June 2014
CIPA Journal
By Anthony C. Tridico, Ph.D.; Carla Mouta-Bellum, Ph.D.
Brace yourself if you are prosecuting a patent application with "claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products." For if you have not yet seen it, a rejection for claiming patent ineligible subject matter is likely on its way. The U.S. Patent and Trademark Office ("USPTO") has the duty to train its Examiners and "the responsibility" to "harmonize conflicting Supreme Court jurisprudence on patent eligibility," said Drew Hirshfeld, speaking as the Deputy Commissioner for Patent Examination Policy during the May 9 Forum ("Forum") held by the USPTO to receive public feedback on the Guidance.
Since March 2014, this duty has resulted in the USPTO reopening prosecution to reject claims under 35 U.S.C. § 101, under the "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (Guidance)." Training Slides issued on March 19 and two public meetings were held to discuss them. Public comments are welcome through June 30, for further iterations of the Guidance.
Other than adding new examples, it is unclear what will change through the promised iterations of the Guidance. Members of the public questioned its reasonableness and breadth at the Forum, but the USPTO believes that its interpretation of at least 65 years of Supreme Court jurisprudence is finally right; Myriad was a "slap on the hand" for their allowance of claims to purified products. The law has not changed. Instead, Myriad was just a reminder of what the law was always supposed to be. That established, the USPTO says it is not likely to allow an Applicant to change their election, if a Restriction Requirement was issued, replied to prior to the issuance of the Guidance, and acted upon by the USPTO afterwards. After an office action issues, other than challenging the Guidance and/or Office Action, the only recourse where the previously elected group is drawn to ineligible subject matter is to file a continuation/divisional application and start over again. Such new filings (continuations, divisionals, reissues) should be considered immediately, if there is a need to rapidly advance prosecution and protect issued patents.
Finally, at first glance, "[t]here is no change to examination of claims reciting an abstract idea, which should continue to be analyzed for subject matter eligibility using the existing guidance in MPEP § 2106(II)." Note that, because the Guidance was written to guide the USPTO Examining Corps, it has multiple references to the Corps' Manual of Patent Examining Procedure ("MPEP"), which is available online (www.uspto.gov/web/offices/pac/mpep/).
B. The Process for Determining Subject Matter Eligibility under the Guidance
1. Broadest Reasonable Interpretation
The process begins with establishing the broadest reasonable interpretation of the claim, in accordance with MPEP § 2103. This is complex and laborious, requiring, for example, that "USPTO personnel [] give claims their broadest reasonable interpretation in light of the supporting disclosure. See MPEP § 2111. Disclosure may be express, implicit, or inherent." But "[w]hile it is appropriate to use the specification to determine what applicant intends a term to mean, a positive limitation from the specification cannot be read into a claim that does not itself impose that limitation. A broad interpretation of a claim by USPTO personnel will reduce the possibility that the claim, when issued, will be interpreted more broadly than is justified or intended."
In interpreting claims, "[t]he goal of claim analysis is to identify the boundaries of the protection sought by the applicant and to understand how the claims relate to and define what the applicant has indicated is the invention." The interpretation begins by identifying and evaluating each claim limitation. For processes, the claim limitations will define steps or acts to be performed. For products, the claim limitations will define discrete physical structures or materials.
The case law requires that, "when evaluating the scope of a claim, every limitation in the claim must be considered. USPTO personnel may not dissect a claimed invention into discrete elements and then evaluate the elements in isolation. Instead, the claim as a whole must be considered." See, e.g., Diamond v. Diehr, 450 U.S. 175, 188-89, 209 USPQ 1, 9 (1981) ("In determining the eligibility of respondents' claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made."). This legal requirement must be reconciled with the Guidance's multifactorial analysis, prone to focus Examiners on individual claim elements rather than the claim "as a whole."
2. Judicial Exceptions
35 U.S.C. 101 defines the four categories of inventions that Congress deemed to be the appropriate subject matter of a patent, namely: processes, machines, manufactures and compositions of matter. But courts find abstract ideas, laws of nature and physical phenomena to be outside of, or exceptions to, these four categories. "These three exclusions recognize that subject matter that is not a practical application of an idea, a law of nature or a physical phenomenon is not patentable. See, e.g., Rubber-Tip Pencil Co. v. Howard, 87 U.S. (20 Wall.) 498, 507 (1874) ("idea of itself is not patentable, but a new device by which it may be made practically useful is").
The challenge has long been in "determining whether an applicant is seeking to patent an abstract idea, a law of nature or a physical phenomenon." Addressing this challenge requires reconciliation of the case law leading up to and applying these exceptions. Instead of leaving this reconciliation to each member of the Examining Corps, the USPTO (June Cohan) insists to have set forth the Guidance as an attempt to reconcile a complex web of cases like Myriad (133 S. Ct. 2107 (2013)), Chakrabarty (447 U.S. 302 (1980)), Bilski (130 S. Ct. 3218 (2010)), Mayo (132 S. Ct. 1289 (2012)), Diehr (450 U.S. 175 (1981)) and Funk Brothers (333 U.S. 127 (1948)), into more easily and consistently examples applied by its Corps.
