Dewipat Inc

Patent Agents & IP Portfolio Builders

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Modicum of Uncertainty

Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. ______ (2014)brings to light conflicting views on how to interpret the requirement of 35 USC 112, second paragraph, also known as the definiteness requirement. 35 USC 112, second paragraph, states that “[T]he specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as the invention.”

Nautilus argued that if a claim is “ambiguous, such that readers could reasonably interpret the claim’s scope differently,” the claim does not meet the definiteness requirement. On the other hand, Biosig argued that the patent needs only “provide reasonable notice of the scope of the claimed invention.” The Federal Circuit took Biosig’s argument a step further by holding that if a claim is “amenable to construction” and not “insolubly ambiguous,” the claim passes the definiteness requirement.

However, the Supreme Court objected to the “amenable to construction” and “insolubly ambiguous” standard as lacking the precision required by 35 USC 112, second paragraph. While the Supreme Court acknowledged that absolute precision is unattainable given the inherent limitation of language, the Supreme Court also held that “[t]o tolerate imprecision just short of that rendering a claim ‘insolubly ambiguous’ would diminish the definiteness requirement’s public-notice function and foster the innovation-discouraging ‘zone of uncertainty’.”

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Claims Not Invalid Due to Omitted Desirable Features

ScriptPro, LLC and ScriptPro USA, LLC (ScriptPro) accused Innovation Associates, Inc. (Innovation Associates) of infringing on claims 1, 2, 4, and 8 of their U.S. Patent No. 6,910,601 (’601 patent). The ’601 patent relates to a collation unit that works with an automatic dispensing system that automatically fills and labels pill bottles or other prescription containers. The district court granted summary judgment to Innovation Associates on the basis that the asserted claims are invalid under 35 USC 112, first paragraph (or 35 USC 112(a) in the current statute). The district court based its holding on the conclusion that “the specification describes a machine containing ‘sensors,’ whereas the claims at issue claim a machine that need not have ‘sensors.’”

ScriptPro appealed to the Federal Circuit, which ultimately reversed the district court’s summary judgment of invalidity (ScriptPro, LLC and ScriptPro USA, Inc. v. Innovation Associates, Inc., Docket No. 2013-1561, 6 August 2014). The main reasons for the reversal are that a skilled artisan upon reading the specification can reasonably conclude that sensors are desirable but ultimately optional in ScriptPro's system and that the original claims in the application resulting in the '601 patent did not require sensors. Original claims not requiring sensors means that at least the possibility of not using sensors was acknowledged at the time the application for patent was filed (Crown Packaging, 635 F.3d at 1380, “Original claims are part of the specification and in many cases will satisfy the written description requirement.”).

It should be noted that the Federal Circuit did not consider whether the claims as drafted rely on sensors. The only question the Federal Circuit addressed was whether the absence of sensors in the claims means that the claims are not supported by the written description.

The specification of the ‘601 patent uses the phrase “broadly includes” when listing the components of its system. This phrase is odd in patent drafting, but the Federal Circuit did not interpret the phrase as meaning that every component following the phrase must be present in the system. Instead, the Federal Circuit noted that the qualifier “broadly” is similar to the qualifier “generally” and allows some wiggle room in interpretation.

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Abstraction in Method of Doing Business Patents

There is nothing that excites the patent community more than having an opportunity to ask the Supreme Court about what is patentable, or not.

In Alice Corp. v. CLS Bank Int’l. (Docket No. 13-298, 2014), the petitioner, Alice Corporation, asked the Supreme Court to weigh in on a decision of the lower courts that claims drawn to a scheme for mitigating settlement risk are invalid, unenforceable, and therefore not infringed. The scheme involved use of a computer system as an intermediary.

It is well known that laws of nature, natural phenomena, and abstract ideas are not patentable. However, inventions that apply these concepts to a new and useful end are eligible for patent protection.

In Alice Corp. v. CLS Bank Int’l., the Supreme Court revisited the framework for determining patent eligibility, as described in Mayo Collaboratives v. Prometheus Laboratories, Inc., 566 U.S. _____ (2012). In this framework, a first determination must be made as to whether the claims are directed to patent-ineligible concepts, i.e., laws of nature, natural phenomena, and abstract ideas. If the claims are, then a second determination must be made as to whether there is anything else in the claims above and beyond the patent-ineligible concepts that could transform the nature of the claims to patent-eligible claims.

The claims at issue were drawn to the concept of intermediated settlement. The Supreme Court determined that the concept of intermediated settlement is an abstract idea because (i) intermediated settlement is a “fundamental economic practice long prevalent in our system of commerce” and (ii) “use of a third-party intermediary (or ‘clearing house’) is also a building block of the modern economy.”

