Table of Contents

1. Introduction to OTM
2. OTM's Standard Operating Procedure
3. Patentability
4. The Patent
5. Preparing for the Attorney Interview
6. The Attorney Interview
7. After the Attorney Interview
8. Patent Prosecution
9. Tangible Research Properties
10. Tips for Biotechnology
11. Tips for Software
12. Tips for Electronics

Appendices

A. How DNA Sequence Information Should Be Presented to the Attorney/Agent
B. ATCC Requirements
C. Who is and is not an inventor
D. Miscellaneous Suggestions

The UCSF Office of Technology Management (OTM) was established in 1996 with the charge to bring the results of the research and educational programs at UCSF forward for public use and benefit, with any net revenues derived from licensing those results to industry to be applied for the purposes of supporting the basic research, clinical research, and education missions of UCSF.

The responsibility for managing technology of the nine University of California campuses rested with the UC Systemwide Office of Technology Transfer (OTT) until a process of decentralization to campus control was begun in 1990. In 1996, agreement was reached with the UC Office of the President whereby, as of July 1, 1996, UCSF would assume responsibility for all UCSF technologies disclosed after that date. The agreement also provides that transfer of management of past UCSF technologies from OTT to UCSF can be made pursuant to certain criteria.

UCSF in 1995 had the largest gross royalty revenues of any single university in the world, over $42 million. It accounted for 76% of the total combined income of the nine UC campuses. Over 100 new technology disclosures per annum, or over two per week, are generated from research and scholarship at UCSF.

UC patent policy requires that technologies conceived or developed by its employees be disclosed on a timely basis. Title to the technologies is assigned to the university. The OTM will receive these disclosures, evaluate the disclosed technology for commercial potential, obtain patent or other intellectual property protection when appropriate, diligently seek to license the technology to industry, manage resulting license agreements, and distribute net revenues of the process to inventors and within UCSF.

An item of technology may be an invention for which a patent is sought or a writing for which a copyright is obtained. Patents and copyrights give their owners the right to exclude, which we can term here an intangible right. In other cases, the item of technology may be a tangible product such as a biological organism or a computer disk with embedded data. In some instances both tangible and intangible rights will be included in a license grant to a company. Section 12 herein will cover what we will term in this document as tangible research products or TRP. In all cases, the process begins with a technology disclosure to OTM.

The next section will describe the process from technology disclosure through licensing in more detail.

Different inventions require different licensing strategies. For example, a basic new scientific tool likely to be widely used is typically licensed on a non-exclusive basis. In contrast, an invention which requires significant investment of resources by a company is typically licensed on an exclusive basis. The exclusive license provides an incentive to the licensee to commit the risk capital investment required for product development.

Part of developing a license strategy involves seeking information and feedback from the market from various sources such as potential licensees and venture capital firms. Confidentiality agreements may be required to protect non-US patent rights if no public disclosure of the invention has occurred.

Based on this information, the LO will determine whether or not UCSF will elect title and file for a patent on the invention.

Typical university licensing experience is that about one in four technology disclosures shows enough commercial promise to justify patent filing.

OTM does not file patent applications for all invention disclosures it receives due to the high cost of filing ($8,000 - $15,000 and more for certain complex biotech inventions.). Also, not all patentable inventions are licensable because they may fail to afford a licensee enough commercial or competitive value to justify paying to license the patent rights. It is desirable to have an interested potential licensee before committing to patent filing. However, in "high potential reward" cases, the commercial potential may justify the risk of filing when guarantee of cost reimbursement by potential licensees is not reasonably assured.

The filing and prosecution of patent applications is done by outside patent law firms. Technical competence, prior experience in similar cases, and inventor preference are considered by the LO in her/his selection of the appropriate patent attorney.

The inventor's (see Appendix C for guidance on who is or is not an inventor) cooperation is essential in patent filing and prosecution. The chosen patent attorney will be familiar with the field of the invention, but he/she is unlikely to be an expert at the level of detail that makes the invention novel, useful, and non-obvious. You, the inventor, by providing both written and verbal information, will make an important difference and are indispensable for obtaining meaningful patent protection.

Many technologies, including Tangible Research Properties (TRP), are marketable without the filing of a patent application.

3. Patentability

Licensable inventions may or may not be patentable. To obtain a U.S. patent for an invention, the invention must be: a) novel, b) useful, and c) non-obvious to one skilled in the art.

