Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 10
`Entered: June 16, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`INOGEN, INC.,
`Petitioner,
`
`v.
`
`SEPARATION DESIGN GROUP IP HOLDINGS, LLC,
`Patent Owner.
`
`
`
`Case IPR2017-00453
`Patent 9,199,055 B2
`
`Before KRISTINA M. KALAN, JON B. TORNQUIST, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Paper 10
`Entered: June 16, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`INOGEN, INC.,
`Petitioner,
`
`v.
`
`SEPARATION DESIGN GROUP IP HOLDINGS, LLC,
`Patent Owner.
`
`
`
`Case IPR2017-00453
`Patent 9,199,055 B2
`
`Before KRISTINA M. KALAN, JON B. TORNQUIST, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-00453
`Patent 9,199,055 B2
`
`I. INTRODUCTION
`Inogen, Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
`inter partes review of claims 12–21 of U.S. Patent No. 9,199,055 B2 (Ex.
`1001, “the ’055 patent”). Separation Design Group IP Holdings, LLC
`(“Patent Owner”) filed a Preliminary Response to the Petition (Paper 8,
`“Prelim. Resp.”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for instituting
`an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that
`an inter partes review may not be instituted “unless the Director
`determines . . . there is a reasonable likelihood that the petitioner would
`prevail with respect to at least 1 of the claims challenged in the petition.”
`After considering the Petition and the Preliminary Response, we
`determine that Petitioner has demonstrated a reasonable likelihood of
`prevailing with respect to claims 12–21 of the ’055 patent. Accordingly, we
`institute inter partes review with respect to those claims.
`
`A. Related Proceedings
`The parties indicate that the ’055 patent, as well as related U.S. Patent
`No. 8,894,751 (“the ’751 patent”), are at issue in Separation Design Group
`IP Holdings, LLC v. Inogen, Inc., Case No. 2:15-cv-08323-JAK-JPR (C.D.
`Cal.). Pet. 12; Paper 5, 2. The parties further note that the ’751 patent is at
`issue in IPR2017-00300. Pet. 12; Paper 5, 2–3.
`
`B. The ’055 Patent
`The ’055 patent discloses “lightweight, portable oxygen concentrators
`that operate using an ultra-rapid, sub one second, adsorption cycle.”
`Ex. 1001, 2:20–22. The disclosed portable oxygen concentrators (POCs)
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`operate using pressure swing adsorption. Id. at 10:48–51. In these POCs, an
`adsorbent bed of molecular sieve material, typically in the form of spherical
`zeolite particles, is filled with pressurized air. Id. at 10:52–56. Nitrogen is
`preferentially adsorbed by the molecular sieve material, resulting in an
`oxygen-enriched product. Id. at 6:65–67, 10:52–56. When the beds are
`depressurized, the adsorbed nitrogen is desorbed from the molecular sieve
`material and expelled from the device. Id. at 10:57, 17:44–48, 18:2–3.
`The ’055 patent explains that, because the disclosed POCs are
`designed to use ultra-rapid pressure cycles, the required amount of adsorbent
`material is significantly reduced. Id. at 10:61–67. For example, where the
`typical POCs use adsorbent beds with approximately 0.5 kilograms of
`adsorbent, the adsorbent beds of the invention may contain less than about
`50 grams of adsorbent. Id. at 10:61–65.
`Because the molecular sieve materials are “highly susceptible to
`contamination by water,” the performance of oxygen concentrators degrades
`over time, necessitating replacement by a “manufacturer or a reseller.” Id.
`at 12:16–24. As the life of the adsorbent is often the limiting factor in the
`life of the device, the ’055 patent posits that it would be “advantageous to
`have an adsorbent that is replaceable by the user.” Id. at 12:24–27.
`
`C. Illustrative Claims
`Claims 12 and 21 are illustrative of the challenged claims and are
`reproduced below:
`12. A portable oxygen concentrator system, comprising:
`at least one removable module comprising a housing;
`at least one adsorbent bed contained in said housing;
`wherein said adsorbent bed comprises at least one molecular
`sieve material;
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`wherein said molecular sieve material has a substantially
`spherical shape;
`wherein the ratio of the length of said adsorbent bed to the
`diameter of said adsorbent bed is less than about 4.8:1;
`and wherein said adsorbent is capable of a ratio of product
`flow rate to mass of said molecular sieve material of greater
`than 3.3 ml/min/g;
`a compressor;
`a manifold to control gas flow into and out of said removable
`module;
`and at least one removable battery pack;
`wherein said portable oxygen concentrator system weighs
`less than about 5 kg.
