DOUGLAS P. WOODLOCK, District Judge.
Plaintiff Millipore Corporation ("Millipore") brought this action against Defendant W.L. Gore & Associates, Inc. ("Gore") for infringement of U.S. Patent No. 7,293,477 (the "`477 Patent"). The '477 Patent relates to fluid sampling devices and kits comprising sterilized components of fluid sampling devices. In response, Gore has filed counterclaims for declaration of non-infringement, invalidity, and inequitable conduct, and has moved for summary judgment of non-infringement.
Under Federal Circuit law, "[e]valuation of summary judgment of non-infringement requires two steps-proper claim construction and comparison of those claims to the accused product." Trading Techs. Int'l, Inc. v. eSpeed, Inc., 595 F.3d 1340, 1350 (Fed.Cir.2010). Both steps are presented by the motion for summary judgment now before me. After addressing the background of the case and the relevant legal principles, I will construe the disputed claim terms and will compare the claims at issue to the accused products.
It is common practice in many industries to have manufacturing processes occur in fluid receptacles. For instance, pharmaceutical products are produced in chemical reactors and milk is pasteurized in pasteurization vats. To ensure the quality of the final product, these processes are customarily monitored by withdrawing fluid samples from time to time. Generally, it is important to keep the fluid samples unaltered, thereby requiring the withdrawal of sample fluid in a sterile manner. A sterile environment means being free from any contaminants that may affect the manufacturing process or the integrity of the sample, including bacteria, fungi, and viruses.
In order to withdraw samples from fluid receptacles, industries have used devices that were integrated with fluid receptacles. Integrated devices required laborious steam sterilization and cleaning which caused risk of sterility failure as well as significant equipment downtime. Other prior fluid sampling devices required the installation of custom fitted ports onto fluid receptacles. Customization of fluid receptacles resulted in additional costs. In light of these disadvantages, "a need exist[ed] for a fluid sampling device that [wa]s sufficiently inexpensive in its construction to promote single-use disposability, capable of being used in standard industrial ports commonly found in fluid receptacles, and capable of several good sterile fluid sample withdrawals per sterilization cycle and/or prior to being exhausted." '477 Patent col. 1 ll. 61-67.
On November 13, 2007, the United States Patent and Trademark Office ("PTO") issued the '477 Patent to Millipore. The '477 Patent is entitled "Disposable, Pre-Sterilized Fluid Receptacle Sampling Device" and consists of Claims 1 to 5, where Claims 1 and 5 are independent and
As expressed in the specification, the '477 Patent "provides a fluid sampling device comprising a port insert, a plurality of flexible conduits, and a plurality of sample containers." Id. at col. 2 ll. 3-5. The purpose of the '477 Patent is to provide "a fluid sampling device that enables the withdrawal of several samples of fluids from a fluid receptacle, wherein said withdrawal occurs in a substantially sterile manner, and wherein inter-sample cross-contamination is substantially discouraged." Id. at col. 2 ll. 40-45. Users of the '477 Patent can withdraw one or more sterile fluid samples sequentially or simultaneously. Thereafter, the devices of the '477 Patent can be easily removed and replaced with a new sampling unit. The devices of the '477 Patent are designed to be simple in construction, inexpensive to manufacture, usable with standard industrial tanks or vats, and disposable after use, thereby eliminating the need for cleaning and resterilization.
Millipore contends that Gore infringes the '477 Patent by making, selling, and importing its Five-Valve STA-PURE
Millipore commenced this action on May 11, 2009 against Gore alleging infringement of the '477 Patent (Count I). Gore counterclaimed on August 5, 2009 seeking declaratory judgment of non-infringement and invalidity of the '477 Patent.
On January 20, 2010, Gore filed an Opening Claim Construction Brief disputing a total of nine claim terms contained in Claims 1 and 5 of the '477 Patent. Simultaneously, Gore filed a motion for summary judgment of non-infringement based on its proposed construction of the cap-related limitations recited in the asserted claims. For its part, Millipore filed an Opening Claim Construction Brief disputing seventeen claim terms used in Claims 1 to 5 of the '477 Patent.
On May 19, 2010, I had a hearing to discuss claim construction and address the pending motions. During the hearing, I indicated my initial inclinations on claim construction while reserving the right to refine them after taking the claim construction under advisement. I set a further hearing regarding Gore's motion for summary judgment for September 8, 2010. This memorandum will definitively resolve the outstanding claim construction questions and the pending summary judgment motion.
At issue are disputed claim terms from Claims 1 to 5 of the '477 Patent.
Under Federal Circuit law, it is a "bedrock principle" that "the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005) (en banc) (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed.Cir.2004)). "[T]he construction of a patent, including terms of art within its claim, is exclusively within the province of the court." Markman v. Westview Instruments, Inc., 517 U.S. 370, 372, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996).
Claim terms are "generally given their ordinary and customary meaning." Phillips, 415 F.3d at 1312 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996)). This refers to "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention." Id. at 1313. Thus, when the ordinary meaning of claim language is readily apparent, claim construction "involves little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314. If this meaning is, however, not readily apparent, the court should review "the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history." Vitronics, 90 F.3d at 1582. First, the court should "look to the words of the claims themselves, both asserted and nonasserted, to define the scope of the patented invention." Id. Second, the court should "review the specification to determine whether the inventor has used any terms in a manner inconsistent with their ordinary meaning." Id. The Federal Circuit has repeatedly stated that "[c]laims must be read in view of the specification, of which they are part." Id. (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.Cir. 1995)) (alteration in original).
If the meaning of a claim term remains ambiguous after the intrinsic evidence is consulted, the court may "rely on extrinsic evidence, which `consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.'" Phillips, 415 F.3d at 1317 (quoting Markman, 52 F.3d at 980). However, the Federal Circuit has instructed that extrinsic evidence is "less significant than the intrinsic record in determining `the legally operative meaning of claim language.'" Id. at 1317 (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed.Cir.2004)).
