APPLICATION DRAFTING AND PROVISIONAL APPLICATIONS

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1 APPLICATION DRAFTING AND PROVISIONAL APPLICATIONS Scott W. Cummings 1 Dentons US LLP 1301 K St. NW Washington, DC scott.cummings@dentons.com 2013

2 APPLICATION DRAFTING AND PROVISIONAL APPLICATIONS I. Introduction Preparing a well-written patent application is a daunting task. A myriad of legal requirements, substantive and formal, must be satisfied. We can become so absorbed with the task of meeting these requirements that we forget one of the key objectives of patent application drafting, to help convince someone of something. The examiner should be convinced that the invention merits a patent, the judge or jury should be convinced that Patent Office did the right thing by granting the patent, the potential investor should be convinced that the patentee s rights have value worthy of investment, and so on. There is difference between technical writing and advocacy, and we should not loose sight of the fact that we are advocates for our clients. That is not to say that a patent application should be written in the same style as a brief trying to overturn a criminal conviction. However, there is still a place for advocacy in patent application drafting. This form of advocacy persuades based on logic, consistency, an appropriate level of detail, and a presentation format that guides the reader to the desired conclusion. One of the challenges alluded to above is that a patent application is ideally written with an extremely diverse audience in mind: the inventor(s); the patent office examiner; IP counsel/tech transfer; investors; CEOs and other corporate officers; prospective licensee(s); potential infringer(s); and IP litigators (both hostile and friendly). How can one possibly draft a document that is convincing to such a varied group? As the old saying goes, everyone likes a good story. On a certain level, that is what a well-written patent application should do, it should tell the story of invention. As the storyteller, the patent practitioner should introduce the reader to a cast of characters (the prior art and the patent applicant), set the stage for the applicant to make a heroic appearance (describe the problems with the state of the art and failures of others) and how the hero of the story, the patent applicant, saves the day for all (description of the invention, its advantages and how it solves the problems associated with the current state of technology). Another component of protecting inventor s rights is implementation of an effective patent filing strategy. An effective filing strategy sometimes includes the use of provisional patent applications. This is especially the case given the recent transition to the current "first-tofile" regime. However, an understanding of the strengths and weaknesses of provisional patent applications is necessary in order to formulate a sound patenting strategy. 4-1

3 II. Attributes of a Well-Written Patent Application Generally, a well-written patent application should satisfy all substantive and formal legal requirements, and be written to tell the story of the invention. For example, a patent application should: Describe the invention adequately so that one skilled in the art can understand and practice it; 2 Disclose the best mode for carrying out the invention; 3 Describe all features that may be necessary to support a claim that distinguishes the invention from the prior art (when it may not be known exactly which features are distinguishing); Claim the invention narrowly enough to avoid the prior art (both known and unknown); 4 Claim the invention broadly enough to prevent competitors from designing around the patent; Claim the invention clearly enough to put the public on notice as to what the applicant considers to be their property; 5 Contain only factually accurate statements in order to avoid damaging credibility and/or charges of lack of enforceability due to inequitable conduct; 6 Satisfy the requirements for patentability of various countries around the world (i.e., serve as an adequate vehicle for foreign filing); and Tell a good story (impress upon the reader the value of the invention). Considering the above list of objectives, one begins to appreciate the challenges posed to the practitioner when drafting a well-written patent application. III. Types of U.S. Patent Applications Specific forms of protection are available for certain types of inventions. Plant applications are available for inventions relating to distinct and new varieties of plants. 7 Design applications are available for inventions relating to ornamental designs embodied in, or applied to, an article of manufacture. 8 A detailed discussion of these types of applications is beyond the scope of this paper. 4-2

4 The majority of inventions can be protected in the United States with issuance of a utility application. 9 The first step in the process is to choose an appropriate filing strategy that will met the client s objectives and lead to the desired result. There are basically three options to choose from when making the initial application filing for inventions originating in the U.S.: 1. Provisional application 10 - establishes a filing date and operates as a 365-day U.S. national and international placeholder (it will never mature into a patent, and must be followed by a utility application); 2. Utility application 11 - establishes a date of invention (constructive reduction to practice), is subject to examination, and must meet all substantive and formal requirements for patentability; and 3. An international or PCT application - filed in accordance with the Patent Cooperation Treaty (PCT), operates as an international placeholder for up to months (as measured from the priority application filing date), and will never mature into a patent in any country without the filing and successful prosecution of national phase or regional patent application(s) where protection is sought. The following schematic illustrates the above-mentioned filing options. Invention Filing Date 12 mths. Provisional Application Utility Application PCT Application Utility AND PCT AND non-pct F.F. Applications PCT AND non-pct F.F. Applications mths. National Phase F.F. National Phase F.F. National Phase F.F. *Incl. U.S. 4-3

