Trials@uspto.gov
`571-272-7822
`
`Paper No. 22
`Date: May 6, 2020
`
`
`
`
`
`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.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper No. 22
`Date: May 6, 2020
`
`
`
`
`
`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.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`
`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
`B1 (Ex. 1001, “the ’050 patent”) on the following grounds (Pet. 6–7):
`
`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
`Jackson, Kerwin,
`Behrstock, Penny,
`Halligan, and Perla7
`Jackson “in view [of] the
`Common Knowledge of
`the POSA [person of
`ordinary skill in the art]”
`
`2
`
`3
`
`4
`
`
`
`§ 103 7
`
`§ 103 10
`
`§ 103 1–10
`
`
`1 U.S. Pat. No. 3,595,234 (iss. July 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. June 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).
`7 U.S. Pat. No. 5,496,268 (iss. Mar. 5, 1996) (Ex. 1010).
`
`2
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`Neotech Products, Inc. (“Patent Owner”) did not file a Preliminary
`Response.
`On May 10, 2019, we instituted inter partes review. Paper 9 (“Dec.”).
`Patent Owner subsequently filed a Patent Owner Response (Paper 13, “PO
`Resp.”), Petitioner filed a Reply to the Patent Owner Response (Paper 15,
`“Pet. Reply”), and Patent Owner filed a Sur-reply (Paper 17, “PO Sur-
`reply”). A hearing was held on February 6, 2020, and a transcript of the
`hearing is included in the record. Paper 21 (“Tr.”).
`We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden
`of proving unpatentability of the challenged claims, and the burden of
`persuasion never shifts to Patent Owner. See Dynamic Drinkware LLC v.
`Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing
`burdens of proof in inter partes reviews). To prevail, Petitioner must prove
`unpatentability by a preponderance of the evidence. See 35 U.S.C. § 316(e)
`(2012); 37 C.F.R. § 42.1(d) (2018). This decision is a Final Written
`Decision under 35 U.S.C. § 318(a). For the reasons discussed below, we
`hold that Petitioner has demonstrated by a preponderance of the evidence
`that claims 1–10 of the ’050 patent are unpatentable under 35 U.S.C.
`§ 103(a).
`
`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). The parties indicate that Patent Owner filed a new
`action in the District of Delaware, which was transferred to the District of
`Massachusetts. Id. (citing Ex. 1012 ¶ 8); Paper 6, 2. Petitioner disputes that
`
`3
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`it has been served, but states that Patent Owner alleges that it effected
`service on November 14, 2017. Pet. 4 (citing Ex. 1012 ¶ 8). Petitioner
`informed us at the oral argument that the district-court action has been
`stayed pending the outcome of this proceeding. Tr. 6:10–12.
`
`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,
`codes (45), (22), (54). Figure 1, reproduced below, depicts a side elevation
`view of a preferred embodiment:
`
`
`
`
`Figure 1 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.
`
`4
`
`
`
`
`
`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 finger control of said inlet and control
`of said primary section to control tip portion bending,
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`
`5
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`
`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.
`
`
`Testimonial Evidence
`E.
`In support of its asserted grounds of unpatentability, Petitioner enters
`into the record Declarations of Leslie H. Sherman (Ex. 1011) and Read
`McCarty (Ex. 1012), a Reply Declaration of Mr. Sherman (Ex. 1028), and a
`Second Declaration of Mr. McCarty (Ex. 1029). In support of the
`patentability of its claims, Patent Owner enters into the record a Declaration
`of James E. Moore, Jr., Ph.D. (Ex. 2001), a Declaration of Michael A.
`DiNardo (Ex. 2006), and a Sur-reply Declaration of Dr. Moore (Ex. 2007).
`Petitioner deposed Dr. Moore and entered the transcript of the deposition
`into the record (Ex. 1027).
`
`F. Objective Indicia of Nonobviousness
`Patent Owner has submitted evidence that it characterizes as objective
`indicia of nonobvious. PO Resp. 29–31 (citing Exs. 2003, 2004, 2006).
`
`6
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`
`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 (citing Ex. 1011 ¶ 20). 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).
`Patent Owner responds that one of ordinary skill in the art “must also
`have an understanding of fluid mechanics, i.e., fluid and mass transport, in
`order to have a greater understanding and recognition of the operational
`benefits of an aspirator conforming to the claimed inside diameter profile of
`the ‘050 patent.” PO Resp. 5–6 (citing Ex. 2001 ¶¶ 16, 41). Petitioner
`disagrees, arguing that Dr. Moore, on whose testimony Patent Owner’s
`definition of the ordinary skill level is based, is not sufficiently familiar with
`the relevant art. Pet. Reply 5.
