## United States Court of Appeals for the Federal Circuit

2006-1350 BIOMEDINO, LLC, Plaintiff-Appellant,

v. WATERS TECHNOLOGIES CORPORATION, Defendant-Appellee, and GENERAL ELECTRIC COMPANY (doing business as GE Healthcare), Defendant-Appellee, and AGILENT TECHNOLOGI ES, INCORPORATED, Defendant-Appellee.

Alisa Anne Lipski , Goldstein, Faucett & Prebeg, LLP, of Houston, Texas, argued for plaintiff-appellant. On the brief was Edward W. Goldstein

. Robert P. Taylor , Howrey LLP, of East Palo Alto , California, argued for defendantappellee, General Elec tric Company (d/b/a GE Heal thcare), and all other defendantsappellees. With him on the brief fo r General Electric Company were Matthew M. Wolf , Howrey LLP, of Washington DC, Wallace Wu , of Los Angeles, California, and Richard L. Stanley , of Houston, Texas. With him on the brief for Waters Technologies Corporation were Aslan Baghdadi , Lawrence J. Gotts , and June E. Cohan , Paul, Hastings, Janofsky & Walker LLP, of Washington, DC. With him on the brief for Agilent Technologies, Incorporated, were James W. Geriak , Kurt T. Mulville , and Hardip B. Passananti , Orrick, Herrington & Sutcliffe LLP, of Irvine, California. Of counsel was Joseph K. Liu

. Appealed from: United States District Court for the Western District of Washington Chief Judge Robert S. Lasnik

## United States Court of Appeals for the Federal Circuit
2006-1350 BIOMEDINO, LLC, Plaintiff-Appellant,

v. WATERS TECHNOLOGIES CORPORATION, Defendant-Appellee, and GENERAL ELECTRIC COMPANY (doing business as GE Healthcare), Defendant-Appellee, and AGILENT TECHNOLOGI ES, INCORPORATED, Defendant-Appellee.

_______________________ DECIDED: June 18, 2007

_______________________ Before RADER, Circuit Judge , ARCHER, Senior Circuit Judge , and GAJARSA, Circuit Judge

. ARCHER, Senior Circuit Judge

. Biomedino, LLC (“Biomedino”) appeals the j udgment of the United States District Court for the Western District of Washington that claims 13-17 and 40 of U.S. Pat. No. 6,602,502 (“the ’502 patent”) are in valid for indefiniteness under 35 U.S.C. § 112, ¶ 2. Biomedino v. Waters Techs. Corp. , No. CV05-0042 (W.D. Wa sh. Mar. 15, 2006). Because the claim limitation “control means ” has no corresponding structure describedin the specification as requi red by 35 U.S.C. 112, ¶ 6, we affirm the district court’s invalidity determination. I Section 112, ¶ 6 of Title 35 of the Un ited States Code permits an applicant to express a claim limitation as a means or step for performing a specified function without claiming the structure that performs the function: An element in a claim for a combination may be expressed as a means or step for performing a specified functi on without the recita l of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, ma terial, or acts described in the specification and equivalents thereof. 35 U.S.C § 112, ¶ 6 (2000). In Valmont Industries, Inc. v. Reinke Manufacturing Co. , we explained that § 112, ¶ 6 permitted “broad means-plus-function language, but provided a standard to make the broad claim language mo re definite[: ] . . . [t]he appl icant must describe in the patent specification some structure which performs the specified function.” 983 F.2d 1039, 1543 (Fed. Cir. 1993). Thus, in return for generic claiming ability, the applicant must indicate in the specification what structure constitutes the means. 1 “If the specification is not clear as to the structur e that the patentee intends to correspond to the claimed function, then the patentee has not paid the price but is rather attempting to claim in functional terms unbounded by any refer ence to structure in the specification.” Med. Instrumentation & Diagnostics Corp. v. Elekta AB , 344 F.3d 1205, 1211 (Fed. Cir.

1 Permitting an applicant to use a br oad means expression for claiming a functional limitation provided that the specific ation indicates what structure constitutes the means for performing the claimed f unction is often referred to as the “ quid pro quo ” for the convenience of employing § 112, ¶ 6. Atmel Corp. v. Info. Storage Devices, Inc. , 198 F.3d 1374, 1378 (Fed. Cir. 1999).

