The USPTO has issued a set of case examples under the categories (1) fundamental economic practices (2) an idea of itself (3) certain method of organizing human activity and (4) mathematical relationships/formulas. An abbreviated chart from this update is below. Link to USPTO
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.
Natural Product analysis under the guidelines:
A claim is considered to recite a nature based product limitation if that limitation does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state. The “markedly different characteristics analysis compares the nature based product limitation to its naturally occurring counterpart in its natural state. “Markedly different” characteristics can be expressed as the product’s structure, function and/or other properties”. Even a small change can result in “markedly different” characteristics from the product’s naturally occurring counterpart.
When the nature based product is produced by combining multiple components, the “markedly different” characteristics analysis should be applied to the resultant nature based combination, rather than its component parts. An example would be a claim to “a probiotic composition composition comprising a mixture of Lactobacillus and milk in a container”. While the “Lactobacillus bacterium” alone would certainly be considered a product of nature, your analysis must look at the mixture of Lactobacillus and milk. The container, however, would not be subject to the markedly different characteristics analysis as it is not a nature based product. Also note that only product claims are subject to the judicial exception. Process claims are not subject to the exception except in the limited situation where a process claim is drafted in such a way that there is not difference in substance form a product claim. An example of such a claim might be “a method of providing an apple”.
Once a markedly different characteristic for the product is shown, your job is done because no “product of nature” exception is recited. The claim, as shown in the chart above, qualifies as eligible subject matter under 35 USC 101. If the claims recites a nature based product limitation that does not exhibit markedly different characteristics, the claim is directed to a “product of nature” judicial exception (a law of nature or naturally occurring phenomenon). Your next step in your analysis in accordance with the chart above is to ask whether the claim as a whole contains additional elements that add “significantly more” to the exception. The “significantly more” has been equated with an “inventive concept”. You must ask whether the claim as a whole add significantly more than the judicial exception (i.e., product of nature) itself.
Abstract Ideas
Abstract ideas include fundamental economic practices, certain methods of organizing human activities, an idea “of itself” and mathematical relationship/formulas. An often cited case cited in this context is Bilski v. Kappos. In this case, the inventors tried to patent a business process for hedging against risk.
Another very important case involving business methods is Alice Corp. v. CLS Bank and US Patent Nos. 5.970,479 and 7,725,375. The claims at issue here were directed to a computerized scheme for mitigrating “settlement risk” which is a risk that only one party to an agree upon financial exchange will satisfy its obligation. The court held that intermediated settlement, like the risk hedgining above in Bilski, although not a preexisting fundamental trust, is a longstanding method of organizing human activity. It is a fundamental economic practice long prevalent in commerce which is in the realm of abstract ideas. In determining the particular claim invalid, the Court found that the claim did not recite any element or combination of elements sufficient to ensure that the claims amounted to significantly more than the exception. Although the claim recited a computer to implement the intermediate settlement, the Court held that use of an unspecified, generic computer does not transform an abstract idea into a patent eligible invention.
(methods for screening): An interesting later case in this area comes from the Federal Court in the University of Utah Research Foundation v. Ambry Genetics (2014): One of the claims read as follows: “A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wil-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject[,] wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which specifically hydridizes to a BRCA1 allele to genomic DNA isolated form said sample and detecting the presence of a hydridization product wherein a presence of said product indicates the presence of said allele in the subject.” The Court started the analysis using a two step method which is part of the chart above. First, one must ask whether the claim is directed to a patent ineligible concept and if so, one must then ask “what else is there in the claim?”. That is, you must ask whether the remaining element(s), either in isolation or combination with the other non-patent ineligible element(s) are sufficient to “transform “ the nature of the claim into a patent eligible application. Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. The Court divided the claim into two part; the first part before the “wherein clause” which describe the comparison of sild-type genetic sequences with the subject’s genetic sequence and the second part after that clause which describe the techniques to be used in making the comparison. The Court held that the first part was directed to an abstract mental process of “comparing” and “analyzing” two gene sequences and thus directed to a patent ineligible abstract idea because it only requires comparing the patient’s gene with the wild type and identifying any differences that arise. The concern here for the Court is that the number of covered comparisons is unlimited and they are not restricted by the purpose of the comparison or the alteration being detected. Because of its breadth, the comparison step covers detection of yet undiscovered alterations, as well as comparisons for purposes other than detection of cancer. Allowing such a patent on the comparison step could impede a great swath of research relating ot the BRCA genes which of course is antithetical to the patent laws to allow these basic building blocks of scientific research to be monopolized. Having decided that the comparison step was an abstract idea, the Court next asked whether the particular mechanism for the comparison rendered the claim patent-eligible. The answer was no since the steps of 10 hybridizing a BRCA gene probe and 2) detecting the presence of a hybridization product were well-understood, routine and conventional activity engaged in by scientists at the time of the patent application (routine and conventional activity is one factor to consider in determining if the other element(s) of the claim are sufficient to transform the claim into a patent eligible application). The Court did seem to leave a little window open up at the end of its decision for a method of screening claim for detecting specific mutaitons from the wild type gene. The Court stated that it expressed no view on such a claim in the present case but noted that the claim in issue in this case was much broader and more abstract as they claim all comparisons between the patient’s BRCA genes and the wild type BRCA genes.
