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The USPTO revises guidelines regarding patentable subject matter

December 17, 2014

We previously reported that the United States Patent and Trademark Office (USPTO) issued final guidelines on March 4, 2014 for determining patent-eligible subject matter under 35 U.S.C. § 101 with respect to laws of nature/natural principles, natural phenomena and/or natural products. The previous guidelines were purportedly based on the Supreme Court decisions in Mayo Collaborative Services v. Prometheus, Inc. and Association for Molecular Pathology v. Myriad Genetics, Inc. , but the prescribed examining procedures included an extremely broad interpretation of the Mayo and Myriad cases, that had the potential for a detrimental impact on the biotech and pharmaceutical industries, as well as any business with intellectual property involving “natural products.”

On December 15, 2014, the USPTO released their 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), which was published in the Federal Register on December 16, 2014. As evidenced by the title of the document, it is an interim Guidance and, unlike the March 4, 2014 final guidelines, the USPTO is soliciting public comment by March 16, 2015.

The Interim Eligibility Guidance supersedes the March 4, 2014 Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena and/or Natural Products and supplements the June 25, 2014 Preliminary Examination Instructions in view of the Supreme Court decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.

The Interim Eligibility Guidance sets forth a two-part test for determining patent subject matter eligibility, which is consistent with previous USPTO materials regarding abstract ideas, including computer software and business methods. However, the test is significantly different from the USPTO’s previous position regarding laws of nature and natural phenomena.

The test requires that if the claim is directed to a process, machine, manufacture or composition of matter (Step 1), then the examiner must determine if it is directed to a judicial exception, including a law of nature, a natural phenomenon or an abstract idea (Step 2A). In the event that the answer to Step 2A is “yes,” the examiner must determine whether the claim recites additional elements that amount to significantly more than the judicial exception (Step 2B).

Perhaps the greatest difference in the new procedures is with respect to natural products, or what the USPTO is now referring to as “nature-based products.” Step 2A includes comparing a nature-based product to its naturally occurring counterpart to determine whether the claimed product is markedly different from the naturally occurring counterpart. In contrast to the previous position that a marked difference requires a structural difference, the Interim Eligibility Guidance makes it clear that a marked difference may be the result of a structural or functional difference. If the product is markedly different, then the claim does not recite a product of nature exception, therefore the subject matter is patent-eligible and it is not necessary to proceed to Step 2B. In another departure from the previous procedures, claims that recite a judicial exception, but clearly do not seek to monopolize the judicial exception, are subject to a streamlined eligibility analysis, in which the markedly different characteristics analysis is not necessary.

The USPTO has posted on its website examples regarding nature-based products, which are intended to replace the examples from the March 4, 2014 materials. Many of the new examples involve claims that were discussed in the March materials, but the analysis and conclusion is different, resulting in far more patent-eligible claims under the new procedures. Although isolated DNA, and other naturally occurring products, remain(s) ineligible patent subject matter, the new Guidance is substantially more permissive than the March 4, 2014 procedures. Examples and discussion regarding diagnostic claims and personalized medicine are limited, thus it is not as clear how the new procedures will change the analysis with respect to such discoveries. Nonetheless, the revised procedures are a huge step in the right direction. Ultimately, congress will have to rewrite § 101 of the Unites States Code if isolated DNA and other isolated naturally occurring products are to once again be patent-eligible.   
Members of the Honigman patent prosecution team are available to discuss the impact of the guidelines and advise you as to how it will affect your business and future patent strategies.