Free Declaration - District Court of Delaware - Delaware

Case 1:07-cv-00468-JJF

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CONTACT Case 1:07-cv-00468-JJF Document 17-2 Filed 10/29/2007 Page 8 of 68

Page 1 of 2

Corporate Headquarters RyMed Technologies, Inc. 137 Third Avenue North Franklin, TN 37064 Phone: 615-790-8093 FAX: 615-790-8984 e-mail: [email protected] Sales and Marketing Craig Turner National Sales Training Manager 137 Third Avenue North Franklin, TN 37064 Phone: 615-790-8093 FAX: 615-790-8984 e-mail: [email protected] Scott Kaiser Territorial Manager (Texas, Louisiana) Austin, TX Phone: 512-577-6815 e-mail: [email protected] Anthony Lepetic Territorial Manager (Missouri, Arkansas, Central/Southern Illinois) St. Louis, MO Phone: 314-363-2820 e-mail: [email protected] Brandon Ryan National Sales Manager 137 Third Avenue North Franklin, TN 37064 Phone: 615-790-8093 FAX: 615-790-8984 e-mail: [email protected] Paul Rovinsky Territorial Manager (Florida) 1554 Tally Circle Oviedo, FL 32765 Phone: 407-288-5614 e-mail: [email protected] Scott Chase Territorial Manager (Tennessee, Kentucky, Alabama, Mississippi 503 Ashlawn Court Nashville, TN 37215 Phone: 615-364-6916 e-mail: [email protected] Courtney Bryant Territorial Manager (North Carolina, Virginia, West Virginia, Maryland, Delaware)

http://www.rymedtech.com/html/body_contact.htm

10/24/2007

CONTACT Case 1:07-cv-00468-JJF Document 17-2 Filed 10/29/2007 Page 9 of 68

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Raleigh, NC Phone: 919-607-3183 e-mail: [email protected] Lydia Jarvis Clinical Training Specialist Raleigh, NC Phone: 740-407-3121 e-mail: [email protected] Customer Service/Technical Assistance RyMed Technologies, Inc. 6000 W. Wm. Cannon Drive Building B, Suite 300 Austin, TX 78749 Technical Assistance: 512-301-7334 e-mail: [email protected] Customer Service: 512-301-1949 e-mail: [email protected] For Investor Relations Contact: Dana Wm. Ryan, President and CEO e-mail: [email protected] Telephone: 615-790-8093

© 2007 RyMed Technologies, Inc. All rights reserved 06/07 Web Site Design by ACT 2, Inc.

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10/24/2007

Case 1:07-cv-00468-JJF

Document 17-2

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Franklin, TN to Los Angeles, CA - Google Maps Case 1:07-cv-00468-JJF Document 17-2

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Start Franklin, TN End Los Angeles, CA Travel 1,999 mi ­ about 1 day 5

hours

ata ©2007 LeadDog Consulting, NAVTEQTM, Europa Technologies - Terms of Use

Franklin, TN Drive: 1,999 mi ­ about 1 day 5 hours 1. Head southwest on Main St toward 5th Ave S 2. Turn right at 5th Ave N 3. Turn left at TN-96 4. Turn left at TN-100/TN-96 5. Take the TN-96 W ramp to Dickson/I-40 6. Merge onto TN-96 7. Turn left to merge onto I-40 W 8. Take exit 10B to merge onto I-40 W Passing through Arkansas Entering Oklahoma 9. Take the exit onto I-35 S/I-40 W/Stanley Draper Expy/US-62 W toward Amarillo Continue to follow I-40 W 240 ft 0.1 mi
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10/18/2007

Franklin, TN to Los Angeles, CA - Google Maps Case 1:07-cv-00468-JJF Document 17-2

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Passing through Texas, New Mexico, Arizona Entering California 10. Merge onto I-15 S 11. Take the exit onto I-15 S toward Los Angeles/San Diego 12. Take the exit onto I-10 W toward Los Angeles 13. Merge onto US-101 N 14. Take exit 2C for Spring St 15. Turn right at N Spring St 16. Turn right at Tom Bradley Blvd Los Angeles, CA

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These directions are for planning purposes only. You may find that construction projects, traffic, or other events may cause road conditions to differ from the map results. Map data ©2007 NAVTEQTM, Sanborn

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10/18/2007

Wilmington, DE to Franklin, TN - Google Maps Case 1:07-cv-00468-JJF Document 17-2

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Start Wilmington, DE End Franklin, TN Travel 789 mi ­ about 12 hours 28

mins

©2007 Google - Map data ©2007 NAVTEQTM - Terms of Use

Wilmington, DE Drive: 789 mi ­ about 12 hours 28 mins 1. Head northwest on E 4th St toward N Market St 2. Turn left at N Washington St 3. Turn right at W 2nd St 4. Slight left to merge onto I-95 S toward Delaware Memorial Bridge/ Baltimore Partial toll road Entering Maryland 5. Take exit 27 to merge onto Capital Beltway/I-495 W toward Silver Spring Entering Virginia 6. Take exit 49 to merge onto I-66 W toward Front Royal/Manassas 7. Take exit 1A to merge onto I-81 S toward Roanoke Entering Tennessee 8. Take exit 1B to merge onto I-40 W toward Knoxville 0.3 mi
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10/18/2007

Wilmington, DE to Franklin, TN - Google Maps Case 1:07-cv-00468-JJF Document 17-2

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3 hours 8 mins

9. Continue on I-24 E (signs for I-440 W/Chattanooga/Memphis/I-24 E) 10. Take exit 53 to merge onto I-440 W toward Memphis 11. Take exit 5 to merge onto I-65 S toward Huntsville 12. Take exit 65 for TN-96 toward Franklin/Murfreesboro 13. Turn right at Murfreesboro Rd/TN-96 Continue to follow TN-96 14. Continue on 3rd Ave S 15. Turn right at Public Square 16. Turn left to stay on Public Square 17. Turn right at Main St Franklin, TN

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125 ft 256 ft 0.1 mi

These directions are for planning purposes only. You may find that construction projects, traffic, or other events may cause road conditions to differ from the map results. Map data ©2007 NAVTEQTM, Sanborn