These cases highlight the importance of not trying to cover concepts whether it be a business method or making comparisons between a DNA sequence found in nature and a patient’s DNA sequence itself so that you would effectively exclude anyone else from practicing the concept. If you do attempt to do so, at least have narrower claims in your patent application. While such a claim would indeed be very broad and thus potentially capture may potential infringers, the net effect is that it will be rejected by the patent office. Even if allowable, you will find such a broad claim easily subject to an invalidity challenge by competitors later on in court, leaving you with nothing at the end of the day. The decisions remind me of claims directed to antibodies. Typically one must claim the nucleotide and amino acid sequences for new antibodies simply because most antibodies in the general sense (e.g., an antibody to TNF-alpha) would not be considered novel since the protein or compound to which the antibody is already known. Likewise, in cases involving claims to genomic DNA sequences or making comparisons based on such sequences, the days are gone when one can tie up the entire genus. Instead, one will be forced to keep claim(s) directed to specific mutations or individual sequences which differ from their natural counterpart.
In Abbvie v. Centocor, (Fed. Cir, 2014), Abbvie’s representative claim was directed to a neutralizing isolated human antibody, or antigen-binding portion thereof, that binds to human IL-12 and disassociates from the human IL-12 with a Koff rate contant of 1×10-2s-1 or less, as determeind by surface plasmon resonance. Abbvie had developed its IL-12 antibodies using phage display. In brief, Abbview identified a lead antibody that neutralized IL-12 through screening and called this antibody “Joe-9” which had VH3 type heavy chais and Lambda type light chains. In order to improve IL-12 binding affinity, it introduced mutations to the CDRs of Joe-9 and identified an improved antibody that it named “Y61”. Abbive then used site directed mutagenesis to alter individual amino acids at selected positions in Y61 and generated additional antibodies, among which an antibody that it named “J695” showed a signfiicant increase in IL-12 binding and neutralizing activity. Abbvie’s patent described the aino acid sequence of about 300 antibodies having a range of IL-12 binding affinities. Because the IL-12 antibodies described in Abbvie’s patents were all derived from Joe-9, they all had VH3 type heavy chains and Lambda light chains. The described antibodies shared a 90% or more amino acid sequence similarity in the variable regions.
Centocor had developed its own human IL-12 neutralizing antibody. Of significance to the decision, its antibody had VH5 type heavy chains and Kappa type light chains, not VH3 and Lambda, as with the antibodies of Abbvie. This fact was significant because in finding lack of written support for the functional claim of Abbvie; the Federal Court dwelled on the fact that no representative species could be found in Abbvie’s specification of this parent antibody type. Whereas Abbvie’s claim was directed to a class of fully human antibodies defined by their high affinity and neutralzing activity to human IL-12, a well known antigen, the patents did not disclose structural features common to the members of the claimed genus. Nor did the patents disclose sufficient representative species encompassing the breadth of the claims because the antibodies disclosed were all devived from Joe-9 and had VH3 type heavy chains and Lambda type lights chains but the patents did not describe any example of human IL-12 antibodies having VH5 type heavy chains and Kappa type light chains (the Court also noting that the variable regions of Centocor’s antibody only shared a 50% sequence similarity with the Joe-9 antibodies. In other words, the asserted claims encompassed both the Joe-9 antibodies and the allegedly infringing antibody of Centocor, but Abbvie’s patents only described species of structurally similar antibodies that were derived form Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and did not qualitatively represent other types of antibodies encopassed by the genus. While it is true that every species in a genus need not be described in order that a genus meet the written description requirement, the patents must at least described some species representative of antibodies that are structurally similar to Centocor’s
Also of importance was the dismissal of Abbvie’s argument that structural differences of the antibodies are legally irrelevant and that reliance should be placed on the Koff rates to show representativeness. In dissmissing this argument, the Court stated that it is undisputed that the structure of the antibody determines its antigen bidning characteristic. In order to demonstrate that it had invented what is claimed, the patents must adequately describe representative antibodies to reflect the structural diversity of the claied genus.
