UNDERSTAND USPTO 35 U.S.C. SECTION 101

UNDERSTAND USPTO 35 U.S.C. SECTION 101

Section 101 AND THE Eligibility Requirement for Subject Matter ?

The patent office assigns a patent examiner to check that a patent application satisfies the legal conditions for patentability before granting any patent. Examiners consider, among other things, whether the invention listed in the application qualifies as the proper subject matter for Section 101 of the Patent Act protection. According to this legislative clause, 'any new and useful process, machine, manufacture, or composition of matter' is eligible for patents. For instance, a new method of manufacturing a product, a novel machine, a unique composition of matter, or a new process for performing a task could all be eligible for patent protection. An innovation is ineligible for patenting if it is not a process, machine, manufacturing, or composition of matter.?

The concept of patent eligibility is not static. An invention must avoid falling into a judicially crafted 'exception' to patentable subject matter to be patented. While the way these exceptions have been expressed has evolved, we know that natural phenomena, laws of nature, and abstract concepts are not statutory subject matter. Therefore, inventions that are abstract concepts or natural laws are not patentable. In the past ten years, these subject matter eligibility exclusions have gained significant importance, particularly in the context of inventions involving computer software and medical diagnostic procedures.?

If your application has been rejected under Section 101 (also known as 'subject matter eligibility' or 'Alice'), the examiner has determined that your claims pertain to an invention that is not eligible for patent protection. Section 101 rejections can be of two kinds: either the examiner is stating that your invention is not within one of the four legislative categories, or the examiner is stating that your invention is within one of the patent-ineligible exceptions (typically an abstract concept or a natural law/phenomenon). Each of these two kinds is covered in turn below. While it can occasionally be challenging to overturn a Section 101 denial, in any situation, such a rejection does not have to mean the end of your patent application. There are strategies and guidance available to help you navigate this process and potentially secure your patent.?

The Four Statutory Categories Under Section 101 ?

Section 101 of the Patent Act states, as was already said, that patents may be issued on "any new and useful process, machine, manufacture, or composition of matter." Accordingly, an innovation that does not fit into one of these four categories—that is, is not a process, machine, production, or composition of matter—will not be qualified for patent protection. Though some inventions do not fit into one of these categories, the majority do. A wave is neither a process, a machine, a manufacturing, or a composition of matter. Hence, a patent application claiming that your invention is an electromagnetic wave with specific properties will be refused. Additionally, unpatentable is pure data—that is, data claimed alone instead of data stored on a computer or altered during a computer operation.?

The extensive debate does not cover these statutory category rejections and worries over Section 101. These statutory categories provide simple, readily overturned rejections that are supported by unambiguous statutory wording. Instead, all the concerns about "Section 101 issues" are limited to the patent-ineligible notions of abstract concepts and natural laws/phenomena, which are covered below.?

Non-Statutory Exclusions: Incomprehensible Concepts in Patents ?

Not all processes, machinery, manufactures, or compositions of matter are patentable, even though Section 101 lists four kinds of such subject matter. The courts have placed other limitations on the kinds of inventions that can be patented, even though the statute's language may suggest that the four categories are the only criteria for subject matter eligibility. As the Supreme Court put it in its ruling in Myriad Genetics, "[w]e have long held that this provision contains an important implicit exception: Laws of nature, natural phenomena, and abstract ideas are not patentable." The Supreme Court has clarified that these kinds of ideas "are not patentable as they are the basic tools of scientific and technical work." Prometheus Labs., Inc. versus Mayo Collaborative Services. The Court worries that, although the patent system is meant to encourage innovation, granting patents on a law of natural or natural phenomena (or a related notion) might obstruct it. Consequently, even though the official Patent Statute is silent on this issue and does not specify that abstract conceptions or natural phenomena are to be excluded from patent eligibility, the Supreme Court has established that patents should not be granted on these patent-ineligible concepts.?

When defining the exclusions to patent eligibility, the Supreme Court needs to be consistent. The Court has independently declared any of the following ideas invalid in several cases:??

  • natural laws ?
  • fundamental concepts of natural phenomena ?
  • abstract ideas in philosophy ?
  • brain functions ?
  • procedures in mathematics ?

