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Archived updates for Wednesday, November 01, 2006

C-I-P Claim to Best Mode Leads to Invalid Parent Application

In Go Medical Indus. v. Inmed Corp. (October 27, 2006), the claims of continuation-in-part U.S. Patent No. 4,652,259 required a catheter sheath to be inserted "about 1.5 cm" or up to a "known position of maximum pressure" because most of the bacteria are concentrated in the first 1.5 cm to 2 cm of the urethra, due to a natural pressure barrier located about 1.5 cm from the outer end. The question before the Federal Circuit was whether the inventor failed to satisfy the best mode requirement in the parent application where the 1.5 cm distance was not disclosed.

According to the opinion by Chief Judge Michel:

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.

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 where the distance from the stop member to the distal end of the sheath was 1.5 cm. He further characterized it as "the preferred embodiment at that stage." O'Neil Dep. 228:12-14, Sept. 21, 1994. The '259 patent, at col.2, ll.65-69, describes this distance as "crucial" to
preventing bacteria from being pushed into the bladder by the catheter or by the sheath itself. The district court thus correctly concluded that Dr. O'Neil possessed a best mode—i.e., a sheath length of 1.5 cm. SJ Order, slip op. at 13.

We also agree with the district court that the 1979 application lacked sufficient disclosure to allow others to practice the best mode. Id., slip op. at 14. There is no dispute that the preferred length of 1.5 cm was not expressly disclosed. 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.

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 pecification 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. In light of this ruling, we need not address whether the district
court erred in finding that the 1979 application also failed to meet the written description requirement. We affirm the grant of summary judgment of patent invalidity.

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