MEMORANDUM ON CONSTRUCTION OF CLAIMS
This is a patent infringement action in which the plaintiff, aclosely held Massachusetts corporation called MBO Laboratories,Inc. ("MBO"), alleges that the defendant, Becton, Dickinson andCompany ("Becton"), a company that manufactures and sells medicaldevices, infringed MBO's United States Patent No. RE. 36,885("the '885 patent"). The '885 patent relates to a safety needleand blood collection and sampling system that is designed toreduce the risk of injury caused to healthcare workers byneedlesticks from contaminated needles. MBO claims that Becton'sSafetyGlide™ shielding hypodermic needle infringes claims 13, 19,20, 27, 28, 32, and 33 of the '885 patent. Both parties briefedtheir respective views as to the construction of the claims atissue and presented argument at a Markman hearing on July 20,2005.
1. The applicable legal standards
A. Patent infringement analysis — general points
There are two steps to a patent infringement analysis. CyborCorp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998)(en banc). First, the meaning and scope of the patent claims alleged to have been infringed must be determined.Markman v. Westview Instruments, Inc., 517 U.S. 370, 384(1996). This step is commonly referred to as "claimconstruction." Second, the accused device must be compared to theproperly construed clams to determine whether the deviceinfringes the patent. Cybor Corp., 138 F.3d at 1454. While thesecond step presents a question of fact for the fact-finder, thefirst step is a question of law for the court. Markman,517 U.S. at 372 (holding that "the construction of a patent,including terms of art within its claims, is exclusively withinthe province of the court"). It is this first step, claimconstruction, that is the subject of this memorandum.
The Supreme Court has emphasized that the purpose of patentclaims is to apprise the public of what is protected by aparticular patent. Markman, 517 U.S. at 373 (noting that "[i]thas long been understood that a patent must describe the exactscope of an invention and its manufacture to `secure to [thepatentee] all to which he is entitled, [and] to apprise thepublic of what is still open to them'" (quoting McClaim v.Ortmayer, 141 U.S. 419, 424 (1891))); Phillips v. AWH Corp.,2005 WL 1620331, at *4 (Fed. Cir. July 12, 2005) (emphasizingthat "it is a `bedrock principle' of patent law that `the claimsof a patent define the invention to which the patentee isentitled'" [citation omitted]); see also Corning Glass Works v.Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir.1989) (stating that "[a] claim in a patent provides the metes andbounds of the right which the patent confers on the patentee toexclude others from making, using, or selling the protectedinvention"). While the construction of the claims of a patent isclosely akin to construing other written documents, likecontracts or statutes, special considerations apply to patentclaim construction, based upon the need for the public, and otherinventors, to understand as clearly as possible the scope of apatentee's claimed invention. Therefore, in construing the claims of a patent, a court mustfirst look to matters in the public record. Burke, Inc. v. BrunoIndep. Living Aids, Inc., 183 F.3d 1334, 1340 (Fed. Cir. 1999)(emphasizing that "the language of the claims, the specificationand the prosecution history are principally involved inconstruing patent claims because these constitute the publicrecord") (citing Markman v. Westview Instruments, Inc.,52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370(1996)).
The primary sources for guidance in claim construction are theintrinsic sources: the language of the claim; the writtendescription portion of the specification, including any relevantdrawings; and the prosecution history. Phillips, 2005 WL1620331, at *6; Zodiac Pool Care, Inc. v. Hoffinger Indus.,Inc., 206 F.3d 1408, 1414 (Fed. Cir. 2000); see Teleflex, Inc.v. Ficosa N. Am. Corp., 299 F.3d 1313, 1324-25 (Fed. Cir. 2002)(interpreting the claim terms in light of the intrinsic evidenceand explaining that "[t]he intrinsic evidence may provide contextand clarification about the meaning of claim terms"); VitronicsCorp. v. Conceptronic, Inc., 90 F.3d 1576, 1582-83 (Fed. Cir.1996) (noting that "intrinsic evidence is the most significantsource of the legally operative meaning of disputed claimlanguage"; emphasizing that allowing the public record to bealtered or changed by extrinsic evidence introduced at trial,such as expert testimony, would make the right of the public tobe on notice of the patent's limitations meaningless); see alsoToro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299(Fed. Cir. 1999) (stating that "[d]etermining the limits of apatent claim requires understanding its terms in the context inwhich they were used by the inventor, considered by the examiner,and understood in the field of the invention"). (1) The words of the claim
In construing the claims of a patent, the court's initialresort is to the words of the claim itself. Teleflex,299 F.3d at 1324 (beginning claim construction analysis "as always, withthe words of the claim"); Bell Communications Research, Inc. v.Vitalink Communications Corp., 55 F.3d 615, 620 (Fed. Cir. 1995)(noting that "resort must be had in the first instance to thewords of the claim" (quoting Envirotech Corp. v. Al George,Inc., 730 F.2d 753, 759 (Fed. Cir. 1984))). The court "mustpresume that the terms in the claim mean what they say, and,unless otherwise compelled, give full effect to the ordinary andaccustomed meaning of claim terms." Johnson Worldwide Assocs.,Inc. v. Zebco Corp., 175 F.3d 985, 989 (Fed. Cir. 1999). The"ordinary and customary" meaning of a claim term is "the meaningthat the term would have to a person of ordinary skill in the artin question at the time of the invention, i.e., as of theeffective filing date of the patent application." Phillips,2005 WL 1620331, at *5; Teleflex, 299 F.3d at 1325 (explainingthat the court must presume that claim terms carry their ordinarymeaning, as understood by someone of ordinary skill in the art ofwhich the invention is a part).
It is important to note that "the person of ordinary skill inthe art is deemed to read the claim term not only in the contextof the particular claim in which the disputed term appears, butin the context of the entire patent, including thespecification." Phillips, 2005 WL 1620331, at *5; see Medrad,Inc. v. MRI Devices, Corp., 401 F.3d 1313, 1319 (Fed. Cir. 2005)(explaining that the court "cannot look at the ordinary meaningof the [disputed claim] term . . . in a vacuum," but must,instead, "look at the ordinary meaning [of the term] in thecontext of the written description and the prosecution history");Unitherm Food Sys., Inc. v. Swift-Echrich, Inc., 375 F.3d 1341,1351 (Fed. Cir. 2004) (noting that the proper definition of adisputed claim term is the "definition that one of ordinary skill in the art could ascertainfrom the intrinsic evidence in the record"). Thus, the construingcourt should look at "the context in which a [claim] term is usedin the asserted claim." Phillips, 2005 WL 1620331, at *6(explaining that the context "can be highly instructive"). "Otherclaims of the patent in question, both asserted and unasserted,can also be valuable sources of enlightenment as to the meaningof a claim term." Id. (citing Vitronics, 90 F.3d at 1582).Because patentees normally use claim terms "consistentlythroughout the patent, the usage of a term in one claim can oftenilluminate the meaning of the same term in other claims."Phillips, 2005 WL 1620331, at *6 (citing Rexnord Corp. v.Laitram Corp., 274 F.3d 1336, 1342 (Fed. Cir. 2001)). Likewise,differences among claims can guide the court in "understandingthe meaning of particular claim terms." Phillips, 2005 WL1620331, at *6.
Furthermore, plain English words are entitled to their plainEnglish meaning, In re Wright, 866 F.2d 422, 425 (Fed. Cir.1989), unless it is apparent from the patent specification andthe prosecution history that the inventor used a term with adifferent meaning, Hoechst Celanese Corp. v. BP Chems. Ltd.,78 F.3d 1575, 1578 (Fed. Cir. 1996). In short, while terms used in apatent generally should be construed to have the ordinary meaningthey had at the time of the patent application, a patentee isstill entitled to "choose to be his own lexicographer and useterms in a manner other than their ordinary meaning, as long asthe special definition of the term is clearly stated in thepatent specification or file history." Vitronics,90 F.3d at 1582 (citing Hoechst Celanese Corp., 78 F.3d at 1578); seeAlloc, Inc. v. Int'l Trade Comm'n, 342 F.3d 1361, 1368 (Fed.Cir. 2003) (explaining that "[a] patent applicant mayconsistently and clearly use a term in a manner either more or less expansive than its generalusage in the relevant art, thereby expanding or limiting thescope of the term in the context of the patent claims").
