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Hollister Incorporated v. Convatec Inc

August 18, 2012

HOLLISTER INCORPORATED, PLAINTIFF,
v.
CONVATEC INC., DEFENDANT.



The opinion of the court was delivered by: Matthew F. Kennelly, District Judge:

MEMORANDUM OPINION AND ORDER

Hollister Incorporated sued ConvaTec Inc. for patent infringement. ConvaTec asserted counterclaims of false patent marking, false advertising, and state law claims. In July 2011, the Court granted summary judgment in favor of ConvaTec on Hollister's infringement claim, but ConvaTec's counterclaims remain, including the false marking claim. The parties agree that this claim requires the Court to construe certain claims in Hollister's patents. The Court now rules on the construction of disputed terms in those patents.

Discussion

"[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, 517 U.S. 370, 372 (1996). "[T]he words of a claim are generally given their ordinary and customary meaning," specifically, the meaning the words would have to a person of average skill in the relevant field in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312--13 (Fed. Cir. 2005) (en banc).

The words of a claim are read in the context of that claim and in the context of the patent as a whole. Id. at 1313. In construing the language of a claim, courts consider the language of the other claims, because terms used in multiple claims are presumed to be used in the same way, and differences among the claims can help define the meaning of particular terms. Id. at 1314--15.

Courts also consider the patent specification and the patent's prosecution history when determining the meaning of the claim language. Id. at 1313. Along with the claims, the specification and prosecution history are considered intrinsic evidence of the meaning of the language of the claims. The specification is an important basis for construing the claims, because federal law requires "that the specification describe the manner and process of making and using the patented invention." Id. at 1315 (internal quotation marks omitted). The specification must "describe the claimed invention in full, clear, concise, and exact terms." Id. at 1316 (internal quotation marks omitted). If the specification reveals that a word is being used in a way different from ordinary meaning, the specification's use controls. Id. Similarly, if the specification reveals that the inventor intended to disavow a certain scope regarding a claim, that disavowal is dispositive. Id.

Despite the importance of the specification, however, limitations in the specification or particular embodiments contained in the specification should not be read into the claims. Id. at 1323--24. The specification is a guide to reading the claims, but it does not trump the language of the claims unless the patentee intended the specification and claims to be strictly coextensive. Id. Thus, a patent can cover devices that do not look like those shown in the specification. MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1333 (Fed. Cir. 2007). On the other hand, "a claim interpretation that excludes a preferred embodiment from the scope of the claim is rarely, if ever correct." Id. (alterations omitted).

Courts also consider the prosecution history of a patent when construing its terms. Generally, however, the prosecution history is not as clear or useful as the specification, because it represents a negotiation between the inventor and the patent office. Phillips, 415 F.3d at 1317. "[A]n applicant can make a binding disavowal of claim scope in the course of prosecuting the patent, through arguments made to distinguish prior art references. Such argument-based disavowals will be found, however, only if they constitute clear and unmistakable surrenders of subject matter." Cordis Corp. v. Medtronic AVE, Inc., 511 F.3d 1157, 1177 (Fed. Cir. 2008).

The court can also consider extrinsic evidence, including expert testimony, dictionaries, and treatises. Phillips, 415 F.3d at 1317. These sources are less useful, however, and should be used with caution, keeping in mind their flaws, and considering them in the context of the intrinsic evidence. Id. at 1318--19. In particular, the court can consult dictionaries, particularly technical dictionaries, to construe claim terms, but the dictionary definition cannot contradict any definition given or suggested by the patent itself. Id. at 1322--23. Additionally, courts may not begin with the dictionary definition of a term in the claims before examining the claims and specification themselves. Id. at 1321--22.

The parties dispute the meaning of terms in three patents: U.S. Patent No. 5,569,216 (216 patent), U.S. Patent No. 7,147,627 (627 patent), and U.S. Patent No. 7,722,583 (583 patent). The 583 patent is a continuation of the 627 patent, and they share the same specification. There are six disputed terms in the 216 patent and five in the 627 and 583 patents. The full text of all of the claims containing disputed terms is set out in the appendix to this decision.

A. 216 patent

The 216 patent claims a multipurpose colostomy device that can be inserted into the rectum or into surgically-created stomas (holes) in a patient's abdomen, although one of the disputed terms involves where the device can be used. There are two balloons on the patient proximal end of the device, that is, the end that goes inside the patient. The outer of the two balloons is inflated to keep the device in place. The inner balloon can be inflated or deflated to block off or open up a connecting tube. The connecting tube connects to a joint tube, which then connects to a drainage hose so that waste can flow out of the body.

