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American Medical Systems, Inc. v. Biolitec, Inc.
618 F.3d 1354
Fed. Cir.
2010
Check Treatment
Docket

*1 priately weigh expert In witness testimo- by special master this case. en Moberly, treating physicians none of the ny. that the claimant’s in-

expressed the view

jury was caused the vaccination she Instead, the record evidence

received. of the claimant’s

supporting opinion

expert showing to a “amount[ed] most temporal association between a vaccina- seizure, together

tion and a with the ab- any other identified cause for

sence of SYSTEMS, AMERICAN MEDICAL case, injury.” ... Id. at 1323. Laserscope, Plaintiffs- INC. contemporaneous created treat- records Appellants, ing physicians support Broekelschen’s the- Furthermore, ory. special master and experts both noted that there is evidence BIOLITEC, INC., Defendant-Appellee. support in the record to and refute each of potential diagnoses. the two noth- While No. 2009-1323. ing conclusively proves record Appeals, United States Court of symptoms Broekelschen’s were caused vaccination, Federal Circuit. TM resulting from the conclu- proof required. sive is not Knudsen v. Sept. Servs., Sec’y Heath & Human (Fed.Cir.1994) (“The 543, 548-49 determi- nation of causation in fact under Vac- Act ascertaining

cine involves whether a

sequence ‘logical’ of cause and effect is

legally probable, medically or scienti- Althen, certain.”);

fically see also (“[T]he purpose

at 1280 of the Vaccine preponderance

Act’s standard is to allow finding in a causation field bereft of

complete proof and direct of how vaccines

affect the body.”). human majority special holds that the mas- in weighing expert

ter’s wit- error

nesses’ credibility is This is harmless. speculation.

mere It is not clear that the

outcome of the case would have been the

same if special appropri- master had

ately weighed expert witness testimo-

ny, particularly if he had done so within prevailing framework of Althen al-

lowing attempt Broekelschen to to make a

prima showing symptoms facie that his

resulted from TM. I vaccine-induced would

therefore special remand allow the mas-

ter properly apply the test laid out in appro-

Althen to Broekelschen’s claim and *2 Hansen, McAndrews,

Leland G. Held & IL, Ltd., Malloy, Chicago, argued plaintiffs-appellants. With him on the brief was Scott P. McBride. Giarratana, Mark D. En- McCarter & LLP, Hartford, CT, glish, argued for him defendant-appellee. With on the brief were Eric E. Grondahl and Charles D. Ray. BRYSON, PROST, DYK,

Before Judges. Circuit Opinion for the court filed Circuit Judge Dissenting opinion BRYSON. filed Judge DYK. by Circuit BRYSON, Judge. Circuit action, patent infringement plain- Systems, American tiffs Medical an Laserscope appeal granting order sum- mary judgment noninfringement to de- Biolitec, suit, Inc. The fendant 6,986,764 Laserscope’s U.S. Patent No. (“the '764 is entitled “Method patent”), System Vaporiza- for Photoselective Prostate, It tion of the and Other Tissue.” claims various and devices for methods by using laser radiation. vaporizing tissue summary judg- The district court based its ment order on its conclusion that Biolitec’s perform “photose- accused device does not tissue,” a term that lective only preambles is contained we asserted claims. Because conclude disputed preamble term does limit we reverse and the asserted remand. blood, selectively leading

I hemostasis,” good and when sufficient can be invention wavelength, pro- used at that power is Benign Hyperplasia to treat Prostatic *3 layer a of denatured cess leaves behind (“BPH”), growth in which of a condition thick, than 1 tissue less millimeter passage of prostate gland restricts the swelling painful reduces and urination. through urine out of the bladder and Id., 2, specification col. 11. The 49-56. ablation, Vaporization, or of urethra. adds, however, using that even when a prostate tissue some of the reduces nm, prior techniques of 532 art and can bladder prostate size of the relieve significant inefficient re- were and caused outlet obstructions. As described in the Id., coagulation. sidual col. 11.59-65. gener- BPH patent, type of treatment ally cytoscope involves the insertion of a The inventors deter- urethra, provision into the of an irri- high mined that the use of “volumetric water, gant applica- such as sterile and the i.e., power density,” high amount of ener- high-intensity tion of laser radiation tissue, gy given delivered to a volume of target optical tissue means of an fiber. vaporization would result increased effi- ciency minimizing coagula- while residual

