Court Opinion

ID: 9841132
Source: CourtListenerOpinion
Date Created: 2023-09-21 15:01:12.39158+00
Date Added: 2024-06-11T08:39:33.482442
License: Public Domain

Case: 21-1985    Document: 64    Page: 1   Filed: 09/21/2023

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

                   ELEKTA LIMITED,
                       Appellant

                            v.

           ZAP SURGICAL SYSTEMS, INC.,
                       Appellee
                ______________________

                        2021-1985
                  ______________________

     Appeal from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in No. IPR2019-
 01659.
                  ______________________

                Decided: September 21, 2023
                  ______________________

     JENNIFER LIBRACH NALL, DLA Piper US LLP, Austin,
 TX, argued for appellant. Also represented by STANLEY JO-
 SEPH PANIKOWSKI, III, San Diego, CA; AARON PATRICK
 BOWLING, Arnold & Porter Kaye Scholer LLP, Chicago, IL.

     APRIL ELIZABETH ISAACSON, Kilpatrick Townsend &
 Stockton LLP, San Francisco, CA, argued for appellee.
 Also represented by ANDREW JAMES ISBESTER; MATTHEW
 MEYER, Menlo Park, CA.
                 ______________________

     Before REYNA, STOLL, and STARK, Circuit Judges.
Case: 21-1985     Document: 64     Page: 2    Filed: 09/21/2023

 2               ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.

 REYNA, Circuit Judge.
     Appellant Elekta Limited appeals from a Final Written
 Decision of the United States Patent Trial and Appeal
 Board that found certain claims of U.S. Patent No.
 7,295,648 unpatentable as obvious. Elekta challenges the
 Board’s findings related to motivation to combine and rea-
 sonable expectation of success. We affirm.
                         BACKGROUND
                  U.S. Patent No. 7,295,648
     Elekta Limited (“Elekta”) is the owner of U.S. Patent
 No. 7,295,648 (the “’648 patent”), titled “Method and appa-
 ratus for treatment by ionizing radiation.” J.A. 2–3. The
 ’648 patent discloses a device for treating a patient with
 ionizing radiation for certain types of radiosurgery and ra-
 diation therapy. ’648 patent, 1:6–8. The invention uses a
 radiation source, e.g., a linear accelerator (referred to as a
 “linac”), mounted on a pair of concentric rings to deliver a
 beam of ionizing radiation to the targeted area on the pa-
 tient. See id. at 4:4–13; see also id. at 4:33–34; see also id
 at 7:24–25. Figures 5 and 7 illustrate the claimed device
 features.
 Id. at Figs. 5 & 7.

     Figure 5 shows the claimed apparatus’ interior struc-
 ture from the foot end with the patient table [18] and all
 exterior covers removed. Id. at 5:8–9; id. at 7:5–6. Figure
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 ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.                 3

 7 shows the claimed apparatus’ interior structure from the
 head end. See id. at 5:10–12. A rotatable ring [24] is sup-
 ported by a mounting ring [20]. Id. at 7:12–13. The rotat-
 able ring [24] rotates around the patient [18]. Id. at 7:13–
 14. Extending out of the rotatable ring [24] are two mount-
 ing brackets [26, 28], which provide a pivotal mounting
 point [30]. Id. at 7:14–23. A linac [32] is mounted to the
 pivotal mounting point [30], and a motor [36] is used
 around the linac housing [34] to assist in rotating the linac
 [32] around the pivotal mounting point [30]. Id. at 7:24–
 27. The apparatus allows the linac to be manipulated such
 that it can move closer to and further from the patient and
 approach the patient at various angles. Id. at 7:31–34.
 This movement allows for the delivery of ionizing radiation
 to different target areas from different angles on the pa-
 tient, as well as in differing intensities. See id. at 7:41–49.
     The ’648 patent contains apparatus and method
 claims. There is one independent, apparatus claim (Claim
 1) and one independent, method claim (Claim 18). We do
 not find it necessary to reach Claim 18. The parties agree
 that Claim 1 is illustrative. Claim 1 recites:
     1. A device for treating a patient with ionising ra-
     diation comprising:
         a ring-shaped support, on which is provided a
         mount,
         a radiation source attached to the mount;
         the support being rotateable about an axis co-
         incident with the centre of the ring;
         the source being attached to the mount via a
         rotateable union having a [sic] an axis of rota-
         tion axis which is non-parallel to the support
         axis;
         wherein the rotation axis of the mount passes
         through the support axis of the support and the
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 4                 ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.

