Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365 (2006)
`79 U.S.P.Q.2d 1865
`
`" KeyCite Yellow Flag — Negative Treatment
`Distinguished by
`Zenon Environrriental, Inc. V. U.S. Filter Corp.,
`Fed.Cir.,
`November 7, 2007
`
`460 F.3d 1365
`United States Court of Appeals,
`Federal Circuit.
`
`COOK BIOTECH INCORPORATED,
`
`Plaintiff-Cross Appellant,
`and
`
`Purdue Research Foundation,
`
`Plaintiff-Cross Appellant,
`V.
`
`ACELL, INCORPORATED, Stephen F. Badylak
`
`and Alan R. Spievack, Defendants-Appellants.
`
`Nos. 05-1458, 05-1558, 05-1559.
`I
`Aug. 18, 2006.
`I
`Rehearing and Rehearing En
`Banc Denied Oct. 18, 2006.
`
`Synopsis
`Background: Patent holder brought action for infringement
`of patents for a tissue composition used as a scaffold for
`tissue reconstruction. The United States District Court for
`
`the Northern District of Indiana, Allen Sharp, J., 2005 WL
`2136107, 2005 WL 1500301, ruled that the patents was
`infringed and that the patent holder's employee was not a co-
`inventor of alleged infringer's patent. Parties appealed.
`
`Holdings: The Court of Appeals, Prost, Circuit Judge held
`that:
`
`[1] alleged infringer's product did not literally infringe patent;
`
`[2] patent was not infringed under the doctrine of equivalents;
`and
`
`[3] patent holder's employee was not a co-inventor.
`
`Affrrrned in part and reversed in part.
`
`WESTLAW
`
`Attorneys and Law Firms
`
`*1367 Daniel J. Lueders, Woodard, Emhardt, Moriarty,
`McNett & Henry LLP, of Indianapolis, Indiana, argued for
`plaintiff-cross appellant, Cook Biotech Incorporated. With
`him on the brief was Holiday W. Banta.
`
`William P. Kealey, Stuart & Branigin LLP, of Lafayette,
`Indiana, argued for plaintiff-cross appellant, Purdue Research
`Foundation.
`
`J. Alan Galbraith, Williams & Connolly LLP, of Washington,
`DC, argued for defendants-appellants. With him on the brief
`were Thomas H.L. Selby, Shruti Rana, and Jessamyn S.
`Berniker.
`
`Before NEWMAN, LOURIE, and PROST, Circuit Judges.
`
`Opinion
`
`PROST, Circuit Judge.
`
`(“ACell”), Stephen F.
`Inc.
`Defendant—appellants, ACell,
`Badylak, and Alan R. Spievack appeal the decision of the
`United States District Court for the Northern District of
`
`Indiana denying ACell's post-trial motions pertaining to
`claim construction, infringement, and the adequacy of the
`jury verdict form following the jury's finding that ACell's
`
`commercial product, ACell Vet TM, infringed U.S. Patent
`No. 5,554,389 (the “ '389 patent”) owned by Purdue Research
`Foundation and that Drs. Badylak and Spievack willfully
`induced ACell
`to infringe. Cook Biotech Inc. v. ACell,
`Inc, No. 4:03-CV-0046 AS, 2005 WL 2136107 (N.D.Ind.
`Aug.17, 2005) (“P0st—Trial Order ”). Plaintiffs-appellees,
`Cook Biotech Inc. and Purdue Research *1368 Foundation
`
`(respectively, “Cook” and “PRF”; collectively, “appellees”
`or “cross-appellants”), cross-appeal the district court's grant
`of summary judgment with respect to inventorship and the
`district court's denial of their post-trial motions pertaining
`to willful infringement and whether any relief should have
`been awarded following the jury's finding of infringement.
`Bccau sc the district court erred in its claim construction which
`
`formed the basis for the jury's finding of infringement and
`because, under the correct construction, there is no material
`
`factual dispute that the ACell Vet TM product carmot infringe
`claims 1, 7, and 8 of the '389 patent literally or under
`the doctrine of equivalents, the judgment of infringement is
`reversed. As a result, the issues raised in Cook's cross-appeal
`pertaining to its willful infringement case and its requests for
`relief following the jury verdict in its favor are rendered moot.
