USPTO Provides New Guidance Regarding Section 101

On May 4, 2016, Robert Bahr, Deputy Commissioner For Patent Examination Policy at the U.S. Patent and Trademark Office (USPTO), published a memorandum to the examining corps (Memorandum) clarifying how the examiners should analyze claims for subject matter eligibility. On the same date, the USPTO also published six new subject matter eligibility examples, mostly in the life sciences field. All of these materials may be found here. The materials that follow summarize the Memorandum and each of the new examples.

The Memorandum

The Memorandum built upon the 2014 Interim Guidance on Patent Subject Matter Eligibility 79 Fed. Reg. 74618 (2014 Guidance) and the July 2015 Update: Subject Matter Eligibility 80 Fed. Reg. 45429 (2015 Update). This Memorandum describes specific steps that an examiner should take when rejecting a claim for lack of subject matter eligibility.

In particular, the Memorandum states:

A subject matter eligibility rejection… should:

  • identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception;
  • identify any additional elements (specifically point to claim features/limitations/steps) recited in the claim beyond the identified judicial exception; and
  • explain the reason(s) that the additional elements taken individually, and also taken as a combination, do not result in the claim as a whole amounting to significantly more than the judicial exception.
Judicial Exception

The Memorandum then elaborates on each of these points. For a law of nature or natural phenomenon, the rejection should identify the exception and provide “a reasoned rationale as to why it is considered a law of nature or natural phenomenon.” Similarly, for a product of nature, the rejection should identify the product of nature “as it is recited… in the claim and explain using a reasoned rationale why the product does not have markedly different characteristics from its naturally occurring counterpart.”

To find that a claim is directed to an abstract idea, the examiner must find that it is similar to an abstract idea previously identified in a court case. The USPTO has summarized the abstract idea court cases in a Quick Reference Sheet that was published with the 2015 update. The Quick Reference Sheet divides the cases into four categories:

  • Concepts relating to the economy and commerce, such as agreements between people in the form of contracts, legal obligations, and business relations;
  • An idea standing alone such as an uninstantiated concept, plan or scheme, as well as a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper;”
  • Concepts relating to interpersonal and intrapersonal activities, such as managing relationships or transactions between people, social activities, and human behavior; satisfying or avoiding a legal obligation; advertising, marketing, and sales activities or behaviors; and managing human mental activity; and
  • Mathematical concepts such as mathematical algorithms, mathematical relationships, mathematical formulas, and calculations.

The Quick Reference Sheet provides a brief summary of the abstract idea in each of the categorized cases.

Additional Elements

The Memorandum instructs examiners to go beyond merely identifying the abstract idea to “explain why [the identified abstract idea] corresponds to a concept that the courts have identified as an abstract idea.” In addition, the Memorandum cautions examiners to “not go beyond those concepts that are similar to what courts have identified as abstract ideas.”

Once a judicial exception has been identified, the rejection must state why the additional claim elements do not result in the claim as a whole amounting to significantly more than the judicial exception. The Memorandum instructs the examiners to “identify any additional elements… recited in the claim beyond the judicial exception and explain why they do not add significantly more than the exception. The explanation should address the additional elements both individually and as a combination….” (Emphasis in original). One way in which an examiner may find an element to be not significantly more is if the element and combination of elements is “well-understood, routine, conventional activity.” Importantly, the Memorandum advises examiners that “finding the element in the prior art … does not necessarily show that an element is well-understood, routine conventional activity previously engaged in by those in the relevant field.” This may allow an applicant use a Rule 132 declaration to contest a finding that one or more claim elements do not contribute “significantly more” than the judicial exception. We note that the Memorandum recites “well-understood, routine, conventional activity” without an “or” or “and” separating the second and third terms. Thus, examiners will treat these as being alternative characteristics, requiring an activity to be well-understood, routine, or conventional.

Evaluation of Applicant’s Response

Finally, the Memorandum instructs the examiner on how the applicant’s response is to be evaluated. In particular, the examiner “must carefully consider all of applicant’s arguments and evidence rebutting the subject matter eligibility rejection.” In particular, the Memorandum states that “[i]t is especially necessary for the examiner to fully reevaluate his or her position when such additional elements are not discussed in the specification as being known generic functions/components/activities or not treated by the courts as being well-understood, routine, conventional activities.”

In conclusion, the Memorandum should result in rejections under 35 U.S.C. § 101 that are clearer and have better basis in the law. If a rejection is unclear or invalid, an applicant should not hesitate to quote the Memorandum back to the examiner and perhaps involve his or her supervisor.

