USPTO Examining What It Means to Be "Human"

"I don't think anyone knows in terms of crude percentages how to differentiate between humans and nonhumans," John Doll, Deputy Commissioner for Patents at the USPTO reportedly told The Washington Post. Yet neither is the office comfortable with a "we'll know it when we see it" approach, he added: "It would be very helpful . . . to have some guidance from Congress or the courts."

His comments followed from a discussion of U.S. Patent Application Serial No. 10/308135 which originally claimed "A chimeric embryo comprising cells from a first and one or more second animal species, wherein said first animal species is human, wherein said second animal species is non-human, and wherein said second animal species is non-primate." In its final rejection of the application, the USPTO noted, among other things, that

Applicant argues that an interspecific animal maturing from the chimeric embryo contains cell contributions from both species throughout all its organs, regardless of whether the chimeric embryo consisted of 100 human cells and one non-human cell or vice versa. There does not appear to be a factual basis in the specification for this argument. Instead, the specification discloses that an animal developing from the chimeric embryo would be a source of human organs. Further, as presented previously in this office action, [prior art references] teach that chimeric embryos can develop into animals of chimerism limited to one organ or no chimerism. Thus based on these results, an embryo of the present claims could certainly produce an animal of only one cell type or an animal predominantly of one cell type. Further, there is no basis for excluding a human that has no non-human cells from the scope of claim 50, which claims a descendant of the chimeric animal. The germ cells of the claimed chimeric animal would be either human or non-human, but not interspecific. Descendant progeny would not be interspecific.

Applicant argues that the statute does not restrict patentability based on whether the claims cover a human being, and that the Director lacks authority to impose a limitation on patenting a human. For reasons already stated on the record, the Office does not agree that humans are patentable subject matter.

In fact, MPEP Section 2105 states that "If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter."

"There are chimeras out there that serve very valuable purposes in medical research, such as mice that make human antibodies," Michael Werner, Chief of Policy for the Biotechnology Industry Organization, reportedly told the Post in the same article. "This is sufficiently technical scientifically that it should be left to scientific bodies like the National Academy of Sciences to decide." The NAS report is now due in April.