*1 majority opin- and I therefore concur in
ion. CORP.,
DATASCOPE
Appellee/Cross Appellant,
v. INC.,
SMEC, Appellant/Cross Appellee. 85-812,
Appeal Nos. 85-837. Appeals,
United States Court of
Federal Circuit. 1, 1985.
Nov.
of certain claims of its ’339 and interest, costs, requesting damages, treble 14, 1982, attorney January and fees. On infringement, alleged denied SMEC invalid- ity of all claims of the under 35 101, 102, 103, 112, U.S.C. and al- §§ leged unenforceability ineq- for acts of during prosecution. uitable conduct SMEC damages also counterclaimed for an injunction, alleging various acts of unfair competition and antitrust violations. On 16, February Datascope answered SMEC’s counterclaim. 1, January 1983, Datascope
On amended complaint, alleging infringement of cer- N.J., appel- Sutton, Woodbridge, for Ezra patent. 4, tain April claims of its ’709 On lant. 1983, responded SMEC as described above. Celia, Bosses, Fitzpatrick, Har- J. Stevan Datascope answered SMEC’s counterclaim appellee. Scinto, City, for per & New York April 20, on 1984.2 Sidney P. Bresnick him on brief were With jury January Trial held without was on Diana, City. New York Leonard P. 11, 13, 16-18, 8-10, February 9- July 12, 10- 1984. DAVIS, MARKEY, Judge, Before Chief HARVEY, Dis Judge, and Senior 12,
Circuit July district court ordered Judge.* trict Findings proposed and Conclusions be by August submitted and that clos- MARKEY, Judge. Chief 13, ing argument August heard on 1984. September from a appeal Consolidated par- does not reflect that either The record 24, judgment of the Unitеd States Findings ty submitted and Conclusions. District Court for District of New Jer Following closing argument August on (D.N. 1306, USPQ sey, F.Supp. decision. the district court reserved its J.1984), 1-8, 18, 19, 21, 22, holding claims opinion The district court’s was filed on (Da Datascope Corporation’s and 24-27 of 24, 1984. filed notice of September 4,261,339 (’339 tascope’s) U.S. Patent No. appeal 1984. On October on October patent) infringed, valid and and all claims 30, court entered a final 1984 the district 4,327,709 Datascope’s U.S. Patent No. judgment order. (’709 obviousness, patent) invalid for ap- supplemental filed a notice of (1985).1 part U.S.C. We affirm in § Datascope 1985. peal on November part. and reverse in appeal on November filed notice
1984. Background ’339Patent The
(1) Proceedings in the District Court SMEC, (SMEC) Datascope application for “Bal- Datascope sued Inc. on filed Support” alleging infringement loon Catheter with Rotatable December * any Judge, Harvey, claims of the '709 Honorable James Senior discuss patent. Court Dis- United States District Eastern Michigan, sitting by designation. trict of request parties, the district court 2. At the counter- deferred the issues raised 1. The district court found that if the '709 valid, infringe- n. liability claims. 594 were would exist for involved in this In n. 1. Those issues are not of claims and 9-15 of that ment 1-3 affirmance, appeal. and do not of our we need not view par- ting
March 1978. The invention related fluid withdrawing into and fluid ticularly to “inflatable balloon catheters” chamber, from said support means for pumping. used intra-aortic supporting extending said chamber said chamber from the distal end thereof (IAB) was, pumping Intra-aortic balloon to said invention, portion catheter tube recognized at the and termi- time of failing nating method of cardiac assistance for a in said portion, cathetеr tube said *3 treating cardiogenic heart and of shock. It support being non-rotatably means con- help patient away had been used to wean a nected to one of said ends of said cham- cardiopulmonary bypass, from support a rotatably coupled ber and to the other of patient during postoperative pe- a difficult said ends of permit said chamber to rela- riod, provide pulsation and to to the linear angular tive motion support between said supplied by cardiopulmonary bypass flow a means and said chamber when said IAB pumping device. had also been used chamber is twisted longitudinal about its following myocardial infarction to limit the configuration axis such that a of said therapy extension of necrosis and as for catheter in obtained which said angina pectoris. wrapped chamber is support about said In IAB catheter disclosed the ’339 means, whereby insertion of said cathe- patent, an por- inflatable balloon chamber3 body ter into a passageway or the like is “tightly tion of a catheter is twisted into a aided. diameter”, i.e., small cross-sectional di- a generally greater ameter no than that of (3) The ’709 Patent inflating gas supply tube of the cathe- ter. That is supporting achieved patent, The ’709 which resulted from a balloon chamber “support about