Update on Patentability of Diagnostic Claims: Brazil (Part 2 of an 8-part Series)

This is the second update to our 2014 10-part series “The Thorny Problem of Patentable Eligible Subject Matter.” Since that series, the U.S Patent and Trademark Office (USPTO) issued further guidance on December 16, 2014, updated in July 2015 and May 2016 (May 2016 Update), for evaluating subject matter eligibility under Section 101 (Guidance). The new Guidance superseded the March 4, 2014 Guidance.  Part 1 – Update on Patentability of Diagnostic Claims: Australia can be found here.

On July 16, 2016, the USPTO issued a memo commenting on recent decisions by the U.S. Supreme Court (Supreme Court) and the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in two subject matter eligibility cases directed to life sciences method claims: Sequenom v. Ariosa and Rapid Litigation Management v. CellzDirect, (Rapid Litigation Management) respectively. The memo concludes that neither decision changes the subject matter eligibility framework and that the existing Guidance and training examples are consistent with these cases; however, the memo also notes that the Rapid Litigation Management decision further clarifies the inquiry involved in determining whether a claim is directed to a judicial exception. In particular, the Federal Circuit stated that the “directed to” analysis of a process claim requires more than “merely identify[ing] a patent-ineligible concept underlying the claim” and instead requires an analysis of whether “the end result of the process, the essence of the whole, was a patent-ineligible concept.”

The May 2016 Update provided more detailed instructions for Examiners regarding the formulation of a rejection under Section 101 and evaluation of an Applicants response thereto. Specifically, Examiner’s must identify the exception to patentable subject matter (referred to as a “judicial exception”) that is being claimed, explain what is recited  in the claim and why it is an exception, and identify any additional elements that define claim features/limitations/steps that are beyond the exception. The Examiner must then explain why the additional elements individually AND in combination do not result in the claim as a whole amounting to “significantly more” than the exception.

The May 2016 Update also provided additional examples for application of the Guidance to specific types of life science claims, which were not well represented in the December 2014 Guidance.

As discussed in our 2014 series, Article 10 of Brazilian Intellectual Property law (IPL) defines what is not considered to be an invention or a utility model and thus, patent ineligible subject matter.  In fact, Article 10 may be considered the counterpart of 35 U.S.C. § 101 in the U.S. According to Article 10, the following are not considered be patent eligible subject matter:

  1. Discoveries, scientific theories, and mathematical methods;
  2. Purely abstract concepts;
  3. Schemes, plans, principles or methods of a commercial, accounting, financial, educational, publishing, lottery or fiscal nature;
  4. Literary, architectural, artistic, and scientific works or any aesthetic creation;
  5. Computer programs per se;
  6. Presentation of information;
  7. Rules of games;
  8. Operating or surgical techniques and therapeutic or diagnostic methods for use on the human or animal body; and
  9. Natural living beings, in whole or in part, and biological material, including the genome or germplasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes.

Additionally, Article 18 of Brazilian Intellectual Property law further limits what may be patentable and indicates that the following are not patentable:

  1. Anything that is contrary to morals, good customs, and public security, order, and health;
  2. Substances, matter, mixtures, elements or products of any kind, as well as the modification of their physical-chemical properties and the respective processes of obtaining or modifying them, when they result from the transformation of the atomic nucleus; and
  3. Living beings, in whole or in part, except transgenic micro-organisms* meeting the three patentability requirements provided for in Article 8 (i.e., novelty, inventive activity, and industrial application) and which are not mere discoveries.

*For the purposes of this law, transgenic micro-organisms are organisms, except the whole or part of plants or animals, that exhibit, due to direct human intervention in their genetic composition, a characteristic that cannot normally be attained by the species under natural conditions.

