1. Over the last two decades, society has witnessed dramatic advances in the field of biotechnology. Today, we not only engineer the buildings we live in, but also engineer our food and the organisms around us to improve our quality of life. Biotechnicians have produced drought-resistant crops that offer improved resistance to pests.[1] Genetically-altered organisms have been developed to perform a wide array of functions. Harvard University created an “oncomouse,” which is susceptible to a certain type of cancer;[2] bacteria have been engineered to consume oil spilled in the oceans;[3] and genetically altered livestock produce milk containing drugs valuable to human health.[4] Recently, the Human Genome Project was successful in deciphering the complete sequence of human DNA, and in the near future, we may receive vaccinations for diseases such as measles and polio by munching on foods instead of enduring painful shots.[5]

2. This rapid development in biotechnology has created significant challenges in many areas of the law. Patent law, in particular, has been directly affected by the advances in biotechnology. The Supreme Court’s 1980 decision in Diamond v. Chakrabarty ushered in a new era in which patents could be obtained for non-naturally-occurring living organisms.[6] While this decision set forth the framework for determining whether or not a particular organism qualifies as patentable subject matter, it did not resolve all of the issues associated with patenting organisms.

3. In 1996, Dolly the sheep made headlines as the first mammal brought into existence by cloning a cell taken from an adult animal.[7] This scientific breakthrough generated a flurry of commentary directed toward the various moral, ethical, and legal issues of cloning.[8] Some of this commentary focused on how patent law might handle the first applications for patent protection for organisms created through cloning.[9] It has been suggested that the acceptance of cloned unnaturally-occurring organisms as patentable inventions by the Patent and Trademark Office is imminent.[10] What is less clear, however, is whether or not clones of non-transgenic, or non-genetically altered, organisms are patentable. This paper analyzes the potential patentability of cloned, non-transgenic organisms specifically when the species to which the cloned organisms belong has become extinct.

4. One of the fundamental principles of patent law that appeared in the very first U.S. patent act[11] and that continues to apply today is that “naturally-occurring” organisms do not constitute patentable subject matter.[12] For example, under the present law, one cannot merely discover an animal living happily in the wild and obtain a patent for that animal. Such discoveries have been held as “manifestations of . . . nature, free to all men and reserved exclusively to none.”[13] The ability to clone an organism creates a potential paradox within the patent system that results from the possibility of regenerating an extinct organism. For instance, once a species becomes extinct, there is a compelling argument that organisms of that species are no longer “naturally-occurring.” Thus, it appears that once a species becomes extinct there would be no bar to patenting that organism if it could somehow be regenerated. Cloning provides just such a method for regeneration. Indeed, cloning offers the possibility to resurrect an organism from extinction, and thus regenerate an extinct species. The fundamental question addressed here is whether these regenerated, formerly extinct organisms, created by cloning, are patentable.

5. Cloning offers a method of reproducing an organism without relying upon sexual reproduction.[14] Interestingly, reproduction by cloning does not require any input from male organisms; the entire process of cloning can be accomplished with female organisms. To clone an organism, one must have an egg donor, a surrogate mother (both of which are necessarily female organisms), and an organism that supplies the DNA, which can also be female. In a sense, cloning could make the males of the world obsolete.[15] Additionally, cloning is unique in that the organism that supplies the DNA necessary for cloning does not need to be alive. As long as DNA from the parent organism is preserved, for example by cryogenic freezing in liquid nitrogen,[16] this DNA can be used to create a clone of the parent organism long after the parent organism has died.

6. This possibility suggests a scenario that once was reserved only for science fiction. One can imagine a “Jurassic Park-like” tale where a species has become extinct, yet scientists discover preserved DNA from members of that species and use it to clone the species back into existence. [17] With current cloning technology, such a tale is far from fantasy. While it may not yet be possible to clone dinosaurs due to the lack of both suitable surrogate mothers and sufficiently preserved DNA,[18] scientists are quite able to clone organisms that have more recently become extinct. Since Dolly was cloned in 1996, researchers have begun targeting endangered species and recently extinct species as prime candidates for cloning. One primary motivation for this new focus is to demonstrate that cloning can serve as a viable means for conservation.[19] In January of 2001, the first clone of an endangered species was born.[20] Noah, an Asian gaur (a heavily muscled, humpbacked, ox-like animal that has become endangered through decades of sport hunting) was cloned from skin cells taken from a recently deceased adult gaur.[21] Not only was Noah the first endangered species to be cloned, but he was also to be the first cloned animal to gestate in the womb of another species; rather than using another gaur as a surrogate mother, researchers enlisted the aid of an ordinary Iowa cow named Bessie to act as Noah’s surrogate mother.[22] Unfortunately, Noah died of dysentery two days after his birth.[23]

7. The same group that cloned Noah has reached an agreement with the Spanish government to clone the first extinct animal, a Pyrenean mountain goat called the bucardo.[24] In January of 2000, the last remaining bucardo was killed by a falling tree in Ordesa National Park.[25] Recognizing the impending fate of the bucardo species, scientists retrieved a tissue sample from the last bucardo prior to its death.[26] Researchers are presently planning to use the tissue sample and a common ibex as a surrogate mother[27] to create the world’s first clone of an extinct species.[28]

8. Determining whether extinct organisms regenerated by cloning are patentable is no longer just a theoretical question. Soon, a clone of an extinct species, whether it is the bucardo or another species, will come into existence. At that time, the patent system could be confronted with the difficult task of determining whether regenerated organisms qualify as patentable subject matter under the Chakrabarty framework. That is, are regenerated organisms “naturally-occurring,” or did their natural occurrence cease upon extinction? Furthermore, the Patent and Trademark Office (PTO), and potentially the courts, will have to determine whether the regenerated organisms are novel. This paper examines whether regenerated organisms are included in the types of inventions that may be patented under the patent statutes. It also looks at the considerations necessary in making a determination of whether regenerated organisms can constitute patentable subject matter, and whether they can satisfy the novelty requirements of the patent statute. Finally, several policy considerations are contemplated regarding whether granting patents for regenerated organisms would have a negative impact on currently living endangered species.

The Cloning Process

9. Conceptually, the process of cloning is fairly simple. First, cells from the organism to be cloned are acquired. These cells may be embryonic (meaning that they originate from an embryo), or they may be somatic (such as skin cells taken from an adult organism).[29] These “donor” cells are grown in a culture in the laboratory to increase their numbers. Next, unfertilized eggs are harvested from either a female of the species to be cloned or a female of a closely related species. These unfertilized eggs are then enucleated by removing all of their natural nuclei by microsurgery.[30] The crucial step in the cloning process involves transferring the nuclear material from the donor cells to the enucleated eggs. Prior to nuclear transfer, the donor cells are starved to “freeze” the cells in a quiescent (resting) phase of their division cycles; this treatment is believed to make the chromosomes of the donor cells more susceptible to reprogramming to initiate the growth of the new organism upon nuclear transfer.[31] To effect the transfer of the nuclear material of the donor cells to the enucleated eggs, the donor cells are placed next to the eggs and fused with a mild electric current.[32] Upon fusion, the recipient eggs contain a complete set of genes, and they behave just as if they had been fertilized by sperm.[33] These “fertilized” eggs are then transferred to the womb of a surrogate mother where they proceed to divide and develop naturally into a fetus.[34] While the surrogate mother is usually a female of the species to be cloned, in certain instances, a surrogate mother may be chosen from a species that is closely related to the cloned species.[35]

10. As a result of this process, the cloned organism has no genetic relationship to the surrogate mother. Rather, the cloned organism is genetically identical to the organism that provided the donor cell from which the transferred nucleus was taken.[36]

Importance of Determining Proper Claim Scope for Cloned Organisms

11. In exchange for public disclosure of an invention, the patent system grants an inventor a right to exclude others from making, using, or selling that invention for a limited amount of time.[37] Because the inventor enjoys a monopoly over the invention for a limited time, this right to exclude often translates to significant commercial value. With such a valuable right at stake, it is important that the scope of the patent does not improperly extend beyond the subject matter of the invention.

