Developing New Products for Patent

by

Denise Zanecchia, Ph.D., R.N.

Part 1 The path from idea to patent

An endless pursuit for novel, efficacious and safe products inspires scientists around the world. These inventors strive to discover new drugs, devices, processes and tools that can be patented. When the idea is patentable, an application is made to the U.S. Patent and Trademark Office (PTO).

Many ideas originate from a basic problem. The saying "Necessity is the mother of invention" was first a play called "Northern Memoirs" written by Richard Franck in 1658.¹

Complex and simple ideas may lead to unique discoveries and subsequently to patented inventions. Usually patents identify alternatives or improvements to existing products or processes. Patents stimulate continued research efforts for new products and may preserve the current state of the art. ²

History of Patents

Patents date from 15th century Venice. In 1474, the first patent law recognized the exclusive rights of an inventor for a specific but limited period. Galileo received a patent for a one horsepower irrigation pump in 1593.

U.S. colonies and states issued the first U.S. patents until 1787 when the U.S. Constitution created the patent provision: "Congress shall have the power . . . to promote the progress of science and useful arts.... by securing for limited times, to authors and inventors.... the exclusive right to their respective writings and discoveries."³

The first U.S. patent was granted to Samuel Hopkins of Philadelphia. It was issued for an improvement in the making of potash. Today, in a world exploding with information, the century old established philosophy of patents prevails.

The goal of a patent is to encourage invention. The objective of a patent is to discover and to continue the advance of science. The main purposes of patents today remain what they were two hundred years ago: protecting the inventors' rights to his or her inventions. Patents further promote the progress of technology.⁴

A few years ago, the U.S. Patent and Trademark Office (PTO) issued patent Number 5, 397, 696 for a human T-cell line. The T-cell was found in the blood of a young primitive New Guinea tribesmen. These Hagaha tribesmen carry a virus but do not suffer its disease. Dr. Carol Jenkins, an American medical anthropologist at National Institutes of Health helped obtain the patent. She and other scientists are concerned with biological patents. The potential for flu vaccine development raises many global issues and creates ethical and legal patent dilemmas.⁵

Patent Terms

A neophyte inventor needs a basic understanding of the patent process, its language and terminology. Many unique terms are used in patent work. A list of the most common patent terms appears in Table 1, Glossary of Selected Patent Terms. ⁶

Anticipation: When the prior art indicates that a patent application lacks novelty.

Applicant: Person(s) applying for a patent who claim to be the inventor; person filing the patent

Article of Manufacture: A class of patentable subject matter; any item that can be made by man.

Assignee: The person or organization to whom the rights associated with the invention have been transferred. In the U.S., the corporate body who acquires the rights to manufacture or license the invention from the inventor.

Assignment: The legal document that describes the terms and conditions under which the rights to the invention are transferred to another.

Assignor: The person or organization owning the patent rights and transferring them to another.

Background of Invention: A section of the patent application in which the technological area of the invention is described.

Best Mode: The best way, known to the inventor, of making or operating the invention; must be presented in the patent application.

CRF: An abbreviation for Code of Federal Regulations. (Volume 37 includes the rules and regulations for patents, trademarks, and copyrights).

Claim: The precise descriptions of the part of the invention for which the inventor is seeking patent protection.

Conception: The act of visualizing an invention with all details.

Diligence: The activity of the inventor after conception, demonstrating steady progress toward reducing invention to practice.

Examiner: An employee of the Patent and Trademark Office charged with determining the patentability of an application

Hamonization: The proposed alignment f the patent laws that will be establishuniformity of rights in all countries.

Infrigement: An alleged or actual manufacture or import of an invention currently protected by a patent

reduced the invention to practic

Inventor, Joint: One who, in connection with one or more other persons, conceives an invention and plays a part in csin the same to be reduced to practice.

Manual of Classification: The set of documents that lists all the classes and subclasses that are contained in the .S. Patent Classification Syste

Marking, Patent: The placing of one or more U.S. patent numbers on the surface or on the surrounding packaging of a patented article

Novelty: The concept that the claim defining an invention in a patent application must be totally new,

Obviousness: The concept that the claim defining an invention in a patent application must not be a predictable improvement on what has been done or published before the priority date.

Official Gazette: The weekly publication of the U.S. Patent and Trademark Office that lists the patents of the week.

Patentability: The ability of an invention to satisfy the legal requirements for obtaining a patent including novelty.

