*1 liability crosoft failed under it when reconsiders the proper disburse- I, 271(f) § Amado thus liability and its ment funds from escrow remand. by mandate cemented rule. III. CONCLUSION We first address Amado’s conten precludes tion that the mandate rule Mi the foregoing reasons, For the decision receiving crosoft from the benefit of the of the district court is AT & T noted, previously As decision. PART, IN AFFIRMED VACATEDIN mandate rule forecloses reconsideration of PART, and REMANDED. implicitly explicitly issues decided on Indus., appeal. Engel 166 F.3d at 1383. COSTS not, however, The mandate rule does affect No costs.

issues that have been “explicitly reserved or remanded.” Id. request Microsoft’s the AT & T decision does

application damages

not relate to the pre- award for infringement,

verdict which we affirmed in Amado I. Rather, Microsoft seeks have The REGENTS OF the UNIVERSITY applied only decision to the district CALIFORNIA, OF Molecular, Abbott 13, court’s March post- award for Inc., Laboratories, Inc., and Abbott verdict sales. That issue was not ad Plaintiffs-Appellants, I by was, dressed Amado panel fact, specifically reserved for the district v. I, court on remand. See Amado 185 Fed. CALIFORNIA, DAKOCYTOMATION Appx. Consequently, at 953. the issue is INC., Defendant-Appellee. by not foreclosed the mandate rule. Regents University of Cali-

It is well-settled that “[w]hen [the fornia, Molecular, Inc., Abbott Supreme] applies Court a rule of federal it, Laboratories, law to the parties Inc., before that rule Abbott is the Plaintiffs- controlling interpretation of federal Appellants, law given and must be full retroactive effect in v. all open cases still on direct review and as A/S, Dako America, and Dako North events, to all regardless of whether such Inc., Defendants-Appellees. predate events or postdate [] announce v. Harper Dep’t Va. ment the rule.” 2006-1334, 2006-1452, Nos. 2007-1202. Taxation, 86, 97, 2510, 509 U.S. 113 S.Ct. United States Appeals, Court of (1993). Although L.Ed.2d we con Federal Circuit. clude, pursuant Harper, that Microsoft is entitled to assert the AT & T decision, Feb. we are unable to determine whether the Rehearing and En Rehearing Banc infringing products sold Microsoft were Denied April 2008.* provided way in such a “sup as to not be plied from the United required States” as 271(f) § extinguish liability. The dis court,