(2) The written description and drawings of the specification
The specification operates "as a sort of dictionary, whichexplains the invention and may define terms used in the claims."Markman, 52 F.3d at 979-80. By statute, the specification mustcontain "a written description of the invention . . . in suchfull, clear, concise, and exact terms as to enable any personskilled in the art . . . to make and use [the invention]."35 U.S.C. § 112, ¶ 1.1 For that reason, the specification is"highly relevant to the claim construction analysis. Usually, itis dispositive; it is the single best guide to the meaning of adisputed term." Phillips, 2005 WL 1620331, at *6 (quotingVitronics, 90 F.3d at 1582, and citing numerous casesemphasizing the importance of the specification in construing thedisputed claims); see Netword, LLC v. Centraal Corp.,242 F.3d 1347, 1352 (Fed. Cir. 2001) (emphasizing that "[t]he claims aredirected to the invention that is described in the specification;they do not have meaning removed from the context from which theyarose").
A court may use the specification, first, to identify theordinary meaning of disputed claim terms. Vitronics,90 F.3d at 1582 (stating that "the specification . . . is the single bestguide to the meaning of a disputed term"). "The specification, ofwhich the claims are part, teaches about the problems solved by the claimed invention, the way the claimedinvention solves those problems, and the prior art that relatesto the invention. These teachings provide valuable context forthe meaning of the claim language." Eastman Kodak Co. v.Goodyear Tire & Rubber Co., 114 F.3d 1547, 1554 (Fed. Cir.1997), overruled on other grounds by Cybor Corp.,138 F.3d 1448.
In addition, the specification may sometimes narrow orotherwise alter the ordinary meaning of claim terms. Thecategories of cases in which this may occur, as set forth invarious Federal Circuit opinions, are not entirely consistent.Indeed, some of the categories seem to overlap. Nevertheless, onemay glean from the relevant precedents four principal ways inwhich the patent specification may modify the ordinary meaning ofclaim terms.
The best-established method is that by which "the patentee[has] acted as his own lexicographer and clearly [has] set fortha definition of the disputed claim term in either thespecification or prosecution history." CCS Fitness, Inc. v.Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002).Accordingly, the construing court should consider carefully thewritten description portion of the patent specification todiscern any special meaning that the patentee may have given toany terms found in the patent's claims. Phillips, 2005 WL1620331, at *8 (explaining that, where the patentee has defined aclaim term in a way that "differs from the meaning it wouldotherwise possess," the patentee's lexicography controls). Whilethe definition of a term in the specification must be expressed"clearly," it need not be done explicitly. "Indeed, [the FederalCircuit] ha[s] specifically held that the written description ofthe preferred embodiments `can provide guidance as to the meaningof the claims, thereby dictating the manner in which the claimsare to be construed, even if the guidance is not provided inexplicit definitional format.'" Bell Atlantic Network Servs., Inc. v. CovadCommunications Group, Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001)(quoting SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys.,Inc., 242 F.3d 1337, 1344)); see Vitronics, 90 F.3d at 1582(explaining that "[t]he specification acts as a dictionary whenit expressly defines terms used in the claims or when it definesterms by implication."). But cf. Teleflex, 299 F.3d at 1325(stating that "an inventor may choose to be his own lexicographerif he defines the specific terms used to describe the invention`with reasonable clarity, deliberateness, and precision'"(quoting In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994))).For example, "when a patentee uses a claim term throughout theentire patent specification, in a manner consistent with only asingle meaning, he has defined that term `by implication.'" BellAtlantic, 262 F.3d at 1271 (quoting Vitronics,90 F.3d at 1582)).
A second category in which the specification may modify theordinary meaning of a claim term is when the claim term, if givenits ordinary meaning, "`so deprive[s] the claim of clarity' as torequire resort to the other intrinsic evidence for a definitemeaning.'" CCS Fitness, 288 F.3d at 1367 (quoting JohnsonWorldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 990 (Fed.Cir. 1999)). In this situation, it is not the claim term itselfthat is ambiguous, but the claim as a whole.
Third, "[t]he patentee may demonstrate an intent to deviatefrom the ordinary and accustomed meaning of a claim term byincluding in the specification expressions of manifest exclusionor restriction, representing a clear disavowal of claim scope."Teleflex, 299 F.3d at 1325, 1327 (noting that the specificationmust include "clear statements of scope" that limit the claimterm).
Finally, several Federal Circuit cases suggest thatcharacteristics of the invention that the specification describesas, or otherwise indicates are, "important" may modify themeaning of claim terms. For example, in Toro, the court construed theclaims of a patent for a convertible vacuum/blower that providedfor a "cover" "including" a "restriction ring." 199 F.3d at 1301.The Toro court stated that "[i]t is a matter of interpretationof the words `including' and `cover' to determine whether, as amatter of law, the claim require[d] that the cover and the ring[be] attached to each other[.] The specification described therestriction ring as `buil[t] . . . as part of the air inletcover,' and d[id] not suggest that the cover and the ring [could]be two distinct components to be inserted and removed separately.To the contrary, the specification describe[d] the advantages ofthe unitary structure as important to the invention." Id.
While "the claims must be read in view of the specification, . . .limitations from the specification are not to be read intothe claims." Teleflex, 299 F.3d at 1326 (citations omitted).Generally then, claims are not delimited by the preferredembodiment disclosed in the specification. See, e.g., Phillips,2005 WL 1620331, at *15-16 (emphasizing that, "although thespecification often describes very specific embodiments for theinvention, [the court] ha[s] repeatedly warned against confiningthe claims to these embodiments"; "expressly reject[ing] thecontention that if a patent describes only a single embodiment,the claims of the patent must be construed as being limited tothat embodiment"); Interactive Gift Express v. Compuserve,231 F.3d 859, 874 (Fed. Cir. 2000); Dow Chem. Co. v. United States,226 F.3d 1334, 1342 (Fed. Cir. 2000); Tate Access Floors v.Maxcess Techs., 222 F.3d 958, 966 (Fed. Cir. 2000); see alsoCCS Fitness, 288 F.3d at 1366 (stating that "[a]n accusedinfringer . . . [cannot] narrow a claim term's ordinary meaning . . .simply by pointing to the preferred embodiment"). That istrue even if the specification reveals only one preferredembodiment. Teleflex, 299 F.3d. at 1327 (explaining that "the number of embodiments disclosed in the specification is notdeterminative of the meaning of disputed claim terms"); see CCSFitness, 288 F.3d at 1366 (noting that "a patentee need not`describe in the specification every conceivable and possiblefuture embodiment of his invention'" (quoting Rexnord Corp. v.Laitram Corp., 274 F.3d 1336, 1344 (Fed. Cir. 2001))). To avoidimporting the limitations contained in the specification into thepatent claims, the court must keep in mind that the purpose ofthe specification is to "teach and enable those of skill in theart to make and use the invention and to provide a best mode fordoing so." Phillips, 2005 WL 1620331, at *16 (citingSpectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1533(Fed. Cir. 1987), and explaining that one of the best ways toteach a person how to make and use the invention is to "providean example of how to practice the invention in a particularcase"). Most of the time, on "reading the specification in thatcontext, it will become clear whether the patentee is setting outspecific examples of the invention to" teach one skilled in theart how to practice the invention, "or whether the patenteeinstead intends for the claims and the embodiments in thespecification to be strictly coextensive." Phillips, 2005 WL1620331, at *16.
(3) The prosecution history
The third intrinsic source of evidence for claim construction,along with the claims and the specification, is the prosecutionhistory. Phillips, 2005 WL 1620331, at *9. This historyconsists of a "complete record of all the proceedings before thePatent and Trademark Office [`PTO'], including any expressrepresentations made by the applicant regarding the scope of theclaims." Vitronics, 90 F.3d at 1582; see Phillips, 2005 WL1620331, at *9. The prosecution history is often of criticalsignificance in determining the meaning of the claims, seeVitronics, 90 F.3d at 1582, because it "limits theinterpretation of claim terms so as to exclude any interpretationthat was disclaimed during prosecution," Southwall Techs., Inc. v.Cardinal IG Co., 54 F.3d 1570, 1576 (Fed. Cir. 1995).
