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 and/or end-users 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 used to rest with the UC Systemwide Office of Technology Transfer (OTT) until a process of decentralization to campus control was begun in 1990. In 1996, the UC Office of the President and UCSF reached an agreement whereby, as of July 1, 1996, UCSF would assume management responsibility for all UCSF technologies disclosed after that date. The agreement also provided that transfer of management of past UCSF technologies from OTT to UCSF could be made pursuant to certain criteria and, likewise, that UCSF inventions disclosed after that date that were related to UCSF inventions already under the OTT's management could be transferred to OTT so that those inventions could be managed in an integrated manner.

In 1995, UCSF 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. Currently, UCSF investigators generate from about 150 - 200 new technology disclosures per annum. Among the 10 UC campuses, UCSF is #1 in license income, #1 in licenses, and #1 in patents.  

UC patent policy requires that technologies conceived or developed by its employees be disclosed to the OTM in a timely manner. As per the California Labor Code, UCSF inventors assign their title in their inventions to the university and these inventions are managed by the OTM as assets of the State. The OTM evaluates each disclosed technology on the merits for commercial potential, patentability and, most importantly, licensability. The OTM will then obtain patent or other intellectual property protection when and however warranted, diligently market the technology to industry and/or end-users, negotiate all license terms, draft the actual license agreement, manage the resulting license agreements over their term (which can exceed 20 years in the case of multiple patents or substantially longer in the case of copyrights) to insure licensee compliance, and distribute net license income to the inventors, any joint owners, and 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 an organism, antibody, 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 tangible research products or TRP. In all cases, the process begins when the inventor discloses his/her technology to the OTM.

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

IP Strategy:  Based on the Director's and LO's evaluations, input from other OTM staff at the OTM's weekly group meetings, and industry-specific feedback, the LO will develop and implement an IP management strategy that includes whether or not UCSF will elect title and file a patent application on the technology. The decision to file a patent application is not solely based on the likely patentability of the technology, but rather, and more importantly, on its licensability. Not every technology needs to be patented in order to be licensed and not every patentable technology is licensable. The OTM often licenses unpatented technologies including software (license of UC's copyrights) and Tangible Research Properties such as cell lines, mouse lines, plasmids, etc. (license of UC's property rights). Companies frequently license these unpatented technologies for internal research use to save the time and expense of re-creating them.

Patent Filing:  The OTM prefers to have identified a licensee before investing in a patent application filing for two reasons: 1) the OTM can pass the patent costs to the potential licensee, and 2) the potential licensee can work with the OTM to draft an optimum patent application that takes into account the commercial landscape and the licensee's business strategy and thereby produce a license of greater value for the company. However, the OTM will file a patent application "at risk" (without a potential licensee in hand) if it believes the technology has a good likelihood of being licensed. But, if the OTM has not been able to identify a licensee after a reasonable period, it will most likely abandon such at-risk patent applications in order to cut its financial loss because of the high cost of obtaining and maintaining a patent in the U.S. and especially abroad.

Term Sheet:  If the company remains interested in licensing the technology after completing its own detailed analysis, the LO may negotiate a Letter of Intent with the company that commits the OTM to negotiate exclusively with that party for a specified period of time.  At this point, the parties anticipate that these negotiations will result in a license. The first step towards the actual license is for the parties to negotiate a Term Sheet, which is a short document that defines the high-level financial and business terms to which the parties can agree that are most important to the parties.

License Agreement:  Once the Term Sheet is in place, the parties will commence negotiating the actual license agreement which entails multiple iterations during which time numerous other points will emerge that need to be discussed and resolved to mutual satisfaction. Successful license negotiations invariably require flexibility, creativity, and commitment by both parties. A technology can be licensed exclusively to one company (or to more than one company for different field-limited uses), or non-exclusively to many different companies. A company may prefer first entering into an Option Agreement to license the technology at a later date during which time it can fully evaluate the technology in-house for a specified period without the risk of seeing it licensed to a competitor. A license agreement for an exclusive patent license can range around 40-50 pages. All of the OTM's licenses must pass independent legal review by UC's Office of the General Counsel before the OTM's Director will sign them.