According specification patent, prior vaporization sys- art tion. The directed various tems were inefficient with con- achieving high when used methods and devices for they irrigation, frequently tinuous and power volumetric density vapori- for tissue including zation, caused side effects residual tis- by manipulating variables such as i.e., coagulation, sue of a generation wavelength, output power, quality, beam tissue, layer thermally denatured which irrigant composition, and distance between retention, led to swelling, urinary transient the optical fiber and the tissue. Those 2,11. and infection. col. 33-41. resulting variables turn affect the irradi- sys- ineffectiveness of the art level, spot-size, absorption depth. ance and tems in part longer was due to their use of representative 31 is Claim of the method radiation, wavelengths of laser such as It claims. recites: (“nm”). 2100 or At 1064 nanometers A for photoselective vaporization method nm, explains, laser radia- tissue, comprising: “strongly tion is water delivering laser radiation to treatment prostate “essentially tissue” and there is area on the the laser radiation absorption by no selective blood.” When having wave-length having and irradi pulse energies combined with the ance the treatment area sufficient to pulse in the prior durations used art de- vaporization cause substantially of a vices, the use of radiation of that wavel- greater volume of tissue than a volume ength disruption led to violent tissue coagulated of residual tissue caused “poor (stoppage bleeding). hemostasis” radiation, the laser wherein the deliv Id., 17-20, nm, col. 28-32. At 1064 average ered laser radiation has an irra the radiation is hemostatic when used at greater diance treatment area levels, high power but has low spot than 10 in a size at kiloWatts/cm2 in blood tissue that “leads to least 0.05 mm2. inefficient a large ablation and residual layer thermally apparatus generally claims are simi- denatured tissue several Id., lar, except they millimeters thick.” col. 11.36-38. also recite laser and contrast, By la- an specification explains, endoscope having optical an fiber for ser radiation at a delivering of 532 “is the laser radiation. Biolitec, Inc., Sys., Inc. v. claims do not Am. Med. independent Most of the (D.Mass.2008). F.Supp.2d or minimum wavel- Most a maximum specify sharply the terms in the ength disputed for the laser radiation were appara- the claimed “A preambles claimed methods or of the asserted claims: tus, depen- of them have although photoselective vaporization several method for that “the laser radi- specifying dent claims “An apparatus photoselec- tissue” and in a from ation has plaintiffs of tissue.” The about 200 nm.” The other about 650 to argued preamble language (partic- “laser independent expressly recite ularly phrase “photoselective vaporiza- *4 wavelength a in a having tion”) radiation the invention as a simply describes 200 nm to about 650 nm.” With of about a whole and should not be construed as 1 exception of claims and all of the any limitation of of the asserted claims. limitations re- independent claims contain however, court, The district ruled that the that the laser radiation have a quiring repeated phrase “photoselective use of the and in the treat- “wavelength irradianee and vaporization to cause ment area sufficient “photoselective claims indicated that va- substantially greater a volume of tissue of is a porization” “fundamental characteris- coagulated than a volume of residual invention, tic” of the albeit not its central 1 by caused the laser radiation.” Claim innovative feature. Id. at 320-22. The requires that the laser radiation be “ab- support court found for that conclusion substantially completely by sorbed tis- In patent’s prior discussion of the art. surface,” 1 mm and sue within about particular, patent’s the court relied on the “average that it have irradianee in the systems criticism of earlier laser that used than 10 kilo- greater treatment area longer wavelengths of 2100 nm or 1064 spot in a size at least about 0.05 Watts/cm2 systems, nm. according Those delivery of requires mm2.” Claim 16 specification, produced “low” or “no” selec- transparent and a flow of laser radiation by absorption of radiation blood liquid irrigant, “causing with the laser va- tissue; by systems, and to those contrast greater a of