 |
|
| |
|
|
|
| |
Date: 01/15/99
By
Kurt E. Richter
Kathryn E. Diaz
[Editor's Note: Mr. Richter is partner in the New York-based law firm of Morgan & Finnegan, L.L.P. Ms. Diaz is an associate at the firm. This commentary is part of a series of articles by the firm. Copyright 1999 Kurt E. Richter and Kathryn E. Diaz.]
INTRODUCTION
As the growth in patent applications1 and patent infringement cases2 continues unabated, involving ever more complex inventions, an inevitable question arises: Has the measure of the adequacy of the enabling disclosure gotten concomitantly more stringent?
In addition, since the Federal Circuit reverses, in whole or in part, about 53% of all patent infringement decisions appealed from the district courts,3 what trends are perceptible in its opinions regarding enablement? And can we expect the differences in applying the enablement requirement to the “unpredictable” biotechnology and chemical arts versus the mechanical and electrical arts to continue?
DISCUSSION
I. Enablement Requirement
In exchange for a patent, an inventor must enable others to practice the invention. The inventor must disclose, for the benefit of the public, how to make and use the invention, as codified in 35 U.S.C. § 112, 1:
Specification
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 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....
While both the enablement and written description requirements appear in Section 112, they are distinct requirements, to be analyzed separately. The description of the invention must be more specific in certain respects than the description that enables one to make or use it. Indeed, the description of the invention serves as notice that, as of the filing date, the inventor was in possession of whatever is now claimed—namely, the invention.4 This paper addresses only the enablement requirement.
II. The Requisite Criteria For An Enabling Disclosure
1. The Enablement Requirement Is Directed
To A Person Skilled In The Art Since those skilled in the art are the audience, an inventor is not required to explain every little detail as to how to make and use the invention. Conventional knowledge will be read into the disclosure. Accordingly, the duty to tell all that is necessary to make or use an invention varies greatly depending on its underlying art.5
Who is deemed skilled in the art? The inventor himself serves as one measure. The key is “enabling the inventor or others skilled in the art to reduce the conception to practice without any further exercise of inventive skill.”6 Generally, scientists in the field are considered those having ordinary skill in the art.
This August, the Federal Circuit addressed who is not skilled in the art. In The Johns Hopkins Univ. v. CellPro, Inc.,7 CellPro challenged the enablement of a Johns Hopkins patent for monoclonal antibodies. The district court granted Hopkins’ motion for a new trial following an adverse jury verdict and subsequently granted Hopkins’ motion for summary judgment on the issue of enablement. In opposing the motion, CellPro submitted evidence that the inventor himself had been unable, using the patent’s techniques, to produce more than the single antibody disclosed in the specification. In reversing, the Federal Circuit was quick to note the deficiency of CellPro’s proofs:
CellPro failed to offer evidence that many of those working on projects in [inventor] Civin’s lab, including undergraduate students or others who had never before made a monoclonal antibody, were of ordinary skill in the art.... Despite being warned of this evidentiary shortcoming, CellPro...produced no evidence concerning the level of skill of those individuals working under Civin’s supervision.... Because it is imperative when attempting to prove lack of enablement to show that one of ordinary skill in the art would be unable to make the claimed invention without undue experimentation,...CellPro’s evidence concerning Civin’s subsequent work is insufficient as a matter of law.8
Just what degree of "lesser" skill than the inventor's would permit a finding of lack of enablement is no doubt a question to be decided on a case-by-case basis. But it should never be forgotten that it is what the enabling disclosure irrefutably teaches, not who is receiving the instruction, that is of paramount importance.9
The hypothetical person of ordinary skill is presumed to be informed of prior art that would enable practice of the invention. Enablement is determined as of the application filing date; accordingly, such prior art is that which was available on that date. This means, for example, that a § 102(e) reference that constitutes prior art for purposes of obviousness under § 103 is not “enabling” prior art under § 112 because a skilled person would not have seen it.10
An enabling specification may assume familiarity with prior art that is well known.11 “[H]ydraulic and electrical systems for metal scrap shears are well known to those skilled in the art...selection and connection of the elements of such systems was simply a matter of plumbing.” The defendant’s proofs of the time and money it spent on developing its shear were found lacking, as there was no evidence of the time required to develop the allegedly non-enabled control system.12
