Novoluto GmbH

Patent Trials and Appeals Board

Jun 14, 2021

IPR2019-01302 (P.T.A.B. Jun. 14, 2021)

Trials@uspto.gov Paper 50
571-272-7822 Date: June 14, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

EIS GMBH,
Petitioner,
v.
NOVOLUTO GMBH,
Patent Owner.

IPR2019-01302
Patent 9,937,097 B2

Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining Challenged Claims Not Unpatentable
35 U.S.C. § 318(a)
Denying Petitioner’s Motion to Exclude
37 C.F.R. § 42.64

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I. INTRODUCTION
A. Background and Summary
EIS GmbH (“Petitioner”) filed a Petition requesting inter partes
review of claims 1–30 of U.S. Patent No. 9,937,097 B2 (Ex. 1001, “the ’097
patent”). Paper 1. (“Pet.”). NOVOLUTO GmbH (“Patent Owner”) filed a
Preliminary Response to the Petition. Paper 14. On January 13, 2020 we
issued our Decision Denying Institution. Paper 17 (“Dec”).
Petitioner filed a Request for Rehearing of our Decision Denying
Institution under 37 C.F.R. § 42.71 (c) and (d). Paper 18 (“Req. Reh’g”).1
Upon reconsideration of the arguments and evidence of record at the time,
we granted the Request for Rehearing and instituted inter partes review on
all grounds presented in the Petition. Paper 23. (“Reh’g Dec.” or “Rehearing
Decision”).
Patent Owner then filed a Response on September 11, 2020. Paper 30
(“Resp.”). Petitioner filed a Reply on December 14, 2020. Paper 37
(“Reply”). Patent Owner filed a Sur-Reply on January 15, 2021. Paper 42
(“Sur-Reply”). On February 2, 2021, the parties jointly informed the Board
that no oral hearing was needed in this case. Paper 44.
We have jurisdiction under 35 U.S.C. § 6. This Decision is a Final
Written Decision under 35 U.S.C. § 318(a) as to the patentability of the

1 Petitioner also sought review of the Decision by the Precedential Opinion
Panel. Ex. 3001. That request was denied on April 6, 2020. Paper 21.
Following denial by the Precedential Opinion Panel, Petitioner brought an
action in the United States District Court for the Eastern District of Virginia
seeking review of denial by the Precedential Opinion Panel under the
Administrative Procedure Act. Paper 22. The district court action was
dismissed following our granting Petitioner’s Request for Rehearing. Paper
34, 2.
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claims on which we instituted trial. Based on the complete record before us,
we determine that Petitioner has not shown, by a preponderance of the
evidence, that claims 1–30 are unpatentable. In addition, for the reasons
explained below, we deny Petitioner’s Motion to Exclude evidence.
B. Real Parties in Interest
Petitioner identifies the following entities as real parties-in-interest:
EIS GmbH, EIS Inc., Triple A Import GmbH, Triple A Marketing GmbH,
Triple A Sales GmbH, and Triple A Internetshops GmbH (formerly known
as “Internetsupport Bielefeld”). Paper 43.
Patent Owner identifies itself as the real party-in-interest and that
WOW Tech International GmbH is the corporate parent of Novoluto GmbH.
Paper 41.
C. Related Matters
Petitioner has stated that the ’097 patent is the subject of litigation in
two district court actions: EIS Inc. v. WOW Tech International GmbH et al.,
No. 1:19-cv01227-LPS, (D. Del.) and Novoluto, GmbH v. Uccellini LLC
d/b/a Lora DiCarlo, C.A. No. DOR-6-20-cv-02284-MTK (D. Ore.). Paper
43, 3.
Petitioner also states that two related patents, US 9,763,851 B2 and
US 9,849,061 B2 are the subject of IPR2019-01444 and IPR2020-00007
respectively. Id. Both of those proceedings are currently pending before the
Board.
D. The ’097 Patent
The ’097 patent, titled Stimulation Device Having an Appendage,
issued on April 10, 2018, from Application 15/487,123 filed on April 13,
2017. Ex. 1001, codes (10), (21), (22), (45)col. 3, , and (54). It claims
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priority to German Patent Application No. 102015103694.0, filed March 13,
2015. Ex. 1001, col. 1, ll. 7–12.
The ’097 patent relates to a sexual stimulation device which applies
positive and negative pressure to a human body part, such as the clitoris.
Ex. 1001, col. 3, ll. 21–22. The positive and negative pressures are created
by changing the volume of a chamber in the device. Id. at col. 3, ll. 19–20.
The volume of the chamber is changed by deflecting a flexible wall of the
chamber. Id. at col. 3, ll. 16–19. Positive and negative pressures are
determined relative to a “reference pressure.” Id. col. 4, l. 63– col. 5, l. 4.
The device may also have an appendage which can be used as a handle. Id.
at col. 4, ll. 27–28. The appendage may be in the form of a dildo. Id. at col.
8, ll. 24–31.
E. Illustrative Claims
Claims 1 and 12 are representative of the challenged claims and read
as follows:

1. A stimulation device comprising:
a chamber having a flexible wall portion
a drive unit in physical communication with the flexible
wall portion so as to cause deflections of the flexible wall
portion in opposing direction, thereby resulting in a changing
volume of the chamber,
the changing volume of the chamber resulting in
modulating positive and negative pressures with respect to a
reference pressure;
an opening for applying the modulated positive and
negative pressures to a body part;
a control device for controlling the drive unit; and
an appendage, wherein the appendage is a dildo
configured to be inserted into a vagina.

12. A method comprising:
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causing deflections of a flexible wall portion of a
chamber of a stimulation device in opposing directions, thereby
resulting in a changing volume of the chamber, the changing
volume of the chamber resulting in modulated positive and
negative pressures with respect to a reference pressure; and
applying the modulated positive and negative pressures
to a body part through an opening, wherein the stimulation
device is positioned by the user for applying the modulated
positive and negative pressures using an appendage of the
stimulation device, wherein the appendage is a dildo configured
to be inserted into a vagina.

F. Evidence
Petitioner relies on the following references:
Taylor, US 5,725,473, issued March 10, 1998. (Ex. 1004) (“Taylor”).
Hovland et al., US 6,964,643 B2, issued November 15, 2005. (Ex.
1005) (“Hovland”).
Guan, CN2153351Y, issued December 11, 1993. (Ex. 1007)
(“Guan”).
Lee, US 7,828,717 B2, issued November 9, 2010. (Ex. 1006) (“Lee”).
Petitioner also relies on the declarations of Michael R. Prisco, P.E.,
Ph.D., Exs. 1002 and 1018, and the declaration of Richard Meyst. Ex. 1020.
Patent Owner relies on the declarations of Morton Olgaard Jensen, Ph. D.,
Dr. Med. (Exs. 2001 and 2026) and Debra Herbenick, Ph.D. (Ex. 2004 and
2028).
G. Prior Art and Asserted Grounds
Petitioner asserts that claims 1–30 would have been unpatentable on
the following grounds:
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1–9, 12–24, 26–30 102 Taylor
1–30 103 Taylor, Hovland
1–30 103 Guan, Lee, Hovland
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II. ANALYSIS
A. Legal Standards
1. Burden
In an inter partes review, the burden of proof is on the Petitioner to
show that the challenged claims are unpatentable, and that burden never
shifts to the patentee. 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l,
Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016).
2. Anticipation
Section 102(a) provides that “[a] person shall be entitled to a patent
unless . . . the claimed invention was patented [or] described in a printed
publication . . . before the effective filing date of the claimed invention.”
35 U.S.C. § 102(a)(1) (2018).2 Accordingly, unpatentability by anticipation
requires that the four corners of a single, prior art document describe every
element of the claimed invention, either expressly or inherently, arranged as
in the claims. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369
(Fed. Cir. 2008); Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed.
Cir. 1999); In re Paulsen, 30 F.3d 1475, 1479 (Fed. Cir. 1994).
3. Obviousness
The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)

2 The provisions of the Leahy-Smith America Invents Act (“AIA”) regarding
novelty and obviousness apply to patents containing at least one claim
having an effective filing date on or after March 16, 2013. Pub L. 112–29,
125 Stat. 284 (2011). On its face, the ’097 patent has an effective filing date
of July 24, 2015. Therefore, the AIA provisions of 35 U.S.C. §§ 102 and
103 apply to this decision.
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the level of skill in the art, and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). If the
differences between the claimed subject matter 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 said
subject matter pertains, the claim is unpatentable under 35 U.S.C. § 103.
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007).
A proper § 103 analysis requires “a searching comparison of the
claimed invention—including all its limitations—with the teaching of the
prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
“Obviousness requires more than a mere showing that the prior art
includes separate references covering each separate limitation in a claim
under examination.” Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352,
1360 (Fed. Cir. 2011). “Rather, obviousness requires the additional showing
that a person of ordinary skill at the time of the invention would have
selected and combined those prior art elements in the normal course of
research and development to yield the claimed invention.” Id.
“[O]bjective evidence of nonobviousness includes copying, long felt
but unsolved need, failure of others, commercial success, unexpected results
created by the claimed invention, unexpected properties of the claimed
invention, licenses showing industry respect for the invention, and
skepticism of skilled artisans before the invention.” In re Rouffet, 149 F.3d
1350, 1355 (Fed. Cir. 1998) (citations omitted). “For objective [evidence of
secondary considerations] to be accorded substantial weight, its proponent
must establish a nexus between the evidence and the merits of the claimed
invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010)
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(alterations in original) (quoting In re GPAC Inc., 57 F.3d 1573, 1580 (Fed.
Cir. 1995)).
B. Level of Ordinary Skill in the Art
The level of ordinary skill in the art is a factual determination that
provides a primary guarantee of objectivity in an obviousness analysis. Al-
Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing
Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-
Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)).
In our Decision on Institution, we adopted Petitioner’s proposed
definition of one skilled in the art as an individual with “a bachelor’s degree
in mechanical engineering, biomechanical engineering, or the equivalent,
and three or more years of experience in fluid mechanics and pump-based
medical devices,” and Petitioner’s proposal that “practical experience could
qualify one not having the aforementioned education as a [person of
ordinary skill in the art], while a higher level of education could offset lesser
experience.” Dec. 6–7.
Patent Owner renews its argument that in addition to the education
level recited above, a person of ordinary skill in the art would have “three or
more years of experience in research, development, or design of devices that
interact with the human female body (and specifically the vulva).” Resp. 4.
Patent Owner supports this contention by citing to the Technical Field
discussion in the Specification where it states that field relates to “a
stimulation device … for erogenous zones, in particular for the clitoris.” Id.
at 3 (citing Ex. 1001, col. 1, ll. 17–20). Patent Owner also contends that the
claims support this definition as the claims
explicitly define a stimulation device with “an opening for
applying the modulated positive and negative pressures to a body
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part” and a dildo appendage “configured to be inserted into a
vagina” and associated methods of applying the modulated
pressures to a body part, by the user having positioned the device
using the vaginal dildo.
Resp. 3–4 (citing Ex. 1001, claims 1, 12, 17, and 26).
We have considered Patent Owner’s argument and are not persuaded
that our original definition of a person of ordinary skill in the art was in
error. We do not agree that one of ordinary skill in the art requires such
specific expertise for the subject matter set forth in the field of invention or
the claims of the ’097 patent. A “hypothetical ‘person having ordinary skill
in the art’ to which the claimed subject matter pertains would, of necessity
have the capability of understanding the scientific and engineering principles
applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394
(BPAI 1988). Although the device disclosed in the ’097 patent is a sexual
stimulation device, the scientific and engineering principles applicable to the
claimed device and method involve mechanical engineering and fluid flow
that are not necessarily specific to the application of the device.
As we previously noted in our Decision on Institution:
While the invention generally relates to a device for stimulating
female erogenous zones, as seen from the discussion below, the
design and operation of the device largely relates to issues of
mechanical engineering and fluid flow. Thus, we conclude that
experience in developing devices that interact with the female
body is not needed to define a person of ordinary skill in the art.
Dec. 7.
Based on the forgoing, we continue to apply the same definition of a
person of ordinary skill in the art we used in our Decision Denying
Institution.
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C. Claim Construction
We interpret a claim “using the same claim construction standard that
would be used to construe the claim in a civil action under 35 U.S.C.
282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the
claim “in accordance with the ordinary and customary meaning of such
claim as understood by one of ordinary skill in the art and the prosecution
history pertaining to the patent.” Id. Furthermore we need only construe the
claims to the extent necessary to determine the patentability of the
challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean
Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe
terms ‘that are in controversy, and only to the extent necessary to resolve the
controversy . . . .’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
F.3d 795, 803 (Fed. Cir. 1999))).
After considering all of the arguments presented by the parties we find
that it is only necessary to construe the term “reference pressure.” Although
the parties have also presented arguments concerning the construction of the
term “pressure field generator,” we determine that it is not necessary to
construe that term to determine the patentability of the challenged claims in
light of the asserted grounds.3
1. Reference Pressure
In our Decision Denying Institution, we construed the term “reference
pressure” to mean “a prevailing pressure within the device prior to placing