tissue porization of volume system a art specification praised coagulation than a of of volume residual that of 532 nm shorter tissue, having irradianee the treat- “selectively by absorbed blood.” was greater ment than 10 area kiloWatts/cm2 Accordingly, the court con- Id. spot in a size at least about 0.05 mm2.” vaporiza- “photoselective strued the term “using wavelength tion” to mean that is Biolitec plaintiffs against The filed suit tissue, highly absorptive being while in the United States District Court for the only negligible degree by to a Massachusetts, alleging that District of irrigant.” water or other Id. at 327. system Biolitee’s Evolve" laser and meth- infringed od of use a number of the claims light of the district court’s claim con- patent. product The accused ruling, struction Biolitec moved for sum- laser-powered system tissue ablation mary judgment noninfringement, assert- having wavelength uses radiation ing system operated that its Evolve™laser optical probe nm. It includes an fiber (980 nm) at a at which the administering the radiation direct “a energy negli- is absorbed to more than target contact with the tissue. irrigant.” or other gible degree water granted court Biolitec’s mo- district Following hearing, a Markman the dis- Biolitec, Sys., tion. Am. Med. construing trict court issued an order sev- (D.Mass.2009). key F.Supp.2d eral terms in the asserted claims. 603 by noting undisputed require wavelength certain that is “absorbed began court nm concerning properties only negligible degree by facts of 980 to a water or (as (3) light product), laser in the accused other if the district irrigant”; (the correct, with nm laser compared court’s construction is patent’s preferred infringement district court erred in its embodiment). and commercial For exam- analysis in respects. several We conclude nm ple, the coefficient of 980 preamble phrase “photoselective 0.43, energy in whereas the laser water is tissue,” particularly absorption coefficient of 532 laser ener- descriptor “photoselective,” does not limit 0.00036; only ingy water is and 4.2% of Therefore, patent. energy 980 nm laser is absorbed water plaintiffs’ we need address the remain- at a distance of 1 mm from ing arguments. Because the district only whereas 0.004% of 532 laser ener- grant summary judgment court’s was gy is absorbed water at that distance. entirely predicated on its conclusion that Id. at 255-56. The district court also ob- Biolitec’s accused device “does not violate *5 oper- served Biolitec’s accused device ‘photoselective vaporization’ the claim limi- in placing ates the device direct contact patent tation in the '764 as in construed with the target prevent tissue so as to Order,” Sys., the Markman Am. Med. 603 energy by of the the water 256, F.Supp.2d at we reverse remand facts, irrigant. light In of those the court proceedings. for further compared concluded that to “[w]hen 532 light, light laser 980 laser is more II negligibly than the irri- water a preamble Whether to treat gant” satisfy “photo- and thus did not the term as a claim limitation is “determined selective limitation of the light on the facts of each case the '764 the court district construed claim as a whole and the invention de it. at Id. 256. The court held therefore patent.” Storage scribed in the Tech. that Biolitec’s accused device did not liter- Inc., 823, Corp. Sys., v. Cisco 329 F.3d 831 ally infringe the patent. (Fed.Cir.2003). simple While there is no The district court also addressed the determining test for preamble when a lim infringement issue of under the doctrine of scope, its claim we have set forth some equivalents. The court concluded that the general principles guide inquiry. to “function-way-result” test was ill-suited to said, “Generally,” preamble we have “the suit, evaluating patent it but held Eng’g does not limit the claims.” Allen that under the “all limitations” rule and Indus., Inc., Corp. v. Bartell 299 F.3d corollary “specific principle exclusion” (Fed.Cir.2002). 1336, Nonetheless, 1346 court, developed Biolitec’s device the preamble may limiting be construed as infringe did not equiva- “if it steps, recites essential structure or or Sys., lents. Am. Med. F.Supp.2d 603 at life, if ‘necessary give meaning, it is 257-58. vitality’ to the claim.” Mktg. Catalina Int’l, Inc., (1) Coolsavings.com, Inc. v. appeal, plaintiffs

