`571-272-7822
`
`Paper 50
`Date: June 14, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`EIS GMBH,
`Petitioner,
`v.
`NOVOLUTO GMBH,
`Patent Owner.
`
`IPR2019-01302
`Patent 9,937,097 B2
`
`
`
`
`
`
`
`
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`SCHNEIDER, Administrative Patent Judge.
`
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining Challenged Claims Not Unpatentable
`35 U.S.C. § 318(a)
`Denying Petitioner’s Motion to Exclude
`37 C.F.R. § 42.64
`
`
`
`
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`IPR2019-01302
`Patent 9,937,097 B2
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`I.
`INTRODUCTION
`A. Background and Summary
`EIS GmbH (“Petitioner”) filed a Petition requesting inter partes
`review of claims 1–30 of U.S. Patent No. 9,937,097 B2 (Ex. 1001, “the ’097
`patent”). Paper 1. (“Pet.”). NOVOLUTO GmbH (“Patent Owner”) filed a
`Preliminary Response to the Petition. Paper 14. On January 13, 2020 we
`issued our Decision Denying Institution. Paper 17 (“Dec”).
`Petitioner filed a Request for Rehearing of our Decision Denying
`Institution under 37 C.F.R. § 42.71 (c) and (d). Paper 18 (“Req. Reh’g”).1
`Upon reconsideration of the arguments and evidence of record at the time,
`we granted the Request for Rehearing and instituted inter partes review on
`all grounds presented in the Petition. Paper 23. (“Reh’g Dec.” or “Rehearing
`Decision”).
`Patent Owner then filed a Response on September 11, 2020. Paper 30
`(“Resp.”). Petitioner filed a Reply on December 14, 2020. Paper 37
`(“Reply”). Patent Owner filed a Sur-Reply on January 15, 2021. Paper 42
`(“Sur-Reply”). On February 2, 2021, the parties jointly informed the Board
`that no oral hearing was needed in this case. Paper 44.
`We have jurisdiction under 35 U.S.C. § 6. This Decision is a Final
`Written Decision under 35 U.S.C. § 318(a) as to the patentability of the
`
`
`1 Petitioner also sought review of the Decision by the Precedential Opinion
`Panel. Ex. 3001. That request was denied on April 6, 2020. Paper 21.
`Following denial by the Precedential Opinion Panel, Petitioner brought an
`action in the United States District Court for the Eastern District of Virginia
`seeking review of denial by the Precedential Opinion Panel under the
`Administrative Procedure Act. Paper 22. The district court action was
`dismissed following our granting Petitioner’s Request for Rehearing. Paper
`34, 2.
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`claims on which we instituted trial. Based on the complete record before us,
`we determine that Petitioner has not shown, by a preponderance of the
`evidence, that claims 1–30 are unpatentable. In addition, for the reasons
`explained below, we deny Petitioner’s Motion to Exclude evidence.
`B. Real Parties in Interest
`Petitioner identifies the following entities as real parties-in-interest:
`EIS GmbH, EIS Inc., Triple A Import GmbH, Triple A Marketing GmbH,
`Triple A Sales GmbH, and Triple A Internetshops GmbH (formerly known
`as “Internetsupport Bielefeld”). Paper 43.
`Patent Owner identifies itself as the real party-in-interest and that
`WOW Tech International GmbH is the corporate parent of Novoluto GmbH.
`Paper 41.
`
`C. Related Matters
`Petitioner has stated that the ’097 patent is the subject of litigation in
`two district court actions: EIS Inc. v. WOW Tech International GmbH et al.,
`No. 1:19-cv01227-LPS, (D. Del.) and Novoluto, GmbH v. Uccellini LLC
`d/b/a Lora DiCarlo, C.A. No. DOR-6-20-cv-02284-MTK (D. Ore.). Paper
`43, 3.
`
`Petitioner also states that two related patents, US 9,763,851 B2 and
`US 9,849,061 B2 are the subject of IPR2019-01444 and IPR2020-00007
`respectively. Id. Both of those proceedings are currently pending before the
`Board.