Millipore argues that the terms "elongate members" used in Claims 1 and 5 of the '477 Patent should be construed as "a part of extended length." Gore contends, however, that the proper construction of the "elongate members" is "a rigid and monolithic structure of extended length." Gore's argument is derived from
Because the specification is highly relevant to the claim construction analysis, it is considered to be "the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d at 1582). Nonetheless, "[w]hen consulting the specification to clarify the meaning of claim terms, courts must take care not to import limitations into the claims from the specification." Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1288 (Fed.Cir.2009) (en banc). The Federal Circuit has recognized that "the distinction between using the specification to interpret the meaning of a claim and importing limitations from the specification into the claim can be a difficult one to apply in practice." Phillips, 415 F.3d at 1323. In construing claim terms, "the court's focus [must] remain[] on understanding how a person of ordinary skill in the art would understand the claim terms." Id. For example, "although the specification often describes very specific embodiments of the invention," the Federal Circuit has "repeatedly warned against confining the claims to those embodiments." Id. In particular, "[w]hen the specification describes a single embodiment to enable the invention, [a] court will not limit broader claim language to that single application unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction." Abbott, 566 F.3d at 1288 (internal quotation marks and citation omitted).
Here, I find Millipore's intention to limit the claim term to "rigid and monolithic" elongate members to be clear from the language of the claims and the specification, as well as from the prosecution history. First, the term "rigid" is expressly provided in Claim 1 to describe the elongate members. See '477 Patent col. 8 ll. 42-43 ("rigid elongate members").
Id. at col. 7 ll. 9-18. Third, Millipore's intention to limit the claim term is also reflected in the prosecution history record during which Millipore expressly distinguished the '477 Patent over the Arthun device, because that product "fails to teach a rigid and/or monolithic elongate member." '477 Patent, Prosecution History Record, p. 57. Similarly, Millipore stated in the prosecution history record that "Claim 13 [issued as Claim 1] requires a rigid monolithic elongate member which is neither taught nor suggested by Arthun." Id. at 58.
Consequently, I construe the claim term "elongate members" as "a rigid and monolithic structure of extended length."
The parties dispute the claim construction of the limitations related to the term "cap" used in Claims 1 and 5 of the '477 Patent. See '477 Patent col. 8 ll. 46-50 ("the elongate members having a cap and an opening to a passage of the elongate member behind the cap, the elongate members being displaceable between `open' and `closed' positions such that liquid can flow into the opening behind the cap") (Claim 1); id. col. 9 l. 20-col. 10 l. 2 ("said one or more elongate members having a cap and an opening to a passage of each of the one or more elongate members behind the cap") (Claim 5). Here, three aspects of the term "cap" are in dispute: (a) its function, (b) its structure, and (c) its location vis-à-vis the opening.
Millipore argues that the main function of the term "cap" is to create a tight seal and that the cap can, but is not required to, prevent the elongate member from being pulled out from the shaft. Gore contends, however, that the function of the cap is to create a liquid tight seal as well as to prevent the elongate member from being pulled out, both functions being inherent to the cap.
As a basis for their contentions, both parties rely on the passage of the specification that lists several features depicted in Figure 2, i.e., the cap, the anchor and the block, that "should be provided to prevent the elongate means from being prematurely moved into its open position, as well as prevent it from being moved too far past its open and/or closed positions." Id. at col. 7 ll. 38-41. In particular, the specification provides that "[a] cap [
Phillips is instructive in resolving this issue. In Phillips, the disputed term was "baffles" recited in independent claim 1 of the patent as applied to vandalism-resistant wall panels. 415 F.3d at 1310-11. The specification of the patent discussed positioning the baffles so as to deflect projectiles, a function served by the baffles that was also recited in some of the claims but not in claim 1. Id. at 1325. The court found that the mere fact that the specification discussed the projectile-deflecting function of the baffles did not, however, imply that in order to qualify as baffles within the meaning of claim 1, the structures of the baffles necessarily had to serve this function in all the embodiments of all the claims; rather the function was a limitation only in the claims that specifically recited projectile-deflecting baffles. Id. The specification of the patent also discussed several other functions served by the baffles and depicted those in several figures. Id. Likewise, the court held that the mere fact that the written description of the patent at issue set forth multiple objectives to be served by the baffles did not require that the term "baffles" be construed so as to require that the baffles serve all of the recited functions in every circumstance. Id. at 1326-27.
Although the present case differs from Phillips in the sense that the claims of the '477 Patent do not provide that the cap must perform a specific function and that
Importantly, the specification itself indicates that the means described in Figure 2 "will vary depending on the ultimate configuration of the fluid sampling device" and that "the embodiment described in Figure 2 illustrates certain examples thereof." '477 Patent, col. 7 ll. 42-44 (emphasis added). Along the same lines, the specification further provides that:
Id. at col. 8 ll. 29-34. It is therefore clear, at least from the specification, that the intention of the patentee was not to limit the claims to the particular embodiment described in Figure 2. In the absence of a demonstrated intention on the part of Millipore to the contrary, it would be improper to construe the cap referred to in Claims 1 and 5 of the '477 Patent as being required to prevent the elongate members from being pulled out. See Abbott, 566 F.3d at 1288 ("[w]hen the specification describes a single embodiment to enable the invention, [a] court will not limit broader claim language to that single application unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction.") (internal quotation marks and citation omitted); see also Northrop Grumman Corp. v. Intel Corp., 325 F.3d 1346, 1355 (Fed.Cir.2003) ("Absent a clear disclaimer of particular subject matter, the fact that the inventor may have anticipated that the invention would be used in a particular way does not mean that the scope of the invention is limited to that context.").
