DRAFTING THE PATENT SPECIFICATION

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1 DRAFTING THE PATENT SPECIFICATION Adriana L. Burgy 1 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC Phone: Fax:

2 DRAFTING THE PATENT SPECIFICATION Some persons seem to suppose that a claim in a patent is like a nose of wax which may be turned and twisted in any direction, by merely referring to the specification, so as to make it include something more than, or something different from, what its words express. White v. Dunbar, 119 U.S. 47, 51 (1886). I. INTRODUCTION The claims are without question the most important part of a patent, as they define the scope of the invention. Your goal must always be to try to get claims allowed that will be construed to have the scope you intended, with a minimum of prosecution history. Once you draft the claims, however, your next task is to draft the text of the patent, that is, the specification. In this endeavor, the claims you have carefully prepared are your most important tool. We will discuss below the mechanics of drafting, focusing on how the information in a patent application must be organized and presented. We will also discuss substantive strategies for drafting the specification, with an emphasis on obtaining claims that will be construed as broadly as possible if they are ever in dispute. II. LEGAL REQUIREMENTS The legal requirements for specification drafting can be divided into two general categories. First, the formal requirements are set forth in the patent statute, 35 U.S.C., the United States Patent and Trademark Office ( USPTO ) rules, 37 C.F.R., and the USPTO Manual of Patent Examining Procedure, the M.P.E.P. The patent statute provides general outlines (e.g., the requirement for the specification to provide written description support for the claims), while the rules and manual provide detailed guidelines for the parts, form, and content of a patent application. The relevant sections of the code are 37 C.F.R Additional requirements as to the paper size, margins, and other details, can be found in 37 C.F.R The M.P.E.P. devotes all of chapter 600 to Parts, Form and Content of Application, but section 608 is most relevant to the drafting of the specification itself. Specific references to C.F.R. and M.P.E.P. sections will be included in the discussion below. Second, the law of claim construction, based on case law decisions, necessarily influences how patent applications are drafted. The key to claim construction lies in what source(s) a court will rely on, outside of the claim language itself, to interpret a claim. In 1995, 7-1

3 the Federal Circuit held, in Markman v. Westview Instruments, Inc., that when construing a claim, a judge should look to three intrinsic sources: the claims themselves; the description portion of the specification; and the prosecution history. 2 In the ten years following the Markman decision, various panels of the Federal Circuit began to stray from the traditional idea of intrinsic sources set forth in Markman, and to hold that dictionaries and scientific treatises were properly considered intrinsic evidence as well, and possibly could even be relied on before the specification when interpreting claims. 3 It became conventional wisdom that a claim term would be construed according to its ordinary dictionary definition, unless otherwise indicated in the specification. In 2005, however, the Federal Circuit, in an en banc ruling in Phillips v. AWH Corp., 4 reaffirmed the Markman holding that a patent s claim language, written description, and prosecution history should serve as the primary sources of claim interpretation, and rejected holdings that dictionaries should automatically be the starting point for determining a claim s meaning. The court relied heavily on its previous decisions in Markman, Vitronics Corp. v. Conceptronic, Inc. 5, and Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc. 6 in holding that the words of the claims themselves provide substantial guidance as to the meaning of claim terms. 7 After the words at issue are considered, the context in which a term is used in the asserted claim can be highly instructive, and after that [o]ther claims of the patent... both asserted and unasserted can be consulted. 8 As noted in the Phillips decision, [t]he claims, of course, do not stand alone.... [and] must be read in view of the specification; in fact, the specification is usually dispositive; it is the single best guide to the meaning of a disputed term. 9 The importance of relying heavily on the specification for guidance as to the meaning of the claims is discussed at length. 10 The court also pointed out that the patent s prosecution history should also be considered but that the prosecution history often lacks the clarity of the specification and thus should be used to inform the meaning of the claim language by showing how the inventor understood the invention and whether he limited the claim scope during prosecution. 11 Reliance on dictionaries or other extrinsic evidence is not out of the picture, however. The Federal Circuit in Phillips stated that extrinsic evidence in the form of dictionaries, treatises, and expert and inventor testimony can be useful and should not be precluded but it should not be the starting point and in general... [is] less reliable than the patent and its prosecution history in determining how to read claim terms. 12 In light of the above, the importance of a well written specification cannot be overemphasized. 7-2

