Lead Opinion
Opinion for the court filed by Circuit Judge BRYSON. Concurring opinion filed by Circuit Judge DYK.
SciMed Life Systems, Inc., (SciMed) owns three U.S. patents drawn to features of balloon dilatation catheters: U.S. Patent Nos. 5,156,594 (the '594 patent), 5,217,482 (the '482 patent), and 5,395,334 (the '334 patent). SciMed filed suit against Advanced Cardiovascular Systems, Inc., (ACS) in the United States District Court for the Northern District of California,
I
Balloon dilatation catheters are used in coronary angioplasty procedures to remove restrictions in coronary arteries. The SciMed patents describe catheters having three sections: a first shaft section, a second shaft section, and a transition section between the two. The first shaft section is long, relatively stiff, and generally tubular. The second shaft section is relatively flexible and contains a balloon at the end, which is inflated to relieve the arterial restriction. The transition section connects the first and second shaft sections and provides a gradual transition in stiffness between the two shaft sections.
The catheters claimed in the SciMed patents contain two passageways, or lu-mens. The first lumen, the guide-wire lumen, is used to guide the catheter through a patient’s arteries to the site of the arterial restriction. A guide wire is first inserted into one of the patient’s arteries. The guide-wire lumen is then threaded over the guide wire to guide the catheter through the patient’s arteries until the catheter reaches the coronary restriction. In the invention recited in the SciMed patents, the guide wire does not enter the catheter at the proximal end of the catheter, i.e., the end closer to the surgeon, but at a point nearer to the distal end of the catheter, i.e., the leading end of the catheter as it is inserted into the patient. The guide-wire lumen is present only in the distal portion of the catheter and does not extend' the entire length of the catheter. The second lumen is the inflation lumen. It extends through all sections of the catheter and terminates in a connection with the balloon. The balloon is inflated by forcing fluid into the inflation lumen. The balloon then compresses the material restricting the artery, thereby relieving the restriction.
The parties agree that only two arrangements of the two lumens are known and practiced in the art. In the dual (or adjacent) lumen configuration, the two lumens ^ positioned side-by-side within the eath-eter> jn y^ coaxjai iumen configuration, g^g -^g iumen runs inside the infla-yon ¡Umen;' in that configuration the infla-yon jumen, viewed in-cross-section, is annular in shape. The parties also agree y^ accused ACS devices employ only the dua¡ iumen configuration and that the preferred embodiment described in the SciMed patents employs the coaxial lumen configuration,
Based on language in the common writ-^en description portion of the three SciMed Patents- the district court construed the asserted claims of the patents to be limited to catheters with coaxial lumens, and not to read on catheters with a dual lumen configuration. The court noted that “the language contained in SciMed’s specifications expressly limits all embodiments of the claimed invention to a coaxial strue-ture.” The court focused in particular on language from the common specification describing the coaxial lumen structure as the “basic sleeve structure for all embodiments of the present invention contemplated and disclosed herein.” That language, the court concluded, “leaves no doubt that a person skilled in the art would conclude that the inventor envisioned only one de
In light of the district court’s construction of the asserted claims, SciMed conceded that ACS’s accused catheters did not literally infringe any of the asserted claims. In addition, the court held on summary judgment that the two lumen arrangements were sufficiently different that no reasonable jury could find the accused catheters to infringe the SciMed patents under the doctrine of equivalents. SciMed appeals the claim construction and the summary judgment based on that construction.
II
The principal question in this case is a narrow one: whether the common specification of the three patents limits the scope of the asserted claims to catheters with coaxial lumens. There is nothing pertinent to this issue in the prosecution history of the three patents; the case turns entirely on an interpretation of the asserted claims in light of the specification, which is essentially identical for each of the three patents. Like the district court, we interpret the specification to disclaim the dual lumen configuration and to limit the scope of the asserted claims to catheters with coaxial lumen structures having annular inflation lumens. We therefore construe the asserted claims to read only on catheters with coaxial lumens, and not on catheters with dual or side-by-side lumens.
Claim 19 of the '594 patent is representative of the asserted claims of the three patents in suit. It claims the following:
In an elongate dilatation catheter of the type that can be slidably moved along a guide wire that can extend past a distal end of the catheter, wherein the guide wire is received in a guide wire lumen of the catheter, the guide wire extending from a distal guide wire lumen opening to a proximal guide wire lumen opening disposed in a portion of the catheter that is spaced distally from a proximal end of the catheter, the dilatation catheter including an inflatable balloon and an inflation lumen extending through the catheter separate from the guide wire lumen, an improvement comprising:
a first proximal shaft section of the catheter defined by a relatively rigid metallic tube;
a second shaft section disposed distally of the first shaft section, the second shaft section being relatively more flexible than the first shaft section; and
a transition section disposed between the first shaft section and the second shaft section, the transition section including a transition member comprising a metallic element of gradually diminished dimension, the transition member extending adjacent to the proximal guide wire lumen opening, and the transition member having gradually decreasing rigidity in the distal direction to provide a relatively smooth transition between the first shaft section and the second shaft section.