         radiation source is collimated so as to produce
         a beam which passes through the co-incidence
         of the rotation and support axes.
 Id. at 9:54–67.
     On September 27, 2019, ZAP Surgical Systems, Inc.
 (“ZAP”) filed before the United States Patent Trial and Ap-
 peal Board (“Board”) a petition for inter partes review
 (“IPR”) challenging claims 1–4, 7–13, 16–18, 20, and 22–23
 of the ’648 patent. On April 1, 2020, the Board instituted
 an IPR on all grounds asserted in the petition. The petition
 relied on several prior art references, but pertinent to this
 appeal are three references: U.S. Patent No. 4,649,560
 (“Grady”); a publication, K.J. Ruchala et al., Megavoltage
 CT image reconstruction during tomotherapy treatments,
 PHYS. MED. BIOL. 45, 3545–3362 (2000) (“Ruchala”); and
 U.S. Patent No. 4,998,268 (“Winter”).
      Grady discloses an X-ray tube mounted on a sliding
 arm connected to a rotating support. Grady, Abstract. Fig-
 ure 1 illustrates the X-ray stand, where inner rings [3, 4]
 rotate around the patient lying on the table [T]. Id. at
 1:46–52. Figures 1 and 2 illustrate a rectangular sleeve [8]
 that extends from the rings, in which an arm [9] slides via
 motor drive. Id. at 1:53–56. The outer end of the arm [9]
 is connected to a carriage [10], which carries an X-ray tube
 that is rotated around a patient to take X-ray images. See
 id. at 1:56–66.
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 ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.             5

     Grady Figures 1 and 2 are illustrated as follows:

 Id. at Fig. 1.

 Id. at Fig. 2.
    Ruchala discloses a linac-based tomotherapy treat-
 ment system, whereby, like a computerized tomography
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 6               ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.

 (“CT”) scanner, “the patient remains still, but the linac and
 detector rotate about the patient” to deliver a treatment
 dose to the target tumor. J.A. 2147; see also J.A. 2144–61.
 Ruchala notes that the linac is fitted with a “multileaf col-
 limator” to “allow for a highly conformal treatment that
 will deliver [a] dose to the tumour while sparing sensitive
 structures.” J.A. 2144. The CT imaging capability, accord-
 ing to Ruchala, ensures “properly positioning the patient’s
 body and interior organs” and “know[ledge] that the treat-
 ment was delivered as intended.” Id.
     Winter—relied on as background art in the petition—
 discloses the “combination [of] a diagnostic CT scanner us-
 ing radiant energy for imaging,” which is used “for thera-
 peutically irradiating a target.” Winter, Abstract; see J.A.
 7. It touted the combination as “provid[ing] more accurate
 localization of the area to be irradiated than prior art use
 of the gamma knife as a standalone radiation therapy
 unit.” Winter, 2:23–26. According to Winter, this is be-
 cause the combination allows for “more accurate position-
 ing of the patient due to the fact that a single device having
 diagnostic imaging capability is used for both imaging and
 therapy purposes.” Id. at 2:41–45.
              BOARD’S FINAL WRITTEN DECISION
     On March 30, 2021, the Board issued its Final Written
 Decision, concluding that all the challenged claims were
 unpatentable as obvious. Specifically, the Board found
 that claims 1–4, 7–8, 11, 12, 17, 18, 20, and 23 were obvious
 over the combination of Grady and Ruchala (and inde-
 pendently obvious over the combination of U.S. Patent No.
 5,207,223 (“Adler”), and Grady); and that claims 9, 10, 13,
 16, and 22 were obvious over of the combination of Grady,
 Ruchala, and U.S. Patent No. 5,945,684 (“Lam”) (and
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 ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.                7

