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Manders v. McGhan Medical Corp.

February 23, 2006

ERNEST K. MANDERS, M.D., PLAINTIFF,
v.
MCGHAN MEDICAL CORPORATION, A SUBSIDIARY AND OR DIVISION OF INAMED CORPORATION A DELAWARE CORPORATION, INAMED MEDICAL PRODUCTS CORPORATION A SUBSIDIARY AND OR DIVISION OF INAMED CORPORATION A CALIFORNIA CORPORATION, DEFENDANTS.



The opinion of the court was delivered by: Conti, J.

MEMORANDUM OPINION

Ernest K. Manders, M.D. ("Manders" or "plaintiff") brings this patent infringement action against McGhan Medical Corporation (now known as "Inamed Medical Products Corporation") and Inamed Medical Products Corporation (collectively, "defendants"). Manders is the owner of United States Patent No. 4,574,780 (the "'780 patent") entitled "Tissue Expander and Method," issued on March 18, 1986 to Manders. Manders alleges that defendants make and sell certain breast tissue expanders which infringe the '780 patent. Defendants deny infringing the '780 patent and counterclaim for declaratory relief, seeking, among other things, a declaration that the '780 patent is invalid and was not infringed by defendants. Jurisdiction and venue are proper in this district. See 28 U.S.C. §§ 1331, 1338(a), 1332(a), 1391(b), 1400(b).

Pending before the court is the patent claim construction dispute. The parties briefed their positions and a Markman hearing was held before this court on September 23, 2004, October 7, 2004 and October 18, 2004. This opinion addresses the proper interpretation of the claim phrases in dispute.

I. BACKGROUND

Manders is the inventor of the '780 patent and is employed as a professor of surgery at the University of Pittsburgh Medical Center. His academic and clinical careers focus on reconstructive surgery. When Manders was a chief resident he began carrying out tissue expansion to reconstruct a nose and later scalps. He determined to develop a directional or differential expander that would be used to reconstruct male pattern baldness. In November 1984 Manders filed for a patent. The patent was issued on March 11, 1986.

The '780 patent discloses a differential soft tissue expander device used to create new tissue for plastic and reconstructive surgery. When the device is implanted below the patient's soft tissue and saline is injected into the device through an injection port, the fluid forces the device and the overlying tissue to expand from the pressure and create new tissue.

Prior to the issuance of the '780 patent, expanders having uniform covers only allowed for creation of generally uniform length tissue flaps. While these devices were useful for many types of surgeries, the ability to form a differential width flap greatly enhances the usefulness of the expansion procedures by allowing the expanded flap to be applied to non-planar or non-uniform length areas.

The '780 patent was designed to allow creation of differential width flaps for greater flexibility in uses, such as treating male pattern baldness or breast mound reconstruction. The differential expansion is achieved through the use of two portions in the expander device. The first portion allows limited expansion, while the second, adjacent portion allows greater expansion when additional fluid is added.

II. GENERAL PRINCIPLES OF CLAIM CONSTRUCTION

Patent claim construction is a matter of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995). The analysis begins with the words of the claim. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996); see Nystrom v. Trex Co., Inc., 424 F.3d 1136, 1142 (Fed. Cir. 2005)(citing Vitronics Corp.). Generally, claim terms take on their ordinary and customary meaning as understood by those of ordinary skill in the art at the time of invention. Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d 1111,1116 (Fed. Cir. 2001); Nystrom, 424 F.3d at 1142 ("The person of ordinary skill in the act views the claim in the light of the entire intrinsic record."). Sometimes the ordinary meaning of a claim term can be readily apparent, in which case claim construction may involve "little more than the application of the widely accepted meaning of commonly understood words." Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005)(en banc). In more complicated situations, to find the ordinary meaning as given to the claim terms by one of the ordinary skill in the art, the claims are read in light of the intrinsic evidence, including the written description, the drawings, and the prosecution history, if in evidence. Teleflex, Inc. v. Ficosa North America Corp., 299 F.3d 1313, 1324 (Fed. Cir. 2002). The focus of the analysis, however, must remain centered on the language of the claims. Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). "[T]he context in which a term is used in the asserted claim can be highly instructive." Phillips, 415 F.3d at 1314. Other claims, both asserted and unasserted, may also be helpful in construing claim terms, since claim terms are generally used consistently throughout the patent. Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 1342 (Fed. Cir. 2001). The specification is "highly relevant" and usually dispositive. Phillips, 415 F.3d at 1315 (quoting Vitronics , 90 F.3d at 1582).

The ordinary meaning of the claim terms as understood by one of ordinary skill in the art can be restricted in one of four situations: (1) if the patentee acted as his own lexicographer and clearly set forth a different definition in the specification, (2) if the patentee distinguished that term from the prior art thereby expressly disclaiming certain subject matter, (3) if the term chosen deprives the claim of clarity such that reference to the specification for meaning is required, or (4) if the patentee phrased the claim in step- or means-plus-function format. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366-67 (Fed. Cir. 2002). It is inappropriate for the court to import a limitation found solely in the written description into the claim. Markman, 52 F.3d at 980. "We do not import limitations into claims from examples or embodiments appearing only in a patent's written description, even when a specification describes very specific embodiments of the invention or even describes only a single embodiment unless the specification makes clear that the 'patentee . . . intends for the claims and the embodiments in the specification to be strictly coexenstive.'" JVW Enterprises, Inc. v. Interact Accessories, Inc., 424 F.3d 1324, 1335 (Fed. Cir. 2005) (quoting Phillips, 415 F.3d at 1323).

