Drafting Claims for Allowability Under § 101 in Anticipation of The New Guidelines
The pendulum of 35 U.S.C. § 101 law appears to be shifting back toward patentability. This seems particularly true when the patented invention is carefully crafted by not-too-broad claims and does not raise concerns of preemption. According to recent case law, the “directed to” analysis is often improperly applied by patent examiners at the United States Patent and Trademark Office (USPTO) and lower courts. An improper “directed to” analysis involves abstracting the entire claimed subject matter down to an isolated concept without consideration of all parts of the claim. A proper § 101 inquiry requires consideration of the claimed subject matter “as a whole” and in light of the specification. The § 101 analysis presently applied by patent examiners at the USPTO appears to be lagging from recent case law. In the past, following § 101 clarification from the court, the USPTO has issued revised § 101 guidelines for patent examiners to apply to pending patent applications. For patentability under § 101, careful consideration should be given to draft claims that are not too broad and to not raise issues of preemption in anticipation of the new guidelines from the USPTO.
To be eligible for a patent, the patented invention must be directed to patentable subject matter in accordance with § 101. Patentable subject matter under § 101 includes “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof...” In other words, a patented invention must be directed to a process, a machine, an article of manufacture, or a composition of matter. For many years, § 101 was largely ignored as it was not applied to the majority of patent applications by the USPTO and/or by courts. In recent years, the United States Supreme Court (“Supreme Court”) has reviewed its limit on § 101 patent-eligibility and further defined and/or clarified a number of judicially recognized exceptions that are not patent eligible, including laws of nature, physical phenomena, and abstract ideas. See Bilski v. Kappos, 130 S. Ct. 3218 (2010). Following Bilski, the Supreme Court and lower courts have provided additional details for the eligibility analysis under Bilski.
On June 13th 2013, the Supreme Court in Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107, ruled that (1) isolated genomic DNA (gDNA) is not patent-eligible under § 101 and (2) complementary DNA (cDNA) is. Following recent patent decisions such as Mayo v. Prometheus, 132 S. Ct. 1289 (2012), the Court struck down patent claims on gDNA as having been merely “isolated” from the body— meaning, removed and separated from its natural environment in the cell. It upheld claims directed to cDNA as being “synthetically created DNA...which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins.” Said differently, cDNA was chemically different than what occurred in natural DNA.
The Supreme Court clarified in Alice Corp. V. CLS Bank International, 134 Ct. 2347 (2014), the two-part test § 101 as previously established in Mayo. The two-part test established in Mayo and clarified by Alice includes determining whether the claims contain a patent ineligible concept, and if so, determining whether the patent claim embodies an “inventive concept.”
The Court of Appeals for the Federal Circuit (“Federal Circuit”) has recently issued a number of decisions further clarifying § 101 in light of the Mayo, Myriad, and Alice decisions. In Ariosa v. Sequenom, 788 F.3d 1371 (2015), the Federal Circuit applied the two-part test of Mayo/Alice and affirmed the claims were invalid under §101. The claim at issue had two simple steps: (1) amplifying paternally inherited DNA from a plasma sample taken from a pregnant female, and (2) detecting the presence of DNA. The technology for amplifying and detecting DNA was known at the time of invention, but the presence of fetal DNA in plasma from a pregnant female was alleged to be unknown. The Federal Circuit held that the claims were directed to a law of nature, and the testing and determination steps were well known in the art at the time of invention and thus not an “inventive concept.”
