Novoluto GmbH

Patent Trials and Appeals Board

Sep 23, 2021

IPR2020-00007 (P.T.A.B. Sep. 23, 2021)

Trials@uspto.gov Paper 41
Tel: 571-272-7822 Entered: September 23, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

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

Case IPR2020-00007
Patent 9,849,061 B2

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

JUDGMENT
Final Written Decision
Determining Challenged Claims Not Unpatentable
35 U.S.C. § 318(a)
Granting Patent Owner’s Motion to Seal and for Entry of a Protective Order
37 C.F.R. §§ 42.14, 42.54
Granting Patent Owner’s Unopposed Motion to
Submit Supplemental Information
37 C.F.R. § 42.123(b)
Denying Petitioner’s Motion to Exclude
37 C.F.R. § 42.64
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I. INTRODUCTION
A. Background and Summary
On October 2, 2019, EIS GmbH (“Petitioner”) filed a Petition (Paper
1, “Pet.”) requesting an inter partes review of claims 1–3, 5, 7, 8, 11, 14, 15,
17–19, and 20–26 (the “challenged claims”) of U.S. Patent No. 9,849,061
B2 (Ex. 1001, “the ’061 patent”). See 35 U.S.C. §§ 311–319. On January 8,
2020, Novoluto GmbH (“Patent Owner”) filed a Preliminary Response to the
Petition. Paper 6 (“Prelim. Resp.”). On April 6, 2020, we denied institution
of an inter partes review. See Paper 8, 2, 30 (“Dec.”).
Petitioner filed a Request for Rehearing of the Decision Denying
Institution of Inter Partes Review of the challenged claims of the ’061
patent. Paper 9, “Req. Reh’g.”1 Upon reconsideration of the arguments and
evidence of record at the time, we found that at least a fact question exists
concerning whether Taylor or Hovland teaches or suggests positive and
negative pressures with respect to a reference pressure, an issue of fact that
we resolved in favor or Petitioner at institution, and instituted inter partes
review on all grounds presented in the Petition. Paper 15, 16–20 (“Reh’g
Dec.” or “Rehearing Decision”); see 37 C.F.R. § 42.108(c) (2020).2 We also

1 Petitioner also sought review of the Decision by the Precedential Opinion
Panel. Ex. 3001. That request was denied on June 16, 2020. Paper 11.
Following denial by the Precedential Opinion Panel, on June 25, 2020,
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 12, 1–2. The
district court action was dismissed following our granting Petitioner’s
Request for Rehearing. Paper 19, 4–5; Paper 21, 2.
2 This Rule has since been amended to delete the requirement that an issue
of fact created by testimonial evidence at the institution stage be viewed in
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vacated the portion of our previous Decision on Institution regarding
construction of “reference pressure” and invited further briefing by the
parties. Id. at 20–21.
Patent Owner filed a Response on December 18, 2020. Papers 23, 24
(“Resp.”). Petitioner filed a Reply on March 12, 2021. Paper 25 (“Reply”).
Patent Owner filed its Sur-Reply on April 23, 2021. Paper 35
(“Sur-Reply”). On May 14, 2021, the parties jointly informed the Board that
no oral hearing was necessary in this case. Paper 37.
This is a Final Written Decision under 35 U.S.C. § 318(a) as to the
patentability of the challenged 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 1–3, 5, 7, 8, 11, 14, 15, 17–
19, and 20–26 are unpatentable. In addition, for the reasons set forth below,
we grant Patent Owner’s Combined Motion to Seal and Motion for a
Protective Order, and we deny Petitioner’s Motion to Exclude Evidence.
See Papers 25, 38.
B. Real Parties in Interest
Petitioner identifies EIS GmbH, EIS Inc., Triple A Import GmbH,
Triple A Marketing GmbH, Triple A Sales GmbH, Triple A Finance GmbH
& Co. KG, and Triple A Internetshops GmbH (formerly known as
“Internetsupport Bielefeld”), as the real parties in interest. Pet. 1; Paper 7, 1;
Paper 12, 1; Paper 21, 1; Paper 31, 1. Patent Owner identifies itself as the
owner of the ’061 patent and WOW Tech International GmbH, Patent

the light most favorable to the petitioner. See 85 Fed. Reg. 79,120, 79,122,
79,129 (Dec. 9, 2020).
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Owner’s corporate parent, which later changed to IntiHealth Ger GmbH, as
the real parties in interest. Paper 4, 2; Paper 13, 2; Paper 14, 2; Paper 19, 2;
Paper 27, 2; Paper 33, 2 (identifying IntiHealth Ger GmbH as the corporate
parent); Paper 36, 2 (same).
C. Related Proceedings
The parties identify two ongoing court proceedings involving the ’061
patent: EIS, Inc. v. IntiHealth Ger GmbH, No. 19-1227 (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.). Pet. 1; Paper 4, 3; Paper 36, 2–3. The parties
also identify U.S. Patent No. 9,937,097 (“the ’097 patent”) that issued from
a continuation application of the ’061 patent, which has been challenged in
IPR2019-01302. Pet. 1; Paper 4, 3. An inter partes review in IPR2019-
01302 has been conducted, and all claims were found not unpatentable. See
EIS GmbH v. Novoluto GmbH, IPR2019-01302, Paper 50, 73 (PTAB
June 14, 2021).
The parties also identify U.S. Patent No. 9,763,851 B2 (“the ’851
patent”) that they assert discloses related subject matter that has been
challenged by Petitioner in IPR2019-01444. See Pet. 2; Paper 4, 3. An inter
partes review in IPR2019-01444 has been conducted, and all claims were
found not unpatentable. See EIS GmbH v. Novoluto, GmbH, IPR2019-
01444, Paper 45, 52 (PTAB Aug. 5, 2021).
Patent Owner also identifies several patent applications pending
before the Office that are related to either the ’097 or ’851 patents. Paper 4,
2–4.

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Patent 9,849,061 B2
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D. The ’061 Patent
The ’061 patent, titled “Stimulation Device Having an Appendage,”
generally relates to a device having a pressure field generating arrangement
with a first chamber connected to a second chamber with an opening for
placing on a body part, and a drive unit that varies the volume of the first
chamber such that a pressure field that serves for stimulation is generated in
the second chamber. Ex. 1001, Abst. The pressure field generating
arrangement is more specifically described as follows.
This embodiment according to the invention, of chambers
in fluidic communication via at least one connection element,
allows simple generation of a pressure field in the second
chamber by changing the volume in the first chamber, this
pressure field being temporarily directed at the area of skin to be
stimulated.

A pressure field, in the context of the invention, is a field
of medium pressures that is variable over time and has temporary
positive pressures and temporary negative pressures, a negative
pressure being a pressure of medium that is below the reference
pressure and a positive pressure being a pressure of medium that
is above the reference pressure. As a result, the medium flows
back and forth in the pressure field according to the invention.
Thus, preferably a (largely) intermittent exchange of said
medium can occur.
Id. at 3:11–25.
The described reference pressure “is usually the atmospheric pressure
acting on the stimulation device that prevails when application begins (i.e.
prior to placing the stimulation device on the area of skin to be stimulated).”
Id. at 3:38–41. In the preferred embodiment that uses air as the medium, the
reference pressure “is the currently prevailing air pressure or normal
pressure.” Id. at 3:41–43.
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The pressure field generating arrangement is described further by
reference to Figures 4 through 6 reproduced below.

Figure 4 depicted above shows:
[T]he pressure field generating arrangement 2 in a first state, with
the second chamber 4 placed on the area of skin or body part 11
to be stimulated. The first state of the pressure field generating
arrangement 2 is characterized by a neutral deflection of the first
chamber 3, i.e. no external force acts on the first chamber 3, for
example from the drive unit. Here, the volume V1 of the first
chamber is the standard volume of this chamber 3.
. . . .
Because it is placed on the body part 11 to be stimulated,
the second chamber 4 forms a chamber that is largely or
completely closed off from the exterior of the pressure field
generating arrangement 2 and whereof the only remaining
connection to the second chamber is via the connection
element 5, wherein the edges of chamber 4 ideally form an air-
tight enclosure with the surface of the body part II. Two
communicating chamber 3 and 4 are created in this way, wherein
a corresponding pressure equalization between the chambers 3
and 4 via the connection element 5 occurs in the event of a
change in volume in one of the chambers 3 or 4.
Id. at 10:1–8, 18–28.
Figure 5 depicted below shows the pressure field generating
arrangement in a second state.
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The second state of the pressure field generating arrangement shown
in Figure 5 above is
[C]haracterized in that a force A acting on the first chamber 3
causes the chamber 3 to expand. To be precise, in this exemplary
embodiment the force A draws the wall 31 of the first chamber 3
in a direction away from the second chamber 4.
This increases the volume V2 in the chamber 3, i.e.
V2>V1. To equalize the difference in pressure created between
the chambers 3 and 4, the medium or air now flows from the
second chamber 4 into the first chamber 3.
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.
Id. at 10:52–67.
Figure 6 depicted below shows the pressure field generating
arrangement in a third state.
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The third state of the pressure field generating arrangement shown in
Figure 6 above is
[C]haracterized in that a force B acting on the first chamber 3
causes a volume reduction or compression in the chamber 3. To
be precise, the direction of the force B is opposed to the direction
of the force A and deforms the wall 31 of the first chamber such
that the resulting volume V3 of the chamber is smaller than the
volume V1. The compression of the chamber 3 causes a positive
pressure in the chamber 3, which is equalized by the medium or
air flow through the connection element 5 in the direction of the
second chamber 4.
Id. at 11:3–15.
This oscillation between positive and negatives pressures in relation to
a reference pressure is touted as superior to previous devices that utilized a
vacuum or negative pressure alone. See id. at 1:53–2:63. The ’061 patent
lists several disadvantages of using negative pressure alone for stimulation.
One disadvantage entails habituation effects that may occur with long-term
continuous use of negative pressures. Negative pressure also has to be
limited by a control valve, and injury may be caused by improper use of the
device or by malfunction where a valve for releasing the negative pressure
does not work properly to release the device from the skin. Id. at 2:51–63.

