Neotech Products, LLC

Patent Trials and Appeals Board

May 6, 2020

IPR2019-00246 (P.T.A.B. May. 6, 2020)

Trials@uspto.gov Paper No. 22
571-272-7822 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)

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I. INTRODUCTION
A. Background
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. Reference[s] Basis Claim[s] Challenged
1 Jackson,1 Kerwin,2
Behrstock,3 Penny,4 and
Halligan5
§ 103 1–6 and 8–10
2 Jackson, Kerwin,
Behrstock, Penny,
Halligan, and Shedlock6
§ 103 7
3 Jackson, Kerwin,
Behrstock, Penny,
Halligan, and Perla7
§ 103 10
4 Jackson “in view [of] the
Common Knowledge of
the POSA [person of
ordinary skill in the art]”
§ 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).
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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).
B. Related Proceedings
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
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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.
C. The ’050 Patent
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.
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D. The Challenged Claims
Petitioner challenges claims 1–10. Pet. 1. Claim 1 is the sole
independent claim, and is reproduced below:
1. A multi-purpose medical suctioning device,
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,
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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.

E. Testimonial Evidence
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).
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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
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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.
B. Claim Construction
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.
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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.
1. “relatively lesser taper angle”; “relatively greater taper
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,
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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
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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
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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-
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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.
2. device maximum diameter
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
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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.
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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.
1. Jackson (Ex. 1003)
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
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opening 28 to supply suction and removing the finger to release suction. Id.
at 3:70–4:5.
2. Kerwin (Ex. 1004)
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.
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3. Behrstock (Ex. 1006)
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.
4. Penny (Ex. 1009)
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, 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.
5. Halligan (Ex. 1005)
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 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.
6. Principles of Law
“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).
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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
a. The Combined References Teach All of the
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
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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” consisted of a “flexible” plastic tube (id. at 32 (quoting
Ex. 1009, 1:12–17)).
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Based on our review of the record, and specifically relying on the
evidence cited by Petitioner, we determine that Petitioner has established by
a preponderance of the evidence that the combination of Kerwin and Jackson
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, 550 U.S. at 416 (“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 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). Pet. 36. Petitioner asserts, however, that Penny teaches this
limitation. Id. at 36 (citing Ex. 1009, 2:58–62). Petitioner asserts that it
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.” Id. 37 (citing Ex. 1011 at 37–39).
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Based on our review of the record, and specifically relying on the
evidence cited by Petitioner, we determine that Petitioner has established by
a preponderance of the evidence that Penny teaches the claimed connector
arrangement and 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.
Pet. 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
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).
Based on our review of the record, and specifically relying on the
evidence cited by Petitioner, we determine that Petitioner has established by
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a preponderance of the evidence 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. Ex. 1005, 2:52–55; Ex.
1006, 1:6–19, 4:22–27; see KSR, 550 U.S. at 416.
b. Patent Owner’s Arguments Are Unpersuasive
Patent Owner’s primary argument is that none of the references
discloses the claimed “inside diameter profile.” PO Resp. 24. This
argument is premised on Patent Owner’s incorrect construction of the “taper
angle” limitations as referring to the inside profiles of the secondary and
tertiary sections. Because these limitations are properly construed as
applying to the outside profiles of these sections, this argument is
unavailing.
Patent Owner also contends that none of the prior art references
discloses “the claimed relative rigidities.” Id. at 25. Patent Owner
acknowledges that the references may disclose using “hard plastic” and “soft
plastic,” but argues that the references “fail[] to disclose those materials
properties coordinated with the claimed structures, relative taper angles, and
relative lengths,” which “impact the relative flexibilities of each section just
as much as the materials properties.” Id. at 28.
We disagree. The combination of Jackson and Kerwin teaches a
relatively hard plastic first tubular body portion and a relatively soft plastic
second tubular portion, as well as the claimed “relative lengths” of the
secondary and tertiary sections. Ex. 1003, 2:51–55, 3:57–61, 4:64–66,
Fig. 1; Ex. 1004, 6:17–26; Ex. 1011 ¶ 53; see also Ex. 1005, 1:71–2:2
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(Halligan) (teaching “a regulator for a suction catheter apparatus which
includes in combination a relatively elongated flexible tube having a
regulator made of substantially rigid plastic material”); Ex. 1009 (Penny)
(“Traditionally, suction catheters having consisted of a flexible plastic
tube.”). Further, as discussed above, one of ordinary skill in the art would
have combined Jackson, Kerwin, Halligan, and Penny. Indeed, Patent
Owner does not substantively argue otherwise.13 Patent Owner also does not
dispute that Jackson teaches the relative “outside” taper angles and the
relative lengths of the secondary and tertiary sections.
c. Patent Owner’s Evidence of Copying is
Unpersuasive
Patent Owner asserts “objective evidence of Petitioner’s intentional
copying of [Patent Owner’s] products.” PO Resp. 30. This evidence
“relates to the parties’ respective packaging, namely the instructions printed
thereon.” Id. (citing Ex. 2004, Ex. 2006 ¶ 3). According to Patent Owner:
In Petitioner’s original packaging, Petitioner copied the words on
[Patent Owner’s] packaging—to the point of leaving [Patent
Owner’s] common law trademark “Suction Caddy” in instruction
number 5—even down to the capitalization. . . . In addition to
using [Patent Owner’s] common law trademark, Petitioner
copied [Patent Owner’s] instructions verbatim, with the
exception of one word.