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10/18/2007

Case 1:07-cv-00468-JJF

Document 17-2

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Case 1:07-cv-00468-JJF Document 17-2 Case 3:01-cv-03202-CRB Document 306

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1 2 3 4 5 6 7 8 9 10 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA

United States District Court

11 12
For the Northern District of California

ICU MEDICAL, INC., Plaintiff, v. B. BRAUN MEDICAL, INC., Defendant. /

No. C 01-03202 CRB CLAIM CONSTRUCTION ORDER

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This suit involves the alleged infringement of United States Patent No. 6,669,673 (the "`673 Patent"). The `673 Patent discloses a valve to be used in medical environments to connect two fluidcarrying instruments allowing transmission of fluids between them. Now before the Court is the task of construing certain claim terms over which the parties remain in dispute. A. Legal Standard Patent infringement analysis involves two steps. The first step is to construe the asserted claims, and the second step is to determine whether the accused method or product infringes any of the claims as properly construed. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd 517 U.S. 370 (1996). The first step, construction of the patent claims, is a matter of law and thus the responsibility of the court. See id. at 979. "[I]n interpreting an asserted claim, the court should look first to intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). In examining

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intrinsic evidence, the court should first look to the words of the claims themselves to define the scope of the patented invention. See id. Words in a claim "are generally given their ordinary and customary meaning." Id. The specification is also examined "to determine if the presumption of ordinary and customary meaning is rebutted." Brookhill-Wilk 1 v. Intuitive Surgical, 334 F.3d 1294, 1298 (Fed. Cir. 2003) (citations omitted). The presumption of ordinary meaning may be rebutted in two ways. First, the inventor can rebut ordinary meaning where she "has disavowed or disclaimed scope of coverage, by using words or expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope." Id. at 1299 (citations omitted). Second, the patentee may "act[] as his or her own lexicographer [by] clearly set[ting] forth a definition of the term different from its ordinary and customary meaning." Id. (citations omitted). With respect to this second method of redefinition, the Federal Circuit has recently established that this may be done "by implication," that is, by "[using] a claim term throughout the entire patent specification, in a manner consistent with only a single meaning." Irdeto Access, Inc. v. Echostar Satellite Corp., 383 F.3d 1295, 1301 (Fed. Cir. 2004) (quoting Bell Atlantic Network Services, Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1271 (Fed. Cir. 2001)). This is accomplished where the patent "repeatedly, consistently, and exclusively" uses the term such as to indicate "the patentee's clear intent to . . . limit the term." Id. at 1302. Much of the parties' dispute in the present construction centers around their different views of how this Court should determine whether the terms at issue have an "ordinary and customary" meaning. Braun's argument relies, in part, on their position that many of the terms in the claim do not possess any specialized meaning to those of skill in the art and thus must be defined by the usage of the terms in the specification. ICU's view is that the terms in the claims can be defined according to the generalized, non-technical meanings that would be understood by any layperson. In this regard, ICU's argument is that this Court's claim construction should begin with the definition provided by a general usage dictionary. Braun's argument is that the specification acts as the primary source for defining the terms.

United States District Court

11 12
For the Northern District of California

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Both parties' positions find at least some basis in law. Braun's position is supported by one line of cases which provides that "where evidence such as expert testimony or technical dictionaries demonstrates that artisans would attach . . . no meaning to the claim term independent of the specification `general-usage dictionaries are rendered irrelevant with respect to that term.'" Irdeto Access, 383 F.3d at 1300 (quoting Vanderlande Indus. Nederland BV v. Int'l Trade Comm'n, 366 F.3d 1311, 1321 (Fed. Cir. 2004)). ICU's position is bolstered by a second line of cases, which state that "[i]t is well settled that dictionaries provide evidence of a claim term's ordinary meaning" and that where a particular term does not have "an established specialized meaning in technical dictionaries . . . of the relevant field of art . . . standard dictionaries of the English language are the proper source of ordinary meaning of the phrase." Inverness Med. Switz. Gmbh v. Princeton Biomeditech Corp., 309 F.3d 1365, 2369 (Fed. Cir. 2002) (citations omitted). This Court acknowledges that there is tension between these cases, and that this tension will almost certainly be resolved by the Federal Circuit in the coming months. See Phillips v. AWH Corp., 376 F.3d 1382 (Fed. Cir. 2004) (granting petition for rehearing en banc and directing briefing, inter alia, on the relative roles that dictionaries and the specification play in claim construction). However, with respect to the case at bar, this Court finds that the tension does not preclude decision because the parties positions are similar enough that the result would be the same regardless of which line of cases is adopted. Both parties in their briefs have agreed that a general-usage dictionary should play some role in this claim construction. Cf. ICU Opening Brief, at 11 (arguing for use of dictionary definition of "flexible element") with Braun Brief, at 10 (arguing for use of dictionary definition of "flexible"). The focus of the parties' dispute is therefore narrower than the dispute that Phillips will resolve. That is, the parties here merely dispute what weight should be given to the available dictionary definitions when compared to the specification. ICU argues that the dictionary definitions represent "ordinary meaning" and thus there should be a strong presumption that their full breadth is claimed unless something in the specification expressly narrows the scope of the terms. See Brookhill-Wilk 1, 334 F.3d at 1298-99 (claims given full scope unless patentee has expressly disavowed scope of coverage). Braun argues that no such presumption should be given, and that instead this Court should evaluate all of the intrinsic evidence­particularly the 3

United States District Court

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For the Northern District of California