5 IV. Substantive Legal Requirements The specifics of PCT applications are discussed elsewhere in this course. Provisional applications will be discussed in greater detail infra. The following is a general discussion of the key requirements for utility applications. A. Eligible Subject Matter & Operability - 35 USC 101 An application must be directed to an invention that qualifies for patent protection under the above-identified statutory provision. Section 101 reads: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. This eligible subject matter requirement of this section has been broadly interpreted by the courts to include anything under the sun that is made by man, and rarely presents a barrier. 12 This section also requires the invention to have utility, or be useful for some explicit or implicit purpose. A well-drafted patent application should therefore include some explicit statement as to how the invention is used. An application containing such a statement can be rejected for lacking utility only if some basis is set forth to challenge the credibility of the explicit assertion by the applicant. 13 Again, the utility requirement rarely presents a barrier. However, special issues may arise in some arts, such as business methods, biological materials, pharmaceutical compounds, nuclear fusion, etc. When drafting an application directed to an such technologies the relevant case law and examination guidelines 14 promulgated by the U.S. Patent Office (USPTO) should be consulted. B. 35 USC 112, 1 The specification of a patent application must satisfy 112, 1, which states: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 4-4

6 The Court of Appeals for the Federal Circuit has interpreted 112, 1 as having three separate requirements: enablement, written description and best mode. 15 At the core of 112, 1 is the policy objective of introducing technology and ideas into the public domain in exchange for a limited monopoly for that technology. The purpose of 112, 1 is to ensure the public gets adequate information about the invention as a part of that exchange. (1) Enablement The enablement requirement dictates that the invention be described in the application in a way such that one of ordinary skill in the art can make and use the invention without undue experimentation. 16 Various factors are analyzed when making a determination as to whether the enablement requirement has been satisfied: (i) the amount of experimentation necessary to make and use the invention, if any, (ii) the amount of guidance provided by the inventor (in the application), (iii) whether the specification contains working examples, (iv) the nature of the invention, (v) the state of the prior art, (vi) the relative skill level of those in the art, (vii) the level of unpredictability in that art, and (viii) the breadth of the claims. 17 A review of these factors provides some guidance for drafting a patent application that satisfies the enablement requirement. A well-drafted patent application should include examples, where such examples are available. The invention should be explained in a way that guides the reader (including one of ordinary skill in the art) from a broader conceptual appreciation for the invention to a more concrete embodiment thereof. The background section of the application should provide information about the state of the art. The claims should be drafted with a scope that is commensurate with the scope of the invention as set forth in the specification. With respect to the scope of the claims, it should be noted that a claim that is drafted such that it omits one or more aspects of the invention that are disclosed as being essential to the invention can be rejected under 35 USC 112, 1 as lacking enablement. 18 Thus, use of terms such as essential, critical and necessary should be avoided when describing the features of the invention. (2) Written Description The written description requirement is separate from the enablement requirement. Compliance with the written description requirement is a fact-based inquiry that will vary depending on the nature of the invention. The written description and enablement requirements, while related and springing from the same factual predicates, each has a separate purpose. The 4-5

7 purpose of the description requirement is to ensure that the inventor had possession, as of the filing date of the application, the specific subject matter later claimed. 19 This possession test requires assessment from the viewpoint of one of skill in the art. 20 Therefore, a well-written patent application should, as alluded to above in connection with the discussion of the enablement requirement, provide a description of the invention that is commensurate with the scope of the claims. One drafting technique that can be employed to facilitate meeting this requirement is to provide verbatim support for the claims, at least as originally drafted, in the summary of the invention section of the specification. Thus, it is common practice to insert a reiteration of at least the independent claims in the summary of the invention section, thereby providing a basis to assert that the inventor considered the scope of the invention to be at least as broad as the broadest claims presented in the application. (3) Best Mode The best mode requirement creates a statutory bargained-for exchange by which the public receives knowledge of the preferred embodiments for practicing the claimed invention. 21 A holding of invalidity for failure to disclose the best mode requires clear and convincing evidence that the inventor both knew of and concealed a better mode of carrying out the claimed invention than that set forth in the specification. 22 In explaining its purpose the Federal Circuit has described the best mode requirement as separate and distinct from the enablement requirement: Manifestly, the sole purpose of this [best mode] requirement is to restrain inventors from applying for patents while at the same time concealing from the public preferred embodiments of their inventions which they have in fact conceived. 23 Compliance with the best mode requirement is a question of fact, which involves a two-pronged inquiry. The first prong is subjective; focusing on the inventor s state of mind at the time he filed the patent application, and asks whether the inventor considered a particular mode of practicing the invention to be superior to all other modes at the time of filing. The second prong is objective and asks whether the inventor adequately disclosed the mode he considered to be superior. With respect to both the first and second prongs, the best mode is related to what the applicant regards as the invention, which in turn is defined by the scope of the claims. Under the America Invents Act, failure to comply with the best mode requirement has been eliminated as a possible invalidity defense in all civil litigation commenced after 4-6