Life Sciences Examples

Example 28 encompasses hypothetical claims relating to vaccines and vaccine delivery devices for an influenza strain, the “Pigeon flu.”

Claims directed to vaccines comprising either live attenuated Pigeon flu virus or inactivated Pigeon flu virus are considered patent eligible subject matter, because the live attenuated Pigeon flu virus and inactivated Pigeon flu virus have different structural (altered nucleic acids or nucleotide sequences) and functional characteristics (reduced virulence or inability to cause disease) than those that occur in nature in the closest natural counterpart, wild Pigeon flu virus.

Claims directed to vaccines comprising a naturally occurring peptide (Peptide F) in a pharmaceutically acceptable carrier (such as water) are not patent eligible, because mixing the naturally occurring components of Peptide F and water does not change the structure, function, or other properties of Peptide F and water such that the compositions recited in the claims amount to “significantly more” than each naturally occurring component.

In contrast, claims directed to vaccines comprising naturally occurring Peptide F and a pharmaceutically acceptable carrier such as a cream (defined as water and oil in a homogenous emulsion producing a semi-solid form), are patent eligible because the claimed cream has different structural and physical characteristics than its naturally occurring counterparts, the oil and water, such that the cream allows for adherence to a patient’s skin better than oil or water alone.

Claims directed to vaccines comprising Peptide F and an immuno-effective amount of an aluminum salt adjuvant, with or without a pharmaceutically acceptable carrier such as water, are patent eligible. This is because the combination of Peptide F with the immuno-effective amount of aluminum salt adjuvant has a greatly enhanced immunogenicity, a functional characteristic, when compared to the natural counterparts of Peptide F and aluminum salt adjuvant alone.

Claims directed to a vaccine delivery device comprising a microneedle array coated with a vaccine comprising Peptide F are patent eligible because the microneedle array coated with the vaccine peptide is an unconventional delivery device that confines the naturally-occurring exception of Peptide F to a particular useful application. This results in the claim reciting “significantly more” than merely the “product of nature” exception represented by naturally-occurring Peptide F.

Example 29 relates to hypothetical claims for methods of detecting, diagnosing, and treating “julitis,” a fictional autoimmune disease in which sufferers have a protein, “JUL-1,” in their plasma, skin, hair, and nails. Non-sufferers do not have this protein. Unfortunately, sufferers of julitis are frequently misdiagnosed with rosacea.

  • Claims directed to methods for detecting JUL-1 in a patient comprising 1) obtaining a plasma sample from the patient and 2) detecting JUL-1 presence by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody are patent eligible. This is because the recited steps are not themselves directed to a recognized judicial exception as set forth in Mayo.
  • In contrast, claims directed to a method of diagnosing julitis in a patient comprising the same 2 steps recited above, but also including a third step of “diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected” are not patent eligible. This is because diagnosing the patient with julitis when JUL-1 is detected in the plasma sample describes a correlation or relationship between the presence of JUL-1 and the presence of julitis in a patient; such correlation is a “law of nature”—a judicial exception. The first two steps do not successfully amount to “significantly more” than the judicial exception because they are so general (any antibody, including isolated naturally-occurring human JUL-1 antibody, could be used), that they merely amount to insignificant pre-solution activity.
  • Claims directed to methods of diagnosing julitis in patients including steps of detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with either porcine anti-JUL-1 antibody or mAb-D33 antibody and detecting binding between JUL-1 and the respective antibodies are patent eligible. These claims are eligible because the use of the porcine anti-JUL-1 antibody or the use of mAb-D33 antibody is an unconventional step resulting in more than instruction to “apply” a correlation; thus, the claims as a whole amount to “significantly more” than the judicial exception.
  • Claims reciting methods for diagnosing and treating julitis comprising detecting the presence of JUL-1 in a plasma sample, diagnosing a patient with julitis, and administering an effective amount of either topical vitamin D or anti-tumor necrosis factor (TNF) antibodies are patent eligible, despite including the law of nature/correlation exception of diagnosing the patient. This is because 1) administration of topical vitamin D was not widely prevalent and represents an unconventional step that is more than a mere instruction to “apply” the exception, thereby resulting in “significantly more” than the exception itself, and 2) administration of anti-TNF antibodies integrates the exception into the diagnostic and treatment process that amounts to more than generically “treating” julitis; and the specific combination of steps is unconventional and rectifies the issue of erroneously diagnosing patients with rosacea instead of julitis.
  • Claims simply directed to methods of treating a patient with julitis by administering an effective amount of anti-TNF antibodies to a patient suffering from julitis are similarly patent eligible because the claim is focused on a process of practically applying a nature-based product limitation (anti-TNF antibodies) to treat a disease, and does not focus on the nature-based product per se.

