Howmedica Osteonics Corp. v. Zimmer, Inc., 640 Fed.Appx. 951 (2016)
`
`640 Fed.Appx. 951
`This case was not selected for
`
`publication in West's Federal Reporter.
`
`See Fed. Rule of Appellate Procedure 32.1
`
`generally governing citation ofjudicial
`decisions issued on or after Jan. 1, 2007.
`
`Newman, Circuit Judge, filed an opinion concurring in
`
`part and dissenting in part.
`
`*952 Appeals from the United States Patent and
`
`Trademark Office, Patent Trial and Appeal Board in No.
`95/000,428.
`
`See also U.S.Ct. of App. Fed. Cir. Rule 32.1.
`
`Attorneys and Law Firms
`
`United States Court of Appeals,
`Federal Circuit.
`
`HOWMEDICA OSTEONICS CORP., Appellant
`v.
`
`ZIMMER, INC., Cross—Appellant.
`
`Nos. 2015—1498, 2015—1503.
`
`|
`Feb. 26, 2016.
`
`Timothy J. Malloy, McAndrews, Held & Malloy, Ltd.,
`
`Chicago, IL, argued for appellant. Also represented by
`
`Patricia J. McGrath, Christopher M. Scharff.
`
`David K. Callahan, Latham & Watkins LLP, Chicago,
`
`IL, argued for cross-appellant. Also represented by Bryan
`
`Scott Hales, Bryan Rutsch, Kirkland & Ellis LLP,
`
`Chicago, IL.
`
`Before NEWMAN, LOURIE, and BRYSON, Circuit
`
`Synopsis
`
`Background: Patentee appealed from an inter partes
`reexamination decision of the United States Patent and
`
`Trademark Office (PTO) Patent Trial and Appeal Board
`
`Judges.
`
`Opinion
`
`(PTAB), which affirmed an examiner's rejection of claims
`
`Opinion for the court filed by Circuit Judge LOURIE.
`
`in a patent for ultra-high molecular weight polyethylene
`
`with improved properties for use in medical implants as
`
`anticipated.
`
`Holdings: The Court of Appeals, Lourie, Circuit Judge,
`held that:
`
`[1] term “medical implant” in preambles of patent claims
`
`was not limiting;
`
`[2]
`
`substantial
`
`evidence
`
`supported
`
`the
`
`PTAB's
`
`determination that claims in the patent were anticipated
`
`by a prior academic thesis; and
`
`[3] the PTAB's finding that a skilled artisan would not
`
`have reasonably expected that modifying a prior academic
`
`thesis according to a prior patent would generate ultra
`
`high molecular weight polyethylene lacked substantial
`
`evidence support.
`
`Affirmed in part and reversed in part.
`
`H&S Mfg. Co., Inc. v. Oxbo Int'l Co. IPR2016-00950
`H&S Mfg. Co., Inc. v. Oxbo Int'l Co. IPR2016-00950
`
`Opinion concurring in part, dissenting in part filed by
`
`Circuit Judge NEWMAN.
`
`LOURIE, Circuit Judge.
`
`Howmedica Osteonics Corp.
`
`(“Howmedica”) appeals
`
`from an inter partes reexamination decision of the United
`
`States Patent and Trademark Office (“PTO”) Patent Trial
`
`and Appeal Board (“the Board”) affirming the examiner's
`
`rejection of claims 1—6 of US. Patent 6,818,020 (“the
`
`#020 patent”) as anticipated. See Smith & Nephew, Inc. v.
`
`Howmedica Osteonics Corp, No. 2013—007710, 2014 WL
`
`1729260, at *12 (P.T.A.B. Apr. 30, 2014) (“Decision ”).
`
`Zimmer, Inc. (“Zimmer”) cross-appeals from the Board's
`
`decision reversing the examiner's rejection of claims 7—12
`
`of the #020 patent as obvious. Id. at *16. For the reasons
`
`that follow, we affirm in part and reverse in part.
`
`BACKGROUND
`
`Howmedica owns by assignment
`
`the #020 patent
`
`(now expired), directed to ultra-high molecular weight
`
`polyethylene (“UHMWPE”) with improved properties
`
`for use in medical implants. UHMWPE is widely used
`
`H&S Mfg. Co., Inc. Exhibit 1033
`H&S Mfg. Co., Inc. Exhibit 1033
`Page 1 of 11
`Page 1 of 11
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`Howmedica Osteonics Corp. v. Zirnmer, Inc., 640 Fed.Appx. 951 (2016)
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`in biomedical applications, and for “articulation surfaces
`
`(claims 3, 7, and 9), 11 days (claims 6, 10, 11, and 12),
`
`in artificial knee and hip replacements” in particular.