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specification­in order to come to a conclusion with respect to the scope of the terms. See Irdeto Access, 383 F.3d at 1300 ("absent . . . an accepted meaning [in the art, the court] construe[s] a claim term only as broadly as provided for by the patent itself.") (citing J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1570 (Fed. Cir. 1997)). This Court, however, does not view Irdeto Access as foreclosing any reference to general-usage dictionaries or, for that matter, common sense in construing terms that lack any specialized meaning. To so hold would mean that novel phrases used to describe novel ideas would always have to be defined ad nauseam in a patent specification when resort to simple, commonly understood words in the English language would provide sufficient meaning to satisfy the patent's "notice function." See Irdeto Access, 383 F.3d at 1303. See also RF Delaware, Inc. v. Pacific Keystone Tech., Inc., 326 F.3d 1255, 1263 (Fed. Cir. 2003) (holding that "when a claim term is expressed in general descriptive words, it typically will not be limited" by the preferred embodiment or by other claims). It would also mean that in cases, such as this one, where the specification does not use disputed terms or uses them only sparingly, such terms would be rendered meaningless, making the process of claim construction impossible. Irdeto Access itself refused to go so far, restricting its holding to the particular circumstances in that case in which the applicant had "unequivocally directed the patent examiner, as well as the public, to the specification as the complete source of meaning for the disputed terms." Id. Moreover, in that case the court also limited its holding to the fact that the specification had "repeatedly, consistently, and exclusively" used the disputed term in a manner consistent with a narrow interpretation. Id. In short, this Court finds it enough to hold that in the instant case the ordinary meaning of a term may be determined by reference to a general usage dictionary. However, because this Court finds that none of the disputed terms have specialized meanings in the relevant art,1 they will not obtain the strong presumption that is provided for in the relevant cases. Instead, this Court will resort to the specification to determine whether the ordinary meaning should be abandoned in favor Braun's expert argues that none of the disputed terms have specialized meanings, while ICU's expert states that an individual skilled in the relevant art would recognize the terms to mean what ICU says they mean. ICU's expert, however, cites no specialized dictionaries, treatises or other support of the specialized status of the relevant terms. Moreover, the patent itself is often not internally consistent in its use of the terms: it uses one term (e.g. "flexible element") to refer to an object in the claims and another (e.g. "seal") to refer to the same object in the specification. For these reasons, the Court finds that the none of the disputed terms have specialized meanings. 4
1

United States District Court

11 12
For the Northern District of California

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of a meaning that is more consistent with the use of the term in context. In any event, the overarching rule remains that the claim serves as the primary reference point for the meaning of the terms. See Teleflex, Inc. v. Ficosa North America Corp., 299 F.3d 1313, 1328 (Fed. Cir. 2002) (absent a clear statement regarding scope, the court is constrained to follow the language of the claim rather than the written description). B. Flexible Element ICU argues that the term "flexible element" should be defined as "portion that is capable of being bent or flexed" while Braun argues that it should mean an element that is "capable of being bent without breaking, easily bent" but "not using mechanical or moving parts such as springs or diaphragms." Revised Joint Claim Construction and Prehearing Statement for `673 Patent ("RJCCPS") at 3. Thus, Braun's definition is narrower than ICU's in two respects: 1) "flexible" means flexible without breaking; and 2) "flexible" means not using mechanical or moving parts.2 1. Bent Without Breaking The parties agree that the construction of the term "flexible" begins with its dictionary definition. ICU Opening Brief at 11; Braun Brief at 10. The parties further agree that the 1987 edition of the Random House Unabridged Dictionary is the proper general-usage dictionary for this claim construction. ICU Opening Brief at 11; Braun Brief at 10. Random House defines "flexible" as: 1. capable of being bent, usually without breaking; easily bent . . . 2. susceptible to modification or adaptation.; adaptable . . . ; 3. willing or disposed to yield; pliable . . . 4. a flexible substance or material, as rubber or leather. Random House Unabridged Dictionary 733 (2d ed. 1987). This Court thus may easily dispose of Braun's limitation that a "flexible" object must be able to be bent without breaking. The dictionary definition makes no such categorical statement. Both parties would have been more consistent with their dependence on the dictionary had they argued that "flexible" means "usually without breaking." Accordingly, this Court will construe the term as including structures that are capable of being bent, but usually without breaking. Braun also contends that this Court's construction of "flexible element" must incorporate the other requirements of the object stated in the claim. However if this Court were to read those other limitations into the definition of the term then the claim would become redundant. 5
2

United States District Court

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For the Northern District of California

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This construction is consistent with the use of the term in the patent. The claim states that the flexible element must be "movable between an uncompressed position . . . and a compressed position," while also being able to "flex[] to accommodate axial compression." Col. 16:4-12. The specification refers to the "seal"3 as being "reusable," and "resilient." Col. 2:43-44, 3:35. A construction of the term "flexible" as being easily broken upon compression would conflict with these statements and thus is excluded. However, a construction of the term as being so resilient as to stand up to very strong compression such that it could never be broken would define term in a way not supported by the patent. 2. Mechanical Parts, Springs and Diaphragms Braun is incorrect in asserting that the specification "disavows or distinguishes" the "flexible element" from "prior art valves and connectors that use `springs or diaphragms'" such that an interpretation of the "flexible element" including mechanical parts is foreclosed. Braun Brief at 14. The specification's description of the advantages of the invention over prior art devices cannot limit the definition of the claim unless it constitutes a clear disavowal. See Brookhill-Wilk 1, 334 F.3d at 1301 ("Advantages described in the body of the specification, if not included in the claims, are not per se limitations to the claimed invention.") (citations omitted); Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc. v. Mutual Pharmaceutical Co., Inc., 384 F.3d 1333, 1340 (Fed. Cir. 2004) (criticism of prior art may be a disavowal if implication is clear from discussion of particular feature of the invention). Contrary to Braun's reading of the patent, it can not be said that the specification "repeatedly, consistently and exclusively" discusses seals as not having mechanical parts. Irdeto Access, 383 F.3d at 1303. The specification describes the prior art mechanical connectors as inferior because they were more prone to malfunction upon repeated use. Col. 1:35-46. The specification does not say that the invention in the `673 Patent will never have mechanical parts. Nor does it say that all inferior designs have mechanical parts. Col. 1:35 (stating that prior art connectors "often have mechanical or moving parts" (emphasis added)). Instead, the specification describes the claimed invention as The parties agreed at oral argument that the term "seal" in the specification is equivalent to the term "flexible element" in the claim. Thus in construing the term "flexible element," this Court will take into consideration the use of the term "seal" in the specification. 6
3

