Writing the Specification

Transcription

1 Chapter 9 Writing the Specification 9:1 Introduction: The Requirements of 35 U.S.C. 112 and the Utility Requirement 9: U.S.C :1.2 Utility 9:2 Satisfying the Description Requirement of 112 9:3 Satisfying the Enablement Requirement of 112 9:3.1 What Is the Enablement Requirement? 9:3.2 Guidelines for Satisfying the Enablement Requirement [A] The Enablement Requirement Applies Only to Claimed Subject Matter [B] The Specification Need Be Enabling Only to Someone Skilled in the Relevant Art [C] The Skill of the Art Is Determined As of the Date of Filing [D] The Specification Need Not Explain How or Why the Invention Works [E] Undue Experimentation Must Not Be Required to Reproduce the Invention [F] The Claimed Matter Must Not Be Unduly Broad in Relation to the Disclosure [G] The Specification Must Teach How to Make and Use Each Member of a Markush Group [H] Working and Prophetic Examples Can Be Used to Satisfy the Enablement Requirement [I] The Enablement Requirement Does Not Extend to Technology That Arises After the Time of Filing [J] How-To-Use Aspect of Enablement Requirement Requires Satisfaction of Utility Requirement [K] The Most Optimized Configuration of the Invention Does Not Need to Be Enabled [L] Testing in Animals Can Enable Use in Humans 9:4 Satisfying the Best Mode Requirement of 112 (Sheldon, Rel. #1, 4/16) 9 1

2 HOW TO WRITE A PATENT APPLICATION 9:4.1 What Is the Best Mode Requirement? 9:4.2 Guidelines for Satisfying the Best Mode Requirement [A] The Best Mode Requirement Applies Only to Claimed Subject Matter and Unclaimed Elements Necessary for Operation of the Invention [B] Only the Best Mode As of the Filing Date Need Be Disclosed [C] The Best Mode Is Not Necessarily the Eventual Commercial Method [D] The Specification Need Only Disclose What the Inventor Subjectively Believes to Be the Best Mode [E] Violation of the Best Mode Standard Can Be Accidental [F] The Best Mode Must Be Disclosed Even If the Applicant Did Not Invent It [G] The Description of the Best Mode Has to Be Objectively Enabling [H] The Use of Trademarks to Satisfy the Best Mode Requirement [I] The Disclosure of the Best Mode Cannot Rely on Prior Art That Is Nonconventional or Not Widely Known [J] The Best Mode Need Not Be Identified As Such, But It Should Not Be Hidden [K] The Public Cannot Be Misled As to the Best Mode [L] A Working Example Is an Effective Way to Disclose the Best Mode [M] Trade Secrets and the Best Mode Are Incompatible [N] The Best Mode Requirement Does Not Include Unclaimed Uses of the Invention 9:5 Writing the Specification 9:5.1 Introduction 9:5.2 Parts of the Application 9:5.3 Title 9:5.4 Identification of Inventors 9:5.5 Cross-References and Priority Claims [A] Types of Applications 9:5.6 Government Rights 9:5.7 Reference to CDs 9:5.8 Background [A] Heading [B] What the Background Section Should Not Include [C] What the Background Section Should Include 9:5.9 Summary Section [A] Heading [B] Opening [C] Contents [D] Closing 9 2

3 Writing the Specification 9:5.10 Drawings [A] Transitional Clause [B] Refer to Version of the Invention [C] Use of Suffixes for Similar Drawings [D] Cross-Reference the Drawings [E] Refer to Different Versions of the Invention 9:5.11 Description [A] Caption [B] Purpose of the Description [C] Outline of a Typical Description [C][1] The Opening [C][2] Definitions [C][3] Overview [C][4] Detailed Description of the Elements (Including Means-Plus-Function Elements) [C][5] How the Invention Is Used [C][6] Advantages of the Invention [C][7] Specific Embodiments and Examples [C][8] Alternatives and the Closing [D] Use of Prior Art Patents [E] Ranges and Preferences [F] Use of Trademarks [G] Incorporation by Reference [H] Reference Numbers [H][1] The Description Is Written As If No Reference Numbers Are Used [H][2] The Reference Numbers Should Be Kept Sequential [H][3] Numbers Higher Than Drawing Numbers Should Be Used [H][4] Chart the Reference Numbers [H][5] Skip the Reference Numbers [H][6] Use the Reference Numbers Consistently [H][7] Use Suffixes to Distinguish Similar Elements [H][8] Use Series of Numbers for Clarity [I] Antecedent [J] Use of Spatial Directions [K] Avoid Absolutes [L] Use Present Tense [M] Avoid etc. and Carefully Use i.e. [N] Copyright or Mask Work Notice [O] Line Numbers and Docket Numbers [P] Tabular Data [Q] Use of Optional, Preferable, and Other Equivocal Terms [R] Use of Present Invention and Object of Invention [S] Support for Negative Limitations [T] Improving Patent Quality 9:5.12 Abstract (Sheldon, Rel. #1, 4/16) 9 3