`The “level of skill in the art might be gleaned from the prior art
`itself.” Litton Indust. Prods. V. Solid State Sys. Corp., 755 F.2d 158,
`163–164 (Fed. Cir. 1985). The products described in the prior art of record
`are intended for the removal of bodily fluids in a controlled manner. See,
`e.g., Ex. 1004, 1:13–15 (stating that surgical suction devices “are used for
`removing blood and other body fluids from surgical sites”); Ex. 1005,
`1:10–15 (“This invention relates to . . . an improved regulator adapted to be
`used in combination with a suction catheter apparatus in which the fluid
`
`7
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`flow therethrough is controlled by regulating the flow of a second fluid
`therethrough.”); Ex. 1009, 1:5–7 (“This invention relates to suction catheters
`for aspiration of mucus and other fluids from the tracheobronchial
`passages.”). It stands to reason, therefore, that, in addition to the skill level
`proposed by Petitioner, one of ordinary skill in the art would have
`sufficiently familiar with basic principles of fluid mechanics to understand
`the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
`2001). Therefore, we adopt Petitioner’s proposed definition of the level of
`ordinary skill, modified to clarify that one of ordinary skill in the art would
`also have an understanding of the basic principles of fluid mechanics. We
`note, however, that our claim construction and patentability analyses
`presented below would reach the same findings and determinations under
`either level of ordinary skill in the art.
`
`Claim Construction
`B.
`Because the Petition in this proceeding was filed before the effective
`date of the USPTO’s 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
`
`
`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) (changing claim construction standard for petitions
`filed on or after November 13, 2018); 37 C.F.R. § 42.100(b) (2019). The
`Petition in this case was filed November 9, 2018. Paper 4, 1.
`
`8
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`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. We
`need only construe terms “that are in controversy, and only to the extent
`necessary to resolve the controversy.” Nidec Motor Corp. v. Zhongshan
`Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017), cert.
`denied sub nom. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.,
`138 S. Ct. 1695, 200 L. Ed. 2d 951 (2018) (internal quotation marks and
`citation omitted).
`The parties dispute the construction of the following terms in claim 1:
`“relatively lesser taper angle,” “relatively greater taper angle,” and “device
`maximum diameter.” We construe these terms below, and determine that no
`other term requires express construction.
`“relatively lesser taper angle”; “relatively greater taper
`1.
`angle”
`Claim 1 recites a “second tubular portion” having “primary secondary
`and tertiary lengthwise extending sections” and a “tip portion,” the tertiary
`section “tapering toward said tip at a relatively lesser taper angle,” the
`secondary section extending between the primary and tertiary sections “at a
`relatively greater taper angle.” Ex. 1001, 4:15–38 (emphasis added).
`Petitioner contends that “‘relatively lesser taper angle’ refers to the angle of
`the tertiary section which is lesser than the angle of the secondary section,
`
`9
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`and ‘relatively greater taper angle’ refers to the angle of the secondary
`section which is greater than the angle of the tertiary section.” Pet. 23.
`Patent Owner agrees with Petitioner that “greater” and “lesser” mean
`in comparison with each other. Tr., 29:10–19. Patent Owner contends,
`however, that “taper angle” refers to the angle at which the inside profile of
`the secondary and tertiary sections tapers. PO Resp. 7–9; PO Sur-reply 3–6.
`Petitioner disagrees, asserting that the claimed taper angles refer to the
`tapering of the exterior profiles of the secondary and tertiary sections. Pet.
`Reply 6–13.
`We discern nothing in claim 1 that directly addresses whether “taper
`angle” refers to the inside or outside profiles of the secondary and tertiary
`sections. The Specification of the ’050 patent, however, and particularly
`Figure 2, makes clear that “taper angle” refers to angles associated with the
`exterior of the secondary and tertiary sections. Depicted below is the
`relevant portion of Figure 2 illustrating angles designated α and β (the
`Figure modified to remove extraneous lead lines):
`
`
`The portion of Figure 2 reproduced above depicts secondary section 37 on
`the left and a portion of tertiary section 38 on the right. Ex. 1001, 2:64–66,
`Fig. 2. According to the Specification, tertiary section 38 “tapers toward tip
`
`
`
`10
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`12a at a relatively small or lesser tape[r] angle α,” and secondary section 37
`“extends between [primary section] 36 and [tertiary section] 38 at a
`relatively larger taper angle β.” Id. at 3:1–5. By comparing the description
`of taper angles α and β with limitation (f) of claim 1, it is clear that taper
`angles α and β correspond to the claimed lesser and greater taper angles,
`respectively, and are clearly depicted as representing the outside profiles of
`the tertiary and secondary sections, respectively. We have not found any
`reference to or depiction of a “taper angle” in the Specification that
`associates this term with the inside profiles of the tertiary and secondary
`sections.
