UPDATE: Subject Matter Eligibility under 35 U.S.C. § 101 – Life Sciences
The United States Patent And Trademark Office (USPTO) issued a memorandum on May 4, 2016 (May 2016 Memo) to the Patent Examining Corps to provide further Examiner instructions relating to subject matter eligibility under 35 U.S.C. § 101. The memorandum addresses (1) how Examiners should formulate rejections under 35 U.S.C. § 101 and (2) how Examiners should evaluate applicant responses to rejections under 35 U.S.C. § 101. The May 2016 Memo provides additional instructions from the Interim Eligibility Guidance (2014) and the July 2015 Update. We previously posted synopses of the Interim Eligibility Guidance and the July 2015 Update.
This update focuses on how the May 2016 guidelines affect the patents and patent applications that relate to the life sciences. Mintz Levin has a separate update for how the May 2016 guidelines affect abstract ideas.
Reinforcing the guidelines set forth in the 2014 and 2015 USPTO guidelines, the May 2016 Memo applied the same two-part inquiry (Step 1 and Step 2A/2B) to assess the subject matter eligibility of each claim in the life sciences examples. A subject matter eligibility rejection under the two-part analysis should:
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- Step 1: Determine if the claim is directed to a statutory category (e.g., process, machine, manufacture, or composition of matter);
- Step 2A: If the answer to Step 1 is “yes”, then the Examiner should determine if the claim is directed to one or more of the judicial exception(s);
- Step 2B: If the answer to Step 2A is “yes” then the Examiner should determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the judicial exceptions.
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In the life sciences examples, the analyses set forth by the USPTO make it clear that the markedly different characteristics (MDC) analysis should be used when the Examiner has determined the claim recites a nature-based product, but not when the claim as a whole is directed to a process. In the MDC analysis for a nature-based product, the Examiner should compare the nature-based product to its closest naturally occurring counterpart to determine if there are markedly different characteristics. If there are markedly different characteristics than what occurs with its naturally occurring counterpart, then the claim is not directed to an exception and is deemed subject matter eligible without the need to further analyze under Step 2B.
Examples of Eligible and Ineligible Claims to Life Sciences-Related Inventions
The May 2016 Memo provides six new life sciences examples (Examples 28-33) with multiple claims that contain different types of language to provide guidance on subject matter eligibility. Two examples are directed to hypothetical nature-based products (Examples 28 and 30). One example is directed to claims of methods of detecting or diagnosing and/or treating a hypothetical disease (Example 29). A fourth example (Example 31) is directed to screening for gene alternations and is modeled on issues raised in Association for Molecular Pathology v. Myriad Genetics, Inc. The remaining examples demonstrate the use of the streamlined analysis, using claims from the patents at issue in Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923) (Example 32) and Tilghman v. Proctor, 102 U.S. 707 (1881) (Example 33). All of the claims in these six examples pass the Step 1 test for whether the claimed subject matter falls within one of the statutory categories of invention and as such, the analysis provided by the USPTO are for inquiry on Step 2A or Step 2B.
Vaccines (Example 28)
This example provides seven claims directed to vaccines to illustrate how to achieve subject matter eligibility in nature-based products. Six of the seven claims are deemed to be eligible as further described below.
The claims are directed to various types of Pigeon flu vaccines that contain either an influenza A viral strain that was discovered in pigeons or a naturally occurring peptide isolated from the virus (Peptide F).
Nature-based product and MDC analysis for judicial exceptions
Claims that recite a nature-based product (e.g., claim 1 directed to a vaccine comprising live attenuated Pigeon flu virus) are analyzed for MDC that would take them out of being a judicial exception for being eligible subject matter. In exemplary claim 1, the live attenuated Pigeon flu virus is compared to its naturally occurring counterpart and found to have markedly different characteristics from what exists in nature because the sequence is different from the sequence that occurs in nature. Because the live attenuated virus has markedly different characteristics than what occurs in nature, it is not a “product of nature” exception. As such, the vaccines containing live attenuated Pigeon flu virus is deemed to be subject matter eligible and no further analysis under Step 2B is required.