`
`1
`
`USAA 1023
`
`

`
`Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365 (2006)
`79 U.S.P.Q.2d1865
`
`Finally, because the district court did not err in detennining on
`summary judgment that (1) Dr. Badylak is not a co-inventor
`of U.S. Patent No. 6,576,265 (the “ '265 patent”), (2) Dr.
`Spievack is an inventor ofthe ’265 patent, and
`PRF’s unjust
`enrichment claim must fail, we affirm the district court's
`mlings with respect to those issues as raised i11 PRF's cross-
`appeal.
`
`I. BACKGROUND
`
`A. Factual Background
`
`1. Dr. Badylak's activities and the '389 patent
`
`Dr. Badylak was employed by Purdue University from 1977
`until October 6, 2002. In the 1nid—l980s, Dr. Badylak a11d
`others in his laboratory at Purdue University discovered
`that certain tissue compositions could be used as scaffolds
`for
`tissue reconstmction. As advancements were made
`
`using these tissue compositions, now known as extracellular
`matrices or ECMs.
`the tissues came to be categorized
`according to the source of the tissue, e.g., small intestinal
`submucosa (“SIS”), stomach submucosa,
`liver basement
`membrane, urinary bladder submucosa (“UBS”), and urinary
`bladder matrix (“UBM”). The two organ tissue sources
`relevant to this case are UBS a11d UBM.
`
`The '389 patent, entitled “Urinary Bladder Submucosa
`Derived Tissue Graft,” issued on September 10, 1996. The
`'3 89 patent is directed to a urinary bladder submucosa derived
`tissue graft composition comprising bladder submucosal
`tissue “delaminated from the abluminal muscle layers and at
`least the luminal portion of the tunica mucosa of the urinary
`bladder tissue, ” '389 patent, col. 1, 11. 56-58, that can be
`implanted to replace or support damaged or diseased tissues.
`Claim 1 of the '389 patent is representative of the claims at
`issue:
`
`1. A composition comprising urinary
`bladder .vu/7muco.va delaminated from
`
`both the abluminal muscle layers and
`at
`least
`the luminal portion of the
`tunica mucosa of a segment of a
`urinary bladder of a warm blooded
`vertebrate.
`
`'389 patent, col. 5, II. 20-23 (emphasis added).
`
`WESTLAW
`
`The '3 89 patent names four inventors, one of whom is Dr.
`Badylak. Pursuant to his employment contract, Dr. Badylak
`assigned the '389 patent and the rights to other patents
`on inventions he had developed to PRF. On February 9,
`2003, PRF granted Cook an exclusive license with respect
`to many of its patents i11 this field of tissue engineering,
`including the '389 patent for all non-orthopedic and non-
`cardiac applications.
`
`2. Dr. Spievack, the '265 patent, and ACell
`
`Dr. Spievack, a Harvard University professor and surgeon,
`developed an interest *l369 in the regenerative capabilities
`of the epithelial basement membrane during his studies as a
`Fulbright scholar in the 1950s. 111 early 1996, Dr. Spievack
`first met Dr. Badylak at a conference during a presentation
`given by Dr. Badylak pertaining to SIS.
`
`in March I996, he tested
`According to Dr. Spievack,
`techniques for removing various tissue layers of the bladder
`wall and in July of that year, he successfully treated poison
`ivy on one of his legs with a bladder basement membrane
`composition. Dr. Spievack testified that between February
`and October 1996, he did not discuss the results of his
`basement membrane tests with Dr. Badylak, but from the
`end of 1996 through the end of 1999, he visited Dr.
`Badylak at Purdue University and discussed his work on graft
`compositions.
`
`Beginning in 1998, Dr. Spievack sought to obtain a license
`from PRF for non—SIS products. When PRF ultimately
`turned him down, Dr. Spievack continued to work on what
`he considers to be his own UBM technology. In 1999,
`Dr. Spievack formed ACell, Inc. to research a11d develop
`extracellular matrix technology. On December 22 of that
`year, Dr. Spievack filed a provisional application on a UBM
`composition, which led to the issuance of two patents naming
`him as the sole inventor, the '265 patent and U.S. Patent No.
`6,579,538 (the “ '538 patent”). The term UBM first appeared
`in the ’265 patent, which issued on June 10, 2003. UBM
`refers to a matrix of tissues including the basement membrane
`and tunica propria of the urinary bladder of a mammal. The
`'265 patent discloses and claims,
`inter alia, a tissue graft
`composition including the epithelial basement membrane.