trict presided trial over the matter,

this is thus better-suited to decide T, of AT & applicability may do so

* Judge Circuit participate Schall did not in the vote. *3 PROST, LOURIE, MAYER,

Before Judges. Circuit by Circuit filed for the court Opinion dissenting Opinion Judge LOURIE. PROST. Judge by Circuit filed part LOURIE, Judge. Circuit University of Cali- Regents Ab- Inc. Molecular and Abbott fornia *4 (collectively re- Inc. Laboratories bott two from appeal “appellants”) ferred District States United decisions of Califor- District Northern for the Court the district first Appellants nia. prelimi- a for their motion denial court’s and Dako enjoining A/S injunction nary (“Dako”) from American, Inc. North Dako FISH selling its HER2 manufacturing and kit”), ap- which (“HER2 kit pharmDX™ suit, in patents infringe the allege pellants (“the pat- 5,447,841 viz., Patents U.S. (“the patent”). 6,596,479 ent”) and interlocutory ap- an filed also Appellants court’s decision the district from peal judgment summary part granting Be- patents. of these noninfringement court the district we conclude cause “heterogene- term correctly construed sequence ous mixture con- in its erred fragments,” acid nucleic Strawn, Hurst, & Winston F. James identifiable “morphologically struction plaintiffs- for IL, argued Chicago, LLP, of concluding by nucleus,” erred and cell H. Lynn were the briefs On appellants. doctrine by the barred were C. Mewes, Carolyn Pasahow, N. Heather affirm we history estoppel, & prosecution Chuang, Fenwick C.J. Alice and Chang, fur- for remand and part, View, Of CA. reverse part, LLP, of Mountain West, ther proceedings. K. DeMarehi. Virginia counsel Finnegan, Jenkins, H. Thomas BACKGROUND Dunner, Farabow, & Garrett Henderson, all DC, for argued L.L.P., Washington, Technology on Background A. him With defendants-appellees. contain organisms living cells Wash- Tridico, of C. Anthony briefs nucle- cell in the chromosomes—structures David E. Hulse DC, Tina ington, deoxyribo- part of composed are us that Alto, the brief On CA. Hoffman, Palo C. complex (“DNA”). acid nucleic Dakocytomation defendant-appellee for informa- genetic encodes molecule Smith, of J. Richard California, Inc. was a cell to for order organism. an tion of Alto, CA. Palo replicate divide, it undergoes process col.2 11.19-23. procedures used cyto- known as mitosis. There are two main logical techniques to stain the chromo- phases in the cell-division cycle somes, thereby revealing —meta- “a longitudinal phase and interphase. During metaphase, segmentation into entities generally re- the chromosomes are condensed and are ferred to as bands.” Id. col.2 11.25-27. thus visible with a microscope. At this Banding analysis, however, required “cell stage mitosis, the condensed chromo- culturing and preparation of high [q]uality align somes in the middle of the cell before metaphase spreads, which is extremely dif- dividing into two daughter cells. That ficult and time consuming, and almost im- phase is relatively short-lived, as the rest possible for tumor cells.” Id. col.2 11.36— cycle spent in interphase. During interphase, the chromosomes are not visi- Second, other techniques, ble with a microscope they because are not probes used comprised of DNA and condensed and spread are throughout the RNA fragments gene, mapping, were nucleus. limited the nonspecificity of that tech- The inventions claimed patents *5 nique. Those probes “comprise labeled suit are directed to improved “methods for fragments of single stranded or double identifying and classifying chromosomes” stranded DNA or RNA which hybri- are in order to detect chromosomal abnormali- dized to complementary sites on chromo- ties. '841 patent col.l 11.21-22.1 Such somal DNA.” Id. col.2 11.57-60.The hybri- abnormalities “are associated genetic with dization process of the probes labeled to disorders, degenerative diseases, and expo- the target chromosomal DNA requires the sure agents [sic] known to degen- cause denaturation, or the unraveling, of the dou- diseases,” erative such as cancer. Id. col.l ble-stranded nucleic acids by heating or 11.23-26.There are general three types of some other means. Id. col.3 11.4-17. chromosomal That abnormalities, viz., extra or process then requires missing several chromosomes, individual additional extra or steps. problem A missing portions a chromosome, of associated with or chro- technique, however, mosomal rearrangements. was the Id. col.l nonspecificity 11.34- 36. of a While staining normal reagents human cell due to repetitive contains twenty-three pairs of chromosomes, sequences nucleotide present were genetic disorder known throughout as Down syn- the chromosomes. Id. col.4 drome, for example, is caused by an extra 11.47-52. Nucleotide sequences general- are copy of chromosome 21. Id. ly col.l 11.45-46. divided into three different categories based on their frequency: Several problems highly repetitive existed in the prior art (or DNA), with satellite respect which is screening located in the chromosomes. First, procedures region centromeric of the prior the chromosome; art were limited to and required middle-repetitive, which is generally chromosomes inter- be in the metaphase spersed phase among of cycle. unique the cell sequences; or Those procedures required unique. use of Id. col.4 meta- 11.27-30.The presence of phase chromosomes because repetitive it sequences was not “greatly reduces the “possible to visualize nonmetaphase, degree or in- of chromosome-specificity of the terphase chromosomes due to their dis- staining reagents invention, particu- persed condition in the cell nucleus.” Id. larly in genomes containing a significant 1. The patent '479 is a divisional of the reference, '841 throughout opinion we will patent, specification and has a nearly that is cite patent when referencing the identical to that of the '841 For ease specification. common nu- hybridized mit detection as such sequences, repetitive fraction segments, containing acid cleic 11.40-44. col.8 Id. genome.” human chromosomal wherein hybridize only would probes Labeled DNA, morphologically but identifi- chromosomal target with during well, thereby cell nucleus as chromosome able sequences repetitive with re- false-positive hybridization. in situ unacceptable producing sults. added). (emphases patent, '841 problems, of those light patent, of the During prosecution technique that staining employ sought the claims of indicated rapid possibility up “open[ed] blocking embod- limited patent of chromosomal detection sensitive highly that claims indicated further They iment. and inter- metaphase in both abnormalities of disabl- major embodiment the other lab- clinical using standard cells phase ie., re- capacity, hybridization ing the To 11.29-38. Id. col.5 oratory equipment.” sequences, would repetitive moval staining specificity increase application. in another pursued it state at issue patents reagents, pat- in the '479 resulted application That hybridization disable “desirable ent. Id. col.4 sequences.” repetitive capacity reads 1 of the Claim three discloses specification 11.47-48. follows: capacity disable ways to consisting sequences, inter- target staining A method screening removal, and *6 an selective blocking, to detect DNA chromosomal phase patent The '841 sequences. repetitive of a portions or portion missing or extra blocking repeti- to directed are claims an or chromosome, translocation aor patent 1 of the '841 Claim sequences. tive of a portions or portion of a inversion follows: reads comprising: chromosome, method chromo- target staining method 1. A mixture heterogeneous (a) providing comprising: DNA somal acid nucleic sequence unique labeled acid 1) nucleic (a) labeled providing com- substantially are which fragments are substan- which fragments comprises segments acid nucleic to plementary seg- acid nucleic to complementary tially chromosomal interphase within DNA for chromosomal within ments and is desired detection which DNA 2) block- desired, and is detection which an detection to allow designed are frag- comprises acid ing nucleic aof or portions portion missing or extra comple- substantially are which ments or an chromosome, a translocation or segments repetitive mentary of a portions a portion inversion acid; and nucleic labeled chromosome; acid, nucleic (b) labeled said employing mix- (b) employing acid, chromosomal blocking nucleic DNA interphase chromosomal ture so hybridization in in situ DNA detec- permit hybridization situ substan- are segments repetitive labeled fragments acid nucleic labeled the chro- binding to from blocked tially chro- interphase hybridized are which hybridization DNA, while mosomal chromosom- DNA, wherein mosomal nu- the labeled within segments unique morphologically ain present is al DNA chromosomal cleic acid to during nucleus cell labeled blocking of the allowed, identifiable wherein hybridization; situ per- is sufficient segments (c) detecting the labeled nucleic acid tion of the '841 patent under the doctrine fragments which hybridized are to the equivalents. interphase chromosomal DNA to deter- On March appellants appealed mine whether an extra or missing por- the district court’s denial of the prelimi- portions tion or of a chromosome, or a nary injunction. While translocation or an inversion portion of a pending, the district court issued another or portions of a chromosome is order May 17, 2006, amending the basis in the target interphase chromosomal for its denial of the preliminary injunction. DNA. Specifically, the district court amended its '479 patent claim 1 added). (emphases basis for rejecting appellants’ proposed patent '479 does not refer construction of the term “heterogeneous blocking Instead, method. the claimed in- mixture of unique labeled sequence nucleic vention patent '479 employs compo- acid fragments.” original order sitions that comprised are of “a heteroge- denying the preliminary injunction, neous mixture of sequence district court rejected appellants’ proposed nucleic acid fragments” that excludes re- construction term, of that only ap- petitive sequences. Thus, the invention of pears in the patent, '479 based on its '479 employs the method of conclusion that the '841 removing or screening repetitive '479 patent, and that adopting ap- quences from the heterogeneous mixture pellants’ proposed construction would like- in order to disable capac- ly render the '479 patent invalid. The ity of repetitive sequences contrast to —in court amended previous “its order to the using blocking acid, nucleic as claimed in extent it improperly cite[d] 35 U.S.C. '841 § 102 as the basis for questioning the va-