`Although Patent Owner asserts, without explanation, that taper angles
`α and β illustrate the interior diameters of the tertiary and secondary
`sections, PO Resp. 7, Patent Owner’s declarant, Dr. Moore, disagrees.
`According to Dr. Moore, Figure 2 “illustrates α and β relative to the exterior
`of the second tubular body.” Ex. 2001 ¶ 36. Dr. Moore attempts to explain
`this away, however, testifying that “[w]hile this FIG. 2 illustrates α and β
`relative to the exterior of the second tubular body, I believe that such was
`done for purposes of improved readability because of the relative scale of
`the drawing figure and the closeness of the interior lines.” Id. We give no
`weight to this testimony. First, it is unsupported by the record evidence or
`reasoned explanation. For example, Dr. Moore does not explain why the
`patentee could not have enlarged the scale of Figure 2—as was done with
`Figure 4—to illustrate interior angles, rather than to incorrectly (according to
`Dr. Moore) illustrate exterior angles. See Phillips v. AWH Corp., 415 F.3d
`1303, 1315 (Fed. Cir. 2005) (holding that “conclusory, unsupported
`assertions by experts as to the definition of a claim term are not useful to a
`
`11
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`court”). Second, Dr. Moore’s opinion is not rendered from the perspective
`of one of ordinary skill in the art. Dr. Moore does not state that “taper
`angle” had any special meaning to one of ordinary skill in the art at the time
`of the invention, or otherwise explain how one of ordinary skill would have
`interpreted the α and β markings in Figure 2 to represent interior angles. See
`Chef America, Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1375 (Fed. Cir.
`2004) (rejecting expert opinion regarding interpretation of claim term
`because it was not established that term had a special meaning in the art).
`Patent Owner argues that because the Specification teaches that the
`inside cross-sectional area of the device affects fluid flow through the
`device, one of ordinary skill in the art would have understood that the inside
`profiles must taper as claimed (i.e., the inside of the tertiary section must
`taper at a “relatively lesser taper angle,” and the inside of the secondary
`section must taper at a “relatively greater taper angle”) to optimize fluid
`flow through the device. PO Resp. 7–9; PO Sur-reply 4–5. For example,
`Patent Owner relies on the following excerpt from the Specification:
`[T]he inside cross-section is typically smallest at the tip.
`Therefore, material that is sucked into the device encounters less
`resistance to flow once it enters the tip, due to highest flow
`velocity at lesser cross sectional area. Thus there will be no hang
`ups of, or blockages by, secretions, within the product.
`PO Resp. 8 (quoting Ex. 1001, 3:52–57); see also id. (quoting Ex. 1001,
`1:47–48, 3:1–3, 4:17–20); PO Sur-reply 4–5 (citing Ex. 1001, 4:23–25, 48–
`49). Patent Owner contends that “[a] person of ordinary skill in the art
`would also view the ‘Relatively Lesser Taper Angle’ of the tertiary section
`and the ‘Relatively Greater Taper Angle’ of the second section of the tubular
`portion to refer to the taper angles of the inside diameter or inside cross-
`
`12
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`section of the secondary and tertiary sections of the second tubular portion,
`consistent with the illustrations and description in the Specification.” PO
`Resp. 8–9 (citing Ex. 2001 ¶¶36–38).
`This is not persuasive. That the tip of the device may have the
`smallest inside cross-section does not specify the inside cross-sections of the
`secondary and tertiary sections, other than that they be larger than the tip’s
`inside cross-section. Stated differently, there is no reason to infer from this
`disclosure that the inside cross-section of the tertiary angle must taper any
`less than the inside cross-section of the secondary section in order to reduce
`flow resistance or prevent hang ups and blockages (a consistent taper
`through both sections would presumably obtain the same results). Even if
`this teaching would have suggested to one of ordinary skill in the art that the
`inside cross-sections taper as claimed, such suggestion would fall far short
`of contradicting the clear depiction in Figure 2 of taper angles with respect
`to the outside profile of the secondary and tertiary sections, rather than the
`inside profile. Thus, reading the Specification in its entirety, one of ordinary
`skill in the art would still have understood the claimed taper angles to refer
`to the outside profiles of these sections.