`
`On August 27, 2002, while the '265 patent was still pending,
`PRF asked the United States Patent and Trademark Office
`
`(the "PTO”) to declare an interference pursuant to 37 C .F.R.
`
`2
`
`

`
`Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365 (2006)
`79 U.S.P.Q.2d1865
`
`four other
`In its petition, PRF asserted that
`l.47(a).
`§
`individuals, including Dr. Badylak, were co-inventors with
`
`Dr. Spievack of the invention claimed in the ’265 patent. 1
`
`is sold by ACell
`The accused product, ACell Vet TM,
`in three forms: hydrated, lyophilized, and powdered. Since
`the issuance of the ’265 patent, ACell has represented that
`its product includes the epithelial basement membrane as
`disclosed and claimed in the '265 patent.
`
`B. Procedural History
`
`1. Appellees' infringement case
`
`Cook and PRF sued ACell for, inter alia, patent infringement
`of claims 1, 7, and 8 of the '389 patent, correction of
`
`inventorship for a number of issued patentsz (collectively,
`the “Disputed Patents”), and common law unjust enrichment
`for the research and inventions disclosed iii the Disputed
`Patents. On September 4, 2003, appellees moved for a
`preliminary injunction, seeking to enjoin the sale of ACell
`
`Vet TM. The district court denied the motion based on the
`
`record before it, preliminarily finding that claim 1 of the '389
`patent “does not
`extend beyond an essentially submucosa
`composition,” and emphasized that its findings were based on
`a preliminary record and were not intended to be a Markman
`*1370
`ruling on claim construction. Cook Biotech Inc. V.
`ACell, Inc., No. 4:03—CV—0046 AS, slip op. at 10 (N.D.lnd.
`Dec.22, 2003).
`
`After conducting a Markmcm hearing, during which the
`district court solicited the parties‘ proposed constructions
`in the form of jury instructions, the district court adopted
`appellees’ proposed instructions. See Cook Biotech Inc.
`v. ACell, Inc, No. 4:03—CV—0046 AS (N.D.Ind. Oct.25,
`2004) (“Markman Order ”). Of particular relevance,
`the
`district court rejected ACell's proposed construction for
`“urinary bladder submucosa” and “at least the luminal portion
`of the tunica mucosa” and adopted appellees’ proposed
`construction of the phrase “at least the l11minal portion of the
`tunica mucosa.” The district court rejected ACell's proposed
`construction of “urinary bladder submucosa” because it
`believed that the invention disclosed in the '3 89 patent was
`broad enough to include compositions that contained tissues
`other than submucosa. Id, slip op. at 9-10. F11rther, because
`the district court believed that ACell's proposed construction
`of “urinary bladder submucosa” would rewrite the claims
`
`WESTLAW
`
`(i.e., change an open transition, comprising, into a closed
`transition, consisting essentially of),
`it was unwilling to
`accept that construction. The district court was also convinced
`by the evidence presented at the hearing and the ordinary
`meaning of the tunica mucosa that “the luminal portion of the
`tunica mucosa” refers only to the epithelial cells. let, slip op.
`at 10-1 1.
`
`On June 17, 2005, the district court considered a motion by
`appellees seeking summary judgment of patent infringement
`or,
`i11 the alternative, partial summary judgment that the
`only issue remaining for the jury with respect to whether
`ACell
`infringes claims 1, 7, and 8 of the '389 patent is
`whether ACell's product contains submucosa. Based on the
`submissions ofthe parties, the district court granted appellees’
`alternative motion for partial summary judgment leaving only
`one issue for trial with respect to infringement of those claims:
`whether the ACell product contained any urinary bladder
`
`submucosa.3 Accordingly, the district court i11st1ucted the
`jury that appellees must prove
`
`[ACell's] product
`[t]hat it is more likely than not that
`In making this
`includes any amount of submucosa.
`determination you should keep in mind that submucosa, as
`l have defined it, does not require any particular amount of
`submucosa, and that the presence of any submucosa in the
`ACell product requires a finding of infringement.
`In response, the jury returned a verdict finding that ACell
`infringed claims l, 7, and 8 of the '389 patent, but found
`that the infringement was not willful.