B. Procedural Background lidity of the claims of the patent” light of the patent, and instead stated

On September 29, 2005, appellants, who that the '479 patent likely would be ren- are the owner and exclusive licensee of the *7 dered invalid under the doctrine of non- patents suit, filed complaint for patent (obviousness) statutory double patenting. infringement against Dako. 14, On October Appellants then appealed 2005, from the appellants court’s filed a motion prelimi- for order, amended and both preliminary nary injunction in- seeking prohibit Dako junction appeals from consolidated for manufacturing and selling its HER2 briefing and oral argument. kit. The court denied appellants’ motion on 10, March In denying the mo- While the appeals were pending, Dako tion, the court concluded that appellants moved for summary judgment of nonin- failed to show a likelihood success on fringement. Prior to ruling on that mo- the merits of their infringement claim tion, un- the district court held a Markman der the '479 patent on, based alia, inter its hearing and construed certain claim limita- claim construction of two limitations, 31, tions. On July 2006, the court granted viz., “morphologically identifiable chromo- summary judgment of noninfringement of some or cell nucleus” and “heterogeneous the '479 patent as to all of the accused mixture of labeled unique sequence products nucleic based on its construction of acid fragments.” The court also based its “heterogeneous mixture” limitation. The conclusion appellants’ on failure to show a court granted further summary judgment likelihood of success that the prod- accused of noninfringement on the '841 uct met the “blocking nucleic acid” limita- to two of products, Dako’s viz., the HER2 (Fed.Cir.1995) (en kit, 52 F.3d 970-71 concluding upon kit and TOP2A asserting banc), in- Cybor from de v. FAS Corp. were barred novo. “blocking (Fed.Cir. nucleic acid” Techs., Inc., fringement 138 F.3d equiva- (en the doctrine 1998) banc). limitation under Whether the district summary court also denied lents. The application court erred its as to on judgment history estoppel to limit the effect of the products. twenty accused The remaining equivalents question doctrine of is also a whether Dako’s court did address de law that reviewed novo. Pharmacia “morphologically identifi- products met the Pharms., Inc., Mylan v. Upjohn & Co. claim limitation that limitation—a able” (Fed.Cir.1999). 1373,1376 F.3d injunction preliminary at issue motion. Summary B. Presented in the Issues Judgment Appeal2 cer- parties jointly filed a motion to the district tify appeal immediate mix- “heterogeneous 1. Construction of judgment under 28 summary order court’s unique sequence nu- ture labeled 1292(b) proceed- § stay and to U.S.C. fragments” acid cleic mo- granted court ings. The district injunction preliminary In both the 15, 2006, and on Febru- tion on December summary appeals, judgment appel 14, 2007, granted ary permission we argue that the court erred in lants district interlocutory we order. While appeal its construction of the claim limitation motions for generally have not certified “heterogeneous unique mixture labeled construction, interlocutory of claim appeal fragments,” nucleic acid limita sequence especially that it was desir- we determined required every claim the tion that is pendency in this case view of the able court construed that lan on the denial of the the related “heterogeneous to mean mixture of guage preliminary injunction based some in fragments nucleic acid argument, At oral the same issues. injunc- fragments,” parties preliminary only sequence agreed cludes appeals summary judgment repetitive se whereas Dako’s kits contain together in appeal should be considered court quences. Appellants assert that the that are light overlapping issues language to by interpreting that erred jurisdiction pursuant us. We have before mixture ex mean 1292(c)(1). § to 28 U.S.C. They sequences. assert cludes contrary construction *8 DISCUSSION pat that claims of the dependent fact sequences. clearly require repetitive ent Review A Standard of argue further that district Appellants in Appellants raise three issues by relying prosecution on the court erred from the prelimi combined their Ac history construction. support in its summary judgment nary injunction “unique cording appellants, the term con Two issues concern claim orders. to the claim to was not added sequence” prosecu concerns struction and the other mix scope heterogeneous of the limit history estoppel. We review tion Rather, ture, as court concluded. it law, construction, is an issue of which Inc., Instruments, clarify that the invention added v. Markman Westview dispositive has a mixture” in case We the issues raised in the ous first address injunction appeal, appeal. our summary judgment impact preliminary as decision on ''heterogene- concerning construction of of unique patent related the detection '841 would likely render the '479 quences, opposed as to the detection of patent appellants’ invalid if construction taught in repetitive sequences prior as had adopted. been art. error, After realizing its the dis response, argues In Dako in- trict an preliminary court issued amended supports

trinsic evidence the district injunction order, relying a new basis Dako, According construction. court’s rejecting appellants’ proposed con language supports the claim a construction struction. court reasoned that repetitive sequences, that excludes not- construction would likely render the '479 claims, withstanding the be- dependent (obvi patent invalid nonstatutory based on specification supports cause the that con- ousness) patenting double view of the struction statements embodiments patent. however, Appellants, '841 had light prosecution history and in previously disclaimer, addition, filed terminal patent. In argues the '479 Dako which cures such a patenting rejec of claim double doctrine differentiation is Pharms., not an absolute rule. construction tion. Where Geneva Inc. v. GlaxoS- independent of an PLC, (Fed. claim leads a clear mithKline 349 F.3d dependent Cir.2003). conclusion inconsistent with a Thus, the court erred re claim, the doctrine of claim differentiation jecting appellants’ construction on that ba yield. must sis as well. initial denying preliminary its order Although the district court erred

injunctive relief, the court concluded that reasoning above, its as forth set we none mixture excludes re- theless will affirm the court’s construction petitive sequences light of the '841 of the heterogeneous mixture limitation. patent, which court characterized correctly prosecu court evaluated the art to patent. The court history and determined proper construction, appellants’ reasoned that claim construction. also agree We with contemplates the use both the court’s conclusion forth set in its sum repetitive sequences, raised mary judgment decision that the “serious [appellants’] concerns about the disclaimed embodiments include re ability to simultaneously preserve validity petitive sequences during the infringement and establish respect with Thus, the district patent.” claim of the court Regents Cal., was correct DakoCytomation concluding Univ. Cal. v. the accused Inc., 05-CV-03955, 618769, products, No. which employ a mixture WL that in (N.D. 2006). Thus, at *9 repetitive sequences, Cal. Mar. cludes do not infringe rejected the court appellants’ proposed the '479 patent.

