· In In re Hubbell the Federal Circuit confirmed the rejection of all of the pending claims in an application, filed with Jeffrey Hubbell, Jason Schense, Andreas Zisch, and Heike Hall as named inventors. The invention disclosed in the application was based on research performed while all of the named inventors were at California Institute of Technology (CalTech). As a result, the application is assigned to CalTech. Approximately five years before the CalTech application was filed, Hubbell left CalTech for Eidgenossische Technische Hochschule Zurich (ETHZ). A second application filed based on research Hubbell and Schense conducted at ETHZ was filed less than a year before the CalTech application, which is assigned to ETHZ and Zurich University. Aside from Hubbell and Schense, the two patents do not have identical inventive entities, or common owners or assignees. The ETHZ application, which issued as a U.S. patent in 2009, was used as the basis for an obviousness-type double patenting rejection, which was upheld by the Board of Patent Appeals and Interferences.
Hubbell appealed the Board decision, arguing that the judicially created obviousness-type double patenting rejection should not apply where an application and a conflicting patent share common inventors, but do not have identical inventive entities, were never commonly owned, and are not subject to a joint research agreement. Alternatively, Hubbell argued that should the court find the obviousness-type double patenting rejection is applicable, he should either be allowed to file a terminal disclaimer as an equitable measure, or the court should employ a two-way obviousness analysis for the rejected claims.
The Federal Circuit affirmed the Board, finding that both the MPEP and Federal Circuit precedent supported application of the obviousness-type double patenting rejection to cases where an application and a conflicting patent have one or more inventors in common but the inventive entities are not identical and the applications were never commonly owned. The court rejected Hubbell’s argument that the case precedent only involved applications that were once commonly owned by the same entity, and did not apply to his application because CalTech never controlled the ownership of the second application. The court based its decision on the underlying concerns over the possibility of harassment by multiple assignees that exists when issued patents lack common ownership—if the claims of the ETHZ application were to issue, a potential infringer could be subject to suit from both CalTech and ETHZ. The court also rejected Hubbell’s argument that a terminal disclaimer should be permitted, based on the fact that there is no statutory basis for doing so. Finally, the court affirmed the Board’s rejection of Hubbell’s request to have the two-way obviousness analysis applied in the case. The court concluded that Hubbell’s application did not meet the requirements to apply the narrow exception to the general rule of the one-way test.
Judge Newman dissented in the opinion, concluding that the majority’s decision is a “flawed ruling on incorrect law.” Specifically, Judge Newman concluded that because there are different inventive entities and that there is not common ownership, obviousness-type double patenting does not apply, but if there indeed is obviousness-type double patenting, then a terminal disclaimer is necessarily available. Judge Newman took issue with the circularity of the majority opinion—a terminal disclaimer is not available because there is not common ownership, yet if there is not common ownership or common inventorship, there cannot be double patenting.
· In Dawson v. Dawson, the Federal Circuit upheld the USPTO Board of Patent Appeals and Interferences (BPAI) decision determining that an earlier-filed patent application for topically treating and preventing infections of the eye, naming Dr. Chandler Dawson as inventor, had priority over a later-filed patent application, also naming Dr. Chandler Dawson as inventor. The earlier-filed application was submitted by Dr. Dawson and Dr. Lyle Bowman and assigned to InSite Vision Incorporated. The University of California San Francisco (UCSF) filed the later-filed application, without the involvement of Dr. Dawson but naming Dr. Dawson as the sole inventor, for the sole purpose of instituting an interference. The BPAI determined that UCSF had not met its burden to show that Dr. Dawson had conceived of the invention prior to his collaboration with Dr. Bowman.
On appeal to the Federal Circuit, UCSF asserted that the invention embodied in the InSite application was conceived of by Dr. Dawson while he was employed at UCSF and before he joined InSite, and therefore priority of the invention should rest in the UCSF later-filed application. UCSF argued that the conception requirement was met by the time Dr. Dawson made a presentation at a WHO conference, as demonstrated by documents produced from that conference. UCSF argued that even though the conference documents lacked the particular carrier and concentrations recited in the claims, conception was achieved because the documents showed that Dr. Dawson had formed the idea that of topical use of azithromycin would be effective for treating eye infections, and that the subsequent preparation of an effective ointment was merely corroboration of the idea.
The court rejected UCSF’s arguments, reasoning that the WHO documents themselves demonstrated the lack of conception because they constituted “a ‘preliminary’ statement about a ‘possibility’ or ‘potential use,’ alongside a recommendation for continued work and a ‘report back’ in the future.” The court concluded that this fell short of the requirement for a definite and permanent idea of the complete and operative invention, as it is to be applied in practice, as set out in Hybritech Inc. v. Monoclonal Antibodies, Inc. The court further held that UCSF failed to make a sufficient showing with respect to the individual interference counts—the specific concentrations, the suspending agent, or the claimed “amount effective to treat infection in a tissue of the eye.” Finally, the court rejected UCSF’s argument that the BPAI had improperly required a showing of reduction to practice in order to prove conception, concluding that UCSF’s argument was based on an erroneous view of what is needed to prove conception, and holding that “there is a critical difference between conceiving a way to make an idea operative and knowing that a completed invention will work for its intended purpose.”
Judge Reyna dissented in the opinion, concluding that the record was sufficient to demonstrate that Dr. Dawson possessed a definite and permanent idea of his complete and operative invention when he was employed by UCSF, not InSite, and therefore UCSF had demonstrated prior conception.
· In Saffran v. Johnson &Johnson, Dr. Bruce N. Saffran (Saffran) sued Johnson & Johnson and Cordis Corporation (collectively “J&J”), alleging that J&J infringed a number of claims in Saffran’s U.S. patent. The patent involved methods and apparatus that would sequester macromolecules within a defined area, for example a sheet that could be wrapped around a bone fracture that would keep growth factors from diffusing out of the fractured area. The claims of the patent were also drawn to the additional capability of controlled release of a substance incorporated into the apparatus via a “means for release.” The alleged infringing device was a drug-eluting stent comprising a metallic mesh with a microscopic layer of polymer that coats the surface of each strut, the polymer being mixed with a macromolecular drug that would gradually escape through gaps in the polymer matrix. The U.S. District Court for the Eastern District of Texas held that J&J infringed the patent based on its construction of the terms “device” and “release means”. J&J appealed to the Federal Circuit, arguing that the district courts construction of the two terms was erroneous, and that a proper construction precluded infringement.
On appeal, the Federal Circuit construed the term “device”—as used in the preamble and body of independent claim 1, in the bodies of independent claims 8 and 15, and at least by reference in each of the dependent claims—to mean a continuous sheet and to exclude stents having open mesh holes. The court came to this conclusion based on the prosecution history, during which the patentee sought to distinguish the prior art by asserting that the device used in the invention is a sheet rather than the structure disclosed in the prior art reference. The court confirmed that this corresponded to the disclosure in the specification, and Saffran’s argument that the specification contained alternative embodiments did not persuade the court otherwise.
The court confirmed that “[u]nder § 112, ¶ 6, the question is not what structures a person of ordinary skill in the art would know are capable of performing a given function, but what structures are specifically disclosed and tied to that function in the specification” and “a patentee cannot rely on claim differentiation to broaden a means-plus-function limitation beyond those structures specifically disclosed in the specification.” Thus, the court construed “release means” to only include treating material attached to the substantially impermeable sheet via hydrolyzable bonds or an equivalent thereof.
Based on its construction of “device” and “release means” the court concluded that J&J did not infringe the asserted Saffran patent.