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E. Challenged Claims
Petitioner challenges claims 1–3, 5, 7, 11, 14, 15, 17–19, and 20–26 of
the ’061 patent. Claims 1, 20, and 21 are the only challenged independent
claims. Challenged claims 2, 3, 5, 7, 11, 14, 15, and 17–19 depend directly
from claim 1, and challenged claims 22 through 26 depend directly from
claim 21. Claim 1 is illustrative and recites with emphasis on the claim
limitation at issue:
1. A stimulation device for erogenous zones, comprising:
at least one pressure field generating arrangement with:
at least one first chamber;
at least one second chamber having at least one opening for
placing on a body part; and
at least one connection element that connects the at least one
first chamber to the at least one second chamber;
a drive unit that varies the volume of the at least one first chamber
such that a stimulating pressure field is generated via the at least one
connection element in the at least one second chamber;
a control device that activates the drive unit; and
an appendage;
wherein the stimulating pressure field generated in the at least one
second chamber comprises a pattern of negative and positive pressures,
modulated []3 with respect to a reference pressure;
wherein the at least one first chamber is connected to the at least one
second chamber solely by the at least one connection element, and

3 Petitioner explains that the word “onto” represented by the empty brackets
in claim 1 was deleted during prosecution, but erroneously included in the
’061 patent. Pet. 37 (citing Ex. 1003, 172). Patent Owner has since received
a Certificate of Correction deleting the word “onto” that was erroneously
included in the claim. See Ex. 2073. Throughout this proceeding, the
parties have treated claim 1 as not including the word “onto.” See, e.g.
Papers 1, 6, 24, 31.
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wherein the appendage is a dildo configured to be inserted into a
vagina.
Ex. 1001, 16:23–45.
F. Prior Art and Asserted Grounds of Unpatentability
Petitioner argues that claims 1–3, 5, 7, 11, 14, 15, 17–19, and 20–26
would have been unpatentable based on the following grounds:
Claim(s) Challenged 35 U.S.C. § References
1–3, 5, 7, 11, 14, 15,
17–19, 21, 23–26 102(a)(1) Taylor
4
1–3, 5, 7, 8, 11, 14,
15, 17–19, 21–26 103 Taylor, Hovland
5
20 103 Taylor, Zipper6
20 103 Taylor, Zipper, Hovland
Petitioner submits the Declarations of Michael R. Prisco, P.E., Ph.D.
and Richard P. Meyst in support of its positions. See Ex. 1002; 1018, 1020.
Patent Owner submits the Declarations of Morten Olgaard Jensen, Ph.D., Dr.
Med, and Debra Herbenick, Ph.D. See Exs. 2001, 2004, 2034, 2035.
II. ANALYSIS
A. Principles of Law
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

4 Taylor, U.S. Patent No. 5,725,473, issued Mar. 10, 1998 (Ex. 1004,
“Taylor”).
5 Hovland et al., U.S. Patent No. 6,964,643 B2, issued Nov. 15, 2005
(Ex. 1006, “Hovland”).
6 Zipper, US 2013/0261385 A1, published Oct. 3, 2013 (Ex. 1007,
“Zipper”).
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shifts to the patentee. See 35 U.S.C. § 316(e); in re Magnum Oil Tools Int’l,
Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (citing Dynamic Drinkware, LLC
v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)).
2. Anticipation
To establish anticipation, each and every element in a claim, arranged
as recited in the claim, must be found in a single prior art reference. Net
MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008);
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
2001). “A reference anticipates a claim if it discloses the claimed invention
‘such that a skilled artisan could take its teachings in combination with his
own knowledge of the particular art and be in possession of the invention.’”
In re Graves, 69 F.3d 1147, 1152 (Fed. Cir. 1995) (internal citation and
emphasis omitted). Moreover, “it is proper to take into account not only
specific teachings of the reference but also the inferences which one skilled
in the art would reasonably be expected to draw therefrom.” In re Preda,
401 F.2d 825, 826 (CCPA 1968); see Eli Lilly and Co. v. Los Angeles
Biomedical Res. Inst. at Harbor-UCLA Medical Center, 849 F.3d 1073,
1074–75 (Fed. Cir. 2017). “A single prior art reference may anticipate
without disclosing a feature of the claimed invention if such feature is
necessarily present, or inherent, in that reference.” Allergan, Inc. v. Apotex
Inc., 754 F.3d 952, 958 (Fed. Cir. 2014) (citing Schering Corp. v. Geneva
Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003)). “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 disclosed steps; ‘[i]nherency . . . may not be
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established by probabilities or possibilities.’” In re Montgomery, 677 F.3d
1375, 1379–80 (Fed. Cir. 2012) (citations omitted, alterations in original).
3. Obviousness
A patent claim is unpatentable under 35 U.S.C. § 103 if the
differences between the claimed subject matter and the prior art are such
that the claimed invention as a whole would have been obvious before the
effective filing date of the claimed invention to a person having ordinary
skill in the art to which said subject matter pertains (“POSITA”). KSR Int’l
Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). 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) the level of ordinary skill in the
art; and (4) objective evidence of nonobviousness. Graham v. John Deere
Co., 383 U.S. 1, 17–18 (1966). In determining obviousness when all
elements of a claim are found in various pieces of prior art, “the factfinder
must further consider the factual questions of whether a person of ordinary
skill in the art would be motivated to combine those references, and whether
in making that combination, a person of ordinary skill would have had a
reasonable expectation of success.” Dome Patent L.P. v. Lee, 799 F.3d
1372, 1380 (Fed. Cir. 2015); see also WMS Gaming, Inc. v. Int’l Game
Tech., 184 F.3d 1339, 1355 (Fed. Cir. 1999) (“When an obviousness
determination relies on the combination of two or more references, there
must be some suggestion or motivation to combine the references.”). “Both
the suggestion and the expectation of success must be founded in the prior
art, not in the applicant’s disclosure.” In re Dow Chemical Co., 837 F.2d
469, 473 (Fed. Cir. 1988).
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An obviousness analysis “need not seek out precise teachings directed
to the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” KSR, 550 U.S. at 418; see In re Translogic Tech,
Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). In KSR, the Supreme Court also
stated that an invention may be found obvious if trying a course of conduct
would have been obvious to a POSITA:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this leads
to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.
550 U.S. at 421. “KSR affirmed the logical inverse of this statement by
stating that § 103 bars patentability unless ‘the improvement is more than
the predictable use of prior art elements according to their established
functions.’” In re Kubin, 561 F.3d 1351, 1359–60 (Fed. Cir. 2009) (citing
KSR, 550 U.S. at 417).
“[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) (internal 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.
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Cir. 2010) (alterations in original) (quoting In re GPAC Inc., 57 F.3d 1573,
1580 (Fed. Cir. 1995)).
We analyze the asserted grounds of unpatentability in accordance
with the above-stated principles. In making such an analysis, we find that
Petitioner has failed to show by a preponderance of the evidence that any
challenged claims is unpatentable, because for each challenge, Petitioner has
failed to show that all of the limitations of any challenged claim are taught
or suggested by the asserted art. We also found Patent Owner’s evidence of
secondary consideration of non-obviousness persuasive.
B. Level of Ordinary Skill in the Art
We consider the asserted grounds of unpatentability in view of the
understanding of a person of ordinary skill in the art. KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 399 (2007) (stating that obviousness is
determined against the backdrop of the scope and content of the prior art, the
differences between the prior art and the claims at issue, and the level of
ordinary skill in the art). Factual indicators of the level of ordinary skill in
the art include “the various prior art approaches employed, the types of
problems encountered in the art, the rapidity with which innovations are
made, the sophistication of the technology involved, and the educational
background of those actively working in the field.” Jacobson Bros., Inc. v.
U.S., 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co. v.
U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson
Bros.).
In our Decision on Institution, we applied 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,
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and three or more years of experience in fluid mechanics and pump-based
medical or personal use devices,” and 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. 10–11.
Patent Owner renews its argument that in addition to the education
level recited above, a person of ordinary skill in the art would also have “at
least three years’ experience in research, development, or design of devices
that interact with and sexually stimulate the human female vulva,” with
more experience offsetting the requisite amount of education and vice versa.
Resp. 3. Patent Owner concludes that “Petitioner’s proposed POSITA fails
to consider the necessary relevant experience related to female sexual
stimulation.” Id. (citing Ex. 2034 ¶¶ 68–69; Ex. 2035 ¶ 28).
Patent Owner supports this contention by citing to the Technical Field
discussion in the Specification of the ’061 patent where it states that field
relates to “a stimulation device . . . for erogenous zones, in particular for the
clitoris.” Id. (citing Ex. 1001, 1:16–19). Patent Owner also contends that
the language recited in the claims supports this definition. Id.
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 ’061 patent. As Petitioner points out and Patent owner
acknowledges in its discussion of the hypothetical person or ordinary skill in
the art, the claims are not limited to stimulating the human female vulva, but
more generally to “a body part.” See Reply 2; Resp. 3 (citing claims 1–20).
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Thus, Patent Owner’s definition of one of ordinary skill in the art appears to
be too narrow based on the claim language of the ’061 patent. See also Ex.
1001, 10:9–17 (stating the body part to be stimulated includes “all body
parts or erogenous zones (such as the inside of the thighs, lumbar region,
nape of the neck, nipples, etc.) which can be stimulated by means of
medium- or air-pressure massage and/or negative pressure”).
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 ’061 patent is a stimulation device for
erogenous zones, 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, especially
the more narrow focus of Patent Owner’s definition of sexual stimulation of
the human female vulva.
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 [and specifically the human female vulva] is not
needed to define a person of ordinary skill in the art.
Dec. 11.
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 construe claims 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 (2019). Therefore, we construe the challenged
claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d
1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim
terms are given their ordinary and customary meaning, as would be
understood by a person of ordinary skill in the art (“POSITA”), at the time
of the invention, in light of the language of the claims, the specification, and
the prosecution history of record. Id. Only those terms that are in
controversy need be construed and only to the extent necessary to resolve
the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor
Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v.
Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
At this stage of the proceeding, we find that it is only necessary to
construe expressly the term “reference pressure.” Although the parties have
also presented arguments concerning the term “pressure field generating
arrangement,” see Pet. 18–20; Resp. 19–22, 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.7