4 III. IMPORTANT CONCEPTS A. DRAFTING THE SPECIFICATION: WHERE TO BEGIN It may seem an overwhelming task to begin drafting a patent application. Most likely a patent attorney will find himself or herself somewhere on the spectrum that ranges from having an overabundance of data and reports collected from the inventors, making it hard to decide where to begin, to having received a brief and non-detailed description of the invention from the inventors, with no apparent hope of getting any other information before a fast-approaching deadline. Many experienced practitioners offer the following advice, based on years of experience: always start by drafting the claims. Interview the inventors, read the materials they have given you, determine the scope of protection desired, and then draft the claims. You can start with just the independent claims, making sure you have at least one claim covering each embodiment of the invention for which you desire patent protection. If you want to add dependent claims at this point, you may do so, but remember that other dependent claims will probably present themselves as you prepare the specification. B. USE THE CLAIMS AS THE OUTLINE FOR THE SPECIFICATION Once you are satisfied with the claims you have drafted, you can begin drafting the specification. The easiest way to do this is to block copy the claims with your word processing program. Then paste them into your specification document twice. The first set will become the outline for the Summary of the Invention section, and the second set will become the outline for your Detailed Description. These and the other sections of the application are discussed below. After reviewing these, we will discuss more substantive strategies for drafting the specification. C. SECTIONS OF THE APPLICATION 37 C.F.R. 1.77(b) provides guidelines for the arrangement of the elements of a patent application. Specifically, this rule states that the specification should include the following sections in order: 1. Title of the invention, which may be accompanied by an introductory portion stating the name, citizenship, and residence of the applicant (unless included in the application data sheet). 2. Cross-reference to related applications (unless included in the application data sheet). 3. Statement regarding federally sponsored research or development. 4. The names of the parties to a joint research agreement. 7-3

5 5. Reference to a Sequence Listing, a table, or a computer program listing appendix submitted on a compact disc and an incorporation-by-reference of the material on the compact disc (see 37 C.F.R. 1.52(e)(5)). The total number of compact discs including duplicates and the files on each compact disc shall be specified. 6. Background of the invention. 7. Brief summary of the invention. 8. Brief description of the several views of the drawing. 9. Detailed description of the invention. 10. A claim or claims. 11. Abstract of the disclosure. 12. Sequence Listing, if on paper (see through 1.825). The rule further states that the text of the specification sections defined in paragraphs (b)(1) through (b)(12), if applicable, should be preceded by a section heading in uppercase and without underlining or bold type. 37 C.F.R. 1.77(c). According to the M.P.E.P., [I]f no text follows the section heading, the phrase Not Applicable should follow the section heading. M.P.E.P (a). Those sections pertinent to the substantive content of the specification, not including the claims, are discussed below. Drawings and sequence listings and other appendices are not addressed herein, but M.P.E.P (a) provides references to the relevant M.P.E.P. and C.F.R. sections regarding these parts. 1. THE TITLE AND THE ABSTRACT OF THE INVENTION 37 C.F.R. 1.72(a) requires that the title of a patent application may not exceed 500 characters in length and must be as short and specific as possible. See also M.P.E.P Ideally, the title should be brief but technically accurate and descriptive and be preferably from two to seven words in length. See M.P.E.P (a), citing from 6.02(a). 37 C.F.R. 1.72(b) states that the abstract must be filed on a separate sheet of paper and may not exceed 150 words in length. It is worthwhile to remember that, as set forth in Rule 1.72(b), the purpose of the abstract is to enable the United States Patent and Trademark Office and the public generally to determine quickly from a cursory inspection the nature and gist of the technical disclosure. See M.P.E.P (b). Accordingly, you should probably not draft your title or your abstract until you finish preparing the specification. In fact, the best way to write an abstract or choose wording for a title is to use your independent claims as a guide. That way these important notice-giving elements 7-4

