Novoluto GmbH

Patent Trials and Appeals Board

Aug 5, 2021

IPR2019-01444 (P.T.A.B. Aug. 5, 2021)

Trials@uspto.gov Paper 45
571-272-7822 Entered: August 5, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

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

IPR2019-01444
Patent 9,763,851 B2

Before SUSAN L. C. MITCHELL, SCOTT C. MOORE, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining No Challenged Claims Unpatentable
35 U.S.C. § 318(a)
Denying 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 1–6 of U.S. Patent No. 9,763,851 B2 (Ex. 1001, “the ’851
patent”). Paper 1 (“Pet.”). NOVOLUTO GmbH (“Patent Owner”) filed a
Preliminary Response to the Petition. Paper 11. On January 13, 2020 we
issued our Decision Denying Institution. Paper 12 (“Dec.”).
Petitioner filed a Request for Rehearing of our Decision Denying
Institution under 37 C.F.R. § 42.71(c) and (d). Paper 14 (“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 18 (“Reh’g Dec.” or “Rehearing
Decision”).
Patent Owner then filed a Response on November 3, 2020. Paper 28
(“Resp.”). Petitioner filed a Reply on January 26, 2021. Paper 35 (“Reply”).
Patent Owner filed a Sur-Reply on March 9, 2021. Paper 37 (“Sur-Reply”).
On March 30, 2021, the parties jointly informed the Board that no oral
hearing was needed in this case. Paper 38.
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 16.
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 grant of 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 1–6 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 34.
Patent Owner identifies itself as the real party-in-interest and that
WOW Tech International GmbH is the corporate parent of Novoluto GmbH.
Paper 39.
C. Related Matters
Petitioner has stated that the ’851 patent is the subject of litigation in
two district court actions: EIS Inc. v. WOW Tech International GmbH et al.,
No. 1:19-cv-01227-LPS, (D. Del.) and Novoluto, GmbH v. Uccellini LLC
d/b/a Lora DiCarlo, No. DOR-6-20-cv-02284-MTK (D. Ore.). Paper 34, 3.
Petitioner also states that two related patents, US 9,937,097 B2 and
US 9,849,061 B2 are the subject of IPR2019-01302 and IPR2020-00007
respectively. Id. We issued a Final Written Decision in IPR2019-01302 on
June 14, 2021. IPR 2020-00007 remains pending.
D. The ’851 Patent
The ’851 patent, titled Stimulation Device, issued on September 19,
2017, from Application 15/023,471 filed on March 21, 2016. Ex. 1001,
codes (10), (21), (22), (45), and (86). It claims priority to German Patent
Application No. 102013110501, filed September 23, 2013. Id., col. 1, ll. 6–
10.
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The ’851 patent relates to a sexual stimulation device for erogenous
zones, in particular the clitoris. Ex. 1001, col. 1, ll. 12–13. The stimulation is
produced by the application of positive and negative pressures with negative
pressure defined as “a media pressure below the reference pressure” and a
positive pressure being defined as “a media pressure above the reference
pressure.” Id. at col. 4, ll. 3–8. The reference pressure is expressly defined in
the Specification of the ’851 patent as “the existing ambient pressure in
relation to the stimulation device at the beginning of use (i.e. prior to placing
the stimulation device on the area of skin to be stimulated). In the preferred
use of the stimulation device with air, the reference pressure is the currently
existing air pressure or normal pressure.” Id. at col. 4, ll. 20–25. The positive
and negative pressures are created by changing the volume of a chamber in
the device. Id. at col. 9, ll. 27–58.
E. Illustrative Claims
Claims 1 is representative of the challenged claims and reads as
follows:
1. A stimulation device for a clitoris, comprising:
a pressure field generator comprising:
a first chamber having a single opening;
a second chamber having first and second openings,
the second opening of the second chamber for placing
over the clitoris; and
a connection element having a first opening and a
separate second opening thereby forming a straight
channel connecting the single opening of the first
chamber with the first opening of the second chamber;
a drive unit that changes a volume of the first
chamber in such a manner that a stimulating pressure
field is generated in the second chamber via the
connection element; and
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a control device that actuates the drive unit; and a
housing enclosing the pressure field generator, the drive unit,
and the control device; wherein:
the pressure field generated in the second chamber
consists of a pattern of negative and positive pressures
modulated with respect to a reference pressure,
the first chamber is connected with the second
chamber solely by the connection element,
the stimulation device has no valves,
the stimulation device is a portable hand-held device
with a battery,
the connection element is rigid and the first and
second openings of the connection element are aligned to one
another so that a media flow during a compression of the first
chamber is directed to the clitoris through the straight channel
with a nozzle effect, and
the second opening of the connection element is
configured to face the clitoris through the second chamber.
Ex. 1001, col. 14, ll. 16–50 (emphasis added).
F. Evidence
Petitioner relies on the following references:
Guan, CN2153351Y, issued December 11, 1993 (Ex. 1004)
(“Guan”).
Hovland et al., US 6,964,643 B2, issued November 15, 2005
(Ex. 1005) (“Hovland”).
Gloth, US 5,813,973, issued September 29, 1998 (Ex. 1007)
(“Gloth”).
Makower et al., US 8,579,837 B1, issued November 12, 2013
(Ex. 1006) (“Makower”).
Petitioner also relies on the declarations of Michael R. Prisco, P.E.,
Ph.D., Exs. 1002 and 1018, and the declaration of Richard Meyst.
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Ex. 1020. Patent Owner relies on the declarations of Morton Olgaard
Jensen, Ph.D., Dr. Med. (Exs. 2001 and 2036) and Debra Herbenick,
Ph.D. (Exs. 2004 and 2038).