Patent Attorney: a legally trained person with a technical background who is permitted to practice before the patent office in the interest of the inventors.

Patentee: In the U.S., the inventor in a specification, who has the theoretical rights to the invention.

Patent Cooperation Treaty (PCT): A treaty between the U.S. and Canada which provides a method for the preservation of rights in designated foreign countries for later filing of the patent application in those countries.

Patent Pending: Words used on an item to indicate that a patent application has been filed with the U.S. Patent Office.

Patent Search: Usually a search of the prior art to determine whether previously issued patents have disclosed the subject of the search.

PDL: Patent Depository Libraries, established throughout the United States, which contain a file of patents for searching and trained personnel to help the searcher.

Prior Art: Previously used or published technology, that may be referred to in an application; all prior knowledge, patent, literature etc., relating to the claimed invention.

Occasionally, an irritation generates an idea worthy of examination. Perhaps a new way to solve an old problem is needed or an improvement to an existing product or process is warranted. Strong desire and motivation drive an inventor. Whatever challenges the inventor, rigorous determination and earnest work are necessary to persevere through each step in the process: from idea to patented product. The Steps of the Patent Process are in Figure 1. Several steps may be conducted simultaneously.

What is a Patent? Definition and Characteristics

A patent is a grant to the patentee, of the right to exclude others from making, using, offering for sale or selling an invention. ⁷ It is a written, legal document with territorial limits. U.S. patents apply throughout the United States and are valid for twenty years beginning on the date the patent application is filed. ⁸ The definition of a patent is set forth in Title 35 of the U.S. Code, Section 154 (35 USC 154). ⁹

Patents have three basic characteristics: contractual, property and monopoly. A contractual agreement exists between two parties, the inventor and the government. Therefore, the patent must fully disclose how to make and use the invention. The government protects the invention and excludes others from making, using or selling it for the designated period. When the patent expires, the invention is dedicated to the public.

Conceptually, the property aspect of a patent is similar to real estate. A patent is transferable and salable. When licensed for development by others, it is rentable. Patented inventions sometimes generate royalties. Monopoly is the third patent characteristic. A patent is an exclusive right for a limited time. The patent monopoly does not grant the right to practice the invention but to excludes others from doing so.^{10 11}

Types of Patents

The U.S. Patent and Trade Mark Office ( PTO) issues three types of patents: design patents, plant patents and utility patents.¹² Design patents protect any new and original ornamental design for an article of manufacture. Plant patents grant protection for the discovery or a sexual reproduction of a distinct and new variety of plant. Utility patents are the most common type of patent and protect the utilitarian aspects of a device. They provide protection for processes, new machines, novel articles of manufacture or compositions of matter.

Criteria for Patented Invention

For an invention to be considered for a utility patent, the invention must be either a process, a machine, a manufactured article or a composition of matter. A process invention is a method or a series of steps done to an article to produce a change. A machine invention includes mechanical devices or groups of elements that interact to produce a result. Manufactured inventions or an article of manufacture includes any humanly made item. Composition of matter includes a chemical compound, a mixture of ingredients or a formulation.

Legal Requirements

There are three legal requirements for an invention to receive a patent: novelty, utility and nonobviousness.¹³ The invention must never have been described in the literature or manufactured. In the United States, a patentable invention must be unknown, never published or patented anywhere. The person applying for the patent must be the original and first inventor. The invention must be useful, practical, and not a work of art.

Patents must not be obvious or predictable improvements of what is already in existence. Non-obviousness is usually a debatable quality. The patent law requires that the subject matter for the patent be different from the prior art in the public knowledge domain. If the differences between the prior art and the invention are obvious to a person of ordinary skill in the art, the new invention is not patentable. The invention must improve substantially over what is available. It must have unique features which are not illegal or immoral.

Phases of the Patent Process

The path from idea to patent is a long, tedious process with three distinct phases: pre-patent application, patent application and prosecution. First, the pre-patent application phase begins with an idea. In a typical case, a more effective or consistent, a more reliable methodology, a standardized device, are discovered and the invention is developed into a prototype.

The conception of a clinical device is a mental image of the complete invention. It is a definite and lasting image that is drawn on paper. A written description of the perception of its use and function is prepared. Initial notes and sketches describe how the invention would apply in clinical trials and in practice. The graphic art for the device derives from these rough sketches. Following several trial versions, a final one is selected and used to create the first model or prototype.

