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 TECHNOLOGIES, 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 Electric Company (d/b/a GE Healthcare), and all other defendantsappellees. With him on the brief for 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 TECHNOLOGIES, 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 judgment 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 invalid for indefiniteness under 35 U.S.C. § 112, ¶ 2. 

Biomedino v. Waters Techs. Corp., No. CV05-0042 (W.D. Wash. Mar. 15, 2006). 

Because the claim limitation “control means” has no corresponding structure described 
in the specification as required by 35 U.S.C. 112, ¶ 6, we affirm the district court’s 

invalidity determination. 

I 

 Section 112, ¶ 6 of Title 35 of the United 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 function without the recital of structure, 

material, or acts in support thereof, and such claim shall be construed to 

cover the corresponding structure, material, 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 more definite[: ] . . . [t]he applicant 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 structure 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 reference 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 broad means expression for claiming a 

functional limitation provided that the specification indicates what structure constitutes 

the means for performing the claimed function 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 2
2003). 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; binding means in said device for 

binding a species substantially specifically, said binding means being in 

fluid communication with said passage; exposure means in said device for 

exposing said species to said binding means and for preventing said 

binding means from leaving said device; closed regeneration means for 

separating said species from 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 automatically 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 comprising a first reagent, a first valve 

selectively connecting said first reagent in fluid communication with said 

molecule bound to the binding species to separate said molecule from 

said binding species, a second reagent, a second valve selectively 

connecting said second reagent in fluid communication with said binding 

species to return said binding species to a regenerated condition, and 

control means for automatically 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 contains the term “means” and recites a function, 

there is a presumption that § 112, ¶ 6 applies. Biomedino, slip op. at 8. Concluding 

that the inclusion of the word “control” did not identify structure and thus did not 

 2

 The parties treat “control means for automatically operating said valving” 

and “control means for automatically operating said valves” as identical. 

2006-1350 3
overcome the presumption that the claim limitation was a means-plus-function limitation, 

the district court began a § 112, ¶ 6 analysis. 

 The only references in the specification to the “control means” are a box labeled 

“Control” in Figure 6 and a statement that the regeneration process of the invention 

“may be controlled automatically by known differential pressure, valving and control 

equipment.” ’502 patent col.11 ll.55-58. From 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 fact that no structure capable of 

performing that function was disclosed by the inventor. 

Biomedino, slip op. at 11. As a result, the court held that “[t]he failure to disclose a 

structure corresponding to the ‘control means’ function makes claims 13-17 and claim 

40 of indefinite scope in violation of § 112, ¶ 2 of the Patent Act.” Id.

 Biomedino appeals, and we have jurisdiction 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 conclusion that is drawn from 

the court’s performance of its duty as the construer of patent 

claims[, and i]ndefiniteness, therefore, 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 4
III 

A 

 As an initial matter, we address Biomedino’s assertion that use of the term 

“control” to describe “means” takes the phrase “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 “control” is a precise structure well understood by those of skill 

in the art, and thus, the word “means” in claims 13 and 40 can be ignored. Additionally, 

Biomedino contends that “control” is analogous to the term “controller” and conveys, to 

one skilled in the art, structure for controlling the valves and other equipment. We 

disagree. 

When a claim uses the term “means” to describe a limitation, a presumption 

inheres that the inventor used the term to invoke § 112, ¶ 6. Altiris, Inc. v. Symantec 

Corp., 318 F.3d 1367, 1375 (Fed. Cir. 2003). “This presumption can be rebutted when 

the claim, in addition to the functional language, recites structure 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 ‘control’ is simply an adjective describing 

‘means:’ [sic] it is not a structure or material 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 limitation is a means-plus-function limitation, 

two steps of claim construction remain: 1) the court must first identify the function of the 

