Technicon Instruments Corp. v. Alpkem Corp.

• Decision Date: 11 September 1986
• Docket Number: Civ. No. 85-1564-PA.
• Citation: 2 USPQ 2d 1729,664 F. Supp. 1558
• Parties: TECHNICON INSTRUMENTS CORP., Plaintiff, v. ALPKEM CORPORATION, Defendant.
• Court: U.S. District Court — District of Oregon

664 F. Supp. 1558

2 USPQ 2d 1729

TECHNICON INSTRUMENTS CORP., Plaintiff, v.ALPKEM CORPORATION, Defendant.

Civ. No. 85-1564-PA.

United States District Court, D. Oregon.

September 11, 1986.

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Paul R. Gary and Christopher H. Kent, Bullivant, Houser, Bailey, Hanna, Pendergrass, Hoffman, O'Connell & Goyak, Portland, Or., Eugene Moroz, Kurt E. Richter, William S. Feiler and Michael P. Dougherty, Morgan & Finnegan, New York City, for plaintiff.

George K. Meier, III, Hardy Myers, Paul S. Angello and Joseph D. Cohen, Stoel, Rives, Boley, Fraser & Wyse, Portland, Or., for defendant.

OPINION

PANNER, Chief Judge.

PlaintiffTechnicon Instruments Corporation("Technicon") brings this patent infringement action against defendantAlpkem Corporation("Alpkem").Plaintiff asserts that Alpkem'sRFA-300 liquid analyzer infringes U.S. PatentNo. 3,804,593('593).The '593 patent applies to continuous flow analysis of liquid samples.It issued April 16, 1974 to William J. Smythe and Morris H. Shamos as inventors.The patent application was filed May 25, 1964.Technicon, a New York corporation, is the assignee.I find for the defendant.

Alpkem denies that the RFA-300 infringes the '593 patent.It further contends that the '593 patent is invalid for the following reasons: (1) that Technicon, in prosecuting the '593 patent application, committed fraud or engaged in inequitable conduct by violating its duty of disclosure, set forth in 37 C.F.R. § 1.56(a) pursuant to 35 U.S.C. §§ 131and132;(2) the apparatus and methods described and claimed in the '593 patent are inoperative in violation of 35 U.S.C. § 101; and (3) the '593 patent's disclosures are inadequate or nonenabling or both, to allow a person of ordinary skill in the art to practice the alleged invention.Alpkem also asserts the defense of patent misuse and filed antitrust and unfair competition counterclaims.These claims were severed and stayed pending the trial of this phase of the action.The issue of Technicon's damages was also severed from this part of the trial.

A court trial was held.This opinion constitutes findings of fact and conclusions of law pursuant to Fed.R.Civ.P. 52(a).Alpkem'sRFA-300 does not infringe the '593 patent.Although the apparatus and methods claims in the '593 patent were operative and useful at the time of the application, the patent is invalid because it did not contain adequate disclosure and because Technicon engaged in inequitable conduct in prosecuting the patent application.

FACTS

1. Background.

The '593 patent is entitled "Automatic Analysis Apparatus and Method."It is concerned with a method of analyzing samples called continuous flow analysis ("CFA").The patent states that it especially relates to the analysis of substances in the blood and other body fluids.CFA involves drawing samples into a tube and mixing the sample with a reagent.The mixture changes color or intensity in relation to the amount of a known substance in the sample.It then flows through a flow cell where the change in color or intensity of each sample is measured by a colorimeter.The colorimeter output is recorded on a graph by a stylus.

Dr. Leonard Skeggs introduced the use of air bubbles to separate samples in the flowing stream in 1957.A key aspect of the Skeggs system is the division of each sample slug into many segments by intrasample air.This intrasample air is accurately and reliably pumped into the flowing stream.The air was then removed (debubbled) before the samples were passed to the flow cell for measurement.The Skeggs system incorporated a "wash" cycle between samples.It is a "wetted" system.

Dr. Skeggs obtained patents for many of his inventions.Technicon was the assignee of many of his patents and commercialized the Skeggs system as the AutoAnalyzer ("AA").In 1957 this system became the first commercially available automatic CFA equipment.

