On March 4, 2014, the U.S.P.T.O. issued guidelines to its Patent Examining Corps for determining whether inventions are eligible for patenting under 35 U.S.C. § 101 or ineligible under the judicially created exceptions from eligibility for laws of nature, natural phenomena, or natural products.  (Previously established guidelines will continue to be followed for analyzing whether the “abstract ideas” exclusion from eligibility applies.)  The new guidelines, which may be applied across a broad spectrum of technologies, address the Supreme Court’s interpretation of § 101 in Mayo Collaborative Services v. Prometheus Laboratories, Inc. in 2012 and Ass’n for Molecular Pathology v. Myriad Genetics, Inc. in 2013.  InMayo (previously reviewed here) the Court held that a method for dosing a medication based on a patient’s metabolite levels after drug administration was an ineligible application of a “law of nature” and in Myriad (previously reviewed here) it held that an isolated molecule of DNA whose nucleotide sequence matches that of naturally occurring genes is an ineligible “product of nature.”  The new guidelines, effective immediately, supersede preliminary guidance the U.S.P.T.O had issued in June 2013 soon after Myriad was handed down.  They may provide some predictability for patent applicants in the wake of uncertainty created by Mayo and Mriad.  But they also signify a broad application of these holdings and greater scrutiny during examination.  Applicants and practitioners should adjust their strategies and expectations accordingly.

Under the new guidelines, examiners are to ask whether a “claim recite[s] or involve[s] judicial exception(s)” cited above.  If so, examiners must ask whether as a whole the claim recites “something significantly different than the judicial exception(s).”  Claims that recite or invoke something that is not “significantly different” from an exception are to be rejected for failing to satisfy § 101.

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As the guidelines acknowledge, the Myriad holding was directed to subject matter at issue in the case:  nucleic acids.  But the overall rationale of the decision was not.  Thus, the guidelines nonexclusively list a wide array of subject matter whose recitation or invocation may require further examination for the presence of something “significantly different” in the claim, and instruct that the analysis applies where there is even “any doubt” about whether an exception is involved.  Examples of claimed subject matter that may trigger such an analysis include “chemicals 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.”  The guidelines therefore reveal a broad conception of the eligibility exceptions and potential applicability to many different arts.  For example, they state that gunpowder is a natural product because it is “a mixture of naturally occurring saltpeter, sulfur and charcoal” and that a method for treating a mood disorder by exposure to a synthetic source of white light invokes a “natural principle or phenomenon.”

For claims that do recite or invoke an exception, the next step is to determine if the subject matter of the claim as a whole is “significantly different” from the exception.  For determining whether such a “marked” difference exists, the guidelines list twelve factors, six of which indicate the presence of something “significantly different” from nature and thus support eligibility, and six that do not.  The guidelines state:  “The Examiner’s analysis should carefully consider every relevant factor and related evidence before making a conclusion.  The determination of eligibility is not a single, simple determination, but is a conclusion reached by weighing the relevant factors, keeping in mind that the weight accorded each factor will vary based upon the facts of the application.”  The twelve factors, paraphrased, are:

Factors that weigh toward eligibility (significantly different):

  • Product appears to be a natural product but turns out to be non-naturally occurring and “markedly different in structure” from natural products;
  • Claim meaningfully limits scope of method so that others are not substantially foreclosed from using an exception;
  • Claimed elements are more than nominally, insignificantly, or tangentially related to an exception;
  • Claims do more than describe exception with general instructions to apply or use it;
  • A machine or transformation of matter implements or integrates an exception, but the claim recites additional elements or steps;
  • Something more than well-understood, purely conventional or routine is added to the exception.

Factors that weigh against eligibility (not significantly different):

  • Product is not markedly different in structure from natural product;
  • High level of generality encompassing substantially all practical applications of exception;
  • Recited elements/steps are those that are required by any application of the exception;
  • Recitations in addition to the exception are well-understood, purely conventional or routine;
  • Recitations in addition to the exception are insignificant extra-solution activity, such as being merely appended to the exception;
  • Recitations in addition to the exception are merely a field of use.

To assist in applying these factors, the guidelines provide eight sets of exemplary claims and applies the factors to conclude whether each claim is patent eligible, some of which are discussed here in some detail.  As one example, a pair of DNA primers would not be eligible because they are not “markedly different” from naturally occurring DNA.  (Unaddressed was the eligibility of a primer whose nucleotide sequence spans the junction between adjacent exons in a molecule of mRNA, a composition whose eligibility arguably survived Myriad.)  However, after weighing the applicable factors, the guidelines state that a method of using the claimed primers to amplify copies of DNA by polymerase chain reaction (PCR) would be eligible.  In this respect, the conclusion that adding a routine method (PCR) to otherwise ineligible subject matter (DNA primers) can be enough to confer eligibility belies some tension between Mayo and Myriad.  Echoing Mayo, and as noted above, the guidelines state that in general elements or steps in a claim that are merely “well-understood, purely conventional or routine” cannot confer eligibility to otherwise ineligible subject matter.  Yet in this primer/PCR example, the guidelines echo Myriad, which held that although isolated genes are not eligible, some cDNA molecules (whose synthesis is routine if the gene sequence is known) are eligible.  Elsewhere the guidelines discuss this aspect of Myriad and state that “[t]he fact that a marked [structural] difference came about as a result of routine activity or via human manipulation of natural processes does not prevent the marked difference from weighing in favor of patent eligibility.”  This perspective is extended to analyzing a method in the primer/PCR example.  The friction between the analyses reveals a possible silver lining: a pressure point to leverage in responding to § 101 rejections by nudging an examiner’s analogy away from Mayo and towards the window left open in Myriad, where possible.

In another example, a compound purified from the leaf of a Brazilian tree that is useful in treating breast cancer is found ineligible, whereas a chemical derivative of it that does not occur naturally is eligible.  Curiously, however, the modified derivative differs from the natural chemical not only structurally but also functionally in that it stimulates hair growth.  Although the guidelines state that “[w]hile a functional difference is not necessary in order to find a marked difference, the presence of a functional difference resulting from the structural difference makes a stronger case that the structural difference is a marked difference.”  Declining to provide a clean example here and instead confounding structural and functional considerations in the analysis of a composition’s eligibility reveals the need for further refinement on this issue.  Notably, this example recalls Justice Alito’s question during oral argument in Myriad of why the eligibility of a medicine isolated from a plant would survive if the petitioner’s request to find isolated DNA ineligible were granted.  Although the petitioner responded that the eligibility of such a medicine should not be affected by a rule that made isolated genes ineligible, no such reasoning appeared in the Myriad holding nor, it appears, is the U.S.P.T.O. apt to apply it.

Applicants and practitioners are encouraged to read these and other examples in the guidelines to discern how the U.S.P.T.O. may be applying Mayo and Myriad going forward.  Some examples merely recapitulate other, prior Supreme Court holdings as to eligibility, whereas others suggest answers to some lingering questions.  For example, the guidelines demonstrate how a claim to a diagnostic method involving biomarker detection can be eligible despite involving the “natural principle” of the correlation between the presence of the biomarker and having the disease, and the fact that the biomarker and the tissue in which it is identified are “natural products” (provided that more than an “abstract idea” is invoked, as cautioned in another example).