Stated otherwise, a patent application must contain details concerning the structure and function of the elements in question, unless they are well known in the art. An expert’s conclusory declaration that something is “well known”—absent a detailed explanation or citations to prior art—will not suffice.13
B. Some Experimentation, But Not
“Undue Experimentation,” Permitted
“[T]hough not explicitly stated in Section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” 14 Accordingly, some experimentation to practice an invention is not fatal to validity, but the experimentation must not be unduly extensive. 15 As noted above, however, “[a]n inventor need not…explain every detail since he is speaking to those skilled in the art.” 16
Whether making and using an invention would require undue experimentation is a legal conclusion based upon several underlying factual inquiries. 17 “The determination of what constitutes undue experimentation in a given case requires the application of a standard of reasonableness, having due regard for the nature of the invention and the state of the art.” 18 Most importantly—and this should be stating the obvious—the invention has got to work. 19
This doesn’t mean the applicant is required to submit proof that an invention will work in humans, for example, if animal tests show therapeutic value and usefulness. 20 And “the mere fact that something has not previously been done clearly is not, in itself, a sufficient basis for rejecting all applications purporting to disclose how to do it." 21 Still, the disclosure has to do what it says. 22
The legal question of enablement also may involve subsidiary issues of fact, such as whether an essential teaching incorporated by reference was available to the public. 23
The In re Wands, 24 decision by the Federal Circuit sets forth a number of factors to weigh in considering compliance with the enablement requirement as follows:
1. the quantity of experimentation necessary;
2. the amount of direction or guidance presented;
3. the presence or absence of working examples;
4. the nature of the invention;
5. the state of the prior art;
6. the relative skill of those in that art;
7. the predictability or unpredictability of the art; and,
8. the breadth of the claims. 25
“It is not necessary that a court review all the Wands factors to find a disclosure enabling. They are illustrative, not mandatory. What is relevant depends on the facts.” 26
C. The Patent Disclosure Need Not Be A
Commercial Production Document
“Patents are not production documents and nothing in the patent law requires that a patentee must disclose data on how to mass-produce the invented product, in patents obtained on individual parts of the product or on the entire product….Nor is it an objective of the patent system to supply, free of charge, production data and production drawings to competing manufacturers.” 27
D. Scope Of Enablement Must Be Commensurate With That
Of The Utility Asserted And The Subject Matter Claimed
Some twenty years ago in a seminal decision interpreting what constitutes an adequate enabling disclosure, In re Hogan, 28 the Court of Customs and Patent Appeals observed, “Rejections under §112, first paragraph, on the ground that the scope of the enablement is not commensurate with the scope of the claims, orbit about the more fundamental question: To what scope of protection is this applicant’s particular contribution to the art entitled?”
Hogan involved claims to certain polymers. The examiner had rejected three claims on grounds that the scope of the enablement was narrower in the ancestral application than the breadth of the claims sought in the continuation-in-part. In brief, the examiner concluded that while the disclosed chromium oxide catalyst enabled preparation of solid polymers, it did not allow preparation of later-discovered amorphous species. The examiner supported the rejection with a publication issued several years after the original application and describing the amorphous polymers embraced by the claims at issue. The Court reversed and remanded the case to the PTO to determine whether the application was enabling in view of the state of the art existing as of the original filing date:
If later states of the art could be employed as a basis for rejection under 35 U.S.C. § 112, the opportunity for obtaining a basic patent upon early disclosure of pioneer inventions would be abolished.
… Appellants disclosed, as the only then existing way to make such a polymer, a method of making the crystalline form. To now say that appellants should have disclosed in 1953 the amorphous form which on this record did not exist until 1962, would be to impose an impossible burden on inventors and thus on the patent system. There cannot, in an effective patent system, be such a burden placed on the right to broad claims. To restrict appellants to the crystallene form disclosed, under such circumstances, would be a poor way to stimulate invention, and particularly to encourage its early disclosure….