The Court ended its decision with a warning that functionally defined genus claims can be inherently vulenrable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
The federal Court referred to several important court precedential decision phrases as supporting its rationale.
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:
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. :
The patents in Alice Corporation 573 US _ (2014) were directed to a scheme for mitigating “settlement risk”. The representative method claim included the steps of (1) “creating” shadow records for each counterparty to a transaction; (2) “obtaining” start of day balances based on the parties” real-world accounts at exchange institutions; (3) “adjusting” the shadow records as transactions are entered, allowing only those transactions for which the parties have sufficient resources; and (4) issuing irrevocable end-of-day instructions to the exchange institutions to carry out the permitted transactions.
The US Supreme Court had little trouble finding the claims at issue as being directed to an abstract idea and thus invalid. Like the risk heding in in Bilski (see below), the concept of intermediated settlement is “a fundamental economic practice long prevalent in our system of commerce” and under the Court’s second prong of the Mayo’s test (discussed below), the function performed by the computer at each step of the prcoess steps was “purely conventional” (e.g., using a computer to create and maintain “shadow” accounts amounts to electronic recordkeeping – one of the most basic functions of a computer, using a computer to obtain data, adjust account balances and issue automated instructions also amount to well-understood, routine, conventional activities previously known in the industry). In short, each step in the process did no more than require a generic computer to perform generic computer functions. Even as considered “as an ordered combination” (see Mayo test below), the method claims simply recited the concept of intermediated settlement as performed by a generic computer. The claims did not, for example, purport to improve the functioning of the computer itself nor did they effect an improvement in any other technology or technical field. The steps amounted to “nothing significantly more” than an instruction to apply the astract idea of intermedaited settlement using some unspecified, generic computer. That was not enough, according to the Court, to transform an abstract idea into a patent eligible invention. The same was true with respect to the product claims to a computer system and computer readable medium because they were no different from the method claims in substance, the Court warning once again against interpreting seciton 101 “in ways that make patent eligibility “depend simply on the draftsman’s art”.
Perhaps the most illustrative of the decision was the Court’s summary of prior court decisions concerning laws of nature, natural phenomena and abstract which the Court has long held are not patentable. A brief resynopsis is presented here (many of these decisions are also discussed in prior blod posts on this site):
A rule 131 affidavit/declaration allows an inventor of an application or the owner of a patent under reexamination to swear behind a reference which is being applied under 35 USC 102(a) and/or 35 USC 102(e) unless the reference is (1) a statutory bar or (2) is a US patent or a published US application which claims the “same patentable invention” as the rejected claim. The term “statutory bar” refers to a reference which are prior art under 35 USC 102(b).
A reference claims “the same patentable invention” if the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa. If the two-way test is satisfied (i.e., the rejected claim recites the “same patentable invention” as the claims in the reference US patent or published US application), an applicant can either (1) file a Rule 130 affidavit or declaration to avoid the reference in an obviousness rejection (if commonly owned) or (2) file a request under 37 CRR 41.202 for declaration of an interference.
Formalities: When to File/Signatures
A 131 affidavit must be presented prior to final rejection or before appeal in an application not having a final rejection. Under certain situations a Rule 131 affidavit can be submitted after appeal.
All of the inventors of the subject matter of the rejected claim must sign the 131 affidavit with some exceptions such as where some or all of the inventors cannot sign.