12. The metes and bounds of the invention are determined by the claims of the patent.[38] Two commonly used claim types found in patents are process claims and product (or apparatus) claims. A patent which includes both product claims and process claims entitles the owner of the patent to exclude others not only from making, using, or selling the product itself, but also from practicing the patented process of making the invention. Thus, a patent including both process claims and product claims provides potentially broader protection than one including only one type of claim.

13. With respect to cloning and cloned organisms, one can direct claims to the process for cloning, and additionally, one may elect to direct claims to the cloned organism itself. Claims to the process of cloning would exclude others from practicing the claimed method of making the organism. Process claims, however, do not prohibit others from making, using, or selling the same organism if it was created by a process different from the claimed process of the patent. Product type claims directed to the organism would exclude others from making, using, or selling the organism regardless of the process used to produce the organism. Therefore, it is important to consider the patentability of process claims and product claims independently to ensure that patents for cloned organisms have an appropriate scope. The patent owner’s right to exclude should not extend to what is not patentable. With respect to formerly extinct organisms regenerated by cloning, it is important to determine first whether the process for regenerating the organism is patentable and then if the right to exclude may properly be extended to include the cloned organism itself.

Do Regenerated Organisms Constitute Statutory Subject Matter?

14. Like many other developments in the field of biotechnology, cloning offers some unique challenges in determining whether certain biological materials are suitable for patenting. The first hurdle a potential patent claim must overcome is to qualify as statutory subject matter under 35 U.S.C. §101, which states that anyone who “invents or discovers any new and useful process, machine, manufacture, or composition of matter…may obtain a patent therefor.”[39] Interpretation of the language of Section 101 involves determining what kinds of things constitute a process, machine, manufacture, or composition of matter. According to the Supreme Court, Congress intended statutory subject matter under Section 101 to “include anything under the sun that is made by man.”[40] While this interpretation appears to be very broad, the phrase “made by man” suggests that statutory subject matter under Section 101 has limits. In fact, laws of nature, physical phenomena, and abstract ideas have been held not patentable for failure to constitute statutory subject matter.[41] Additionally, “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc²; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of . . . nature, free to all men and reserved exclusively to none.’”[42] These limitations form the basis for the principle that naturally-occurring organisms do not constitute statutory subject matter.[43]

15. The Supreme Court’s decision in Diamond v. Chakrabarty, which provided that a genetically-engineered bacterium constituted statutory subject matter that could be patented, caused a revolution in biotechnology. That decision solidified the principle that a living organism could qualify as a “manufacture” or a “composition of matter” according to the language of Section 101.

16. Chakrabarty, a micro-biologist, applied for a patent directed to an engineered bacterium capable of breaking down multiple components of crude oil. This property was not possessed by any naturally-occurring bacteria. Chakrabarty’s application included claims both for a process of making the bacterium and for the bacterium itself. The process claims were allowed, but the claims to the bacterium were rejected on the grounds that the microorganisms are “products of nature” and that as living things they are not patentable under Section 101.[44] The Court held that the oil-consuming micro‑organism plainly qualified as patentable subject matter. It found that the claim was not to a hitherto unknown natural phenomenon, but was to a non-naturally-occurring manufacture or composition of matter – a product of human ingenuity.[45]

17. Aside from creating a flood of patent applications relating to living organisms,[46] the Chakrabarty decision provided a framework for assessing whether a certain organism qualifies as statutory subject matter under Section 101. Specifically, to qualify as statutory subject matter, an organism must be non-naturally-occurring (different than any found in nature) and it must be a product of human ingenuity (made by man).

18. In applying this framework to cloned organisms, it is useful to consider three different types of patent claims (process, product-by-process, and product) to evaluate whether each constitutes statutory subject matter. Process claims directed to a method of cloning and product-by-process claims directed to an organism created by cloning most likely constitute statutory subject matter regardless of whether the cloned species is extinct. Product claims directed to the organism, however, are dependent on whether the cloned species is extinct.

Process Claims

19. A process claim for cloning an organism could begin as “a method for cloning a sheep comprising the steps of … .” The claim would then proceed to list the necessary steps of the cloning process, such as the enucleation of an egg, the fusion of the egg with a donor cell, etc. When examining the process of cloning in light of the Chakrabarty framework, one immediately recognizes that the cloning process satisfies both prongs of the statutory subject matter test. First, the process is non-naturally-occurring. Cloning is a method of reproduction entirely different from the naturally-occurring process of sexual reproduction. Second, cloning, as a process, clearly results from human ingenuity; cloning would not exist without human research and experimentation. Therefore, a claimed process for cloning would constitute statutory subject matter. In fact, the Patent and Trademark Office has granted patents claiming a process for cloning,[47] which includes regenerating extinct species via cloning. While this patent includes claims directed to a process of cloning a non-human mammal, there are no claims directed to the cloned organism itself as a “product” type claim.

Product-By-Process Claims

20. A product-by-process claim is somewhat unusual and would appear in the form of “a sheep formed by a cloning method including the steps of….” In this type of claim, the product is defined and limited by the process used to create the product. Similar to the process claim, the product-by-process appears to satisfy the requirements for finding statutory subject matter. A sheep formed by cloning is not a natural occurrence, and it is a product of a process invented by human ingenuity.

Product Claims

21. The product claim does not include any reference to the particular method used to create the product. Instead, the product claim recites only the product itself. This type of claim might recite only “a sheep.” Additionally, the product claim might also include specific characteristics of the sheep. In considering the product claim for a cloned organism, it is instructive to consider whether the claim recites a clone of a non-extinct species or an extinct species.

22. A product claim to a cloned organism that is a member of a non-extinct species would not constitute statutory subject matter. For example, Dolly is a clone of a Finn Dorset ewe. Because there are many “naturally-occurring” Finn Dorset sheep, however, a claim to a Finn Dorset sheep would fail to satisfy the first prong of the Chakrabarty test. As an organism, Dolly would not be patentable because she is no different than any other Finn Dorset sheep “found in nature.” In fact, by definition, Dolly is an identical twin of the sheep that provided the DNA for the cloning process. Because the first prong of the Chakrabarty test is not satisfied, there is no need to address the second prong. Cloned organisms of non-extinct species, under current law, would not constitute statutory subject matter.

23. The question of whether a regenerated organism from an extinct species constitutes statutory subject matter is much less clear. Specifically, even though a regenerated organism appears to satisfy the “product of human ingenuity” portion of the test, it is difficult to test an extinct species against the “naturally-occurring” standard.

24. As explained supra, the bucardo, which is a type of Pyrenean mountain goat, is an example of a species that recently became extinct; the last known bucardo was crushed under a falling tree in Spain in January of 2000.[48] Researchers are currently planning to clone the bucardo, and if successful, conceivably a patent application could be filed that might include claims not only to the method of cloning the bucardo, but also to the bucardo itself. To apply the first prong of the Chakrabarty test, one must determine if the regenerated bucardo constitutes a non-naturally-occurring organism. Prior to extinction, the bucardo was clearly a naturally-occurring species. After extinction, however, there is a compelling argument that the bucardo is no longer naturally-occurring. After all, by definition, extinction means “no longer existing or living.”[49] Based on this reasoning and the absolute certainty of extinction, a regenerated organism could constitute statutory subject matter.