6 will most accurately reflect what is contained in your patent application. Also, in certain instances the abstract has been used to construe the claims: another incentive to make sure the invention is accurately reflected CROSS-REFERENCE TO RELATED APPLICATIONS See 37 CFR 1.78 and M.P.E.P STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT See M.P.E.P BACKGROUND OF THE INVENTION The M.P.E.P. divides the Background of the Invention into two subsections: (i) Field of the Invention and (ii) Description of the Related Art. M.P.E.P (c). The first is merely a statement of the field of art to which the invention pertains. Typically this is only about one sentence in length. Thus, the bulk of the Background section is the Description of the Related Art. M.P.E.P (c) provides that this description should be [a] paragraph(s) describing to the extent practical the state of the prior art or other information disclosed known to the applicant, including references to specific prior art or other information where appropriate. Where applicable, the problems involved in the prior art or other information disclosed which are solved by the applicant s invention should be indicated. See also MPEP (a), (p) and (b). While this guidance from the USPTO should be heeded, the background section, like the other parts of the application, must be written carefully to balance competing interests. You should, as set forth in the M.P.E.P., make it clear what the state of the art was at the time your invention was made, and it is often helpful to tell the story of how your invention solves existing disadvantages. With respect to discussing prior art, if your invention is an improvement over a certain piece of prior art, you may choose to cite that particular document. The advantage of comparing your invention to specific prior art is that it helps define the scope of your invention by showing how it differs from the art. The disadvantage is that the Examiner will probably look more closely at such cited documents and may even try to apply them against your claims. In addition, derogatory remarks such as statements disparaging the products or processes of others, are not permitted. M.P.E.P (r). Comparisons between the invention and the prior art are not considered to be disparaging, per se. Documents that may not otherwise be considered prior art can, if identified as such by the applicant, may be used as prior art to defeat the patentability of the claims. 14 Therefore, 7-5

7 practitioners should try to minimize any admissions made in the background section of the specification. In addition, an admission can also foreclose the inventor from arguing that the invention predated such art. Merely describing something as prior art necessarily limits the inventor to a date of invention after the date of the prior art. Although in general the background section is probably best kept to a minimum, there are notable exceptions to this rule. There are certain situations where your invention needs to be distinguished from the existing art in order to be fully defined. In such a case, referring to specific prior art is appropriate and acceptable. 5. BRIEF SUMMARY OF THE INVENTION According to 37 C.F.R. 1.73, a brief summary of the invention indicating its nature and substance, which may include a statement of the object of the invention, should precede the detailed description. Such summary should, when set forth, be commensurate with the invention as claimed and any object recited should be that of the invention as claimed. The M.P.E.P. explains that [t]he brief summary, if properly written to set out the exact nature, operation, and purpose of the invention, will be of material assistance in aiding ready understanding of the patent in future searches [and] should be consistent with the subject matter of the claims. M.P.E.P (d). One particular area of concern in the summary section is the listing of objectives. Many patent application drafters like to discuss the prior art, set forth what problems are faced in the art, and then begin their Summary of the Invention with a description of the objectives of the invention, particularly as they will meet the already-discussed deficiencies of the art. Approaching the introductory section of the specification with care is prudent, however, because the Federal Circuit has in the past looked to sections such as, Objectives of the Invention and Summary of the Invention, to narrowly construe claim terms. 15 In C.R. Bard, Inc. v. U.S. Surgical Corp., 16 the Federal Circuit explained how the Summary of the Invention is used to construe claims: Although a statement's location is not "determinative," the location can signal the likelihood that the statement will support a limiting definition of a claim term. Statements that describe the invention as a whole, rather than statements that describe only preferred embodiments, are more likely to support a limiting definition of a claim term. [citation omitted] Statements that describe the invention as a whole are more likely to be found in certain sections of the specification, such as the Summary of the Invention. [citation omitted] Accordingly, other things being equal, certain sections of the specification are more likely to contain statements that support a limiting definition of a claim term 7-6

8 than other sections, although what import to give language from the specification must, of course, be determined on a case-by-case basis. (emphasis added). 17 Thus, for example, let s say you have an inventive composition which is useful for washing of a keratinous material, where you define keratinous material as, e.g., hair, skin, and nails. The commercial embodiment of the invention is probably only going to be a shampoo (i.e., for washing hair), but the composition will work perfectly well to wash skin and nails. Don t lose sight of the big picture, therefore, and recite that the objective of the invention is to provide a composition for washing hair. Doing so could very well cause your claims to be limited to compositions for washing hair only, i.e., shampoos, even if you draft them to recite a composition for washing keratinous material. Reciting shampoos as examples of the inventive composition is acceptable, just choose your words carefully so it does not sound as if the entire objective of the invention is to wash hair. If you must list objectives, do so in a manner that requires only one objective to be met at a time, e.g., the objective of the invention is to accomplish at least one of the following.... This satisfies your need to explain what the invention accomplishes without limiting you to a situation where every listed objective must be met for a court to find infringement. Note, however, that the M.P.E.P. cautions that [o]bjects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention. M.P.E.P (a), citing from 6.02(g). As discussed above, the summary of the invention is probably the first thing you should prepare after drafting your claims. Take your independent claims and use them as the outline for your summary. This will ensure that your summary set[s] out the exact nature, operation, and purpose of the invention, while maintaining the big picture that will support your quest for broadly construed claims. If you want to discuss how your invention solves problems in the prior art, and, in doing so, wish to include objectives and/or advantages of the invention in your summary, you can start the summary section with a discussion of objectives and advantages and then say, therefore, disclosed herein is... and insert the language of your first independent claim. You can then go on to summarize the additional embodiments of the invention using the language of the other independent claims. 6. DESCRIPTIONS OF THE DRAWINGS The applicant for a patent is required to furnish a drawing of his or her invention where necessary for the understanding of the subject matter sought to be patented. 37 C.F.R According to 37 C.F.R. 1.74, when there are drawings, the specification should contain a brief description of each drawing, and then the detailed description of the invention should refer to the 7-7

