GEORGE Z. SINGAL, District Judge.
Defendant CareFusion 303, Inc. ("Defendant" or "Carefusion") manufactures and sells infusion systems, which are medical devices used to deliver intravenous fluids to patients in controlled amounts. Plaintiffs Ergo Licensing, LLC and Dr. Uvo Holscher (together, "Plaintiffs" or "Ergo") claim that Carefusion's infusion systems infringe on United States Patent No. 5,507,412 ("the '412 Patent").
As a result of various agreements by the parties, the Court currently has before it the following terms for construction: (1) "set" (Claims 1 & 18), (2) "adjusting means" (Claims 1 & 18), (3) "programmable control means/control means" (Claims 1 & 18), (4) "data input means" (Claim 1 & 18), and (5) "flow measuring means" (Claim 10). (See Aug. 3, 2010 Order Setting Hearing (Docket # 184) & Stipulation Regarding Claims (Docket # 196).)
The parties each filed an opening claims construction brief (Docket # s 137 & 139). Each side also filed a responsive claims construction brief. (Docket # s 151 & 153). The Court held a Markman hearing on October 4, 2010.
The '412 Patent contains twenty claims only three of which are explicitly at issue for purposes of the pending claims construction. The Court begins by laying out those three claims with each instance of the disputed terms highlighted:
('412 Patent at 8:19-10:47 (emphasis added).)
The term "set" appears multiple times in Claim 1 and Claim 18 (where the term appears in singular and plural form). In both of these independent claims, the term "set" appears as part of the phrase "set of fluid flow sources." Ergo contends that in this context "set" means "one or more." Carefusion contends that set means "collection" or "two or more." In short, this Court is asked to determine whether the term "set" can ever mean just one in the context of the '412 Patent. More specifically, whether a "set of fluid flow sources," as used in Claims 1 and 18, encompasses just one fluid flow source.
The Court begins its construction by considering the "ordinary and customary" meaning of "set" to a "person of ordinary skill in the art in question at the time of the invention." Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed.Cir. 2005). "Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." Id. at 1313. At oral argument, Carefusion advocated for the ordinary and customary construction of "set" in part by arguing that
However, the Court's inquiry does not end here. For, the customary "two or more" construction becomes problematic once a person skilled in the art considers dependent Claims 16 and 19. Dependent Claim 16 reads, in relevant part:
('412 Patent at 9:41-43 (emphasis added).) Claim 19 reads in relevant part:
('412 Patent at 10:49-51 (emphasis added).) In short, Claims 16 and 19 explicitly contemplate sets that contain "only one" fluid flow source. Thus, these dependent claims suggest that the patentees of the '412 Patent acted as their own lexicographers using the term "set" to encompass both the customary definition of "two or more" as well as "only one." See CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir.2002) ("[T]he claim term will not receive its ordinary meaning if the patentee acted as his own lexicographer and clearly set forth a definition of the disputed claim term in either the specification or prosecution history.")
Notably, these dependent claims were added to the '412 Patent after the initial patent application was rejected. In the initial application, the term "set" was not used at all. Rather, Original Claim 1 claimed that "a selector switch [was to be] associated with each individual fluid flow source or associated with predetermined groups of said fluid flow sources." (ERGO004837 (Docket # 140-1).
In addition to the support for the "one or more" construction found in dependent claims and the prosecution history, the specification and figures offer further evidence
('412 Patent at 2:14-16.) In relevant part, the specification later explains:
('412 Patent at 2:32-41.)
As these portions of the specification make clear, the '412 Patent contemplates a "one-to-one" configuration between the fluid flow sources and the selector switches so long as there are no more than six fluid flow sources. With more than six fluid flow sources, the specification contemplates that the fluid flow sources would be divided into groups thereby allowing one selector switch to be connected to two or more fluid flow sources. At oral argument and in various filings, the parties have described this as the "one-to-many" configuration. Carefusion's proposed "two or more" construction of "set," which would cover only a "one-to-many" configuration, simply cannot be reconciled with these quoted portions of the specification. See Laryngeal Mask Co. Ltd. v. Ambu, 618 F.3d 1367, 1371 (Fed.Cir.2010) (explaining that "the specification is the single best guide to the meaning of a disputed term"). Likewise, the figures of the patent display both the "one-to-one" configuration and the "one-to-many" configuration. Specifically, Figure 1 shows a single fluid flow "set" connected to a selector switch. But, Figure 4 shows a "set" with multiple fluid flows connected to a single selector switch.