4 9:1 HOW TO WRITE A PATENT APPLICATION 9:6 Strategic Writing of the Specification for Broad Claim Interpretation Exhibit 9-1 Terminology Exhibit 9-2 Chart of Numbered Elements (Partial) Exhibit 9-3 Tree Diagram of Numbered Elements 9:1 Introduction: The Requirements of 35 U.S.C. 112 and the Utility Requirement This chapter deals with the nuts and bolts of writing the specification. Before discussing the how to aspects of writing the specification, this chapter presents the legal requirements that must be followed. 9: U.S.C. 112 To write an effective patent application, it is necessary to understand the legal requirements for the specification. At a bare minimum, these legal requirements need to be satisfied. If these legal requirements are not met, no patent will issue, or if contested, the patent will be invalidated. The statutory requirements are set forth in 35 U.S.C. 112, 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. The requirements of 35 U.S.C. 112 are threefold: 1. The Description Requirement ( shall contain a written description of the invention ); 2. The Enablement Requirement ( enable any person skilled in the art... ); and 3. The Best Mode Requirement ( set forth the best mode contemplated by the inventor of carrying out his invention ). At the practical level, these requirements can be summarized by the question, How much do I really need to put in the specification? In other words, how much detail needs to be put into the application to satisfy the description, enablement, and best mode requirements? For example, in general, one does not need to put the exact dimensions 9 4

5 Writing the Specification 9:1.2 of each of the components of a rifle. Thus, exact dimensions are generally not included in the application. However, for some inventions, the exact dimensions can be critical and thus would need to be disclosed. One of the purposes of this chapter is to answer the question of how much and what information needs to be in the application. For this purpose, the legal requirements under 35 U.S.C. 112 are discussed. An understanding of those legal requirements is important for every patent practitioner, because each practitioner must decide for each application exactly what needs to be described; there are few absolute rules. After presenting the legal requirements of 35 U.S.C. 112, this chapter presents a systematic approach for preparing the specification. In addition, many hints and suggestions for writing an effective specification are presented. 9:1.2 Utility Another legal requirement of an invention which needs to be addressed in the specification is the utility requirement. According to 35 U.S.C. 101, a patentable invention has to be useful. Utility is also required by 35 U.S.C. 112, under the theory that if the written description fails to illuminate a credible utility, there is a failure to teach how to use the invention as required by section Therefore, the Patent Office can, and does, reject applications for lack of utility. Such rejections are extremely rare in the mechanical and electrical arts. Only when the inventor is claiming a perpetual motion machine, or mechanical or electrical cures for diseases, or cold fusion, does the issue arise in the mechanical and electrical arts. 2 Even an invention whose intent was to deceive purchasers into believing they were getting a premixed drink rather than a post-mixed drink is useful, because it provides some identifiable benefit, that is, that one product can be altered to make it look like another. 3 However, such rejections are more common in the chemical and biotechnological arts. Therefore, the concept of utility is discussed in the chapters dealing with those technologies, namely chapters 16 and 1. In re Joyce A. Cortright, 165 F.3d 1353, 49 U.S.P.Q.2d 1464 (Fed. Cir. 1999). 2. See In re Chilowsky, 229 F.2d 457, 108 U.S.P.Q. 321 (C.C.P.A. 1956); In re Swartz, 232 F.3d 862, 56 U.S.P.Q.2d 1703 (Fed. Cir. 2000) (cold fusion not patentable because applicant provided no persuasive objective evidence sufficient to overcome the reasonable doubt established by PTO). 3. Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 51 U.S.P.Q.2d 1700 (Fed. Cir. 1999). (Sheldon, Rel. #1, 4/16) 9 5

6 9:1.2 HOW TO WRITE A PATENT APPLICATION 17. The reader is referred to those chapters if there is concern that questions may arise in the Patent Office about lack of utility. In general, all that needs to be included in the application regarding utility is some claim for utility. Even a small degree of utility is sufficient to satisfy the utility requirement. 4 Proof is generally not required. The only time proof may be required is if the Patent Office raises an issue as to utility, that is, the utility claimed seems unreasonable. In that situation, evidence of utility would have to be presented. 5 Furthermore, the invention need not accomplish all the objectives specified in the application, as long as the invention can be used to achieve at least one of the stated objectives. 6 Thus, as a practical matter, for most inventions the utility requirement is satisfied by specifying some utility for the invention. The specification of utility needs to be specific. Merely asserting that a compound is useful for the treatment of diseases and is an anti-tumor substance can be an insufficient disclosure of utility, while a statement that the claimed compound is better than known anti-tumor substances with known anti-tumor activity against leukemia tumor models is adequate. 7 Utility requires that the claimed invention have a significant and presently available benefit to the public. A claim directed to expressed sequence tags (ESTs), small pieces of a DNA sequence that can (1) serve as a marker for an underlying gene, where the utility of the gene was unclear, and (2) measure the level of mrna in a tissue sample, did not satisfy the utility requirement. 8 Because of inconsistent and overly stringent application of the utility requirement in the biotechnology arts, the Patent Office established guidelines for examiners with regard to the utility requirement. 9 Although these guidelines and the accompanying discussion of the law are particularly directed to biotechnology inventions, they are applicable to all inventions, and thus are discussed here. 10 According to the Patent Office, the applicable legal principles are: 1. The claimed invention must have a well-established utility, or the specification must assert for the claimed invention at least 4. Envirotech Corp. v. Al George, Inc., 730 F.2d 753, 221 U.S.P.Q. 473 (Fed. Cir. 1984). 5. See In re Chilowsky, 229 F.2d 457, 108 U.S.P.Q. 321 (C.C.P.A. 1956). 6. Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173 (Fed. Cir. 1991). 7. In re Brana, 51 F.3d 1560, 34 U.S.P.Q.2d 1436 (Fed. Cir. 1995). 8. In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005) Fed. Reg (Jan. 5, 2001); see also Synopsis of Application of the Revised Utility Guidelines, Application of these principles to biotechnology inventions can be found in chapter