The patent specification describes two embodiments of the invention. The first has an annular, ring-shaped, supporting plate that braces against the outside of the body to hold the device in place. It appears that this device is most suited for use in surgically-created stomas. The second embodiment is intended for use in the rectum and lacks a supporting plate.

1. "An enema fluid passage passed through said internal balloon"

Claims 1 and 7 of the patent state that the device contains a supply tube that "includ[es] an enema fluid passage passed through said internal balloon for communicating with the colon through an enema one-way valve." JA8 at 5:66--6:2, 6:59--61. The parties dispute the meaning of the term "passed through." ConvaTec contends that this must mean that the fluid passage, a tube, "passes inside the internal balloon." Def. Br. at 7. Hollister contends that "passed through" means only that the fluid passage must "traverse the length of the internal balloon." Id.

The description and figures in the specification are unclear regarding whether the enema tube passes inside the internal balloon. The written description states that a supply tube "is passed through the internal balloon." JA7 at 3:12--13. The enema fluid passage is described only as "disposed in parallel with the supply tube." Id. at 3:17--18. The claim and the figures in the specification make clear that for at least part of its length, the enema tube is within the supply tube. JA4--5; JA8 at 5:66--67, 6:58--59. The supply tube also includes an air passage connecting to the inner balloon for inflation. JA8 at 5:63--66, 6:55--58.

Figures 1(A) and 1(B) of the patent show the enema valve, which is located on top of the enema fluid passage, coming out of the interior balloon; the position of the valve changes as the balloon is inflated or deflated. JA2; JA8 at 6:2--4, 6:61--63. Figure 2, a top-down view of the device, might show the enema tube lying on top of the internal balloon. JA2. Figure 3 shows the deflated internal balloon located on both sides of the enema tube and the supply tube in which part of the enema tube is contained. JA3. Hollister contends that Figure 3 shows that the enema tube does not pass inside the balloon and that the deflated balloon is just wrapped around the tube. The figure, however, could equally show the enema fluid passage going inside the balloon.

The patent specification also contains five cross-section figures, labeled figures 6(A) through 6(E). The first three cross-section figures show both the inner balloon and the enema tube. Figure 6(A) seems to show the enema tube passing out of the balloon, but the other two show it in a position where it might be resting on the balloon. JA4--5. Hollister contends that figure 6(A) shows the inflated balloon bulging around the enema fluid passage, but there is nothing in the figure, such as a line drawn on the balloon, to indicate that the balloon is bulging around the tube, as opposed to the tube passing out of the balloon. The cross-section figures also show the supply tube, which contains the enema tube, and the air passage to the inner balloon. JA4. The figures could show the supply tube either lying on top of the inner balloon or located within it. Id. The air passage clearly opens into the inner balloon in figure 6(C). Id.

Hollister contends that the figures representing the second embodiment of the patent, figures 7(A)--(C), clearly show the enema tube on top of the balloon. JA5. Although they appear to do so, ConvaTec argues persuasively that the second embodiment described in the patent specification is excluded by the language of the claims. See TIP Sys., LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364, 1373 (Fed. Cir. 2008) (if claim language unambiguously does not include embodiment, court must follow claim language and exclude embodiment from patent protection).

Both of the independent claims in the 216 patent, claims 1 and 7, expressly require a connecting tube, a joint tube, an enema one-way valve, and a holder at the distal end of the supply tube. JA8 at 5:49--51, 5:60--61, 6:46--48, 6:52--53. The description in the specification of the second embodiment does not mention any joint tube, enema valve, or supply tube holder. Id. at 5:5--22. In addition, the claims require the joint tube to be disposed under the connecting tube, further away from the patient's body. Id. at 5:51, 5:48. The second embodiment, by contrast, states that the connecting tube connects directly to the drainage hose. Id. at 5:19--21; see JA5.

Hollister contends that the second embodiment has a joint tube, just one that is not described. The connecting tube attaches directly to the drainage hose in the second embodiment, however, so there is no place for a joint tube to go. Additionally, the description of the first embodiment in the specification does discuss the location of the joint tube, the enema valve, and the holder, making it less likely that the description of the second embodiment simply failed to mention a joint tube, enema valve, and holder even though they are present. JA7 at 3:1--30. Finally, in its brief, Hollister stated that the second embodiment had no joint tube, although it took a different position at the hearing once the potential exclusion of the second embodiment was raised. See Pl. Resp. at 15 (describing embodiment shown in figures 2, 3, and 5 as "the only described embodiments with a joint tube"). Although construing claims in a way that excludes embodiments contained in the specification is usually disfavored, the Court concludes that the express language of the claims excludes the second embodiment in the 216 patent. See MBO Labs., 474 F.3d at 1333.