Additionally, on July 15, 2016, the Ministry of Development, Industry and Foreign Trade, National Institute of Industrial Property (INPI) published Part II of its guidelines for the examination of patent applications relating to patentability (Guidelines).  According to Paragraph 1.38 of the Guidelines, a diagnostic method is not considered an invention when the series of steps that comprise the method are applied “in a human or animal body”.  Specifically, Paragraph 1.39 states that:

A diagnostic method for application in the human or animal body in accordance with the provisions of item VIII of Article No. 10 of IPL falls within, when it meets the following criteria:  (i) it has direct application in the human or animal body, such as, for example, in the base of determining the allergic conditions by diagnostic examination applied in the body, or requires the presence or participation of the patient for its interpretation; and (ii) allows the conclusion of the clinical state of the patient, or indicate various possible clinical states, just based on data processing, analysis or interpretation, information and/or clinical results associated with the patient.

The following is an example provided in the Guidelines of a diagnostic method not considered to be an invention (and hence not patentable):

  1. Automated diagnostic method of a patient, characterized in that it comprises the steps of:
    1. examining the patient to provide at least a first symptom element having a first relative degree of importance to the symptom;
    2. examining the patient to provide at least a second symptom element having a second relative degree of importance to the symptom;
    3. apply the relative degrees of importance for the symptoms, in order to obtain a diagnostics core for the conclusion of a medical condition.

Paragraph 1.41 of the Guidelines makes it clear that methods consisting of in vitro tests that are carried out on blood samples or other tissue removed from the body are considered to be an invention because such tests are not applied to a human or animal body and thus do not “conclude regarding the clinical state of the patient”.  However, this same paragraph also notes that diagnostic methods may include a combination of in vivo and in vitro steps.  In these instances, “…if the claimed method includes technical steps carried out in vivo, which are inseparable from the in vitro step, the method as a whole will be regarded as being applied on the body and, therefore, it will not be considered invention.  In addition, the treatment of tissues, cells or body fluids after they have been removed from the human or animal body, or methods applied onto them, such as methods in vitro, are considered entitled to protection.  The methods of measurement of enzymes and blood glucose, complete blood count, serology tests, among others, are included in this case.”

Paragraph 1.42 of the Guidelines further specifies that methods of obtaining information from a human or animal body where the data collected is just an “intermediate result that, by itself, is not enough for defining a diagnosis, are not considered diagnosing methods.”  Therefore, such methods are considered to be inventions and thus entitled to protection.

We at the BRIC Wall thought it would be insightful to update our analysis of subject matter eligibility under Brazilian patent law for diagnostic method claims based on the May 2016 updated Guidance and Life Science examples.

Analysis of Life Sciences Examples from May 2016 Update to USPTO Guidance

Example 29 – Diagnosing and Treating Julitis

Background:  Example 29 of the May 2016 Update relates to a hypothetical situation relating to an autoimmune disease called “Julitis.”  An Applicant for a patent discovered that Julitis could be diagnosed by detecting the presence of the hypothetical “JUL-1” protein in patients’ plasma, skin, hair and nails.  Applicant has disclosed detecting JUL-1 using anti-JUL-1 antibodies that may be naturally occurring (e.g., a human anti-JUL-1 antibody isolated from a patient known to have julitis), or non-naturally occurring (e.g., a porcine anti-JUL-1 antibody created by injecting pigs with JUL-1, or a specific monoclonal antibody named “mAb-D33”).

Two representative claims from this Example are analyzed below.

Claim 1. A method of detecting JUL-1 in a patient, said method comprising:

  1. obtaining a plasma sample from a human patient; and
  2. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

Claim 2. A method of diagnosing julitis in a patient, said method comprising:

  1. obtaining a plasma sample from a human patient;
  2. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and
  3. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

Analysis of claims 1 and 2:  Both claims 1 and 2 would constitute patent eligible subject matter in Brazil. In the U.S., claim 1 constitutes patent eligible subject matter, while claim 2 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the claim is directed to a judicial exception (i.e., the correlation between the presence of JUL-1 and the presence of julitis in the patient) and as a whole does not amount to significantly more than the exception itself.

Example 31 – Screening for Gene Alterations

Background:  Applicant discovered the “wild-type” sequence of the human BRCA1 gene (i.e., the typical sequence of the gene in humans), and has also discovered naturally occurring alterations from the wild-type sequence that are correlated with an increased likelihood of developing breast or ovarian cancer. Applicant’s disclosure provides methods of screening patients for alterations in the BRCA1 gene by comparing a patient’s BRCA1 sequence with the wild-type BRCA1 sequence. The compared sequences can be germline (genomic) DNA sequences, RNA sequences, or cDNA sequences.

