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.