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Federal Circuit Holds Medical Diagnostics Patent Invalid under 35 USC 101.

The Federal Circuit, in a three-judge panel, recently decided a medical diagnostics patent case that has an unusual concurrence written by one of the three judges, Judge Linn. In Ariosa Diagnostics, Inc. et.al. v. Sequenom, Inc. et.al. (Fed. Cir. June 12, 2015), (“Sequenom”) the Court affirmed a district court summary judgment holding that U.S. Patent No. 6,258,540 (“the ‘540 patent”) is invalid under 35 U.S.C. § 101 as not directed to patent eligible subject matter.

The Court based its holding on Mayo Collaborative Services v. Prometheous Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012) (“Mayo”).

The ‘540 patent claims a method for detecting cell-free fetal DNA (“cffDNA”) in maternal blood samples. A sample claim of the ‘540 patent is:

  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 Court followed the two step Mayo method of determining subject matter eligibility for processes claiming the use of laws of nature, natural phenomena, and abstract ideas.

In the first step, the Court determines whether the claims at issue are “directed to” a patent-ineligible concept. Here, the Court held that the claims are directed to a natural phenomenon because the method “begins and ends with a natural phenomenon.”

In the second step, the Court determines whether “additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Here, the Court held that the claims do not pass the second step because “the method steps were well-understood, conventional and routine.”

In its analysis, the Court, citing Alice Corp. v. CLS Bank Int’l, __ U.S. __, 134 S. Ct. 2347, 2354 (2014), (“Alice”) “made clear that the principle of preemption is the basis of the judicial exceptions to patentability.” However, the Court also stated that “[W]here 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.” The Court declined to adopt the appellee’s “distinction among natural phenomena based on whether or not they will interfere signifcantly with innovation in other fields now or in the future.” The Court also stated that the Supreme Court has instructed that a “[g]roundbreaking, innovative or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Assn for Molecular Biology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2117 (2013) (“Myriad”).

Judge Linn wrote a concurring opinion but stated he was doing so “only because I am bound by the sweeping language of the test set out in [Mayo].” He further explained:

“The Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers.”

Sequenom is notable for the stringent application of the Mayo analysis even in the case of (admittedly) an absence of prior art and the presence of a “new way that revolutionized prenatal care.” This is an indication of the Federal Circuit’s new obeisance to its chastising by the Supreme Court in Alice, Mayo, and Myriad. However, Judge Linn’s concurrence suggests that not all of the members of the Court fully subscribe.

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Covered Business Method Patent Held Invalid under 35 USC 101 and Alice.

The Patent Trial and Appeal Board (PTAB) has issued a Final Written Decision of the invalidity of an Internet-related patent under the subject matter restrictions of 35 U.S.C. 101.

In Bank of America, N.A., PNC Financial Services Group, Inc. and PNC Bank, N.A, vs. Intellectual Ventures I LLC, the PTAB found claims 1-23 of U.S. Patent No. 7,603,382 B2 (“the ‘382 patent”) to be unpatentable as directed to patent-ineligible subject matter under 35 U.S.C. 101 and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014) as being directed to an “abstract idea.”

A sample claim of the challenged patent is as follows:

  1.  A system for providing web pages accessed from a web site in a manner which presents the web pages tailored to an individual user, comprising:an interactive interface configured to provide dynamic web site navigation data to the user, the interactive interface comprising:a display depicting portions of the web site visited by the user as a function of the web site navigation data; anda display depicting portions of the web site visited by the user as a function of the user’s personal characteristics.

In arriving at its decision, the Board considered the following arguments on the part of the Patent Owner:

  1. that the claims of the ‘382 patent are not “directed to ‘an idea itself, a mathematical formula or algorithm, a fundamental economic practice long prevalent in our system of commerce, or a method of organizing human activity.'”
  2. that the claims of the ‘382 patent “do not preempt the alleged abstract idea and are transformed by an inventive concept.” That claims 1-6 and 16-23 user the claimed interactive interface to provide tailored content based upon the user’s personal characteristics and the user’s website navigation data.
  3. That the ‘382 patent is not a covered business method patent because the claims are directed to a technological invention.
  4. That Section 101 is not a proper ground upon which a covered business method patent review may be maintained.

The Board based its decision regarding argument 1 on the recent U.S. Supreme Court holding in Alice, setting out a two-step test for patentability of an abstract idea. Key to this step 1 was a statement by the Patent Owner’s expert, who testified that “the patent is described at what may appear to be a fairly high abstract level.” In responding to argument 2, the Board held that the limitations of the claims do not contain an “inventive concept” to “transform” the claimed abstract idea into patentable subject matter. Key to this step was, again, testimony of the Patent Owner’s expert that “the ‘382 patent lacks implementation details because it is written at a ‘fairly high abstract level.’” The Board distinguished the ‘382 patent from the Federal Circuit’s decision in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014). In responding to argument 3, the Board held that in at least claim 11 “there is no technological feature in that claim that is novel and unobvious.” Finally, in regard to argument 4, the Board held that Section 101 is a proper ground for instituting a Covered Business Method patent proceeding.

