Kaneka – The Circuit vacates a summary judgment of noninfringement based on improper construction of two different terms in the claims. First, t he district court improperly relied on a dictionary definition of the claim term “sealed” instead of relying on the intrinsic evidence. Second, the district court properly interpreted the method claims as covering the steps in the order recited because the language of the claims suggested that the prior steps needed to be performed first. However, the court improperly required that each step be completed before the next one begins, as neither the claims nor the specification required that.

OIP – OIP Technologies alleged that Amazon.com infringed a patent directed to a e-commerce method of price optimization. The district court granted judgment on the pleadings, concluding that the patent was invalid under § 101. In a thorough analysis of Alice and other computer-implemented patentable subject matter cases, the panel agrees that the claims recite no more than an abstract idea coupled with routine data-gathering steps and conventional computer activity.

Ariosa – Based on Mayo, the panel affirms the grant of summary judgment of invalidity under ‎§ 101‎ of a patent directed to detecting paternity-identifying DNA in a blood sample from a pregnant female. The panel first determines that the claims are directed to a patent-ineligible concept, and then concludes that the claims did not include additional elements sufficient to transform the nature of the claim into a patent-eligible application. The panel recognized the significance of the inventors’ contribution but nonetheless holds that the claimed methods are directed to unpatentable natural phenomena.

Kaneka Corp. v. Xiamen Kingdomway Group Co., Fed. Cir. Case 2014-1373, -1399 (June 10, 2015)

Kaneka owns a ‘340 Patent, which describes processes for producing oxidized and reduced coenzyme Q 10 , which are sold as dietary supplements. Independent claim 22 recites a process for producing on an industrial scale the oxidized coenzyme Q 10 , and includes the steps of disrupting the microbial cells to obtain reduced coenzyme Q 10, oxidizing thus-obtained reduced coenzyme Q 10 to oxidized coenzyme Q 10 and then extracting the oxidized coenzyme Q 10 by an organic solvent in a “sealed tank.” Independent claim 33 is identical to claim 22 except the extraction step is recited before the oxidation step.

The District Court Should Have Interpreted “Sealed Tank” Based on Intrinsic Evidence

In construing the term “sealed tank,” the court relied on a dictionary definition that defined “seal” as “a tight and perfect closure (as against the passage of gas or water)” because the term “sealed” is not defined in the specification. On that basis, the court construed the term “sealed tank” to mean “a tank that is closed to prevent the entry or exit of materials.”

The panel determines that the reliance on the dictionary definition and related testimony conflicts with the intrinsic record. Although the specification does not specifically define the term “sealed,” the appropriate definition can be ascertained from the specification. Figure 1 and Example 8 of the specification suggest that the “sealed tank” should be sealed to the atmosphere, but not necessarily to other materials, such as solvents. Though Example 8 refers to extracting reduced coenzyme Q 10 , the specification describes how to similarly extract oxidized coenzyme Q 10. By depicting solvent flowing into and out of the extraction tanks, the specification indicates that the “sealed tank” is not sealed to prevent entry or exit of all materials. Accordingly, the panel holds that the term “sealed tank,” means “a tank that prevents exposure of the tank’s contents to the atmosphere.”

The Lower Court Also Misinterprets the “Oxidizing” Step

The “oxidizing” step of claim 22 was construed to mean “actively converting all or substantially all of the reduced coenzyme Q 10 obtained from the disruption step to oxidized coenzyme Q 10 in a step before beginning the extraction step,” while the “oxidizing” step of claim 33 was construed to mean “actively converting all or substantially all of the extracted reduced coenzyme Q 10 obtained from the disruption step to oxidized coenzyme Q 10 in a separate step after the extraction step has been performed.” The district court granted Xiamen’s motion for summary judgment of noninfringement because of the court’s construction of “sealed tank” and the “oxidizing” step.

This construction has four limitations. First, oxidation “must be an active, not a passive, process.” Second, “all or substantially all” of the reduced coenzyme Q 10 must be converted during the oxidation step. Third, oxidation must occur either before the extraction step in claim 22 or after the extraction step in claim 33. Fourth, oxidation must occur separately from the culturing, disruption, and extraction steps.

