During the week of January 21, 2019, the Patent Trial and Appeal Board (“the Board”) issued two decisions in TC 1600. In those, the Board denied institution of inter partes and post-grant reviews.
Benson Hill Biosystems, Inc. v. The Broad Institute Inc., Presidents & Fellows of Harvard College & Massachusetts Institute of Technology, No. PGR2018-00072 (Decision Denying Institution of Post-Grant Review Entered January 22, 2019). The Board refused to institute a post-grant review sought by Benson Hill Biosystems, Inc. (“Benson Hill”) against U.S. Patent No. 9,790,490 (“the ’490 patent”) owned by The Broad Institute, Inc., President and Fellows of Harvard College, and Massachusetts Institute of Technology (“Patent Owner”). Benson Hill raised seven grounds for challenge: two based on lack of written description, two based on lack of enablement, one based on indefiniteness, one based on lack of utility, and one based on obviousness. IPR2018-00072, Paper 11 at 5. Benson Hill relied on the last two as alternative grounds if the Board disagreed with its claim construction position. Id. The § 112 grounds also depended on a claim construction issue, and the Board’s decision centered on that aspect of the case.
The claims pertained to non-naturally occurring Clustered Regularly Interspaced Short Palindromic Repeats (“CRISPR”) systems for targeting nucleic acid sequences. The systems comprised a Cpf1 effector protein, a novel RNA-endonuclease, and an engineered guide polynucleotide, which together form a complex designed to hybridize to a target nucleic acid sequence. The systems also lack a trans-activating crRNA (“tracr”) sequence. Id. at 3–4.
Benson Hill sought a construction under which the Cpf1 effector protein performs the specific function of cleaving a target sequence. Id. at 9. But the Board rejected this construction. Neither the plain language of the claims nor the term “effector protein” required this functionality, and the written description described systems with functions other than cleaving, including preferred embodiments with no cleavage activity whatsoever. Id. at 11–14. The Board also rejected Benson Hill’s prosecution history estoppel arguments, reasoning that Patent Owner’s arguments to overcome an anticipation rejection relied on the claimed systems’ hybridization function (not any cleaving function), and Patent Owner’s amendments required the systems only to lack a tracr sequence, not have cleaving activity. Id. at 14–16.
The Board therefore dismissed Benson Hill’s § 112 claims, which were premised on this “cleavage” limitation. Id. at 17–18. Benson Hill’s two alternative grounds—obviousness and lack of utility—also failed. The obviousness ground required the Board to construe the systems as having no functional activity at all, id. at 19, but the Board refused to limit the claims this way because they required hybridization activity and the written description contemplated other additional functionality (including functions not involving cleavage). Id. The lack of utility ground failed for the same reasons as the § 112 claims. The Board thus denied the petition.
Thermo Fisher Scientific Inc. v. Regents of the University of California, No. IPR2018-01347 (Decision Denying Institution Entered January 22, 2019). Thermo Fisher Scientific, Inc. (“Thermo”) filed a petition for inter partes review (“IPR”) directed to five claims of U.S. Patent No. 9,085,799 (“the ’799 patent”), owned by The Regents of the University of California (“UC”). Thermo raised one ground of unpatentability, anticipation under § 102(b) by U.S. Patent Application No. 2004/0142344 (“Bazan”), the first published application in the ’799 patent’s family. IPR2018-01347, Paper 10 at 5. Thermo’s petition relied on a priority challenge: it asserted the ’799 patent was not entitled to the August 26, 2002 filing date of the family’s provisional application or the August 26, 2003 filing date of the first non-provisional application in the chain, and was thus entitled to a priority date no earlier than September 12, 2007, the filing date of the second non-provisional application. Id. at 18. Bazan, the asserted anticipatory reference, published before this date, on July 22, 2004. Id.
The claims at issue covered methods of analyzing polynucleotides in a sample using light-harvesting multichromophore systems based on fluorescence resonance energy transfer (“FRET”). Id. at 3. The samples are contacted with systems comprising a “signaling chromophore” and a “water-soluble conjugated polymer” that can transfer energy to the signaling chromophore to provide a “greater than 4 fold increase in fluorescence emission” from the signaling chromophore over what can be achieved by “direct excitation of the signaling chromophore” absent the polymer. Id. at 5. The claims then require applying a light source to the sample and detecting whether light is emitted from the signaling chromophore. Id.
After construing “greater than 4 fold increase in fluorescence emission” in accordance with its plain and ordinary meaning and “in the absence of the polymer” broadly to encompass “without polymer present” and “lack of energy transfer (via FRET),” id. at 15–18, the Board turned to the priority issue. UC first claimed that Thermo raised impermissible grounds under § 311 (which allows challenges under only § 102 and § 103) because the anticipation claim was a disguised attack on written description under § 112. Id. at 21. But the Board explained that it may assess written description issues bearing on priority claims and the applicability of prior art for allowable challenges under § 311. Id. at 22–23.
The Board then determined the claims were entitled to a priority date prior to Bazan’s publication date because Thermo had failed to establish that the provisional application and first non-provisional application lacked adequate written support for the claims. Id. at 33. Thermo had argued the “greater than 4 fold increase in fluorescence emission” limitation represented a broad genus of emission increases, but the provisional and first non-provisional application provided only one species within that genus. Id. at 28. The Board disagreed, finding instead that four covered species were disclosed. Id. at 29. Thermo had asserted three examples were outside the claims, including one with two signaling chromophores, id. at 29–30, but according to the Board, the claims were broad enough to cover systems with multiple signaling chromophores. Id. at 30. Thermo neglected to address a second covered example, id. at 31, and discounted a third because there was no mention of an “absence of the polymer,” a required limitation in the claims, id. at 32. But the Board reasoned that this example involved no polymer because it used the same term as the preceding example, “direct C* excitation,” which referred to excitation in the absence of a polymer. Id. Thermo thus failed to establish that the four disclosed species were inadequate support for the claims, particularly given the predictable nature of the art. Id. at 33. Bazan therefore was not § 102(b) prior art, and the challenge failed. Id.