Earlier today, in a memorandum issued to the Patent Examining Corps by Deputy Commissioner for Patent Examination Policy Andrew Hirshfeld, the U.S. Patent and Trademark Office implemented a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012). The guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance" as the file is named), indicates that "all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products should be examined using the Guidance" (emphasis in memo), and that the Myriad-Mayo Guidance is effective as of today and supersedes the Office's preliminary guidance on the Myriad decision that was issued on June 13, 2013 (see "USPTO Issues Memo on AMP v. Myriad to Examining Corps"). The memo does not specifically indicate whether the new procedure outlined in the Myriad-Mayo Guidance also supersedes the "2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature" (see "USPTO Issues Interim Guidance Regarding Mayo v. Prometheus"). The memo does note, however, that the new procedure outlined in the Myriad-Mayo Guidance does not impact the examination of claims reciting an abstract idea, which will continue to be analyzed using the guidance set forth in MPEP § 2106(II).
Before outlining the new procedure for assessing subject matter eligibility, the memo explains that the guidance addresses the impact of the Myriad decision on the Supreme Court's long-standing "rule against patents on naturally occurring things," as expressed in the Court's decisions in Diamond v. Chakrabarty and Mayo. The Myriad-Mayo Guidance notes that:
Myriad relied on Chakrabarty as "central" to the eligibility inquiry, and re-affirmed the Office's reliance on Chakrabarty's criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products). [Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107,] 2116-17. Myriad also clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., "isolated") in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not "depend simply on the draftsman's art"). Thus, while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.
(emphasis in original).
The new procedure described in the Myriad-Mayo Guidance involves a three-step analysis in which examiners are to ask the following questions:
1. Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
2. Does the claim recite or involve one or more judicial exceptions?
3. Does the claim as a whole recite something significantly different than the judicial exception(s)?
This analysis is depicted in the memo using the following flowchart (click on flowchart to enlarge):
With regard to whether an examiner should proceed from the second question to the third question, the Myriad-Mayo Guidance states that:
Judicial exceptions include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products. In particular, claimed subject matter that must be analyzed under Question 3 to determine whether it is a natural product includes, but is not limited to: 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.
If there is any doubt as to whether the claim recites a judicial exception (e.g., the claim recites something similar to a natural product), the claim requires further analysis under Question 3.
(emphasis in original).
The second part of the memo concerns the analysis of whether the claim recites something significantly different than a judicial exception. The Myriad-Mayo Guidance indicates that:
A significant difference can be shown in multiple ways, such as: (1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature (and thus not a judicial exception).
The memo then lists a dozen factors: six that weigh toward eligibility (i.e., the claim recites something that is significantly different from a judicial exception) and six that weigh against eligibility (i.e., the claim recites something that is not significantly different from a judicial exception). Noting that two of the factors "concern the question of whether something that initially appears to be a natural product is in fact non-naturally occurring and markedly different from what exists in nature, i.e., from naturally occurring products," the memo explains that:
This question can be resolved by first identifying the differences between the recited product and naturally occurring products, and then evaluating whether the identified differences together rise to the level of a marked difference in structure. Not all differences rise to the level of marked differences, e.g., merely isolating a nucleic acid changes its structure (by breaking bonds) but that change does not create a marked difference in structure between the isolated nucleic acid and its naturally occurring counterpart.
(emphasis in original; citation omitted).
The Myriad-Mayo Guidance further explains that "[t]he fact that a marked 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," citing Myriad for the proposition that "cDNA having a nucleotide sequence that is markedly different from naturally occurring DNA is eligible subject matter, even though the process of making cDNA is routine in the biotechnology art."
In the third part of the Myriad-Mayo Guidance, which covers almost thirteen of the memo's nineteen pages, the Office applies the memo's new analytic framework to eight examples:
A. Composition/Manufacture Claim Reciting A Natural Product
B. Composition vs. Method Claims, Each Reciting A Natural Product
C. Manufacture Claim Reciting Natural Products
D. Composition Claim Reciting Multiple Natural Products
E. Composition vs. Method Claims, Each Reciting Two Natural Products
F. Process Claim Involving A Natural Principle And Reciting Natural Products
G. Process Claims Involving A Natural Principle
H. Process Claim Reciting An Abstract Idea And A Natural Product
While practitioners are encouraged to thoroughly review the examples, the exemplary claims, subject matter eligibility determinations, and a brief summary of the rationales provided in the memo are listed below.
Example A:
Claim 1: A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.
Claim 2: A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.
The memo finds claim 1 to be drawn to ineligible subject matter and claim 2 to be drawn to eligible subject matter, explaining that "although the plasmids themselves are natural products, in claim 2 the recited 'something that initially appears to be a natural product' . . . is the bacterium containing the plasmids, and not the bacterium alone or the plasmids alone." The memo notes that the bacterium of claim 2 was held to be patent-eligible subject matter in Chakrabarty.
Example B:
Claim 1: Purified amazonic acid.
Claim 2: Purified 5-methyl amazonic acid.
Claim 3: A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.
The memo finds claim 1 to be drawn to ineligible subject matter and claims 2 and 3 to be drawn to eligible subject matter. With respect to claim 2, the memo states that "[t]he 5-methyl amazonic acid is structurally different than naturally occurring amazonic acid (because of the addition of the 5-methyl group), and this structural difference has resulted in a functional difference (5-methyl amazonic acid stimulates the growth of hair in addition to treating cancer)." More importantly, however, the memo indicates that "a functional difference is not necessary in order to find a marked difference," but suggests that "the presence of a functional difference resulting from the structural difference makes a stronger case that the structural difference is a marked difference." As for claim 3, the memo explains that "[t]he step of administering a particular dosage of amazonic acid (0.75 to 1.25 teaspoons per day) for a particular length of time (10-20 days) to a particular patient (patient with colon cancer), meaningfully limits the scope of the claim to a particular application of amazonic acid," and therefore "others are not substantially foreclosed from using amazonic acid in other ways, e.g., to treat colon cancer at other dosages or for other lengths of time, to treat other cancers, etc."
