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October 27, 2006
Pissed Away
Aussie
Dr. Alexander O'Neil invented a urinary catheter (4,652,259)
that reduced the risk of urinary tract infection by limiting the length of
the catheter sheath to stop short of a natural pressure barrier in the bladder.
Dr. O'Neil also stopped short of disclosing the known best mode in his 1979
patent application, finally rectifying the specification in his 1985 CIP. But
O'Neil had published an article with specifics in 1982. [CAFC
05-1241]
Go Medical Industries, Pty., Ltd., founded by Dr. O'Neil in 1982, is an Australian... company that manufactures and markets the type of urinary catheters described in the '259 patent.
In 1988, Go and MMG entered into a long-term contract that gave MMG the exclusive right to distribute the catheters within the United States, sharing the profits equally.
In 1992, MMG urged Go to sue when C.R. Bard entered the market with a competing catheter. Go alleges that MMG refused to share in the costs of litigation, despite their contractual obligation to do so. In March 1999, the district court granted summary judgment in favor of C.R. Bard, finding the '259 patent unenforceable due to inequitable conduct and invalid as anticipated.
While the case was appealed and was remanded, it settled shortly thereafter.
Meanwhile, in a letter dated June 21, 1999, MMG notified Go that it believed they "no longer ha[d] a contract" since the district court had found the '259 patent invalid. Consequently, it started placing its royalty payments in escrow around April 1999. In August 1999, Go terminated the agreement and demanded that MMG cease using the "O'Neil" trademark. MMG refused and continued to sell "MMG/O'Neil" catheters even after it sold its assets to Rüsch in February 2000 for $38 million. In 2003, however, Rüsch changed the name of its catheters to "Rüsch/MMG."
On February 1, 2001, Go sued MMG and Rüsch in the United States District Court for the Northern District of Georgia. Go alleged patent infringement, breach of contract, tortious interference with contract, conspiracy to breach fiduciary duty, trademark infringement, and unfair competition.
On July 3, 2003, the district court granted summary judgment in favor of MMG and Rüsch, finding the '259 patent infringed, but invalid as anticipated. The parties agreed that a 1982 article written by Dr. O'Neil anticipated the '259 patent if Go could not claim the 1979 priority date. The court concluded that Go was not entitled to claim the benefit of that filing date because the 1979 application did not satisfy the written description or best mode requirements under 35 U.S.C. § 112, ¶ 1. It denied summary judgment on the issue of enablement, however, because there remained a genuine factual dispute whether the amount of experimentation required to practice the invention was undue.
Herein only the issue of patent infringement is covered.
A patent application for an invention disclosed in a previously-filed application in a manner that satisfies all the requirements of 35 U.S.C. § 112 is entitled to the benefit of the earlier filing date. 35 U.S.C. § 120. A continuation-in-part application "contains subject matter from a prior application and may also contain additional matter not disclosed in the prior application." Augustine, 181 F.3d at 1302. New subject matter does not receive the benefit of the earlier priority date. Id.
In determining whether the best mode requirement of 35 U.S.C. § 112, ¶ 1 is met, we first determine whether Dr. O'Neil subjectively considered a particular mode of practicing the invention to be superior to all other embodiments at the time the 1979 application was filed. See, e.g., Liquid Dynamics Corp. v. Vaughan Co., 449 F.3d 1209, 1223 (Fed. Cir. 2006). If so, we then ask whether he provided a sufficient disclosure to allow others to practice that best mode. Id. Dr. O'Neil even testified at his deposition that when drafting the 1979 application, he purposely "avoid[ed] any comment with relation to length" because he "was aware that numbers would become limiting themselves." O'Neil Dep. 228:23-229:6.
As to the first prong of this test, Dr. O'Neil admitted during his deposition that at the time he filed his patent application in 1979, he had already made sample catheters...that... possessed a best mode.
We also agree with the district court that the 1979 application lacked sufficient disclosure to allow others to practice the best mode. There is no dispute that the preferred length of 1.5 cm was not expressly disclosed.
Nor were the drawings submitted with the 1979 application sufficient. There is no indication that Figure 1 was drawn to any particular scale, much less one where the distance between the "X" and the outer end of the urethra is exactly 1.5 cm. “[P]atent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.” Hockerson-Halberstadt, Inc. v. Avia Group. Int’l, Inc., 222 F.3d 951, 956 (Fed. Cir. 2000); see also In re Wright, 569 F.2d 1124, 1127 (C.C.P.A. 1977) (“Absent any written description in the specification of quantitative values, arguments based on measurement of a drawing are of little value.”).
Moreover, Dr. O'Neil also testified that "[i]t took [him] a few weeks of experiments to define the distance" and others would "have to do a small amount of experimental work" to reach the same conclusion. O'Neil Dep. 229:12-19. In other words, one of ordinary skill would not know from reading the 1979 application that the preferred length between the stop member and the distal end of the sheath was 1.5 cm.
In sum, we conclude that the invention of the '259 patent was not disclosed in the 1979 application in a manner that satisfies the best mode requirement—and no reasonable jury could find otherwise—such that Go is not entitled to claim the priority date of that application. Thus, the 1982 article anticipates.
Obviously, O'Neil's mistake was not to disclose what he already knew in 1979. O'Neil, cleverly stupid and ignorant of patent prosecution, fooled himself in thinking that "numbers would become limiting themselves."
Posted by Patent Hawk at October 27, 2006 11:35 AM | Prior Art