Consideration of a later existing state of the art in testing for compliance with § 112, first paragraph, would not only preclude the grant of broad claims, but would wreak havoc in other ways as well. The use of a subsequently-existing improvement to show lack of enablement in an earlier-filed application on the basic invention would preclude issuance of a patent to the inventor of the thing improved, and in the case of issued patents, would invalidate all claims...therein. 29
It remains to be seen how frequently Hogan will be applied to new fact patterns and new technologies such as biotechnology. The case does not lighten the applicant’s burden of enabling his invention to the full measure of the patent claims. Further, it is highly questionable that patent claims would be found enabled within their full scope if the evidence shows that it was beyond the teachings of the patent to prepare embodiments, foreseen or contemplated as of the filing date but only later successfully reduced to practice. As the Hogan court stated, the inquiry is whether the invention claimed is enabled as of the filing date in the light of all proper evidence. 30
E. Guidance Required Depending On The Prior Art
The guidance provided by the specification for selecting embodiments of the invention that achieve the disclosed utility is essential where the invention involves an unpredictable art. 31 “[A]n examiner may reject a claim if it is reasonable to conclude that one skilled in the art would be unable to carry out the claimed invention.” 32 A higher level of predictability is recognized in mechanical or electrical environments, whereas the level of predictability in chemical reactions and physiological activity is ordinarily assumed to be lower. 33
For instance, in Cedarapids, Inc. v. Nordberg, Inc., 34 the Federal Circuit reversed the decision below, explaining that “[a]ll of the cases cited by the district court to support its conclusion that the specification...is not enabling are chemical cases....Rock crusher technology is not in the same category as the chemical arts where a slight variation in a method can yield an unpredictable result or may not work at all.” 35
F. The Guidance And Teaching Required By Recent
Biotech Cases For An Enabling Disclosure
Biotechnology companies, under intense competition, often seek broad claims to protect contemplated embodiments of inventions not yet reduced to practice. As a less predictable art, biotechnology “reflect[s] the tension between the need for broad claims to meaningfully reward valuable...advances and the concern that granting broad claims will hinder further advances or disproportionately reward those who make small, but timely, contributions.” 36 A further strain is that the unpredictable aspects of recombinant DNA technology, which make these inventions nonobvious and patentable, also make them difficult to enable. 37
As shown below, this play between broad claims and adequate enabling disclosure in biotechnology patents comes up repeatedly.
1. Historical Perspective
It is the biotechnology cases that most often grapple with the question posed by the Hogan court, to what scope of protection is this applicant’s particular contribution to the art entitled? And yet, while biotech garners much publicity today, the core issues it raises as to enablement have been with us for a while; it is worth keeping this in mind as a kind of grounding in the face of a dizzying array of patents and questions about enablement.
For instance, in rejecting an application for a patent for an adrenal gland stimulating concentrate, the Court of Customs and Patent Appeals wrote some 28 years ago: 38
It is apparent that such an inventor should be allowed to dominate the future patentable inventions of others where those inventions were based in some way on his teachings. Such improvements, while unobvious from his teachings, are well within his contribution, since the improvement was made possible by his work. It is equally apparent, however, that he must not be permitted to achieve this dominance by claims which are insufficiently supported and hence not in compliance with the first paragraph of 35 U.S.C. § 112. That paragraph requires that the scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art. In cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.
2. Recent Federal Circuit Cases
Five recent Federal Circuit biotech cases suggest that the complexity of the technology is attended by an unyielding demand to enable the full scope of the claimed subject matter. These cases underscore that claim scope will be heeded and that the efficacy of the enabling disclosure will be scrutinized accordingly. All feature a rigorous inquiry into the technical problems solved by the invention and the disclosed means for solving them. None cuts the applicant any slack, each upholding claim rejections or holding patent claims invalid for failure to comply with § 112.
a) Ex Parte Decisions
In In re Vaeck, 39 the claims were directed to gene expression in cyanobacteria. The specification’s working examples all related to the transformation of a single strain of cyanobacteria, one of some 150 different cyanobacteria genera. The PTO rejected the claims as exceeding the enablement provided by the specification, since the field was unpredictable and cyanobacteria were poorly studied and only recently the subject of intense investigation. Notwithstanding the appellants’ plea that their invention was pioneering, that narrower claims would provide inadequate protection and that skilled microbiologists would be able to transform other species of cyanobacteria, the rejection was affirmed.40 Noting the unpredictability of the science, the Court remarked:
There is no reasonable correlation between the narrow disclosure in appellants' specification and the broad scope of protection sought in the claims encompassing gene expression in any and all cyanobacteria….Accordingly, we affirm the § 112 rejection as to those claims.