G. Prior Art and Asserted Grounds
Petitioner asserts that claims 1–6 would have been unpatentable on the
following grounds:
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1, 2, 4–6 1032 Guan, Hovland
3 103 Guan, Hovland, Gloth
5, 6 103 Guan, Hovland, Makower

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) (2018); In re Magnum Oil Tools
Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016).
2. 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 The provisions of the Leahy-Smith America Invents Act (“AIA”) regarding
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 ’851 patent has an effective filing date
of July 22, 2014. Therefore, the post-AIA version of 35 U.S.C. § 103 applies
to this Decision.

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(2) any differences between the claimed subject matter and the prior art, (3)
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 (alteration in original).
Focusing on use of the claimed stimulation device specifically for
erogenous zones, 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. 2. Patent Owner supports this contention by citing to the
Technical Field discussion in the Specification where it states that the field
relates to “a stimulation device for erogenous zones, in particular for the
clitoris.” Id. (citing Ex. 1001, col. 1, ll. 12–13). Patent Owner also contends
that the claims support this definition as the claims recite a stimulation
device and system that directs “media flow . . . to the clitoris” with an
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opening “configured to face the clitoris.” Id. (quoting Ex. 1001, claims 1–6)
(alteration in original).
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 ’851 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 USPQ 2d 1393, 1394
(BPAI 1988). Although the device disclosed in the ’851 patent is a sexual
stimulation device, the scientific and engineering principles applicable to the
claimed device and method involve mechanical engineering and fluid flow
and are not necessarily specific to the application of such a device.
As we previously noted in our Decision on Institution:
Although 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 on Institution.
However, the findings and conclusions set forth below would have been the
same had we instead adopted Patent Owner’s proposed definition.
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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))).
In our Decision on Institution, we declined to construe any term
because the parties contended that no construction was needed at that stage.
Dec. 8. Petitioner now proposes an express construction for the term
“reference pressure,” arguing that Patent Owner has improperly defined
reference pressure to be only the existing ambient pressure in the device
prior to use. Reply 8. Petitioner contends that this construction is improper
as it is limited to a specific embodiment of the ’851 patent and ignores the
broader teachings of the ’851 patent. Id. at 8–9.
Petitioner now contends that the proper construction of the term
reference pressure should be “a ‘given’ pressure around which higher and
lower pressures are generated for stimulating the body, which may be
determined prior to or after application of the device to the body.” Reply, 9
(emphasis omitted). Petitioner explains:
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The specification describes atmospheric pressure as
exemplary, not required. See Ex. 1001, 4:20–25, 12:51–53;
Ex. 1018 ¶¶11–18; Ex. 1020 ¶¶36–42. Indeed, the ’851
teaches that “negative-pressure…is preferably less than the
usual systolic blood pressure in the blood vessels of body part
11.” Ex. 1001, 9:38–46 (emphasis added), 1:62–65.
Accordingly, setting a “negative” pressure that is above
systolic pressure–which is indisputably higher than ambient
pressure–would require a reference pressure that is also above
systolic pressure, and accordingly, above ambient pressure.
Ex. 1018 ¶¶14–15; Ex. 1020 ¶¶43–46; Ex. 1049; Ex. 1017
¶88.
Reply 8–9.
Petitioner supports this proposed construction with the testimony of
Messrs. Prisco and Meyst as well as citations to portions of the ’851 patent.
Id. (citing Ex. 1018 ¶¶ 17–18; Ex. 1020 ¶ 46; Ex. 1001, col. 4, ll. 20–25).
Patent Owner responds that both Patent Owner and Petitioner initially
applied the same definition of “reference pressure” as the ambient pressure
in the device prior to use. Sur-Reply 2. Patent Owner contends that
Petitioner’s newly proposed construction here is improper and is not
supported by the ’851 patent. Id. at 2–5.
We have considered the arguments advanced by the parties and the
evidence of record, and conclude that the original construction used by the
parties was proper. Contrary to Petitioner’s contention, the construction set
forth in our Institution Decision is not limited to a single example, but is
consistent with the overall teachings of the Specification of the ’851 patent.
See, e.g., Ex. 1001, col. 4, ll. 20–25, col. 12, ll. 51–53, Fig. 14. Also, the
construction originally used by the parties is not limited to atmospheric
pressure, but refers generally to the prevailing pressure in the device before
it is applied to the body, i.e., the ambient pressure, as described in the
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Specification of the ’851 patent. See Pet. 5–6 (stating “the reference pressure
is the existing ambient pressure prior to placing the stimulation device on the
region of skin to be stimulated”); Ex. 1002 ¶ 28 (same); Prelim. Resp. 5
(stating “[t]he reference pressure is usually the existing ambient pressure in
relation to the stimulation device at the beginning of use (i.e., prior to
placing the device on the area to be stimulated [Ex. 1001], 4:20–25)”). This
“ambient pressure” as described in the Specification of the ’851 patent that
both parties referenced refers to the pressure within the device regardless of
the environment in which it is used. For instance, the Specification of the
’851 patent lists additional environments for use of the claimed device to
include “a liquid medium, such as water or commercially available
lubricant.” Id. at col. 4, ll. 9–19.
Even if agree with Petitioner that the proposed new construction is in
response to arguments raised by Dr. Jensen, Petitioner’s reliance on the
teachings with regard to systolic pressure does not support its position that
the “reference pressure” may not be the prevailing pressure or ambient
pressure in the device before it is applied to the body. The entire paragraph
regarding systolic pressure, which relates to Figure 5 of the ’851 patent,