8 September 16, However, the best mode remains a requirement for patentability. Thus, the U.S. Patent Office will still examine patent applications for compliance with the best mode. 25 Thus, a well-written patent application should clearly disclose all preferred embodiments of the invention known as of the date the application is filed. The scope of the claims should again be commensurate with the scope disclosed invention. C. 35 USC 112, 2 The second paragraph of section 112 requires, inter alia, that the claims particularly and distinctly define the subject matter that applicant regards as the invention. This is often referred to as the definiteness requirement. One purpose behind this requirement is to ensure that the public is provided with adequate notice of the scope of the protected subject matter such that infringement can be avoided. Another purpose is to provide a discernable definition of the invention so that it can be compared with the prior art, and judged against the requirements of 35 USC 112, 1. The essential inquiry when judging compliance with the definiteness requirement is whether the claims describe the invention with a reasonable degree of clarity and precision. In this regard, the definiteness of the claim language is evaluated in light of (i) the content of the application, (ii) the teachings of the prior art, and (iii) the interpretation that would be given to the claims by one of ordinary skill in the art. 26 Another important concept is that patent applicants are entitled to be their own lexicographers, that is, they can use whatever terms they chose to define the invention. 27 To the extent that a patent applicant uses a term in a way such that it has a meaning that is not readily apparent, that term must be defined as in the written description of the invention. 28 In light of the above, a well-written patent application should be drafted with claims that are clear and unambiguous. To the extent that one or more of the terms used in the claims to define the invention have a meaning that is not universally well-recognized, an effort should be made to provide definitions of such terms in the specification. This practice of defining claim terms in the specification can have additional advantages beyond satisfying the requirements of 35 USC 112, 2, as will be discussed infra. D. 35 USC 102 & 103 The claims must also define the invention in a way that is different from the prior art. Section 102 requires that the claimed invention be novel when compared with the prior art. A 4-7

9 claimed invention is not considered novel if every element recited in the claim is found in a single prior art reference. 29 In addition to the novelty requirement, section 103 requires that even where one or more differences exist between the claimed invention and a particular prior art reference, the difference(s) must not have been obvious to one of ordinary skill in the art at the time the invention was made. The analytical framework for judging compliance with the obviousness requirement is dictated by Supreme Court precedent. The Graham v. John Deere decision 30, as recently affirmed in KSR Int'l v. Teleflex 31, sets forth four factual inquires that must be addressed: (i) the scope and content of the prior art, (ii) the differences between the prior art and the claim(s) under consideration, (iii) the level of ordinary skill in the art pertaining to the invention, and (iv) evaluation of any secondary considerations. 32 In light of the above requirements, a well-written patent application should be drafted with some knowledge of the scope and content of the prior art, and how the invention can be distinguished therefrom. Armed with this knowledge, potential obviousness issues can be anticipated and the distinguishing characteristics of the invention presented in a manner that is most likely to avoid or rebut an assertion of obviousness. For example, the patent practitioner should consult with the inventor(s) to ascertain whether there is long-felt need in the art for the technical solution offered by the invention, wherein others in the art have tried, but failed, to provide the solution offered by the invention, whether there are technical reasons why those in the art would have been discouraged from trying to modify the prior art in a manner that would result in the invention, whether the invention provides unexpectedly superior results, and whether the invention has experienced commercial success or met with enthusiastic acceptance. While it is not necessary for such information to be present in the application in order to be relied upon to traverse or rebut an assertion of obviousness, it makes it less likely that you will have an obviousness rejection to address at all. V. Some Application Drafting Ideas A. Tell the Story of Invention Like all writings, a patent application is a vehicle for communicating something to another person. Actually, the application should be capable of effectively communicating with many people, of dramatically different backgrounds, levels of education, interests, and capacities to comprehend the invention. Communicating with such a diverse audience is not an easy assignment. 4-8