`device maximum diameter
`2.
`Petitioner contends that “device maximum diameter” should be
`construed as “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.” Pet. 22 (citing Ex. 1011 ¶ 45). Patent Owner appears
`to agree with this construction, but contends that it should apply to “the
`inside circumference of the circular portion of the device that passes through
`the center of the circular portion” of the device. PO Resp. 9 (emphasis
`
`13
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`added).9 According to Patent Owner, the term must refer to the diameter
`measured at the inside of the device because: (1) to interpret the term as
`referring to the outside of the device would necessarily mean the width of
`the device at its side inlet; and (2) as with its construction of “taper angle,”
`“the dimensions of the device are described in the context of optimizing the
`flow cross-sectional area to avoid hang ups or blockages therein,” and “[a]
`POSA having the knowledge of fluid mechanics would have a greater
`understanding and recognition of the operational benefits of a medical
`suctioning device conforming to the claimed inside diameter profile of the
`‘050 patent.” Id. at 10.
`We disagree with Patent Owner that “device maximum diameter”
`refers to an inside diameter. Simply put, the inside diameter is, by
`definition, not the “maximum” diameter of the device, as it is necessarily
`less than the outside diameter. Further, construing the term to apply to the
`outside diameter would not require applying it to the side inlet, because the
`claim specifies that the device maximum diameter is located “proximate the
`entrance of [the] side inlet,” thereby excluding the side inlet from the term.
`Finally, we are not persuaded that considerations of fluid mechanics require
`the term to apply to the device’s inside diameter, for the reasons discussed
`above in connection with the “taper angle” limitations.
`Accordingly, we construe “device maximum diameter” to mean 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.
`
`
`9 We agree with the parties (Pet. 22; PO Resp. 10) that the device maximum
`diameter does not refer to the width of the device at its side inlet.
`
`14
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`
`C. Ground 1: Claims 1–6 and 8–10—Obvious over Jackson,
`Kerwin, Behrstock, Penny, and Halligan
`Petitioner asserts that claims 1–6 and 8–10 would have been obvious
`over Jackson, Kerwin, Behrstock, Penny, and Halligan. Pet. 25–48.
`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. Figures 1
`and 5 depict perspective and cross-sectional views of a preferred
`embodiment, and are reproduced below:
`
`
`
`
`Figures 1 and 5 depict vacuum controller 2 comprising central body portion
`4 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 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. 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
`
`15
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`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:
`
`
`
`
`Figure 1 depicts Kerwin’s medical hand-held suction device 10;
`Figure 2 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.
`
`16
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`
`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:
`
`
`
`
`As shown in Figure 4, Behrstock’s device 10 is attached at one end to
`suction tubing 20, which in turn is attached to wall suction device 44. Id. at
`3:55–56, 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:
`
`17
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`
`
`
`
`As shown in Figure 1, 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 58–61. 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.
`
`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:
`
`
`
`
`
`18
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`
`Figure 1 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).10
`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
`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
`
`
`10 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
`statute. See Leahy-Smith America Invents Act (AIA), Pub. L. No. 112–29,
`§ 3(n)(1), 125 Stat. 284, 293 (2011).
`
`19
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`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).
`7.
`
`Claim 1
`The Combined References Teach All of the
`a.
`Limitations of Claim 1
`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
`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 (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).
`Based on our review of the record, and specifically relying on the
`evidence cited by Petitioner, we determine that Petitioner has established by
`
`20
`
`
`
`
`
`IPR2019-00246
`Patent 6,958,050 B1
`
`a preponderance of the evidence that Jackson teaches the above
`limitations.11
`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. Pet.
`28–29. Petitioner specifically relies on Kerwin’s “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). Petitioner relies on Kerwin and Jackson to
`teach the second tubular portion being “maneuverable as by bending,”12 (id.
`(citing Ex. 1003, Fig. 1; Ex. 1004, 6:17–20, 2232)), and the tertiary section
`of the second tubular portion being bendable and flexible (id. at 29, 31–32,
`34 (citing Ex. 1004, 6:17–20, 22–32, Fig. 2)). 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. Id. 29
`(quoting Ex. 1003, 1:6–19).
`
`
`11 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).
`12 Petitioner also contends that Behrstock teaches this limitation (Pet. 29
`(citing Ex. 1006, 5:16–33)) and that Penny teaches that suction catheters
`have “[t]raditionally” consi
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