Accordingly, I construe the term "cap" as "a feature that creates a liquid tight seal and can, but is not required to, prevent the elongate member from being pulled out of the shaft."
Millipore construes the term "cap" used in Claims 1 and 5 of the '477 Patent as "an element distinct from the elongate member."
The term "having" is used in Claims 1 and 5 of '477 Patent to introduce features and attributes of the elongate members. '477 Patent col. 8 ll. 46-47 ("the elongate members having a cap and an opening") (claim 1); id. col. 9 l. 20-col. 10 l. 1 ("said one or more elongate members having a cap and an opening to a passage"). Such features are not limited to the cap but also refer to other elements, such as the front and the rear. See id. col. 8 ll. 43-44 ("the elongate members having a front and a rear"). I note that other terms, such as "in fluid communication with" or "connected to," are used in the claims to refer to separate elements of the elongate members. See id. col. 8 ll. 54-55 ("each flexible conduit in fluid communication with an individual passage of a member"); id. col. 10 ll. 10-11 ("one or more sterilized flexible tubes connected to said back of each of said one or more elongate members"). The patentee could have used the term "connected to" instead of the term "having" to introduce the cap as a structure separate from the elongate members in Claims 1 and 5 of the '477 Patent. Given that the patentee chose not to do so, there is a presumption that the cap and the elongate member are part of the same structure. See Phillips, 415 F.3d at 1314 ("Differences among claims can also be useful in understanding the meaning of particular claim terms.").
This presumption is consistent with Figure 2 of the '477 Patent. As seen below, Figure 2 uses different shading patterns to show whether features are part of, or distinct from, other features. For instance, the elongate members "30" are designated with different shading patterns than the body "20," thereby suggesting that the elongate members and the body are separate structures. However, the elongate members "30" and the cap "65"
Also consistent with the presumption that the cap is part of the elongate member is the prosecution history record. The originally presented claims did not recite a cap; the cap was added to the claims by amendment filed on May 2, 2006. Shortly after this amendment, the patent examiner listed prior art references that he found to be "pertinent." Among these references, the examiner distinguished the device Jaeger from the '477 Patent, indicating that "Jaeger samples wine, presumably in a
Based on the language of the claims and specification of the '477 Patent, as well as on the prosecution history, I therefore construe the term "having" to mean that "the elongate members and the cap are part of the same structure."
Millipore initially argued that the term "behind" used in Claims 1 and 5 of the '477 Patent should be given its ordinary meaning, namely "beyond in depth." Gore contends, however, that no construction of the term "behind" is necessary.
When the ordinary meaning of claim language as understood by a person of skill in the art is readily apparent even to lay judges, claim construction "involves little more than the application of the widely accepted meaning of commonly understood words." Phillips, 415 F.3d at 1314. "In such circumstances, general purpose dictionaries may be helpful." Id. Here, because the meaning of the term "behind" is readily apparent, I construe the term "behind" as "at the back of." See WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY at 199 (2002). Consequently, the location of the opening vis-à-vis the cap is to be construed as "the opening is located at the back of the cap."
The terms "open" and "closed" appear in Claims 1 to 5 of the '477 Patent to describe the position of the elongate members. See '477 Patent col. 8 ll. 48-52 ("the elongate members being displaceable between `open' and `closed' positions such that fluid can flow into the opening behind the cap and through said passage in each member when in said `open' position, but not in said `closed' position.") (Claim 1); id. col. 10 ll. 2-4 ("said one or more elongate members being movable within said one or more shafts from an open position to a closed position") (Claim 5).
Gore seeks to have the "open" and "closed" clauses construed as a whole to mean that "the elongate members are opened by pushing forward and closed by pulling them backwards from the open position." (emphasis added.) To the contrary, Millipore argues that the "open" and "closed" clauses should not be construed as a whole; rather the related disputed terms "moved," "moveable," "displaceable," and "linearly displaceable" should be construed separately to provide a more meaningful construction.
Contrary to Gore's contentions, neither the language of the specification nor the prosecution history supports Gore's restriction of the movement of the elongate members to "forward" or "backwards." In fact, the patentee specifically stated in the prosecution history record that "the elongate member . . . can be opened by moving them [sic] forward or by rotating them [sic]." '477 Patent, Prosecution History Record, pp. 57, 87, 108 (emphasis added). I turn then to construe the related claim terms.
The term "displaceable" appears in independent Claim 1 and the term "linearly
The first issue is therefore to determine whether the limitation contained in Claim 2 can be read into Claim 1, thereby excluding rotational movement. Under the doctrine of claim differentiation in patent law, "the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Phillips, 415 F.3d at 1315. Consequently, I conclude that the limitation found in Claim 2 should not be read in Claim 1. This conclusion is further supported by the prosecution history, which suggests that there is a difference between linear and rotational movement. For instance, in prosecuting the patent, Millipore characterized the elongate member of the sampling device as being "capable of linear and rotation [sic] movement to be selectively moved from a closed to open position." '477 Patent, Prosecution History Record, p. 60. Additionally, Millipore articulated the broad scope of the term "displaced" to mean that "claim 1 [as filed] is not limited to either movement [linear or rotational] and that the claims as filed have always covered both movements." Id. at 107.
This treatment of the term "displaceable" is consistent with ordinary usage as reflected in dictionaries. As noted in Phillips, a court may rely on dictionary definitions, "so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents." 415 F.3d at 1322-23 (quoting Vitronics, 90 F.3d at 1584 n. 6). Because I find that the dictionary definitions provided for the term "displaceable" are not contradicted by the specification or any other patent documents, I construe this term, as Millipore now concedes, to mean "that can be displaced," i.e. "that can be put out of place." See WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY at 654 (2002). Accordingly, I construe the term "linearly displaceable" in the same fashion with the exception that the movement be limited to linear and not rotational.