The panel agrees that oxidation requires an active step. Because the claims affirmatively recite the step of “oxidizing,” oxidizing cannot be interpreted as doing nothing, or to simply allow oxidation to occur on its own. However, while the oxidation step requires action, it does not require the use of an oxidizing agent. Though the preferred embodiment uses an oxidizing agent, we must be cautious not to import preferred limitations into the claims. Thus, an oxidizing agent is not required to carry out the “oxidizing” step.

Some oxidation must occur before the extraction step in claim 22 or after the extraction step in claim 33. Where the steps of a method claim actually recite an order, we ordinarily construe the claim to require order. The oxidation step in claims 22 and 33 refers to the product of the previous step, and, therefore, at least some action resulting in oxidation must be applied to the product of the disruption step in claim 22, and the product of the extraction step in claim 33. However, the claimed order does not exclude passive oxidation during other process steps. Requiring active oxidation during the oxidation step preserves the claimed order, but does not exclude passive oxidation during other steps.

Further, the claimed order does not require that each step occur independently or separately. In claim 22, some action resulting in oxidization must be applied to the product of the disruption step. This does not necessarily mean that the disruption step has to be complete before the oxidation step begins. The claims do not exclude a continuous process, in which later steps are initiated as soon as at least some product from the previous step forms, while previous steps are still ongoing. The written description contemplates continuous process steps. The claims do not exclude a process in which every claim step is occurring simultaneously. By the same logic, the extraction step recited in claim 33 does not have to be complete before the oxidation step begins as long as the oxidation step is applied to at least some extracted product. In other words, the claims require order but do not require discrete steps. Because the claims read on a continuous process, a process step does not need to be complete before another step begins. Thus, it is not required that any one step be carried out separately or independently of any other step.

Comment: The claims at issue indicate that the steps need to be performed in the order recited since the subsequent steps refer to what was performed in the prior steps. In drafting method claims it is critical to be alert to this possible claim construction. If the process can also be performed in a different order, it is important to state, even in the preamble, that the steps need not be performed in the order recited. Only if the order is critical to perform the process or to distinguish the prior art should reference be made to the prior steps or to include words like “first,” “then” and the like. 

OIP Technologies, Inc. v. Amazon.com, Inc., Fed. Cir. Case 2012-1696 (June 11, 2015)

A ‘713 patent claims computer-implemented methods for “pricing a product for sale.” The specification explains that traditionally merchandisers manually determine prices based on their qualitative knowledge of the items, pricing experience, and other business policies. In setting the price of a particular good, the merchandiser estimates the shape of a demand curve for a particular product based on, for example, the good itself, the brand strength, market conditions, seasons, and past sales. The ‘713 patent states that a problem with this approach is that the merchandiser is slow to react to changing market conditions, resulting in an imperfect pricing model where the merchandiser often is not charging an optimal price that maximizes profit. Accordingly, the ‘713 patent teaches a price optimization method that “helps vendors automatically reach better pricing decisions through automatic estimation and measurement of actual demand to select prices.” Claim 1 recites:

1. A method of pricing a product for sale, the method comprising:

    • testing each price of a plurality of prices by sending a first set of electronic messages over a network to devices;

      • wherein said electronic messages include offers of said product;

      • wherein said offers are to be presented to potential customers of said product to allow said potential customers to purchase said product for the prices included in said offers;

      • wherein the devices are programmed to communicate offer terms, including the prices contained in the messages received by the devices;

      • wherein the devices are programmed to receive offers for the product based on the offer terms;

      • wherein the devices are not configured to fulfill orders by providing the product;

      • wherein each price of said plurality of prices is used in the offer associated with at least one electronic message in said first set of electronic messages; gathering, within a machine-readable medium, statistics generated during said testing about how the potential customers responded to the offers, wherein the statistics include number of sales of the product made at each of the plurality of prices;

      • using a computerized system to read said statistics from said machine-readable medium and to automatically determine, based on said statistics, an estimated outcome of using each of the plurality of prices for the product;

      • selecting a price at which to sell said product based on the estimated outcome determined by said computerized system; and

      • sending a second set of electronic messages over the network, wherein the second set of electronic messages include offers, to be presented to potential customers, of said product at said selected price.

