October 2016
CIPA Journal
In May 2016, the United States Patent and Trademark Office (USPTO) issued additional §101 guidance for examiners and patent practitioners.1 The guidance includes several new examples illustrating patent eligibility, as well as long-awaited examples for diagnostic methods. The USPTO retained its two-step eligibility analysis but emphasizes that an examiner must support a §101 rejection with a reasoned rationale, and must carefully consider the applicant’s rebuttal arguments and evidence. Although certain aspects of this guidance—like the guidance before it—may leave practitioners scratching their heads, the guidance does shed light on what the USPTO deems "well-understood, routine, or conventional" for purposes of determining whether claim elements add "significantly more."
The May guidance affirms the two-step eligibility analysis of the USPTO’s 2014 Interim Guidance.2 That analysis asks in Step 1: Is the claim directed to a statutory category? If yes, the examiner must then ask (Step 2(A)): Is the claim directed to a judicial exception? If yes, the examiner moves onto Step 2(B): Does the claim, as a whole, amount to significantly more than the exception? The May guidance provides further instruction on how to apply that rubric in formulating a rejection during prosecution.
The examiner should begin by identifying the judicial exception and explaining—"using a reasoned rationale"—why it is considered an exception.3 The examiner should then identify any additional elements in the claim beyond the judicial exception and explain why "the additional elements taken individually, and also taken as a combination, do not result in the claim as a whole amounting to signifi cantly more than the judicial exception."4 When considering abstract ideas, examiners are invited to rely on US appellate court decisions for what amounts to an abstract idea. However, the USPTO cautions examiners not to reach beyond concepts that are similar to what the courts have identified as abstract ideas, and points to a chart of court decisions available on the USPTO’s website.5
To determine whether claim elements add "significantly more" to a judicial exception, examiners must determine whether the elements are well-understood, routine, conventional activities previously engaged in by those in the relevant field. According to the USPTO, a prior art search "should not be necessary" for this analysis because finding the element in the art does not, by itself, establish that an activity or element is routine or conventional. Even the fact that a particular laboratory technique was discussed in several widely-read scientific journals may not be dispositive. Beyond repeating the phrase, however, the guidance provides little concrete advice on what constitutes "well-understood, routine, conventional activity previously engaged in by those in the relevant field."6 This somewhat circular definition begs the question whether the analysis will become subjective instead of objective-based entirely on a given examiner’s perception of what is and is not well-known, routine, or conventional.
Examiners are reminded that an additional claim element may qualify as significantly more if it meaningfully limits the judicial exception, improves another technology or technical field, improves the functioning of a computer itself, or adds a specific limitation that is unconventional and confines the claims to a particular useful application.7 Several of the new examples address such limitations.
The guidance also clarifies that "preemption is not a stand-alone test" for patent eligibility.8 Thus, an applicant’s argument that a claim does not preempt all applications of the judicial exception, without more, may not overcome a §101 rejection. "While a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible."9 In other words, preemption is a one-way test.
The new §101 examples provide insight into how the two-step analysis should be applied in several hypothetical situations. The examples are intended to be illustrative and are not meant to form the basis for a rejection. Examiners should not require applicants to model their claims or responses after the examples to attain eligibility.10 Nonetheless, the examples give applicants tools for crafting patent-eligible claims, especially for diagnostic methods—subject-matter missing from prior USPTO §101 guidance.
Example 28 recites seven hypothetical claims and describes how the two-step analysis was applied to show that six of those seven claims are patent eligible. The first two claims are directed to non-natural structurally altered viruses. Only step 1 of the 2 step analysis was considered because the viruses are not products of nature. The next four claims are directed to compositions comprising a combination of ingredients including a peptide isolated from naturally occurring virus. The broadest claim (claim 3) is directed to a vaccine comprising the peptide and a pharmaceutically acceptable carrier—which the USPTO reads as water by applying Broadest Reasonable Interpretation (BRI). The USPTO determined that although the two components did not occur together in nature, mixing them together did not change the structure or function of either component or add "significantly more".