The terms "movable" and "moved" are found in Claim 5 of the '477 Patent. See '477 Patent col. 10 ll. 3-4 ("elongate members being movable within said one or more shafts from an open position to a closed position"); id. col. 10 l. 17 ("elongate members are moved to said open position"). Millipore contends that the term "movable" should be given its ordinary meaning, namely "capable of being moved." Millipore further argues that the term "moved" should be construed to refer to the past principle of the verb to move, i.e., "to change position." In making this argument, Millipore relies on dictionary definitions.
As noted above, when the meaning of claim language is readily apparent, "general purpose dictionaries may be helpful." Phillips, 415 F.3d at 1314. Consequently, I adopt Millipore's construction of the terms "movable" and "moved," as being respectively "capable of being moved" and
The term "positioned adjacent" used in Claim 1 of the '477 Patent designates which end of the elongate member is nearest to the fluid receptacle. See '477 Patent col. 8 ll. 43-46 ("the elongate members having a front and a rear with the front of the elongate members being positioned adjacent a fluid receptacle"). Millipore argues that this claim term should be given its ordinary meaning, which includes "nearby," but should not require that there be contact between the elongate member and the fluid receptacle. Gore counters that the term "positioned adjacent" should be construed as "next to or adjoining, with no intervening structure between the elongate members and the fluid receptacle."
Although the term "adjacent" is a commonly understood word, I consider the intrinsic evidence for the proper construction. See Phillips, 415 F.3d at 1315 (referring to the specification as "the single best guide to the meaning of a disputed term"). I find that Gore's construction of the term "adjacent" to be consistent with the specification, which requires the elongate member to stop the flow of fluid when placed in the closed position. See '477 Patent col. 4 ll. 57-67 ("the elongate members
Consequently, I construe the term "adjacent" as "next to or adjoining with no intervening structure between the elongate members and the fluid receptacle."
The term "shaped to fit substantially water-tight within" appears twice in Claim 5 of the '477 Patent. See '477 Patent col. 9 ll. 12-13 ("said body shaped to fit substantially water-tight within said port"); id. col. 9 ll. 15-17 ("elongate members. . . shaped to fit substantially water-tight within said one or more shafts"). Millipore initially sought to have this term construed as "object A is shaped to fit substantially water-tight within object B if object A, alone or in combination with additional parts, when disposed within object B, causes a water-tight seal." (emphasis added).
Nothing in Claim 5 of the '477 Patent suggests that parts other than the elongate members and the body are required to be shaped to cause a water-tight seal. Millipore's addition of other parts is unsupported by intrinsic evidence. Consequently, I construe the term "shaped to fit substantially water-tight within the body," as Millipore now concedes, to mean that "the elongate member, when disposed within the body, causes a water-tight seal."
The term "sample gating means" appears in Claim 1 of the '477 Patent. See id. col. 8 ll. 39-43 ("sample gating means for individually opening and closing any of said plurality of shafts to enable the flow of liquid, said sample gating means comprising a plurality of rigid elongate members positioned within the plurality of shafts."). Gore argues that the term "sample gating means" should be construed as a means-plus-function limitation pursuant to 35 U.S.C. § 112 ¶ 6 to the extent that the claims are themselves construed to cover any form of movement, i.e., both linear and rotational, between the "open" and "closed" positions.
Section 112, paragraph 6, of title 35 provides that:
35 U.S.C. § 112 ¶ 6.
As a general proposition, the "[u]se of the word `means' in claim language creates a presumption that § 112 ¶ 6 applies." TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, 1259 (Fed.Cir.2008). This presumption is rebutted, however, "[i]f, in addition to the word `means' and the functional language, the claim recites sufficient structure for performing the described functions in their entirety." Id.; see also Phillips, 415 F.3d at 1311 ("Means-plus-function claiming applies only to purely functional limitations that do not provide the structure that performs the recited function."). "Sufficient structure exists when the claim language specifies the exact structure that performs the functions in question without need to resort to other portions of the specification or extrinsic evidence for an adequate understanding of the structure." TriMed, 514 F.3d at 1259-60. "Claim construction of a means-plus-function limitation includes two steps. First, the court must determine the claimed function. Second, the court must identify the corresponding structure in the written description of the patent that performs the function." Applied Med. Res. Corp. v. U.S. Surgical Corp., 448 F.3d 1324, 1332 (Fed.Cir.2006) (internal citation omitted).
In this case, it is clear that the claimed function is "to enable the flow of liquid." See id. col. 8 l. 41. Contrary to Gore's contentions, I find that, regardless of whether I construe the claim to include any form of movement, i.e. either or both linear and rotational, the structure recited in Claim 1 is sufficient to perform the claimed function. Claim 1 provides that "the elongate members being displaceable between `open' and `closed' positions such that fluid can flow into the opening behind the cap and through said passage in each member when in said `open' position, but not in said `closed' position." Id. at col. 8 ll. 48-52. Under these circumstances, I
The term "port insert" appears in Claim 1 of the '477 Patent. See '477 Patent col. 8 l. 38. Millipore initially argued that this term is not a claim limitation but rather a collective term for the elements of the claimed device recited in paragraph (a) of Claim 1. To support its argument that the term "port insert" is not a claim limitation, Millipore observes that this term precedes the transitional term "comprising." This fact alone supports a finding, according to Millipore, that the term "port insert" was part of a preamble, i.e., the language preceding the transitional term "comprising," thereby preventing this term from being a claim limitation.
Usually, "the preamble does not limit the claims." Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed.Cir.2002). Yet, "the preamble may be limiting `when the claim drafter chooses to use both the preamble and the body to define the subject matter of the claimed invention.'" Id. (quoting Bell Commc'ns Research, Inc. v. Vitalink Commc'ns Corp., 55 F.3d 615, 620 (Fed.Cir.1995)). Here, Millipore ignores the fact that Claim 1 of the '477 Patent begins with the preamble "[a] fluid sampling device comprising" before defining the term "port insert." See '477 Patent col. 8 l. 37. Under these circumstances, I conclude that the term "port insert" is not solely a part of the preamble and should be construed as a claim limitation.