means” of part continuation in application (described small diameter specifica- in the patent, resulted apparat- claims “support wire”), tion as a one end of which us and a method for percutaneous in- is “rotatable relative to the chamber where- sertion of an intra-aortic balloon into an adаpted chamber is being com- artery through a repre- sheath. Claim 1 is pactly wrapped, rolled or twisted about the sentative: upon means rotation of the cham- system 1. A inser- ber which swiveling causes tion of an comprising intra-aortic balloon means.” The small cross-sectional di- in combination: ameter of the resulting IAB per- catheter mitted insertion of that “through device a flexible hollow having sheath an end small incisions by percutaneous or even adapted to be artery inserted into an insertion,” and enabled the catheter to be subjeсt through puncture, a a “guided through smaller and more tortu- a balloon comprising catheter ous canals passageways.” tube, a catheter representative: Claim is envelope a balloon having one end con- 1. A comprising catheter an inflatable nected tube, to one end of said catheter and deflatable having proxi- chamber a elongated flexible end, mal end and a distal said chamber envelope having within said one end being use adapted to substantially have coupled to the other end of en- said the samе surface area when inflated and velope which is remote from said cath- deflated, when a portion catheter tube tube, envelope eter said folding gener- adjacent connected at or an end thereof ally longitudinally along proximal end axis of of said chamber and
having passage said communicating member to with have reduced the interior of said chamber for admit- sufficiently diameter small to be in- Datascope's application patent clarity, and the ’339 the term "chamber". For the text here employ interchangeably employs throughout. the term "balloon” with “balloon chamber” through distinguish prior art,” into the serted said sheath over the because the artery.4 rotatability art teaches between the
support means and one end of the balloon chamber; (2) Issues Presented “it is clear that these obvious,”5 claims are because the (1) erred in Whether the district court “clearly alleged teaches the differences.” refusing claims of the ’339 to hold (1) The Prior Art invalid. (2) the district court’s Whether (a) Grayzel Patent infringed that SMEC’s device certain says juncture between two the doctrine claims of the ’339 under Figure Grayzel elements in 2 of would have erroneous. was represented joint a ball and socket to one the district court erred Whether ordinary art, skill in the and that Data- holding the claims of the ’709 invalid scope’s (one witness Wolvek of the inven for obviousness. *4 tors) “admitted” on cross examination that 2 Figure depicted a ball-joint.6 Opinion What SMEC calls an “admission” is a Validity
I. the ’339 Patent Wolvek statement respect made with to a says appeal by the issue on is freehand blackboard sketch SMEC SMEC’s trial, respect Figure the trial court erred counsel at not with “whether [sic, holding] patent the ’339 valid view 2. Counsel’s trial tactic substituted a dis- prior the issue. tortion of the prior thing, art.” That is not art for the real Nor, statute, 282, attempt manipulate 35 under the U.S.C. art we § thoroughly improper. stated This have found can ever as be issue. See Co., spoken misconception Corp. Mfg. court has that Panduit v. Dennison 774 1082, hold or no there exists some need for courts to F.2d 1095. At time did Wolvek patents Grayzel’s valid: “Patents are born “admit” that disclosure of a rod declare Corp. Mfg. valid.” Panduit v. Dennison “attached to” a hollow tube disclosеd a 1082, Co., (Fed.Cir.1985), ball-joint. Inc.,
Roper Corp. Systems, v. Litton Grayzel’s specification neither teaches (Fed. F.2d suggests “ball-joint” nor or its like. As Cir.1985). presumption that the observed, cogently had the district court valid, 35 U.S.C. continues until the § Grayzel intended to disclose a rotatable validity-challenger has “so carried his bur member, expected “one have would persuaded den as to have the decisionmak feature, express to such a as it reference longer accept er that can no be significant depar- represented a would have Stratoflex, Aeroquip ed as valid.” Inc. v. art.” 594 ture from USPQ 871, Corp., 713 F.2d Moreover, at 698. SMEC (Fed.Cir.1984). present and cannot reconcile its does not says: claim inserted the statement of its own SMEC limitations assertions with witness, Marzullo, Figure that if expert to obtain allowance “do not in themselves Anticipation argued appeal. not been 4. Claims 1-15 of the '709 are directed to a has system facilitating Grayzel’s says sup- or combination of elements disclosure of a thin percutaneous that, insertion of an IAB catheter. “clearly by port teaches setting Claims 16-23 are directed to a “method” recognized advantages the use and of a steps taken in the forth insertion support member the balloon thin to enable artery patient. of an IAB into the of a wrapped to a reduced cross-sec- an IAB to be clear, drawings make how- tional area.” As question 5. The is never whether "claims are” ever, entirely Grayzel’s "wrapping” is different obvious, but whether claimed inventions would twisting from that achieved the balloon U.S.C. § have been obvious. 