10 A well-written patent application should do more than simply recite facts, numbers, and technical details. It should present the information in a way that the reader can follow; it should tell the story of invention. Even if the reader is incapable of understanding every technical detail set forth in the specification, they should at least be able to follow the plot, and leave with some appreciation for the nature of the invention. Some are naturally gifted storytellers. However, regardless of our innate abilities, writing skills can be improved with practice that is guided by an underlying philosophy. (1) Introducing the cast of Characters The characters in the story of invention include the inventors and users of the prior technology (prior art), and the inventor(s) of the invention embodied by the application. The reader should be introduced to the inventors and users of the related prior art in the background section of the patent application. No formal introductions are necessary; an identification of the most relevant prior art should suffice. When appropriate, the users of the technology should also be identified. Take the following hypothetical example: Police officers around the country have been relying on the abovedescribed conventional ballistic vest technology for years, despite a criminal element that arms itself with a progressively more sophisticated and powerful arsenal of weapons. A patent practitioner writing the application with only the statutory and USPTO requirements in mind might very well omit such information. There is no legal requirement that the expected beneficiaries of the technology be identified. Yet, without it the reader is free to assume that the most likely users of the technology will be soldiers of a hostile foreign army. Consider which approach results in a more persuasive application. The hero of the story, our inventor(s), usually first appears in the summary of the invention section of the application. (2) Setting the Stage The background section of the application should also be used to set the stage of the appearance of the hero (inventor(s)). The stage is set, for example, by explaining the need(s) that is (are) fulfilled by the invention, the problems associated with the most closely related prior art, and the failures of others to accomplish what the invention accomplishes. A well-written background section should get the reader s attention. Consider the following hypothetical 4-9

11 introductory paragraph in the background section of a patent application directed to an invention for treating diabetes: According to the American Diabetes Association, diabetes is the fifth-deadliest disease in the United States and kills more than 213,000 people a year, the total economic cost of diabetes in 2002 was estimated at over $132 billion dollars, and the risk of developing type I juvenile diabetes is higher than virtually all other chronic childhood diseases. Did this paragraph get your attention? It should, this is a very serious problem. As the writer it is your responsibility to get the reader s attention, and to make sure the reader appreciates the importance of the problem(s) being addressed. A well-written background should also convey the nature of the problem that the invention solves, and the difficulties associated with finding a solution. This can be accomplished though a discussion of relevant prior art. Consider the following hypothetical discussion of the relevant prior art: Recent surveys of urban residents identify frequent activation of automobile alarms as one of the most significant contributors to noise pollution, and the associated reduced quality of life. Numerous attempts have been made by those in the art to address the problem of false activations of automotive alarms, yet to date these attempts have failed to deliver the necessary solution. U.S. patent nos. 7,000,000, 8,000,000 and 9,000,000 are illustrative of such attempts. U.S. patent No. 7,000,000 is directed to an alarm system with the stated goal of reducing false activations. However, this system has proven unreliable and was recently recalled by the manufacturer. U.S. patent No. 8,000,000 is directed to an alarm system with at least one feature that is provided for the stated purpose of reducing false alarm activations. While the system appears to have reduced the number of false alarms, it has proven easy to disable by car thieves, and ineffective in preventing theft. U.S. Patent No. 9,000,000 is also directed to an alarm system with the stated purpose of reducing false alarm activation. However, the system described therein is exceedingly expensive, at least two times as expensive as comparable systems on the market. Thus, despite the attempts made by many skilled practitioners in the art, an automotive alarm system that is reliable, effective in preventing property theft, cost competitive, and reduces the number of false alarm activations, has been unattainable until the advent of the present invention. 4-10

12 Many practitioners advise caution when drafting the background section, with some even advocating omitting the background entirely. There are essentially three pitfalls to avoid when drafting the background: (i) art 33 ; disclaimer of claim scope through "criticism and disavowal" of the prior (ii) written description problems due to failure of claimed subject matter to address stated problems or objects 34 ; and (iii) Use of the stated problem(s) as a basis to allege obviousness 35. With respect to issue (i), there are instances where the courts have used characterizations in the specification to limit the scope of the claimed invention as not covering certain features that were characterized as being in the prior art. 36 One suggestion for avoiding this pitfall is to keep the discussion at a general level. In other words, focus on problems and deficiencies, not specific features. See the example of the car alarm background discussion above as an example. Another approach is to add a "disclaimer" to the specification. For example: While certain aspects of conventional technologies have been discussed to facilitate disclosure of the invention, Applicants in no way disclaim these technical aspects, and it is contemplated that the claimed invention may encompass one or more of the conventional technical aspects discussed herein. Claims that do not recite elements that address at least one stated problem or object of the disclosed invention may be vulnerable to attack under the written description requirement of 35 U.S.C. 112, 1. So, this is an issue that should be addressed during the claim drafting process as well. Suggestions for avoiding this problem include avoiding listing "objects" of the invention, and adding a disclaimer. A disclaimer contained in the summary section (usually immediately following the background section) along the following lines may be useful: The present invention may address one or more of the problems and deficiencies of the prior art discussed above. However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein. 4-11