2006-1350 22003). Thus, “[i]f an applicant fails to set forth an adequate disclosure, the applicant has in effect failed to particularly point out and distinctly claim the invention as required by the second paragraph of § 112.” In re Donaldson Co. , 16 F.3d 1189, 1195 (Fed. Cir. 1994) (en banc). The independent claims at issue in the present case recite as follows: 13. A device comprising a passage; bi nding means in said device for binding a species substantially specif ically, said bindi ng means being in fluid communication with said passage; exposure means in said device for exposing said species to said bi nding means and for preventing said binding means from leaving said device; closed regeneration means for separating said species fr om said binding means for reuse of said binding means in said device; valving for selectively connecting said closed regeneration means in fluid communication with said binding means, and control means for automatica lly operating said valving

. 40. A closed regeneration device for separating a molecule bound substantially specifically to a binding species for reuse of said binding species said regeneration device compri sing a first reagent, a first valve selectively connecting said first r eagent in fluid communication with said molecule bound to the bi nding species to separat e said molecule from said binding species, a second reagent, a se cond valve selectively connecting said second reagent in flui d communication with said binding species to return said binding species to a regenerated condition, and control means for automat ically operating valves

. ’502 patent col.13 ll.25-35, col.16 ll.20- 31 (claim terms at issue emphasized). 2 Claims 14-17 are dependent from claim 13. The district court began its construction of the term “control means” with the observation that if a claim element contai ns the term “means” and recites a function, there is a presumption t hat § 112, ¶ 6 applies. Biomedino , slip op. at 8. Concluding that the inclusion of the word “control” did not identify stru cture and thus did not

2 The parties treat “control means for automatically operati ng said valving” and “control means for automatically oper ating said valves” as identical.

2006-1350 3overcome the presumption that the claim limit ation was a means-plus- function limitation, the district court began a § 112, ¶ 6 analysis. The only references in the specificati on to the “control means ” are a box labeled “Control” in Figure 6 and a st atement that the regeneration process of the invention “may be controlled automatically by known di fferential pressure, valving and control equipment.” ’502 patent col.11 ll.55-58. Fr om this, the district court concluded: The specification says nothing more than that unspecified equipment may be used to control the regeneration process. The fact that one skilled in the art could envision various types of equipment capable of automatically operating valves does not change the fa ct that no structure capable of performing that function was di sclosed by the inventor. Biomedino , slip op. at 11. As a result, the c ourt held that “[t]he failure to disclose a structure corresponding to the ‘control means ’ function makes clai ms 13-17 and claim 40 of indefinite scope in violation of § 112, ¶ 2 of the Patent Act.” Id. Biomedino appeals, and we have jurisdicti on pursuant to 28 U.S.C. § 1295(a)(1). II “A determination that a patent claim is invalid for failure to meet the definiteness requirement of 35 U.S.C § 112, paragraph 2, is ‘a legal conclu sion that is drawn from the court’s performance of its dut y as the construer of patent claims[, and i]ndefiniteness, ther efore, like claim construction, is a question of law that we review de novo .’” Intellectual Prop. Dev., Inc. v. UA-Columbia Cablevision of Westchester, Inc. , 336 F.3d 1308, 1318 (Fed. Cir. 2003) (quoting Atmel , 198 F.3d at 1378).

2006-1350 4III A As an initial matter, we address Biomed ino’s assertion that use of the term “control” to describe “means” takes the ph rase “control means” outside the realm in which § 112, ¶ 6 applies. This argument is based on the premise that “control means” recites sufficient structure on its own such that it obviates the need for § 112, ¶ 6. Biomedino argues that a “contro l” is a precise structure we ll understood by those of skill in the art, and thus, the word “means” in cl aims 13 and 40 can be ignored. Additionally, Biomedino contends that “contro l” is analogous to the term “controller” and conveys, to one skilled in the art, structure for c ontrolling the valves and other equipment. We disagree. When a claim uses the term “means” to describe a limitatio n, a presumption inheres that the inventor used t he term to invoke § 112, ¶ 6. Altiris, Inc. v. Symantec Corp. , 318 F.3d 1367, 1375 (Fed. Cir. 2003). “Thi s presumption can be rebutted when the claim, in addition to t he functional language, recites st ructure sufficient to perform the claimed function in its entirety.” Id. Claims 13 and 40 recite no such structure. As the district court noted, the “reference to ‘c ontrol’ is simply an adjective describing ‘means:’ [sic] it is not a structure or mate rial capable of performing the identified function.” Biomedino , slip op. at 12. We agree with the district court and hold that Biomedino has not rebutted the presumption that § 112, ¶ 6 applies to “control means.” B Once a court concludes that a claim limit ation is a means-plus-function limitation, two steps of claim construction remain: 1) the court must first identify the function of the