The district court granted Amazon’s motion to dismiss, finding that the claims merely use a general purpose computer to implement the abstract idea of “price optimization” and are therefore ineligible for protection under § 101. Without the “insignificant computer-based limitations,” the court concluded that claims merely describe what any business owner or economist does in calculating a demand curve for a given product.

The Claims are Directed to an Abstract Idea Implemented by Generic Computer Functions

The panel first states that, under the now familiar two-part test described by the Supreme Court in Alice, “we must first determine whether the claims at issue are directed to a patent-ineligible concept,” such as an abstract idea. Alice Corp. Pty. Ltd. v. CLS Bank Inc., 134 S. Ct. 2347 (2014). If so, we must then “consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.”

Here, the claims are directed to the concept of offer based price optimization. Claim 1 broadly recites a “method of pricing a product for sale,” and the specification describes the invention as an “automatic pricing method and apparatus for use in electronic commerce.” This concept of “offer based pricing” is similar to other “fundamental economic concepts” found to be abstract ideas by the Supreme Court and this court. See, e.g., Alice (intermediated settlement); Bilski v. Kappos, 561 U.S. 593 (2010) (risk hedging); Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir. 2014) (using advertising as an exchange or currency); Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat’l Ass’n, 776 F.3d 1343 (Fed. Cir. 2014) (data collection); Accenture Global Servs., GmbH v. Guidewire Software, Inc., 728 F.3d 1336 (Fed. Cir. 2013) (generating tasks in an insurance organization). And that the claims do not preempt all price optimization or may be limited to price optimization in the e-commerce setting do not make them any less abstract.

Beyond the abstract idea of offer-based price optimization, the claims merely recite “well-understood, routine conventional activities,” either by requiring conventional computer activities or routine data-gathering steps. Considered individually or taken together as an ordered combination, the claim elements fail to transform the claimed abstract idea into a patent eligible application. For example, claim 1 recites “sending a first set of electronic messages over a network to devices,” the devices being “programmed to communicate,” storing test results in a “machine-readable medium,” and “using a computerized system to automatically determine” an estimated outcome and setting a price. Just as in Alice, all of these computer functions are well-understood, routine, conventional activities previously known to the industry. Moreover, the claims are exceptionally broad and the computer implementation limitations do little to limit their scope. Indeed, the specification makes clear that this “programming” and the related computer hardware refers to any sequence of instructions designed for execution on a computer system.

At best, the claims describe the automation of the fundamental economic concept of offer-based price optimization through the use of generic-computer functions. Both the prosecution history and the specification emphasize that the key distinguishing feature of the claims is the ability to automate or otherwise make more efficient traditional price-optimization methods. But relying on a computer to perform routine tasks more quickly or more accurately is insufficient to render a claim patent eligible. See Alice (“use of a computer to create electronic records, track multiple transactions, and issue simultaneous instructions” is not an inventive concept); Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can. (US.), 687 F.3d 1266 (Fed. Cir. 2012) (a computer “employed only for its most basic function . . . does not impose meaningful limits on the scope of those claims”); cf. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014) (finding a computer-implemented method patent eligible where the claims recite a specific manipulation of a general-purpose computer such that the claims do not rely on a “computer network operating in its normal, expected manner”).

Nor does the claims’ recitation of “presenting offers to potential customers” and “gathering statistics generated during said testing about how the potential customers responded to the offers” provide a meaningful limitation on the abstract idea. These processes are well understood, routine, conventional data-gathering activities that do not make the claims patent eligible. Like the claims in Mayo, which added only the routine steps of administering medication and measuring metabolite levels for the purposes of determining optimal dosage, here the addition of steps to test prices and collect data based on customer reactions does not add any meaningful limitations to the abstract idea.

On appeal OIP focuses its arguments on comparing the claimed invention to the invention found patent eligible in Diamond v. Diehr, 450 U.S. 175 (1981). However, we must read Diehr in light of Alice, which emphasized that Diehr does not stand for the general proposition that a claim implemented on a computer elevates an otherwise ineligible claim into a patent-eligible improvement. Rather, Diehr involved a well-known mathematical equation used in a process designed to solve a technological problem in conventional industry practice. Just as Diehr could not save the claims in Alice, which were directed to “implementing the abstract idea of intermediated settlement on a generic computer,” it cannot save OIP’s claims directed to implementing the abstract idea of price optimization on a generic computer.