`
`or up to 23 days (claims 4 and 8);
`
`#020 patent col.
`
`1 11. 28—29. The #020 patent explains
`
`that all implant components go through a sterilization
`
`process, most often irradiation, before use. Id col. 1 11. 42—
`
`56. One consequence of that irradiation, however, is the
`
`generation of free radicals. Id col. 1 11. 57—59.
`
`(4) an FTIR oxidation index of 0.01 (claim 11) or less
`
`(claim 12); and/or
`
`(5) a weight percent of polyethylene with a molecular
`
`weight below 100,000 of less than 18.4% (claim 9).
`
`Free radicals are highly reactive and, when exposed to
`air, can effect “oxidative chain scission reactions.” Id
`
`col. 2 11. 35—36. Through those oxidative reactions, the
`
`Id col. 12 11. 1—54. Claims 7—12 further require the
`
`UHMWPE to be “annealed at a temperature greater than
`25°C for a sufficient time” to achieve one or more of the
`
`“material properties of the [implant], such as molecular
`
`above properties. Id. col. 1211. 24—54.
`
`weight, tensile, and wear properties, are degraded.” Id
`col. 211. 36—38. If, however, irradiation occurs in an inert
`
`environment, the free radicals react with each other to
`form carbon-carbon cross-links. Id. col. 211. 50—54. Such
`
`cross-linking decreases the implant's overall degradation.
`
`The #020 patent describes a method for “providing a
`
`polymeric material, such as UHMWPE, with superior
`
`oxidative resistance upon irradiation,” and thereby
`
`generating UHMWPE implants with improved material
`
`properties. Id. col. 3 11. 35—37. In particular, the #020
`
`patent sets forth a two-step process, whereby the polymer
`
`is first irradiated and then heat treated. Both steps take
`
`place in an “oxidant-free atmosphere” to improve the
`
`*953 cross-linking of free radicals. Id. col. 3 1. 65—col. 4
`
`l. 4. The #020 patent further provides that “the implant
`
`is heated for at least 48 hours at a temperature of about
`
`37°C to about 70°C and preferably for 144 hours at
`
`50°C.” Id col. 4 11. 35—37 (the preferred embodiment is
`
`further described as Method D, #020 patent col. 7 ll. 51—
`
`58, the method Howmedica states generates the claimed
`
`properties, Appellant's Br. 5).
`
`Claims l—12 of the #020 patent all recite “[a] medical
`
`implant comprising an irradiated [UHMWPE] having a
`
`weight average molecular weight greater than 400,000,”
`
`and at least one of the following properties:
`
`(1) a solubility of less than 80.9% in trichlorobenzene
`
`(claims 1—4, 7—9, and 12), and more particularly in
`
`1,2,4—trichlorobenzene (claim 5);
`
`(2) the level of free radicals at 1x10 17 spins/gram or less
`(claims 2, 6, and 10);
`
`In 2005, Howmedica sued Zimmer in the US District
`
`Court for the District of New Jersey, alleging infringement
`
`of claims 1—3, 5—7, and 10—12 of the #020 patent, as well as
`
`the claims ofthree related patents. 1 Howmedica Osteom'cs
`Corp. v. Zirnmer, Ina, Civ. No. 05—897, 2008 WL 3871733,
`
`at *l
`
`(D.N.J. Aug. 19, 2008).
`
`In 2007,
`
`the district
`
`court
`
`issued its Markman Order, construing various
`
`disputed terms. Id. Notably, it construed “annealed at a
`
`temperature greater than 25°C” to mean “annealed at a
`
`temperature greater than 25°C and less than the melting
`
`point of the material—approximately 140°C.” Id. at *2.
`
`In light of that construction, Zirnmer moved for partial
`
`summary judgment of noninfringement of claims 7, 10, 11,
`
`and 12 of the #020 patent. Id. at * l. The court granted the
`
`motion, concluding that Zimmer's accused products were
`
`annealed above the melting temperature, i.e., at or about
`
`150°C, and thus did not satisfy the limitation as construed,
`
`either literally or under the doctrine of equivalents. Id
`
`at *7 (“Absolutely distilled, Plaintiffs argument is: ignore
`
`the specific language and meaning of the claim element.
`
`Unmelt is the same as melt. An antonym is a synonym.
`
`Accordingly, the Court finds that there is no genuine issue
`
`of material fact....”).
`
`In 2006, Zirnmer moved for summary judgment with
`respect to the three related patents. The district court
`granted the motion in part, concluding that the claims
`of the three related patents were invalid as indefinite.
