`571-272-7822
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`Paper No. 9
`Entered: May 10, 2019
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`SANDBOX MEDICAL, LLC,
`Petitioner,
`
`v.
`
`NEOTECH PRODUCTS, INC.,
`Patent Owner.
`_______________
`
`Case IPR2019-00246
`Patent 6,958,050 B1
`_______________
`
`
`
`Before BENJAMIN D. M. WOOD, RICHARD H. MARSCHALL,
`and JASON W. MELVIN, Administrative Patent Judges.
`
`WOOD, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314
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`I.
`
`INTRODUCTION
`
`Background
`A.
`Sandbox Medical, LLC (“Petitioner”) filed a Petition (Paper 3, “Pet.”)
`requesting inter partes review of claims 1–10 of U.S. Patent No. 6,958,050
`(Ex. 1001, “the ’050 patent”). Neotech Products, Inc. (“Patent Owner”) did
`not file a Preliminary Response.
`We have authority under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is 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). A decision to
`institute under 35 U.S.C. § 314 may not institute on fewer than all claims
`challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60
`(2018).
`Upon considering the Petition and the evidence currently of record,
`we determine that Petitioner has shown a reasonable likelihood that it would
`prevail in showing the unpatentability of at least one of the challenged
`claims. Accordingly, we grant the Petition.
`
`Related Proceedings
`B.
`Petitioner states that Patent Owner filed a patent infringement action
`asserting the ’050 patent against Petitioner in the Central District of
`California, but voluntarily dismissed the action prior to service. Pet. 4
`(citing Ex. 1012 ¶ 8). According to Petitioner, Patent Owner filed a new
`action in the District of Delaware, which was transferred to the District of
`Massachusetts. Id. (citing Ex. 1012 ¶ 8). Petitioner disputes that it has been
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`served, but states that Patent Owner alleges that it effected service on
`November 14, 2017. Id. (citing Ex. 1012 ¶ 8).
`
`The ’050 Patent
`C.
`The ’050 patent issued October 25, 2005 from an application filed
`June 18, 2002, and is titled “Nasal/Oral Aspiration Device.” Ex. 1001, [45],
`[22]. Figure 1, reproduced below, depicts a side elevation view of a
`preferred embodiment:
`
`
`
`
`Figure 1, reproduced above, depicts two-part suctioning device 10
`comprising first tubular body portion 11 connected end-to-end with second
`tubular portion 12. Id. at 2:31–34. First portion 11 is made from a
`“relatively hard non-deformable plastic material,” whereas second portion
`12 is “flexibly and resiliently yieldably deformable, sidewardly.” Id. at
`2:45–48. Flexible tapered tip 12a, located at the end of second portion 12,
`“flexes easily and helps provide better access to nasal and oral cavities.” Id.
`at 2:38–40, Fig. 4.
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`3
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`suctioning
`
`device,
`
`The Challenged Claims
`D.
`Petitioner challenges claims 1–10. Pet. 1. Claim 1 is the sole
`independent claim, and is reproduced below:
`1. A multi-purpose medical
`comprising:
`a) a one piece first tubular body portion,
`b) a one piece second tubular portion operatively
`connected to said first tubular body portion,
`c) said second tubular portion having a flexible tip
`portion which is relatively soft and pliable and has an
`entrance of reduced area, said second tubular portion
`being easily maneuverable as by bending,
`d) there being a side inlet associated with at least one of
`said first and second portions, to be manually blocked
`and unblocked to control suctioning of fluid from said
`tip portion entrance and through said second and first
`tubular portions,
`e) and wherein said first tubular body portion consists of
`relatively hard plastic material, and said second tubular
`portion consists of relatively soft plastic material, the
`tip being maneuverable as by one hand of the user,
`while the user’s other hand controls said side inlet,
`f) said second tubular portion having primary secondary
`and tertiary [sic] lengthwise extending sections, said
`primary section fitting telescopically to said first
`tubular body portion, and with friction, said tertiary
`section being flexible and tapering toward said tip at a
`relatively lesser taper angle, and said secondary
`section extending between said primary and tertiary
`section, at a relatively greater taper angle, said primary
`section fitting over said first tubular body portion to
`define a device maximum diameter proximate the
`entrance of said side inlet and between said inlet and
`said flexible tip portion, for finger control of the
`device including finder control of said inlet and control
`of said primary section to control tip portion bending,
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`g) said secondary and tertiary sections having respective
`lengths L2, [sic] and L3 where L3 is elongated and
`L3>>L2, flexibility of said tertiary section thereby
`being enabled along its major elongated length, to
`facilitate suctioning usage of the tertiary section as the
`tertiary section is easily bent in response to
`engagement with tissue of a patient,
`h) and wherein said device is characterized by one of the
`following:
`i) said body portions are transparent
`ii) said body portions are translucent
`iii) at least one of said body portions is transparent
`iv) at least one of said body portions is translucent.