In so doing we do not imply that patent applicants in art areas currently denominated as "unpredictable" must never be allowed generic claims encompassing more than the particular species disclosed in their specification. It is well settled that patent applicants are not required to disclose every species encompassed by their claims, even in an unpredictable art. In re Angstadt, 537 F.2d 498, 502-03, 190 USPQ 214, 218 (CCPA 1976). However, there must be sufficient disclosure, either through illustrative examples or terminology, to teach those of ordinary skill how to make and how to use the invention as broadly as it is claimed. This means that the disclosure must adequately guide the art worker to determine, without undue experimentation, which species among all those encompassed by the claimed genus possess the disclosed utility. Where, as here, a claimed genus represents a diverse and relatively poorly understood group of microorganisms, the required level of disclosure will be greater than, for example, the disclosure of an invention involving a "predictable" factor such as a mechanical or electrical element. 41, 42
In re Wright, 43 considered live, non-pathogenic vaccines against pathogenic RNA viruses, and processes for producing and using them. The specification provided a general description of this subject matter, but only a single working example—production of a recombinant vaccine that conferred immunity in chickens against a particular RNA tumor virus. Both the examiner and the Board rejected the claims as requiring undue experimentation, and the Federal Circuit affirmed: 44
Wright argues that he has constructed successfully an env C recombinant vaccine according to the present invention and that certain recombinant AIDS virus vaccines carrying SIV (simian immunodeficiency virus) and HIV (human immunodeficiency virus) envelope genes have been produced which confer protective immunity in the animal models where they have been tested, and that these developments illustrate that the art is not so unpredictable as to require undue experimentation. However, all of these developments occurred after the effective filing date of Wright's application and are of no significance regarding what one skilled in the art believed as of that date. Furthermore, the fact that a few vaccines have been developed since the filing of Wright's application certainly does not by itself rebut the PTO's assertions regarding undue experimentation. Moreover, whether a few AIDS virus vaccines have been developed which confer immunity in some animal models is not the issue. The Examiner made reference to the difficulty that the scientific community is having in developing generally successful AIDS virus vaccines merely to illustrate that the art is not even today as predictable as Wright has suggested that it was back in 1983.
In re Goodman, 45 dealt with claims for a method of producing mammalian peptides in plant cells, which called for integration into plant cells of a DNA construct encoding the peptide. The issue was whether a single example of producing gamma-interferon in the dicotyledonous species, tobacco, was enabling. Deciding it was not, the Federal Circuit agreed with the PTO that such a single example does not enable a biotechnician of ordinary skill to produce any type of mammalian protein in any type of plant cell. In reaching this conclusion, the Court considered a number of published papers showing that the production of peptides in monocotyledonous plants involved extensive problems that were not addressed in the specification and “the need for extensive experimentation to practice the claimed method for just a few plants, let alone all plant cells as broadly claimed in the application.” 46
b) Litigation Decisions
In Amgen, Inc. v. Chugai Pharmaceutical Company, Ltd.,47 the patent-in-suit claimed DNA analogs “sufficiently duplicative” of the erythropoietin (EPO) gene to possess the property of increasing production of red blood cells. In sum, Amgen claimed every possible analog of the 4,000-nucleotide EPO gene, but the disclosure was limited to how to make EPO and a few analogs.