Accordingly, I now turn to the construction of the term "port insert" as a claim limitation. Anticipating that the term "port insert" might be determined to be a claim limitation, Millipore initially sought to have this term construed as "device to be mated with a port." Gore countered that the term "port insert" should be construed to mean "a structure installed into a port provided on a fluid receptacle." I note that the specification contemplates an embodiment "[w]hen the port insert is installed into a suitable port." '477 Patent col. 2 ll. 21-22. In this instance, I find that using the specification would merely interpret the meaning of a claim rather than to import limitations from the specification into the claim. See Phillips, 415 F.3d at 1323.
Consequently, I construe the term "port insert," as Millipore now concedes, to mean "structure installed into a suitable port."
The term "port" can be found twice in Claim 5 of the '477 Patent. See '477 Patent col. 9 ll. 5-6 ("the fluid receptacle provided with a port"); id. col. 9 ll. 12-15 ("said body shaped to fit substantially water-tight within said port such that said first open end faces inside said fluid receptacle and said second open end faces outside said fluid receptacle"). However, Millipore initially sought to have the term "port" construed to include other parts that permit attachment of additional devices to the port, such as seals, alignment features, clamps, and collars, which in combination permit the additional devices (here, the fluid sampling device) to be in fluid communication with a fluid receptacle.
While the language of Claim 5 itself does not provide any other language helpful in further construing the term "port," the
Id. at col. 5 ll. 11-19. From the specification, it is therefore clear that the port is distinct and separate from the mechanical restraints, such as clamps, screws, bolts, or mated interlocking parts. Construing the term "port" to include such restraints would therefore be improper.
Consequently, I adopt Gore's construction of the term "port" and construe that term, as Millipore now agrees, as "a part of a fluid receptacle that provides an opening to the receptacle."
The term "plurality" appears in Claim 1 of the '477 Patent to refer to the plurality of shafts, elongate members, conduits, or sample containers. See id. col. 8 ll. 38-60. Millipore seeks to have this term construed as "an indefinite number, two or more." Gore argues, however, that no construction is necessary and that alternatively it should be construed as "two or more."
Because the ordinary meaning of the term "plurality" is readily apparent, I may rely on dictionary definition to construe this term. See Phillips, 415 F.3d at 1314. The definition of the term "plurality" includes "the state of being plural," "the state of being numerous," and "a large number of quantity." See WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY at 1745 (2002). Similarly, the term "plural" can be defined as "relating to or consisting of or containing more than one." Id. Consequently, I adopt Millipore's claim construction of the term "plurality" and therefore construe this term to mean "an indefinite number, two or more." See Bilstad v. Wakalopulos, 386 F.3d 1116, 1122 (Fed.Cir.2004) (adopting the definition of "plurality" of the Board of Patent Appeals) ("Two may properly be referred to as a plurality and so may a large number. Thus, `plurality' connotes an indefinite numerical range. The range is bounded by two . . . and . . . infinit[y].").
The term "rigid" appears in Claim 1 to describe the elongate members. See '477 Patent col. 8 ll. 42-43 ("rigid elongate members"). To the extent that any construction is necessary, I adopt the construction to which both parties agree and construe the term "rigid" as "having the quality of resisting change in form."
The term "integral locking means in the form of an anchor" appears in dependant Claim 3 of the '477 Patent to further describe the fluid sampling device. See id. col. 8 l. 64-67 ("the fluid sampling device of claim 1, further comprising integral locking means in the form of an anchor to secure said elongate member in either open position or said closed position or both"). Millipore initially sought to have this term construed as "a part or a portion of something [here, the fluid sampling device] that performs a locking function (i.e., securing against accidental movement) and includes a device for fixing one
In this instance, the key term that needs to be construed is "anchor." The specification expressly refers to this term as follows:
Id. at col. 7 ll. 45-49. I find Millipore's construction of the term "anchor" as "a device for fixing one object to another" to be inconsistent with the language of the specification and the claim terms. Here, the function of the anchor is "to prevent the elongate member from being pushed into its open position P
Consequently, I construe the term "integral locking means in the form of an anchor" as "an element of the fluid sampling device designed to prevent the elongate member from being pushed into its open position prematurely."
The term "integral block" is used in dependant Claim 4 of the '477 Patent to further describe the elements comprised in the fluid sampling device. See '477 Patent col. 9 ll. 1-3 ("The fluid sampling device of claim
Considering that claim construction is necessary in this instance, I construe the term "integral block" in light of the claim language as "an element of the fluid sampling device designed to prevent the elongate member from being pushed too far in the open position."
The term "connected to" appears in Claim 5 of the '477 Patent to describe the relation of the flexible tubes with the elongate members. See '477 Patent col. 10 ll. 10-11 ("one or more sterilized flexible tubes connected to said back of each of said one or more elongate members"). Here again, Gore argues that no construction is necessary. Millipore initially contended that this term should be construed as "joined or linked together" without requiring that there be contact between the two objects.
I agree with Millipore that the term "connected to" should be construed as "joined or linked together." See WEBSTER'S
In order "[t]o prove infringement, the patentee must show that an accused product embodies all limitations of the claim either literally or by the [doctrine of equivalents.]" Amgen Inc. v. F. Hoffman-LA Roche Ltd., 580 F.3d 1340, 1374 (Fed. Cir.2009). Before turning to the doctrine of equivalents, I will therefore discuss Millipore's allegations of literal infringement with respect to Claims 1 to 5 of the '477 Patent.