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.
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Ex. 1001, col. 9, ll. 38–46. It is clear that, when read in context, the
reference pressure referred to in this paragraph is the prevailing pressure in
the device.
Based on the foregoing, we construe 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.”
D. Obviousness Based on Guan Combined with Hovland
Petitioner contends that the subject matter of claims 1, 2, and 4–6
would have been obvious to one of ordinary skill in the art at the time the
invention was made over Guan combined with Hovland. Pet. 23.
1. Guan
Guan discloses a health massager which generates pulsating air
pressure to stimulate meridian points for therapeutic purposes. Ex. 1004, 3.
Guan teaches the contraction of an air bag to produce the pulsating air
pressure. Id.
2. Hovland
Hovland discloses an electrically-operated stimulation device which
can be used to stimulate various body parts including the clitoris. Ex. 1005,
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 Hovland as
Guan is non-analogous art. Resp. 40–42.
“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. 40. 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 10. Petitioner also contends that Patent Owner’s contention that the
device described in the ’851 patent is limited to stimulating erogenous zones
is contradicted by the teachings of the ’851 patent and by Patent Owner’s
experts. Id. at 11.
Patent Owner responds by contending that the presence of acupressure
points in the genital region does not render Guan relevant prior art.
Sur-Reply 16–17. 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. 2038 ¶ 91; Ex. 1016, 191–194 (first Herbenick deposition); Ex. 1023, 97
(second Herbenick deposition)).
Patent Owner also argues that Petitioner’s reliance on the location of
meridians in the perineum or genitals is misplaced. Sur-Reply, 17. Patent
Owner contends that treatment for sexual dysfunction is different than
sexual stimulation and that they entail different approaches. Id. Patent
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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.
Finally, Patent Owner contends that while the Specification of the
’851 patent may include a reference to stimulating other body parts, the
challenged claims are specifically limited to stimulating the clitoris. Id. at
18. Patent Owner contends that Guan is directed to treatment of various
ailments and is not relevant to sexual stimulation of erogenous zones. 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. 1004, 1; Ex. 1002 ¶ 70. Although we agree
with Patent Owner that the claims are directed to a device for stimulation of
the clitoris, the ’851 patent teaches its general applicability to stimulating a
body part. Ex. 1001, col. 8, ll. 60–65. Patent Owner’s description of the field
of endeavor as sex toys is too narrow in light of the breadth of the teachings
of the ’851 patent of stimulating a body part. We find that both Guan and the
’851 patent relate to the same field of endeavor of stimulating a body part.
See Ex. 1020 ¶¶ 68–71.
Moreover, the Specification of the ’851 patent teaches that the
disclosed device stimulates the body part in an indirect way. Ex. 1001, col.
2, ll. 60–62; col. 4, ll. 26–29. Guan also massages a body part indirectly. See
Ex. 1004, 3. Thus, both the present invention and Guan address similar
problems, and Guan is considered analogous art.
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4. Analysis of Claim 1
Petitioner contends that the combination of Guan and Hovland teaches
each of the limitations recited in claim 1. Pet. 23–52. 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
Hovland, we will concentrate our analysis on only the limitation that
Petitioner has failed to show is taught by the combination, which is the
requirement for “the pressure field generated in the second chamber consists
of a pattern of negative and positive pressure modulated with respect to a
reference pressure.”
Petitioner contends that Guan teaches this limitation. Pet. 38–43.
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 ¶¶ 90–
91). 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 this contention, Petitioner initially relies on the
testimony of Dr. Prisco where he compares the operation of Guan with an
embodiment disclosed in the ’851 patent. Pet., 38–43. In his testimony,
Dr. Prisco testifies that the ’851 patent discloses an embodiment that
operates in the same manner as a piston pump. Ex. 1002 ¶ 90. Dr. Prisco
then testifies that the device in Guan operates in the same manner as the
piston pump disclosed in the ’851 patent, and therefore it modulates between
positive and negative pressure as required by the claims. Id. ¶¶ 91–92.
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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 are not
supported by the limited disclosure in Guan. Id. at 31–33.
Patent Owner supports these arguments with the testimony of
Dr. Jensen who testified:
It is worth noting that 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. 2036 ¶ 94. Dr. Jensen goes on to note that Dr. Prisco’s analysis of Guan
is not supported by the teachings of Guan, but is instead based on
assumptions using information gleaned solely from the ’851 patent in an
inappropriate hindsight analysis. Id. ¶ 93 (“Dr. Prisco’s arguments that Guan
teaches or suggests this limitation of claim 1 of the ’851 Patent appear to be
guided solely by having read the ’851 Patent first and then improperly
applying hindsight to reconstruct Guan.”).
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.
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Patent Owner contends that Petitioner’s analysis of Guan improperly
uses the ’851 patent as a road map. Resp. 37–41.
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 4–5. 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 6.
For the first time, Petitioner advances the argument in its Reply that if
Guan alone does not teach modulation between positive and negative
pressure, this element is taught by Hovland.3 Reply 12. Petitioner points to
the following paragraph in Hovland as supporting its contention that
Hovland teaches modulation between positive and negative pressure:
According to other 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. Petitioner contends that one skilled in the art
would have interpreted this passage as referring to modulation between the
effects recited. Reply 13–14.
Patent Owner responds that the teachings of Guan do not support
Petitioner’s analysis and that Guan is limited to producing only positive