Alice Corp. v. CLS Bank Intl: the Supreme Court supports a “New Hermeneutic of Suspicion?”

Alice Corp. v. CLS Bank Intl (573 U.S. ___ (2014)) held that Petitioner’s method, computer readable media, and system claims are drawn to a patent-ineligible abstract idea. Here, I focus not on the definition of an “abstract idea” (the Court avoided such a definition) but rather on how the Court’s holding appears to affirm the “new hermeneutic of suspicion” that I discussed in my blog post analyzing the per curia Federal Circuit opinion (CLS Bank Intl v. Alice Corp., 717 F.3d 1269, 106 U.S.P.Q.2d 1696 (C.A. Fed. 2013)). In the case at hand, the Court did not distinguish among the ineligibility under 35 U.S.C. 101 of the method, media, and system claims, but rather rejected them all. The Court also did not take into account the dissenting in part opinions of Federal Circuit Judges Rader, Linn, Moore, and O’Malley that the system claims are eligible for patent protection under 35 U.S.C. 101 even though the method claims are not. Rather, in passing the Court stated that “This Court has long ‘warned…against’ interpreting §101 ‘in ways that make patent eligibility depend simply on the draftsman’s art.’” The Court appears to accept Judge Lourie’s opinion in the per curia case that “the asserted method and system claims require performance of the same basic process” and therefore simply adding a computer to the system claims does not save them from ineligibility. 106 U.S.P.Q.2d 1696. The Court’s opinion appears to support the Federal Circuit’s analysis whereby system claims, even though drawn to a computer with hardware,  are no more eligible than the method claims because the reviewing court suspects the patent draftsman of  “artfully” attempting to avoid the ineligibility of the method claims. As Federal Circuit Judges Moore, Linn, and O”Malley said in their dissenting opinion, such a hermeneutic “may open to ineligibility challenges “hundreds of thousands of patents, including all business method, financial system, and software patents as well as many computer implemented and telecommunications systems.” 106 U.S.P.Q.2d ___ (Moore, J; Linn, J; and O’Malley, J. dissenting-in-part). The Supreme Court has not attempted to “delimit the precise contours of the ‘abstract ideas’ category.” In other words, the Court is essentially saying “we will know it when we see it.”

Here is a link to my previous blog post.

 

 

Myriad Genetics: Laws of Nature and the Philosophy of Science

In Association for Molecular Pathology vs. Myriad Genetics, the Federal Circuit on August 16, 2012 issued its opinion regarding the patentability of Myriad’s method and composition of matter claims after the case was remanded by the Supreme Court in light of Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012).  The Federal Circuit upheld the patentability of Myriad’s composition of matter claims to isolated DNA encoding a mutation that is associated with an increased risk of breast cancer in women.  The Federal Circuit also upheld the patentability of Myriad’s therapeutic screening method but affirmed its earlier position that Myriad’s diagnostic methods are invalid under 35 U.S.C. § 101. This article discusses the composition of matter claims only.

 Recall that in this case, the issue (in regard to the composition of matter claims) was whether the cDNAs were or were not patentable as naturally-occurring compositions of matter (products of nature) under the Chakrabarty and Funk Brothers Supreme Court cases. The composition of matter claims were not precisely at issue under the “law of nature” doctrine. Still, a judgment had to be made as to what is “naturally occurring.” And this depends on one’s view of the “laws” of nature involved in gene sequencing and isolation.

 For many philosophers of science, laws of nature are descriptive not prescriptive. If we push a ball bearing off a table, it will fall to the floor. But we don’t imagine that, at the exact instant that the ball bearing ceases to be on the table, it says to itself “Oh my gosh, I’d better hurry up and fall to the floor, or I will be violating a law of nature!” No. What we call a “law” of nature here is that over thousands of years, people have observed that ball bearings or other objects fall to the floor when they are pushed off tables. We describe the result rather than prescribing it. Certainly, we can generalize the “law” well beyond ball bearings and tables. We can say that any macro object in a gravitational field will behave similarly. But our ability to generalize depends upon the lack of observation, in similar circumstances, of any exception to the “law.”

Until relatively modern times, we did not have the testing tools available that would let us modify the “law.” But now we know that in a zero-G environment such as an aircraft following a parabolic arc or in a spacecraft circling the earth, a ball bearing will not always fall to the floor when pushed off a table. Again, though, we don’t imagine the ball bearing saying to itself, “Thank God I don’t have to fall to the floor in this environment.” We can describe what will happen in that particular environment, but we don’t prescribe it.

 Because “laws” of nature are descriptive rather than prescriptive, natural laws can change over time. But we don’t imagine that before a zero-G environment was available for testing, ball bearings would have behaved any differently than they do now that we have the means to vary the testing environment. We just describe the effects of gravity differently, because now we are able to observe instances in which ball bearings don’t fall to the floor.