`Howmedica Osteonics Corp. v. Zimmer, Inc., Civ. No.
`05—897, 2007 WL 1741763 (D.N.J. June 13, 2007).
`We affirmed without opinion in 2010. Howmedica
`Osteom'cs Corp. v. Zirnmer, Inc., 397 Fed.Appx. 654
`(Fed.Cir.2010).
`
`(3)
`
`a Fourier Transform Infrared Spectroscopy
`
`In 2009, Zirnmer requested inter partes reexamination
`
`(“FTIR”) oxidation index that does not increase
`
`of claims 1—12 of the # 020 patent. The PTO granted
`
`during oven aging in air at 80°C for up to 11 days
`
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`Howmedica Osteonics Corp. v. Zimmer, Inc., 640 Fed.Appx. 951 (2016)
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`the request, and the district court stayed its remaining
`
`patent undermined Dr. Clough's demonstration that the
`
`proceedings pending the outcome of the reexamination.
`
`claimed properties were inherent in Lue. Id at *10—12. In
`
`light of affirming the examiner's rejection of claims 1—6 as
`
`The examiner adopted many of Zimmer's proposed
`
`inherently anticipated by Lue as evidenced by the Clough
`
`rejections, and rejected claims 1—12 over various prior
`art references *954 and combinations thereof. Joint
`
`declaration, the Board declined to address the remaining
`
`rejections with respect to those claims. Id at *12.
`
`App. (“J .A.”) 706—21. In particular, the examiner rejected
`
`claims 1—6 as inherently anticipated by Ching—Tai Lue,
`“Effects of Gamma Irradiation and Post Heat Treatments
`
`The Board then reversed the examiner's
`
`rejections
`
`of claims 7—12 as obvious in view of several prior
`
`on the Structure and Mechanical Properties of Ultra High
`
`art combinations. Addressing the additional limitation
`
`Molecular Weight Polyethylene (UHMWPE),” Masters
`
`in claims 7—12—“annealed at a temperature greater
`
`Thesis, University of Lowell, 1979 (“Lue”), as evidenced
`
`than 25°C”—the Board adopted the district court's
`
`by the declaration of Dr. Robert L. Clough (“Clough
`
`declaration”). J.A. 710—12. The examiner also rejected
`claims 7—12 as obvious over Lue in view of U.S. Patent
`
`3,362,897 (“Lawton”). J.A. 715—16. Howmedica timely
`
`appealed to the Board.
`
`construction from the parallel proceeding2 and likewise
`interpreted the
`term to require
`annealing “at a
`
`temperature greater than 25°C and less than the melting
`
`point of the material, approximately 140°C.” Id at *12—
`13.
`
`The Board first affirmed the examiner's rejection of claims
`
`1—6 as inherently anticipated by Lue as evidenced by the
`
`Clough declaration. It noted that “[i]t is undisputed that
`Lue describes UHMWPE that has been irradiated in an
`
`inert atmosphere and heat treated at 150°C for one hour.
`
`Lue does not [, however,] teach all the properties recited in
`the claims.” Decision, 2014 WL 1729260, at *3. The Board
`
`accordingly examined whether Lue's material inherently
`
`possesses the claimed properties, and found that it does.
`
`Turning to the Clough declaration, the Board noted that
`
`Dr. Clough testified to acquiring two different resins of
`
`UHMWPE and followed a detailed protocol reproducing
`
`the irradiation and heating procedures in Lue. Id at
`
`*9. Dr. Clough then measured the treated UHMWPE
`
`for solubility, level of free radicals, and FTIR oxidation
`
`index, closely following the testing procedures in the #
`
`020 patent. Id Dr. Clough testified that the resulting
`
`measurements fell within the ranges recited in the #020
`
`patent. Id The Board accordingly found that Zimmer had
`
`met its burden of showing that the properties recited in the
`
`claims necessarily were present in the UHMWPE samples
`treated as described in Lue, and shifted the burden to
`Howmedica to show otherwise. Id at *12.
`
`The Board rejected each of Howmedica's arguments
`
`in response,
`
`finding (1)
`
`that
`
`the preamble language
`
`“medical
`
`implant” did not
`
`limit claim scope, and
`
`(2) that Howmedica failed to show how any alleged
`
`difference between Dr. Clough's reproduction and either
`
`the procedure in Lue or the solubility testing in the # 020
`
`The #020 patent expired during reexamination; the
`Board accordingly reviewed the claims under the
`framework set forth in Phillips v. AWH Corp, 415
`F.3d 1303 (Fed.Cir.2005) (en banc), and adopted the
`district court's interpretation of the “annealed at ...”