3 Petitioner contends that Patent Owner “opened the door” to this argument
by asserting that Hovland does not tech modulation of pressures in its
Response. Reply 12.
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pressures. Sur-Reply 6–11. With respect to Hovland, Patent Owner contends
that Petitioner is improperly offering a new grounds of unpatentability in
Petitioner’s Reply. Id. at 1, 11–12. Patent Owner also contends that Hovland
does not teach modulation between positive and negative pressures. Id. at
11–16.
We have considered the arguments presented by the parties and the
evidence of record and conclude that Petitioner has not demonstrated that
Guan teaches or suggests the claim element “the pressure field generated in
the second chamber consists of a pattern of negative and positive pressure
modulated with respect to a reference pressure.”
Petitioner’s arguments with respect to Guan creating a positive and
negative pressure with respect to a reference pressure are based on the bag in
Guan starting in an intermediate positon. Reply 5 (citing Ex. 1018 ¶¶ 30–34
and Ex. 1020 ¶¶ 50–61); see Ex. 1020 ¶ 54–57. Guan, however, is silent
with respect to the starting position of the airbag. See Ex. 1011. Moreover,
Dr. Prisco testified:
A person of skill in the art would also have understood that the
depicted position in Guan’s would not necessarily be the starting
position when the device is placed on the body and powered on.
Ex. 1004. Guan does not provide a mechanism or teaching for
returning the air bag to the depicted position prior or after use.
Ex. 1018 ¶ 32; see also Ex. 1020 ¶ 54 (absent a reverse polarity, there is no
magnetic force to return the magnet to the starting position).
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
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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.
While Dr. Prisco and Mr. Meyst based their opinions on the air bag of
Guan being in an intermediate position, as Dr. Prisco testified, there is no
mechanism to return the bag to that position for each use. Ex. 1018 ¶ 32.
Thus the intermediate positon of the air bag is not a natural result that
necessarily flows from the use of the bag as described in Guan.
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 6. We are not persuaded by this
argument. The discussion of cupping in Guan appears as part of a discussion
of prior art solutions. Ex. 1004, 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.4 Moreover, even if Guan’s device could be used for cupping,
Petitioner has not pointed to any reasoning or teaching that would have led
one skilled in the art to combine cupping with acupressure as used in Guan’s
device. See Reply 6.
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 3. 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

4 Cupping is a traditional Chinese medical therapy that involves the
application of negative pressure for therapeutic purposes. Ex. 1033, 8 (Liu
alternative medicine article).
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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.
Turning to Petitioner’s argument with respect to Hovland, we agree
with Patent Owner that this represents a new argument that is not properly
raised on Reply. Sur-Reply 1. As we noted in our Decision on Institution, in
the Petition, “Petitioner does not point to any teaching in Hovland regarding
the modulation of positive and negative pressure relative to a reference
pressure. See Pet. 38–43.” Dec. 13. The argument that Hovland supplies the
necessary teaching of modulation of positive and negative pressures is a new
theory advanced in Petitioner’s reply.
Petitioner contends that Patent Owner “opened the door” for it to
assert Hovland teaches modulation of pressures by contending that Hovland
does not tech modulation between positive and negative pressures. Reply 12.
We are not persuaded. While Patent Owner made the argument, we do not
find that it was sufficient to permit Petitioner to introduce a new theory of
unpatentability in its Reply. As the Supreme Court has found, it is the
Petition that defines the scope of inter partes review. SAS Institute, Inc. v.
Iancu, 138 S. Ct. 1348, 1356 (2018); see Wasica Fin. GmbH v. Cont’l Auto.
Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017) (rejecting petitioner’s
attempt to cure a petition’s deficiencies in reply, noting the “obligation for
petitioners to make their case in their petition”); PTAB Consolidated Trial
Practice Guide 74 (November 2019)5 (“[A] reply or sur-reply that raises a
new issue or belatedly presents evidence may not be considered.”).