construction upon concluding that it It is a truism that the claims of a likely would render the invalid un- claimed, define the 102(b). invention that is § der 35 U.S.C. The court’s rea- *9 prosecution history but “the can often in however, soning, was erroneous because form the meaning language by the claim patent the '479 is a division of the '841 demonstrating patent and how the inventor priority claims the under the fil- ing stood the date the '841 invention and whether the See 35 inven such, § 120. U.S.C. As the tor limited the in court erred invention the course of in characterizing prosecution, the as prior making scope the claim nar art, concluding and thus erred in that the rower than it would otherwise be.” Phil- desired; which detection 1303, DNA 415 F.3d Corp., lips v. AWH banc). (en (Fed.Cir.2005) mix- (b) heterogeneous the employing in the history DNA interphase chromosomal scope ture the light decisive sheds case detec- permit to originally situ As term. claim disputed fragments acid nucleic result- of labeled application tion filed, the divisional chro- single interphase a to hybridized included which are

ed 17, DNA, read: the chromo- claim, claim wherein That claim. mosomal morphologi- a present in staining chromosomal DNA somal A method 17. type during the chromosome cell nucleus particular cally aof DNA identifiable group thereof, particular or a portion hybridization. in situ com- method types, the chromosome added). (emphases at 6650-51 Supp. J.A. of: steps prising “unique added Thus, patentees mixture heterogeneous a providing limita- limitation, as other as well quence” substan- fragments, acid nucleic labeled chromosomal interphase regarding tions acid nucleic labeled of each portions tial identifiable morphologically and a DNA mixture heterogeneous in the fragment did patentees Although cell nucleus. substantially sequences having base “unique whether state expressly not of the sequences base to complementary in re- added limitation was sequence” DNA; and chromosomal given rejection, any particular sponse with mixture heterogeneous reacting the accompanying arguments patentees’ hybri- in situ by DNA chromosomal state- amendment, previous well as as dization. prosecu- during the made ments original Notably, 6592. J.A. Supp. “unique term patent, the tion of “unique phrase include claim did to overcome clearly added sequence” sequence.” rejection. the enablement issued 1996, examiner April rejection, enablement issuing the When including an en rejections, separate three worded, “[a]s stated examiner 112, para § first under rejection ablement actual practice specificity is no there rejection under indefiniteness an graph; stain- in the result that would steps claim anticipa and an paragraph; § second much so only without target ing prior three in view rejection nucleic target desired background al, Mont et viz., Landegent references, Thus, the ex- [obscured].” would acid al. To al., et Cannizzaro gomery et claim original recognized aminer rejections, those overcome to- directed limitation to include failed a new and submitted canceled binding of nonspecific reducing the ward well as claim, claim independent key problem sequences —a 18 read: Claim claims. dependent several specifica- in the art, as disclosed inter- target staining A method however, able patentees, tion. am- to detect chromosomal phase rejection the enablement overcome rearrange- deletion, and plifications, mixture heterogeneous limiting the comprising: ments restricting Indeed, by unique sequences. mixture heterogeneous (a) providing mixture acid nucleic sequence unique of labeled problem sequences, probes substantially com- are fragments repet- binding to probes resulting from segments acid nucleic plementary *10 not arise. would sequences itive chromosomal interphase the within That conclusion is supported by pat- the Appellants argue that the addition entees’ earlier decision to pursue claims to “unique sequence” limitation was certain embodiments in the patent, '479 not made to overcome the enablement re while limiting patent the '841 jection the block- instead was added to over —but ing method. When prosecuting the '841 come the anticipation rejection. partic In patent, the patentees stated: ular, appellants contend that the patentees added the “unique sequence” language invention is directed to to distinguish the invention

chromosome-specific staining by in situ 102(b) § from the prior hybridization. aspect One references. the inven- According to appellants, the prior art disabling involves ref hybridiza- erences repetitive used tion capacity sequence repeat probes sequences. In for the detection of embodiment, one repetitive sequences, that disabling per- in contrast by formed '479 invention selective which blocking of the re- unique sequence used petitive sequences. probes for the All de the newly tection of unique sequences. such, added claims are As be directed this embod- cause the addition of “unique iment sequence” invention. had nothing to do with the issue concern Previously, the broadest claims had been ing the nonspecific binding repetitive directed to the generic invention where sequences issue by raised the examin —an repetitive sequences are by disabled er in connection with the enablement re any means, the major other embodiment jection appellants argue that paten — by being removal repetitive se- tees did not intend to limit the scope quences. matter, Claims to that subject heterogeneous mixture adding “unique applicants which also pat- believe to be sequence” to the claims. entable, pursued will be in a separate application. areWe persuaded by appellants’ argument. As a preliminary matter, only Supp. added). 6124 (emphases J.A. That two three art references dis- separate application pat- became close the use of repetitive sequence probes ent. Notably, patentees’ statements in to detect repetitive sequences. Indeed, the prosecution history of the appellants acknowledge in their opening important indicate two points, viz., that the brief support of their summary judg- disabling of capacity of ment reference, third Can- repetitive sequences by blocking key was a al., nizzaro et “disclosed the use of unique aspect of the '841 invention and that sequence probes.” Thus, the argument claims to embodiments involving the re- inserted the “unique moval of repetitive sequences would sequence” limitation to overcome the antic- pursued in separate application. Hence, ipation rejection in 102(b) § view the addition of “unique sequence” to the prior art unpersuasive. references is limitation, mixture coupled with patentees’ Second, patentees’ statements during statements prosecution, evince clear Remarks intent to section limit accompanying the claims of the '479 patent amendment indicate those other language in embodiments in amended claim was intended to over- quences have been come the anticipation excluded from the rejection. het- partic- erogeneous ular, mixture in order to argued: disable the hybridization capacity of repetitive se- Claim 17 rejected has been under 35 quences. 102(b) § U.S.C. as being anticipated by