`Ex. 1001, 25:24–26:9 (emphasis added).
`21. A portable oxygen concentrator system of claim 12,
`wherein said removable module is replaceable by a user.
`Id. at 26:32–33 (emphasis added).
`D. The Asserted Grounds of Unpatentability
`Petitioner contends claims 12–21 of the ’055 patent are unpatentable
`based on the following grounds (Pet. 34–68):1
`References
`Basis Claims Challenged
`McCombs,2 Whitley,3 and AAPA4
`§ 103 12–18 and 21
`
`McCombs, Whitley, and Occhialini5
`
`§ 103 12–18 and 21
`
`
`1 Petitioner also relies on a declaration from Brenton A. Taylor (Ex. 1011).
`2 US 2006/0117957 A1, published June 8, 2006 (Ex. 1002).
`3 US 2007/0137487 A1, published June 21, 2007 (Ex. 1003).
`4 Petitioner contends that certain statements within the ’055 patent are
`Applicant Admitted Prior Art. Pet. 32–33.
`5 U.S. Patent No. 7,279,029 B2, issued Oct. 9, 2007 (Ex. 1004).
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`References
`Jagger,6 McCombs, and AAPA
`
`Basis Claims Challenged
`§ 103 12–18 and 21
`
`McCombs, Whitley, AAPA, and
`Bliss7
`
`§ 103 19 and 20
`
`McCombs, Whitley, Occhialini, and
`Bliss
`
`§ 103 19 and 20
`
`Jagger, McCombs, AAPA, and Bliss
`
`§ 103 19 and 20
`
`Petitioner contends McCombs, Whitley, Occhialini, Jagger, and Bliss
`
`are prior art to the ’055 patent under 35 U.S.C. § 102(b). Pet. 20.
`
`II. ANALYSIS
`
`A. Claim Construction
`In an inter partes review, “[a] claim in an unexpired patent shall be
`given its broadest reasonable construction in light of the specification of the
`patent in which it appears.” 37 C.F.R. § 42.100(b); Cuozzo Speed Techs.,
`LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (upholding the use of the broadest
`reasonable interpretation standard). In determining the broadest reasonable
`construction, we presume that claim terms carry their ordinary and
`customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). A patentee may define a claim term in a manner that
`differs from its ordinary meaning; however, any special definitions must be
`set forth in the specification with reasonable clarity, deliberateness, and
`precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`
`6 US 2006/0174874 A1, published Aug. 10, 2006 (Ex. 1005).
`7 US 2006/0230931 A1, published Oct. 19, 2006 (Ex. 1006).
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`The District Court has construed several terms of the ’055 patent.8
`See Ex. 1014. Petitioner adopts these constructions; Patent Owner disputes,
`for purposes of this Decision, the constructions adopted by the District Court
`and relied upon in the Petition for “removable module” and “replaceable by
`a user.” Pet. 18–20; Prelim. Resp. 11–25.
`
`Removable Module
`The District Court construed the term “removable module” to mean a
`“unit comprised of one or more assembled components that is releasably
`connectible to one or more other components.” Ex. 1014, 9–11, 28–29;
`Pet. 19. Petitioner asserts this construction encompasses, at a minimum,
`“the broadest reasonable interpretation” of the term. Pet. 19–20. Patent
`Owner contends a “removable module” is “a unit comprised of one or more
`assembled components that is releasably connectible to the remainder of the
`POC, the unit being readily accessible and disconnectible without substantial
`disassembly of the POC.” Prelim. Resp. 14.
`Patent Owner’s proposed construction differs, in relevant part, from
`that of the District Court in requiring a module that is “readily accessible and
`disconnectible without substantial disassembly of the POC.” Patent Owner
`reasons that a “removable” module is described throughout the ’055 patent
`as a module that is “designed to be easily removed rather than merely
`capable of being removed.” Id. at 12 (citing 12:27–34 (“the invention
`features a removable and replaceable adsorbent module that is designed to
`
`8 We are not generally bound by a prior judicial construction of a claim term.
`See Power Integrations, Inc. v. Lee, 797 F.3d 1318, 1326 (Fed. Cir. 2015).
`When such a construction is made of record, however, we must
`acknowledge the construction and determine whether it is consistent with the
`broadest reasonable construction of the term. Id.