13 Patent Owner merely asserts that because the references fail to disclose
“the inside diameter profile of the second tubular body portion” and “the
transition from rigid to flexible tubular body portions,” “no POSA at the
time of the invention would have combined the cited prior art references
without the benefit of hindsight reconstruction from the disclosure of the
‘050 patent.” PO Resp. 18.
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Id. at 30–31 (citing Ex. 2006 ¶¶4–5). Petitioner responds, inter alia, that
“copying user instructions from a label is irrelevant to secondary
considerations.” Pet. Reply 21.
We agree with Petitioner. Evidence of secondary considerations is
relevant only to the extent that its proponent establishes a nexus between the
evidence and “the merits of the claimed invention.” In re GPAC, Inc., 57
F.3d 1573, 1580 (Fed. Cir. 1995). Patent Owner has not offered evidence
that a product embodying the claims of the ’050 patent has been copied, only
that certain packaging has allegedly been copied. Therefore, Patent Owner
has not established the required nexus, and we accord no weight to this
evidence.
d. Summary as to Claim 1
For the reasons discussed above, we find that the combination of
Jackson, Kerwin, Behrstock, Penny, and Halligan teaches all of the
limitations of claim 1, that one of ordinary skill in the art would have had
reason to combine the references to achieve the subject matter of claim 1,
and Patent Owner’s evidence of secondary considerations is deserving of no
weight. We therefore conclude that claim 1 would have been obvious over
Jackson, Kerwin, Behrstock, Penny, and Halligan.
8. Claims 2–6 and 8–10
For claims 2–6 and 8–20, which depend directly or indirectly from
claim 1, Petitioner identifies specific excerpts from Jackson, Kerwin,
Behrstock, Halligan, and Penny that teach the additional limitations of these
claims. Pet. 39–48 (citing Ex. 1003, 1:6–19, 3:28–36, 61–69, Fig. 1; Ex.
1004, 2:46–60, 3:20–23, Figs. 1–4; Ex. 1005, 2:11–15, 29–32, 52–55; Ex.
1006, 3:31–34, 4:22–27, Fig. 4; Ex. 1009, 2:58–62, 2:65–3:4, Figs. 1, 10;
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Ex. 1011, 32, 41–47). Patent Owner does not separately argue any of the
dependent claims. Based on our review of the record, specifically relying on
the evidence cited by Petitioner, we determine that Petitioner has established
by a preponderance of the evidence that the additional limitations of claims
2–6 and 8–10 are taught by the cited references, and conclude that claims
2–6 and 8–10 would have been obvious over Jackson, Kerwin, Behrstock,
Penny, and Halligan.
9. Summary as to Ground 1
For the above reasons, we determine that claims 2–6 and 8–10 would
have been obvious over Jackson, Kerwin, Penny, Behrstock, and Halligan.
D. Ground 2
Petitioner contends that claim 7 would have been obvious over
Jackson, Kerwin, Penny, Behrstock, Halligan, and Shedlock. Pet. 48–49.
Claim 7 depends from claim 1 and additionally recites “a soft pliable flange
on said tertiary section near said tip.” The Specification explains that “a soft
pliable flange” is placed near the tip of the device “for sideward positioning
engagement with a nostril inner wall, and [to] seal off (or partially seal off)
the nostril, increasing suction in the nostril.” Ex. 1001, 3:25–29. Petitioner
relies on Shedlock to teach this limitation. Pet. 48–49. Shedlock discloses a
hand-held, oral and nasal suctioning device for infants. Ex. 1007, 1:42–51.
The device comprises a nozzle, which may be conical and “tapered very
gradually,” that “abuts the entrance to the baby’s nostril while suctioning
takes place.” Id. at 1:54–63. A “flange having air passage holes may be
included to partially block the oropharynx and nasopharynx openings when
using the apparatus.” Id. at 1:67–2:2. According to Petitioner, “[i]t would
have been obvious to a POSA to include a soft pliable flange on the tertiary
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section near the tip as flanges were well known in the prior art and used
routinely in suction devices.” Pet. 49 (citing Ex. 1011, 46). Patent Owner
does not dispute Petitioner’s contentions or otherwise raise any arguments