 The same is true in the wacky worlds of quantum mechanics and particle physics. “Laws” that work at the macro level simply don’t work at the quantum level. Some philosophers believe that fundamental physics is the only science in which it is possible to discover “exceptionless regularities” that can be called “laws.” All other sciences (including genomics) can only specify regularities that are true in a particular context. An interesting discussion of this idea and the idea of laws of nature generally can be found in Carroll, John W., “Laws of Nature”, The Stanford Encyclopedia of Philosophy (Spring 2012 Edition), Edward N. Zalta (ed.), URL = <http://plato.stanford.edu/archives/spr2012/entries/laws-of-nature/&gt;.

 This is why it is difficult to apply Section 101 of the U.S. patent law consistently. The case law around Section 101 states certain inventions are a priori unpatentable, namely, inventions that pre-empt a law of nature or a product of nature. There is a sense that the laws and products of nature should be freely available to anyone. The problem comes in figuring out 1) what law or product of nature is at stake and 2) does the particular invention pre-empt that law. Furthermore, because “laws” of nature are descriptive of the state of scientific knowledge at a given point in time, and scientific knowledge changes as discoveries are made, “laws” of nature (as described by human beings) for many philosophers of science cannot be prescriptive, that is, covering all known instances and unknown future instances. Thus, the really difficult question in cases such as Myriad is whether the issue is one of law or one of philosophy.

 In the August 16 decision, Judge Lourie re-affirmed his earlier holding that the claimed cDNAs were not “naturally occurring” because they do not exist in nature in their exact molecular form. In nature, the cDNAs only exist as a part of genomic DNA. The cDNAs were created by severing covalent chemical bonds, removing the DNA from its natural state where it is bound to histones, and then removing the introns from the genomic DNA. To put his holding into the concepts we are discussing, Judge Lourie was saying, in effect, “genomic scientists have not found any instance of a free standing cDNA with the sequence of nucleotides claimed.”  Thus, the “law” of nature is that living cells do not have such free standing cDNAs (a description). It is conceivably possible that a cell might be found in nature with such cDNAs, so the “law” is not prescribing that such cDNAs cannot be found in nature. It is enough that they are not. Furthermore, Judge Lourie is saying that what makes a cDNA patentable subject matter is not its nucleotide sequence (which is the same in the genomic DNA), but rather the absence of covalent chemical bonds between the cDNA and other entities. Yet this is a challengeable position, and Judge Bryson does challenge it, as we will see below.

 Judge Moore agreed with Judge Lourie that there are chemical differences between the chemical structure of the cDNAs and naturally occurring DNA.  However, for Judge Moore, it is not the absence of chemical bonds alone in the claimed cDNAs that make them patent eligible under Section 101. Rather, it is the different function that cDNAs perform (such as use in primers and probes) that makes them patentable.

 Judge Bryson’s view is that breaking chemical bonds is not patentably different from taking a cutting from a wild plant. For Judge Bryson, “there is no magic in a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered.” Judge Bryson seems to be saying that different “laws” of nature are not involved in breaking a chemical bond vs. cutting tissue with a scissors.  He is not clear, however, on why breaking a chemical bond does not involve a different “law” than physical cutting. As discussed above, for some philosophers of science, the closer we get to fundamental physics, the more likely the possibility of finding “exceptionless regularities.” Clearly, breaking a chemical bond is much closer to fundamental physics than cutting tissue with a scissors. His other theory is that the inventors in Myriad Genetics were simply isolating the cDNAs “according to nature’s predefined boundaries, i.e., at points that preserve the ability of the gene to express the protein for which it is coded.” This sounds like a prescriptive law, not a descriptive law. Are there “predefined boundaries” in nature?  For example, Judge Bryson says:

 “…the function of the claimed molecule is dictated by the nucleotide sequence of the gene – a sequence that is determined by nature and that appears in nature exactly as it appears in the claimed isolated DNA.”

The continuing discoveries of genomic scientists on the precise inter-working of codons with non-coding portions of DNA makes such a pronouncement risky.

 Judge Lourie stated:

 “The remand of this case for reconsideration in light of Mayo might suggest, as Plaintiffs and certain amici state, that the composition claims are mere reflections of a law of nature. Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature. Everything and everyone comes from nature, following its laws. But the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.” (italics added)

But for many philosophers compositions of matter (whether they be ball bearings or cDNAs) do not “follow” laws of nature (in the sense of obeying them). At any point in time, we only perceive that there are no instances of a particular type of entity not behaving in accordance with observable natural “laws.” Laws of nature describe the way objects in the natural universe behave; they do not prescribe such behavior.

As Judge Lourie further stated:

 Under the statutory rubric of § 101, isolated DNA is a tangible, man-made composition of matter defined and distinguished by its objectively discernible chemical structure. Whether its unusual status as a chemical entity that conveys genetic information warrants singular treatment under the patent laws as the district court did is a policy question that we are not entitled to address. Cf. Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, slip op. at 6 (2012) (“[W]e possess neither the expertise nor the prerogative to make policy judgments. Those decisions are entrusted to our Nation’s elected leaders, who can be thrown out of office if the people disagree with them.”).

 Ultimately, whether or not isolated cDNAs should be unpatentable because they have the same nucleotide sequence as “naturally occurring” DNA is a philosophical, scientific, and policy question, not purely a legal question.

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