25. There are two issues worth considering, though, when applying the “non-naturally” occurring test to formerly extinct organisms. First, to what degree of certainty must an organism be extinct in order to find that it is no longer naturally-occurring? The Chakrabarty test seems to favor a bright line rule — either the species is naturally-occurring or it is not. If even one organism representative of the species remains alive, then the species clearly remains “naturally-occurring,” and the first prong of the test fails. In the case of many species, however, it may be extremely difficult to ascertain whether extinction has actually occurred. For example, researchers have expressed doubt over whether the bucardo is extinct; some believe that individuals of the species may have migrated over the Pyrenees into France.[50] Under one standard, an organism is declared extinct when it has not been observed for fifty years and all specimens in captivity have died.[51] Basing the statutory subject matter determination on such a standard would be highly impractical; a patent applicant would be forced to wait at least fifty years before her claim to a regenerated organism could be patented.

26. Second, does the “non-naturally-occurring” standard cease to apply to a species once all living organisms of that species have died, or can the existence of an organism’s remains still qualify the organism as “naturally” occurring? The argument that an extinct organism is no longer “naturally-occurring” rests on the assumption that the remains of a dead organism fail to satisfy the “naturally-occurring” test. Such an assumption is questionable, however, because once an organism dies, some component of the organism remains in nature. Some of the remains are consumed by other organisms for energy, and some are preserved in the form of fossils. Today through cloning, preserved remains may be used to clone the species back into existence. A bright line rule finding that a species is no longer “naturally-occurring” once there are no more “living” members of that species is arbitrary.

27. The meaning of “naturally-occurring” could validly be extended to include biological remains of dead organisms. Regeneration of extinct species fundamentally depends on the existence of viable remains of an organism to supply the DNA necessary for cloning. It would be somewhat illogical to suggest that these remains are no longer “naturally-occurring” once the organism dies. Further definition of the limits of the “naturally-occurring” standard are necessary to determine whether regenerated organisms could or should constitute statutory subject matter.

28. The second prong of the Chakrabarty test merely asks whether the regenerated organism is a product of human ingenuity. Continuing with the bucardo example, it appears that the regenerated bucardo is indeed a product of human ingenuity. Assuming the bucardo is truly extinct, no bucardos would exist if not for cloning, a process created by human ingenuity. The second prong of the test, however, is subject to some of the same considerations necessary when applying the “naturally-occurring” standard of the first prong. Specifically, if the species is believed to be extinct, but some members of the species are later found in an isolated pocket of habitat, those discovered members of the species exist not as products of human ingenuity. Therefore, in this example, the regenerated organism would not satisfy the second prong of the Chakrabarty test. Clearly, some practical means for declaring a species extinct in a short period of time with near absolute certainty is necessary to declare confidently that regenerated organisms constitute statutory subject matter.

29. In summary, both process claims for cloning organisms and product-by-process claims for organisms created by cloning constitute statutory subject matter whether or not the subject organism is a member of an extinct species. Product claims for organisms, on the other hand, would not constitute statutory subject matter if the cloned organism is a member of a non-extinct species. When the cloned organism is a member of an extinct species, a product claim directed toward the cloned organism may constitute statutory subject matter, dependent upon further interpretation of the scope and meaning of the “naturally-occurring” standard.

Are Regenerated Organisms Novel?

30. In addition to constituting statutory subject matter, an invention must also be new or novel to be patentable.[52] The novelty requirement is set forth as a list of conditions that will bar an applicant from obtaining a patent. From this list, two conditions are especially applicable to the question of whether or not regenerated organisms are novel. First, an applicant is not entitled to a patent if the invention was known or used by others in this country or printed in a publication in this or a foreign country before the invention by applicant.[53] Second, an applicant is not entitled to a patent if the inventor “did not himself invent the subject matter sought to be patented.”[54]

31. To determine whether a regenerated organism can be novel, it is useful to examine independently three of the possible claim types for regenerated organisms. A process claim reciting the specific steps used to clone the extinct species would include the heart of invention, and 35 U.S.C. §102 provides clear guidance for determining whether such a process claim is novel in view of the prior art. Applying Section 102 to product claims presents more of a challenge because the language of the statute does not squarely apply to regenerated organisms. Yet a further challenge occurs when evaluating the novelty of a product-by-process claim.

Process Claims

32. There is no fundamental reason why a process for cloning an extinct organism could not satisfy the novelty requirement of Section 102. Cloning an extinct organism involves a human-invented process enabling reproduction of an organism without relying upon sexual reproduction. To determine whether such a process is novel, the process as claimed would simply be compared to the processes disclosed by the prior art (e.g., patents and publications prior to the invention of the applicant). If the prior art did not “teach” the claimed method, then the claimed method for cloning the extinct organism would be novel and could issue as a patent.

Product Claims

33. Determining whether a product claim, directed toward a regenerated organism, can be novel is more difficult. On the surface, the answer to this question seems obvious. A species that has become extinct has, by definition, already existed. Further, a clone of an extinct organism is genetically identical to a particular organism that has already existed.[55] Because the species to which the regenerated organism belongs has already existed, it appears as though the regenerated organism is not novel. This observation is further supported by the fact that the regenerated organism is a clone that possesses the same DNA as a particular animal that has already occurred in the wild. Thus, the regenerated organism may be even less novel than an organism produced by sexual reproduction whose DNA includes components of both the mother’s and father’s DNA.

34. The language of Section 102 does not easily apply to regenerated organisms. Section 102 has never before been applied to the situation of regenerated organisms because, until recently, the technology did not exist for creating regenerated organisms. Before cloning was developed as a feasible method to resurrect extinct species, all species in existence could be regarded as “naturally-occurring.” Because “naturally-occurring” living organisms have been held as failing to constitute statutory subject matter, it has never before been necessary to consider the novelty of these living organisms according to the language of Section 102.[56] Cloning of extinct species, however, will create the very real situation of regenerating an organism that may be viewed as no longer “naturally-occurring.” If this regenerated organism constitutes statutory subject matter, then it is necessary to consider whether the regenerated organism is novel.

35. Section 102(a) states that an applicant is not entitled to a patent if the invention was known or used by others in this country or printed in a publication in this or a foreign country before the invention by applicant. Certainly, in the case of an extinct species that is regenerated, there will exist printed publications including pictures and a description of the regenerated organism. Such publications in themselves would serve as evidence that the organism was “known,” and would, therefore, be viable as prior art against the claimed invention. To demonstrate lack of novelty, the prior art must anticipate the claimed invention, which means that a single prior art reference must teach each and every element as set forth in the claim, either expressly or inherently.[57] If teaching every element of the claimed invention were the only requirement in demonstrating a lack of novelty of a claimed invention, then a publication clearly showing the anatomy of the regenerated organism would be sufficient to conclude that the regenerated organism was not patentable for lack of novelty.

36. There is an additional, judicially-created standard for evaluating novelty that is more problematic when applied to regenerated organisms. In order to anticipate a claimed invention, a description in a printed publication must also describe the invention in sufficient detail to place the public in possession of it. In other words, the description must provide enough disclosure to enable one of ordinary skill in the art to “make” the invention.[58] Therefore, not only must the prior art provide a description of every element of the invention, but in order to anticipate the invention, the prior art must also teach how to make the invention. The argument can be made that during the time that a species exists in the wild, a description in a publication of that species enables one to make the invention because the organism may still be produced by sexual reproduction. Once the species becomes extinct, however, sexual reproduction is impossible. No longer would the printed publications describing the species be enabling because one of ordinary skill in the art could no longer obtain the organisms necessary to “make” the invention. This argument would continue that even if DNA or other biological materials were preserved from the extinct species, these materials would not serve as anticipatory prior art because one of ordinary skill could not make the invention (i.e., the regenerated organism) without undue experimentation.[59] Under this standard and argument, there would be no bar to patentability of regenerated organisms on novelty grounds.