3 In section IX of its Reply, Petitioner presents argument that we were
somehow misled by changes to the Specification of the ’097 patent relating
to the term “pressure field generator.” Reply 27–28. As we declined to
construe the term in our decision on institution and in this final decision, we
do not address the arguments presented in Section IX of the Reply.
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the stimulation device on the area of the skin to be stimulated.” Dec. 10.
While Patent Owner agrees with this construction, Petitioner contends that
we improperly limited the construction to one example in the Specification.
Resp. 19; Reply 9.
In the Petition, Petitioner originally asserted that the “reference
pressure” is “atmospheric pressure.” See Pet. 22 (stating “[w]hen the
bellows 160 is neither compressed nor expanded, the air within the bellows
160 is at atmospheric pressure (i.e., the reference pressure)”). In its Reply,
Petitioner presents a new interpretation of the term “reference pressure,”
contending that the term should be construed to mean a “given” pressure
around which higher or lower pressures are generated for stimulating the
body, which may be determined prior to application or after application of
the device to the target body part. Reply 10. In support of this construction,
Petitioner points to the discussion in the Specification involving pressures
above and below systolic pressure. Id. (citing Ex. 1001, col. 11–57.).
Patent Owner contends that Petitioner is presenting a new argument
not raised in the initial petition. Sur-Reply 2. Patent Owner argues that
Petitioner has improperly argued that the construction adopted by the Board
is limited to atmospheric pressure. Id. at 4. Patent Owner also contends that
Petitioner’s arguments with regard to systolic pressure are without merit and
that the Board’s original construction is proper. Id. at 5–6.
We have considered the arguments advanced by the parties and the
evidence of record, and conclude that our original construction was proper.
Contrary to Petitioner’s contention, the construction is not limited to a single
example, but is consistent with the overall teachings of the Specification.
See, e.g., Ex. 1001, col. 5, ll. 5–27; col. 15, ll. 34–37; Figure 14. The
construction we adopted is not limited to atmospheric pressure (as originally
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proposed in the Petition), but refers generally to the prevailing pressure in
the device before it is applied to the body as described in the Specification of
the ’097 patent. This refers to the pressure within the device regardless of
the environment in which it is used. For instance, the Specification of the
’097 patent lists additional environments to include “a liquid medium, such
as water or commercially available lubricant.” Id. at col. 5, ll. 5–27.
Even if we consider Petitioner’s new claim construction argument as
being properly presented in its Reply, Petitioner’s argument regarding
systolic pressure is unconvincing. The entire paragraph regarding systolic
pressure reads
Assuming that in the first state the pressure in the chambers 3
and 4 corresponds to the currently prevailing external reference
pressure (air pressure for example), the overall pressure that is
present in the second state will be lower than the external
reference pressure. This negative pressure is set such that it is
preferably lower than the usual systolic blood pressure in the
blood vessels of the body part 11. The blood circulation in this
area thus increases, and the clitoris 12 is better supplied with
blood in the second state.
Ex. 1001, col. 11, ll. 49–57. It is clear that, when read in context, the
reference pressure referred to in this paragraph is the prevailing pressure in
the device before the device is applied to the body part. Moreover, only the
negative pressure is set with regard to systolic pressure, not the positive
pressure. Id.
Based on the foregoing, we maintain our original construction of the
term “reference pressure” as “a prevailing pressure within the device prior to
placing the stimulation device on the area of the skin to be stimulated.”
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D. Anticipation by Taylor
Petitioner contends that claims 1–9, 12–24, and 26–30 are anticipated
by Taylor. Pet. 19.
1. Taylor
Taylor discloses a sexual aid that includes a means for introducing a
vacuum to stimulate the clitoris. Ex. 1004, Abst. In this embodiment, the
device comprises a suction cup which engages the upper portion of the
vulva. Id. at col. 5, ll. 28–30. The suction cup is in fluid communication with
a bellows that cyclically introduces a vacuum within the suction cup. Id. at
col. 5, ll. 32–38. The cyclical vacuum stimulates the clitoris. Id. at ll. 40–41.
Taylor discloses:
Referring to FIG. 3, an alternative embodiment of the
drive mechanism is shown with the motor 18 mounted on the arm
26. As in the original embodiment the lever 22 mounted 55 on
the output shaft 20 of the motor 18 is pivotally mounted on the
connecting rod 36. The connecting rod 36 is pivotally mounted
on the housing 12. As the output shaft 20 rotates, the lever 22
urges the connecting rod 36 against the housing 12 oscillating the
arm 26 along with the motor 18.
Ex. 1004 col. 4, ll. 52–59. Petitioner’s annotated version of an excerpt of
Taylor Figure 3 is reproduced below.
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Excerpt of Figure 3 of Taylor as annotated by Petitioner to show the
relationship of the drive unit to the bellows. Pet. 20.