At the time the invention was made and the application was filed, scientists routinely compared DNA sequences using two-data generating techniques:  (1) hybridizing two different DNA molecules (e.g., a probe and DNA isolated from a patient sample), and detecting whether the molecules bind to each other and form a hybridization product and (2) amplifying (making copies of) at least part of a DNA molecule such as DNA isolated from a patient sample, by using a set of primers to produce amplified nucleic acids, and then sequencing the amplified nucleic acids.  The probes and primers used in these techniques are short single-stranded DNA molecules that typically have a naturally occurring nucleotide sequence.

In one embodiment, Applicant discloses using a computer-implemented micromechanical method known as Scanning Near-field Optical Microscopy (SNOM) to detect hybridization of a single probe to its target. At the time the invention was made and the application was filed, the use of SNOM to study DNA hybridization had been discussed in several articles in widely-read scientific journals. However, scientists were not commonly or routinely using SNOM to study DNA hybridization at the time the invention was made and the application was filed.  Instead, scientists at the time typically used autoradiography to detect hybridization products.

In another embodiment, Applicant discloses using Cool-Melt polymerase chain reaction (Cool-Melt PCR) to amplify BRCA1 DNA from the patient sample. Cool-Melt PCR uses lower melting and annealing temperatures than conventional PCR, which results in Cool-Melt PCR having a 20-fold higher sensitivity of mutation detection than conventional PCR.  At the time the invention was made and the application was filed, Cool-Melt PCR was known and used by a few scientists in the field.  Several years after filing the application, Cool-Melt PCR became a standard laboratory technique that appeared in virtually every laboratory manual and was conventionally used by most scientists in the field to amplify mutant nucleic acids.

Three representative claims from this Example are analyzed below.

Claim 1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

Claim 70. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:

  • hybridizing a wild-type probe to a BRCA1 gene isolated from said sample; and
  • detecting the presence of a hybridization product by measuring conformational changes in the probe that are indicative of hybridization to the BRCA1 gene with scanning near-field optical microscopy.
  • Claim 80. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:
  • amplifying by Cool-Melt PCR all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids; and
  • sequencing the amplified nucleic acids.

Analysis of claims 1, 70, and 80:  Claims 1, 70, and 80 would constitute patent eligible subject matter in Brazil.  In the U.S., claim 1 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the “comparing” amounts to an abstract idea, which is a judicial exception, and the claim as a whole does not amount to significantly more than the exception itself.  In contrast, claims 70 and 80 are patent eligible in the U.S., as each claim recites additional elements that distinguishes the claim from well-understood, routine, or conventional techniques in the field (i.e., SNOM and Cool-Melt PCR, respectively), and, therefore, each of claims 70 and 80 as a whole amounts to significantly more than the exception itself.

In view of the above, Brazilian patent law is less restrictive concerning the eligibility of diagnostic method claims as compared to U.S. patent law, at least for the foreseeable future.

This post was written by Lisa L. Mueller and Melissa E. Kolom of Michael Best, and Roberto Rodrigues and Anna Carolina Correa of Licks Attorneys.

New Patent Examination Guidance in Canada for Evaluating Medical Diagnostic Methods: Will Canada’s Application Be More Flexible than the U.S.?

Patentable Subject Matter in Canada

In Canada, patentable subject matter is embodied in section 2 of the Canadian Patent Act (Patent Act), which defines an invention as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter”. While section 2 is broad, not all inventions can be patented. Specifically, scientific principles, abstract theorems, methods of medical treatment and surgery, higher life forms and forms of energy (e.g., such as electromagnetic and acoustic signals, regions of the electromagnetic spectrum, electric currents and explosions) are examples of some of the inventions that do not constitute patentable subject matter in Canada.