Like the specification, the prosecution history also can modifythe meaning of claim terms either because the patentee has actedas his or her own lexicographer, Teleflex, 299 F.3d. at 1325,or because the prosecution history includes "expressions ofmanifest exclusion or restriction," id. at 1326; seePhillips, 2005 WL 1620331, at *9 (explaining that "theprosecution history can often inform the meaning of the claimlanguage by demonstrating how the inventor understood theinvention and whether the inventor limited the invention in thecourse of prosecution, making the claim scope narrower than itwould otherwise be"). The prosecution history, however, "oftenlacks the clarity of the specification and thus is less usefulfor claim construction purposes" because it "represents anongoing negotiation between the PTO and the applicant, ratherthan the final product of that negotiation." Phillips, 2005 WL1620331, at *9. In addition, although the prosecution historycan, and should, be used to understand the language of theclaims, it cannot "enlarge, diminish, or vary" the limitations inthe claims. Markman, 52 F.3d at 980.
(4) Extrinsic evidence
If a claim term, read in light of the intrinsic evidence,remains ambiguous, the court may turn to extrinsic sources ofevidence to resolve the ambiguity. Phillips, 2005 WL 1620331,at *10 (explaining that extrinsic evidence "consists of allevidence external to the patent and prosecution history,including expert and inventor testimony, dictionaries, andlearned treatises" [citation omitted]); see Vitronics,90 F.3d at 1583 (cautioning that, "where the public record unambiguouslydescribes the scope of the patented invention, reliance on anyextrinsic evidence is improper"); see also Bell Atlantic,262 F.3d at 1269 (adding that "extrinsic evidence may be used only to assist in the proper understanding of the disputedlimitation; it may not be used to vary, contradict, expand, orlimit the claim language from how it is defined, even byimplication, in the specification or file history" [citationsomitted]). When the implications of two pieces of extrinsicevidence, such as the testimony of two witnesses of ordinaryskill in the art, are contradictory, they are inconclusive. CCSFitness, 288 F.3d at 1368.
In construing a patent claim, extrinsic evidence is generally"less reliable than the patent and its prosecution history."Phillips, 2005 WL 1620331, at *10. Technical dictionaries,however, can help the court "`to better understand the underlyingtechnology' and the way in which one of skill in the art mightuse the claim terms." Id. (quoting Vitronics, 90 F.3d at 1583n. 6); Bell Atlantic, 262 F.3d at 1267 (explaining that"[d]ictionaries and technical treatises, which are extrinsicevidence, hold a `special place' and may sometimes be consideredalong with the intrinsic evidence when determining the ordinarymeaning of claim terms").2 In sum, "[j]udges . . . may . . .rely on dictionary definitions when construing claim terms,so long as the dictionary definition does not contradict anydefinition found in or ascertained by a reading of the patentdocuments." Vitronics, 90 F.3d at 1584 n. 6; see Phillips,2005 WL 1620331, at *11 (concluding that, while "extrinsicevidence may be useful to the court, . . . it is unlikely toresult in a reliable interpretation of patent claim scope unless considered in thecontext of the intrinsic evidence").3, 4
B. The doctrine of claim differentiation
An additional consideration in claim construction is thedoctrine of claim differentiation. Under this doctrine, "eachclaim in a patent is presumptively different in scope." WengerMfg., Inc. v. Coating Mach. Sys., Inc., 239 F.3d 1225, 1233(Fed. Cir. 2001). Claim differentiation, however, does notrequire "that every limitation ? be distinguished from itscounterpart in another claim, but only that at least onelimitation ? differ." Kraft Foods, Inc. v. Int'l Trading Co.,203 F.3d 1362, 1368 (Fed. Cir. 2000); see Wenger,239 F.3d at 1233 (noting that the doctrine of "[c]laim differentiation . . .is clearly applicable when there is a dispute over whether alimitation found in a dependent claim should be read into anindependent claim, and that limitation is the only meaningfuldifference between the two claims").
"However, claim differentiation is not a `hard and fast rule ofconstruction,' and cannot be relied upon to `broaden claimsbeyond their correct scope.'" Wenger, 239 F.3d at 1233 (quotingKraft Foods, 203 F.3d at 1368); see also Toro Co.,199 F.3d at 1302 (explaining that "the doctrine of claim differentiationdoes not serve to broaden claims beyond their meaning in light of the specification and does not override clear statements of scopein the specification and the prosecution history"); MultiformDesiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1480 (Fed. Cir.1998) (emphasizing that claims written in "different words mayultimately cover substantially the same subject matter"; statingthat the doctrine of claim differentiation cannot enlarge thescope of disputed claims). Thus, "although different claimsshould be presumed to cover different inventions, `if a claimwill bear only one interpretation, similarity [with anotherclaim] will have to be tolerated.'" Laitram Corp. v. MorehouseIndus., Inc., 143 F.3d 1456, 1463 (Fed. Cir. 1998) (quotingLaitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1538 (Fed. Cir.1991) [alterations in original]).
C. The recapture rule5
Under the recapture rule, "claims that are `broader than theoriginal patent claims in a manner directly pertinent to thesubject matter surrendered during prosecution' areimpermissible." Hester Indus., Inc. v. Stein, Inc.,142 F.3d 1472, 1480 (Fed. Cir. 1998) (quoting In re Clement,131 F.3d 1464, 1468 (Fed. Cir. 1997)). This rule effectively "prevents apatentee from regaining through reissue the subject matter thathe had surrendered in an effort to obtain allowance of the original claims." In re Clement,131 F.3d at 1468. In applying the recapture rule, the court must first"determine whether and in what `aspect' the reissue claims arebroader than the patent claims." Id.; see Hester Indus.,Inc., 142 F.3d at 1480 (explaining that "[a] reissue claim thatdoes not include a limitation present in the original patentclaims is broader in that respect"). Next, the court must"determine whether the broader aspects of the reissue claimsrelate to surrendered subject matter." In re Clement,131 F.3d at 1468-69; Hester Indus., Inc., 142 F.3d at 1480. Indetermining whether the patent applicant surrendered a particularsubject matter, the court must "look to the prosecution historyfor arguments and changes to the claims made in an effort toovercome a prior art rejection." In re Clement,131 F.3d at 1469, and cases cited; Hester Indus., Inc., 142 F.3d at 1480-81(explaining that surrender of a particular subject matter "canoccur by way of arguments or claim changes made during theprosecution of the original patent application" [emphasis inoriginal]).
Whether a reissue patent violates 35 U.S.C. § 251 (dealing withthe reissue of defective patents) "is a question of law, which[the court must] review de novo" (emphasis in original). N.Am. Container v. Plastipak Packaging, Inc., 2005 WL 1645620, at*13-14 (Fed. Cir. July 14, 2005). Accordingly, in evaluating thereissue patent, this court owes no deference to the patentexaminer.
With the foregoing legal principles in mind, I turn to thepatent-in-suit. 2. The '885 Patent
The '885 patent is a broadening, reissue patent based on theUnited States Patent No. 5,755,699 ("the '699 patent").6The '885 patent discloses a safety needle and blood collectionand sampling system that precludes accidental needlestick injuryby a contaminated needle by capturing the needle within aprotective guard (also referred to as the "body") immediatelyafter the needle is withdrawn from the donor. The invention "(1)shields the blood-contaminated needle simultaneously with itswithdrawal from the donor, and (2) uses a separate shieldedneedle in a blood sample tube holder for the safe drawing ofblood samples," greatly reducing the probability of "an exposedcontaminated point being in any injury-causing proximity to amedical worker." '885 patent, col. 2, ll. 57-62. On withdrawal ofthe blood-contaminated needle from the donor, the needle isimmediately retracted within a snap-on guard, and a shield blocksreemergence of the contaminated needle. '885 patent, col. 3, ll.3-6.
