University of Cincinnati Medical Center v. United States Department of Commerce

537 F.2d 518, 63 C.C.P.A. 107
CourtCourt of Customs and Patent Appeals
DecidedJuly 15, 1976
DocketNo. 75-25 C.A.D. 1174
StatusPublished
Cited by3 cases

This text of 537 F.2d 518 (University of Cincinnati Medical Center v. United States Department of Commerce) is published on Counsel Stack Legal Research, covering Court of Customs and Patent Appeals primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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University of Cincinnati Medical Center v. United States Department of Commerce, 537 F.2d 518, 63 C.C.P.A. 107 (ccpa 1976).

Opinion

Lane, Judge.

This is an appeal by the University of Cincinnati Medical Center from a decision of the Secretary of Commerce denying its application for duty-free entry of a surgical laser pursuant to item 851.60, Tariff Schedules of the United States (TSUS),1 added by section 6 of the Educational, Scientific, and Cultural Materials Importation Act of 1966.2 We affirm.

Appellant filed its first application for duty-free entry of Medilase 791 surgical laser manufactured in Israel by Laser Industries Ltd. on October 10,1973. The application alleged that the imported laser was to be used in investigative laser surgery, to study safety programs, and to teach the use of the laser to students and residents. The application also asserted that a similar domestically manufactured unit, an American Optical high-output C02 laser, was not scientifically equivalent to the imported laser because the imported unit had a “higher out-put,” was “flexible, reliable, sterizable [sic],” and had a “small probe.” The appli[109]*109cation also stated that no domestic laser was “flexible enough and precise enough to produce results desired in investigative laser surgery.”

A notice of appellant’s application was published in the Federal Register3 as required by statute.4 In response to this notice American Opticál Corp. submitted a letter dated December 21, 1973, to the Department of Commerce describing its surgical laser. Accompanying the letter was a brochure detailing the specifications of the American Optical surgical laser and copies of several journal articles authored by surgeons who had used the American Optical laser. Also attached was a bibliography listing numerous other articles describing the use of the American Optical laser in surgery. The letter indicated, contrary to assertions in appellant’s application, that the American Optical laser had a higher output than the imported laser (100 watts vs. 50 watts), and that the American Optical unit was sterilizable to the same extent as the imported laser. The letter also stated that reliability of the Medilase 791 vis-a-vis the American Optical unit could only be judged over extended periods of use. The letter did concede that the handpiece of the imported laser utilized a smaller probe than the American Optical unit.

■ Appellant’s application was forwarded to the National Institutes of Health’s Florence Agreement Committee5 for a recommendation on appellant’s application. The Florence Agreement Committee recommended a denial of appellant’s application, stating:

In view of the paper by Kaplan and Ger, entitled “The Carbon Dioxide Laser in Clinical Surgery,” Israel Journal of Medical Science, Vol 9, No 1, pp 79-83, January 1973, the justification * * * [of scientific nonequivalency] is inadequate. The application fails to show wherein this late model laser for surgery made by American Optical Corp. is not the scientific equal of the [imported] article.

Based on this recommendation, appellant’s application was denied by the Secretary of Commerce, without prejudice to resubmission, on March 24, 1974.

Thereafter, on June 10, 1974, appellant resubmitted its application. The resubmitted application was identical to the original with respect to the allegations of the intended use of the imported laser and the allegations of deficiencies of the American Optical laser quoted above. However, accompanying the resubmitted application was a statement by Dr. Goldman, the director of appellant’s laser laboratory, concerning the imported laser. Relevant portions of Dr. Goldman’s statement are as follows:

The delivery system developed by Laser Industries Ltd., Amada St., Israel, is unique [110]*110and not available in this country or anywhere else in the world. Prior to this laser we used an experimental laser surgical model from American Optical, Co. This was unsatisfactory and inadequate for our cancer patients and we had to give this up. So at present, the imported laser system with its American components is the only one which can be used now in our laser cancer and burn program, and for other research at the Medical Center at the University of Cincinnati.
This laser is used for research purposes in the Surgery Unit Operating Room area, our own staff fixes and modifies this laser so that it can be used on patients. This often requires considerable work since this is a research tool and is not an assembly live [sic] instrument and in itself is not ready for surgery. So, again, this is a research and experimental tool.
* * * This laser is used both for research then, in laser safety, and in laser surgery
This is the only laser, or as a matter of fact, the only effective instrument which can be used to treat burns without significant blood loss at the fames [sic] Shriner’s Burn Institute of the Medical Center of the University of Cincinnati. Burn experts all over the country are watching these studies and viewing the special exhibits of this important work.
For certain forms of cancer in women, the laser can do the surgery 'required without significant blood loss. This is work done by the Department of Surgery, Dr. James Fidler and the Department of Obstetrics and Gynecology, Dr. Helmut Schellhaus. Also, in a similar manner with this horrible venereal disease epidemic of almost inoperable extensive venereal warts, this laser is the only surgical instrument found, as yet, which can be used without much bleeding and with only minimal recurrences.
For cancer deep in the throat and for Papillomas in children, bloodless surgery can be done with this laser more effectively than with other instruments at the present time.
4* *Í* 'I'
In brief, this is a unique, important research tool, as yet, not available in the U.S.A. This is flexible, effective, safe design and development.

A notice of appellant’s resubmitted application was published in the Federal Register.6

Comments in response to appellant’s application were again submitted by American Optical Corp. in a letter dated August 7, 1974.7 This second letter by American Optical Corp. was again accompanied by scientific articles. Particularly relevant portions of the letter stated that the American Optical Model 200 Research Laser was capable of delivering up to 80 watts to the operating site, double the power of the Medilase 791. The letter also disputed Dr. Goldman’s assertion that the Medilase 791 “is the only laser . . . which can be used to treat burns without significant blood loss * * citing two articles in support.8 American Optical Corp. further disputed Dr. Goldman’s assertion “[f]or [111]*111cancer deep in the throat * * * bloodless surgery can be done with this laser more effectively than with other instruments at the present time,” stating:

The comment of Dr. Goldman relative to “cancer deep in the throat” (sic) is disturbing since it is either willfully misleading or reveals a loss of touch with the clinical state of the art of C02 laser surgery. Indeed the American Optical surgical C02 laser with its coupling to a Zeiss operation microscope is the only

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537 F.2d 518, 63 C.C.P.A. 107, Counsel Stack Legal Research, https://law.counselstack.com/opinion/university-of-cincinnati-medical-center-v-united-states-department-of-ccpa-1976.