United States District Court

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For the Northern District of California

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superior to prior art devices because "the fewer the mechanical parts the more these connectors can be relied on . . . ." Col. 1 44-45. Thus the specification merely states that it is preferable for medical valves of the type disclosed in the `673 Patent to have few, although not necessarily zero, mechanical parts. If Braun's interpretation of this portion of the specification as a clear disavowal of all flexible elements using mechanical parts were accepted, then the claimed invention could also never have "moving parts." See Col. 1:41-43 ("[t]he more mechanical or moving parts such as springs and diaphragms, the more likely that they will function improperly." (emphasis added)). However, the claimed invention undisputedly does have at least one moving part­the flexible element itself. Col. 9:37 (describing the seal in one preferred embodiment as a "movable part[]"). Accordingly, this Court construes the term "flexible element" to mean a portion of the valve that is capable of being bent, usually without breaking. C. Compressed Position ICU argues that the term "compressed position" should be interpreted to mean "location in which the flexible element is depressed into less space in the cavity." RJCCPS at 4. Braun contends that the proper definition of the phrase is "the position of the flexible element when it is under axial compression and fully opens the valve." Id. The parties' central point of contention on this issue is whether "compressed position" requires full or complete compression, or put differently, whether partial compression is within the scope of the term. The parties also dispute whether the compression referred to is necessarily axial compression, or includes other directions of compression as well. 1. Fully Open Reading "compressed position" in the context of the claim and specification,4 it becomes clear that the term refers to a configuration of the flexible element in which the valve is in an open state and fluid is allowed to move through it. Col. 16:5-8 (describing "a compressed position in which fluid flow is permitted through said valve"). Thus the parties' disagreement can be described

United States District Court

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For the Northern District of California

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The parties agree that the terms "compressed position" and "uncompressed position" in the claim are equivalent to the terms "compressed state" and "decompressed state," respectively, in the specification. Therefore, the use of the latter terms in the specification is relevant to the construction of the former terms. 7

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as whether the flexible element can be in a "compressed position" even though the flexible element may still be partially obstructing the fluid from flowing through the valve. Braun's argument focuses on Claim 1's use of the word "between" in its statement that the flexible element is "movable between an uncompressed position . . . and a compressed position . . . " Col. 16:5-8. According to Braun, this requires that there is only one single compressed position in which the flexible element is fully compressed. However, there is nothing inherent in the word "between" that implies that the valve be fully opened. The flexible element could just as easily be understood to move "between" a closed position and a partially open position. Although Braun insists that ICU's understanding is an attempt to rewrite the claim language, it is Braun's interpretation that seeks an impermissible revision. Under Braun's construction the claim would be rewritten from "a compressed position in which fluid is permitted through said valve" to "a fully compressed position in which maximum fluid flow is permitted through said valve." This Court is not permitted to do so, and thus Braun's proposed limitation is rejected. 2. Axial Compression Braun also argues that the compression referred to by the terms "compressed position" and "uncompressed position" may only be axial compression. This time Braun is correct. ICU contends that the claim contains no such limitation and gives as examples statements in the specification indicating that the flexible element exerts radial compression on the inner wall of the valve in both the compressed and uncompressed positions: The seal in the decompressed state . . . bears against the wall structure near the opening to seal the opening . . . A fluid tight seal is maintained between the seal section and the wall structure as the seal is moved into the compressed state. The seal section bears against the wall structure . . . . Col. 3:38-48. However ICU must rip this excerpt from its context in order to retrieve the desired

United States District Court

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For the Northern District of California

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meaning. Immediately before this portion, the specification states "[t]he third feature is that the 24 resilient seal is adapted to be moved into a compressed state upon insertion of the tip of the medial 25 [sic] implement into the opening and returns to a decompressed state upon removal of the tip." Col. 26 3:35-38. It is clear from this statement that the source of the compression is the insertion of the 27 medical implement into the opening of the valve. The direction of that compression is axial, that is, 28 it moves along the axis of the valve. See Random House Unabridged Dictionary 145 (2d ed. 1987) 8

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(defining axial as "situated in or on an axis"). The compression referred to in the excerpt cited by ICU is the force applied by flexible element against the inner wall of the valve while it under axial compression from the medical implement. If, on the other hand, ICU is claiming that the statement that the flexible element "bears against the wall structure" in the "decompressed state" demonstrates non-axial compression, then ICU refutes its own argument. As discussed more thoroughly below, it cannot be the case that the flexible element is experiencing any compression from the medical implement in the "uncompressed position." In using the terms "compressed," "uncompressed" and "decompressed" the patent repeatedly, consistently and exclusively refers to axial compression. For example, the claim discusses the wall of the flexible element as "flexing to accommodate axial compression." Col. 16:11-12. The specification states that "[a] two-way valve eliminating dead space is used which includes a seal which, upon being compressed by the medical implement, is pierced to open the valve and reseals upon being decompressed . . . ." Col. 1:22-26 (emphasis added). ICU has failed to offer any statement in intrinsic evidence that contradicts this meaning. As such, this Court finds that the terms "compressed position" and "uncompressed position" refer only to axial compression. Accordingly, the term "compressed position" is construed as the position of the flexible element when it is under axial compression from a medical implement5 and opens the valve. E. Uncompressed Position ICU argues that the term "uncompressed position" refers to the "location in which the flexible element is not depressed into less space in the cavity" while Braun states that it means "the position of the flexible element when it is not under axial compression and closes the valve." RJCCPS at 3. The only difference in the parties' positions is whether or not the flexible element may remain under some axial compression in the "uncompressed position." At the outset, ICU's attempt to turn "un" into "some" clearly conflicts with ordinary meaning. ICU argues that its construction is supported by a statement in the specification that "[t]he seal has a lip . . . [that] upon assembly . . . is compressed between the locking elements." In

United States District Court

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For the Northern District of California

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The addition of "from a medical implement" is described under the Court's construction of "uncompressed position." 9