A. The prosecution history
On November 8, 1990, MBO filed its first United States patentapplication (Serial No. 610583) for a safety needle systemoffering healthcare workers protection from injury — specificallyinfection — by used hypodermic needles. MBO's originalapplication contained 29 claims and focused on a shielding assembly for needles, in whichthe needle was immediately blocked by an adjacent imperforateflange when the needle was retracted into a guard upon withdrawalfrom the patient. Becton Exh. 2. The patent examiner rejected all29 claims as being anticipated and/or obvious over several priorart references, including Kothe (United States Patent No.4,943,281) and Macalalad (United States Patent No. 3,709,223).Becton Exh. 3. In response, MBO amended the pending claims,adding a tubular guard into which the needle was retracted uponbeing withdrawn from the donor. Becton Exh. 4, pp. 1, 3, 4. MBOsought to distinguish its invention from Kothe by pointing outthat the "chief feature" of its invention was not only "the saferetraction of the needle . . . into the tubular member" (i.e.,the body), but also "precluding the inadvertent reemergencethereof to [prevent] physical and contamination hazard." BectonExh. 4, p. 5. MBO also explained that Kothe taught a movableneedle and a reversible needle cover, and noted that with Kothe,in the absence of blood or tissue on the needle, there was "noway of telling whether the needle" had already been used. MBOmaintained that, in contrast, its invention enabled the userimmediately to tell "whether the needle ha[d] been used, [becausethe needle could not] be extended or projected once retracted"into the body after use. Becton Exh. 4, pp. 5-6. MBO furthercontended that, while the Kothe device was confined to syringes,its proposed invention provided "a needle safety assembly fordiverse medical use, as the winged IV infusion needle . . ., adouble-ended blood collection needle, a catheter placementneedle, a dental needle, a transfusion needle for blood bank andlike purposes, and also a syringe needle." Becton Exh. 4, p. 6.
The examiner rejected the amended claims as anticipated byadditional prior art references. Becton Exh. 5. In response, MBOexplained, inter alia, that the invention in one of the priorart references, DuPont (United States Patent No. 4,915,697), provideda needle fixed to its guide by threads, and did not contain any"comparable or cooperatively associated flexible straps orseparation-preventing abutments whatever." MBO added that, until"physically capped by a totally separate cap element, the DuPontneedle [wa]s never prevented from hazardous reemergence, incontrast to the automatic and immediate safety means of" itsinvention. Becton Exh. 7, p. 7. The examiner then allowed theclaims as limited and refined by the foregoing interactions withMBO. The United States Patent No. 5,176,655 (the '655 patent)thus issued on January 5, 1993.
After the '655 patent issued, MBO prosecuted acontinuation-in-part application, which claimed the benefit ofpriority to MBO's original November 3, 1990, application. Thecontinuation-in-part application included 17 claims. All of theclaims relating to safety needle devices were limited to devicesrequiring retraction of the needle into the body. Becton Exh. 8.The patent examiner rejected all the claims as obvious overseveral prior art references, including Smith (United StatesPatent No. 5,026,356). Becton Exh. 9. Smith disclosed a safetyneedle system comprising a fixed needle and a guard that theoperator manually could extend to cover the needle tip. BectonExh. 17. In response, MBO sought to distinguish its claimedinvention from Smith by remarking that, in Smith, the needle (1)was not slidably received in the barrel; and (2) could be "fullywithdrawn from the patient's flesh . . . with the needle pointand needle end portion fully exposed and hazardous forneedlestick and contamination!" With regard to the second point,MBO particularly emphasized that the invention in Smith protectedonly the tip of the needle, leaving the adjoining needle endportion exposed. Becton Exh. 10, p. 8. In sum, MBO maintainedthat, in contrast to Smith, its invention required, among otherthings, a safety means "which immediately block[ed the] reemergence of [the]needle ? as soon as the needle [wa]s flush with [the] frontsurface [of the body] by unidirentional [sic] and irreversiblemovement." Becton Exh. 10, pp. 8-9.
The patent examiner allowed some claims and rejected others,citing Vadher (United States Patent No. 4,998,924) in view ofRanford (United States Patent No. 4,946,446). Vadher disclosed asafety needle retractable into the body, but did not disclose amovable safety means, precluding reversing movement. Ranforddisclosed a safety means that fit over the body and could belocked in an extended position to block the needle. Becton Exh.11, p. 2. In response, MBO sought to distinguish its inventionfrom the prior art by limiting its claims to a device having "animperforate blocking flange disposed in adjacent relation to saidbody front surface. . . ." Becton Exh. 12, p. 2. Thereafter, onMarch 7, 1995, the examiner allowed the patent to issue as UnitedStates Patent No. 5,395,347 ("the '347 patent"). The patentissued on March 7, 1995.
MBO also prosecuted a separate continuation application, whichclaimed priority to the original November 3, 1990, application.The specification of this application was substantially identicalto that of the '347 patent. Claim 18, the only independent claimin this application, included the retraction limitation, theblocking flange limitation, and the immediate and positiveblocking of reemergence limitation. Becton Exh. 14, pp. 2-4. Thepatent examiner rejected the claims as anticipated by Bayless(United States Patent No. 4,850,977) in view of Smith. Baylessdisclosed a safety needle system comprising a stationary needleand a movable safety means, including a blocking flange and aspring means. Becton Exh. 15, p. 3.7 As noted earlier,Smith disclosed a device comprising a stationary needle and a guardthat could be extended to cover the needle tip.8
In response, MBO sought to distinguish its invention fromBayless by emphasizing that Bayless required, among other things,(1) a needle that is fixed to the body and never moves; (2) aseparate hollow needle sheath which propels forwardly only on"manual release of a separate hooked latch"; and (3) flaps at theend of the sheath intended to be flexed and pulled apart. BectonExh. 13, p. 3. MBO pointed out that, in contrast to Bayless, itsinvention contemplated (1) a slidable needle; (2) a body with afront surface through which the needle is extended for use andinto which it is slidably retracted after use; (3) an imperforateblocking flange positioned adjacent to the front surface of thebody; (4) a spring that automatically moves the blocking flange when the needle is slidably retracted into the body. MBO furthernoted that, in its invention, after the blocking flange ispositioned "overlying and against" the front surface of the body,there is "no practical way that the flange could be 'pulledapart' like Bayless." MBO also distinguished its invention fromSmith, by explaining that, like Bayless, Smith contemplated aneedle that is fixed to a syringe and is immovable, and requiredthat the operator manually extend the safety system over theneedle tip. Becton Exh. 13, p. 4.
The examiner rejected each of the pending claims as beingunpatentable over Bayless in view of Cohen (United States PatentNo. 5,125,908). Cohen disclosed a retractable needle "in the samefield of endeavor for the purpose of safely disposing of aneedle." Becton Exh. 18, pp. 2-4. To overcome the examiner'srejection, MBO identified three elements "required" by itsclaimed invention and absent from the prior art: "(1) a bodyhaving means, as a bore, for slidably receiving a needle; (2) asafety flange transversely movable under spring force intooverlying and adjacent relation to the front surface of theneedle-carrying body when the needle is slidably retractedtherein[; and] (3) a mount for the spring precluding any axialmovement thereof along the needle-carrying body." MBO emphasizedthat, "with the needle retracted into the body and blocked at thebody front face from emergence or any human contact," itsinvention would enable medical workers "positively [to] avoid?"any contamination hazard. MBO explained that Bayless lacked allthree features set forth above, because Bayless (1) disclosed aneedle that was fixed and immovable, (2) did not contain a flangemovable into overlying and adjacent relation to the needleretracted in the body at the body front face, and (3) any springin Bayless was not axially fixed on the body. MBO also assertedthat Smith lacked all three features, and that Cohen lacked "atleast" features (2) and (3), because it did not disclose a flangeand a spring mount. Becton Exh. 19, pp. 5-6. The patent examiner allowed MBO's claims. On May 26,1998, the '699 patent issued.
On July 1, 1999, MBO filed a request for reissue of the '699patent. The request was accompanied by the required reissuedeclaration, which stated, in relevant part, that the '699 patentwas "wholly or partly inoperative or invalid" because its claimswere narrower than the claims MBO was entitled to receive. BectonExh. 21, p. 2. Specifically, MBO explained that the claims of the'699 patent called for the needle "retracting" into the body, anddid not encompass advancing the body to cover the tip of theneedle. MBO Exh. 2.9 When referring to the needle and thebody, instead of using the "retraction" language of the '699patent, the new claims used terms such as "relative movement,"and "relatively moved." The PTO allowed the reissue application.The '885 patent, containing 36 claims, issued on September 26,2000.
