Source: http://www.patenthawk.com/blog/2010/03/enabling_written_description.html
Timestamp: 2017-04-24 13:19:45
Document Index: 494843302

Matched Legal Cases: ['§ 112', '§ 112', '§ 112', '§ 112', '§ 112', '§ 26', '§ 112', '§ 112', '§ 112', '§ 8']

Patent Prospector: Enabling Written Description
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Enabling Written Description
Ariad sued Eli Lilly over
6,410,516. Trial found a valid patent infringed. A first appeal "held the asserted claims invalid for lack of written description." "Ariad petitioned for rehearing en banc, challenging this court's [CAFC's] interpretation of 35 U.S.C. § 112, first paragraph, as containing a separate written description requirement." Reaffirmation.
Ariad Pharmaceuticals et al v. Eli Lilly (CAFC en banc
This ruling addressed two questions:
In addition to the parties' briefs, the court received twenty-five amicus briefs. Of those, seventeen were filed in support of Lilly, one was filed in support of Ariad, and seven were filed in support of neither party.
As in any case involving statutory interpretation, we begin with the language of the statute itself. Consumer Prod. Safety Comm'n v. GTE Sylvania, Inc., 447 U.S. 102, 108 (1980). Section 112, first paragraph, reads as follows:
We agree with Lilly and read the statute to give effect to its language that the specification "shall contain a written description of the invention" and hold that § 112, first paragraph, contains two separate description requirements: a "written description [i] of the invention, and [ii] of the manner and process of making and using [the invention]. 35 U.S.C. § 112, ¶ 1 (emphasis added).
[W]e see nothing in the statute's language or grammar that unambiguously dictates that the adequacy of the "written description of the invention" must be determined solely by whether that description identifies the invention so as to enable one of skill in the art to make and use it. The prepositional phrase "in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same" modifies only "the written description . . . of the manner and process of making and using [the invention]," as Lilly argues, without violating the rules of grammar. That the adequacy of the description of the manner and process of making and using the invention is judged by whether that description enables one skilled in the art to make and use the same follows from the parallelism of the language.
If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently. Specifically, Congress could have written the statute to read, "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 make and use the same," or "The specification shall contain a written description of the manner and process of making and using the invention, in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same." Under the amicis' construction a portion of the statute--either "and of the manner and process of making and using it" or "[a written description] of the invention"--becomes surplusage, violating the rule of statutory construction that Congress does not use unnecessary words. See United States v. Menasche, 348 U.S. 528, 538-39 (1955) ("It is our duty 'to give effect, if possible, to every clause and word of a statute." (quoting Montclair v. Ramsdell, 107 U.S. 147, 152 (1883)).
Furthermore, since 1793, the Patent Act has expressly stated that an applicant must provide a written description of the invention, and after the 1836 Act added the requirement for claims, the Supreme Court applied this description requirement separate from enablement. See infra Section I.B. Congress recodified this language in the 1952 Act, and nothing in the legislative history indicates that Congress intended to rid the Act of this requirement. On the contrary, "Congress is presumed to be aware of a[] . . . judicial interpretation of a statute and to adopt that interpretation when it re-enacts a statute without change." Forest Grove Sch. Dist. v. T.A., 129 S. Ct. 2484, 2492 (2009) (quoting Lorillard v. Pons, 434 U.S. 575, 580 (1978)).
Finally, a separate requirement to describe one's invention is basic to patent law. Every patent must describe an invention. It is part of the quid pro quo of a patent; one describes an invention, and, if the law's other requirements are met, one obtains a patent. The specification must then, of course, describe how to make and use the invention (i.e., enable it), but that is a different task. A description of the claimed invention allows the United States Patent and Trademark Office ("PTO") to examine applications effectively; courts to understand the invention, determine compliance with the statute, and to construe the claims; and the public to understand and improve upon the invention and to avoid the claimed boundaries of the patentee's exclusive rights.