`
`D. The ’097 Patent
`The ’097 patent, titled Stimulation Device Having an Appendage,
`issued on April 10, 2018, from Application 15/487,123 filed on April 13,
`2017. Ex. 1001, codes (10), (21), (22), (45)col. 3, , and (54). It claims
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`priority to German Patent Application No. 102015103694.0, filed March 13,
`2015. Ex. 1001, col. 1, ll. 7–12.
`The ’097 patent relates to a sexual stimulation device which applies
`positive and negative pressure to a human body part, such as the clitoris.
`Ex. 1001, col. 3, ll. 21–22. The positive and negative pressures are created
`by changing the volume of a chamber in the device. Id. at col. 3, ll. 19–20.
`The volume of the chamber is changed by deflecting a flexible wall of the
`chamber. Id. at col. 3, ll. 16–19. Positive and negative pressures are
`determined relative to a “reference pressure.” Id. col. 4, l. 63– col. 5, l. 4.
`The device may also have an appendage which can be used as a handle. Id.
`at col. 4, ll. 27–28. The appendage may be in the form of a dildo. Id. at col.
`8, ll. 24–31.
`
`E. Illustrative Claims
`Claims 1 and 12 are representative of the challenged claims and read
`as follows:
`
`1. A stimulation device comprising:
`a chamber having a flexible wall portion
`a drive unit in physical communication with the flexible
`wall portion so as to cause deflections of the flexible wall
`portion in opposing direction, thereby resulting in a changing
`volume of the chamber,
`the changing volume of the chamber resulting in
`modulating positive and negative pressures with respect to a
`reference pressure;
`an opening for applying the modulated positive and
`negative pressures to a body part;
`a control device for controlling the drive unit; and
`an appendage, wherein the appendage is a dildo
`configured to be inserted into a vagina.
`
`12. A method comprising:
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`causing deflections of a flexible wall portion of a
`chamber of a stimulation device in opposing directions, thereby
`resulting in a changing volume of the chamber, the changing
`volume of the chamber resulting in modulated positive and
`negative pressures with respect to a reference pressure; and
`applying the modulated positive and negative pressures
`to a body part through an opening, wherein the stimulation
`device is positioned by the user for applying the modulated
`positive and negative pressures using an appendage of the
`stimulation device, wherein the appendage is a dildo configured
`to be inserted into a vagina.
`
`
`F. Evidence
`Petitioner relies on the following references:
`Taylor, US 5,725,473, issued March 10, 1998. (Ex. 1004) (“Taylor”).
`Hovland et al., US 6,964,643 B2, issued November 15, 2005. (Ex.
`1005) (“Hovland”).
`Guan, CN2153351Y, issued December 11, 1993. (Ex. 1007)
`(“Guan”).
`Lee, US 7,828,717 B2, issued November 9, 2010. (Ex. 1006) (“Lee”).
`Petitioner also relies on the declarations of Michael R. Prisco, P.E.,
`Ph.D., Exs. 1002 and 1018, and the declaration of Richard Meyst. Ex. 1020.
`Patent Owner relies on the declarations of Morton Olgaard Jensen, Ph. D.,
`Dr. Med. (Exs. 2001 and 2026) and Debra Herbenick, Ph.D. (Ex. 2004 and
`2028).
`
`G. Prior Art and Asserted Grounds
`Petitioner asserts that claims 1–30 would have been unpatentable on
`the following grounds:
`Claim(s) Challenged
`1–9, 12–24, 26–30
`1–30
`1–30
`
`Reference(s)/Basis
`Taylor
`Taylor, Hovland
`Guan, Lee, Hovland
`
`35 U.S.C. §
`102
`103
`103
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`
`II. ANALYSIS
`A. Legal Standards
`1. Burden
`In an inter partes review, the burden of proof is on the Petitioner to
`show that the challenged claims are unpatentable, and that burden never
`shifts to the patentee. 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l,
`Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016).
`2. Anticipation
`Section 102(a) provides that “[a] person shall be entitled to a patent
`unless . . . the claimed invention was patented [or] described in a printed
`publication . . . before the effective filing date of the claimed invention.”
`35 U.S.C. § 102(a)(1) (2018).2 Accordingly, unpatentability by anticipation
`requires that the four corners of a single, prior art document describe every
`element of the claimed invention, either expressly or inherently, arranged as
`in the claims. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369
`(Fed. Cir. 2008); Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed.