`
`
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`Asserted Grounds of Unpatentability
`E.
`Petitioner contends that the challenged claims are unpatentable based
`on the following specific grounds (Pet. 3):
`No.
`1
`
`Basis Claim[s] Challenged
`
`§ 103 1–6 and 8–10
`
`Reference[s]
`Jackson,1 Kerwin,2
`Behrstock,3 Penny,4 and
`Halligan5
`Jackson, Kerwin,
`Behrstock, Penny,
`Halligan, and Shedlock6
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`2
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`§ 103 7
`
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`1 U.S. Pat. No. 3,595,234 (iss. Jul. 27, 1971) (Ex. 1003).
`2 U.S. Pat. No. 4,813,926 (iss. Mar. 21, 1989) (Ex. 1004).
`3 U.S. Pat. No. 4,699,138 (iss. Oct. 13, 1987) (Ex. 1006).
`4 U.S. Pat. No. 3,965,901 (iss. Jun. 29, 1976) (Ex. 1009).
`5 U.S. Pat. No. 3,319,628 (iss. May 16, 1967) (Ex. 1005).
`6 U.S. Pat. No. 5,114,415 (iss. May 19, 1992) (Ex. 1007).
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`No.
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`4
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`Reference[s]
`Jackson, Kerwin,
`Behrstock, Penny,
`Halligan, and Perla7
`Jackson “in view [of] the
`Common Knowledge of
`the POSA”
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`Basis Claim[s] Challenged
`
`§ 103 10
`
`§ 103 1–10
`
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`In support of its proposed grounds, Petitioner relies on the Declaration
`of Leslie H. Sherman (Ex. 1011).
`
`II. ANALYSIS
`
`A. Level of Ordinary Skill in the Art
`Petitioner asserts that a person of ordinary skill in the art at the time of
`the ’050 patent “would have been a mechanical technician having the
`equivalent of 4 years of undergraduate education in mechanical technology,
`or two years of education and two years of practical experience in industrial
`design.” Pet. 25. According to Petitioner, the level of skill “could be
`achieved through formal education, a combination of education and
`experience, or even purely through experience.” Id. (citing Ex. 1011 ¶ 20).
`For purposes of determining whether to institute the Petition, we
`adopt Petitioner’s definition. We also presume that the cited prior art
`references reflect the level of ordinary skill at the time of the invention. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
`
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`7 U.S. Patent No. 5,496,268 (iss. Mar. 5, 1996) (Ex. 1010).
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`Claim Construction
`B.
`Because the Petition in this proceeding was filed before the effective
`date of the USPTO’s recent change to the claim-construction standard in
`trial proceedings before the Board,8 we construe the claims based on the
`“broadest reasonable construction” of the claims in light of the specification
`in which the claims appear. 37 C.F.R. § 42.100(b) (2018); see Cuozzo Speed
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (upholding the use of the
`broadest reasonable interpretation standard). Under this standard, claim
`terms are generally given their ordinary and accustomed meaning as
`understood by one of ordinary skill in the art, unless it appears from the
`specification, the file history, or other evidence asserted by the parties that
`the inventor used them differently. In re Paulsen, 30 F.3d 1475, 1480 (Fed.
