Patent, statutory subject matter

There are two basic components to the utility requirement as included in 101. The first concerns itself with statutory subject matter, meaning the types of inventions or discoveries that are patentable, which are limited to a process, machine, manufacture... 

So let s briefly summarize what we know about utility. The utility of the invention must be statutory subject matter, meaning that it must describe a process, a composition of matter, a machine, or a manufacture. It must be tangible a purely mental process, scientific law, or mathematical relationship will not do. Further, the utility must be substantial and specific, meaning that the utility must be of immediate and real value and cannot be speculative. Finally, the utility asserted in the patent application must be credible. Fulfill these criteria, and you are on your way to a patent. But don t get too excited yet—as we have seen, the utility rejection hurdle is actually rather low. 

Member states can object to granting a patent in their territory, a provision which is necessary because member countries have no common policy on certain statutory exclusions of patentable subject matter. Member states of the ARIPO are Botswana, Ghana, Kenya, Lesoto, Malawi, Sudan, Swaziland, Uganda, Zambia and Zimbabwe. Sierra Leone, Somalia and Tanzania have not yet signed the Harare Protocol. 

To obtain a patent on an invention in the United States, the inventor or inventors must, as the initial step, file a patent application describing the invention in such terms as to teach one of ordinary skill in the art how to make and use the invention and claiming the subject matter that the inventor (or inventors) regards as the invention. The subject matter of the claimed invention must be within the statutory classes of patentable inventions. In addition, the claimed invention must have utility and be both new and nonobvious. The requirements for patentability (especially as to what constitutes patentable subject matter) can vary considerably throughout the world. 

An invention may also not be patentable under 102 if certain events (so-called statutory bars) occur more than 1 year before the patent application is filed in the PTO. The statutory bars are designed to encourage the inventor to file his or her patent application in a timely manner. For example, a written description of the invention, a public use, or offer of sale of the subject matter of the invention in the United States more than 1 year before the filing date of the application bars the invention from being patented. An inventor thus has a 1-year grace period after such a public disclosure in which to file a patent application in the United States. 

Since the Chakrabarty decision, the Patent and Trademark Office has adopted the interpretation of the three laws governing plants that any subject matter protectable under either the PPA or PVPA cannot be protected under the general patent law (35 U.S.C. 101). This interpretation is based on application of certain principles of statutory construction. 

Co-crystals, as a class of compounds, represent compositions of matter which are within the statutory classes of patentable subject matter. Most countries also allow claims for methods of making a co-crystal and often methods of using them, as well as pharmaceutical compositions containing them. The basis for this patentability is that a new co-crystal is a new composition of matter between an API and a co-former(s) with a unique binding interaction between them. The crystalline nature of the co-crystal composition may, and in most countries does, add to co-crystal patentability. 

PATENTABILITY. The qualifications for obtaining a patent on an invention of chemical process. These arc (1) the invention must not nave been published in any country or in public use in the U.S., in either case for more than 1 year before the date of filing the application (2) it must not have been known in the IJ.S. before date of invention by the applicant (3) it must not be obvious to an expert in the art (4) it must be useful for a purpose not immoral and not injurious to the public welfare (5) it must fall within the five statutory classes on which patents may be granted, i.e., (a) composition of matter, (b) process of manufacture or treatment, (c) machine, (d) design (ornamental appearance), or (e) a plant produced asexually. Special regulations relate to atomic eneigy developments and subjects directly affecting national security (Robert Calvert). Note In 1980, the Supreme Court m al landmark decision upheld the patentability of synthetic bacteria created by recombinant DNA techniques. 

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