35 103. longitudinal chamber around its axis. argument allegation at relates to its Grayzel anticipated patent. thе '399 trial had ball-joint, issue, been intended to disclose a im- ousness/nonobviousness it is improperly was (even drawn. proper erroneously suggested by if party) to consider the as the (b) Other Prior Art difference may invention. The “difference” says Patent Nos. United States (as slight has often been the case with 3,585,983 3,671,979 Kantrowitz and inventions, some of history’s greatest Moulopoulos taught rotation of the balloon e.g., telephone), but it also have respect chamber with to a member. key been the to success and advancement found, properly As the district court how- resulting thе art from the invention. ever, Kantrowitz does not teach rotation as taught that term is in the ’339 As As the district properly under trial, moreover, Dr. Kantrowitz testified at stood, the issue with to obviousness twisting the wire “braid” disclosed in the is whether SMEC has carried its burden of damage Kantrowitz reference tended to proving, by convincing evidence, clear and eventually destroy the IAB device. facts from which it must be concluded that Moulopoulos discloses an artificial heart one skilled in the art at the time the inven having folding valve a flexible membrane. tion was made would have found it tо have taught suggest- That reference neither nor obvious, been from the references as a rotatability ed as pat- disclosed whole, to create the claimed matter ent, pertinent and was not more than other Assocs., a whole. See W.L. Gore & Inc. art that was before the Examiner. Garlock, Inc., v. disclosing Patents use of a distendable USPQ 303, (Fed.Cir.1983). The district (Tower, Fettel, latex balloon chamber Fo court’s effective determination that SMEC *5 garty) are cited in SMEC’s brief. Those carry failed to respect that burden in of patents thoroughly were by the considered was correct. during prosecution, Examiner see Ameri Sons, can Hoist & Derrick Co. v. Sowa & Infringement II. the '339 Patent of Inc., 725 F.2d USPQ 220 - says SMEC claim 1 was limited dur (Fed.Cir.), denied, U.S. -, 770 cert. ing prosecution distinguish to over (1984), 105 S.Ct. 83 L.Ed.2d and no art on the support basis of means: error has been shown in the district court’s rotatably coupled to the other end of the failing consideration of them as to indicate chamber, (2) terminating balloon respecting obviousness. SMEC’sassertions portion. catheter tube says SMEC then it Patent, drawings of a British says as SMEC infringement avoids under the doctrine of text”, “without reference to the distort thаt (a) because: there is no “cou thoroughly art and are frivolous. pling” between its means the simply wrong SMEC is in arguing that proximal chamber; (b) end of its balloon its the claim taught limitations it attacks were support means does not in terminate the suggested by or the art. portion; (c) catheter tube IAB its cath (2) Differences perform eter does not substantially the misperceives SMEC the law substantially same function in the same urging solely that we focus on the “differ way. ences” between the matter of the art,
claims and the though those (a) “Coupling” “differences” were the clаimed invention. In Jones v. Hardy, The district summarily rejected USPQ 1021, (Fed.Cir.1984), this court prosecution history SMEC’s contention of said: estoppel “coupling”, of saying
Though proper SMEC “failed to adduce evidence of to note the differ- [any] ence in rejection a claimed pri- invention from the whatsoever based on the art, or because that coupling.” F.Supp. difference serve location at as one determining element in appeal, obvi- at 701. reading specification its device avoids Nor does a of the its assertion that renews [support position. taught “stylet bolster SMEC’s As there- infringement because in, through proximal the end of the means freely passes “extends means] ‘coupled’ sufficiently being portion into” the catheter of the balloon without tube end it, prevent being 1.” by Datascope Claim to from withdrawn to as claimed added.) through opening assertion is of the catheter (Emphasis tube Datascope portion never amended into the balloon The con- without merit. chamber. rejection expressed specification to overcome a based cern with re- its claims coupling, spect length nev- “location” of means was thus minimum, patentability on the basis of directed to the argued er maxi- location, coupling mum, length required proper op- and did not claim to insure such proximal end of balloon chamber eration of the IAB. (see 1, supra). claim (c) Equivalents