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`be patient friendly and require very little physical strength or dexterity to
`install.”)). To be easily removed, according to Patent Owner, a module and
`all of its connections/disconnections to and from the remainder of the POC
`should be easily accessible, “such that accessing the removable adsorbent
`module . . . does not require substantial disassembly of the device.”
`Id.
`
`Patent Owner further contends that a removable adsorbent module
`that is configured to be releasably connectable to a POC must be “readily
`releasable,” which requires a module that is designed to be “connected and
`disconnected simply, quickly, easily, repeatedly, and reliably . . . without
`having to expend much time or physical effort.” Id. at 13 (citing Ex. 1001,
`12:27–34). As support for this construction, Patent Owner notes that a
`battery pack in one embodiment of the ’055 patent is explicitly described as
`“releasably connect[ed]” to the POC, and does not require the removal of
`screws, bolts, adhesive, etc. during removal or installation. Id. at 14 (citing
`Ex. 1001, 19:45–46).
`On this record, we are not persuaded by Patent Owner’s arguments.
`Claim 12 recites a “removable module,” not an “easily removable module,”
`or a module that is “disconnectible without substantial disassembly of the
`POC.” Ex. 1001, 25:25. And, where the written description of the ’055
`patent discusses a patient friendly design, or the physical strength and
`dexterity required to install the module, it is with respect to a “replaceable”
`or “removable and replaceable” module, not a “removable module,” as
`recited in claim 12. See Ex. 1001, 12:26–30, 18:4–10, 26:32–33 (further
`limiting claim 12 to require that the “removable module is replaceable by a
`user.”). Finally, even if certain removable components of the ’055 patent
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`can be released from the POC “without having to expend much time or
`physical effort,” we may not import such limitations from the disclosed
`embodiments into the claims. See Laitram Corp. v. NEC Corp., 163 F.3d
`1342, 1347 (Fed. Cir. 2005) (noting that it is a “well-established principle
`that a court may not import limitations from the written description into the
`claims”); Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 913 (Fed.
`Cir. 2004) (“[I]t is improper to read limitations from a preferred embodiment
`described in the specification—even if it is the only embodiment—into the
`claims absent a clear indication in the intrinsic record that the patentee
`intended the claims to be so limited.”). Thus, on this record, we are not
`persuaded that Patent Owner’s proposed construction, requiring that a
`removable module be “readily accessible and disconnectible without
`substantial disassembly of the POC,” is adequately supported by the claims
`or the written description of the ’055 patent.
`On the present record, we determine that the broadest reasonable
`construction of the term “removable module” is a “unit comprised of one or
`more assembled components that is releasably connectible to one or more
`other components.” This construction is consistent with the claim language,
`the disclosures of the ’055 patent, the District Court’s construction of the
`term, and the construction adopted in IPR2017-00300. Ex. 1014, 11;
`IPR2017–00300, Paper 8, 8.
`Replaceable by a User
`
`Claim 21 depends from claim 12 and further recites “wherein said
`removable module is replaceable by a user.” Ex. 1001, 26:32–33. The
`District Court construed “replaceable by a user” to mean “capable of being
`removed and reinstalled by a user of the device.” Ex. 1014, 28. Petitioner
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`contends this construction encompasses, at a minimum, the broadest
`reasonable construction of the term. Pet. 19.
`Patent Owner contends “replaceable by a user” means “configured
`with a user-friendly design, such that the module is capable of being easily
`removed and replaced in a minimal number of steps by a typical end user of
`the device.” Prelim. Resp. 24. This construction differs from the
`construction adopted by the District Court and advocated for by Petitioner in
`requiring: (1) a user-friendly design; (2) a module capable of being easily
`removed and replaced with a minimal number of steps; and (3) a module that
`is removable and replaceable by a typical end user of the device.
`
`According to Patent Owner, a module that is “replaceable by a user”
`includes all the aspects of a “removable module,” but goes even further in
`ensuring that “the design is configured such that a user—i.e., the patient—
`can easily perform the replacement of the module.” Id. at 18. Patent Owner
`reasons that the term “user” is always used in the ’055 patent to refer to a
`patient, and “[t]here can be no dispute that ‘replaceable by a user’ means
`that [the adsorbent module] is configured to be easily replaceable by a
`patient, as opposed to bringing the concentrator into a factory or reseller” for
`labor-intensive replacement. Id. at 19. Patent Owner further contends that
`the “large majority of users of POCs are elderly and/or have limited strength
`or dexterity” and these limited capabilities of a typical user must be taken
`into account when construing the term “replaceable by a user.” Id. at 20.