Example 30 relates to dietary sweeteners, in particular sweeteners based on a sweet-tasting compound (“texiol”) found in nature.

  • Claims directed to a dietary sweetener comprised of texiol and water are considered patent ineligible, because they either add nothing significantly more to what exists in nature (where texiol occurs in the sap of a plant) or because the claimed mixture does not display markedly different characteristics compared to the closest naturally occurring counterpart (sap).
  • In contrast, claims reciting either a dietary sweetener comprising texiol, water and Compound N (a natural flavor) or a dietary sweetener comprising texiol, water/fruit juice and sufficient pectin to form a gel should be considered to constitute patent eligible subject matter, even though each component of the composition is found in nature and even though combining the components does not change the structure of the components. This is because the claimed dietary sweetener formulations have markedly different characteristics as compared to the closest naturally occurring counterparts.
  • Claims directed to a dietary sweetener comprising granular particles of texiol having a specified particle size and a dietary sweetener comprising texiol in a controlled release formulation should likewise be found eligible for patent protection, for the same reason.

Example 31 encompasses claims related to comparing, hybridizing, amplifying, and screening for alterations in BRCA1 gene sequences. Alterations from the wild-type BRCA1 gene sequence are correlated with an increased likelihood of developing breast or ovarian cancer.

  • Claims directed to methods for screening a germline of a human subject for an alteration of the BRCA1 gene involving comparing a germline sequence of a BRCA1 gene/RNA/cDNA from the subject with wild-type BRCA1 gene/RNA/cDNA, wherein a difference between the two indicates an alteration in the BRCA1 gene of the subject is not patent eligible. This is because the claim involves a single step of “comparing” recited at a high level of generality without limit on how the comparison is performed; such a step is an abstract idea. There are no other limitations in the claim that would cause the claim as a whole to amount to “significantly more” than the abstract idea; thus, the claim is patent ineligible.
  • In contrast, hypothetical claims directed to methods which build upon the above method claims by comparing BRCA1 sequences in specific ways may be patent eligible; these hypothetical method claims comprise either 1) hybridizing a wild-type probe to a BRCA1 gene isolated from a subject sample and detecting the presence of hybridization with scanning near-field optical microscopy, or 2) amplifying by (hypothetical technique) Cool-Melt PCR all of part of a BRCA1 gene from the subject sample using a set of primers to produce amplified nucleic acids and sequencing the amplified nucleic acids. Such claims are determined to be patent eligible despite the “comparison” step because 1) the use of scanning near-field optical microscopy to detect DNA hybridization was not conventional such that the claim as a whole recites “significantly more” than the abstract idea of “comparing,” and 2) the use of Cool-Melt PCR to amplify nucleic acids was not conventional at the time the invention was made and the application was filed, such that the overall claim is “significantly more” than the judicial exception of an abstract idea.
  • Other hypothetical claims directed to methods for 1) hybridizing BRCA1 sequences comprising hybridizing a wild-type probe to a BRCA1 gene isolated from a subject sample and detecting the presence of a hybridization product with scanning near-field optical microscopy, and 2) amplifying by (hypothetical technique) Cool-Melt PCR all of part of a BRCA1 gene from the subject sample using a set of primers to produce amplified nucleic acids and sequencing the amplified nucleic acids, are patent eligible. This is because the steps reciting in these methods do not recite any recognized exceptions to patentable subject matter; such steps are not natural laws themselves despite involving nature-based product limitations such as the probes, primers, and BRCA1 gene.

In Example 32, a claim to a paper-making machine which uses gravity to feed stock into the machine is found to meet the requirements of Section 101, despite the claim’s reference to a law of nature (“whereby stock is caused to travel by gravity”). Although the claimed machine operates using gravity, which is a law of nature, the claim does not seek to tie up this law of nature so that others cannot utilize it and adds meaningful limitations to the use of the law of nature, in view of the claim’s additional recitation of a machine having a specific structure.

The hypothetical claim of Example 33 is directed to a process for fat splitting, wherein the fat is hydrolyzed to produce free fatty acids and glycerol. The claim itself does not recite a law of nature, but the process being claimed does rely on a chemical principle or scientific fact that may be regarded as a law of nature. The Example notes “that although the claim is founded upon a chemical principle relating to neutral fats, it is not attempting to tie up any judicial exception so that others cannot practice it.” This is because the claim as a whole, which describes particular conditions for accomplishing the hydrolysis, is considered to “amount to significantly more than any potential recited exception.” Such a claim therefore is patent eligible.