The United States Patent and Trademark Office (USPTO) published its examiner training materials (Training Materials) for applying "2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products" (Guidance), that advised U.S. patent examiners and the public of the factors for determining whether a patent claim satisfies the U.S. Supreme Court's interpretation of 35 U.S.C. §101, as applied to products and processes that might fall under one of the judicial exceptions to patentable subject matter (see my prior posts of March 5th and March 7th for a review of the Guidance). A few points raised in the Training Materials bear close attention.
Notable Points to Ponder
- The Guidance replaces the 2012 USPTO Guidance document (see MPEP § 2106.01) related to the U.S. Supreme Court's Mayo/Prometheus decision, and therefore, the Guidance applies to products of nature, such as isolated genes, and process claims, such as method for identifying patients that might be beneficially treated by a specific pharmaceutical product.
- The Guidance does not apply to claims that combine an abstract idea with a "judicial exception." The Training Materials instruct examiners to continue to review these hybrid claims as instructed in MPEP § 2106(II). Thus, if the claim recites a "comparing step," or utilizes an algorithm or computer program to analyze data or provide a recommendation, this claimed subject matter would appear to fall outside this Guidance. However, this is unlikely to be the final word from the USPTO, as the Guidance indicates that the USPTO is waiting for the U.S. Supreme Court's Alice v. CLS Bank decision, expected this year.
- All claims are reviewed as a whole, given their broadest reasonable interpretation. Perhaps then, if two naturally occurring products are combined, if the combined product is structurally different from the components (such as a natural host vector combined with an isolated gene fragment) under the "as a whole" review, the combined vector with gene fragment should pass muster for patent-eligibility. However, the Training Materials also advises examiners that claims terms such as "vector", "recombinant" or "synthetic" will not give the claim a free pass to patent-eligibility.
- The Training Materials note that treating a patient by performing a medical procedure or using an existing drug in a new way are not per se ineligible, but could be ineligible if they involve a different judicial exception.
- Eligibility now requires more than a showing of the "hand of man." To be eligible, the Training Materials advise, the claimed subject matter must be both non-naturally occurring and markedly different from naturally occurring products. Determining what makes the subject matter "markedly different" will be where the majority of applicant-USPTO discourse will lie. Patent applicants should give careful thought to this factor when drafting patent applications that may be reviewed under the new Guidance and collect information to rebut a future USPTO rejection.
- The Training Materials provide as an of a patent-ineligible combination, a composition containing a mixture of copper and tin, because the mere aggregation of naturally occurring metals does not change the materials from how they exist in nature. However, a metal alloy of this combination would be patent-eligible because an alloy is structurally different from the purified metals.
- In rejecting the claims under 35 U.S.C. § 101, the examiner must provide a rationale or evidence to support the rejection. Any evidence, pre- or post-filing, can be used to support or rebut the rejection.
Public Reaction to the Guidance
There has been public reaction to the Guidance, and whether or not the USPTO exceeded its authority in issuing the examination guidelines. Kevin Noonan reviewed this issue nicely in his post " Thoughts on the USPTO's Patent Eligibility Guidelines (and What to Do About Them)". The USPTO appears to have heard the public and is now inviting the public to comment on the Guidance. Comments can be submitted here: myriad-mayo_2014@uspto.gov.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.