Example C:
Claim 1: A fountain-style firework comprising: (a) a sparking composition, (b) calcium chloride, (c) gunpowder, (d) a cardboard body having a first compartment containing the sparking composition and the calcium chloride and a second compartment containing the gunpowder, and (e) a plastic ignition fuse having one end extending into the second compartment and the other end extending out of the cardboard body.
The memo finds the claim to be drawn to eligible subject matter, explaining that "the claimed elements in addition to the calcium chloride and gunpowder narrow the scope of the claim so that others are not foreclosed from using the natural products in other ways, e.g., others can still use calcium chloride in products such as concrete, foods, fire extinguishers, etc., and can still use gunpowder in other products such as rifle cartridges."
Example D:
Claim 1: An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.
The memo finds the claim to be drawn to ineligible subject matter, explaining that "[t]he specification describes that applicant has not changed the bacteria in any way, but instead has simply combined various strains of naturally occurring bacteria together." The memo notes that the inoculant of this claim was held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948).
Example E:
Claim 1: A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2.
Claim 2: A method of amplifying a target DNA sequence comprising:
providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of claim 1 wherein the first primer is complementary to a sequence on the first strand of the target DNA and the second primer is complementary to a sequence on the second strand of the target DNA, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine;
heating the reaction mixture to a first predetermined temperature for a first predetermined time to separate the strands of the target DNA from each other;
cooling the reaction mixture to a second predetermined temperature for a second predetermined time under conditions to allow the first and second primers to hybridize with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers; and
repeating steps (b) and (c) at least 20 times.
The memo finds claim 1 to be drawn to ineligible subject matter and claim 2 to be drawn to eligible subject matter. With regard to claim 1, the memo notes that "neither of the natural products recited in the claim is markedly different," adding that "the first and second primers have the same function as their natural counterpart DNA, i.e., to hybridize to their complementary nucleotide sequences," and that "[t]he minor structural differences taken together with the lack of any functional difference between the primers and the natural DNA fail to demonstrate that the recited products are markedly different from what exists in nature." With respect to claim 2, the memo explains that "the heating and cooling steps contain a number of limitations that narrow the scope of the claim," and that "others can still apply and use the natural products in other methods, such as a method of treatment or even an amplification method that does not involve Taq polymerase or thermal cycling."
Example F:
Claim 1: A method for determining whether a human patient has degenerative disease X, comprising: obtaining a blood sample from a human patient; determining whether misfolded protein ABC is present in the blood sample, wherein said determining is
performed by contacting the blood sample with antibody XYZ and detecting whether binding occurs between misfolded protein ABC and antibody XYZ using flow cytometry, wherein antibody XYZ binds to an epitope that is present on misfolded protein ABC but not on normal protein ABC; and
diagnosing the patient as having degenerative disease X if misfolded protein ABC was determined to be present in the blood sample.
The memo finds claim 1 to be drawn to eligible subject matter, noting that "[a] review of the specification indicates that antibody XYZ does not exist in nature, and is not purely conventional or routine in the art (it was newly created by the inventors)," and explaining that "others can still apply and use the natural principle in other methods, such as a method of treatment or a method of assessing whether a particular treatment regimen has resulted in a decrease in the amount of misfolded protein ABC in a patient's blood."
Example G:
Claim 1: A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to sunlight, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder.
Claim 2: A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to a synthetic source of white light, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.
Claim 3: A method for treating a mood disorder in a human patient, the mood disorder associated with
neuronal activity in the patient’s brain, comprising: providing a light source that emits white light; filtering the ultra-violet (UV) rays from the white light; and positioning the patient adjacent to the light source at a distance between 30-60 cm for a
predetermined period ranging from 30-60 minutes to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.
The memo finds claims 1 and 2 to be drawn to ineligible subject matter and claim 3 to be drawn to eligible subject matter. With respect to claim 1, the memo explains that "the only step in addition to the judicial exceptions is the step of exposing a patient to sunlight, and this step is not a meaningful limit on the claim scope, in that it substantially forecloses others from using or applying sunlight (a natural phenomenon) alone or in connection with the natural principle." According to the memo, claim 2 is directed to patent ineligible subject matter, in part because "the step of exposing a patient to synthetic white light for the purpose of affecting a mood disorder is just an attempt to limit the use of the natural principle to a particular technological environment (use of artificial light as opposed to sunlight)." Finally, with respect to claim 3, the memo notes that "the filtering and positioning steps meaningfully limit the claim to a particular application of the natural principle," and that "[o]thers are not substantially foreclosed from using or applying the natural principle in other ways, e.g., by exposing a patient to sunlight, by positioning the patient for a different length of time or at a different distance, etc."
Example H:
Claim 1: A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.
The memo indicates that "[b]ecause the claim recites an abstract idea, Question 3 should be analyzed using only the existing guidance in MPEP § 2106(II)." The memo also notes that claim 1 was found to be directed to ineligible subject matter in Association for Molecular Pathology v. Myriad Genetics, Inc., 689 F.3d 1303, 1333-35 (Fed. Cir. 2012), aff’d in part and rev’d in part on other grounds, 569 U.S. __, 133 S. Ct. 2107, 2116 (2013).
