The claim at issue in Genetic Technologies Limited v. Merial LLC  Fed. Cir. 2016, was the following:

1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:

(a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to proudce an amplified DNA sequence characteristic of said allele; and b) analyzing the amplified DNA sequence to detect the allele. 

In holding the claim a directed to a law of nature, the Court said the case was similar to Mayo where the Supreme Court considered method claims that likewise required analysis of a biological sample (the blood fo a patient being treated with a thiopurine drug) and in which the focus of the claimed advance over the prior art was allegedly newly discovered information about human biolgy: the likelihood that a pateint could suffer toxic side effeccts from particular doses of the drug (Claim 1, for example, states that if the levels of 6-TG in the blood exceed about 400 pmol per 8×108 red blood cells, then the adminsitered dose is likely to produce toxic side effects) and Ariosa v. Sequenom which covered a method of detecting fetal DNA by amplifying and analyzing cell-free fetal DNA (“cffDNA:) samples from a pregnant woman’s blood. 

The Court then proceeding to step two of the Mayo/Alice anlysis to examine the elements of the claim to determine whether they contain an inventive concept sufficient to transform the claimed abstract idea (or law of nature) into a patent-eligible application. Alice, 134 S. Ct at 2357. The question is whether the claims do significantly more than describe a natural relation. The inventive concept necessary at step two fo the Mayo/Alice anlysis cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself. Instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity”. Simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.  

The Court found that the additional elements of claim 1 were insufficient to provide the inventive concept necessary to render the claim patent eligible. The first claimed step of “ampliyfing” genomic DNA with a primer pair was indisputably well known, routine, and conventional in the filed of molecular biology as of 1989. The second physical implementation step “analyzing” amplified DNA to provide a user with information about the amplified DNA, including its sequence was also well knonw, routine, and conventional at the time the patent was filed because techniques to analyze amplified DNA were known. 

In dismissing GTG’s argument that once the noncoding DNa has been amplified and sequenced, an instruction to users to analyze the amplified ANA sequence to detect the coding region allele provided a sufficient inventive concept, the Court held that the term “to detect the allele” is a mental process step that does not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed by the human mind. As held in Cybersource, 64 F3d 1366, 1373 (Fed. Cir. 2011), “methods which can be performed entirely in the human mind are unpatentable not because there is anything wrong with claiming metnal method steps as part of a process containing non-mental steps, but rather because computational methods which can be performed entirely in the human mind are the types of methods that embody the basic tools of scientific and technology work that are free to all men and reserved exclusively to none.”  The Court further pointed to Mayo which considered and rejected diagnostic and therapeutic method claims that combined routine and conventional physical implementation of a law of nature with a simple mental process step. An exemplary claim in Mayo recited “a method of optimzing therapeutic efficacy for treatment of a gastrointestinal disorder, comprising (a) adminstiering a thiopurine drug and (b) determining the level of a metabolite wherein a certain low metabolite level indicated a need to increase drug dosage and a certain high metabolite level indicated a need to decrease drug dosage. Mayo held that the “wherein” clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take htose laws into account when treating his patient. Here, the phrase “to detect the allele” in claim 1 of the ‘179 patent also merely informs the relvant audience to apply a law of nature of a purpose of detecting a polymorphism within a coding region fo an allele of itnerest. The limtiation “to detect the allele” merely asks the user to compare the non-coding sequence he has amplified and anlyzed with a library of non-coing sequences known to be in linkage disequilibrium with certain coding reigon alleles. 

The Court further pointed out that the case is also simliar to In re BRCA1 & BRCA2 based hereditary Cancer Test, 774 F.3d 755 (Fed. Cir. 2014) wehre claim 8 of US Patent No. 5,753,441 recited a method of screening for alternations of the BRCA1 gene that included the steps of amplifying all or part of a BRCA1 gene form a sample using a set of primers to produce amplified nucleic acids and sequencing the amplified nucleic acids and comparing the sequence with wild type BRCA1. The calims was invalid because it was directed to an abstract idea and did not add enough to distinguish it from a claim to the abstract idea. 