[W]e also read Supreme Court precedent as recognizing a written description requirement separate from an enablement requirement even after the introduction of claims. Specifically, in Schriber-Schroth, the Court held that a patent directed to pistons for a gas engine with "extremely rigid" webs did not adequately describe amended claims that recited flexible webs under the then-in-force version of § 112, first paragraph.3 305 U.S. at 56-57. The Court ascribed two purposes to this portion of the statute, only the first of which involved enablement:
Id. at 57. The Court then concluded that even if the original specification enabled the use of a flexible web, the claim could derive no benefit from it because "that was not the invention which [the patentee] described by his references to an extremely rigid web." Id. at 58-59 (emphasis added); see also Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306 U.S. 86, 98-102 (1939) (holding invalid claims amended to include structures "not within the invention described in the application" even though the variations were small). Although the Court did not expressly state that it was applying a description of the invention requirement separate from enablement, that is exactly what the Court did.4
3 Section 26 of the 1870 Patent Act provided, in relevant part: "[B]efore any inventor or discoverer shall receive a patent for his invention or discovery, he shall . . . file in the patent office a written description of [his invention or discovery], and of the manner and process of making, constructing, compounding, and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art or science to which it appertains, or with which it is most nearly connected, to make, construct, compound, and use the same."
4 Morse, decided under the 1836 Act, can also be interpreted as involving a separate written description inquiry. 56 U.S. (15 How.) 62. The patent at issue contained eight claims, only seven of which recited the specific instrumentalities of the telegraph developed by Morse. The eighth claim, in contrast, claimed every conceivable way of printing intelligible characters at a distance by the use of an electric or galvanic current. Id. at 112. The Court rejected the latter claim as too broad because Morse claimed "an exclusive right to use a manner and process which he has not described and indeed had not invented, and therefore could not describe when he obtained his patent." Id. at 113 (emphasis added). Such a rejection implies a distinct requirement for a description of the invention. Yet, in reaching its conclusion, the Court also detailed how the claim covered inventions not yet made, indicating the additional failure of the description to enable such a broad claim. See id. at 113-14.
Further, both before and after Schriber-Schroth, the Court has stated that the statute serves a purpose other than enablement. In Gill v. Wells, 89 U.S. (22 Wall.) 1 (1874), the Court held invalid a reissue patent for claiming a combination not described in the original application, but the Court also emphasized the need for all patents to meet the "three great ends" of § 26, only one of which was enablement. Specifically, the Court stated:
(1) That the government may know what they have granted and what will become public property when the term of the monopoly expires. (2.) That licensed persons desiring to practice the invention may know, during the term, how to make, construct, and use the invention. (3.) That other inventors may know what part of the field of invention is unoccupied. Id. at 25-26. Finally, most recently in Festo, the Court recited three requirements for § 112, first paragraph, and noted a written description requirement separate from the others:
535 U.S. at 736 (emphasis added) (internal citations omitted). As a subordinate federal court, we may not so easily dismiss such statements as dicta but are bound to follow them. See Stone Container Corp. v. United States, 229 F.3d 1345, 1349-50 (Fed. Cir. 2000).
A separate written description requirement also does not conflict with the function of the claims. 35 U.S.C. § 112, ¶ 2. Claims define the subject matter that, after examination, has been found to meet the statutory requirements for a patent. See In re Vamco Mach. & Tool, Inc., 752 F.2d 1564, 1577 n.5 (Fed. Cir. 1985). Their principal function, therefore, is to provide notice of the boundaries of the right to exclude and to define limits; it is not to describe the invention, although their original language contributes to the description and in certain cases satisfies it. Claims define and circumscribe, the written description discloses and teaches.
Meeting the requirement for written description is demonstrated by having possession of the invention.
Since its inception, this court has consistently held that § 112, first paragraph, contains a written description requirement separate from enablement, and we have articulated a "fairly uniform standard," which we now affirm. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562-63 (Fed. Cir. 1991). Specifically, the description must "clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed." Id. at 1563 (citing In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989)). In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Id. (quoting Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985)); see also In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983).