37. A potential problem with this argument is that it does not contemplate that the level of ordinary skill encompasses cloning as a viable method for regenerating an extinct species. Dolly was produced by cloning in 1996.[60] By now, general knowledge of cloning is widespread, and certainly those skilled in the art are quite capable of producing clones of various organisms based on preserved biological materials.[61] Already it is likely that the level of skill in the art has progressed to the point that no undue experimentation would be required to clone an extinct organism back into existence. All that is required is DNA from a member of the extinct species (assuming public accessibility), a description of the organism for choosing an appropriate surrogate mother, and the necessary equipment. Based on this approach, because printed publications coupled with the general knowledge in the art would enable the invention, regenerated organisms would be unpatentable for lack of novelty.

38. Section 102(f) is, perhaps, more applicable to the question of whether or not regenerated species are unpatentable based on novelty. Section 102(f) states that if the inventor did not himself invent the subject matter sought to be patented, then the invention lacks novelty.[62] When considering a product claim reciting the regenerated organism itself, the question under Section 102(f) becomes, did the inventor invent the regenerated organism?

39. The answer to this question depends somewhat on the definition of “invention.” One such definition of “invention” includes any new device or process developed from study and experimentation.[63] Applying this definition to a regenerated organism, one must ask whether the regenerated organism would qualify as a “new” organism. At first glance, it appears that the creator of the regenerated organism did not actually create a “new” organism. Rather, she created an old organism, the genetic equivalent of which has already existed, by a potentially novel method. All of the study and experimentation that goes into cloning an extinct species back into existence deals with the specific method for reproduction and not with the particular properties of the organism as an end product. In fact, in regenerating an extinct species, the goal is to create an organism that is as representative of the former species as possible.

40. Furthermore, invention requires conception.[64] In the case of a regenerated organism, the conception relates not to the organism itself but to the method for generating the organism. No conception of the organism to be regenerated occurs because the idea of the organism does not extend beyond what is already known. That is, the goal of the “inventor” is to regenerate a known organism that has gone extinct. Unless the inventor has planned to modify the organism from the form that it took in its earlier existence, then only the basic idea of the known organism is necessary to clone the organism. This basic idea that is either learned or originates from a general knowledge base does not rise to the level of conception. Conception of the organism itself would require that the inventor create an idea of a new organism that, at the very least, was different from any form taken during an earlier existence. Therefore, because the inventor of the cloning process used to regenerate an extinct species does not conceive of the extinct species, the inventor would not himself be an inventor of the regenerated organism.

Product-By-Process Claims

41. In contrast to the product claim case, the law is somewhat more capable of handling a product-by-process claim for a regenerated organism. In this case, the regenerated organism would be claimed in terms of the process used to create the organism. For example, a product-by-process claim could recite “a bucardo made by a cloning process including the steps of enucleating an egg cell…” and so on. This type of claim, like the process claim, seems to have no obvious bars to novelty beyond an ordinary evaluation of the prior art. A product-by-process for a regenerated organism is, however, probably not novel.

42. The Court of Appeals for the Federal Circuit has held that “[e]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.”[65] In this case, the inventor had invented an improved process for making a color developer used in carbonless copy paper systems. Both process and product-by-process type claims were included in the patent application. The process claims were allowed, but the product-by-process claims were rejected.[66] The Court held that “[t]he patentability of a product does not depend on its method of production.”[67] Further, “[i]f the product in a product-by-process claim is the same as … a product from the prior art, the claim is unpatentable even though the prior product was made by a different process.”[68]

43. This decision directly applies to the case of a product-by-process claim for a regenerated species. A regenerated organism, such as a bucardo, created by cloning is genetically identical to an organism that has already lived. As already discussed, the particular method for cloning the regenerated organism may be novel, but a product-by-process claim reciting a “bucardo created by cloning…” could not be patentable based on the novelty of the cloning process alone. One must evaluate the novelty of the product itself independent of the process. Applying the rule that if the product in a product-by-process claim is the same as a product from the prior art, then the claim is unpatentable even though the prior product was made by a different process, it is likely that a product-by-process claim for a regenerated organism would be unpatentable. Because a regenerated bucardo would be an identical replica of a product from the prior art (the DNA donor), the product of the product-by-process claim for the bucardo would be identical to a product of the prior art. Thus, this type of claim to a regenerated organism would likely be unpatentable regardless of the method used to create the regenerated bucardo.

44. While claims directed toward the process for creating a regenerated organism may satisfy the novelty requirement of Section 102, product and product-by-process type claims for a regenerated organism probably would not satisfy the novelty requirements of Section 102.

Is the Lost Art Doctrine Applicable to Regenerated Organisms?

45. At least one source has suggested that under the doctrine of lost arts, a claim directed toward a regenerated organism would be patentable.[69] An examination of the characteristics of regenerated organisms in light of the requirements for invoking the lost arts doctrine reveals that regenerated organisms do not meet all of the requirements for qualifying as “lost art.” Therefore, one who regenerates a formerly extinct species should not be entitled to a patent claiming the organism itself (product or product-by-process type claims) based on the doctrine of lost arts.

46. In 1850, the Supreme Court created the doctrine of “lost arts” by holding in Gayler v. Wilder that prior knowledge and use of an invention does not preclude a second, independent inventor from obtaining a patent for the same invention where the original invention has been completely lost.[70] One purpose of the patent system is to provide an original inventor an exclusive right to exclude in exchange for publicly disclosing his invention. If the invention was already publicly disclosed, however, no patent would be granted for at least the reason that the invention would no longer be novel. There is an exception to this principle. If the public disclosure was in the form of knowledge or use in a foreign country, or if the invention was suppressed or concealed, then there is no novelty bar for a patent issuing in the United States. The Supreme Court used this foreign use exception as a basis for creating the lost arts doctrine.

47. The Supreme Court in Gayler noted that knowledge or use of an invention abroad does not preclude an inventor for obtaining a patent for the invention in the United States. The Court found that a similar exception should exist for “lost arts.”[71] In Gayler, an inventor named Fitzgerald received a patent in 1843 for a double-walled, fire-resistant chest for storing papers. Between the walls was a layer of plaster of Paris that served as a heat insulator.[72] The patent was assigned to Wilder who brought suit against Gayler for alleged infringement of the fire-resistant chest. In defense, Gayler claimed that Fitzgerald was not the first and original inventor of the claimed chest, but rather, sometime between the years 1829 and 1832, James Conner had made the same double-walled safe to protect his papers against fire. Conner had continued to use the safe until 1838, when it passed into other hands. The safe was kept in his counting‑room and known to the persons he worked with. After the safe passed out of his hands, he used others of different construction.[73]

48. The Court upheld the finding of the jury that the Fitzgerald patent was valid because Connor had not made his discovery public and had either forgotten it or abandoned it prior to Fitzgerald’s patent.[74] The Court drew a parallel between foreign use of an unpatented invention, which does not bar a U.S. patent, and the lack of disclosure to the public of Connor’s prior invention and concluded that a subsequent inventor is entitled to a patent if: (1) the subsequent inventor made the discovery by his own efforts and independent from the earlier inventor (with no knowledge of the first), and (2) the earlier inventor and any in contact with the prior invention had completely forgotten the invention.[75]

49. The Court was somewhat skeptical of the memory test included in the jury instructions, but believed that the idea of “lost arts” was valid. The Court said that if the Connor safe had passed away from the memory of Connor himself, and of those who had seen it, and the safe itself had disappeared, then the knowledge of the improvement was indeed completely lost.[76]