SciMed argues at length that in construing the claims based on the written description, the district court has committed one of the cardinal sins of patent law— reading a limitation from the written description into the claims. See Comark Communications, Inc. v. Harris Corp.,
As this court has recently explained, “[o]ne purpose for examining the specification is to determine if the patentee has limited the scope of the claims.” Watts v. XL Sys., Inc.,
Another case in which the claims were given a narrow construction in light of the written description is Wang Labs., Inc. v. America Online, Inc.,
The court in Cultor Corp. v. A.E. Staley Manufacturing Co.,
In another similar case, O.I. Corp. v. Tekmar Co.,
Finally, we find instructive the analysis in Toro Co. v. White Consolidated Industries, Inc.,
The analysis in these cases is directly applicable to the claim construction issue presented here. At various points, the common specification of the three patents indicates that the claimed invention uses coaxial, rather than side-by-side lumens, i.e., that the guide wire lumen is contained within the inflation lumen and that the inflation lumen is annular. Read together, these portions of the common specification lead to the inescapable conclusion that the references in the asserted claims to an inflation lumen “separate from” the guide wire lumen must be understood as referring to coaxial lumens, and thus that the asserted claims read only on catheters having coaxial lumens.
First, the abstract of each of the patents refers to the intermediate sleeve section of the invention as including “an inner core tube which defines a guide wire lumen.” The abstract adds that the inflation lumen is “continued as an annular inflation lumen” through the sleeve section of the catheter. Thus, from the outset the specification identifies the inflation lumen, as that term is used in the SciMed patents, as annular, i.e. coaxial rather than dual in structure.
Second, in discussing the disadvantages of certain prior art structures, the written description of each of the patents explains that the prior art catheters with shortened guide wire lumens “suffer from several disadvantages.” The first cited disadvantage is that “[s]uch catheters have been one piece polyethylene catheters having dual lumen configurations adjacent their distal regions. Typically, such catheters have larger than necessary shaft sizes and
Third, the “Summary of the Invention” portion of the patents describes “the present invention” as having a sleeve section with an inner core tube having a guide wire lumen extending through it and an outer sleeve defining “a longitudinally extending annular inflation lumen.” '594 patent, col. 3,11. 33^45; '482 patent, col. 3, 11.34-46; '334 patent, col. 3,11. 40-52. The characterization of the “present invention” includes several more references to the “annular inflation lumen” as well, see '594 patent, col. 3,11. 58-59, 61, col. 4,11. 43-44; '482 patent, col. 3, 11. 59-60, 62, col. 4, 11. 45-46; '334 patent, col. 3, 11. 65, 68, col. 4, 11. 51-52, and the “Conclusion” section of the written description again refers to the “guide wire lumen and annular inflation lumen” in the distal portions of the catheter. '594 patent, col. 14, 11. 26-28; '482 patent, col. 14,11. 31-33; '334 patent, col. 3, 11. 41-44. As in the Wang Labs and Mod-ine cases cited above, the characterization of the coaxial configuration as part of the “present invention” is strong evidence that the claims should not be read to encompass the opposite structure.
The most compelling portion of the specification, and the portion on which the district court principally focused, is the passage in the section entitled “Catheter Intermediate Sleeve Section” in which the inflation lumen is described as annular in structure, being formed from an outer sleeve or tube (the inflation lumen) and an inner core tube (the guide wire lumen). See '594 patent, col. 7, 11. 26-28, 63-65; '482 patent, col. 7, 11. 29-31, 66-68; '334 patent, col. 7, 11. 41-43, col. 8, 11. 10-12. The patents then recite:
The intermediate sleeve structure defined above is the basic sleeve structure for all embodiments of the present invention contemplated and disclosed herein — namely, an inner core tube bonded to a distal portion of the main catheter shaft, with an outer sleeve forming an annular continuation of the inflation lumen through the main shaft between the core tube and outer sleeve. As discussed below and illustrated herein, various configurations of the connections and components relative to the formation of the distal guide wire lumen, including the coupling of the main shaft to the intermediate sleeve section, are contemplated.
’594 patent, col. 8,11. 3-14; '482 patent, col. 8, 11. 6-17; '334 patent, col. 8, 11. 18-29 (emphasis added).