Taylor goes on to disclose:
Referring only to FIG. 3, a second embodiment of the first
stimulator 154 is shown. The first stimulator 154 includes a
suction cup member 156 that conformingly and sealingly 30
receives the upper portion of the vulva. The suction cup member
156 of the first stimulator 154 is more specifically directed at
receiving the clitoris. The suction cup member 156 is in fluid
communication with a bellows 160 or squeeze ball (not shown)
via flexible conduit 162. As the arm 26 oscillates relative to the
housing, the arm 26 compresses and expands the bellows 160
relative to the housing 12. The arm 26 and bellows 160 cyclically
introduce a vacuum in the volume defined by the suction cup
member 156 and the portion of the vulva received therein. The
cyclical vacuum phenomenon stimulates the clitoris.
Ex. 1004, col. 5, ll. 28–41.
2. Analysis of Claim 1
Petitioner contends that each of the limitations of claim 1 is disclosed
by Taylor. Pet. 19. Patent Owner contends that Taylor does not teach the
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following limitations of claim 1: (1) the changing volume of the chamber
resulting in modulating positive and negative pressures with respect to a
reference pressure; (2) an opening for applying the modulated positive and
negative pressures to a body part; and (3) a control device for controlling the
drive unit. Because we agree with Patent Owner that Petitioner has failed to
show that Taylor teaches these three limitations, we determine that Petitioner
has failed to show by a preponderance of the evidence that Taylor
anticipates claim 1 of the ’097 patent. We focus only on these limitations in
our analysis below.
a) The changing volume of the chamber resulting in modulated positive
and negative pressures with respect to a reference pressure
Petitioner contends that the bellows of Taylor produces modulated
positive and negative pressures with respect to a reference pressure, and thus
satisfies this limitation. Pet. 22–23. In particular, Petitioner contends that
when the bellows is in a position where it is neither contracted nor
expanded, the air within the bellows is at atmospheric pressure—i.e., the
reference pressure. Id. Petitioner contends that when the bellows expands,
the pressure in the bellows falls below atmospheric pressure—a negative
pressure. Id. Petitioner contends that as the bellows contracts past the
midpoint, the air pressure increases above atmospheric pressure—i.e., a
positive pressure. Id. Petitioner supports these contentions with the
testimony of Dr. Prisco and Mr. Meyst. Id.; Reply 12–17; Ex. 1002 ¶¶ 58–
74; Ex. 1020 ¶ 64.
Patent Owner contends that Taylor discloses a device that only
provides suction, i.e., negative pressure. Resp. 46. Patent Owner argues that
Taylor does not disclose the use of positive pressure let alone modulating
between positive and negative pressure. Id. Patent Owner contends that the
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portions of Taylor cited by Petitioner do not disclose modulated positive and
negative pressures with respect to a reference pressure, but are limited to
varying negative pressure. Id. at 47.
Patent Owner further contends that Petitioner’s argument is based on
inherency and that Petitioner has failed to show that the mode of operation
ascribed to Taylor by Petitioner’s expert is necessarily present and that one
skilled in the art would recognize that it is present. Id. at 47–48. Patent
Owner also contends that Petitioner’s argument relies on unsupported
attorney argument and unsupported expert testimony. Id. at 48. Patent
Owner contends that Petitioner’s argument is premised on Taylor’s bellows
160 at some point in operation being in a position that is neither fully open
nor fully closed resulting in atmospheric pressure as the reference pressure.
Id. Patent Owner contends that there is no basis for this assumption in
Taylor as Taylor does not disclose such a point. Patent Owner contends that
Taylor teaches that the bellows operates to provide a cyclic vacuum to the
suction cups. Id. (citing Ex. 2026 ¶¶ 122, 128).
Patent Owner explains:
As the bellows expands it creates a vacuum pulling air
flow into the bellows—i.e., creating negative pressure with
respect to the reference Pressure. Id. As the bellows
compresses, the vacuum releases and pressure in the bellows
returns toward the reference pressure, i.e., the prevailing
pressure of the sexual aid. Id. This cycle is illustrated below.
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Id. ¶ 123. Although pressure within the bellows during
compression may increase in the negative pressure region and
may approach or reach atmospheric pressure, pressure within
the bellows is never positive with respect to the reference
pressure, which is required by the claims of the ’097 patent. Id.
Resp. 50.
In its Reply, Petitioner applies its construction for “reference
pressure,” which we have rejected above, and contends that the reference
pressure can be the pressure in the device shortly after it begins operation.
Reply 11. Petitioner states:
The claimed reference pressure could instead be a reference
pressure prior to activating the device or after (e.g.,
immediately after) applying the device [to] the vulva. Taylor
discloses compressing and then expanding the bellows after
applying member 156 to the vulva, resulting in a positive and
negative pressure relative to the pressure in bellows 160 (i.e.,
the reference pressure).
Reply 11 (citing Pet. 21; Ex. 1004, col. 5, ll. 29–40; Ex. 1002 ¶¶ 57–58, 74;
Ex. 1018 ¶ 55; Ex. 1020 ¶¶ 55–56). Petitioner contends that using this
definition of reference pressure, the cyclic vacuum of Taylor meets this
limitation as the vacuum increases and decreases relative to the pressure
shortly after activation. Id. at 11–12.
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Petitioner also contends that when the suction cups are first applied, it
creates a positive pressure with respect to the reference pressure and that the
operation of the bellows would create a modulation of positive and negative
pressure with respect to the reference pressure as it defines it as a “given
pressure” during operation of the device. Id. at 12–16. Petitioner also
contends that Taylor’s disclosure that the suction cups seal against the skin
does not preclude the presence of a positive pressure with respect to the
reference pressure. Id. at 15–16.
In sur-reply, Patent Owner contends that Petitioner’s argument is
based on the incorrect assumption that the “reference pressure” can be any
arbitrary “given pressure.” Sur-Reply 9. Patent Owner also contends that
Petitioner’s argument with respect to the pressure in the suction cup being a
positive pressure is unsupported by the record and is a new theory that
should be disregarded. Id. at 10.
We have considered the arguments of the parties and the evidence of
record and conclude that Petitioner has not demonstrated that Taylor
discloses that the changing volume of the bellows results in modulation of
positive and negative pressures with respect to a reference pressure.
First, Petitioner is basing its argument on a shifting and incorrect
claim construction that “reference pressure” may include any “‘given’
pressure around which higher and lower pressures are generated for
stimulating the body, which may be determined prior to application or after
application of the device to the target body part.” Compare Reply 10, with
Pet. 21–23 (stating “reference pressure” is “atmospheric pressure”). Based
on such reliance on an incorrect claim construction alone, we find that
Taylor does not disclose the changing volume of the chamber resulting in
modulated positive and negative pressures with respect to a reference
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pressure. But even if we were to adopt Petitioner’s erroneous claim
construction, we find Petitioner’s substantive arguments concerning the
teachings of Taylor are unavailing.
Petitioner’s contentions with respect to this limitation are also based
on the erroneous premise that the bellows in Taylor must necessarily start in
a positon that is neither fully expanded nor fully compressed. Pet. 22 (stating
“[w]hen bellows 160 is neither compressed nor expanded, the air within
bellows 160 is at atmospheric pressure (i.e., the reference pressure)) (citing
Ex. 1002 ¶¶ 58, 74; Ex. 1020 ¶ 64). Taylor, however is silent as to the
starting position of the bellows. See Ex. 1004 col. 5, ll. 27–49; Ex. 2026
¶ 121. Petitioner’s declarant, Mr. Meyst, confirms this silence by drawing a
negative inference from such silence that does not meet the inherency test. In
particular, Mr. Meyst testifies:
It is my opinion that pressures above and below the
initial pressure would be generated by Taylor. This is at least
because there is no reason to assume that an initially generated
positive pressure in suction cup member 156 immediately after
it is applied to the vulva would somehow be contrary to the
operation of Taylor, and because there is no teaching that the
device must begin operation with the bellows at its smallest
volume.
Ex. 1020 ¶ 64 (emphasis added).
Thus, we agree with Patent Owner that Petitioner appears to argue that
the starting positon would inherently be neither fully compressed nor fully
expanded, see Resp. 48–50, which is simply not supported by Taylor or the
testimony of Petitioner’s declarants.
“A reference may anticipate inherently if a claim limitation that is not
expressly disclosed ‘is necessarily present, or inherent, in the single
anticipating reference.’ The inherent result must inevitably result from the
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disclosed steps; ‘[i]nherency . . . may not be established by probabilities or
possibilities.’” In re Montgomery, 677 F.3d 1375, 1379–80 (Fed. Cir. 2012)
(citations omitted, alterations in original).
We discern nothing in Taylor, the testimony of Dr. Prisco, or the
testimony of Mr. Meyst to support the conclusion that the device in Taylor
starts with the bellows in a positon that is neither expanded nor compressed.
See Ex. 1004, col. 5, ll. 27–49, Ex. 1002¶¶ 58; Ex. 1020 ¶ 64. In fact, given
that Taylor explicitly teaches that the bellows acts to create a cyclic vacuum,
one skilled in the art is just as likely to conclude that the bellow starts in the
fully compressed positon creating a stronger vacuum as the bellows is
expanded. See Ex. 1004, col. 5, ll. 27–49; Ex. 2026 ¶¶ 121 (stating “Taylor
describes a bellows for cyclically introducing only a vacuum . . . a POSITA
would understand a bellows selected for purposes of creating a vacuum to
provide unidirectional medium flow”).
For instance, as Dr. Jensen, Patent Owner’s declarant, explains:
[A] POSITA reading Taylor would want to maximize Taylor’s
vacuum feature. As such, a POSITA might understand that the
bellows is fully compressed initially. The way a POSITA would
understand Taylor’s bellows to work is likely the following: As
the bellows is expanded, a vacuum is created that allows for air
flow to be pulled into bellows. As the bellows is compressed,
the pressure in the bellows returns toward the starting pressure,
i.e., the prevailing pressure of the sexual aid. In other words, as
the bellows is expanded, a negative pressure with respect to a
reference pressure is created in the bellows that draws air into
the bellows. As the bellows is compressed, the pressure in the
bellows returns toward the prevailing pressure of the sexual aid
as the vacuum is released. Regardless of the starting point of
the bellows, a POSITA would understand that atmospheric
pressure would be the “reference pressure” as understood in the
context of the ’097 Patent. While the pressure within the
bellows as the bellows is being compressed may increase, the
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pressure within the bellows remains negative at all times
and is never positive with respect to the reference pressure
as claimed. This is also the only explanation based on the
suction cups as described and disclosed in Taylor. Every other
working principle generating positive pressures would lead to
the cups disengaging from the body or falling off.
Ex. 2026 ¶ 122 (emphasis in original). As we find that Dr. Jensen’s analysis
of the operation of Taylor’s device is more consistent with Taylor’s
disclosure, we conclude that the evidence does not support Dr. Prisco’s
contention that the bellows in Taylor must necessarily start in a positon that
is neither fully expanded nor fully compressed.
For all the reasons expressed above, we find that Petitioner has failed
to show that Taylor discloses “the changing volume of the chamber resulting
in modulated positive and negative pressures with respect to a reference
pressure.”
b) An opening for applying the modulated positive and negative pressures
to a body part
Petitioner contends that Taylor teaches this limitation based on the
disclosure that one of the suction cups receives a portion of the vulva and
that a cyclic vacuum is applied to the vulva through the suction cup. Pet. 23.
Patent Owner contends that Taylor does not teach this limitation as
the suction cups of Taylor do not apply a positive pressure. Resp. 56–57.
Patent Owner contends that if a positive pressure were applied through the
suction cups, the cups would fall off, rendering Taylor inoperative. Id.
As discussed above, we do not find that Taylor discloses applying
positive and negative pressure. Therefore we agree with Patent Owner that
Taylor also does not disclose this limitation.
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c) A control element for controlling the drive unit
Petitioner contends that Taylor meets this limitation in that Taylor
discloses a power cord that supplies power to the electric motor. Pet. 24
Patent Owner contends that the power cord of Taylor is not a control
element in that the cord does not control the function of the device, but
merely provides power to the device. Resp. 57.
In its Reply, Petitioner argues that one skilled in the art would
understand the power cord of Taylor to be a control device as it is the only
element in Taylor that activates or deactivates the device. Reply 17–18.
Petitioner contends that the Specification does not limit the term to a specific
device. Id.
In Sur-Reply, Patent Owner contends that a power cord is not a
control device as the term in used in the ’097 patent in that it does not
control the action of the device. Sur-Reply 12–13.
We have considered the arguments of the parties and the evidence of
record and conclude that Petitioner has failed to establish that Taylor
discloses this limitation.
While the Specification of the ’097 patent does not specifically define
the term control element, the Specification discloses that
the variation over time in the pressure field or the modulation of
the pressure field by the control device is controlled largely
automatically. Thus, the modulation of the pressure field, such
as intensity, time profile or sequence, can be previously stored in
the control device.
Ex. 1001, col. 7, ll. 18–22. The Specification also discloses
A control device 7 activates the drive unit 6, optional
operating elements 71 and at least one optional display 72. Here,
the control device 7 and the drive unit 6 are supplied with power
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for example by the internal battery 76 and/or the external power
supply 73.
Id. at col. 9, ll. 58–62. The Specification goes on to disclose “the control
device controls the excitation of the drive unit such as the size of the
deflection, the frequency, the modulation, etc.” Id. at col. 14, ll. 60–62.
Thus, the Specification makes it clear that the control unit does more
than simply turn the device on and off, but controls the operation of the unit
including the modulation of positive and negative pressures. See Ex. 2026
¶ 137. Moreover, as shown above, the Specification makes it clear that the
control unit is separate from the power source. Id. ¶ 138. We discern nothing
in Taylor, nor does Petitioner point to any disclosure in Taylor that the
power cord shown in Fig. 2 of Taylor does anything but provide power to
the device. See Pet. 24; Ex. 2026 ¶ 139.
Based on the foregoing we conclude that Taylor does not disclose this
limitation.
d) Conclusion
Based on the foregoing analysis, we conclude that Petitioner has
failed to show by a preponderance of the evidence that claim 1 is anticipated
by Taylor.
3. Claim 17
Claim 17 is an independent apparatus claim and like claim 1 includes
the limitations calling for changing volume resulting in modulated positive
and negative pressure, and for a control device. Ex. 1001, col. 18, ll. 1–13.
The parties’ arguments with respect to claim 17 mirror those made with
respect to claim 1. Pet. 36–38; Resp. 46–52.
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For the reasons set forth with respect to claim 1 above, we find that
Petitioner has not shown by a preponderance of the evidence that claim 17 is
anticipated by Taylor.
4. Claims 2–6, 8, 9, and 18–24
Claim 2–6, 8, 9, and 18–24 are apparatus claims that depend from
claim 1 or 17. Petitioner contends that each of the additional elements
recited in claims 2–6, 8, 9 and 18–24 are disclosed in Taylor. Pet. 25–29;
39–41.
In addition to its arguments regarding claim 1, Patent Owner also
contends that Taylor does not disclose the additional elements recited in
claims 2, 9, 13, 14, 18 and 24. Resp. 57–58.
“A dependent claim shall be construed to incorporate by reference all
the limitations of the claim to which it refers.” 35 U.S.C. § 112(d). Thus, the
dependent claims include all of the limitations of claim 1 or claim 17. As
discussed above, Petitioner has failed to show that all of the limitations
recited in claim 1 and claim 17 are disclosed by Taylor; therefore, the same
holds true for dependent claims 2–6, 8, 9, and 18–24.
5. Claims 12 and 26
Claim 12 is an independent claim and reads:
12. A method comprising:
causing deflections of a flexible wall portions of a
chamber of a stimulation device in opposing directions,
thereby resulting in a changing volume of the chamber, the
changing volume of the chamber resulting in modulated positive
and negative pressures with respect to a reference pressure; and
applying the modulated positive and negative pressures to
a body part through an opening, wherein the stimulation device
is positioned by the user for applying the modulated positive and
negative pressures using an appendage of the stimulation device,
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wherein the appendage is a dildo configured to be inserted into a
vagina.
Ex. 1001, col. 7, ll. 40–53. Claim 26 is similar to claim 12. Compare id.,
with id. at col. 18, ll. 33–46.
Like claim 1, claim 12 includes limitations calling for modulating
positive and negative pressures with respect to a reference pressure. Id.
Claim 26 is similar to claim 12 in that it also calls for producing such
modulated positive and negative pressures. Id. at col. 18, ll. 33–46.
Petitioner presents the same arguments with respect to these elements
of claims 12 and 26 that it presented with respect to claim 1. Pet. 31, 41–42.
Patent Owner’s arguments with respect to this element are also the
same as those presented with respect to claim 1. See Resp. 46–52.
For the reasons set forth with respect to claim 1 above, we find that
Petitioner has not shown by a preponderance of the evidence that claim 12 or
claim 26 is anticipated by Taylor.
6. Claims 13–16 and 27–30
Claim 13–16 and 27–30 depend from claims 16 and 26. Ex. 1001, col.
17, ll. 53–62, col. 18, ll. 47–61. As they all include the limitation calling for
modulated positive and negative pressures with respect to a reference
pressure, we conclude that Petitioner has not shown that these claims are
anticipated by Taylor.
E. Ground 2 – Obviousness based on Taylor Combined with Hovland
Petitioner contends that claims 1–30 are unpatentable as obvious over
Taylor combined with Hovland.
1. Hovland
Hovland generally discloses a stimulation device wherein suction or a
vacuum is applied to the clitoris to promote engorgement of the clitoris with
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blood. Ex. 1005, Abst. An alternative embodiment of Hovland teaches the
use of super-atmospheric pressure to massage the clitoris. Id. at col. 4, ll.
22–24.
2. Claim 1
Petitioner contends that Taylor combined with Hovland teaches all of
the elements of claim 1. Pet. 45. As discussed with respect to the
anticipation ground above, Petitioner contends that Taylor teaches or
suggests all of the elements of claim 1. Id. Petitioner alternatively contends
that to the extent Taylor does not teach modulated positive and negative
pressures with respect to a reference pressure, Hovland teaches this
limitation. Id. at 45–46.
Petitioner contends that Hovland teaches that both suction and
increased pressure can be used to massage the clitoris, thereby increasing
blood flow and engorgement of the clitoris. Id. Petitioner contends Hovland
refers to creating a vacuum and/or using increased pressure to produce
percussion and/or massage of the clitoris and that one skilled in the art
would have interpreted this to teach the use of pressure below ambient and
pressure above ambient—positive and negative pressures with respect to a
reference pressure. Id. at 46–47. Petitioner contends that one skilled in the
art would have been motivated to combine the teachings of Hovland and
Taylor to produce a product that achieves improved and faster clitoral
engorgement. Id. at 47–48.
Petitioner also contends that to the extent the power plug of Taylor is
not a control device, Hovland teaches the use of a control device. Pet. 48.
Patent Owner contends that neither Hovland nor Taylor teach or
suggest modulated positive and negative pressures with respect to a
reference pressure. Resp. 52. Hovland teaches: “According to other
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embodiments, pump/motor assembly 300 provides pneumatic and/or
hydraulic actuation to create e.g. vibration, percussion, subatmospheric
pressure and/or superatmospheric pressure, or modulation of these effects.”
Ex. 1005, col. 13, ll. 20–24. Patent Owner contends that this passage in
Hovland teaches the modulation of either a vacuum or super atmospheric
pressure, but not modulating between them. Resp. 53. Patent Owner
contends that while Hovland uses the term “and/or” with respect to certain
embodiments, one skilled in the art would not have considered the term to
refer to modulating between positive and negative pressures in the teachings
of the ’097 patent. Id. at 53–54. Patent Owner contends that the use of the
term and/or refers to a choice of effects and not modulating between them.
Id. at 55. Patent Owner also argues that Hovland does not disclose any
structure or means for modulating between positive and negative pressures.
Id.
Patent Owner also contends that one skilled in the art would not have
been motivated to combine the teachings of Taylor and Hovland. Resp. 58–
59. Patent Owner argues that Petitioner has not adequately explained or
supported its contention that it would have been obvious to modify Taylor
with the teachings of Hovland to achieve the results stated in Hovland. Id.
Petitioner responds that the plain meaning of “and/or” supports its
interpretation that Hovland teaches modulation between positive and
negative pressures. Reply 8. Petitioner argues that Hovland specifically
teaches modulation between various effects, including between positive and
negative pressures. Id. Petitioner also contends that combining Taylor with
Hovland is nothing more than modifying Taylor with a known method to
produce a predictable result. Id. at 9.
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In its Sur-Reply, Patent Owner contends that, when read in context,
the term “and/or” as it appears in Hovland refers to a series of alternative
modes, but not alternating between these modes to achieve modulation of
positive and negative pressures with respect to a reference pressure. Sur-
Reply 17–18. Patent Owner also contend that Petitioner misconstrues the
teachings of Hovland with respect to using different pressures to stimulate
the clitoris. Id. at 19–21.
As discussed above, we find that Taylor teaches all of the elements of
claim 1 with the exception of the limitations calling for modulated positive
and negative pressure, a control device, and an opening for applying positive
and negative pressure. We now turn to the questions of whether those
elements are taught by Hovland; whether Petitioner has shown that one
skilled in the art would have been motivated to combine the teachings of
Taylor and Hovland if Hovland teaches the missing limitations; and whether
Patent Owner has offered sufficient evidence of objective indicia of
patentability to overcome Petitioner’s arguments that the subject matter of
claim 1 would have been obvious.
a) Modulated Positive and Negative Pressure
Petitioner contends that, to the extent the elements of modulated
positive and negative pressure and control device are not taught by Taylor,
those elements are taught by Hovland. Pet. 46–48.
Hovland teaches that in one embodiment, the device disclosed therein
has a “pump/motor assembly [which] provides pneumatic and/or hydraulic
actuation to create e.g. vibration, percussion, subatmospheric pressure and/or
superatmospheric pressure, or modulation of these effects.” Ex. 1005, col.
13, ll. 21–24. Petitioner construes this passage as teaching that the device in
Hovland can modulate both positive and negative pressures as required by
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claim 1. Reply 6–9. Petitioner contends that the use of the term “and/or”
would lead one skilled in the art to understand that the device of Hovland
can modulate between subatmospheric and superatmospheric pressures. Id.
Patent Owner contends that although Hovland may teach a device that
can produce positive (superatmospheric) or negative (subatmospheric)
pressures, it does not teach modulating between those pressures. Resp. 53.
Patent Owner contends that the recited paragraph only indicates that the
individual effects can be modulated, but not that the device can modulate
between the effects. Id. at 54.
We have considered the arguments advanced by the parties and the
evidence of record and conclude that Patent Owner has the better argument.
While we agree with Petitioner that Hovland teaches a device capable of
producing positive and negative pressures individually, we do not find that
Hovland discloses modulating between those effects. We agree with Patent
Owner that, when read in context, the cited passage refers to modulation of
the individual effects recited in the sentence, but not modulation between the
effects. Resp. 54–55. As Patent Owner points out, this interpretation is
consistent with the overall teachings of Hovland, which describe modulation
of the vacuum or negative pressure effect. Resp. 55 (citing Ex. 2026 ¶161).
For example, Hovland teaches the use of a vacuum modulator to vary the
suction pressure applied by the device, in a manner similar to Taylor’s
device. Ex. 1005, col. 12, ll. 42–59. Hovland also teaches that the vacuum
modulator can be used to pulsate the vacuum level of the device. Id. at col.
14, ll. 21–22. Hovland goes on to teach:
When applied to the clitoris, the vacuum applied by device
200 will cause the clitoris to become engorged, i.e. filled with
blood. Vacuum level and modulation can be adjusted by either
the patient or her partner, as needed, to maintain engorgement.
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Thus, embodiments of the invention provide the ability both to
rapidly modulate vacuum pressure with modulator 290, in a
manner akin to the modulation of alternating current, for
example, and simultaneously to more evenly hold underlying
vacuum pressure at a substantially constant level or gradually
change it, e.g. with wheel 280, in a manner akin to direct current.
This dual functionality provides substantial advantages over the
prior art.
Id. at col. 14, ll. 27–39 (emphasis added). Thus when read in the context of
the entire disclosure of Hovland, we find that the reference in Hovland to
modulation refers to modulation of one specific effect, not modulation
between two or more effects.
Petitioner contends that Patent Owner’s interpretation of Hovland
limits the device to one which produces a vacuum or superatmospheric
pressure. Reply 6–9. Petitioner contends that this ignores the use of the term
“and/or” as it appears in Hovland, which calls for the device to create both
effects. Id.; Ex. 1018 ¶¶ 42–55; Ex. 1020 ¶¶ 67–76.
While we agree with Petitioner that the term “and/or” calls for a
device that can create both positive and negative pressures, as discussed
above, we do not read Hovland as teaching modulating between effects, as
required for claim 1. This is confirmed by the plain language of Hovland,
which refers to “modulation of these effects” rather than “modulation
between effects.” Ex. 1005, col. 13, ll. 20–24. Moreover, when the cited
paragraph is read in the context of the other disclosures in Hovland
discussed above, we find that the overall teachings of Hovland are focused
on modulation of the individual effects, not modulating between the effects.
Ex. 1005, col. 12, ll. 21–24; Ex. 2026 ¶¶ 161–163. While Hovland teaches a
device that can produce positive and negative pressures we discern nothing
in Hovland that teaches modulating between these effects.
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Therefore, we conclude that neither Taylor nor Hovland teach the
feature of modulating positive and negative pressures with respect to a
reference pressure in a sexual stimulation device.
b) Motivation to Combine
As noted above, a determination of obviousness requires more that
showing that all of the elements are present in the prior art. There must be a
motivation to combine those elements to produce the claimed invention.
Unigene, 655 F.3d at 1360. Because we have found that neither Taylor nor
Hovland teach modulating between positive and negative pressures with
respect to a reference pressure, we need not analyze whether Petitioner has
failed to establish by a preponderance of the evidence that the combination
of Taylor and Hovland renders obvious claim 1 of the ’097 patent.
Nonetheless, even assuming that the Hovland teaches this requirement based
on the its disclosure of “subatmospheric pressure and/or superatmospheric
pressure, or modulation of these effects,” we further find that Petitioner has
also failed to show a rationale as to why one of ordinary skill in the art
would have combined the teachings of Taylor and Hovland to arrive at the
claimed subject matter of the challenged claims.
In the present case, Petitioner contends that the motivation to combine
the teaching of Taylor and Hovland arises from the teachings in Hovland
that percussion and/or massage of the clitoris achieves improved and faster
clitoral engorgement. Pet. 47 (citing Ex. 1005, col. 4, ll. 19–28; Ex. 1002
¶ 105). Petitioner also contends that the combination of references is nothing
more than using a known technique to improve a similar device. Id. at 47–
48.
Patent Owner contends that Petitioner’s argument is factually
unsupported in that Petitioner does not explain how one skilled in the art
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would have modified the references or how the references teach modulation
between positive and negative pressures. Resp. 58–59.
We have considered the arguments presented by the parties and the
evidence of record and find that Petitioner has not adequately explained why
one skilled in the art would have been motivated to combine the teachings of
Taylor and Hovland to produce a stimulation device that modulates between
positive and negative pressure.
The paragraph relied upon by Petitioner for establishing such a
rationale reads:
A vacuum created over the clitoris, or suction applied to
the clitoris, for example, creates a negative pressure in the clitoris
that is or is likely to be lower than the systolic blood pressure.
Alternatively, super-atmospheric pressure may be provided to
produce massage or percussion of the clitoris and/or the
surrounding area. In either case, the pressure differential tends to
promote engorgement of the clitoris with blood and/or otherwise
stimulate blood flow, providing the benefits described above
while increasing the likelihood of short-term pleasurable effect
and beneficial longer-term usage. Embodiments of the invention
thus may encourage more regular and active compliance with a
treatment program for urinary and/or fecal incontinence, while at
the same time treating female sexual dysfunction if needed.
Embodiments of the invention also are non-invasive, non-
pharmacological, relatively inexpensive and easy to use.
Ex. 1005, col. 4, ll. 18–34 (emphasis added). It is clear from reading this
paragraph that Hovland is talking about the benefits of using either negative
or positive pressure, but not both. Thus, insofar as Hovland does not teach
such modulation, Hovland does not provide the motivation to modify Taylor
to modulate between positive and negative pressure.
Based on the foregoing we find that Petitioner has failed to establish a
motivation to combine the teachings of Taylor with those of Hovland.
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c) Objective Indicia
Before reaching an ultimate conclusion on obviousness, we must
consider so-called objective indicia of non-obviousness when they are in
evidence. Graham, 383 U.S. at 18. Objective indicia of non-obviousness, or
“secondary considerations,” guard against hindsight reasoning in an
obviousness analysis, and are often “the most probative and cogent evidence
in the record.” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1328 (Fed. Cir.
2016) (citations omitted). As such, objective indicia of non-obviousness
must be considered in every case in which they are presented. Id. (citing
Transocean Offshore Deepwater Drilling Inc. v. Maersk Drilling USA, Inc.,
699 F.3d 1340, 1349 (Fed. Cir. 2012)). The secondary considerations
evidence we must consider, if presented, include “copying, long felt but
unsolved need, failure of others, commercial success, unexpected results
created by the claimed invention, unexpected properties of the claimed
invention, licenses showing industry respect for the invention, and
skepticism of skilled artisans before the invention.” Rouffet, 149 F.3d at
1355. We must also determine if Patent Owner has shown a nexus between
the evidence and the merits of the claimed invention. Wyers, 616 F.3d at
1246.
(1) Nexus
There must be a “nexus” between the merits of the claimed invention
and the evidence of secondary considerations for such evidence to be
accorded substantial weight. In re Kao, 639 F.3d 1057, 1068 (Fed. Cir.
2011). Nexus is presumed if a marketed product embodies the claimed
features and is coextensive with them. Teva Pharms. USA, Inc. v. Sandoz,
Inc., 723 F.3d 1363, 1372 (Fed. Cir. 2013). A patent owner is entitled to a
presumption of a nexus if it shows that “the asserted objective evidence is
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tied to a specific product and that product ‘is the invention disclosed and
claimed in the patent.’” WBIP, 829 F. 3d at 1335.
Patent Owner contends that two of its commercial products, the
Womanizer® InsideOut and Womanizer® Duo, “embody and are
coextensive with” the claims of the ’097 patent. Resp. 67. In support of this
contention Patent Owner relies on the testimony of its experts Drs. Jensen
and Herbenick. Resp. 10 (citing Exs. 2006, 2026 and 2028).4
Both Dr. Herbenick and Dr. Jensen reviewed the Womanizer®
InsideOut and concluded that the device was coextensive with at least claim
1 of the ’097 patent. Ex. 2026 ¶ 41; Ex. 2028 ¶ 39. Dr. Herbenick prepared a
detailed claim chart tracking each element of the independent claims to
specific components of the Womanizer® InsideOut, concluding that the
device contained each of the structural elements recited in the independent
claims. Ex. 2028 ¶¶ 41–47; Ex. 2006. Dr. Jensen reviewed the device and
Dr. Herbenick’s claim charts and also concluded that all of the structural
elements were present in the device. Ex. 2028 ¶ 41.
Dr. Jensen also conducted an experiment to determine whether the
Womanizer® InsideOut produced modulated positive and negative pressures
with respect to a reference pressure. Ex. 2028 ¶¶ 42–44. The following
images from Dr. Jensen’s declaration shows the equipment used to test the
pressure of the InsideOut, as well as the pressure graph generated as a result
of the tests:

4 As both Dr. Herbenick and Jensen have testified, the Womanizer®
InsideOut and Womanizer® Duo differ only in style features with the
structure and mechanics of the two devices being the same. Ex. 2026 ¶ 41;
Ex. 2028 ¶ 38. For this reason, Dr. Herbenick and Jensen focused their
analyses on the Womanizer® InsideOut. Ex. 2026 ¶ 41; Ex. 2028 ¶ 38.
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Ex. 2026 ¶ 42. As shown in the top images above, Dr. Jensen’s testing set-up
included an oscilloscope, data acquisition equipment (“DAQ”), and a
pressure sensor with an air-tight pressure sensing plug connected to the
device. Id. In the pressure graph shown above, the y-axis indicates pressure
(as a voltage measurement) relative to ambient or atmospheric pressure (zero
line) and the x-axis indicates time (milliseconds). Id. Based on the results of
that experiment and the product literature relating to the Womanizer®
InsideOut, Dr. Jensen concluded that the commercial devices meet the
limitations calling for modulated positive and negative pressures with
respect to a reference pressure. Ex. 2028 ¶¶ 43–44.
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Petitioner contends that Patent Owner has failed to establish a nexus
between the commercial products and the challenged claims. Resp. 21.
Petitioner contends that Patent Owner’s arguments are largely based on the
testimony of Dr. Herbenick, who Petitioner contends is not qualified to
render such opinions. Id.
Petitioner contends that Patent Owner is not entitled to a presumption
that the commercial devices embody the claimed invention as they include
features not recited in the claims. Id. at 22. Petitioner also argues that Dr.
Jensen’s testing of the alleged commercial embodiment is unsound and does
not establish a nexus between the device and the claims. Id.
We have considered the arguments presented by the parties and the
evidence of record and find that Patent Owner has established a nexus
between the claims of the ’097 patent and its commercial products. The
testimony of both Dr. Herbenick and Dr. Jensen demonstrate that the
elements of the claims are present in the Womanizer® InsideOut and
Womanizer® Duo products and that the products are essentially the claimed
invention. Ex. 2026 ¶¶ 40–44; Ex. 2028 ¶¶ 36–47.
Petitioner contends that the presence of additional, unclaimed features
precludes a presumption of a nexus between the commercial embodiments
and the claims of the ’097 patent. Reply 22. In support of this contention
Petitioner cites to Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366 (Fed. Cir.
2019). Petitioner’s reliance on Fox Factory is misplaced. As the court in Fox
Factory stated:
To be sure, we have never held that the existence of one or
more unclaimed features, standing alone, means nexus may not
be presumed. Indeed, there is rarely a perfect correspondence
between the claimed invention and the product. As we explained,
the purpose of the coextensiveness requirement is to ensure that
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nexus is only presumed when the product tied to the evidence of
secondary considerations “is the invention disclosed and
claimed.” Thus, if the unclaimed features amount to nothing
more than additional insignificant features, presuming nexus
may nevertheless be appropriate.
Id. at 1375. The court went on to state: “Although we do not require the
patentee to prove perfect correspondence to meet the coextensiveness
requirement, what we do require is that the patentee demonstrate that the
product is essentially the claimed invention.” Id.
In Fox Factory, the alleged commercial embodiment included
unclaimed features that the patentee described as critical to the products’
performance. Id. at 1374–1375. It was the presence of these critical,
unclaimed features that lead the court to hold: “A patent claim is not
coextensive with a product that includes a ‘critical’ unclaimed feature that is
claimed by a different patent and that materially impacts the product’s
functionality.” Id.
The case before us is factually distinct from Fox Factory. While
Petitioner has identified several features of the Womanizer® products that
are not recited in the claims, Petitioner has not pointed to nor do we discern
any evidence to suggest that these unclaimed features are critical to the
products and impact the products’ functionality. See Reply 22. While Dr.
Herbenick testified that additional features were present in the Womanizer®
devices, Petitioner has not pointed to any testimony by Dr. Herbenick or
other evidence to support the contention that these additional features
significantly affect the functionality of the devices. See Reply 22–23; Ex.
1023, 115–116.
Petitioner also contends that Patent Owner’s evidence that the
commercial products are coextensive with the claims of the patent is
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unreliable. Reply 23. Petitioner contends that Dr. Herbenick did not perform
a technical analysis of the devices herself and lacks the technical expertise to
perform such an analysis. Id. With respect to Dr. Jensen’s testimony,
Petitioner contends that Dr. Jensen’s testing technique is unsound and should
not be relied upon. Id. at 23–24. We find both of these argument
unpersuasive.
While we agree with Petitioner that Dr. Herbenick does not have a
technical degree that would enable her to opine about the operation of
various components in the commercial embodiments, we note that she has
studied and tested various sexual stimulation devices. Ex. 2018 ¶¶ 12–13.
Based on her experience with such devices we find that Dr. Herbenick is
qualified to identify the various components of the commercial embodiments
as she did in her declaration and claim chart. Ex. 2006; Ex. 2028 ¶¶ 39–47.
Moreover, Dr. Jensen, who has a background in medical devices, examined
the commercial embodiments and Dr. Herbenick’s analysis and claim charts
and concurred in Dr. Herbenick’s findings. Ex. 2026 ¶¶ 41, 170.
We are similarly unpersauded by Petitioner’s critique of Dr. Jensen’s
testing methodology. In particular, Petitioner and Dr. Prisco point to Dr.
Jensen’s deposition testimony indicating that he used a rubber plug or bottle
stopper with the pressure sensor for his testing. Ex. 1018 ¶¶ 77–78; Ex.
2022, 61:2–20. Petitioner contends that this technique is unreliable because
the rubber stopper used by Dr. Jensen ‘could be filling most of the
chamber.” Reply 23–24. In support of this contention Petitioner cites to Dr.
Prisco’s and Mr. Meyst’s testimony concerning the use of the stopper by Dr.
Jensen. Id. Dr. Prisco, however, never testified that the stopper might fill the
chamber, but rather that the use of the stopper could affect the pressures
generated. Ex. 1018 ¶ 78. Dr. Prisco offers no explanation why this might be
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so or that it actually occurred when Dr. Jensen conducted his experiments.
For this reason, we give little weight to Dr. Prisco’s critique of Dr. Jensen’s
methodology. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354,
1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of
the witnesses . . . .”) (internal citation omitted).
Mr. Meyst also testified that he had issues with how Dr. Jensen
conducted his experiments. Ex. 1020 ¶¶ 91–95. As part of his critique, Mr.
Meyst identified several potential issues with respect to Dr. Jensen’s test
method. Id. While Mr. Meyst opines that he would have conducted the
experiments differently, Mr. Meyst does not explain how the alleged
irregularities affected the results achieved by Dr. Jensen that the
Womanizer® devices modulated positive and negative pressure with respect
to a reference pressure. Id.
Dr. Prisco also testified that the data produced by Dr. Jensen shows
that the pressure in the device modulated at a pressure greater that
atmospheric pressure. Ex. 1018 ¶¶ 82–83. Petitioner contends that this
further supports the conclusion that Dr. Jensen’s test results are unreliable.
See Reply 24. Again, we are not persuaded by this argument. Even if we
were to accept Petitioner’s argument that the reference pressure in Dr.
Jensen’s test was something other than atmospheric pressure, our
construction of reference pressure does not limit the term to atmospheric
pressure, but only the pressure in the device before it is placed in operation.
Petitioner does not dispute that the data produced by Dr. Jensen show
modulation of positive and negative pressure with respect to a reference
pressure regardless of whether it is atmospheric pressure. See id.; Ex. 1018
¶¶ 82–83.
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Based on the foregoing we conclude that Patent Owner has
established a nexus between the Womanizer® InsideOut and Womanizer®
Duo products and the claims of the ’097 patent.
(2) Commercial Success
The commercial response to an invention is significant to
determinations of obviousness and is entitled to fair weight. Demaco Corp.
v. F.von Langsdroff Licensing Ltd., 851 F.2d 1387, 1391 (Fed. Cir. 1988).
Patent Owner contends that the Womanizer® products are “stand-out
successes.” Resp. 67. In support of this contention, Patent Owner points to
various consumer testimonials as well as Dr. Herbenick’s testimony
regarding the sales of Womanizer® products. Id.
Petitioner contends that Dr. Herbenick’s testimony should be given
little weight as Patent Owner did not produce the sales data referenced in Dr.
Herbenick’s testimony. Reply 25.
Patent Owner responds that the failure to produce revenue data is
irrelevant given the significant number of consumer reviews and Dr.
Herbenick’s testimony. Sur-Reply 25.
We have considered the arguments presented by the parties and the
testimony of Dr. Herbenick and evidence of record and find that Patent
Owner has not shown that the Womanizer® products are commercially
successful.
Commercial success in the context of secondary considerations is
typically established by evidence of sales of the product embodying the
claimed invention and relevant market share.5 In re Applied Materials, Inc.,