In contrast, claim 4 is directed to a composition comprising the peptide and a carrier selected from a cream, emulsion, gel, liposome, nanoparticle, or ointment. Focusing on the cream composition, the USPTO determined that although a cream comprises naturally occurring components, such as oil and water, together the components form a semi-solid emulsion that is structurally and physically distinct from water and oil. The USPTO concluded that the claimed peptide-cream composition is not considered to be a product of nature and thus the claim is not directed to a judicial exception. No "significantly more" analysis was performed. Interestingly, the USPTO only analyzed the cream component of the Markush group, but concluded that the whole claim is patent eligible. No mention is made of separately analyzing the other members of the group. Presumably, the USPTO considers the cream to be representative of the group. If claiming a natural product in a composition comprising a cream, emulsion, gel, liposome, nanoparticle, or ointment renders the composition patent eligible, we may see more effort to formulate drugs in this fashion in the future.
In claims 5 and 6, the components of the claimed vaccine—peptide and AlPO4 plus a carrier in claim 6 (read water)—are naturally occurring and no structural changes result from the mixture. In spite of this, the USPTO says that these claims are patent eligible. The determination is based solely on a functional change (enhanced immunogenicity) that amounted to more than the sum of the components. In other words, a synergistic combination of natural components should be considered patent-eligible subject-matter. Again, in these examples, no "significantly more" analysis is performed because the claim is considered not to recite a judicial exception.
Claim 7 is directed to microneedle arrays coated with the virus peptide. Because the peptide is considered to be a natural product, the USPTO conducted the "significantly more" analysis. It found that even though microneedle arrays were known to most scientists in the field, this type of needle was not "routinely or conventionally used to administer vaccine." As a result, the USPTO concluded that a vaccine composition claim reciting "coated microarray needles" is patent eligible because it is directed to a product that amounts to significantly more than the natural product itself.
The distinction between the analysis of claims 4 and 7 is interesting. The combinations of elements in the vaccines of claims 4-6 were considered as a whole in the step 2A analysis, with a conclusion that the presence of a non-natural or structurally-altered element, or a synergistic combination is sufficient to make the claim patent eligible. However, the combination of elements in the peptide coated needle of claim 7—one of which is clearly a non-natural product—are analyzed as separate elements in step 2A and the combination was only considered when applying the step 2B analysis. The USPTO does not provide a rationale for treating these claims differently.11
This example illustrates how the "significantly more" analysis is applied to diagnostic and treatment claims. The applicant had found that the presence of a particular protein (JUL-1) in a patient sample is indicative of a particular skin disease (julitis). JUL-1 is not present in persons who do not suffer from julitis. Prior to the invention, julitis was known to be difficult to diagnose. The disease was traditionally treated with anti-TNF antibodies. The applicant discovered that it was possible to treat julitis with topical vitamin D.
The first claim is directed to (1) obtaining a patient sample and (2) detecting the JUL-1 in a patient sample using an antibody. This claim is patent eligible because it does not recite or describe any recognized exception. The USPTO indicates that the fact that the protein and the antibody may be natural products is irrelevant because the claim is to a method and not to the products themselves. Claim 2, however, which recites the same two steps as claim 1 and adds a third step to diagnosing julitis based on the detection of JUL-1, is ineligible. The USPTO describes this claim as being directed to a "law of nature, an abstract idea [because the diagnosis step can be performed using basic critical thinking], or both." According to the USPTO, the "significantly more" analysis shows that the additional elements, i.e., the steps of obtaining a sample and using an antibody to detect JUL-1 "are recited at such a high level of generality" that "there is no meaningful limitation… that distinguishes [the steps] from well understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention."
It is hard to reconcile the analysis of claims 1 and 2. The two steps that did not amount to "significantly more" in diagnosis claim 2 are the same steps recited in detection claim 1 that was found to be patent eligible. The fact pattern does not provide enough information to determine whether JUL-1 was previously known and only its association with julitis is new, or whether JUL-1 was newly discovered along with its association with julitis. If we assume that claim 1 is novel and non-obvious (e.g., because JUL-1 was not previously known), how can the same two steps recited in claim 1 be considered well understood, routine, and conventional in claim 2?
Claim 3 is identical to claim 2, but specifies that the antibody is a porcine antibody raised against JUL-1. This claim is considered patent eligible because "there is no evidence" that use of porcine antibodies to detect human proteins was well understood, routine, and conventional. This example suggests that an examiner must provide some form of evidence to support a charge of "well-understood, routine, and conventional." Claim 4 is identical to claim 3 but replaces the porcine antibody with a specific antibody created by the applicant. The analysis is the same as in claim 3. Requiring the use of a specific antibody that was not routinely used to detect human proteins amounts to "an unconventional step that is more than a mere instruction to 'apply' the correlation and critical thinking step (the exception) using well-understood, routine, or conventional techniques in the field." In other words, recitation of a specific antibody "results in a claim as a whole that amounts to significantly more than the exception itself."