The USPTO Patent Trial and Appeal Board found that treatment of a subject for pre-eclmpsia based on the elvel of soluble endoglin and sFlt-1 together was a specific application of natural principles that is not conventional. Appeal 2015-00426 US application 12/226,658.

The claim at issue was the following:

A method of diagnosing a subject as having, or having a predisposition to, preterm pre-eclampsia, said method comprising measuring the level of a soluble endoglin polypeptide and an sFlt-1 polypeptide from said subject and calculating the relationship between said levels of soluble endoglin and sFlt-1 using a [soluble endoglin x sFlt-1] metric, wherein an increase in the metric value in the subject sample realtive to the metric value in a normal reference sample, is a diagnostic indicator of, or a propensity to evelop, pre-term pre-eclampsia in said subject, and based on said diagnosis treating said subject for said pre-eclampsia.

The examiner rejected the claim as being drawn to a mathematical relationship between polypeptide levels in a pateint sample and the presence of a particular disorder which is a law of nature. 

The Board agreed. Important to the decision was evidence that the specification itself pointed to the fact that the claimed measurement steps were well-understood and/or convention and routin. Regarding the “treating” step, the examiner found that not only is the step specified at a high level of generality as it encompasses and and all possible treatments for pre-eclampsia, but that treating “after amking a diagnosis …is obvious and routin int he medical arts.” In light of this, the examiner found that “no matter how important, unexpected or useful” the discvoery that “increased levels of sFlt-1 and soluble endoglin are correlated with increased risks for preeclampsia and other pregnancy related hypertensive disorders” of the determiantion of “the mathematical equation by which they can be combined to acheive a diagnosis of increased accuracy as compared to the priro art,” the additional measurement and treating steps beyond the mathematical relationship recited in the claims do not transform the law of nature recited by the claim into a patent eligible application of such a law. The Board also noted that the the calim could be distinguished from Example F of the “2014 Guidance for determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products” because there the claim made use of a novel product. In contrast, here there was a prior art publication that taught methods for diagnosing pregnancy related hypertensive disorder or a predisposition to a pregnancy realted hypertensive disorder, such as preeclampsia, by measuring soluble endoglin (sEng) in combination with other markers including soluble Flt-1, calculating a diagnostic index which adds sFlt-1 and sEng concentraiton values, and methods of treating women so daignosed.

Some take home points:

1. The Board and examiner noted that the claim did not specify any particular type of treatment, such as use drug A rather than drug B. There is nothing in the general statement to treat after the diagnosis is made that could be deemed an unconventional step. The claim thus preempts all practial uses of the natural law/phenomenon/correlation”. This suggests that particular types of treatment steps might be enough to make a claim a practical application of the natural principle. 

The US Court of Appeals for teh Federal Circuit  on Dcember 2, 2015 denied the petition for rehearing en banc for Ariosa Diagnostics. The conurring opinions and dissenting opinions are, however, illustrative of important take home points and perhaps also of things to come, likely at the US Supreme Court level.

The en banc decision is worth studying for two reasons. First, the concurring and dissenting opinions set forth a new review of the current test for patent eligibility. Second, these opinions note the large concern of the Justices that the current Mayo/Alice framework for determining patent eligibility needs to be revisited by the US Supreme Court or perhaps (as noted in the dissenting opinion) that claims such as those in Ariosa are patent eligible under the current framework and that the en banc decision was incorrectly decided. No matter which is right, the Ariosa deicision to deny en ban review appears likely to be the ideal case to provide the US Supreme Court with a further opportunity to further define the Mayo decision. In other words, we could finally have arrived to the time where more guidance will be provided by the US Supreme Court. 

The Ariosa case has been earlier discussed in this blog. As a reminder, the claims are directed to an actual use of the natural material of cffDNA. It was undisputed that before the invention, the amplification and detection of cffDNA from maternal blood and the use of these methods for prenatal diagnoses, were not routine and conventional. But applying Mayo, Justices Lourie and Moore state that “we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process.”