9 different drawings in more detail, by defining and describing each reference numeral used in the drawings. The brief description of drawings is addressed in M.P.E.P (f), which also notes that the brief description will be used to determine whether all of the figures of drawings described in the specification are present. The brief description should be just that, a few words telling what the figure represents, i.e., describe the nature of each view. For example, Fig. 1 is a perspective view of a mascara-type applicator consistent with the present invention or Fig. 2 is a graph showing time versus temperature in the reaction of compounds A and B. The detailed description of the drawings is much more involved. See M.P.E.P (g). This section is considered part of the detailed description, so the USPTO does not appear to require that it have a separate heading. The detailed description of the drawings should be placed wherever it makes the most sense and will be the most helpful in describing the invention. In applications in the mechanical area, the description of the drawings is likely of utmost importance in explaining the invention, and is inserted near the beginning of the specification, whereas in the chemical area, the drawings are often merely supplemental and are not even discussed until right before the examples and/or claims. Nevertheless, the purpose of the detailed description of drawings is to make sure every aspect of every drawing is explained and every reference numeral or variable shown in a figure is defined. Standards for Drawings (37 C.F.R. 1.84) Drawing categories = Black ink and Color Photographs not usually permitted in utility and design patent applications. Identifying indicia should be included on the front of each sheet within the top margin. The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1. Chemical or mathematical formulae, tables and waveforms may be submitted as drawings. Only one side of the sheet of paper may be used for the drawing. All drawing sheets in an application must be the same size. Paper size should be 21.0 cm by 29 cm (A4) or 21.6 cm by 27.9 cm (8 1/2 by 11 inches). Each sheet must contain a top margin of at least 2.5 cm (1 inch), a left side margin of at least 2.5 cm (1 inch), a right side margin of at least 1.5 cm (5/8 inch), and a bottom margin of at least 1.0 cm (3/8 inch). 7-8

10 The scale to which a drawing is made must be large enough to show the mechanism without crowding when the drawing is reduced in size to two-thirds in reproduction. The weight of all lines must be heavy enough to permit adequate reproduction. Reference characters not mentioned in the description shall not appear in the drawings. Reference characters mentioned in the description must appear in the drawings. A copyright or mask work notice may appear in the drawing, but must be placed within the sight of the drawing immediately below the figure representing the copyright or mask work material and be limited to letters having a print size of.32 cm to.64 cm (1/8 to 1/4 inches). 7. DETAILED DESCRIPTION OF THE INVENTION The detailed description is the heart of the patent application. Here you will set forth all the necessary details about the invention and its embodiments. As recommended above, it is useful to make your independent claims the outline for this section of the application. Then, and most importantly, make sure to describe every element of each embodiment in a manner that will satisfy the statutory requirements of 35 U.S.C The first paragraph of 112 requires that the specification must describe (1) the subject matter recited in the claims, i.e., written description, (2) how to make and use the invention in such full, clear, concise, and exact terms as to enable one skilled in the art to do so, i.e., enablement, and (3) the best mode contemplated by the inventor of carrying out the invention at the time of filing. The standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. 18 In contrast, the enablement requirement ensures that the information contained in the patent application is conveyed in a manner that is meaningful to those skilled in the art. Thus, the specification must contain sufficient information as to enable one skilled in the art to make and use the claimed invention. The test for enablement is whether one skilled in the art could make or use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation. 19 If undue experimentation is required, there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. 20 There are many factors that are considered in determining whether there is sufficient disclosure and whether experimentation would be undue. These factors, called Wands factors, 7-9

