Requirements of Patent Enablement, Written Description, Best Mode, and Definite Claims

1. Chapter 4

2. Four Requirements of § 112 • 1. Enablement. The two issues that typically arise are: (i) Is the disclosed invention operative for some use? (ii) Did the applicant enable all that is being claimed? • 2. Written Description. This requirement is considered separate from enablement. In part, it is designed to enforce the “no new matter” requirement of § 132. • 3. Best Mode. It is an odd feature of US law. Designed so that patentee cannot keep the optimal parameters of invention as a trade secret. • 4. Definite Claims. Patentees is required to give public precise notice of their property rights.

3. Incandescent Lamp Case: History • 1802: Sir Humphrey Davy produces incandescence in a platinum wire. • 1841: Frederik de Moleyns obtains a British patent on an incandescent light using powdered charcoal set between two platinum wires inside a glass globe with a partial vacuum. • 1860: British inventor Joseph Swan invents a light using a carbonized incandescing conductor inside a glass globe. The light works but burns out quickly because of the poor vacuum. • 1865: Herman Sprengle invents an improved vacuum pump. • 1870: The first economical electric generators are produced. • 1875: William Crookes perfects a method to create a high vacuum in glass globes. • 1875-79: Race to invent among many researchers.

4. Incandescent Lamp Case: History • Nov. 4, 1879: Edison files an application on an improved light having high resistance and small surface area. • January 9, 1880: Sawyer and Man (SM) file an application on their improved light. • Jan. 27, 1880: Edison’s patent issues as No. 223,898. • May 12, 1885: SM patent issues as No. 317,676. • December 8, 1887: Assignees of SM file suit against electric companies that use Edison’s lights. • 1889: Trial court rules against SM • 1895: S.Ct. rules.

5. Incandescent Lamp Case: Questions • Was Edison’s patent legally relevant to this lawsuit? • No!!! The suit is an action for infringing the SM patent. It requires an evaluation of 1) whether the SM patent is valid; and 2) whether the accused devices fall within any valid claims of the SM patent. • What was the technical achievement of SM? • They probably had made a better filament than prior art filaments. Their filament was a thick filament of carbonized wood or paper; it was in the shape of an arch. • What did SM claim? • 1. An incandescing conductor for an electric lamp, of carbonized fibrous or textile material and of an arch or horseshoe shape, substantially as hereinbefore set forth

6. Incandescent Lamp Case: Lights Sawyer and Man Invention Edison-Style Light

7. Incandescent Lamp Case: Questions • What result the Court would have reached if the defendants in the case were not licensed by Edison — in other words, if the defendants were infringing Edison’s patents? • Same!!! • Does is matter whether Edison’s patent was valid or not? • No! • Could both Sawyer and Man’s and Edison’s patents have been valid? • Yes. Patents are negative rights only; they exclude others from practicing the invention but do not guarantee that the patentee can practice the invention. Both patents could be valid; Edison would then need a license from SM to practice his improved light.

8. Incandescent Lamp Case: Questions • Was there something about the language in Sawyer and Man’s patent claims themselves that made them too broad or insufficiently specific? • No. Broad, pioneering patents are a permissible, and even key, feature of the patent system. What matters is whether the applicant truly enabled the broad field which is claimed. • If SM really did discover a new carbonized paper lamp, why weren’t they entitled to a broad patent? • They claimed a broad sphere in which many of the embodiments could not be viewed as “successful.” There was no quality common to all of the claimed embodiments that made them particularly suited for incandescent filaments. • The Court asks rhetorically: “Was everybody then precluded by this broad claim from making further investigation?” Has such a concern animated prior cases? • Yes. Morse; Manson.

9. In re Fisher • The Fisher claim—from 1 to infinity—suffers from an infirmity similar to, but distinct from, the problem identified in the Incandescent Lamp case. • In Incandescent Lamp the disclosure enabled someone skilled in the art to construct the lamp of any fibrous material, but success was questionable given the goals of the patent. • Here, someone skilled in the art would be hard pressed to read from the specification how to create ACTH purities beyond 2.3. Both cases present enablement problems, but though the problem is more easily recognized in Fisher because the person skilled in the art would not even be able to obtain the claimed concentrates.

