4.1 Intellectual Property Basics

The process of background searching and then preparing a patent filing can often seem monumental to the first-time innovator. Fortunately, the "upstream" parts of the biodesign innovation process provide a useful base of information that can be augmented with the materials and guidelines outlined on Chapter 4.1. The steps below have been excerpted from the chapter and are presented with active web links to assist innovators in getting started.
Compile Background Information

1. What to Cover - Begin by assembling complete background information on the concept/invention and the area in which it will be practiced. This will generally include the disease state and a review of existing treatment technologies/approaches. Consider writing draft claims that cover the basic invention. These can be in plain language, not "legalese." Brainstorm about keywords for the search. Try to identify as many of these as possible (see example in text). A thesaurus and medical dictionary can be helpful.
2. Where to Look - Refer back to information collected as part of 2.1. Disease State Fundamentals and 2.2 Treatment Options. Augment this data with additional research as needed.

1. What to Cover - Start with patent database searches as the most efficient way to see a broad range of prior art (before searching non-patent sources). Consider hiring a patent agent or attorney to assist with the prior art search. Many inventors benefit greatly from a more formal "prefiling search" or patentability assessment. An attorney can help identify the areas where patent protection is most likely and can help focus the content of the patent application covering the invention.
2. Where to Look -
   • The U.S. Patent and Trademark Office Web Patent Databases - U.S. patents issued from January 1976 through present are full-text search enabled. Patents from 1790 through 1975 are searchable only by patent numbers and current U.S. classifications. Full-page images are available for most patents from 1970 to present. A tutorial on how to use the database is available on the site. Note that issued patents and patent applications are in separate search fields.
   • U.S. Patent and Trademark Office Official Gazette - Weekly publication to announce those patents being issued and those trademarks being registered or published for opposition. Users can search or browse from 1964 to present to stay informed regarding new patents and changes in the field.
   • Google Patent Search - Provides searchable access to the full text of the U.S. patent corpus to find patents of interest.
   • Delphion Intellectual Property Network - A subscription database that allows individuals to search the bibliographical and claims portions of U.S. patents from 1974 to present. This service recently added European Patent Office and World Intellectual Property Office (WIPO) text and images. All patent references are hyperlinked for citation searching. Classification codes are also hyperlinked to assist in finding similar patents granted.
   • Derwent Innovations Index - Provides a database of international patent information. On the site, "equivalent" patents are available in multiple languages. This database is provided by the Institute for Scientific Information.
   • Free Patents Online - Allows quick searching through U.S. patents, U.S. applications, and European patents. The most useful aspect of the site is being able to download PDFs of actual patents.
   • International Patents Databases -
   • Other Databases - Be sure to search PubMed and other medical sites for articles and abstracts, as well as perform general Google searches for more obscure references to relevant information.

Identify Relevant Prior Art for Patentability
Prepare a Patent Application
File a Patent Application

1. What to Cover - The first step is to determine which of the patents and other materials that have been located via the prior art search are most relevant to the patentability of the invention. The draft claims from section 1.1 above are useful here. The more elements of the claims that are taught by the prior art, the more relevant this patent is to the search. Aim for the most relevant 10 to 20 patents in the first cycle. The second step is to broaden the search out again, using either citation search or classification index from the patents of interest identified in the first cycle. This should result in some new patents, and excluding some others from the first step. Repeat this cycle of broadening and filtering. Once the list of patents of interest stabilizes at some relatively small number (probably 5 to 15), these are key patents. Remember that new art is published daily, however, so searching is an ongoing process
2. Where to Look - Use the information gathered from the prior art search to complete this analysis. When necessary, go back to the sources listed above to perform additional research.

1. What to Cover - For provisional patent applications, the application can be prepared by the inventor, but it is wise to have it reviewed by a patent attorney or patent agent. Although any material can be filed as a provisional patent application (including a drawing on a napkin or a PowerPoint presentation), it is essential to have a thorough description of the invention, including the main sections of a provisional application described in the chapter. For a utility patent application, a patent attorney or agent needs to be involved in writing the application, but the inventor can save considerable time and expense by drafting the background, providing rough drawings, and drafting key claims in plain language (see 5.1 IP Strategy for more information about selecting an IP attorney and the costs involved). If draft claims have already been written (as in step 1.1 above), modify these based on the prior art to clearly demonstrate advantages provided by the new invention. Identify possible variations. Make sure all possible ways of putting together and carrying out the invention have been covered. Consider drafting both method and device claims. Prepare all necessary figures - the USPTO requires that drawings show each and every element claimed in the patent application. Next, draft the specification. With the new claims and the drawings as a guide, write a description of the invention. Be sure to include all of the elements of the invention, and all variations that have been brainstormed. Now there can be an effective meeting with a patent attorney or agent.
2. Where to Look - Even if an inventor is planning to work with a patent attorney to file, the following resources can be helpful in understanding and preparing for the patent application process:

1. What to Cover - Both provisional and utility patent applications can be filed online using the USPTO's system, EFS-Web. Documentation of receipt will be provided by the site. To file the application by mail, download the coversheet and transmittal form from the USPTO website. Make sure to fill out a return receipt postcard (this will be the only documentation of the priority date provided if the filing is by mail). It is wise to use a stable return address (students may want to use the address of their university's office of technology licensing). It is best to mail by United State Postal Service (USPS) Express Mail rather than FedEx or some other express carrier. If the document gets lost, only USPS handling guarantees that the mailing date will be the filing date.
2. Where to Look - Refer to the USPTO website and the EFS-Web system for more information.