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addition, ICU maintains that the flexible element is always under axial compression by atmospheric pressure. While both of these creative arguments do confirm that there is some axial force acting on the flexible element in its uncompressed position, they still mischaracterize the relevant term. Clearly "uncompressed" refers to a lack of compression. This begs the question as to what source of compression is referenced. The logical answer­supported by the patent's repeated use of the relevant terms­is that the compression is caused by the insertion of a medical implement into the valve. Col. 1:23-25 (the valve "includes a seal which, upon being compressed by a medical implement"); Col. 3:35-38 ("The third feature is that the resilient seal is adapted to be moved into a compressed state upon insertion of the tip of the medial [sic] implement into the opening and returns to a decompressed state upon removal of the tip . . . ."); Col. 42-45 ("In the compressed state, the seal section is pushed by the delivery end of the medical implement . . . ."); Fig. 5 (depicting compression of the flexible element by a syringe). The term "uncompressed position" is therefore construed as the position of the flexible element when it is not under axial compression from a medical implement and closes the valve. F. Ring Shaped Support ICU argues that the term "ring shaped support" should be construed as "a circular-shaped structure that serves as a foundation, prop, brace or stay." Braun seeks a much narrower construction, limiting the term to "an annular cuff into which the flexible element fits." Braun cites as support for its limitation a portion of the preferred embodiment labeled the "annular cuff 28." Col. 7:29-38. However, in doing so Braun seeks to impermissibly import a limitation contained in the preferred embodiment onto the claim language. See Teleflex, Inc. v. Ficosa North America Corp., 299 F.3d 1313, 1328 (Fed. Cir. 2002) (cautioning against "limiting the claimed invention to preferred embodiments or specific examples in the specification" (citations omitted)). The term "ring shaped support" uses plain words and the phrase has an ordinary meaning based on the constituent terms' general usage. Braun's attempt to inject ambiguity where there is none is rejected. ICU's interpretation, on the other hand, simply redefines the term "ring shaped support" using dictionary definitions that in no way clarifies the scope of the term. This Court finds little use

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in doing so and instead agrees with ICU's alternative interpretation that the term is unambiguous and construction is unnecessary. RJCCPS at 4. G. Diameter ICU defines "diameter" as a "straight line passing through the center of an object from side to side." RJCCPS at 4. Braun counters that it means "a straight line passing through the center of a circle and meeting the circumference or surface at each end." Id. The disagreement, then, concerns whether a "diameter" can pass through a non-circular object. Once again, both parties begin their definition of the term with the dictionary, which defines "diameter" as: 1 . . . a. a straight line passing through the center of a circle or sphere and meeting the circumference or surface at each end. b. a straight line passing from side to side of any figure or body, through its center. 2. The length of such a line. 3. the width of a circular or cylindrical object. Random House Unabridged Dictionary 547 (2d ed. 1987). The parties are consequently asking this

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13 Court to choose between two equally applicable dictionary definitions. In this context, the Federal Circuit has instructed that, [b]ecause words often have multiple dictionary definitions . . . the intrinsic record must always be consulted to identify which of the different possible dictionary meanings of the claim terms in issue is most consistent with the use of the words by the inventor . . . .If more than one dictionary definition is consistent with the use of the words in the intrinsic record, the claim terms may be construed to encompass all such consistent meanings. Texas Digital Sys. v. Telegenix, Inc., 308 F.3d 1193, 1203 (Fed. Cir. 2002); Blistad v. Wakalopulos, No. 03-1528, 2004 WL 2248109 (Fed. Cir. Oct. 7, 2004). Under this rule, this Court finds that Braun's definition is "most consistent" with the use of the word in the patent. ICU points to two examples in the specification that it contends demonstrates the correctness of its interpretation. First, ICU points to the statement in the context of the description of an embodiment that "during compression of the seal 36a, the diameter of the ringed wall portions 94 expand outward in the radial direction." Col. 12:13-15. However the "ringed wall" is circular and thus is consistent with Braun's definition. Second, ICU cites a preferred embodiment that "has a bell-shaped skirt and an upper, preferably cylindrical, conduit." Col. 6:65-67. Apparently it is ICU's contention that the excerpts use of the term "preferably" alludes to the possibility of non-circular 11 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

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shapes. The excerpt, however, doesn't even use the term "diameter." Moreover, the shapes it does refer to are circular, in that a cross section of a "bell-shaped skirt" or a "cylindrical" conduit would be a circle. Each of the specification's uses of the term "diameter" correspond with circular objects. Col. 4:4-5 ("The O-ring elements have increasing diameters, with the smallest diameter element begin [sic] adjacent the proximal end of the cavity."); Col. 7:12-24 (referring to the "outer diameter" of the "upper conduit" in Figs. 4, 5 and 19, which the diagrams depict as circular). The term "diameter" shall thus be construed as proposed by Braun. H. Substantially Flat and Substantially Flush The Court finds that the terms "substantially flat" and "substantially flush" are unambiguous and therefore require no construction. I. Support Member ICU proposes that this term be defined as "a constituent part that serves as a foundation, prop, brace or stay." RJCCPS at 4. Braun defines the term as "a member that supports the valve in a manner that allows it to be removably attached to a fluid dispenser." Id. Braun's definition therefore attempts to define the term according to the surrounding claim language, which recites: "The valve of claim 1, wherein said medical valve further comprises a support member enabling said valve to be removably attached to a fluid dispenser." Col. 16:28-31. Braun's definition also adds a further limitation­that the "manner" of support provided by the support member relates to its ability to enable the valve to be removably attached to a fluid dispenser. The specification discusses the "support member" in the following context: The fifth feature is that the medical valve includes a support member connected to the spike which seals off the distal end of the cavity. The support member may have a Luer-Lock type connector element that enables the valve to be removably attached to, for example, a fluid line connected to a patient. The support member may also be in the form of an adaptor that enables the valve to be removably attached to a fluid dispenser or container. Col. 4:26-33. This description reveals that there is nothing inherent in "the manner" the support

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member supports the valve that relates to its ability to be "removably attached to a fluid dispenser." 27 In fact, this excerpt demonstrates that the support member may allow the valve to be removably 28 attached to a fluid dispenser either by having a part that is a "Luer-Lock type connector" or by itself 12