`Cir. 1999); In re Paulsen, 30 F.3d 1475, 1479 (Fed. Cir. 1994).
`3. Obviousness
`The question of obviousness is resolved on the basis of underlying
`factual determinations including (1) the scope and content of the prior art,
`(2) any differences between the claimed subject matter and the prior art, (3)
`
`
`2 The provisions of the Leahy-Smith America Invents Act (“AIA”) regarding
`novelty and obviousness apply to patents containing at least one claim
`having an effective filing date on or after March 16, 2013. Pub L. 112–29,
`125 Stat. 284 (2011). On its face, the ’097 patent has an effective filing date
`of July 24, 2015. Therefore, the AIA provisions of 35 U.S.C. §§ 102 and
`103 apply to this decision.
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`the level of skill in the art, and (4) where in evidence, so-called secondary
`considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). If the
`differences between the claimed subject matter and the prior art are such that
`the subject matter, as a whole, would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains, the claim is unpatentable under 35 U.S.C. § 103.
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007).
`A proper § 103 analysis requires “a searching comparison of the
`claimed invention—including all its limitations—with the teaching of the
`prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
`“Obviousness requires more than a mere showing that the prior art
`includes separate references covering each separate limitation in a claim
`under examination.” Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352,
`1360 (Fed. Cir. 2011). “Rather, obviousness requires the additional showing
`that a person of ordinary skill at the time of the invention would have
`selected and combined those prior art elements in the normal course of
`research and development to yield the claimed invention.” Id.
`“[O]bjective evidence of nonobviousness includes copying, long felt
`but unsolved need, failure of others, commercial success, unexpected results
`created by the claimed invention, unexpected properties of the claimed
`invention, licenses showing industry respect for the invention, and
`skepticism of skilled artisans before the invention.” In re Rouffet, 149 F.3d
`1350, 1355 (Fed. Cir. 1998) (citations omitted). “For objective [evidence of
`secondary considerations] to be accorded substantial weight, its proponent
`must establish a nexus between the evidence and the merits of the claimed
`invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010)
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`(alterations in original) (quoting In re GPAC Inc., 57 F.3d 1573, 1580 (Fed.
`Cir. 1995)).
`
`B. Level of Ordinary Skill in the Art
`The level of ordinary skill in the art is a factual determination that
`provides a primary guarantee of objectivity in an obviousness analysis. Al-
`Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing
`Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-
`Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)).
`In our Decision on Institution, we adopted Petitioner’s proposed
`definition of one skilled in the art as an individual with “a bachelor’s degree
`in mechanical engineering, biomechanical engineering, or the equivalent,
`and three or more years of experience in fluid mechanics and pump-based
`medical devices,” and Petitioner’s proposal that “practical experience could
`qualify one not having the aforementioned education as a [person of
`ordinary skill in the art], while a higher level of education could offset lesser
`experience.” Dec. 6–7.
`Patent Owner renews its argument that in addition to the education
`level recited above, a person of ordinary skill in the art would have “three or
`more years of experience in research, development, or design of devices that
`interact with the human female body (and specifically the vulva).” Resp. 4.
`Patent Owner supports this contention by citing to the Technical Field
`discussion in the Specification where it states that field relates to “a
`stimulation device … for erogenous zones, in particular for the clitoris.” Id.
`at 3 (citing Ex. 1001, col. 1, ll. 17–20). Patent Owner also contends that the
`claims support this definition as the claims
`explicitly define a stimulation device with “an opening for
`applying the modulated positive and negative pressures to a body
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`part” and a dildo appendage “configured to be inserted into a
`vagina” and associated methods of applying the modulated
`pressures to a body part, by the user having positioned the device
`using the vaginal dildo.
`Resp. 3–4 (citing Ex. 1001, claims 1, 12, 17, and 26).
`We have considered Patent Owner’s argument and are not persuaded
`that our original definition of a person of ordinary skill in the art was in
`error. We do not agree that one of ordinary skill in the art requires such
`specific expertise for the subject matter set forth in the field of invention or
`the claims of the ’097 patent. A “hypothetical ‘person having ordinary skill
`in the art’ to which the claimed subject matter pertains would, of necessity
`have the capability of understanding the scientific and engineering principles
`applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394
`(BPAI 1988). Although the device disclosed in the ’097 patent is a sexual
`stimulation device, the scientific and engineering principles applicable to the
`claimed device and method involve mechanical engineering and fluid flow
`that are not necessarily specific to the application of the device.
