Astra-Sjuco, AB v. US Intern. Trade Com'n

• Decision Date: 28 August 1980
• Docket Number: Appeal No. 80-3.
• Citation: 629 F.2d 682
• Parties: ASTRA-SJUCO, A. B., Medline Industries, and Caring International Division of Medline Industries, Appellants, v. UNITED STATES INTERNATIONAL TRADE COMMISSION and Steridyne Corporation, Appellees.
• Court: U.S. Court of Customs and Patent Appeals (CCPA)

629 F.2d 682

ASTRA-SJUCO, A. B., Medline Industries, and Caring International Division of Medline Industries, Appellants, v. UNITED STATES INTERNATIONAL TRADE COMMISSION and Steridyne Corporation, Appellees.

Appeal No. 80-3.

United States Court of Customs and Patent Appeals.

August 28, 1980.

Andrew P. Vance, Barnes, Richardson & Colburn, New York City, for appellants.

Dana M. Raymond, Allan H. Bonnell and James J. Maune, Brumbaugh, Graves, Donohue & Raymond, New York City, for Astra-Sjuco AB.

Gary L. Fairchild, Winston & Straw, Chicago, Ill., for Medline Industries.

Russell N. Shewmaker, Gen. Counsel, Claud L. Gingrich, Deputy Gen. Counsel, Theodore W. Kassinger, N. Tim Yaworski, Washington, D.C., of counsel, for International Trade Commission.

Richard L. Aitken, Lane, Aitken & Ziems, Washington, D.C., for Steridyne Corp.

Before MARKEY, Chief Judge, RICH, BALDWIN and MILLER, Judges, and RE, Chief Judge.^*

BALDWIN, Judge.

This is an appeal from the July 25, 1979, order of the International Trade Commission (Commission) pertaining to investigation No. 337-TA-56, In the Matter of Certain Thermometer Sheath Packages. The Commission with one member dissenting, determined that there was a violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337,¹ by the importation into, and sale in, the United States of certain thermometer sheath packages found by the Commission to infringe certain claims of valid U.S. patents, and ordered that the subject packages be excluded from entry into the United States for the terms of the patents except where such importation is licensed by the patent owner. We affirm.

Background

A complaint was filed with the Commission on June 7, 1978, on behalf of Steridyne Corporation (Steridyne), alleging that Astra-Sjuco A.B. (Astra-Sjuco), Medline Industries (Medline), and Caring International Division of Medline (Caring) were violating section 337 by the unauthorized importation and sale of certain thermometer sheath packages alleged to infringe certain claims of U.S. Patent Nos. 3,552,558 ('558) and 3,847,280 ('280), both issued to George W. Poncy (hereinafter the Poncy patents).

Steridyne is the exclusive licensee under the Poncy patents and manufactures and sells in the United States thermometer sheath packages covered by said patents.

Astra-Sjuco is a Swedish company which supplies the imported sheath packages, marketed under the TempoTek trademark, which it buys under a long-term contract with a Swedish manufacturer, Devello A.B. (not a party to this action). Medline is the importer of the TempoTek sheath packages and distributes them under its own name and through its Caring division. The TempoTek sheath is made in accordance with U.S. Patent No. 4,051,950 ('950), issued to Harry Jarund, a principal in Devello A.B.

The majority of the Commission determined that the TempoTek sheath falls within claims 1, 4, 5, 8, 9, 13, 15, 16, 17 and 18 of the '558 patent and claims 1, 2 and 5 of the '280 patent. The Commission treated the claims of the '280 patent as though they stand or fall with independent claims 1 and 13 of the '558 patent. Appellants' discussion in its brief also focuses on these claims, which read as follows:

1. A flexible sheath package for clinical tools and instruments comprising:

a. a sheath body of heat sealable material having an open end for the insertion of an instrument;

1. said sheath having a sterilizable exterior surface;

b. a separable, disposable outer cover for said sheath comprising heat sealable material wholly enclosing the outer surfaces of the sheath and sealed thereto on each side at the area of said sheath opening;

1. said cover having a sterilizable interior surface;

c. said sheath being defined by a seal line in the form of a tear seal, said tear seal joining said sheath and said cover together along the line of said seal, thereby enclosing said sheath body within the interior body of said cover; and

d. said outer cover and the waste portions of said sheath material outside of said seal line being separable from said sheath along said tear seal to expose said sheath for clinical use when said instrument is inserted therein.