Subject Matter Eligibility of Medical Diagnostic Methods

On June 29, 2015, the Canadian Intellectual Property Office (CIPO) issued a guidance document for patent examiners (Notice) examining patent applications claiming medical diagnostic methods. The Notice defines a “diagnostic method” as a sequence of steps to be followed to extract diagnostic meaning from data which often comprises steps to:

  1. Acquire data about an analyte (such as identifying, detecting, measuring, etc. the presence or quantity of X in a sample); and
  2. Analyze the significance of the acquired data (such as the presence, increase/decrease of the quantity, etc. of X correlates to condition Y)

The Notice defines “analyte” broadly to include a chemical substance or a biomarker that is the subject of analysis.

A determination of whether a diagnostic method claim is directed to patentable subject matter is made based on the essential elements as determined through a purposive construction of the claim. A proper purposive construction is a two-step analysis requiring an Examiner to identify: (1) the problem the inventors set out to solve; and (2) the solution disclosed.

Problem to be Solved

The Notice states that the identification of the problem to be solved is guided by the specification, as well as the Examiner’s understanding of the common general knowledge in the art (but not by reference to the closest prior art). The Notice reminds Examiners that an application may describe more than one problem to be solved, but states that for diagnostic methods, it may be appropriate for Examiners to consider that an inventor is looking to solve a “data acquisition problem” and/or a “data analysis problem”.   The Notice provides the following examples of factors recited in a description that may suggest the existence of a “data acquisition problem” or “data analysis problem”:

  1. Factors indicating a possible “data acquisition problem”: (a) a disclosure of a non-common general knowledge analyte and method of identifying or quantifying the analyte; (b) explicit statements that a specific problem or solution relates to how to identify or quantify a particular analyte; (c) a significant level of detail devoted to describing the technical details of how data about a particular analysis is acquired; and/or (d) an emphasis on the challenges or deficiencies of prior means to identify or quantify a particular analyte.
  2. Factors indicating a possible “data analysis problem”: (a) explicit statements suggesting the problem to be solved is a “data analysis problem” or something other than a “data acquisition problem”; (b) placing an emphasis on the discovery of an allegedly new correlation between a condition and an analyte that is common general knowledge with a relative absence of technical details pertaining how to acquire the data about the analyte; (c) indicators or explicit statements that, in order to acquire data about a particular analyte, it is common general knowledge to apply the means contemplated by the application; and/or (d) an absence of an explicit indication in the application that any practical problems were overcome relating to how to acquire data about an analyte that is common general knowledge.

Solution

The solution is the element or set of elements essential to the resolution of the problem. The choice of a solution should be guided by the description, selecting the solution given the greatest emphasis by the inventors.

For a “data acquisition problem,” the solution can be provided by those elements that provide a means to acquire data about an analyte. The means, by which is the data is acquired, can be represented by either a single or multiple steps recited in the claim. Examples of elements relating to data acquisition that may be represented by steps include: (a) detecting protein X in a subject sample; (b) determining the expression levels of genes A, B, and C; (c) contacting a urine sample with antibody A and determining the optical density; or (d) incubating a sample with a nucleic acid problem consisting of SEQ ID NO:1 and detecting hybridization between the probe and target sequence Z.

For a “data analysis problem,” the solution can be provided by those elements that relate to the analysis of acquired data for the purposes of providing diagnostic meaning. Examples of elements relating to data analysis that may be represented by steps include: (a) relating the presence of protein X from said test sample to a diagnosis of whether the test sample is from a subject suffering from disease Y; (b) comparing the expression levels of genes A, B and C to a control standard, wherein a decrease in the levels as compared to the control is indicative of disease Y; or (c) wherein hybridization of the probe to a target is indicative of the presence of disease Y.

Determining the Essential Elements of a Claim

Once the problem and solution have been identified, the meaning of various terms used in the claims are construed and a determination made of whether elements recited in the claims are essential (meaning the element provides a solution to the problem) or non-essential. Next, considering the elements required to solve the problem, the Examiner analyzes the claims to determine whether: (a) those elements or set of elements that are essential to the solution; and (b) all of the elements required for providing the solution are encompassed by the claim.

A claim that appears to lack an essential element may be found defective for over-breadth (namely, lack of support) and/or lack of utility.