Judge Mayer’s Concurring Opinion

I commend the district court’s adherence to the Supreme Court’s instruction in Bilski that patent eligibility is a “threshold” issue by resolving it at the first opportunity on a motion to dismiss.

Comments: Other than a brief affirmance of an invalidity ruling in Fuzzy Sharp Techs., Inc. v. Intel Corp., 595 Fed. Appx. 996 (Fed. Cir. 2015), OIP is the first case this year to deal with ‎§ 101 ‎issues under Alice and Mayo. Since Alice was decided, the Circuit has now evaluated ‎§‎ 101 eligibility in seven different computer-implemented cases and in ‎every instance, other than the divided opinion in DDR in December, has found the claims invalid. See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir. 2014), buySAFE, Inc. v. Google, Inc., ‎‎765 F.3d 1350 (Fed.Cir. 2014), Planet Bingo, LLC v. VKGS, LLC, 2014 U.S. App. LEXIS 16412 (Fed. Circ. 2014)(non-precedential), Digitech Image Technologies, LLC v. Electronics for Imaging, 758 F.3d 1344 ‎‎(Fed.Cir. 2014), and Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343 (Fed. Cir. 2014). It is clear that former Chief Judge Rader’s pre- Alice admonition about § 101 being a coarse filter‎ is not the accepted thinking in the Circuit.

In Ultramercial the panel noted that it was not holding that claims in all software-based patents will ‎necessarily be held to have be directed to an abstract idea, but claiming software and computer-implemented inventions will continue to be a challenge for software engineers and their patent attorneys to get past what is an increasingly fine § 101 filter at the ‎Circuit.‎ The best direction we can take is from the DDR majority’s discussion of the claims in that case, including representative claim 19:

19. A system useful in an outsource provider serving web pages offering commercial opportunities, the system comprising: 

(a) a computer store containing data, for each of a plurality of first web pages, defining a plurality of visually perceptible elements, which visually perceptible elements correspond to the plurality of first web pages;

    • (i) wherein each of the first web pages belongs to one of a plurality of web page owners;

    • (ii) wherein each of the first web pages displays at least one active link associated with a commerce object associated with a buying opportunity of a selected one of a plurality of merchants; and

(iii) wherein the selected merchant, the outsource provider, and the owner of the first web page displaying the associated link are each third parties with respect to one other;

(b) a computer server at the outsource provider, which computer server is coupled to the computer store and programmed to:

    • (i) receive from the web browser of a computer user a signal indicating activation of one of the links displayed by one of the first web pages;

    • (ii) automatically identify as the source page one of the first web pages on which the link has been activated;

    • (iii) in response to identification of the source page, automatically retrieve the stored data corresponding to the source page; and

    • (iv) using the data retrieved, automatically generate and transmit to the web browser a second web page that displays: (A) information associated with the commerce object associated with the link that has been activated, and (B) the plurality of visually perceptible elements visually corresponding to the source page.

DDRDDR’s discussion of claim 19:

Like claims in the cases discussed above [ Alice, Bilski, Ultramercial, and buySAFE], the claims involve both a computer and the Internet. But these claims stand apart because they do not merely recite the performance of some business practice known from the pre-Internet world along with the requirement to perform it on the Internet. Instead, the claimed solution is necessarily rooted in computer technology in order to overcome a problem specifically arising in the realm of computer networks.

The ‘399 patent’s claims address the problem of retaining website visitors that, if adhering to the routine, conventional functioning of Internet hyperlink protocol, would be instantly transported away from a host’s website after “clicking” on an advertisement and activating a hyperlink. Upon the click of an advertisement for a third-party product displayed on a host’s website, the visitor is no longer transported to the third party’s website. Instead, the patent claims call for an “outsource provider” having a web server which directs the visitor to an automatically-generated hybrid web page that combines visual “look and feel” elements from the host website and product information from the third-party merchant’s website related to the clicked advertisement. In this way, rather than instantly losing visitors to the third-party’s website, the host website can instead send its visitors to a web page on the outsource provider’s server that 1) incorporates “look and feel” elements from the host website, and 2) provides visitors with the opportunity to purchase products from the third-party merchant without actually entering that merchant’s website.