7 Writing the Specification 9:1.2 one specific and substantial utility that is credible. See below for definitions of specific, substantial, and credible. 2. An invention has a well-established utility if a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention (for example, properties or applications of a product or process), and the well-established utility is specific, substantial, and credible. 3. If there is an assertion that the invention is useful for a particular practical purpose (that is, it has a specific and substantial utility ) and the assertion would be considered credible by a person of ordinary skill in the art, the utility requirement is satisfied. Credibility is assessed from the perspective of one of ordinary skill in the art in view of the disclosure and any other evidence of record (for example, test data, affidavits or declarations from experts in the art, patents or printed publications) that is probative of the applicant s assertions. See below for a definition of credible utility. 4. The requirement that there be a specific and substantial utility excludes throw-away, insubstantial, or nonspecific utilities, such as the use of a complex invention as landfill, as a way of satisfying the utility requirement of 35 U.S.C The application need only provide one credible assertion of specific and substantial utility for each claimed invention to satisfy the utility requirement. 6. The Patent Office will treat as true a statement of fact made by an applicant in relation to an asserted utility, unless countervailing evidence can be provided that shows that one of ordinary skill in the art would have a legitimate basis to doubt the credibility of such a statement. Similarly, Patent Office personnel will accept an opinion from a qualified expert that is based upon relevant facts whose accuracy is not being questioned. In its training materials, the Patent Office elaborates on these guidelines by providing definitions of key terms and applying the guidelines to many specific situations. 11 Since most of the specific fact situations are in the biological arts, an attorney/agent preparing an application in these arts should carefully review those training 11. Synopsis of Application of the Revised Utility Guidelines, web/menu/utility.pdf. (Sheldon, Rel. #1, 4/16) 9 7

8 9:1.2 HOW TO WRITE A PATENT APPLICATION materials to anticipate the utility rejections that may await an application in the Patent Office. The definitions of key terms are: 1. A specific utility is a utility that is specific to the subject matter claimed. This contrasts with a general utility that would be applicable to the broad class of the invention. For example, a claim to a polynucleotide whose use is disclosed simply as a gene probe or chromosome marker would not be considered to be specific in the absence of a disclosure of a specific DNA target. Similarly, a general statement of diagnostic utility, such as diagnosing an unspecified disease, would ordinarily be insufficient absent a disclosure of what condition can be diagnosed. 2. A substantial utility is a utility that defines a real world use. Utilities that require or constitute carrying out further research to identify or reasonably confirm a real world context of use are not substantial utilities. For example, both a therapeutic method of treating a known or newly discovered disease and an assay method for identifying compounds that themselves have a substantial utility define a real world context of use. An assay that measures the presence of a material that has a stated correlation to a predisposition to the onset of a particular disease condition would also define a real world context of use in identifying potential candidates for preventive measures or further monitoring. On the other hand, the following are examples of situations that require or constitute carrying out further research to identify or reasonably confirm a real world context of use and, therefore, do not define substantial utilities : i. Basic research such as studying the properties of the claimed product itself or the mechanisms in which the material is involved. ii. iii. iv. A method of treating an unspecified disease or condition. A method of assaying for or identifying a material that itself has no specific and/or substantial utility. A method of making a material that itself has no specific, substantial, and credible utility. 3. A credible utility is an asserted utility where the assertion of utility is believable to a person of ordinary skill in the art based on the totality of evidence and reasoning provided. An assertion is credible unless (A) the logic underlying the assertion is seriously flawed, or (B) the facts upon which the 9 8

