Baxter Travenol Labs, In re, 91-1313

CourtUnited States Courts of Appeals. United States Court of Appeals for the Federal Circuit
Citation21 USPQ2d 1281,952 F.2d 388
Docket NumberNo. 91-1313,91-1313
PartiesIN re BAXTER TRAVENOL LABS.
Decision Date30 December 1991

Daniel D. Ryan, of Fuller, Ryan & Hohenfeldt, Milwaukee, Wis., argued, for Baxter. Of counsel was Bradford R.L. Price, of Baxter International Inc., Deerfield, Ill.

Teddy S. Gron, argued, for the Com'r of Patents and Trademarks, Arlington, Va. With him on the brief, were Fred E. McKelvey, Sol., and Richard E. Schafer, Associate Sol.

Before NIES, Chief Judge, PLAGER and LOURIE, Circuit Judges.

LOURIE, Circuit Judge.

Baxter International, Inc. (Baxter) appeals from the February 28, 1991, decision of the United States Patent and Trademark Office Board of Patent Appeals and Interferences, Appeal No. 90-2204. The Board affirmed the rejection of claims 1, 3-12, 14-16, 20-23, and 29-37, in a reexamination of U.S. Patent 4,222,379 (the Smith patent) as anticipated under 35 U.S.C. § 102(b). The Board also affirmed the rejection of claims 1-24 as obvious under 35 U.S.C. § 103. Claims 25-28 were allowed by the examiner and are not in issue. We affirm.

BACKGROUND

The Smith invention relates to a multiple blood bag system for collecting, processing and storing the therapeutic components of whole blood (red blood cells, plasma, and platelets). 1 The system includes a first (donor) bag for collection and storage of the red blood cells and at least one second (transfer) bag 2 for collection and storage of another blood component. According to the Smith invention, the donor bag contains a hemolysis-suppressing, blood-leachable plasticizer, di-2-ethylhexyl phthalate (DEHP), whereas the second bag is made of a different plastic polymer, free of blood leachable plasticizer. Prior to the time of the Smith invention, the industry used DEHP as a plasticizer in blood storage bags, but desired to eliminate DEHP due to concern about its possible deleterious effects. It was discovered by another Baxter employee that DEHP had the apparently unexpected effect of suppressing hemolysis in red blood cells, thus making it desirable to store red blood cells in bags containing On October 16, 1987, Baxter filed a request for reexamination of the Smith patent. With the request, Baxter submitted a copy of a document entitled "Contract PH 43-67-1403; Final Technical Progress Report; Development of Containers for Preservation of Frozen Blood Components" (Becker document). This document, describing a new blood bag system, was authored by Mr. Becker, a Baxter employee, in October 1969 and was discovered during preparation for an earlier interference proceeding. Mr. Becker's testimony, taken during the earlier proceeding, was also submitted. In reexamination, the examiner rejected most of the patent claims over the Becker reference and the Board affirmed. Baxter then appealed to this court.

                DEHP.   The Smith patent claimed this discovery as a multiple bag system
                
DISCUSSION
A. Anticipation

Anticipation is a question of fact. Therefore, we will not reverse the Board's finding of anticipation unless it is clearly erroneous. In re Bond, 910 F.2d 831, 833, 15 USPQ2d 1566, 1567 (Fed.Cir.1990).

The Board found that the Becker document taught both two- and three-blood bag systems in which the primary or donor bag was made of polyvinyl chloride (PVC) and a secondary or satellite bag was made of unplasticized Teflon TM. The Board also found that one skilled in the art would have known that the primary bag was plasticized with DEHP, thereby anticipating the Smith invention. We agree.

In describing its blood bag system, the Becker document makes two references to then-available commercial blood bag systems. The most significant reference is on page 49, where Becker describes his double blood pack system design as "very similar to [Baxter] Travenol's commercial, two bag blood container. The exception is that the secondary transfer pack was a 350 ml Teflon container...." The Board was correct in characterizing the dispositive question regarding anticipation as whether one skilled in the art would reasonably understand or infer from the Becker document's teaching that Becker's primary bag was plasticized with DEHP. As Baxter notes, there is no express reference to DEHP in the Becker document.

Testimony from those skilled in the art, through depositions and declarations, and Baxter's own admissions, established that Baxter's commercial systems during this time period all contained a primary bag plasticized with DEHP. Therefore, since Becker referred to Baxter's commercial system and Baxter's commercial systems utilized a DEHP-plasticized primary bag, it is clear that one skilled in the art would have known that Becker was referring to a DEHP-plasticized primary bag. That fact, coupled with Becker's disclosure that the second bag was made of Teflon TM, leads to the unmistakable conclusion that the claims at issue were anticipated.

Baxter argues that these depositions, declarations, and admissions are extrinsic evidence, which may not be considered when determining the anticipatory teaching of a reference. This is incorrect. Baxter acknowledges, as it must, that extrinsic evidence may be considered when it is used to explain, but not expand, the meaning of a reference. Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565, 1576-77, 18 USPQ2d 1001, 1010 (Fed.Cir.1991). Here, the depositions and declarations of skilled workers and Baxter's admissions were used to identify what materials Baxter's commercial bags contained at the time of the Becker document, thereby explaining what the phrase "[Baxter] Travenol's commercial, two blood bag container" would have meant to one skilled in the art. This evidence clearly shows that those skilled in the art, reading the Becker document, would have known that Becker's primary bag was plasticized with DEHP.

Additionally, Becker testified during the earlier interference that the primary bag in "[Baxter] Travenol's commercial, two bag blood container," to which he referred, contained DEHP. Baxter argues that this too is improperly considered extrinsic evidence and that we must look only at what the Becker document said, not at what Becker Baxter further argues that the Becker system was experimental, not FDA approved. Therefore, one skilled in the art would not necessarily have thought that Becker's primary bag must have been plasticized with the only FDA approved plasticizer (DEHP), since there were other non-DEHP (non-FDA approved) plasticizers available at that time. This argument is not persuasive. The fact that Becker's system was experimental is irrelevant. Becker taught use of the primary bag from Baxter's commercial system, which was plasticized with DEHP. Therefore, all the elements of the Smith...

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