Having considered all of the intrinsic evidence, including the related dependent claims, the prosecution history, the specification and the figures, the Court concludes that "set" as used in Claims 1 and 18 encompasses one or more fluid flow sources. This conclusion undoubtedly expands the "ordinary and customary" meaning of "set." However, due consideration of all of the intrinsic evidence makes clear that the patentees acted as their own lexicographers to overcome an initial rejection based on indefiniteness. See, e.g., Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1381 (Fed.Cir.2008) ("A patentee
The parties agree that the remaining four terms to be constructed are "means-plus-function" claims subject to 35 U.S.C. § 112, paragraph 6. (See Stipulation Regarding Claims (Docket # 196).) "In construing a means-plus-function claim, the district court must first determine the claimed function and then identify the corresponding structure in the written description of the patent that performs that function." Baran v. Med. Device Techs., Inc., 616 F.3d 1309, 1316 (Fed.Cir.2010) (citing Applied Med. Res. Corp. v. U.S. Surgical Corp., 448 F.3d 1324, 1332 (Fed. Cir.2006)). As the Federal Circuit has repeatedly explained:
Medical Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1211 (Fed.Cir.2003) (quoting O.I. Corp. v. Tekmar Co., 115 F.3d 1576, 1583 (Fed.Cir. 1997).) "Whether the written description adequately sets forth the structure corresponding to the claimed function must be considered from the perspective of a person skilled in the art." Telcordia Techs., Inc. v. Cisco Sys., 612 F.3d 1365, 1376 (Fed.Cir.2010) (citing Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1365-66 (Fed. Cir.2003)). Ultimately, if no corresponding structure is disclosed in the specification, the claim term must be construed as indefinite. See Biomedino, LLC v. Waters Techs. Corp., 490 F.3d 946, 950 (Fed.Cir. 2007) ("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.").
Both sides agree that the function of the "adjusting means" is to "act[ ] on said fluid flow sources to influence fluid flow." ('412 Patent at 8:27-28.) Ergo contends the structure for this function is simply "motor drives" (and equivalents thereof). Carefusion asserts the structure is more limited to either "a self-locking motor drive with a clutch" or a "non-self-locking [motor] drive with a brake" (and equivalents thereof).
The term "motor drive" appears a total of eight times in the specification of the '412 Patent. When all of the "motor drive" references in the specification are considered, it is clear that the reference to "self-locking motor drive with clutch" and "non-self-locking [motor] drive with brake" are simply examples of the types of motor drives that might be used as adjusting means. In two other places, the specification states the adjusting means is simply "a motor drive actuating the plunger of the syringe." ('412 Patent at 3:2-3; 3:62-63.) Given this more general use of "motor drive," the corresponding structure appears to cover any motor drive that would actuate the plunger of the syringe; such a broad construction necessarily includes "a self-locking motor drive with a clutch" or a
As with the previous term, the function of "programmable control means" is not disputed. The function is: controlling the adjusting means. More specifically, under the Court's construction of adjusting means, the function is: controlling a motor drive or the equivalents thereof. Thus, the core dispute on the construction of "control means" is whether the specification adequately discloses a structure for controlling said motor drive. Carefusion contends the term is indefinite with no structure disclosed in the specification. Ergo, however, asserts that the structure is: "any programmable computer or programmable control device suitable for use in a multichannel infusion system and equivalents thereof." (Ergo Response Brief (Docket # 151) at 20.)