9 Writing the Specification 9:2 assertion is based are inconsistent with the logic underlying the assertion. A credible utility is assessed from the standpoint of whether a person of ordinary skill in the art would accept that the recited or disclosed invention is currently available for such use. For example, no perpetual motion machines would be considered to be currently available. However, nucleic acids could be used as probes, chromosome markers, or forensic or diagnostic markers. Accordingly, if the Patent Office reasonably applies these standards, the utility requirement is easily satisfied when preparing an application. All that needs to be disclosed in the specification is one asserted utility that benefits the public and is credible. It is recommended for safety that multiple credible utilities be asserted in an application. 12 For example, if the claimed invention is directed to an automobile tire composition, if there are other possible credible utilities for the composition, such as bicycle tires, tennis shoe soles, gaskets, etc., these can be disclosed in the application. However, one disadvantage of asserting multiple utilities that must be considered is that the scope of analogous art applicable under section 103 can be broadened unduly to include a reference outside the scope of the principal utility. 9:2 Satisfying the Description Requirement of 112 The purpose of the description requirement is to persuade those skilled in the art that the inventor has invented the claimed subject matter. 13 The description requirement can be satisfied in a fairly straightforward manner: include in the specification a description of the invention that is claimed in the claims. 14 The best way to be sure that every claim is included is to either paraphrase all of the claims or reproduce the claims in the specification verbatim. Only what is disclosed in the actual disclosure of the application counts to satisfy the written description requirement. For example, an undisclosed clinical protocol cannot be used to support the written description The Patent Office can require cancellation of unsupported utilities that could deceive the public. In re Hozumi, 226 U.S.P.Q. 353 (Comm r Pat. & Trademarks 1985). 13. In re Wilder, 736 F.2d 1516, 222 U.S.P.Q. 369 (Fed. Cir. 1984), cert. denied, 469 U.S (1985). 14. In re Certain Ltd.-Charge Cell Culture Microcarriers, 221 U.S.P.Q (1983), aff d sub nom. MIT v. A.B. Fortia, 774 F.2d 1104, 227 U.S.P.Q. 428 (Fed. Cir. 1985). 15. Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293 (Fed. Cir. 2015). (Sheldon, Rel. #1, 4/16) 9 9

10 9:2 HOW TO WRITE A PATENT APPLICATION It is possible to live dangerously and not set forth exactly the claimed subject matter if the written description conveys with reasonable clarity to those of skill in the art that the inventor actually invented what is claimed. However, taking this approach opens an issued patent to attack during litigation. 16 Failure to satisfy the description requirement with regard to the originally submitted claims is usually not fatal. The description of the invention can always be amended during prosecution to include anything that is in the claims that were originally filed. This is not considered new matter because the claims are part of the specification as of the filing date. 17 Another description requirement is associated with 35 U.S.C. 112, 6, which allows use of means-plus-function language. Such language covers the corresponding structures disclosed in the specification and equivalents thereof. If means-plus-function language is used in a claim, the specification must set forth an adequate disclosure of what is meant by the claim language. Thus, structure supporting the means-plus-function language must be described in the specification. 18 The description requirement becomes very important if additional claims need to be added after the initial filing. This can occur if the originally filed claims are not sufficiently broad to cover the entire invention, or additional species claims are required. An insufficient description can lead to problems when the application is amended and there is a need to retain the original filing date. If an attempt is made to amend the claims, or add new claims during prosecution, and there is no supporting description in the application as originally filed, the amended and new claims will be rejected as not being within the scope of the originally described invention, and for introducing new matter as prohibited by 35 U.S.C Union Oil Co. of Cal. v. Atl. Richfield Co., 208 F.3d 989, 54 U.S.P.Q.2d 1227 (Fed. Cir. 2000). 17. In re Smith, 481 F.2d 910, 178 U.S.P.Q. 620 (C.C.P.A. 1973). 18. Atmel Corp. v. Info. Storage Devices, Inc., 198 F.3d 1374, 53 U.S.P.Q.2d 1225 (Fed. Cir. 1999); Default Proof Credit Card Sys., Inc. v. Home Depot USA, Inc., 412 F.3d 1291 (Fed. Cir. 2005) (because means for dispensing was not clearly linked to any structure in the specification, claim is invalid); Biomedino, LLC v. Waters Techs. Corp., 490 F.3d 946 (Fed. Cir. 2007); Robert Bosch, LLC v. Snap-On Inc., 769 F.3d 1094 (Fed. Cir. 2014) ( program loading device and program recognition device are meansplus-function terms lacking corresponding structure in the specification). 19. In re Wright, 866 F.2d 422, 9 U.S.P.Q.2d 1649 (Fed. Cir. 1989); In re Barker, 559 F.2d 588, 194 U.S.P.Q. 470 (C.C.P.A. 1977), cert. denied, 434 U.S (1978). 9 10