Affirming the trial court’s determination that the claim was invalid under § 112, the Federal Circuit stated that, while “it is not necessary that a patent applicant test all the embodiments of his invention, ...what is necessary is that he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims. For DNA sequences, that means disclosing how to make and use enough sequences to justify grant of the claims sought.” 48
The Court further explained that a review of all Wands factors is not necessary; they are illustrative, not mandatory. 49 “What is relevant depends on the facts, and the facts here are that Amgen has not enabled preparation of DNA sequences sufficient to support its all-encompassing claims.” 50
Genentech, Inc. v. Novo Nordisk, A/S, 51 addressed enablement of, a process for specifically cleaving human growth hormone (hGH) enzymatically from a fusion expression polypeptide. On appeal from a preliminary injunction against Novo Nordisk, the Federal Circuit considered whether the patent’s generic statement of the possibility of cleavable fusion expression—along with the DNA sequence encoding hGH, a single enzyme (trypsin) for cleaving undisclosed conjugate proteins, and a statement of that enzyme's cleavage sites as being potential amino acid extensions conjugated to hGH—constituted a sufficient enabling disclosure commensurate in scope with the claim.
The patent contained no working example of the claimed process. At the preliminary injunction hearing, however, Genentech’s expert testified at length how scientists in the field could have prepared enzymatically cleavable hGH conjugate proteins using information in reference books on enzyme activity, and could have successfully used trypsin with the disclosed cleavage sites if implemented with certain available techniques not expressly mentioned in the patent.
In concluding that the expert’s testimony could not supply what was missing in the specification, the Court observed: 52
[W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. This specification provides only a starting point, a direction for further research.
The Court additionally noted the unpredictability of the science in this field and that, for years, skilled scientists, supplied with the teachings Genentech now asserts were sufficient, could not produce human proteins by cleavable fusion expression. “This specification is so lacking with respect to the [cleavage limitation] that providing testimony regarding the skill in the art has been an exercise in futility.” 53 Id. at 1367.
III. The Impact Of A Proper Claim Construction
On The Enablement Requirement
Certainly in the wake of Markman v. Westview Instruments, Inc.,54 the intersection of claim interpretation with enablement compliance commands close attention.
A good example is Amgen, Inc., supra. There, a patent claimed a purified erythropoietin protein in terms of its physical properties including “a specific activity of at least 160,000 IU/AU.” The claim did not specify whether the specific activity measurement was in vitro or in vivo, but it was construed to mean in vivo. This resulted in the claim being held invalid for lack of enablement because, although products in excess of 160,000 in vitro had been made, there was no evidence that persons had prepared products with comparable in vivo activity, there sometimes being a discrepancy between the activity as measured by the two assay techniques.
Decisions in the electrical arts also emphasize proper claim construction. In DeGeorge v. Bernier,55 for example, priority in an interference action depended on a proper construction of the senior party’s claim corresponding to the count, a two-counter comparison paragraph indent (TCCPI) circuit for word processors. The Court disagreed with the Board that the non-described word processor was an element of the patent claim, and reversed. It then went on to decide that the specification was enabling for the claimed circuit: “[T]here was nothing exotic or unique about the logic elements of the ... circuit and how they interfaced with signal generating control circuits in a word processor.”56
Similarly, in Alco Standard Corp. v. TVA,57 the Court turned to the patent specification and the file history to interpret the terms “correlating” and “combining.” Once these terms were understood, the Court had no problem in affirming the District Court’s holding that one skilled in the art would have known how to correlate and combine the ultrasonic data from a reading of the patent disclosure.
IV. The Enablement Concept In The Context
Of Obviousness And Anticipation
Whether a prior art reference invalidates a patent for obviousness or anticipation depends on whether the reference would have enabled one skilled in the art to practice the patent. This a mixed question of law and fact.58 If the prior art is not enabling, it does not invalidate the patent.59 On the other hand, it is not necessary for such an invention disclosed in a publication to have been actually or constructively reduced to practice in order to constitute enabling prior art.60
CONCLUSION Evaluating an enabling disclosure is very much an exercise in astute claim construction and technological criticism. While some may question the harmony of certain decisions with established enablement doctrines, overall the legal criteria have remained remarkably consistent. The measure of the adequacy of the enabling disclosure is more stringent only to the extent that the technology is more unpredictable. The core principles for evaluating enablement were enunciated years ago for all the arts, and the Federal Circuit closely adheres to them. For patent applicants, the message is that the patent specification must be thoughtfully drafted, with an appreciation of the nature of the invention and any attendant problems that are likely to arise in attempting to practice the subject matter of the claims. For accused infringers, a successful challenge to the patent on enablement grounds means properly construing and comparing the language of the claims with the substantive content of the specification. For both patentees and the accused, there will be no clever arguments to the jury. The longstanding law of enabling disclosure and the recent Markman decision establish that these are questions of law.