1375 prior over the distinguished the invention al, Montgomery Landegent et of any one addition was sequence” “unique art.3 The al. view et al, or et Cannizzaro to overcome part in of new made at in favor least 17 of claim cancellation rejection. that record, it is believed enablement claims now art is prior in view rejection this that the dis argue also Appellants dis- to moot. now fails incorrect is construction trict court’s the methods suggest even close re claims that dependent of certain light chromo- [sic] target staining interface sequences. repetitive quire inclusion de- amplifications, to detect somal v. Corp. Sol rely on AK Steel Appellants now rearrangements, letions (Fed. 1234, 1242 F.3d 344 Ugine, lac and is rejection of this Withdrawal claimed. “depen that Cir.2003), proposition for order. to be in thus believed of narrow to be presumed are dent claims added). Thus, (emphasis 6654 Supp. J.A. from claims scope independent er than patentees’ language plain on based the doctrine under they depend” which overcame statements, argument, That claim differentiation. clarifying by rejection anticipation Pre however, unpersuasive. likewise is applied staining was claimed method held have We are rebuttable. sumptions DNA, in contrast chromosomal interphase dependent that it is true that “[w]hile DNA, which chromosomal metaphase scope of interpreting can aid claims art references. in the prior was disclosed they are depend, they claims from that state Indeed, three references all are not interpretation and only an aid sequences target detecting probes Vaccine, v. Am. Inc. N. Am. conclusive.” chromosomes. metaphase used were (Fed.Cir. Co., 7 F.3d Cyanamid (Landegent refer- at 6618 Supp. J.A. See created 1993). Indeed, presumption was tested stating procedure ence differentiation of claim by the doctrine sequences “mouse satellite optimized on will be rule and and fast “not a hard of a mouse-human preparations metaphase dic contrary construction by a overcome (Montgomery line”); id. at hybrid cell prose description or written by the tated with “[h]ybridization stating that reference Int’l, v. Inc. Seachange history.” cution local- in situ has chromosomes metaphase (Fed. 1361, 1369 C-COR, Inc., 413 F.3d homoge- either the sequences to ized these above, the Cir.2005). Here, as discussed double-minute regions or staining neously pre history overcomes (Cannizzaro chromosomes”); id. at “het construction correct sumption; “metaphase [chromosomes stating that that excludes one mixture” erogeneous (em- subjects”) both examined from were] notwithstanding sequences, repetitive added). Thus, conten- appellants’ phases dependent claims of certain presence sequence” “unique addition of tion that the them. do not exclude anticipation to overcome added addition- appellants’ have considered We re- the enablement than rejection, rather position their support of arguments al own patentees’ jection, is belied mixture does interphase limitation statements added). (emphasis Reply brief, J. Br. at argue Summ. that in their We note however, reference, reveals of that Our review interphase limitation “the addition used metaphase chromosomes anticipa- overcome was not sufficient and no mention Landegent experiments Landegent regard to the rejection" with We thus was made. interphase chromosomes "discloses reference because that reference be unsubstantiat- appellants’ statement find probes to detect the use of unpersuasive. ed hence Appellants’ cells.” interphase sequences in *12 repetitive sequences, exclude and find no sumption of surrender was overcome basis for reversing the claim court’s con- because amendment was merely Accordingly, struction. having determined tangential equivalent. accused In patentees limited scope response, Dako argues that the court heterogeneous mixture to only one that correctly applied presumption that contains sequences, the court’s equivalents surrendered claim construction of “heterogeneous mix- the nucleic acid limitation ap- and that ture containing labeled unique sequence pellants have failed to rebut pre- nucleic fragments” acid Thus, affirmed. sumption. grant court’s summary judgment of noninfringement toas patent agree We with appellants that affirmed. the district court erred applying prose history cution estoppel to the “blocking

2. History Prosecution Estoppel nucleic acid” limitation. “Prosecution his The district court granted also tory estoppel prevents a patentee from summary judgment of noninfringement of recapturing under the equiva doctrine of as to two products, accused subject lents matter surrendered during viz., the HER2 kit and the TOP2A kit. In prosecution to obtain a patent.” Cross reaching conclusion, the court ad Prods., Med. Inc. v. Medtronic Sofamor dressed the claim limitation “blocking nu Danek, Inc., (Fed.Cir. 1335, 480 F.3d cleic acid”—a required by term all the 2007) (citing Festo Corp. v. Shoketsu Kin claims of the In the district zoku Co., Kogyo Kabushiki 722, 535 U.S. court, parties stipulated that “blocking 741, 122 1831, S.Ct. 152 L.Ed.2d 944 nucleic acid” means “fragments repeti (2002)). Thus, “a narrowing amendment tive-sequence-enriched DNA or RNA.” Be made satisfy any requirement of the cause the HER2 and TOP2A kits do not Patent may Act give rise to an estoppel.” DNA, use human synthetic and instead use Festo, 535 736, U.S. at 122 S.Ct. “A nucleic acids referred to as peptide nucleic patentee’s decision to narrow his claims (“PNA”), acids the court concluded that through amendment may presumed be those products do literally not infringe the be a general disclaimer of the territory '841 patent. The court then considered between the original claim and the amend whether those products infringe under the ed claim.” 740, Id. at 122 S.Ct. 1831. The of equivalents. doctrine After determining presumption surrender, however, “may narrowed scope if rebutted the patentee can “blocking demon nucleic acid” limitation dur (1) strate ing prosecution, that: alleged equivalent the court concluded that would were have been barred from unforeseeable at asserting that the time PNAs were an ... equivalent narrowing of a “blocking made; amendment was acid,” (2) nucleic and granted summary judg rationale underlying the narrowing ment of noninfringement under the doc amendment bore no more than a tangen trine equivalents. tial relation to the equivalent issue; at (3) there was some other reason