`As we previously noted in our Decision on Institution:
`While the invention generally relates to a device for stimulating
`female erogenous zones, as seen from the discussion below, the
`design and operation of the device largely relates to issues of
`mechanical engineering and fluid flow. Thus, we conclude that
`experience in developing devices that interact with the female
`body is not needed to define a person of ordinary skill in the art.
`Dec. 7.
`Based on the forgoing, we continue to apply the same definition of a
`person of ordinary skill in the art we used in our Decision Denying
`Institution.
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`C. Claim Construction
`We interpret a claim “using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
`282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the
`claim “in accordance with the ordinary and customary meaning of such
`claim as understood by one of ordinary skill in the art and the prosecution
`history pertaining to the patent.” Id. Furthermore we need only construe the
`claims to the extent necessary to determine the patentability of the
`challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean
`Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe
`terms ‘that are in controversy, and only to the extent necessary to resolve the
`controversy . . . .’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 795, 803 (Fed. Cir. 1999))).
`After considering all of the arguments presented by the parties we find
`that it is only necessary to construe the term “reference pressure.” Although
`the parties have also presented arguments concerning the construction of the
`term “pressure field generator,” we determine that it is not necessary to
`construe that term to determine the patentability of the challenged claims in
`light of the asserted grounds.3
`1. Reference Pressure
`In our Decision Denying Institution, we construed the term “reference
`pressure” to mean “a prevailing pressure within the device prior to placing
`
`
`3 In section IX of its Reply, Petitioner presents argument that we were
`somehow misled by changes to the Specification of the ’097 patent relating
`to the term “pressure field generator.” Reply 27–28. As we declined to
`construe the term in our decision on institution and in this final decision, we
`do not address the arguments presented in Section IX of the Reply.
`
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`the stimulation device on the area of the skin to be stimulated.” Dec. 10.
`While Patent Owner agrees with this construction, Petitioner contends that
`we improperly limited the construction to one example in the Specification.
`Resp. 19; Reply 9.
`In the Petition, Petitioner originally asserted that the “reference
`pressure” is “atmospheric pressure.” See Pet. 22 (stating “[w]hen the
`bellows 160 is neither compressed nor expanded, the air within the bellows
`160 is at atmospheric pressure (i.e., the reference pressure)”). In its Reply,
`Petitioner presents a new interpretation of the term “reference pressure,”
`contending that the term should be construed to mean a “given” pressure
`around which higher or lower pressures are generated for stimulating the
`body, which may be determined prior to application or after application of
`the device to the target body part. Reply 10. In support of this construction,
`Petitioner points to the discussion in the Specification involving pressures
`above and below systolic pressure. Id. (citing Ex. 1001, col. 11–57.).
`Patent Owner contends that Petitioner is presenting a new argument
`not raised in the initial petition. Sur-Reply 2. Patent Owner argues that
`Petitioner has improperly argued that the construction adopted by the Board
`is limited to atmospheric pressure. Id. at 4. Patent Owner also contends that
`Petitioner’s arguments with regard to systolic pressure are without merit and
`that the Board’s original construction is proper. Id. at 5–6.
`We have considered the arguments advanced by the parties and the
`evidence of record, and conclude that our original construction was proper.
`Contrary to Petitioner’s contention, the construction is not limited to a single
`example, but is consistent with the overall teachings of the Specification.
`See, e.g., Ex. 1001, col. 5, ll. 5–27; col. 15, ll. 34–37; Figure 14. The
`construction we adopted is not limited to atmospheric pressure (as originally
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`proposed in the Petition), but refers generally to the prevailing pressure in
`the device before it is applied to the body as described in the Specification of
`the ’097 patent. This refers to the pressure within the device regardless of
`the environment in which it is used. For instance, the Specification of the
`’097 patent lists additional environments to include “a liquid medium, such
`as water or commercially available lubricant.” Id. at col. 5, ll. 5–27.