In claim 2 of this example, a similar analysis is applied for a vaccine with inactivated Pigeon flu virus. The inactivated virus is compared with its naturally occurring counterpart and found to have a different structural characteristic because the exposure to formalin which inactivated the virus has chemically modified the nucleic acids in a manner that does not occur in nature. Because the virus has markedly different characteristics than what occurs in nature, it is not a “product of nature” exception. As such, the vaccines containing inactivated Pigeon flu virus is deemed to be subject matter eligible and no further analysis under Step 2B is required.
When the nature-based product contains components that do not occur together in nature such that there is no naturally occurring counterpart (as exemplified by claim 4), then the appropriate analysis is to compare to its naturally occurring components. Claim 4 recites vaccines comprising peptide F and a pharmaceutically acceptable carrier that can be a cream, emulsion, gel, liposome, nanoparticle, or ointment. Based on the broadest reasonable interpretation from the disclosure in the specification, the components of the vaccine are found to have different structural and physical characteristics than its naturally occurring components. Therefore, the claimed subject matter does not fall under the “product of nature” exception and is subject matter eligible.
Functionality as an eligibility feature
Claims that recite nature-based products that possess a functionality that is not found in the naturally occurring components can also be found to be subject matter eligible. For instance, claim 5 of this example is directed to vaccines comprising Peptide F and an immuno-effective amount of an aluminum salt adjuvant. The components of the claims (Peptide F) and aluminum phosphate do not occur together in nature so there is no counterpart. As such, the MDC analysis looks at each naturally occurring component. There is no indication that mixing these components has any changes to the structure of either component. However, the mixture has a changed functional property in that the immunogenicity is higher than the sum of its individual components. Importantly, this immunogenicity is a changed functional property that constitutes a markedly different characteristic. Therefore, the claim is not directed to an exception and thus, is considered eligible subject matter.
Claim 6, which is directed to a vaccine comprising Peptide F, an immuno-effective amount of an aluminum salt adjuvant and a pharmaceutically acceptable carrier, is subject matter eligible for the same reason as claim 5. The mixture of Peptide F, aluminum salt adjuvant and carrier confers a changed immunogenicity that is a marked difference in functional characteristics as compared to the natural counterparts. As such, the mixture is not a “product of nature” exception and thus, is eligible.
Nature-based products without any additional elements
Claim 3 illustrates a situation where there is no eligibility. Claim 3 is directed to a vaccine comprising Peptide F and a pharmaceutically acceptable carrier. Unlike claim 4 where specific types of carriers are recited, this claim recites a pharmaceutically acceptable carrier generically. Using broadest reasonable interpretation, a pharmaceutically acceptable carrier can be water. Since this is a nature-based product, the MDC analysis is applied to the naturally occurring components of Peptide F and water. There is no change in structure to either Peptide F or water by combining them together. Mixing them together does not confer any change to structure, function or any other properties. Therefore, it fails the MDC test under Step 2A and is considered a “product of nature” exception.
The next step (Step 2B) is to inquire if the claim, as a whole, amounts to significantly more than the exception and looks at whether there are any additional element(s) or combinations of elements and whether they were routinely used as of the filing date.[1] In this example, using a carrier in a peptide vaccine was well-understood, routine and conventional prior to the applicant’s invention. Therefore, mixing the carrier and the peptide and recited at this level of generality does not meaningfully limit the claim and, as such, does not amount to significantly more than the exception. Therefore, the outcome of the analysis under Step 2B is that claim 3 is not subject matter eligible.
Devices in combination with nature-based products
An unconventional device that is used in combination with a nature-based product can also confer eligibility. Claim 7 of Example 28 is directed to a vaccine delivery device comprising a microneedle array coated with a vaccine comprising peptide F. Under Step 2A, the query as to whether the claim is directed to any judicial exception, the microneedle is not a nature-based product but Peptide F is. There is no markedly different characteristic of Peptide F used here as that found in nature. Therefore, the peptide is a “product of nature” exception.