(b) Support Length Member The district court’s that there is employs “long” sup- The SMEC device no literal has not been shown extending through the cathe- port member have been erroneous. Data- portion connecting scope’s to a “wind- ter tube burden therefore bеcame one of (to ing permit manipulation establishing by preponderance means” the evi chamber). court, dence, The district not- Hughes balloon v. Co. United Aircraft States, 1351, 1361, USPQ 473, ing that SMEC’s device differed from that (Fed.Cir.1983), disclosed in the ’339 because “the that the SMEC device is i.e., patent clearly equivalent, performs indicates that that it sub [the tip stantially extends from the distal the same function in substantial member] point adja- ly way substantially to a in the catheter tube the same balloon obtain chamber,” found in- cent to balloon same result as the claimed invention. See fringement equiva- under the Mfg. doctrine Graver Tank & Co. v. Linde Air 1314-15, Co., lents. Prods. 339 U.S. 70 S.Ct. at (1950). at 701. 94 L.Ed. at says only there amendments to The district court found that “the were *6 escape the Tower and Fettel references and real difference” between the mat- support that those references showed mem- ter of the invention claimed ’339 running length the full the accused device “is that in bers of the catheter and prosecution history using patented grasps device one tube. Because the “length” and rotates the support shows that of means in end of the balloon distаl turning hand instead of rejec- support the catheter tube was not a basis for member tion, amendment, or of at the other end of the catheter.” allowance a knob USPQ claims, at argument F.Supp. SMEC’s mer- 594 at is without Although the district court characterized it.7 limiting length support Fig- application warrant exists for 7. The of means disclosed in son or patent drawings originally equivalents ures 1 and 6 of the as of the doctrine of to those com- Figures exactly origi- paratively is identical to that filed shown in 1 and few claims allowed as Although nally 6 of the ’339 as issued. filed and never аmended. Amendments urges types may us to construe the may Examiner’s broad lan- serve dif- be of different and rejecting fully guage structurally a claim “as Depending functions. nature ferent anticipated” encompassing "length” amendment, may purpose of an it have a means, prosecution history support read as ranging limiting spectrum effect within a clearly a whole indicates that that was not of may great effect from to small to zero. The Examiner, applicant ap- concern to or and that may application range of a or not be fatal to plication equivalents the doctrine of would of enough encompass broad not vitiate limitations entered in re- therefore product. It is not fatal to accused rejection. sponse any application of the doctrine itself. States, Hughes practice Co. v. United Amendment of claims is a common Aircraft (Fed.Cir.1983). USPQ prosecution patent applications. No rea- improvement”, compelled holding that difference as “an enees invalidity. It infringement. did Grayzel held that not avoid noted that “the reference discloses every element of the IAB described in argues appeal, On that: its bal- patent,” claim one of the ’709 and that “freely does not in- loon chamber unwind” through insertion of a catheter a sheath or body; manipulated side the its device is cannula “had been described in the medical end, entirely proximal from its and was many years literature earlier.” designed elongate the balloon chamber F.Supp. USPQ at at 700.8 It also cross-section; reduce its “secondary sup- noted that considerations winding perform knob a num- port finding invalidity, since the performed by ber of functions not the de- Id., has never been commercialized.” vice of the ’339 USPQ at 700. arguments do not establish that appeal, Datascope says the district the district court erred in (a) failing court in: erred to consider the equiva- under doctrine of whole; (b) improper- claimed invention as a lents. SMEC said at trial that its device ly holding that lack of commercialization torque uses the catheter tube to transmit against (c) validity; undervaluing militated from the member to the balloon statutory presumption validity be- during wrapping, chamber and the district pertinent prior cause the most art had been correctly found that “in this