ENDNOTES:
1 The number of patent applications filed each year has more than doubled over the past 20 years. Table 2, 1997 U.S. Patent & Trademark Office Annual Report, http://www.uspto.gov/web/offices/com/ annual/1997.pdf.
2 There was a 14% increase in patent cases commenced in 1997, over 1996. Table C-2A, Judicial Business of the United States Courts 1997, http://www.uscourts.gov/judicial/business/contents.html.
3 Margaret Cronin Fisk, Confusion Follows ’96 Landmark Patent Case, ‘Markman’ Decision Didn’t Turn Out as Most Predicted, Nat’l L.J. June 15, 1998, at A1.
4 See generally, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991).
5 In re Howarth, 654 F.2d 103, 105, 210 USPQ 689, 691 (CCPA 1981).
6 Gould v. Schawlow, 363 F.2d 908, 916, 150 USPQ 634, 641 (CCPA 1966) (emphasis added).
7 ___ F.3d ___ , 47 USPQ2d 1705 (Fed. Cir. 1998).
8 Id. at 1718.
9 See, e.g., Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997), cert. denied, ___ U.S. ___, 118 S.Ct. 397 (“Genentech’s arguments, focused almost exclusively on the level of skill in the art, ignore the essence of the enabling requirement. Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”).
10 In re Glass, 492 F.2d 1228, 1232, 181 USPQ 31, 34 (CCPA 1974).
11 Lindemann Maschinenfabrik GMBH v. Am. Hoist and Derrick Co., 730 F.2d 1452, 221 USPQ 481 (Fed. Cir. 1984).
12 Id. at 1463.
13 In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991) (“If the relatively complex phase comparator and divider described in [the expert’s] declaration were so ‘well known’ and ‘routinely built’ as of the effective filing date, the declarant should have had no trouble documenting the same”).
14 In re Wright, 999 F.2d 1557, 1560, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991).
15 Amgen, Inc. v. Chugai Pharmaceutical Company, Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991), cert. denied, 502 U.S. 856, 112 S.Ct. 109; Atlas Powder Co. v. E.I. du Pont de Nemours and Company, 750 F.2d 1569 (Fed. Cir. 1984).
16 DeGeorge v. Bernier, 768 F.2d 1318, 226 USPQ 758 (Fed. Cir. 1985), citing, In re Howarth, 654 F.2d 103, 105, 210 USPQ 689, 691 (CCPA 1981)
17 In re Wands, 858 F.2d 731, 735, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
18 Id., citing Ansul Co. v. Uniroyal, Inc., 448 F.2d 872, 878-79, 169 USPQ 759, 762-63 (2d Cir. 1971).
19 See Newman v. Quigg, 877 F.2d 1575, 11 USPQ2d 1340 (Fed. Cir. 1989), cert. denied, 495 U.S. 932, 110 S.Ct. 2173 (1990) (Invention not enabled because it was an impossibility; it would violate the first law of thermodynamics).
20 See In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995).
21 Gould v. Quiqq, 822 F.2d 1074, 3 USPQ2d 1074 (Fed. Cir. 1987), citing, In re Chilowsky, 229 F.2d 457, 461, 108 USPQ 321, 325 (CCPA 1956) "). See also, In re Ferens, 417 F.2d 1072, 1074, 163 USPQ 609, 611 (CCPA 1969).
22 Raytheon Co. v. Roper Corp., 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983) (“Common cavity” oven requiring a means for continuing convection during autoignition not enabled because autoignition could not happen). See also Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 28 USPQ2d 1190 (Fed. Cir. 1993) (Unrebutted evidence showed that replication of some of the fifty-odd patent examples produced a complex mixture of compounds, some of which existed in the prior art, but not any compounds which could be shown to possess the claimed connectivity).