11 include the evaluation of: (A) the breadth of the claims; (b) the nature of the invention; (C) the state of the prior art; (D) the level of one of ordinary skill; (E) the level of predictability in the art; (F) the amount of direction provided by the inventor; (G) the existence of working examples; and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. 21 The third requirement under Section 112, first paragraph is that the disclosure must set forth the best mode contemplated by the inventor. The best mode requirement creates a statutory bargained-for-exchange by which a patentee obtains the right to exclude others from practicing the claimed invention for a certain period of time, and the public receives knowledge of the preferred embodiments for practicing the claimed invention. 22 In order to comply with this requirement, the inventor, at the time of filing, must possess a best mode for practicing the invention and if so, then the best mode must be disclosed in the description such that a person skilled in the art could practice it. 23 M.P.E.P (a) contains 6.02, which makes some additional comments about drafting the specification. In particular, the form paragraph notes that the description should be as short and specific as is necessary to describe the invention adequately and accurately. Further, where elements are conventional and already known in the field of the invention, and their exact nature or type is not necessary for an understanding and use of the invention by one of ordinary skill in the art, they should not be described in detail. However, where additional explanation or description is necessary, the specification should refer to another patent or readily available publication which adequately describes the subject matter. Thus, the M.P.E.P. is telling us to be short and specific and 112 talks about being concise, but how can one accomplish this without running the risk of rejections under 112 for providing an inadequate description or insufficient information to enable someone to make and use your invention? The answer is to remain focused on the task at hand, and using your claims as a guide is the way to do this. 24 D. DESCRIBE EACH ELEMENT OF THE CLAIMS Look at your independent claims. What are the main elements contained therein? You already made this decision when drafting the claims, but now you are adding details. Let s say your claimed invention includes the element at least one surfactant. What broad categories of surfactants are useful in the invention? Within each category, which surfactants are most useful? Where relevant, to satisfy the best mode requirement of 112, you should list the manufacturers and brand names of preferred products. Such disclosure could be pages and pages in length if many surfactants are potentially useful, but that may be the full disclosure that is necessary to satisfy

12 Also, note that you do not have to put a flashing red light above the most preferred components of your invention. For instance, you can preface a listing of most preferred species of surfactants by saying for example, the surfactant can be chosen from species x and y. Additional aspects of the ingredient can then be discussed, such as its properties or other attributes, such as how much of it is used. Adequate written description requires a precise definition for all elements, whether it be in terms of physical properties, structure, or identification of a part or component by name. E. USE EXAMPLES TO FURTHER ILLUSTRATE THE INVENTION You may want to use examples to further describe your invention. Examples are not necessary, but can be relied upon as additional descriptive material to help meet the requirements of 35 U.S.C. 112, first paragraph or to help obtain a broader claim construction. During prosecution, the Examiner may try to limit your claims to the embodiments or examples set forth in the specification. There are numerous cases from the Federal Circuit restricting claim scope to the embodiments explicitly described and several other cases construing a claim more broadly than the examples in the specification. In an effort to be on the side of broad construction, the more examples you have, the greater your chances of being able to sustain a broad claim. Note the outcome in LizardTech, Inc. v. Earth Resource Mapping, Inc., 25 where the Federal Circuit affirmed that a broad claim supported by only one example was invalid: [Allowing the claim] would lead to sweeping, overbroad claims because it would entitle an inventor to a claim scope far greater than what a person of skill in the art would understand the inventor to possess or what a person of skill in the art would be enabled to make and use.... A patentee cannot always satisfy the requirements of section merely by clearly describing one embodiment of the thing claimed. In some situations, comparative examples can be very helpful. Consider a real-life example (changed slightly to protect the parties involved): the claimed invention was the hydrochloride salt of the known compound X. Not only was X well-known in the art, but the closest prior art disclosed X, provided an example of making a citrate salt of X, and then provided a list of useful salts, included in which were both the citrate and the hydrochloride. The Examiner initially found that the art rendered the claims obvious but allowed the case, asserting the prima facie case of obviousness was overcome by a comparative example in the specification showing that the inventive hydrochloride salt had improved properties over the citrate salt. Without this data in the comparative examples, it is doubtful we would have received an allowance on the first Office Action. Having the comparative example saved time and money in getting a patent for this important compound