`Patent Owner also contends that the ’055 patent provides “an unmistakable
`disavowal” of claim scope when it expressly distinguishes between
`replaceable modules known in the art and the easily replaceable modules
`disclosed in the ’055 patent. Id. at 21–22.
`
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`The ’055 patent indicates that the disclosed “removable and
`
`replaceable adsorbent module” is designed to be “patient friendly and
`require very little physical strength or dexterity to install.” Ex. 1001, 12:27–
`30. Patent Owner has not explained sufficiently, however, why the term
`“user-friendly design” unambiguously supports a requirement that the
`adsorbent module of claim 21 be easily removed and replaced in a minimal
`number of steps by a typical end user. See Prelim. Resp. 24; see also
`Ex. 1014, 28 (District Court noting that the term “designed to be user
`friendly” is “unclear”). Moreover, Patent Owner does not request that we
`expressly limit the scope of claim 21 to modules that require “very little
`physical strength or dexterity to install.” Patent Owner, instead, advocates
`for a limitation on the number of steps or the amount of time that would be
`required to remove and replace the adsorbent modules. Prelim. Resp. 13
`(asserting that a releasable connection requires that a component be
`connected and disconnected “without having to expend much time or
`physical effort”), 24 (asserting that “significant physical manipulation” is
`excluded by the term “replaceable by a user”).
`With respect to the proposed requirement that the module be “easily
`removed and replaced,” as noted by Patent Owner, the ’055 patent appears
`to distinguish between a “replaceable” sieve bed and one that is “easily
`replaceable.” Ex. 1001, 18:4–10. The claims are directed, however, to a
`“replaceable” module, not an “easily replaceable” module. Ex. 1001, 26:33.
`In addition, the discussion in the ’055 patent identified by Patent Owner as
`an “unmistakable disavowal” of claim scope is directed to a “second
`moisture management approach,” and its implementation is described with
`respect to “one embodiment” of the ’055 patent. Ex. 1001, 18:4–15. Patent
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`Owner has not explained sufficiently why the description of one easily
`replaceable adsorbent module in the ’055 patent rises to the level of an
`unmistakable disavowal of claim scope. See Thorner v. Sony Computer
`Entm’t Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012) (noting that “[m]ere
`criticism of a particular embodiment” does not rise to the level of a clear
`disavowal). Thus, on this record, we are not persuaded that the removable
`module of claim 21 must be “easily removed and replaced.”
`
`With respect to the proposed requirement that the module be
`replaceable using a “minimal number of steps,” Patent Owner contends this
`requirement is supported by the fact that each disclosed embodiment of the
`’055 patent uses certain elements, such as a battery and adsorbent module,
`that require very few steps to install. Prelim. Resp. 20–21. Even if certain
`elements disclosed in the ’055 patent could be installed with a minimum
`number of steps, however, that is not, by itself, sufficient justification for
`importing limitations from the specification into the claims. See Liebel-
`Flarsheim, 358 F.3d at 913.
`
`Patent Owner also has not explained sufficiently why the term “a
`user” should be limited to a “typical end user.” For example, Patent Owner
`does not identify where the ’055 patent defines “a user” as “a typical end
`user of the device” or clearly disavows atypical users from the scope of the
`term “a user.” See Thorner, 669 F.3d at 1366 (explaining that the standard
`for disavowal of claim scope is “exacting”). And, although the ’055 patent
`distinguishes between an adsorbent module that is “replaced by the
`manufacturer or a reseller” and an adsorbent module that is “replaceable by
`the user,” Petitioner does not explain adequately why this distinction
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`supports limiting the scope of “a user” to a “typical end user.” Thus, we
`decline to construe “a user” as a “typical end user.”
`
`In view of the foregoing, we construe the term “replaceable by a user”
`to mean “capable of being installed and uninstalled by a user of the device.”
`This construction differs slightly from the District Court’s construction,
`replacing “removed and reinstalled” with “installed and uninstalled,” to
`avoid suggesting that the removable module must be reusable.
`
`B. 35 U.S.C. § 325(d)
`As a preliminary matter, Patent Owner argues that we should exercise
`our discretion and decline to institute inter partes review of the ’055 patent
`under 35 U.S.C. § 325(d) because Jagger, Whitley, and AAPA were
`considered by the Examiner during prosecution of the ’055 patent, and
`because McCombs is merely cumulative of Whitley. Prelim. Resp. 25–27.