The term "possession," however, has never been very enlightening. It implies that as long as one can produce records documenting a written description of a claimed invention, one can show possession. But the hallmark of written description is disclosure. Thus, "possession as shown in the disclosure" is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 1575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v. Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue." Id. at 1359.
The law must be applied to each invention at the time it enters the patent process, for each patented advance has a novel relationship with the state of the art from which it emerges. Thus, we do not try here to predict and adjudicate all the factual scenarios to which the written description requirement could be applied. Nor do we set out any bright-line rules governing, for example, the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each invention, and it changes with progress in a field.
There are, however, a few broad principles that hold true across all cases. We have made clear that the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement. Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366-67 (Fed. Cir. 2006). Conversely, we have repeatedly stated that actual "possession" or reduction to practice outside of the specification is not enough. Rather, as stated above, it is the specification itself that must demonstrate possession. And while the description requirement does not demand any particular form of disclosure,
Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008), or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement, Lockwood v. Am. Airlines, 107 F.3d 1565, 1571-72 (Fed. Cir. 1997).
The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function--a problem that is particularly acute in the biological arts. See Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, 1, "Written Description" Requirement, 66 Fed. Reg. 1099, 1105-1106 (Jan. 5, 2001).
Not tottering from tradition, the CAFC affirms that the old ways are the best.
In addition to the statutory language and Supreme Court precedent supporting the existence of a written description requirement separate from enablement, stare decisis impels us to uphold it now. Ariad acknowledges that this has been the law for over forty years, see Appellee Br. 24, and to change course now would disrupt the settled expectations of the inventing community, which has relied on it in drafting and prosecuting patents, concluding licensing agreements, and rendering validity and infringement opinions. As the Supreme Court stated in admonishing this court, we "must be cautious before adopting changes that disrupt the settled expectations of the inventing community." Festo, 535 U.S. at 739; see also Watson v. United States, 552 U.S. 74, 82 (2007) ("A difference of opinion within the Court . . . does not keep the door open for another try at statutory construction, where stare decisis has special force [since] the legislative power is implicated, and Congress remains free to alter what we have done." (internal quotations omitted)). If the law of written description is to be changed, contrary to sound policy and the uniform holdings of this court, the settled expectations of the inventing and investing communities, and PTO practice, such a decision would require good reason and would rest with Congress.
Analysis delved into meeting the written description requirement given the scope of the claims, with particular regard to genus claims supported by species disclosure.
Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.
Recognizing this, we held in Eli Lilly that an adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries. 119 F.3d at 1568. The patent at issue in Eli Lilly claimed a broad genus of cDNAs purporting to encode many different insulin molecules, and we held that its generic claim language to "vertebrate insulin cDNA" or "mammalian insulin cDNA" failed to describe the claimed genus because it did not distinguish the genus from other materials in any way except by function, i.e., by what the genes do, and thus provided "only a definition of a useful result rather than a definition of what achieves that result." Id.
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.
Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
The CAFC rightfully closed the door on overreaching claims under the rubric of "basic research," a topic brought up by the propensity of academics to be long on theory and short on fact.
Ariad complains that the doctrine disadvantages universities to the extent that basic research cannot be patented. But the patent law has always been directed to the "useful Arts," U.S. Const. art. I, § 8, cl. 8, meaning inventions with a practical use, see Brenner v. Manson, 383 U.S. 519, 532-36 (1966). Much university research relates to basic research, including research into scientific principles and mechanisms of action, see, e.g., Rochester, 358 F.3d 916, and universities may not have the resources or inclination to work out the practical implications of all such research, i.e., finding and identifying compounds able to affect the mechanism discovered. That is no failure of the law's interpretation, but its intention. Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. "[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." Id. at 930 n.10 (quoting Brenner, 383 U.S. at 536). Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of "invention"--that is, conceive of the complete and final invention with all its claimed limitations--and disclose the fruits of that effort to the public.