Novelty
To be considered novel, an invention must be the inventor's original work. In addition, the inventor must file a patent application within one year of: 1) publication (i.e., any unrestricted written description of the invention) anywhere in the world; 2) public use in the US; or 3) an offer for sale in the US. While the United States grants this one year "grace period" to file after first public disclosure, most foreign countries have no grace period. In these countries, a patent will not be granted if the invention was known publicly, e.g., orally presented in a non-confidential setting, or disclosed in a publication even one day before the patent application filing date. In patent law, the word "publication" is interpreted much more broadly than when used in the typical research community (i.e., in a journal); if you have a question about whether or not a written or oral disclosure of any kind is a publication, please contact a LO.

Usefulness
An invention will be considered useful if it has some qualitative benefit, i.e., the patent application must specify a demonstrable utility for the invention.

Non-obviousness
A patentable invention must be "non-obvious" to someone of "ordinary skill in the art." This imaginary person "of ordinary skill in the art" does not necessarily include recognized experts in the field; rather it is a hypothetical reference to someone knowledgeable in the field who can understand the invention and has access to the relevant prior art. Because of the abstract quality of this requirement, it is sometimes difficult to predict with certainty whether the patent examiner will find the invention non-obvious.

"Non-obviousness" describes the concept of "unsuggested results, advantages or features." An invention can be "non-obvious" if it is a combination of old elements in a new way to produce a new result. Similarly, an invention can be considered "non-obvious" if others have tried to achieve the invention and failed, or if others have been "teaching away from" the invention. Some situations will require affidavits from qualified persons in the field stating the invention is not obvious to one skilled in the art.

4. The Patent

A patent is intended to publicly disclose the best mode of practicing an invention and, in particular, to point out the features that distinguish the invention from prior art. The patent includes drawings, if appropriate; and a specification that is typically broken into several distinct sections, including: the field of the invention; background of the invention; summary of the invention; description of the figures, if any; detailed description of the invention, including a detailed description of one or more embodiments of the invention, how the invention operates and is used, and examples, if any; and one or more claims.

The field of the invention briefly describes the general field of the invention. A sentence or two is sufficient to aid the Patent Office in assigning the patent application to an Examiner and in classifying the resulting patent.

The background section describes the work done in the past and what has prompted the inventor to pursue this invention. This information is referred to as prior art; inventors have an absolute duty to disclose all material prior art. The background section typically develops the progression of work and sets forth the shortcomings of the prior art. It is therefore important for the inventor to include all the prior art and to include a description of the shortcomings and differences between each of the prior art references and the invention in this section. Typical sources of prior art include journal articles, published conference proceedings, issued patents, and other printed materials.

The summary of the invention sets forth in broad terms what the inventor considers to be the invention and what advantages are gained by the invention. Since it must be written broadly, it typically does not include all the intricate details of the invention's operation. In fact, in most cases, it merely paraphrases the broadest claim.

The figures are provided to aid in understanding the invention. Where drawings do not aid understanding or are impractical, they are not included; but, nearly all inventions will have a drawing of some sort. Graphs and tables may also be included in this section.

The brief description of the drawings merely identifies the view shown in each figure.

The detailed description of the invention sets forth the theory on which the invention rests and the intricate details of at least one way (and sometimes several ways) the invention can be implemented. This description must be detailed enough for someone who is skilled in the art to make and use the invention and must include a description of the best way, in the inventor's view, the invention can be implemented. Each implementation is called an embodiment and the best one is the "preferred embodiment" of the invention.

The detailed description typically includes a section describing the operation and application (utility) of the invention.

The claims define the metes and bounds of the invention and are generally written using specialized terms. The claims describe the essential elements of an invention, first as broadly as possible and subsequently, more narrowly. It is generally easier to obtain a patent with narrow claims but, if too narrow, others can invent around the patented invention. In order to determine whether or not a product comes within the scope of a patent, one compares the product with each element of the claim; if the product is described by all the elements of the claim, then the product will come within the scope of that claim. For instance, a claim of "a vehicle with two or more wheels" covers bicycles, tricycles, cars, motorcycles etc., but not unicycles.

Patent prosecution (see below) typically involves two issues: (i) is the invention nonobvious over the prior art; and (ii) are the claims commensurate in scope with the specification; that is, would the specification allow one skilled in the art to make and use the invention, as claimed, without undue experimentation.

7. After the Attorney Interview

Following the meeting, the attorney (or agent) will prepare a draft of the patent for review by the inventor. Alternatively, the attorney may prepare a draft of proposed claims for review by the inventor before proceeding further. The latter approach may be more efficient in the long run, because it helps the parties reach a common understanding of the nature and scope of the invention at an early stage.