Appellants suggest argue that the doctrine of ing that patentee prosecution could history reasonably estoppel does not have apply expected been here to have because the “nucleic described the acid” limitation alleged equivalent.” was never during Honeywell narrowed Int’l Inc. prosecution. alternative, v. even if Hamilton Corp., Sundstrand 370 F.3d prosecution history estoppel 1131, (Fed.Cir.2004) appli- (quotations omit cable, appellants argue ted). pre- Thereafter, on and obviousness. pation, his- case,

In the conducted the examiner February 1 of the '841 tory reveals of the inven- re- with one reason interview personal a substantial amended *13 The Examiner Inter- In the '841 counsel. his tors and patentability. to lated they that claims that filed Record indicates Summary the view application, of dis- general methods the instant distinguish to ways to directed discussed repeti- capacity of hybridization references the abling from certain invention a claim and also submitted sequences, “proposed tive a further discussed and blocking nucleic recited specifically that nu- blocking the use solely to directed appli- patentees’ particular, In acids. hybridization probe to direct cleic acids follows: and 99 read 28 cation claims claim, claim That unique segments.” amended) method (Twice A 28. read: be that can DNA chromosomal staining staining chromosomal A method 132. chromosome particular a to stain used comprising: DNA thereof, a particular or portion type or 1) that (a) nucleic acid labeled providing portions types or chromosome group of are which substan- fragments chromo- targeted comprises thereof, whether acid se- at normal to nucleic tially complementary are sequences somal cells DNA haploid or chromosomal diploid numbers for within copy quences 2) numbers, desired, the method higher copy staining at which steps of: comprising comprises acid that blocking nucleic substantially com- mixture heterogeneous are fragments providing fragments sequences nucleic acid repetitive labeled plementary to contains substantially complementary acid; that are labeled nucleic complexity regions of sequence unique acid, nucleic (b) labeled said employing (kb) in the tar- 35 kilobases at least acid, and chromosomal blocking nucleic DNA[;] chromosomal geted so hybridization in situ DNA capacity disabling hybridization are sub- sequences repetitive labeled said hetero- within sequences repetitive to the binding from stantially blocked mixture; geneous sub- DNA, allowing while chromosomal mixture with heterogeneous reacting unique hybridization stantial by in DNA situ chromosomal target acid nucleic the labeled within quences hybridization; DNA. to the chromosomal hybridized, visible the rendering added). In filing (emphases Id. at fragments. amendment, patentees stated chromo- staining The method limited patent would claims Claim according to somal blocking involving embodiment to the includes disabling step said wherein other embodi- claims to and that method repeti- blocking the labeled substantially involving ments, the embodiment including in the heter- fragments acid tive nucleic sequences, would repetitive hybridization with the removal mixture ogeneous application,” separate frag- acid pursued nucleic “be repetitive unlabeled to those Because complementary are to the leading ments pat- history suggests mixture. blocking limited the claim entees added). The ex- (emphases J.A. overcome part at least method of those rejections issued several aminer pre- rejections, indefiniteness, examiner’s alia, antici- for, inter claims sumptively surrendered all equivalents of hybridization for the detection unique the “blocking nucleic acid” limitation. sequences. contrast, the Weissman reference involved the pure use of

However, even if the Festo sequence probes probes from which presumption applies, we must —or consider repetitive sequences have been re- whether rebutted “pre opposed moved—as blocking. Both sumption of total surrender by demon Sealey references, however, Yunis strating that it did not par surrender disclosed the use of method, equivalent blocking ticular in question.” Festo but that method was limited Corp. testing v. Shoketsu Kinzoku Kogyo Kabush Co., Ltd., (Fed.Cir. *14 sequences iki 344 F.3d 2003). and did not concern Appellants targeting rely on tangential the quences, ground in does the claimed use of support their block- assertion that ing such, the nucleic presumption acids. As patentees has been the rebutted. argued that inquiry “[T]he into the whether a invention patentee can would not have rebut been presumption Festo obvious view of prior under art be- ‘tangential’ person cause ordinary criterion focuses on paten skill would not objectively tee’s apparent have considered reason for the the use of blocking for narrowing amendment.” Id. at In detection of unique sequences. deed, prosecution history estoppel will not The history therefore re- bar the equivalents doctrine of “the when veals that in narrowing the claim to over- reason for the narrowing amendment was prior come the rejections, art the focus of peripheral, or directly relevant, not to the patentees’ arguments centered on the alleged equivalent.” Id. of blocking method particular —not Here, the patentees identified two main type of nucleic acid that could be used for reasons for the narrowing amendment. blocking. Indeed, the “nucleic acid” limi- First, patentees narrowed the claims tation was never during prosecu- narrowed in order to prosecution.” “facilitate In tion and was not at issue in the office deciding to limit the claims of the '841 action rejecting claims, the Examiner patent to the blocking method and to pur- Interview Summary Record, or paten- sue other means of disabling in a separate tees’ remarks accompanying the amend- application, argued that Moreover, ment. Dako not dispute does “[b]y separating the different inventions that none of the cited references con- separate into applications, it is believed type cerned the of nucleic acid that could that prosecution will be facilitated.” Such perform the blocking, or mentioned the a reason for amending the claim clearly equivalent. accused We thus conclude that nonsubstantive and does not help us in our appellants have met their burden of show- analysis. ing that the amendment did not surrender equivalent