5 The Consolidated Trial Practice Guide can be found at
https://www.uspto.gov/TrialPracticeGuideConsolidated

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The case cited by Petitioner in support of its argument does not
require a different result. In Belden, the issue before the court was whether
the Board properly denied patent owner’s motion to exclude the reply
declaration of petitioner’s expert. Belden Inc. v. Ber-Tek LLC, 805 F.3d
1064, 1078 (Fed. Cir. 2015). The Board declined to exclude the declaration,
concluding that the declaration responded to patent owner’s expert
declaration and patent owner’s response to the petition. Id. Our reviewing
court determined that the Board’s decision was not in error. Id. The court
found that the reply declaration of petitioner’s expert responded only to
arguments made in patent owner’s response and by patent owner’s expert.
Id.
Unlike the situation in Belden, Petitioner here does not merely seek to
introduce evidence to rebut positions taken by Patent Owner, but instead
seeks to introduce an entirely new theory on unpatentability. This is not
permitted.
Moreover, even if we were to permit Petitioner to introduce a new
argument based on Hovland, we do not find that argument persuasive.
Petitioner contends that, to the extent the element of modulated
positive and negative pressure is not taught by Guan, that element is taught
by Hovland. See Reply. 12–15.
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

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Hovland can modulate both positive and negative pressures as required by
claim 1. Id. 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. Sur-Reply
12. 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 13.
We have considered the arguments advanced by the parties and the
evidence of record and conclude that Patent Owner has the more persuasive
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. Sur-Reply 13. This interpretation is
consistent with the overall teachings of Hovland, which describe modulation
of the vacuum or negative pressure effect. For example, Hovland teaches the
use of a vacuum modulator to vary the suction pressure applied by the
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 the use of the term “and/or” as it appears in
Hovland, calls for the device to create both effects. Reply 14–15; Ex. 1018
¶¶ 53–55.
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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5. 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 objective indicia evidence we
must consider, if presented, 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.” 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.
a) 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 five of its commercial products, the
Womanizer® Classic, Premium, Starlet, Liberty, and Pro, “are covered by
the challenged claims.” Resp. 8. In support of this contention Patent Owner
relies on the testimony of its experts Drs. Jensen and Herbenick. Id. at 8–14
(citing Exs. 2036 and 2038).6
Both Dr. Herbenick and Dr. Jensen reviewed the Womanizer® Classic
and concluded that the device was coextensive with at least claim 1 of the
’851 patent. Ex. 2036 ¶ 46; Ex. 2038 ¶ 36. Dr. Herbenick prepared a detailed
claim chart tracking each element of the independent claims to specific
components of the Womanizer® Classic, concluding that the device contains
each of the structural elements recited in the independent claims. Ex. 2038
¶¶ 37–52; Ex. 2041. Dr. Jensen reviewed the device and Dr. Herbenick’s
claim charts and also concluded that all of the structural elements are present
in the device. Ex. 2036 ¶ 46–51.
Dr. Jensen also conducted an experiment to determine whether the
Womanizer® Classic produced modulated positive and negative pressures
with respect to a reference pressure. Ex. 2036 ¶¶ 48–49. The following
images from Dr. Jensen’s declaration shows the equipment used to test the
pressure of the Womanizer® Classic, as well as the pressure graph generated
as a result of the tests:

6 As Dr. Herbenick has testified, the Womanizer® Classic, Premium, Starlet,
Liberty, and Pro differ only in style features with the structure and
mechanics of the devices being the same. Ex. 2038 ¶ 35. For this reason,
Dr. Herbenick and Jensen focused their analyses only on the Womanizer®
Classic. Ex. 2036 ¶ 45; Ex. 2038 ¶ 35.
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Figures from Ex. 2036 ¶ 48 showing equipment set up used by Dr. Jensen.

Figure from Ex. 2036 ¶ 48 showing pressure recorded in the Womanizer®
Classic evaluated by Dr. Jensen.

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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®
Classic, Dr. Jensen concludes that the commercial devices meet the
limitations calling for modulated positive and negative pressures with
respect to a reference pressure. Id. ¶¶ 48–49.
Petitioner contends that Patent Owner is attempting to mislead the
board by alleging that there are no relevant technical differences between the
various commercial products where, in fact, there are. Reply 21. Petitioner
also contends that Patent Owner has failed to establish a nexus between the
commercial products and the challenged claims. Reply 22. 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
testimony. Id. at 23.
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. Reply 21–23. 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. at 23–24.
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 ’851 patent and its commercial products. The
testimony of both Dr. Herbenick and Dr. Jensen demonstrate that all of the
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elements of the claims are present in the Womanizer® Classic, Premium,
Starlet, Liberty, and Pro products and that the products are essentially the
claimed inventions. Ex. 2036 ¶¶ 45–51; Ex. 2038 ¶¶ 35–52.
Petitioner contends that the presence of additional, unclaimed features
precludes a presumption of a nexus between the commercial embodiments
and the claims of the ’851 patent. Reply 23. 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
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.
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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, we do not discern any evidence to suggest that
these unclaimed features are critical to the products and impact the products’
functionality. See Reply 23. 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 id. at 22; Ex. 1023, 116–121.
Petitioner also contends that Patent Owner’s evidence that the
commercial products are coextensive with the claims of the patent is
unreliable. Reply 23. Petitioner contends that Dr. Herbenick testimony
regarding the Womanizer® Classic that Dr. Herbenick did not actually
observe the connection element. 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 arguments
unpersuasive.
We are not convinced that Dr. Herbenick has not established that there
is a connection element as required by the challenged claims in the
commercial device. In her Declaration, Dr. Herbenick specifically identified
item 13 in the photos below as the connection element. Ex. 2038 ¶ 51.
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Figure from Ex. 2038 ¶ 51 showing the inner and outer chambers of the
Womanizer® Classic device.