The PTO discusses the claims at issue in many of the post- Alice cases at www.uspto.gov/patents/law/exam/abstract_idea_examples.pdf but until the Circuit finds valid additional computer-implemented inventions, we are pretty much on our own. Prosecutors will continue to be well advised to include a wide variety of narrower claims in their patent applications.

Ariosa Diagnostics, Inc. v. Sequenom, Inc., Fed. Cir. Case 2014-1139, -1144 (June 12, 2015)

Drs. Lo and Wainscoat discovered cell-free fetal DNA (“cffDNA”) in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. cffDNA is non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. Applying a combination of known laboratory techniques to their discovery, they implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. The invention created an alternative for prenatal diagnosis of fetal DNA that avoids the risks of widely-used techniques that took samples from the fetus or placenta.

The ‘540 patent claims certain methods of using cffDNA. The steps of the method of claim 1 of the ‘540 patent include amplifying the cffDNA contained in a sample of plasma or serum from a pregnant female and detecting the paternally inherited cffDNA. Amplifying cffDNA results in a single copy, or a few copies, of a piece of cffDNA being multiplied across several orders of magnitude, generating thousands to millions of copies of that particular DNA sequence. In the amplification step, DNA is extracted from the serum or plasma samples and amplified by polymerase chain reaction (“PCR”) or another method. PCR exponentially amplifies the cffDNA sample to detectable levels.

The ‘540 patent also provides a diagnosis of certain fetal characteristics based on the detection of paternally inherited cffDNA. The specification explains that analysis of cffDNA permits more efficient determination of genetic defects and that a pregnant woman carrying a fetus with certain genetic defects will have more cffDNA in her blood than will a woman with a normal fetus.

Claim 1 is representative:

1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises

amplifying a paternally inherited nucleic acid from the serum or plasma sample and

detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

The dependent claims explain how the method of detection occurs and how it can be used.

In response to letters threatening claims of infringement, defendants filed separate declaratory judgments, and Sequenom counterclaimed alleging infringement in each case. After consolidation of the cases, the parties filed cross motions for summary judgment regarding invalidity under § 101. The district court ruled that the claims were directed to the natural phenomenon of paternally-inherited cffDNA and did not add enough to the natural phenomenon to make the claims patent eligible under § 101.

The Claims are Directed to a Patent Ineligible Concept, and Additional Elements Do Not Transform the Nature of the Claim.

In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), the Court set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts. First, we determine whether the claims at issue are directed to a patent ineligible concept. If the answer is yes, then we next consider the elements of each claim both individually and “as an ordered combination” to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. The Supreme Court has described the second step of this analysis as a search for an “inventive concept”—i.e., an element or combination of elements that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.”

The asserted claims are directed to a multistep method that starts with cffDNA taken from a sample of maternal plasma or serum—a naturally occurring non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon. The method ends with paternally-inherited cffDNA, which is also a natural phenomenon. Thus, the claims are directed to matter that is naturally occurring.

The written description supports the conclusion that the claims of the ‘540 patent are directed to a naturally occurring thing or natural phenomenon. In the Summary and Objects of the Invention section of the ‘540 patent, the patent states that “it has now been discovered that fetal DNA is detectable in maternal serum or plasma samples.” The patent goes on to state that “this is a surprising and unexpected finding; maternal plasma is the very material that is routinely discarded by investigators studying noninvasive prenatal diagnosis using fetal cells in maternal blood.”

Because the claims at issue are directed to naturally occurring phenomena, we turn to the second step of Mayo’s framework. In the second step, we examine the elements of the claim to determine whether the claim contains an inventive concept sufficient to “transform” the claimed naturally occurring phenomenon into a patent eligible application. Mayo made clear that transformation into a patent eligible application requires “more than simply stating the law of nature while adding the words ‘apply it.'” A claim that recites an abstract idea, law of nature, or natural phenomenon must include “additional features” to ensure “that the claim is more than a drafting effort designed to monopolize the abstract idea, law of nature, or natural phenomenon.”