As this court has repeatedly stated, the purpose of the written description requirement is to "ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Rochester, 358 F.3d at 920 (quoting Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000)). It is part of the quid pro quo of the patent grant and ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time. Enzo, 323 F.3d at 970.
The en banc cabal thereupon adopted the panel decision of the claims not meeting the written description requirement.
Because we reaffirm our written description doctrine, we see no reason to deviate from the panel's application of that requirement to the facts of this case. As such, we adopt that analysis, as follows, as the decision of the en banc court.
Eminent Judge Newman joined, but with "additional views" on patenting "basic research."
I write separately because the real issue of this case is too important to be submerged in rhetoric. The issue was recognized by Ariad, who complained that the written description requirement "has severe adverse consequences for research universities" because it prevents the patenting of "the type of discoveries that universities make," that is, it prevents the patenting of basic scientific research. Ariad Br. on Rehearing En Banc at 38-39. This question is squarely joined in this case, for the subject matter is indeed basic research, which was taken to the patent system before its practical application was demonstrated. In the district court, this aspect was discussed in terms of Section 101. The panel preferred Section 112; and the en banc court has now been diverted into a scholarly debate about the punctuation in the first paragraph of Section 112.
Ariad argues that the patentees made a basic discovery, and are not required to demonstrate its application in order to patent their "pioneering" achievement. Indeed, pioneering inventions can receive broad patents, when shown to have broad scope. The court deems the absence of any specific example of the postulated method of reducing symptoms to be a failure in the description of the invention. The dissenters appear to deem the inclusion of general methods whereby this result could be achieved, to suffice for patentability of the basic scientific concept. These are close, fact-dependent questions, raising many issues, as the large number of amicus curiae briefs attest.
In my view, the overriding policy of patent systems requires both written description and enablement, and it is less critical to decide which statutory clause applies in a particular case, than to assure that both requirements are met. This has been the practice since the first Patent Act, as the opinions and amici have explored. How this is achieved varies with many factors, including "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, the predictability of the aspect at issue." Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005). Although the content varies, the threshold in all cases requires a transition from theory to practice, from basic science to its application, from research plan to demonstrated utility.
The written description is the way by which the scientific/technologic information embodied in patented inventions is disseminated to the public, for addition to the body of knowledge and for use in further understanding and advance. See id. at 1357 ("The written description requirement thus satisfies the policy premises of the law, whereby the inventor's technical/scientific advance is added to the body of knowledge, as consideration for the grant of patent exclusivity."). This accords with long-standing principles, as in the classical case of O'Reilly v. Morse, 56 U.S. (15 How.) 62 (1853), where the Court approved Samuel Morse's claims based on the system of current boosters that achieved his long-distance communication called the telegraph, but denied his claims for this use of an electric current "however developed." Id. at 113. As the court debates the relationship between "written description" and "enablement," let us not lose sight of the purpose of Section 112.
The practical utility on which commercial value is based is the realm of the patent grant; and in securing this exclusionary right, the patentee is obliged to describe and to enable subject matter commensurate with the scope of the exclusionary right. This is not a question of grammatical nuance of the placement of commas in Section 112; it is a question of the principle and policy of patent systems. The court's opinion implements these precepts.
Judge Gajarsa joined, but disagreed that there is "an independent written description requirement as a necessity of patent law."
I do not believe that this issue has a significant, practical impact... Section 112, ¶ 1's enablement requirement is a more than adequate vehicle for invalidating claims that are broader than their disclosure.
Confining written description to the priority context would provide greater clarity to district courts and practitioners, both of whom are currently left to trudge through a thicket of written description jurisprudence that provides no conclusive answers and encourages a shotgun approach to litigation. Yet, this thicket is the result of our best efforts to construe an ambiguous statute; only Congress wields the machete to clear it.
Posted by Patent Hawk at March 24, 2010 10:33 AM
"The CAFC rightfully closed the door on overreaching claims under the rubric of "basic research," a topic brought up by the propensity of academics to be long on theory and short on fact."