`the
`With respect
`to damages, on the first day of trial,
`district court granted ACell's motion in limine seeking to
`preclude appellees from presenting lost profits damages
`to the jury because the district court found that appellees
`failed to establish an “appropriate record” with respect to
`damages sufficient to raise ajury issue. That ruling effectively
`precluded appellees from obtaining damages because they
`had sought only lost profits damages, and not a reasonable
`royalty. Thus, even though the jury returned a verdict in their
`favor, appellees were not awarded any damages.
`
`Following the judgment, both parties filed post-trial motions.
`ACell moved the *1371 district co11rt to amend the judgment
`after this court issued its opinion i11 Phi/lips v. AWH Corp.,
`415 F.3d 1303 (Fed.Cir.2005) (en banc). ACell contended
`that
`this court's decision in Phillips made it clear that
`ACell's proposed claim constructions were correct and that
`a product that did not remove the lamina propria, basement
`
`3
`
`

`
`Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365 (2006)
`79 U.S.P.Q.2d1865
`
`membrane, and epithelial cells could not infringe the '389
`patent. Appellees filed post-trial motions for lost profits
`damages, willfulness as a matter of law, and attorney fees.
`VVhiIe the district court denied the parties’ motions, it also
`stayed enforcement of a permanent injunction because it
`found that this court's decision i11 Phillips “raises enough
`doubt at this point under these under [sic] the totality of
`the circumstances of this case to cause this court to stay its
`hand and grant the stay of enforcing a permanent injunction
`pending the appeal in this case.” PosI—Trial Order, slip op.
`at 3.
`
`2. PRF's Case and lnventorship
`
`The district court also considered several motions
`
`for
`
`summary judgment relating to inventorship issues filed
`by appellees and ACell. Specifically, appellees sought to
`establish on summary judgment that Dr. Badylak is a joint
`inventor of the ’265 patent. Appellees alleged that Dr.
`Badylak collaborated with Dr. Spievack in developing the
`urinary bladder as a tissue graft composition as claimed
`in the '265 patent, and that because Dr. Badylak is under
`an obligation to assign the inventions he made while at
`Purdue to PRF, PRF is a rightful owner of the ’265 patent.
`ACell filed its own summary judgment motion on Count
`IV (“unjust enrichment”) of PRF's complaint and a partial
`summary judgment motion on Counterclaim Counts I (“rights
`to technology”) and H (“inventorship”).
`
`The district court first noted that appellees had failed to
`assert that Dr. Badylak is the sole inventor of the ‘265 patent
`in their complaint,
`their interrogatory responses, and the
`Pretrial Order. Instead, the district court found that appellees’
`assertions were limited to “omitted” inventors. Thus,
`the
`
`district court precluded appellees from asserting that Dr.
`Badylak was the sole inventor or that Dr. Spievack was not a
`proper inventor of the '265 patent because of those failures.
`
`Second, the district court found that appellees had failed
`to present clear and convincing evidence that Dr. Badylak
`contributed in some significant manner to the conception of
`the invention claimed in the ’265 patent. In reaching that
`conclusion,
`the district court began its analysis with the
`presumption that the named inventors on a patent are correct,
`and also found that: (1) Dr. Badylak had filed papers under
`oath with the PTO in which he denied inventorship of the
`'265 patent; (2) the evidence demonstrated that Dr. Spievack
`conceived and reduced to practice the invention claimed in
`
`WESTLAW
`
`the '265 patent; (3) Dr. Spievack had completed the invention
`claimed in the "265 patent by the summer of 1996 when
`he successfully treated his poison ivy with it; and (4) any
`discussions between Drs. Badylak and Spievack after the
`summer of 1996 were irrelevant to the issue of inventorship
`because Dr. Spievack conceived the '265 patented invention
`by that summer.
`
`Finally, the district court found that the deposition excerpts
`cited by appellees,
`in support of their assertion that Dr.
`Spievack discussed the use of the basement membrane as a
`tissue graft material with Dr. Badylak at the 1996 conference,
`“fail[ed] to show that [Dr.] Badylak contributed anything
`to [Dr.] Spievak’s [sic] conception of the invention,
`let
`alone that [Dr.] Badylak contributed ‘in some significant
`manner’ ” as required by our holding in *1372 BJ Services
`Co. v. Halliburton Energy Services, Inc., 338 F.3d 1368,
`1373 (Fed.Cir.2003). Cook Biotech Inc. v. ACell, Inc., No.