Dr. Herbenick unequivocally testified that element 13 in the photograph is
the connection element. Ex. 1016, 82. In addition, Dr. Jensen also testified
that a connection element is present in the commercial embodiment.
Ex. 2036 ¶¶ 46–47, 51.
We are similarly unpersauded by Petitioner’s critique of Dr. Jensen’s
testing methodology. In particular, Petitioner and Dr. Prisco and Mr. Meyst
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
¶¶ 82–94; Ex. 1020 ¶¶ 72–76. Petitioner contends that this technique is
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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 ¶ 84. Dr. Prisco offers no
explanation why this might be 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 . . . .”) (alteration in
original); see 37 C.F.R. § 42.65 (Expert testimony that does not disclose
underlying facts or data is entitled to little weight.).
Mr. Meyst also testified that he had issues with how Dr. Jensen
conducted his experiments. Ex. 1020 ¶¶ 72–76. 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 modulate 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 than
atmospheric pressure. Ex. 1018 ¶¶ 84–90. 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
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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 applied to the body.
Petitioner does not dispute that the data produced by Dr. Jensen shows
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.
Based on the foregoing we conclude that Patent Owner has
established a nexus between the Womanizer® devices and the challenged
claims of the ’851 patent.
b) 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. 71. 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. Patent Owner also points to
its sales data for the Womanizer® products. Id.
Petitioner contends that Dr. Herbenick’s testimony should be given
little weight as Patent Owner did not produce evidence relating to market
share, sales expectations or other evidence showing the comparative success
of the Womanizer® devices with other products. 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 on the record before us.
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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.7 In re Applied Materials, Inc.,
692 F.3d 1289, 1299 (Fed Cir. 2012). In the present case Patent Owner has
not offered any testimony regarding the market share for the relevant
products. See Ex. 2038 ¶¶ 53–54.
Absent 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.
c) 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
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. 71 (citing Ex. 2038 ¶¶ 55–57). 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. 72. Citing the testimony of Dr. Herbenick, Patent Owner
contends that the Womanizer® products satisfied this need. Id. at 71–72
(citing Ex. 2038 ¶¶ 55–57).