`limitation. See In re Rambus Inc., 694 F.3d 42, 46
`
`(Fed.Cir.2012).
`
`In light of that determination, the Board reversed the
`
`examiner's rejection of claims 7—12 as obvious over
`
`Lue in View of Lawton. The Board first acknowledged
`
`that Lue inherently discloses the claimed properties, but
`
`only by annealing above the temperature range recited
`
`in the # *955
`
`020 patent. Id at *14. The Board
`
`then turned to Lawton for guidance, finding that it
`
`indeed teaches annealing within the claimed range, but
`
`nevertheless fails to suggest that lowering the annealing
`
`temperature necessarily generates the same properties
`
`for a given sample of UHMWPE. Id Accordingly, the
`
`Board found that “neither the Examiner nor the Requester
`
`provided a basis in fact and/or technical reasoning” to
`
`show why a skilled artisan would expect modifying Lue
`
`in light of Lawton to generate UHMWPE with the
`
`claimed properties. Id; id. at *15 (“[T]he Examiner and
`
`Requester have not shown that, more likely than not, the
`
`skilled artisan would have recognized that the particular
`
`required properties could be achieved at temperatures
`
`below 140°C by optimizing these parameters”). The
`
`Board consequently reversed the examiner's rejection of
`claims 7—12 as obvious over Lue in View of Lawton. It
`
`then found the examiner's remaining rejections similarly
`
`flawed, and reversed on those grounds as well. Id at *15.
`
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`Howmedica Osteonics Corp. v. Zimmer, Inc., 640 Fed.Appx. 951 (2016)
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`As a result, the Board declined to address the secondary
`considerations of nonobviousness. Id at *16.
`
`giving life, meaning, and vitality to the claims. Howmedica
`
`argues that this is relevant for two reasons: first, Lue
`
`Howmedica requested rehearing but the Board rejected
`
`anticipate; *956 and second, Dr. Clough's reproductions
`
`the request. Howmedica timely appealed, and Zimmer
`
`were not prepared using medical grade UHMWPE, and
`
`timely cross-appealed. We have jurisdiction pursuant to
`
`thus cannot establish inherent anticipation.
`
`does not disclose medical implants, and therefore does not
`
`28 U.S.C. § 1295(a)(4)(A).
`
`DISCUSSION
`
`I. Howmedica's Appeal
`
`“Determining whether claims are anticipated is a two-
`
`step analysis. The first step involves construction of the
`
`Claims l—12 all contain the preamble, “medical
`implant.”
`Howmedica
`challenges
`the
`Board's
`determination only with respect to claims 1—6.
`
`Zimmer responds that the preamble language, “medical
`
`implant,” is not limiting. In particular, Zimmer contends
`
`that the body of each claim defines a structurally complete
`
`invention, and that the preamble offers no more than a
`
`purpose or intended use for UHMWPE with the claimed
`
`claims of the patent at issue.” In re Aoyama, 656 F.3d
`
`properties.
`
`1293, 1296 (Fed.Cir.2011). Whether a preamble limits
`
`a claim is a question of claim construction. Catalina
`
`Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,
`
`808 (Fed.Cir.2002). In this case, because the intrinsic
`
`record fully determines the proper construction, we review
`
`the Board's construction de novo. Microsoft Corp.
`
`v.
`
`Proxyconn Inc., 789 F.3d 1292, 1297 (Fed.Cir.2015) (citing
`Teva Pharm. USA, Inc. v. Sandoz, Inc., —U.S. —, 135
`
`S.Ct. 831, 840—42, — L.Ed.2d — (2015)).