3. TheThree Questions
Having completed the broadest reasonable interpretation of the claims, the Guidance sets up a flow chart that walks through three questions.
Question 1: Is the claim directed to one of the four statutory categories, i.e., process, machine, manufacture, or composition of matter?
Question 2: Does the claim recite or involve one or more judicial exceptions?
Question 3: Does the claim as a whole recite something significantly different than the judicial exception(s)?
Question 1: Is the claim directed to one of the four statutory categories, i.e., process, machine, manufacture, or composition of matter?
Question 1 is the simplest, for if a claim is not drawn to a statutory category it does not even fall under 35 U.S.C. 101. Questions 2 and 3 together represent the position that, though necessary, it is not sufficient for a claim to NOT be drawn to a judicial exception (Question 2). The subject matter, says the USPTO, must also be "significantly different than the judicial exception." (Question 3).
Question 2: Does the claim recite or involve one or more judicial exceptions?
This is over-inclusive. "If there is any doubt as to whether the claim recites a judicial exception [] the claim requires further analysis under Question 3." Recitations needing to move through Question 3 include laws of nature, physical phenomena, natural phenomena, products of nature, natural products, naturally occurring things, "something similar to a natural product," scientific principles, disembodied concepts, and their combinations.
Under the Guidance, "natural products" includes 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, and combinations or compositions comprising one of the same. "Derived from" is not defined, but covers purified, isolated, and chemically modified (see Guidance Example B, purified 5-methyl amazonic acid) products of nature.
Natural principles, naturally occurring relations or correlations, and methods/processes reciting the same (law of gravity, the disinfectant qualities of ultraviolet light), the relationship between blood glucose levels and diabetes (i.e., method of diagnosis), and the effect of a natural product in treating a disease (i.e., method of treatment), are "laws of nature" and "natural phenomena." Treating patients by performing medical procedures, and new ways of using an existing non-natural drug do not involve laws of nature.
Question 3: Does the claim as a whole recite something significantly different than the judicial exception(s)?
Instead of setting forth bright line rules or per se categories of ineligible subject matter, the Guidance sets forth pathways to patent eligibility under a new "significantly different" test. These pathways are only exemplary; there could be other paths to prove a significant difference. According to June Cohan, from the USPTO Office of Patent Legal Administration, the "significantly different" test is a combination of the "markedly different" requirement of Myriad and the "significantly more" requirement of Mayo, Benson, and Flook and those are the two pathways exemplified. But as long as alternative pathways to "significantly different" find support in Supreme Court precedent, and the Applicant articulates that support, the USPTO, according to June Cohan, is likely to consider them. For now, the Guidance follows the common theme from the previous 101 guidance of evaluating factors that weigh for or against eligibility. "No one factor is controlling." The initial burden is on the Examiner to establish a prima facie case of ineligibility. The Examiner must provide a rationale or evidence to reasonably support patent ineligibility. Speculation is not reasonable support. But evidence is not limited by the application's filing date. A scenario discussed by June Cohan includes later filed continuation applications being rejected under evidence that the claimed product was found in nature, which evidence was not available at the time the parent application was filed.
Neither the "substantially different" test nor this "balancing of factors" is explicitly recited in Supreme Court jurisprudence. But "many of these factors originate from past eligibility factors," and are reproduced below.
a. First pathway to eligibility: marked differenceDoes the claim include features or steps that demonstrate that the claimed or recited subject matter is markedly different from what exists in nature? This question applies both to product claims and to process claims reciting a natural product. See slides 57-60 of the USPTO's Training Slides. The key to relying on this pathway is recognizing that the differences should be claimed.
The Guidance does not emphasize "claiming" enough; it simply states that "[f]actors a) and g) 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." But in the recent, post-Guidance case of In re Roslin (Fed. Cir. 2014), where the USPTO is a party, the requirement that differences must be claimed was clearly made. In In re Roslin, the claims were drawn to living clones of certain mammalian organisms. The Applicant attempted to show that the claimed clones were "markedly different" from their parent natural organisms, but the Court held otherwise:
Roslin argues that environmental factors lead to phenotypic differences between its clones and their donor mammals that render their claimed subject matter patentable. However, these differences are unclaimed. See J.A. 17. Indeed, the word "cloned" in the pending claims connotes genetic identity, and the claims say nothing about a phenotypic difference between the claimed subject matter and the donor mammals.Second, Roslin urges that its clones are distinguishable from their original donor mammals because of differences in mitochondrial DNA . . . But any difference in mitochondrial DNA between the donor and cloned mammals is, too, unclaimed.There is nothing in the claims, or even in the specification, that suggests that the clones are distinct in any relevant way from the donor animals of which they are copiesThe USPTO cited to In re Roslin as consistent with its Guidance, in the recent Myriad Forum: the case "affirmed that subject matter eligibility analysis is a case-by-case inquiry that focuses on what is claimed."
