Blicharz v. Hays

496 F.2d 603, 181 U.S.P.Q. (BNA) 712, 1974 CCPA LEXIS 168
CourtCourt of Customs and Patent Appeals
DecidedMay 9, 1974
DocketPatent Appeal No. 9116
StatusPublished
Cited by7 cases

This text of 496 F.2d 603 (Blicharz v. Hays) 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.

Bluebook
Blicharz v. Hays, 496 F.2d 603, 181 U.S.P.Q. (BNA) 712, 1974 CCPA LEXIS 168 (ccpa 1974).

Opinion

BALDWIN, Judge.

Blicharz and Jackson (Blicharz) appeal from that portion of the decision of the Board of Patent Interferences which awarded priority of count 1 of interference No. 96,557 to Hays, the senior party.1

The Subject Matter

The count in issue reads (paragraphing added):

1. Granulation method, which comprises uniformly mixing substantially dry particles of a physiologically active material adapted to be ingested and being damaged at elevated temperatures with substantially dry particles of a physiologically inactive and physiologically compatible thermoplastic material which softens at a temperature below the temperature at which said physiologically active material is damaged,
heating the thus formed mixture to above the softening temperature of said thermoplastic material and below the temperature at which said physiologically active material is damaged so as to cause agglomeration of the particles of physiologically active material with the particles of the thermoplastic material and thereby forming powdered agglomerates,
and cooling the resulting agglomerates to a temperature below the softening point of said thermoplastic material so as to form a granulate which can be directly pressed into tablets wherein said particles of active material and said particles of thermoplastic material are mixed throughout the steps of heating and cooling.

The recited method requires simultaneously granulating the physiologically active material (increasing the size of the initially very small particles) and coating it with the thermoplastic material. Consequently, it is sometimes referred to as a “one-step” process to distinguish it from a prior art technique in which the active material was first granulated and then coated with wax.

The Record

Hays took no testimony, but relied on his July 1, 1963 filing date. Blicharz took testimony and introduced evidence to prove prior actual reduction to practice. The testimony includes that of the co-inventors, Blicharz and Jackson. During the pertinent period, Blicharz worked at Lederle Laboratories of American Cyanamid on the development of an improvement on a process for making Lederle’s line of “Sequels” products, which would release a medicament or active ingredient over a period of time after being ingested. Jackson was Blicharz’s group leader. Also testifying was Weidenheimer, who was head of the Pharmaceutical Product Development Section in which Blicharz and Jackson worked. Other witnesses were Tiesler, Weidenheimer’s immediate superior, and Butensky, a co-worker of Blicharz and Jackson.

The principal exhibits include pages from Blicharz’s laboratory notebook, which had not been signed or witnessed, certain reports referring to the Sequels work, and a “Record of Invention” which had been submitted to the patent departriient of American Cyanamid by March 5, 1963.

For an actual reduction to practice, Blicharz particularly relies upon an experiment recorded as “D” on page 88 of his notebook dated December 7, 1962, although many related experiments are also reported therein. The notebook describes experiment D as involving mixing 800 grams of ferrous fumarate pow[605]*605der and 200 grams of glyceryl monosterate (Arlacel 161), placing them in an 8-inch coating pan, and heating them with a 250-watt infrared lamp. After 15 minutes of heating, Blicharz noted that the contents “looked good” and that the temperature was 64° C. He cooled and dumped the contents and found that a layer containing the original mixture had formed at the bottom of the pan. He then returned the removed material to the pan and heated it for 20 minutes at a temperature of 66° C, cooled and removed the contents again, screened out the undersized and oversized particles, and sent the material to the assay department of Lederle for analysis. The results of the assay, subsequently recorded in the notebook, showed what Blicharz testified was an excellent release rate and very good iron potency. He further considered the yield of appropriate size particles to be satisfactory “to demonstrate that we had a workable process.” He showed the particles to others, including the co-inventor Jackson, and they decided to scale up the test and try the process with other active ingredients. The further tests do not require any particular description here.

Weidenheimer recalled a previous test (described in Blicharz’s notebook on page 84) where Blicharz sprayed a wax solution- on dry powdered ferrous fumarate to form what appeared to be a satisfactory granulate. The inventors and Weidenheimer felt that better results, including avoiding the use of an expensive solvent in the wax spray solution, could be obtained by starting with a dry mix. He testified that he witnessed the first experiment using dry powdered active material ánd dry powdered wax. During cross examination, he stated that he knew that he observed experiments C (an experiment similar to D, but on a smaller scale, run just prior to D) and D, reported on page 88 of Blicharz’s notebook, since he had previously asked Blicharz to inform him when the experiment using dry powders was to be run.

The Board Decision

The board held that the Blicharz record failed to establish an actual reduction to practice prior to Hays’ July 1, 1963 date, setting forth several conclusions of law to support that view. It concluded first that there was nothing in the record to evince a conviction of success in the process at Cyanamid prior to the filing of the application in 1965. The board remarked that “the record is devoid of any comment by management after January 1963 relative to the Blicharz experiments.” Largely on that basis, it held that “what we are dealing with here is an abandoned experiment.” The board also commented that Weidenheimer, whom Blicharz principally relied upon for corroboration of the work performed in Experiment D, purportedly witnessed, in whole or in part, many other experiments conducted by Blicharz after the claimed date of December 7, 1962. It considered it “nothing short of phenomenal” that Weidenheimer, testifying from memory nearly eight years later, could distinguish Experiment D from all the others. Finally, the board expressly rejected the corroborating testimony of Weidenheimer relative to Experiment D as “unreliable since it is based solely on testimony based on his memory in 1970 as to events occurring in 1962; Weidenheimer kept no contemporaneous diary of events occurring in 1962 but his testimony is dependent wholly on his memory refreshed by examining the contemporaneous notebook pages of Blicharz, the inventor, which notebook had not been signed by Weidenheimer, as a witness or otherwise.”

Opinion

We are convinced from the record as a whole that Experiment D reported on page 88 of Blicharz’s notebook for December 7, 1962, was performed as described with the results set forth. While it is clearly established that the notebook was assigned to Blicharz, the pages are unsigned and not witnessed. This notebook alone is not sufficient to [606]*606corroborate his detailed testimony concerning the single step process of Experiment D.

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Cite This Page — Counsel Stack

Bluebook (online)
496 F.2d 603, 181 U.S.P.Q. (BNA) 712, 1974 CCPA LEXIS 168, Counsel Stack Legal Research, https://law.counselstack.com/opinion/blicharz-v-hays-ccpa-1974.