13 Since the purpose of examples is to teach one of ordinary skill in the art how to make and use the invention, the examples in an application do not actually have to have been carried out to be helpful. Examples that have not been performed are called prophetic or hypothetical and must be written in the present tense to make clear that they were not carried out. In Hoffmann- LaRoche v. Promega, the court held it was inequitable conduct to describe a hypothetical example in the past tense, thereby implying the example was actually performed. 27 IV. PRACTICE STRATEGIES Remember, there is no exact science of application drafting. Instead, you must keep certain goals in mind and strive to achieve them through a thorough and accurate description of the invention. A. DEFINE CLAIM TERMS TO MAXIMIZE CHANCES OF BROAD CLAIM CONSTRUCTION The importance of describing your invention in a clear, accurate, and complete manner cannot be overemphasized. Definitions of claim terms in the specification is a way to do this and important in particular because, if no special definition of a term is provided, terms in a claim are given their ordinary and accustomed meaning. 28 For example, if you want the term triangle as used in your claims to mean isosceles triangle instead of the conventional any three-sided figure, you must define the term in the specification. A concern with respect to defining claim terms is that an applicant will be stuck with a definition that seemed broad at the time of filing but turns out to be insufficient to keep infringers at bay. Often, it is best to define terms yourself in the specification so, if possible, a court can determine the meaning of a claim term from the claims and specification only, without ever having to consult the prosecution history or any extrinsic sources. A clear meaning from the intrinsic evidence will give your opponent less foundation for arguing an alternative (and usually narrower) construction. This method provides the most certainty for the client. For example, in 3M Innovative Properties v. Avery Dennison the patentee was found to have provided a definition in the specification, and, accordingly, the claim was construed consistent with the written description rather than the words ordinary meaning. 29 In defining terms, use your best judgment. For example, think of a fastener. Is this fastener metallic or plastic? Does it fasten permanently or temporarily? If such fine distinctions are relevant in defining the invention at hand, include them in the specification. Terms to be defined may also include ordinary words as well as art-specific words. 7-12

14 Despite your best efforts, a court may still construe your claim narrowly. But only by including definitions in your specification will there be a chance that the claim terms are construed as you intended. B. DESCRIBE ALL EMBODIMENTS KNOWN AT TIME OF FILING As mentioned above, the Federal Circuit continues to flip-flop on the issue of whether the scope of claims can encompass more embodiments than those explicitly described. Compare e.g., the line of cases following SciMed Life Sys. v. Advanced Cardiovascular Sys., 30 with those following Advanced Cardiovascular Sys. v. Medtronic. 31 When the preferred embodiment is described in the specification as the invention itself, the claims are not necessarily entitled to a scope broader than that embodiment. 32 To be safe, claim any and all embodiments so you don t give up any unclaimed subject matter. 33 Using cascading disclosures within each embodiment, i.e., describing the invention with increasing specificity, will help you to keep track of whether you have covered all aspects of each embodiment. C. BE CAREFUL ABOUT SELLING THE INVENTION TOO ENTHUSIASTICALLY Words that imply a certain element or step of an invention is an essential part of the invention may be interpreted as limiting the scope of the invention. For example, words such as critical, special, peculiar, superior, 34 very important, 35 essential, key, 36 and necessarily or necessary 37 were all held to limit claim scope. Other words to avoid are preferably and significant. A general rule of thumb is to be wary of adjectives and to stick with clear statements of fact about the elements of your invention. D. USE CLAIM TERMS CONSISTENTLY Using different terms for the same concept may lead to confusion and an unfortunately narrow claim construction, unless done deliberately and explicitly in an attempt to expand the scope of equivalents accorded an element of the invention. In Aqua-Aerobic Systems v. Aerators for example, the phrases, prevent flow of air and prevent passage of air, were interpreted as having different meanings as to the amount of air excluded, even though the patentee apparently intended them to be construed the same. 38 In Epcon Gas Systems v. Bauer Compressors by contrast, the Federal Circuit noted that [a] word or phrase used consistently throughout a claim should be interpreted consistently. 39 Applying this axiom, the court in Epcon was able to ascertain the subtle difference in the two uses of the term substantially. The phrase substantially constant denotes language of approximation, while the phrase substantially below signifies language of magnitude, i.e., not insubstantial. 7-13

15 The principle of using the same terms consistently applies to modifiers also. For example, if using the term, about, use it consistently or any nonmodified element may be considered absolute. 40 V. CONCLUSION The practitioner s goal should be to try to secure claims that will be construed to have the scope intended by the inventor with a minimum of prosecution history. Careful drafting of the patent application is the key to such a result because by focusing on the objective of literal infringement, the prosecuting patent attorney can try to include all the support in the specification that will be needed to obtain a broad claim construction. Thus, throughout the drafting of your patent application, keep in mind that literal infringement is the objective. As the Federal Circuit noted in Sage v. Devon Products: for a patentee who has claimed an invention narrowly, there may not be infringement even though the patentee might have been able to claim more broadly[.] 41 Describing and claiming your invention in various and creative ways that will literally encompass what your client wants to exclude its competitors from practicing takes foresight and imagination, but pays dividends. 7-14