`Even if we consider Petitioner’s new claim construction argument as
`being properly presented in its Reply, Petitioner’s argument regarding
`systolic pressure is unconvincing. The entire paragraph regarding systolic
`pressure reads
`Assuming that in the first state the pressure in the chambers 3
`and 4 corresponds to the currently prevailing external reference
`pressure (air pressure for example), the overall pressure that is
`present in the second state will be lower than the external
`reference pressure. This negative pressure is set such that it is
`preferably lower than the usual systolic blood pressure in the
`blood vessels of the body part 11. The blood circulation in this
`area thus increases, and the clitoris 12 is better supplied with
`blood in the second state.
`Ex. 1001, col. 11, ll. 49–57. It is clear that, when read in context, the
`reference pressure referred to in this paragraph is the prevailing pressure in
`the device before the device is applied to the body part. Moreover, only the
`negative pressure is set with regard to systolic pressure, not the positive
`pressure. Id.
`Based on the foregoing, we maintain our original construction of the
`term “reference pressure” as “a prevailing pressure within the device prior to
`placing the stimulation device on the area of the skin to be stimulated.”
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`D. Anticipation by Taylor
`Petitioner contends that claims 1–9, 12–24, and 26–30 are anticipated
`by Taylor. Pet. 19.
`
`1. Taylor
`Taylor discloses a sexual aid that includes a means for introducing a
`vacuum to stimulate the clitoris. Ex. 1004, Abst. In this embodiment, the
`device comprises a suction cup which engages the upper portion of the
`vulva. Id. at col. 5, ll. 28–30. The suction cup is in fluid communication with
`a bellows that cyclically introduces a vacuum within the suction cup. Id. at
`col. 5, ll. 32–38. The cyclical vacuum stimulates the clitoris. Id. at ll. 40–41.
`Taylor discloses:
`Referring to FIG. 3, an alternative embodiment of the
`drive mechanism is shown with the motor 18 mounted on the arm
`26. As in the original embodiment the lever 22 mounted 55 on
`the output shaft 20 of the motor 18 is pivotally mounted on the
`connecting rod 36. The connecting rod 36 is pivotally mounted
`on the housing 12. As the output shaft 20 rotates, the lever 22
`urges the connecting rod 36 against the housing 12 oscillating the
`arm 26 along with the motor 18.
`Ex. 1004 col. 4, ll. 52–59. Petitioner’s annotated version of an excerpt of
`Taylor Figure 3 is reproduced below.
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`Excerpt of Figure 3 of Taylor as annotated by Petitioner to show the
`relationship of the drive unit to the bellows. Pet. 20.
`
`
`Taylor goes on to disclose:
`Referring only to FIG. 3, a second embodiment of the first
`stimulator 154 is shown. The first stimulator 154 includes a
`suction cup member 156 that conformingly and sealingly 30
`receives the upper portion of the vulva. The suction cup member
`156 of the first stimulator 154 is more specifically directed at
`receiving the clitoris. The suction cup member 156 is in fluid
`communication with a bellows 160 or squeeze ball (not shown)
`via flexible conduit 162. As the arm 26 oscillates relative to the
`housing, the arm 26 compresses and expands the bellows 160
`relative to the housing 12. The arm 26 and bellows 160 cyclically
`introduce a vacuum in the volume defined by the suction cup
`member 156 and the portion of the vulva received therein. The
`cyclical vacuum phenomenon stimulates the clitoris.
`Ex. 1004, col. 5, ll. 28–41.
`2. Analysis of Claim 1
`Petitioner contends that each of the limitations of claim 1 is disclosed
`by Taylor. Pet. 19. Patent Owner contends that Taylor does not teach the
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`following limitations of claim 1: (1) the changing volume of the chamber
`resulting in modulating positive and negative pressures with respect to a
`reference pressure; (2) an opening for applying the modulated positive and
`negative pressures to a body part; and (3) a control device for controlling the
`drive unit. Because we agree with Patent Owner that Petitioner has failed to
`show that Taylor teaches these three limitations, we determine that Petitioner
`has failed to show by a preponderance of the evidence that Taylor
`anticipates claim 1 of the ’097 patent. We focus only on these limitations in
`our analysis below.