As I noted earlier, MBO alleges that Becton infringes claims13, 19, 20, 27, 28, 32, and 33 of the '885 patent. Claims 13, 19,and 20 are identical to claims 13, 19, and 20 of the '699 patent.Claims 20, 27, 28, 32, and 33 of the '885 patent are reissueclaims not found in the '699 patent. The parties substantiallyagree on the majority of the terms in these claims. At theMarkman hearing, the parties narrowed the disputed claim termsto the following: (1) "relative movement" versus "retraction" asthese terms relate to the "movement of the guard with respect tothe needle tip after the device has been used"; (2) "immediately"as that term relates to "how the spring snaps shut"; (3)"adjacent" as that term relates to the location of the blockingflange with respect to the front of the guard; and (4) "mounted on" asthat term relates to the positioning of the blocking flangevis-a-vis the body. Tr. 1:7:7-1:7:12, 1:7:25-1:8:11; 1:46:3-1:46:9.Only the disputed terms are discussed below. See VividTechs. v. Am. Science & Eng'g, 200 F.3d 795, 803 (Fed. Cir.1999) (explaining that the court need only construe the claimlanguage that is in dispute).
B. Whether the '885 patent is limited to a blood collectionsystem
At the Markman hearing, Becton raised, for the first time, theargument that the invention disclosed in the '885 patent shouldbe limited to a blood collection system. That argument had notbeen made in the claim construction papers filed by Becton priorto the hearing. MBO objected to the late inclusion of an argumentas to the nature of the invention, asserting unfair surprise.MBO's objection is well-founded. The failure of Becton to raisethe argument in its pre-hearing briefs constitutes a surrender ofany right it otherwise might have had to challenge the nature ofthe invention in this proceeding. Accordingly, I hold that Bectonhas waived this argument. More to the point, however, as MBOcorrectly points out, Becton has previously conceded that MBO"incorporated by reference the teachings of the '655 patent"(disclosing an invention that was not limited to bloodcollection) into the '885 patent. Becton's Response MarkmanBrief, p. 16, n. 9. In light of the foregoing considerations, Ihold that no issue as to the nature of the invention is properlybefore me.
C. The application of the recapture rule
The reissue claims in dispute are broader than the originalpatent claims in that, inter alia, they no longer contain the"retraction" limitation, and no longer require the immediatecapture of the needle by the guard, and the positioning of theflange flush against the guard. Moreover, as in N. Am. Container, 2005 WL 1645620, at *14, "the broaderaspect[s] of the reissue claims relate? to subject matter thatwas surrendered during the prosecution of the original-filedclaims." Hester Indus., Inc., 142 F.3d at 1480-81 (focusing onthe "arguments and changes to the claims made [by the patenteethroughout the prosecution history] in an effort to overcome aprior art rejection"; emphasizing that "[a]rguments made toovercome prior art can ? evidence admission sufficient to giverise to a finding of surrender"). Indeed, during prosecution, asdiscussed in detail above, MBO sought to distinguish itsinvention from Bayless and Smith by pointing out that bothBayless and Smith disclosed a stationary needle and a movablesafety device. MBO also contrasted its adjacent blocking flangewith the separate safety device in Bayless, and emphasized theimportance of immediate protection of the needle tip and theadjacent needle shank. See, e.g., Becton Exh. 10, p. 8; Exh.13, p. 4; Exh. 19, pp. 5-6. Consequently, MBO, "by way of [its]repeated prosecution arguments, surrendered claim scope that doesnot include these limitations." Hester Indus., Inc.,142 F.3d at 1482; see SciMed, 242 F.3d at 1343 (emphasizing that "theclaims should not be read so broadly as to encompass thedistinguished prior art structure").
D. Claim 13
Claim 13 of the '885 patent recites: A method of immediately and positively precluding needlestick injury from a contaminated needle comprising the steps of: providing an elongated needle having a pointed end, providing a body [i.e., guard] slidably receiving the needle and having a front surface through which the needle extends for use and is retracted into the body after use, providing a spring having an imperforate blocking flange portion, and affixing said spring to the body so as to preclude axial movement of said spring and to dispose the flange portion in adjacent relation to the body front surface and in springurged relation against the needle extending from the body when the needle is in use, whereby when the needle is retracted after use to bring its pointed end flush with the body front surface, the imperforate blocking flange is spring urged over the body front surface past the needle point thereby to block any reemergence of the needle from the body.'885 patent, col.10, ll. 24-43 (emphasis added). The claim termsin dispute have been emphasized in the quoted passage above.
MBO contends that the word "immediately" should mean right awayor without delay. Tr. 1:31:21-1:31:23. MBO points out that theword "immediately" appears in the preamble to claim 13,describing the purpose of the invention. Citing CatalinaMarketing Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,808 (Fed. Cir. 2002), MBO insists that the body of the claimlanguage in claim 13 (and in claims 19 and 27) defines astructurally complete invention. MBO explains that "the preambleis not limiting where a patentee defines a structurally completeinvention in the claim body and uses the preamble only to state apurpose or intended use for the invention." Schumer v. Lab.Computer Sys., Inc., 308 F.3d 1304, 1310 (Fed. Cir. 2002)(emphasizing that, "[i]f the body of the claim sets out thecomplete invention, and the preamble is not necessary to give`life, meaning and vitality' to the claim, `then the preamble isof no significance to claim construction because it cannot besaid to constitute or explain a claim limitation'" [citationomitted]).
MBO also insists that the specification uses the term"immediately" to refer solely to the action of the spring whenthe needle passes it and does not describe the amount of timebetween the withdrawal of the needle from the patient and theblocking flange's sealing of the needle tip. '885 patent, col. 6,ll. 56-58. Tr. 1:30:10-1:30:15. MBO contends that the claims ofthe '885 patent make clear that the body and the spring are"closely adjacent" to the patient's flesh at the injection site, but are not touching it. MBO reasons that,because there is space between the patient and the body, therenecessarily would be some delay between the withdrawal of theneedle tip from the patient and its recapture by the body.
Becton's position is that, in the context of the assertedclaims, the term "immediately" should be interpreted to mean"simultaneously with" the needle's withdrawal from the donor.Becton explains that the use in the specification of thefollowing phrases establishes that the needle tip is neverexposed after it is inserted into the patient: (1) "uponwithdrawal of the needle from the blood donor, the needle isimmediately retracted within the guard and a shield positivelyblocks the contaminated needle point and access thereto"; (2) theneedle "is shielded simultaneously with its withdrawal from thedonor whereby no inadvertent puncture can occur"; and (3) "thehealthcare worker at no time has to manipulate an unshieldedblood-contaminated needle." '885 patent, col. 3, ll. 3-5; col. 5,ll. 3-4; col. 8, ll. 16-17. Becton points out that, in the"Summary of the Invention" section of the specification of the'885 patent, MBO characterizes its invention as a "new andimproved system which ? shields the blood-contaminated needlesimultaneously with its withdrawal from the donor." '885 patent,col. 2, ll. 57-58. Tr. 1:55:6-1:55:8. Citing 37 C.F.R. § 1.73(requiring that the summary of the invention be "commensuratewith the invention as claimed"), Becton argues that MBO's attemptto make its invention more comprehensive than the summary of theinvention is improper as a matter of law. Becton also insiststhat MBO's assertions throughout the prosecution history limitall the claims, including the reissue apparatus claims 32 and 33(in which the word "immediately" does not appear) to a methodwhereby the body traps the needle tip simultaneously with theneedle's removal from the donor.10
In this instance, the preamble aids in the construction of thedisputed claim term. As noted above, the preamble to claim 13describes "[a] method of immediately and positively precludingneedlestick injury from a contaminated needle. . . ." '885patent, col. 10, ll. 24-26 (emphasis added). This languageappears unambiguously to indicate that the term "immediately"should be interpreted to mean that the needle is shielded as itis withdrawn from the donor. It limits MBO's claims because, inthis case, it is "necessary to give life, meaning, and vitality"to these claims. Pitney Bowes, Inc. v. Hewlett-Packard Co.,182 F.3d 1298, 1305 (Fed. Cir. 1999).