11 Writing the Specification 9:2 If the new claim is rejected, the inventor can submit a new application. However, the original filing date will be lost. The description requirement will therefore be an issue where an inventor wishes to add a new claim and needs to retain the original filing date. Only if the original description is broad enough to encompass the new claim can the inventor keep the benefit of the earlier filing date. 20 The Federal Circuit has identified certain information that can be absent from a specification that still satisfies the written description requirement, namely: 1. Examples; 2. Evidence of an actual reduction to practice; and 3. The recitation of a known structure of a biological macromolecule. 21 The importance of a sufficient description is demonstrated by the inability of the inventors of an audiocassette storage case to obtain a utility patent. These inventors filed an application for a design patent and then filed a utility patent application based on the design application. Because the storage case was not sufficiently described in the design application, the inventors could not rely on the earlier filing date, and because the storage case was on sale more than one year before the utility application was filed, the patent was denied under 35 U.S.C. 102(b). 22 The written description requirement can also be invoked to invalidate what the author considers to be wouldn t it be nice inventions. For example, a claim directed to selectively inhibiting prostaglandin synthesis of a non-steroid compound, without describing any particular compound that achieved the function, was invalid because the specification did not satisfy the written description requirement. No compound that could be used to practice the claimed method was known at the time the application was filed. 23 Thus, the claim was directed to wouldn t it be nice if there was a compound that.... Disclosing a sequence of only ten of the 185 to 192 amino acids comprising a particular protein does not put one in possession of the claimed DNA sequence, and thus the description requirement is not satisfied In re Smith, 481 F.2d 910, 178 U.S.P.Q. 620 (C.C.P.A. 1973). 21. Falkner v. Engliss, 448 F.3d 1357 (Fed. Cir. 2006). 22. In re Berkman, 642 F.2d 427, 209 U.S.P.Q. 45 (C.C.P.A. 1981). 23. Univ. of Rochester v. G.D. Searle & Co., 375 F.3d 1303 (Fed. Cir. 2004); Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010); Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011). 24. In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004). (Sheldon, Rel. #1, 4/16) 9 11

12 9:2 HOW TO WRITE A PATENT APPLICATION The written description requirement is not satisfied merely by including all of the claim limitations in the specification; rather, it is necessary to identify a particular combination of limitations the claimed invention is considered as an integrated whole. Somewhere the specification needs to describe the combination of these limitations. 25 However, even drawings alone can satisfy the written description requirement, if the drawings sufficiently demonstrate that the inventors had possession of the claimed subject matter at the time of filing. 26 The Federal Circuit is placing more emphasis on the description requirement and making it more difficult to satisfy. For example, the Federal Circuit held in 1993 that the specification supports a claim to a product only if the structure, name, formula, or definitive chemical or physical properties of the product are disclosed. Thus, as discussed in chapter 16, dealing with biotechnology patent applications, the description requirement was not satisfied in a claim directed to DNA because the DNA was not described, even though a method of producing the DNA was enabled. 27 As a result of the increased emphasis of the description requirement, the Patent Office has promulgated guidelines for examination of a patent application under the written description requirement. 28 The Federal Circuit endorsed these guidelines. 29 These guidelines provide that: 1. The goal of the written description requirement is to clearly convey the information that an applicant has invented the subject matter that is claimed to put the public in possession of what the applicant claims as the invention. 2. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. 25. Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013). 26. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 19 U.S.P.Q.2d 1111 (Fed. Cir. 1991). 27. Fiers v. Revel, 984 F.2d 1164, 25 U.S.P.Q.2d 1601 (Fed. Cir. 1993) Fed. Reg (Jan. 5, 2001); see also M.P.E.P. 2163; Synopsis of Application Written Description Guidelines, available at web/menu/written.pdf; 2008 Examiner Guidelines, offices/pac/writtendesc.pdf (these are most helpful for biotechnology inventions). 29. Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008). 9 12

13 Writing the Specification 9:2 3. Possession may be shown by: i. Actual reduction to practice, by a clear depiction of the invention in detailed drawings that permit a person skilled in the art to clearly recognize that applicant had possession of the claimed invention. Actual reduction to practice of a biological material may be shown by specifically describing a deposit made in accordance with the requirements of 37 C.F.R et seq. ii. iii. iv. A written description of the invention describing sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. A specification showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim, and determined that the invention would work for its intended purpose. Disclosure of sufficiently detailed relevant identifying characteristics that provide evidence that applicant was in possession of the claimed invention, that is, complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. 4. There is a strong presumption that an adequate written description of the claimed invention is present when the application is filed. Consequently, rejection of an original claim for lack of written description should be rare. 5. An issue of a lack of adequate written description can arise when: i. an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention; ii. iii. an essential or critical element is not adequately described in the specification and is not conventional in the art; an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function; (Sheldon, Rel. #1, 4/16) 9 13

14 iv. Practising Law Institute 9:2 HOW TO WRITE A PATENT APPLICATION the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. 6. A claim that omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement The claim as a whole, including all limitations found in the preamble, the transitional phrase, and the body of the claim, must be sufficiently described in the specification to satisfy the written description requirement. Sufficient structures, acts, or functions must be recited to make clear the scope and meaning of the claim, including the weight to be given the preamble. 8. There is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. 9. What is conventional or well known to one skilled in the art need not be disclosed in detail. If a skilled artisan would have understood the inventor to be in possession of the claimed invention at the time of filing, even if every nuance of the claims is not explicitly described in the specification, then the adequate description requirement is met. The description need only describe in detail that which is new or not conventional. 10. In most technologies that are mature, and wherein the knowledge and level of skill in the art are high, a written description question should not be raised for original claims even if the specification discloses only a method of making the invention and the function of the invention. In contrast, in emerging and unpredictable technologies, more evidence is required to show possession. 11. The description requirement applies to each genus claim and each species of the genus specifically claimed. 12. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction practice, reduction to drawings, or by disclosure of relevant identifying characteristics, that is, structure or other physical and/or chemical 30. See Reifin v. Microsoft Corp., 214 F.3d 1342, 54 U.S.P.Q.2d 1915 (Fed. Cir. 2000). 9 14