10. In re Fisher • Is the court’s distinction between the instant case and Parke-Davis case compelling? How many concentrations of purity exist between 99.9 % and 100% purity? • How would you redraft the claim in Fisher to avoid an enablement problem? • How appropriate is it that we grant patents on chemical products without regard to their process of production?

11. Amgen • Amgen is a composition of matter claim; note that it uses a “Parke-Davis” format, claiming only “a purified and isolated DNA sequence.” • Amgen’s problem was that it claimed both the specific DNA sequence encoding EPO and any others that could do the same job. • Finding all of those sequences would require “undue experimentation.” • The Amgen decision constrained the trend in the biotechnology industry to push for greater claim breadth in rDNA claims. The claim here would be valid only if the specification disclosed a unifying principle that permitted straightforward discovery of the other sequences.

12. Goodman • Goodman is another good example of an Amgen-type problem. The specification did not make it clear that similar levels of success could be anticipated with other plant types. In fact, a person skilled in the art would expect difficulties, as the court intimated. • Goodman makes the point that when claiming a process on a class of products, the specification must enable the process for the entire class, not merely select members of the class. • Could the applicant have cured the defect in his application by including more examples in the specification? • How does the Goodman situation differ from the patent granted for the Harvard onco-mouse (as discussed on pages 297-298)?

13. Wands • Wands was claiming only a process for using the antibodies, not the antibodies themselves. Nevertheless, the decision here shows that, as part of the disclosure of how to practice an invention, applicants must reveal how to make or obtain the starting materials for their invention if such materials are not readily available. • By requiring inventors to enable the starting materials as part of the disclose of the invention, the courts prevent inventors from simultaneously garnering both the protection inherent in patent rights and the benefits of a trade secret. • Could an inventor truly enable an invention if no one else could access the starting materials? • Why, if the yield from the revealed process for making the antibodies was only on the order of 1-2 %, was this enablement sufficient? • The court emphasizes the degree to which the field of art influences the “undue experimentation” standard. Here, yields of 1-2% are considered standard for the field.

14. Wands • Imagine that a “space rock” falls to Earth. No one knows how to make such a rock, but pieces of the rock can be purchased on the open market. An inventor discovers a new and nonobvious process for using the rock. Can the inventor patent the process even though she cannot enable the creation of the space rock? • The Patent Office permits an inventor to enable starting materials by depositing them in a publicly available database. In fact, patent deposits were first used for starting materials and only later were permitted for elements actually claimed (recall the plant patent discussions from Chapter 2). What policy distinctions can you see between the deposit of starting materials versus deposit of that which is claimed?

15. Strahilevitz • The invention here is designed to "detoxify" people with too much artificial stimulant (eg, LSD) in their systems. • The applicant describes the use of "off-the-shelf" components to achieve a useful end but relies solely on other’s research to demonstrate the effectiveness of his invention. • What has the inventor achieved here? • “Conceptual invention.” • What are the benefits and drawbacks of allowing inventors to rely on “wholly prophetic” examples in the specification? • Should the PTO issue “licenses to experiment”? • How reliable must the “prophecy” be? • This issue is addressed in cases such as Wands and Atlas Powder. It depends on the predictability of the art.

16. Written Description • Three statutes are important to understanding this area of the law: 112, 120, 132. • § 112. Specification. • [¶ 1] 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 … • § 120. Benefit of Earlier Filing Date in the United States • An application for patent for an invention disclosed in the manner provided by the first paragraph of section 112 of this title in an application previously filed in the United States . . . , shall have the same effect as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application • § 132. Notice of rejection; reexamination • … [Right to make amendments.] No amendment shall introduce new matter into the disclosure of the invention.

17. Written Description: Textual Analysis of Section 112 • § 112. Specification. • [¶ 1] The specification shall contain a written description of the invention, … , 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 … • This parsing of the language suggests that the sufficiency of the written description requirement is tested by whether the person skilled in the art can make and use the invention (i.e., it is viewed as part of the enablement requirement). Or • [¶ 1] 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 … • This version suggests that section 112 contains two distinct requirements: a written description and an enablement requirement.

18. Written Description: Rationales • First, the written description predates the inclusion of claims in the patent application, making it an historical remnant today. • Second, it may serve an independent function of limiting the ability of inventors to amend their claims after filing. This function substantially overlaps with § 132’s prohibition on introducing “new matter” into applications. • Third, if an inventor fails to recognize some part of his or her contribution to the art, and manifests that failure in the written description, then perhaps the inventor does not deserve patent rights on that unrecognized contribution. • The standard test for the written description requirement is whether the inventor demonstrates that he or she was “in possession” of the claimed invention.