There is nothing in the written specification to suggest that the patentee used a specialized or idiosyncratic meaning of the word through, and the figures in the specification are ambiguous or contradictory. As such, it is appropriate to consult dictionary definitions. See Wilson Sporting Goods Co. v. Hillerich & Bradsby Co., 442 F.3d 1322, 1328 (Fed. Cir. 2006) (using ordinary and customary meaning of annular when nothing in specification indicated differently); Phillips, 415 F.3d at 1314. ConvaTec states that a definition from Merriam-Webster defines the word through to mean "movement into at one side or point and out at another and especially the opposite side." Def. Ex. 1. Hollister argues that other definitions from Merriam-Webster support its construction. It offers two definitions: "from one end or side to the other" and "extending from one surface to the other." Id. Neither of these definitions, however, supports Hollister's position that the word through can mean going around or over the top of an object. The Court concludes that the customary and ordinary meaning of through is going inside and then out of an object.

The Court construes the disputed claim language as advocated by ConvaTec: "The enema fluid passage passes inside the internal balloon." Def. Br. at 7.

2. "An enema one-way valve"

The term "an enema one-way valve" is contained in claims 1 and 7 of the patent. JA8. Hollister has agreed to ConvaTec's proposed construction: "A device that enables forward fluid flow but prevents backward fluid flow." Def. Br. at 10. The Court adopts the proposed construction.

3. "An enema fluid one-way valve located over said internal balloon and in the colon"

Claims 1 and 7 of the patent describe "an enema fluid one-way valve located over said internal balloon and in the colon." JA8. The parties disagree about whether the enema valve must extend past, and further into the patient's body than, all of the inner balloon. ConvaTec asserts the valve "extends axially beyond the internal balloon in both its deflated and inflated state, and into the colon." Def. Br. at 10. Hollister contends that the valve need only be "located at the patient proximal end of the internal balloon." Id.

Hollister concedes that the valve must be located over at least some part of the internal balloon, to convey enema fluid into the colon. When inflated, the balloon blocks any liquid from traveling through the device. JA7 at 4:11--14. Thus the enema valve must be on the proximal side of the balloon to be of any use in conveying enema fluid into the patient. Hollister contends that there is no requirement, however, that the valve extend beyond the most proximal end of the fully inflated balloon. It could reach past some of the inner balloon, while not extending as far as all parts of the internal balloon.

As the claim language states, the valve must be located in the colon when the device is in use. JA8 at 6:4--5, 63. ConvaTec admitted during the hearing that the valve could be located in the patient's colon without extending past all of the balloon. Although excluded by the language of the claim, and apparently lacking an enema valve, the embodiment shown in figures 7(A) and 7(B) depicts the enema tube, on the top of which the enema valve should be located, extending past some but not all of the inflated inner balloon. JA5.

ConvaTec contends that the valve must extend beyond all of the inflated inner balloon based on language and figures in the specification. The specification states that the valve is on top of the enema tube, which "is higher than the internal balloon." JA7 at 3:16--20. The specification does not state, however, that the tube is higher than all of the internal balloon, so this language does not add much to the claim's requirement that the valve is over the inner balloon. Figures 1(A) and 1(B) appear to show the enema valve protruding beyond the inner balloon both when the balloon is inflated and when it is deflated. JA2. Figures 2, 3, and 5 also show the enema tube and valve extending beyond every part of the inner balloon. JA2--4. As ConvaTec recognizes, however, the mere fact that the only embodiment in the patent has an enema valve extending past all of the balloon does not mean that the claim language is limited to enema valves that extend past all of the balloon. See Phillips, 415 F.3d at 1323 (claims are not be confined to embodiments contained in specifications). In light of the fact that the function of the enema valve does not require it to extend beyond all of the balloon, the fact that diagrams in the specification show the valve extending beyond the balloon (without explanation of this in the written specification) does not aid in interpreting the word over.

The Court concludes that Hollister's proposed construction is the proper construction of the disputed language and construes the language to mean "[t]he enema fluid one-way valve is located at the patient proximal end of the internal balloon." Def. Br. at 10. The customary and ordinary meaning of the phrase "over said internal balloon and in the colon" does not require the enema valve to extend past all of the internal balloon whether it is inflated or deflated. For the valve to be in the colon, it need only reach beyond some part of the inflated balloon. Unlike the word through from the first disputed term, ConvaTec does not suggest that the plain meaning of the word over requires that the valve extend past all of the inner balloon.