It is well settled that "[l]iteral infringement of a properly construed claim is a question of fact." Wavetronix LLC v. EIS Elec. Integrated Sys., 573 F.3d 1343, 1358 (Fed.Cir.2009) (quoting Applied, 448 F.3d at 1332). A district court may grant "summary judgment of non-infringement only if, after viewing the alleged facts in the light most favorable to the non-movant, there is no genuine issue as to whether the accused device is encompassed by the claims." Id. (quoting Combined Sys., Inc. v. Def. Tech. Corp. of Am., 350 F.3d 1207, 1210 (Fed.Cir.2003)). In other words, "[i]f any claim limitation is absent from the accused device, there is no literal infringement as a matter of law." Amgen, 580 F.3d at 1374.
Gore's principal argument that summary judgment of non-infringement should be granted turns upon construction of the cap-related limitations.
Gore contends that the Accused Products do not infringe the asserted claims of the '477 Patent because these products do not include a seal that prevents the valve from being pulled out. Having construed the term "cap" as a feature that can, but is not required to, prevent the elongate member from being pulled out, see Section II. B.2.a. supra, the pull-out prevention function of the cap is no longer in dispute.
The only function that remains at issue is therefore the creation of a liquid tight seal by the cap. In this case, there is no dispute that the function of the silicone seal, i.e. the equivalent of the elongate member in the Accused Products, is, as with the claimed cap, to create a liquid seal. As noted in the declaration of Domenic Sciamanna, a project specialist for the Accused Products, when a valve is in the closed position, "it seals the opening on the device face and fluid cannot flow out of the tank and through the device." A fluid sampling device would not work, according to Sciamanna, if there was no liquid tight seal in closed position. Under these circumstances, a jury could reasonably find that the Accused Products perform the
Gore further alleges that the Accused Products do not infringe the asserted claims of the '477 Patent because they do not have a cap that is part of the structure of an elongate member. In making this argument, Gore has relied on its proposed claim construction of the term "having" used in the Claims 1 and 5 of the '477 Patent. See '477 Patent col. 8 ll. 46-47 ("the elongate members having a cap and an opening") (Claim 1); '477 Patent col. 9 l. 21-col. 10 l. 1. ("one or more elongate members having a cap and an opening") (Claim 5).
As discussed in Section II.B.2.b. supra, I have construed the term "cap" used in Claims 1 and 5 of the '477 Patent as being part of the same structure as the elongate members, rather than as a distinct element. The silicone seal, i.e., the equivalent of the cap in the Accused Products, is clearly a structure separate from the rigid rod, i.e., the equivalent of the elongate member in the Accused Products. No reasonable jury could conclude that the silicone seal and the rigid rod of the Accused Products are part of the same structure. For this reason, I conclude that the Accused Products do not literally infringe Claims 1 and 5 of the '477 Patent.
Finally, Gore contends that the Accused Products do not infringe the asserted claims because they do not have any opening behind the cap. In making this argument, Gore relies on the term "behind" used in Claims 1 and 5 of the '477 Patent. See '477 Patent col. 8 ll. 47-48 ("an opening to a passage of the elongate member behind the cap, the elongate members being displaced between `open' and `closed' positions such that fluid can flow into the opening behind the cap") (Claim 1); id. col. 9 l. 21-col. 10 l. 2. ("an opening to a passage of each of the one or more elongate members behind the cap") (Claim 5).
Based on my construction of the term "behind" as "at the back of," see Section II.B.2.c. supra, I find that no jury could reasonably conclude that the opening through which the fluid flows in the Accused Products is placed behind the cap. To the contrary, the opening of the Accused Products is located in front, rather than in the back, of the silicone seal.
Even in the absence of literal infringement, an accused process or device can still be found to infringe under the doctrine of equivalents. See Festo Corp. v.
It is well-settled that "[t]he doctrine of equivalents allows the patentee to claim those insubstantial alterations that were not captured in drafting the original patent claim but which could be created through trivial changes." Festo I, 535 U.S. at 733, 122 S.Ct. 1831. "However, prosecution history estoppel may bar the patentee from asserting equivalents if the scope of the claims has been narrowed by amendment during prosecution." Felix v. Am. Honda Motor Co., Inc., 562 F.3d 1167, 1181-82 (Fed.Cir.2009) (quoting Honeywell Int'l, Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1139 (Fed.Cir. 2004 (en banc))). Amendment-based "[e]stoppel arises when an amendment is made to secure the patent and the amendment narrows the patent's scope." Festo I, 535 U.S. at 736, 122 S.Ct. 1831. The rationale is that "the inventor might [otherwise] avoid the PTO's gatekeeping role and seek to recapture in an infringement action the very subject matter surrendered as a condition of receiving the patent." Id. at 734, 122 S.Ct. 1831.
To rebut this presumption, a patentee must show that (1) "the alleged equivalent would have been unforeseeable at the time of the narrowing amendment," (2) "that the rationale underlying the narrowing amendment bore no more than a tangential relation to the equivalent in question," or (3) "that there was `some other reason' suggesting that the patentee could not reasonably have been expected to have described the alleged equivalent." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd. ("Festo II"), 344 F.3d 1359, 1368 (Fed.Cir.2003) (citing Festo I, 535 U.S. at 740-41, 122 S.Ct. 1831). Because the applicability of the prosecution history estoppel is not a complete bar to the doctrine of equivalents, "[a] district court must look to the specifics of the amendment and the rejection that provoked the amendment to determine whether estoppel precludes the particular doctrine of equivalents argument being made." Intervet Inc. v. Merial Ltd., 617 F.3d 1282, 1291 (Fed.Cir.2010).