`As noted by Patent Owner, Jagger and Whitley were cited by the
`patentee on an IDS during prosecution. See Exs. 2006, 2010; Prelim. Resp.
`25–26. Patent Owner does not assert, however, that Bliss or Occhialini were
`cited on an IDS or otherwise put before the Examiner during prosecution.
`Nor does Patent Owner demonstrate that the Examiner ever considered the
`same arguments with respect to Jagger and Whitley as are presented in the
`Petition. Thus, Patent Owner has not demonstrated sufficiently that the
`Petition presents the same or substantially the same prior art or arguments as
`were before the Examiner during prosecution.
`With respect to Patent Owner’s argument that McCombs is
`cumulative of Whitley, we note that, contrary to Patent Owner’s assertions,
`the Petition relies upon McCombs, not Whitley, as disclosing an adsorbent
`bed that provides a ratio of product flow rate to mass of the molecular sieve
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`material that is greater than 3.3 ml/min/g. Compare Pet. 38–39, 78
`(asserting that McCombs discloses a ratio that “is greater than 3.3
`ml/min/g”) with Prelim. Resp. 26–27 (asserting that Petitioner “alleges that
`Whitley,” and not McCombs, expressly discloses a ratio of greater than 3.3
`ml/min/g). Thus, Patent Owner has not demonstrated that McCombs is
`cumulative of Whitley.
`In view of the foregoing, we do not exercise our discretion under
`§ 325(d) to deny institution of inter partes review.
`
`C. Claims 12–18 and 21 over McCombs, Whitley, and AAPA
`Petitioner contends the subject matter of claims 12–18 and 21 would
`have been obvious over McCombs, Whitley, and AAPA. Pet. 36–51.
`
`1. McCombs
`McCombs discloses a “gas concentration apparatus for separating gas
`mixtures by pressure swing adsorption (‘PSA’) and vacuum pressure swing
`adsorption (‘VPSA’).” Ex. 1002 ¶ 2. Figure 7 of McCombs is reproduced
`below:
`
`Figure 7 is an exploded view of the
`preferred embodiment of McCombs
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`As shown in Figure 7, adsorber beds 30 and 32 are mounted vertically
`between, and in fluid communication with, feed/waste manifold 120 and
`product manifold 122. Id. ¶ 28. Compressor 24 provides ambient air to
`manifold 120, which then directs this air to absorber beds 30 and 32.
`Id.
`
`Each absorber bed may contain a synthetic zeolite material and is
`“about 5.25 inches in length and 1.375 inches in diameter.” Id. ¶¶ 21, 37.
`McCombs indicates that the disclosed apparatus can achieve 8.75 mL, 17.5
`mL, and 26.25 mL pulse doses at 1 LPM, 2 LPM, and 3 LPM settings,
`respectively, and that the apparatus has a weight of less than about 5 lbs.
`Id. ¶ 36. Rechargeable internal battery 989 provides power for the apparatus.
`Id. ¶ 44.
`
`2. Whitley
`Whitley discloses a portable medical oxygen concentrator. Ex. 1003
`¶ 5. This concentrator uses “a pressure swing adsoption unit” having “a
`rotary valve to direct gas flow to, from, and between multiple adsorbent
`columns.” Id. ¶ 77. “The rotary valve and the adsorbent columns may be
`mounted in a compact base assembly, and the columns may be detachably
`connected to the base assembly at one end to allow easy replacement.”
`Id.
`
`
`9 U.S. Patent No. 6,764,534 is incorporated by reference in McCombs and
`discloses a removable, nickel metal hydride battery pack used to power a
`POC apparatus. Ex. 1008, 13:38–52; Ex. 1002 ¶ 5.
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`Figure 3 of Whitley is reproduced below:
`
`
`Figure 3 is an exploded view of the disclosed
`portable medical oxygen concentrator
`As shown in Figure 3, the concentrator of Whitley has outer shell 1,
`interface panel 2, air inlet grille 7, air outlet grille 8, battery packs 11 and 13
`detachably connected to the rear external wall of the shell, and air separation
`system 15, which is mounted on the upper surface of the flat bottom portion
`of base 9. Id. ¶¶ 82, 84.