2006-1350 5limitation; and 2) t he court must then look to t he specification and identify the corresponding structure for that function. Med. Instrumentation , 344 F.3d 1205 at 1210. If there is no structure in the specification corresponding to the means-plus-function limitation in the claims, the claim wil l be found invalid as indefinite. See Atmel , 198 F.3d at 1378-79 (citing In re Donaldson , 16 F.3d at 1195). While the specification must contain stru cture linked to claimed means, this is not a high bar: “[a]ll one needs to do in order to obtain the benefit of [§ 112, ¶ 6] is to recite some structure corresponding to the means in t he specification, as th e statute states, so that one can readily ascertain what the claim means and comply with the particularity requirement of [§ 112,] ¶ 2.” Atmel , 198 F.3d at 1382. Additi onally, interpretation of what is disclosed in the specification mu st be made in light of the knowledge of one skilled in the art. Id. at 1380. Thus, in order for a mean s-plus-function claim to be valid under § 112, the corresponding structure of the limitati on “must be disclosed in the written description in such a manner that one skilled in t he art will know and understand what structure corresponds to the means limitation. Otherwis e, one does not know what the claim means.” Id. at 1382. However, “the testimony of one of ordinary skill in the art cannot supplant the total absence of structure from the specification.” Default Proof Credit Card Sys., Inc. v. Home Depot U.S.A., Inc. , 412 F.3d 1291, 1302 (Fed. Cir. 2005). In the present case, there is no dispute th at the claimed function is “automatically operating said valving”/” automatically operating va lves.” The parties also agree that the only references in the specification to the “control means” are the box labeled “Control” in Figure 6 and a statement that the regeneration pr ocess may be “controlled

2006-1350 6automatically by known differential pressu re, valving and control equipment,” ’502 patent col.11 ll.55-58. Biomedino argues that the excerpt from t he written description demonstrates that “known differential pr essure equipment can be used to operate valves, known valving equipment may be us ed, or known contro l equipment may be used.” Biomedino further argues that the only remaining inqu iry is whether one skilled in the art would identi fy the structure from that descr iption. To demonstrate that one skilled in the art would identify structure fr om the description in the written description, Biomedino points to two prior art referenc es and the appellees’ (co llectively “Waters”) own expert’s testimony. Together, this evidenc e suggests that there were many known ways to operate valves, including pneumati cally, hydraulically, mechanically, and electrically. In response, Waters argues that there is no s pecific structure identified in the specification to correspond to the claimed function of automatic ally operating the valves/valving: “the reference to ‘differentia l pressure, valving and control equipment’ is not at all descriptive of specific structure by which the ‘control means’ will automatically operate the claimed valving.” As to the prio r art references and ex pert testimony, citing Medical Instrumentation , 344 F.3d at 1212, Waters contends that the proper inquiry for identifying the structure corresponding to the recited function is “whether one of skill in the art would understand the specification itse lf to disclose the structure, not simply whether that person woul d be capable of implement ing that structure.” Essentially this case asks the following que stion: for purposes of § 112, ¶ 6, is sufficient corresponding structure disclosed when the specification simply recites that a claimed function can be performed by known methods or using known equipment where

2006-1350 7prior art of record and the testimony of experts suggest that known methods and equipment exist? In Medical Instrumentation , 344 F.3d 1205, we came close to answering that question in the negative. In that case t he alleged infri nger argued that the district court improperly included softw are for digital-to-digital conversion as corresponding structure for the claimed “conve rting means.” Medical Instrumentation’s expert never pointed to any disclosure of structure for digital-to-digital conversion in the specification. When asked about digital-to-digital conv ersion in the patents, he explained that such conversion was not di sclosed or discussed in the specification presumably because it was well-known in t he art and required no explanation. We observed that there was no evi dence to indicate that a pers on skilled in the art would actually understand from the sp ecification that software for digital-to-digital conversion was structure that corresponded to the means for converting. Id. at 1217. “Because software [wa]s not clearly linked in the specific ation or prosecution hi story to the claimed function” of converting means, we held that t he district court’s iden tification of software as a corresponding structure for § 112, ¶ 6 purposes was erroneous. Id. at 1222. In another similar case, Atmel , we also stated that the specification must disclose some structure but found that such a disclosu re had been made. The claim limitation at issue in Atmel was “high voltage generating means disposed on said semiconductor circuit for generating a high voltage from a lo wer voltage power supply.” 198 F.3d at 1376. The portion of the writt en description that pertained to the structural component of the means plus function lim itation was the following: “the present invention may include high-voltage generator circuit 34. Known Circuit [sic] techniques are used to implement high-voltage circui t 34. See On-Chip High Voltage Generation in NMOS