 independently obvious over the combination of Adler,
 Grady, and Lam). J.A. 70. 1
     The Board addressed Elekta’s arguments that a skilled
 artisan would not have been motivated to combine, and
 would not have had a reasonable expectation of success in
 combining, the Grady device with the linac described in
 Ruchala. See J.A. 27–36. The Board also considered
 whether a skilled artisan would have been dissuaded from
 combining the devices because one device was an imaging
 device, rather than a radiation device, and because the
 linac’s weight would render the Grady device inoperable,
 imprecise, and unsuitable for treatment. J.A. 34–35. The
 Board concluded that a skilled artisan would have been
 motivated to combine Grady and Ruchala. J.A. 36.
     Elekta appealed. We have jurisdiction under 28 U.S.C.
 § 1295(a)(4)(A).
                    STANDARD OF REVIEW
     We review the Board’s legal conclusions de novo and its
 factual findings for substantial evidence. ACCO Brands
 Corp. v. Fellowes, Inc., 813 F.3d 1361, 1365 (Fed. Cir.
 2016). Substantial evidence means “such relevant evi-
 dence as a reasonable mind might accept as adequate to
 support a conclusion.” In re Gartside, 203 F.3d 1305, 1312
 (Fed. Cir. 2000) (citation omitted).
     Obviousness is a question of law with underlying fac-
 tual issues relating to the “scope and content of the prior
 art, differences between the prior art and the claims at is-
 sue, the level of ordinary skill in the pertinent art, and any
 objective indicia of non-obviousness.” Randall Mfg. v. Rea,

     1    Elekta also moved during the proceeding to amend
 its claims. J.A. 2; J.A. 67–68; J.A. 71. The Board denied
 that motion. J.A. 71. Elekta does not challenge that denial
 on appeal.
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 8              ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.

 733 F.3d 1355, 1362 (Fed. Cir. 2013) (first citing KSR Int’l
 Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007); then citing
 Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–
 18 (1966)). Whether a skilled artisan would have been mo-
 tivated to combine references or would have had a reason-
 able expectation of success in combining references are
 questions of fact reviewed for substantial evidence. Re-
 gents of Univ. of California v. Broad Inst., Inc., 903 F.3d
 1286, 1291 (Fed. Cir. 2018).
                         DISCUSSION
     On appeal, Elekta makes three principal arguments:
 that the Board’s findings on a motivation to combine are
 unsupported by substantial evidence, Appellant’s Br. 26;
 that the Board failed to make any findings, explicit or im-
 plicit, on a reasonable expectation of success, id. at 4, 18;
 and that even had the Board made such findings, those
 findings are not supported by substantial evidence, id. at
 2.
                               I
     We first address Elekta’s argument that a skilled arti-
 san would not have been motivated to combine prior art
 references disclosing radiation imagery with the references
 disclosing radiation therapy. Appellant’s Br. 26.
     Obviousness requires, inter alia, a finding that a
 skilled artisan would have been motivated to combine the
 teachings of prior art in such a way that the combination
 discloses the claimed limitations. See OSI Pharms., LLC
 v. Apotex Inc., 939 F.3d 1375, 1382 (Fed. Cir. 2019). The
 inquiry into the existence of a motivation to combine as-
 sumes that a skilled artisan is a person of ordinary creativ-
 ity with common sense, common wisdom, and common
 knowledge. See Fleming v. Cirrus Design Corp., 28 F.4th
 1214, 1223 (Fed. Cir. 2022). Thus, an obviousness deter-
 mination does not always require prior art to expressly
 state a motivation for every obvious combination. See, e.g.,
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 ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.               9