50. While these circumstances are theoretically possible, they are unlikely. In Gayler, the Court’s decision was based on the jury’s finding that the evidence submitted supported the conclusion that the Connor invention was completely forgotten and that Fitzgerald had again discovered it. Based on the jury’s finding, the Court regarded Fitzgerald as “standing upon the same ground with the discoverer of a lost art, or an unpatented and unpublished foreign invention, and like him entitled to a patent.”[77] They further stated that when the knowledge of an invention “has been lost for ages,” then a subsequent inventor can be an inventor of what is “new and at that particular time unknown.”[78]

51. While the Supreme Court has not explicitly overturned the “lost arts” doctrine, its only other treatment of the lost arts doctrine cast further doubt on the memory test. In Coffin v. Ogden, the Court questioned whether it is proper to consider whether the invention was still in the memory of the first inventor in determining if the invention was lost.[79]

52. In other cases invoking treatment of the lost arts doctrine, some courts have assumed the existence and validity of the doctrine, but no court has applied this doctrine to find for the patentee.[80] Specifically, no court has found the original invention to be so completely lost or abandoned that a patent on the subsequent invention was held valid under the lost arts doctrine. While it appears that the lost arts doctrine remains valid, precedent suggests that it is restricted to certain conditions. First, the first invention and all knowledge of that invention must be completely lost. It may not be sufficient that the invention is merely forgotten from memory alone, and at the very least, knowledge of the first invention must not be available to the public. Second, the subsequent inventor must have made the second invention by his own effort, independent of the first inventor, and with no knowledge of the first invention.

53. Rohrbaugh has suggested that under the lost arts doctrine, a regenerated organism could be found patentable.[81] Rohrbaugh argues that an extinct organism, by definition, is “one that is totally lost.”[82] He asserts that an extinct organism qualifies as a lost art when the organism is so completely lost that no one of ordinary skill in the art can reproduce it without re‑inventing it. Nature, the first inventor, no longer provides the invention to the public.[83] Application of the lost arts doctrine to regenerated organisms would avoid the problematic memory test of Gayler, and instead would rely on objective criteria rather than testimony of memory loss for determining extinction.[84] Rohrbaugh further reasons that in the case of regenerated organisms, “the second inventor could not have ‘learned’ of the invention from the first inventor, nature.”[85]

54. Applying the lost arts doctrine in this manner is problematic. For instance, contrary to Rohrbaugh’s reasoning, application of the Gayler two-prong test for determining whether an invention qualifies as a lost art actually leads to a conclusion that regenerated organisms should not qualify as rediscovered “lost arts.” According to the first prong of the test, the first invention and all knowledge of that invention must be completely lost. Rohrbaugh maintains that an extinct organism would qualify as a lost art when the organism is so completely lost that no one of ordinary skill in the art could reproduce it without re‑inventing it. Nature, the first inventor, no longer provides the invention to the public.[86] There are two potential problems with this analysis. First, organisms that have become extinct probably do not rise to the level of “completely lost.” Second, a biologist who regenerates an organism using cloning as a reproduction method does not actually “re-invent” the organism.

55. According to the first prong of the lost arts doctrine, for an organism to qualify as “completely lost” there must be no remaining public knowledge of the organism. Rather than considering the presence and extent of public knowledge of an extinct organism, Rohrbaugh displaces the public knowledge requirement with a determination of extinction. He suggests an objective standard for determining whether an organism is completely lost: “when there is ‘no reasonable doubt’ that the last organism has died.”[87] This approach, however, neglects the public knowledge existing in the form of books, fossils, photographs, and preserved specimens. To fully satisfy the first element of the lost art doctrine, all knowledge of the earlier existing organism must be completely lost. Saying that all knowledge of a particular species is lost when there is no reasonable doubt that the last organism has died is analogous to the proposition that once Connor’s safe ceased to exist (e.g., was destroyed or thrown away), all knowledge of the safe also ceased to exist.

56. Furthermore, a biologist who regenerates an organism using cloning as a reproduction method does not actually “re-invent” the organism. Invention requires conception. Thus, reinvention implies that the biologist actually conceived of a new life form having a unique strand of DNA, successfully created the unique strand of DNA by assembling the constituent amino acids in the appropriate sequence, and transformed that DNA into the new life form. Cloning, however, is not a method of re-inventing an organism; it is merely another form of reproduction. Regeneration of a formerly extinct organism involves no more re-inventing of the organism itself than does ordinary breeding by sexual reproduction. Prior to extinction of a particular species, both cloning and sexual reproduction are viable methods of reproducing organisms of that species. Under these circumstances, neither sexual reproduction nor reproduction by cloning serves to “re-invent” the organism. Once the species becomes extinct, sexual reproduction is no longer viable because there are no more living members of the species. After extinction, cloning remains the only viable method of reproduction. It seems contrary to reason to suggest that after extinction, cloning results in a “re-invented” organism, when prior to extinction, the identical process having the identical result would not result in a “re-invented” organism.

57. According to the second prong of the lost arts doctrine, for an invention to qualify as lost art, a subsequent inventor must have made the invention by his own effort, independent of the first inventor, and with no knowledge of the first invention. In addressing this issue, Rohrbaugh states that in the case of a regenerated organism, “the second inventor could not have ‘learned’ of the invention from the first inventor, nature.”[88] A person who regenerates a formerly extinct organism by cloning, however, has necessarily learned of the “invention” from nature, or at least has relied upon a relationship with nature to regenerate the organism. Cloning cannot be accomplished independent of nature for at least the reason that cloning is impossible without nature first supplying the necessary DNA. Thus, a biologist who clones an extinct organism cannot do so independent from nature, the first inventor. If a person discovers a set of engineering drawings for a fire-resistant safe, and he proceeds to build the safe according to the drawings, that person has not invented the safe independent from the engineer who designed the safe. To the extent that DNA is analogous to a blueprint for a particular life form, a biologist that clones an organism using DNA from an extinct organism has not created the organism independent of the designer of the DNA. Instead, he has relied upon nature to supply the necessary blueprint for creation of the desired organism. Therefore, if nature serves as the “first inventor” of the organism, then the second inventor, by using DNA supplied by nature, has necessarily relied upon the first inventor to make the invention. As a result, a regenerated organism fails to qualify as a “lost art.”

58. As further support for the proposition that a regenerated organism does not qualify as “lost art,” cloning cannot be accomplished without detailed knowledge of the organism to be regenerated. Thus, in violation of the second prong of the lost art doctrine, one must have knowledge of the previous “invention” (the organism) in order to create the subsequent invention (the regenerated organism). For instance, prior to cloning an organism, one must be able to determine the closest relative to that organism in order to select the most appropriate surrogate mother. Even if one happened upon some preserved DNA material from an unknown extinct organism, cloning the extinct organism would be impossible (with current technology) without first knowing from what type of animal the DNA originated. As an illustrative example, the most closely related species to the giant panda is a rabbit. Because rabbits are too small to serve as surrogate mothers for giant pandas, however, certain species of bears are currently being evaluated for suitability as surrogate mothers for a giant panda.[89] If giant pandas became extinct, one would not be able to clone a giant panda without understanding this relationship.

59. Regenerated organisms likely would not qualify as “lost arts” under the lost arts doctrine. Both prongs of the doctrine are violated for the following reasons: that public knowledge of a species is not lost upon extinction, that one must retrieve from nature the DNA of the organism designated for regeneration, and that one must learn of an organism from nature before regeneration by cloning can occur. One who regenerates a formerly extinct species, therefore, should not be entitled to a patent claiming the organism itself under the doctrine of lost arts.