5 The analysis also requires a showing of a nexus between the claimed
features and the sales of the relevant product. Applied Materials. 692 F.3d at
1299.
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692 F.3d 1289, 1299 (Fed Cir. 2012). In the present case Patent Owner has
only offered the testimony of Dr. Herbenick that the relevant products have
achieved significant sales volumes and that sales continue to increase. Resp.
67 (citing Ex. 2028 ¶ 49). However, Patent Owner has not produced the
sales data that served as the basis for Dr. Herbenick’s conclusion, precluding
an independent analysis of the data. See Reply 24; Sur-Reply 24; Ex. 2028
¶ 49, n.11.6 Moreover, Dr. Herbenick did not offer any testimony regarding
the market share for the relevant products. See Ex. 2028 ¶ 49.
Patent Owner contends Dr. Herbenick’s testimony, coupled with the
consumer reviews of the relevant products, is sufficient to establish
commercial success. Sur-Reply 25. We are not persuaded by this argument.
While the customer reviews may be relevant to showing a nexus between the
commercial sales and the claimed features, the reviews do not provide any
information regarding the actual sales and relevant market share.
Absent sales and market share information, we cannot determine if the
relevant products enjoyed commercial success sufficient to support a finding
of non-obviousness. Applied Materials, 692 F.3d at 1299.
(3) Long-Felt Need
“Evidence of a long felt but unsolved need that is met by the claimed
invention is further evidence of non-obviousness.” Millennium Pharms., Inc.
v. Sandoz Inc., 862 F.3d 1356, 1369 (Fed. Cir. 2017). Evidence of a long felt