 id. Nor does an obviousness showing “require that a par-
 ticular combination must be the preferred, or the most de-
 sirable, combination described in the prior art in order to
 provide motivation for the current invention.” Novartis
 Pharms. Corp. v. West-Ward Pharms. Int’l Ltd., 923 F.3d
 1051, 1059 (Fed. Cir. 2019) (citation omitted).
     Elekta contends that “[n]o substantial evidence sup-
 ports the Board’s finding that there was a motivation to
 combine these references by replacing the X-ray imaging
 source in Grady with a linac therapeutic source as proposed
 in the Petition,” because the linac “ionising radiation
 source [would] not offer any imaging improvement and also
 requires extreme precision due to its potentially lethal side
 effects.” Appellant’s Br. 29, 31. According to Elekta, the
 Grady device is for imaging and does not contemplate a
 heavy linac or account for the lack of precision that would
 result from the linac’s additional weight. Id. at 30–31.
     The Board acknowledged Elekta’s argument that a
 skilled artisan would not have been motivated to combine
 Grady and Ruchala because the weight of the linac would
 render the device essentially inoperable and thereby fail to
 provide a viable solution for focusing therapeutic radiation
 on the target. See J.A. 31–33. But the Board found that
 heavy linacs were known in the art during the pertinent
 period and that their weight could be adequately handled
 by robotic arms. J.A. 35. The Board supported this conclu-
 sion by reviewing “the prosecution of the ’648 patent,
 [which demonstrated that] patents directed to imaging de-
 vices were cited, and were not distinguished based on an
 argument that imaging devices were not relevant art.” J.A.
 32. In addition, the Board framed the pertinent field as one
 that “includes the engineering design of sturdy mechanical
 apparatus[es] capable of rotationally manipulating heavy
 devices in three dimensions oriented in a variety of ap-
 proach angles with high geometrical accuracy, in the con-
 text of the radiation imaging and radiation therapy
 environment.” J.A. 34 (emphasis added). The Board
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 10             ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.

 credited ZAP’s expert as having experience with such de-
 vices. Id. It also recognized the differences between radi-
 ation imaging devices and radiation therapy devices, and it
 found that a skilled artisan would not have been dissuaded
 from combining the references based on these differences.
 See J.A. 35.
      The Board determined that “persons of ordinary skill
 in the applicable art would have readily understood the ad-
 vantages of the three-dimensional manipulation capabili-
 ties of the Grady approach” and not been dissuaded by the
 “difficulty in accommodating heavy linacs” or the need for
 “precision” in making that combination. Id. On that basis,
 the Board determined that a skilled artisan would have
 been motivated to combine the references disclosing radia-
 tion imaging with references disclosing radiation therapy.
 J.A. 36.
      We hold that the Board’s finding that a skilled artisan
 would have been motivated to combine the Grady device
 with Ruchala’s linac is supported by substantial evidence,
 including the prosecution history of the ’648 patent, the
 teachings of the asserted prior art references, and the ex-
 pert testimony of record. Specifically, as explained above,
 during prosecution, the patentee notably did not argue that
 prior art references directed to imaging devices were not
 relevant art. See J.A. 32 (citing J.A. 949–81). In addition,
 Ruchala teaches that combining imaging with the delivery
 of radiation is advantageous because it can improve the ac-
 curacy of radiation delivery and verify that the dose of ra-
 diation was received.       See, e.g., J.A. 2144, Abstract.
 Another prior art reference in the record before the Board,
 Winter, discloses that combining an imaging system with
 a radiation source is preferable because it allows for “more
 accurate positioning of the patient due to the fact that a
 single device having diagnostic imaging capability is used
 for both imaging and therapy purposes.” Winter, 2:41–45.
 And ZAP’s expert, Dr. McCarthy, opined that a person of
 ordinary skill in the art would have been motivated to
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 ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.               11