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`Figure 5 of Whitley is reproduced below:
`
`
`
`Figure 5 shows the adsorbent columns,
`gas storage column, and rotary valve of the apparatus of Whitley
`As shown in Figure 5, bottom member 52 contains attached collars 29, 31,
`and 55, as well as one additional collar that is not depicted in Figure 5.
`Id. ¶¶ 92–93. Adsorbent columns 25, 27, 53 and 61 are each detachably
`connected to one of these collars. Id. ¶ 93. “Column 63, which is used for
`product gas storage and may be empty (i.e., contains none of the adsorbent
`for air separation located in the adsorbent columns), is detachably mounted
`in and detachably connected to a fifth collar (not visible).” Id. Rotary valve
`65 is mounted to bottom member 52 by four bolted mounts. Id. Molded
`tubes 71, 73, 75, and 77 connect the absorbent columns to the feed stator of
`rotary valve 65. Id.
`
`The adsorbent material used in the columns is a “commercially-
`available adsorbent[],” such as “type X zeolite or low silica type X zeolite,
`wherein at least 80% of the cation sites are exchanged with lithium cations.”
`Id. ¶ 95. The shape of the adsorbent particles “may be spherical, cylindrical,
`[or] granular.” Id.
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`3. AAPA
`The ’055 patent describes devices, adsorbents, and operating
`conditions that were known in the art. For example, the ’055 patent
`discloses that “[p]ressure swing adsorption systems typically use adsorbent
`beds filled with spherical particles.” Ex. 1001, 10:52–54. The ’055 patent
`also discloses that it was known in the art to use replaceable sieve beds and
`interchangeable battery packs. Id. at 18:5–10, 18:36–42.
`
`4. Analysis
`Petitioner asserts that McCombs, either expressly or through
`incorporation-by-reference (with respect to a removable battery pack),
`discloses every limitation of claim 12, except a molecular sieve material that
`is spherical. Pet. 36–41. Petitioner contends, however, that both Whitley
`and AAPA disclose the use of spherical molecular sieve materials. Id. at 41
`(citing Ex. 1001, 10:52–56; Ex. 1003 ¶ 95).
`With respect to dependent claims 13–18, Petitioner contends
`McCombs discloses using multiple adsorbent beds (claims 13 and 14);
`molecular sieve material that has a mass less than about 50 grams (claim
`15); and the use of a zeolite as the molecular sieve material (claim 16).
`Id. at 42–44. Petitioner further contends that Whitley discloses the use of a
`metal exchanged zeolite (claim 17), which may be in the form of a “Li+-
`exchanged zeolite” (claim 18). Id. at 44 (citing Ex. 1003 ¶ 95).
`With respect to claim 21, which requires that the “removable module”
`be “replaceable by a user,” Petitioner contends the internal components of
`McCombs are “readily accessed for servicing” and, therefore, are
`replaceable by a user. Id. at 45 (citing Ex. 1002 ¶¶ 7, 30; Ex. 1011 ¶¶ 110–
`18, 169 (Mr. Taylor testifying that one of ordinary skill in the art would
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`understand that the detachable adsorbent unit of McCombs is “replaceable
`by a user”)).
`In the event that it is determined that McCombs does not disclose a
`“removable module” that is “replaceable by a user,” or a removable battery
`pack, Petitioner contends Whitley and/or AAPA disclose these elements.
`Id. at 40, 45–46 (citing Ex. 1003 ¶ 77 (explaining that the design of Whitley
`“allow[s] easy replacement” of the adsorbent columns); Ex. 1001, 18:4–10
`(noting that at least one prior art device had a “replaceable” sieve bed)).
`Petitioner contends one of ordinary skill in the art would have sought
`to include the spherical particles, removable battery pack, metal exchanged
`zeolites, and “user-replaceable, easily-removable adsorbent bed” of Whitley
`and/or AAPA in McCombs, because: (1) spherical particles were well
`known in the art; (2) Whitley “explicitly touts the benefits of an externally-
`mounted, easily-detachable” battery pack; (3) metal exchanged zeolites were
`commonly used in POCs and marketed by adsorbent manufacturers for such
`use; and (4) one of ordinary skill in the art would have understood, given the
`need to periodically replace sieve beds, that there was a need in the art for an
`easily removable and replaceable adsorbent module. Pet. 47–51. According
`to Petitioner, incorporation of these elements from Whitley and AAPA into
`the device of McCombs would merely comprise the use of familiar
`elements, according to known methods, to yield predictable results. Id. at
`47–48 (citing Ex. 1011 ¶¶ 172–175).