15 Writing the Specification 9:2 properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A representative number of species means that the species that are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, a sufficient variety of species must be described to reflect the variation within the genus. What constitutes a representative number is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a representative number depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. In an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. 31 While the description requirement is easily satisfied when the original application is filed, later problems can arise if the inventor wants to add new claims. 32 Because of that possibility, it is important that the description fully describes, as broadly as possible, the invention that exists on the date of filing. A full listing of alternative versions of the invention should be included in the description, including all species in a chemical invention. The problem of having inadequate disclosure applies not only to chemical and biotechnology inventions, but also in the so-called predictable arts such as mechanical inventions. It is advisable to include multiple species even in the predictable arts. 33 Also, any new claims that are later 31. See, e.g., Noelle v. Lederman, 355 F.3d 1343, 69 U.S.P.Q.2d 1508 (Fed. Cir. 2004) (a genus claim for a particular antibody was not described by a description of the mouse antibody within the genus); In re Curtis, 354 F.3d 1347, 69 U.S.P.Q.2d 1274 (Fed. Cir. 2004) (disclosure of microcrystalline wax did not support a claim directed to friction enhancing coatings ). 32. Atl. Research Mktg. Sys. v. Troy Indus., 659 F.3d 1345, (Fed. Cir. 2011) (broader claims eliminating an element from the original claims not supported by the original specification). 33. Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332 (Fed. Cir. 2013) (disclosure of peripheral grooves did not support claim requiring openings ). (Sheldon, Rel. #1, 4/16) 9 15

16 9:2 HOW TO WRITE A PATENT APPLICATION added should use the same terminology as the original description to ensure that the claims are construed within the scope of the description. 34 A written description problem can also arise when a combination of elements is not supported by the specification, even though all of the elements appear in the specification. 35 The written description requirement is satisfied where the specification describes multiple related solutions to a problem, where claims are directed to just one of the solutions. 36 The written description requirement requires only that a skilled reader of the patent disclosure recognize that what was claimed corresponds to what was described. It is not about whether the patentee has proved to the skilled reader that the invention works, or how to make it work, because the latter is an enablement issue. 37 Describing a large number of species within a generic claim has been standard practice in unpredictable arts such as genetic engineering. However, doing so in the so-called predictable arts is also strongly recommended in view of the position of the Federal Circuit that a generic claim that allowed for placement of controls at multiple locations was not supported by a description that taught only one location. 38 Similarly, the Federal Circuit held that a description of two species of the shape for a cup for an artificial hip did not support a claim to a generic shape, which would have encompassed prior art shapes, because the specification touted an advantage of the specific shapes disclosed. 39 A claim directed to all methods that result in seamless image compression is invalid because the specification described only one embodiment of seamless image compression. 40 Disclosure of only a single input unit does not support claims that allow for multiple input units. 41 Similarly, the written description requirement is not satisfied for a claim that requires substantially all 34. M.P.E.P (o). 35. Hyatt v. Dudas, 492 F.3d 1365 (Fed. Cir. 2007). 36. Crown Packaging Tech., Inc. v. Ball Metal Beverage Container Corp., 635 F.3d 1373 (Fed. Cir. 2011). 37. Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180 (Fed. Cir. 2014). 38. Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 45 U.S.P.Q.2d 1498 (Fed. Cir. 1998); cf. Utter v. Hiraga, 845 F.2d 993, 6 U.S.P.Q.2d 1709 (Fed. Cir. 1988); see also Laurence H. Pretty, The Recline and Fall of Mechanical Genus Claim Scope Under Written Description in the Sofa Case, J. PAT. TRADEMARK OFF. SOC Y 469 (July 1998). 39. Tronzo v. Biomet, 156 F.3d 1154, 47 U.S.P.Q.2d 1829 (Fed. Cir. 1998). 40. Lizardtech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005). In the author s opinion, the Lizardtech court seems confused. It appears that the court was actually stating that there was a failure to satisfy the enablement requirement rather than the written description requirement. 41. Anascape, Ltd. v. Nintendo of Am. Inc., 601 F.3d 1333 (Fed. Cir. 2010). 9 16

17 Writing the Specification 9:3.2 dot profiles to have a certain characteristic when the specification discloses that all of the dot profiles have that characteristic. 42 9:3 Satisfying the Enablement Requirement of 112 9:3.1 What Is the Enablement Requirement? Section 112 of 35 U.S.C. requires that the specification shall contain a written description of the invention, and of the manner 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 The description and the enablement requirements are separate, and both must be met. 44 The enablement requirement means that the specification must teach someone skilled in the art how to make and how to use the invention. If the specification is not sufficiently enabling, an infringer can challenge the validity of the patent and the patent can be invalidated. Therefore, it is extremely important that the enablement requirement be satisfied. 9:3.2 Guidelines for Satisfying the Enablement Requirement A difficulty with satisfying the enablement requirement is that it is desirable to leave out the endless minutiae that can unduly lengthen an application. Contrarily, sufficient minutiae need to be included to allow a reasonable balance between too much detail and insufficient disclosure, always keeping in mind that the disclosure is aimed at someone with ordinary skill in the art. One good way to ensure that this requirement is met is to ask the inventor if his colleagues would be able to practice the invention after reading the disclosure statement. If the answer is yes, then the enablement requirement probably is satisfied; if the answer is no, more detail needs to be included. The following discussion provides some guidelines. The guidelines followed by the PTO examiners with regard to the enablement requirement are found in the Manual of Patent Examining Procedure Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010) U.S.C In re Barker, 559 F.2d 588, 194 U.S.P.Q. 470 (C.C.P.A.), cert. denied, 434 U.S (1977). 45. M.P.E.P (Sheldon, Rel. #1, 4/16) 9 17

