Dolly the sheep was a petri-dish creation. She was a new mammal reprogrammed from an adult cell—one that was a fully differentiated cell extracted from a pre-existing adult mammal. Cell biologists, geneticists, biochemists, philosophers, bioethicists, pundits, politicians, the Pope, and now patent examiners, attorneys, and judges—all have something to say about this feat, technically called cloning by somatic cell nuclear transfer. And yet no one fully understands the characteristics of the animals resulting from this cloning process (or, as the inventors call it, the “second creation”).

Although Dolly herself is long dead, the issue of whether such clones are patentable is still unresolved. The USPTO’s Patent Trial and Appeal Board (PTAB) recently upheld a rejection of U.S. Patent Application No. 09/225,233, which claims the clone.  The rejection effectively bars, for the time being, the patenting of Dolly and other clones of non-embryonic mammals as not patent-eligible under 35 USC § 101, unpatentable under §§102, and 103. Now, the U.S. Court of Appeals for the Federal Circuit has been asked to address the issue.

It seems the extraordinary scientific feat that led to Dolly has created more barriers than it has opened doors. Indeed, within days of Dolly’s birth announcement in 1997, calls to ban human cloning spread throughout the world. For the next ten years, exclusive licenses were drawn and patent interferences fought and settled over the technology used to create Dolly. Now, claims to cloned animals stand rejected by the USPTO. Some might argue that the impact of the PTAB decision is softened by the portfolio of patents already issued to methods of cloning by somatic cell nuclear transfer. However, method claims have not satisfied others, including, notably, Myriad Genetics, which recently defended its patented gene based product claims before the Supreme Court. And the issuance of method patents hasn’t stopped the Roslin Institute and Dolly’s creators from taking the USPTO to task in In Re Roslin Institute (Edinburgh), pending at the Federal Circuit.

On February 5th, the Federal Circuit will hear arguments over whether or not Dolly and other somatic cell nuclear transfer clones are (i) patent-eligible subject matter or mere products of nature, (ii) novel over prior-art clones made by a different process, and (iii) rendered obvious by that same prior art. No small task. Or is it?

From Roslin’s perspective, the Supreme Court’s decision in Myriad already resolved the patent eligibility issue, and in its favor. Perhaps the PTAB’s decision that Roslin’s claims were not patent-eligible was simply a question of timing. After all, the PTAB did not have the Myriad decision in hand when it affirmed the Examiner’s rejection of all pending claims. The USPTO, however, did have the benefit of the Myriad decision when it filed its brief with the Federal Circuit. Needless to say, the USPTO does not agree that the Myriad decision supports Roslin’s view that the clone is patent- eligible, arguing instead that it supports its own position to the contrary. Which side does the law favor?

Roslin’s representative claim is drawn to “a live-born clone of a pre-existing, non-embryonic donor mammal . . . .” Perhaps not surprisingly, claim construction is pivotal to all three of the patentability issues (§§ 101, 102, and 103) in this case. Again not surprisingly, the parties disagree on how to define the creature Roslin created and now claims. The USPTO reduces Roslin’s clone to its genetic information. Thus, its pervading argument is that the claimed clone has the same genetic information as its parent/donor. For all intents and purposes under the patent law, the USPTO argues that this genetic identity makes the clone identical to its parent. The USPTO argues that because the parent exists in nature, its cloned copy is also a product of nature.

Naturally, Roslin’s view differs significantly. Roslin argues that the claimed clone is not identical to its parent/donor, in spite of its shared genetic information. Roslin also argues that because a clone does not exist in nature and cannot arise naturally, it is a laboratory creation and thus cannot fall under the product-of-nature exception to patentability. But wasn’t that the argument Myriad made about genomic DNA?

At first blush, the USPTO’s approach perhaps looks more attractive for its simplicity. In fact, it tracks Myriad’s simplification of isolated genomic DNA to its genetic information. In Myriad, the claimed isolated DNA was boiled down to its informational content, without regard to any acknowledged structural and functional differences between DNA in its natural genomic environment and isolated DNA. But key to the Court’s reasoning in Myriad was its observation that “the claims are not expressed in terms of chemical composition . . .  Instead, they focus on the genetic information encoded by” the claimed genomic DNA.

In briefing its position in In Re Roslin, the USPTO has not argued that the claimed subject matter is written in an information-centered manner. Nonetheless, according to the USPTO, the claims must be construed entirely by reference to the clone’s genetic information. The USPTO argues that “a clone is a genetic copy of an original living thing, in that the clone has the same genetic code as the original living thing.”  In the USPTO’s view, this is the pivotal fact that determines the patentability of the claimed clones. Quoting Diamond v. Chakrabarty, the USPTO reasoned that any differences that do exist “do not, on the present record, result in a creature having a name, character and use distinctive from those of the donor.”

