CAFC Provides Potent Remedy For Common PTO Obviousness Rejections
| September 27, 2013
Leo Pharmaceutical Products v. Rea
August 12, 2013
Panel of Rader, O’Malley and Reyna; opinion by Rader
The Court of Appeals for the Federal Circuit recently provided excellent guidance for responding to obviousness rejections which at first blush seem strong. In Leo Pharmaceutical Products Ltd. v. Rea, decided August 12, 2013, it reversed the Board of Patent Appeals and Interferences because the Board incorrectly weighed the objective indicia of non-obviousness.
The appeal arises from an inter partes reexamination of U.S. Patent No. 6,753,013 (the ‘013 patent). Claim 1 is directed to a pharmaceutical composition for dermal use which included a vitamin D analog, a corticosteroid and a solvent. During the inter partes reexamination proceeding, claim 1 had been amended to include the phrase “wherein said pharmaceutical composition is storage stable and non-aqueous,” which proved to be pivotal in securing the favorable decision for Leo Pharmaceutical Products, Ltd.
Election of species in case where there is no generic claim amounts to a “restriction” for applying safe harbor provision of 35 U.S.C. §121
| September 18, 2013
St. Jude Medical, Inc. v. Access Closure, Inc.
September 11, 2013
Panel: Lourie, Plager and Wallach. Opinion by Plager. Concurring opinion by Lourie.
Summary:
St Jude Medical, Inc. asserts two sets of patents against Access Closure, Inc. (ACI). The patents claim methods and devices for sealing a “vascular puncture” into a vein or artery made during a medical procedure.
Claims 7, 8 and 9 of the Janzen patent are invalid for double patenting over the claims of a copending “sibling” application because claims 7, 8 and 9 are directed to an invention identified as Group II in a restriction requirement, further limited to species C, and the claims in the sibling patent are directed to a Group II invention but without any limitation to species. The safe harbor provision of 35 U.S.C. §121 does not apply because the claims of the Janzen patent are not patentably distinct from the claims of the sibling patent, and the patents do not maintain the “consonance” created by the original restriction requirement and requirement for election of species.
The claims of the two Fowler patents asserted by St Jude Medical are not obvious over a combination of two cited references because the references teach alternative methods (inserting a balloon or inserting a gelfoam stick) for achieving hemostasis, whereas the claims in the Fowler patents use a balloon for another purpose, i.e., to help position a plug and prevent it from entering a blood vessel.
Tags: double patenting > election of species > obviousness > restriction > safe harbor rule
Predictably Divided CAFC Panel Finds Computer System Claims Not Patent-Eligible
| September 17, 2013
Accenture Global Services, GMBH v. Guidewire Software, Inc. September 5, 2013 Panel: Lourie (author), Reyna, Rader (dissent) Summary:Not surprisingly, the decision of the latest Federal Circuit case on software patent eligibility can be predicted based on the makeup of the CAFC panel. Judge Lourie, joined by Judge Reyna, issued the majority opinion that the system claims were invalid. The Court followed the analysis for determining patent eligibility from CLS Bank, 717 F.3d 1269 (Fed. Cir. 2013) and affirmed the district court’s finding that the system claims of U.S. Patent No. 7,013,284 (“the ‘284 patent”) were ineligible. Judge Rader dissented.
Tags: §101 > abstract idea > CLS Bank > preemption > software patent
Inventorship disputes raise difficult issues; involvement of State universities adds layers of complexity
| September 6, 2013
University of Utah v. Max-Planck-Gesellschaft
August 19, 2013
Panel: Moore, Reyna and Wallach. Opinion by Reyna. Dissent by Moore.
Summary:
This case started with the University of Utah suing the University of Massachussetts and others to obtain correction of inventorship in a group of patents co-owned by UMass and the other defendants. But the main issues in this appeal relate to the status of the plaintiff UUtah and initial co-defendant UMass as State entities.
To overcome UMass’ sovereign immunity defense (a State can be sued by another State only in the Supreme Court under Article III of the Constitution), UUtah amended its complaint to name individual UMass officials, instead of UMass itself.
The District Court held that the lawsuit could proceed, and the Federal Circuit affirms on the grounds that (1) UMass is not a “real party of interest” because deciding inventorship does not involve a core state interest, and (2) UMass is not an “indispensable party” because the officials can adequately represent the interest of UMass as co-owner of the patents.
Tags: indispensable party > inventorship correction > sovereign immunity
Incorporation by reference by its entirety without further relevant citation to specific contents is insufficient to provide intrinsic record to trump the disclaimer in the specification
| September 4, 2013
SkinMedica, Inc. v. Histogen Inc. et al.
August 23, 2013
Panel: Rader, Clevenger, Prost. Opinion by Prost. Dissent by Rader.
Summary:
SkinMedica owns the ’494 patent. It filed a patent infringement suit against Histogen. During the prosecution, the inventors limited their claimed inventions to pharmaceutical compositions comprising cell culture medium conditioned by animal cells cultured in three-dimensions. The issue is whether the claimed term, “culturing … cells in three-dimensions,” covers the use of beads. The ordinary meaning of the claimed term, “culturing … cells in three-dimensions” would cover the use of beads. The court found that the inventors expressly defined the use of beads as culturing in two-dimensions. Also, the inventors avoided anticipatory prior art during prosecution by asserting that the conditioned medium produced by two-dimensional cultures was inferior and chemically distinct from the conditioned medium produced by three dimensional cultures. SkinMedica also argued that the ’494 specification incorporates Doyle by reference, which explains the use of beads. However, the court rejected this argument since specific reference to the relevant discussion is not made in the intrinsic record, which does not trump the disclaimer in the specification.
SkinMedica は494特許を所有しており、Histogen社を特許侵害で訴えた。494特許の審査段階において、出願人はクレーム発明を補正し、3次元培養に限定し た。争点は、クレーム発明がビーズの使用を含むかどうかである。クレーム用語である「細胞を3次元で培養する」の通常の意味は、ビーズの使用を含む。しか しながら、裁判所は、内部証拠から判断して、発明者が、ビーズの使用は2次元培養であることを明確に定義したと判断した。また、発明者は審査段階において 新規性拒絶をクリアするために2次元培養で製造した調整媒体は劣っており、3次元媒体で製造した調整媒体と化学的に区別できることを主張した、と判断し た。また、494特許は、ビーズの使用を説明した文献（Doyle）を明細書に引用していたが（incorporation by reference）、関連箇所を示す説明が何もないとして、SkinMedicaの主張を退けた。