Perhaps key here is the use of the word “unfortunately” which signifies their view that the current Mayo/Alice framework is not a good one. The Justices go on to state “Moreover, the claims here are not abstract. There is nothing abstract about performing actual physical steps on a physical material”. 

Circuit Judge DYK restated the courrent test for patent ineligibility under the Mayo decision. First, we determine whether the claims at issue are directed to a patent ineligible conecpt. Second, one looks to determine whether the method amounts to a general instruction to apply routine, conventional techniques. This two step test was confirmed in Alice Corp to distinguishing patents that claims 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 one of those patent ineligible concepts and if so, we then ask, what else is there in the claims? The process is described as a two step analysis as a search for an inventive concept –an element or combination of elements that is sufficient to ensure that the patent in practice aomunts to significantly more than a patent upon the ineligible concept itself. Applying the test to Ariosa, DYK stated that the Court had no other alternative but to find the claims ineligible. For, the claims are generally directed to detecting the presence of a naturally occuring thing or a natural phenomenon, cffDNA in materanl plasma or serum. Second, the method amounted to a general instruction to apply routine, conventional techniques when seeking to detect cffDNA. 

However, DYK noted that the Mayo/Alic fraemwork words well when the law of nature in question is well known and longstanding, as was the situation in Mayo. or in respect to abstract ideas such as claims to business methods and other processes that merely organize human activity asin Alice. But DYK stated that Mayo is problematic insofar as it concludes that inventive concept cannot come from discovering something new in nature (e.g., identificaiton of a previously unkown natural relationship or property). DYK stated that in his view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional applicaiton of a natural law, but also from the creativity and novelty of the discovery of the law itself. DYK further stated that the Mayo decision may not be entirely consistent with the Supreme Court’s decision in Myriad wehre the patent applicant discovered a previously unkown natural phenomenon: the sequences of the BRCA1 and BRCA2 genes and their connection with cancer. While the Court found ineligible Myraid’s claims to naturally occurring gDNA sequences, it suggested that new applications of knowledge about the BRCA1 and BRCA2 genes could generally be eligible with reference to claim 21 of the US Patent No. 5,753,441. Myriad thus appeared to recognize that an inventive concept can sometimes come from discovery of an unkown natural phenomenon, not just from unconventional application of a phenomenon. As Myriad emphasized, the first party with knowledge of a law of nature, natural phenomenon, or abstract idea should be in an excellent position to claim applications of that knowledge.

Finally, the dissenting opinion from Justic Newman points to a second possibility which may occur in the future with the Supreme Court –that in fact the claims to Ariosa Diagnostics are entirely consistent with the current framework of Mayo. Newman noted that Mayo recognized the principle that patent eligibility is not disabled when science is put to practical use, stating that “a new way of using an existing drug” is patent eligible. Similarly in Myriad Genetics, the Court stated that “this case does not involve patents on new applicaitons of knowledge about BRCA1 and BRCA2 genes” and further explained with respect to its holding “we merely hold that genes and the information they encode are not patent eligible under seciton 101 simply because they have been isolated from the surrounding genetic material”. Newman pointed out that in Ariosa, the inventors are not claiming the scientific fact of the discovery of paternal DNA in the blood of a pregnant woman; they are claiming the discovery and development of a new diagnostic method of using this information which all recognized as a “breakthrough”.  

The High Court of Austrialia (October 7, 2015 order) has recently come down with a decision in the Myriad Genetics case which while having no precedent value for US court decisions, is nonetheless illustrative of the concerns about patenting DNA. 

Claim 1 at issues reads:

“An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set for in SEQ. ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.”

