`Tel: 571-272-7822
`
`Paper 41
`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
`
`
`
`IPR2020-00007
`Patent 9,849,061 B2
`
`INTRODUCTION
`I.
`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
`
`2
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`IPR2020-00007
`Patent 9,849,061 B2
`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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`3
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`Patent 9,849,061 B2
`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.
`
`
`
`4
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`IPR2020-00007
`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.
`
`5
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`Patent 9,849,061 B2
`
`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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`6
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`Patent 9,849,061 B2
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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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`7
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`IPR2020-00007
`Patent 9,849,061 B2
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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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`8
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`Patent 9,849,061 B2
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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,
`102(a)(1)
`Taylor4
`17–19, 21, 23–26
`1–3, 5, 7, 8, 11, 14,
`15, 17–19, 21–26
`20
`20
`
`Taylor, Hovland5
`103
`Taylor, Zipper6
`103
`Taylor, Zipper, Hovland
`103
`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
`
`11
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`IPR2020-00007
`Patent 9,849,061 B2
`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.
`
`17
`
`
`
`IPR2020-00007
`Patent 9,849,061 B2
`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
`
`18
`
`
`
`IPR2020-00007
`Patent 9,849,061 B2
`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
`
`19
`
`
`
`IPR2020-00007
`Patent 9,849,061 B2
`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 referenc