`Patent Owner contends the challenged claims would not have been
`obvious over McCombs, Whitley, and AAPA because these references do
`not teach or suggest an adsorbent module that is “removable” or
`“replaceable by a user,” and because Petitioner has not explained sufficiently
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`how or why one of ordinary skill in the art would have modified McCombs
`in view of Whitley and AAPA to arrive at the claimed portable oxygen
`concentrator. Prelim. Resp. 27–42, 45–47.
`
`a. Removable Module
`Patent Owner contends the adsorbent modules of McCombs are not
`“removable” as they are “not designed to be easily accessible or replaced in
`minimal steps.” Prelim. Resp. 28. In support of this argument, Patent
`Owner notes that the adsorbent modules of McCombs are located behind
`many other components of the POC, and the service manual for the
`commercial product that allegedly corresponds to the invention of McCombs
`has “11 pages of instruction on how to replace the adsorbent bed columns.”
`Id. at 29–31 (citing Ex. 1002, Fig. 7; Ex. 2003, 10, 27, 29–35, 41–43).
`As noted above, we do not construe the term “removable module” to
`require a module that is readily accessible and disconnectible without
`substantial disassembly of the POC, as asserted by Patent Owner.
`Moreover, despite the numerous steps necessary to access the sieve beds of
`McCombs, the reference explicitly describes the internal components of the
`device, including the sieve beds, as being “readily accessed for servicing.”
`Ex. 1002 ¶ 30. Thus, on this record, Petitioner has demonstrated sufficiently
`that McCombs discloses a removable module.
`
`b. Replaceable by a User (Claim 21)
`Patent Owner contends McCombs does not disclose a module that is
`“replaceable by a user.” Prelim. Resp. 27–32, 42. Patent Owner reasons
`that McCombs requires substantial disassembly of the device to access the
`adsorbent bed columns and a user is “strictly prohibited,” at risk of waiving
`the device warranty, from removing the exterior housing of the commercial
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`embodiment of McCombs. Id. at 30–32. Given these limitations, Patent
`Owner contends it would be “prohibitively difficult and complex for a
`typical user of the concentrator, who is elderly and/or has limited strength or
`dexterity, to replace” the adsorbent modules of McCombs. Id. at 32.
`McCombs indicates that the disclosed apparatus is “readily accessed
`for servicing,” Ex. 1002 ¶ 30, and Mr. Taylor testifies that many users would
`be capable of servicing even a “comparatively complex concentrator
`system.” Ex. 1011 ¶¶ 110, 113. Although Patent Owner disputes this
`conclusion, Patent Owner’s attorney arguments focus on the complexity of
`the removal and installation process, not on the strength or dexterity required
`to remove and replace the adsorbent modules. Prelim. Resp. 30–31
`(addressing the tools and steps required to replace the adsorbent beds in
`McCombs). Patent Owner also does not explain sufficiently why any of the
`challenged claims require that the removal and replacement of the adsorbent
`module be conducted in a manner desired by the manufacturer.
`Based on the foregoing, on this record Petitioner has demonstrated
`sufficiently that the adsorbent modules of McCombs are “replaceable by a
`user.”
`
`c. Reason to Combine
`Patent Owner asserts that Petitioner has not explained sufficiently
`how or why one of ordinary skill in the art would have modified McCombs
`to make the adsorbent modules easily replaceable by a user. Prelim.
`Resp. 45–47; see also Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1066
`(Fed. Cir. 2016) (noting that one must provide an explanation as to how and
`why the references would be combined to produce the claimed invention).
`According to Patent Owner, the Petition at most demonstrates that
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`removable modules configured to be replaceable were known in the art, but
`does not explain how the device of McCombs would be modified to achieve
`this result or why one of ordinary skill in the art would have sought to do so,
`as other methods for addressing moisture degradation of sieve beds were
`known in the art. Prelim. Resp. 46–47.
`On this record, Petitioner has demonstrated sufficiently that the sieve
`beds of McCombs are “removable” and “replaceable by a user.” Thus, we
`need not address Patent Owner’s arguments regarding the alleged motivation
`to modify McCombs with Whitley and AAPA with respect to these
`limitations. With respect to the shape of the sieve bed material, the use of a
`removable battery pack, and the use of metal exchanged zeolites, Petitioner
`provides uncontested explanations as to why one of ordinary skill in
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