16 1 Thalia Warnement, the orginial author of this article, passed away in January Adriana Burgy coauthored the annual updates of the article starting in 2006 with the late Ms. Warnement. This article could not be possible without Thalia and her knowledge of patent law. Adriana and Finnegan are indebted to Thalia for the contributions she made to eduate her colleagues and the patent law community. Adriana Burgy is an associate in the Chemical/Metallurgical Practice Group of Finnegan, Henderson, Farabow, Garrett, & Dunner, L.L.P. She received a graduate degree in Biotechnology from Johns Hopkins University, undergraduate degrees in Biology and Chemistry from the University of North Carolina at Chapel Hill, and her law degree from Franklin Pierce Law Center. She practices patent prosecution, opinion work, and client counseling, focusing on chemical, cosmetic, and biotechnology innovations. Ms. Burgy is a registered patent attorney with extensive experience handling procurement matters before the U.S. Patent and Trademark Office, including patent application drafting and prosecution, conducting Examiner interviews, filing appeals and presenting oral arguments before the Board of Patent Appeals and Interferences, and reissue and reexamination proceedings. Ms. Burgy s prosecution practice includes both domestic and foreign prosecution, ranging from work on focused portions of large international-based clients prosecution portfolios to the management of entire prosecution portfolios for smaller to mid-size clients. In addition, Ms. Burgy advises clients on IP due diligence opinion matters, such as conducting patent landscape investigations and preparing freedom to operate, validity, infringement and patentability opinions, and enforcement of their patent portfolios. 2 Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), aff d, 116 S. Ct (1996). 3 See, e.g., Texas Digital Systems Inc. v. Telegenix Inc., 308 F.3d 1193, 64 U.S.P.Q.2d 1812 (Fed. Cir. 2002); see also Intellectual Property Development Inc. v. UA-Columbia Cablevision of Westchester Inc., 336 F.3d 1308 (Fed. Cir.). 4 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 5 Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576 (Fed. Cir. 1996). 6 Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d 1111 (Fed. Cir. 2004). 7 Phillips, at Id. 9 Id. at Id. at Id. 12 Id. at See Howmedica Osteonics Corp. v. Tranquil Prospects, Ltd., 401 F.3d 1367, 1372, 74 U.S.P.Q.2d 1680 (Fed.Cir. 2005); Versa Corp. v. AG-Bag Int l, Ltd., 392 F.3d 1325, 73 U.S.P.Q.2d 1191 (Fed. Cir. 2004); C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 864 (Fed. Cir. 2004); and 37 C.F.R. 1.72(b), which no longer contains a prohibition forbidding the use of the abstract for the purpose of construing patent claims. 68 Fed. Reg. 38,614 (June 24, 2003). 14 See, In re Nomiya, 509 F.2d 566 (C.C.P.A. 1975). 15 See, e.g., Scimed Life Systems, Inc. v. Advanced Cardiovascular Systems, Inc., 242 F.3d 1337, 58 U.S.P.Q.2d 1059 (Fed. Cir. 2001) (Based on the abstract, the recited disadvantages of certain prior art structures, the recited advantages of the present invention, and the Summary of the Invention portion of the specification, the Federal 7-15