The conventional art prior to the '593 patent was commercialized as the AA and later as the SMA.(A later version was called the "SMAC.")They operated as "wetted" systems."Wetting" generally means the adherence of a liquid to the walls of a conduit.In a "wetted" CFA system the walls of the conduit which the sample flows through are "wetted" either by the sample or by added surfactants.This wetting forms a thin film on the conduit and helps create a smooth flow in the conduit.Wetted CFA systems require intrasample segmentation by bubbles to help minimize contamination.A wash is used between samples to cleanse the system and reduce intersample contamination.

In a wetted system, all measurements of all sample segments flowing through the conduit were recorded.It took a number of the segments flowing through the conduit to reach a "steady state" so clinicians feel comfortable measuring the sample reached.The segments flowing through the conduit before the steady state was reached were essentially used to wash the system.Because each segment was recorded, the recording on a wetted system generally was in the form of an S curve.

Contamination in a CFA system means the carryover or mixing of each sample segment with the liquid film left on the walls of the conduit by the previous sample.Sample segments passing through the conduit prior to reaching the steady state mix with the film from the previous sample.After a number of these segments have passed through the conduit, they cleanse it so that only the current sample is being measured.

The amount of contamination (or wash) in the wetted system presented problems for users of CFA systems.The contamination in the wetted system, the need for many intrasample bubbles and the consequent debubbling process slowed down analysis and limited the instrument's speed and precision.The wetted system also required relatively large quantities of samples and reagents.

2.Development of the '593.

Mr. Smythe began working as a researcher with Technicon in 1960.Dr. Shamos was hired as a scientific advisor to Technicon in 1964.The two men began working together in 1964.In October of 1961, Mr. Smythe theorized the debubbler might be contributing to the contamination of the system and that elimination of the debubbler would be helpful.In March 1964they theorized that the real problem with wash in the conventional CFA system was with the flow cell and, more importantly, with the debubbling device.They filed the patent application in May 25, 1964.Following a number of amendments and rejections, including an appeal to the CCPA, the '593 patent issued on April 16, 1974.

The specification and preferred embodiment of the '593 patent describe a nonwetted system.In theory, a nonwetted system is one in which the conduits are made of material which is not wetted by either the sample segments or the segmentizing fluid.The film on the inside of the conduits between the sample segments that is present in a wetted system is missing and the output is a square wave form as opposed to the S curve that is generally seen in a wetted system.

The key difference between a wetted and nonwetted system is the presence or absence of film on the inside of the conduit which results in the characteristic difference in the output record.Although a totally nonwetted system exists in theory only, I find that wetted and nonwetted systems are based on significantly different principles of operation and involve fundamentally distinct methods and materials for performing CFA.

Because there is little or no contamination or film left in a nonwetted system, there is no need for the many intrasample segments to act as a wash as in the wetted system.The intersample bubbles in a nonwetted system are introduced at the sampler probe rather than by a pump as in a wetted system.Because of the need for many intrasample bubbles in a wetted system, the sample segments in the wetted system tend to be smaller than those in the nonwetted system.

3. Specification.

The '593 patent states that the primary object of the invention is to improve the precision of the analysis of the samples of liquid.It states that this object can be accomplished by using "as much as possible, liquid conduits, such as Teflon tubing, which have non-wetting surfaces...." '593 Patent, Col. 1.It goes on to state that "the sample liquid which is transmitted through the flow cell during the analysis operation ... has a volume at least as large and preferably larger than the volume of the flow cell, so that there is no air in the flow cell when the liquid analysis operation is being performed."Id.The specification goes on to state that it is unnecessary to remove the bubbles in the stream before the treated liquid goes through the flow cell, "since the segmentation of the liquid stream by air bubbles is such that a sufficient volume of the treated sample liquid is devoid of air bubbles...."Id.The specification states that another object of the invention is to provide both apparatus and method of analysis so that the measurement of the analysis of each sample is indicated "substantially instantaneously during the flow of the treated sample through the flow cell, to the extent that the recorder is able to provide such substantially instantaneous recording, so that the trace on the recorder chart has a square wave form."Id.

The specification shows some major differences between the prior wetted CFA systems and the system described in the specification: (1) the use of a conduit tubing such as Teflon, with a nonwetting surface; (2) sample segments as large as the flow cell; (3) the removal of the debubbler; and (4) instantaneous chart recording in a square wave form.

4.Preferred Embodiment.

The preferred embodiment of the '593 patent describes the best mode of the invention as operating in essentially the following manner.

An indexible table carries several liquid sample containers.A probe can be controlled to dip into...