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Genetic Veterinary Sciences., Inc. v. LABOKLIN GmbH & Co.

Representative Claim(s)

Claim 1. An in vitro method for genotyping a Labrador Retriever comprising:

a) obtaining a biological sample from the Labrador Retriever;

b) genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1 and

c) detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2.

Claim 2. The method according to claim 1, wherein the genotyping is achieved by [polymerase chain reaction (“PCR”)], real-time PCR, melting point analysis of double-stranded DNA, mass spectroscopy, direct DNA sequencing, restriction fragment length polymorphism (RFLP), single strand conformation polymorphism (SSCP), high performance liquid chromatography (HPLC), or single base primer extension.

Claim 3. The method of claim 1, wherein the genotyping utilizes a primer pair comprising a first primer and a second primer, each compromising a contiguous span of at least 14 nucleotides of the sequence SEQ ID NO: 2 or a sequence complementary thereto, wherein:

a) said first primer hybridizes to a first DNA strand of the SUV39H2 gene;

b) said second primer hybridizes to the strand complementary to said first DNA strand of the SUV39H2 gene; and

c) the 3’ ends of said first and second primers are located on regions flanking the position 972 of SEQ ID NO: 2, or of nucleotide positions complementary thereto.

Posture:

Appeal from Eastern District of Virginia’s conclusions as to jurisdiction and patent-ineligibility

Exception Category: Natural Phenomenon

As explained by the parties’ experts, first, step (a) “obtaining a biological sample” requires a sample of DNA from a dog, which both parties’ experts testified usually requires obtaining a blood sample or cheek swab from the dog, see J.A. 1366, 1493; second, step (b) “genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1,” identifies the location of the genetic mutation, see J.A. 1496; and third, step (c) “detect[ing] the presence of a replacement of a nucleotide” at a specific base pair position identifies the location of the equivalent normal gene, see J.A. 1496, 1598; see also ’114 patent col. 15 ll. 14-19. In other words, claim 1 simply states that the search for the mutation involves the laboratory examination of Labrador Retriever DNA, which resulted in the revelation of the mutation. See id. col. 15 ll. 11-19. The mutation location itself and the fact that it is inherited through male and female dog carriers mating are both natural phenomena. See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 590, 133 S. Ct. 2107, 186 L. Ed. 2d 124 (2013) (“Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them.”). Taken together, the plain language of claim 1 demonstrates that it is directed to nothing more than “observing or identifying” the natural phenomenon of a mutation in the SUV39H2 gene. See CellzDirect, 827 F.3d at 1048. Claims 2 and 3 depend from independent claim 1 and add only generic methods of detecting the natural phenomenon. Thus, the Asserted Claims are directed to natural phenomenon at Alice step one.

Genetic Veterinary Scis., Inc. v. LABOKLIN GmbH & Co. KG, 933 F.3d 1302, 1318 (Fed. Cir. 2019.

Significantly More: No

The Asserted Claims do not recite an inventive concept that transforms the observation of a natural phenomenon into a patentable invention. Nothing in claim 1’s language suggests the invention of a new method for genotyping. See ʼ114 patent col. 15 l. 16 (claiming “genotyping” but not explaining specific steps of how to genotype). Rather, instructive to our analysis is that LABOKLIN’s expert agreed that the genotyping method in claim 1 uses conventional or known laboratory techniques to observe the newly discovered mutation in the SUV39H2 at position 972. See, e.g., J.A. 1520 (agreeing with counsel that claim 1 is “not talking about a particular way to genotype the [SUV39H2] gene encoding”). Conducting conventional detection in a laboratory does not transform the discovery of a natural phenomenon into patent eligible subject matter. Rather, similar to the claims at issue in Mayo, a natural phenomenon, together with well-understood, conventional activity, is not patent-eligible under § 101. See Mayo, 566 U.S. at 73, 79-80.

Claims 2 and 3 also do not move the natural phenomenon into eligible § 101 territory… As the Supreme Court explained in Mayo, “simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.” Mayo, 566 U.S. at 82. Therefore, the Asserted Claims are patent-ineligible at Alice step two.

Genetic Veterinary Scis., Inc. v. LABOKLIN GmbH & Co. KG, 933 F.3d 1302, 1318-1319 (Fed. Cir. 2019).