Subject matter eligibility: interpreting the USPTO guidelines

In March 4, 2014, the US Patent and Trademark Office (USPTO) published examination guidelines designed to aid examiners in applying the principles of recent Supreme Court decisions addressing when inventions relating to laws of nature, natural phenomena, and natural products are eligible for patenting under 35 USC §101.

While the guidelines respond directly to Molecular Pathology v Myriad Genetics, Inc, 133 SCt 2107 (2013), and Mayo Collaborative Services v Prometheus Laboratories, Inc, 132 SCt 1289 (2012), they also draw from older Supreme Court decisions, such as Diamond v Chakrabarty, 447 US 303 (1980), and Funk Brothers Seed Co v Kalo Inoculant Co, 333 US  127, 131 (1948), and reach subject matter far beyond the ‘isolated DNA’ at issue in Myriad and the personalised medicine methods at issue in Prometheus.

Indeed, many have criticised the guidelines for broadening the exceptions to patent eligibility and threatening to discourage investment and innovation in biotechnology, pharmaceuticals, and personalised medicine.

The guidelines outline a three-step process for analysing a claim for subject matter eligibility, with the crux of the new analysis embodied in step three.

Step one asks whether the claim is directed to subject matter that falls under one or the four categories in §101 (process, machine, manufacture or composition of matter). For most claims, the answer will be ‘yes’. (If the answer is ‘no’ then the claim is not patent-eligible.)

Step two asks whether the claim involves an abstract idea, law of nature, natural principle, natural phenomenon,or natural product. If the answer is 'no, then the claim is patent eligible. If the answer is 'yes' because the claim involves an abstract idea, the claim must be analysed under the Bilski guidelines set forth in the Manual of Patent Examining Procedure (MPEP)§2106(II).

If the answer is ‘yes’ because the claim involves a law of nature, natural principle, natural phenomenon, or natural product, then step three is that the claim must be analysed under the new guidelines to determine whether it claims “significantly more” than the law of nature, natural principle, natural phenomenon, or natural product.

Significantly more

The guidelines outline a multifactored analytical framework for answering the “significantly more” question. Examiners are instructed to analyse the claims based on their “broadest reasonable interpretation”, to consider every relevant factor, and to assess whether “the totality of the relevant factors” weighs for or against eligibility.

If satisfied, factors (a)–(f) of the guidelines weigh towards eligibility, while factors (g)– (l) weigh against eligibility. The guidelines indicate that the list of factors will be supplemented “as the developing case law may generate additional factors over time”.

"To have the guidelines overturned, however, innovators will need to challenge them in court."

For single element product claims directed to a “natural product” only factors (a) and (g) are relevant. Such a claim will be eligible under the guidelines only if factor (a) is satisfied and the analysis determines that the claimed product is both “non-naturally occurring” and “markedly different in structure” from naturally occurring products.

(Factor [g] is the converse of factor [a], and applies when the claim recites “something that appears to be a natural product that is not markedly different in structure from naturally occurring products”.)

What is natural?

The far-reaching scope of this guidance is illustrated by the list of exemplary “natural products”.

Natural products include, but are not limited to: chemicals derived from natural sources (eg, antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc); foods (eg, fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (eg, rocks, sands, soils); nucleic acids; organisms (eg, bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature.

The potential impact of this guidance is underscored by the examples which state that a cancer-fighting compound isolated from a tree is not patent-eligible (although a chemically modified version of the compound is) and that calcium chloride and gunpowder (the latter a mixture of naturally occurring potassium nitrate, sulphur and charcoal) are both “natural products” that are not patent-eligible.

For multi-element product claims (eg, articles of manufacture or compositions of matter), all factors could be relevant. However, the guidance instructs examiners to consider only whether claim elements or steps other than the “natural product(s)” support eligibility. Thus, a claim directed to a composition with several “natural product” components may not be eligible for patenting under the guidance.

This is illustrated by the example of pomelo juice, which explains that a composition comprising pomelo juice and a preservative is not patent-eligible unless the preservative is restricted to synthetic preservatives. Extrapolating this example to pharmaceutical compositions, a composition comprising a drug that is a “natural product” (eg, a compound that occurs in nature, even if made synthetically) and a pharmaceutically acceptable carrier would not be eligible for patenting unless the carrier is restricted to synthetic carriers.

For method claims relating to a law of nature, natural principle, or natural phenomenon, all factors could be relevant. Indeed, because most of the factors were drawn from cases where claims like this were at issue, the analytical framework outlined in the guidance is more familiar for this class of claims. For example, factors that weigh in favour of patent eligibility include claim elements or steps that impose meaningful limits on claim scope, that are more than pre- or post-solution activity, that involve a machine or transformation, or that are more than well-understood, routine, or conventional.

Factors that weigh against patent eligibility include elements or steps recited at a high level of generality or that “amount to nothing more than a field of use”. While this aspect of the guidelines is consistent with how the USPTO has been applying the Supreme Court’s decision in Prometheus, the examples appear to misapply the machine or transformation factor, finding for example that a claim reciting the use of flow cytometry does not recite a machine, and that a claim that recites that DNA primers are “extended” does not recite a transformation.

Another puzzling aspect of the guidelines is its treatment of method claims that involve a “natural product”. The guidelines subject all claims that involve a law of nature, natural principle, natural phenomenon, or natural product to the same analysis, including method of making and method of using claims that involve a natural product. As a result,claims directed to making a composition by combining specific amounts of specific “natural product” components may not be eligible under the guidelines.

Likewise, claims directed to a method of treatment that involves administering a drug that is a “natural product”” may not be patent eligible unless there are other elements or steps that satisfy one or more factors (a) - (f). Although the guidelines do not include any examples of a method of treatment claim that is not patent-eligible, the example that is patent-eligible includes so many details (patient population, dose, administration period), that examiners are rejecting claims that recite a new method of treatment at a more general level.

Comment and interpretation

The USPTO is accepting comments on the guidelines, and particularly seeks alternative interpretations of the Supreme Court precedent and additional examples of eligible and ineligible subject matter. Applicants who face rejections under the guidelines should study the examples and consider whether the examiner misapplied the guidelines, made incorrect findings under the factors, or failed to give supporting factors sufficient weight.

Applicants pursuing subject matter that is not eligible under the guidelines should study the Supreme Court precedent and consider whether their claims would be eligible under alternative interpretations. Applicants also should watch for new Federal Circuit and Supreme Court decisions on patent eligibility, and confirm that the USPTO is applying the most recent interpretations of the ‘judicial exceptions’.

The guidelines do not carry the weight of law, and it is not likely that the extreme aspects of the guidelines will withstand judicial scrutiny. To have the guidelines overturned, however, innovators will need to challenge them in court. Only then will the ability to protect IP and investments in biotechnology, pharmaceuticals, and personalised medicine be preserved.

Courtenay C. Brinckerhoff is a partner at f Foley & Lardner LLP. . She can be contacted at: cbrinckerhoff@foley.com