Thus, the next step of the analysis under Step 2B is to determine whether any additional elements, or combination of elements, confer significantly more than the exception. Besides Peptide F, the claim recites the additional element of a microneedle array which is coated with the peptide. The analysis then turns on whether it was well-understood and conventional at the time of filing to use microneedle arrays to administer vaccines. Under the fact pattern of this example, it is not and therefore the recitation of the coated microneedle array makes the claim, as a whole, significantly more than “product of nature” exception itself. Therefore, the claim is subject matter eligible.
Diagnosing and Treating Julitis (Example 29)
This example provides seven claims directed to diagnostic and/or treatment methods to illustrate how to achieve subject matter eligibility in processes or methods that correlate with natural processes or law of nature, including reciting limitations or elements to aid the claim as a whole to amount to significantly more than a judicial exception. Six of the seven claims are deemed to be eligible as further described below.
The claims are directed to methods of detecting, diagnosing and/or treating a disease (julitis). The applicant has discovered that JUL-1 is a protein that is found in a person with julitis but is not found in people who do not have julitis.
Detection methods as eligible
Claim 1 is directed to a method of detecting JUL-1 in a patient by (a) a plasma sample and (b) contacting a plasma sample with an anti-JUL-1 antibody and detecting the binding between JUL-1 and the anti-JUL-1 antibody. The steps of obtaining a plasma sample and detecting whether JUL-1 is in that plasma sample do recite or describe any judicially recognized exception. As such, this claim is eligible subject matter and no further analysis under Step 2B is required.
Diagnosing step recited with generalities can make a claim ineligible
Claim 2 is directed to a method of diagnosing julitis in a patient by steps (a) and (b) as described in claim 1 but recites an additional step (c) of “diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.” Under Step 2A of the eligibility analysis which inquires whether the claim as a whole is directed to any judicial exception, step (c) of the claim 2 of “diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected” is considered to describe a correlation between the presence of JUL-1 in a patient’s plasma and the presence of julitis in a patient. Therefore, it is directed to a judicial exception of reciting a law of nature. In addition, step (c) of claim 2 can be considered to represent an abstract idea because it can be performed by a human using mental steps or basic critical thinking. For at least these two reasons, the claim is found to recite judicial exception(s).
The analysis then proceeds to Step 2B where the claim is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that it amounts to significantly more than an exception. Besides the law of nature, the claim recites additional steps of (a) obtaining plasma sample, which was well-understood and conventional and is recited at such a high level of generality that it is an insignificant pre-solution step and (b) detecting the JUL-1 by binding of anti-JUL-1 antibody and JUL-1, which is deemed to not have any meaningful limitations because any detection technique can be used with any anti-JUL-1 antibody. Using an antibody of detecting a protein is well-understood and conventional at the time of filing of the application. Taken together, the combined steps of claim 2 also do not confer any meaningful limitations to the exception than when the steps are considered separately. Therefore, the claim as a whole does not amount to significantly more than the exception itself and therefore is not eligible.
Turning a diagnostic step into eligible subject matter
Claims 3 and 4 illustrate “tweaks” that can be used to convert an ineligible claim to an eligible claim. In claim 3, the same steps (a) and (b) as claim 2 are recited except that a porcine anti-JUL-1 antibody is used to bind to JUL-1. In this fact pattern, the porcine antibody was not routinely or conventionally used to detect human proteins such as JUL-1 at the time of filing of the application. Therefore, the claim’s recitation of detecting JUL-1 using a porcine antibody is an unconventional step that more than a mere instruction to apply the correlation. Either alone or combined with other elements, the claim, as a whole, amounts to significantly more than the exception itself and therefore is eligible.
Similarly, in claim 4, the same steps (a) and (b) as claim 2 are recited except that antibody mAb-D33 is used to bind to JUL-1. In this fact pattern, antibody mAb-D33 was not routinely or conventionally used to detect human proteins such as JUL-1 at the time of filing of the application. Therefore, the claim’s recitation of detecting JUL-1 using antibody mAb-D33 is an unconventional step that more than a mere instruction to apply the correlation. Either alone or combined with other elements, the claim, as a whole, amounts to significantly more than the exception itself and therefore is eligible.