On 289 contend that 801, (Fed.Cir.2002), quoting F.3d 808 “photoselective vaporization” the term Pit Bowes, Co., ney Inc. v. preamble of each of the Hewlett-Packard asserted (Fed.Cir.1999). claims should not 182 F.3d 1305 A be construed as a claim (2) limitation; preamble if “photoselective vaporiza- regarded limiting, is not how ever, tion” a body limitation on the “when the claim describes construing structurally district court erred in that term complete invention such that

1359 particular type being or location of tissue preamble phrase does deletion steps generic of the claimed treated. Nor does the term “tis- the structure or affect Catalina, If provide any “context preamble invention.” sue” reasonably susceptible to preamble “is understandfing]” meaning essential to merely duplicative of to be being construed body of “the tissue” of each claim. body Int’l, C-COR, Inc., the limitations Seachange (and to overcome a clearly was not added (Fed.Cir.2005). Thus, F.3d it rejection), we do not construe [prior art] rely preamble claim drafters did not on the Symantec limitation.” separate to be a scope to define or refine the Inc., Int’l, Computer Assocs. Corp. Catalina, claims. the asserted See (Fed.Cir.2008). 1279, 1288-89 We F.3d (“[Dependence on a particular F.3d at 808 sepa- has no preamble have held that the disputed preamble phrase for antecedent if, example, limiting rate effect “the may scope limit claim it basis because merely gives descriptive name preamble on both the preamble indicates reliance body the set of limitations body in- and claim to define the claimed completely set forth the inven- claim that vention.”). Tech, Inc. v. Haas Automa tion.” IMS Third, importantly, and most the des- (Fed.Cir. tion, criptor “photoselective” embody does not 2000). component an of the invention. essential principles, of those we con Instead, “photoselective vaporiza- the term language in the preamble clude that simply descriptive tion” is name for the claims of the '764 does not asserted *6 fully that is set forth in the invention a limitation of the claims. More constitute Tech, Storage of the claims. bodies See reject the district court’s specifically, we (preamble “policy at term in claim construc suggestion, implicit its caching method” did not limit claims be- analyses, that the infringement tion and only cause it served as a “convenient label limits preamble descriptor “photoselective” whole”). for the as a The bodies invention (albeit particular unspeci to a the claims (claims apparatus claims asserted fied) range wavelengths at which laser 63-64) structurally complete describe a de- only negligible is to a radiation “absorbed vice, adapted including a laser to deliver irrigant.” or other degree by water and irradiance “radiation First, suggestion pros- no there is vaporiza- ... [tissue] sufficient to cause history ecution The bodies of those claims identi- tion[.]” phrase “photoselective inventors added the by function fy wavelengths the covered distinguish in order to their (“sufficient vaporization”), and to cause Rather, art. invention from the language suggests in claim nothing primary approval reason for examiner’s lim- “photoselective” further that the term high power the claims’ use densities was that wavelengths. those The inference its causing signifi- tissue without vaporize to apparatus claims do not re- the asserted damage. cant residual tissue energy particular the use of of a quire considerably strengthened Second, contrary argument, Biolitec’s to appara- of other by the fact that number preamble “photoselective vapori- term (claims 67-74), tus claims provide not a neces- zation of tissue” does disputed preamble lan- contain the same sary for the term “the antecedent basis wavelength of the radia- limit the guage, tissue” in the bodies of each of the inde- nm range from “about 200 to tion to the pendent preamble’s claims. The reference “photoselec- nm.” If the term specify about 650 “vaporization to of tissue” does independent requirement being “photo- independently limiting, tive” were deemed matter, While, in practical redundant or conflict as a it would either be selective.” wavelength range set specific with the that of a of laser radiation use body of those claims. forth to at least selectively likely necessary to degree some will be that apparatus claims make clear satisfy requirements, the functional practice one can the invention without us- language require any par- does not wavelengths in the 200 to 650 ing (or limit). wavelength range upper ticular range described oxyhemoglobin absorp- having “strong apparatus As the case of the “relatively absorp- weak water tion” and among pro- other claims the method claims tion,” long energy applied as the strong support plaintiffs’ argu- vide for the of a sufficient to “cause sub- ment that the asserted method claims are stantially volume of tissue than a greater wavelengths having pre- not limited to coagulated tissue.” volume of residual degree of differential scribed fact point That is underscored 1, 16, tissue and water. Method claims apparatus reciting claims the 200 to dependent and 31 each have claims require a lower mini- also wavelengths recite the use of “from about irradiance, mum which indicates that the 200 nm to 650 nm.” about Under purpose of the claims is to maximize volu- differentiation, doctrine of claim those de- power density through metric different give pendent presumption rise to variables; combinations the broader are independent claims thus that with an contemplates increase that range. Phillips not confined to wavelength, power the laser’s more will be (Fed.Cir. Corp., AWH necessary vaporize the tissue and mini- 2005) (en banc). Thus, every asserted coagulation. mize claim of the '764 Likewise, the bodies of the asserted body complete of the claims recites a steps all method claims contain neces- achieving invention for purpose stated sary practice Indepen- the invention. *7 in applying high of laser radiation volu- 40, 16, 31, 36, 42 require dent claims density. power metric Removal of the du- delivery “causing” the of radiation or “suf- plicative preamble language would neither vaporization ficient to cause” “of a sub- scope alter the nor introduce stantially greater volume of tissue than a ambiguity coverage. as their volume of In- coagulated residual tissue.” specification fur- dependent claim 1 explicitly does not re- that “photoselective vapori- ther confirms quire vaporization, it that requires but the zation” a label for is the overall invention laser substantially radiation be “absorbed and not a limitation on Al- the claims. completely by the within 1 mm tissue though phrase “photoselective vapori- the Thus, the surface.” in each of the assert- title, abstract, in in appears zation” the the claims, in apparatus ed method the six in times the rest the written claims, the invention is recited in function- description, consistently it is used in refer- terms; objective al long as the stated is emphasis ence to the entire on invention’s achieved, through the various com- recited improved vaporization efficiency through irradiance, wavelength, output binations of high power densities. The broad recita- size, power, spot irrigant type, and dis- Invention,” in tion the “Field of which optical tance fiber between the and the