or oval shape is not
`inconsistent with our construction.
`During prosecution, the Examiner interpreted the word “substantially”
`in the “substantially circular or oval shape” limitation to modify the word
`“oval.” See Ex. 1015, 557. However, the Examiner did not provide any
`explicit analysis for arriving at that conclusion. The Examiner allowed the
`application based on amendments made to claim limitations other than the
`“substantially circular or oval shape” limitation, so the applicants did not
`address how the Examiner construed the limitation. See id. at 583–598,
`634–643; Pet. 13. Although the broadest reasonable construction must be
`applied during patent prosecution, the record is devoid of any analysis by the
`Examiner in reaching a construction of the claim term “substantially circular
`or oval shape.” Accordingly, given the absence of any analysis by the
`Examiner in the record, and based on our own claim construction analysis,
`we construe the phrase differently.
`As we indicated above, we depart from the plain and ordinary
`meaning of a claim term in two very limited situations only—where the
`patentee acted as his or her own lexicographer or when the patentee
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`disavowed certain claim scope. We have reviewed the record and we do not
`discern anything in the Specification or the prosecution history to warrant
`departing from the plain and ordinary meaning of the “substantially circular
`or oval shape” limitation. Although the prosecution history offers some
`evidence that “substantially” modifies “oval,” we do not discern from the
`prosecution history that we should depart from the plain and ordinary
`meaning of the term as we find no clear disavowal or definition. Similarly,
`neither Fisher nor ResMed directs us to anything in the record to warrant
`departing from the plain and ordinary meaning of the “substantially circular
`or oval shape” limitation. See PO Resp. 12 (“Patent Owner maintains [the
`plain and ordinary meaning of the term ‘substantially circular or oval’] in the
`analysis of clams 15, 41, and 60.”); Reply 21 (“The Board should . . . adopt[]
`the plain and ordinary meaning of the [‘substantially circular or oval shape’
`limitation].”). “Absent a clear disavowal or contrary definition in the
`[S]pecification or the prosecution history, the [claim] is entitled to the full
`scope of its claim language.” Home Diagnostics, Inc. v. LifeScan, Inc., 381
`F.3d 1352, 1358 (Fed. Cir. 2004).
`To reiterate, we construe the “substantially circular or oval shape”
`limitation to require the rear portion of the headgear, in use, to assume either
`a substantially circular shape or an oval shape.
`3. “inextensible,” “substantially inextensible,” and “relatively
`inextensible”
`In our Decision on Institution, we construed the terms “inextensible,”
`“substantially inextensible,” and “relatively inextensible.” Dec. on Inst. 13–
`16. Based on a review of the entire record, we see no need to alter our
`constructions for these terms. Accordingly, for the reasons provided in our
`Decision on Institution, we interpret the term “inextensible” to mean “not
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`extensible, incapable of being stretched” and the term “substantially
`inextensible” to mean “a structure that when subject to the forces normally
`encountered in use of a respiratory mask, will have an elongation of less
`than about 5%.” See id. We interpret the term “relatively inextensible” to
`encompass a structure that is less extensible relative to another structure.
`See id.
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`C. Overview of the Prior Art
`The Petition relies on three prior art references in its asserted grounds
`of unpatentability for the Challenged Claims—Amarasinghe, Ho, and
`Corrigall. We briefly discuss relevant portions of these references, below.
`1. Amarasinghe
`Amarasinghe, titled “Headgear Assembly for a Respiratory Mask
`Assembly,” published as an international application on May 21, 2004. Ex.
`1002, (54), (43). Amarasinghe’s “Applicant” is ResMed. Id. at (71).
`Amarasinghe is generally directed to “a headgear assembly for use in
`holding a respiratory mask assembly in position on a patient’s face, the mask
`assembly being used for treatment, e.g., of Sleep Disordered Breathing
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`(SDB) with Non-invasive Positive Pressure Ventilation (NPPV).” Id. at
`1:7–10. Amarasinghe’s Figures 1 and 2 are reproduced below:
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`Figures 1 and 2 depict “a side view illustrating a mask assembly
`having a headgear assembly . . . mounted on a patient’s head” and “a rear
`view illustrating the headgear assembly of [Figure] 1,” respectively. Ex.
`1002, 3:23–26. Mask assembly 10 is removably attached to headgear
`assembly 16 at frame 12. Ex. 1002, 4:21–23. Headgear assembly 16
`includes upper side strap 22, lower side strap 24, and rear portion 20, which
`interconnects with the upper and lower side straps. Id. at 5:3–6. Rear
`portion 20 includes upper strap 26, lower strap 28, and intermediate strap
`arrangement 30. Id. at 5:5–7. Intermediate strap arrangement 30 is formed
`by upper straps 32, lower straps 34, and cross-bar strap 36. Id. at 5:7–8.
`Curved upper strap 26 engages a posterior portion of the parietal bone of the
`patient’s head and cross-bar strap 36 is structured to engage a lower portion
`of the occipital bone of the patient’s head. Id. at 8:3–6.
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`Upper side straps 22 and lower side straps 24 connect to the upper and
`lower portion of frame 12, respectively. Ex. 1002, 5:15–16. End portions of
`the upper and lower side straps have a reduced width to wrap around clip
`structure 42 on frame 12. Id. at 5:17–19. Upper side straps 22 and lower
`side straps 24 may employ hook and loop mate