In RE. Dane K. Fisher and Raghunath V. Lalgudi
Decided September 7, 2005
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Judge Michel with Judges Rader and Bryson, Rader dissenting
* A patent claim must be supported by a disclosed "specific and substantial" utility showing of "a specific benefit (that) exists in currently available form.""
The PTO refused Dane's claims to certain unique but partial DNA sequence segments, or "ESTs" because Dane "did not know the precise structure or function of either the genes or the proteins encoded for by those genes." The examiner and PTO Board rejected Dane's proffered utility (diagnostic uses for yet unknown compounds) as insufficiently specific. Dane appealed to the Court of Appeals for the Federal Circuit.
A panel majority affirmed, because a patent disclosure must show a use "which provides some immediate benefit to the public" (emphasis in original). The claimed invention here was "mere 'object[s] of use y may undergo revision. However, this refinement of the utility test should not affect the patentability of research method tools, which exploit specific discovered biological effects and/or chemical reactions, and thus have demonstrated "immediate value." The Federal Circuit pointed out in this case that the frustrated applicant could not even prove industry interest in his ESTs.
Gary H. Rasmusson and
Glenn F. Reynolds v. Smithkline Beecham Corp.
Decided June 27, 2005
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Judge Bryson with Judges Plager and Prost
* "[U]tility must be disclosed [by
real data or believable logic] to satisfy the
section 112 enablement requirement."
* "[A]nticipation does not require actual performance of suggestions in a
disclosure."
This case affects the use of prophetic claiming in biotech patent applications. Gary and Smithkline each filed a series of progressively more detailed patent applications covering ideas in the field of prostate cancer treatment. The PTO Board of Patent Appeals and Interferences held an interference and declared Smithkline the first inventor for use of an enzyme inhibitor because Gary’s first 8 applications failed the enablement requirement. Gary had asserted in early applications that a compound was an anticancer agent but did not provide any data to challenge conventional wisdom and thus was not "obviously correct." The PTO also found that a European patent application did not anticipate Smithkline’s disclosure because the European application was not enabled for the same reason as. Both sides appealed various issues to the Federal Circuit.
The Federal Circuit affirmed that Gary’s applications were unenabled for lack of persuasive support (i.e. either a showing of real data or an obviously correct argument). The Federal Circuit explained that "[I]f mere plausibility were the test for enablement under section 112, appliants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success." The court also reversed the non-anticipation holding because enablement of prior art for 102 purposes can be proven by later results and the European reference inherently was enabled. That is, enablement for patentability purposes and enablement of prior art for anticipation purposes differ because section 112 requires a disclosure to teach how to make and use an invention, wherein section 102 lacks this requirement.
Prophetic inventions often are easy to write but are not enabled unless an ordinary skilled artisan would believe the assertions of utility as obviously correct. Unfortunately for Gary, a scientific report finally confirmed the prophetic clinical usefulness of his claimed compound 10 months before his ninth application. Enablement was not possible until that date because his data-less prophesy was not believable until proof was available.
Princeton Biochemicals, Inc. v. Beckman Coulter, Inc.
Decided June 9, 2005
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Judge Rader with Judges Schall and Gajarsa
* Motivation to combine claim elements for obviousness can arise from a
skilled
artisan's general knowledge of how closely related prior art solves similar
problems.
Princeton sued Beckman for allegedly infringing patent claims to a coiled capillary electrophoresis apparatus at the U.S. District Court for the District of New Jersey. A jury found infringement and no invalidity but Judge Mary Cooper deemed the verdict unsupported by substantial evidence and granted judgment as a matter of law in favor of Beckman. Princeton appealed to the Federal Circuit.
The Federal Circuit affirmed the invalidity holding after reviewing evidence of motivation to combine a coiled (versus straight) tube to a capillary tube apparatus from the prior art. An implicit suggestion to combine was found in the knowledge of the skilled artisan and "the nature of the problem (which) called for exactly the solutions in the prior art." Still further, the court pointed out (as expressed by the PTO during examination) the cited prior art that contained all claim elements in combination "are closely related techniques." That is, motivation to combine existed because all elements were found in close prior art that solved the same problem, and it was established (using expert testimony in this case) that "one of ordinary skill in the art would look to these related fields."
The plaintiff in this case may have lacked sufficient expert testimony. The jury decision was overturned because "there was not substantial evidence to support the jury verdict (of no motivation to combine)." Furthermore, the Federal Circuit decision emphasized that the plaintiff "offered no evidence to rebut" statements from the defendant that a suggestion to combine items of prior art merely came from knowledge of a skilled artisan. If rebuttable evidence had been presented, perhaps the jury verdict would have stood scrutiny.
The case summaries and other information here
represent the contemporary, private views of Marvin Motsenbocker and are
intended to be informative only and not to give legal advice or opinions. Any
views expressed or implied are subject to change and are not necessarily those
of any law firm, its attorneys or clients.