`4:03—CV—0046 AS, slip op. at 9 (N.D.lnd. J11ne 22, 2003)
`(“Invent0rship Order ”). Because the district court found that
`appellees’ evidence failed to meet the clear and convincing
`evidence standard to correct inventorship, it denied appellees’
`motion for summary judgment that Dr. Badylak was a co-
`inventor of the ’265 patent.
`
`In considering ACell's partial summary judgment motion
`on Counterclaim Counts I (“rights to technology”) and II
`(“inventorship”), the district court noted that it interpreted
`ACell's motion as a request for a declaration to the effect that
`Dr. Spievack is an inventor of the '265 patent. Relying o11
`its previous determinations with respect to inventorship, the
`district court granted ACell's motion for a declaration that
`Dr. Spievack is an inventor of the ‘265 patent. See infira Part
`Il.B.4.
`
`With respect to ACell's motion for summary judgment on
`appellees’ Counterclaim Count
`IV (“unjust enrichment”)
`under Indiana law, the district court found that because the
`rights of the parties were controlled by an express contract,
`recovery could not be based upon a theory implied in law, e.g.,
`unjust enrichment. Additionally, the district court found that
`appellees’ chosen remedy, assuming they could prove unjust
`enrichment, of a constructive trust was not available because
`they failed to assert either actual or constructive fraud in their
`complaint.
`
`ACeII appeals the district court's construction of “urinary
`bladder submucosa” and “at least the luminal portion of the
`tunica mucosa,” the jury's findings of infringement of claims
`
`4
`
`

`
`Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365 (2006)
`79 U.S.P.Q.2d1865
`
`1, 7, and 8 of the '389 pate11t, and the adequacy of the verdict
`form. Cook cross-appeals several rulings by the district court
`with respect to its willfulness case and the district court's
`decision to stay an award of a permanent injunction until after
`appeal to this court. PRF cross-appeals several of the district
`court's rulings pertai11i11g to inVe11torsl1ip and its dismissal of
`PRF’s unjust enrichment claim. We have jurisdiction pursuant
`to 28 U.S.C. § 1295(a)(1).
`
`II. DISCUSSION
`
`A. Standard of Review
`
`We review a district court's grant of summary judgment
`de novo, reapplying the standard applicable at the district
`court. Rodime PLC v. Seagate Tech, Inc, 174 F.3d 1294,
`1301 (Fed.Cir.1999). Summary judgment is appropriate when
`it has been shown “that
`there is no genuine issue as to
`any material fact and that the moving party is entitled to a
`judgment as a matter of law.” Fed.R.Civ.P. 56(c); Scaife v.
`Cook County, 446 F.3d 735, 739 (7th Cir.2006).
`
`We review the district court's denial of a motion for JMOL
`
`de novo. Harris Corp. v. Ericsson Inc., 417 F.3d 1241,
`1248 (Fed.Cir.2005). A court may grant JMOL on an issue
`when “there is no legally sufficient evidentiary basis for a
`reasonable jury to find for [the nonmoving] party on that
`issue ....” Fed.R.Civ.P. 50(a)(1).
`
`[1] Determining infringement generally requires two steps.
`“First, the claim must be properly construed to determine its
`scope and meaning. Second, the claim as properly constmed
`must be compared to the accused device or process.” Carroll
`Touch, Inc. v. Electro Mech Sys, Inc., 15 F.3d 1573, 1576
`(Fed.Cir.l 993).
`
`Claim construction is an issue of law that
`
`[4]
`[31
`I21
`we review de novo. Cybor Corp. v. FAS Techs, Inc., 138
`F.3d 1448, 1456 (Fed.Cir.1998) (en banc); Mar/cman v.
`Westview Instruments, Inc, 52 F.3d 967, 979 (Fed.Cir.l 995)
`(en banc), affd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d
`577 (1996). “When interpreting claims. we inquire into how
`a person of ordinary skill in *1373 the art would have
`understood [the] claim terms at the time of the invention.”
`Pfizer, Inc. v. Teva Pharms. USA, Inc, 429 F.3d 1364,
`1372-73 (Fed.Cir.2005) (citing Phillips, 415 F.3d at 1313).