Manufacture of a prototype is the reduction to practice. The production of the first graphically designed prototype may be through a vendor. A few devices are made to use with normal subjects in clinical trials. After a few changes, an updated model prototype is produced.

The second phase is the patent application phase. This includes the decision to file for a patent and the preparation of the patent application. Patents applications are one of the most difficult legal documents to prepare.¹⁴ Most inventors retain a registered patent attorney or patent agent.

A patent agent or attorney is someone who has demonstrated the required qualifications to the PTO. These professionals must know the patent laws and must pass the "Patent Bar Exam". This examination has a reputation of being more difficult than state bar exams. The lawyers and agents who master the Patent Bar Exam may represent the inventor before the PTO. In the corporate setting, the inventor usually takes the invention to a patent attorney in the legal department.

Prosecution is the third phase. It begins with the process of examination of the application by the PTO. This phase ends when ends the patent application is finally rejected or a patent is issued. Each year, the PTO receives more than 150,000 applications for patents. It has granted more than 5 million since 1790.¹⁵ The average time for completion of these three phases is 18-24 months.

Searching for Prior Art

What is thought to be unique, may not be. There is a need to explore all existing devices, patented or not. Timing is a critical factor in the pursuit of patent information. A review of the basic literature can be an overwhelming task for the average person. An information scientist conducts extensive literature searches involving several months. In addition to the basic literature search, a search of the patent literature is necessary. This search usually requires the services of a professional patent attorney.

Searching for prior art may be helpful to assure that the invention is novel and improves on the existing product. Numerous on-line services are available for inventors who prefer to conduct their own searches, but the process is complex. The PTO suggests that searching for prior art is best done by a patent attorney.

There are four types of searches included in the prior art search. The searches are patentability, infringement, validity and assignment. Patentability search is a general search of the concept/idea and its relationship to the state of the art. An infringement search aims to find overlap with any other patent and to identify any conflict areas. A validity search asks about any references that affect an issued patent, and is similar to a patentability search. Assignment search finds out who holds the patent to develop the product.

The PTO has a Search Room in the patent research library in Washington, D.C. Also there are 70 Patent Depository Libraries (PDLs) located in 45 states throughout the country. A hand search may be done in the public search rooms in the PDLs. Public access is available for the PTO Databases in Arlington, Virginia.

The PTO uses a classification system with four groupings--electronic, chemical, engineering and mechanical. For a keyword search, there are more than 400 main classes and 160,00 subclasses of patents found in the Index of Patent Classifications. The Index is an alphabetical list of subject references for the classes and subclasses. ¹⁶ Certain PTO Databases are available in the PDLs across the country. The PTO also has placed patents on CD-Rom disks for sale to the public. Changes in the patent process are planned for the U. S. PTO. ^{17 18} In the future, the patent processes also may be changed within the Japanese and European patent organizations. ^{19 20}

Searching on the WEB

Computer Online services are available for searching.²¹ America On Line (AOL) has a basic reference available.²² Questel-orbit and Datastar are other online vendors. Online searching can be expensive and time consuming. ²³

Several sites on the WEB are providing patent information. Knight Ridder's Dialog charge as much as $100.00 an hour to search its patent databases, http://www.dialog.com. MicroPatent @ micropat.com provides free full text searches of recent U.S. patents published in the previous 10 days. Other patents dating back to 1974 can be downloaded for 25 cents per page.

Source Translation and Optimization (STO) in Belmont, MA is building a free WEB site with an archive of U.S. patent abstracts from 1981 to 1989. STO conducts prior art patent searches for $200.00 and prior art literature searches for $400.

IPNS is a weekly mailing of all patents listed in the most recent issue of the PTO Patent Gazette for the previous week. One may subscribe to IPNS through the STO WEB site. The U.S. Patent and Trademark Office site is http://www.uspto.gov and the European Patent Office is http://www.epo.co.at/epo/.²⁴

Drafting the Patent Document

The patent application has two functions. One is to describe the invention so that it can be understood by someone skilled in the art. The other is to inform the public of the limits of the patent. These limits are called claims.²⁵ The patent document or application is both a legal and a technical document. It is composed with collaboration of the technical expert-- the inventor and the legal expert--the patent attorney. The patent document is authored by the legal expert, the patent attorney, based on the information supplied by the inventor.

