CAFC holds “Dolly the Sheep” claims ineligible, but leaves door open to claims reciting clones “markedly different” from nature

Ryan Chirnomas | May 21, 2014

In Re Roslin Institute (Edinburgh)

May 8, 2014

Panel: Dyk, Moore, Wallach. Opinion by Dyk.

Summary

Although the method of creating a cloned animal was patent eligible, the CAFC held that claims directed to the clone itself were not patent-eligible. The court further holds that simply because something is made by man is insufficient to render it patent-eligible, absent a showing that the claimed composition is markedly different from that found in nature. Although a cloned animal may have some differences from the DNA donor animal, unless these differences are claimed, the CAFC will not consider them.

 

Details

In 1995, scientists at the Roslin Institute of Edinburgh, Scotland developed a technique of cloning mammals called somatic cell nuclear transfer, and later became famous when “Dolly” the sheep was disclosed to the world as the first cloned mammal. Their method included fusing the nucleus of an adult sheep somatic cell (any cell other than a sperm or egg) with an enucleated oocyte (an immature egg cell having had its nucleus removed). This then develops into an embryo, which is implanted into a surrogate.

Roslin filed a patent application, and eventually received U.S. Patent No. 7,514,258 in 2009 for the above-described method. Roslin also filed a series of continuation applications, claiming the cloned animal itself.   Representative claims are as follows:

155. A live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.

164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.

These claims were rejected by the Examiner under 35 U.S.C. §101 as reciting non-patent eligible subject matter. The claims were also rejected under §102 and §103 in view of animals produced by prior art cloning methods, such as in vitro fertilization. The rejections were upheld by the PTAB, and appealed to the CAFC, although the decision only discusses the §101 rejection, and ignores the §102 and §103 rejections.

After briefly summarizing relevant Supreme Court precedent of Funk Brothers, Chakrabarty and Myriad, the CAFC dismissed Roslin’s first argument that the claimed clones are patentable because they are “the product of human ingenuity,” and not “nature’s handiwork.” Rather, because the clones are exact genetic clones of the parent animal, the court held that they are not “markedly different” from animals found in nature, in a similar manner that the isolated DNA in Myriad was not “markedly different” from the DNA found in nature. As such, the claims did not meet the requirements for patent eligibility under §101 in view of precedent.

Roslin argued that even if the clones were not patent-eligible merely due to being the product of human ingenuity, they were patent-eligible because the clones were indeed distinguishable over DNA donor. First, Roslin argued that the clones exhibited phenotypic differences due to vaguely described “environmental factors,” such as the uterine environment. However, the court stressed that these phenotypic differences were unclaimed. Further, the CAFC stressed that these phenotypic differences occur due to environmental factors, not the work of the inventors.

Next, Roslin argued that the clones were distinguishable from natural animals because the clones possess mitochondrial DNA from a different source than a natural animal. Mitochondrial DNA is maternally inherited. In the oocyte of a natural animal, the mitochondrial DNA is from the same source as the nuclear DNA. However, in Dolly, the mitochondrial DNA is from the oocyte, and the nuclear DNA is from a different source (the somatic cell donor). However, the CAFC again stated that this feature was unclaimed. The panel seemed to leave the door open for patent-eligibility based on a claimed difference, such as the mitochondrial DNA source, by stating that “having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case.” However, the court also questioned whether a difference such as the mitochondrial DNA source would be sufficient to influence the characteristics of the animals. In other words, even this subject matter was recited, this difference may or may not be enough for the clones to be markedly different from the somatic cell donor animals.

Finally, Roslin argued that the clones were patentable because they were “time-delayed versions of their donor animals” and were therefore different. The CAFC dismissed this argument briefly, seemingly on the basis of the animals being structurally identical.   The court thus concluded that the claims are not patent eligible under §101.

Take away

Although it may be tempting to interpret this case as standing for the proposition that animal clones are not patent-eligible per se, that may or may not be the case. It appears that the CAFC will not read anything into the term “clone”, similar to how Examiners are instructed in the recent USPTO guidelines not to read anything into terms like “isolated”, “synthetic”, “cDNA”, etc. However, creative claim drafting highlighting differences from a similar natural product/animal might help to cross the §101 threshold. Although untested here, it appears that a claim limitation such as “wherein said clone comprises mitochondrial DNA from a different source than nuclear DNA” may have been sufficient to make it clear that the claimed animal is “markedly different” from the donor animal. However, it would appear that in the case of the oocyte donor and somatic cell donor being the same animal, this may be insufficient, and further limitations may be required. Alternatively, claiming the clones in a product-by-process format, along with evidence demonstrating the difference from the donor animal regarding mitochondrial DNA inherent in that process, may have been successful. One thing is clear, however—simply because a claimed article is made by man is not sufficient to make it patent eligible, where the claim is interpreted as broad enough to read on a natural animal, composition, etc.

Full Opinion

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