7 Petitioner presents argument that the term “pressure field generator” should
be construed as a means-plus-function term limited to the following
structure: at least one first chamber, at least one second chamber, and at
least one connection element. Reply 25–26. As we find that it is not
necessary to construe this term to resolve the issues before us, we do not
address these arguments presented by Petitioner.
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Reference Pressure
In our Decision Denying Institution, we construed the term “reference
pressure” to mean “a prevailing pressure within the device prior to placing
the stimulation device on the area of the skin to be stimulated.” Dec. 14. In
our Decision on Rehearing, we vacated this construction because we found
on rehearing that at least a fact question exists concerning whether Taylor
teaches positive and negative pressures with respect to a reference pressure,
which we resolved in favor of Petitioner at the institution stage. Reh’g Dec.
20–21. We invited the parties to provide further briefing concerning how
“reference pressure” should be construed. Id. at 21.
Although Patent Owner agrees with this construction with a slight
modification of “the prevailing pressure ‘acting on’ the device, rather than
‘within’ the device,” see Resp. 22–26, Petitioner contends that we
improperly limited the construction to one example in the Specification, see
Reply 3–4.
In the Petition, Petitioner originally asserted that the “reference
pressure” is “atmospheric pressure.” See Dec. 12–13; Pet. 7, 35, 64, 69;
Ex. 1002 ¶¶ 64, 87. Petitioner presented an alternative construction—
“reference pressure” should mean “given pressure”—for the first time in its
Rehearing Request. See Req. Reh’g 4. In its Request for Rehearing,
Petitioner states that “the plain meaning of ‘reference pressure’ is a ‘given
pressure’ around which higher and lower pressures are generated.” Id.
Petitioner reiterates this position in its Reply stating again that
“reference pressure” should be given its plain meaning, “which is a ‘given’
pressure around which higher and lower pressures are generated for
stimulating the body, which may be determined prior to application or after
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application of the device to the target body part.” Reply 4 (citing Ex. 1018
¶ 18; Ex. 1020 ¶ 51, Ex. 1001, 3:38–41. In support of this construction,
Petitioner points to the discussion in the Specification involving pressures
above and below systolic pressure. Reply 3–4. Petitioner asserts that the
statement in the Specification of the ’061 patent that “negative pressure is
set such that it is preferably lower than the usual systolic blood pressure”
would encompass embodiments where the negative pressure is above
systolic blood pressure, which one of skill in the art would understand is
always above ambient pressure, leading to the conclusion that any reference
pressure in such a scenario would be above ambient pressure. See Reply 3–
4 (quoting Ex. 1001, 10:61–67 (emphasis added) (citing Ex. 1018 ¶¶ 12–18;
Ex. 1020 ¶¶ 43–51; Ex. 1034 ¶ 88; Ex. 1040)); see also Ex. 1001, 3:26–37
(discussing use of the claimed devices with liquid media such as water or
lubricants); Ex. 1018 ¶ 17.
Patent Owner responds that Petitioner is inappropriately presenting a
new argument that was nowhere raised in the Petition or Dr. Prisco’s
Declaration (Ex. 1002). Sur-Reply 5–6. Patent Owner also asserts that
Petitioner’s argument addresses an incorrect construction—that “reference
pressure” is limited to atmospheric pressure. Id. at 5. Patent Owner asserts
that it
has never taken the position that “reference pressure” must be
limited to atmospheric pressure, nor would it, as doing so
would ignore the plain language of the ’061 Patent. The patent
explains the device may be used in various environments,
meaning the prevailing pressure acting on the device prior to
operation (the reference pressure) would have a different value
depending on the environment (e.g.., in a bathtub versus on a
bed). Ex. 1001, 3:26–49. But always, the reference pressure is
that prevailing pressure acting on the device prior to placing the
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device on the area of skin to be stimulated. Id. Petitioner’s
argument that Novoluto’s proffered construction would limit
the term to a single embodiment (Reply 3–4) is baseless and
misleading.
Sur-Reply 6. Patent Owner also notes that the reference pressure is not an
absolute value because the measure for ambient pressure would change
based on location. Id. at 4 (citing Ex. 1001, 3:26–49). Patent Owner points
out that Petitioner’s new argument concerning systolic blood pressure does
not take this into account. Id. at 6.
We have considered the arguments advanced by the parties and the
evidence of record, and conclude that our original construction set forth in
our Decision Denying Institution 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, 3:26–49, 14:49–54, Figure 14. For instance, the Specification of the
’061 patent sets forth that “[t]he reference pressure is usually the
atmospheric pressure acting on the stimulation device that prevails when
application begins (i.e. prior to placing the stimulation device on the area of
skin to be stimulated).” Ex. 1001, 3:38–41.
The construction we adopted is not limited to atmospheric pressure (as
originally 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 ’061 patent. This refers to the prevailing pressure within
the device regardless of the environment in which it is used. For instance,
the Specification of the ’061 patent lists additional environments to include
“a liquid medium, such as water or commercially available lubricant.” Id. at
3:26–28. This is also consistent with the position advanced by Patent Owner
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during prosecution stating that the claimed pattern of negative and positive
pressures was not taught by a device that “purely acts with negative pressure
(i.e., as a vacuum) on the skin.” Ex. 1003, 183.
Even if we consider Petitioner’s shifting claim construction argument,
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, 10:61–11:2. Petitioner’s reading of this description to include a
negative pressure that is set higher than systolic blood pressure is too
strained a reading to support Petitioner’s conclusions. 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, which is
consistent with our original construction.
Based on this analysis, we conclude that the construction of the term
“reference pressure” should be “a prevailing pressure acting on the device
prior to placing the stimulation device on the area of skin to be stimulated.”8