At all stages of drafting, it is important to point out any errors or misrepresentations the attorney has made and to explain any possible changes you have made to the preferred embodiment since the initial meeting.

After the attorney prepares the final draft of the patent application, you will be asked to sign an oath or declaration stating that you are the inventor and sign an assignment of the patent application to The Regents of the University of California.

Your copy of the application and Technology Disclosure Form should be treated as confidential and kept in a safe location. Similarly, the filing date and the serial number assigned to the application by the Patent and Trademark Office should not be revealed to outsiders.

A provisional application, introduced under GATT legislation in 1995, allows an inventor to file an informal application, but still obtain a priority filing date for a later-filed US and foreign application. As a rule, provisional applications are easier and less expensive to prepare, since claims and some other legalities of a formal application, e.g., inventorship determination, are not required.

Therefore, an inventor who needs to file quickly in order to preserve foreign patent rights before an upcoming publication or presentation may simply file a preprint or completed invention disclosure on short notice. A provisional application also allows an inventor to establish a priority date of an invention, relatively inexpensively, until a more complete assessment of technical or commercial feasibility can be made.

A provisional application is never examined, nor can it mature into a patent. It only serves as a placeholder, for priority of invention purposes, until a formal application based on the provisional is filed. The formal application (claiming priority of the provisional case) must be filed in the US within one year of the provisional filing date.

In a typical case, the provisional application will be updated with new data or improvements, for filing as a formal application within the one-year period. The revised formal application will also serve as the application for foreign filing.

There is one important caveat in provisional practice: a provisional application should contain a full and complete description of how to make and use the invention, because the standard of "enablement" is the same in both provisional and formal applications.

8. Patent Prosecution

The attorney sends the patent application and accompanying papers to the US Patent and Trademark Office (PTO) for filing and prosecution. Usually, within a year of the filing date, a Patent Examiner will search through the PTO files and will usually reject all or some of the claims based on his/her search findings. The Examiner will send a first Office Action to our patent attorney explaining the reasons for rejecting the claims.

When the attorney receives the Office Action, you will be asked to comment on the Examiner's technology-related rejections. You may need to provide additional information to the attorney regarding differences between the cited references and your invention. We have three months to respond to the Examiner, extendible month by month for three months by paying extra fees.

The attorney then will prepare an Amendment that modifies the scope of the original claims and/or argues that the Examiner's interpretations of the prior art and claims are in error. Upon receiving the Amendment, the Examiner will again consider the claimed invention in view of the prior art and either allow or reject all or some of the claims, as amended. This process will continue until the Examiner either allows the claims or makes the rejection "final" (often at or after the second Office Action).

There are several possible courses of action from a "final" rejection. If there is good reason to believe that the examiner's rejection(s) can be overcome and all of the necessary arguments and proofs are in the prosecution record, it is reasonable to proceed with an appeal to the PTO Board of Patent Appeals and Interferences. If the case should be winnable, but additional arguments or proofs should be introduced into the record before appeal, this can be done by filing a continuation application and, in essence, "resetting" the prosecution clock to allow at least one more exchange between the PTO and inventor. In such an event, you will be asked to provide further information such as: additional characteristics distinguishing your invention from the cited references, changes you have made or plan to make to your invention, and any additional uses of your invention.

The cost of prosecution and the likelihood of getting commercially useful claims helps OTM determine the course of patent prosecution. If licensed, the licensee typically can provide useful input in the course of patent prosecution.

Patent prosecution often takes many years before a patent is granted. Once granted, a US patent is presumed valid and enforceable for 20 years from the date of patent filing. One advantage of filing a provisional application is that the 20-year period begins from the filing of the formal application, even though the invention has the benefit of a filing date up to a year earlier. For this reason, the OTM may recommend that an application be filed with a "provisional" status even if the application has been prepared to meet the requirements of a formal application.

Foreign (non-US) patent applications corresponding to the US applications are generally filed within one year of the US filing date to avoid loss of rights. Such corresponding foreign applications are generally not filed unless (a) reimbursement by a licensee has been negotiated or (b) the market size of the invention is very large and there is high potential for successful licensing.

For additional information or miscellaneous suggestions, see Appendix D.

9. Tangible Research Properties (TRP)

This distribution is made at either no cost or at the nominal costs of preparing the TRP and its handling and shipping. The recipient is asked to sign a simple letter agreement wherein the recipient agrees to not further transfer the TRP to another party without prior permission in writing from UCSF (in practice, it will be the TRP developer that authorizes OTM to permit the transfer). In the letter agreement, the recipient also accepts that there is no guarantee the TRP is useful for any purpose, relieves UCSF of any liability, and acknowledges neither UCSF nor the TRP creator/developer has any responsibility for providing support or consultation.