Under the Step 2A analysis, claims 3 and 4 recite or describe judicial exceptions and are further analyzed under Step 2B and deemed to be eligible because the steps recited the use of a specific antibody that is not routine and/or conventional.
The diagnostic examples note that the markedly different characteristics analysis is not needed because the claims are not focused on product per se.
Does adding a “treating” step help with eligibility?
When a claim recites both diagnosis and treatment steps, then the determination of eligibility turns on whether the agent used for treating the disease was routinely used, well-known or conventional at the time of filing. Claim 5 recites a method of diagnosing and treating julitis in a patient by (a) obtaining a plasma sample from a human patient, (b) detecting whether JUL-1 is present in the sample, (c) diagnosing the patient when JUL-1 is detected, and (d) administering an effective amount of topical vitamin D to the patient. Because claim 5 recites the same correlation and critical thinking step (c) as claim 2 above, the claim is directed to a judicial exception.
The inquiry must then proceed to Step 2B to determine whether any element, or combination of elements, is sufficient to ensure that it amounts to significantly more than an exception. As detailed above, the other steps recited in the claim do not add significantly more to the exception. In contrast to the previous claims, claim 5 recites a treatment step where topical vitamin D is administered in an effective amount to the diagnosed patient. The evaluation would then turn on whether topical vitamin D was routinely used for treating julitis at the time of filing. In this fact pattern, it was not routinely used for treating julitis and as such, claim 5 is deemed to be eligible.
A combination of known steps can confer eligibility
Even when the agent for treatment was already known for treating a particular disease at the time of filing, a combination utilizing additional elements can confer eligibility. This is exemplified by claim 6 which is directed to method of diagnosing and treating julitis in a patient by (a) obtaining a plasma sample from a human patient (b) detecting whether JUL-1 is present in the sample (c) diagnosing the patient when JUL-1 is detected and (d) administering an effective amount of anti-tumor necrosis factor (TNF) antibodies to the diagnosed patient. Because claim 6 recites the same law of nature correlation and critical thinking/abstract idea of step (c) in claim 2 above, the claim is directed to one or more judicial exception(s). Thus, the analysis moves to Step 2B to determine whether any element, or combination of elements, is sufficient to ensure that it amounts to significantly more than an exception.
In this fact pattern, using anti-TNF antibodies to treat a patient diagnosed with julitis was well-understood, routine and conventional at the time of filing. However, when the combination of steps (a), (b), and (d) are considered as a whole, then they add meaningful limitations on the use of the exception (law of nature correlation and abstract idea). The totality of the steps includes the recitation of a specific treatment (anti-TNF antibodies) that amounts to more than just diagnosing the patient and instructing a doctor to “treat it.” The guideline cites Diamond v. Diehr, 450 U.S. 175,188 (1981) for “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.”
Method of treatment claims — not a judicial exception
Exemplary claim 7 is directed to a method of treating a patient by administering an effective amount of anti-TNF antibodies to a patient suffering from julitis. Under Step 2A, the claim is analyzed to determine if it is directed to any judicial exception. The recited step of administering anti-TNF antibodies to a patient suffering from julitis does not recite or describe any recognized exception. This method of treatment claim is deemed to be eligible since it does not recite any exception.
Dietary Sweeteners (Example 30)
This example provides six claims directed to dietary sweeteners to illustrate how to achieve subject matter eligibility in nature-based products, including by reciting limitations or elements to give the claimed composition markedly different characteristics, and/or to aid the claim as a whole to amount to significantly more than a judicial exception. Four of the six claims are deemed to be eligible as further described below.
The claims are directed to various types of dietary sweetener that contain texiol. The “Texas mint” plant has a thin liquid sap that contains about 10% texiol. Texiol is lower in calories and is sweeter than table sugar but does have a bitter aftertaste. Texiol can be admixed with other components (e.g., water, a specific compound, fruit juice, pectin), texiol in granular form, or texiol in a specific release formulation.