13. Means for sheathing instruments against transmission of infectious diseases comprising an assembly having:

a. upper and lower layers of material with heat sealable, sterilizable facing surfaces;

b. intermediate layers of heat sealable, sterilizable material disposed between said upper and lower layers;

1. each of said intermediate layers being in contact with the respective adjacent heat sealable facing surface and with each other;

2. each of said intermediate layers being sealed along a marginal portion to its adjacent outer layer;

c. all of said layers being united by a seal defining the outline of the sheath, whereby a sheath is formed by said intermediate layers within the line defining said seal, said line forming a tear seal in said intermediate layers, said sheath having an open end and a closed end;

d. said upper and lower layers being strippable from said sheath and from each other substantially along said tear seal to expose said sheath for clinical use when an instrument is inserted therein.

Claims 1 and 5 of the '280 patent read:

1. A sheath package for surgical instruments and the like comprising superimposed laminations of material formed into two separate layers, the inner layer of each lamination forming a sheath for the reception of an instrument, said sheath having an open end and a closed end, the outer portions of each lamination comprising a cover for said sheath, said laminations being joined together by a seal defining said sheath, said seal between said laminations being constructed so that said outer portions are strippable from said sheath along said seal upon the insertion of an instrument into said sheath.

5. A flexible sheath package comprising two flexible layers sealed together along a seal line to define a sheath, a cover enclosing the outer surfaces of said layers within said seal line, the seal between said inner layers being constructed and said cover being fixed to said layers in a manner so that the outer portions of said flexible layers outside of said seal line is torn away from said sheath when said outer layer is peeled from said sheath with an instrument within said sheath.

As shown in figures 1 and 2 of the Poncy '558 patent reproduced above, the Poncy sheath package comprises two inner strips 12 and 14 of thin, flexible material and two outer strips 10 and 11 sandwiching said inner strips between said outer strips. The inner strips are joined together by a tear seal along the seal line 16, thus providing a thermometer sheath formed between the two inner strips. The outer cover strips 10 and 11 are releasably sealed to the inner strips along the tear seal line 16. The interior of the sheath 20 is open to the exterior of the package through the mouth of the sheath so that a thermometer can be readily inserted into the sheath while the sheath is still in the package.

To use the sheath, a thermometer is inserted therein while the sheath is still in the package and the cover strips are then pulled off, leaving the thermometer sheath 20 on the thermometer. The waste material of the inner strips 12 and 14 outside the tear seal line 16 is left attached to the sheath in the sheath package until the cover strips are pulled off, at which time this waste material is automatically torn away from the sheath. The nature of the tear seal formed between the inner two strips is that it is weakened along the center of the seal line 16 so that when the waste material of the inner two strips 12 and 14 is torn away, the tear seal tears down the middle of the tear seal leaving the waste portion of the inner two strips 12 and 14 still joined together along the outer half of the tear seal with the inner half of the tear seal also still joined together to form the sheath 20.

The imported TempoTek sheath package, as shown in figures 1 and 2 of Steridyne's Exhibit CS-9, reproduced above, comprises two inner strips 50 and 51 of thin plastic material which are joined together by a tear seal 58 to form a thermometer sheath in the two inner strips. The two inner strips 50 and 51 are sandwiched between paper cover strips 53 and 54 and are releasably sealed to the paper cover strips along the seal line 58. A green plastic end cover strip 56 is sealed to the upper strip 51 in the area of the mouth of the sheath and overlaps the paper cover strip 53. A white plastic end cover strip 57 is sealed to the lower inner strip 50 along the seal 61 and overlaps the paper cover strip 54. To use the TempoTek sheath package, a thermometer is inserted between the plastic strips 56 and 57 into the sheath defined by the tear seal line 58 in the inner strips 50 and 51. The cover strips are then pulled off causing the waste material of the inner strips 50 and 51 outside the seal line 58 to be torn away from the thermometer sheath with the cover strips and leaving the thermometer sheath on the thermometer.

An evidentiary hearing was conducted by a Commission Administrative Law Judge (ALJ), who recommended that the Commission determine that there was no violation of section 337 in the importation and sale in the United States of the TempoTek sheath packages. This recommendation resulted from his conclusion that the subject claims were invalid as obvious under 35 U.S.C. § 103 in view of prior art, or, if valid, the subject claims were not infringed. The ALJ also concluded that the importation and sale of the TempoTek sheath had the effect or tendency to injure substantially the domestic industry.

The Commission, with one member dissenting, ordered the exclusion from entry into the United States of the TempoTek sheaths for the terms of the Poncy patents except where properly licensed. The majority determined that there was a violation of section 337 in the importation and sale of the TempoTek sheath...