What to include in your 1.131 affidavit
You must present facts/evidence to establish reduction to practice (either actual or constructive) prior to the effective date of the reference being applied against you or conception of your invention prior to the effective date of your reference coupled with due diligence from prior to this date to a subsequent reduction to practice or to the filing of your patent application. The term “conception” is the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention as it is to be thereafter applied in practice. The test is whether the concept of the invention is clear enough for one skilled in the art to actually reduce it to practice without undue experimentation. The term “actual reduction to practice” occurs when the claimed invention is actually made (e.g., an apparatus is assembled) or performed (e.g., for a method) and seen to be suitable for its intended purpose. The term “constructive reduction to practice” means a filing of a US patent application meeting the written description requirement. The term “due diligence” is the reasonable effort to reduce your invention to practice.
It is important to remember when completing a 131 affidavit that when you are providing your examiner evidence of a date of invention that the location of these acts is important; they must have been preformed in the U.S. or in a NAFTA country (Mexico; Canada) to prove a date of invention on or after 12/8/93 or in a WTO country to provide a date of invention on or after 1/1/96. If you do not specifically state in your affidavit where your acts were performed, you are likely to have your 1.131 rejected.
For more information on 1.131 affidavits see MPEP sections 715-715.10 which covers swearing back of a reference and 2138-2138.06 which covers conception, diligence, and reduction to practice
Any post Bilski analysis needs to start off with the Supreme Court decision at the basis which of course is Bilsk v. Kappos 561 (U.S. _ (2010). The claims at issue here pertained to an invention which explained how buyers and sellers of commodities in the energy market could protect, or hedge, against the risk of price changes. Key claim 1 described a series of steps instructing how to hedge risk:
(a) initiating a series of transactions between said commondity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical averages, said fixed rate corresonding to a risk position of said consumers;
(b) identifying market participants for said commodity having a counter risk position to said consumers: and
(c) initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions.
Claim 4 merely put the concept articulated in claim 1 into a simple mathematical formula.
The remaining claims explained how claims 1 and 4 could be applied to allow energy suppliers and consumers to minimize the risks resulting from fluctuations in market demand for energy. For example, claim 2 claimed “the method of claim 1 wherein said commodity is energy and said market participants are transmission distributors.” Some of the claims also suggested familiar statistical approaches to determine the inputs to use in claim 4’s equation.
The Court started its analysis with Section 101 of the Patent Act itself which states that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title” .
The Court thus noted that section 101 specifies four independent cateogires of inventions that are eligible for protection: processes, machines, manufactures, and compositions of matter. However, the Court also noted that the Court’s precedents provide 3 specific exceptions to section 101’s broad patent-eligibility principles: laws of nature, physical phenomena and abstract ideas. While not specifically in the text of the statute, the Court noted that they are consistent with the notion that a patentable process must be “new and useful.”
The Court noted that the present case inovled a “process” under section 101 and that section 100(b) defines “process” as “process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.”
At the outset, the Court rejected any categorical limitations on “process” patents such as the categorical exclusion of business methods patents or rigid application of the “machine-or-transformation test” which although useful should not be an exhaustive or exclusive test.
The Court instead rested its decision to reject the above claims on the basis that they claim an abstract idea. The Court noted in Gottschalk v. Benson, 409 U.S. 73, 67, 72 (1972) which explained that “a principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive rigth”. In that case the Court considered whether a patent application for an algorithm to convert binary coded decimal numerals into pure binary code was a “process” under section 101. The Court there stated that a contrary holding “would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself”.
The Court also discussed Parker v. Flook, 437 U.S. 584 (1978) where the applicant there attempted to patent a procedure for monioring the conditions during the catalytic conversion process in the petrochemical and oil-refining industries. The application’s only innovation was reliance on a maethmatical algorithm. Flood held the invention was not a patentable “process” because while, unlike the algorithm in Benson, the invention had been limited so that it could still be freely used outside the petrochemical and oil refining idustries, the Court rejected “the notion that post solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process.”
The Court then distinguished Diamond v. Dierh, 450 U.S. 175, 185 (1981) which claimed a previously unknown method for “molding raw, uncured synthetic rubber into cured precision products,” using a mathematical formula to complete some of its several steps by way of a computer. Diehr explained that while an abstract idea, law of nature, or mathematical formula could not be patented, “an applicaiton of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”. Dierh emphasized the need to consider the invention as a whole, rather than “dissecting the claims into old and new elemetns and then…ignoring the presecne of the old elements in the analysis.” The Court distguished Dierh on the basis that the claim was not “an attempt to patent a mathematical formula, but rather was an industrial process for the moding of rubber products”.