`Cir. 1994). Any special definition for a claim term must be set forth in the
`specification with reasonable clarity, deliberateness, and precision. Id.
`Petitioner proposes the following constructions for terms in
`independent claim 1:
`
`Term
`
`device maximum
`diameter
`
`relatively lesser taper
`angle
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`Proposed Construction
`The largest straight line between two points on the
`circumference of a circular portion of the device
`that passes through the center of the circle
`The angle of the tertiary section which is less than
`the angle of the secondary section
`
`
`8 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. pt. 42) (changing claim
`construction standard for petitions filed on or after November 13, 2018).
`The Petition in this case was filed September 28, 2018. Paper 3, 1.
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`The angle of the secondary section which is
`greater than the angle of the tertiary section
`Consisting of parts that slide one within another
`
`relatively greater
`taper angle
`telescopically
`
`Pet. 21–24. On this record, and for the limited purpose of determining
`whether to institute the Petition, we adopt these constructions.
`
`Analysis
`C.
`Petitioner asserts, inter alia, that claims 1–6 and 8–10 would have
`been obvious over Jackson, Kerwin, Behrstock, Penny, and Halligan. Pet.
`25–48. Because Patent Owner did not submit a Preliminary Response, we
`determine whether to institute inter partes review based on whether
`Petitioner has shown a reasonable likelihood of prevailing in showing the
`unpatentability of claim 1 over Jackson, Kerwin, Behrstock, Penny, and
`Halligan. See 35 U.S.C. § 314(a) (requiring Petitioner to show a reasonable
`likelihood of prevailing “with respect to at least 1 of the claims challenged in
`the petition”).
`Jackson (Ex. 1003)
`1.
`Jackson describes a vacuum controller for a medicosurgical tube that
`can be used for the aspiration of mucus from the nose and mouth. Figure 1
`is a perspective view of a preferred embodiment, and is reproduced below:
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`Figure 1, reproduced above, depicts vacuum controller 2 comprising a
`central body portion having a pair of opposed transverse ends 6 and 8. Ex.
`1003, 3:14–16. Integral male connector portion 10 extends axially from end
`6 and integral female connector portion 12 extends axially from end 8. Id. at
`3:16–18. Bore 14 (depicted in Figure 2) extends axially through vacuum
`controller 2. Id. at 3:18–20, Figs. 2–4. Body portion 4 has a triangular
`cross-section, including concave face 24 with elliptical opening 28 that
`extends through the face into bore 14. Id. at 3:34–36, Fig. 5. Connector
`tube 38 is positioned over male connector 10 and is connected at the other
`end to a vacuum source (not shown). Id. at 3:65–67. Suction catheter 40 is
`inserted into female connector 12. Id. at 3:68–69. An operator controls
`suction through the device by placing a finger over opening 28 to supply
`suction and removing the finger to release suction. Id. at 3:70–4:5.
`Kerwin (Ex. 1004)
`2.
`Kerwin describes a hand-held, fine tip medical suction device.
`Ex. 1004, 1:9–10. Figures 1 and 2 are reproduced below:
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`Figure 1, reproduced above, depicts Kerwin’s medical hand-held
`suction device 10; Figure 2, reproduced above, is an enlarged view of the
`distal end of the device depicted in Figure 1. Id. at 2:11–15. Suction device
`10 comprises handle 14 connected to probe 16, which has flexible suction tip
`18 at its distal end. Id. at 2:29–32. Tip 18 includes longitudinally extending
`tapered portion 44 with integral enlarged connector portion 46 at its
`proximal end. Id. at 3:4–7. Handle 14 and probe 16 may be made of a
`relatively rigid plastic material, whereas tip 18 is preferably formed of a
`flexible plastic material. Id. at 6:17–23. The tip “may be formed of a
`polyvinyl chloride that is soft and flexible but which supports itself and is
`resilient enough to return to its original shape after being bent during use.”