19. Vas-Cath:

20. Vas-Cath • March 8, 1982: The inventor files for a U.S. design patent. • August 9, 1982: The inventor obtains a Canadian design patent. • October 4, 1984: The inventor files for a U.S. utility patent. • November 30, 1984: The inventor abandons his U.S. design patent application. • The inventor must use the filing date of his design patent + section 120. Otherwise, the section 102(b) will bar his 1984 application.

21. Vas-Cath • The catheter’s key inventive feature was the relationship between the diameters of the two passages, and the claims specified that the return lumen must have “substantially greater than one-half but substantially less than a full diameter” of the catheter. See page 308. • How could someone discern from the drawings the claimed mathematical relationship between the return lumen and the overall catheter diameter? • See page 309, describing the testimony of the plaintiff’s expert, Dr. Ash. • Yet, the court notes that the drawings do not “necessarily exclude all diameters other than those within the claimed range.” The court doubts that “any drawing could ever do so.” Does this show that the drawings cannot really provide a written description of the claims?

22. Gentry Gallery • Gentry’s patent claimed a sofa with • i) two recliners on the same section of the sofa, • ii) a center console between the two recliners, and • iii) a pair of recliner controls (one for each recliner) “mounted on the double reclining seat sofa section.” • Berkline asserted that the patent’s written description could support only a sofa having the recliner controls on the center console, as opposed to anywhere on the recliner section of the sofa. • Gentry’s original patent specification referred only to permutations of the sofa that included the recliner controls somewhere on the center console.

23. Gentry Gallery • Applying Vas-Cath, what would someone skilled in the art understand from the specification’s drawings? • The drawings in the patent show the controls on the center console, but the center console is a part of the “double reclining seat sofa section.” • In Vas-Cath, the court allowed the inventor to claim a range of permutations even though the drawings showed only one point in the range. Shouldn’t then the inventor here be able to claim a range (controls on anywhere on the reclining section) including the single position show in the drawings? • Note court’s finding, at page 318 in the text, that the inventor in Gentry Galley stated in his specification that the location of the controls on the console was “an essential element of his invention.” • Since it is a factual issue whether the inventor has satisfied the written description requirement, why didn’t the Federal Circuit defer to the findings of the district court?

24. Regents of the Univ. of Cal. v. Ely Lilly • The University of California appealed from a district court ruling that its patents to a microorganism containing the complementary DNA (cDNA) sequences for human, mammalian, and vertebrate insulin were invalid. • The specification disclosed the cDNA structure for rat insulin and included an example stating generally how to obtain the cDNA sequence for human insulin.

25. Regents of the Univ. of Cal. v. Ely Lilly • Based on the inventor’s specification, would people skilled in the art recognize the DNA sequence for human insulin if they saw it? • Why wasn’t this case decided on enablement grounds? • Would the inventor have been unduly rewarded had the patent been upheld? • How would you cast the appropriate role of the written description requirement? Is it to prove the inventor recognizes his or her invention (see Gentry Gallery)? If this is so, is Regents wrongly decided?

26. University of Rochester v. Searle & Co. • In the early 1990s, scientists discovered the existence and separate functions of ‘‘COX–1’’ and ‘‘COX–2’’ (or PGHS–1’’ and ‘‘PGHS–2’’). • Aspirin, etc. inhibit both COX–1 (stomach) and COX–2 (inflammation). (New compounds such as Vioxx inhibit only COX-2.) • Rochester scientists developed a screening assay for use in determining whether a particular drug inhibited COX-2 but not COX-1. • Rochester obtains a patent (“479”) for methods ‘‘for identifying a compound that inhibits prostaglandin synthesis catalyzed by mammalian prostaglandin H synthase–2 (PGHS–2).’’ Not at issue. • It also get a patent (850) directed to methods ‘‘for selectively inhibiting PGHS–2 activity in a human host’’ by ‘‘administering a non-steroidal compound that selectively inhibits activity of the PGHS–2 gene product to [or in] a human host in need of such treatment.’’ At issue.

27. University of Rochester v. Searle & Co. • P. 921 Statute requires both enablement and written description. • P. 923 Person skilled in the art must be able to recognize what is claimed. • P. 925 Even now, one cannot recognize what chemicals will inhibit COX-2. • P. 928 The only claims supported are the assay methods, which issued in the 479 patent.