This distribution is priced at the value to the company of its licensed use of the TRP. The letter agreement is basically the same as for distribution to other scientists for research purposes except for the higher cost and that it is in the form of a paid-up license. It may be a site license or company-wide license. The company is limited to internal use only of the TRP.

These licenses are typically exclusive and where the licensee further develops the TRP and assumes all commercial risks. For software, the licensee will debug it, may port it to other platforms, develop manuals, add subroutines, etc. The licensee will market the commercial embodiment and provide support to its customers.

Who is and is not a creator of TRP. Establishment of who is a creator or developer of an item of TRP is important for the allocation of the "inventor's share", should net income result from distribution of that TRP. Part 9 of Section 2 OTM Technology Development Process   describes the UCSF royalty distribution formula. It is the inventor's share that we are concerned with here.

Appendix C: Who is and is not an Inventor describes in summary form the criteria for determining an inventor according to patent law. We can roughly apply these criteria to the creation of the TRP.

An agreement in writing with developers of the TRP as to distribution of the "inventor's share" will be made before OTM undertakes distribution. In most cases, the determination will be clear. In those cases where it may not be clear, the Director of OTM will consult with the developers and their supervisor, department chairman, or thesis advisor, and recommend disposition of the inventor's share.

10. Tips for Biotechnology

Prepare an information packet including a description of the materials, methods, and results (a draft manuscript is ideal) and a collection of the most pertinent background publications and references. You should also prepare a brief description of the invention's novel features, including differences from and advantages over earlier work in the field.

Describe, in a broad sense, the potential uses of the invention, e.g., diagnostic, therapeutic, or research. This description should include not only those uses that you have established through experimentation, but also any possible uses for which you can imagine your invention being used.

If DNA sequences are included in any part of the patent application, the Patent and Trademark Office (PTO) requires the sequences to be expressed in a specific and unique format. Most patent attorneys and agents use computer software developed in collaboration with the PTO to express the sequences in the required format. The guidelines listed in Appendix A are intended to help you submit the sequence data to the attorney or agent so that he/she can use that software.

If the invention includes algae, animal cell lines (including hybridomas), animal embryos, plant or animal viruses, bacteria (with or without plasmids), fungi (including yeasts), oncogenes, plant tissue cultures, plasmids, protozoa or seeds, samples may need to be deposited with the ATCC (American Type Culture Collection). The patent attorney or agent will inform you if such a deposit is necessary. Appendix B outlines the ATCC sample requirements and the information that must be submitted with the sample.

US Patent Office rules allow a depositor, if it so chooses, to restrict the availability of a deposited strain until a pertinent US patent issues. The culture must be made available to investigators after the patent issues, but the depositor can request to be notified of all parties receiving samples. ATCC's release of cultures to others, however, does not grant the recipient a license, either express or implied, to infringe the patent. If notified that a patent application has been abandoned, ATCC will return the strain to the depositor.

11. Tips for Software

If your invention involves computer software, describe the function of the code in the form of flow charts. It is very difficult and time consuming to understand the function of complex software without a flow chart and it is likely that the attorney will include the flow chart in the patent application.

In general, a patent cannot be obtained on a mathematical algorithm alone. To be considered patentable subject matter, the computer program must be applied to physical elements or process steps, including computer processes. Thus, in addition to describing the software's function, you should provide information to the attorney regarding all the potential physical elements or processes to which the software may be applied.

12. Tips for Electronics

If your invention involves electronic circuitry, provide a copy of the schematic and also illustrate the circuit in functional form, i.e., a block diagram. In most cases, the block diagram will be included in the drawings submitted with the patent application. Note: the block diagram can be completed most easily on the schematic by circling the relevant components and labeling the circle indicating the function performed by the enclosed components. If this is not done, it is best to otherwise relate the blocks of the diagram to the specific circuitry.

Appendix A: How DNA Sequence Information Should Be Presented to the Attorney/Agent

Appendix B: American Type Culture Collection Requirements

If your invention is likely to require depositing a sample at the ATCC, prepare a brief description of the biological material answering the following questions:

Appendix C: Who is and is not an Inventor

Important Note:

Do not confuse inventorship with authorship on a scientific publication. The courts have specifically held that authorship and inventorship have different criteria and are not equivalent.

Appendix D: Miscellaneous Suggestions

If there are several functional devices operating together, illustrate their interrelationship with a block diagram or a flow of control diagram.