PTAB

PGR2020-00076

Boehringer Ingelheim Animal Health USA Inc v. Kansas State University Research Foundation

Key Events

Petition

petition

Title: Porcine Circovirus Type 3 Immunogenic Compositions and Methods of Making and Using the Same
Brief Description: The ’351 patent discloses immunological compositions, including recombinant proteins and nucleic acids, derived from the genome of a newly discovered virus, Porcine Circovirus Type 3 (PCV3). The compositions, which relate to PCV3’s Open Reading Frames (ORFs) 1, 2, and 3, are intended to induce an immunological response in swine.

Core Argument for this Ground: Petitioner argued that the ’351 patent fails to teach a person of ordinary skill in the art (POSITA) how to make and use the full scope of the claimed invention without undue experimentation. The argument was based on several Wands factors. The field of vaccine development for a novel virus was described as highly unpredictable, and the patent’s claims are exceptionally broad, covering thousands of potential protein and nucleic acid sequences that have at least 90% homology to the disclosed sequences. The patent provides no working examples of an effective immunogenic composition, no challenge experiment data, and insufficient guidance for a POSITA to determine which of the countless claimed embodiments are operative. Petitioner contended that a POSITA would be forced to engage in a laborious, iterative process of synthesizing and screening thousands of compositions to practice the full scope of the claims, which constitutes undue experimentation.

Core Argument for this Ground: Petitioner asserted the patent’s specification fails to demonstrate that the inventor possessed the full scope of the claimed invention as of the filing date. The disclosure was characterized as a "wish or a plan" rather than a description of an actually invented and possessed genus of compositions. The inventor identified a single PCV3 genome and its ORFs but then claimed broad genera of compositions—including all proteins and nucleic acids with 90% homology—without providing any data, representative species, or structural features to show possession of the entire claimed scope. For example, no working examples demonstrated possession of a composition containing an ORF1 or ORF3 protein, and the only example involving an ORF2 protein used a truncated version in mice, not the full-length protein in swine as claimed. This failure to describe representative species was argued to be fatal in an unpredictable art.

Core Argument for this Ground: Petitioner argued the claims are directed to patent-ineligible products of nature. The claims encompass recombinant proteins and nucleic acids that are structurally identical to naturally occurring PCV3 proteins and genomic sequences. The term "recombinant" does not alter the fundamental nature of the claimed sequences, which are indistinguishable from their natural counterparts. Under the Alice/Mayo framework, this directs the claims to a law of nature. The additional claim elements, such as a "veterinary-acceptable carrier" or an "immune stimulant," were described as conventional, well-understood components in vaccine technology that do not provide an "inventive concept" sufficient to transform the patent-ineligible natural products into a patent-eligible application.
Additional Grounds: Petitioner asserted that claims 5-6 are unpatentable as indefinite under §112(b) due to ambiguous terms lacking clear antecedent basis ("ORF," "the final composition"). Petitioner also asserted that claims 1-11 are unpatentable for lack of practical utility under §101, arguing that if the patent does not need to demonstrate immunogenicity to satisfy §112, then the claims lack a credible, substantial, and specific utility.

"porcine circovirus type 3 recombinant protein": Petitioner argued this term in Claim 1 should be construed to cover proteins that are structurally identical to naturally-occurring PCV3 ORF proteins. This construction is central to the §101 argument, as it means the claims encompass patent-ineligible products of nature despite the "recombinant" modifier, because the resulting protein sequence is indistinguishable from what is found in nature.
"nucleotide sequence encoding ORF[1/2/3]": Petitioner argued this term in dependent Claim 5 is indefinite under §112(b). The term "ORF" lacks a clear antecedent in independent Claim 4, and the specification uses it ambiguously to refer to both specific sequences and broad homologous groups. This alleged ambiguity prevents a POSITA from ascertaining the scope of the claim with reasonable certainty.

High Unpredictability of the Art: A central contention was that vaccine development for a novel virus like PCV3, about which little was known at the time of filing, is a highly unpredictable field. This technical principle was used to argue that the patent’s lack of working examples and specific guidance requires a higher level of disclosure to satisfy the enablement and written description requirements of §112.
Insufficiency of Data: Petitioner heavily emphasized that the patent provides no data from challenge studies, no evidence of a protective immune response in the target species (pigs), and no working examples for most of the claimed compositions (e.g., those with ORF1/ORF3 or chimeric constructs). The only in-vivo data involved administering a truncated, unclaimed protein to mice to detect antibodies, which was argued to be insufficient to support the broad claims to immunogenic compositions.

Petitioner argued that the Board should not exercise its discretion to deny institution under §325(d). The reasoning was that the Examiner's allowance was based on legal error, specifically by failing to recognize that the amended claims still covered patent-ineligible products of nature under §101. Petitioner also contended that the Examiner did not sufficiently analyze the §112 issues and that the petition presented new evidence, namely the expert declaration of Dr. Bob Nordgren, which was not before the Examiner during prosecution.

Petitioner requested institution of a post-grant review and cancellation of claims 1-16 of Patent 10,450,351 as unpatentable.