Examiner; (d) improperly before the the SMEC device does not differ from the holding invalid claims not in suit. patented device.” Id. at n. 700 n. 5. not SMEC has shown clear error (a) The claimed invention as a whole findings in the district court’s winding Datascope says that before the invention by manipulating the balloon chamber patent, disclosed no sheath had proximal member at its end is sub- ever been used for the inser- stantially winding the same as the balloon patient. tion of an IAB catheter into a by grasping chamber its distal end and Conceding thаt sheaths have been used for manually rotating member. years in connection with various medical predecessor As this court and its courts procedures (e.g., “Seldinger the so-called stated, have pos- “an embellishment” made Technique”), Datascope argues that “no by technological sible advances procedures previously such had been avail- permit an escape accused device to “the able for the insertion of IABs.” infringement.” web of Hughes See Air- Datascope’s argument persuasive. is not States, Co. v. United 717 F.2d at crаft advantages taught Grayzel’s One of at 483. court, The district specification [Gray- was that because “the record, which reviewed all evidence of thinner, very device can be made much zel] found that the differences in SMEC’s de- patient its insertion in the is facilitated *7 vice do not infringement, citing avoid Lock- reducing severity surgery of the need- States, heed v. United 553 F.2d 193 patent ed for its insertion.” Prior art ref- 449, USPQ (Ct.Cl.1977). 461 SMEC has not disclosing specifi- erences did not sheaths shown that to have been cally percutaneous teach insertion of IAB erroneous. catheters, percutaneous but insertion of Validity III. the ’709Patent of types thoroughly other of catheters was literature, e.g., in acknowledged district court described in that the pertinent Seldinger, most respect Replacement art with to the “Catheter ’709 system Examiner, Arteriography,” was before the Needle in Percutaneous but con- 39 (Stockholm, 1953). cluded nonetheless that the art refer- Acta Radiol 368 Data- “anticipated”. 8. The district court used the word art at the time the invention was made. 35 Datascope correctly points context, out "anticipa- that the issue is § U.S.C. 103. In the use of patent whether matter of the '709 ted” a was mere inadvertence. would have been obvious to one skilled in the scope has not record, convinced us that the district the entire indicated, as above court failed to consider the invention as a carried its proving burden of by clear and whole, or that it erred it convincing when concluded evidence facts sufficient that one skilled in the art at the time presumption overcome the and to the ’709 invention was made would have the district court’s conclusion that the ’709 apply patent found obvious to is invalid. techniques
insertion of the sheath referenc- (d) Claims in Suit es to an IAB catheter of reduced cross-sec- diameter, gain tional advantage of did not counterclaim for a Grayzel.9 easier insertion discussed in declaratory judgment of invalidity of all of (b) patent Lack ’709 Commercialization claims. The district court’s of holding patent that invalid, how say “secondary It is error to consid ever, encompassed all claims of that finding [sic, erations conclusion] pleadings References in do not suffice to invalidity, patent [sic, of since thе the in judgment claims has never been commercialized.” vention] invalid, are specific when the validity of Lack of commercialization of an invention those claims was litigated by not par support holding cannot alone invalidity of ties at trial. Sears, See Connell v. Roe aof on that invention. The error Co., 1542, buck 1552, & 722 F.2d USPQ here, however, was harmless where SMEC 193, (Fed.Cir.1983). 201-02 pro The record carried its burden with art evidence vided appeal does not indicate that the establishing that the claimed invention validity of claims litigated 16-23 was obvious, would have been no showing trial, and the opinion district court in its of commercial success due to the invention recognized twice that those claims “are not in the ’709 is sufficient to rebut alleged to infringed.” Nor does SMEC showing. reply its Datascope’s brief refer to asser validity tion that the of claims 16-23 was (c) Presumption Validity litigated. We therefore reverse the Datascope correctly says that district holding invalidity court’s with pertinent where the most art was before to those claims. Vandenberg v. Examiner, validity challenger’s bur Co., Dairy Equipment 1560, 740 F.2d overcoming den of presumption man 1568, 195, USPQ 200 (Fed.Cir.1984) 282, datеd 35 U.S.C. easily is less § (“Each presumed claim must be valid inde carried. See Fromson v. Advance Offset