7 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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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 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.
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 24.
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 those women experienced one or more side effects
including genital numbness, pain, irritation, inflammation/swelling, tears or
cuts. Ex. 2038 ¶ 56 (citing Ex. 2011, 1861–63, Table 5). Dr. Herbenick
testified that these injuries resulted in the need for a sexual stimulation
device that “met the need for sexual stimulation devices that facilitate
orgasm but without physically coming into contact with the clitoris.” See id.
¶ 57. 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 my
research, published in a 2009 issue of the Journal of Sexual
Medicine, had found that physical contact has caused numbness
or even tears or cuts in a subset of female vibrator users.
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Id. Dr. Herbenick also testified that the prior art devices failed to meet this
need. Id. ¶ 58.
Petitioner contends that indirect stimulation devices were known in
the art. Reply 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
they 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 stimulation devices. 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 that the Womanizer® products fulfill the 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 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 that have
fewer detrimental side effects, we credit Dr. Herbenick’s extensive
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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 2010. Ex. 2038
¶¶ 7, 12, 13, 16, 55–59. Petitioner did not offer any expert with a similar
expertise to rebut Dr. Herbenick’s testimony.
d) 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. 72. In support of
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. 2038 ¶¶ 58–61.
Petitioner does not address Patent Owner’s argument or evidence. See
Reply 22–27.
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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. 2038 ¶¶ 60–62.
Dr. Herbenick testified that each prior device of which she was aware was
limited to “either direct contact (such as a vibrator or flicking) or was limited
to providing suction.” Id. ¶ 62. Neither of these approaches solved the issue
of clitoral discomfort or numbness. See id.
e) 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. 73 (citing Ex. 2038 ¶¶ 63–67).
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 27 (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
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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 includes 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. 2018, 78. Another expert is Vanessa
Marin, a licensed psychotherapist specializing in sex therapy, who reviewed
the product and expressed skepticism about it. Ex. 2016, 124–128. These
reviews in addition to the testimony of Dr. Herbenick show industry
skepticism about the Womanizer® products. Ex. 2038 ¶¶ 63–67.
f) 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).
Patent Owner contends that, notwithstanding the industry skepticism
discussed above, the industry has also praised the Womanizer® products
extensively. Resp. 73. Patent Owner contends that reviews of the
Womanizer® products have described them as “innovative, unique, and [in]
other similar terms.” Id. at 73–74 (citing Ex. 2038 ¶ 68). Patent Owner also
contends that the Womanizer® has been honored with many awards. Id. at
75.
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Petitioner has not presented any arguments in response to Patent
Owner’s showing. See Reply 21–27.
We find that Patent Owner has presented sufficient evidence showing
praise in the industry favoring a finding of non-obviousness. As
Dr. Herbenick testified,
[t]he Womanizer has been honored with many awards,
several of them recognizing the entire brand or product line. As
examples, the Womanizer W-100 was named the Most
Innovative Female Product at the ADULTEX Awards on May 3,
2015. On May 30, 2015, the Womanizer was named Best New
Female Product by the ETO Awards. In January 2016, the
Womanizer W-100 was named Outstanding Product for Women
at the Adult Video News (AVN) O Awards hosted at the AVN
Novelty Expo in Las Vegas, Nevada. The Womanizer was also
named Product of the Year in each of 2015 and 2016, as well as
Product Line of the Year in 2017 by the EROTIX Awards.
Ex. 2038 ¶ 74 (footnotes omitted, citing Ex. 2044, 1, 6, 13, 17, 13, and 30).
In addition, the Womanizer® products have received praise by both sex toy
retailers and consumers. Ex. 2038 ¶¶ 68–75.
g) 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).
Patent Owner contends that Petitioner and others have copied the
Womanizer® products and that this copying supports a finding on non-
obviousness. Resp. 75–80. In support of this contention Patent Owner points
to Petitioner’s statement that it would stop selling devices that violated
Patent Owner’s German equivalent of the ’851 patent as well as a decision
of a German court that a later version of Petitioner’s product infringed that
patent. Id. at 75–77. Patent Owner also points to a statement submitted by
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Petitioner in an unfair competition lawsuit where a store owner stated that
Petitioner had “ripped off the technology of Womanizer.” Id. at 77. Patent
Owner also cites to various product reviews comparing Petitioner’s products
to Patent Owner’s. Id. at 77–79. Patent Owner also cites to reviews of other
products which compare the products to the Womanizer. Id. at 79–80.
Petitioner contends that Patent Owner’s evidence of copying is
insufficient as it comprises conclusory statements based on undisclosed
testing and data. Reply 25. With respect to the decision of the German court,
Petitioner contends that this is not evidence of copying as there is no
evidence that Petitioner or anyone else “changed any designs to copy the
’851 after learning of the patent.” Id. at 25–26.
Patent Owner responds by again pointing to Petitioner’s statement
regarding infringing the German equivalent of the ’851 patent. Sur-Reply
23–24. Patent Owner contends that Petitioner has offered only attorney
argument that does not rebut the evidence of copying. Id.
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 a finding of non-obviousness. Patent Owner
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first marketed its Womanizer product in 2014. Ex. 2038 ¶ 77. Petitioner
produced its first Satisfyer product just over a year later. Id. Petitioner
acknowledged that this device violated Patent Owner’s “technical property
rights” and withdrew the product from the market. Id. ¶ 78; Ex. 2045
(Novoluto press release).
Petitioner then launched a second version of the product which
Petitioner described as offering “pressure wave stimulation and contactless
clitoral stimulation.” Ex. 2038 ¶ 79; Ex. 2019. Petitioner also describes its
Satisfyer products as providing “a touch-free climax” and offering a “rapid
change between suction and pressure.” Ex. 2038 ¶ 83; Ex. 2021. Patent
Owner has also introduced evidence that shows that Petitioner’s products are
substantially similar to the Womanizer products. Ex. 2038 ¶¶ 82–83, 86–87;
see, e.g., Ex. 2016, 102–105; Ex. 2020. This demonstrates that Petitioner had
access to the Womanizer products and produced products substantially
similar to the patented product.
Patent Owner has also introduced persuasive evidence that other
manufacturers have copied the Womanizer products. Ex. 2038 ¶¶ 84–85, 88;
see, e.g., Exs. 2046–2049. One example of a device sold by other
manufacturers that copies the claimed invention is the Blowfish clitoral
stimulator which was described as mimicking the technology of the
Womanizer. Ex. 2049; Ex. 2038 ¶ 84.
Given this evidence of the similarity of the competitive products to
the Womanizer® products and Petitioner’s failure to offer any persuasive
evidence in rebuttal, we find that Patent Owner has presented persuasive
evidence of copying to support a conclusion of non-obviousness.
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h) 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, several types of objective
indicia evidence in the record weigh in favor of a determination that the
challenged claims are non-obviousness.
6. The Remaining Claims
All of the remaining claims challenged in Ground 1 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 Guan
combined with Hovland and that Patent Owner has presented persuasive
evidence regarding objective indicia of non-obviousness.
7. Conclusion
From the foregoing analysis, and weighing all of the evidence and
arguments presented by both sides, we conclude that Petitioner has not
demonstrated by a preponderance of the evidence that the subject matter of
1, 2, and 4–6 would have been obvious to one of ordinary skill in the art
over Guan combined with Hovland.
E. Grounds 2 and 3
The remaining grounds rely on the combination of Guan and Hovland
as advanced in Ground 1. See Pet. 64–72. Petitioner does not point to nor do
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we discern any teaching in Gloth or Makower that remedies the deficiencies
of Guan and Hovland discussed above. See id. Thus, for the reasons stated
above for Ground 1, we find that Petitioner has not demonstrated that claims
3, 5, and 6 are unpatentable as obvious.
III. PETITIONER’S MOTION TO EXCLUDE
Petitioner has moved to exclude Patent Owner’s two expert
declarations (Exhibits 2036 and 2038), as well as Exhibit 2048. Paper 40
(“MTE”). For the reasons set forth below, Petitioner’s Motion is denied.
A. Exhibit 2038 — 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 2–5. Second,
Petitioner contends that Patent Owner failed to produce all documents relied
upon by Dr. Herbenick in rendering her opinions. Id. at 6–9. 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 9–13. Fourth, Petitioner contends
that Dr. Herbenick is not qualified to testify as a technical expert. Id. at 15.
Finally, Petitioner contends that we should strike Dr. Herbenick’s testimony
as she did not disclose her work as a witness in other proceedings. Paper 43,
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
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information relating to the experiments that produced the graph discussed in
paragraph 47 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 47 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 is 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 drafts of
Dr. Jensen’s declaration that Dr. Herbenick reviewed in connection with her
declaration and documents relating to the differences between the various
Womanizer products. MTE 5–8. Petitioner also points to Dr. Herbenick’s
failure to disclose the fact that she has testified for Patent Owner in other
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matters as evidence that Patent Owner has withheld other information and
documents. MTE 8–9. We address each of these issues in turn.8
a) 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) that would be required to be produced. Paper 41, 6–7 (“MTE
Resp.”)
Petitioner contends that Patent Owner failed to produce documents
relating to the differences between the various Womanizer products and that
those difference show that there are technical differences between the
products. MTE 7–8. Petitioner contends that this contradicts the testimony of
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 various Womanizer
products were different but that the difference did not affect their analyses.
Ex. 2036 ¶ 41; Ex. 2038 ¶ 35. Moreover, the “technical difference”
identified by Petitioner relates to lights on the device, a feature that does not
appear to be related to the issue of whether the devices embody the claimed
inventions. MTE 7.