Additionally, the Notice states:

Recognizing that how data is analyzed or interpreted in a diagnostic method generally has no material effect on how the data needs to be physically acquired (and vice versa), the data acquisition elements and data analysis elements in the diagnostic method claim likely have a relationship reflecting an aggregation rather than a combination.

Where a ‘data acquisition problem’ exists, the essential element or set of essential elements providing the solution is the means to acquire data about the analyte. If the identified problem does not relate to data acquisition, then it will presumably relate instead to a ‘data analysis problem’. Where this is the case, the essential elements will include steps relating to the mental analysis and/or intellectual significance of the data and will likely not include any steps to acquire the data since the way the data is acquired does not change the nature of the solution.

Determining whether a claim defines statutory subject-matter

The Notice states that when a physical step of data acquisition is identified as an essential element of a construed claim, then the claimed subject matter will likely be deemed to be statutory. However, in contrast, the notice further states:

…a diagnostic method claim construed as consisting solely of essential elements that are disembodied (e.g., mental process, lacking physicality, no practical application, etc.) will be identified as defective for not complying with section 2 of the Patent Act. This would generally apply to situations where the identified solution is only provided by an element or set of elements associated with the analysis or significance of the acquired data (e.g., the correlation).

What happens now?

CIPO advised Applicants that examination of patent applications claiming medical diagnostic methods had been delayed pending release of this Notice. Now that the Notice has been published, Applicants should start receiving Office Actions possibly rejecting medical diagnostic claims for lack of patentable subject matter. Because the Notice does not have the force of law, it will be interesting to see how strictly it is applied by Examiners and, if any final Office Actions are received, whether any Applicants appeal to the Federal Court challenging such application.

It will be interesting for Applicants to see how the analysis of subject matter eligibility of claims to medical diagnostic methods will compare in Canada versus the U.S. As many readers will recall, on December 16, 2014, the U.S. Patent and Trademark Office (USPTO) issued the 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Guidance), which superseded the March 2014 Interim Guidance for natural phenomenon and laws of nature and supplemented the June 2014 Interim Guidance for abstract ideas. The below flow chart summarizes the subject matter eligibility analysis used by the USPTO for evaluating whether a claim is drawn to patent eligible subject matter.

USPTOsubjectmattereligibilty

Time will tell whether CIPO’s application of the Notice will allow Applicants to obtain broader claims to medical diagnostic methods than currently possible in the U.S.

This post was written by Lisa Mueller.

The Thorny Problem of Patentable Eligible Subject Matter: Update to Part 1 of the 10-Part Series: U.S.

This is an update to Part 1 of the 10-part series examining patent eligible subject matter in the U.S., BRIC and several non-BRIC countries.

In Re Roslin Institute (Edinburgh)

In part 1 of this series (which can be found here), the statutory classes of patentable subject matter in the U.S. as well as the guidance issued by the United States Patent and Trademark Office (USPTO) for evaluating subject matter eligibility (Guidance) were discussed. As an update to that discussion, provided below is a brief overview of a recent decision by the United States Court of Appeals for the Federal Circuit (CAFC) regarding patentable subject matter. In the U.S. court system, the CAFC hears appeals relating to patent law and any appeals to CAFC decisions are to the U.S. Supreme Court (Supreme Court). Specifically, the CAFC decided on May 8, 2014 in In Re Roslin Institute (Edinburgh) (Roslin) that Roslin’s clone (i.e., Dolly the Sheep) was unpatentable subject matter under Section 101.

In Roslin, the application at issue was U.S. Patent Application No. 09/225,233 (the ‘233 Application), which contained product claims to clones resulting from somatic cell nuclear transfer (i.e., a clone from an adult or differentiated cell). A representative claim is claim 155, which stated:

A live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.

In its opinion, the CAFC stated that “Roslin’s claimed clones are exact copies of patent ineligible subject matter [i.e., the donor mammal].” These exact copies (e.g., Dolly the Sheep), according to the CAFC, did not possess markedly different characteristics from any farm animals found in nature. The genetic information and genetic structure of the DNA used to make the clones was not created or altered by the inventors.