`Id. at 6:24–28.
`Behrstock (Ex. 1006)
`3.
`Behrstock describes an endotracheal intubation device that can be
`inserted into a baby’s mouth or nose to remove meconium at birth. Ex.
`1006, 1:8–10, 33–41. Figure 4 of Behrstock is reproduced below:
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`As shown in Figure 4, reproduced above, Behrstock’s device 10 is
`attached at one end to suction tubing 20, which in turn is attached to suction
`device 44. Id. at 4:13–15. Device 10 is attached at the other end to
`endotracheal (E-T) tube 22. Id. at 4:18–20. “E-T tube 22 is a commonly
`used stock item in the art” that is “made of a variety of clear plastic material
`as is also commonly known in the art.” Id. at 4:21–26. An operator controls
`suction by placing or removing a finger over port 36. Id. at 5:3–7, 53–54.
`Penny (Ex. 1009)
`4.
`Penny describes a suction catheter for aspiration of mucus and other
`fluids from tracheobronchial passages. Ex. 1009, 1:5–7. Figure 1 of Penny
`is reproduced below:
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`As shown in Figure 1, reproduced above, suction catheter 1 comprises
`flexible tubular body 2 attached to rigid connector 3 and tubular body 4. Id.
`at 2:50–52. “The end of connector 3 opposite suction port 7 has a tubular
`extension 10 with external retaining rigs 11 over which the proximal end
`section 13 of flexible tubular member 2 is telescoped.” Id. at 5–61.
`Connector 3 includes regulator 16 having upstanding cylindrical body 17
`and atmospheric port 19 connected to axial passage 5 via a passage through
`body 1. Id. at 2:52–53, 2:65–3:1. An operator controls the degree of suction
`through tubular member 2 by opening or closing port 19 with a finger. Id. at
`3:1–4.
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`Halligan (Ex. 1005)
`5.
`Halligan discloses a regulator for a catheter for suctioning tracheal,
`bronchial, oral, or nasal passages. Ex. 1005, 1:10–17. Figure 1 is
`reproduced below:
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`Figure 1, reproduced above, depicts regulator 10. Id. at 2:26–28.
`“The regulator is preferably formed of nylon, although other plastics having
`rigid properties may be used.” Id. at 2:29–31. Regulator 10 is attached to
`“flexible tubular member 16 such as a suction catheter.” Id. at 2:33–36. “It
`is convenient to use a tubing which is translucent or transparent as opposed
`to an opaque tubing.” 2:52–53.
`Principles of Law
`6.
`“A patent for a claimed invention may not be obtained though the
`invention is not identically disclosed or described as set forth in [35 U.S.C.
`§ 102], 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 the subject matter pertains.” 35 U.S.C. § 103(a) (2011).9
`
`
`9 Because the ’050 patent issued from an application filed before March 16,
`2013, the effective date of the amendments to 35 U.S.C. § 103 enacted by
`the Leahy-Smith America Invents Act, we apply the pre-AIA version of the
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`Obviousness is a question of law based on underlying factual considerations
`that “include the scope and content of the prior art, the differences between
`the prior art and the claimed invention, the level of ordinary skill in the art,
`and any relevant secondary considerations” of non-obviousness, including
`commercial success of the patented product or method, a long-felt but unmet
`need for the functionality of the patented invention, and the failure of others
`who have unsuccessfully attempted to accomplish what the patentee has
`achieved. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). The
`obviousness analysis should not be conducted “in a narrow, rigid manner,”
`but should instead focus on whether a claimed invention is merely “the
`result[ ] of ordinary innovation,” which is not entitled to patent protection.
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007).
`Discussion
`7.
