United States Patent and Trademark Office: Update on Subject Matter Eligibility Under 35 U.S.C. § 101 for Life Sciences

On May 2016, the United States Patent and Trademark Office (USPTO) updates guidelines on how subject matter eligibility rejection under 35 U.S.C. § 101 for patent applications and patents related to life sciences should be formulated and how its response should be evaluated.

The updated guidelines still reinforce the use of the same two-part analysis in previous guidelines to assess the subject matter eligibility of each claim in patent applications and patents related to life sciences.

The two-part analysis comprises the following steps:

Step 1: determine if the claim is directed to a statutory category (patentable), such as process, machine, manufacture, or composition of matter

If step 1 is no, then the claim is not patentable.

If step 1 is yes, then step 2A should be proceeded.

Step 2A: determine if the claim is directed to one or more of the judicial exceptions, such as product of nature, law of nature, abstract idea

If step 2A is no, then the claim is deemed to be subject matter eligible.

If step 2A is yes, then step 2B should be proceeded.

Step 2B: determine if any additional element or combination of elements is sufficient to ensure that the claim amounts to significantly more than the judicial exceptions.

If Step 2B is no, then the claim is deemed to be subject matter ineligible.

If Step 2B is yes, then the claim is deemed to be subject matter eligible.

Please note a markedly different characteristics (MDC) analysis should be performed when the claim has been determined to recite a natured-based product, but not when the claim as a whole is directed to a process. In the MDC analysis for a nature-based product, the nature-based product is compared to its closest naturally occurring counterpart to determine if there are markedly different characteristics. If yes, then the claim is deemed to be subject matter eligible without the need to further analyze under step 2B.

The following table shows how subject matter eligibility of claims in patent applications and patents related to life sciences is assessed. Specifically, the table indicates the relevant statutory categories, judicial exceptions, characteristics compared in the MDC analysis, and considerations evaluated in the significantly more inquiry for each life sciences example.

 

Title	Step 1: Statutory Category	Step 2A: Judicial Exception	Step 2A: MDC Analysis	Step 2B: Significantly More Considerations
Amazonic Acid, Pharm. Compositions & Methods of Treatment	composition, process	product of nature	function/activity, chemical/physical property, structure or form	n/a
Purified Proteins	composition	product of nature	function/activity, chemical/physical property, structure or form	n/a
Genetically Modified Bacterium	composition, manufacture	product of nature	function/activity, structure or form	n/a
Bacterial Mixtures	composition	product of nature	function/activity	n/a
Nucleic Acids	composition	product of nature	function/activity, structure or form	n/a
Antibodies	composition	product of nature	function/activity, structure or form	n/a
Cells	composition	product of nature	function/activity, phenotype	improving another technology, limitation that is not well-understood, routine, and conventional, mere instructions to “apply it”, limitation is well-understood, routine, and conventional
Vaccines	composition	product of nature	function/activity, structure or form	limitation that is not well-understood, routine, and conventional, limitation is well-understood, routine, and conventional
Screening for Gene Alterations	process	abstract idea	n/a	limitation that is not well-understood, routine, and conventional, limitation is well-understood, routine, and conventional
Hydrolysis of Fat	process	streamlined analysis no need to perform the step 2A/2B eligibility analysis

 

Source of Information

http://www.uspto.gov/blog/director/entry/update_to_examiner_guidance_on

http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-memo.pdf

http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex_index.pdf

http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf

 

Keyword

United States; Subject Matter Eligibility; Life Science; 2016 Update; 35 U.S.C. § 101