Claim 5 is the same as the first diagnosis claim but adds a treatment step, i.e., a step of administering a drug—in this case, topical vitamin D. The USPTO states that:
"the mere knowledge of vitamin D or its use in other ways [oral dosage] to treat other medical conditions [bone health] does not make the administration of topical vitamin D to treat julitis a conventional step that those in this field would routinely practice."
Because administering vitamin D is an unconventional step, the claim as a whole amounts to significantly more than the exception and is patent eligible.
Again, it is difficult to square this analysis with that of claim 2. Whether or not JUL-1 is a newly discovered protein, it is only found in patients with julitis—an association that is newly discovered by the applicant. Therefore, it seems highly unlikely that antibodies to JUL-1 had any conventional, routine, or well-known use in the field prior to the invention.
The precise rationale for claim 2 becomes even more difficult to understand in view of the discussion of claim 6, which includes all of the steps of claim 2 but adds a treatment step that recites administration of an anti-TNF antibody—i.e., the art-recognized treatment for julitis. The USPTO states that claim 6 is patent eligible in spite of the presence of what it characterizes as a judicial exception (the diagnosis step) and three steps that it previously described as well-understood, routine, and conventional. The USPTO indicates that the totality of the steps "amounts to more than merely diagnosing a patient with julitis and instructing a doctor to generically 'treat' it." The USPTO states that the combination of steps—which it characterizes as "not routine and conventional" (without any explanation as to how that determination was made)—"ensures that patients with julitis will be accurately diagnosed… as opposed to being misdiagnosed" as often previously occurred.
Claim 7 presents a standard method of treatment claim, which is considered patent eligible under step 2A. Interestingly, the USPTO chose to make this example claim recite the acknowledged prior art method of treatment (administering anti-TNF antibody) rather than the acknowledged new treatment (topical vitamin D). Perhaps, the USPTO is attempting to demonstrate that it has not confused eligibility with anticipation and obviousness by acknowledging the patent eligibility of a claim that may be unpatentable under §102 and §103.
Example 30 involves a newly discovered sweetener (texiol) derived from the sap of a mint plant, which forms irregular crystals when the plant breaks and the released sap dries. The natural form of this sweetener has a bitter aftertaste. This example is similar to the pomello juice example presented in the USPTO’s earlier Nature Based Products Examples.
The first two sample claims are directed to a sweetener comprising texiol and water. Claim 1 includes no other limitations; claim 2 defines the percentages of water and texiol. Both of these claims are considered patent ineligible, even though the specific percentages defined in claim 2 are not found in nature. This is because there is nothing to suggest that mixing the texiol with water changes the structure or properties of either component. As a result, these claims are not "markedly different from" or "significantly more than" the judicial exceptions (water and texiol).
Claim 3 of this example illustrates that a combination of natural products can meet the "markedly different" test of step 2A. In this case, a natural compound is added to the texiol and water and the resulting composition no longer has a bitter aftertaste. The fact pattern makes clear that no structural change or chemical reaction occurs—the change in taste is what rises to the level of a marked difference. Notably, this claim also recites the percentages of each component, but the USPTO did not discuss the percentages in its analysis. Presumably, if the evidence showed that any amount of the compound added to texiol would eliminate the bitter aftertaste, these limitations would not be relevant to the patent eligibility analysis.
Claim 4 is directed to a sweetener comprising texiol, water or fruit juice, and enough pectin to provide a solid gel. Like the peptide-in-cream claim of the vaccine example, this claim is patent eligible. However the USPTO’s analyses for the two claims are not entirely consistent. In the vaccine/cream example, the USPTO stated that the cream "has different structural and physical characteristics than its naturally occurring components." It did not suggest that the peptide had altered properties but stated that the changed form of the components (into a cream) permitted "a sufficient amount of peptide to transfer from the cream into the patient’s skin." In the sweetener example, however, the USPTO stated that the gel formed by the combination of water and pectin did not change the structure of either component. Instead, the texiol has changed properties because it "is present in a solid yet spreadable gel form and has improved organoleptic properties (e.g., a more pleasant mouthfeel)." These changed properties represent a marked difference.