28. Orthokinetics v. Safety Travel Chairs

29. Orthokinetics v. Safety Travel Chairs • 1. In a wheel chair having a seat portion, a front leg portion, and a rear wheel assembly, the improvement wherein • said front leg portion is so dimensioned as to be insertable through the space between the doorframe of an automobile and one of the seats thereof [Emphasis added.] • whereby said front leg is placed in support relation to the automobile and will support the seat portion from the automobile in the course of subsequent movement of the wheel chair into the automobile, and the retractor means for assisting the attendant in retracting said rear wheel assembly upwardly independently of any change in the position of the front leg portion with respect to the seat portion while the front leg portion is supported on the automobile and to a position which clears the space beneath the rear end of the chair and permits the chair seat portion and retracted rear wheel assembly to be swung over and set upon said automobile seat.

30. Orthokinetics v. Safety Travel Chairs • CLAIMS DO NOT HAVE TO ENABLE!!! • The goal of claims is to define the scope of the right, NOT to provide blueprints. • Claim definiteness does not necessarily require incredible detail, as seen in Orthokinetics. So long as someone skilled in the art would understand the scope of the invention from the claim, the standard is met. • As a prophylactic rule, the PTO generally requires language in claims to be supported by language in the antecedent specification, though this rule is also designed to avoid written description problems.

31. Orthokinetics v. Safety Travel Chairs • As a practical matter, could the inventor in Orthokinetics have included more specific language in his claims without articulating the dimensions for every make and model vehicle on the market? • Did the inventor enable the wheelchair for all vehicles? • This question can be answered only be reference to the specification, not the claims. • Here the answer is yes. Witnesses for Orthokinetics testified that, based on the specification, a person skilled in the art could “easily” determine the appropriate dimensions for any particular automobile. • What did the inventor invent here if persons skilled in the art could figure out the necessary dimensions to make the chair fit in a car?

32. Standard Oil v. American Cyanamid • The claim used the term “partially soluble” to describe a necessary chemical precursor for the claimed process. • “Partially soluble,” however, had no accepted definition in the field, and the patent specification provided no definition of the term. • If this patent claim had not been invalided, how would it be enforced? • If you are prosecuting a patent, and the patent examiner objects to some language in the claim, should you simply amend the claim to reflect the examiner’s concerns? • You should probably cross-reference the new language with previous patents and check with the inventor to ensure the new language is well understood in the art. • If in doubt, you should include appropriate definitions in the specification. Of course, once the application has been filed, an applicant cannot add new matter to the application, so terms of art must have support in the original specification.

33. Randomex v. Scopus • The patent at issue covers a cleaning device for the magnetic memory disks found in mainframe computers. • Practicing the invention required the use of a cleaning fluid, which Randomex had disclosed in the specification as either (i) “a 91 percent alcohol solution” or (ii) “a non-residue detergent solution such as Randomex Cleaner No. 50281.” • The “91 percent alcohol solution” was a common cleaning solution for magnetic disks, but it was admittedly the worst mode for Randomex’s invention because it could cause an explosion. • The “non-residue detergent solution such as Randomex Cleaner No. 50281” was also well-known in the industry, but the exact formula of Randomex’s cleaner was not disclosed in the specification.

34. Randomex v. Scopus • At least in cases where “one of ordinary skill in the art could readily determine the best operating mode,” there is no violation of the best mode requirement where the inventor has disclosed the best mode requirement indiscriminately with other embodiments. • The court states that “a trade name alone may be inappropriate in a best mode disclosure when suitable substitutes are unavailable.” Why? • Why doesn’t Randomex lose here because of the use of its trade name? • “commercial substitutes were readily available in the prior art” • The dissent objects that “His disclosure does not satisfy section 112 because he buried his best mode in a list of less satisfactory ones.” Is the disagreement on an issue of fact or law?