`
`“The second step involves comparing the claims to the
`
`prior art.” In re Aoyama, 656 F.3d at 1296. A prior art
`
`reference anticipates a claim if it discloses each and every
`
`limitation. Schering Corp. v. Geneva Pharm., 339 F.3d
`
`1373, 1377 (Fed.Cir.2003). A single reference may also
`
`anticipate without expressly disclosing a limitation of the
`
`claimed invention, if that limitation is necessarily present,
`or inherent, in the reference. See id. Indeed, the inherent
`
`result must inevitably result from the disclosed steps; it
`
`cannot be established by probabilities or possibilities. See
`Bettcher Indus, Inc. v. Bunzl USA, Inc., 661 F.3d 629,
`
`639 (Fed.Cir.2011). Whether a reference anticipates is a
`
`“Whether to treat a preamble as a limitation is a
`
`determination ‘resolved only on review of the entire[ ]
`
`patent to gain an understanding of what the inventors
`
`actually invented and intended to encompass by the
`
`claim.’ ” Catalina, 289 F.3d at 808 (quoting Corning
`Glass Works v. Sumitomo Elec. USA, Inc., 868 F.2d
`
`1251, 1257 (Fed.Cir.l989)). “|_T]here is no simple test for
`
`determining when a preamble limits claim scope, [but]
`
`we have set forth some general principles to guide that
`
`inquiry.” Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d
`
`1354, 1358 (Fed.Cir.2010). Generally, a preamble is not
`
`limiting. Allen Eng'g Corp. v. Bartell Indus, Inc., 299 F.3d
`
`1336, 1346 (Fed.Cir.2002). But a preamble may limit the
`
`invention if it recites essential structure or steps, or if it
`
`is “necessary to give life, meaning, and vitality” to the
`
`claim. See Pitney Bowes, Inc. v. Hewlett—Packard Co., 182
`
`F.3d 1298, 1305 (Fed.Cir.l999). Conversely, a preamble
`
`does not limit an invention “where a patentee defines a
`
`structurally complete invention in the claim body and
`
`uses the preamble only to state a purpose or intended
`use for the invention.” Rowe v. Dror, 112 F.3d 473, 478
`
`question of fact that we review for substantial evidence on
`
`(Fed.Cir.l997).
`
`appeal. In re Morsa, 713 F.3d 104, 109 (Fed.Cir.2013).
`
`A.
`
`On appeal, Howmedica first faults the Board for finding
`
`that the preamble, “medical implant,” does not limit claim
`
`scope.3 According to Howmedica, “medical implant”
`permeates the specification and is an essential feature,
`
`[1]
`
`In light of those principles, we agree with the Board
`
`and conclude that the preamble, “medical implant,” does
`
`not limit claim scope. The applicant did not rely on
`
`that phrase to define the invention, cf. Rowe, 112 F.3d
`
`at 479 (noting that the use of Jepson format “suggests
`
`the structural importance of the recitations found in the
`
`preamble”), or to distinguish prior art during prosecution,
`IA. 5469; see also Am. Med, 618 F.3d at 1359. Nor does
`
`any term in the bodies of the claims rely on “medical
`
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`Howmedica Osteonics Corp. v. Zimmer, Inc., 640 Fed.Appx. 951 (2016)
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`implant” for antecedent basis. Cf. Pitney Bowes, 182 F.3d
`
`(Fed.Cir.2012) (Lourie, J., dissenting). “An unbounded
`
`at 1306 (finding the preamble “necessary to give life,
`
`concept of inherency
`
`threatens to stymie innovation by
`
`meaning, and vitality” to the claim because terms from
`
`the body of the claim “c[ould] only be understood in the
`
`withdrawing from the realm of patentability that which
`has not been before known, used, or benefited from.”
`
`context of the preamble statement”).
`
`Id at 1383—84. As a result, there are strict requirements
`
`before a finding of inherent anticipation is made. Indeed,
`
`On the contrary. The body of each claim describes a
`
`inevitability is at the heart of inherency; “that a certain
`
`structurally complete invention, e. g., #020 patent col. 12
`
`11. 2—4 (“[A]n irradiated [UHMWPE] having a weight
`
`thing may result from a given set of circumstances
`is not sufficient.” In re Robertson, 169 F.3d 743, 745
`
`average molecular weight greater than 400,000 and a
`
`(Fed.Cir.1999) (citations and quotation marks omitted).
`
`solubility of less than 80.9% in trichlorobenzene.”), and
`
`deletion of the preamble language does not affect that
`
`“[W]hen the PTO shows sound basis for believing that
`
`structure, Catalina, 289 F.3d at 808. The preamble merely
`
`the products of the applicant and the prior art are the
`
`describes a use or purpose for irradiated and heat treated
`
`same, the applicant has the burden of showing that they
`
`UHMWPE with the claimed properties. Rowe, 112 F.3d
`
`are not.” In re Spada, 911 F.2d 705, 708 (Fed.Cir.1990).
`
`at 478; Decision, 2014 WL 1729260, at *3 (finding that
`
`Such a burden-shifting framework is fair because of “the
`
`“medical implant” “imports that a UHMWPE is suitable
`
`PTO‘s inability to manufacture products or to obtain and
`
`as a medical implant if it has the claimed properties”).
`
`compare prior art products.” In re Best, 562 F.2d 1252,
`
`The specification's regular use of the preamble language,
`
`1255 (CCPA 1977) (referencing In re Brown, 59 CCPA
`
`“medical
`
`implant,” is of no additional
`
`import here;
`
`1036, 459 F.2d 531 (1972)).