6 Dr. Herbenick states that the reason the underlying data was not produced
was that the standard protective order did not provide sufficient protection
for this highly confidential material. Ex. 2028 ¶ 49, n.11. We note that if
Patent Owner had wished to rely on the sales data shown to Dr. Herbenick,
Patent Owner could have requested a modification of the Protective Order to
protect its highly confidential information. See 37 C.F.R. § 42.52(a)(7).
Patent Owner did not avail itself of this option.  
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but unresolved need tends to show non-obviousness because it is reasonable
to infer that the need would have not persisted had the solution been
obvious. WBIP, 829 F.3d at 1332.
Patent Owner contends that there was a long-felt but unmet need for a
sexual stimulation device that provided sexual pleasure while minimizing
potential side effects. Resp. 68 (citing Ex. 2028 ¶ 50). Patent Owner
contends that the use of prior art stimulation devices could cause numbness
or damage to genitalia creating a need for a device which avoided these
effects. Resp. 68. Citing the testimony of Dr. Herbenick, Patent Owner
contends that the Womanizer® products satisfied this need. Id. at 69 (citing
Ex. 2028 ¶¶ 52–54).
In its Reply, Petitioner contends that indirect stimulation devices such
as the claimed device were known in the art before the invention of the
claimed device and that such devices would have avoided the side effects
recited by Dr. Herbenick. Reply 25–26. Petitioner also contends that Patent
Owner has not presented any empirical data to show that the commercial
embodiments filled the long-felt need. Id. at 26.
In its Sur-Reply, Patent Owner contends that the testimony of Dr.
Herbenick is sufficient to support a finding that the Womanizer® products
satisfied a long-felt need. Sur-Reply 25.
We have considered the arguments presented by the parties and the
evidence of record and conclude that Patent Owner has shown that there was
a long-felt need that was satisfied by the Womanizer® products.
Dr. Herbenick testified that she led a study of women who used
vibrators and found that 28.5% of women who used vibrators experienced
one or more side effects including genital numbness, pain, irritation,
inflammation/swelling, tears or cuts. Ex. 2028 ¶ 51 (citing Ex. 2008, 1861–
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1863, Table 5). Dr. Herbenick testified that these injuries resulted in the
need for a sexual stimulation device “that was effective at facilitating sexual
pleasure and/or orgasm while minimizing the potential for side effects.” Id.
Dr. Herbenick testified that the Womanizer® products satisfied this need by
“providing alternating positive and negative pressures to the clitoris so as to
provide indirect stimulation to the clitoris sufficient to facilitate female
orgasm. This is important as physical contact has caused numbness or even
tears or cuts in a subset of female vibrator users.” Dr. Herbenick also
testified that the prior art devices, including the device disclosed in Taylor,
failed to meet this need. Id. ¶ 53.
Petitioner contends that indirect stimulation devices were known in
the art and that such devices could also cause unwanted effects. Reply 25–
26. We find this argument unpersuasive. Petitioner cites to the testimony of
Dr. Herbenick to support this contention. Id. However, a careful reading of
the cited pages reveals that Dr. Herbenick testified that, in the study she
conducted, women were merely asked what type of vibrator was used but
not whether the vibrator was used directly or indirectly. Ex. 1023, 61–62.
We also note that Dr. Herbenick testified that at the time she conducted her
study most of the vibrators available in the market would have been direct
vibration without a lot of indirect possibilities. Ex. 1023, 62–63. While she
testified that there were some devices in the market that provided indirect
stimulation, they were suction-only devices that were less popular. Id. Dr.
Herbenick testified that these suction-only devices are not the same as the
Womanizer® devices, which apply alternating positive and negative
pressures. Id.
Petitioner also contends that Patent Owner has failed to present any
empirical data to support show that the Womanizer® products fulfill the
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alleged long-felt need. Reply, 26. Again we are unpersuaded by Petitioner’s
argument. Petitioner has not stated what specific “empirical data” is needed
to show that the Womanizer® products fulfill the need, nor has Petitioner
cited any case law holding that such data is required. Id. Moreover,
Petitioner has not presented any evidence to rebut Dr. Herbenick’s
conclusion that the Womanizer® devices do fulfill the long-felt need.
In reaching our decision that the Womanizer® products fulfilled a
long-felt need in the market for female sexual stimulation devices, we credit
Dr. Herbenick’s extensive experience in studying sexual health and
behavior, including vulvar and vaginal health, as well as the use of sexual
enhancement products such as vibrators including her detailed studies
reported in Exhibit 2008. Ex. 2028 ¶¶ 7, 12, 13, 16, 50–54. Petitioner did not
offer any expert with a similar background to rebut Dr. Herbenick’s
testimony.
(4) Failure of Others
Evidence that others tried but failed to develop a claimed invention
may carry significant weight in an obviousness inquiry. In re
Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
676 F.3d 1063, 1081 (Fed. Cir. 2012). This objective indicia factor is closely
tied to the long-felt need factor discussed above. Id. at 1082 (“Longfelt need
is closely related to failure of others.”).
Patent Owner contends that prior to the development of the
Womanizer® products, “experts in sexual health and behavior were well
aware of the potential adverse side effects of using vibrators for sexual
stimulation, yet no one had successfully designed a product that facilitated
orgasm while physically contacting the clitoris without also having these
potential side effects, despite numerous attempts.” Resp. 69. In support of
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this contention, Patent Owner cites Dr. Herbenick’s testimony that while
experts in the field were aware of the issues of clitoral discomfort and
numbness that arose from direct clitoral contact, none of the prior art devices
accomplished the goal of providing a stimulation device without discomfort
or numbness. Id.; Ex. 2028 ¶¶ 53–57.
Petitioner does not address Patent Owner’s argument or evidence. See
Reply 21–26.
We find that Patent Owner has persuasively shown that others in the
field failed to develop a sexual stimulation device that avoided the issues of
clitoral discomfort or numbness.
Dr. Herbenick testified based on her own experience in teaching the
use of various stimulation devices and her work in developing such devices
that no one had developed a product that achieved sexual stimulation in the
same manner as the Womanizer® devices. Ex. 2012 ¶¶ 55–57. Dr.
Herbenick testified that each prior device of which she was aware was
limited to “either direct contact (such as vibrator or flicking) or was limited
to providing suction.” Id. ¶ 57. Neither of these approaches solved the issue
of clitoral discomfort or numbness. See id.
(5) Skepticism
Evidence of industry skepticism about whether or how a problem
could be solved, or the workability of the claimed solution, weighs in favor
of nonobviousness of the claimed invention. United States v. Adams, 383
U.S. 39, 52 (1966); WBIP, 829 F.3d at 1335.
Patent Owner contends that “industry experts and participants were
skeptical about the commercial embodiments and, specifically, about how
modulating between positive and negative air pressure might facilitate
orgasm.” Resp. 70 citing Ex. 2028 ¶¶ 58–61.
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Petitioner contends that skepticism must be evaluated from the
viewpoint of industry experts and that, with the exception of Dr. Herbenick,
the evidence submitted by Patent Owner is limited to consumer reviews.
Reply 26 (citing WBIP, 829 F.3d at 1335; PharmaStem Therapeutics, Inc. v.
ViaCell, Inc., 491 F.3d 1342, 1365 (Fed. Cir. 2007)).
We have considered the arguments presented by the parties and the
evidence of record and find that Patent Owner has shown industry
skepticism relating to the Womanizer® products. Although we agree with
Patent Owner that most of the reviews cited by Dr. Herbenick are consumer
reviews and not experts in the field, the compilation of reviews cited by Dr.
Herbenick include reviews from experts who expressed skepticism about the
products. For example, there is a review by Dr. Emily Morse, “a sexologist
with a doctorate in human sexuality,” who expressed skepticism about the
product in her review. Ex. 2015, 1–2. Another expert is Vanessa Marin, a
licensed psychotherapist specializing in sex therapy, who reviewed the
product and expressed skepticism about it. Ex. 2016, 124–130. These
reviews plus the testimony of Dr. Herbenick show industry skepticism about
the Womanizer® products. Ex. 2028 ¶¶ 58–61.
(6) Praise by Others
Evidence of industry praise of the claimed invention weighs in favor
of nonobviousness. Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1053
(Fed. Cir. 2016). Evidence of industry praise may include evidence of
industry awards given to commercial embodiments of the claimed invention.
See Henny Penny Corp. v. Frymaster, LLC, 938 F.3d 1324, 1333–1334 (Fed.
Cir. 2019) (finding evidence of industry praise, including industry awards
for the patented product).
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Patent Owner contends that, notwithstanding the industry skepticism
discussed above, the industry has also praised the Womanizer® products
extensively. Resp. 70. Patent Owner contends that reviews of the
Womanizer® products have described them as “innovative, unique, and [in]
other similar terms.” Id. at 71 (citing Ex. 2028 ¶¶ 62–69). Patent Owner also
contends that the Womanizer® products have received at least 18 industry
awards including the Most Innovative Product award at the 2018
ADULTEX Awards. Id.
Petitioner has not presented any arguments in response to Patent
Owner’s showing. See Reply 23–26.
We find that Patent Owner has presented evidence showing praise in
the industry favoring a finding of non-obviousness. As Dr. Herbenick
testified, the Womanizer® InsideOut was named the most innovative
Product at the 2018 ADULTEX Awards. Ex. 2028 ¶ 68; Ex. 2017, 1–4. The
Womanizer® Duo was recognized and the Luxury Product/Range of the
Year at the 13th annual StorErotica Awards in 2019 and was named the Sex
Toy Product/Line of the Year – Powered (Vibrating) at the XBIZ Europa
Awards. Ex. 2028 ¶ 68; Ex. 2017, 5–25. Dr. Herbenick also testified that the
Womanizer® Duo was praised by Cosmopolitan magazine as having
pressure waves that “gently suck the clitoris to give you an entirely different
orgasmic sensation.” Ex. 2028 ¶ 65; Ex. 2016, 64. In addition, the
Womanizer® products have received praise by both sex toy retailers and
consumers. Ex. 2028 ¶¶ 62–69.
(7) Copying
“Copying may indeed be another form of flattering praise for
inventive features.” Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294, 1311
(Fed. Cir. 2010).
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Patent Owner contends that Petitioner and others have copied that
Womanizer® products and that this supports a finding on non-obviousness.
Resp. 72–73. To support this contention, Patent Owner points to descriptions
of competitors’ devices which describe the devices as offering “pleasure air
technology” or “touchless air technology,” which Dr. Herbenick contends
describes modulated positive and negative pressures with respect to a
reference pressure. Id.; Ex. 2028 ¶ 71.
Petitioner contends that Patent Owner has not shown sufficient
evidence of copying to support a finding of non-obviousness. Reply 25.
Petitioner contends that Dr. Herbenick did not review tests of the
competitors’ devices, nor could she describe how the products worked. Id.
In reply, Patent Owner contends that Petitioner mischaracterizes Dr.
Herbenick’s testimony and fails to rebut the evidence of copying. Sur-Reply
25.
Copying in the context of objective indicia of non-obviousness can be
demonstrated either through internal documents, direct evidence such as
disassembling a patented prototype, photographing its features, and using the
photograph as a blueprint to build a virtually identical replica, or access to,
and substantial similarity to, the patented product (as opposed to the patent).
Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed.
Cir. 2004). Marketing materials may also be used to show copying. See
Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1368 (Fed.
Cir. 2012).
We have considered the arguments presented by the parties and the
evidence of record and find that Patent Owner has presented sufficient
evidence of copying to support to finding of non-obviousness. Although Dr.
Herbenick did not physically examine the competitors’ devices, she did
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review various product descriptions which either compared the competitors’
devices to the Womanizer® products or described the action of the products
in a way that mirrored the actions of the Womanizer® products. Ex. 2028
¶¶ 70–71. For example, a review of the Blowfish clitoral stimulator was
described by Cosmopolitan magazine as “Mimicking the technology of the
Cosmo-loved Womanizer.” Ex. 2034. Similarly the Satisfier website
described the Satisfyer Pro G-Spot Rabbit as offering a “rapid change
between suction and pressure.” Ex. 2024, 4.
Given this evidence of the similarity of the competitive products to
the Womanizer® products and Petitioner’s failure to offer any evidence in
rebuttal, we find that Patent Owner has presented persuasive evidence of
copying to support a conclusion of non-obviousness.
(8) Conclusion
Based on the foregoing we conclude that Patent Owner has presented
sufficient evidence relating to objective indicia to support a finding of non-
obviousness. Although Patent Owner failed to present persuasive evidence
relating to commercial success, Patent Owner has presented persuasive
evidence relating to long-felt need, failure of others, praise by others, and
copying. Patent Owner has also shown a nexus between its commercial
products and the claimed invention. In sum, the objective indicia evidence in
the record supports the non-obviousness of the challenged claims.
3. The Remaining Claims
As discussed above with respect to Ground 1, all of the remaining
claims include a limitation calling for modulation of positive and negative
pressures with respect to a reference pressure. Based on our analysis above,
we find that Petitioner has not presented sufficient persuasive evidence that
the subject matter of the remaining claims would have been obvious over
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Taylor combined with Hovland and that Patent Owner has presented
persuasive evidence regarding objective indicia of non-obviousness.
4. Conclusion
From the foregoing analysis we conclude that Petitioner has not
demonstrated that the subject matter of claims 1–30 would have been
obvious to one of ordinary skill in the art over Taylor combined with
Hovland.
F. Ground 3 – Obviousness Based on Guan Combined with Lee and
Hovland
Petitioner contends that claims 1–30 are unpatentable as obvious over
Guan combined with Lee and Hovland. Pet. 53.
1. Guan
Guan discloses a gas health massager that generates pulsating air
pressure to stimulate meridian points for therapeutic purposes. Ex. 1007, 3.
Guan teaches the contraction of an air bag to produce the pulsating air
pressure. Id.
2. Lee
Lee discloses a mechanized dildo having vibratory elements placed on
the dildo so as to stimulate a clitoris. Ex. 1006, Abst.
3. Non-Analogous Art
Before we begin our analysis of the claims we first address Patent
Owner’s contention that Guan cannot be properly combined with Lee as
Guan is non-analogous art. Resp. 42–45.
“Two criteria have evolved for determining whether prior art is
analogous: (1) whether the art is from the same field of endeavor, regardless
of the problem addressed, and (2) if the reference is not within the field of
the inventor’s endeavor, whether the reference still is reasonably pertinent to
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the particular problem with which the inventor is involved.” In re Clay, 966
F.2d 656, 658–59 (Fed. Cir. 1992).
Patent Owner argues that the field of endeavor for the present
invention is sex toys whereas Guan is directed to medical treatment using a
variation of acupuncture. Resp. 43. Patent Owner supports this argument by
pointing to the teachings in the Specification that the claimed device is
designed to be used to stimulate erogenous zones. Id. at 43–45. Patent
Owner contends that Guan is directed to acupressure/acupuncture and is not
relevant to sexual stimulation. Id.
Petitioner contends that acupressure can be used in the genital region.
Reply 19. Petitioner also contends that Patent Owner’s contention that the
device described in the ’097 patent is limited to stimulating erogenous zones
is contradicted by the teachings of the ’097 patent and by Patent Owner’s
experts. Id. at 20. Petitioner also argues that Patent Owner’s argument that
Guan is not relevant because the invention is limited to sex toys fails. Id. at
21 (citing 21 C.F.R. § 884.5960 (categorizing genital vibrators as medical
devices); Ex. 1034).
Patent Owner responds by contending that the presence of acupressure
points in the genital region does not render Guan relevant prior art.
Sur-Reply 21. In support of this contention Patent Owner points to the
testimony of Dr. Herbenick that acupressure meridian theory is not
concerned with sexual arousal and orgasms and that one skilled in the art
would not look to meridian theory to aid in developing a sex toy. Id. (citing
Ex. 2028 ¶ 78; Ex. 1023, 97).
Patent Owner also argues that Petitioner’s reliance on the location of
meridians in the perineum or genitals is misplaced. Id. at 21–22. Petitioner
contends that treatment for sexual dysfunction is different than sexual
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stimulation and that they entail different approaches. Id. at 22. Patent Owner
also contends that the regions where the meridians are located, e.g., the
perineum, are significantly different than the vulva or the clitoris. Id.
In our Rehearing Decision, we addressed Patent Owner’s contention
that Guan is non-analogous art and held that although Guan is not directed to
a sex toy, it is reasonably pertinent to the problem faced by the inventor.
Reh’g Dec. 6. Having considered the arguments of the parties and the
evidence of record, we affirm our original conclusion that Guan is analogous
art.
Guan is directed to a device that uses pulses of air to massage or
stimulate a body part. See Ex. 1007, 1; Ex. 1002 ¶ 70. Although we agree
with Patent Owner that the principle use of the claimed device is stimulation
of the clitoris, the ’097 patent teaches its general applicability to stimulating
a body part. Ex. 1001, Abst.; col. 1, ll. 19–20, col. 4, ll. 51–56, col. 10, l. 63
to col. 11, l. 4, claim 1.
Moreover, the Specification teaches that the disclosed device creates a
massaging effect on the body part in an indirect way. Ex. 1001, col. 5, ll. 39–
41. Guan also massages a body part indirectly. See Ex. 1007, 3. Thus, both
the present invention and Guan address similar issues and Guan can be
considered analogous art.
4. Analysis of Claim 1
Petitioner contends that the combination of Guan, Lee, and Hovland
teaches each of the limitations recited in claim 1. Pet. 53–62. Because we
find that Petitioner has not shown by a preponderance of the evidence that
the challenged claims are unpatentable as obvious over the combination of
Guan, Lee, and Hovland, we will concentrate our analysis on only the
limitation that Petitioner has failed to show taught by the combination,
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which is the requirement for “the changing volume of the chamber resulting
in modulated positive and negative pressures with respect to a reference
pressure.”
a) The changing volume of the chamber resulting in modulated positive
and negative pressures with respect to a reference pressure
Petitioner contends that Guan teaches this limitation. Pet. 55–56.
Petitioner contends that prior to starting any motion of the air bag, the
pressure in the device is the reference pressure. Id. (citing Ex. 1002 ¶¶ 70,
128–129). Petitioner contends that as the lever in Guan compresses the air
bag, it creates a positive pressure with respect to the reference pressure. Id.
Petitioner contends that as the lever expands the airbag, it creates a negative
pressure with respect to the reference pressure. Id. Petitioner contends that
this results in modulated positive and negative pressures with respect to a
reference pressure. Id.
In support of these arguments Petitioner initially relies on the
following testimony of Dr. Prisco:
69. In Guan, when power is turned on to activate
electromagnet 5, the electromagnet 5 will drive the magnet 4 and
the lever 3 to oscillate about the pinned connection (as annotated
using the curved arrow in the figure of Guan reproduced above),
and cause the wall of air bag 2 marked A (in the figure above) to
reciprocate towards and away from mouth 1 to cyclically expand
and contract the air bag 2. (Id.)
70. Before wall A starts to reciprocate, the pressure of air
in air bag 2 is at the prevailing atmospheric pressure. When
mouth 1 is in contact with the body and air bag 2 contracts, the
air in air bag 2 gets compressed, and its pressure increases to a
value above the prevailing atmospheric pressure. Similarly,
when mouth 1 is in contact with the body and air bag 2 expands,
the air in air bag 2 also expands, and its pressure decreases below
the prevailing atmospheric pressure. As the pressure inside air
bag 2 increases above the prevailing atmospheric pressure, air
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flows from the air bag 2 through the mouth 1 on to the body part
that is in contact with the mouth 1. (Id.) And, when the pressure
inside air bag 2 decreases below the prevailing atmospheric
pressure, air flows from the mouth 1 into the air bag 2 and applies
a suction force on the body part. In this manner, activation of the
electromagnet 5 generates and applies a “pulsating air pressure”
on the body for stimulation.
Ex. 1002 ¶¶ 69–70; see also id. ¶¶ 127–129. Dr. Prisco testified that the
operation of Guan as he described would result in “modulated positive and
negative pressures with respect to a reference pressure.” Id. ¶ 128.
Patent Owner responds that Guan does not disclose modulated
positive and negative pressures, but is limited to pulsing positive pressure.
Resp. 30–31. Patent Owner contends that Petitioner’s contentions with
respect to Guan teaching modulated positive and negative pressures is not
supported by the limited disclosure in Guan. Resp. 32–34.
Patent Owner supports these arguments with the testimony of
Dr. Jensen who testified:
Guan fails to provide a complete or clear description of the
device’s elements or the interactions and functioning of its
elements. Guan fails to provide specific details of, for example,
the coupling of lever (3) to other components, the orientations of
the electromagnet and magnet (e.g., orientations of the charges
and poles), which are required to determine the movement of the
lever (3) and the magnet (4), and details regarding how air enters
and exits the air bag or even deformation of the airbag.
Ex. 2027 ¶ 103. Dr. Jensen goes on to note that Dr. Prisco’s analysis of
Guan is not supported by the teachings of Guan, but are based on
assumptions using information gleaned solely from the ’097 patent in an
inappropriate hindsight analysis. Id. ¶ 104 (stating “[n]othing in Guan
discloses an air-tight seal between the mouth (1) and the body. . . A POSITA
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would not interpret Guan as Petitioner and Dr. Prisco have, without
knowledge gleaned from the ’097 Patent”).
Patent Owner also contends that the reciprocating motion of Guan
only creates a variation in positive pressure and does not result in a negative
pressure. Resp. 34–35. Patent Owner contends that one skilled in the art
would have understood the device described in Guan to pulse air in only one
direction and not between positive and negative pressures. Id.
Patent Owner contends that one skilled in the art would not have been
motivated to modify Guan to modulate positive and negative pressures.
Resp. 35–36. Patent Owner contends that Guan is directed to mimicking
meridian-based therapies, which use either positive pressure or negative
pressure, but not both. Id. Patent Owner contends that nothing in Guan
would have led one skilled in the art to modify the device to produce both
positive and negative pressures. Id. Patent Owner contends that Petitioner’s
experts improperly used the ’097 patent as a guide in their analyses. Id.
Petitioner contends that one skilled in the art would have understood
that the air bag in Guan is in an intermediate position and that the action of
the lever causes the air bag to expand and contract, thereby creating positive
and negative pressures. Reply 2–3. Petitioner also contends that the plain
meaning of the term pulsation supports the conclusion that the device in
Guan produces positive and negative pressures. Id. at 4. Petitioner also
contends that Guan’s teaching of both acupressure and cupping indicates
that the device in Guan can create both positive and negative pressures. Id.
at 5.
In addition to relying on the testimony of Dr. Prisco, Petitioner also
cites to the testimony of Mr. Meyst. Id. Mr. Meyst testified that:
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A person of skill in the art, prior to March 2015, would
have understood, based on the figure of Guan, that because the
lever 3 is described as reciprocating and driving the air bag 2,
and because the lever 3 is depicted in an intermediate/neutral
position (i.e., the lever 3 is expected to move both left and right
of the depicted position in the figure), the resulting motion would
generate modulated positive and negative pressures. Further, a
person of ordinary skill in the art would have expected that, other
than when a seal is created against mouth 1 when the air bag 2 is
completely expanded or compressed, Guan would always
generate modulated positive and negative pressures, relative to
ambient air pressure, due to the electromagnet 5 driving the
magnet 4, lever 3, and the wall of air bag 2 to have a reciprocating
motion during operation.
Ex. 1020 ¶ 86.
Patent Owner responds that the teachings of Guan do not support
Petitioner’s analysis and that Guan is limited to producing only positive
pressures. Sur-Reply 14.
We have considered the arguments presented by the parties and the
evidence of record conclude that Petitioner has not demonstrated that Guan
teaches the element “the changing volume of the chamber resulting in
modulated positive and negative pressures with respect to a reference
pressure.”
Both Dr. Prisco and Mr. Meyst based their opinions on the premise
that the air bag of Guan is in an intermediate position that would allow it to
expand creating a pressure below the reference pressure. Ex. 1002 ¶¶ 69–70;
Ex. 1018 ¶ 34; see Ex. 1020 ¶ 87. Guan, however is silent with respect to the
starting position of the airbag. As Mr. Meyst testified, if the airbag were in
the fully expanded position or in the fully compressed position, the airbag
would not create positive and negative pressures relative to a reference
pressure. Ex. 1020 ¶¶ 86–87.
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Given Guan’s silence as to the starting positon of the air bag,
Petitioner and its experts appear to rely on an assumption that Guan
inherently teaches that the air bag always starts in a position that is neither
fully expanded nor fully compressed. Although inherency may supply a
missing element in an obviousness analysis, the petitioner must show that it
is a natural result flowing from the operation of the device. PAR Pharm.,
Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014). In the
instant case, Petitioner has not established that the intermediate positon
would naturally result from the operation of the device.
Mr. Meyst testified that Guan shows the lever that drives the airbag in
an intermediate positon and that because the lever can reciprocate, the airbag
must also must generate positive or negative pressures with respect to a
reference pressure. Ex. 1020 ¶ 86. However, Mr. Meyst does not state, nor
does Guan teach, that an intermediate position is always the starting positon.
See id. Thus it cannot be said that Guan inherently starts in the neutral
position and invariably produces a positive and negative pressure with
respect to a reference pressure without such a teaching.
Petitioner contends that the device of Guan can also be used for
cupping, which in turn is a teaching that the device can be used to generate
positive and negative pressures. Reply 5. We are not persuaded by this
argument. The discussion of cupping in Guan appears as part of a discussion
of prior art solutions. Ex. 1007, 3. We do not discern, nor does Petitioner
point to, any specific teaching in Guan that the device of Guan can be used
for cupping.7 Moreover, even if the device could be used for cupping,