8 We agree with Patent Owner that “acting on” as opposed to “within” is
more consistent with what is described in the Specification of the ’061
patent. See Ex. 1001, 3:38–41.
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D. Anticipation by Taylor
Petitioner asserts that claims 1–3, 5, 7, 11, 14, 15, 17–19, 21, and 23–
26 are anticipated by Taylor. Pet. 3. Petitioner provides an analysis of how
each claim limitation is taught by Taylor. Pet. 20–66. Petitioner relies on
the declaration of Dr. Prisco in support of its positions. See generally
Ex. 1002. We focus our analysis on claims 1 and 21 as they are the only
independent claims at issue in this ground.
Patent Owner asserts that Taylor teaches a cyclical vacuum, and not
modulated negative and positive pressures with respect to a reference
pressure as required by the challenged claims. Resp. 32–49. Patent Owner
relies on the declarations of Morten Olgaard Jensen, Ph.D., Dr. Med, and
Debra Herbenick, Ph.D., in support of its positions. See generally Exs.
2001, 2003, respectively.
For the following reasons, we find that Petitioner has failed to show
by a preponderance of the evidence that any of the challenged claims are
anticipated by Taylor because we agree with Patent Owner that Petitioner
has not sufficiently shown how Taylor teaches “a pattern of negative and
positive pressures, modulated with respect to a reference pressure,” as
required by claims 1–20, or modulating “the pressure field in a pattern of
negative and positive pressures with respect to a reference pressure” as
required by claims 21–26. We begin our analysis of Petitioner’s first
challenge with a description of the pertinent teachings of Taylor.
1. Taylor (Ex. 1004)
Taylor discloses a sexual aid that includes a means for introducing a
vacuum to stimulate the clitoris. Ex. 1004, Abstr. In one embodiment, the
device comprises a suction cup which engages the upper portion of the
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vulva. Id. at 5:28–30. The suction cup is in fluid communication with a
bellows which cyclically introduces a vacuum within the suction cup. Id. at
5:32–38. 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 level 22 mounted
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, 4:52–59. Petitioner’s annotated version of an excerpt of Taylor
Figure 3 is reproduced below. Pet. 14.
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The annotated portion of Figure 3 of Taylor shown above describes a
second embodiment of first stimulator 154 that introduces a vacuum to
stimulate the clitoris using a drive unit, arm, and bellows.
Taylor states:
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
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
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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, 5:28–41.
2. Analysis
Petitioner relies heavily on Taylor’s statement that the suction cup
member 156 sealingly receives the upper portion of the vulva. Pet. 35.
Petitioner asserts that when this seal is engaged, the cyclical vacuum
oscillates between positive and negative pressures with respect to a reference
pressure or atmospheric pressure. Id. at 35–36.
With reference to Taylor’s Figure 3 shown above, Petitioner explains
this position as follows.
When suction cup member 156 is sealed against the vulva,
and bellows 160 is not compressed or expanded, air within
bellows 160 and suction cup member 156 is at atmospheric
pressure (i.e., at a reference pressure). Ex. 1002 at ¶¶ 62–64,
75(vii). When arm 26 compresses bellows 160 . . . with suction
cup member 156 “sealingly” engaged with the vulva, the volume
within bellows 160 is reduced. Id. As a result, air within bellows
160 is pushed out of bellows 160, through flexible conduit 162,
and into suction cup member 156. Id. And, since the volume
within suction cup member 156 is fixed as a result of sealingly
receiving the vulva, the pressure within suction cup member
increases above atmospheric pressure (i.e., at a positive pressure
with respect to the reference pressure). Ex. 1004 at 5:30–31, 36–
37; Ex. 1002 at ¶75(vii). In contrast, when arm 26 expands
bellows 160 . . . with suction cup member 156 “sealingly”
engaged with the vulva, the volume within bellows 160
increases, and air from suction cup member 156 rushes out of
suction cup member 156, through flexible conduit 162, and into
bellows 160. Ex. 1002 at ¶75(vii). Consequently, the pressure
within suction cup member 156 is reduced below atmospheric
pressure (i.e., at a negative pressure with respect to the reference
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pressure). Id. Thus, during time periods of “vacuum” in suction
cup member 156, the pressure of the air in suction cup member
156 is negative with respect to a reference pressure, and during
the time periods in between two successive vacuum time periods,
the pressure of air in suction cup member 156 is above the
reference pressure, or positive with respect to the pressure.
Thus, the pressure field generated in suction cup member 156, by
the compression and expansion of bellows 160, “comprises a
pattern of negative and positive pressures, modulated with
respect to a reference pressure.” Id.
Pet. 35–36 (emphases added).
Patent Owner asserts that Taylor discloses a suction-only system that
applies only negative pressures to a body part, and does not teach positive
pressure at all, much less the modulated pressures required by the challenged
claims. See Resp. 31–34 (citing Ex. 2034 ¶¶ 102–104). Patent Owner
explains that “[a]t most, Taylor discloses a suction cup with a vacuum
feature based on negative pressure, not positive pressure.” Id. at 34 (citing
Ex. 2034 ¶ 109).
Patent Owner also asserts that Taylor does not inherently disclose the
modulation of negative and positive pressures with respect to a reference
pressure because Taylor’s description does not support a teaching of a closed
system as being necessarily present such that one of skill in the art would
recognize this teaching, which is required for inherency. Id. at 34–48.
Petitioner’s inherency argument, Patent Owner asserts, relies on a single
sentence in Taylor that states a suction cup “conformingly and sealingly
receives” the vulva. Resp. 34 (citing Pet. 35). Patent Owner asserts that
Petitioner’s inherency argument assumes that the bellows in Taylor is a
sealed container with only one opening. Id. at 35–36. Patent Owner also
asserts that such a conclusion is counter to the ordinary and customary
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meaning of “bellows” as a unidirectional device “that by alternate expansion
and contraction draws in air through a valve or orifice and expels it through
a tube.” Id. at 36 (citing Ex. 2003 (dictionary); Ex. 2034 ¶¶ 108–109).
Based on this understanding of the meaning of “bellows,” Patent Owner
asserts that one of skill in the art “would understand Taylor’s bellows to
provide suction only at the suction cup,” and would not interpret Taylor as a
closed system. Id.
In reviewing Petitioner’s explanation of how Taylor discloses
negative and positive pressures modulated with respect to a reference
pressure set forth above, Patent Owner asserts that such an argument
requires that Taylor discloses: (1) the suction cup member being sealed
against the vulva; (2) simultaneously with the bellows being in a state that is
neither compressed nor expanded, and (3) that, also at the same time, the air
within the bellows is at atmospheric pressure. Id. at 37. Patent Owner
points out that Taylor does not teach that the bellows is ever in a state that it
is not compressed or expanded, nor does it describe the suction cup being
sealed against the vulva when the bellows are in such a state. Id. at 37, 48–
49. “Rather, Taylor discloses that the suction cup ‘sealingly receives’ the
vulva when Taylor’s bellows creates a vacuum within the suction cup. A
POSITA would easily understand that when the vacuum releases, the seal
and suction cup likely release as well.” Id. (citing Ex. 2034 ¶¶ 121–122).
Patent Owner explains that nothing in Taylor discloses Petitioner’s
proposed arbitrary point when Taylor’s bellows are not compressed or
expanded. Id. at 39–40 (citing Ex. 1004; Ex. 2034 ¶¶ 108–115).
Taylor discloses a bellows that cyclically introduces a
vacuum to a suction cup sealed against the body. [Ex. 2034
¶¶ 108–115.] Regardless of the starting point of the bellows, a
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POSITA would understand that the pressure acting on Taylor’s
device does not change based on the initial position of the
bellows. Id., ¶ 110. 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 (and may or may not reach) the
reference pressure, i.e., the prevailing pressure of the sexual aid.
Id. This cycle is illustrated below.

Id. ¶ 111. Whether or not negative pressure returns to
atmospheric pressure, Taylor’s cyclical vacuum would create
negative pressure that would never pass atmospheric pressure to
reach positive pressure with respect to atmospheric pressure,
because Taylor discloses a suction-only system. Thus, although
the pressure within the bellows during compression may
increase in the negative pressure region, the pressure within the
bellows is never positive with respect to the reference pressure,
regardless of the starting point of the bellows. Id.
Resp. 39–40.
Patent Owner concludes that “[n]othing about Taylor’s bellows
suggests that compressing the bellows would create a positive pressure, as
Petitioner has argued, particularly because Taylor’s bellows operates to
introduce cyclical vacuum to suction cups.” Id. at 40.
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Patent Owner also asserts that Petitioner’s inappropriately belated
argument that a squeeze ball may be used adds support to its conclusion that
Taylor teaches a closed system is incorrect.9 Patent Owner explains that
“Taylor’s only description of the squeeze ball’s function is in the context of
a non-dildo alternative ‘secretable embodiment’ that relies on suction cups
applied to the user’s vulva and nipples, illustrated in Fig. 4,” set forth below.

Resp. 44. Patent Owner explains that Taylor describes this embodiment as
follows.
To begin, Taylor’s Fig. 4 shows a squeeze ball
resembling a nasal aspirator that is separate from the wearable
embodiment, which consists of three suction cups connected by
open-ended flexible conduits and straps. This is not a closed
system. 2034, ¶ 127-129. Next, Taylor explains the squeeze ball
is for introducing “cyclical vacuum” (i.e., negative pressure) to
the suction cups. Ex. 1004, 5:60-64. Cyclical vacuum is not
modulating positive and negative pressures with respect to a

9 Patent Owner asserts that we should not consider this argument as it was
not made in the Petition. Resp. 33, n.3.
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reference pressure. To introduce a cyclical vacuum, which is
Taylor’s only stated purpose for the suction-cup embodiments, a
user would need to squeeze the ball, connect it to the tube,
release (to create suction in the suction cup), disconnect, and
repeat the process. Exs. 1004, Fig. 4; 2034, ¶ 129; 2035, ¶ 102.
That process would not result in modulation of positive and
negative pressures relative to the reference pressure. Nor would
squeezing the ball repeatedly while keeping it connected to the
tube. That process would simply return the air sucked from the
space within the sealed suction cup back into the suction cup,
causing a return to reference pressure. Id. Significantly, and
as in Taylor’s other suction-cup embodiments, introducing
positive pressure relative to the prevailing ambient pressure of
the device, i.e., the reference pressure, would stop the “cyclical
vacuum,” cause the suction cups to disengage or fall off, and
thereby render the device inoperable. Id.
Resp. 45–46. Patent Owner also explains that one of skill in the art would be
familiar with the use of squeeze balls and would not view Taylor’s squeeze
ball as “generating a pressure field in the suction cups with a pattern of
positive and negative pressures modulated with respect to a reference
pressure.” Id. (citing Ex. 2034 ¶ 129; Ex. 2034 ¶ 102).
In its Reply, Petitioner refutes Patent Owner’s position that one of
skill in the art would assume bellows 160 contains a valve because there are
many examples of bellows with a single opening such as lungs, squeeze
balls, squeak toys, and pen fillers. Reply 5 (citing Ex. 1018 ¶¶ 24–32;
Ex. 1020 PP 63–67; Ex. 1036, 6–7; Ex. 1017, 95:12–96:25). Petitioner
states:
Flexible conduit 162 is the only opening shown in
bellows 160. Ex. 1004, 5:28–41, Fig. 3; Ex. 1018 ¶¶ 29–32.
There is no basis to conclude from Taylor that there must be
another opening or that air in bellows 160 must flow
unidirectionally, especially where the bellows 160 is
interchangeable with squeeze ball 74. Ex. 1004, Fig. 4, 5:33–
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35, 5:50–63; Ex. 1018 ¶¶ 29–32; Ex. 1020 ¶¶ 63–67. A
POSITA would infer that bellows 160 has only one opening
because squeeze ball 74 also has a single opening forming a
closed system with bidirectional flow. Ex. 1018 ¶¶ 29–32.
Reply 5–6 (internal citations and footnotes omitted).
Petitioner then applies its construction for “reference pressure,” which
we have rejected as set forth above in Section II.C., and contends that the
reference pressure can be the pressure in the device shortly after it begins
operation. Reply 7–10. 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 8 (citing Pet. 12–13; Ex. 1018 ¶ 46; Ex. 1002 ¶¶ 59–64). Petitioner
contends that using this definition of reference pressure, the cyclic vacuum
of Taylor meets the modulation of positive and negative pressures relative to
a reference pressure limitation as the vacuum increases and decreases
relative to the pressure shortly after activation. Id. at 8–14. For instance,
Petitioner argues “Taylor discloses that arm 26 ‘compresses . . . and then
expands bellows 160’ after member 156 ‘sealingly’ engages the vulva. That
is, Taylor teaches to first compress bellows 160 to a smaller size, and then to
expand to a larger size, after member 156 is placed on the vulva as shown in
Fig. 3.” Reply 9 (internal citations omitted); see also Reply 14 (asserting
Taylor has an air-tight seal). Petitioner also asserts that Taylor teaches the
bellows start in a neutral position because in Figure 3 of Taylor “the
depicted position of bellows 160 is an intermediate or neutral state, and not
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its most compressed (or expanded) state.” Id. at 10 (citing Ex. 1018 ¶¶ 49–
52).
Petitioner explains that even if Taylor’s device does not start in a
neutral position, it would still create positive and negative pressures with
respect to a reference pressure. See Reply 12–14. Petitioner explains:
A POSITA would have understood [as shown in the
figures set forth below] that when member 156 (blue) is pressed
into the body using force F1 (e.g., by hand), an above ambient
positive pressure is generated in member 156 due to the change
in volume defined by member 156 resulting therefrom:

