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There are essentially five substantive requirements that must be satisfied before any invention can be patented. These requirements together are commonly referred to as the patentability requirements. Each of these patentability requirements are discussed briefly below.

1. Patentable Subject Matter - 35 U.S.C. 101

Perhaps the first and certainly the most basic question with respect to patentability is whether or not the claimed invention consists of patentable subject matter. In other words, is the claimed invention something that the patent laws are designed to protect?

The Legislative History of the 1952 Patent Act inform us that Congress intended the patentable subject matter referred to in §101 to "include anything under the sun that is made by man." Given that Congress intended everything made through human intervention to be patentable it is sometimes more helpful when discussing patentable subject matter to search for that which cannot be patented. In this regard the United States Supreme Court has repeatedly and consistently stated that there are only three categories of subject matter for which one may not obtain patent protection: (1) laws of nature; (2) natural phenomena; and (3) abstract ideas.

Today, at least in the United States, there are few questions with respect to patentable subject matter. From time to time, the United States Patent and Trademark Office does attempt to breathe new life into rejections for want of patentable subject matter, but ultimately the legislative history and the guidance of the Supreme Court is clear. With this in mind, for better or for worse, virtually everything, including computer software, living organisims and business methods, is patentable in the United States.

On the horizon, one patentable subject matter issue may become the scope of the protection afforded to business methods. With respect to business methods, in State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 cert. denied, 119 S.Ct. 851 (1999), the United States Court of Appeals for the Federal Circuit first categorically and unceremoniously did away with what had previously been come to be known as the business method exception to patentability. In this and subsequent decisions the Federal Circuit has not limited business method patents to any particular embodiment. Nevertheless, the United States Patent Office has interpreted this and other decisions to require a business method be used in conjunction with a computer in order to be patentable. It is hardly arguable that this is not the correct interpretation of the Federal Circuit precedent, but the Patent Office has nonetheless taken this position, which will remain in effect until either the policy is changed at the office or an appeal is taken to the Federal Circuit and the Federal Circuit orders the Patent Office to award patents on business methods that are disembodied from computer programs.

2. The Utility Requirement - 35 U.S.C. 101

To satisfy the requirements of §101 it is not only necessary to demonstrate that the subject matter of the invention is patentable, but the patentee is also required to demonstrate that the claimed invention is "useful" for some purpose. This statement of utility, while necessary, can be made either explicitly or implicitly. The utility requirement finds its foundation in the belief that an invention that is inoperative is not a "useful" invention within the meaning of §101 and, therefore, does not deserve patent protection. For a claimed invention to violate the utility requirement, it must be "totally incapable of achieving a useful result." Therefore, an invention that is at least partially useful will passes muster under §101 and the Patent Office will not issue a utility rejection.

Notwithstanding the extremely low utility hurdle, claimed inventions can and do fail the utility requirement. An invention that fails the utility requirement does so for one of two reasons. First, an applicant can fail to identify any specific utility for the invention or fail to disclose enough information about the invention to make its utility immediately apparent to those familiar with the technological field of the invention. Second, the applicant’s asserted utility for the invention is not credible. A good example of the later is an invention claiming a perpetual motion machine.

It is important to remember, however, that the Patent Office has the initial burden of challenging the applicant’s assertion of utility. This is true because the applicant’s assertion of utility in the disclosure will be initially presumed to be correct. Only if the Patent Office provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince the Patent Office of the invention’s asserted utility.

An assertion by the patentee regarding utility will be credible unless: (1) the logic underlying the assertion is seriously flawed; or (2) the facts upon which the assertion is based are inconsistent with the logic underlying the assertion. Credibility as used in this context refers to the reliability of the statement based on the logic and facts that are offered by the applicant to support the assertion of utility. One situation where an assertion of utility would not be considered credible is where a person of ordinary skill would consider the assertion to be incredible in view of contemporary knowledge and where the applicant has not provided any information to counter that which the contemporary knowledge suggests. Again, a perpetual motion machine is a good example.

3. The Novelty Requirement - 35 U.S.C. 102

Despite the impression given by the low hurdle presented by the first two patentability requirements, not every invention is patentable. One of the most common problems for applications is §102, which sets forth the doctrine of anticipation by requiring novelty of invention. Essentially, §102 requires the applicant for the patent to demonstrate that the invention is new. Absolute newness is not required, but those who are first to invent must soon thereafter file for a patent application or risk the loss of patent rights. In order to understand the requirements of §102, it is helpful to briefly explore the concept of anticipation.

A claim is said to be "anticipated" if comparison of the claimed invention with a prior art reference reveals that each and every element in the claim under attack is shown or described, organized, and functioning in substantially the same manner as in the prior art reference. Anticipation is perhaps most easily understood as the converse of infringement: "That which will infringe, if later, will anticipate, if earlier."