Policy Considerations in Allowing Patenting of Regenerated Organisms

60. Using cloning as a method to reproduce both endangered species and extinct species is controversial. Many feel that cloning would have severe negative effects such as detracting from ongoing conservation efforts to preserve habitat.[90] Others believe that cloning offers a viable solution to maintaining bio-diversity while not detracting from conservation efforts. While it is unclear exactly how patents for regenerated organisms would impact this controversy, two possible effects are foreseeable. Specifically, allowing patents for regenerated organisms could provide enough incentive for certain entities, motivated by financial gain, to eradicate all remaining members of a species to clear the way for a patent. On the other hand, the availability of patents in this area could provide sufficient motivation to regenerate a species that otherwise would have remained extinct.

61. Aside from patent related considerations, many believe that endangered and extinct organisms should not be cloned. The most prominent argument against cloning endangered species is that cloning would overshadow efforts to preserve the species’ habitat, which is necessary for its survival.[91] The logic is that if cloning were used to reproduce endangered species, people would become more apathetic toward conserving current animal populations and habitat. People may feel that there is no crucial need to conserve when cloning provides the possibility to generate as many new organisms as desired. Supporters of cloning endangered species, however, argue that while habitat preservation is the keystone of species conservation, some countries are too poor or too unstable to support sustainable conservation efforts. Further, the continued growth of the human population increases the difficulty of saving enough habitat for some species. These supporters maintain that cloning by interspecies nuclear transfer offers the possibility of keeping the genetic stock of endangered species on hand without the cost of maintaining captive populations.[92]

Possible Negative Effects on Conservation

62. On the negative side of this controversy, issuing patents with claims to regenerated organisms could hinder conservation efforts. Because a patent grants the patent owner a right to exclude others from making, using, or selling the claimed invention, the patent owner enjoys a monopoly over the invention for a limited time.[93] It is easy to see, then, that patents may have tremendous monetary value. Assuming that a regenerated organism of a particular species could be found patentable based on an “extinction equals non-naturally-occurring standard,” a patent for the regenerated organism could provide enough incentive for an entity, motivated by financial gain, to eradicate all remaining members of the species to clear the way for a patent having claims directed to the regenerated organism. Armed with a patent for the regenerated organism, the very entity responsible for the extinction of the species could regenerate organisms of the species through cloning, control the supply of the organisms, and exploit any commercial value of the organisms. Such an incentive to exterminate the remaining population of a given species is certainly contrary to the goals of conservation.

63. Whether or not allowing patents for regenerated organisms would actually have a negative impact on conservation efforts is unclear. The actual effects on conservation would depend on the actions of groups interested in preservation and groups who stand to profit from the extinction of a particular species. Preservation groups, who probably would not be motivated by patent rights, would continue their conservation efforts whether or not patents were allowed for regenerated organisms. Groups who could profit from owning a patent for a regenerated organism, however, would be inclined to discourage conservation if such patents were allowed, and would, at the very least, be indifferent toward conservation if such patents were not allowed. While disallowing patents for regenerated organisms may not have a significant impact on the effort put forth in conserving endangered species, it would at least remove any potential incentive for an entity to contribute to the extinction of a species. Disallowing patents for regenerated organisms, therefore, would reduce the possibility of anti-conservation behavior, at least to some degree.

64. Even though, precluding patents for regenerated organisms could in theory benefit endangered species, the actual magnitude of any benefit would likely be small compared to the operation of other mechanisms. For example, the Endangered Species Act of 1973[94] and other laws are currently in place to prevent poaching of endangered species. Therefore, even if patents were allowed for regenerated organisms, any possible negative effect on conservation would likely be greatly tempered by the existence of laws designed specifically to prevent anti-conservation behavior.

65. As an aside, in contrast to the potential incentive against conservation produced by product claims to a regenerated organism, process claims directed to a method of cloning an organism would not create the same negative effects. A patent for a process of cloning prevents others from practicing the claimed method of cloning. This right to exclude, however, does not depend on whether or not the cloned organism is extinct. Therefore, a patent applicant seeking only process claims would not be motivated to contribute to a species’ extinction. Product claims for the regenerated organism itself, however, would presumably only be found patentable if the particular species was extinct (interpreted as no longer “naturally-occurring”). Thus, unlike process claims, the value of product claims actually depends on whether or not the species is extinct.

Possible Benefits of Patents for Regenerated Organisms

66. The availability of patents for regenerated organisms could provide sufficient motivation for one to regenerate a species that otherwise would have remained extinct. Currently, there are several extinct species that researchers are already planning to regenerate. In addition to the bucardo, scientists plan to clone the Huia,[95] the Tasmanian tiger,[96] and, if possible, the woolly mammoth.[97] The current interest in regenerating these species via cloning exists mainly for purposes of science and scientific research. In some ways, researchers intend to clone these animals mainly just to show that it can be done. In the future, however, cloning will be more mundane and there may exist less interest in cloning extinct organisms for purposes of scientific study.[98] Cloning of extinct organisms may be limited to species whose immediate use is apparent. With no incentive to clone a wide array of extinct species, biodiversity would diminish. Providing patent rights to one who regenerates an extinct organism could provide the incentive necessary ensure that biodiversity would be maintained.

67. In view of the substantial benefit offered by regeneration of extinct species (biodiversity, scientific study), it would be unwise to discourage cloning of extinct species in general. Further, if the regenerated organisms themselves were found to satisfy all of the requirements for patentability, there should be no bar against patenting of the regenerated organisms.

Conclusion

68. Of the possible claim types for regenerated organisms under current law, only process claims for a method of cloning likely constitute patentable subject matter. Indeed, the PTO has confirmed this conclusion by issuing a patent that claims a method for cloning non-human mammals, which would cover a process for cloning an extinct organism.[99] This patent, however, contains no claims directed to the cloned organism itself. While product-by-process claims would probably qualify as statutory subject matter under the Federal Circuit’s decision in In re Thorpe, this type of claim for a regenerated organism would most likely not satisfy the novelty requirements for patentability.

69. Determination of whether a product claim directed to the regenerated organism itself constitutes statutory subject matter would depend on further interpretation of the phrase “naturally-occurring,” and on what standard is used to determine when extinction has actually occurred. If “naturally-occurring” refers only to a condition where “living” members of a species exist, then product claims to regenerated organisms could constitute statutory subject matter. If, however, “naturally-occurring” is interpreted more broadly to include the remains of a dead organism, then product claims to regenerated organisms would not constitute statutory subject matter. Even if one adopts the more narrow interpretation of “naturally-occurring,” there still exists an element of doubt as to whether a regenerated organism can constitute statutory subject matter. That is, there may always exist some uncertainty over whether or not the species is really extinct. If even one organism remains alive, then the species remains “naturally-occurring” even under the narrow interpretation.

70. Nevertheless, even if a product claim for a regenerated organism was considered statutory subject matter, such a product claim would likely still not be patentable. A regenerated organism would not satisfy the novelty requirements for patentability for at least the reason that printed publications detailing the extinct species combined with general skill in the cloning art would enable a skilled practitioner to make the invention. Furthermore, the biotechnician that clones an extinct species did not invent the organism of that species. Additionally, regenerated organisms would not be patentable under the lost arts doctrine.

71. On policy grounds, there is no particular reason why patents for regenerated organisms should be barred. Nonetheless, patent applicants face a difficult task in convincing the Patent and Trademark Office that a regenerated organism constitutes statutory subject matter and satisfies the novelty requirements for patentability.

* J.D., Georgetown University Law Center; M.S.E., University of Pennsylvania; B.S., College of William and Mary. The author is an associate at Finnegan, Henderson, Farabow, Garrett, and Dunner LLP.

[1] See Juan J. Estruch et al., Transgenic Plants: An Emerging Approach to Pest Control, 15 NATURE BIOTECHNOLOGY 137 (1997).

