First published in CIPA Journal

USPTO Guidance to Address Changes in the Law Relating to Patentable Subject Matter Under35 U.S.C. § 101

It has been a rough year for the biotech industry at the U.S. Patent and Trademark Office (USPTO). In the past nine months, the USPTO has twice changed its examination policies regarding biotech-related inventions. And while the first change, on the day that Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (Myriad), was restricted to Myriad's holding, the USPTO has now taken steps to significantly alter the administrative history surrounding the patenting of biotech inventions in the United States, citing Myriad as a "reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty."

Whether effectively a reminder or a new teaching, effective March 4, 2014 the USPTO Patent Examining Corps is instructed to follow a new procedure "in determining whether a claim reflects a significant difference from that which exists in nature and thus is eligible [subject matter], or whether it is effectively drawn to something that is naturally occurring" and thus ineligible for patenting.

The new procedure for determining subject matter eligibility under 35 U.S.C. § 101 is set forth in the Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (Guidance). This Guidance expressly supersedes the June 13, 2013 memo titled "Supreme Court Decision inAssociation for Molecular Pathology v. Myriad Genetics, Inc." (Myriad memo). In practice, however, the Guidanceappears to also supersede the 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature (2012 Interim Procedure for Laws of Nature), issued in view of the decision by the United States Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)(Mayo).

New Procedure for Assessing Subject Matter Eligibility:

Balance Factors to Evaluate Significant Differences Between the Claims and Judicial Exceptions 

While the Guidance is intended for the Patent Examining Corps, as is the case with the Manual of Patent Examining Procedure (MPEP), practitioners also have much to learn from studying it. For any claim drawn to a machine, composition, manufacture or process/method, Examiners are instructed to first ask whether the claim recites or involves "laws of nature/natural principles, natural phenomena; and/or natural products," all of which are considered "judicial exceptions" to the patent protection offered to "[w]hoever invents or discovers any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement [thereof]," by the U.S. Patent Act.

A claim is deemed to involve a "natural product" if, among other examples, it is drawn to chemicals derived from natural sources (e.g., antibiotics), nucleic acids, organisms, proteins and peptides, "and other substances found in or derived from nature." What is meant by "derived from nature" is left to future interpretation. Assuming a claim "initially appears" to involve a judicial exception, the next step is to determine whether or not this assumption proves true to the Examiner by assessing whether the claim is drawn to something that actually is "significantly different" than the judicial exceptions. To this end, the USPTO walks the reader through various examples of how this determination is to be made.

The test for "significantly different" is a balancing of factors, similar to balancing Wands factors when determining "undue experimentation" under enablement.1 A non-exclusive, non-exhaustive list of 101-related factors is provided in the Guidance. The language is somewhat convoluted, and thus somewhat modified below, but they are worth remembering:

Factors That Weigh Toward Eligibility (Significantly Different):

  1. Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products.
  2. Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s).
  3. Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the [additional] elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s).
  4. Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s).
  5. Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application.
  6.  Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than [features that are] well-understood, purely conventional or routine in the relevant field.

Factors That Weigh Against Eligibility (Not Significantly Different):

  1. Claim is a product claim reciting something that appears to be a natural product [but] that is not markedly different in structure from naturally occurring products.
  2. Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered.
  3. Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s).

For each claim, Examiners are asked to discern which ones apply to the claim at hand and then determine, by balancing the totality of relevant factors, whether they weigh toward or against eligibility.

All "related evidence" of being "significantly different" from judicial exceptions must be considered. Presumably, if aWands-like analysis is indeed to be applied, this means that after the Examiner establishes its prima facie case, Applicant can submit additional evidence, at which point the Examiner must balance all the factors de novo. Patent eligibility, like enablement, is a legal question heavily based upon factual determinations, which are specifically related to the application from which the claims arise. It is unclear if Applicant can submit post-filing evidence of significant difference through Declarations, and how much weight would those be afforded, or whether the evidence must be provided within the specification proper as filed.