`Petitioner contends that “[t]he vast majority of the claimed elements
`can be found explicitly in [Jackson].” Pet. 25. Specifically, Petitioner
`contends that Jackson teaches: (1) a one-piece first tubular body portion;
`(2) a one-piece second tubular portion operatively connected to said first
`tubular body portion; (3) a side inlet associated with at least one of the first
`and second portions that can be manually blocked and unblocked to control
`suction from a tip through the first and second portions; (4) the second
`tubular portion having primary, secondary, and tertiary sections; (5) the
`primary section fitting telescopically to the first tubular body portion; (6) the
`secondary section extending between the primary section at a relatively
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`statute. See Leahy-Smith America Invents Act (AIA), Pub. L. No. 112–29,
`§ 3(n)(1), 125 Stat. 284, 293 (2011).
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`greater taper angle; (7) the tertiary section length L3 >> the secondary
`section length L2; and (8) a device maximum diameter located proximate the
`side inlet entrance and between the inlet and the flexible tip portion. Id. at
`27–37. These contentions are supported by specific citations to the record,
`including an annotated version of Figure 1 of Jackson, as well as by Mr.
`Sherman’s testimony. Id. (citing Ex. 1003, 1:6–19, 64–73, 2:52–55, 3:57–
`61, 4:64–66, Figs. 1–3; Ex. 1011 at 29–39). Upon review of the evidence of
`record, we determine that Petitioner has provided a sufficient showing at this
`stage of the proceeding that Jackson teaches the above limitations.10
`Regarding the limitations requiring the second tubular portion to have
`a relatively soft, pliable, flexible, single-handedly maneuverable tip with an
`entrance of reduced area, Petitioner relies on, inter alia, Kerwin. Id. at 28–
`29. Petitioner specifically relies on Kerwin’s description of “fine tip 18”
`shown in Figures 1 and 2, which “is preferably formed of a suitable flexible
`plastic material,” and which is “soft and flexible” but “resilient enough to
`return to its original shape after being bent during use.” Id. at 29 (citing Ex.
`1004, 6:17–20, 22–32, Figs. 1–2). Likewise, Petitioner relies on Kerwin to
`teach the limitations that require the second tubular portion, and the tertiary
`section thereof, to be bendable and flexible. Id. at 29, 31–32, 34 (citing Ex.
`1004, 6:17–20, 22–32, Fig. 2). For these limitations Petitioner also notes
`Penny’s teaching that suction catheters have “[t]raditionally” consisted of a
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`10 Petitioner asserts that many of these limitations are also taught by other
`cited references. See, e.g., Pet. 28 (asserting that Penny, Halligan,
`Behrstock, and Kerwin also teach a one-piece second tubular portion).
`Because we are persuaded on this record that Jackson teaches these
`limitations, we do not, for purposes of this decision, decide whether the
`limitations are also taught by other references.
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`“flexible” plastic tube. Id. at 32 (quoting Ex. 1009, 1:12–17). Petitioner
`asserts that one of ordinary skill in the art would have used Kerwin’s flexible
`tip with Jackson’s vacuum controller because Jackson teaches that its
`vacuum controller can be used “with any form of medicosurgical suction
`tube,” which vary in size and shape depending on the medical application.
`Pet. 29 (quoting Ex. 1003, 1:6–19).
`We determine that Petitioner has provided a sufficient showing at this
`stage of the proceeding that Kerwin teaches the limitations discussed above,
`and that one of ordinary skill in the art would have had reason to combine
`teachings from Jackson and Kerwin. Jackson teaches that all forms of
`suction tubes can be used with its vacuum controller, including those used
`for surgical operations. Ex. 1003, 1:13–22. Kerwin teaches a suction tip
`used in connection with a suction tube on a surgical suction device. Ex.
`1004, 1:13–50. Thus, combining Kerwin’s suction tip with Jackson’s
`vacuum controller amounts to no more than the combination of prior art
`elements according to known methods to yield predictable results. See KSR
`Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of
`familiar elements according to known methods is likely to be obvious when
`it does no more than yield predictable results.”).
