A patent can be viewed as a contract between an inventor and the government. During prosecution, the two parties negotiate the limited monopoly property right the government will grant the inventor based on a number of factors.

The inventor must thoroughly disclose the full scope of the invention in the application. Viewed as a publication, the application must provide all of the materials and methods necessary to enable a third party to duplicate the invention solely by reading the application with reference to the state of the art and information in the public domain when the application was filed. You know it can be difficult, if not impossible, to modify a completed contract. The same applies to patent applications. Once filed, you generally do not want to concede your filing date by altering the substance of your application. Thus, you will maximize the value of your patent applications by ensuring that each of your applications thoroughly discloses the full range of embodiments of your invention, actual and contemplated.

The invention must contribute new and useful subject matter to the public storehouse of knowledge. Novelty (or anticipation) is satisfied if the claimed invention is not described explicitly or inherently (necessarily) in a single prior art reference, product or action.

More subjective is the process of determining whether an idea is inventive (not obvious). An Examiner may rely on one, but commonly on more than one, patent, printed publication or other prior art reference to assert that the combined teachings of those references suggest or render obvious the claimed invention. If the hypothetical person of ordinary skill in the art would be motivated to or could combine the individual features disclosed in the several references, an Examiner will conclude that the claims are obvious and are not inventive. The standards for determining whether an invention is obvious are framed by legal decisions. Currently, those standards rely on notions of reasonable predictability, a limited number of options from which to choose, a teaching to combine the references and so on.

Your property right is defined by the claims, sentences that describe the bounds of your property. The limits of your property right are negotiated to be as broad as the prior art allows, such as what is new and unobvious, and as broad as your application describes in an enabling fashion. A claim must clearly define the invention so that an artisan can recognize the scope of the monopoly granted to the inventor.

Here are illustrations of a series of fact patterns relating to the state of the art, the extent of the research conducted, the scope of the application, and what sort of claims could be obtained.

For example, you discovered what you believe to be a new antigen, and you produced several monoclonal antibodies to that antigen in several fusions. To make those mAbŐs, you developed a novel immunization scheme and a novel fusion protocol. You do not know about deposits, and in a rush to satisfy a potential investor, you decided to forego sequencing either the antigen or any antibody.

You hastily filed an application mentioning the antigen, you did not provide all of the details on how you made and screened your clones, instead you referred to a text book teaching making monoclonal antibodies (you were concerned about disclosing what you believed to be very valuable methods), and you mentioned all of the positive clones you obtained.

You may be disappointed that an Examiner could find that disclosure insufficient to support and obtain any claims because necessary details for an artisan to practice your invention are not provided in the application. You need to disclose how to obtain the antigen, or thoroughly describe the antigen so a third party can obtain the antigen, and you need to disclose details of your protocols so that the artisan can indeed make an antibody to that antigen.

Let us embellish the above facts, you discover the antigen is not new, although there are no previous reports of antibodies to that antigen. In the second patent application, you supplement the specification described above by including all of the materials and methods for making the antibodies of interest.

From that second application, you may secure a claim to either or both the immunization and fusion protocols because your application disclosed your obtaining several monoclonal antibodies from multiple experiments using those novel methods. However, you may not obtain claims to an antibody unless you can prove, but for your methods, it would not have been possible to obtain antibodies, whether polyclonal or monoclonal, to that antigen.

Another scenario, you add to the substance of the second application above by including in the specification, information on some of the properties of some of the monoclonal antibodies, such as a high KD, unusual effector function and unexpected cross-reactivity with an unrelated but disease-associated antigen. A publication comes to light where a third party obtained polyclonal antibodies to the antigen using unusual but not unique methods.

Based on those new facts, you may obtain claims to individual antibodies with unexpected properties, however, you may need to deposit the hybridomas, such as at the ATCC across the Potomac River in Manassas. (A hybridoma deposit after filing to obtain claims to a particular mAb is not possible outside of the U.S.)

Once the formalities associated with filing an application are completed, an Examiner will review the application. The Examiner will issue an Office Action detailing why certain or all of the claims are believed not to be patentable. We file a response which includes possibly changing the claims, arguing why the position of the Examiner is untenable and so on. This process can be repeated, and generally occurs more than once in an interplay of scientific arguments and legal procedure. Nevertheless, there are a number of devices available to you to ensure you do not abandon your rights until a patent is obtained.

When prosecution is completed on a positive note, your reward is a Letters Patent. At that point, you should place the patent number on the product or in some conspicuous site on an item associated with the product or service. The term of the patent is twenty (20) years from the earliest application filing date in the family. The term is adjusted by the flow of prosecution and can be extended for patents relating to medical or veterinary products requiring FDA/USDA approval prior to market.

Thus, do not cut corners with what likely will be, next to you, your most valuable asset. Prepare thorough and detailed applications, and, ideally, with a disclosure that allows you to present claims of graded scope in your application.

Your challenge is to arrive at a stage of having an operable invention, although it is not necessary that the invention be reduced to practice, and to file a thorough disclosure thereof as soon as possible to secure an early filing date of your invention against all others. Remember, the scope of your potential property right will be determined by the state of the art and the content of your application.

Outside of the U.S., the first to file an application describing patentable subject matter will prevail despite who might have invented first. Only in the U.S. will your notes, memoranda, laboratory notebook pages and other memorialized evidence of your thoughts and activities come into play as proof of when you conceived of the invention (conception) and when you reduced the invention to practice (either by actually practicing the invention or by filing an application) to determine who will obtain the patent. Sometimes the process of conception on to reduction to practice must have been continuous, without abandonment, particularly when the timelines between your invention and that of a competitor overlap.

Also, while securing an early filing date for your enabled invention is crucial relative to others, recognize that your first application filing triggers some immutable timelines for the full exploitation of your patent rights to that subject matter.