18 [A] Practising Law Institute 9:3.2 HOW TO WRITE A PATENT APPLICATION The Enablement Requirement Applies Only to Claimed Subject Matter The enablement requirement applies only to the claimed subject matter. Therefore, before writing the disclosure section it is important to first define the claimed invention. 46 It is important for the applicant to define the claimed invention clearly and precisely. If there is a possibility of varying interpretation in scope of what is claimed, then the PTO is likely to attach the broadest meaning to the claims during the prosecution, so that the enablement requirement is not satisfied unless the full scope of the claim, as broadly defined, is enabled in the disclosure. Moreover, if such varying interpretations can be given to what is claimed, then the courts are likely to attach the narrowest meaning to the claims during an infringement proceeding, so that a competitor may be able to design around the invention. The reason for the latter is that the courts want to avoid the possibility of an applicant s obtaining in court a scope of protection that encompasses subject matter that, through the conscious efforts of the applicant, the PTO did not examine. 47 The inventor has no duty to enable an unclaimed use of the invention. Moreover, if the application does not claim a method of commercial production of an invention, the method does not need to be disclosed. 48 For example, a patent for a rifle was challenged on the basis that it did not disclose how to mass produce the rifle. The Federal Circuit upheld the patent because the inventor claimed only the rifle, and not the method of mass production. 49 [B] The Specification Need Be Enabling Only to Someone Skilled in the Relevant Art Someone skilled in the art for the purposes of 35 U.S.C. 112 means someone skilled in the art that is the most appropriate to practice the invention. 50 There is an assumption that anyone attempting to reproduce an invention will hire expert consultants for any special technical component. 51 To write a clear and concise specification, it is important to keep the future reader in mind and remember to include sufficient information for someone of ordinary skill in the art. It is not 46. In re Moore, 439 F.2d 1232, 169 U.S.P.Q. 236 (C.C.P.A. 1971). 47. Genentech, Inc. v. Wellcome Found., 29 F.3d 1555, 31 U.S.P.Q.2d 1161 (Fed. Cir. 1994). 48. Christianson v. Colt Indus. Operating Corp., 822 F.2d 1544, 3 U.S.P.Q.2d 1241 (Fed. Cir. 1987). 49. Id. 50. Int l Standard Elec. Corp. v. Ooms, 157 F.2d 73, 70 U.S.P.Q. 32 (D.C. Cir. 1946) D. CHISUM, PATENTS 7 26 (1989). 9 18

19 Writing the Specification 9:3.2 necessary to fill the application with a great amount of detail so that someone not skilled in the art can reproduce the invention. 52 For example, in a patent for a device that used a computer to measure seismic waves, the appropriate art was computer programming, and not seismic prospecting. 53 Therefore, the inventor did not need to include in the application sufficient information to teach the skill of computer programming to someone skilled in seismic prospecting. 54 The inventor must disclose sufficient information to bridge the gap between the knowledge of someone skilled in the relevant art and that knowledge required to practice the invention. 55 Any information not widely known must be disclosed in the specification. An expert s unsupported conclusion that integral elements of the invention were well-known and routinely built does not make the disclosure enabling. 56 Thus, it is always better to err on the side of including too much information rather than too little. This bridging is best illustrated with patents for computer programs. If an application for a computer software patent were required to disclose every step of every well-known subprogram necessary to the invention, the application would be cumbersome and overinclusive. Thus, the Court of Customs and Patent Appeals differentiated between the droning use of a clerical skill and true inventiveness and experimentation, and upheld a patent that disclosed sufficient data and mathematical tools to satisfy the needs of one skilled in the art of computer programming. 57 In a patent application for a batch data processor, the inventor did not include the entire computer program necessary to reproduce the invention. The Federal Circuit upheld the patent, because the excluded information was a routine computer program and there was sufficient information to enable a programmer of reasonable skill to write a satisfactory program with ordinary effort. 58 In the specification, all information necessary to reproduce the invention must be included. A patent for an antidepressant drug was invalidated because the specification did not disclose the subject of the dosage tests, whether it was human, dog, or rat. 59 In this case, it was 52. In re Howarth, 654 F.2d 103, 210 U.S.P.Q. 689 (C.C.P.A. 1981). 53. In re Naquin, 398 F.2d 863, 158 U.S.P.Q. 317 (C.C.P.A. 1968). 54. Int l Standard Elec. Corp. v. Ooms, 157 F.2d 73, 70 U.S.P.Q. 32 (D.C. Cir. 1946). 55. In re Sherwood, 613 F.2d 809, 816, 204 U.S.P.Q. 537 (C.C.P.A. 1980), cert. denied, 450 U.S. 994 (1981). 56. In re Buchner, 929 F.2d 660 (Fed. Cir. 1991). 57. Id. 58. N. Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 15 U.S.P.Q.2d 1321 (Fed. Cir. 1990). 59. In re Gardner, 427 F.2d 786, 166 U.S.P.Q. 138 (C.C.P.A. 1970); see also Union Pac. Res. Co. v. Chesapeake Energy Corp., 236 F.3d 684, 57 U.S.P.Q.2d 1293 (Fed. Cir. 2001). (Sheldon, Rel. #1, 4/16) 9 19