`Regarding the requirement that the primary section of the second
`tubular body portion “fit[] over” the first tubular body portion, Petitioner
`acknowledges that Jackson’s primary section fits inside of, not over,
`Jackson’s first tubular body portion (i.e., the primary section uses a male
`connection to connect to a female connection on the first tubular body
`portion). Id. at 36. Petitioner asserts, however, that Penny teaches this
`limitation. Id. at 36 (citing Ex. 1009, 2:58–62). Petitioner asserts that it
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`would have been obvious to one of ordinary skill in the art to use a female
`connecter to connect to a male connector on the first tubular body portion as
`taught in Penny because deciding between a male or female connection “was
`merely a design choice and male and female connections were well known
`in the art.” Pet. 37 (citing Ex. 1011 at 37–39).
`We determine that Petitioner has made a sufficient showing at this
`stage of the proceeding that Penny teaches the claimed connector
`arrangement. We also determine that Petitioner has adequately shown at this
`stage of the proceeding that using Penny’s connector arrangement with
`Jackson would have been obvious to one of ordinary skill in the art at the
`time of the invention, because it would merely have been a simple
`substitution of one known element—a female/male connection—for
`another—a male/female connection—to obtain predictable results. See KSR,
`550 U.S. at 416 (holding that “when a patent claims a structure already
`known in the prior art that is altered by the mere substitution of one element
`for another known in the field the combination must do more than yield a
`predictable result”).
`Regarding the requirement that at least one of the first and second
`tubular portions be transparent or translucent, Petitioner relies on Behrstock,
`and particularly Behrstock’s teaching that it was “commonly known in the
`art” to use a “clear plastic material[]” to make an endotracheal suction tube.
`Id. at 38 (citing Ex. 1006, 1:6–19, 4:22–27). Petitioner further notes
`Halligan’s teaching that “[i]t is convenient to use a tubing which is
`translucent or transparent as opposed to an opaque tubing” for suction
`catheter tubing, “although an opaque tubing may be used.” Id. (citing Ex.
`1005, 2:52–55). Petitioner contends that “[i]t would have been obvious to a
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`POSA to use any number of clear or translucent materials for both primary
`and secondary sections” of the second tubular portion because “transparent
`and/or translucent materials were well known in the prior art and used
`routinely in suction devices.” Id. at 39 (citing Ex. 1011 at 39–41).
`We determine that Petitioner has sufficiently shown at this stage of
`the proceeding that Behrstock and Halligan teach this limitation, and that
`one of ordinary skill in the art would have combined Behrstock and Halligan
`with Jackson. The record indicates that transparent suction tubes were well-
`known and could have been used in place of opaque tubes to accomplish the
`result of providing suction. See KSR, 550 U.S. at 416.
`In sum, we are persuaded that there is a reasonable likelihood that
`Petitioner would prevail in showing that claim 1 would have been obvious
`over Jackson, Kerwin, Penny, Behrstock, and Halligan. Accordingly, we
`determine to institute inter partes review of the ’050 patent.
`
`III. CONCLUSION
`
`For the foregoing reasons, we determine that Petitioner has shown that
`there is a reasonable likelihood that it would prevail with regard to at least
`one of the claims challenged in the Petition. Accordingly, we institute inter
`partes review of the ’050 patent.
`
`IV. ORDER
`
`For the reasons given, it is
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review of U.S. Patent 6,958,050 B1 is instituted on all grounds;
`and
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`FURTHER ORDERED pursuant to 35 U.S.C. § 314(a) and 37 C.F.R.
`§ 42.4 that notice is hereby given of the institution of a trial, which
`commences on the entry date of this Decision.
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`
`For PETITIONER:
`
`Vincent McGeary
`MCGEARY CUKOR LLC
`vmcgeary@mcgearycukor.com
`
`For PATENT OWNER:
`
`Michael DiNardo
`KELLY & KELLY, LLP
`mike@kelly-kelleylaw.com
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`18
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`