Naturally, the meaning of “abstract idea” was at issue in this case. Alice Corporation argued that the abstract-ideas category is confined to “preexisting, fundamental truths that exist in principle apart from any human action.” Alice Corporation based this definition of abstract idea at least in part on other cases involving mathematical algorithms. However, the Supreme Court pointed to the Bilski case, where the court determined that the concept of risk hedging was held to be an abstract idea. The Supreme Court noted that risk hedging is not a fundamental truth in the manner suggested by Alice Corporation, but that it was an abstract idea nonetheless because it was a fundamental economic practice.

Thus it seems that the abstract-ideas category is not confined to fundamental truth but also encompasses fundamental practice, or at least fundamental economic practice.

Having established that the concept of intermediated settlement is an abstract idea, the Supreme Court moved on to resolve whether the claims at issue contained anything else above and beyond an abstract idea.

The method claims at issue required generic computer implementation. The Supreme Court had already held in Bilski, for example, that “mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”

It is worth noting that the representative method claim was cast in a manner to recite that the steps were actually carried out by the computer. The Supreme Court noted that the relevant question here is not whether the computer is carrying out the steps but whether the claims are doing more than simply asking the practitioner to implement the abstract idea on a generic computer. The court concluded that the claims were not. For example, the claims require no more than a generic computer and do not improve the functioning of the computer when implemented in the computer.

The Supreme Court decided that the claims are not patent-eligible because (i) they are directed to an abstract idea of intermediated settlement and (ii) they amount to nothing significantly more than an instruction to apply the abstract idea on a generic computer.

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The Court Says No to Patenting Dolly the Sheep

Keith Campbell and Ian Wilmut successfully cloned a sheep, which they called "Dolly", using a process known as somatic cell nuclear transfer. (Dolly lived from 1996 to 2003.) The process of cloning Dolly involved fusing “the nucleus of an adult, somatic mammary cell with an enucleated oocyte.” Campbell and Wilmut obtained US Patent No. 7,514,258 on the somatic method of cloning mammals and assigned this patent to Roslin Institute of Edinburgh, Scotland (Roslin). Campbell and Wilmut filed U.S. Patent Application No. 09/225,233 (the ‘233 application), which they also assigned to Roslin, for products of their cloning method. The following are representative claims from the ’233 application.

155. A live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.

164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.

The Patent and Trademark Office (PTO) examiner rejected the claims of the ‘233 patent application on the basis that they were directed to non-statutory subject matter under 35 USC 101 and that they were anticipated under 35 USC 102 and obvious under 35 USC 103. Roslin appealed to the Patent Trial and Appeal Board (Board) against the rejections, but the Board affirmed the examiner’s rejection. Roslin then appealed to the Federal Circuit, the decision of which can be found in In Re Roslin Institute, Appeal No. 2013-1407, Decided 8 May 2014.

The Federal Circuit noted that the Supreme Court had already “made clear that naturally occurring organisms are not patentable” (Chakrabarty and Funk Bros. Seed Co., v. Kalo Inoculant Co., 333 U.S. 127 (1948)). The Federal Circuit further noted that a modified organism having “new and markedly different characteristics from any found in nature” and “the potential for significant utility” is patentable (Diamond v. Chakrabarty, 447 U.S. 303, 305 (1980)). The Federal Circuit also noted that naturally occurring, isolated genes are not patentable because they are products of nature (Myriad Genetics, Inc., 133 S. Ct. 2107 (2013)).

Roslin argued that “copies (clones) are eligible for protection because they are ‘the product of human ingenuity’ and ‘not nature’s handiwork, but their own.’” The Federal Circuit argued that the clone is an exact replica of another sheep and therefore does not satisfy the “new and markedly different characteristics from any found in nature.”

Roslin argued that there are phenotypic differences between the clones and the donor mammals used to create them due to environmental factors. The Federal Circuit argued that phenotypic differences were not claimed and that any phenotypic differences were not due to any effort on the part of the patentee. The Federal Circuit noted that the phenotypic differences due to environmental factors are the work of nature, and patents cannot be issued for discovery of phenomena of nature.

Roslin further argued that there are differences in mitochondrial DNA of the clones and the donor mammals used to create them because the mitochondrial DNA of the clones came from the donor oocyte rather than the donor nucleus. The Federal Circuit argued that these mitochondrial DNA differences are not claimed and that the claims and specification do not suggest that the clones have markedly different characteristics from their donor animals.

Roslin also argued that the “clones are patent-eligible because they are time-delayed versions of their donor mammals, and therefore different from their original mammals.” The Federal Circuit argued that time delay cannot be used as a basis for patent eligibility. The Federal Circuit further noted that any copy of an original will necessarily be a time-delayed version of the original.