Conflict of Interest:  If an innovator has or will have a financial relationship with a prospective UCSF licensee (e.g. the innovator, spouse, or dependent child receives money from or has stock in the licensee), the innovator needs to disclose this financial interest to the LO for guidance about this potential conflict of interest. The OTM's Director is a member of the Chancellor's Advisory Committee on Conflict of Interest and can advise the innovator accordingly.

3. Patentability

It is not always necessary to patent an invention in order to be able to license it, and not every patentable invention is necessarily licensable. 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. Novelty is defined differently in the US and the rest of the world. In the US, the inventor must file a patent application within one year of: 1) publication (i.e., any unrestricted enabling 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, public use or offer to sell, 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 the OTM.

Utility
An invention will be considered useful if it has some qualitative benefit, i.e., the patent application must specify a demonstrable and meaningful 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 through published statements in scientific publications, reviews, etc. implying or stating that something is not likely to be or to work. 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 that collectively define the invention for patent purposes.

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 known to the inventor at the time of preparing the patent application and also throughout the patent prosecution process. 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 patent 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, which are each one sentence long, 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.

7. After the Attorney Interview

Following the meeting, the patent attorney (or patent agent) will prepare a draft of the patent application 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 before the attorney commits time to drafting the full application.

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 to sign an assignment of the patent application to The Regents of the University of California. Although your signature on your Technology Disclosure Form assigns your rights to The Regents, the Patent and Trademark Office requires your signature on its own assignment form for patent purposes.

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 patent application, introduced under GATT legislation in 1995, allows an applicant 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, if the OTM needs to file quickly in order to preserve foreign patent rights because the inventor has an upcoming publication or presentation, the OTM may simply file a preprint or completed invention disclosure on short notice. A provisional application also allows the OTM 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 by the United States Patent and Trademark Office, nor can it be mature into a patent. It only serves as a placeholder, for priority of invention purposes, until a formal application based on the provisional application 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. Also at this time, the OTM will have to decide to file the patent application abroad for international patent purposes.

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 legal standard of "enablement" is the same in both provisional and formal applications. Failure to file a provisional patent application that is written to these standards can create serious problems at the time the applicant wants to convert the provisional application to a formal application at the one-year point.

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 1-2 years of the filing date (depending on the PTO's work load and staff size), 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 that can consist of rejections based on legal points and rejections based on the science and technology.

When the attorney receives the Office Action, you will be asked to comment on the Examiner's science and 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, extendable 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, these additions can be made 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. In this way, filing a provisional application shifts the patent term by one year which allows the applicant to benefit from one more year of product sales than would have otherwise been possible. For this reason, the OTM may file a patent application with a "provisional" status even though 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 foreign rights. Such corresponding foreign applications are generally not filed unless (a) reimbursement by a licensee has been negotiated or (b) the commercial potential 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)

Distribution of the TRP to other scientists for research purposes only. 

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 not to 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.

Distribution of the TRP to companies.

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.

Distribution by a third party of a commercial embodiment of the TRP under license from UCSF at terms that are commensurate with the technology's value.

These licenses can be exclusive entail the licensee further developing the TRP and assuming all commercial risks. For software, the licensee will debug it, may port it to other platforms, develop manuals, add subroutines, provide an attractive user interface, etc. The licensee will market the commercial embodiment and provide support to its customers.

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.

The developers of the TRP need to agree in writing about how they will share the "inventors' share" of the license income. In most cases, the distribution will be straightforward. In those cases where it may not be clear or the developers cannot agree among themselves, the Director of the OTM will consult with the developers and possibly other parties and recommend an appropriate distribution.

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 to be included in any part of the patent application, the United States 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 patent 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 method is not used, 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.