An ideal patent document follows the rules in the Code of Federal Regulations (CFR), Volume 37. The application becomes the text of the patent, it is easier to understand if a standard format is used. ²⁶ The first page of the patent document is the title page. It includes the name of the country issuing the patent, the patent number, the last name(s) of the inventor(s) and the date of the issuance of the patent. Internationally accepted codes called the International Numbers for Identification of Data (INID) identify the bibliographic information. The title of the invention is found on the second page. The complete list of all eight parts of the patent document appear in Table 2. Parts of the Patent Document.

Table 2 Parts of the Patent Document

1. Title of the invention

2. Cross references to related application, if any

3. Background of the invention-field of the invention, description of related art 4. Summary of the invention

5. Brief description of drawings (if any)

6. Detailed description of the invention

7. One or more claims

8. Abstract of the disclosure

Patent documents are also subject to a system of codes. International agreements are in place for standardization of codes for the names of countries on the front page. Numbers for the identification of bibliographic data (INID) are found in brackets on the front page. The American patent application numbering system began with Number 1 in 1836 and sequenced from 1 to 1,000,000. ²⁷ A patent number reverts to Number 1 approximately every nine years.

No matter what type of patent is sought, the basic elements of the application are similar: a written description, drawings and claims. The written description begins with a short background section to explain quickly the problem encountered and what is to be accomplished by the invention. A longer detailed description of the invention follows and is the main text of the application. The written description is called the specification. It uses exact terms and must be complete, clear and concise. The best way to make or use the invention must be described in this section. Anyone skilled in the art should be able to make the invention from the description given in the specification.

The specification may also include a description of any drawings at are included in the application. Drawings are used with the written description to clarify the details of the invention and simplify the text. Examples of drawings are schematics, chemical chains, computer codes or for designs patents, how the item will look. Except in the case of a perpetual motion machine, a working model of the invention does not have to be submitted with the application for the patent.²⁸ Drawings will almost always be required.

Claims

Claims are found near the end of the patent document after the specification. Patent claims define the boundaries of the patent and the scope of the inventor's monopoly.²⁹ Claims use highly technical language and are best written with the help of an experienced patent attorney or agent.

Claims have three parts: preamble or introduction, the transitional phase and the body. There are two types of claims, independent and dependent. Independent claims stand on their own, and do not rely on language incorporated from any other claim. Dependent claims incorporate the features of one or more of the preceding claims by reference, and they add a further limitation or condition.

Claims identify the "metes and bounds" of a patent and are the focus of any infringement lawsuit. The sweeping multimedia software claims of Compton are an example.³⁰ When a patent is granted, infringement is based on the wording of the claims. If an inventor believes his invention is an improvement or a different way to accomplish the same thing than is described in a patent, a new patent may be obtained. But if the improvement is too close to the original, then a claim of infringement may be made. Infringement means an unauthorized making, use or sale of the invention claimed in the patent. Since 1982, the courts have found infringement of patent rights in about 70% of the cases.

Prosecuting the Patent Application

Patent prosecution is not prosecution in the commonly understood meaning. Prosecution in the patent process simply means advancing the patent application through the PTO to issuance. Issuance of an application is not automatic and patent applications are subject to a rigorous examination by the PTO.

Most applications are initially rejected. Prosecution time for most U.S. patents ranges from 2 to 2 1/2 years. In June 1995, U.S. patent legislation increased the period of patent protection two years. The period begins on the date of grant and ends 20 years from the filing date of the application.³¹

The completed patent application includes an oath of declaration signed by the inventor(s) and payment of the filing fee. Filing fees are $375.00 for a small entity and $750.00 for a large entity. Once the patent is allowed, the inventor must pay the Issue Fee. The Issue fee for a patent is $625.00 for a small entity and $1250.00 for large ones. Inventors also must pay maintenance fees after 3 1/2, 7 1/2 and 11 1/2 years.

Maintenance fees for small entities are $495.00, $995.00 and $1495.00. For large ones, these are $990.00, $1990.00 and $2990.00. If a patent lapses due to non-payment of maintenance fees or expires when it runs the full term, the invention disclosed in the application is dedicated to the public.

Following an inspection of the formal requirements, the filing date is given and the PTO gives the patent application a serial number. The application is assigned to an examining group that has someone with technical specialization. The application is held secret by the PTO until the patent issues, although legislation has recently been introduced that will provide for publication of patent applications 18 months after the filing date. No substantial changes in the specifications may be made after this filing date. Minor errors, however, may be corrected and claims amended.