`
`it reiterates that a “medical
`
`implant” is one use for
`
`UHMWPE with the claimed solubility, FTIR oxidation
`index, and level of free radicals.
`
`The Board implemented that burden-shifting
`[2]
`framework in this case, and we find no error in its
`
`Because we agree with the Board, and conclude that the
`
`preamble language, “medical implant,” does not limit the
`claims, we need not also address whether Lue teaches
`
`application. With the principles of In re Spada and In re
`
`Best in mind, the Board first analyzed the disclosure of
`Lue. See Decision, 2014 WL 1729260, at *3. It found that
`
`Lue discloses irradiating and heat treating UHMWPE,
`
`medical implants or whether Dr. Clough's reproductions
`
`but at a higher temperature and for a shorter period of
`
`fail to use medical grade UHMWPE and thereby fail to
`
`time than in the #020 patent. Compare #020 patent col. 4
`
`establish inherent anticipation.
`
`11. 35—37 (heating preferably for 144 hours at 50°C), with
`
`*957 B.
`
`Howmedica next challenges two aspects of the Board's
`
`finding that claims 1—6 of the #020 patent are inherently
`
`anticipated by Lue as evidenced by Clough's declaration.
`
`First, Howmedica argues that Dr. Clough did not
`
`faithfully reproduce Lue, either in the UHMWPE resin
`
`used or in the irradiation procedure. It contends that the
`
`deviations at best show that the claimed properties might
`
`be present in Lue, and thereby fail to establish a sound
`basis for the Board to believe that Lue discloses the same
`
`product claimed by the # 020 patent and to then shift the
`
`burden to Howmedica to prove otherwise. We find this
`
`first challenge unpersuasive.
`
`Without question, “[i]nherency is a very tricky concept
`
`in patent law.” In re Montgomery, 677 F.3d 1375, 1383
`
`Decision, 2014 WL 1729260, at *4 (stating Lue teaches
`
`heating for 1 hour at 150°C). According to the Board, the
`
`procedures were not, on their face, similar enough such
`
`that the Board could presume, without more, that Lue's
`
`product was the same as that in the #020 patent. Decision,
`2014 WL 1729260, at *5. The Board thus turned to other
`
`evidence of record for guidance. Id at *6, *9.
`
`In particular, the Board turned to the Clough declaration
`
`and found that it demonstrated that heat treating by the
`
`procedures described in both Lue and the #020 patent
`
`generated UHMWPE with the same properties. Id at *9,
`
`*12. In reaching that determination, the Board analyzed
`
`how faithfully Dr. Clough reproduced Lue's procedure. It
`
`first addressed the resin used by Lue, acknowledged that
`
`Lue's resin source no longer exists in its original form,
`
`but nevertheless found that Dr. Clough “took reasonable
`
`steps to find similar UHMWPE to that available at the
`
`time of Lue.” Id at *10. Indeed, as Dr. Clough testified:
`
`Page50f11
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`

`

`Howmedica Osteonics Corp. v. Zimmer, Inc., 640 Fed.Appx. 951 (2016)
`
`(1) Lue obtained UHMWPE from Dixon Corporation's
`
`(“Dixon”) Bristol, Rhode Island manufacturing
`
`facility;
`
`(2) Dixon became St. Gobain Performance Plastics (“St.
`
`Gobain”);
`
`(3) Dr. Clough obtained two lots of GUR 4130
`material from St. Gobain's *958 Bristol, Rhode
`
`Island facility, “which continues to manufacture
`
`UHMWPE under the trade name Pennlon according
`
`to the same process, using the same resin-grade, and
`l as,
`equipment it has been using since the 1970 s , and
`
`(4) Dr. Clough obtained one lot of GUR 4030, which
`was sent to St. Gobain “to be made into UHMWPE
`
`sheets using the same process and equipment they use
`to make Pennlon.”
`
`J.A.2049.
`
`The Board then addressed Dr. Clough's application
`
`of the procedures set forth in Lue. According to the
`
`Board, Dr. Clough “prepared a detailed protocol for
`
`reproducing the irradiation and heating procedures set
`forth in Lue on GUR 4030 and GUR 4130 UHMWPE
`
`samples.” Decision, 2014 WL 1729260, at *9. Those tests
`
`demonstrated a level of free radicals, solubility, and FTIR
`
`oxidation index within the ranges recited in the claims of
`
`the #020 patent. J .A.2050. The Board found Dr. Clough's
`
`test results to be the “most detailed data presented in the
`record.” Decision, 2014 WL 1729260, at *9.
`
`Howmedica argues that the Board accepted too many
`deviations from the strict disclosure of Lue and that, with
`
`findings clouded by such uncertainty, the Board lacked a
`
`sound basis for believing that the products of Lue and the
`
`# 020 patent are the same.