Claim 5 is directed to a sweetener comprising texiol particles of specified sizes. The irregular sized crystals found in nature do not dissolve evenly, and require larger amounts to reach the desired sweetness. The more evenly sized crystals of the claim allow use of less sweetener by increasing the dissolution rate and avoiding a gritty nature of the natural texiol crystals. As a result of these structural and functional changes, the claimed sweetener is markedly different from its natural counterpart and thus, patent eligible. No step 2B analysis was carried out. Claim 6 is directed to texiol in a controlled release formulation and is also considered to be markedly different from the natural product because of its altered time release properties, resulting in a patent-eligible claim.
This example is modeled after the claims in Myriad’s U.S. Patent 5,753,441, and the analysis is based on the Federal Circuit and Supreme Court decisions relating to that technology. All but the first claim, however, are hypothetical. In the fact pattern provided with the example, the use of hybridization and amplification techniques were routinely used to screen genetic sequences for mutations. The example describes two additional techniques that were known, but not yet "commonly or routinely" used at the time of the invention (although at least one of those methods became the industry standard after filing).
Claim 1 is ineligible, since it is taken directly from the Myriad claims that were reviewed and found ineligible by the Federal Circuit.12 Two of the hypothetical claims are reported to be patent eligible because they recite specific and unconventional ways of gathering data that amount to significantly more than an abstract idea, i.e., they recite the use of a technique that was not commonly used at the time the application was filed. The other two hypothetical examples are eligible because they are not directed to a judicial exception. Of the latter two hypothetical claims, one recites a first step of hybridizing a wild-type probe to a gene isolated from a patient sample and a second step of detecting a hybridization product by measuring conformational changes in the probe. The other claim recites a first step of amplifying nucleic acids and a second step of sequencing the amplified nucleic acids. Both of these claims recite one of the two unconventional techniques. However, the USPTO does not point to those techniques as having any bearing on the patent eligibility question. Nor does it suggest that the scope of the claim impacts the decision. Thus, it should not matter whether the method is limited to a specific technique to reach the conclusion of patent eligibility. The USPTO notes that even though nature-based products are recited in these claims, the claims are not directed to the products themselves, and thus there is no need to perform the patent eligibility analysis for either "marked difference" or "significantly more."
This example evaluates the patent eligibility of a paper-making machine that recites a step that employs gravity, a law of nature. Because the claim recites a machine having a specific structure that optimizes speed while maintaining quality of the paper formed, the claim "clearly does not seek to tie up this law of nature so that others cannot utilize it." The claim as a whole amounts to significantly more than any recited exception and adds meaningful limitations to the use of the law of nature. In addition, the USPTO notes that the use of the law of nature improves paper-making technology. As a result, the claim is patent eligible.
Example 33 describes a hypothetical claim to a process for obtaining free fatty acids and glycerol from fat. The claim includes a series of steps for mixing and heating water for a defined period of time. The claim is based on a law of nature, but because there is no judicial exception recited in the claim, it is patent eligible without further analysis. Analysis under the "significantly more" standard also results in a conclusion that the claim is patent eligible because the claim as a whole effects a transformation of the fat and water into different chemicals.
Overall, the USPTO guidance offers patent applicants a far more positive outlook than previous guidance. Time—and further developments—will tell how patent examiners in the natural products, diagnostics, and therapeutic arts will apply this guidance.
Endnotes
1 See Federal Register notice in Vol. 81, No. 88, page 27381; Memorandum on "Formulating a Subject-Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject-Matter Eligibility Rejection".
2 See Federal Register notice in Vol. 79, No. 241, page 74618;
3 Memorandum at 1.
4 Id. at 2; emphasis in original.
5 Id. at 3.
6 Id.
7 Id. at 5.
8 Id. at 7.
9 Id. at 6-7.
10 Id. at 5.
11 This analysis also differs from the analysis of a natural product coated prosthesis example issued last year by the USPTO. In that case, the claim was entitled to streamlined examination because the claim was clearly not intended to preempt all uses of the natural product.
12 Association for Molecular Pathology v Myriad Genetics, Inc., 569 U.S. (2013).
Originally printed in CIPA Journal in October 2016. 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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