4. "An annular supporting plate upwardly disposed"

The term"an annular supporting plate upwardly disposed" appears in claim 1. JA8. The parties dispute whether the requirement that the plate is upwardly disposed refers to the location where it attaches to the device or to the plate's orientation. ConvaTec contends that the annular plate must be "angled toward the patient proximal end of the multipurpose colostomy device." Def. Br. at 11. Hollister argues that the term requires no construction and means only that the supporting plate is located "near the patient-proximal end of the colostomy device rather than the patient-distal end." Pl. Resp. at 10.

The claim states that the device includes an "annular supporting plate upwardly disposed between said connecting tube and said joint tube." JA8 at 5:53--54. If the term upwardly disposed refers only to the location of the supporting plate, the claim includes redundant terms, because the plate's location is defined both by the phrase upwardly disposed and by locating it between the connecting and joint tubes. "[C]laims are interpreted with an eye toward giving effect to all terms in the claim." See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006). Hollister acknowledges this redundancy but contends that the phrase upwardly disposed gives additional information. The claim language also states that the purpose of the plate is to "fix[ ] the multipurpose colostomy device to the abdominal wall." JA8 at 5:54--56. ConvaTec contends that if the supporting plate is for fixing or bracing the device against the abdomen, then logically, the plate should be oriented toward the body.

Hollister contends that the claims frequently uses the word disposed as a synonym for located, such as when the connecting tube is said to be "disposed under said internal and external balloons." JA8 at 5:49--50. Because "claim terms are normally used consistently throughout the patent," this might make it inappropriate to interpret disposed in the phrase at issue as referring to orientation. See Phillips, 415 F.3d at 1314. At times, however, the claims seem to use the word disposed to refer to orientation. Specifically, claims 1 and 7 refer to "a supply tube vertically disposed in said connecting tube and between said internal and said external balloons." JA8 at 5:57--58, 6:49--50.

The specification does not describe the orientation of the supporting plate, although it does describe it as "disposed under the connecting tube," another usage of the word disposed to refer to location. JA7 at 3:1--2. The figures in the specification, however, show the supporting plate angled toward the patient's body. Specifically, figures 2, 3, and 5 show the plate angled toward the abdominal wall to accommodate a stoma that protrudes beyond the abdomen. JA2--3. As shown in the figures, any supporting plate would have to be angled upward to reach the abdominal wall around the protruding stoma. See TIP Sys., 529 F.3d at 1373 (using depictions in patent diagrams to interpret claim language).

The parties dispute whether, according to the first embodiment shown in the specification, the supporting plate is really located in the patient proximal area of the device. Hollister suggests that the plate is proximally located compared to the drainage hose. As ConvaTec notes, however, the claim does not include a drainage hose. The specification discusses a drainage hose, but it also states that the hose can be detached and replaced with a plug. JA7 at 4:16--17, 4:57--64. ConvaTec contends that If there is no drainage hose, the supporting plate is closer to the distal end of the device than the proximal end. Figures 2 and 3 position the supporting plate in the middle of the device as shown, but Hollister contends that much more of device is not shown in these figures. JA2--3.

The Court adopts the construction proposed by ConvaTec: "An annular plate angled toward the patient proximal end of the multipurpose colostomy device." Def. Br. at 11. ConvaTec's construction avoids any redundancy in the claim language, because the position of the supporting plate is fixed by reference to the plate being located between the connecting and joint tubes and the phrase upwardly disposed refers to its orientation. The same structure and usage of the term is employed later in claim 1 and in claim 7 to describe the orientation and position of the supply tube. The term "upwardly disposed" also seems most naturally to refer to orientation, not position. The embodiment shown in the specification figures confirms this interpretation by displaying a supporting plate that is oriented towards the patient's abdomen, as indeed it must be to accommodate the stoma.

Hollister argues that ConvaTec's interpretation improperly reads restrictions in the specification into the claim, because "even where a patent describes only a single embodiment, claims will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words of expressions of manifest exclusion or restriction." Arlington Indus. v. Bridgeport Fittings, Inc., 632 F.3d 1246, 1254 (Fed. Cir. 2011). The Court adopts ConvaTec's construction, however, because it best represents the ordinary meaning of the claim language to a person with average skill in the field. The fact that the specification supports the proposed construction is an aid to interpreting the claim, which confirms the interpretation otherwise suggested by the claim language.

5. "For fixing the multipurpose colostomy device to the abdominal wall of the stoma"

The phrase "an annular supporting plate upwardly disposed between said connecting tube and said joint tube, for fixing the multipurpose colostomy device to the abdominal wall of the stoma" appears in claim 1. JA8 (emphasis added). The parties dispute what constitutes a stoma. ConvaTec argues that a stoma is only "a surgically ...


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