specific to this proposed ground of unpatentability.
Based on our review of the record, and specifically relying on the
evidence cited by Petitioner, we determine that Petitioner has established by
a preponderance of the evidence that Shedlock teaches the additional
limitation of claim 7, and that one of ordinary skill in the art would have had
reason to combine Shedlock with the other cited references. Therefore, we
determine that claim 7 would have been obvious over Jackson, Kerwin,
Penny, Behrstock, Halligan, and Shedlock.
E. Ground 3
Petitioner contends that claim 10 would have been obvious over
Jackson, Kerwin, Penny, Behrstock, Halligan, and Perla. Pet. 49–51. Claim
10 depends from claim 1 and additionally recites “said body portions consist
of molded plastic material that excludes vinyl and latex.” Petitioner relies
on Perla to teach this additional limitation. Pet. 50. Perla teaches an
aspirating device formed from “flexible, transparent, non-irritating plastic
material, such as polyethylene.” Ex. 1010, 4:3–7, Figs. 1, 3. Petitioner
contends that “[i]t would have been obvious to a POSA to use any number
of plastic materials including plastic materials that exclude vinyl and latex as
catheters made of plastic material that excludes vinyl and latex were well
known in the prior art.” Pet. 50–51 (citing Ex. 1011, 48–49). Patent Owner
does not dispute Petitioner’s contentions or otherwise raise any arguments
specific to this proposed ground of unpatentability.
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Based on our review of the record, and specifically relying on the
evidence cited by Petitioner, we determine that Petitioner has established by
a preponderance of the evidence that Perla teaches the additional limitation
of claim 10, and that one of ordinary skill in the art would have had reason
to combine Perla with the other cited references. Therefore, we determine
that claim 10 would have been obvious over Jackson, Kerwin, Penny,
Behrstock, Halligan, and Perla.
F. Ground 4
Petitioner asserts that “Jackson modified by the Common Knowledge
of the skilled artisan renders all the claims unpatentable.” Pet. 51. In
support of this Ground, Petitioner appears to rely on the same references
discussed above in connection with Grounds 1–3. Id. at 51–55. Unlike with
the previous grounds, however, Petitioner substitutes attorney argument for
precise citations to the references, and fails to explain why one of ordinary
skill in the art would have combined the references. It is Petitioner’s burden
to “specify where each element of the claim is found in the prior art patents
or printed publications relied upon,” and “identif[y] specific portions of the
evidence that support the challenge.” 37 C.F.R. § 42.104(b)(4), (5).
Petitioner has failed to do so here in connection with Ground 4. We decline
Petitioner’s implicit invitation to incorporate Petitioner’s citations and
analysis from Grounds 1–3 into this Ground. Accordingly, we determine
that Petitioner has failed to show unpatentability of claims 1–10 under
Ground 4.
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III. CONCLUSION
For the foregoing reasons, we determine that Petitioner has shown by
a preponderance of the evidence that claims 1–10 of the ’050 patent are
unpatentable under 35 U.S.C. § 103(a),14 as set forth in the following table:

14 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
Claims
35
U.S.C.
§
Reference(s)/Basis
Claims
Shown
Unpatentable
Claims
Not shown
Unpatentable
1–6, 8–
10
103 Jackson, Kerwin,
Behrstock, Penny,
and Halligan
1–6, 8–10
7 103 Jackson, Kerwin,
Behrstock, Penny,
Halligan, and
Shedlock
7
10 103 Jackson, Kerwin,
Behrstock, Penny,
Halligan, and Perla
10
1–10 103 Jackson in view of
Common
Knowledge of
POSA
1–10
Overall
Outcome
1–10
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IV. ORDER
For the reasons given, it is
ORDERED that claims 1–10 of U.S. Patent 6,958,050 B1 have been
shown to be unpatentable;
and
FURTHER ORDERED that, because this is a final written decision,
parties to this proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

PETITIONER:

Vincent McGeary
vmcgeary@mcgearycukor.com

PATENT OWNER:

Michael A. DiNardo
KELLY & KELLEY, LLP
mike@kelly-kelleylaw.com