 make the proposed combination because it would “elimi-
 nat[e] the need to move a patient from an imaging appa-
 ratus to a separate treatment apparatus” and would
 “reduce the patient’s exposure to radiation.” J.A. 1378–84
 ¶ 74. Taken together, this evidence provides substantial
 support for the Board’s finding that a person of ordinary
 skill in the art would have been motivated to make the pro-
 posed combination.
                              II
     Elekta argues that the Board erred as a matter of law
 because it failed to articulate any findings on reasonable
 expectation of success. Appellant’s Br. 18. We disagree.
     To be clear, an obviousness determination requires
 finding that a person of ordinary skill in the art would have
 had a reasonable expectation of success. Regents of Univ.
 of Cal., 903 F.3d at 1291. Reasonable expectation of suc-
 cess refers to the likelihood of success in combining refer-
 ences to meet the limitations of the claimed invention.
 Intelligent Bio–Systems, Inc. v. Illumina Cambridge Ltd.,
 821 F.3d 1359, 1367 (Fed. Cir. 2016).
      Unlike a motivation to combine determination, which
 requires an explicit analysis, KSR, 550 U.S. at 418, a find-
 ing of reasonable expectation of success can be implicit, see
 Merck & Cie v. Gnosis S.P.A., 808 F.3d 829, 836 (Fed. Cir.
 2015). We understand that requiring less than an explicit
 statement may appear to be in tension with our review of
 Board determinations under the Administrative Procedure
 Act (“APA”), which requires the Board to “explain[] its de-
 cisions with sufficient precision, including the underlying
 factfindings and [its] rationale.” Packard Press, Inc. v.
 Hewlett-Packard Co., 227 F.3d 1352, 1357 (Fed. Cir. 2000).
 But there is no such tension where the Board makes an
 implicit finding on reasonable expectation of success by
 considering and addressing other, intertwined arguments,
 including, as we hold today, a motivation to combine. See
 Merck, 808 F.3d at 836. In those circumstances, we can
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 12              ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.

 “reasonably discern” an implicit finding by the Board on
 reasonable expectation of success. In re NuVasive, Inc.,
 842 F.3d 1376, 1382 (Fed. Cir. 2016).
     We have previously held that an implicit finding on
 reasonable expectation of success under such circum-
 stances is acceptable. Merck, 808 F.3d at 836–37. In
 Merck, the patent owner argued that the prior art teaches
 away from the proposed combinations. Id. at 834. The
 Board disagreed. Id. On appeal, the patent owner faulted
 the Board’s final written decision for failing to make an ex-
 press finding that a skilled artisan would have had a rea-
 sonable expectation of success in combining the references.
 Id. at 836. We held that “[b]y rejecting [the patent owner’s]
 argument that the prior art taught away from combining
 [the references], the Board impliedly found a reasonable
 expectation of success.” Id. Under these circumstances, we
 declined to overturn the Board’s decision simply because it
 did not “state expressly” that a skilled artisan would have
 had a reasonable expectation of success. Id. at 836–37.
     Here, as in Merck, we can reasonably discern that the
 Board considered and implicitly addressed reasonable ex-
 pectation of success based on the arguments and evidence
 presented to the Board on motivation to combine. See id.
 For example, Elekta raised reasonable expectation of suc-
 cess arguments before the Board in asserting that ZAP’s
 proposed combination would result in an inoperable device,
 result in an inferior quality product, and would teach away
 because the combination would not produce the result
 sought by the ’648 patent owner due to the heavy weight of
 the linac. See J.A. 3385–87; see also J.A. 3170.
     Elekta also argued that because the prior art combina-
 tion would not “provide a viable solution for focusing a ther-
 apeutic radiation source on the target,” it would not work
 for its intended purposes, and thus would “negat[e] any
 reasonable expectation of success.” J.A. 914–15; J.A. 3885–
 87.    And when asked during oral argument what
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 ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.               13