Additionally, while the Appellant argued that Dolly possessed distinguishable characteristics from the donor mammal (i.e., phenotype and mitochondrial DNA), the CAFC pointed out that these differences were not indicated in the claims directed to the clone. The CAFC further stated that the phenotypic differences arose independent of the inventors’ efforts and the specification of the ‘233 Application did not identify how differences in mitochondrial DNA would have influenced characteristics of the cloned mammals.

Accordingly, the CAFC concluded that the claimed clones were defined in terms of the identity of their nuclear DNA relative to the nuclear DNA of the donor mammals. The CAFC thus decided that Dolly’s genetic identity to her donor parent rendered her unpatentable subject matter, and as the claims did not describe clones that had markedly different characteristics from the donor animals of which they were copies, the claims were directed to patent ineligible subject matter under Section 101.

It should be noted that the CAFC did not comment upon what may or may not constitute a markedly different characteristic. While the characteristic considered by the CAFC here in Roslin was genetic identity (i.e., genetic information and nuclear DNA structure), does a markedly different characteristic always have to be a marked difference in structure as stated in factors a and g of the Guidance or can a markedly different characteristic be, in certain instances, differences in function, use, and the like, where no change in structure occurs? It will be interesting to see how the U.S. courts interpret the term “markedly different characteristic” in future cases in relation to the patent eligibility of product claims.

Please continue to watch the BRIC Wall for further updates on patentable eligible subject matter.

This post was written by Laura Opperman and Lisa Mueller.

The Thorny Problem of Patentable Eligible Subject Matter: Part 1 of a 10-Part Series: U.S

This is Part 1 of a 10-part series examining patent eligible subject matter in the U.S., BRIC and several non-BRIC countries.

Statutory Classes of Patentable Subject Matter

In the U.S., patentable subject matter is defined by Section 101 of the Patent Act which states: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. 35 U.S.C. §101 (Section 101).

The Patent Act of 1793, authored by Thomas Jefferson, contained the original statute defining patentable subject matter which ultimately evolved into modern day Section 101. At that time, the statute defined patentable subject matter as any new and useful: art, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.

In 1952, when the patent laws were recodified, Congress replaced the word “art” with the word “process” but otherwise Jefferson’s original wording remained unchanged. Although the term “process” was not added until 1952, “processes” historically enjoyed patent protection because they were considered a form of “art” as used in the 1793 Act. Interestingly, according to the Committee Reports accompanying the 1952 Act, Congress intended statutory subject matter to “include anything under the sun that is made by man.”

Thus, under Section 101, all patents issued in the U.S. must be classified into at least one of the following four statutory classes:

  1. Machines – A concrete thing consisting of parts or devices;
  1. Manufacture – An article produced from raw or prepared materials;
  1. Composition of Matter – A composition of substances or composite articles; and
  1. Processes -An act or a series of acts.

Inventions that do not fall within any of above described statutory classes are not eligible for patenting.

The U.S. Supreme Court (Supreme Court) has long held that Section 101 contains a number of important “implicit” exceptions. Specifically, laws of nature, natural phenomena and abstract ideas are not patentable. For example, the Supreme Court has written that a new mineral discovered in the earth, a new plant found in the wild, Einstein’s law E=mc2 or Newton’s law of gravity are not patentable subject matter. As the Supreme Court stated in Gottschalk v. Benson, 409 U.S. 63, 67 (1972), “[P]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable as they are the basic tools of scientific and technological work.” Additionally, Section 33(a) of the Leahy-Smith American Invents Act provides that human organisms (such as claims to a human embryo) are not patent eligible subject matter.

U.S. Patent and Trademark Office Guidelines

In view of recent Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo), the U.S. Patent and Trademark Office (USPTO) on March 4, 2014, issued a guidance for evaluating subject matter eligibility under Section 101 (Guidance). The Guidance superseded the June 13, 2013 memorandum issued on the day of the Myriad decision. While the Guidance was issued without public notice or opportunity for the public to comment, the USPTO is holding a forum on May 9, 2014 to receive feedback from organizations and individuals regarding the Guidance.