Second, in question because more the nar- significantly, howev- er, rowing only amendment was tangential did amend the claim in i.e., order accused PNA distinguish equivalent, pep- invention over tide prior art. nucleic acid. Accordingly, examiner the court issued rejections of, erred concluding view alia, appellants that inter are al., Weissman al., precluded et Sealey et estoppel and Yunis from asserting that et al. To overcome references, products those Dako’s infringe under the doc- patentees argued that the invention trine equivalents. they Whether in- do new and nonobvious because it fringe used the question is a of fact for the trial blocking method connection inwith situ court to consider on remand. required DNA of chromosomal Prelimi- a full set Remaining Issue

C. objective. Appeal to achieve nary Injunction that the dis- in their appellants with agree two issues We presented Appellants in- of this in its construction injunction court erred trict preliminary —both first issue of the First, language construction. plain volving term. “hetero- construction identifiable “morphologically related claim term limitation, we mixture” geneous the nucleus suggests nucleus” cell court The district already dealt with. structure, have by form or be identifiable must preliminary motion appellant’s denied full set of that a not indicate does alia, concluding, inter upon injunction in the DNA must chromosomal a likelihood to show failed note, Dako Appellants cell nucleus. viz., issue, at product the sole success “morpho- the word dispute, does not “heterogeneous kit, met the Dako’s HER2 or struc- to form refers logical” generally limitation mixture” identity of ture, chromosomal con- the court’s affirmance of our light content. denial the court’s struction, affirm we *15 history of addition, prosecution the In injunction. preliminary the that the term reveals patent the '841 con the also Appellants cell nucleus” identifiable “morphologically term claim another struction the clarify to that the claim added injunc preliminary in its construed court in a remained DNA target chromosomal viz., order, “morphologically identifi during situ biological structure natural not need we nucleus.” While cell able ar- Indeed, patentees the hybridization. of our affirmance light issue that reach that: gued injunction preliminary the the denial of “morphologically [addition The we ground, mixture on the the addresses language] identifiable” judicial efficien in the interest do so will that the chromo- concern Examiner’s and fully briefed has been issue cy, as the from taken have been could DNA somal on remand. likely at issue will be that term processed but a chromosome “morphological- term claim disputed The the clear that It makes hybridization. in both appears cell nucleus” ly identifiable while is conducted hybridization situ district The '479 patents. and morpholog- in a present is still the DNA single cell “a term as that construed court or cell chromosome recognizable ically complement the full contains that nucleus nucleus. argue Appellants DNA.” of chromosomal Thus, disputed the by adding at 447. J.A. on incorrect based is construction that that that “the in clarified patentees the phrase, history of prosecution and specification the the while is conducted hybridization situ appellants, According patents. morphologically ain still DNA is that nucleus merely requires cell nucleus.” or chromosome identifiable or by form its being identified “capable is that statement of that implication full set require the not and does function” the identifi- present, still DNA is while the of DNA. by iden- DNA morphological, cation is the in- argues Dako response, In meth- contrasted tity. con- supports court’s trinsic evidence methods, as “Southern such with other od Dako asserts struction. biological hybridization blot one the invention characterized destroyed, and been has structure ab- of chromosomal detection allows the frag- restriction cut into has been and thus cell-by-cell basis normalities ments separated by size.” Significant- tangential exception applies, from which I ly, prosecution in the history, nowhere respectfully dissent. The majority con- specification matter, for that do we that, cludes by amending claims, any find indication that the “morphologi- patentees all surrendered other methods cally language identifiable” was added to of disabling capacity of impose requirement that the cell nucleus repetitive sequences, but did not surrender must retain its full complement of chromo- equivalents of the nucleic acid that could somal DNA. Accordingly, the proper con- be used perform blocking. my struction of “morphologically identifiable view, this conclusion is contrary to this cell capable nucleus” one that is of being precedent court’s appli- proper by identified its form or structure —a con- cation of history estoppel as struction that we find to be consistent with set forth Supreme Court. the intrinsic evidence. Under Corp. Festo v. Shoketsu Kinzoku

CONCLUSION (“Festo Kogyo Kabushiki /”), Co. if the For reasons, the foregoing patentee we affirm the narrows scope of the claims district court’s denial of the preliminary in response rejection to a injunction, affirm part grant court’s during prosecution, there is a presumption of summary judgment of noninfringement that the patentee estopped arguing from as to the '479 patent, and in part reverse territory surrendered comprises grant court’s summary judgment of an equivalent for purposes of infringe noninfringement as to the with ment under the doctrine equivalents. respect to the products. HER2 TOP2A *16 722, 739-40, 535 U.S. 1831, 122 S.Ct. 152 We affirm the court’s of construction “het- (2002); L.Ed.2d 944 see Int’l Rectifier erogeneous of mixture se- Corp. v. IXYS Corp., 515 F.3d 1358 quence nucleic acid fragments,” reverse (Fed.Cir. 2008). Prosecution history es the court’s conclusion that appellants are toppel applies to any narrowing amend estopped from asserting that prod- Dako’s ment made for a substantial reason related ucts “blocking meet the nucleic acid” limi- I, patentability. Festo at 739- U.S. tation under the equivalents, doctrine of 40, 122 S.Ct. 1831. The majority recog and reverse the court’s construction of nizes that the amendment here was made “morphologically identifiable cell nucleus.” in order to overcome prior certain art ref The case is remanded to the district court and, erences thus, the amendment was for further proceedings consistent with made for a substantial reason related to opinion. this patentability. A narrowing amendment is PART, AFFIRMED IN REVERSED all that is required for the presumption of PART, IN and REMANDED prosecution history estoppel to attach to bar the application of the doctrine of COSTS equivalents.