III. DISCUSSION -- CLAIM CONSTRUCTION

The '780 patent includes 46 claims. The parties selected apparatus claim 31 and method claim 24 as representative of the claimed invention. Also asserted are claims 32, 33, 34, 35, 37, 39, 40, 44, 46, and 25. Plaintiff is electing to limit the claims in issue in this litigation to those claims and reserves the right to seek to amend the list of claims in issue. Defendant reserves the right to contend that any claim not asserted by plaintiff should be deemed dismissed with prejudice.

A. Claim 31

The preamble of claim 31 reads:

A soft tissue expander device adapted to be implanted collapsed beneath a soft tissue layer of skin and subcutaneous tissue, A preamble limits the claimed invention if it recites essential structure or steps, or if it is necessary to give life, meaning and vitality to the claim. Eaton Corp. v. Rockwell Int'l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003). Additionally, if limitations in the body of the claim rely upon and derive antecedent basis from the preamble, the preamble may act as a limitation of the claimed invention. 323 F.3d at 1339 (structure identified in the preamble was referred to in the body of the claim with the definite articles "the" or "said"). If, however, the body of the claim sets out the complete invention, then the language of the preamble is not limiting. Id. at 1339.

The only claim limitation which appears to derive antecedent basis from the preamble is "a soft tissue layer of skin and subcutaneous tissue," which is referred to later in the body of the claim as "the layer of skin and subcutaneous tissue." Despite this, the preamble in this case does not appear to give any additional scope or meaning to the construction of the claim and, therefore, the preamble will not be considered limiting.

The Transition of Claim 31 Reads: the Device Comprising

The parties agree to the construction "the device including but not limited to the following." Claim 31 continues: flexible wall means defining a fluid impervious chamber, The parties agree that even though this limitation uses the word "means," it recites sufficient structure to take it outside of the means--plus--functions limitation recognized by 35 U.S.C. § 112, ¶ 6. Both parties also agree that the wall means is pliable, demarcates an enclosed space and does not allow fluids to pass through. Therefore, the court finds this limitation to mean "a pliable barrier that demarcates an enclosed space and does not allow fluids to pass through."

Claim 31 continues: and an injection port communicating with the interior of the chamber for admitting fluid into the chamber to expand the chamber, The parties agree that the injection port has an opening connected to the interior of the chamber that allows fluid to enter the chamber. The court finds that this limitation means "a sealable opening, located either remote from or in the flexible wall means, connecting to the interior of the chamber allowing the entrance of fluid into the chamber to expand the chamber."

Claim 31 continues: said wall means including an expandable cover in contact with the layer of skin and subcutaneous tissue when the device is implanted, The parties agree that the wall means includes a portion that is capable of increasing in size or area. The parties disagree as to how "contact" should be construed.

The specification only discusses the device as being implanted "beneath the skin and subcutaneous tissue", col. 2, line 9; col. 3, lines 11-23, of the port "facing" the skin, col. 4, line 60, and of the base "paralleling and facing away from the overlying soft tissue" col. 4, lines 56-58. There is no discussion of how the cover "contacts" the skin and subcutaneous tissue, but it is impossible for the cover to be in direct contact with both the skin and the tissue. The word "contact" in this context is most clearly understood as used in place of "facing."

The court finds this limitation means "a portion of the wall means that can be increased in size which would face the layer of skin and subcutaneous tissue when implanted."

The next limitation in claim 31 requires: the cover including a first limited expansion portion expandable by initial fluid injected through the port and into the chamber from a collapsed implantation position to a taut position above the collapsed position The parties agree that the limited expansion portion is a part of the cover that is expandable by the initial fluid injected through the port and into the chamber from a collapsed implantation position to a taut or tight position above the collapsed position. Defendants, however, would like to construe "collapsed" as meaning "compactly folded" while the plaintiff would like to construe "collapsed" as meaning "folded down to a more compact shape or closed together."

The parties disagree as to the interpretation of "collapsed" as used in both claim 31 and claim 24. Generally, the same word in a patent has the same meaning each time it is used. Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1345 (Fed. Cir. 1998). The written description notes both embodiments where the cover is folded when collapsed (col. 3, lines 63-64; col. 4, lines 54-55) and where it is not folded (col. 7, lines 44-46). The second mention of "collapsed" comes when the written description notes that the surgeon is to "withdraw the saline solution" from the chamber to collapse it. (Col. 5, lines 33-34)(emphasis added). Since this phrase does not say that "some saline" is removed, or even simply "saline" is removed, it implies that all of the saline solution in the device is removed. The "conventional manner" for the method of implantation, however, is referred to twice in the written description. (Col. 2, lines 22-24; col. 6, lines 53-54). It may be important to understand the "conventional manner" before the possibility of a non-completely emptied "collapsed position" could be completely excluded from the scope of this patent.

The court finds this limitation means "the cover including a portion that is capable of increasing in size by the initial fluid injected through the port and into the chamber from collapsed implantation position to a taut position over the collapsed position" where "collapsed," at this time and without the knowledge of the "conventional manner," means the device is empty of fluid.

The next limitation in claim 31 provides: and a second differential expansion portion adjacent said limited expansion portion expandable by said initial injected fluid with the limited expansion portion above the collapsed implantation position

The parties agree that the differential expansion portion is a second portion or part of the cover capable of expanding further than the limited expansion portion and that can expand with the limited expansion portion by the initial injected fluid above the collapsed position. The written description only describes the two cover portions as being "joined," col.2, lines 4-7, and all the figures show that limited expansion portion next to or connected to the differential expansion portion. It appears that for this particular term, the general usage of the word "adjacent" is what the inventor intended.

The court finds this limitation means "another portion of the cover, joined to the limited expansion portion either directly or through a tapered portion, capable of expanding differently from but expandable with the limited expansion portion by the initial injected fluid above the collapsed position."

Claim 31 continues: said limited expansion portion including limiting means preventing further expansion of such portion beyond said taut position by further fluid injected into the ...


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