Applying the precedent to the current case, the Court held that claims 1 and 4 explain the basic concept of hedging or protecting against risk. Hedging is a fundamental economic practice long prevalent in commerce and taught in any introductory finance class. The concept of hedging, described in claim 1 and reduced to a mathematical formula in claim 4, is an unpatentable abstract idea, jsut like the algorithms at issue in Benson and Flook. Allowing petitioners to patent risk hedging would preempt use of this approach in all field, and would effectively grant a monopoly over an abstract idea.
The Court state that the petitioners’ remaining claims are broad examples of how hedging can be used in commodities and energy markets. However, Flook established that limiting an abstract idea to one field of use or adding token postsolution components did not make the concept patentable. The claims in Bilski attempt to patent the use of the abstract idea of hedging risk in the energy market and then instruct the use of well-known random analysis techniques to help establish some of the inputs into the equation.
The Federal Court in Classen Immunotherapies, Inc., v. Biogen IDEC (Fed. Cir. August 31, 2011) concerns the application of the common-law exclusions from section 101 of “laws of nature, natural phenomena, and abstract ideas” in the post-world of the Myriad and Prometheus cases. This case concerned three patents totalling some 230 claims. The claims of the ‘139 and ‘739 were directed to a method whereby information on immunization schedules and the occurrence of chronic disease is screened and compared and the lower risk schedule identified and then a vaccine is administered based on that schedule. The third ‘283 patent was similar but did not include performing immunizations in accordance with the information learned by the claimed method. This performance of immunizations was key to the Courts decision holding the ‘283 patent invalid while holding the other two patents valid.
In its analysis, the Court noted once again the Diamond v. Diehr, 450 US 175 (1981) decision which stated that “it is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”.
The Court also noted Bilski v. Kappos (2010) which stated that the “machine-or-transformation test” is not the sole standard of eligibility for patenting. The Bilski Court also reiterated its concern for “barring at the threshold” and encouraged preservation of the legal and practical distinctions between the threshold inquiry of patent-eligiblity, and the substantive conditions of patentability.
The Federal Court also noted the precedent has recognized that the presence of a mental step is not itself fatal to section 101 eligibility, and that the “infinite variety” of mental and physical activity negates application of a rigid rule of ineligbility (p. 15, citing Application of Prater, 415 F2.d 1393, 1402 n.22 (CCPA 1969). The Court in Prater noted that “in ascertaining whether a particular step is “mental” or “physical”, each case must be decided on its own facts, considering all of the surrounding cirumstances, to determine which end of the spectrum that step is nearer. It may well be that the step of “comparing” may be “mental” in one prcoess, yet “physical” in another. In this respect, the Court noted its prior case in Research Corporation 627 F.3d at 868 where the question on appeal was whether the computer conducted method of comparing images was an abstract idea and concluded that the specified method was “functional and palpable” and that the claims recite tangible limitations on performing the specified method of comparing images. The court in Research Corporation explained that the claims must be considered as “a whole” when determining eligibility to seek patentability.
Coming now to the key factor in this case, the Court in Classen Immuno states that the ‘139 and ‘739 patents were directed to a method of lowering the risk of chronic immune-mediated disorder, including the physical step of immunization based on the determiend schedule. These claims, according to the court, were directed to a specific, tangible application and the Court concluded that they traversed the course eligibility filter of 101. The ‘282 patent, on the other hand, did not include the subsequent step of immunization based on an optimum schedule. The claim of the ‘283 patent claims the idea of comparing known immunization results that are, according to the patent, found in the scientific literature, but does not require using this information for immunization purposes. This was key according to the Court, because as in Association for Molecular Pathology v. U.S. Patent 7 Tradmark Office, No. 10-1406 (Fed. Cir. July 29, 2011), methods that simply collect and compare data, without applying the data in a step of the overall method, may fail to traverse the section 101 filter.
This case raises the interesting question of whether including another step in the patent claim which simplies implements the mental step will suffice to meet a section 101 analysis post Prometheus and Myriad (note that the Classen Immuno v. Biogen IDEC case was issued after Bilski but prior to the Supreme Courts’s Prometheus and Myriad decisions).
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”.