Source: https://www.lalaw.com/news_resources/updated-patent-office-guidance-regarding-patent-eligible-subject-matter/
Timestamp: 2019-04-24 02:54:24+00:00

Document:
The United States Patent and Trademark Office (USPTO) recently issued two new memos to provide clarified examination instructions to the Patent Examining Corps relating to subject matter eligibility of claims under 35 U.S.C. § 101. The memos are intended to assist examiners in applying the guidance in the previously issued 2014 Interim Guidance on Patent Subject Matter Eligibility and the July 2015 Update: Subject Matter Eligibility.
The first of these memos, issued on May 4, 2016, titled May 2016 Update: Memorandum – Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection (hereinafter the May 4 memo), provides additional clarification on how examiners should formulate a subject matter eligibility rejection under § 101. This memo was accompanied by examples of claims that the USPTO considers should be eligible for patentability under 35 U.S.C §101 and those that should not. Explanations of how the examples should be analyzed to make a determination as to subject matter eligibility accompanied the examples. Some of the examples are similar to claims evaluated in recent Federal Circuit and Supreme Court cases and others are more hypothetical. The claim examples were directed primarily to nature based products and to subject matter in the field of life sciences. The claim examples supplement those previously published by the USPTO in December 2014, January 2015, and July 2015.
The May 4 memo clarifies how an Examiner should identify an abstract idea in a claim to be analyzed for subject matter eligibility. The memo clarifies that “when an examiner determines that a claim is directed to an abstract idea . . . the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim. . . Similarly, when an examiner determines that a claim is directed to a law of nature or a natural phenomenon . . . the rejection should identify the law of nature or natural phenomenon as it is recited (i.e., set forth or described) in the claim.” (Emphasis added.) This clarification may be welcomed by practitioners who have been facing subject matter eligibility rejections from the USPTO. Anecdotal evidence suggests that when making subject matter eligibility rejections, Examiners have tended to describe the exception (the abstract idea, law of nature, or natural phenomenon) to which a claim is allegedly directed at a high level of generality (for example, “a method of organizing human activity”). If Examiners are required to identify the exception to which a claim is allegedly directed using language from the claim itself, the Examiners may find it more difficult to identify an idea that is truly a subject matter ineligible exception to the types of subject matter identified as patentable in §101.
The May 4 memo also clarifies that if an abstract idea, law of nature, or natural phenomenon is identified in a claim, the remaining elements in the claim should be analyzed “individually and in combination” (emphasis in original) to determine if the remaining elements amount to “significantly more” than the identified exception. It is insufficient for an Examiner to assert that each additional claim element on its own is something that is well-understood, routine, and conventional in the relevant field of art “because while individually-viewed elements may not appear to add significantly more, those additional elements when viewed in combination may amount to significantly more than the exception by meaningfully limiting the judicial exception.” Further, the test for whether the additional claim elements are well-understood, routine, and conventional in the relevant field is described in the May 4 memo as being stricter than the test for novelty or obviousness. For a claim element to be well-understood, routine, and conventional in the relevant field, it must not only be known in the relevant field, but “widely prevalent.” The May 4 memo gives an example that “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 particular laboratory technique by a few scientists is not sufficient to make the use of the particular laboratory technique routine or conventional in the relevant field.” The clarification of what is meant for a claim element or combination of claim elements to be well-understood, routine, and conventional in the relevant field may make it more challenging for an Examiner to show that a claim element does not amount to significantly more than a judicial exception.
An additional clarification that may be favorable to applicants made in the May 4 memo is that the claim examples provided by the USPTO should not be relied on by Examiners as illustrating patent ineligible exceptions. Rather, the May 4 memo instructs Examiners that an alleged patent ineligible exception should be similar to one that has been identified by a court of law and that “Examiners should be familiar with any cited decision relied upon in making or maintaining a rejection to ensure that the rejection is reasonably tied to the facts of the case and to avoid relying upon language taken out of context. Examiners should not go beyond those concepts that are similar to what the courts have identified as abstract ideas.” The claim examples provided by the USPTO, however, may be analogized to by applicants to show that their claims are directed to concepts similar to those that the USPTO has deemed subject matter eligible for patentability.
Further guidance provided in the May 4 memo includes instructions that when making rejections of the claims of a patent application under §101, “the Office action must provide an explanation as to why each claim is unpatentable.” (Emphasis added.) It is insufficient for an Examiner to provide an analysis of why a single independent claim in an application is rejected under §101 and provide no explanation with regard to the remaining claims. These instructions place an additional burden on Examiners in making rejections under §101.