13 Others have expressed concerns over certain dicta contained in the KSR v. Teleflex decision. Specifically, the Supreme Court stated therein: One of the ways in which a patent's subject matter can be proved obvious is by noting that there existed at the time of invention a known problem for which there was an obvious solution and compassed by the patents claims. The first error of the Court of Appeals in this case was to foreclose this reasoning by holding that courts and patent examiners should look only to the problem the patentee was trying to solve. 119 Fed. Appx., at 288. The Court of Appeals failed to recognize that the problem motivating the patentee me be only one of many addressed by the patent's subject matter. The question is not whether the combination was obvious to the patentee but whether the combination was obvious to a person with ordinary skill in the art. Under the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in a manner claimed. 37 (Emphasis added) The concern here is that the applicants own statements about the problem to which the invention is directed may be used as the supporting rationale or motivation to reach a conclusion that the claimed invention was obvious. While there is reason for concern and caution, it should be noted that to date there does not appear to have been any controlling authority interpreting the above quoted dicta. Thus, whether the Federal Circuit will seize upon the above quoted language, and to what extent, remains to be seen. It should be noted that the patent office guidelines for the application of the KSR decision do not advocate for use of the applicant's own statement of the problem as the sole basis for reaching a conclusion of obviousness. 38 In each of the exemplary rationales given in the examination guidelines, additional factual findings by the patent office are required in order to establish a prima facie case of obviousness. 39 One possible approach to try and avoid negative inferences based upon the background section of the specification, other than totally avoiding description of the problems of the prior art, is to include a disclaimer, such as: In this specification where a document, act or item of knowledge is referred to or discussed, this reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was at the priority date, publicly available, known to the public, part of common general knowledge, or otherwise constitutes prior art under the 4-12

14 applicable statutory provisions; or is known to be relevant to an attempt to solve any problem with which this specification is concerned. (3) The Hero Saves the Day The summary of the invention section of the application should provide the vehicle to introduce the reader to attributes of the invention, at least with respect to the problems solved or benefits obtained. The summary conveys that the invention is the solution to the problems described in the background. One way to approach the summary is to provide a paragraph along the lines of the following hypothetical example: Certain embodiments of the present invention are directed to automotive alarm systems that provide one or more benefits and advantages not previously offered by the prior art, including, but not limited to, automotive alarm systems that are reliable, effective in preventing property theft, cost competitive, and reduce the number of false alarm activations. This paragraph may be followed by a more detailed description of the features of the invention. The best approach is to include a reiteration of the independent claims. As discussed above, this approach ensures support for the claimed invention in the specification and thus some assurance of compliance with the written description requirement. The detailed description necessarily sets forth the specifics of the invention in a comprehensive manner. Whenever possible, these features should be related back to an advantage provided to the present invention, thus adding some continuity to the story. Also, the detailed description can be an appropriate place to introduce technical reasons why those in the art would have been discouraged from trying to modify the prior art in a manner that would result in the invention, whether the invention provides unexpectedly superior results, and successes achieved by the invention. B. Define Special Claim Terms As discussed above in connection with the definiteness requirement of 35 USC 112, 2, claim terminology must be reasonably clear and precise. For some terms, this is not an issue. Terms like benzene, capacitance, and right angle have well-known meanings on their face and would not normally require further elaboration or explanation. However, terms like readily dissolvable, therapeutically active, or substantially flattened may be more 4-13