[2] The “oncomouse” was developed by Harvard researchers Philip Leder and Timothy Stewart; see U.S. Patent No. 4,736,866 (issued Apr. 12, 1988).

[3] See Diamond v. Chakrabarty, 447 U.S. 303 (1980) (explaining that Chakrabarty invented a genetically altered bacterium that thrived on a wide range of hydrocarbons including crude oil and Bunker C oil); see also U.S. Patent No. 4,259,444 (issued Mar. 31, 1981).

[4] See Justin Gillis, Down On The High-tech Pharm; Researchers Tap Goat Milk For Genetically Enhanced Drugs, WASH. POST, Jan. 17, 2000, Page A01; see also Justin Gillis, Cows And Clones On A Va. Pharm; Where Animals Make Drugs And Gene Research Goes To The Frontier, WASH. POST, Feb. 28, 1999, at A01.

[5] See William H. R. Langridge, Edible Vaccines, Sci. Am., Sept. 2000 (explaining that in the near future, foods such as bananas, potatoes, tomatoes, lettuce, and rice will be engineered to contain antigens in their edible parts), at http://www.sciam.com/2000/0900issue/0900langridge.html (last visited Dec. 9, 2000).

[6] See Diamond, 447 U.S. 303.

[7] See Briefing Notes on Dolly, Roslin Institute Online, Dec. 12, 1997 (explaining that Dolly was derived from cells that had been taken from the udder of a six-year old Finn Dorset ewe and cultured for several weeks in the laboratory, and that Dolly was born on July 5, 1996), at http://www.ro.bbsrc.ac.uk/library/research/cloning/dolly.html (last visited Nov. 13, 2000).

[8] See Tim Beardsley, A Clone in Sheep’s Clothing, SCI. AM, Mar. 1997 (explaining that in response to the possibility of cloning technology being used to clone humans, President Clinton, who had asked the National Bioethics Advisory Commission to make recommendations on what controls should be placed on human cloning research, banned the use of federal funds for such work and called for a voluntary moratorium among private companies in this area), at http://www.sciam.com/explorations/030397clone/030397beards.html (visited Nov. 9, 2000).

[9] See Timothy G. Hofmeyer, Everybody’s Got Something to Hide Except Me and My Patented Monkey: Patentability of Cloned Organisms, 16 J. MARSHALL J. COMPUTER INFO. L. 971 (1998).

[10] Id. at 994 (comparing cloned organisms to transgenic organisms for which many patents have already issued, and concluding that since naturally propagated offspring of unnaturally-occurring transgenic animals are patentable, then it follows that unnaturally-propagated (cloned) offspring of unnaturally-occurring transgenic animals are patentable as well).

[11] See Act of Feb. 21, 1793, §1, 1 Stat. 319 (Feb. 21, 1793) (reflecting that Thomas Jefferson defined statutory subject matter as “any new an useful art, machine, manufacture, or composition of matter, or any new or useful improvement [thereof]”).

[12] See Diamond, 447 U.S. at 309 (explaining that unlike naturally-occurring plants, minerals, or organisms found in the wild, non-naturally-occurring manufactures of compositions of matter that are products of human ingenuity having a distinctive name, character, and use constitute patentable subject matter).

[13] Id. (citing Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)).

[14] See I. Wilmut et al., Viable Offspring Derived From Fetal and Adult Mammalian Cells, 385 NATURE 810 (1997) (describing that a group from the Roslin Institute successfully cloned a sheep from an adult cell; a process that does not depend upon sexual reproduction).

[15] See supra note 8.

[16] See Cloning and Nuclear Transfer: Cloning in the Conservation of Rare Breeds, Roslin Institute Online (explaining that cells from endangered species could be collected by biopsy or from scrapings of the soft skin inside the mouth or from hair follicles, and that these cells could be grown in a laboratory and then stored indefinitely by freezing at –173 ºC in liquid nitrogen), at http://www.ri.bbsrc.ac.uk/library/research/cloning/rarebreed.html (last visited Nov. 13, 2000).

[17] See Jurassic Park (MCA 1993) and The Lost World — Jurassic Park (MCA 1997), directed by Steven Spielberg, based on Michael Crichton, Jurassic Park (1990) (describing a scenario in which DNA preserved in amber was used to create cloned organisms of many different species of dinosaurs to live in the fictional theme park Jurassic Park, but something went dreadfully wrong, and the cloned dinosaurs feasted on several of the park’s first visitors).

[18] See Bill Redeker, Stopping Extinction, abcNEWS.com (broadcast Oct. 8, 2000) (explaining that cloning of dinosaurs would be impossible at this stage, because fossilized species offer no living tissue from which to harvest DNA, and suitable surrogate mothers would be improbable), at http://abcnews.go.com/onair/worldnewssaturday/wnt001008_cloning_feature.html.

[19] See Robert P. Lanza et al., Cloning Noah’s Ark, SCI. AM., Nov. 2000 (reporting successful use of cloning to produce an Asian gaur, which is presently on the endangered species list).

[20] Id.

[21] See Rick Weiss, Cloning a Comeback?, WASH. POST, Oct. 8, 2000, at A01.

[22] Id.

[23] See BBC News Online, Endangered Animal Clone Dies (Jan. 21, 2001), at http://news.bbc.co.uk/hi/english/sci/tech/newsid_1113000/1113719.stm (last visited Sept. 13, 2001); see also Kimberley Durnan, Rare Asian Ox Clone Dies After Birth, abcNEWS.com (Jan. 12, 2001), at http://more.abcnews.go.com/sections/scitech/DailyNews/gaur_clone010112.html (last visited Sept. 2, 2001).

[24] Advanced Cell Technology, Inc. press release, Advanced Cell Technology Reaches Agreement With Spanish Government to Clone First Extinct Animal, October 8, 2000, at http://biz.yahoo.com/prnews/001008/ma_act_clo.html (visited Nov. 24, 2000).

[25] Id.

[26] See John Hodgson, Gone, Butt Not Begotten, NATURE BIOTECHNOLOGY, vol. 18, Feb. 2000, at 133.

[27] See supra note 21.

[28] See supra note 24.

[29] See supra note 8.

[30] Id.

[31] Id.

[32] See Cloning and Nuclear Transfer — Nuclear Transfer Technology, Roslin Institute Online, at http://www.ri.bbsrc.ac.uk/library/research/cloning/nt_technology.html (last visited Nov. 13, 2000).

[33] See supra note 8.

[34] Id.

[35] See supra note 19 (explaining that a domestic cow has been used as a surrogate mother for an Asian gaur, and also reporting that a domestic house cat has given birth to an African wildcat by interspecies embryo transfer).

[36] See supra note 8.

[37] See Eli Lilly & Co. v. Premo Pharm. Labs., Inc., 630 F.2d 120, (3d Cir. 1980).

[38] The right to exclude is limited to subject matter falling within claim scope.

[39] See 35 U.S.C. §101 (1952).

[40] See Committee Reports accompanying the 1952 Patent Act. S. REP. NO. 82-1979 at 5 (1952); H. R. REP. NO. 1923 at 6 (1952).

[41] See Diamond, 447 U.S. at 309.

[42] Id. (citing Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)).

[43] Id. at 306.

[44] Id.

[45] Id. at 309.

[46] See supra note 3. The Chakrabarty decision opened the door for the patenting of many biotechnology related inventions. Purified DNA and genetically altered mice (called the Harvard oncomouse) have been patented. A key consideration in all of these applications is whether the material or organism sought to be patented is “naturally-occurring.” For example, DNA does not occur in nature in a purified form outside of the nucleus of a cell, and it therefore constitutes statutory subject matter.

[47] See U.S. Patent No. 5,945,577 issued Aug. 31, 1999 (claiming an improved method of cloning a non-human mammal by nuclear transfer; no claims are directed to the cloned organism itself).