Like the patentee in Mayo, Sequenom contends that the claimed methods are patent eligible applications of a natural phenomenon, specifically a method for detecting paternally inherited cffDNA. Using methods like PCR to amplify and detect cffDNA was well-understood, routine, and conventional activity in 1997. The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.

The specification of the ‘540 patent confirms that the preparation and amplification of DNA sequences in plasma or serum were well-understood, routine, conventional activities performed by doctors in 1997. The ‘540 patent provides that “the preparation of serum or plasma from the maternal blood sample is carried out by standard techniques.” It also provides that “standard nucleic acid amplification systems can be used, including PCR, the ligase chain reaction, nucleic acid sequence based amplification (NASBA), branched DNA methods, and so on.” The detecting step was similarly well-understood, routine, and conventional. This was also conceded during prosecution of the application that became the ‘540 patent.

The dependent claims are broad examples of how to detect cffDNA in maternal plasma, focusing on the use of the natural phenomenon in combination with well-understood, conventional activity. For example, claim 2 identifies the polymerase chain reaction as the amplification technique to be used in the detection method of claim 1. This technique was conventional in 1997, as specified by the patent itself. Like claim 1, claims 5 and 8 focus on detecting a specific chromosome within the cffDNA—a natural phenomenon again, adding no inventive concept to the limitations of claim 1. None of the remaining asserted claims differ substantially from these claims.


Sequenom argues that there are numerous other uses of cffDNA aside from those claimed in the ‘540 patent, and thus, the ‘540 patent does not preempt all uses of cffDNA. Sequenom also argues that “a method applying or using a natural phenomenon in a manner that does not preclude alternative methods in the same field is non-preemptive, and, by definition, patent-eligible under ‎§‎ 101.” Similarly, Sequenom and amici argue that because the particular application of the natural phenomena that the ‘540 patent claims embody are narrow and specific, the claims should be upheld.

The Supreme Court has made clear that the principle of preemption is the basis for the judicial exceptions to patentability. Alice, 134 S. Ct at 2354. For this reason, questions on preemption are inherent in and resolved by the § 101 analysis. The concern is that “patent law not inhibit further discovery by improperly tying up the future use of these building blocks of human ingenuity.” In other words, patent claims should not prevent the use of the basic building blocks of technology—abstract ideas, naturally occurring phenomena, and natural laws. While preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility. In this case, Sequenom’s attempt to limit the breadth of the claims by showing alternative uses of cffDNA outside of the scope of the claims does not change the conclusion that the claims are directed to patent ineligible subject matter. Where a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot.

Significant Contribution Does Not Mean that the Claims are Directed to Patentable Subject Matter

While Drs. Lo and Wainscoat’s discovery regarding cffDNA may have been a significant contribution to the medical field, that alone does not make it patentable. We do not disagree that detecting cffDNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science. But even such valuable contributions can fall short of statutory patentable subject matter, as it does here.

Judge Linn’s Concurrence

I join the court’s opinion invalidating the claims of the ‘540 patent only because I am bound by the sweeping language of the test set out in Mayo. In my view, the breadth of the second part of the test was unnecessary to the decision reached in Mayo. This case represents the consequence—perhaps unintended—of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.

Comment: Despite industry’s protestations to the contrary, there could have beenlittle doubt that the broad recitations of claim 1, drafted years prior to Mayo, were not going to withstand scrutiny under§ 101. Thepanel’sdiscussion of the dependent claims, however, provides some guidance as to how the patentee might have set forth patent-eligible subject matter.Given the opinion’s description of the dependent claims as broad examples of how to detect cffDNA in maternal plasma, focusing on the use of the natural phenomenon in combination with well-understood, conventional activity,” wouldn’t it have been possible to recite something novel about how to detect cffDNA in maternal plasma? An argument based on dependent claims reciting novel steps could have stressed the requirement in ‎§‎ 101 that to recite patentable subject matter, the invention must be “new.” The absence of those novel steps in the dependent claims rendered it impossible to present that argument.

Judge Linn’s concurrence reads like a petition for certiorari for the Supreme Court to revise its Mayo ruling but there would seem to be little basis for the Court to do that, given that Mayo was decided little more than three years ago, and input from industry based on the decision was certainly predictable.

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