2006-1350 5
limitation; and 2) the court must then look to the 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 will 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 structure 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 the specification, as the 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. Additionally, interpretation of 

what is disclosed in the specification must be made in light of the knowledge of one 

skilled in the art. Id. at 1380. Thus, in order for a means-plus-function claim to be valid 

under § 112, the corresponding structure of the limitation “must be disclosed in the 

written description in such a manner that one skilled in the art will know and understand 

what structure corresponds to the means limitation. Otherwise, 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 that the claimed function is “automatically 

operating said valving”/”automatically operating valves.” 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 process may be “controlled 

2006-1350 6
automatically by known differential pressure, valving and control equipment,” ’502 

patent col.11 ll.55-58. Biomedino argues that the excerpt from the written description 

demonstrates that “known differential pressure equipment can be used to operate 

valves, known valving equipment may be used, or known control equipment may be 

used.” Biomedino further argues that the only remaining inquiry is whether one skilled 

in the art would identify the structure from that description. To demonstrate that one 

skilled in the art would identify structure from the description in the written description, 

Biomedino points to two prior art references and the appellees’ (collectively “Waters”) 

own expert’s testimony. Together, this evidence suggests that there were many known 

ways to operate valves, including pneumatically, hydraulically, mechanically, and 

electrically. 

 In response, Waters argues that there is no specific structure identified in the 

specification to correspond to the claimed function of automatically operating the 

valves/valving: “the reference to ‘differential 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 prior art references and expert 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 itself to disclose the structure, not simply 

whether that person would be capable of implementing that structure.” 

 Essentially this case asks the following question: 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 7
prior 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 the alleged infringer argued that 

the district court improperly included software for digital-to-digital conversion as 

corresponding structure for the claimed “converting 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 conversion in the patents, he 

explained that such conversion was not disclosed or discussed in the specification 

presumably because it was well-known in the art and required no explanation. We 

observed that there was no evidence to indicate that a person skilled in the art would 

actually understand from the specification 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 specification or prosecution history to the claimed 

function” of converting means, we held that the district court’s identification 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 disclosure 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 lower voltage power supply.” 198 F.3d at 

1376. The portion of the written description that pertained to the structural component 

of the means plus function limitation was the following: “the present invention may 

include high-voltage generator circuit 34. Known Circuit [sic] techniques are used to 

implement high-voltage circuit 34. See On-Chip High Voltage Generation in NMOS 

2006-1350 8
Integrated 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-plus-function claim under § 112, ¶ 6 must appear in the 

specification. Further, we noted that “consideration of the 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 indefiniteness analysis “asks first 

whether structure is described in the specification, and, if so, whether one skilled in the 

art would identify the structure 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 that does not appear in the specification. 

As noted, however, the written description in Atmel sets forth the article’s title, 

viz., “On-Chip High Voltage Generation in NMOS Integrated Circuits Using an Improved 

Voltage Multiplier Technique, IEEE Journal of Solid State Circuits.” Id. at 1382. Atmel’s 

expert had testified that the article’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 court 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 structure 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 9
 There is a significant difference between the facts of Atmel and those in the 

present case. In Atmel it was not the fact that one skilled in the art was aware of known 

circuit techniques that resulted in a conclusion that sufficient structure was recited. 

Rather, it was the inclusion in the written description of the title of the article which itself 

described the structure for a “known circuit technique.” Expert testimony was used to 

show what the title of the article would convey 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 suggest a structure for the claimed control 

means. As we have previously explained, § 112, ¶ 6 requires some disclosure of 

structure in the specification corresponding to the claimed means. “[W]hile it is true that 

the patentee need not disclose details 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 structure 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 specification is not clear as 

to the structure that the patentee intends to correspond to the claimed function, then the 

patentee has not paid [the price for use of the 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 impermissible under the statute.”); 

Donaldson, 16 F.3d at 1195 (“[I]f one employs means-plus-function language in a claim, 

one must set forth in the specification an adequate disclosure showing what is meant by 

that language. If an applicant fails to set forth an adequate disclosure, the applicant has 

2006-1350 10
in effect failed to particularly 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 simply whether that person 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 techniques or methods can be 

used does not disclose structure. To conclude otherwise would vitiate the language of 

the statute requiring “corresponding structure, 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. 

2006-1350 11