The term "programmable computer" does not appear in the specification. The term "programmable control device" does appear in the section of the specification describing the background of the invention:
('412 Patent at 1:27-33.) However, as Ergo itself admits, this description pertains to the prior art contained in the European Patent application EP-B 302,-752. (See Ergo Response Brief (Docket # 151) at 15.) Notably, the specification does reference a "control device" that has the means for "storing information" and "programming" but this device is not further described and is depicted in a "black box" fashion in Figure 1. ('412 Patent at 5:44-48.)
The Court fails to see how specification of the '412 Patent adequately discloses the structure proposed by Ergo. Therefore, the Court construes "programmable control means" to be an indefinite term. Ultimately, this conclusion is in line with Biomedino LLC v. Waters Tech. Corp., 490 F.3d 946 (Fed.Cir.2007), in which the term "control means" was similarly declared indefinite based on a finding that no structure had been disclosed for the claimed "control means." Id. at 952-53; see also Aristocrat Techs. Austl. Pty. Ltd. v. Int'l Game Tech., 521 F.3d 1328, 1337-38 (Fed. Cir.2008) (affirming the finding the term "game control means" was indefinite based on the lack of a disclosed structure in the patent).
Both sides agree that the function of the data input means is the input of data. Likewise, both sides urge the Court to look towards the following portion of the specification for the corresponding structure:
('412 Patent at 2:55-61.) Ergo contends this structural recitation means that the
Review of the figures and preferred embodiment in the patent reveals multiple references to an "analog adjusting member with integrated acknowledge key" (labeled number 23). (E.g., '412 Patent 5:54-61 & 6:50-68.) Thus, the Court concludes that one skilled in the art would find the corresponding structure to include both discrete keys and a continuously variable adjusting member (i.e., knob) with an acknowledge key. Based on this conclusion, the Court construes "data input means" to be limited to: discrete keys and a continuously variable adjusting member (i.e., a knob) with an acknowledge key, as well as equivalents thereof.
Similar to programmable control means, the dispute regarding construction of "flow measuring means" is whether there is adequate disclosure of a structure or whether the term should be construed as indefinite. The undisputed function of the "flow measuring means" is clearly laid out in Claim 10: to "determin[e] fluid flow being metered into said discharge lines." ('412 Patent 9:11-12.) Ergo's proposed structure for this function is: screw rotation counters, drip counters and equivalents thereof. The problems with this proposed structure, as Carefusion points out, is that it appears nowhere in the specification.
Ergo nonetheless argues that one skilled in the art would implicitly understand reading Claim 10 that flow measuring means refers to screw rotation counters or drip counters. This assertion, Ergo contends, is supported by the deposition testimony of Dr. Daniel Raemer, Ergo's expert. In fact, Dr. Raemer testified at his deposition that the '412 Patent disclosed no structure for the flow measuring means. (See Raemer Dep. (Docket # 137-9) at 105 & 109.) Nonetheless, as a person skilled in the art, Raemer indicated that measuring of the fluid flow could be accomplished by the screw mechanism that is part of the syringe pump driver or by drip counters. (See id. at 108-109.) Having considered the Raemer testimony, the Court nonetheless concludes that this testimony "cannot supplant the total absence of structure from the specification." Biomedino, 490 F.3d at 950 (quoting Default Proof Credit Card Sys., Inc. v. Home Depot U.S.A., Inc., 412 F.3d 1291, 1302 (Fed.Cir.2005)). The fact that Dr. Raemer indicated that he and others skilled in the art "would be capable of implementing a structure" that would measure the fluid flow being metered into the discharge line does not excuse the fact that no structure is disclosed in the specification. Biomedino, 490 F.3d at 953. Thus, the Court finds no corresponding structure disclosed for "flow measuring means" and, therefore, construes "flow measuring means" as indefinite.
The First Round Claims Construction is now complete. To summarize, "set" is construed as "one or more;" "adjusting means" is construed to cover a motor drive and equivalents thereof; and "data input means" is construed to cover discrete keys and a continuously variable adjusting member (i.e., a knob) with an acknowledge key, as well as equivalents thereof. Both "programmable control means" and "flow measuring means" are construed as indefinite in accordance with 35 U.S.C. § 112 ¶ 6.
SO ORDERED.