The Guidance is divided into four sections. Part I discusses the three-part test for determining subject matter eligibility. Part II explains how to determine whether a claim (as a whole) is “significantly different.” This portion of the Guidance provides a list of 12 factors – six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference).  Part III provides seven examples explaining the application of the factors. Part IV provides a new form paragraph for Examiners to use when rejecting claims in accordance with the guidance.

The USPTO has made it clear that the Guidance is to be used for making subject matter eligibility determinations for all four statutory categories of subject matter (namely, a machine, composition, manufacture or process) that recite or involve laws of nature, natural principles, natural phenomena and/or natural products. The Guidance is not to be used if the subject matter recites or involves an abstract idea {alone or in combination with other judicial exceptions (namely, laws of nature, natural principles, natural phenomena and/or natural products)}.

In addition to the Guidance, the USPTO has prepared detailed training materials (containing 93 PowerPoint slides) for Examiners. During the Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting on April 16, 2014 (BCP meeting), June Cohan and Ali Salimi from the Office of Patent Legal administration, and Daniel Sullivan, a supervisor patent Examiner from Art Unit 1611, provided insight on how the Guidance was developed, including its basis in Supreme Court precedent. As discussed during the presentation, the first round of training for Examiners on the Guidelines is in progress and a second round of training is currently in development. Plans for this second round of training include providing additional training materials containing more examples from the seven provided in the current Guidelines. Moreover, the USPTO plans to update the MPEP. It will be interesting to see the content of the next round of training materials, particularly after the USPTO receives feed-back from the public during the forum on May 9th.

Three-Part Analysis

The Guidance provides a three-step analysis for determining the subject matter eligibility of a claim. The analysis involves determining the broadest reasonable interpretation for a claim and asking the following questions:

  1. Does the claim recite one of the four statutory categories of patent eligible subject matter (namely, a machine, a composition, a manufacture or a process)? If the answer to this question is no, then the analysis is complete and the claim is rejected under Section 101 as drawn to ineligible subject matter. If the answer to this question is yes, proceed to question 2.
  1. Does the claim recite or involve one or more judicial exceptions (namely, an abstract idea*, law of nature or natural principle, natural phenomena or natural product)? If the answer to this question is no, then the analysis is complete and the claim qualifies as eligible subject matter. If the answer to this question is yes, proceed to question 3.

*If an abstract idea, however, is recited or involved, then the Guidance should not be used to determine if the claim qualifies as eligible subject matter.

  1. Does the claim as a whole recite something significantly different from the judicial exception? If the answer to this no, then the analysis is complete and the claim is rejected under Section 101 as drawn to ineligible subject matter. If the answer to this question is yes, then the analysis is complete and the claim qualifies as eligible subject matter.

According to the Guidance, it is not enough that a claim is directed to a product or composition that is non-naturally occurring. Rather, the claimed product or composition must also be significantly different in structure from a naturally occurring product.

What does “significantly different” mean?

According to the Guidance, if a claim recites or involves a judicial exception (a law of nature/natural principle or natural phenomenon and/or something that appears to be natural product), the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself. This raises the question of the meaning of “significantly different.” According to the USPTO, the Supreme Court has articulated two pathways to eligibility for claims reciting judicial exceptions (such as natural products):

  1. Marked difference from what exists in nature; or
  1. Addition of significantly more to the judicial exception.

The “marked difference” inquiry focuses on the structural differences of a claimed product or composition and whether these structural differences impart one or more unique functions to the product when compared to a naturally occurring product. Applicants must be cognizant that including limitations in a claim such as “synthetic,” “isolated,” “recombinant,” “cDNA,” “composition,” “primer,” “purified,” and “vector” are not likely to be found to constitute a “marked difference” from what exists in nature. In fact, in the Examiner training materials, the USPTO made it clear that “[T]hese words may reflect ‘hand of man’ but are not necessarily determinative of eligibility.”

Additionally, a claim reciting a method that involves or recites a judicial exception must recite meaningful limitations that add significantly more (namely, practically apply) to the judicial exception. A claim that recites limitations that are insignificant or tangentially related and/or are well known or understood and purely conventional or routine steps or features are not likely to be found to have added “significantly more” to a judicial exception.

