Juno Therapeutics (Juno) has filed a Petition for Rehearing with the Supreme Court, requesting that the Court vacate its previous order denying Juno’s petition for certiorari and hold the case in abeyance pending the resolution of Amgen Inc. v. Sanofi, Aventisub LLC.
Just days after agreeing to review the scope of the enablement requirement in Amgen Inc. v. Sanofi, Aventisub LLC, the Supreme Court denied Juno’s request to review the scope of the written description requirement. In granting certiorari in the Amgen case, the Supreme Court agreed to address:
Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort.”
In denying certiorari in the Juno case, however, the Supreme Court refused to address the following question:
Is the adequacy of the “written description of the invention” to be measured by the statutory standard of “in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same,” or is it to be evaluated under the Federal Circuit’s test, which demands that the “written description of the invention” demonstrate the inventor’s “possession” of “the full scope of the claimed invention,” including all “known and unknown” variations of each component?
In its Petition for Rehearing, Juno argues that the questions presented in the two cases are closely related because they involve the same sentence of the same statute (35 U.S.C. § 112(a)) and both ask whether written description and enablement are governed by the statutory standard or by the Federal Circuit’s “full scope” requirement:
These two cases involve the very same sentence of the very same statute, 35 U.S.C. § 112(a). Both ask whether the “make and use” language from the statute provides the proper statutory test, and both ask whether the Federal Circuit’s addition of a “full scope” requirement is an appropriate addition to Congress’s language choice. The issues presented are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of, this case. Accordingly, rehearing should be granted.
According to Juno, if the Court concludes that the Federal Circuit erred in importing a “full scope” requirement into the enablement inquiry, it “will call into serious question that court’s ‘possessed the full scope’ test that it applies to assess written description.”
Just days after agreeing to review the scope of the enablement requirement in Amgen Inc. v. Sanofi, Aventisub LLC, the Supreme Court denied Juno Therapeutics, Inc.’s (Juno) request to review the scope of the written description requirement. Interestingly, both cases involved similar questions – whether the respective portion of 35 U.S.C. §112(a) is governed by the statutory language or whether enablement and written description apply to the “full scope” of the claimed invention.
Section 112 of the Patent Act requires a patent’s specification to “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” 35 U.S.C. §112(a). A specification is said to provide adequate written description when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In Juno Therapeutics, Inc. v. Kite Pharma, Inc., the Federal Circuit stated that written description is satisfied when the inventors convey that they possessed all known and unknown parts of the claimed invention. 10 F.4th 1330, 1338 (Fed. Cir. 2021), cert. denied, No. 21-1566, 2022 WL 16726060 (U.S. Nov. 7, 2022). Thus, Juno requested that the Court address the following question:
Is the adequacy of the “written description of the invention” to be measured by the statutory standard of “in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same,” or is it to be evaluated under the Federal Circuit’s test, which demands that the “written description of the invention” demonstrate the inventor’s “possession” of “the full scope of the claimed invention,” including all “known and unknown” variations of each component?
Claims 3, 5, 9, and 11 of U.S. Patent No. 7,446,190 (the ’190 patent) were at issue in the case. Claim 1 of the ’190 patent reads as follows:
1. A nucleic acid polymer encoding a chimeric T cell receptor, said chimeric T cell receptor comprising
(a) a zeta chain portion comprising the intracellular domain of human CD3 ζ chain,
(b) a costimulatory signaling region, and
(c) a binding element that specifically interacts with a selected target,
wherein the costimulatory signaling region comprises the amino acid sequence encoded by SEQ ID NO:6.
Claims 3 and 9 require that the antibody is a single chain antibody (scFv), and claims 5 and 11 require that the single chain antibody bind to CD19.
Kite Pharma, Inc., argued that the claims at issue encompass “millions of billions” of scFvs but that only a fraction of those satisfy the functional requirement of the claims – the ability to bind to a target. Juno Therapeutics, Inc., 10 F.4th at 1336. Juno, on the other hand, argued that scFvs are well-known molecules, that making scFvs was well known, that multiple scFvs for specific targets are well known, and that the ’190 patent provides two working examples of scFvs, which “are representative of all scFvs.” Id. The Federal Circuit did not agree with Juno’s arguments, stating that the ’190 patent “fails to provide a representative sample of species within, or defining characteristics for, that expansive genus.” Id.
The Federal Circuit first evaluated whether the patent provides a representative number of species falling within the scope of the claimed genus. The court found that although the ’190 patent discloses two scFvs – one derived from the SJ25C1 antibody that binds CD19 and the other derived from the J591 antibody that binds PSMA – claims 3 and 9 encompass a limitless number of targets. Id. According to the Federal Circuit, the disclosure of one scFv that binds to CD19 and one scFv that binds to a PSMA “in the manner provided in this patent does not provide information sufficient to establish that a skilled artisan would understand how to identify the species of scFvs capable of binding to the limitless number of targets as the claims require.” Id. at 1337.
