Monday, October 30, 2006

Failure to Recite Specific Length Results in Best Mode Violation

Go Medical Industries v. Inmed Corp. (05-1241) October 27, 2006

During litigation regarding catheter technology, defendant Inmed challenged the validity of Go Medical's U.S. Patent 4,652,259, claiming it was anticipated by a prior art publication. Go Medical countered that the prior art was not applicable since the '259 patent was a CIP having priority to a 1979 application that predated the publication.

The claims of the '259 patent require the catheter sheath to be inserted "about 1.5 cm" or up to (but not beyond) a "known position of maximum pressure." The specification of the 1979 application discloses that "the stop means can be set [at] a predetermined distance along the sheath depending on the usual extent of bacteria within the passage."

In order to get priority, Go Medical had to show that the 1.5 cm feature was sufficiently disclosed in the 1979 application to satisfy 35 U.S.C. 112. To meet the best mode requirement of section 112, a determination was made whether Go Medical's inventor, Dr. O'Neil, considered a particular mode of practicing the invention to be superior to all other embodiments at the time the 1979 application was filed. If so, then a determination is made whether sufficient disclosure was provided to allow others to practice that best mode.

The Federal Circuit found from Dr. O'Neil's deposition testimony that a best mode was contemplated - and that Dr. O'Neil failed to disclose this mode in the 1979 application:

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" . . . 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.

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. 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."

[M]oreover, 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 . . . 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.

Since the best mode was violated, Go Medical could not rely on the 1979 application for priority against the prior art. Accordingly, the patent was anticipated by the publication.

Read the opinion here.

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