15 open to interpretation. A common practice is to set forth definitions of special claim terms in the specification. This practice has at least a couple of advantages: (i) since the intended meaning is readily discernable from the specification, there is no lack of definiteness under 35 USC 112, 2, (ii) you may gain some control over how the claims will be interpreted should the patent be litigated. The issue of definiteness has already been addressed. With regard to claim interpretation, there are few areas of patent law that have been more tumultuous and confusing that Federal Circuit jurisprudence relating to claim construction. Some cases rely heavily on the intrinsic record of the patent file (i.e., the other claims, specification, prosecution history, and the prior art) to interpret the meaning of the claim language. 40 Other cases emphasizes the use extrinsic aids such as dictionaries to ascertain the ordinary and customary meaning of the claim terms. 41 However, perhaps the most consistent principle applied in claim construction is that the applicant can act as his own lexicographer and clearly assign a particular definition to a claim term in the specification. 42 The applicant s definition is controlling. Choice and drafting of such definitions should be done with care, for the very reason that you may be stuck with them, and therefore unable to argue for a meaning that goes beyond the four corners of the definition you have chosen. 43 A well-written patent application defines special claim terminology in the specification in order to avoid challenges under 35 USC 112, 2, and to avoid an undesirable claim interpretation by the court. C. Avoid Narrow Characterizations of "The Invention" Caution should be exercised when crafting language that refers to "the invention." Overly narrow characterizations of what constitutes the invention have been used to limit the scope of the patented claims. 44 Therefore, terms such as "critical," "essential," "key," "necessary," and even "important," should also be avoided. For example, the Federal Circuit has relied up language on the specification such as "this invention relates to a...", according to the present invention, a... ", and "a... made pursuant to the teachings of the present invention", coupled with a lack of description of alternative embodiments, to limit the scope of the claimed subject matter. 45 In Honeywell International, Inc. v ITT Industries Inc. 46 at issue was a claim directed to a "fuel injection system component." The claim was being asserted against a quick-connect coupling of a fuel injection system. The District Court construed the claim as being limited to fuel injection system filters, and thus not infringed by the quick-connect couplings. The Federal 4-14

16 Circuit affirmed this construction relying on language contained in the specification that mirrors the above-quoted language, coupled with a lack of description of any other fuel injection system "components" other than fuel filters in the specification. 47 Therefore a well-written patent application avoids narrow characterizations of the invention. Instead of language such as "the invention is directed to...," alternative language such as "certain embodiments of the present invention include, but are not limited to...." A well-written patent application should also describe as many alternative features and embodiments as possible so as to avoid the holding in Honeywell International, Inc. v ITT Industries Inc. D. Avoid Dedication to the Public The so-called disclosure-dedication doctrine is a legal doctrine invoked where the specification lists features or embodiments that are not specifically claimed. A patent applicant who discloses, but does not claim subject matter, has dedicated that subject matter to the public, and cannot subsequently reclaim the disclosed matter after the patent issues. 48 An earlier example 49 of the dedication to the public doctrine applied to an alleged infringer who was using plastic clips, the Court held that a patent that disclosed subject matter in its written description without claiming it dedicated that subject matter to the public, and that use of the dedicated matter did not infringe the patent. The Court reasoned that because the written description of the patent disclosed clips made of plastic parts, but plastic clips were not claimed, the patentee had dedicated plastic clips to the public. Therefore, an alleged infringer could not now be held to infringe the patent by equivalents because plastic clips were already in the public domain. Giving each element a generic name and then providing the laundry list of examples can be used can avoid the dedication rule. For example: the arm is coupled to the body of the device by a fastener which can be a rivet, screw, bolt, nail, snap fit, hinge, weld, glue, and the like. In the alternative, the arm may be integral to the body. If fastener is found in the prior art and you are forced to use a narrower term, you should recite all the terms you have listed in the specification (except those found in the prior art). This will help avoid the dedication rule as applied to the disclosed fasteners. Thus, a well-written patent application includes a claim set that comprehensively recites the various features and alternative embodiments contained in the specification in order to avoid dedication of unclaimed features to the public. 4-15

17 E. Avoid Hyperbole A duty of candor applies to all contacts with the USPTO during prosecution of an application. 50 Misrepresentation, a misleading statement, or an omission can violate this duty. 51 Charges of inequitable conduct have and do arise out of the patent application drafting process. Charges of inequitable conduct can arise from the presentation of technical data and examples in the application. For example, in Hoffmann-La Roche, Inc. v. Promega 52 the patentee presented an example of a specific embodiment of the invention implying that an actual experiment has been carried out. In fact, the example was hypothetical and did not constitute an actual example, as implied. The Federal Circuit determined that this was a misrepresentation that can form the basis for a finding of inequitable conduct. Thus, a well-written patent application does not contain statements or assertions that lack an accurate factual basis. In this regard, good communication between the patent practitioner and the inventors is essential. F. Disclose Testing and Measurement Methodologies Often times an invention will be characterized by a particular measured feature or parameter. When claiming such a feature or parameter it is important that the application disclose the manner in which the characteristic of feature is measured. If the measurement is made according to a standard methodology, such as an ASTM standard, the standard should be at least be identified with some particularity. If the methodology dose not comport to a particular standard, the procedure used should be descried with sufficient detail to allow reproduction. The Honeywell International case provides an illustration. 53 In this case the claims at issue defined a polymeric yarn by referring to its melt point elevation. The measured value was highly dependent upon the manner by which the sample of yarn to be analyzed was collected. There were at least four different techniques by which the yarn could be collected. The patentee failed to disclose which technique was actually used. Under these circumstances the Federal Circuit agreed that the claims were insolubly ambiguous, and thus indefinite under 35 USC 112, 2. A well-written patent application identifies with particularity the testing and measurement methodologies used to characterize the claimed invention. G. Think Globally 4-16