17 Circuit found that the claims should be limited in scope to catheters of a single configuration.). See also, Vehicular Tech. Corp. v. Titan Wheel Int l, Inc., 212 F.3d 1377, 1381, 54 U.S.P.Q.2d 1841, 1844 (Fed. Cir. 2000). 16 C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858 (Fed. Cir. 2004). 17 Id. at In re Gosteli, 872 F.2d 1008, 1012, 10 U.S.P.Q.2d 1614, 1618 (Fed. Cir. 1989). 19 In re Wands, 858 F.2d 731, 737, 8 U.S.P.Q.2d 1400, 1404 (Fed. Cir. 1988). 20 Genentech, Inc. v. Novo Nordisk, 108 F.3d 1361, (Fed. Cir. 1997). 21 Id. 22 Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 963, 58 U.S.P.Q.2d 1865, 1874 (Fed. Cir. 2001). 23 Id. 24 Additional guidelines from the USPTO are provided in the USPTO Examiner Training Materials for 112 at and the Guidelines For Examination Of Patent Applications Under The 35 USC 112 First Paragraph "Written Description" Requirement found at 66 Fed. Reg (January 5, 2001). 25 LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346 (Fed. Cir. 2005), reh g denied, 433 F.3d 1373, 77 U.S.P.Q.2d 1391 (Jan. 5, 2006). 26 See MSM Investments Co., LLC v. Carolwood Corp., 259 F.3d 1335 (Fed. Cir. 2001), where the working examples provided a basis for a broad claim construction. 27 Hoffmann-LaRoche, Inc. v. Promega Corp., 323 F.3d 1354 (Fed. Cir. 2003). See also, Novo Nordisk Pharmaceuticals, Inc. v. Bio-Technology General Corp., 424 F.3d 1347 (Fed. Cir. 2005). 28 See Gart v. Logitech, Inc., 254 F.3d 1334 (Fed. Cir. 2001). 29 3M Innovative Properties Co. v. Avery Dennison Corp., 350 F.3d 1365 (Fed. Cir. 2003); See also, Apple Computer, Inc. v. Articulate Systems, Inc., 234 F.3d 14 n.5 (Fed. Cir. 2000)( a patentee may define claim terms in ways that differ from the common understanding of those skilled in the art. In order to do so, however, a patentee must deliberately and clearly point out how these terms differ from the conventional understanding. ); Guttman, Inc. v. Kopykake Enterprises, Inc., 302 F.3d 1352 (Fed. Cir. 2002) (claim construction explicitly based on inventor s definitions provided in specification and prosecution history). 30 SciMed Life Sys. v. Advanced Cardiovascular Sys., 242 F.3d 1337, 58 U.S.P.Q.2d 1059 (Fed. Cir. 2001) (narrowly construed to only cover described embodiment). 31 Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 265 F.3d 1294 (Fed. Cir. 2001) (claim language broadly construed to cover embodiments not explicitly described in specification). 32 SciMed Life Sys. v. Advanced Cardiovascular Sys., 242 F.3d at 1341, 58 U.S.P.Q.2d at 1063, quoting Modine Mfg. Co. v. United States Int l Trade Comm n, 75 F.3d 1545, 1551, 37 U.S.P.Q.2d 1609, 1612 (Fed. Cir. 1996). 33 Maxwell v. J. Baker, Inc., 86 F.3d 1098, 39 U.S.P.Q.2d 1001 (Fed. Cir. 1996); Johnson & Johnston Assoc., Inc. v. R.E. Service Co., Inc., 285 F.3d 1046, 62 U.S.P.Q.2d 1225 (Fed. Cir. 2002) (en banc). 34 Bayer AG v. Elan Pharmaceuticals Research Corp., 212 F.3d 1241 (Fed. Cir. 2000). 35 Inpro II Licensing, S.A.R.L. v. T-Mobile USA, Inc., 450 F.3d 1350 (Fed. Cir.2006). 36 Pharmacia & Upjohn Co. v. Mylan Pharmaceuticals, Inc., 170 F.3d 1373, 50 U.S.P.Q.2d 1033 (Fed. Cir. 1999). 37 Biovail Corp. Int l v. Andrx Pharmaceuticals, Inc., 239 F.3d 1297, 57 U.S.P.Q.2d 1813 (Fed. Cir. 2001); Atofina v. Great Lakes Chemical Corp., 441 F.3d 991 (Fed. Cir. 2006). 38 Aqua-Aerobic Systems, Inc. v. Aerators Inc., 211 F.3d 1241, 54 U.S.P.Q.2d 1566 (Fed. Cir. 2000). 7-16

18 39 Epcon Gas Systems, Inc. v. Bauer Compressors, Inc., 279 F.3d 1022, 61 U.S.P.Q.2d 1470 (Fed. Cir. 2002), citing Phonometrics, Inc. v. Northern Telecom Inc., 133 F.3d 1459, 1465, 45 U.S.P.Q.2d 1421, 1426 (Fed. Cir. 1998). 40 See Jeneric/Pentron, Inc. v. Dillon Co., Inc., 205 F. 3d 1377, 54 U.S.P.Q.2d 1087 (Fed. Cir. 2000); Merck & Co., Inc., v. Teva Pharmaceuticals USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005); Ortho-McNeil v. Caraco, 476 F.3d 1321(Fed. Cir. 2007). 41 Sage v. Devon Products, 126 F. 3d 1420, 1425 (Fed. Cir. 1997). 7-17

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