APPLICATION OF RYNKIEWICZ

Decision Date11 April 1968
Docket NumberPatent Appeal No. 7894.
Citation55 CCPA 977,390 F.2d 742
PartiesApplication of Henry J. RYNKIEWICZ and Gilbert B. Ayres.
CourtU.S. Court of Customs and Patent Appeals (CCPA)

Samuel Branch Walker, Stamford, Conn., William P. Spielman, Washington, D. C., for appellants.

Joseph Schimmel, Washington, D. C. (S. Wm. Cochran, Washington, D. C., of counsel), for Commissioner of Patents.

Before RICH, Acting Chief Judge, SMITH and ALMOND, Judges, and Judge WILLIAM H. KIRKPATRICK*.

ALMOND, Judge.

This is an appeal from the decision of the Board of Appeals affirming the examiner in finally rejecting claims 1-12 of appellant's application1 entitled "Method of Opening Suture Packages." No claims were allowed.

The application relates to a method of opening plastic packages which contain wet-packed surgical sutures without compromising the sterility of the sutures. This is accomplished by packaging the suture 3 in a plastic envelope 2. This envelope is dehydrated, sterilized, charged with a sterile conditioning fluid adapted to soften the suture, and then sealed. Under sterile conditions, the suture-containing envelope 2 is inserted into previously sterilized larger second envelope 5 which is then sealed by application of heat or use of adhesives. Figure 1 shows the completed package. The second envelope 5 is formed with ears or flaps 21, 22 in a manner so that the two sides may be grasped and pulled apart, thus presenting the inside suture-containing package to the surgeon in a completely sterile field (Fig. 8).

Figures 1 and 8 are reproduced below:

Claim 1 is illustrative:

1. A method of serving surgical sutures in a sterile packet which comprises: stripping apart the two sheets between which the packet is sterilely sealed by a peripheral seal, retaining any contaminants present in location on the surface of the separated sheets, and peeling the sheets back from the packet whereby the packet is presented sterilely to a user.

Claims 2 and 3 limit the type of suture material to a "non-boilable gut suture," recite the presence of a conditioning agent and define generically its composition, and define characteristics of the packet and outer envelope. Claims 4-12, additionally, include the steps of heat sealing and steps to release the inner packet containing the suture.

The references are:

                  Hirsch              1,962,900         June 12, 1934
                  Waugh               1,997,443         April 9, 1935
                  Whitefoot           2,676,702        April 27, 1954
                  Ringlen et al.      2,751,074         June 19, 1956
                      (Ringlen)
                

Hirsch discloses use of a double envelope in preserving sterility of surgical sutures, ligatures and dressings. The patent discloses that the envelopes are seamless tubes of transparent or translucent cellophane. It is stated that the outer envelope may be opened by tearing or clipping without harming or destroying the inner envelope which is clearly visible to the operator. It is further stated that the outer envelope having been torn or clipped:

* * * the inner envelope is still maintained in a sterile condition * * and may be partially shaken from the opened outer envelope and the doctor with his sterile gloved fingers may then grasp the projecting end of the inner envelope and remove * * * the suture * * *.

Waugh relates to packages for sterile surgical cord that can be used as a ligature or suture. The packets are constructed of a porous glassine type paper, and are retained in antiseptic condition by continuous immersion in a germicidal liquid.

Whitefoot discloses an envelope containing bandages, gloves or like material maintained in sterile condition. The envelope is provided with ears or flaps which may be grasped and pulled apart along a side seam to separate the walls of the envelope to present the sterile contents.

Ringlen relates to a hermetically sealed foil package containing a surgeon's blade, the object of the invention being to open the package and remove the contents without requiring manual contact with the contents of the package. The package or envelope is composed of front and back sections adhered to each other at the margins by adhesive. Opening of the envelope is accomplished by pulling apart end tabs to separate the two halves of the envelope along the adhesive seam, thus to expose the contents. It is stated that the "invention is not limited to a surgeon's blade but may be used for packaging other articles."

The examiner, applying the provisions of 35 U.S.C. § 103, rejected all of the instant claims over either Whitefoot or Ringlen in view of Hirsch. He pointed out the disclosure in Hirsch of a sterilized suture package containing a suture in an inner envelope which, in turn, is positioned within a larger outer envelope. The examiner noted that both Whitefoot and Ringlen disclose a sterilized surgical package with two sides comprising a pair of pull tabs to facilitate opening by stripping down or a peeling action. This, he observed, is the same procedure by which appellants open their package. The examiner referred to the Ringlen specification wherein it is stated that

When the blade is ready to be used, the protrusion is grasped and pulled until the free end tabs are exposed. These are grasped and the two sections are separated. Numerals omitted.

Through this opening procedure the blade is exposed so that the blade may be "attached to a handle without manual handling of the blade." Emphasis quoted.

The examiner concluded this phase of his rejection with the observation that:

In view of the teaching of Hirsch, it would be obvious to one of ordinary skill in the art to package the surgical equipment in either Whitefoot or Ringlen et al. in an inner container having a sterilizing aqueous solution. Once Whitefoot and Ringlen et al. are modified in light of Hirsch it immediately becomes apparent that not only is applicants\' package presented but also his method of opening the package. The use of alcohol as a
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