`a) The changing volume of the chamber resulting in modulated positive
`and negative pressures with respect to a reference pressure
`Petitioner contends that the bellows of Taylor produces modulated
`positive and negative pressures with respect to a reference pressure, and thus
`satisfies this limitation. Pet. 22–23. In particular, Petitioner contends that
`when the bellows is in a position where it is neither contracted nor
`expanded, the air within the bellows is at atmospheric pressure—i.e., the
`reference pressure. Id. Petitioner contends that when the bellows expands,
`the pressure in the bellows falls below atmospheric pressure—a negative
`pressure. Id. Petitioner contends that as the bellows contracts past the
`midpoint, the air pressure increases above atmospheric pressure—i.e., a
`positive pressure. Id. Petitioner supports these contentions with the
`testimony of Dr. Prisco and Mr. Meyst. Id.; Reply 12–17; Ex. 1002 ¶¶ 58–
`74; Ex. 1020 ¶ 64.
`Patent Owner contends that Taylor discloses a device that only
`provides suction, i.e., negative pressure. Resp. 46. Patent Owner argues that
`Taylor does not disclose the use of positive pressure let alone modulating
`between positive and negative pressure. Id. Patent Owner contends that the
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`portions of Taylor cited by Petitioner do not disclose modulated positive and
`negative pressures with respect to a reference pressure, but are limited to
`varying negative pressure. Id. at 47.
`Patent Owner further contends that Petitioner’s argument is based on
`inherency and that Petitioner has failed to show that the mode of operation
`ascribed to Taylor by Petitioner’s expert is necessarily present and that one
`skilled in the art would recognize that it is present. Id. at 47–48. Patent
`Owner also contends that Petitioner’s argument relies on unsupported
`attorney argument and unsupported expert testimony. Id. at 48. Patent
`Owner contends that Petitioner’s argument is premised on Taylor’s bellows
`160 at some point in operation being in a position that is neither fully open
`nor fully closed resulting in atmospheric pressure as the reference pressure.
`Id. Patent Owner contends that there is no basis for this assumption in
`Taylor as Taylor does not disclose such a point. Patent Owner contends that
`Taylor teaches that the bellows operates to provide a cyclic vacuum to the
`suction cups. Id. (citing Ex. 2026 ¶¶ 122, 128).
`Patent Owner explains:
`As the bellows expands it creates a vacuum pulling air
`flow into the bellows—i.e., creating negative pressure with
`respect to the reference Pressure. Id. As the bellows
`compresses, the vacuum releases and pressure in the bellows
`returns toward the reference pressure, i.e., the prevailing
`pressure of the sexual aid. Id. This cycle is illustrated below.
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`Id. ¶ 123. Although pressure within the bellows during
`compression may increase in the negative pressure region and
`may approach or reach atmospheric pressure, pressure within
`the bellows is never positive with respect to the reference
`pressure, which is required by the claims of the ’097 patent. Id.
`Resp. 50.
`In its Reply, Petitioner applies its construction for “reference
`pressure,” which we have rejected above, and contends that the reference
`pressure can be the pressure in the device shortly after it begins operation.
`Reply 11. Petitioner states:
`The claimed reference pressure could instead be a reference
`pressure prior to activating the device or after (e.g.,
`immediately after) applying the device [to] the vulva. Taylor
`discloses compressing and then expanding the bellows after
`applying member 156 to the vulva, resulting in a positive and
`negative pressure relative to the pressure in bellows 160 (i.e.,
`the reference pressure).
`Reply 11 (citing Pet. 21; Ex. 1004, col. 5, ll. 29–40; Ex. 1002 ¶¶ 57–58, 74;
`Ex. 1018 ¶ 55; Ex. 1020 ¶¶ 55–56). Petitioner contends that using this
`definition of reference pressure, the cyclic vacuum of Taylor meets this
`limitation as the vacuum increases and decreases relative to the pressure
`shortly after activation. Id. at 11–12.
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`Petitioner also contends that when the suction cups are first applied, it
`creates a positive pressure with respect to the reference pressure and that the
`operation of the bellows would create a modulation of positive and negative
`pressure with respect to the reference pressure as it defines it as a “given
`pressure” during operation of the device. Id. at 12–16. Petitioner also
`contends that Taylor’s disclosure that the suction cups seal against the skin
`does not preclude the presence of a positive pressure with respect to the
`reference pressure. Id. at 15–16.