Patents are available information sources and provide vast amounts of comprehensive information.³² Examiners continually conduct a prior art search that either allows or rejects the application. If the examiner rejects the application after the prior art search, the applicant may amend the claim and present arguments to refute the rejection. The patent is then allowed or finally rejected.

It takes the PTO from 18 months to 3 years for a normal patent to process. The PTO has been trying to shorten this time but the process is easily engthened by adding information or changing the wording. Patents can be extended for up to five years to account for specific delays in processing that are beyond the inventor's control, i.e. agency tests, secrecy orders for national security or successful appeals of rejections.³³

Once the patent is granted, a patent number is assigned. All documents relating to it become available for public inspection. The common practice once the inventor obtains the patent is assigning his rights in the patent to his company. The assignment is a document that is signed by the inventor, notarized, dated and recorded. It gives the assignee ownership of the patent and the legal authority to develop the invention and to receive any payment royalties.

The PTO

The PTO is a part of the Department of Commerce and is located in Alexandria, Virginia just outside in Washington, D.C. Employing 1600 patent examiners, the PTO approves and issues between 1500-2000 patents each week. By 1995, approximately 350,000 design patents, 9000 plant patents and over 5,000,000 utility patents existed. Of the over 5,000,000 utility patents issued, 4 million were issued in the first 200 years and one million issued in the next 14 years. ³⁴ Over 8 million inventions have been published worldwide since 1968. Interestingly, during the past two years, most U.S. patents came from three states. California produced 10,472, while New York generated 5,552 and Texas provided 4,089.

International Patents

Every country has its own rules and regulations on patents that it issues, although through international frontiers, most patent laws have been harmonized. Generally most countries grant patents for a period running 20 years from the filing date of the application. Patents are territorial and enforceable only within the boundaries of the issuing country. If the patented product has international potential, it may be necessary to file a foreign patent application. Repeating the procedure for each country is expensive and time consuming.

In the United States, patents are granted to the first to invent. Foreign patents generally are granted to the first to file an application. Most countries require an applicant to make the initial filing in the home country. If the patent protection is sought in another country, a patent application is required to be filed within twelve months in order to get the benefit of the earlier filing date. In Europe and Japan, utility models exist which have a simpler inventive step as the specification required for U.S. patents. ^{35 36 37}

Conclusion

Global competition in the pharmaceutical/biotechnological marketplace is not unlike the world of business and finance. Being best and being first to produce new patented products is the quest for research and technology companies. Leaders in science and industry watch for new inventions of promise. Tracing patents is a key activity in forecasting future trends in R & D. Tracking newly patented products with potential for profits may predict future research direction. Awareness of the patent literature can be an important knowledge base from which to visualize strategy. Whether the patented invention sparks ethical dilemmas or simply provides better science, the path from idea to patent requires the same process. Patents may yield substantial rewards for those who invent these new products.

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7. T.T. Gordon and A.S. Cookfair. op cit. p.9.

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9. T.T. Gordon and A.S. Cookfair. op cit. p.16.

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11. T.T. Gordon and A.S. Cookfair. op cit. p.16

12. C. Wu and E. Calhoun. op. cit.

13. S. Van Dulken. op. cit.

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16. S. Van Dulken. op.cit.

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19. Japan to get new patent process. Biotechnology Newswatch. p.11 (1) July 17, 1995.

20. S. Nathan. Reforms planned to attract more applicants. (European Patent Organization) Chemistry and Industry n. 11 p.403 line 5, 1995.

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22. AOL op cit.

23. B. Santo. WEB proves patently useful. Electronic Engineering Times n. 869 p. 126 (2) Oct. 9, 1995.

24. B.Santo ibid.

25. T. Gordon and A. Cookfair. op cit. p.50-54.

26. C. Wu. op. cit.

27. S. Van Dulken. op. cit.

28. S. D. Glazer. op.cit.

29. G. Moran. "What are patents? Why do we need them." New York: Arnold, White and Durkee. 1995. p. 4-6.

30. K. Patch. PLO nears resolution of Compton's complaint. PC Week v.11, no. 9. p.97. March 7,1994.

31. M.F. Conlan op.cit.

32. R.S. Campbell. Patenting the Future, A new way to forecast changing technology. Futurist v. 17 no.6 p. 62-67. December 1983.

33. S. Chartrand. op. cit.

34. C. Wu op. cit.

35. S. Van Dulken. op. cit.

36. Japan to get new patent process. op.cit.