I first consider whether any amendment might give rise to a presumption of surrender. The only limitation at issue here is the cap limitation. The "cap" was added on May 2, 2006 as a new limitation to the elongate member. In particular, Claim 1 was amended to recite "the elongate members having a cap and an opening to a passage of the elongate member behind the cap, the elongate members being displaceable between `open' and `closed' positions such that fluid can flow into the opening behind the cap." '477 Patent, Prosecution History Record, p. 102. Likewise, Claim 13 (issued as Claim 5) was amended to recite "elongate members having a cap and an opening to a passage of each of the one or more elongate members behind the cap." Id. at 104. This amendment was made to overcome prior art rejections made by the patent examiner. Under these circumstances, Millipore's decision to narrow the claims by adding the cap limitation in response to an issue of patentability
Millipore argues, however, that it has rebutted the presumption of prosecution history estoppel as to the cap limitation, because "the rationale underlying the narrowing amendment bore no more than a tangential relation to the equivalent in question." Festo II, 344 F.3d at 1368. "[T]he principle that the tangential relation criterion for overcoming the Festo presumption is very narrow." Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 480 F.3d 1335, 1342 (Fed.Cir.2007). "[T]he inquiry into whether a patentee can rebut the Festo presumption under the `tangential' criterion focuses on the patentee's objectively apparent reason for the narrowing amendment. . . . [which] should be discernible from the prosecution history record." Festo II, 344 F.3d at 1369.
In this case, Millipore relies on the following portion of the prosecution history record to show that the cap amendment was at most tangential to the equivalent in question—a silicone seal that creates a liquid tight seal that is distinct from, rather than part of, the elongate member and is located in the back, rather than in the front, of the opening:
'477 Patent, Prosecution History Record, p. 108 (emphasis added).
The recited language suggests that the "objective apparent reason" for the amendment was made to distinguish from Arthun by requiring a cap that "selectively seals off" the end of the elongate member from the vessel, with the elongate member having a cap on its front and an opening behind the cap. Arthun fails to teach an elongate member as thus claimed because it does not contain any cap but merely uses a needle to pierce the septum and allow flow to a sample bag. Accordingly, the "objective apparent reason" for the amendment relates to the addition of a cap that creates a liquid tight seal (function), that would be part of the elongate member (structure) and would be located in front of the opening (location). In this context, "[b]ecause the alleged equivalent focuses on the [cap] limitation, the amendment
Gore contends that Millipore's contentions under the doctrine of equivalents fail because Millipore has not submitted, as is required under Federal Circuit's precedent, adequate particularized testimony or linking argument in support of its infringement claim.
The inquiry under the doctrine of equivalents is "whether `the accused product or process contain[s] elements identical or equivalent to each claimed element of the patented invention.'" Wavetronix, 573 F.3d at 1360 (quoting Warner-Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 40, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997)) (alteration in original). To prove equivalence, a patentee must "provide particularized testimony and linking argument as to the `insubstantiality of the differences' between the claimed invention and the accused device or process, or with respect to the function, way, result test." Tex. Instruments, Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558, 1567 (Fed.Cir.1996). The three-pronged "function-way-result" test requires the patentee to show "that the accused product performs substantially the same function in substantially the same way with substantially the same result as each claim limitation of the patented product." Wavetronix, 573 F.3d at 1360. Because "[e]ach element contained in a patent claim is deemed material to defining the scope of the patented invention," the evidence presented by the patentee "must be applied to individual elements of the claim, not to the invention as a whole."
Warner-Jenkinson, 520 U.S. at 29, 117 S.Ct. 1040; see also Tex. Instruments, 90 F.3d at 1567 ("Such evidence must be presented on a limitation-by-limitation basis. Generalized testimony as to the overall similarity between the claims and the accused infringer's product or process will not suffice.").
Based upon my construction of the term "cap" as a feature that can, but is not required to, prevent the elongate member from being pulled out, see Section II.B.2.a. supra, the pull-out prevention function of the cap is no longer at issue. What remains at issue is whether the silicone seal in the Accused Products performs the function of creating a liquid tight seal in substantially the same way as the claimed cap and whether the difference in the structure and location of the cap contained in the two devices have any impact under the doctrine of equivalents.
To support a finding of infringement under the doctrine of equivalents, Millipore
Thus, I find that Millipore has failed to present "particularized testimony and linking argument" to establish that the Accused Products achieve sealing in the same way as is claimed in the '477 Patent. Indeed, my examination of the Accused Products, which depend upon a lever mechanism for sealing, satisfies me as a matter of law that they do not. Accordingly, I grant summary judgment on this additional basis.
For the reasons set forth more fully above, I GRANT summary judgment in favor of Defendant. (Dkt. No. 28.)
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Millipore's Proposed Gore's Proposed Court's Claim
No Claim Term Claim Construction 1 Claim Construction Construction
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1 "elongate members" "a part of extended "a rigid and monolithic "a rigid and mono-
length" structure of extended lithic structure of
length" extended length"
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2.a Function of the the "cap" can, but is not "a feature on the front of "a feature that
"cap" required to, prevent the the elongate member creates a liquid
elongate member from that creates a liquid tight seal and can,
being pulled out of the tight seal and prevents but is not required
shaft. the elongate member to, prevent the
from being pulled out of elongate member
the shaft" from being pulled
out of the shaft."
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b Structure of the "an element, distinct from "the elongate member "the elongate
"Cap" the elongate member, has as part of its struc- members and the
that creates a liquid tight ture a cap and an open- cap are part of the
seal." The "cap" may or ing to a passage behind same structure"
may not be detachable the cap through which
from the elongate mem- fluid can flow."
ber.
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c Location of the "beyond in depth" No construction of "be- "the opening is lo-
Opening vis-à-vis hind" is necessary. cated at the back
the "Cap" Gore opposes Millipore's of the cap"
proposed construction.