This language defines SciMed’s invention in a way that excludes the dual, or side-by-side, lumen arrangement. SciMed argues that the references to the annular inflation lumen are meant only to refer to the preferred embodiment of the invention, and not to indicate that the claims should
The words “all embodiments of the present invention” are broad and unequivocal. It is difficult to imagine how the patents could have been clearer in making the point that the coaxial lumen configuration was a necessary element of every variant of the claimed invention. Moreover, there is no suggestion that the patentee made that statement unaware of the alternative dual lumen configuration, because earlier in the patent the patentee had distinguished the dual lumen configuration used in prior art devices as having disadvantages that the coaxial lumens used in the patented invention had overcome. See '594 patent, col. 3, 11. 1-22; '482 patent, col. 3, 11. 3-24; '334 patent, col. 3, 11. 8-29. (describing the dual lumen configuration). This is therefore a clear case of disclaimer of subject matter that, absent the disclaimer, could have been considered to fall within the scope of the claim language.
Citing Renishaw PLC v. Marposs Societa’ per Azioni,
Because the three SciMed patents make clear that the lumens referred to in the claims are all coaxial in structure, the district court was correct to construe the patents as disclaiming the dual lumen configuration. Under such a construction, SciMed concedes that no literal infringement can be found. The district court therefore properly entered summary judgment in favor of ACS on the issue of literal infringement.
Ill
In a separate opinion, the district court rejected SciMed’s argument that ACS’s accused devices infringed the three asserted patents under the doctrine of equivalents. We agree with the court that the doctrine of equivalents is inapplicable in this case and that the district court properly granted summary judgment to ACS on that issue.
As noted above, the common specification of SciMed’s patents referred to prior art catheters, identified them as using the dual lumen configuration, and criticized them as suffering from the disadvantages of having “larger than necessary shaft sizes” and being “stiffer in their distal regions than would be desired.” '594 patent, col. 3,11. 6-8; '482 patent, col. 3,11. 8-10; '334 patent, col. 3, 11. 13-15. That criticism of the dual lumen configuration was consistent with the evidence from SciMed witnesses and documents, which noted the advantages of the coaxial lumen configuration in increasing the flexibility of catheters and their ability to track through the coronary arterial system. The disclaimer of dual lumens was made even more explicit in the portion of the written description in which the patentee identified coaxial lumens as the configuration used in “all embodiments of the present invention.”
Having specifically identified, criticized, and disclaimed the dual lumen configuration, the patentee cannot now invoke the doctrine of equivalents to “embrace a structure that was specifically excluded from the claims.” Dolly, Inc. v. Spalding & Evenflo Cos.,
The court did effectively the same thing in Sage Products, Inc. v. Devon Industries, Inc.,
defines a relatively simple structural device. No subtlety of language or complexity of the technology, nor any subsequent change in the state of the art,such as later-developed technology, obfuscated the significance of this limitation at the time of its incorporation into the claim.... If Sage desired broad patent protection for any container that performed a function similar to its claimed container, it could have sought claims with fewer structural encumbrances .... [A]s between the patentee who had a clear opportunity to negotiate broader claims but did not do so, and the public at large, it is the patentee who must bear the cost of its failure to seek protection for this foreseeable alteration of its claimed structure.
Finally, in Athletic Alternatives, Inc. v. Prince Manufacturing, Inc.,
The principle articulated in these cases is akin to the familiar rule that the doctrine of equivalents cannot be employed in a manner that wholly vitiates a claim limitation. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
In that respect, this case is an even stronger one for not applying the doctrine of equivalents than cases such as Dolly, Sage, Eastman Kodak, Moore, and Athletic Alternatives. Each of the SciMed patents specifically recognized and disclaimed the dual lumen structure, making clear that the patentee regarded the dual lumen configuration as significantly inferi- or to the coaxial lumen configuration used in the invention. Where such an explicit disclaimer is present, the principles of those cases apply a fortiori, and the patentee cannot be allowed to recapture the excluded subject matter under the doctrine of equivalents without undermining the notice function of the patent. As the court observed in Sage, the patentee had an opportunity to draft the patent in a way that would make clear that dual lumens as well as coaxial lumens were within the scope of the invention, but the patentee did just the opposite, leaving competitors and the public to draw the reasonable conclusion that the patentee was not seeking patent protection for catheters that used a dual lumen configuration. Under these circumstances, the district court was justified in concluding that a reasonable jury could not find that the accused devices infringe the SciMed patents under the doctrine of equivalents.
AFFIRMED.
Concurrence Opinion
concurring.
On the facts of this particular case, I agree with the result reached by the majority, and I join the opinion. I also agree with the majority that “the written description can provide guidance as to the meaning of the claims, thereby dictating the manner in which the claims are to be construed, even if the guidance is not provided in explicit definitional format.” The problem is that our decisions provide inadequate guidance as to when it is appropriate to look to the specification to narrow the claim by interpretation and when it is not appropriate to do so. Until we provide better guidance, I fear that the lower courts and litigants will remain confused.