pendently validity any other Plate, Inc., 1549, 755 F.2d USPQ claim.”). (Fed.Cir.1985); American Hoist & PART; AFFIRMED IN REVERSED IN Sons, Derrick Inc., Co. v. Sowa & PART. at 770. The district case, however, this ignored neither DAVIS, Judge, concurring Circuit in part nor statutory demeaned the presumption of dissenting part. validity. On contrary, plain as made opinion, appropriate a, b, accorded join (including defer I in Part III c there- ence to the of) Examiner’s determination. On opinion (“Validity the court’s Datascope (Fed.Cir.1984); asserts that Orthopedic thе inventors of the Equipment Co. States, were unable “ever to construct a worka- v. United according [Gray- ble device the disclosure of (Fed.Cir.1983). *8 zel],” and that one skilled in the art would not Grayzel have found in the capable device a structure appear 10. The district court does not to have being percutaneously. inserted invalidity based its conclusion of on lack of Those assertions miss the mark: Whether the alone, appears commercialization but to have Grayzel physically device could be substituted in merely noting objective been the absence of a combination like that of the 709 is (commercial success) might sup- evidence that irrelevant under U.S.C. § 103. See In re port contrary a conclusion. Yamamoto, Patent”) However, determining invalidity length the of the member.
the ’709 challenged claims of the ’709 broadly rejected original the examiner the court), (thus sustaining as well the district structurally anticipated” claims “as fully d, III, reversing the joining as in Part added),1 by prior (emphasis the and the invalidity holding of district court’s particular amendments with which we are patent which were 16-23 of the ’709 claims acceptеd concerned now were made and I dissent as to the not in issue below. only after at least and earli- two interviews (in opinion) II of its holding court’s Part enough er amendments which not were infringed, patent was and that me, pertinent the examiner. For the my position on that issue of because of amendments were made to obtain allow- not, not, and do reach infringement I need (who by ance the examiner had theretofore validity issue of the ’339 the persisted rejection) and therefore the (discussed by court in Part I of its the equivalents “may doctrine of not include opinion). range anything within its that would vitiate patent, the my ’339 expressed limitations before the Patent Of- (a) history lim- prosecution is that view fice.” Autogiro Co. America v. United ited claims and to mem- States, (Ct.C1.1967). 400-01 (i) “rotatably coupled” bers which were particularly This is clear to me with (rather simply than “secured” or “dis- requiring to the amendment claims) posed” original in the to the end terminate within catheter (ii) ended of the balloon and also within device, (The markedly tube. accused ex- itself, it; (b) beyond catheter and tube beyond tends and the catheter balloon accordingly, infringe- there can be here no tube, knob.) ending in an external ment under the doctrine of be- that, me, prosecution short of is histo- (SMEC’s cause accused means ry appraised realistically try should be —to (instead, stylet) “coupled” freely is not so actually happened discover what passing through the balloon catheter rigid priori instance—not tube), likewise does not end within My judgment mechanical or rules. this passes freely beyond catheter tube but ques- case two amendments outside that tube. tion were made in a successful effort to I position prosecution take this histo- rejection on the basis of art. overcome ry estoppel because, original after (which claims did not contain either of limitations) repeatedly rejected
these were art, rejections
over the after those continued, interviews,
were and after amendments,
applicant introduced these they accepted. were The court refuses apply prosecution history estoppel be- showing partic-
cause there is no that those
ular amendments were made to overcome a very
rejection specifically referring to the
application’s predecessor “coupling”
(i.e., “disposed”), “secured” or or to the amendment, (referring “rotatably coupled”
1. The examiner also said to two As for the patents): rejection (prior examiner's final to the "ro- the tatably сoupled” amendment) said that the earli- patents "Both show the recited structure of the Leininger patent non-plastic er "shows cham- [original] “Applicant’s claims" and remarks having support connected at one end ber persuasive have been considered but are not inherently capable thereof of rotational move- language." broad claim These ob- view of the Thereafter, "rotatably coupled" ment.” (inter alia) servations seem to refer to at least accepted. amendment was made and length the initial absence of a limitation.