`“The inquiry into how a person of ordinary skill in the art
`understands a claim term provides an objective baseline from
`
`WESTLAW
`
`which to begin claim interpretation.” Id. “Importantly, the
`person of ordinary skill in the art is deemed to read the
`claim term not only in the context of the particular claim
`in which the disputed term appears, but in the context of
`the entire patent,
`including the specification.” Id. “[O]ur
`cases recognize that the specification may reveal a special
`definition given to a claim term by the patentee that differs
`from the meaning it would otherwise possess. In such cases,
`the inventors lexicography governs.” Phillips, 415 F.3d at
`1316.
`
`Infringement, whether literal or under the doctrine
`[6]
`[5]
`of equivalents, is a question of fact. Bai v. L & L Wings,
`Inc, 160 F.3d 1350, 1353 (Fed.Cir. 1998). The proper inquiry
`is whether the evidence is such that a reasonable jury could
`return a verdict for the non-movant. See Anderson v. Liberty
`Lobby, Inc., 477 U.S. 242, 252, 106 S.Ct. 2505, 91 L.Ed.2d
`202 (1986). We must draw alljustifiable inferences in favor of
`the non-movant. Id. VVhen a district court's determination of
`
`infringement is premised on an erroneously construed claim,
`however,
`that determination is not entitled to deference.
`
`Playtex Prods, Inc. v. Procter & Gamble Co., 400 F.3d 901,
`906 (Fed.Cir.2005) (citing Elkay Mfg. Co. v. Ebco ll/fig. Co.,
`192 F.3d 973, 976 (Fed.Cir.1999)).
`
`[3]
`[7]
`Evidentiary rulings are generally not unique to
`patent law and therefore we review them under the law of
`the regional circuit. Advanced Cardiovascular Sys, Inc. v.
`Medtronic, Inc, 265 F.3d 1294, 1308 (Fed.Cir.2001). The
`Seventh Circuit reviews a district court's evidentiary rulings
`for an abuse of discretion. Wollenburg v. Comtech Mfg. Co.,
`201 F.3d 973, 977 (7th Cir.2000) (citations omitted).
`
`[111
`I101
`[91
`Generally, inventorship is a question of law
`that is reviewed de novo. subject to review of underlying
`factual findings for clear error. Univ. of Colo. Found, Inc. v.
`Am. Cyanamid Co., 342 F.3d 1298, 1308—09 (Fed.Cir.2003).
`However, where the inventorship issues were resolved on
`summary judgment, “such factual inferences as are material
`to the grant [of summary judgment] are not reviewed under
`the clearly erroneous standard, as if they were findings of fact
`made following a trial of issues[,]” Lemelson v. TRW, Inc.,
`760 F.2d 1254, 1260 (Fed.Cir.1985), but rather are reviewed
`de 11ovo, reapplying the standard applicable at the district
`court, see Rodime PLC. 174 F.3d at 1301 (Fed.Cir.1999).
`“[T]o be a joint
`inventor, an individual must make a
`contribution to the conception of the claimed invention that
`is not insignificant in quality,” and the inventors must “have
`some open line of communication during or in temporal
`
`5
`
`

`
`Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365 (2006)
`79 U.S.P.Q.2d1865
`
`proximity to their inventive efforts ....” Eli Lilly & Co. v.
`Aradigm, 376 F.3d 1352, 1358-59 (Fed.Cir.2004).
`
`bladder tissue.” Id. at col. 1, 11. 55-58 (emphasis added). The
`first paragraph of the “DETAILED DESCRIPTION OF THE
`INVENTION” section states:
`
`Assignment of ownership is governed by state law doctrines.
`Univ. ofColo., 342 F.3d at 1308.
`
`B. Analysis
`
`1. Claim Construction
`
`a. “urinary bladder submucosa”
`
`[12] ACell asserts that the district court erred in construing
`the term “urinary bladder submucosa” in claims 1, 7, and 8
`of the '389 patent. ACell asserts that the PTO did not grant
`the '3 89 patent inventors a patent to the naturally occurring
`submucosa layer of a urinary bladder, but rather that it
`granted them a patent covering a tissue graft composition
`derived *1 374 from that layer. ACell argues that the '38,‘)
`specification makes clear that “urinary bladder submucosa”
`is a defined term which was defined to expressly exclude
`other urinary bladder tissue layers, specifically the abluminal
`muscle cell layers and at least the luminal portion of the tunica
`mucosa layer.