The Federal Circuit then evaluated whether the patent discloses structural features common to the members of the genus so that one of skill in the art can visualize or recognize the members of the genus. The court noted that the ’190 patent fails to provide the amino acid sequence of either of the disclosed scFvs. Id. And although the court stated that “[i]t is not fatal that the amino acid sequences of these two scFvs were not disclosed” (id.), it noted that written description requires “other means of identifying which scFvs would bind to which targets, such as common structural characteristics or shared traits,” which the patent was said to lack. Id. According to the Federal Circuit, to satisfy written description “the inventors needed to convey that they possessed the claimed invention, which encompasses all scFvs, known and unknown, as part of the claimed CAR that bind to a selected target.” Id. at 1338.
The Federal Circuit reversed the district court’s ruling that claims 3, 5, 9, and 11 are not invalid for lack of written description, finding that the ’190 patent “does not disclose representative species or common structural features to allow a person of ordinary skill in the art to distinguish between scFvs that achieve the claimed function and those that do not.” Id. at 1342.
It is unclear why the Supreme Court denied Juno’s petition just days after granting Amgen’s. For now, the Federal Circuit’s ruling that written description requires applicants to convey that they possessed all known and unknown aspects of the claimed invention will stand. Time will tell if the Supreme Court will require a similar level of disclosure to satisfy the enablement requirement.
Anticipation of a claim generally requires that a single prior art reference explicitly discloses each and every claim element.[1] However, absent an express teaching in the prior art, a claim may also be anticipated if it is directed to a member of a limited class that a person of ordinary skill in the art would “at once envisage” from the teachings of the reference.[2] The U.S. Court of Appeals for the Federal Circuit recently provided more guidance on the bounds of its “at once envisage” standard in affirming a notable Patent Trial and Appeal Board (PTAB) decision.
The Supreme Court has granted Amgen’s Petition for a Writ of Certiorari, agreeing to address what it means to provide an enabling disclosure. In particular, Amgen asked the Court to address:
Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort.”
As part of the Trademark Modernization Act of 2020 (reported in the IP Intelligence Blog on Dec. 23, 2021), beginning on Dec. 3, trademark applicants will have three months (with a possible three-month extension) to respond to office actions issued during the examination of trademark applications at the United States Patent and Trademark Office (USPTO). The same change will go into effect next year (on Oct. 7, 2023) for post-registration office actions.
In a May 2022 post, we noted that the Supreme Court called for the views of the Solicitor General on whether to accept review of Abitron Austria GmbH v. Hetronic International, Inc., a case involving the international reach of U.S. trademark law. The issue is whether a U.S. trademark owner can recover damages for infringing sales outside the U.S. to non-U.S. customers. The Tenth Circuit Court of Appeals said yes, if those non-U.S. sales diverted sales that the U.S. trademark owner otherwise would have made.
The Solicitor General filed a brief last week, disagreeing with the Tenth Circuit’s decision and recommending that the Supreme Court take the case. In the brief, the Solicitor General argues that U.S. trademark law “provide[s] a remedy for a foreign defendant’s use of a plaintiff’s U.S. trademark abroad only if that use is likely to cause confusion in the United States.” The Tenth Circuit’s diversion-of-sales analysis, according to the Solicitor General, allowed the trademark owner to “recover even for sales that were not likely to result in consumer confusion in the United States.” The Solicitor General urged that the Tenth Circuit’s decision “risks globalizing U.S. trademark law, allowing U.S. trademark protection to serve as a springboard for regulating foreign conduct that has no likelihood of affecting consumer perceptions in the United States.”
In light of the Solicitor General’s views and the split between at least the Tenth and Fourth Circuits on the extraterritorial reach of U.S. patent law, the Abitron certiorari petition appears significantly more likely than most petitions to be granted.
In many countries, marks such as single letters or numerals are considered nondistinctive. This is not so in the US, which has a very broad definition of what comprises a trademark in 15 U.S.C. Section 1127:
A trademark is any word, name, symbol, or design, or any combination thereof, used in commerce to identify and distinguish the goods of one manufacturer or seller from those of another and to indicate the source of the goods.
In an attempt to broaden a patent’s disclosure and provide Section 112 support for features that are not explicitly disclosed within the patent’s specification (such as reagents, assays, techniques, etc.), patent applications are often drafted with boilerplate language to indicate that other “conventional,” “well-known” or “routine” features may be used. But acknowledging that features of a claimed invention are conventional, well-known or routine can be detrimental to patentability. Take the Federal Circuit’s recent decision in CareDx, Inc. v. Natera, Inc., for example, in which the court held that methods for detecting organ transplant rejection were directed to “a natural law together with conventional steps to detect or quantify the manifestation of that law.” (CareDx, Inc. v. Natera, Inc., No. 2022-1027, 2022 WL 2793597, at *8 (Fed. Cir. July 18, 2022).)
Should copyright protection be given for AI-generated inventions? Stephen Thaler, the president and CEO of Imagination Engines, thinks so.
The Complaint
In 2018, Thaler filed an application to register a copyright for an AI-generated work produced by one of his AI systems, the Creativity Machine. The work, titled “A Recent Entrance to Paradise,” is part of a series that depicts a simulated near-death experience. The U.S. Copyright Office denied Thaler’s application on the grounds that the work lacked human authorship. Last week, Thaler sued the Copyright Office, alleging that the agency’s denial of his copyright registration is an arbitrary and capricious action and not in accordance with the law. You can find the complaint here.