The second of the memos recently issued by the USPTO on May 19, titled May 2016 Update: Memorandum – Recent Subject Matter Eligibility Decisions (Enfish, LLC v. Microsoft Corp. and TLI Communications LLC v. A.V. Automative, LLC) was published to inform Examiners of additional clarification with regard to §101 rejections that could be gleaned from the Enfish v. Microsoft decision by the Court of Appeals for the Federal Circuit issued on May 12, 2016.
The claim examples provided with the May 4 memo are generally directed to subject matter in the life sciences field. In a first set of examples, the USPTO explains what may be required for claims directed to a vaccine to be eligible for patentability. The USPTO explains that patent eligible claims directed to a vaccine should recite more than a simple combination of naturally occurring nature-based products. The patent eligibility of such claims may be analyzed by comparing the components of the claimed vaccine against their naturally occurring counterparts to determine if the claimed vaccine has markedly different characteristics than the counterparts or a simple sum of the properties of the naturally occurring counterparts. If an element in the claimed vaccine has been modified from its naturally occurring counterpart, for example, by attenuating or inactivating a naturally occurring virus, this may render the claim patent eligible. Further, even if the vaccine is substantially similar to its naturally occurring counterpart, if the subject claim recites the vaccine as being delivered in a manner that is not routinely or conventionally used to administer vaccines, this may render the claim to the vaccine and delivery system eligible for patentability.
A second set of examples is directed to methods of diagnosing and treating a hypothetical disease. In this set of examples, the USPTO explains that a claim reciting obtaining a biological sample and detecting whether a protein is present in the sample may be subject matter eligible due to the lack of the recitation of an abstract idea. If, however, the claim further recites an act of diagnosing a patient, this may render the claim subject matter ineligible because the diagnosing act may be considered a mental step, which has been held to constitute an abstract idea. This example illustrates the somewhat counterintuitive result that an addition of an act to an otherwise subject matter eligible claim may render the claim ineligible under §101. The USPTO also uses this set of examples to illustrate that reciting a non-conventional method of diagnosis (e.g., non-conventional method of detecting a biomarker) or an unconventional method of treatment may be sufficient to render a claim to medical diagnosis or treatment subject matter eligible for patentability.
A third set of examples is directed to a dietary sweetener. These claims are analyzed with regard to whether a claim reciting a combination of naturally occurring nature-based products may be subject matter eligible. Similar to explanations provided with regard to the first set of examples directed to the vaccine, the USPTO explains that if the combination of naturally occurring nature-based products in a claim results in a markedly different characteristic than the mere sum of the characteristics of the individual products, the claim may be subject matter eligible for patentability. Also, similar to explanations provided with regard to the first set of examples directed to the vaccine, the USPTO explains that if one of the naturally occurring nature-based products is recited in a claim as being somehow modified from its naturally occurring state so that it exhibits markedly different characteristics than its naturally occurring counterpart, the claim may be subject matter eligible for patentability.
Another set of claim examples is modeled partially on the claims at issue in the Association for Molecular Pathology v. Myriad Genetics, Inc. case decided by the Supreme Court in 2013. These claims are generally directed to methods of screening for gene alterations. This set of examples further illustrate that the USPTO may consider claims directed to something that could be considered a mental step, for example, comparing one sample with another, to be subject matter ineligible for patentability. Consistent with the themes in the other sets of examples, the USPTO explains that if a claim recites performing an analysis, for example, detecting the presence of a gene, or amplifying a gene using an unconventional method, this may render the claim subject matter eligible.
In a final set of examples, directed to a paper making machine and to the hydrolysis of fat, respectively, the USPTO explains that a claims reciting the utilization of a natural law, for example, gravity or chemical reactions, may be subject matter eligible for patentability if the claim is not directed to the law of nature itself.
The latest guidance issued by the USPTO provides the patent practitioner with additional useful tools for guiding how to construct a claim to avoid a §101 rejection and for how to respond to a §101 rejection of a claim. The guidance provides examination instructions to the Examination Corps that may require Examiners to adhere to a more strict approach to examination of claims for subject matter eligibility than they may have been applying in the past. The guidance also provides patent practitioners with additional examples of claims that the USPTO would consider patent eligible that practitioners can analogize their claims to or model their claims after.

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