tissue, particular present it is irrelevant whether a states that invention relates “[t]he tissue, satisfy is used that would an generally to laser treatment of soft photoselective principle, expressed va- ludes to the elsewhere particularly and more PYP, prostate patent, practice the and to in the that in the porization of irradi- vaporization of other tis- to a can photoselective ance delivered treatment area be sue,” that plaintiffs’ position supports increased and the of the laser is meant to serve as label phrase energy irrigant correspondingly de- The other refer- the invention as a whole. only by selecting appropri- creased not an term, including those in the ences to the wavelength for output, ate the laser but key passage in a cited abstract and by reducing also the distance between the court, phrase also indicate that the district tissue, optical thereby fiber and the mini- vaporization” describes the “photoselective mizing liquid through the amount of overall invention. energy pass. must pat- laser See '764 ent, 5, Thus, 11. col. 52-59. we conclude claim con- The district court based its sentence, context, quoted read in largely following struction on the sentence “photoselective does not use the term va- ('764 3, patent, col. line porization” to confine the invention to the 6): 4, through col. line particular wavelengths use of but is better tissue, vaporization of Photoselective description understood as a of the overall prostate such as the for treatment of process described and claimed BPH, upon applying high is based patent. intensity prostate radiation to tissue us- In support argument of its ing highly absorptive a radiation the term being only “photoselective” while absorbed limitation on the negligible degree by to a water or other points portion Biolitec also to a irrigant during operation, power at Description” the “Detailed section of the majority states, densities such specification, which “The wavel- energy is converted to ength according present used inven- significant the tissue without residual BPH strongly tion for treatment should be coagulation adjacent tissue. help absorbed tissue to initiate maintain vaporiza- acknowledged, F.Supp.2d the court As .... tion also must be upon,” the use of the words “based minimally irrigant ... “is,” rather than “means” or undermines during procedure, typically wa- suggestion “photoselec- that the term ter.” '764 col. That 16-21. used as definition or using indicates that radiation of In any limitation of the claim terms. wavelengths may certain increase the ef- event, however, to the extent that the sen- *8 invention, the it fectiveness of but does not “photoselective vaporiza- tence describes suggest the invention is limited to tion,” describing it is not limited to radia- particular wavelengths regardless of the wavelengths tion with that are absorbed to particular values of the other variables in a substantially greater degree by tissue Although device. the quoted passage ex- water, than but also describes other presses a preference using wavelengths for key aspects of the overall invention. nm, portions of 200 to 650 other high Those include the use of irradiance specification using discuss embodiments high “power levels to achieve densities” wavelengths up radiation with to 1000 nm. vaporization and efficient which 4,11. Moreover, patent, in- col. 28-29. as the district court deemed the “central noted, presence reciting the of claims novative feature” of the invention as a Moreover, nm wavelengths gives whole. the sentence’s reference of 200 to 650 rise to absorption “during operation” remaining to the al- the inference that the volume of tissue than a stantially greater wavel- express do not contain that tissue,” limitation, coagulated no and volume of residual processes read on ength wavelength range required. particular outside that using wavelengths devices addition, par specification does not delineate range. specification refers later, wavelength range nm until when in the 200 to 1000 ticular wavelengths (a specific a more that includes Biolitec’s de- it addresses embodiment: range range embodiments, the delivered laser vice, wavel- “In other which uses radiation of 980 nm in a range radiation has a “preferabl[e]” wavelengths ength) as Id., nm to 650 nm.” col. in invention. '764 about 200 about practicing for use 4,11. passages 11.41-42. The cited 28-29. patent, col. dissent, most of which refer to the inven that, 200 to argues The dissent while whole, support tion as a do not the exis wavelengths pre- nm are described as separate “photoseleetive vapori of a tence embodiments,” “pho- ferred “for some embodiment”; they merely suggest, zation vaporization toselective embodiment” is require, but do not the use of certain embodiment” that “is consistent- “separate wavelengths increasing as a means of in ly having wavelength described as conjunc invention’s overall effectiveness However, speci- range.” the '764 Accordingly, tion with other variables.1 interpreta- support fication does not a whole indicates that specification as In the in which an tion. sole instance wavelength is one of the variables while specifically described as “embodiment” (oth invention, employed in the the claims involving “photoseleetive vaporization,” the than limited to 200 to specifically er those subsequent description expresses pre- no nm) particular are not limited to wave Instead, wavelength range. pro- it ferred lengths exhibiting particular levels of dif following general explanation: vides the absorption ferential tissue and water. embodiment, “According to this the meth- sure, specification radiation to To be out delivering points od includes laser prior area ... wherein the laser the drawbacks of art lasers that use treatment longer-wavelength perform radiation has a and irradiance radiation to ablation, noting area on that 2100 nm radia- the treatment the surface tissue “essentially sufficient of a tion results in no selective ab- [to tissue cause] substantially greater sorption volume of tissue than blood” and that 1064 radi- ation “low coagulated volume of residual has blood and tissue,” patent, leading caused the laser radiation.” '764 to inefficient abla- Here, tion. See col. 11. patent’s col. 22-29. as 15-41. However, employing nearly examples identical lan- both of those lie above (the guage, “photoseleetive vaporization” the 200 to 1000 whole) descriptor “preferabl[e].” invention as a refers as terms; i.e., long in functional art therefore expressed discussion “mak[ing] falls far short of clear that the selected and irradiance together “vaporization particular result in of a sub- invention does not include a fea- *9 language lengths appeared application 1. The dissent asserts that the dis- all in the initial however, wavelengths cussing greater than for the '764 while claims 77- use of 650 parent patent nm is a remnant of an earlier 80 were not added until later amendment. sequence suggests support retained order to addi- That of events was in (claims 77-80), longer-wavelength tional claims which did not references were included original "photoseleetive vaporiza- "photoseleetive vaporization” recite and were because the anticipated encompass being rejected tion” claims were intended to abandoned after as by prior longer longer wavelengths. wave- art. The references to