35. Randomex v. Scopus • Assume that the specification for a patented engine indiscriminately listed 1,000,000 different lubricants for the engine. All the lubricants work, but the inventor knows that one is best. Has the inventor satisfied the best mode requirement? • Randomex does not provide a clear answer here. Certainly, if a person skilled in the art can “readily determine the best operating mode,” then the best mode requirement has been satisfied. But the court does not say that all indiscriminate disclosures will be viewed as satisfying the requirement. • If someone skilled in the art of baseball bats could not immediately say which of the two metal alloys disclosed in a new baseball bat patent specification would perform the best, but the inventor had a preferred metal, would the inventor have satisfied the best mode requirement? • Randomex suggests that the answer might be “no,” although in Randomex itself the person skilled in the art would have probably been able to tell which of the two modes would work best. Chemcast gives additional insight into this question, though it too is not clear.

36. Chemcast Corp. v. Arco Industries • Chemcast sued Arco for infringing on its patent for a type of grommet designed to seal openings in thin metal surfaces. • The question Chemcast was whether the inventor disclosed his preferred level of hardness for the “locking portion” of the grommet. • Both the claim language and the specification stated that the locking portion was to have durometer hardness reading of “70 Shore A” or more. • The inventor knew that his best mode of practicing the invention was to have the locking portion be hardness of 75 ± 5 Shore D, but he did not disclose this hardness level. The inventor also knew, but did not disclose, that his best mode of practicing the invention was to make the locking portion from a specific material sold under the trade name R-4467, though he did not know the composition of R-4467.

37. Chemcast Corp. v. Arco Industries • While enablement is a purely objective inquiry, best mode contains a subjective component (whether the inventor's knew of a best mode) coupled with an objective component (whether the disclosure was sufficient to enable one skill in the art to practice the best mode). • Here the inventor did not disclose sufficient information. Why? • If you were to seek a patent on an engine which runs best on ethanol of 99.95% purity, would you need to disclose how to make the fuel with your proprietary (and much cheaper) process when the fuel is otherwise widely available? • No. If a user of the invention can otherwise obtain the materials from third-party sources, then you need not reveal your process for making the optimum fuel, since it is not the fuel for which you are seeking a patent.

38. Chemcast Corp. v. Arco Industries • If you were to seek a patent on an engine which runs best on ethanol of 99.95% purity, would you need to disclose how to make the fuel with your proprietary process, when the fuel is not otherwise available? • To satisfy the enablement requirement, you would need to disclose some process to create the fuel. According to Eli Lilly v. Barr Labs., you would not have to reveal your best mode for making the fuel. • Joe invents a new form of gasoline which he decides to exploit as a trade secret. Later Joe invents a new gasoline engine, which he chooses to patent. At the time he files his patent application, Joe knows that his new engine runs best using his own trade-secret protected gasoline blend. Must Joe disclose the formulation of his gasoline blend in his patent application on the engine? • If Eli Lilly v. Barr Labs. is read very broadly, then the inventor would not have to disclose the composition of the gasoline because it is not claimed subject matter. • However, in Randomex the court assumed that the best mode requirement did apply to a cleaning fluid needed to use the invention. If the gasoline formulation is analogized to the cleaning fluid and the best mode requirement does apply, then the applicant would have to disclose the formulation.

39. Transco Products v. Performance Contracting • If we required an inventor to update the best mode disclosure any time the application is changed before the patent is granted, what would the practical effect of such a rule be? • Consider the following hypothetical: Texaco researchers invent a new form of gasoline called Tex-X, which the company decides to exploit as a trade secret. Later other Texaco researchers invent a new gasoline engine, which the company chooses to patent. At the time of filing, these Texaco researchers know that their new engine runs best using the Tex-X gasoline blend. Must the formulation of Tex-X be disclosed in the patent application on the engine? • Here the answer depends on whether the engine inventors know the formulation of Tex-X. If they do not, then they must disclose that the engine runs best on Tex-X but they needed disclose the formulation because, subjectively, they don’t know it. This hypothetical shows that an assignee’s knowledge is not relevant in the best mode inquiry. If, of course, the engine researchers do know the formulation, then they must disclose it unless it is considered unclaimed subject matter under Eli Lilly v. Barr Labs.

40. Transco Products v. Performance Contracting • Assume your client intends to file patent applications in Europe this year and then file a U.S. application next year (within one year of the European filing). Europe does not require a best mode disclosure; the U.S. does. Should your client disclose the best mode? • Yes. If your client wants to take advantage of the priority rule in §119, then the European disclosure will have to satisfy all of the requirements of § 112, including the best mode requirement. This hypothetical shows why applicants in other countries may disclose a best mode even though none is required under that country’s patent laws.