Courts and the USPTO have lately whittled down this list to three categories: natural phenomena, abstract conceptions, and laws of nature. These days, intellectual ideas, mental operations, and even mathematics are typically seen as falling under the "abstract ideas" exclusion to patentable subject matter. Moreover, the first category, "laws of nature," is usually combined into a single exception and is hardly ever examined independently of the exception for natural phenomena. We shall also put laws of nature and natural phenomena together for this study to concentrate on just two distinct patent-ineligible concepts: "natural phenomena" and "abstract ideas."?

It still needs to be determined how these exclusions to patent-eligible inventions should be applied to specific inventions, even once we have identified them. Numerous courts have observed that a procedure is not unpatentable only because it incorporates an abstract concept or a natural phenomenon. All creations must in some way abide by the rules of nature and will connect to some articulated abstract concept. The Supreme Court has ruled that "a novel and useful structure created with the aid of knowledge of some scientific truth" may be patented, but a scientific truth (or "natural phenomenon") cannot. May 10. Put otherwise, while all inventions are related to unpatentable natural phenomena or abstract ideas, unpatentable inventions try to claim these ineligible concepts directly. In contrast, patentable inventions incorporate these concepts into a structure or process that converts an ineligible idea into a patentable application of that concept.?

OVERVIEW OF THE ALICE TEST FOR NON-STATUTORY EXCEPTIONS ?

Undoubtedly, the section above raises the complex question of how one can discern between a patent-eligible invention that claims an acceptable application of the concept and a patent-ineligible innovation that tries to claim the ineligible concept. While it's clear that a new kind of internal combustion engine is patentable, and the law of gravity is not, many inventions fall between these two poles. For many years, courts have debated where to draw the line between patentable and unpatentable inventions. The Supreme Court has devised a 'test' to make this determination in its Mayo and Alice rulings. However, this 'test' is not always definitive and often leaves the matter just as unclear as before the test was administered. Yet, we also know that this standard determines whether the idea being assessed for patent ineligibility is a natural phenomenon or an abstract concept. Though this test originated in the Court's Mayo judgment from two years prior, we shall refer to it as the 'Alice test' because it was most succinctly stated in the Alice case.?

According to the Supreme Court, the Alice test encompasses two stages. The initial step is to determine if the claims are aimed at an ineligible notion (such as an abstract concept or a natural phenomenon). The Supreme Court has underlined in reaching this conclusion that "tread carefully in construing this exclusionary principle lest it swallows all of the patent law" since, in some sense, "all inventions... embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas". We are to look at the claims and the specification to identify the "claimed concept" (also called the "focus" of the claims or the "claimed advance") to ascertain if the claims are "directed to" the ineligible concept rather than just embodying or applying that concept. Then, one can contrast this thought with previous inventions that inspired natural phenomena or abstract concepts. The claimed concept fails step one, and the invention is examined further under step two if it is like prior innovations previously determined to be directed to an ineligible concept. Step two of the test does not need to be examined to determine if the claimed notion is sufficiently distinct, in which case the invention qualifies for a patent. The Guidance discussion on Applying Step One of the Alice exam goes further into this initial test portion.?

The Alice test's second step is to "consider the elements of each claim individually and 'as an ordered combination' to determine whether the additional elements 'transform the nature of the claim' into a patent-eligible application." Carroll. The Guidance discussion on Applying Step Two of the Alice test goes further into this second exam component.?

Alice Test WORKS FOR NATURAL PHENOMENON AS WELL AS ABSTRACT IDEAS ?

The Supreme Court first established the "Alice test" in Mayo concerning natural phenomena and rules of nature. Many observers thought the Supreme Court's instructions in Mayo had no bearing on abstract concepts and computer software because the Court needed to address them in this ruling. Given the abstract concepts, even the USPTO initially thought that Mayo should keep its analysis the same. In its Alice ruling, the Supreme Court made this point more evident, holding that computer software and abstract notions were covered by the fundamental methodology for evaluating patent-ineligible concepts established in Mayo.?

Today, this Alice test applies to natural events (often examined in connection with medical tests and genetic inventions) and abstract concepts (often examined in connection with computer software). Therefore, most of the analysis in the following pages applies to both natural phenomena and abstract notions. Where specific problems only touch on one of these ineligible ideas, they will be covered separately.?

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