1363 DYK, ture,” Sys., Judge, dissenting. Inc. v. Advanced Circuit SciMed Life Inc., 1337, 242 Sys., F.3d Cardiovascular respectfully I majori- dissent from the (Fed.Cir.2001), and does not rise to 1341 ty’s preamble decision that is not a wavelengths the level of disclaimer claim limitation. nm.

between 650 and 1000 I whole, Read as a dis- precedent, preamble Under our is con increasing closes methods and devices for limiting strued as “if it recites essential power density application of laser steps, structure or if it ‘necessary or energy, may ways which be achieved life, give meaning, vitality’ require specific wavelength that do not claim,” if body but not “the claim describes ir- range. (including, e.g., Other variables 1 structurally complete invention.” Over radiance, size, spot opti- distance between years struggled our court has to make tissue, irrigant type, cal fiber and and out- preamble sense of when a should be con- put power) incorporated are in various limiting. strued as See Bell Commc’ns independent combinations in the and de- Research, Inc. v. Vitalink Commc’ns pendent suggests that while 615, (Fed.Cir.1995) Corp., 55 F.3d 620 of an appropriate wavelength selection (“Much has, course, ink been consumed objectives one means which the set regarding debates when and to what forth in the asserted claims can be extent claim preambles scope limit the achieved, particular wavelength range no they the claims in which appear.”). required by the claims. majority appears As the itself recog- nize, we have not in articulating succeeded Ill simple a clear and Majority Op. rule. reasons, foregoing For the we conclude 1358; Flinn, see also Patrick J. Claim that the district court erred when it con- Construction Trends in the Federal Cir- phrase “photoselective vaporiza- strued the cuit, (1999) 317, 335-36 PLI/PAT limitation, claim tion” as a rather than (characterizing preamble limitations merely a label for the invention as a whole. “opaque” test as and without a set frame summary judg- therefore reverse the We work). clarity As a result of the lack of as noninfringement ment of and remand for preamble to whether a should be con proceedings further addressing whether limiting, strued as our case law has be Biolitec’s accused device meets the remain- inconsistency, come rife with both in result ing claim patent. limitations of the '764 the articulation of the test.2 As the observes, AND REMANDED leading REVERSED treatise on law Int’l, Mktg. Coolsavings.com, 1. Catalina case of the claim as a whole and the Inc., 801, 808, (Fed.Cir. 289 F.3d patent.”); invention described in the Catalina Bowes, 2002) (quoting Pitney Inc. v. Hewlett- (Fed.Cir.2002) ("No Mktg., 289 F.3d at 808 Co., 1298, (Fed.Cir. Packard 182 F.3d preamble litmus test defines when a limits 1999)). Bernier, scope.”). Compare DeGeorge (Fed.Cir.1985) (s 768 F.2d 1322 n. 3 tati Bicon, Co., 2. See Inc. v. Straumann case, ng "[g]enerally, and in this (Fed.Cir.2006) ("While it is true that claims”), preamble does not limit the with preamble language is often treated nonlim Commc'ns, nature, (noting Bell 55 F.3d at 621 iting it is not unusual for this court preamble DeGeorge preamble limiting, to treat the observation in as it is case.”); Storage Corp. in this Tech. v. Cisco generally only does not limit claims "can (Fed.Cir.2003) Sys., descriptive, prescriptive have been rather than ("Whether preamble to treat a as a claim preamble's .... cannot determine a [0]ne *10 limitation is determined on the facts of each va- “photoselective term preamble to reconcile.” 3 are difficult “the decisions Chisum, Chisum on Patents construed as Donald S. should have been porization” (2010). § 8.06[l][d] a claim limitation. The determination a claim limi- preamble serves as whether recognizing that a rule It seems to me only on review of the tation is “resolved make limiting are would preambles that all an patent gain and would better serve ... to understand- entire[ ] sense better is, concerned. There after interests of all actually invented ing of what the inventors all, allowing an little to be said favor of encompass by the claim.” and intended to drafting process, to in the claim applicant, Corning Works v. Sumitomo Elec. Glass in the that is not material claims include (Fed.Cir. U.S.A., Inc., 1251, 1257 868 F.2d allowed to in patentees If are binding. Materials, 1989); Applied see also material in the claim definitions clude Am., Advanced Semiconductor Materials suggest can or binding, patentees (Fed.Cir.1996) 1563, 1572-73 position one before the U.S. Patent imply (“Whether preamble stating purpose (“PTO”) to secure & Trademark Office and context of the invention constitutes theory that patent allowance of the on the process limitation of the claimed is deter- another, in preamble limiting and of each ease in mined on the facts infringement litiga position consistent claim, and the the overall form of the theory limiting.3 that it is not tion on invention as described Principles of fairness thus dictate that the prosecution histo- and illuminated clearly de patentee required should be ry.”). generally A limits an in- preamble scope. By invention’s cre fine the claimed if vention it recites essential structure or are ating preambles a uniform rule that all life, “necessary give if steps or it is has limiting, patentee we would ensure the meaning, vitality” and to a claim. Catalina drafting patent that avoids the burden (quoting Pitney M ktg., scope as to the of the claims. As confusion 1305). Bowes, Supreme Court concluded Merrill v. 182 F.3d at Yeomans, 568, 573-74, 24 L.Ed. 94 U.S. view, my photoselective vaporiza- (1876), “nothing just can be and more tion must be treated as a claim fair, patentee public, and to the both (“the 6,986,764 limitation. Patent No. U.S. understand, than former should patent”) continuation-in-part '764 was a describe, just has correctly what he (“the 6,554,824 pat- U.S. Patent No. invented, patent.” what he and for ent”). application Neither the '824 nor the Supreme Neither Court nor our “photose- the term issued '824 sitting court en banc has ever addressed lective in the claims or in the I preamble limitation issue. think the specification. The addition of the term may time have come for us to eliminate pream- “photoselective vaporization” vague confusing rule. was ble of the claims of