Ex. 1018 ¶ 52. Accordingly, because the volume of member
156 decreases after force is applied, a positive pressure is
generated even if the bellows was fully compressed at the
beginning of operation, resulting in positive and negative
pressures modulated with respect to a reference pressure when
the device is powered on. Ex. 1018 ¶ 52. Further, F1 would be
greater than the F2 generated by positive/negative pressures
inside member 156, which is why member 156 does not detach
or become rendered inoperable when positive pressure is
generated.
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Reply 12–13.
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 12. Patent Owner contends that such
a definition creates a moving target for the claimed “reference pressure,”
which contravenes the ’061 patent’s definition of surrounding pressure
acting on a device prior to operation that provides an understandable,
consistent, and reliable baseline from which to judge whether positive and
negative pressures are applied to a body part. Id.
Patent Owner also contends that Petitioner’s argument with respect to
the pressure in the suction cup being a positive pressure is based on
demonstrative drawings set forth for the first time in Petitioner’s Reply,
which is nowhere found or taught by Taylor. Id. at 13. Patent Owner states:
Taylor discloses a suction-only system that, in one embodiment
(the only embodiment Petitioner relies on in the Petition), uses
a bellows to apply “cyclical vacuum phenomenon” to suction
cups to stimulate the upper vulva and nipples. Ex. 1004, 5:29–
49; Ex. 2034 ¶¶ 104–112. Regardless of what position the
bellows begins operation, cyclical vacuum is repetitive
negative, not modulation of positive and negative pressures.
Sur-Reply 14. Therefore, Patent Owner asserts, discussion of whether
Taylor’s bellows have a valve or the use of a squeeze ball in place of the
bellows does not alter the teaching of Taylor of creation of a “cyclical
vacuum” through a suction cup. Id. at 15–17.
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.
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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 4, with
Pet. 21–23 (stating “reference pressure” is “atmospheric pressure”). Based
on such reliance on an incorrect claim construction alone, we find that
Petitioner has failed to prove by a preponderance of the evidence that Taylor
discloses the changing volume of the chamber resulting in modulated
positive and negative pressures with respect to a reference pressure.
We also find that Petitioner’s explanation of what Taylor teaches to
support that application of its erroneous claim construction is also flawed.
We find Petitioner’s substantive arguments concerning the teachings of
Taylor are not supported by Taylor’s disclosure.
For instance, Taylor expressly and consistently teaches applying a
cyclical vacuum or negative pressure using suction cups. See Ex. 1004,
5:35–48; see Ex. 2034 ¶¶ 104–106. As Dr. Jensen states, “Taylor provides a
device that introduces a vacuum, and releases the vacuum.” Ex. 2034 ¶ 106.
Petitioner’s attempt to assert that Taylor teaches positive, as well as negative
pressures, that are modulated with respect to a reference pressure is
unconvincing and not supported by the express disclosure of Taylor.
Petitioner relies almost exclusively on Taylor’s statement that the
suction cup member 156 sealingly receives the upper portion of the vulva to
attempt to prove that Taylor teaches modulation of positive and negative
pressures with respect to a reference pressure because such a sealing to the
body part creates a closed system. Pet. 35; see Ex. 1002 ¶ 64; Resp. 35. As
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Patent Owner notes, however, Taylor does not disclose such a closed system
either expressly or inherently.
We agree with Dr. Jensen that when read in context, Taylor’s
disclosure of a suction cup “sealingly” receiving the vulva occurs when the
vacuum is applied, not before. See Ex. 2034 ¶ 121. We disagree with
Petitioner’s conclusion that “Taylor discloses that arm 26 ‘compresses . . .
and then expands bellows 160’ after member 156 ‘sealingly’ engages the
vulva.” Reply 9. The single statement in Taylor on which Petitioner relies
states, with reference to Figure 3 set forth above in Section II.D.1, “[t]he
first stimulator 154 includes a suction cup member 156 that conformingly
and sealingly receives the upper portion of the vulva.” Ex. 1004, 5:29–31.
We agree with Dr. Jensen that this does not support Petitioner’s conclusion
that a seal is achieved before the vacuum is applied, and credit Dr. Jensen’s
testimony that reads as follows as consistent with Taylor’s disclosure.
Petitioner alleges Taylor discloses a positive pressure
with respect to the reference pressure in the bellows,
because Taylor states that “suction cup member 156 ...
conformingly and sealingly receives” the vulva. Petition at
34-35. Specifically, Petitioner appears to argue that because
there is a seal, there must be modulated positive and
negative pressure. Petitioner’s logic is clearly flawed. As an
initial matter, Taylor’s disclosure of a suction cup “sealingly”
receiving the vulva is in the context of when the vacuum is
applied. Based on Taylor’s disclosure, the suction cup
member of Taylor would not stay sealingly engaged if a
positive pressure is applied. Again, Taylor discloses a
cyclical vacuum, which most likely returns to atmospheric
pressure every time the bellows is compressed, resulting in
the suction cup releasing from the vulva. Regardless,
Petitioner’s argument is also flawed because providing a
seal does not mean a positive pressure with respect to the
reference pressure is applied to the suction cup. Taylor only
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discloses a vacuum is applied. The fact that the suction cup
“sealingly” receives the vulva is not itself evidence of both a
negative pressure and a positive pressure. Rather, a suction
cup that sealingly receives a vulva while a vacuum or
negative pressure is applied is further evidence that Taylor
provides only a negative pressure, not a positive pressure.
If Taylor were to provide a positive pressure, the
“suction” cup would not “sealingly receive” the vulva as
Taylor describes. A POSITA would understand that a
positive pressure would unseal suction cup member 156
from the vulva. Moreover, the additional suction cup
members 58 for receiving a user’s nipples and areolae that
are in fluid communication with the bellows would also
be nonfunctional if a positive pressure with respect to the
reference pressure resulted from a varied volume of the
chamber, as the cups would detach and fall off the nipple area
in response to the positive pressure. Once the suction cups
disengage from the body, the cyclical vacuum can no longer
be applied to the body, and, therefore, there can be no pattern
of negative and positive pressures modulated with respect to
the reference pressure, as alleged by Petitioner. Thus,
Petitioner’s modulated pressure scenario relies on
modifications to the Taylor system – introduction of a
positive pressure and modulation of negative and positive
pressures – that are entirely inconsistent with Taylor’s
disclosure and render Taylor’s system inoperable. Because
Taylor discloses a vacuum-only system, further evidenced
by the inclusion of sealed suction cups, a POSITA would not
find that Taylor necessarily provides a positive pressure as
alleged by Petitioner. Therefore, Taylor does not inherently
disclose modulated positive and negative pressures.
Ex. 2034 ¶¶ 121–122; see Ex. 1022, 202:22–205:6.
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. 35
(stating “[w]hen bellows 160 is neither compressed nor expanded, the air
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within bellows 160 is at atmospheric pressure (i.e., the reference pressure)”)
(citing Ex. 1002 ¶¶ 62–64, 75(vii)). Taylor, however is silent as to the
starting position of the bellows. See Ex. 1004, 5:27–49; Ex. 2034 ¶ 110.
Petitioner’s declarant, Mr. Meyst, confirms this silence by drawing a
negative inference from such silence. Such a negative inference, however,
does not meet the inherency test as it must because there is no such express
disclosure. 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 ¶ 61 (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. 36–41, which is simply not supported by Taylor or the
testimony of Petitioner’s declarants.
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, 5:27–49; Ex. 1002 ¶¶ 62–64; Ex. 1020 ¶ 61. 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, 5: 27–49; Ex. 2034 ¶ 109 (stating “Taylor describes
a bellows for cyclically introducing only a vacuum . . . [a] POSITA would
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understand a bellows selected for purposes of creating a vacuum to provide
unidirectional fluid flow”).
For instance, as Dr. Jensen, Patent Owner’s declarant, explains:
According to Petitioner, Taylor’s bellows creates
both negative and positive pressures with respect to a
reference pressure because Taylor’s bellows begins in a
state of being neither compressed nor expanded. See Pet.,
35. It is unclear what Petitioner actually means by this
point. However, the starting point of Taylor’s bellows is
irrelevant. Taylor describes a bellows system for creating
a vacuum-only system, and a POSITA would therefore
understand that the bellows is designed such that it creates a
vacuum, regardless of the position of the bellows when it
starts. Further, Taylor does not disclose anything that
would tell a POSITA that the bellows begins in a state of
being neither compressed nor expanded, which to me, as a
POSITA, is further evidence that the bellows included in the
Taylor system is an ordinary vacuum bellows. Moreover,
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 ’061
Patent, because it is the prevailing pressure acting on the
stimulation device prior to operation. ’061 Patent, 3:38-41.
The pressure acting on Taylor’s device does not change based
on the initial position of the bellows. Even if the starting
position did matter, following Petitioner’s logic, then it
doesn’t make sense for the starting position of the bellows to
be in a neither compressed nor expanded position. Rather,
the logical starting position of the bellows would be a fully
compressed position to maximize Taylor’s vacuum feature.
Ultimately, a POSITA would recognize that if the
bellows is designed to introduce a vacuum as Taylor
describes, the bellows will introduce a vacuum regardless
of where the bellows starts. A POSITA would
understand Taylor’s bellows to work as follows, regardless
of its starting position: As the bellows is expanded, a
vacuum (negative pressure with respect to the reference
pressure) is created. As the bellows is compressed and the
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vacuum is released, the pressure in the bellows returns
toward the starting pressure, i.e., the prevailing pressure
of the sexual aid (reference pressure). While the pressure
within the bellows may increase relative to the negative
pressure as the bellows is being compressed, the pressure
within the bellows remains negative with respect to the
reference pressure at all times and is never positive
