Sufficiency of disclosure

Sufficiency of disclosure is a more straightforward requirement. Sufficient technical detail must be provided in the patent application such that somebody of ordinary technical skill in the area could reproduce/repeat the innovation. Utility or industrial applicability is the last major prerequisite to patenting. This simply means that the innovation must have some applied use. 

The product or process invention claimed in a patent must have an inventive step that is to say the invention must not be obvious to a person skilled in the art . The rationale for this is to prevent novel, but trivial or obvious, variants of a known product or process from being given a monopoly. Inventive step is a separate requirement from novelty the question Is there an inventive step is only relevant once the novelty ol a claimed invention has been established. At least at the EPO, lor the purposes of inventive step, and for the purposes of sufficiency of disclosure (see below) the fictional person skilled in the art is deemed to have the same degree of knowledge, and for bicatalysis inventions is likely to be a team of suitably qualified people e g. one Ph.D. researcher assisted by two laboratory technicians fully acquainted with the known techniques relevant to the technolog> in question. 

In addition to the above three requirements, inventors must also clearly and completely describe the invention. This is called sufficiency of disclosure. The specification of a patent application must clearly and sufficiently describe the subject matter, so that it can be carried out by a skilled person in the subject. Some countries (such as Brazil and the United States) also require an indication, when applicable, of the best way of executing the invention, called the best mode of the invention. 

Under the terms of Article 8 of the Brazilian Industrial Property Law, patentable inventions are those that have the three basic requirements of novelty, inventive step, and industrial application. Additionally, from Article 50, II, if the specification does not clearly and sufficiently describe the subject matter so as to enable its reproduction by a technician in the subject, the so-called sufficiency of disclosure, it is against the provisions of Article 24, and is thus not accepted (Art. 50, II). 

In drafting a patent appHcation, proceeding methodically through the several steps necessary to produce the type of disclosure legally and technically sufficient to satisfy the requirements of the laws of the United States is absolutely essential to a successful granting of the patent. A first step is to outHne those elements of the invention which are absolutely essential to its practice. A body of disclosure should be outlined for each of the essential elements of the claim. This disclosure should describe each element in terms of its function, as weU as the parameters that are relevant to the essential nature of the individual element. For example, if a chemical mixture has a component which acts so as to thicken the mixture, it is appropriate to outHne the family of constituents that can serve this function. At the same time, a full outHne of the disclosure of this individual element will include mention of those chemicals that are preferred for use within the mixture so as to perform the desired thickening function. 

In order to ascertain if there is prior knowledge, three criteria are taken into account public disclosure, sufficient disclosure, and date of disclosure. 

In order to ascertain if there is prior knowledge, three criteria are taken into account public disclosure, sufficient disclosure and date of disclosure. It will thus be investigated whether at the filing date of the patent application it could be known about the invention. It will be also taken into consideration whether the disclosure is sufficient for an expert to be able to perform the invention without an inventive act. Finally the date of the disclosure will be considered, which must be certain and not in doubt. In order to destroy novelty, it must of course be prior to the filing date of the patent application, or prior of the priority date, if any. 

The Patent Statute. A patent represents a "contract" between an inventor and the public. The inventor offers full disclosure of his or her invention in sufficient detail to instruct the public about the invention and its use. In exchange for public disclosure and the societal benefits derived therefrom, a patent holder is granted exclusive rights to make, use, and sell the invention and the right to exclude all others from the same for a period of 20 years. Thus inventions that would otherwise remain preciously held secrets are made known for greater advancement of the public good. 

As with any patent application, to obtain a patent on a gene, genetic component (e.g., EST or SNP), or diagnostic or therapeutic method, the applicant must demonstrate the utility, novelty, and nonobviousness of the discovery. The applicant must also supply a disclosure and written description of the subject of the proposed patent that is sufficient in detail to show that the inventor had possession of the claimed subject matter at the time of application and to enable one skilled in the field to make use of the claimed subject matter. Although the fundamental elements of patentability have been in place for decades for protection of such innovations as new mechani-... 