On the other hand, Roslin specifies a number of features of the claimed clones (e.g., clone, age, behavior, eye color and other phenotypes) that markedly differ from the parent/donor animal, thus resulting in an animal that does have a distinctive name, use, and character. From Roslin’s perspective, nuclear genetic parity is the only thing a clone shares with its parent. In fact, there have been scientific reports demonstrating that somatic cell clones and their donors do differ genetically, at least in the length of their chromosomal tips or telomeres.  Such differences, if Roslin is allowed to rely on them, should help establish that the clones are closer to Myriad’s cDNA than to DNA isolated from a genome.

At times, both Roslin and the USPTO define a clone by referring to the parent/donor. But Roslin defines what is claimed by reference to a “clone of a pre-existing non-embryonic donor,” or in other words, by considering the elements of the claim as a whole. For example, Roslin argues that a clone of a pre-existing, non-embryonic source is necessarily younger than its parent/donor: it is a “time-delayed source of nuclear genomic material” of its parent. No other mammal existing in nature has the utility “[to] exist at a time later than its donor mammal, but have the same genetic component.” Because a claimed clone’s genomic DNA comes from a single non-embryonic cell (the donor), it is always younger than its donor and is an undiluted, unscrambled creation of man.  Roslin’s reliance on “source limitations” as a point of novelty for its clones finds support in well-settled case law regarding recombinant proteins. However, Roslin relies on the same logic in its arguments that the claimed clones are patent-eligible under § 101, where the law is simply not as settled.

Unlike Roslin, the USPTO appears to give no weight to the terms “pre-existing” and “non-embryonic” as applied to the clone and donor material, even though both of these terms are limitations of all pending claims. The USPTO was not persuaded by Roslin’s construction of the claims because, in its view, “the claims are to the clones themselves and do not include parental donor mammals.” The USPTO notes that “the difference in age between a particular mammal encompassed by the claim and its nuclear donor is not a characteristic of the mammal itself and does not distinguish the mammal from naturally occurring mammals, which exist at all different ages.” As for utility, the USPTO takes the position that the cattle, goat, and sheep “resulting from the cloning process have the very same uses as the donor mammals,” such as, dairy, wool, and meat.

Moreover, and still true to its genetic information-centered approach, the USPTO concludes that “Roslin ‘did not create or alter any of the genetic information’ in producing the clones, just as Myriad did not create or alter any genetic information in isolating the DNA. Myriad, 133 S. Ct. at 2116.” Roslin’s claims, however, unlike Myriad’s, are neither to DNA nor are they written in a genetic information-focused fashion. Following the USPTO logic, Myriad’s cDNA should not be any more patent-eligible than a clone. After all, isn’t the genetic information in cDNA essentially the same as that in naturally existing mRNA? Because the Supreme Court found cDNA to be patentable, genetic identity alone cannot be the standard for patentability.

As noted above, the USPTO refused to incorporate donor source limitations into its claim construction, beyond comparing genetic information. Instead, it focused on the relationship between the Roslin clone and “naturally occurring mammals” and argued that “Roslin’s clones look and behave exactly like naturally occurring mammals and thus they are no more patent eligible than the bacteria in Funk Brothers, which ‘perform[ed] in their natural way,’ ‘serve[d] the ends nature originally provided[,] and act[ed] quite independently of any effort of the patentee.’” Funk Bros., 333 U.S. at 131.”

The Supreme Court explained the importance of excluding naturally occurring things from patentability in Myriad, stating that doing otherwise “would be at odds with the very point of patents, which exist to promote creation.” Quoting Chakrabarty, the Court noted that “products of nature are not created.” However, given the technological innovation required to produce a Roslin clone, i.e., a reprogrammed product of a pre-existing, non-embryonic donor cell, it is difficult to view Roslin’s clones as anything other than a creation.

In its anticipation and obviousness analysis, the USPTO again defines the claimed clone based solely on its genetic information. Using that definition, “the claimed clones and the prior art clones [i.e., made from embryonic donors] [are] identical or substantially identical.” In fact, in the USPTO’s view, all clones are identical because they are nothing more than organisms genetically identical to the donor regardless of how they are made—be it by prior-art methods or by Roslin’s somatic cell nuclear transfer methods—or how they are claimed (source limitations notwithstanding). Using this logic, the USPTO determined that Roslin’s assertion of age and phenotypic differences are irrelevant because they are not “structural characteristics.” The USPTO argued that “Roslin’s reliance on Amgen and the cases cited therein for the proposition that [claimed] source limitations can impart novelty to a product is misplaced” and, in the same vein, that Roslin’s declarations providing evidence of the distinguishing features of the claimed clones should be accorded no weight because they “consist only of conclusory statements.”

The biotechnology industry will be watching closely to see whether the USPTO’s definition of the claimed clone based entirely on its genetic information is adopted by the Federal Circuit, or whether Roslin’s definition of the claimed clone based on its donor’s characteristics will prevail. Any decision could potentially have a far-reaching impact on other biotechnology inventions that are based on reproducing a natural product, such as, e.g., a recombinant protein that has the same amino acid sequence as the original protein.