2006-1350 8Integrated Circuits Using an Improved Voltage Multiplier Technique, IEEE Journal of Solid State Circuits, Vol[.] SC-11, No. 3, June 1976.” Id. at 1377. Additionally, the figures of the relevant patent depicted the high-voltage generator circuit as a “black box.” Id. 3 We began our sufficiency of the disclosure analysis in Atmel by explaining that structure supporting a means-plu s-function claim under § 112, ¶ 6 must appear in the specification. Further, we noted that “consideration of t he understanding of one skilled in the art in no way relieves the patentee of adequately disclosing sufficient structure in the specification.” Id. at 1380. We said that a proper indefinit eness analysis “asks first whether structure is described in the specification, and, if so, whether one skilled in the art would identify the struct ure from the description.” Id. at 1381. Thus, we concluded that the district court acted properly in ruling that the cited article could not take the place of structure t hat does not appear in t he specification. As noted, however, the wr itten description in Atmel sets forth the article’s title, viz. , “On-Chip High Voltage Gene ration in NMOS Integrated Circuits Using an Improved Voltage Multiplier Technique, IEEE J ournal of Solid State Circuits.” Id. at 1382. Atmel’s expert had testified that the arti cle’s title alone was sufficient to indicate to one skilled in the art the precise structure of the means recited in the specification. Id. Because this testimony was unrebutted, we concluded that the cour t improperly granted summary judgment that the patent was invalid for indefiniteness.

3 The first part of our analysis in Atmel involved a determination of whether the district court erred by failing to assess whether sufficient struct ure was disclosed in the specification to support the means-plus-function limitation based on the understanding of one skilled in the art. 198 F.3d at 1380. We answered this question in the affirmative.

2006-1350 9There is a significant difference between the facts of Atmel and those in the present case. In Atmel it was not the fact that one skill ed in the art was aware of known circuit techniques that resulted in a conclusi on that sufficient structure was recited. Rather, it was the inclusion in the written description of the title of t he article which itself described the structure for a “known circuit technique.” Expert testimony was used to show what the title of the article would conv ey to one skilled in the art—in that case it was “the precise structure of the means recited in the specification.” Atmel , 198 F.3d at 1382. The expert’s testimony did not create or infer the structure. In the present case, there is nothing to su ggest a structure for the claimed control means. As we have previously explained, § 112, ¶ 6 requires some disclosure of structure in the specification co rresponding to the clai med means. “[W]hile it is true that the patentee need not disclose det ails of structures well known in the art, the specification must nonetheless disclose some structure.” Default Proof , 412 F.3d at 1302; see also Atmel , 198 F.3d at 1382 (“There must be st ructure in the specification” and the requirements of § 112, ¶ 6 will not be met when there is “a total omission of structure.”); Med. Instrumentation , 344 F.3d at 1211 (“If the spec ification is not clear as to the structure that the pat entee intends to correspond to the claimed function, then the patentee has not paid [the price for use of t he convenience of broad claiming afforded by § 112, ¶ 6] but is rather attempting to claim in functional terms unbounded by any reference to structure in the specification. Such is impermissibl e under the statute.”); Donaldson , 16 F.3d at 1195 (“[I]f one empl oys means-plus-function language in a claim, one must set forth in the specification an ad equate disclosure showing what is meant by that language. If an applicant fails to set forth an adequate disclosure, the applicant has

2006-1350 10in effect failed to particularl y point out and distinctly claim the invention as required by the second paragraph of section 112.”). The inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simp ly whether that pers on would be capable of implementing a structure. Med. Instrumentation , 344 F.3d at 1212 (citing Atmel , 198 F.3d at 1382). Accordingly, a bare statement that known te chniques or methods can be used does not disclose structure. To conclu de otherwise would vitiate the language of the statute requiring “corresponding structur e, material, or acts described in the specification.” IV For the foregoing reasons, the judgment of the district court holding claims 13-17 and 40 of the ’502 patent as invalid for indefiniteness is AFFIRMED

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