Posts Tagged: "written description"

The Federal Circuit recently affirmed a Patent Trial and Appeal Board (Board) decision finding that Dr. Stephen Quake and Dr. Christina Fan’s (collectively, “Quake”) asserted claims were unpatentable for lack of written description under 35 U.S.C. § 112. See Quake v. Lo, Nos. 2018-1779, 2018-1780, 2018-1782, 2019 U.S. App. LEXIS 20407 (Fed. Cir. July 10, 2019) (Before Reyna, Chen, and Hughes, Circuit Judges) (Opinion for the Court, Chen, Circuit Judge). The claims were directed to a method for determining the presence of a chromosomal abnormality, called aneuploidy, in fetuses. Aneuploidy occurs when a fetus is born with either an abnormally high or low number of chromosomes. The claimed detection was accomplished using a method called massively parallel sequencing (MPS). Specifically, the claims recited a “random” MPS method, which amplified and sequenced all DNA in a sample rather than specific, targeted sequences of DNA. Quake, based out of Stanford University, and Dr. Dennis Lo (“Lo”) based out of Chinese University of Hong Kong began developing the claimed methods around the same time and requested interferences with respect to a number of applications to determine who invented the method first.

Global IP Holdings, LLC, the owner of U.S. Patent No. 8,690,233, achieved a victory with the Federal Circuit vacating a decision of the Board and remanding for the Board to address predictability and criticality of the claim term to determine whether the written description requirement has been satisfied. Although victorious, Global did not achieve everything it wanted. Global had requested the Federal Circuit to simply overrule the Board. Judge Stoll, however, explained that there was not support in the record sufficient to determine whether the “plastic” claim limitation was critical or important. Therefore, the Federal Circuit vacated the Board’s decision and ordered the Board, on remand, to address predictability and criticality of the claim term in question in order to determine whether the written description requirement has been satisfied.

When drafting Patent Cooperation Treaty (PCT) applications, or applications intended to be prosecuted abroad, a U.S. drafter inevitably faces the challenge of providing a description in line with the requirements of different jurisdictions. By the time feedback is received from the foreign patent offices, it will be too late to make any adjustments, and important aspects of the invention may inadvertently be lost. The challenge might feel impossible when dealing with the requirements of the European Patent Office (EPO), as the European Patent Convention (EPC) regulations on written description are framed in a way that is fundamentally different from U.S. regulations. For example, the requisites of providing an adequate description and notice of the metes and bounds of the claimed invention are framed in the United States as separate requirements (written description and definiteness respectively) with different legal bases (35 USC 112(a) for written description and 35 USC 112(b) for definiteness respectively).

The United States Court of Appeals for the Federal Circuit recently issued a ruling reversing a district court’s grant of summary judgment of non-infringement and invalidity for failure to satisfy the written description requirement. See CenTrak, Inc. v. Sonitor Techs., Inc., 2019 U.S. App. LEXIS 4442 (Fed. Cir. Feb. 14, 2019) (Before Reyna, Taranto, and Chen, Circuit Judges) (Opinion for the Court, Chen, Circuit Judge). The Court said the written description requirement does not require that the specification provide either examples or an actual reduction to practice. Instead, a constructive reduction to practice may be sufficient if the specification identifies the claimed invention in a definite way.

The United Stated Court of Appeals for the Federal Circuit recently held that a district court erred in its claim construction and vacated the district court’s judgment of noninfringement, which the parties stipulated to based on the erroneous construction. See Continental Circuits LLC v. Intel Corp., No. 2018-1076, 2019 U.S. App. LEXIS 3920, 2019 WL 489069 (Fed. Cir. Feb. 8, 2019) (Before Lourie, Linn, and Taranto, J.) (Opinion for the court, Lourie, J.). The Court highlighted that the first step in claim construction should always be to determine the plain and ordinary meaning of the claims. Further, the specification should serve to limit the plain and ordinary meaning only when it includes a definition for a claim term or a clear disclaimer or disavowal of claim scope.

Patents covering an antibody are often claimed by the antibody’s function (the residues where it binds to the antigen) rather than its structure (amino-acid sequence). This tactic can successfully cast a very wide net of patent protection over potentially millions of different antibodies. In doing so, even if the patent holder’s own antibodies never make it out of the laboratory, the patents can nevertheless corner the market on intellectual property covering a new class of inhibitors. The risk of this strategy, however, is that extremely broad patent scope can simultaneously doom a patent’s validity for not being sufficiently enabled or lacking written description. As an example, a recent decision from the District of Delaware, MorphoSys AG v. Janssen Biotech, Inc., No. 16-221 (LPS) (Dkt. 471) (Jan. 25, 2019), invalidated broad antibody patents for not being sufficiently enabled, as well as coming near to invalidating the same patents for lacking written description. The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.