"beyond"
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3 "open" and "closed" Gore seeks to have the 1. "elongate members each claim term is
clauses Court interpret the entire between `open' and each claim term is
phrases that include `closed' positions" to be construed
terms Millipore seeks to (Claim 1) separately
construe. Millipore iden- 2. "elongate members (see below)
tifies the terms to be con- are linearly displaceable
strued; the extraneous within one of said shafts
terms in these entire between said `open' and phrases presented by the `closed' positions" defendant do not add (Claim 2) context that affects the 3. "said one or more analysis of whether each elongate members being individual limitation is movable within said one properly interpreted. or more shafts from an open position to a closed position" (Claim 5) All construed as: "The elongate members are opened by pushing them forward and closed by pulling them backwards from the open position." --------------------------------------------------------------------------------------------------------------------------------- a "displaceable" "physically movable out of See Gore's Proposed "that can be dis- a position" Construction for the placed," i.e. "that "`open' and `closed' can be put out of clauses." place" Now agrees with the Court's proposed claim construction --------------------------------------------------------------------------------------------------------------------------------- "linearly "physically movable out of See Gore's Proposed "that can be dis- displaceable" a position," and limited to Construction for the placed," i.e. "that the movement being lin- "`open' and `closed' can be put out of ear and not rotational. clauses." place," where the movement is limited ed to linear and not rotational --------------------------------------------------------------------------------------------------------------------------------- b "movable" "capable of being moved." See Gore's Proposed "capable of being Construction for the moved" "`open' and `closed' clauses." --------------------------------------------------------------------------------------------------------------------------------- "moved" past participle of the verb See Gore's Proposed past principle of to move, i.e., to change Construction for the the verb to move, position. "`open' and `closed' i.e., "to change po- clauses." sition" --------------------------------------------------------------------------------------------------------------------------------- 4 "positioned The term "positioned ad- "The elongate members "next to or adjoin- adjacent" jacent" should be given are next to or adjoining ing with no inter- its ordinary meaning, the fluid receptacle, with vening structure which includes "nearby." no intervening structure between the elon- The term "adjacent" between the elongate gate members and should not be construed members and the fluid the fluid recepta- to require contact receptacle." cle" between two objects. Now agrees with the Court's proposed claim construction but requests that the terms "Fother than the cap" be added after "no intervening structure" --------------------------------------------------------------------------------------------------------------------------------- 5 "shaped to fit sub- object A is "shaped to fit No construction neces- "the elongate stantially water-tight substantially water-tight sary. Gore opposes Mil- member, when within" within" object B if object lipore's proposed con- disposed within A, alone or in combination struction. the body, causes a with additional parts, water-tight seal" when disposed within object B, causes a water- tight seal.
Now agrees with the Court's proposed claim construction --------------------------------------------------------------------------------------------------------------------------------- 6 "sample gating The term "sample gating This is a 35 U.S.C. The term "sample means" means" should not be § 112(6) means-plus- gating means" is considered to be a term function limitation. not a means-plus- to be construed under 35 function limitation U.S.C. § 112, ¶ 6. under 35 U.S.C. § 112 ¶ 6. --------------------------------------------------------------------------------------------------------------------------------- 7 "port insert" The term "port insert" is "A structure installed "structure install- not a claim limitation and into a port provided on a ed into a suitable is a collective term for the fluid receptacle" port" elements of the claimed device recited in clause (a) of Claim 1. To the ex- tent it is determined that "port insert" is a claim limitation, the term "port insert" should be con- strued to mean "device to be mated with a port." Now agrees with the Court's proposed claim construction --------------------------------------------------------------------------------------------------------------------------------- 8 "port" The "port" is a part or a "A cylindrical structure "a part of a fluid portion of a fluid recepta- extending from the fluid receptacle that cle and it includes an receptacle that provides provides an open- opening that provides ac- an opening to the recep- ing to the recepta- cess to the interior of the tacle." cle." receptacle. The port can include other parts that permit attachment of additional devices to the port, such as seals, align- ment features, clamps, and collars, which in com- bination permit the addi- tional devices (here, the fluid sampling device) to be in fluid communication with a fluid receptacle. Now agrees with the Court's proposed claim construction --------------------------------------------------------------------------------------------------------------------------------- 9 "plurality" "an indefinite number, No construction neces- "an indefinite two or more, and can be sary. Alternatively, number, two or fewer than all of the ele- "two or more." Gore more" ments in question, but not opposes Millipore's less than two." proposed construction. Now agrees with the Court's proposed claim construction --------------------------------------------------------------------------------------------------------------------------------- 10 "rigid" "having the quality of No construction neces- "having the quali- resisting change in form" sary. If the Court ty of resisting decides that further clar- change in form" ification is necessary, Gore does not oppose Millipore's proposed def-
inition of "having the quality of resisting change or form." --------------------------------------------------------------------------------------------------------------------------------- 11 "integral locking "a part or a portion of No construction neces- "an element of the means in the form of something [here, the fluid sary. Gore opposes fluid sampling de- an anchor" sampling device] that per- Millipore's proposed con- vice designed to forms a locking function struction. prevent the elon- (i.e., securing against ac- gate member from cidental movement) and being pushed into includes a device for its open position fixing one object to anoth- prematurely" er (`anchor')." Now agrees with the Court's proposed claim construction but requests that the term "moved" be used in lieu of the term "pushed" --------------------------------------------------------------------------------------------------------------------------------- 12 "integral block" "a part or a portion of No construction neces- "an element of the something [here, the fluid sary. Gore opposes fluid sampling sampling device] that per- Millipore's proposed con- device designed to forms a function of being struction. prevent the elon- an obstacle ("block"), or a gate member from motion limiting struc- being pushed too ture." far in the open po- sition" Now agrees with the Court's proposed claim construction but requests that the term "moved" be used in lieu of the term "pushed" --------------------------------------------------------------------------------------------------------------------------------- 13 "connected to" "joined or linked togeth- No construction neces- "joined or linked er" and should not be sary. Gore opposes together" construed to require Millipore's proposed con- contact between two ob- struction. jects. Now agrees with the Court's proposed claim construction ---------------------------------------------------------------------------------------------------------------------------------