The standard for anticipation is a rigorous one; requiring that every element of the claimed invention, as arranged in the claim, be disclosed either specifically or inherently by a single prior art reference. Every element of the challenged claim need not be expressly delineated in a single prior art reference, but may be inherently disclosed by prior art if "the prior art necessarily functions in accordance with the limitations" of the challenged claim. However, if the court must go beyond a single prior art reference, the proper challenge is under §103 for obviousness, not §102 for novelty. A reference will, however, anticipate a claim if it discloses the claimed invention such that a skilled artisan could take its teachings in combination with his own knowledge of the particular art and be in possession of the invention.

4. The Nonobviousness Requirement - 35 U.S.C. 103

Obviousness is a critical element to patentability. In essence, even if the applicant can demonstrate patentable subject matter, utility and novelty, the patent will not issue if the invention is trivial. In order to determine if an invention is trivial it is necessary to see if there was motivation in the prior art to do what the inventor has done. If the prior art does not explicitly, and with identity of elements, teach the invention, the patent applicant may still be thwarted if there are a number of references that, when combined, would produce the claimed invention.

A patent may not be obtained if it contains only obvious differences from prior art. An invention is obvious if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. The obviousness inquiry is highly fact specific and not susceptible to per se rules. Defendant cannot simply present evidence of anticipation and then say "ditto" to establish obviousness. Nevertheless, for a patent to be nonobvious it must display "ingenuity beyond the compass" of a person of ordinary skill in the art.

The obviousness determination is based on four factual inquiries: (1) the differences between the prior art and challenged claims; (2) the level of ordinary skill in the field of the pertinent art at the time of plaintiff’s invention; (3) what one possessing that level of skill would have deemed to be obvious from the prior art reference; and (4) objective evidence of obviousness or nonobviousness. Notwithstanding these factual inquiries, objective evidence of obviousness or nonobviousness must also be considered before reaching a conclusion on obviousness. Objective evidence includes: (1) the commercial success of the invention; (2) whether the invention satisfied a long felt need in the industry; (3) failure of others to find a solution to the problem at hand; and (4) unexpected results.

In determining what would have been obvious to a person of ordinary skill in the art, the decision maker may examine the following factors: (1) type of problems encountered in the art; (2) prior art solutions to those problems; (3) rapidity with which innovations are made; (4) sophistication of the technology; (5) educational level of the inventor; and (6) educational level of active workers in the field.

5. Adequate Description Requirement - 35 U.S.C. 112

The crux of this so-called adequate description requirement is that once the first four patentability requirements are satisfied, the applicant still must describe the invention with enough particularity such that those skilled in the art will be able to make, use and understand the invention that was made by the inventor. For the most part, this requirement can be explained as consisting of three major parts. First is the enablement requirement, next is the best mode requirement, and finally is the written description requirement.

The enablement requirement requires the inventor to describe his or her invention in a manner that would allow others in the industry to make and use the invention. Enablement looks to placing the subject matter of the claims generally in the possession of the public.

The best mode requirement requires the inventor to disclose his or her preferred way of carrying out the invention at the time the patent application is filed. There is no requirement that the inventors preferred embodiment be updated as the patent application works its way through the Patent Office. Best mode looks to whether specific instrumentalities and techniques have been developed by the inventor and known to him at the time of filing as the best way of carrying out the invention.

The enablement requirement, thus, looks to the objective knowledge of one of ordinary skill in the art, while the best mode inquiry is a subjective, factual one, looking to the state of the mind of the inventor.

The written description requirement is found in the first paragraph of 35 U.S.C. §112. The written description requirement is separate and distinct from the enablement requirement, although related in important ways. The written description requirement serves a teaching function, as a "quid pro quo" in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.

To be sure, the definition of the written description requirement is quite elusive. For generations, the written description requirement had been confined to making sure that what was originally filed in the patent application adequately defined the full parameters of the invention being claimed. Today, the written description requirement means much more, but the Federal Circuit has yet to articulate the requirements in a coherent way. Commentators have called the new written description requirement a super-enablement requirement. The Federal Circuit has dismissed this, but cannot offer a test. Having said this, this new super-enablement requirement aspect of the written description requirement has so far been limited to biotech, genetics and pharma patents. Given this uncertainty and lack of judicial clarity the best thing to do to meet this requirement is to define your invention with as much specificity as possible.

The remaining elements of the adequate description requirement relate to claims. It is the claims that define the invention, so particular attention must be given to writing good, broad claims. Discussion of claims, however, goes well beyond this primer.

Court Blocks USPTO's Patent Rule Changes

Contributed by: Nixon Peabody LLP
Originally published: April 2008
By: Jeffrey N. Townes

On April 1, 2008, the U.S. District Court for the Eastern District of Virginia granted summary judgment for plaintiffs GlaxoSmithKline (GSK) and Tafas to permanently enjoin the United States  Patent and Trademark Office (USPTO) from enforcing the USPTO’s recently enacted patent rule changes. The decision effectively voids the USPTO’s final rules, entitled “Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications” (Final Rules). At the same time, the court denied the USPTO’s motion for summary judgment and motion to strike. While the USPTO can appeal the decision, this ruling postpones, and possibly prevents, the implementation of the Final Rules.