`
`We disagree. A sound basis for believing in identity does
`
`not turn on absolute certainty; rather, a sound basis for
`
`finding identity requires the Board to make sufficient
`
`factual findings, such that it can reasonably infer that the
`
`prior art product and that of the patent at issue are the
`
`same. See In re Spada, 911 F.2d at 708. The Board did that
`here.
`
`With respect to the starting resin, the Board reasonably
`
`found that Dr. Clough used a proper starting material.
`
`As Howmedica contends, Dixon produced several types
`
`of UHMWPE during the 1970s, including several blends.
`
`It produced two resins, GUR 4030 and GUR 4130, J.A.
`619—20; J.A. 637—38, and used GUR 4130 as the base for
`
`each of its blends, J.A. 641. Howmedica contends that
`
`with so many types of UHMWPE to choose from, Lue's
`
`disclosure of Dixon products generally offers no guidance
`
`to a potential reproducer. We find that contention
`
`unpersuasive.
`
`First, any blend that Dixon produced is irrelevant,
`
`for Lue suggests that he used unblended UHMWPE,
`
`compare J.A. 124, with J.A. 126—27; thus, Dr. Clough
`
`used unblended UHMWPE. The only remaining concern
`involves the use of GUR 4030 versus GUR 4130, and
`
`that distinction is of no moment here because Dr. Clough
`
`acquired and used both. J .A.2049. Moreover, all of his
`
`reproductions with both resins generated UHMWPE with
`
`the claimed properties. J.A.2050—51. That Dr. Clough
`
`acquired his materials from Dixon's successor certainly
`
`adds an element of uncertainty. But that should not be
`
`enough to foreclose the Board's sound basis for believing
`
`in identity, where, as here, Dr. Clough took reasonable
`
`steps to acquire an appropriate starting material. We see
`
`no error in the Board's finding on this point.
`
`With respect to the irradiation procedure, we similarly
`
`conclude that the Board reasonably found Dr. Clough's
`
`reproduction to align with the disclosure of Lue.
`
`According to Howmedica, Dr. Clough deviated from
`
`Lue's irradiation procedure in six respects, including using
`
`a different dose rate and time. Appellant's Br. 54—55.
`
`Importantly, however, Howmedica does not assert that
`
`Dr. Clough deviated in total dose. Indeed, Lue subjected
`
`test samples *959 to 2.5 Mrad of radiation, J.A. 126,
`
`and Dr. Clough complied with that dosage, J.A.2049.
`
`Dr. Clough's remaining deviations are of no consequence
`here. Minor deviations from the strict disclosure of the
`
`prior art are accepted, as long as one of skill in the
`art would understand that those minor deviations are
`
`consistent with the prior art's teachings. See Glaxo Inc. v.
`
`Novopharm Ltd, 52 F.3d 1043, 1047 n. 4 (Fed.Cir.1995).
`
`Here, Lue suggests that total radiation dose is the most
`
`relevant variable for the irradiation procedure. J.A. 103.
`Indeed, Lue notes that neither dose rate nor irradiation
`
`time affects the properties of the final material. J .A. 103—
`
`104; J.A. 2142—43; J.A. 2159. Dr. Clough complied with
`
`that prescription, and only deviated in otherwise trivial
`
`respects. It was therefore reasonable for the Board to find
`
`Dr. Clough's testing to be an accurate reproduction of
`
`Page60f11
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`

`

`Howmedica Osteonics Corp. v. Zimmer, Inc., 640 Fed.Appx. 951 (2016)
`
`Lue, and to accordingly place significant weight on the
`
`results of those tests.4 We see no error in the Board's
`
`Howmedica presented expert reports of irradiated and
`
`finding on this point.
`
`4
`
`Howmedica also argues that Zimmer should have
`conducted additional testing of Dr. Clough's product
`by, for example, measuring xylene extraction and/
`or tensile properties. Appellant's Br. 57. While such
`testing could have been useful, the Board nevertheless
`had ample evidence before it to find that Dr. Clough
`accurately reproduced Lue, generating UHMWPE
`with the claimed properties.
`
`Ultimately,
`
`the Board found Dr. Clough faithfully
`
`and accurately reproduced Lue. The results of that
`
`reproduction demonstrated that UHMWPE treated
`
`according to Lue has the same properties as those claimed
`
`in the # 020 patent. We conclude that, in view of such
`
`findings, the Board had a sound basis for believing that
`
`the products of the prior art and the patent at issue are
`
`the same. Thus, the Board correctly shifted the burden to
`
`Howmedica to prove otherwise.