`In sur-reply, Patent Owner contends that Petitioner’s argument is
`based on the incorrect assumption that the “reference pressure” can be any
`arbitrary “given pressure.” Sur-Reply 9. Patent Owner also contends that
`Petitioner’s argument with respect to the pressure in the suction cup being a
`positive pressure is unsupported by the record and is a new theory that
`should be disregarded. Id. at 10.
`We have considered the arguments of the parties and the evidence of
`record and conclude that Petitioner has not demonstrated that Taylor
`discloses that the changing volume of the bellows results in modulation of
`positive and negative pressures with respect to a reference pressure.
`First, Petitioner is basing its argument on a shifting and incorrect
`claim construction that “reference pressure” may include any “‘given’
`pressure around which higher and lower pressures are generated for
`stimulating the body, which may be determined prior to application or after
`application of the device to the target body part.” Compare Reply 10, with
`Pet. 21–23 (stating “reference pressure” is “atmospheric pressure”). Based
`on such reliance on an incorrect claim construction alone, we find that
`Taylor does not disclose the changing volume of the chamber resulting in
`modulated positive and negative pressures with respect to a reference
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`pressure. But even if we were to adopt Petitioner’s erroneous claim
`construction, we find Petitioner’s substantive arguments concerning the
`teachings of Taylor are unavailing.
`Petitioner’s contentions with respect to this limitation are also based
`on the erroneous premise that the bellows in Taylor must necessarily start in
`a positon that is neither fully expanded nor fully compressed. Pet. 22 (stating
`“[w]hen bellows 160 is neither compressed nor expanded, the air within
`bellows 160 is at atmospheric pressure (i.e., the reference pressure)) (citing
`Ex. 1002 ¶¶ 58, 74; Ex. 1020 ¶ 64). Taylor, however is silent as to the
`starting position of the bellows. See Ex. 1004 col. 5, ll. 27–49; Ex. 2026
`¶ 121. Petitioner’s declarant, Mr. Meyst, confirms this silence by drawing a
`negative inference from such silence that does not meet the inherency test. In
`particular, Mr. Meyst testifies:
`It is my opinion that pressures above and below the
`initial pressure would be generated by Taylor. This is at least
`because there is no reason to assume that an initially generated
`positive pressure in suction cup member 156 immediately after
`it is applied to the vulva would somehow be contrary to the
`operation of Taylor, and because there is no teaching that the
`device must begin operation with the bellows at its smallest
`volume.
`Ex. 1020 ¶ 64 (emphasis added).
`Thus, we agree with Patent Owner that Petitioner appears to argue that
`the starting positon would inherently be neither fully compressed nor fully
`expanded, see Resp. 48–50, which is simply not supported by Taylor or the
`testimony of Petitioner’s declarants.
`“A reference may anticipate inherently if a claim limitation that is not
`expressly disclosed ‘is necessarily present, or inherent, in the single
`anticipating reference.’ The inherent result must inevitably result from the
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`disclosed steps; ‘[i]nherency . . . may not be established by probabilities or
`possibilities.’” In re Montgomery, 677 F.3d 1375, 1379–80 (Fed. Cir. 2012)
`(citations omitted, alterations in original).
`We discern nothing in Taylor, the testimony of Dr. Prisco, or the
`testimony of Mr. Meyst to support the conclusion that the device in Taylor
`starts with the bellows in a positon that is neither expanded nor compressed.
`See Ex. 1004, col. 5, ll. 27–49, Ex. 1002¶¶ 58; Ex. 1020 ¶ 64. In fact, given
`that Taylor explicitly teaches that the bellows acts to create a cyclic vacuum,
`one skilled in the art is just as likely to conclude that the bellow starts in the
`fully compressed positon creating a stronger vacuum as the bellows is
`expanded. See Ex. 1004, col. 5, ll. 27–49; Ex. 2026 ¶¶ 121 (stating “Taylor
`describes a bellows for cyclically introducing only a vacuum . . . a POSITA
`would understand a bellows selected for purposes of creating a vacuum to
`provide unidirectional medium flow”).
`For instance, as Dr. Jen