Several weeks ago, in a non-precedential opinion, the Court of Appeals for the Federal Circuit issued a decision in In re: David Tropp, which vacated and remanded a decision of the Patent Trial and Appeal Board (PTAB). The PTAB decision had affirmed an examiner’s rejection of a patent application covering a luggage inspection technology. The Federal Circuit panel of Chief Judge Sharon Prost and Circuit Judges Raymond Clevenger and Kimberly Moore determined the PTAB erred in its written description analysis by failing to consider all of the language of the specification as filed when determining whether there was sufficient support for the claimed invention. “Even if it is new matter, the language in the ’233 application as filed is relevant to assessing compliance with the written description requirement,” Judge Moore wrote. “The Board’s failure to consider this language was erroneous.”

The U.S. Supreme Court denied a petition for writ of certiorari in Two-Way Media Ltd. v. Comcast Cable Communications, refusing to hear yet another appeal in a case involving a question of patent eligibility… Simply put, the answer to the first question asked by Two-Way Media in its Petition for Certiorari is absolutely not. There never has been a requirement that a patent claim must be — or even should be or can appropriately be — read in isolation. In fact, decisions that purport to ascertain the meaning of claim languagewithout the pomp and circumstance of Markman are openly violating the clear dictates of the Supreme Court. 

John O’Quinn, partner at Kirkland & Ellis and counsel representing Time Warner at the Federal Circuit, argued that the entire verdict should be vacated, not just the damages portion, because the court allowed the jury to use a 2007 verdict granted to Sprint against Vonage on the same asserted patents as evidence to determine the damages award. That verdict involved the use of a 25 percent rule of thumb for determining a royalty rate, a rule that the Federal Circuit has subsequently held to be inappropriate in a landmark ruling in 2011. 

Writing a patent application is not as easy as many think. Indeed, the concept of usefully describing the invention, which on its face seems easy enough to understand, is not as straight forward as it might seem, and why you cannot simply file an abbreviate description of an invention and think that suffices to protect anything really. This article looks at the most common parts of a patent application, and provides discussion about what each section needs to include.

The United States Patent and Trademark Office (USPTO) provides invalidity tools via inter partes review (IPR) and post-grant review (PGR), but which route is better? …  PGRs are estimated to cost more because of their broader discovery rules.  If cost is a major factor, IPRs are a less-expensive option due to restricted allowance of discovery, the most expensive aspect of patent litigation… If the invalidating arguments or art are not strong, an IPR may be a better option due to its lower threshold for institution.  The same prior art arguments that failed in a petition for a PGR may have succeeded in an IPR petition due to the lower standard.

Disclosure of one way to attach or position a roof assembly (a species) did not provide an adequate written description of other ways to attach or position the assembly (a genus or different species). Boilerplate language that a patent covers all modifications, permutations, additions, and sub-combinations of the disclosed invention that a POSA would recognize as within the language of the claims is not sufficient to show possession of a specifically claimed combination.

The Amgen v. Sanofi decision put most functional antibody claims into question, including epitope and competitive binding claims, as well as antibody claims based on a newly characterized antigen. After Amgen v. Sanofi, non-sequence based antibody claims may become more difficult to obtain before the USPTO from a written description standpoint.  Yet, to fully protect the essence of the invention and avoid design-arounds, such claims are extremely valuable to patent owners. To obtain antibody genus claims beyond those defined by sequences, the patent applicant will need to make and test a sufficient number of representative antibodies across the claimed genus, or establish a clear structure/function relationship among the members of the genus.  Patent applicants should carefully assess the amount of data they have acquired, in comparison to the scope of claims that they wish to obtain, before rushing to the Patent Office.

Appellant General Hospital Corp. (“GHC”) appealed the Board’s dismissal of an interference because the claims of its involved patent application lacked sufficient written description. The disclosure of a wide range with exemplary values does not provide written description support for a narrower claimed range, absent something to indicate the claimed range was considered critical or that inventor was in possession of the specific claimed embodiments. The Board cannot reject a motion to add a new claim to a patent application involved in an interference without explaining its findings.

The issue was whether the PCT, which disclosed a “connection to fibre optics bundle which provides for lighting” was a sufficient written description to support the “light guide” “permanently affixed” in the “first channel” of the patented claims. The Board reversed the Examiner and concluded that the earlier application had sufficient written description to qualify as a priority document… The Federal Circuit affirmed. The disclosure of a species, here a “fibre optics bundle,” was sufficient support for a priority claim by a later-filed patent application utilizing genus claims, here a “light guide,” because the patent-in-suit was in a predictable art field and the genus claims covered well-known limitations.