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being in the form of an adaptor that provides that ability. Braun's limitation is consequently refuted by the intrinsic evidence. Accordingly, the term "support member" shall be construed in the manner proposed by ICU. J. Removably Attached to a Fluid Dispenser The Court finds that this phrase is unambiguous and therefore does not require construction. K. Single Molding Claim 5 discloses "[t]he valve of claim 1, wherein said flexible element comprises a single molding." Col. 16:32-33. ICU argues "single molding" means "formed from a single mold" while Braun contends it means "that the flexible element must be formed from a single mold." RJCCPS at 5. The parties both agree that the term "single molding" means "formed from a single mold." The parties also agree that it is the flexible element that is formed from a single mold. ICU Reply Brief at 15. Thus there is no real dispute with respect to the construction of this term. Because Braun's definition is redundant, the Court will give the term the construction offered by ICU. L. Rigid Member The only dispute with respect to the construction of this term is the definition of the word "rigid." See RJCCPS at 5. ICU argues that "rigid" means "stiff," while Braun proposes that it be construed as "stiff or unyielding, not pliant or flexible." Id. In the Court's view, neither definition adds clarity to the scope of the term and therefore both are rejected. The term is unambiguous and therefore no construction is necessary. IT IS SO ORDERED.

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Dated: November 8, 2004

/s/ CHARLES R. BREYER UNITED STATES DISTRICT JUDGE

G:\CRBALL\2001\3202\Order 5c.wpd

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1 2 3 4 5 6 7 8 9 10 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA

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ICU MEDICAL, INC., Plaintiff, v. B.BRAUN MEDICAL INC., Defendants. /

No. C 01-3202 CRB ORDER RE: MOTIONS FOR SUMMARY JUDGMENT AND SCHEDULING TRIAL

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Plaintiff and Counterclaim Defendant ICU M edical, Inc. ("ICU") brought this suit against Defendant and Counterclaimant B.Braun Medical, Inc. ("Braun") for infringement of U.S. Patent No. 5,928,204 ("the `204 patent") and U.S. Patent No. 6,669,673 ("the `673 patent") by manufacturing and selling a specialized needleless medical connector. The patents relate to a medical valve for use in controlling the flow of fluid between two medical implements. The alleged infringing device is Braun's Ultrasite valve. ICU and Braun cross-move for summary judgment on the issue of whether the Ultrasite valve1 infringes the `673 patent. Braun also seeks summary judgment of

In late 2004, Braun made a modification to the Ultrasite valve by changing the molds used in manufacturing the piston component to remove an alleged "taper" in the piston skirt. The modified valve will be referred to in this Order as the Ultrasite valve with modified piston. Otherwise, the term "Ultrasite valve" will refer to both the unmodified Ultrasite valve and the Ultrasite valve with modified piston.

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non-infringement of both the `673 and `204 patents by the Ultrasite valve with modified piston. Finally, ICU moves for summary judgment that the `673 patent is not unenforceable due to inequitable conduct on the part of the patentee. Having carefully considered the parties' papers, and with the benefit of oral argument on February 11, 2005, the Court hereby resolves the motions as follows: 1. ICU's motion for summary judgment that Braun's Ultrasite valve infringes the `673 patent is GRANTED in part as to claims 1-2 and 5-6, and DENIED in part as to claim 3. 2. Braun's motion for summary judgment that the Ultrasite valve does not infringe the `673 patent is DENIED in part as to claims 1-2 and 4-6, and GRANTED in part as to claim 3. 3.
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Braun's motion for summary judgment that the Ultrasite valve with modified piston does not infringe the `673 and `204 patents is GRANTED.

4.

ICU's motion for summary judgment of no inequitable conduct is DENIED. BACKGROUND The administration of medication in hospital and medical settings routinely

involves the use of connectors and adaptors for facilitating the movement of fluids (e.g., drugs and intravenous solutions) between medical implements. Since the ready passage of fluids through the connectors and adaptors is often critical to patient survival, it is important that they operate reliably and repeatedly. Both Braun and ICU are providers of needleless medical connectors. Braun's Ultrasite valve is a needle-free, capless, swabbable valve. It contains a piston made of flexible material. When the piston is in its uncompressed state, it seals against the housing of the valve preventing fluid flow through the valve. In this state, the wall of the piston is relatively flat. When a syringe or other appropriate medical device is connected to the valve, the piston is compressed causing the piston wall to buckle. The compressed piston no longer completely seals against the valve housing because the portion of the piston that seals against the housing is moved to a location where there are 2

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channels in the housing. When the piston is compressed, fluid can flow through the valve. ICU is the assignee of two patents (the`673 and `204 patents) for a closed system, needleless valve device which automatically reseals after administering medication using a medical implement that directly connects with the system without the need of any intermediary needles, caps, or adaptors. I. THE `673 PATENT Independent claim 1 reads: A medical valve for controlling the flow of fluid between a first medical implement and a second medical implement, said valve comprising: .... . . . a flexible element positioned in said cavity movable between an uncompressed position in which a portion of the flexible element bears against the wall structure near said opening and obstructs fluid flow through said valve and a compressed position in which fluid flow is permitted through said valve, said flexible element comprising a wall with an inner surface and an outer surface, the wall flexing to accommodate axial compression of said flexible element, said flexible element comprising an end fitting against a ring shaped support to assist in securing said flexible element in said cavity, said flexible element in said uncompressed position comprising a first external diameter near said opening, a second external diameter in said main portion, said second diameter being smaller than said first diameter and said third diameter, and at least a portion of the outer surface of the wall of the flexible element between the second diameter and the third diameter being tapered. U.S. Patent No. 6,669,673 (issued Dec. 30, 2003). Claims 2-6 are dependent claims from claim 1. The Court issued its claim construction order regarding the `673 patent on November 8, 2004 (the "Markman Order"). In its Markman Order, the Court determined that the term "flexible element" should be defined as "a portion of the valve that is capable of being bent, usually without breaking." Markman Order at 7. The flexible element must be moveable from an uncompressed position, in which the valve is closed, to a compressed position, in which "it is under axial compression from a medical implement" and "the valve is in an open state and fluid is allowed to move through it." Id. at 9, 7. When the flexible element is in an uncompressed position, it must "bear against the wall structure" and "obstruct[] fluid flow" through the valve. `673 Patent Claim 1. 3

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II.