7 Cupping is a traditional Chinses medical therapy that involves the
application of negative pressure for therapeutic purposes. Ex. 1033, 8.
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Petitioner has not pointed to any teaching that would have led one skilled in
the art to combine cupping with acupressure. See Reply at 5.
Petitioner contends that Patent Owner has failed to identify any
structure in Guan that would prevent the device from operating in the
manner described by Petitioner’s experts. Reply 4. Petitioner, however,
inappropriately places the burden of persuasion on Patent Owner. It is
Petitioner’s burden to establish that the subject matter of the claims would
have been obvious, not Patent Owner’s burden to establish the negative, that
such subject matter would not have been obvious. See Magnum, 829
F.3d at 1375.
b) Conclusion
For the reasons set forth above, Petitioner has not demonstrated that
Guan teaches “the changing volume of the chamber resulting in modulated
positive and negative pressures with respect to a reference pressure.”
Additionally, as discussed above with regard to Petitioner’s Ground 2
contentions, we find that Hovland also fails to teach this limitation.
Petitioner does not rely upon Lee to satisfy this limitation. Based on the
foregoing, we conclude that Petitioner has not demonstrated that the
combination of Guan, Lee, and Hovland teaches all of the elements of claim
1.
5. Claims 2–11
Claims 2–11 depend from claim 1 and therefore include all of the
limitations of claim 1. 35 U.S.C. § 112 (d). As discussed above, Petitioner
has not shown that Guan combined with Lee and Hovland teaches the claim
element calling for the changing volume of the chamber resulting in
modulated positive and negative pressures with respect to a reference
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pressure. Therefore, we conclude that Petitioner has not demonstrated that
Guan, Lee, and Hovland teach all of the elements of claims 2–11.
6. Claims 12–16 and 16–30
Claims 12 and 26 are independent method claims, which also include
the limitation that the changing volume of the chamber or the pressure field
generator results in modulated positive and negative pressure with respect to
a reference pressure. Ex. 1001, col. 17, ll. 36–62; Col. 18, ll. 33–61. Claims
13–16 and 27–30 depend from claims 12 and 26, respectively.
As discussed above, the combination of Guan, Lee, and Hovland does
not teach modulated positive and negative pressures with respect to a
reference pressure. Therefore we find that Guan combined with Lee and
Hovland does not teach all of the elements of claims 12–16 and 26–30.
7. Claims 17–25
Claim 17 is an independent apparatus claim, which also includes a
claim element calling for the production of positive and negative pressures
with respect to a reference pressure. Ex. 1001, col. 17, ll. 1–13. Claims 18–
25 depend from claim 17. Id. at col. 17, ll. 14–31.
As discussed above, the combination of Guan, Lee, and Hovland does
not teach modulated positive and negative pressures with respect to a
reference pressure. Therefore we find that Guan combined with Lee and
Hovland does not teach all of the elements of claims 17–25.
8. Motivation to Combine Guan, Lee, and Hovland
Having addressed the question of whether the combined teachings of
Guan, Lee, and Hovland teach or suggest all of the elements of the claims,
we now turn to the question of whether one skilled in the art would have
been motivated to make such a combination.
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“Obviousness requires more than a mere showing that the prior art
includes separate references covering each separate limitation in a claim
under examination.” Unigene, 655 F.3d at 1360. “Rather, obviousness
requires the additional showing that a person of ordinary skill at the time of
the invention would have selected and combined those prior art elements in
the normal course of research and development to yield the claimed
invention.” Id.
Petitioner contends that one skilled in the art would have been
motivated to combine the teachings of Guan with those of Lee and Hovland
because Guan teaches that the massager can be used to stimulate any region
of the body including erogenous zones such as the clitoris. Pet. 58–59.
Petitioner contends that one skilled in the art would have been aware of the
disadvantages of direct stimulation of the clitoris and that indirect systems
were better suited. Id. at 59 (citing Exs. 1001, 1005). Petitioner contends that
it was well known in the art to provide a device such as Lee, which
combines a dildo with a stimulation element for the clitoris. Id. at 60.
Petitioner goes on to contend:
Thus, a POSITA at the time of the alleged invention,
recognizing the drawbacks of direct mechanical stimulation and
the benefits of indirect stimulation via air pressure differential on
the clitoris, would have had a reasonable expectation of success
in replacing Lee’s mechanical vibrator with Guan’s massager to
take advantage of the benefits of indirect stimulation discussed
above. Ex. 1002 at ¶¶26-28, 134-137. Accordingly, the POSITA
would have been motivated to incorporate Guan’s massager in
Lee’s dildo so as to replace direct vibratory stimulation with
pulsating air pressure during use of dildo 10. Id. Such a
modification would have amounted to nothing more than a
simple substitution of one known element for another to obtain
predictable results. See KSR, 550 U.S. at 417. This is because at
the time of the invention, a POSITA would have the requisite
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skill level to replace Lee’s mechanical vibrator with Guan’s
massager without any problem. In such a modified device, sleeve
16 would correspond to the claimed appendage in the form of a
“dildo configured to be inserted into the vagina.” Ex. 1002 at
¶137.
Id. at 61–62.
Patent Owner contends that one skilled in the art would not have been
motivated to combine the teachings of Guan and Lee. Resp. 62–65. Patent
Owner contends that one skilled in the art would not have viewed Guan as
teaching stimulation of erogenous zones as Guan deals with acupressure,
which relates to stimulating meridians that do not include erogenous zones.
Id. at 62.
Patent Owner also contends that although one skilled in the art may
have known of the disadvantages of direct clitoral stimulation, one skilled in
the art would not have looked to Guan for the solution insofar as Guan is not
related to treating sexual dysfunction of clitoral engorgement. Id. at 63.
Patent Owner also contends that one skilled in the art would not have
had a reasonable expectation of success in combining the device of Guan
into the dildo of Lee. Id. at 63–64.
Patent Owner also contends that it would not have been a matter of
simple substitution of the massager of Guan for the direct stimulator of Lee.
Id. at 64. Patent Owner contend that such a modification would have
required a complete redesign of the dildo and arm member. Id.
In response, Petitioner contends there are acupoints or meridians in
the female genitalia, thus Guan would be applicable to stimulating these
regions. Reply 19–20. Petitioner also points out that the broader claims are
not limited to stimulating erogenous zones or the clitoris. Id.
In its Sur-Reply, Patent Owner contends that as
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the unrebutted testimony of Dr. Herbenick makes clear, a
POSITA looking to design a sex toy that enhances sexual arousal
and orgasm by stimulating the clitoris with modulated positive
and negative pressures relative to the reference pressure would
not have looked to meridian-based therapies to do so because—
unlike the ’097 Patent—meridian theory is not concerned with
enhancing sexual arousal and orgasm.
Sur-Reply 21 (citing Ex. 2028 ¶ 78); Ex. 1023. 97.
Patent Owner also contends that while references may teach applying
acupressure to the perineum or genitalia, it is to treat sexual dysfunction.
Sur-Reply 21–22. Patent Owner contends that treatment of sexual
dysfunction is different from enhancing sexual arousal and that one would
not look to a device for treating sexual dysfunction to enhance sexual
arousal. Id.
We have considered the arguments presented by the parties and the
evidence of record and find that Petitioner has not demonstrated that one
skilled in the art would have been motivated to combine the teachings of
Guan with Lee.
While Guan is silent as to which part of the body the device is to be
applied, Guan teaches that the device “has good curative effect on blood
pressure, heart disease, cerebral thrombosis, coronary heart disease,
digestive system, nervous system and various pains.” Ex. 1007, Abst.
Nothing in Guan suggests that it has any effect on sexual arousal or sexual
dysfunction. See id. In addition, Dr. Herbenick, who has extensive
experience in evaluating and developing sex toys, testified that:
As a POSITA myself, I do not recall conversations with design
team colleagues in which anyone referenced meridian-based
therapy devices, which makes sense because meridian-based
therapy is not relevant to erogenous zones or sexual arousal.
Additionally, even if a POSITA had come across Guan, I cannot
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imagine why they would have been motivated to combine the
device of Guan with other patents or devices to create something
akin to the ’097 Patent. This is because I do not think most
POSITAs would be skilled in the arts of both meridian therapies
and sexual stimulation, and would certainly not learn anything
about pressures applied to genital parts from reading Guan. Also,
I cannot imagine a POSITA reading Guan, which at most teaches
pulsating pressures for purposes of treating illness and health
problems associated with the meridian channels (which
themselves have nothing to do with sexual arousal), and coming
up with the modulation between positive and negative pressures
with respect to a reference pressure, for purposes of sexual
stimulation. In my opinion, a person of ordinary skill in the art
would not and did not find that feature (the modulation of
positive and negative pressures with respect to a reference
pressure) obvious prior to the invention of the Womanizer
products as claimed in the ’097 Patent. In addition to the reasons
already noted, it occurs to me that those skilled in the art often
considered features that in some way mimicked common human
forms of sexual stimulation (e.g., vibration mimicking rapid
touch, vacuum suction mimicking mouth suction, dildos
mimicking the penis, dildos with a thrusting motion mimicking
intercourse). As a sexuality researcher, educator, and POSITA, I
have never heard anyone describe using modulated pressures in
rapid succession (such as from their mouth) and thus I cannot
imagine that creating this style of stimulation would have been
obvious to sexual stimulation device designers. Again, this is
why the ‘097 Patent was truly inventive. I also cannot imagine
why a POSITA would have read Guan and thought to add an
appendage or dildo to it, again, because Guan is not a sexual
stimulation device, and because there is nothing in the disclosure
of Guan that would suggest to a POSITA that Guan could or
should be combined with another device, let alone a dildo.
Ex. 2028 ¶ 78.
Although we acknowledge that Dr. Prisco testified that one skilled in
the art would have been motivated to combine the teachings of Guan and
Lee to take advantage of Guan’s indirect stimulation, we note that Dr. Prisco
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has no direct experience in developing sex toys. See Ex. 1002 ¶¶ 132–131;
Ex. 1019. Dr. Herbenick, on the other hand, has extensive experience in
evaluating and developing sex toys. Ex. 2028 ¶¶ 7–17; Ex. 2029. For this
reason we give greater weight to Dr. Herbenick’s testimony on this issue.
Although we agree with Petitioner that acupressure and acupuncture
have been used in the genital region, it has been used to relieve pain or to
treat infections. See Exs. 1030, 1032, 1033. We do not see how the teaching
of the use of acupressure for treating pain or illness would have led one
skilled in the art to use the same methods to increase sexual arousal.
Petitioner also contends that Hovland provides a motivation to
combine the teachings of Guan and Lee. Pet. 59. We are not persuaded.
Petitioner argues that Hovland teaches that the advantage of indirect
stimulation of the clitoris “may reduce the likelihood of fibrosis[] at the
clitoris … and consequent reduced clitoral and urethral physiological
function.” Id. (quoting Ex. 1005 at 19:27–31). Like Guan and the
acupressure references cited by Petitioner, Hovland is describing the use of
indirect pressure to treat or prevent a medical condition. Like the
acupressure references, Petitioner does not explain adequately why one
skilled in the art would have combined a device used for sexual stimulation
such as Lee with a device like Guan that is used to treat a medical condition.
Based on the foregoing we conclude that Petitioner has failed to show
why one skilled in the art would have been motivated to combine the
teachings of Guan with those of Lee and Hovland to produce the claimed
invention.
9. Objective Indicia
Our analysis of Petitioner’s obviousness contention is not complete
without considering Patent Owner’s evidence of objective indicia of non-
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obviousness. Graham, 383 U.S. at 18. As discussed above in Section
II.E.2.c), we find that Patent Owner has put forth sufficient evidence of
objective indicia to establish that the claims of the ’097 patent are not
obvious.
10. Conclusion
Based on the foregoing, we conclude that Petitioner has not
demonstrated that the subject matter of the challenged claims would have
been obvious to one of ordinary skill in the art at the time the invention was
made over Guan combined with Lee and Hovland.
III. PETITIONER’S MOTION TO EXCLUDE
Petitioner has moved to exclude Patent Owner’s expert declarations
(Exhibits 2026 and 2028), as well as Exhibit 2032. Paper 45 (“MTE”). For
the reasons set forth below, Petitioner’s Motion is denied.
A. Exhibit 2026 — Declaration of Dr. Herbenick
Petitioner contends that we should either exclude the testimony of
Dr. Herbenick or afford it little weight for several reasons. First, Petitioner
contends that Patent Owner failed to comply with 37 C.F.R. § 42.65(b) in
that Patent Owner failed to provide an affidavit explaining how certain tests
that Dr. Herbenick relied upon were performed. MTE 2–4. Second,
Petitioner contends that Patent Owner failed to produce all documents relied
upon by Dr. Herbenick in rendering her opinions. Id. at 5–8. Third,
Petitioner contends that the testimony of Dr. Herbenick should be excluded
because of allegedly improper objections made by counsel for Patent Owner
during Dr. Herbenick’s deposition. Id. at 9–12. Fourth, Petitioner contends
that Dr. Herbenick is not qualified to testify as a technical expert. Id. at 14–
15. Finally, Petitioner contends that we should strike Dr. Herbenick’s
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testimony as she did not disclose her work as a witness in other proceedings.
MTE 7–8; Paper 47, 5 (“MTE Reply”).
We address each of these arguments in turn.
1. Failure to Comply with 37 C.F.R. § 42.65(b)
Petitioner contends that we should exclude or give little weight to all
of Dr. Herbenick’s testimony because her declaration does not provide any
information relating to the experiments that produced the graph discussed in
paragraph 43 of her declaration. MTE 2–3. While Petitioner may be correct
with respect to Dr. Herbenick’s failure to adequately describe what tests led
to the graph on paragraph 43 of her declaration, we find this objection moot
as we did not rely on that part of her testimony.
Petitioner also argues that we should exclude or give little weight to
Dr. Herbenick’s testimony about the different components in the
Womanizer® products as Patent Owner did not provide an affidavit
concerning the deconstruction and observation of the devices. MTE 4–5.
We do not find that this a sufficient reason to exclude or discount Dr.
Herbenick’s testimony. Rule 42.65(b) refers to “technical” tests. We find
that dismantling a device and identifying the components of the device does
not constitute a “technical” test within the scope of the Rule. We therefore
decline to exclude or give little weight to that portion of her testimony.
2. Withheld Documents and Information
Petitioner contends that we should exclude or give little weight to the
testimony of Dr. Herbenick because Patent Owner failed to provide all the
relevant facts and data that support Dr. Herbenick’s opinions. Specifically
Petitioner contends that Patent Owner failed to produce sales data and
research that supported Dr. Herbenick’s testimony relating commercial
success to Patent Owner’s products; drafts of Dr. Jensen’s declaration that
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Dr. Herbenick reviewed in connection with her declaration; and documents
relating to the differences between the InsideOut and Duo products. MTE 5–
7. Petitioner also points to Dr. Herbenick’s failure to disclose the fact that
she has testified for Patent Owner in other matters as evidence that Patent
Owner has withheld other information and documents. MTE 7–8. We
address each of these issues in turn.8
a) Sales Data
Petitioner’s motion to exclude with respect to sales data is moot. As
discussed above in Section II.E.2.c(2) above, we found that Patent Owner
had failed to establish commercial success, in part, because Patent Owner
failed to produce the relevant sales data.
b) Draft Declarations
We find that Petitioner’s objection to Dr. Herbenick’s declaration on
the basis that Patent Owner did not produce the draft of Dr. Jensen’s
declaration that Dr. Herbenick reviewed in connection with her declaration
to be without merit. We agree with Patent Owner that the declarations of the
other experts do not constitute facts or data as that term is used in 37 C.F.R.
§ 42.65(b). Paper 46, 5–6 (“MTE Reps.”) Documents relating to Patent
Owner’s Products
Petitioner contends that Patent Owner failed to produce documents
relating to the differences between the InsideOut and Duo products and that
those difference show that there are technical differences between the
products. MTE 7. Petitioner contends that this contradicts the testimony of