It is not possible, once the patent application is filed, to add further informahon. The applicant must therefore rely on the original disclosure which should be as complete and accurate as possible. Problems may arise if this is not the case. If the application does not describe the invention in sufficient detail, ideally across the full breadth of the monopoly claimed, the patent claims may be completely bad or their breadth may have to be reduced significantly. Thus, as much information as possible on how to carry out the invention should be given in the patent application. For example, if the patent application claims the production of a polypeptide in a host cell, and the only working example is its... 

Worked examples are, where possible, included. If worked examples are not available it may be desirable to give prophetic or dummy examples which, although they have not been worked, describe how to carry out a particular aspect of the invention. The patent apphcation must give a sufficient disclosure of how to carry out the invention without undue burden (the sufficiency or enablemenf requirement). In the USA it is essential to describe the best way of carrying out the invention known to the inventors when the application is filed (the best mode requirement). For inventions using certain biological material (such as host cells, vectors, hybridomas, bacteria and the like) it may be necessary to make a special deposit of the material in order to fulfil the sufficiency requirement. 

The need to deposit viable cultures of microorganisms to meet the legal requirement of providing a sufficient or enabling disclosure of the invention represents a substantial business risk of giving competitors a head start in their R D if no worthwhile patent protection is obtained ultimately. In other technical areas only information describing the invention is disclosed, and not actual physical materials that either embody the invention or that are very closely related to the invention. 

This form does not authorize redisclosure of medical information beyond the limits of this consent. Where information has been disclosed from records protected by federal law for alcohol/drug abuse, by state law for mental health records or HIV/AIDS related records, federal requirements (42 CFR Part 2) and state requirements (Iowa Code chs..228/141) prohibit further disclosure without the specific written consent of the patient, or as otherwise permitted by such law and/or regulation. A general authorization for the release of medical or other information is not sufficient for these purpose. Civil and/or criminal penalties may attach for unauthorized discloure of alcohol/drug abuse, mental health or HIV/AIDS information. 

This chapter will focus on some, but not all, of the areas in which the U.S. Food and Drug Administration (FDA) and the European Union (EU) regulatory authorities have attempted to coordinate their efforts to provide uniform rules and standards for the pharmaceutical industry. Specifically, we will review the efforts to harmonize approaches relating to inspections (including public disclosure of confidential information) and product approval or authorization (including clinical trials). While space limitations do not provide sufficient opportunity to describe each regulatory authority s system or the harmonization attempts in detail, it is our hope to provide some background of where the efforts are now, where the efforts are intended to go, and what we believe will be the results of these efforts. In addition, the author is much more familiar with the U.S. system than the EU system because of his experience and daily exposure with FDA, this chapter will focus more on the U.S. structure. 

This is known as the Langer test for utility and is based on the court statement As a matter of Patent Office practice, a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of 101 for die entire claimed subject matter unless there is a reason for one skilled in the art to question the objective truth of the statement of utility or its scope (emphasis in the original.) In re Langer, 503 F.2d 1380, 1391 (CCPA 1974). 

Reference C discloses compound C, and that disclosure is probably enabled since a separate reference describes the preparation of similar compounds. This assumes that the level of ordinary skill in the art is sufficient to allow one to bridge the gap between what is disclosed in the separate reference and what would be required to prepare compound C. Assuming enablement, claim 1 is anticipated by reference C. Claim 2 is not anticipated because that claim is directed to compound A. Claim 3 is anticipated if we assume that essentially pure means >95% pure the ultimate determination would... 

In rejecting claims 1-8 of Albrecht s application, the examiner noted that certain mono-basic esters of carbazole were reported to have powerful local anesthetic activity, whereas the corresponding dibenzofuran compounds were less effective. The further disclosure of the bis-basic dibenzofuran as having some minimal anesthetic activity was sufficient, the examiner alleged, to motivate a PHOSITA to make the bis-basic esters of the carbazole compounds like those claimed in Albrecht s application, since the prediction would be that the bis-basic ester of the carbazole would be a more effective anesthetic than the disclosed bis-basic dibenzofuran. It would, therefore, be obvious to make these compounds, and the claims should be rejected. 

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