`
`Cook argues that the '389 patent specification, specifically
`in the “DETAILED DESCRIPTION OF THE INVENTION"
`
`section, teaches that the term “urinary bladder submucosa”
`is broader than ACell‘s proposed construction because it
`states that
`the resulting composition “typically” consists
`essentially of urinary bladder submucosa. Cook thus asserts
`that
`the use of “typically” implies that
`there is another
`possible embodiment of the claimed composition that merely
`comprises urinary bladder submucosa, but may also include
`other tissues.
`
`As noted above, claim 1 recites: “A composition comprising
`urinary bladder submucosa delaminated from both the
`abluminal muscle layers and at least the luminal portion
`of the tunica mucosa of a segment of a urinary bladder
`of a warm blooded vertebrate.” '389 patent, col. 5,
`11.
`20-23 (emphasis added). The ’389 patent specification,
`in the “BACKGROUND AND SUMMARY OF THE
`
`section,
`states
`“[u]rinary bladder
`that
`INVENTION”
`submucosa for use in accordance with the present invention
`is delaminated firom the abluminal muscle layers and at
`least the luminal portion of the tunica mucosa of the urinary
`
`WESTLAW
`
`The tissue graft of composition in
`accordance with the present invention
`comprises urinary bladder submucosa
`of
`a warm-blooded
`vertebrate
`
`delaminated from adjacent bladder
`tissue
`layers. The present
`tissue
`graft composition thus comprises the
`bladder submucosa delaminatedfrom
`abluminal muscle cell
`layers and
`at least
`the luminal portion of the
`mucosal layer of a segment of urinary
`bladder of a warm-blooded vertebrate.
`
`Typically the delamination technique
`described below provides a tissue
`composition
`consisting
`essentially
`of
`urinary
`bladder
`submucosa.
`These compositions are referred to
`herein generically as urinary bladder
`submucosa (UBS).
`
`Id. at col. 2, 11. 1-4 (emphases added).
`
`[13]
`“[T]he specification may reveal a special definition
`given to a claim term by the patentee that differs from
`the meaning it would otherwise possess.
`In such cases,
`the inventor's lexicography governs.” Phillips, 415 F.3d
`at 1316. We believe that
`this is exactly what
`the '389
`patentees did in this case. As the above quoted portions
`of the specification indicate, the composition invented was
`defined to be “urinary bladder submucosa delaminated from
`abluminal muscle cell layers and at least the luminal portion
`of the tunica mucosa of the urinary bladder tissue.” See,
`eg.,
`'389 patent, col. 1, 11. 56-58. The specification also
`indicates that the resulting composition “typically” consists
`essentially of urinary bladder submucosa. Thus, while the
`composition clearly includes urinary bladder submucosa, it
`may also include other tissues, such as the non—luminal
`portion of the tunica mucosal
`layer. However,
`it cannot
`include that which was expressly excluded in the patentees'
`definition, i.e., the “abluminal muscle cell layers and at least
`the luminal portion of the tunica mucosa.” Therefore, we
`construe “urinary bladder submucosa” as it is defined in the
`'3 89 patent specification to mean “urinary bladder submucosa
`delaminated from the abluminal muscle cell layers and at
`least the luminal portion of the tunica mucosa of the urinary
`bladder tissue," *1375 and it thus becomes necessary to
`
`6
`
`

`
`Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365 (2006)
`79 U.S.P.Q.2d1865
`
`determine which tissue layers are encompassed by the phrase
`
`“at least the luminal portion of the tunica mucosa.” 4
`
`b. “the luminal portion of the tunica mucosa”
`
`[14] ACell argues that the district court erred in construing
`the term “the luminal portion of the tunica mucosa.” ACell
`asserts that this term was defined by the patentee through the
`'3 89 patents incorporation by reference of the procedure for
`preparing intestinal submucosa as detailed in U.S. Patent No.
`4,902,508 (the “ '508 patent”). According to ACell, the '508
`patent specification defines “the luminal portion of the tunica
`mucosa” as “layer G” which includes the lamina epithelialis
`mucosa (or the epithelium layer) and its lamina propria. Thus,
`ACell asserts that the term “the luminal portion of the tunica
`mucosa" in the '3 89 patent should be given the same meaning,
`
`i.e., the epithelium layer and the tunica propria 5 layer.