II applicant took considera- significant. The specifi- ble care to add new matter to the existing precedent, Even under our binding panel, describing defining photoselec- on the I believe cation prosecution history specific except reference to the barred the doctrine of effect component”). taking posi- estoppel which is a such inconsistent it from But, cases, many readily tions. it is not course, apparent patentee whether the has taken in- patentee her 3. Of if the makes his or positions. positions explicit, patentee consistent could be *11 appears wavelengths up view, The term vaporization. my 1000 nm. (once), the abstract patent majority title of the the specification misconstrues (once), Invention prosecution the Field of the section and history. (twice), Summary of the Invention sec- majority out, As the points original (twice), Description

tion and the Detailed concerned, patent '824 was among other (once). example, the section For Field of things, reducing with wavelength of present “The the Invention section states: light the laser prior over the art. As the generally invention relates to laser treat- majority recognizes, specification re- tissue, particularly ment of soft and more peatedly criticizes the art use of photoselective vaporization pros- of the systems “earlier laser that used longer PVP, photoselective vaporiza- tate and to wavelengths of 2100 nm or 1064 nm.” Ma- Patent, of '764 tion other tissue.” col. jority Op. at patent 1357. The '824 reduced added). (emphases 11.33-36 the claimed wavelengths to the 200 to 1000 Summary

The of the Invention section nm range, specification and the stated that specification “photoselective defines “wavelength light of the laser pref- vaporization” as follows: erably between 200 and 1000 nm.” '764 tissue,

Photoselective 11.28-29; Patent col.4 see '824 Patent col.3 prostate such as the for treatment of 11.44—45. BPH, a upon applying high based The continuation-in-part application that intensity prostate radiation to tissue us- patent became the '764 further reduced ing highly a radiation that absorptive ranges. the claimed The claims of the tissue, being only while patent were amended to eliminate degree by to a negligible water or other wavelengths in the range 650-1000 and to irrigant during operation, power substitute wavelengths references to majority densities such that the range original for the energy is to vaporization converted range of 200-1000 nm in the claims where significant

the tissue without residual specific range is included. See J.A. SOB- coagulation adjacent tissue. OOS. While the specification continued to pas- Id. col.3 1.66-col.41.6. In of this wavelengths mention in the 200-1000 sage, properly the District con- Court “preferred” for some embodi- photoselective strued method for “[a] va- ments, specification makes clear that porization of apparatus tissue”/“[a]n the photoselective vaporization embodi- photoselective vaporization of tissue” to embodiment, ment is a separate stating “using wavelength highly mean that is that “one pro- embodiment of the invention absorptive in being while ab- vides a method for photoselective vaporiza- only negligible degree by sorbed to a wa- tion tissue.” '764 col.5 irrigant.” Sys., ter or other Am. Med. 11.21-22. specification The states that for Biolitec, Inc., F.Supp.2d that invention “it is provide desirable to (D.Mass.2008). vapori- Photoselective wavelength between 650 and 200 nm.” Id. a product shortening zation is the wave- col. 16 photoselective vapori- 11.32-33.The lengths signal. of the emitted zation embodiment is never described as majority having appears to conclude that the 200-1000 Rather, reading photoselective vaporization range. consistently it is described having clear limitation would with as wavelengths be inconsistent the 200-650 specification, contemplates range.4 repeatedly touts See, ("The e.g., according present col.12 11.16-34 in- *12 1366 (Fed.Cir. Indus., Inc., 402 F.3d 1379 vaporiza- advantages photoselective