Among the points of some of the judges which can serve as take home points for the general discussion in gene patenting invention are the following:

• Breadth of the claim: The claim is a product claim comprised of isolated nuleic acid having a particular characteristic which is the isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, where the sequence of the isolated nucleic acid contains one or more of the mutations or polymorphisms set forth in particular tables. The claim is very broad and if held valid, it will prevent isolation and testing of the BRCA1 gene even if a researcher is diagnostically testing for a purpose unrelated to detection of predisposition to one of the identified cancers. Not only that, Myriad would have an exclusive right to isolate the nucleic acid without having claimed the process of isolation. Granting such a monopoly has the potential to inhibit other researchers and medical practitioners from diagnostically testing the BRCA1 gene for an entirely different purpose. An anlogoy provided by one of the judges is the rule that a claim for a new use of an old product does not confer a monopoly over the old product (just the new use). Parity of reasoning dictates that application of a method of detecting the increased likelihood of certain kinds of cancer by isolating the BRCA1 gene and comparing it to the reference sequence does not conver a monopoly over the mutation BRCA1 gene itself. To state another way, it is one thing to say that a person who has invented a process which consists in isolating and examining a fragment comprising the BRCA1 gene for the presence of specified mutations and polymorphisms as an indicium of malignancy is entitled to a monopoly over the mutated BRCA1 gene istelf, which is used merely as an ingredient in that process. 
• Arguing features not set forth in the claim: Counsel for Myriad stressed that claim 1 was for a discrete chemical molecule achieved by the breaking of chemical covalent bonds in the course of the extraction and amplification processes employed in deriving isolated nucleic acid from the source DNA, which significantly distinguished claim 1 from Myriad’s patent protetion in respect of the BRCA1 gene at issue in the US S. Ct. decision of Myriad Genetics. However, the judge points out that the plurality of the US S Ct. sates that Myraid’s calims are not saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. The claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. 
• Discoveries versus Inventions: For a claimed invention to qualify as a manner of manufacture (a requirement in Australia), it must be something more than a mere discovery. The essence of invention inheres in its artificiality or distance from nature; and thus, whether a product amounts to an invention depends on the extent to which the product individualizes nature. In the instant case, claim 1 is the correlation between the incidence of cancer and the presence of the specified mutations and polymorphisms in the mutated BRCA1 gene. The subject matter of the claim does not make any contribution to the inclusion of the specified mutations and polymorphisms in the mutated BRCA1 gene. Their presence or absence in or from it is the result of the isolated BRCA1 gene being part of the naturally occurring DNA from which the sequence is isolated. 

This case involves the discovery of cell-free fetal DNA (cffDNA) in maternal plasma and serum, a protion of maternal blood that before had been discarded as medical waste. Based on this discovery, a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender was developed. Plainitff commercialized the invention with a “MaterniT21” test. The test was very beneficial in that it created an alternative for prenatal diagnosis of fetal DNA which avoided taking samples from the fetus or placenta. Defendants, including Ariosa Diagnostics, make and sell non-invasive prenatal and paternity tests. The tests are based on the underlying revolutionary technology by Sequenom, Inc. that maternal plasma/serum DNA is a useful source for non-invasive prenatal diagnosis of genetic disorders.

The steps of Plaintiff’s main method claim included amplifying the cffDNA contained in a sample of a plasma or serum from a pregnant female and detecting the paternally inherited cffDNA by PCR. In the detecting step, the cffDNA is added to an agarose gel so that the paternally inherited cffDNA could be visualized. The patent also provided for making a diagnosis of certain fetal characteristics based on the detection of paternally inherited cffDNA. 

Claim 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 form the serum or plasma sample and 

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

The Federal Circuit applied the two step analysis of Mayo which is (1) first to ask whether the claims are directed to a naturally occurring phenomena and (2) second whether the claim contains an inventive concept sufficient to “transform” the claimed naturally occurring phenomenon into a patent eligible application.

Even, the plaintiff conceeded that the step (1) was met, given that even the specification stated that “the most important observation in this study is the very high concentration of fetal DNA in maternal plasma and serum”. All parties thus agreed that the claims at issue were directed to detecting the presence of a naturally occurring thing (natural phenomenon) of cffDNA in maternal plasma or serum.

The Court next turned to the more dificult issue of whether the claims at issued contained an inventive concept sufficient to “transform” the claims into a patent eligible application of the natural law. Plaintiff made the following arguments that the claims in the patent amounted to patent eligible applications of a natural phenomenon, each of which the Court dismissed.

(1) The claimed method contained patent eligible applications of a natural phenomenon, specifically a method for detecting paternally inherited cffDNA using methods like PCR to amplify and detect cffDNA.