with respect to the reference pressure as claimed.
Ex. 2034 ¶ 110 (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 “a pattern of negative and positive pressures,
modulated with respect to a reference pressure” or “a pattern of negative and
positive pressures, modulated with respect to a reference pressure.”
3. Conclusion
Based on the foregoing analysis, we conclude that Petitioner has
failed to show by a preponderance of the evidence that the challenged claims
are anticipated by Taylor.
E. Obviousness Grounds
Petitioner asserts that claims 1–3, 5, 7, 8, 11, 14, 15, 17–19, and 21–
26 are unpatentable under 35 U.S.C. § 103 as obvious over Taylor and
Hovland. Pet. 3, 66–78. Again, we focus on independent claims 1 and 21 at
issue in this challenge. We find that Petitioner has not shown sufficiently
that the combination of the teachings of Taylor and Hovland teach or
suggest “a pattern of negative and positive pressures, modulated with respect
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to a reference pressure” of claim 1 or the similar limitation “a pattern of
negative and positive pressures, modulated with respect to a reference
pressure” of claim 21. We also address Patent Owner’s objective evidence
of non-obviousness, which supports our view that the challenged claims are
not unpatentable on the record before us. Prelim. Resp. 35–53; Ex. 2003.
1. Hovland (Ex. 1006)
Hovland discloses a stimulation device wherein suction or a vacuum is
applied to the clitoris to promote engorgement of the clitoris with blood.
Ex. 1006, Abstr. An alternative embodiment of Hovland teaches the use of
super-atmospheric pressure to massage the clitoris. Id. at 4:22–24.
2. Analysis
Petitioner contends that if Taylor does not teach modulated positive
and negative pressures with respect to a reference pressure, “it would have
been obvious to a POSITA to modify Taylor’s stimulation device with the
teachings of Hovland to apply modulated super-atmospheric pressure along
with Taylor’s ‘cyclical vacuum’ (i.e., sub-atmospheric pressure) to achieve
the benefits described by Hovland.” Pet. 66–67 (citing Ex. 1002 ¶¶ 91–96).
Petitioner points to statements in Hovland discussing embodiments that
increase blood flow to the clitoris “by creating a vacuum around and/or
using increasing pressure to produce percussion and/or massage of e.g., the
clitoris.” Pet. 67 (citing Ex. 1006, 8:49–52). With particular reference to
Figure 15, Petitioner points to a statement that the pump/motor assembly of
the embodiment can provide “pneumatic and/or hydraulic actuation to create
e.g. vibration, percussion, subatmospheric pressure and/or super-
atmospheric pressure, or modulation of these effects.” Pet. 68 (citing
Ex. 1006, 13:20–24 (emphasis in original), 15:23–24).
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From these statements, Petitioner concludes:
Based on Hovland’s disclosure, a POSITA would have
readily recognized that Hovland’s reference to “subatmospheric
pressure,” “suction,” and “vacuum” is intended to encompass
“pressure levels lower than atmospheric or ambient.” [Ex.
1006,] 21:47–50. A POSITA also would have understood that
Hovland’s reference to super-atmospheric pressure for
providing “percussion or massage” is intended to encompass
“pressures higher than ambient or atmospheric.” Id. at 21:50–
52; Ex. 1002 at ¶¶ 93–96.
[I]t would have been obvious to a POSITA to modify
Taylor’s stimulation device with the teachings of Hovland to
apply both modulated sub-atmospheric and super-atmospheric
pressures to clitoris, to take advantage of percussion and/or
massage of the clitoris, in order to achieve improved and
quicker clitoral engorgement and tumescence known to result
from a pressure differential in the clitoris and/or surrounding
areas. Id. at 4:19–28 (emphasis added). Moreover,
modification of Taylor with the teachings of Hovland would
have amounted to nothing more than the use of a known
technique to improve a similar device, and the results of the
modification would have been predictable. See KSR Int’l. Co.
v. Teleflex, Inc., 550 U.S. 398, 417 (2007). This is because at
the time of the invention, a POSITA would have had the
requisite skill level to readily modify the device disclosed by
Taylor to implement the teachings of Hovland without any
problem.
Pet. 68–69.
Patent Owner contends that neither Hovland nor Taylor teach or
suggest modulated positive and negative pressures with respect to a
reference pressure. Resp. 49. Hovland teaches: “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. 1006, 13:20–24. Patent Owner contends that this passage in Hovland
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teaches the modulation of either a vacuum or super atmospheric pressure,
but not modulating between them. Resp. 50–52. 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 ’061 patent. Id. Patent Owner contends that the use of the term
and/or refers to a choice of effects and not modulating between them. Id. at
51–53. Patent Owner also argues that Hovland does not disclose any
structure or means for modulating between positive and negative pressures.
Id. at 51–52. Patent Owner concludes that “[o]ther than having seemingly
searched for isolated statements or phrases (e.g., “and/or”) in Hovland based
exclusively on knowledge gleaned from the ’061 Patent, Petitioner presents
no evidence that Hovland actually discloses this missing limitation.” Id. at
51 (citing Ex. 2034 ¶¶ 135–137).
Patent Owner also contends that one skilled in the art would not have
been motivated to combine the teachings of Taylor and Hovland. Resp. 54–
57. 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 16–18. 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 18–19.
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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 19–22.
As discussed above, we find that Taylor does not teach the limitations
calling for modulated positive and negative pressure with respect to a
reference pressure that are required by all challenged claims. 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; and whether Patent Owner
has offered sufficient evidence of objective indicia of patentability to
overcome Petitioner’s arguments that the subject matter of the challenged
claims would have been obvious.
a. Modulated Positive and Negative Pressure
Petitioner contends that, to the extent the elements of modulated
positive and negative pressure are not taught by Taylor, those elements are
taught by Hovland. Pet. 66–71.
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. 1006,
13:21–24. 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 15–19. 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. 49–
54. 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.
We have considered the arguments advanced by the parties and the
evidence of record and conclude that Patent Owner has the better argument.
Although 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. See Resp. 49–54. As Patent Owner points out, this interpretation is
consistent with the overall teachings of Hovland, in which “[e]ach instance
of ‘modulate’ or ‘modulated’ or ‘modulator’ refers to varying or adjusting
the level of a particular effect, e.g., the vacuum effect.” Resp. 51 (citing
Ex. 2034 ¶ 135 (citing various examples in Hovland).
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. 1006, 12:42–59. Hovland also teaches that the vacuum
modulator can be used to pulsate the vacuum level of the device. Id. at
14:21–22. Hovland further teaches:
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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. 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 14:27–39 (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 disagrees with Patent Owner’s interpretation of Hovland as
disclosing a device that produces only a vacuum. Reply 15–16. 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
¶¶ 44–45; Ex. 1020 ¶¶ 69–70.
Although we agree with Petitioner that the term “and/or” may be read
as 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 the challenged claims. This is confirmed by the plain language
of Hovland, which refers to “modulation of these effects” rather than
“modulation between effects.” Ex. 1006, 13:20–24. 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.
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Ex. 1006, 12:21–24; Ex. 2034 ¶¶ 132–138. Although Hovland teaches a
device that can produce positive and negative pressures, we discern nothing
in Hovland that teaches modulating between these effects.
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 than
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.
See WMS Gaming, 184 F.3d at 1355. 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 established by a preponderance of the evidence that the
combination of Taylor and Hovland renders obvious the challenged claims
of the ’061 patent. Nonetheless, even assuming that the Hovland teaches
this requirement based on the single phrase in its disclosure of
“subatmospheric pressure and/or superatmospheric pressure, or modulation
of these effects,” we also find that Petitioner has 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 teachings 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. 68–69 (citing Ex. 1006, 4:19–28; Ex. 1002
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¶¶ 93–96). Petitioner also contends that the combination of references is
nothing more than using a known technique to improve a similar device. Id.
at 69.
Patent Owner contends that Petitioner’s argument is factually
unsupported in that Petitioner does not explain how one skilled in the art
would have modified the references or how the references teach modulation
between positive and negative pressures. Resp. 54–57.
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 with respect to a reference pressure.
The paragraph from Hovland 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.
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Ex. 1006, 4:18–34 (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 alternating between 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.
c. Objective Indicia
Although the above conclusions would be enough for us to find that
Petitioner has failed to show by a preponderance of the evidence that the
challenged claims are unpatentable based on Taylor and Hovland, we also
find that the objective indicia of non-obviousness supports our conclusion
that these challenged claims are not unpatentable on the record before us.
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).
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.
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(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
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 ’061 patent. Resp. 62. In support of this
contention Patent Owner relies on the testimony of its experts Drs. Jensen
and Herbenick. Resp. 62 (citing Exs. 2037, 2034 ¶¶ 46–54, 2035 ¶¶ 48–
64).10
Both Dr. Herbenick and Dr. Jensen reviewed the Womanizer®
InsideOut and concluded that the device was coextensive with at least the
challenged independent claims of the ’061 patent. Ex. 2034 ¶ 47; Ex. 2035 ¶
49. 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

