35 U.S.C. 101 – USPTO Issues guidelines for examiners on what is patentable subject matter

The recent AMP v Myriad decision1 (‘Myriad’) in the United States Supreme Court explored subject matter excluded from patentability in the US. The Court held that a naturally occurring segment of DNA is a product of nature and is not eligible for patentability merely because it has been isolated.

How the United States Patent and Trademark Office (USPTO) would apply this decision generally, with reference to the recent decision in Mayo v Prometheus2 (‘Prometheus’) with respect to claims reciting or involving laws of nature/natural principles, natural phenomena and/or natural products, has been eagerly awaited. Indeed, the USPTO has now issued a Guidance Memorandum3, an associated Overview4, and a subsequent update for its Examiners and for public consumption. The guidelines set out in the Memorandum will be required to be followed by USPTO Examiner’s and will apply to process, machine, manufacture or composition of matter inventions.

Setting aside the detail, the USPTO guidelines mandate the following as potentially excluded from patent eligibility:

[C]hemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature . . . regardless of whether particular words (e.g., “isolated”, “recombinant”, or “synthetic”) are recited in the claim.

As anticipated by many, the USPTO guidelines have applied the principles of the recent Supreme Court’s decisions liberally. As an example, claims directed to subject matter such as isolated chemical compounds per se (for example those useful as drugs/therapies), isolated antibiotics, isolated proteins per se (for example those associated with, or useful for the treatment of, disease), and isolated genes per se, as they exist in nature, are no longer considered eligible subject matter for patent protection in the United States, unless such subject matter is claimed in a manner that demonstrates a practical application of the discovery which is not inherent to the subject matter. That is, a claim reciting nothing more than a natural product or phenomenon, or a law of nature, is not eligible subject matter.

However, it has been widely recognised in the patent community that the USPTO guidelines do not administer the recent Supreme Court’s decisions by limiting them to their facts but rather the guidelines have expanded the judicial outcomes so as to apply them to products and methods that have not yet been litigated. In effect, the USPTO has arguably de facto expanded the law as it now stands in light of AMP and Prometheus.

Given this tightening by the USPTO of what constitutes patent eligible subject matter, and given the USPTO guidance, it appears that claims which are directed to the aforementioned subject matter must recite something significantly different than the judicial exceptions. For example, claims to a gene per se can be pursued provided the gene is claimed as an isolated cDNA or as part of a recombinant expression construct (and provided the gene has at least one intron). In another example, while methods which make use of naturally occurring products (such as therapeutic applications) may be novel and non-obvious, it would appear that claims directed to such applications will only represent patent eligible subject matter if the claim recites a feature divorced from the inherent ability of the natural product to exert that therapeutic effect.

Needless to say, it will be very interesting to see how the USPTO guidelines play out during examination of patent applications and how long before they are appealed to the Federal Circuit – or indeed if future Supreme Court decisions require another shift of the goal posts. In this regard, there is currently a case pending at the Supreme Court and a further three appeals are pending at the Federal Circuit. Finally, the USPTO hosted a forum on 9 May 2014 for interested parties to voice their concerns and comments on the USPTO guidelines can be sent to the USPTO.


1 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013) at http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf

2 Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf

3 http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf

4 http://www.uspto.gov/patents/law/exam/myriad-mayo_slides_20140319.pdf

5 http://www.uspto.gov/patents/announce/myriad-mayo_bcp_20140416.pdf

6 E-mail submissions to myriad-mayo_2014@uspto.gov




Scott is a registered patent attorney with over 18 years of experience dealing with intellectual property (IP) matters in life sciences. He is also the firm’s medical technology team leader and point of contact for AgTech and FoodTech related subject matter