I further note that the '885 patent is replete with MBO'sassertions that its system substantially reduces or eliminatesthe risk presented by the "open manipulation of the contaminatedneedle between withdrawal and sample securement" by "shield[ing]the bloodcontaminated needle simultaneously with its withdrawalfrom the donor."11 See Toro Co. v. White Consol. Indus.,Inc., 199 F.3d 1295, 1301 (Fed. Cir. 1999) (looking to thespecification in interpreting the claims of the invention). Inaddition, under the established principles of claim construction,the words of the '885 patent must be interpreted in light ofMBO's assertions throughout the prosecution history of theoriginal '699 patent and related patents. Alloc, Inc. v. Int'lTrade Comm'n, 342 F.3d 1361, 1368 (Fed. Cir. 2003) (taking intoaccount the patentee's assertions throughout the prosecution of several relatedpatents). During the prosecution of the '699 patent, MBO soughtto distinguish its invention from the prior art by emphasizingthat its needle safety system provided immediate protection tohealthcare workers by retracting the needle into the body at thesame time as the needle is withdrawn from the donor. For example,to distinguish its invention (set forth in the '699 patent) fromDuPont, MBO contended that, in contrast to DuPont, its inventionprovided "automatic and immediate safety means." Becton Exh. 7,p. 7.
I conclude that, in light of the above, MBO has acted as itsown lexicographer, defining the term "immediately"12 tomean "simultaneously" with the needle's withdrawal from thedonor. Phillips, 2005 WL 1620331, at *8 (explaining that, wherethe patentee has defined a claim term in a way that differs fromthe term's usual meaning, the patentee's lexicography controls);see Bell Atlantic Network Servs., Inc., 262 F.3d at 1268(noting that the patentee need not have explicitly defined theterm).13 I further conclude that the term "immediately,"as I have construed it, limits reissue claims 32 and 33. Myconstruction of this term applies with equal force to the timebetween the retraction of the needle within the guard and theaction of the blocking flange.
b. "slidably receiving"
MBO contends that the term "slidably receiving," which is partof the claim limitation "providing a body slidably receiving the needle," should beinterpreted according to its plain meaning, i.e., a body whichfits around and slides along the needle. MBO calls my attentionto the following language of the specification: "The safety andguard assembly 80 in FIGS. 3 and 4 carrying needle 40 . . .includes a needle shielding or guide body 82 having an openingshown as a bore extending from port means in its front surface ordistal end 84 to proximal end 86 within which needle 40 isslidably received." '885 patent, col. 5, ll. 31-37. MBO recitesseveral dictionary definitions of the terms "slide" and"receive," and concludes that nothing in these definitionsmandates withdrawal or retraction of the needle into the body.According to MBO, the "slidably receiving" claim limitationencompasses any movement of the body sliding over the needle inany direction.
MBO further insists that nowhere in the specification of the'885 patent is the needle retraction emphasized or referred to asthe critical feature of the invention. MBO maintains that thespecification never disclaims or disavows forward motion of thebody to cover the tip of the needle. MBO emphasizes that its useof the terms "retraction" and "rearwardly," in describing thepreferred embodiment for the invention, is not enough to read the"retraction" limitation into all the claims, especially into thereissue claims 27, 28, 32, and 33. MBO contends that itsstatements during prosecution of the '699 patent did not limitthe scope of its claims to retraction.
Becton explains that, the claim language, the specification,and MBO's statements to the patent examiner during theprosecution of the '699 patent support the proposition that theterm "slidably receiving" should be interpreted to mean theretraction of the needle into the body. Tr. 1:72:17-1:76:18.Specifically, Becton argues that MBO's original patentapplication, relied on for the benefit of priority, as well asthe specification of the '885 patent, clearly indicated that the following three elements are crucial to the invention: (1)immediate blocking of the needle tip (2) by an imperforate flangeadjacent to the front surface of the body (3) on retraction ofthe needle into the body. Accordingly, Becton insists that claims13, 17, 19, and 20, issued in the '699 patent and then reissuedin the '885 patent without change, should be interpreted toincorporate these limitations.
The disputed term is part of the following clause: "providing abody slidably receiving the needle and having a front surfacethrough which the needle extends for use and is retracted intothe body after use." It is clear from the context, that the term"slidably receiving," connotes a stationary body through which amovable needle extended for use and retracted after use.
That interpretation is confirmed by the specification. Thepreferred embodiment set forth in the specification contemplatesthe retraction of the needle into the body. The specificationexplains, in relevant part: As similarly taught in [the '655 patent,] safe needle withdrawal from the donor's . . . blood vessel is effected by holding the needly shielding body 82 stationary adjacent the needle skin entry point and with wings 88 relaxed to remove lugs 102 outwardly from behind lug 104. Thereupon, as shown in FIG. 6A, the base section 44 (or the tubing 48 thereat) is pulled in a proximal direction while needle guide body 82 is stationary thereby causing needle 40 to slide rearwardly in the proximal direction through the guideway thereof in body 82.'885 patent, col. 6, ll. 46-55. While generally the preferredembodiment does not limit a claim, in this case, it is clear thatMBO "intend[ed] for the claims and the embodiments in thespecification to be strictly coextensive." Phillips, 2005 WL1620331, at *16.
This case is similar to Alloc, Inc. v. Int'l Trade Comm'n,342 F.3d 1361 (Fed. Cir. 2003). In Alloc, after the patentee'sclaims were allowed, it added new claims that were substantiallyidentical to the allowed claims, except without a particularlimitation (the term "play"), to the final application. 342 F.3d at 1372 (explaining that the applicantnever "retract[ed] or modifi[ed] the representations that securedallowance of the original claims"). In construing the claimsnarrowly to include the "play limitation," the court consideredthe specification and the prosecution history of the entire lineof patent applications. Alloc, 342 F.3d at 1368 (noting thatthe court must "immerse? itself in the specification, the priorart, and other evidence, such as the understanding of skilledartisans at the time of invention, to discern the context andnormal usage of the words in the patent claim").
The Alloc court read into all the claims the limitationscontained in the descriptions of the invention found in thesection titled "Technical Problems and Objects of the Invention,"which is substantially equivalent to the "Summary of theInvention" section of the '885 patent. Id. at 1369 (concludingthat the specification taught that the invention as a whole, notmerely a preferred embodiment, provided for "play" in thepositioning of floor panels); see also 37 C.F.R. § 1.73(mandating that the summary of the invention, "be commensuratewith the invention as claimed"). The Alloc court furtheremphasized that "all the figures and embodiments disclosed in theasserted patents impl[ied the existence of the play limitation]or expressly disclosed [the limitation]." 342 F.3d at 1370. Thecourt also noted that the applicants criticized prior art thatdid not contain the limitation, represented to the PTO that thelimitation is important to the invention, and sought todistinguish the invention from the prior art based on theexistence of the limitation. Alloc, 342 F.3d at 1371. In lightof all the factors set forth above, the court incorporated the"play" limitation into all the claims of the patent. Id. at1371-72 (explaining that "[b]ecause the applicant invoked play toovercome the prior art, [it] cannot now contend that the[patent-in-suit] claims [the invention] without play"). In this case, the language of the specification and MBO'sassertions throughout the prosecution history make clear that MBOintended that the preferred embodiment be coextensive with theclaims. Phillips, 2005 WL 1620331, at *16. The abstract of theinvention, the drawings of the '885 patent, and the writtendescription portion of the specification are all directed toretraction. '885 patent, abstract; col. 3, ll. 4-5; col. 6, ll.46-67; col. 8, ll. 13-16. In addition, as explained more fullyabove, during the prosecution of the '699 patent, MBO repeatedlyrepresented that its device encompassed a needle that retractedinto the guard. MBO contended that its invention wouldsignificantly decrease or eliminate the possibility of accidentalneedlestick injury by retracting the needle into the guardsimultaneously with the needle's withdrawal from the patient. MBOalso sought to distinguish its invention from Bayless and Smithby pointing out, inter alia, that both Bayless and Smithdisclosed stationary needles and movable safety means, whereasits invention disclosed a movable needle. Becton Exh. 13 p. 4;Exh. 19, p. 5. See Tr. 1:72:17-1:76:18. MBO, thus,effectively disclaimed any device that has a stationary needlewith a guard extending forward over the needle. Ekchian v. HomeDepot, Inc., 104 F.3d 1299, 1304 (Fed. Cir. 1997) (explainingthat statements made by the applicant "to induce a patent grant"limit the interpretation of the disputed claims "so as to excludeany interpretation that may have been disclaimed or disavowedduring prosecution in order to obtain claim allowance" [internalcitations omitted]; emphasizing that, by "distinguishing theclaimed invention over the prior art, an applicant is indicatingwhat the claims do not cover, [and, accordingly] he is byimplication surrendering such protection"). It would be impropertherefore to construe the disputed claim language to encompasswhat MBO had "expressly disclaimed" during the prosecution of the'699 patent. SciMed Life Sys., Inc. v. Advanced CardiovascularSys., Inc., 242 F.3d 1337, 1341-43 (Fed. Cir. 2001) (emphasizing that, where the applicants"discuss[ed] the disadvantages of certain prior art structures,"the court should not read the claims "so broadly as to encompassthe distinguished prior art").