The Court dismissed this argument finding that methods like PCR were well understood, routine and conventional activity in 1997. The method thus amounted to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Even applicant’s specification pointed to the fact that the preparation and amplification of DNA sequences in plasma or serum were well-undertood, routine, conventional activities performed by doctors in 1997, stating that “[t]he preparation of serum or plasma from the maternal blood sample is carried out by standard techniques” such as PCR. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA was not new and useful. The only subject matter new and useful as of the date of the application was the discvoery of the presence of cffDNA in maternal plasma or serum. 

(2) Before the patent, no one was using the plasma or serum of pregnant mothers to amplify and detect paternally-inherited cffDNA. In other words, plainitff argued that the inventive concept lies in the discovery of cffDNA in plasma or serum. 

The Court dismissed this argument, finding that even if true, the claim was not directed to disccovery of cffDNA in plasma or serum. 

Another note of importance was plaintiff’s argument that its publication on the discovery had been cited over a thousand times. The Court dismissed this by restating the Supreme Courts statement in Myriad Genetics that “[g]roundbreakin, innovative, or even brilliant discovery does not by itself satisfy the section 101 inquiry”. As with Myridad where the discovery of the BRCA1 and BRCA2 genes was a significant contribution to the medical field, the discovery was not patentable.  While the Court did not disagree that detecting cffDNA in maternal palsma or serum that before was discarded as waste is a postive and valuable contribution to science, it held that it still did not constitute patentable subject matter. 

Given this case, is there any way out for inventors of groundbreaking technology these days?

The answer is probably – NO!  However, the case does leave some openings. As mentioned above, the Court noted that the claim was not directed to discovery of cffDNA in plasma or serum. This is somewhat perplexing because the claim above is directed to “detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample“. So while it is not clear what the Court means by this statement, it could be a possible opening.

It would appear from the case that the only way out would be to come up with novelty in the process steps themselves. In other words, one must take the process steps of the application of the natural principle outside the realm of “conventional” activity in the field. This will be difficult indeed in that coming up with a more useful detection technique such as PCR will be a very difficult if not insurmountable task for most inventors. The case appears to place a real damper on possibly very innovative diagnostic inventions. But as the Court states, the current law is who cares? –novelty or importance of the invention has no place in the analysis where the claim is directed to a natural phenomena. 

The USPTO has issued a June 25, 2014 Memorandum entitled “Priliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. with respect to 35 USC section 101. It goes without saying that instructions from the PTO are important because they govern the way applications are examined at the PTO.

Some important points are the following:

• The same analysis provided by Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 US _ (2012) (guidance in MPEP 2106.01) should be used for all types of juidicial exceptions (laws of nature, natural phenomena and abstract ideas) as well as all categories of claims (e.g., product and process claims) 
• The first inquiry is thus to determine whether the claim is directed to an abstract idea. Examples of abstract ideas reference in Alice Corp. include the following:
  • Fundamental economic practices (e.g., intermediated settlement);
  • certain methods of organizing human activities (e.g., a series of steps instructing how to hedge risk as in Bilski v. Kappos, 561 US 593 (2010);
  • an idea of itself (e.g., a principle, an orginal cuase, a motive (see Gottschalk v. Benson, 409 US 63, (1972).
  • mathematical relationships/formulas (see a mathematical formula for computing alarm limits in a catlytic conversion process in Parker v. Flook, 437 US 584 (1978) or a formula for covnerting binary coded decimal numerals into pure binary form in Gottschalk v. Benson, 409 US 63, (1972). 
• If an abstract idea is present in the claim, the 2nd inquiry is to determine whether any element or combination of elements in the claim are sufficient to ensure that the claim amounts to significanlty more than the abstract idea itself. Limitations referenced in Alice Corp. that may be enough to qualify as “significanlty more” include the following:
  • improvements to another technology or technical field (see a mathematical formula applied in a specific rubber molding process in Diamond v. Diehr, 450 US 175 (1981);
  • improvements to the functioning of the computer itself;
  • meaningful limitations beyond generally linking the use of an abstract idea to a particular technological enviornment.