THE `204 PATENT Independent claim 1 reads: A seal for use in selectively opening and closing a fluid pathway through a medical connector comprising a resilient seal element having a wall having a top end and a bottom end, said wall including at least two generally arcuate segments each having an outwardly extending portion, said segments intersecting one another and defining at least one space between where said segments intersect and a line tangential to the outwardly extending portions of both segments, and at least one segment proximate to said bottom end having a larger maximum diameter than a second segment nearer to said top end of said element.

U.S. Patent No. 5,928,204 (issued July 27, 1999). Claims 2-5 are dependent claims from claim 1. DISCUSSION ICU and Braun cross-move for summary judgment on the issue of whether Braun's Ultrasite valve infringes claims 1-3 and 5-6 of the `673 patent. Braun also seeks
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summary judgment of non-infringement by the Ultrasite valve with modified piston with regard to claims 1-6 of the `673 patent and claims 1-5 of the `204 patent. Finally, ICU moves for summary judgment that the `673 patent is not unenforceable due to inequitable conduct on the part of the patentee. I. STANDARD OF REVIEW FOR SUMMARY JUDGMENT Summary judgment is appropriate when the "pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). An issue is "genuine" only if there is sufficient evidence for a reasonable fact finder to find for the non-moving party. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248-49 (1986). A fact is "material" if the fact may affect the outcome of the case. See id. at 248. "In considering a motion for summary judgment, the court may not weigh the evidence or make credibility determinations, and is required to draw all inferences in a light most favorable to the non-moving party." Freeman v. Arpaio, 125 F.3d 732, 735 (9th Cir. 1997). A principal

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purpose of the summary judgment procedure is to identify and dispose of factually unsupported claims. See Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986). The party moving for summary judgment bears the initial burden of identifying those portions of the pleadings, discovery, and affidavits that demonstrate the absence of a genuine issue of material fact. See id. at 323. Where the moving party will have the burden of proof on an issue at trial, it must affirmatively demonstrate that no reasonable trier of fact could find other than for the moving party. See id. Once the moving party meets this initial burden, the non-moving party must go beyond the pleadings and by its own evidence "set forth specific facts showing that there is a genuine issue for trial." Fed. R. Civ. P. 56(e). The non-moving party must "identify with reasonable particularity the evidence that precludes summary judgment." Keenan v. Allan, 91 F.3d 1275, 1279 (9th Cir. 1996) (quoting Richards v. Combined Ins. Co., 55 F.3d 247, 251 (7th Cir. 1995),
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and noting that it is not a district court's task "to scour the record in search of a genuine issue of triable fact"). If the non-moving party fails to make this showing, the moving party is entitled to judgment as a matter of law. See Celotex, 477 U.S. at 323. II. INFRINGEMENT OF THE `673 PATENT A patent infringement analysis involves two steps: claim construction and then applying the construed claim to the accused device. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995). The first step, construing the claims to determine their meaning and scope, has been held to be purely a matter of law. See Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998). The second step, application of the claim to the accused device, is a fact-specific inquiry. See Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998) ("[I]nfringement, whether literal or under the doctrine of equivalents, is a question of fact."). If each limitation of the patent claim is found in the accused device, either literally or as a substantial equivalent, the accused device infringes that claim. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997).

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Summary judgment is appropriate in infringement suits when, drawing all reasonable inferences in favor of the non-moving party, there is no genuine issue of material fact. Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 988 (Fed. Cir. 1999). Because the relevant aspects of the accused device's structure and operation are undisputed in this case, the question of infringement collapses to one of claim construction and is particularly amenable to summary judgment. Id. A. Literal Infringement

To establish literal infringement, the accused device must "contain each limitation of the claim exactly." Litton Sys., Inc. v. Honeywell Inc., 140 F.3d 1449, 1454 (Fed. Cir. 1998). The Court will proceed to compare the accused Ultrasite valve against all the claims and each of their limitations. 1.
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Claim 1 of the `673 patent

Claim 1 is the only independent claim of the `673 patent. It claims a medical valve for controlling the flow of fluid comprising a flexible element that: (1) obstructs fluid flow through the valve, (2) comprises a wall flexing to accommodate axial compression by a medical implement, (3) comprises an end fitting against a ring shaped support, and (4) is tapered. ICU asserts that Braun's Ultrasite valve satisfies each of these elements. a. "Controlling the flow of fluid"

The Ultrasite valve plainly controls the flow of fluid from one medical implement to another. Braun's argument that its Ultrasite valve does not control fluid flow between two medical implements fails even under its own offered definition in which "control" means "to exercise restraint or direction over." Braun's Opposition Memorandum at 19 (quoting Random House Dictionary 442 (2d ed. 1983)) (emphasis added). Removing the implement inserted into the top of the Ultrasite valve restrains the flow of fluid as the piston moves toward its uncompressed position. Inserting a medical implement opens the valve, allowing fluid to flow between that implement and another implement connected to the other end of the valve. When the Ultrasite valve connects two medical implements, it

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controls the flow of fluid by restraining the fluid within the valve and directing the flow from one implement to the other. The term "control" should not be read so narrowly as to require the regulation of any "maximum" or "minimum" fluid flow. The preferred embodiments in the `673 patent work in a similar way (as does the Ultrasite valve) to control the flow of fluid between two medical implements: inserting a syringe or other medical implement opens the valve by exposing passageways that allow fluid to flow from one implement to the other. The `673 patent does not recite a medical valve that independently starts, shuts off, slows-down, or speeds-up the flow of fluids. To accept Braun's argument would exclude the elected embodiments of the `673 prosecution, and produce a highly disfavored result for which Braun provides insufficient support. Globetrotter Software, Inc. v. Elan Computer Group, Inc., 362 F.3d 1367, 1381 (Fed. Cir. 2004) (vacating summary
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judgment of non-infringement where accused infringer's claim interpretation would have excluded patent's preferred embodiment; such an interpretation is "rarely, if ever, correct."). b. "Flexible element" that "obstructs fluid flow"