20 9:3.2 HOW TO WRITE A PATENT APPLICATION not just a question of determining dosage, but also one of determining the proper subject; thus, the specification did not provide enough guidance for one skilled in the art to reproduce the invention. The inventor must specifically describe how to make and use the invention and cannot expect one skilled in the art to determine for himself how to make the invention. For example, in a patent for a device that made ores react with a wet reagent, the specification neglected to explain how the mixture was heated within a tube. The inventor had stated that the vapor produced at the end of the tube was hot, but neglected to state that it was the hot vapor that was used to heat the mixture in the middle of the tube. When challenged, the inventors claimed that it would have been apparent to one skilled in the art that it would be possible to use the hot vapor for heating the mixture. The court disagreed and held that the disclosure was insufficient because the step was crucial to the invention and the inventors could not expect someone skilled in the art to guess at possibilities. The disclosure was therefore held insufficient because it did not explicitly state how to use the vapor. 60 An enabling disclosure can be found in the background portion of an application, including when the background section is discussing deficiencies in the prior art. 61 To save drafting time, patent practitioners do not include in the specification information that would be well known to a person of ordinary skill in the art, sometimes expressly referring to that information as well known. A trade-off of using such language is that the Federal Circuit has used such admissions to determine that a prior art reference was enabled because only ordinary computer programing skills would be needed Thus, the trade-off: The more detail provided for enablement, the more time it takes to prepare the application and the more costly the application. However, leaving out such detail could result in a conclusion that a sketchy prior art reference is enabled. Because of the serious potential consequences of failing to satisfy the enablement requirement, it is important to follow the rule of doubt ; if there is any doubt as to whether additional information should be included, the information should be included. While this is tempered with the need to write a clear and concise specification, the inventor cannot require someone skilled in the relevant art to engage in undue experimentation to practice the invention. 60. In re Winkhaus, 527 F.2d 637, 188 U.S.P.Q. 129 (C.C.P.A. 1975). 61. Callicrate v. Wadsworth Mfg., Inc., 427 F.3d 1361 (Fed. Cir. 2005) In re Morsa, 803 F.3d 1374 (Fed. Cir. 2015). 9 20

21 Writing the Specification 9:3.2 [C] The Skill of the Art Is Determined As of the Date of Filing When writing the specification, it is important to be aware of the skill of the art on the day of filing. Whether a process or material is well known is determined on this date. 62 A description that is enabling on the date of filing can become unenabling because a starting material becomes unavailable. In that situation the court evaluates each case individually and uses a rule of reason. 63 Because of the uncertainty as to how a court will rule in each case, when an unusual material or trademarked material is used, all possible alternative materials that will also enable the practice of the invention should be provided. [D] The Specification Need Not Explain How or Why the Invention Works Although the inventor must teach how to obtain the claimed result, the inventor need not disclose or explain how or why the invention works. The inventor does not need to understand the scientific principles behind the invention. 64 For example, the inventor of a photographic printing plate, who had no background in lithography, attempted to describe what he believed to be the chemical reaction that was the basis of the invention. When the patent was later challenged, the inventor s theories as to how the invention worked did not limit the scope of the patent. The Federal Circuit held that the patent specification was enabling, and that the inventor did not need to understand or to disclose how the invention worked. 65 [E] Undue Experimentation Must Not Be Required to Reproduce the Invention Undue experimentation to reproduce the invention cannot be required. Exactly what is undue depends on the nature of the invention and what amount of experimentation is reasonable. Factors that a court evaluates include whether the required experiments are routine or unpredictable, the amount of guidance presented in the specification, and how long it will take. 66 Because chemistry and 62. In re Koller, 613 F.2d 819, 204 U.S.P.Q. 702 (C.C.P.A. 1980); Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (written description requirement was not satisfied as of the priority date). 63. In re Metcalfe, 410 F.2d 1378, 161 U.S.P.Q. 789 (C.C.P.A. 1969). 64. Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565, 219 U.S.P.Q (Fed. Cir. 1983). 65. Id. 66. In re Wands, 858 F.2d 731, 8 U.S.P.Q.2d 1400 (Fed. Cir. 1988); Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 52 U.S.P.Q.2d 1129 (Fed. Cir. 1999). (Sheldon, Rel. #1, 4/16) 9 21