Biologics:

Patentable If Markedly Different in Structure and/or Function from Natural Counterparts 

The USPTO examples do not provide significant additional information helpful to practitioners beyond that which is gleaned from the Myriad case, Myriad memo, and Mayo Guidance. For example, it would have been helpful receive guidance regarding how the USPTO will treat claims to proteins, fusion-proteins, fragments of proteins, and antibodies, a significant fraction of the global biotech industry. Instead, three of the eight examples provided are not new: they walk the reader through the holdings of Chakrabarty (Diamond v. Chakrabarty, 447 U.S. 303 (1980)), Funk Brothers (Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948)), and Myriad itself. The sum is that, for claims initially appearing to be drawn to a natural product, one of the relevant factors is whether what is claimed "is in fact non-naturally occurring and markedly different from what exists in nature," the emphasis on the "and" serving as a reminder that not being naturally occurring is not sufficient: the claimed product must also be "markedly different" from its "naturally occurring counterpart[s]" to be patent eligible. A "marked difference must be a significant difference, i.e., more than an incidental or trivial difference." Also, and this according to Myriad, it is helpful if the claims rely "on the chemical changes" that result from the isolation of the claimed product relative to its natural counterpart.

Moreover, the test of "significantly different" for biological products at first appears to be focused on "marked differences" in structure, but functional differences do play an important role. Myriad "did not consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered" and neither did the Guidance. Instead, in a given example, a claim to a pair of primers initially appears to be drawn to a judicial exception because the claimed sequences "are naturally occurring DNA sequences found on a human chromosome." Not explained in the Guidance, but according to Myriad, a primer can be considered a "naturally occurring DNA segment." In other words, the fact that the "pair of primers" itself does not exist in nature is irrelevant because each primer can be initially considered a natural product. After the relevant factors were balanced, they were found to "weigh against significantly different," and thus ineligibility. The details of the analysis are instructive because in determining whether the claimed primers were each "markedly different" from what exists in nature, the example considers both "structural differences" (deemed "minor") and "functional differences" (deemed "lacking"), the same analysis of Chakrabarty.

"Ordinary Meaning" as a Path to Establishing "Markedly Different" Function

First, the USPTO determined the "ordinary meaning of primer" as "being an isolated nucleic acid that can be used as a starting point for DNA synthesis." But this "ordinary meaning" was only openly used for the structural difference analysis, which focused on "isolated" term (breaking bonds was not enough). Indeed, for the functional differences, the USPTO did not rely on whether primers and their natural existing counterparts (presumably, chromosomal DNA) can both be used as a starting point for DNA synthesis, as it would have been called for by the ordinary meaning definition. Instead, the USPTO relied on the conclusion that both the primers and their "natural counterpart DNA" have the same function, namely: "to hybridize to their complementary nucleotide sequences." While this could be a subtlety, it is also an indication that key to the "significantly different" analysis is going to be listing and weighing all functional differences between the claimed products and their natural counterparts. And while "eligibility does not 'depend simply on the draftsman art,'" it is a tool to carefully choose the functional term/characterization of the claimed product, and if a functional term is recited opt for one whose "ordinary meaning" is the most different from the function of the natural counterpart(s). Another possibility is to apply the same strategy to the term's definition in the specification.

In this regard, attention can be called to a recent case under appeal at the U.S. Court of Appeals for the Federal Circuit (CAFC), In Re Roslin, extensively discussed at http://www.aipla.org/committees/committee_pages/Biotechnology/hot/ Shared%20Documents/Hot_Buzz_201402c.pdf. Here, the USPTO rejected a claim to a "clone." Again, the USPTO relied on the ordinary meaning definition of "clone" as "a genetically-identical organism produced from another by asexual reproduction." Because the claimed product, a clone, was thus apparently "genetically identical" to its natural counterpart, it was deemed not "markedly different", and thus not eligible for patenting. None of the other factors were sufficient to outweigh this part of the test.

Finally, it appears that the USPTO will no longer give significant weight to the use of "isolated," "recombinant," or "synthetic" in establishing a "marked difference" between a claimed product and natural counterparts. While the Myriadcase had already taken that step that for "isolated" in the context of "genes and the information they encode," the USPTO's expansion to any claims "reciting or involving natural products" is more than a "reminder" that those claims "should be examined for a marked difference under Chakrabarty." For practitioners it is also a reminder to revisit what isolations and purifications (see Guidance, Example B) do beyond breaking bonds, to study their claimed products for all other structural differences, and also revisit whether there is "a functional difference resulting from the structural difference [that] makes a stronger case" and supports a "significantly different" product.