"Not all differences rise to the level of marked differences." Under Myriad, a claim drawn to isolated DNA, though patent eligible where it reads on cDNA is not patent eligible where it reads on genes. That is because "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" as its genomic information (nucleotide sequence) did not change. Isolation can be a factor in patent eligibility but is no longer sufficient. "Myriad changed our understanding of the law," says the USPTO:
For 30+ years, Office practice was that "isolation" or "purification" of an otherwise unchanged naturally occurring product was sufficient for eligibility.Supreme Court made it clear in Myriad that isolating 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.
The USPTO's emphasis is on limiting "marked differences" to structure. In its view, the "Supreme Court has never held a claim reciting a natural product eligible unless it was structurally different than what exists in nature." But at least some members of the public disagreed with this position, noting that cases like Chakrabarty and Funk Bros. considered functional changes as a factor toward patent eligibility.
Lastly, under the Guidance, the marked difference must also be "more than incidental or trivial." Again, in In re Roslin, the Federal Circuit rejected differences that "came about or were produced 'quite independently of any effort of the patentee.'" Where the "qualities are the work of nature. Those qualities are of course not patentable, for patents cannot issue for the discovery of the phenomena of nature." Holdings like these raise obvious questions regarding the patent eligibility of recombinant proteins claimed by source limitations, and combinations where the new and markedly different property relative to its constituents is "incidental."
b. Second pathway to eligibility: significantly moreDoes the claim include 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? To answer this question, consider factors b-f and h-l. It is the balance of the totality of the relevant factors that determines eligibility. Citing Mayo, for the USPTO:
The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent eligible processes that apply natural laws?
The relevant factors thus concern whether a claim, as a whole, recites elements or steps that (i) are in addition to the recited/involved judicial exception(s); and (ii) add significantly more to the recited/involved judicial exception(s). As stated by the USPTO in the Forum, "adding 'significantly more' can occur in multiple ways (that's why there are 10 different factors)." The USPTO directs the public to Benson, Flook, Diehr, and Mayo for an explanation of the "significantly more" factors. The Guidance and the subsequent training slides offer some examples of the factor-by-factor analysis.Unfortunately, the Examples offered to date are not very useful because they contain more limitations than is often desirable in an enforceable claim. For example, "method of treatment" claims are analyzed but in each instance the claims are less than the sought-after "a method of treating X with natural product Y." At the Forum, it became clear from the public that the USPTO's position is to reject such claims.In contrast, the following claim involving "amazonic acid [] a naturally occurring chemical found in the leaves of Amazonian cherry tree," was found patent eligible in the Guidance because "the claim as a whole recites something significantly different than the natural product, e.g., the claim includes elements in addition to the judicial exception that add significantly more to the judicial exception:"
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 USPTO found all but one of the factors weighing towards eligibility satisfied, whereas none of the factors weighing against it were met.
1. Argue that the Supreme Court's "markedly different" standard does not demand structural changes; things are patent eligible when the claimed product has "markedly different characteristics from any found in nature," i.e., when it has a "distinctive name, character, or use." Use includes function. For support, cite to Myriad and Chakrabarty's reliance on Hartranft v. Wiegmann, 121 U.S. 609.
2. Demand that Examiners establish a prima facie case, i.e., that they explain the rationale and provide evidence for patent ineligibility.
3. Draft both the specification and claims to recite at least some of the "markedly different characteristics" between the claimed product and any a product in nature. Include claims of differing scope.
4. Emphasize differences that are not incidental but instead result from the patentee's efforts (e.g., mutations, conjugations, pegylations); distinguish qualities that are the work of nature from those that are altered by the hand of man. Choose claim terms that emphasize those differences.
5. Choose claim terms carefully, or amend the claims, so that the broadest reasonable interpretation of the claim, as a whole, does not read on any judicial exception.
6. According to at least some post-Guidance office actions (e.g., US Patent Application Nos. 12/977,672; 13/820,261; 13/382,906), truncations are not "markedly different."
7. According to the USPTO (June Cohan, Forum), fusion proteins are patent eligible.
8. Even if the natural product is not markedly different from what exists in nature, there are several ways to make a claim reciting or involving a natural product eligible, says the USPTO:
a. Combine the natural product with something else, and draft a claim to the embodiments of the combination that possess markedly different characteristics from any found in nature, while excluding any embodiment that does not reflect a marked difference, e.g., mere aggregation of components: Chakrabarty bacterium.b. Combine the natural product with something else that adds significantly more to the natural product: a method of using the natural product, or a manufacture comprising the natural product and additional components.
9. For method of treatment claims reciting a product of nature, consider continuations or reissue to amend the claims to add features that provide practical assurance that the method is more than a drafting effort to monopolize the law of nature itself (see factors b.-f. and g.-l.)
10. For factor e.), concerning the "machine or transformation" factors, the machine or transformation must be particular and more than extrasolution activity or field of use, and the result of the transformation cannot be a judicial exception itself.
Originally printed in CIPA Journal. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.
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