the 2005) preferred (noting that “when the is, from these tion, light nm that “532 specifica is described embodiment selectively by absorbed blood lasers itself, the claims are as the more effi- tion invention hemostasis” and leading good to necessarily scope entitled to a broader '764 Patent col.2 cient tissue ablation. embodiment”); Honeywell, 452 than that 11.49-59. to (construing at 1318 claim term F.3d any photoselec- doubt that If there were at least “[o]n include fuel filter because limitation, it is vaporization is a claim tive occasions, re description four the written by specification’s statement resolved invention’ or fers to the fuel filter as ‘this according to wavelength used that “[t]he ”). Minimal ab present ‘the invention’ for BPH treatment present invention sorption by irrigant strong absorp and pros- strongly be absorbed should by vaporiza photoselective tion or help initiate and maintain tate tissue tion, mandatory aspects of this are thus vaporization.... wavelength The tissue invention. particular by the minimally be absorbed also must out, majority points recognize, I as the during procedure, ... used irrigant specification patent for the '764 Patent eol.12 11.16- typically water.” added). wavelengths includes references to 21 this sentence (emphases While they are not photoselective are not because appears Description in the Detailed section “minimally absorbed.” '764 Patent col.8 specification, repeatedly of the we have (“Other systems may be used pres- ‘the 11.7-12 laser held that “the use of the words provide ... the out- adapted limit the which are ent invention’ can be read to put power wavelengths described invention to what is described as such.” Nutrinova, herein, including wavelengths Corp. Martek Biosciences v. (Fed.Cir.2009) Inc., ranges from 200 nm to 1000 nm and from 1383 Indus., nm, Int’l, But example.”). ITT 1100 nm to 1800 for (citing Honeywell Inc. v. (Fed.Cir.2006)); Inc., language speci- I in the as have noted this Int’l, photoselec- fication not relate to the Trading eSpeed, Techs. does see (Fed.Cir.2010) embodiment and is ex- (holding 595 F.3d 1340 the fact that system plained the reference to the that were di- present strongly suggests specification invention included claims fact re-centering longer wavelengths. command re- rected to The the claimed a manual that such was retained quires input); Chimie PPG (com- tissue.”); strongly power to id. col. 15 11.25-55 vention for BPH treatment should be help in the tissue to initiate paring absorbed the 1064 nm vaporization without cre- and maintain tissue art to the 532 nm and con- ating deep heating. The preferable cluding that the beam is 532 laser minimally the irri- also must be absorbed "substantially completely because it is ab- gant during procedure, typically it used sorbed within less than about 1 mm produced water. prostatic coagula- surface of tissue.... FIG.5, system strongly is both very tion thin because of the small zone is oxyhemoglobin weakly absorbed in wa- penetration depth optical of the 532 wavel- embodiments, yet wave- ter.... other ength wavelengths which are sub- .... Other lengths 200 nm-500 nm are from stantially completely absorbed within less used, oxyhemoglobin strong ab- which have prostat- than about 1 mm of the surface of sorption relatively weak water wavelengths than ic tissue include less about ....”); ("KTP energy id. col.14 11.57-59 laser nm, example between about 200 generated by high power will be 532 nm nm.”). and 650 capable delivering 80W of KTP laser laser by a explained include additional claims desire to *13 “photoselec- not directed to the Indeed, a embodiment. appli- amendment

preliminary to the '764 claims

cation recited seven additional 77-80)

(claims that did not include “photoselective vaporization.”

term Claim explicitly using described lasers with the 200 nm to 1000 subsequently These claims were

range. during prosecution being after

abandoned

rejected anticipated by Patent U.S. 5,776,127. 5,776,175

Nos. J.A. 369. circumstances, it clear

Under the seems “photoselective vaporization”

to me that limitation;

should construed as a be during

by adding terminology prose

cution patentee life, meaning, the term gave

conceded that to the vitality claims.5

Therefore, contrary majority, I photoselective vaporization

would hold

is a claim limitation.

The LARYNGEAL MASK COMPANY America, and LMA

LTD. North

Inc., Plaintiffs-Appellants, A/S, Ltd.,

AMBU Ambu and Ambu Appellants.

Defendants-Cross 2010-1028,

Nos. 2010-1062. States Court of Appeals,

United

Federal Circuit.

Sept. out, majority points merely suggests 5. As the reference 1359-60. But this dependent the 200 to photoselective applies limitation 4-6, (claims 19-21, 32-34, longer wavelengths to somewhat than 200 to 67-74) suggests independent 650 nm. Majority Op. broader. claims are See

Case Details

Case Name: American Medical Systems, Inc. v. Biolitec, Inc.
Court Name: Court of Appeals for the Federal Circuit
Date Published: Sep 13, 2010
Citation: 618 F.3d 1354
Docket Number: 2009-1323
Court Abbreviation: Fed. Cir.
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