No costs. The presumption of history PROST, Circuit Judge, dissenting-in- estoppel with regard to a narrowing part. absolute, amendment is i.e., an amendment “presumed is join

I the be a majority opinion general disclaimer except for Part B.2 of section, territory the Discussion between the original revers- claim ing the district court and and the holding that amended I, claim.” Festo 535 U.S. equivalents doctrine precluded is not at 1831; 122 S.Ct. Biagro Sales, W. prosecution history estoppel because the More, Inc. Inc., v. Grow 1296,- 423 F.3d a I, presumption Festo Under Bririkmann Terlep v. (Fed.Cir.2005); territory between surrender wholesale (Fed.Cir.2005). 1379, 1385 F.3d Corp., 418 claim amended claim original to a narrowing the that fact The patentee if the may only be rebutted nu “blocking a blocking with method exceptions of the one show that able to necessary to been may not have acid” cleic at U.s! 740-41, 122 S.Ct. applies. 535 not art does prior over distinguish s suggest not appellants The do has thi court analysis. As change the rea the “some other falls under this case stated: previously do not exception. son” law that principle nois [T]here excep the “unforeseeable” assert cannot mat- subject a surrender scope of prior PNAs discovered tion since to what is limited during prosecution ter narrowing amendment when prior to avoid necessary absolutely Kinzo v. Shoketsu Corp. Festo made. See an the basis that was art reference ”), (“Festo II Co. Kogyo Kabushiki ku it contrary, rejection. To examiner’s Rather, (Fed.Cir.2003). 1359, 1369 F.3d sur- happens frequently appeal, and on court before district than amendment through more render tangential ex only the appellants raised necessary to absolutely may been have tan agrees majority ception. In such art. prior particular avoid prose application of bars exception gential cases, have held we concluding, In so history estoppel. cution claim, and ultimately they what scope of in narrow patentee, they reason to assert them not allowed have we art, to overcome the claims ing they if interpreted as should claims blocking method on the focused had to. they only what had surrendered of nucleic acid particular type on the F.3d Corp., 432 Corp. Stryker v. Norian blocking. in the could be used Here, (Fed.Cir.2005). 1356, 1361-62 , patentee into inquiry whether “[T]he in- scope narrowed amendment under presumption Festo rebut the can disabling any method vention from paten on the focuses criterion ‘tangential’ capacity reason for objectively apparent tee’s *17 disabling repetitive a method quences to The primary Id. narrowing amendment.” acids.” “blocking nucleic using sequences the amendment “whether is consideration “blocking stipulated have parties The relevant, to directly not or peripheral repeti- “fragments means nucleic acid” Here, rea Id. the equivalent.” alleged the RNA.” or DNA tive-sequence-enriched a bears more the amendment than son for all Therefore, surrendered patentee the equivalent. to the relationship tangential disabling hybridization for methods other to a the claims limits The amendment including sequences repetitive capacity sequences disabling repetitive method DNA other than blocking with methods acids” “blocking nucleic with by blocking to the determina- irrelevant It is RNA). or RNA. making In (i.e., or terri- surrendered scope of the of the presumptively amendment, art refer- prior disabling to overcome tory that means any other surrendered to amend not need equivalent, did patentee sequences. ences the repetitive exactly disabling to do however, a method PNA, to functions the claims repetitive repetitive sequences. capacity that, i.e., disable nu- the amendment “blocking for Hence, a blocking purpose with by quences Int’l See equivalent. to the amend- acid,” could have not unrelated instead but cleic Prods., Inc. 1358; Med. Cross disabling Rectifier, at a method the claims ed Inc., Danek, v. Medtronic blocking. sequences repetitive Sofamor (Fed.Cir.2007); F.3d Biagro, were amended to add a limitation requir- 1306; Terlep, 1379; 423 F.3d at 418 F.3d at ing that plate be “differentially Inc., Rhodia Chimie v. PPG Indus. spaced” above the membrane. Id. The (Fed.Cir.2005). 1371, 1383 F.3d alleged equivalent dome, in- contained stead of a plate, which was similarly appellants rely on two cases to sup- spaced above the membrane. Id. We con- port application tangential of the excep- cluded, therefore, equivalent tion, Technologies, Inc. v. CAT Insituform (dome as opposed plate) tangential was Inc., (Fed.Cir. Contracting, 385 F.3d 1360 to the purpose amendment, of the 2004), Primos, Inc. v. Spe- Hunter’s require was to spacing plate between the cialties, Inc., (Fed.Cir.2006). 451 F.3d 841 and the membrane. Id. However, this case is distinguishable from both of cases. The those at issue in In Primos, both “the Insituform was directed to a method for reason for the amendment alleged and the Insituform performing pipe repair without removing equivalent involved different aspects of the damaged pipe from ground. 385 invention.” Biagro, 423 F.3d at 1306. F.3d at patented Here, 1362. The method com- purpose for the amendment and prised impregnating a curable resin equivalent accused do not involve dif- inside of the tube while applying a ferent aspects vacuum. of the Indeed, invention. Id. at original they 1368-69. The both claims did not relate to the means for disabling specify position sequences. number of Therefore, vacuum cups. Id. prior equivalent at 1369. The is not tangential method to the purpose suffered problem from the amendment. vacu- To pre- overcome the um sumption was at far end of opposite the tube history estoppel patentee the resin “[t]he source and required an must show exceed- that at the time ingly large suction compressor. amendment one Id. skilled in To the art could art, overcome reasonably expected claims have drafted a claim that specify amended to would have literally that the vacuum encompassed source alleged was equivalent.” close to the resin source. Id. I, Festo at 535 U.S. at 1369-70. The 122 S.Ct. alleged equivalent dif- Here, the appellants fered from could reasonably only claimed have method in that been expected it to have used multiple vacuum drafted claim that Id. cups. at 1369. encompassed Thus, blocking repetitive sequences we held the narrowing amend- using PNA. The appellants should, ment tangential there- equivalent, fore, be estopped from asserting which used that PNA multiple cups. Id. at 1370. is an equivalent to “blocking nucleic acid” Primos, the patent was directed to a *18 in the '841 patent. diaphragm mouth call used hunters to reasons, For these I respectfully dissent. simulate animal sounds. F.3d at art device contained a shelf structure was directly above the

membrane space with no in between. Id.

at 849. During prosecution, the claims