The Guidance and training materials provide a list of 12 factors (six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference)) to be evaluated for determining if a claim as a whole is “significantly different.” The Guidance makes it clear that not every factor will be relevant to every claim and does not need to be considered in every analysis. The 12 factors are provided in the table below.

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*These factors are only relevant to product claims. The remaining 10 factors (b-f and h-l) are applicable to all claims.

The initial burden is on an Examiner to establish a prima facie case of ineligibility. Specifically, when rejecting a claim, the Examiner is required to provide a rationale or evidence to reasonably support a determination that a product is not markedly different from what exists in nature. The evidence that can be used by an Examiner is not limited to that available as of the filing date of the application. Moreover, as discussed in detail in the Guidance and training materials, an Examiner’s analysis “should carefully consider every relevant factor and related evidence before making a conclusion.” In fact, the materials make clear that a 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.”

Examples

The Guidance and the training materials provide a number of examples demonstrating how the factors are to be weighed when conducting a subject matter eligibility analysis. However, several of the examples have resulted in significant discussion and consternation by practitioners. Some of these examples include:

  1. Examples directed to compositions containing purified natural products and methods of using these purified natural products for various purposes (See, Example B in the Guidance and the examples on pages 41 and 67-85 of the training materials). Specific examples include: a composition containing purified amazonic acid or 2-methyl-2-pentenoic acid, a beverage composition comprising pomelo juice and a preservative or vitamin E and a method of treating colon cancer using purified amazonic acid.
  2. Examples directed to compositions containing a mixture or aggregation of natural products (See, Example D in the Guidance and the example on page 44 of the training materials). Specific examples include: an inoculant for plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria and a composition comprising 90% copper and 10% tin.
  3. Examples directed to articles of manufacture containing a natural product (See, Example C in the Guidance). A specific example includes a fountain-style firework comprising calcium chloride and gunpowder.

But Wait…Didn’t Myriad Just Involve DNA?

During the BCP meeting, the USPTO addressed the question of why the Guidance extends the Myriad decision beyond just nucleic acids. According to the USPTO, the Guidance was not intended to be limited to just Myriad, but addresses Myriad in the context of at least 10 other Supreme Court decisions addressing subject matter eligibility. The USPTO justifies this approach arguing that Myriad “explicitly” relied on earlier Supreme Court precedent such as Chakrabarty and Mayo, all of which are interrelated.

Moreover, the USPTO further argues that despite the fact that for over 30 years Office practice was that “isolation” or “purification” of an otherwise unchanged naturally occurring product was sufficient for eligibility, the Supreme Court has given no deference to this past practice. Specifically, the USPTO states that the:

Supreme Court made it clear in Myriad that isolating a natural product such as a gene, even though it ‘creates a nonnaturally occurring molecule’, is not enough for eligibility. Instead, eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature.

So, what now??

Applicants prosecuting applications that have one or more claims rejected under Section 101 should consider amending their claims to include limitations that impose meaningful limits on the scope of the claims. Applicants should avoid adding limitations that are well-understood, purely conventional or routine and consider explaining why a step or the claim as a whole is not routine or conventional. Other possible suggestions include adding a particular machine or particular transformation (such as a method of treatment) to the claims.

Applicants should consider amending product claims to recite the structural differences between the claimed product and the naturally occurring product. Applicants should also explain how these structural differences impart unique functions to the product when compared to a naturally occurring product. Although such claims would be relatively narrow in scope, Applicants should consider filing one or more continuation applications to await further judicial clarification on the subject matter eligibility in view of the Guidance.

When drafting applications, Applicants should make sure to include multiple claim sets with progressively narrower scope. Additionally, Applicants should make sure that the specification includes sufficient detail to provide the description necessary to provide any support that may be needed to demonstrate “a marked difference” between a claimed product or composition and a naturally occurring product(s) and/or to impart “meaningful limits” to the scope of the claims.

This post was written by Julia Cox, Ph.D., Paul Jenny, Laura Opperman, Ph.D. and Lisa Mueller of Michael Best & Friedrich LLP.