[48] See supra note 26 (explaining that the last known animal of a subspecies of Pyrenean mountain goat known as a bucardo was killed in January 2000 due to a tree that fell on its head; prior to its death, scientists had taken a tissue sample from one of the bucardo’s ears for the purpose of reproducing the goat by cloning).

[49] See THE AMERICAN HERITAGE DICTIONARY OF THE ENGLISH LANGUAGE 465 (1982).

[50] BBC, Spanish Mountain Goat: Cloning vs. Extinction, (Jan. 11, 2000), at http://www.futureframe.de/news/000113-2.htm (last visited Apr. 6, 2001).

[51] See Stephen R. Edwards, Conserving Biodiversity: Resources for Our Future, in THE TRUE STATE OF THE PLANET 217 (Ronald Bailey ed., 1995).

[52] See 35 U.S.C. § 102 (2000).

[53] See 35 U.S.C. § 102(a) (2000).

[54] See 35 U.S.C. § 102(f) (2000).

[55] See Roslin Institute Online, Cloning and Nuclear Transfer: Cloning in the Conservation of Rare Breeds (explaining that offspring resulting from cloning process are “genetically identical” to the animals that provided the DNA-containing original cells), at http://www.ri.bbsrc.ac.uk/library/research/cloning/rarebreed.html (last visited Apr. 6, 2001).

[56] See Diamond, 447 U.S. at 309.

[57] See Verdegaal Bros. Inc. v. Union Oil Co. of California, 814 F.2d 628, 631(Fed. Cir. 1988).

[58] See In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985) (holding that even if the claimed invention is disclosed in a printed publication, disclosure will not suffice as prior art if it was not enabling).

[59] See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).

[60] See I. Wilmut et al., Viable Offspring Derived From Fetal and Adult Mammalian Cells, NATURE, vol. 385, at 810-813.

[61] See supra note 19 (explaining that a group at Advanced Cell Technology, headed by Robert Lanza, was responsible for cloning Noah, the Asian gaur, and they are planning to clone the bucardo, and that other species already cloned, using interspecies surrogate mothers, include the African wildcat, Indian desert cat, red deer, mouflon sheep, and bongo antelope).

[62] See 35 U.S.C. § 102(f) (2000).

[63] See THE AMERICAN HERITAGE DICTIONARY OF THE ENGLISH LANGUAGE 688 (4th ed. 2000).

[64] See Sewall v. Walters, 21 F.3d 411, 415 (Fed. Cir. 1994) (conception exists when a definite and permanent idea of an operative invention, including every feature of the subject matter sought to be patented, is known).

[65] See In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985).

[66] Id. The prior art taught the use of a novolac phenol-aldehyde resin having an incorporated metal salt and specifically taught against the use of metal oxides in preparing the novolac phenol-aldehyde resin. Thorpe discovered a process for making the novolac phenol-aldehyde resin using metal oxides, which were less expensive materials. The Federal Circuit found that while Thorpe’s process for making the novolac phenol-aldehyde resin differed from that of the prior art, the substantial similarity of Thorpe’s resin to the prior art resin was sufficient to establish a prima facie case for rejection of Thorpe’s product-by-process claims.

[67] Id.

[68] Id.

[69] See Mark L. Rohrbaugh, The Patenting of Extinct Organisms: Revival of Lost Arts, 25 AIPLA Q.J. 371 (1997).

[70] See Gayler v. Wilder, 51 U.S. 477, 497-498 (1850).

[71] Id. at 497 (holding that if an invention is patented or printed in a foreign country, then the U.S. public is presumed to have the benefit of the publicly disclosed invention and no patent will be granted for the invention; however, if the invention was merely used in a foreign country, then the invention might be “known and used in remote places for ages, and the people of [the U.S. will be] unable to profit from it” (where the inventor in the latter situation is not barred from obtaining a patent in exchange for disclosure to the public)).

[72] Id. at 478.

[73] Id. at 495.

[74] Id. at 496 (explaining that the trial court instructed the jury, “that if Connor had not made his discovery public, but had used it simply for his own private purpose, and it had been finally forgotten or abandoned, such a discovery and use would be no obstacle to the taking out of a patent by Fitzgerald or those claiming under him, if he be an original, though not the first, inventor or discoverer”).

[75] Id. at 497-498 (explaining that if the Conner safe had passed away from the memory of Conner himself, and of those who had seen it, and the safe itself had disappeared, “the knowledge of the improvement was as completely lost as if it had never been discovered” and “[t]he public could derive no benefit from it until it was discovered by another inventor”; and further explaining that “if Fitzgerald made his discovery by his own efforts, without any knowledge of Conner’s, he invented an improvement that was then new, and at that time unknown; and it was not the less new and unknown because Conner’s safe was recalled to his memory by the success of Fitzgerald’s”).

[76] Id. at 498.

[77] Id.

[78] Id.

[79] See Coffin v. Ogden, 85 U.S. 120, 125 (1873) (questioning whether the proposition expressed by the proviso-that the second inventor would not be entitled to a patent where the invention is still in the memory of the first inventor-is a sound one).

[80] See e.g., Dunlop Holdings Ltd. v. Ram Golf Corp., 524 F.2d 33, 35‑36 (7th Cir. 1975) (citing Gayler as establishing that a patentee may be entitled to credit for making a new discovery or invention even though someone else actually made the discovery before he did because an abandoned invention will not defeat the patentability of the rediscovery of “lost art,” and holding the patent invalid in view of prior commercial use by another that amounted to non‑informing public use but not secret use); Western States Mach. Co. v. S. S. Hepworth Co., 147 F.2d 345, 350 (2d Cir. 1945) (holding that while the doctrine of lost arts applies to prior uses, a patent was found invalid in view of a former patent, which cannot qualify as lost art); Dalby v. Lynes, 64 F. 376, 379 (Mass. Dist. Ct. 1894) (finding a patent invalid because prior use was not forgotten or abandoned).

[81] See Mark L. Rohrbaugh, The Patenting of Extinct Organisms: Revival of Lost Arts, 25 AIPLA Q.J. 371, 404 (1997).

[82] Id.

[83] Id.

[84] Id. at 407.

[85] Id. at 406.

[86] Id. at 404.

[87] Id. at 405.

[88] Id. at 406.

[89] See supra note 19.

[90] See supra note 21.

[91] See supra note 19.

[92] Id.

[93] See Eli Lilly & Co. v. Premo Pharm. Labs., Inc., 630 F.2d 120, 137 (3d Cir. 1980).

[94] See 16 U.S.C. § 1533(a)(1) (1999).

[95] See Emma Dorey, Huia Cloned Back to Life?, NATURE BIOTECHNOLOGY, vol. 17, Aug. 1999, at 736. The Huia is an extinct bird that once flourished in New Zealand and is of great cultural importance to the Maori tribe.

[96] See Bringing Back the Tiger, abcNEWS.com (explaining that the Tasmanian tiger is a striped marsupial, the last known specimen of which died in captivity in 1936, and that hopes to resurrect the tiger depend on the presence of viable DNA in a six-month-old pup that has been preserved in alcohol since 1866) at http://www.abcnews.go.com/sections/science/dailyNews/cloning_tasmaniantiger000822.html. (last visited Nov. 24, 2000).

[97] See Richard Stone, Cloning the Woolly Mammoth, DISCOVER, Apr. 1999, at 58, 62.

[98] This situation is somewhat analogous to the space program in the 1960s. For many years, sending an astronaut to the moon was a primary objective of the space program. Once this mission was accomplished, there was far less interest in making repeat trips.

[99] See U.S. Patent No. 5,945,577 issued on Aug. 31, 1999.