Following Sequenom, the Federal Circuit in Enfish, LLC v. Microsoft Corp, 822 F.3d 1327 (2016) explained that the common “directed-to” practice of invalidating claims that lower courts were applying based on the Mayo/Alice inquiry is wrong, and that the character of the claimed invention as a whole (including all parts of the claim) must be used to conduct this inquiry. Thus, the Court implied/explained in pertinent part that a claim can be patent eligible if the known procedures as a whole are not unduly preempting or too obvious when considering the advancement of the invention. In other words, if the combination of known parts is considered as a whole, then it is not so easy to isolate and argue that the claim is “directed to” a patent-ineligible concept as has happened in so many invalidity decisions. For example, the Federal Circuit explained:
“In setting up the two-stage Mayo/Alice inquiry, the Supreme Court has declared: “We must first determine whether the claims at issue are directed to a patent-ineligible concept.” Alice, 134 S. Ct. at 2355. That formulation plainly contemplates that the first step of the inquiry is a meaningful one, i.e., that a substantial class of claims are not directed to a patent-ineligible concept. The “directed to” inquiry, therefore, cannot simply ask whether the claims involve a patent-ineligible concept, because essentially every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon—after all, they take place in the physical world. See Mayo, 132 S. Ct. at 1293 (“For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”). Rather, the “directed to” inquiry applies a stage-one filter to claims, considered in light of the specification, based on whether “their character as a whole is directed to excluded subject matter.” [citation omitted] see Genetic Techs. Ltd. v. Merial L.L.C., 2016 WL 1393573, at *5 (Fed. Cir. 2016) (inquiring into “the focus of the claimed advance over the prior art”).
Further, on June 27, 2016, in Bascom v. AT&T, No. 2015-1763, the Federal Circuit reversed a lower court’s § 101 invalidity finding because the lower court’s ruling was based on the limitations of the claims which, taken individually, showed nothing new as would be needed to prevent an otherwise abstract/preemptive invention from being patent eligible.
While both Bascom and the Enfish were directed to software, the statute, the case law and the applicable patent-eligibility test for the analysis are common with closely-linked analysis and preemption concerns directed to any patent ineligible subject matter, such as laws of nature. For example, the Federal Circuit in Rapid Litig. Mgt. v. CellzDirect, Inc, No. 2015-1570 (July 5, 2016) upheld patent claims directed to ways of preserving main liver tissue (hepatocyte cells) by using multiple freeze-thaw cycles. Applying the Mayo/Alice test, the Federal Circuit clarified and distinguished the patent claims from Mayo, Alice, and Sequenom, explaining that the claims were “not directed to a patent ineligible concept” (i.e., the ability of hepatocyte cells to survive multiple freezes), but to a new and useful laboratory technique for preserving hepatocytes. Specifically, the Federal Circuit indicated that the “inventors certainly discovered the cells’ ability to survive, but that is not where they stopped, nor is it what is patented.” The Federal Circuit further indicated that while pre-emption is not the test for determining patentability, the claims at issue did not lock up the law of nature in its entirety.
The Federal Circuit, in McRO, Inc.v. Bandai Namco Games America Inc., Docket Nos. 2015-1080 (Fed. Cir. Sept. 13, 2016), further clarified the preemption concern and indicated that where the claimed invention is limited to specific unconventional steps, the “directed to” application of §101 fails. The Federal Circuit upheld the patent claims explaining that “[c]laims to the genus of an invention, rather than a particular species, have long been acknowledged as patentable....The preemption concern arises when the claims are not directed to a specific invention and instead improperly monopolize ‘the basic tools of scientific and technological work.’ Alice, 134 S. Ct. at 2354 (quoting Myriad, 133 S. Ct. at 2116). The abstract idea exception has been applied to prevent patenting of claims that abstractly cover results where ‘it matters not by what process or machinery the result is accomplished.’”
The recent trends in Supreme Court and Federal Circuit decisions emphasize the importance of carefully crafting claims and the relevant description in a manner that does not raise concerns of preemption. The issue of patent claims preempting technological advancements has long been considered an issue under § 101. This follows because if the claimed invention is directed to an abstract invention, the abstraction creates overbreadth and thus would cover all such technological advancements under that abstraction. Presently, the USPTO is lagging in applying the above-analysis to pending applications, which may be due to the fact that a revised § 101 guideline has not yet been issued. As the USPTO tends to issue revised guidelines in response to additional case law, patent applicants may benefit from applying the above-analysis as arguments to overcome a § 101 rejection and/or when drafting claims.
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