By: M. Alexander Otto
A patent on a research model consisting of a beagle dog whose immune system is compromised to allow for the study of pulmonary infections is invalid as obvious under 35 U.S.C. §103, the American Antivivisection Society and the International Center for Technology Assessment's Patent Watch Project charged Feb. 25.
In an letter to the Patent and Trademark Office's commissioner of patents, the requesters maintained that a person of ordinary skill would doubt that a dog is a machine, manufacture, or composition of matter.
Claim 1 of the '872 patent reads as follows:
A canine model for invasive pulmonary
fungal infections in an immunocompromised host
consisting essentially of a beagle dog being rendered profoundly immunocompromised comprising an invasive pulmonary fungal
infections, wherein the fungus is a common species causing pulmonary fungal
infection or an opportunistic pulmonary infectious fungus, wherein symptoms of
pulmonary fungal infections are present.
Claims 2 and 3 describe the fungus used, and Claim 5 outlines the following three-step method for obtaining the "canine model": (a) obtaining a beagle dog; (b) immunocompromising said beagle; and (c) infecting said beagle with a fungus. Claim 6 states that immunosuppression of the beagle is achieved "by total body irradiation," and Claim 7 states that the irradiation "comprises X-ray-cobalt irradiation."
The request for reexamination, filed under Sections 311-318 of Title 35, begins with an obviousness argument. Specifically, the requesters maintain that the combination of several printed publications and one patent (5,833,946) would have made the '872 invention obvious to a person of skill in the art. The prior art references include an article about the use of dog models for pulmonary fungal infections, an article stating that beagles are convenient models in biomedical research, a patent on a method for treating immunosuppressed mammals antifungal medicaments, and an article on immunosuppressing beagles by X-ray.
The requesters go on to argue that the '872 patent claims "lack statutory subject matter under 35 U.S.C. §101 in view of evidence that a person of ordinary skill in the art would reasonably doubt that the claimed 'beagle dog,' as a whole, is a 'machine,' 'manufacture,' or 'composition of matter.'" That evidence, according to the requesters, is in two printed publications: the "Leesti reference" which teaches that a non-human animal does not fall within the definition of machine, manufacture, or composition of matter, and the "Nadon reference," which states that a "complex life form does not fit within the current parameters of the Patent Act.
As further evidence "establishing that the claimed Beagle dogs are complex life forms and thus not mere manufactures or any inventor's composition of matter," the requesters cited the patent holder's admission that the dogs within the scope of the '872 claims had "severe depression," which, according to the requesters is "a mental condition of sentient, self-aware beings."
The requesters admitted that, under Section 2258 of the Manual of Patent Examining Procedure Manual rejections of reexamined patents may not be based on matters other than patents or printed publications. However, the PTO here is being asked to review a substantial new question of patentability based solely upon evidence presented in the form of prior art printed publications, the requesters maintained.
In any event, according to the requesters, the position of the MPEP that Section 101 issues are outside the scope of reexamination is not reflected in the statute itself, nor in any duly promulgated rule. In the requesters' view, the rule at 37 C.F.R. §1.906(a) stipulating that reexaminations must be based on patents or printed publications "does not preclude treatment of an issue under 35 U.S.C. §101 that is based upon printed publications."
There is no prior art evidence that a beagle dog is a manufacture or composition of matter, the requesters maintained, urging that their request "gives the Examiner, for the first time, a chance to benefit from the evidence set forth" in the Leestei and Nadon references.
The requesters discounted the contention that it may seem incongruous that printed publications consisting of court decisions could be constituted as "prior art." At least 64 issued patents have listed legal decisions as evidence, the requesters maintained.
However, the two precedential decisions at issue
here are distinguishable, the requesters argued, pointing to Diamond v.
Chakrabarty,447
The facts here are also distinguishable from Allen,the requesters argued, noting that Allenconcerned an oyster, not a dog "with a large brain, feelings, sentience, self-awareness and intelligence."
If any precedent covers the facts at hand, the requesters asserted, it is American Fruit Growers Inc. v. Brogdex Co.,238 U.S. 1, 8 USPQ 131 (1931), where the Supreme Court, in deciding whether an orange with a rind coated with a preservative was statutory subject matter, held that not everything touched by man rises to the level of manufacture.
In like manner, the requesters urged, "a Beagle inoculated with a fungi is not statutory subject matter, since he remains a product of nature; the fungal treatment does not change any of his essential characteristics."
The requesters acknowledged that it may appear to some that they are "going over ground well-trod in Chakrabarty." However, the requesters stressed that they are not proposing that a beagle is not patentable solely because he is alive. Rather, the letter asserted, "Requesters respectfully submit that he is a complex life form, a friend to millions, and never fit to be categorized as a mere manufacture or inventor's composition of matter."
The American Anti-Vivisection Society and the International Center for Technology Assessment/Patent Watch Project are represented by Peter T. DiMauro, Washington, D.C.
Copyright 2004, The Bureau of National Affairs, Inc., Washington, D.C.