Limitations referenced in Alice Corp that are not enough to qualify as “significantly more” include (1) adding the words “apply it” 9Or an equivalent) with an abstract idea or mroere instructions to implement an abstract idea on a computer (2) requiring no more than a generic computer to perform generic computer funcitons that are well understood, routine and conventional activities previously known to the industry. :

In the post myriad/Prometheus decision of Perkinelmer, Inc. v. Intema Limited, the Federal Court struck down claims directed to a screening method to estimate the risk of fetal Down’s syndrome. The Court reiterated that the key distinction for analysis is between claims that recite ineligible subject matter, and no more, and claims to specific inventive applications of that subject matter. Unlike the former, the later do not risk the broad preemption of “the basic tools of scientific and technological work”. For a process claim to cover a patentable application of, for example, a natural law, it must ‘contain other elements or a combination of elements, something referred to as an ‘inventive concept‘ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.’ 

The Court reviewed the Mayo decision which was a diagnostic assay involving two steps: “administering” a thiopurine compound to a patient and determining the level of 6-thioguanine”, a metabolite of thiopurine, in the patient. The claims contained two “wherein” clauses which did not dictate any step in the process, but disclosed the metabolite concentration range necessary for effective treatment – the purported discovery embodied in the claims. This correlation, i.e., that an effective does of thiopruine produces a certain range of metabolite concentrations, was the result of the natural metabolic process. The claims in dispute thus were drawn to a law of nature and needed to “add enough to their statement of the correlation to allow the processes they describe to qualify as a patent-eligible processes that apply the natural laws” which they failed to do. The Supreme Court emphasized the “inventive concept” requirement section 101, stating that “simply appending conventional steps, specified at a high level of generality, to the laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable. (compare the claims of Diehr which were patent-eligible because of the way the additional steps of the prcoess integrated the [ineligible] equation into the process as a whole” and the Diehr court “nowwhere suggested that all these steps, or at least the combination of those steps, were in context obvious, already in use, or purely conventional”. 

The Court also reviewed the Myriad decision of the Federal Court which were directed to screening methods for cancer predisposing mutations in human gene sequences. The Court there struck down similar claims. For example, one claim, contained the sole step of “analyzing” a human gene sequence to identify a certain mutation. Another required the single step of “comparing” a gene sequence form a sample of a tumor with a sequence from a non-tumor sample to identify a certain mutation with a “wherein” clause stating that a specific difference between the two sequences identified the mutation of concern. The claims were not over an application of the mental process of comparing. Rather, the steps of comparing two DNA sequences was the entire process that was claimed.

Similarly, in the current case (Perkinemer) the claims were directed to analytical methods to determine the risk of fetal Down’s syndrome. One claim, for example, required two “measuring” steps; a screening marker from the first trimester of pregrancy is observed; then, a marker from the second trimester is observed. The claim then contains a “determining” step in which the risk of Down’s syndrome is calculated by comparing both screening marker measurements with known statistical information. The Court pointed out that the “measuring” steps were insufificient to make the claims patent eligible since they merely tell the users of the process to measure the screening markers through whatever known method they wish. In fact, the patent stated “the inividual measurements are obtained through known methods…Any markers which are effective at each particular stage may be selected”. Nor was the “determining” step sufficient because the statistical information mentioned in this step was well-understood, conventional information. 

The Court further pointed out that the claims which were held patentabble in Myriad supported the Courts decision. The claims which were held patentable in Myriad were directed to “comparing” the growth rates of two sets of host cells that had been altered with a cancer-causing human gene – one set was treated with the potential therapeutic and the other was untreated. If the growth rate of the treated cells was slower than the untreated cells, the treatment was effective. The comparison was an ineligible mental step. But the host cells did not occur naturally; they were man made and thus were themselves patetent-eligible subject matter. So, according to the panel, their inclusion in the process made the claims patent eligible despite the reference to an otherwise ineligible mental step. In contrast, the current case (Perkinelmer v. Intema) included no patent-eligible subject matter along with the ineligible concepts. They include only “conventional steps, specified at a high level of generality”.