23 Quaker City Gear Works, Inc. v. Skil Corp., 747 F.2d 1446, 1453-54, 223 USPQ 1161, 1164-67 (Fed. Cir. 1984) (no enablement where essential German Industrial Standard mentioned six times in patent was never produced at trial). In re Howarth, supra, 654 F.2d 103, 210 USPQ 689 (foreign patent applications available to the public prior to applicant’s filing date not to be considered in determining enabling quality of the applicant’s specification).
24 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988).
25 Id. at 737, quoting, In re Forman, 230 USPQ2d 546, 547 (Bd. Pat. App. & Int’f 1986).
26 Amgen, supra, 927 F.2d at 1213.
27 Christianson v. Colt Indus. Oper. Corp., 822 F.2d 1544, 1562, 3 USPQ2d 1241, 1254 (Fed. Cir. 1987).
28 559 F.2d 595, 605, 194 USPQ 527, 537 (CCPA 1977).
29 Id. at 605-606.
30 Id. at 607.
31 In re Sichert, 566 F.2d 1154, 1162, 196 USPQ 209, 215 (CCPA 1977).
32 In re Buchner, 929 F.2d 660, 18 USPQ 2d 1331 (Fed. Cir. 1991).
33 Hogan, supra, 559 F.2d at 559, 194 USPQ at537, citing In re Fisher, 427 F.2d 833, 839, 57 CCPA 1099, 1108 (1970).
34 121 F.3d 727, 1997 WL 452801 (Fed. Cir. Aug. 11, 1997) at *2 (non-precedential).
35 Id.
36 Karen S. Canady, The Wright Enabling Disclosure for Biotechnology Patents, 69 Wash. L. Rev. 455, 464 (1994).
37 Id.
38 In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
39 947 F.2d 488, 20 USPQ2d 1438 (Fed. Cir. 1991).
40 Id. at 495, 20 USPQ2d at 1444.
41 Id. at 495-96, 20 USPQ2d at 1444-45.
42 Hogan was deemed inapplicable because the rejection was not founded on a later state of the art. Id. at 495, n.22.
43 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir. 1993).
44 Id. at 1562-63, 27 USPQ2d at 1514.
45 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993).
46 Id. at 1052, 20 USPQ2d at 2015.
47 927 F.2d 1200 (Fed. Cir. 1991), cert. denied, 502 U.S. 856, 112 S.Ct. 109.
48 927 F.2d at 1213, 18 USPQ2d at 1027.
49 Id.
50 Id.
51 108 F.3d 1361, 42 USPQ2d 1001 (Fed. Cir. 1997), cert denied, _____ U.S. _____, 118 S.Ct. 397.
52 108 F.3d at 1366, 42 USPQ2d at 1005.
53 Id. at 1367.
54 517 U.S. 370, 116 S.Ct. 1384 (1996).
55 768 F.2d 1318, 226 USPQ 758 (Fed. Cir. 1985).
56 Id., 768 F.2d at 1324, 226 USPQ at 762.
57 808 F.2d 1490, 1 USPQ2d 1337 (Fed. Cir. 1986) (Judge Rich dissenting).
58 Cf. In re Epstein, 32 F.3d 1559, 1568, 31 USPQ2d 1817, 1823 (Fed. Cir. 1994).
59 See, e.g. Rockwell Int’l Corp. v. U.S., 147 F.2d 1358, 47 USPQ2d 1027 (Fed. Cir. 1998; Reading & Bates Construction Co. v. Baker Energy Resources Corp., 748 F.2d 645, 651-52, 223 USPQ 1168, 1173 (Fed. Cir. 1984) (One-page promotional brochure for the invention describing the results of the patented process is insufficient, as a matter of law, to constitute an enabling disclosure of the process itself). Accord, In re Borst, 345 F.2d 851, 855, 145 USPQ 554, 557 (CCPA 1965), cert. denied, 382 U.S. 973, 86 S. Ct. 537 (1966).
60 Id.
Publication:
Mealey's Litigation Report: Intellectual Property
by Kurt E. Richter and Kathryn E. Diaz
|
| |
|
|
|
Printable Version