Nature-based products — ineligibility based on MDC analysis
Claim 1 is directed to a dietary sweetener comprising texiol and water (i.e., a sap). Applying the Step 2A analysis, this claim recites a “product of nature” exception because the claim encompasses naturally occurring sap and therefore, cannot have markedly different characteristics. Therefore, the analysis must proceed to Step 2B. There are no additional elements recited that would add significantly more to the exception. Therefore, this claim is not eligible.
Claim 2 is directed to a dietary sweetener comprising 1-5% texiol and at least 90% water. Applying Step 2A analysis, this claim recites a “product of nature” exception because the claimed mixture as a whole does not display markedly different characteristics. As such, the analysis must proceed to Step 2B. The combination of texiol and water, even in the recited percentages, has the same properties in the mixture as it has alone. There are no new functional properties that occur due to the mixture. In this fact pattern, at the time of filing, mixing sweetener and water together was well-understood, routine and conventional. Therefore, the claim as a whole does not amount to significantly more than a “product of nature” by itself and, as such, would not be eligible subject matter.
Nature-based products — eligibility based on MDC analysis
Claim 3 is directed a dietary sweetener with the same components (texiol and water) as claims 1 and 2 but including an additional element, Compound N, which improves the aftertaste. This changed organoleptic property (e.g., taste) is a markedly different characteristic. Therefore the claim is not directed to a “product of nature” exception and, as such, is eligible.
Similar to claim 3, the dietary sweetener recited in claim 4 is deemed to be eligible under the MDC analysis. Claim 4 is directed to texiol mixed with water or fruit juice or a combination thereof and sufficient amounts of pectin to form a solid gel, granular particles of texiol having defined particle dimensions. Under Step 2A, the texiol has changed properties as compared to naturally occurring texiol in plant sap because under the facts presented in this example, the claimed texiol is present in solid yet spreadable form and has improved organoleptic property, both of which are considered markedly different characteristics. Therefore the claim is not directed to a judicial exception (“product of nature”) and, as such, is eligible.
Similar to claim 3, the dietary sweetener recited in claim 5 is deemed to be eligible under the MDC analysis. Claim 5 is directed to a dietary sweetener comprising granular particles of texiol having specific particle diameters. Under Step 2A, one would compare the texiol of specific size to its closest naturally-occurring counterpart (texiol in its natural irregular crystal state). In this case, reciting particle size distribution texiol has a changed property because it has a different dissolution rate than naturally occurring texiol. Because of this MDC, the claim is not directed to a judicial exception (“product of nature”) and, as such, is eligible.
Claim 6 is directed to texiol in a controlled release formulation. Texiol in a controlled release formulation has altered time release properties, which is considered is a markedly different characteristic. Because of this MDC, the claim is not directed to a judicial exception (“product of nature”) and, as such, is eligible.
Screening for Gene Alterations (Example 31)
In this example, an exemplary analysis is provided using the actual claim 1 and hypothetical claims modeled after the invention in U.S. Pat. No. 5,753,441. Actual claim 1 was held ineligible by the Federal Circuit as directed to an abstract idea without additional elements that amount to significantly more than the abstract idea. Claim 1 is directed to a method for screening germline of a human subject for an alternation of a BRCA1 gene by comparing the germline sequence of a BRCA1 gene or RNA with germline sequences of wild-type BRCA1 gene, RNA or cDNA wherein a difference in the sequence indicates an alternation of the BRCA1 gene in the human. Under Step 2A, the claim is directed to a judicial exception of being an abstract idea because the comparison step is recited at a high level of generality and could be performed by a human using mental steps or basic critical thinking.
The next step of the analysis under Step 2B queries whether there are any additional elements or combination of elements that would ensure the claim amounts to significantly more than the abstract idea. This claim recites a single step of comparison and no additional elements or steps in the claim. Therefore, the claim as a whole does not amount to significantly more than the abstract idea of comparing information and, as such, is not eligible.