10 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. 2034 ¶ 46;
Ex. 2035 ¶ 48. For this reason, Dr. Herbenick and Jensen focused their
analyses on the Womanizer® InsideOut. Ex. 2034 ¶ 46; Ex. 2035 ¶ 48.
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elements recited in the independent claims. Ex. 2035 ¶¶ 49–64; Ex. 2037.
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. 2034 ¶ 47.
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. 2034 ¶¶ 50–54. The following
images from Dr. Jensen’s declaration show the equipment used to test the
pressure of the InsideOut, as well as the pressure graph generated as a result
of the tests:

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Ex. 2034 ¶ 52. 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. 2034 ¶¶ 50–54.
Petitioner contends that Patent Owner has failed to establish a nexus
between the commercial products and the challenged claims. Reply 20–22.
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 opinions. Id.
Petitioner contends that Patent Owner is not entitled to a presumption
that the commercial devices embody the claimed invention as they include
beneficial features not recited in the claims. Id. at 20–21. 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 22.
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 ’061 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
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Womanizer® Duo products and that the products are essentially the claimed
invention. See Ex. 2034 ¶¶ 50–54; Ex. 2035 ¶¶ 45–64.
Petitioner contends that the presence of additional, unclaimed features
precludes a presumption of a nexus between the commercial embodiments
and the claims of the ’061 patent. Reply 20–22. 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 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. Although
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 21. Although
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 21;
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
unreliable. Reply 21–22. 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. at 21. 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 22. We find both
of these argument unpersuasive.
Although 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. 2035 ¶¶ 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. 2037; Ex. 2035 ¶¶ 49–60.
Moreover, Dr. Jensen, who has a background in medical devices, examined
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the commercial embodiments and Dr. Herbenick’s analysis and claim charts
and concurred in Dr. Herbenick’s findings. Ex. 2034 ¶¶ 46, 47, 157.
We are similarly unpersuaded 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, which Dr. Prisco asserts
would modify the size of the mouth of the device. Ex. 1018 ¶¶ 66–67;
Ex. 2022, 61:2–20. Dr. Prisco testifies that such use of a stopper could
affect the pressures generated, but offers insufficient explanation as to 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 . . . .”) (internal citation omitted).
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 ¶¶ 71–73. Petitioner contends that this
further supports the conclusion that Dr. Jensen’s test results are unreliable.
See Reply 22. 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
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pressure regardless of whether it is atmospheric pressure. See id.; Ex. 1018
¶¶ 71–73.
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 ’061 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. 63. 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 and an exhibit detailing sales
revenues. Id. (citing Exs. 2017–2019; 2035 ¶ 66; 2056).
Petitioner contends that raw sales data without sufficient context does
not establish commercial success. Reply 22–23. Petitioner asserts “[t]here
is no evidence of market share, sales expectations, or anything showing
comparative success of the Embodiments in relation to other products on the
market. And, anonymous online reviews are not relevant to commercial
success.” Id. at 23.
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
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claimed invention and relevant market share.11 In re Applied Materials,
Inc., 692 F.3d 1289, 1299 (Fed Cir. 2012). In the present case Patent Owner
has offered the testimony of Dr. Herbenick that the relevant products have
achieved significant sales volumes, that sales continue to increase, and raw
sales data. Resp. 63 (citing Ex. 2035 ¶ 66; Ex. 2056). Dr. Herbenick,
however, did not offer any testimony regarding any market context for the
raw sales data. See Ex. 2035 ¶ 66. Petitioner offered one estimate of the
total market size of the sex toy market as $29 billion, which adds some
context for the sales data offered by Patent Owner. See Reply 23, n.14
(citing Ex. 1024). Patent Owner did not comment on this estimate. See
generally Sur-Reply.
Petitioner offers some context for the raw sales data proffered by
Patent Owner that tends to show Patent Owner’s products may not have
enjoyed such a level of sales that would indicate commercial success.
Without more context for the raw sales data, 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
“Existence 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

11 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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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. 63 (citing Ex. 2035 ¶¶ 67–68; Ex. 2058). 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. 64. Citing the testimony of Dr. Herbenick, Patent
Owner contends that the Womanizer® products satisfied this need. Id. at
64–65 (citing Ex. 2035 ¶¶ 69–71).
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 24. 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 26–27.
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. 2035 ¶ 68 (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 my research, published in a 2009 issue of the
Journal of Sexual Medicine, had found that the use of mechanical vibrators
(i.e., those involving direct physical contact) had caused numbness,
irritation, pain, or even tears or cuts in a subset of female vibrator users.” Id.
¶ 69. Dr. Herbenick also testified that the prior art devices, including the
device disclosed in Taylor, failed to meet this need. Id. ¶ 70.
Petitioner contends that indirect stimulation devices were known in
the art and that such devices do not meet a long felt need. Reply 24. We
find this argument unpersuasive. Petitioner cites to the testimony of
Dr. Herbenick to support this contention. Id. (citing Ex. 1023, 61:14–20,
62:20–63:21). A careful reading of the cited pages, however, 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
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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
alleged long-felt need. Reply 24. 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. 2035 ¶¶ 11–14, 67–71. 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 the failure of others.”).
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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. 65 (citing Ex. 2035
¶¶ 72–74; Exs. 2012–2016). In support of this contention, Patent Owner
cites Dr. Herbenick’s testimony that although 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. 2035 ¶¶ 72–74.
Petitioner does not address Patent Owner’s argument or evidence. See
Reply 20–25.
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. 2035 ¶¶ 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.
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(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 Womanizer product and, in particular, skeptical about
how modulating between positive and negative air pressure might facilitate
orgasm.” Resp. 66 (citing Ex. 2035 ¶¶ 75–81; Ex. 2059).
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 24–25 (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
Petitioner 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, 1–2. Another expert is Vanessa
Marin, a licensed psychotherapist specializing in sex therapy, who reviewed
the product and expressed skepticism about it. Ex. 2019, 124–130. These
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reviews in addition to the testimony of Dr. Herbenick show industry
skepticism about the Womanizer® products. Ex. 2035 ¶¶ 75–81.
(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).
Patent Owner contends that, notwithstanding the industry skepticism
discussed above, the industry has also praised the Womanizer® products
extensively. Resp. 66. Patent Owner contends that reviews of the
Womanizer® products have described them as “innovative, unique, and [in]
other similar terms.” Id. at 67 (citing Ex. 2035 ¶ 82). 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. at 68–69.
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. 2035 ¶ 88; Ex. 2060, 8. 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
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Toy Product/Line of the Year – Powered (Vibrating) at the XBIZ Europa
Awards. Ex. 2035 ¶ 88; Ex. 2060, 3, 61. 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. 2035 ¶ 85; Ex. 2019, 64. In addition, the
Womanizer® products have received praise by both sex toy retailers and
consumers. Ex. 2035 ¶¶ 82–89.
(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).
Patent Owner contends that Petitioner and others have copied that
Womanizer® products and that this supports a finding on non-obviousness.
Resp. 69–75. 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.at 75; Ex. 2035 ¶ 92. Patent Owner
also provides details about what Patent Owner asserts is Petitioner’s copying
of the ’061 patent technology. Resp. 70–74.
Petitioner contends that Patent Owner has not shown sufficient
evidence of copying to support a finding of non-obviousness. Reply 23–24.
Petitioner contends that Dr. Herbenick did not review tests of the
competitors’ devices, nor could she describe how the products worked. Id.
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In reply, Patent Owner contends that Petitioner mischaracterizes
Dr. Herbenick’s testimony and fails to rebut the evidence of copying. Sur-
Reply 26.
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
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. 2035
¶¶ 90–97. For example, the Satisfier website described the Satisfyer Pro G-
Spot Rabbit as offering a “rapid change between suction and pressure.” Ex.
2021, 4.
Given this evidence of the similarity of the competitive products to
the Womanizer® products, specifically Petitioner’s products, and
Petitioner’s failure to offer any evidence in rebuttal, we find that Patent
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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. Conclusion
From the foregoing analysis we conclude that Petitioner has not
demonstrated that the subject matter of claims 1–3, 5, 7, 8, 11, 14, 15, 17–
19, or 21–26 would have been obvious to one of ordinary skill in the art over
Taylor combined with Hovland.
III. OBVIOUSNESS OVER TAYLOR AND ZIPPER WITH OR
WITHOUT HOVLAND
Petitioner asserts that claim 20 is unpatentable under 35 U.S.C. § 103
over Taylor and Zipper or Taylor, Zipper, and Hovland. Petitioner asserts
that Zipper teaches a remote control device, but is not offered for teaching
the limitations requiring modulation of positive and negative pressures with
respect to a reference pressure. See Pet. 80, 85. Petitioner continues to
assert either Taylor alone or Taylor in combination with Hovland teaches
these limitations. Therefore, for the same reasons set forth above, we find
that Petitioner has failed to show by a preponderance of the evidence that
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claim 20 is unpatentable under 35 U.S.C. § 103 over Taylor and Zipper, or
Taylor, Zipper, and Hovland.
IV. PATENT OWNER’S MOTION TO SEAL AND FOR ENTRY OF
A PROTECTIVE ORDER
Patent Owner moves to seal Exhibit 2056 as containing highly
confidential sales data relating to Patent Owner’s commercial embodiments.
See Paper 25, 2. Patent Owner asserts that the sales data such as invoice
information, sales units, and revenues that is disclosed in Exhibit 2056 is
relevant to demonstrate commercial success. Id. at 3.
Patent Owner represents that there is good cause to seal Exhibit 2056
because access to such information by a competitor would be detrimental to
Patent Owner’s business. Id. Patent Owner also represents that Petitioner
agrees that the information in Exhibit 2056 is highly sensitive. Id.
We have considered Patent Owner’s argument to seal Exhibit 2056
and determine that it has demonstrated good cause for sealing the exhibit.
Therefore, we grant Patent Owner’s Motion to Seal.
Patent Owner also moves for entry of a Modified Protective Order
(Ex. 2070) that has been modified from the Default Protective Order to
include an “ATTORNEYS EYES ONLY” category, sets forth a mechanism
for a receiving party to challenge such designation, and sets forth who may
access such information. Id. at 4–5. Patent Owner also represents that
Petitioner is unopposed to the entry of this Modified Protective Order. Id.
at 5.
We grant Patent Owner’s request to enter the Modified Protective
Order (Ex. 2070) because the parties have agreed on the modifications to the
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Default Protective Order and the modifications appear necessary to protect
Patent Owner’s sensitive sales data.
V. PATENT OWNER’S UNOPPOSED MOTION TO SUBMIT
SUPPLEMENTAL INFORMATION PURSUANT
TO 37 C.F.R. § 123(b)
Patent Owner moves to submit a Certificate of Correction (“COC”) as
supplemental information because it corrects a clerical error by the Office of
including the word “onto” in claim 1 of the ’061 patent although the word
was removed in amendments prior to issuance. Paper 34, 1–2. Patent
Owner represents that Petitioner is not opposed to this request. Id.
Patent Owner asserts that its request meets all the requirements for
submitting supplemental information set forth in 37 C.F.R. § 42.123(b)
concerning the timing of presentation of the evidence. Id. at 1. Patent
Owner concludes that “[t]o have the recent COC reflecting the correction to
claim 1 of the ’061 Patent as part of the record is in the interests-of-justice
and supports the long-standing policy of having a complete record.” Id. at 2
(citing Liberty Mutual Inc. Vo. v. Progressive Casualty Ins. Co., No
CBM2012-00002, Paper 66 at 60–61 (PTAB Jan. 23, 2014)).
We are persuaded that Patent Owner has met its burden because it
satisfies the requirements of § 42.123(b). We agree that Patent Owner could
not submit the supplemental information earlier (until the Office issued the
COC), and that consideration of the supplemental information is in the
interests-of-justice. In the Petition, Petitioner acknowledged the clerical
error, and we and the parties have consistently treated claim 1 of the ’061
patent as not containing the word “onto” that was removed from claim 1 in
the COC. In other words, we have consistently analyzed claim 1 throughout
this proceeding, with the agreement of the parties, as not containing the
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word “onto” that was incorrectly included in the ’061 patent. Thus,
acknowledgement and consideration of the COC does not affect our analysis
of claim 1 here.
VI. PETITIONER’S MOTION TO EXCLUDE
Petitioner has moved to exclude Patent Owner’s expert declarations
(Exhibits 2034 (Declaration of Dr. Jensen) and 2035 (Declaration of
Dr. Herbenick)), as well as Exhibit 2061, which Patent Owner offers as
evidence of copying. Paper 38 (“MTE”). For the reasons set forth below,
Petitioner’s Motion is denied.
A. Exhibit 2035 — 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 1–6; Paper 40, 3–5
(“MTE Reply”). Second, Petitioner contends that Patent Owner failed to
produce all documents relied upon by Dr. Herbenick in rendering her
opinions in violation of 37 C.F.R. § 42.61(a). MTE 7–9; Paper 40, 5. Third,
Petitioner contends that the testimony of Dr. Herbenick should be excluded
because of allegedly improper speaking objections made by counsel for
Patent Owner during Dr. Herbenick’s deposition. MTE 9–12; Paper 40, 1–3.
Fourth, Petitioner contends that Dr. Herbenick is not qualified to testify as a
technical expert. MTE 14–15. Finally, Petitioner contends that we should
strike Dr. Herbenick’s testimony as she did not disclose her work as a
witness in other proceedings. MTE 14–15; Paper 40, 5.
We address each of these arguments in turn.
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1. Failure to Comply with 37 C.F.R. § 42.65(b)12
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 58 of her declaration depicting pressures generated by Patent
Owner’s alleged commercial embodiments. MTE 2–6. Patent Owner
responds that Dr. Herbenick “observed real-time pressure testing done by a
WOW Tech employee to confirm what she had already directly observed
[during a Zoom session]—that the commercial embodiments modulate
positive and negative pressures with respect to a reference pressure.” Paper
39, 4 (“MTE Resp.”). Patent Owner also states that “[t]he graph in [Dr.
Herbenick’s] declaration was provided as the underlying facts and data
under 37 C.F.R. § 42.65(b).” Id. We need not resolve whether Dr.
Herbenick needed to provide further data to support the graph in Paragraph
58 of her Declaration because 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 that she observed over Zoom calls as Patent Owner
did not provide an affidavit concerning the deconstruction and observation