Braun's Ultrasite valve also comprises a flexible element that obstructs fluid flow through the valve. In its claim construction, the Court construed the disputed claim language as follows. The term "flexible element" means "a portion of the valve that is capable of being bent, usually without breaking." Markman Order at 7. ICU does not assert that the entire piston assembly (including the piston component, rigid plug, and spring) constitutes the flexible element. Rather, ICU contends that only the piston component, or piston, infringes the "flexible element" limitation of claim 1.2 ICU's Reply Memorandum at 4-5. The piston is clearly a flexible element under the claim language. It is made in a single molding of an elastomeric material, which allows it to flex or bend without

For the purposes of this Order, the term "piston" refers to the piston component as opposed to the entire piston assembly. 7

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breaking. The piston bends at several points during operation of the valve. In the uncompressed position, the lip of the piston flexes in response to radial pressure as it is squeezed into the neck of the housing. The shoulder of the piston flexes when it is pressed against the housing shoulder. The neck of the piston also flexes during insertion of the rigid plug and spring at assembly. The piston skirt flexes in response to axial pressure when it is moved into a compressed position by a medical implement. Braun contends that the elastomeric piston is not "flexible" inside the valve because the rigid plug inserted into the neck of the piston is not flexible. The Court's construction, however, does not require that the flexible element must be bent, only that it is capable of being bent. Insertion of the rigid plug does not change the fact that the piston is still capable of being bent in response to pressure (e.g., radially from the rigid plug or housing wall, and axially from the medical implement), which is all the claim
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requires. Indeed, insertion of the rigid plug causes the piston neck to flex in response to radial pressure, and insertion of a medical implement causes the piston skirt to flex in response to axial pressure when it is moved into a compressed position. Braun further contends that ICU's position is inconsistent with its earlier claim that the Ultrasite valve satisfies a "rigid sealing element" limitation in U.S. Patent No. 6,245,048 (the `048 patent). Claim 1 of the `048 patent recites "a rigid sealing element . . . movable between a first position in which said seal prevents fluid flow and a second position in which fluid flow is permitted . . . ." Braun's argument fails because ICU is not contending that the same features of the valve are both a "rigid sealing element" and a "flexible element." Rather, ICU refers to the stiffened lip and neck portion of the combined piston assembly as the "rigid sealing element," but only the piston component as the "flexible element." Although the Ultrasite piston assembly as a whole is rigid, the piston component remains flexible. It does not follow that a stiffened piston assembly cannot comprise a "flexible" piston which is capable of bending in response to pressure.

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The piston also obstructs fluid flow through the valve. In an uncompressed position, the lip of the piston bears against the housing wall and the rigid plug to create a seal that obstructs fluid from entering the valve. The piston shoulder also bears against the internal housing wall and prevents fluid from flowing through the valve. Insertion of a medical implement pushes down on the rigid plug, which moves the piston from an uncompressed position to a compressed position in which fluid is allowed to flow through passageways in the valve. Braun's argument that the rigid plug, not the piston, obstructs fluid flow through the valve is not supported by the evidence. In the Ultrasite valve, the fluid path is around the outside of the piston assembly, not through it. Even without the rigid plug, the piston bears against the housing wall near the valve opening and at the piston shoulder, blocking the passageways that allow fluid to flow through the valve. Although the piston
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component is hollow, a fluid barrier exists at the base where the piston is compressed between the luer nut and the housing wall. So even without a rigid plug, the piston obstructs fluid flow. Moreover, Braun's contention that the piston or flexible element alone must obstruct fluid flow through the Ultrasite valve is not what the claim requires. Claim 1 is a "comprising" claim for "a medical valve . . . comprising . . . a flexible element . . . [that] obstructs fluid flow . . . ." A claim that incorporates the term "comprising" is "generally understood to signify that the claims do not exclude the presence in the accused apparatus . . . of factors in addition to those explicitly recited." Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 811-12 (Fed. Cir. 1999) (reversing summary judgment of non-infringement where accused device included features in addition to elements claimed in a "comprising" claim); see also Stiftung v. Renishaw PLC, 945 F.2d 1173, 1178 (Fed. Cir. 1991) (a claim "which uses the term `comprising,' is an `open' claim which will read on devices which add additional elements"). "The signal `comprising' implements the general rule that absent some special circumstance or estoppel which excludes the additional factor, infringement is not avoided by the presence of 9

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elements . . . in addition to those specifically recited in the claim." Vivid Techs., 200 F.3d at 811. Here, Braun cannot escape infringement by pointing to other elements in the Ultrasite valve such as the rigid plug that also obstruct fluid flow. There are no special circumstances and Braun has not pointed to anything in the `673 prosecution history that would allow it to evade the general rule that an accused infringer cannot escape infringement by pointing to elements in his device that are in addition to those elements in the claimed invention. See id. Braun's Ultrasite valve infringes despite the fact that the piston component is not the only element obstructing fluid flow through the valve. c. "A wall flexing to accommodate axial compression"

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The Ultrasite valve also comprises a wall that flexes to accommodate axial compression. The claim recites "a flexible element . . . comprising a wall . . . flexing to accommodate axial compression." Braun's argument that there can be only one wall that flexes (its entirety) in the flexible element in response to axial compression is not what the claim requires. The claim describes a flexible element that comprises or includes "a wall" that flexes in response to axial compression, but may also include other parts that do not flex in response to axial pressure.3 The claim should not be read to require that the entire piston must flex to accommodate axial compression. See Specialty Composites v. Cabot Corp., 845 F.2d 981, 987 (Fed. Cir. 1988) ("Where a specification does not require a limitation, that limitation should not be read from the specification into the claims."). Here, the piston component is the flexible element. Inserting a syringe or other medical implement moves the piston into a compressed position and causes the piston skirt to