Conferring eligibility by using a non-routine detection technique
The next claim (claim 70) illustrates how to turn an ineligible claim into an eligible claim. Claim 70 depends from claim 1 so it incorporates the abstract idea from claim 1 and, as such, recites a judicial exception. Analyzing under Step 2B, claim 70 additionally recites detecting the presence of the hybridization product with scanning near-field optical microscopy (SNOM). The fact pattern indicates that at the time of filing, SNOM was not routinely or conventionally used to detect DNA hybridization. Therefore, the recitation of using SNOM to detect hybridization yields a claim that, as a whole, is significantly more than the judicial exception itself and therefore, is eligible subject matter.
Similar to claim 70, exemplary claim 80 depends from claim 1 and uses a technique of amplification (Cool-Melt PCR) that was not routinely used at the time of filing to amplify nucleic acids. Therefore, claim 80 is eligible subject matter.
Conferring eligibility by re-framing the claim to avoid judicial exception
Claim 75 illustrates how to re-frame the claim to recite eligible subject matter by using language that recites hybridizing a wild-type probe to BRCA1 and detecting the hybridization by measuring conformational changes. Under Step 2A, these steps do not recite or describe a judicial exception and, as such, are eligible.
Like claim 75, claim 85 has used different language such that the claim is directed to a method of amplifying BRCA1 nucleic acids by amplifying all or part of BRCA1 by Cool-Melt PCR and sequencing the amplified nucleic acids. Under Step 2A, these steps do not recite or describe a judicial exception and, as such, are eligible.
Paper-Making Machine (Example 32)
The hypothetical claim in this example uses a streamlined analysis. The claim is based on the technology from U.S. Pat. No. 845,224, which was upheld by the Supreme Court in Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923). The claim recites a Fourdrinier machine with a paper-making conveyor belt that is passed over a breast-roll. The claimed machine operates using gravity, which is a law of nature but recites Fourdrinier machine which is understood to have a specific structure. Therefore, the claim does not seek to tie up this law of nature so that others cannot use it (i.e., preemption of a law of nature). The law of nature (gravity) is merely exploited to improve paper-making technology. Accordingly, the Step 2A/2B eligibility analysis is not required and the claim is patent eligible.
Hydrolysis of Fat (Example 33)
The hypothetical claim in this example also uses a streamlined analysis. In this example, the hypothetical claim is based on the technology from U.S. Pat. No. 11,766, which was upheld by the Supreme Court in Tilghman v. Proctor, 102 U.S. 707 (1881). Claim 1 recites a process for obtaining free fatty acids using series of steps for mixing and heating fat and water. Although the claim is founded upon a chemical principle relating to neutral fats, the claim recites specific parameters, such as mixing substantially equal quantities of fat and water, heating the mixture at an elevated temperature and under sufficient pressure to prevent formation of steam in the closed vessel, and maintaining the elevated temperature for a defined time period so that the fat and water react with each other to form free fatty acids and glycerol. Taken together, the claim as a whole would amount to significantly more than any judicial exception (e.g., law of nature) and recites sufficient details so that it is not attempting to tie up any judicial exception so that others cannot practice it. Thus, eligibility of the claim is self-evident in the streamlined analysis without needing to perform the full Step 2A/2B eligibility analysis. Therefore, the claim is patent eligible.
Conclusion
The May 2016 Memo was issued after the USPTO had received and carefully considered a total of thirty-seven submitted feedback comments from the public on the July 2015 Update. Life sciences inventions that are directed to diagnosis or nature-based products can be subject matter eligible as illustrated by the claims in the life sciences examples. Careful drafting of claims and requisite support in the specification will be needed to avoid Section 101 issues during patent prosecution.
1 According to the May 2016 Memo, when the Examiner has concluded that particular claim limitations were well-understood, routine conventional activities (or elements) to those in the relevant field, the rejection should explain why the courts have recognized, or those in the relevant field of the art would recognize, those claim limitations as being so. In particular, even if a particular laboratory technique was discussed in several widely-read scientific journals or used by a few scientists, mere knowledge of the particular laboratory technique or use of the technique by a few scientists is not adequate to make the use of the technique routine or conventional in the relevant field. Rather, the evaluation turns on whether the use of the particular laboratory technique was well-understood, routine, conventional activity previously engaged in by scientists in the field.
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