18 A U.S. patent application often serves as the basis for the pursuit of patent rights in many countries around the world. A patent practitioner should also consider the requirements for patentability of foreign jurisdictions when drafting the U.S. application. The first consideration is whether the invention qualifies as patentable subject matter. For example, business methods generally qualify for patenting in the United States and Japan, but are not as readily accepted in Europe. The USPTO, European Patent Office (EPO) and Japanese Patent Office (JPO) released a statement of consensus with regard to patentability of business methods in June The reported consensus was: (1) A technical aspect is necessary for a computer-implemented business method to be eligible for patenting. This technical aspect must be claimed in the European and Japanese applications; and (2) The mere automation of a known human transaction process using wellknown automation techniques is not patentable. Therefore, when engaged in drafting an application directed to a computer software or business method related invention, these requirements should be kept in mind. If possible, the application should describe how the invention solves a particular technical problem. Another area of divergence is patentability of methods of medical treatment. Such methods are generally patentable in the United States, but not in Europe and Japan. Pharmaceutical compounds, on the other hand, are generally patentable in all three jurisdictions. Despite the stated prohibition on patenting methods of treating or diagnosing the body, European practice permits patenting of a first medical use of a compound ( Compound X for use in treating Y. ). With regard to subsequent medical uses, the EPO has approved the Swiss-style format: The use of compound X for the manufacture of a medicament for treatment of disease Y. Therefore a well-written patent application directed to the medical arts should be drafted with claims that are of a form likely to be accepted in jurisdictions such as Europe and Japan. All three jurisdictions require novelty and nonobviousness (inventive step). However, at least with respect to inventive step, the analysis can be quite different. In Europe, the issue of inventive step is analyzed in terms of a problem/solution approach. Generally, this analysis involves considering whether the solution offered by the claimed invention to the technical problem at issue would have been obvious to the skilled person. 55 Similarly, the Japanese examination guidelines instruct the examiner to consider, among other things, the similarity of the problem addressed by the invention compared to the prior art. 56 Therefore, a well-written patent application that includes a background section that describes the problem(s) that the invention is designed to solve, and the advantages of the approach offered by the invention when 4-17

19 compared with the prior art, will serve to smooth the way during prosecution in foreign jurisdictions. Another issue that merits consideration is the strict approach practiced by the EPO in assessing whether claim amendments are objectionable for the addition of new matter. In the United States, new matter is considered new technical subject matter added to the application after the date of filing. By contrast, the EPO applies a stricter standard, not limited to the addition of technical subject matter. For example, filing a claim in the EPO that is broader that the scope of the claim at filing can trigger a new matter objection. The net result is that the ability to amend claims before the EPO is much more limited than in the USPTO. Thus, a wellwritten patent application should contain a comprehensive set of claims of varying scope so that in the event amendment is necessary, the appropriate support will exist in the originally filed application. VI. Provisional Applications & Their Strategic Use A provisional patent application is a U. S. national application filed under 35 U.S.C. 111(b). Provisional applications operate as a placeholder in the USPTO (and abroad); they are never substantively examined and automatically lapse or become abandoned after one year from the date of filing. 57 The formal requirements and fees necessary to file a provisional application are significantly less burdensome that utility applications filed under 35 U.S.C. 111(a). There is no specific requirement to include any of the following in a provisional application: a claim, an oath or declaration, or an information disclosure (prior art) statement. Thus, many clients view the provisional application as an attractive low-cost option for protecting their intellectual property rights. However, there are some pitfalls associated with provisional applications that should be considered when counseling clients as to an effective patent filing strategy. A. Filing Requirements A provisional application must include: (1) a specification 58, (2) a drawing (where necessary to understand the nature of the invention) 59, (3) a cover sheet 60 or cover letter identifying the application as a provisional application 61, and (4) the fee. 62 See 37 C.F.R. 1.51(c) for a more detailed description of these requirements. As mentioned above, claims and an oath or declaration under 37 C.F.R are not required. Provisional applications are not substantively examined. Amendments and information disclosure statements may not be filed in a provisional application. Also, a provisional application is not entitled to claim priority to 4-18