`
`Howmedica next argues,
`
`in the alternative,
`
`that the
`
`Board erred in concluding that Howmedica failed to
`
`show otherwise. Specifically, Howmedica argues that it
`
`sufficiently established that Dr. Clough's failure to use
`
`a hot wire mesh during solubility testing discredited
`
`his results, undermining any finding that Lue's product
`
`necessarily has the solubility claimed in the #020 patent.
`
`We find this challenge similarly unpersuasive.
`
`heat treated UHMWPE, subjected to solubility testing in
`trichlorobenzene in three scenarios: hot filter/hot filtrate,
`
`hot filter/cooled filtrate, and cold filter/cooled filtrate. Id
`
`The Board found that none of the reports contradicted
`
`Dr. Clough's test results. First, the Board found that
`
`no evidence of record reflected the effects of systematic
`
`cooling on Dr. *960 Clough's samples. Id. Indeed, Dr.
`
`Clough testified to using filtrate at 170°C, and nothing
`
`suggested that his filtrate dropped below 140°C. Thus,
`
`two of Howmedica's testing scenarios, those with a cooled
`
`filtrate, were inapposite. The last scenario similarly failed.
`Id As the Board found, the hot filter/hot filtrate scenario
`
`did not show that filter temperature is a critical factor,
`
`largely because it failed to replicate and compare the
`
`cold filter/hot filtrate allegedly used by Dr. Clough. Id
`
`Howmedica does not raise any argument on appeal to
`
`persuade us that the Board's detailed factual findings lack
`
`substantial evidence support. We therefore conclude that
`
`the Board correctly found that Howmedica did not meet
`its burden before the Board.
`
`In sum,
`
`the Board correctly applied the burden-
`
`shifting framework of In re Spada and determined that
`
`Howmedica failed to satisfy its burden before the Board.
`
`We accordingly affirrn the Board's finding that claims 1—6
`
`of the #020 patent are inherently anticipated by Lue.
`
`II. Zimmer's Cross—Appeal
`
`The #020 patent describes a method of testing solubility
`
`in trichlorobenzene as follows: “The samples were then
`
`Whether claims would have been obvious is a legal
`
`hot filtered at approximately 170°C using separate pre-
`
`weighed high temperature filters for each sample.” #020
`
`patent col. 9 11. 54—56. It does not specifically require
`the use of a hot wire mesh. In View of that disclosure,
`
`the Board found that Dr. Clough adequately tested for
`
`solubility. In particular, the Board found that Dr. Clough
`
`“used a high temperature 400—mesh wire filter 0.0001
`
`thick,” placed “between two glass funnels, with the upper
`
`glass funnel preheated to 170°C. The trichlorobenzene
`
`solution (150 mL), which was also at 170°C, was then
`filtered.” Decision, 2014 WL 1729260, at *11. The Board
`
`determination based on underlying factual findings. In re
`
`Baxter, 678 F.3d 1357, 1361 (Fed.Cir.2012). We review
`the Board's ultimate conclusion of obviousness de novo,
`
`In re Eisner, 381 F.3d 1125, 1127 (Fed.Cir.2004), and
`
`we review the Board's underlying factual findings for
`substantial evidence,
`In re Gartside, 203 F.3d 1305,
`
`1316 (Fed.Cir.2000). Whether there would have been
`a motivation to combine references and a reasonable
`
`expectation of success in doing so are such factual
`
`findings. See In re Hyon, 679 F.3d 1363, 1365—66
`
`(Fed.Cir.2012); Wyers v. Master Lock C0., 616 F.3d 1231,
`
`shifted the burden accordingly for Howmedica to show
`
`1237—38 (Fed.Cir.2010).
`
`that the failure to use a hot wire mesh was significant.
`The Board found that Howmedica failed to make such
`
`Zirnmer challenges the Board's conclusion that claims 7—
`
`a showing, and we conclude that substantial evidence
`
`12 of the #020 patent would not have been obvious over
`
`supports that finding.
`
`Page7of11
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`

`Howmedica Osteonics Corp. v. Zimmer, Inc., 640 Fed.Appx. 951 (2016)
`
`the applied prior art. It raises two challenges, and we
`address each in turn.
`
`an oral hearing before the Board, J.A. 2509; J.A. 2526,
`
`moreover, does not remedy that shortcoming. Zimmer
`
`A.
`
`failed to fully raise the Thorpe issue at any point during the
`
`proceedings before the PTO. We therefore find the Thorpe
`issue waived and decline to consider it further.
`
`Zimmer first faults the Board for assigning patentable
`
`weight to the additional limitation i