I conclude that, in light of the language of the claim, thespecification, and MBO's assertions during the prosecution of the'669 patent, the term "slidably receiving" (as well as the terms"relative movement" and "relatively moved" found in other claims)should be construed to refer to a stationary body into which themovable needle retracts. See, e.g., Alloc, 342 F.3d at 1368-72.
c. to dispose the flange in "adjacent" relation to the bodyfront surface
MBO's proposed construction of the term "adjacent" is "nextto." According to MBO, the only "positional limitation" on theflange is that "when the needle tip is inside the body," theflange is disposed forward of the needle tip. MBO also insiststhat the term "adjacent" should not be imported into reissueclaims 32 and 33. Tr. 1:32:10-1:33:8.
Becton's proposed construction of the term "adjacent" is "flushwith," meaning that the protective blocking flange of the springthat seals the needle in the body must be flush with the forwardsurface of the body. Becton maintains that, with respect to the"adjacent" limitation, MBO acted as its own lexicographer,defining the blocking flange as being "flush" with the forwardsurface of the body. Becton notes that, unless the flange is"right next to the front surface, it could not immediately blockthe [needle] tip." Thus, Becton emphasizes that, unless theblocking flange is flush with the front surface of the body, aneedle would have to be "withdrawn at least a minimumpredetermined distance beyond the exit" from the guard body to permit the flange to cover the needle tip. Becton insists thatMBO specifically disclaimed flanges that are not "on," "directlyadjacent to," or "flush with" the front surface of the body.Finally, Becton points out that the figures and other embodimentsof the '885 patent show the blocking flange immediately next tothe front surface of the guard.
The language of the claim is ambiguous. I, therefore, turn tothe specification for illumination. The specification of the '885patent states, in part, that "with the blocking flange face 98immediately adjacent the forward surface of the body at 84, assoon as the needle passes behind the flange 98, the spring snapsthe flange forward surface over the 84 of the body intoneedle-blocking position and positively precludes reemergence ofthe contaminated needle point from the body 82 and thusneedlestick injury is absolutely avoided." '885 patent, col. 7,ll. 2-8. The specification praises this feature as "anoutstanding safety feature of the invention." '885 patent, col.7, ll. 1-2. The specification also contrasts and criticizessafety devices in the prior art, "wherein the needle must bewithdrawn at least a minimum predetermined distance beyond theexit from the tubular body," explaining that, in the prior art,"if the needle is not retracted sufficiently inwardly from theexit aperture, it is still able to be accidentally projected tocause hazard." '885 patent, col. 7, ll. 15-25.
Furthermore, during the prosecution of the '699 patent, MBOsought to distinguish its invention from Smith by arguing thatthe invention disclosed in Smith protected only the tip of theneedle, leaving the adjoining needle end portion exposed, whereasMBO's invention covered both the needle tip and the needle shank.Becton Exh. 10, pp. 8-9. MBO also sought to distinguish itsinvention from Bayless by explaining, inter alia, that Baylessdisclosed a "separate hollow needle sheath," whereas itsinvention had a blocking flange "adjacent" to the front surfaceof the body. Becton Exh. 13, pp. 3-4. See Ekchian, 104 F.3d at 1304(explaining that, by "distinguishing the claimed invention overthe prior art, an applicant is indicating what the claims do notcover"); see also SciMed Life Sys., Inc., 242 F.3d at 1341-42,1342-43 (noting that it is improper for the court to construedisputed claims "to cover what was expressly disclaimed" duringprosecution history).14 In light of the foregoing, Iconstrue the term "adjacent" to mean contiguous or connected withthe front surface of the body.15
E. Claims 19 and 20
Claim 19 of the '885 patent provides: A method of immediately and positively precluding needlestick injury from a contaminated needle comprising the steps of: providing an elongated needle having a pointed end, providing a body slidably receiving the needle and having a forward surface through which the needle extends from the body for use and is retracted toward and into the body after use, providing a spring having an imperforate blocking flange, and, affixing said spring to the body so as to preclude axial movement of said spring with respect to the body and to dispose the flange in adjacent relation to the body forward surface and in spring-urged relation to bear against the needle extending from the body when the needle is in use, whereby when the needle is retracted after use to bring its pointed end into immediate proximity to the body forward surface, the imperforate blocking flange is spring urged over the body forward surface past the needle pointed end thereby to block any reemergence of the needle from the body and past the flange to present a needlestick hazard. '885 patent, col.12, ll. 34-57 (emphasis added). The claim terms in dispute have been emphasized in the passage quoted above.
"Unless the patent otherwise provides, a claim term cannot begiven a different meaning in the various claims of the samepatent." Georgia-Pacific Corp. v. United States Gypsum Co.,195 F.3d 1322, 1331 (Fed. Cir. 1999); see CAE Screenplates,224 F.3d at 1317 (citing Phonometrics, Inc. v. Northern Telecom,Inc., 133 F.3d 1459, 1465 (Fed. Cir. 1998), where the courtexplained that "[a] word or phrase used consistently throughout apatent claim should be interpreted consistently"). Therefore,having interpreted the disputed terms "immediately," "slidablyreceiving," and "adjacent" as they are found in claim 13, I neednot discuss these same terms again when they appear in otherclaims. The meaning of the term is the same in all of the claimsin issue.
(A) the pointed end of the needle being in the "immediateproximity" to the body forward surface
Citing several dictionaries, MBO contends that the term"immediate proximity" (and the term "proximity" found in claim27) should be construed to mean "near." MBO points out that thephrase "flush with," used in the original claim 13, has not beenmade part of claims 19 and 27. To support its position, MBOrelies on Tandon Corp. v. U.S. Int'l Trade Comm'n,831 F.2d 1017, 1023 (Fed. Cir. 1987) (explaining that "[t]here is presumedto be a difference in meaning and scope when different words orphrases are used in separate claims").
Becton proposes that the disputed terms be construed to meanthat the pointed end of the needle is "flush with" the forwardsurface of the body. According to Becton, during the prosecutionof the '347 patent, MBO sought to distinguish its invention fromthe prior art by amending its claims (1) to require immediateblocking of the needle tip by movement of the "flange over the front surface of the body," and (2) to emphasizethat the safety flange slipped over the needle tip when theneedle tip was "flush with [the] front surface" of the body.Becton Exh. 10 p. 9; Exh. 12, p. 4. Citing SciMed Life Sys.,Inc., 242 F.3d at 1342, and Ekchian, 104 F.3d at 1304, Bectonmaintains that the court's construction of the disputed termscannot include the subject matter that MBO had previouslydisclaimed.
The language of the claim strongly supports Becton's proposedinterpretation of the disputed claim term. It provides that, assoon as the pointed end of the needle comes "into immediateproximity to the body forward surface," the flange is "springurged over the body forward surface past the needle pointed end."The flange simply cannot go "over the body forward surface" and"past the needle pointed end" unless the needle tip is at leastflush with the forward surface of the body.
The specification also supports Becton's proposed construction.In particular, the specification explains that, "with theblocking flange face 98 immediately adjacent the forward surfaceof the body at 84, as soon as the needle passes behind theflange 98, the spring snaps the flange forward surface over the84 of the body into needle-blocking position and positivelyprecludes reemergence of the contaminated needle point from thebody 82 and thus needlestick injury is absolutely avoided. Whilethe needle may be withdrawn further into the body 82, such extramovement is unnecessary as the safety spring acts on and over theend face 84 of the body at the immediate point of potentialemergence of the contaminated needle" (emphases added). '885patent, col. 7, ll. 2-12. Several points supporting Becton'sconstruction arise from the quoted language. First, if theblocking flange face is immediately adjacent to the forwardsurface of the body, the needle tip must be at least flush (orlevel) with the forward surface of the body before the flange can snap over the body and block the needlefrom reemerging. Second, the phrase explaining that the flangecovers the needle tip "at the immediate point of potentialreemergence," also supports Becton's proposed construction of thedisputed term. Third, the specification contrasts the inventionwith the prior art that required that "the needle . . . bewithdrawn at least a minimum predetermined distance beyond theexit from the tubular body." '885 patent, col. 7, ll. 16-18.Fourth, the abstract of the invention explains that "a usedneedle is captured immediately within its carrier upon retractionof the needle flush with the carrier" (emphasis added).