`
`Appellees argue in response that the phrase “at least the
`luminal portion of the tunica mucosa” does not require a
`special definition and accuse ACell of “fishing” for a special
`definition. Further, appellees assert that there is no basis for
`importing a definition, even assuming the term is defined
`as ACell alleges, of the term from the '508 patent into the
`'3 89 patent because the ’508 patent is directed to SIS whereas
`the '3 89 patent is directed to UBS. Appellees assert that the
`district court's construction ofthe term as “the epithelial cells”
`should be affirmed.
`
`The phrase “urinary bladder submucosa” is present in all
`three claims at issue. Based on our constmction of that term
`
`as meaning “urinary bladder submucosa delaminated from
`.. at least the luminal portion of the tunica mucosa,” our
`construction of “the luminal portion of the tunica mucosa”
`applies to all three claims with equal force. We begin with the
`representative claim langmage from claim I of the ’389 patent,
`which states:
`
`1. A composition comprising urinary
`bladder submucosa delaminatedfront
`both the abluminal muscle layers and
`at least
`the luminal portion of the
`tunica mucosa of a segment of a
`urinary bladder of a warm blooded
`Vertebrate.
`
`'389 patent, col. 5, 11. 20—23 (emphases added). The '389
`patent specification informs our inquiry into the meaning
`
`WESTLAW
`
`of the claims. The “BACKGROUND AND SUMMARY
`
`OF THE INVENTION” section discloses that “[t]he wall
`of the urinary bladder is composed of the following layers:
`the tunica mucosa (including a transitional epithelium layer
`and the tunica propria), a submucosa layer, up to three
`layers of muscle and the adventitia (a loose connective
`tissue layer)—listed in thickness crossection from luminal to
`abluminal sides.” Id. at col. 1, ll. 49—55. The “DETAILED
`DESCRIPTION OF THE INVENTION”
`section sheds
`
`considerable light on the issue before us. It states:
`
`The preparation of UBS from a
`segment ofurinary bladder is similar to
`the procedure for preparing intestinal
`submucosa detailed in U.S. Patent
`the disclosure of
`
`No. 4,902,508,
`which is expressly incorporated herein
`by reference. A segment of urinary
`bladder tissue is
`first subjected to
`abrasion using a longitudinal wiping
`motion to remove both the outer
`
`abluminal
`(particularly the
`layers
`smooth muscle layers) and the luminal
`portions of the tunica mucosa layers
`— *l376 the epithelial
`layers ).
`The resulting submucosa tissue has
`a thickness of about 80 micrometers,
`
`and consists primarily (greater than
`98%) of a
`cellular,
`eosinophilic
`staining (I-I & E stain) extracellular
`matrix material.
`
`Id. at col. 2, 11. 17-28 (emphasis added). That paragraph
`makes clear that “the luminal portions of the tu11ica mucosa
`
`layers”6 were defined by the patentee as the “epithelial
`layers” and that “the procedure for preparing intestinal
`submucosa” as detailed in the '508 patent
`is expressly
`incorporated by reference into the '389 patent specification.
`
`The term “epithelial layers” may arguably be subject to two
`interpretations. On the one hand, it refers to “layers ” which
`appears to reflect that it was meant to encompass more than
`just the transitional epithelium layer,
`i.e.,
`the transitional
`epithelium layer and the tunica propria layer, the only other
`layer that the '389 patent teaches is part of the tunica mucosa.
`See id. at col. 1, 11. 51-52. On the other hand, as recognized
`by the district court, the epithelium in the urinary bladder
`is made up of multiple layers of epithelial cells. Markman
`Order, slip op. at 10. Even accepting that the disclosure in the
`'389 patent specification itself is less than clear as to which
`
`7
`
`

`
`Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365 (2006)
`79 U.S.P.Q.2d1865
`
`the second important disclosure
`interpretation is correct,
`of the '389 specification is dispositive. As noted, the ‘389
`patent specification expressly incorporates by reference the
`procedure for preparing intestinal submucosa fiom the '508
`patent.
`
`“Incorporation by reference provides a method for integrating
`material from various documents into a host document
`
`by citing such material in a manner that