8 We note that at no time during this proceeding did Petitioner seek
assistance from the panel to obtain the documents it now says warrant
excluding Dr. Herbenick’s testimony.
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Patent Owner’s experts that the mechanics of the two products are the same.
Id.
We find that Petitioner’s objection on this ground is without merit. To
begin, Patent Owner’s experts acknowledged that the InsideOut and Duo
products were different but that the difference did not affect their analyses.
Ex. 2026 ¶ 41; Ex. 2028 ¶ 38. Moreover, the first “technical difference”
identified by Petitioner relates to the number and location of control buttons
on the Duo device, a feature that does not appear to be related to the issue of
whether the Duo device embodies the claimed invention. Ex. 1023, 117. The
other “technical difference” identified by Petitioner is the addition of a light.
Ex. 1053, 146. Again this is not a feature relevant to the issue of whether the
commercial products embody the claimed invention.
3. Dr. Herbenick’s Bias
Petitioner contends that Dr. Herbenick failed to disclose that she had
testified for Patent Owner in other proceedings, which demonstrates
Dr. Herbenick’s bias and Patent Owner’s withholding of relevant
information. MTE 7–8; MTE Reply 5. We are not persuaded that this
warrants excluding Dr. Herbenick’s testimony. Although the testimony
regarding Dr. Herbenick’s work for Patent Owner may be relevant, it goes to
the issue of credibility, not admissibility. See, e.g., NuVasive, Inc. v. Iancu,
752 F. App’x 986, 996 (Fed. Cir. 2018) (“While the Board can and should
weigh the credibility of any expert testimony, it should not outright
disregard expert testimony from a witness simply because that individual is
compensated for his time and expense in testifying.”).
4. Patent Owner’s Alleged Misconduct
Petitioner contends that the testimony of Dr. Herbenick should be
excluded because of alleged misconduct by Patent Owner’s counsel during
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the depositions Dr. Herbenick and Dr. Jensen. MTE 8–12. Petitioner
contends that counsel for Patent Owner repeatedly made speaking objections
which coached the witness and affected Petitioner’s ability to obtain
discovery. Id.
Patent Owner contends that the objections were proper and
necessitated by misrepresentations made by Petitioner’s counsel. MTE Resp.
10–13. Patent Owner also argues that even if the objections were improper,
exclusion of the expert’s declarations is not the proper remedy. Id. at 13.
We begin by noting that several of the alleged speaking objections
identified by Petitioner were from depositions in other proceedings and are
not relevant to the issue of excluding testimony in this proceeding. Exhibits
1051 and 1052 are transcripts from IPR2019-01444 and Exhibits 1053 and
105 are from IPR2020-00007.
With respect to this proceeding, Petitioner has identified only three
possible instances of speaking objections. We do not find this to be such
egregious conduct as to warrant excluding Dr. Herbenick’s testimony.
Moreover the testimony affected by the alleged improper objections has no
bearing on our decision. For example, one objection related to the issue of
the definition of a pressure field generator which does not play a part in our
decision. See Ex. 1023, 149–151. The other concerned the operation of the
device in Guan. Id. at 168. Dr. Herbenick offered no direct testimony
concerning the operation of Guan nor do we rely on Dr. Herbenick’s
testimony regarding Guan in reaching our decision. See Ex. 2028.
Given the limited number of alleged speaking objections and the fact
that the affected testimony is not relevant to our decision, we decline to
impose the sanction of excluding Dr. Herbenick’s testimony.
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5. Dr. Herbenick’s Expertise
Petitioner contends that Dr. Herbenick lacks the relevant technical
expertise to testify about the validity of the ’097 patent or whether Patent
Owner’s commercial products embody the claims of the ’097 patent. MTE
14–15. We do not find that Petitioner has stated sufficient grounds to
exclude Dr. Herbenick’s testimony.
While Dr. Herbenick does not have a technical degree or an extensive
technical background, her testimony was from the point of view of one with
experience evaluating and designing sex toys. See, e.g., Ex. 2028 ¶¶ 50–54
(evaluation of the long-felt need in the industry). It is in this context that
Dr. Herbenick’s testimony has been offered and relied upon by us in
reaching our decision.
On the issue of validity, most of Dr. Herbenick’s testimony has been
with respect to objective indicia, an issue about which we find Dr.
Herbenick well qualified to opine. The only “technical” testimony offered by
Dr. Herbenick that we rely upon is her identification of the various
components found in the Womanizer® devices. Ex. 2028 ¶¶ 39–47. With the
exception of her opinion regarding modulation of positive and negative
pressures, we find that her experience in evaluating and designing sex toys
gives her the relevant experience to identify the various components of the
devices. See Ex. 2028 ¶¶ 4–17.
With respect to Dr. Herbenick’s testimony regarding modulation of
positive and negative pressures, we have not relied on Dr. Herbenick’s
testimony in reaching our decision.
Dr. Herbenick did not offer any technical analysis of the prior art,
therefore her lack of understanding regarding how the prior art operated is
irrelevant to the question of whether her testimony should be excluded.
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6. Conclusion
From the foregoing analysis we see no reason to exclude
Dr. Herbenick’s testimony or to give it little weight. For this reason, that
portion of Petitioner’s Motion to Exclude is denied.
B. Exhibit 2028 — Declaration of Dr. Jensen
Petitioner contends that the testimony of Dr. Jensen should be
excluded or given little weight. MTE 1. As with Dr. Herbenick’s testimony,
Petitioner cites several reasons to exclude Dr. Jensen’s testimony. First,
Petitioner contends that Patent Owner violated 37 C.F.R. § 42.65(b) by not
providing a proper affidavit describing Dr. Jensen’s experiment. Id. at 2–3.
Second, Petitioner contends that Patent Owner did not produce all
documents Dr. Jensen relied upon in reaching his opinions. Id. at 5–8.
Finally, Petitioner contends that the improper conduct by Patent Owner’s
counsel during the deposition of Dr. Jensen warrants exclusion of Dr.
Jensen’s testimony. Id. at 8–11.
1. Failure to Comply with 37 C.F.R. § 42.65(b)
While Petitioner contends that Dr. Jensen’s declaration does not
comply with 37 C.F.R. § 42.65(b), Petitioner does not state how the
declaration fails to comply with the Rule. See MTE 2–4. Petitioner’s
arguments focus on alleged deficiencies in Dr. Jensen’s methodology, which
would go to the weight to be afforded such testimony, and do not address
any failure to comply with our Rules.9 Id.

9 Petitioner contends that Dr. Jensen’s procedure does not comply with the
FDA’s guidance for good laboratory practices found at 21 C.F.R. § 58. That
section of the regulations relates to product safety testing and is irrelevant to
any issue before us. See 21 C.F.R. § 58.1(a). Moreover, Petitioner’s
argument regarding compliance with the FDA rules and well as Petitioner’s
argument that Dr. Jensen’s test is impossible to replicate is unsupported by
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Moreover, failure to comply with 37 C.F.R. § 42.65(b) also goes to
the weight given the evidence. Emerson Elec. Co. v. IPCO, LLC, IPR2017-
00213, Paper 42, 25–26 (PTAB May 11, 2018) (affording expert testimony
no weight for failure to comply with 37 C.F.R. § 42.65(b)); Altair Pharm.,
Inc. v. Paragon Bioteck, Inc., Paper 48, 16–17 (PTAB Nov. 14, 2016)
(“Without the necessary information prescribed in §42.65(b), we cannot
determine whether the evidence … is credible.”). Therefore we decline to
exclude Dr. Jensen’s for failure to comply with 37 C.F.R. § 42.65(b).
2. Withheld Documents and Information
Petitioner’s arguments with respect to this issue are the same as for
Dr. Herbenick’s declaration discussed above. MTE 5–8. For the same
reasons given above, we decline to exclude Dr. Jensen’s declaration.
3. Patent Owner’s Alleged Misconduct
Petitioner’s arguments with respect to this issue are the same as for
Dr. Herbenick’s declaration discussed above. MTE 8–12.
We note that, with respect to Dr. Jensen’s deposition in this
proceeding, Petitioner identified only one allegedly improper objection.
MTE 11. A review of the testimony reveals that the questions relate to the
issue of a pressure field generator, a term not in dispute in this proceeding.
Ex. 1022, 74–75. We do not believe that a single alleged speaking objection
about a term that is not in dispute warrants excluding Dr. Jensen’s
declaration.

any evidence. “Attorneys’ argument is no substitute for evidence.” Johnston
v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).

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4. Conclusion
Based on the foregoing we deny Petitioner’s Motion to Exclude as it
relates to Exhibit 2028.
C. Exhibit 2032
Petitioner contends that Exhibit 2032 should be excluded on the
grounds of hearsay and lack of authenticity. MTE 12–14.
In reaching our decision we did not rely on Exhibit 2032. We
therefore deny as moot Petitioner’s motion with respect to Exhibit 2032.
D. Conclusion
For the reasons stated above, we deny Petitioner’s Motion to Exclude
in its entirety.
IV. CONCLUSION
Weighing the evidence of the disclosures of the references, the
competing testimony, the reasoning to combine the references, and the
evidence showing secondary indicia of non-obviousness, we determine that
Petitioner has failed to show, by a preponderance of the evidence, that any of
claims 1–30 of the ’097 patent is unpatentable.
We also deny Petitioner’s Motion to Exclude.
V. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–30 of the ’097 patent are not determined to
be unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude is denied;
and
FURTHER ORDERED that, because this is a final written decision,
parties to this proceeding seeking judicial review of our decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.
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In summary:

Claims 35
U.S.C. §
Reference(s)/Basis Claims
Shown
Unpatentable
Claims
Not shown
Unpatentable
1–9,
12–24,
26–30
102 Taylor 1–9, 12–24,
26–30
1–30 103 Taylor, Hovland 1–30
1–30 103 Guan, Lee,
Hovland
1–30
Overall
Outcome
1–30
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For PETITIONER:
Dinesh Melwani
Andrew Sutton
BOOKOFF MCANDREWS, PLLC
dmelwani@bomcip.com
asutton@bomcip.com

For PATENT OWNER:
Tammy Dunn
Lisa Margonis
Califf Cooper
Peter Schechter
OSHA BERGMAN WATANABE & BURTON
terry@obwbip.com
margonis@obwbip.com
cooper@obwbip.com
schechter@obwbip.com