12 We note that failure to comply with 37 C.F.R. § 42.65(b) goes to the
weight given the evidence, and does not necessarily call for the exclusion of
that 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.”).
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of the devices. MTE 6. 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 or data. We find that dismantling a device and identifying
the components of the device does not in this context of the graph presented
in Paragraph 58 of Dr. Herbenick’s Declaration constitute a “technical” test
within the scope of the Rule. Dr. Herbenick represents that the graph
depicted in Paragraph 58 is a “pressure graph [that] shows the pattern of
negative and positive pressures, modulated with respect to a reference
pressure.” Ex. 2035 ¶ 58. Dismantling a device and identifying its
components is not technical data or a technical test upon which
Dr. Herbenick relied to create such a graph. 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. MTE 7–9.
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 user manuals for the Womanizer® InsideOut and Duo
products. MTE 7–9. 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 8–9. We address each of these issues in turn.13

13 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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a. Draft Declarations
We find that Petitioner’s objection to Dr. Herbenick’s declaration on
the basis that Patent Owner did not produce drafts of Dr. Jensen’s
declaration that Dr. Herbenick reviewed in connection with her declaration
to be without merit. The declarations of other experts do not constitute “a
technical test or data from such a test” as that phrase is used in 37 C.F.R.
§ 42.65(b). See MTE Resp. 5–6 (“MTE Reps.”).
b. Documents relating to Patent Owner’s Products
Petitioner contends that Patent Owner failed to produce user manuals
for the Womanizer® InsideOut and Duo products that Dr. Herbenick
considered in rendering an opinion. MTE 8. Patent Owner responds that
these manuals are exhibits in this proceeding—Exhibits 2066 and 2068.
MTE Resp. 5.
As the manuals are exhibits in this proceeding, we are not persuaded
by Petitioner’s argument here.
c. 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 14–15; 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
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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 9–12. 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, only one such
alleged objection was made during this proceeding, and such objection was
merely a clarification of the record. 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.
Petitioner responds that the speaking objections in depositions in
proceedings related to this one—IPR2019-01302 and IPR2019-01444—
should be considered here in any remedy we may apply especially because
they relate to differences in the patent at issue in those proceedings and the
’061 patent at issue here. MTE Reply 1–2.
With respect to this proceeding, Petitioner has identified one possible
instance of a speaking objection. We do not find this, even considering the
examples provided from the two related proceedings, to be such egregious
conduct as to warrant excluding Dr. Herbenick’s testimony.
4. Dr. Herbenick’s Expertise
Petitioner contends that Dr. Herbenick lacks the relevant technical
expertise to testify about the patentability of the challenged claims of the
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’061 patent or whether Patent Owner’s commercial products embody the
claims of the ’061 patent. MTE 14–15. We do not find that Petitioner has
stated sufficient grounds to exclude Dr. Herbenick’s testimony.
Although 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. 2035
¶¶ 65–71 (evaluation of the commercial success and 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 patentability, 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. See Ex. 2035 ¶¶ 65–97. 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. 2035 ¶¶ 45–64. 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. 2035 ¶¶ 4–17.
5. Conclusion
For the reasons set forth above, we deny the portion of Petitioner’s
Motion to Exclude with regard to Dr. Herbinick’s testimony in Exhibit 2035.
B. Exhibit 2034 — Declaration of Dr. Jensen
Petitioner contends that the testimony of Dr. Jensen should be
excluded or given no 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 4–5.
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Second, Petitioner contends that Patent Owner did not produce all
documents Dr. Jensen relied upon in reaching his opinions. Id. at 7–9.
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 9–12.
1. Failure to Comply with 37 C.F.R. § 42.65(b)
Although 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 4–5. 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.14 Id.
Therefore we decline to exclude Dr. Jensen’s Declaration 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 7–9. For the same
reasons given above, we decline to exclude Dr. Jensen’s Declaration.

14 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 as 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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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 9–12. For the same
reasons given above, we decline to exclude Dr. Jensen’s Declaration.
4. Conclusion
Based on the foregoing we deny Petitioner’s Motion to Exclude as it
relates to Exhibit 2034.
5. Exhibit 2061
Petitioner contends that Exhibit 2061 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 2061. Therefore,
we therefore deny as moot Petitioner’s motion with respect to Exhibit 2061.
C. Conclusion
For the reasons stated above, we deny Petitioner’s Motion to Exclude
in its entirety.
VII. 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
the challenged claims of the ’061 patent is unpatentable.
We also grant Patent Owner’s Motion to Seal and for Entry of a
Protective Order, grant Patent Owner’s Motion to Submit Supplemental
Information, and deny Petitioner’s Motion to Exclude.
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VIII. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–3, 5, 7, 8, 11, 14, 15, 17–26 of the ’061
patent are not determined to be unpatentable;
FURTHER ORDERED that Patent Owner’s Motion to Seal and for
Entry of a Protective Order is granted;
FURTHER ORDERED that Petitioner’s Motion to Submit
Supplemental Information under 37 C.F.R. § 42.123(b) is granted;
FURTHER ORDERED that Petitioner’s Motion to Exclude is denied;
FURTHER ORDERED that the Modified Protective Order (Ex. 2070)
is hereby entered and shall govern the conduct of this proceeding unless
otherwise modified;
FURTHER ORDERED that Ex. 2056 shall be sealed as “Board
Only,” and will be kept under seal; 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
1–3, 5, 7,
11, 14, 15,
17–19, 21,
23–26
102 Taylor 1–3, 5, 7, 11,
14, 15, 17–19,
21, 23–26
1–3, 5, 7, 8,
11, 14, 15,
17–19, 21–
26
103 Taylor, Hovland 1–3, 5, 7, 8,
11, 14, 15,
17–19, 21–26
20 103 Taylor, Zipper 20
20 103 Taylor, Hovland,
Zipper
20
Overall
Outcome
1–3, 5, 7, 8,
11, 14, 15,
17–26
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PETITIONER:

Dinesh N. Melwani
Andrew Sutton
Biju I. Chandran
BOOKOFF MCANDREWS, PLLC
dmelwani@bomcip.com
bchandran@bomcip.com
asutton@bomcip.com

PATENT OWNER:

Tammy Dunn
Lisa E. Margonis
Peter C. Schechter
Califf T. Cooper
OSHA LIANG LLP
TERRY@OBWBIP.COM
MARGONIS@OBWBIP.COM
SCHECHTER@OBWBIP.COM
cooper@obwip.com