Very well stated. This is problem with many academics who view discovery of the "scientific mechanism" to entitle them to claim broadly the genus, no matter how little they really understand (or can tell others) about how to "implement" that "scientific mechanism." In this regard, Ariad says nothing that hasn't been true since the 1853 case of O'Reilly v. Morse which upheld Samuel Morse patent claims to the telegraph but not on claims to any manner of "electronic communication" (which might have included the yet to be discovered telephone).
Posted by: EG at March 24, 2010 11:26 AM
I had to laugh as my first impression was not commandments, but tombstones.
Posted by: Anon at March 24, 2010 1:39 PM
This post has disappeared from patentlyo. I hope it may be maintained here:
The Written Description requirement is necessary to ensure that patents are not Constitutionally infirm. Every act of Congress must satisfy the requirements of the Constitution. Notice as required by the Due Process Clause of the Fifth Amendment is one of those requirements. A patent is basically a contract between the Federal Government and a private party that has the force of law. If the patent failed to satisfy the aforementioned Notice requirements it would have no effect, because Congress has no authority to grant a monopoly without giving the public adequate notice of prohibited conduct. This is the problem RIAA faces in Copyright enforcement. Basically, every person has a right to fee access to material that we are prohibited to copy. Otherwise, the notice requirements of the Constitution are not satisfied. Can you imagine being made to suffer under laws of which you never had notice? The last time that happened our ancestors rebelled against a lawful government and created the United States of America. Posted by: Ken Brooks at March 24, 2010 3:19 PM
At http://www.patentlyo.com/patent/2010/03/federal-circuit-confirms-that-patents-must-meet-both-the-written-description-and-enablement-requirements-of-section-112/comments/page/2/#comments
Without the written description requirement a patent would be contitutionally infirm for failing to comport with the Notice Requirements of the Due Process clause of the Fifth Amendment. Congress has no authority to grant a monopoly to any party without ensuring that the public be placed on notice of what behavior the public is to avoid so as not to violate the monopoly. This is really very simple stuff. It's just that everyone forgets that the Congress is part of a limited government. A patent is essentially a contract between the Federal Government and a private party that has the force of law. Therefore, the patent, at a minimum, MUST satisfy all Consitutional requirements imposed upon Congress in order to have the force of law. This is the problem RIAA faces in the Copyright situation. Everyone is entitled to access a free copy of the Copyright material so that one is placed on notice of what behavior is to be avoided. It is just that the Courts and the Federal Government do not want this line of thinking in the public consciouness, becasue of the huge amount of revenue lost if everyone was entitled to access free copy of Copyrighted material so that one would be put on notice as to what is not to be copied. Could you imagine if we were held accountable for laws we were never entitled to view. I think the last time that happened we rebelled against a lawful government that was ordained by God, at least that is what King George thought.
Posted by: Ken Brooks | Mar 24, 2010 at 02:42 PM when postys go over a hundred, you need to scroll all the way down and hit the "next" arrow key >
Posted by: Anon at March 24, 2010 7:01 PM
Is this the get out of spec free card for the so-called software patents:?
"We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function."
Posted by: byte me at March 24, 2010 7:40 PM
Anon, I was wondering the exact same thing. Or, to put it more explicitly, can a software patent protect only one implementation of an invention, or all implementations of the same idea, regardless of the language or the code use?
I think this ruling requires the application to disclose code as well as a functional description of the invention. Otherwise, the patent would be overreaching and there would be no way to determine the true limits of the patent.
Posted by: Scott Dunn at May 12, 2010 5:29 AM
I think you might be addressing Ken Brooks' point - I was merely helping him understand that his posts were not being deleted.
But if I may comment on your comment, it sounds like you are conflating copyright and patent protections. I do not want to appear to be condescending, but what is your experience level with patents?
Your sense of "overreaching" based on implementation seems to miss the fact that patents are supposed to be broader than a single implementation. It is copyright that protects (only) the specific implementation (and not the utility) and it is patents that protect the utility.
Posted by: Anon at May 13, 2010 3:53 AM