 reasonable expectation of success arguments it made be-
 fore the Board, Elekta reiterated its argument that “a
 POSITA would not have expected the structure to be a vi-
 able solution for focusing the therapeutic radiation source
 on the target, which was the stated goal of the invention.”
 Oral Arg. 4:22–5:25. Elekta’s briefing and expert declara-
 tions also focused on how the weight of the device, and the
 resulting lack of precision and control, evidenced a lack of
 expectation of success and motivation to combine. J.A.
 3887; J.A. 3375.
     These and other of Elekta’s similar arguments also
 were made in connection with whether a skilled artisan
 would have been motivated to combine the prior art. In
 these circumstances, the Board made no error in address-
 ing the issues of motivation to combine and reasonable ex-
 pectation of success in the same blended manner that
 Elekta chose to present those very issues.
      In finding that “persons of ordinary skill in the appli-
 cable art would have readily understood the advantages” of
 Grady and would not have been dissuaded by the “difficulty
 in accommodating heavy linacs” or concerns related to “pre-
 cision” in targeting for radiation therapy in making that
 combination, the Board implicitly addressed Elekta’s argu-
 ment on reasonable expectation of success. See J.A. 35. On
 this basis, we hold that the Board made a sufficient, im-
 plicit finding that a skilled artisan would have had a rea-
 sonable expectation of success in combining the prior art
 references. See Merck, 808 F.3d at 836–37.
                              III
     We next address Elekta’s argument that, even if the
 Board made an implicit finding, “there is [no] substantial
 evidence that could support a finding that a skilled artisan
 would have reasonably expected to succeed” in combining
 the asserted references. Appellant’s Br. 2, 4.
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 14             ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.

     Evidence of a reasonable expectation of success, just
 like evidence of a motivation to combine, “may flow from
 the prior art references themselves, the knowledge of one
 of ordinary skill in the art, or, in some cases, from the na-
 ture of the problem to be solved.” Brown & Williamson To-
 bacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1125 (Fed.
 Cir. 2000). The evidence need not lead to a single conclu-
 sion to support a finding of substantial evidence. Velander
 v. Garner, 348 F.3d 1359, 1378–79 (Fed. Cir. 2003).
     In this case, and as explained above, the arguments
 and evidence of reasonable expectation of success are the
 same for motivation to combine. To be clear, a finding of a
 motivation to combine does not necessarily establish a find-
 ing of reasonable expectation of success. Eli Lilly & Co. v.
 Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1344 (Fed. Cir.
 2021). But in some cases, such as here, the evidence estab-
 lishing a motivation to combine may establish a finding of
 reasonable expectation of success.
     In view of the foregoing, we conclude that the Board’s
 finding that a skilled artisan would have had a reasonable
 expectation of success in combining Grady and Ruchala is
 supported by substantial evidence.
                              IV
     Elekta argues that “no substantial evidence in the rec-
 ord would support a finding that ZAP met its burden to
 show reasonable expectation of success by clear and con-
 vincing evidence.” Appellant’s Br. 21–22.
     Elekta misstates the applicable burden of proof. See
 id. In an IPR, the petitioner bears the burden in the peti-
 tion to demonstrate by a preponderance of the evidence
 that the challenged patent (or portions thereof) is un-
 patentable. See 35 U.S.C. § 316(e) (“In an inter partes re-
 view instituted under this chapter, the petitioner shall
 have the burden of proving a proposition of unpatentability
 by a preponderance of the evidence.”). Apart from its
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 ELEKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC.               15

 erroneous statement of the law, Elekta further failed to de-
 velop an argument concerning ZAP’s correct burden of
 proof. See Reply 11–13. We therefore deem this argument
 frivolous and waived. See Monsanto Co. v. Scruggs, 459
 F.3d 1328, 1341 (Fed. Cir. 2006).
                        CONCLUSION
     We have considered Elekta’s other arguments and find
 them unpersuasive. We hold that the Board’s findings on
 a motivation to combine and its implicit finding on a rea-
 sonable expectation of success are supported by substantial
 evidence. We affirm.
                        AFFIRMED
                           COSTS
 No costs.