Finally, I note that during the prosecution of the related '347patent, MBO sought to distinguish its invention from Smith byarguing, inter alia, that the safety means in its invention"immediately blocks reemergence of needle 40 as soon as theneedle is flush with front surface 84." Becton Exh. 10, p. 9.See Omega Eng'g, Inc. v. Raytek Corp, 334 F.3d 1314, 1333 (Fed.Cir. 2003) (explaining that "[a]s long as the same claimlimitation is at issue, prosecution disclaimer made on the samelimitation in an ancestor application will attach"; emphasizingthat this rule applies to continuation applications, andcontinuation-in-part applications); Advanced CardiovascularSys., Inc. v. Medtronic, Inc., 265 F.3d 1294, 1305 (Fed. Cir.2001) (noting that "[t]he prosecution history of a related patentcan be relevant if . . . it addresses a limitation in common withthe patent in suit"); Elkay Mfg. Co. v. Ebco Mfg. Co.,192 F.3d 973, 980 (Fed. Cir. 1999) (clarifying that "[w]hen multiplepatents derive from the same initial application, the prosecutionhistory regarding a claim limitation in any patent that hasissued applies with equal force to subsequently issued patentsthat contain the same claim limitation"); see also LoralFairchild Corp. v. Sony Corp., 181 F.3d 1313, 1327 (Fed. Cir.1999). In light of the foregoing considerations, I conclude that theterm "immediate proximity" requires that the needle tip be flushwith the forward surface of the body. The same limitation applieswith regard to the term "proximity" found in reissue claims 27and 28.
F. Claims 27 and 28
Claim 27 of the '885 patent provides: A method of immediately and positively precluding needlestick injury from a contaminated needle comprising the steps of: providing an elongated needle having a pointed end, providing a body slidably receiving the needle and having a forwardly-facing surface through which the needle extends from the body for use and is relatively moved toward and into the body after use, providing a spring having an imperforate blocking flange, and affixing said spring to the body so as to preclude axial movement of said spring with respect to the body and to dispose the flange in adjacent relation to the body forwardly-facing surface and in spring urged relation to bear against the needle extending from the body when the needle is in use, whereby when the needle is relatively moved after use to bring its pointed end into proximity to the body forward surface, the imperforate flange is spring urged over the body forwardly-facing surface past the needle pointed end thereby to block any reemergence of the needle from the body and past the flange to present a needle-stick hazard.'885 patent, col.15, ll. 5-27 (emphasis added). The claim termsin dispute have been emphasized in the passage quoted above.
(A) "relatively moved"
MBO urges that I construe the term "relatively moved" to meanthat the body, or the needle, or both, move in relation to eachother so as to result in the pointed end of the needle beingcovered by the body. MBO calls my attention to the reissuedeclaration it submitted to the PTO on July 1, 1999, where itinformed the PTO that "relative movement" encompassed both theretraction of the needle into the body and the movement of thebody over the tip of the needle. MBO Exh. 2, p. 2. MBO thus claims that its proposed definition ofthe term "relative" is consistent with the prosecution historyof the reissue application. MBO contends that it never soughtto distinguish its invention from the prior art based onretraction, because much of prior art disclosed a retractionfeature.
Becton proposes that the phrase "relatively moved" be construedto encompass only the retraction of the needle into the body.Citing Bayer AG v. Elan Pharm Research Corp., 212 F.3d 1241,1254 (Fed. Cir. 2000), and Pharmacia & Upjohn Co. v. MylanPharm., Inc., 170 F.3d 1373 (Fed. Cir. 1999), Becton explainsthat the court must use an objective test in determining whethercertain claims were surrendered during patent prosecution. Bectonfurther emphasizes that under Microsoft Corp. v. Multi-TechSys., Inc., 357 F.3d 1340, 1349-50 (Fed. Cir. 2004), claim termsmust be interpreted in a way consistent with the terms'definition and usage in related patent applications. Bectonargues that, in light of these principles, the "relatively moved"language of the reissue claims should be limited to mean solelythe retraction of the needle into the body after use. Bectoninsists that to construe MBO's patent claims otherwise wouldeffectively allow MBO to recapture the subject matter itdisclaimed during patent prosecution.
The language of the claim is broad and ambiguous. I, therefore,turn to the specification and the prosecution history forclarification. The specification of the '885 patent is focusedexclusively on the embodiment wherein the needle retracts intothe body. '885 patent, abstract; col. 3, ll. 3-6; col. 6 ll.45-59, 62-64; col. 7 ll. 3-6, 8-12; col. 8 ll. 13-15. Asexplained more fully above, I conclude that, under thecircumstances of this case regarding the retraction limitation,the preferred embodiment is coextensive with the claims of the'885 patent. In addition, during the prosecution of the '699patent, MBO sought to distinguish its movable needle fromstationary needles disclosed in Bayless and Smith — both of which discloseda stationary needle and a movable guard — by pointing out thatMBO's invention had a movable needle. I determine, then, that theterm "relatively moved," as well as the term "relative movement,"found in claim 32, refers to the retraction of the needle intothe body.
G. Claim 32
Claim 32 of the '885 patent provides: A safety system comprising: a needle having an axis, a proximal portion, and a distal portion terminating in a pointed end, a needle pointed end shielding body configured to receive the needle and to enable relative axial slidable movement of said body and said needle, said needle and said body being movable relative to one another between a first position and a second position, said needle and said body in said first position thereof having said distal portion of said needle and said pointed end thereof extending forwardly of said body for use outwardly of said body and in said second position thereof having said needle pointed end in said body, a movable safety device cooperatively associated with said needle and mounted on said body for blocking emergence of said needle pointed end forwardly of said body subsequent to relative movement of said needle and said body into said second position, said safety device including (1) an imperforate blocking flange disposed forwardly of said needle pointed end when said needle and said body lie in said second position, and (2) a spring for moving said flange in a needle blocking direction transversely of said body into a position blocking emergence of said needle pointed end forwardly of said body.'885 patent, col.16, ll. 23-49 (emphasis added). The claim termsin dispute have been emphasized in the passage quoted above.
(A) "mounted on said body"
MBO insists that the term "mounted on" should be construed tomean "attached to" something or "fixed securely to a support."Becton claims that the words "mounted on" should be construed to mean "attached to the exterior surface of thebody."
The claim language unambiguously indicates that the disputedterm should be interpreted to mean "attached to the exteriorsurface of the body." In addition, the drawings of the '885patent uniformly display a blocking flange that is attached tothe exterior surface of the body. Furthermore, in describing thespring and the flange, the preferred embodiment explains that thegripping legs of the spring "snap past the body projections 94,and positively hold the spring on the body with no chance or[sic] accidental removal." '885 patent, col. 6, ll. 10-12. I,therefore, construe the term "mounted on" to mean "attached tothe exterior surface" of the body.
H. Claim 33
Claim 33 of the '885 patent provides: A needle system according to claim 32 wherein flange is positioned relative to said needle to prevent relative movement of said needle and said body from said second position into said first position.'885 patent, col.16, ll. 50-53 (emphasis added). The claim termin dispute has been emphasized in the passage quoted above. Thedisputed claim term has been construed above in connection withclaim 27. I attribute to it in this claim the same meaning as ithas in claim 27. See Georgia-Pacific Corp., 195 F.3d at 1331(explaining that the same word in a patent has the same meaning).
In summary, and as described in greater detail above, Iconstrue the disputed terms as follows: (1) immediately — simultaneously with the needle's withdrawal from the donor; (2) slidably receiving — a movable needle retracts into a stationary body; (3) adjacent — the protective blocking flange is contiguous or connected with the forward face of the body; (4) immediate proximity, proximity — the protective blocking flange is flush with the body; (5) relatively moved, relative movement — the needle is retracted into the body; (6) mounted on said body — the protective blocking flange is attached to the exterior surface of the body.SO ORDERED.