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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b) Dr. Herbenick’s Alleged 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 985, 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.”).
3. 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
the depositions Dr. Herbenick and Dr. Jensen. MTE 9–13. 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.
10–12. Patent Owner also argues that even if the objections were improper,
exclusion of the expert’s declarations is not the proper remedy. Id. at 12.
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
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1022 and 1023 are transcripts from IPR2019-01444 and Exhibits 1053 and
1054 are from IPR2020-00007.
With respect to this proceeding, Petitioner has identified only one
possible instance of a speaking objection. 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. The question related to the teachings of the Taylor
references which are not at issue in this proceeding. Ex. 1016, 183.
Given the single alleged speaking objection and the fact that the
affected testimony is not relevant to our decision, we decline to exclude Dr.
Herbenick’s testimony.
4. Dr. Herbenick’s Expertise
Petitioner contends that Dr. Herbenick lacks the relevant technical
expertise to testify about the validity of the ’851 patent or whether Patent
Owner’s commercial products embody the claims of the ’851 patent.
MTE 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, she has extensive experience evaluating and designing
sex toys. See, e.g., Ex. 2038 ¶¶ 55–59 (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. See SEB S.A. v.
Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (noting that
there is no requirement of a perfect match between the expert’s experience
and the relevant field).
On the issue of validity, most of Dr. Herbenick’s testimony has been
with respect to objective indicia, an issue about which we find
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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. 2038 ¶¶ 35–52.
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 a sufficient background to provide opinion testimony
regarding various components of the devices. See Ex. 2038 ¶¶ 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 alleged lack of understanding regarding how the prior art
operated is irrelevant to the question of whether her testimony should be
excluded.
5. 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 2036 — 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 2–4.
Second, Petitioner contends that Patent Owner did not produce all
documents Dr. Jensen relied upon in reaching his opinions. Id. at 6–9.
Finally, Petitioner contends that improper conduct by Patent Owner’s
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counsel during the deposition of Dr. Jensen warrants exclusion of
Dr. Jensen’s testimony. Id. at 9–13.
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.
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 at 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., PGR2015-00011, Paper 48 at 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).

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
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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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 6–9. 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 two allegedly improper objections.
MTE 11–12. A review of the testimony reveals that the questions relate to
the definition of the term “sexual pleasure” as it is used in the ’851 patent.
Ex. 1015, 56–58. The term “sexual pleasure” is not in dispute in this
proceeding. We do not believe that two alleged speaking objections about a
term that is not in dispute warrants excluding Dr. Jensen’s declaration.
4. Conclusion
Based on the foregoing we deny Petitioner’s Motion to Exclude as it
relates to Exhibit 2036.
C. Exhibit 2048
Petitioner contends that Exhibit 2048 should be excluded on the
grounds of hearsay and lack of authenticity. MTE 13.
In reaching our decision we did not rely on Exhibit 2048. We
therefore dismiss as moot Petitioner’s motion with respect to Exhibit 2048.
D. Conclusion
For the reasons stated above, we deny Petitioner’s Motion to Exclude
in its entirety.
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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 1–6 of the ’851 patent is unpatentable.
We also deny Petitioner’s Motion to Exclude.
V. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–6 of the ’851 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.

In summary:

Claims 35
U.S.C. §
Reference(s)/Basis Claims
Shown
Unpatentable
Claims
Not shown
Unpatentable
1–2, 4–6 103 Guan, Hovland 1, 2, 4–6
3 103 Guan, Hovland,
Gloth
3
5, 6 103 Guan, Hovland,
Makower
5, 6
Overall
Outcome
1–6
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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 LLP
terry@obwbip.com
margonis@obwbip.com
cooper@obwbip.com
schechter@obwbip.com