20 another application. Once a provisional application is filed, the applicants may use the term Patent Pending. B. As a Basis for Priority The Uruguay Round Agreements Act amended the Patent Statute in 1995 to allow applicants for U.S. patents to file provisional applications that could provide a priority date for a subsequent nonprovisional U.S. patent application. Thus, the filing of a provisional application may be viewed as a mechanism for establishing an earlier effective filing date for a subsequently filed nonprovisional U.S. patent. In order to obtain the benefit of priority to the provisional application certain formal requirements must be satisfied. Namely, the nonprovisional application making the priority claim must be filed within twelve months of the filing date of the provisional application, the provisional and the nonprovisional application must name at least one common inventor, and the nonprovisional application must reference the provisional application in an Application Data Sheet. 63 The twenty-year patent term is calculated from the filing date of the nonprovisional application and not the filing date of the provisional application. 64 Under the America Invents Act, patent applications having an effective filing date on or after March 16, 2013 are examiner under a "first-to-file" regime. This obviously makes establishing an early effective application filing date critical to preserving patent rights in the United State. Article 4 of the Paris Convention sets forth the rules for establishing an effective application filing date that will be recognized by other countries that are signatories to the treaty. Article 4 basically calls for the filing date of a regular national filing in one country to be recognized as creating a claim for priority in a subsequent application filed in another member country within twelve months from the filing date of the first application. 65 A provisional application is considered a regular national filing that is sufficient to establish an effective filing date. The ease of preparing and filing a provisional application can facilitate establishing a date that is prior to a patent-defeating disclosure or commercialization. Consider the all-to-familiar scenario where Pat N. Turney is busy toiling away in her office when at 4pm the phone rings. On the line is a Manny Ger who heads one of the divisions of her most lucrative client. Manny tells Pat that he is making a presentation tomorrow at a seminar where he intends to describe the results of one of the company s biggest research initiatives. Manny says he is trying to keep legal costs to a bare minimum this fiscal quarter, so he didn t ask Pat to prepare an application earlier. In fact he tells Pat the he didn t intend to pay you overpriced patent lawyers a dime of 4-19

21 our shareholder s money this quarter, but that one of his senior scientists told him at lunch today that one time a patent attorney told me that making a presentation on company created technology without having a patent application on file is crazy. Under these less than ideal circumstances, filing a provisional application is an attractive option. Since there is little in the way of formal requirements, a provisional application that at least describes the content of the impending disclosure can be prepared and filed in time to establish an effective filing date that is before the public disclosure of the technology and thus hopefully preserve patent rights. However, the filing of a provisional application starts the oneyear convention priority clock ticking. Not only do the applicant and their attorney have to prepare and file any nonprovisional U.S. applications claiming priority to the provisional application, but they must also prepare and file any PCT applications 66 and/or direct national foreign applications by the same one year deadline. Perhaps the most important requirement for obtaining the benefit of priority to an earlier filed provisional application, and one that is often overlooked, is that the disclosure of the provisional application must satisfy the requirements of 35 U.S.C. 112, 1 with respect to the invention claimed in the subsequent nonprovisional application. 67 This presents a trap for the unwary. It is easy to be lulled into a false sense of security by the minimal formal requirements of getting a provisional application on file with the USPTO. However, the quality and scope of the disclosure of a provisional application must be sufficient to satisfy, for example, the written description requirement with respect to the invention claimed in the subsequent nonprovisional application if that easily obtained filing date is to mean anything. The New Railhead Manufacturing case 68 illustrates the potential consequences of failing to meet the above requirement. In this case suit was filed alleging infringement of a patented drill bit for drilling rock. The asserted independent claim of the patent called for the drill bit to be disposed at an angle with respect to its housing. Commercial embodiments of the patented technology had been sold in the spring-summer time frame of A provisional application was filed in February 1997, followed by a nonprovisional application in November 1997 that claimed priority to the provisional application. The Federal Circuit agreed with the District Court s determination that the provisional application failed to satisfy the written description requirement with respect to the claimed angle of the drill bit. Thus, the effective filing date of the asserted patent was determined to be the November 1997 date. Since this effective filing date was more than one year after the prior sales of the claimed invention in the spring-summer of 1996, the patent was invalid under 35 U.S.C. 102(b). 69 This case highlights the need for constant reevaluation of the adequacy of the disclosure of a provisional application as the technology evolves, and as the client s circumstances change. 4-20