Obviousness: Is a Reasonable Expectation of Success Sufficient

by Dennis Crouch
In Vanda v. Teva , the Federal Circuit confirmed the obviousness of Vanda’s claims covering use of tasimelteon (Hetlioz) to treat circadian rhythm disorders (Non-24-Hour Sleep-Wake Disorder).  Teva and Apotex, filed Abbreviated New Drug Applications (ANDAs) with the FDA seeking to market generic versions of the $100m+ drug.  Vanda sued, but lost on obviousness grounds — with the court holding that the claimed combination was obvious because it was directed to a set of known elements and a person of ordinary skill would have a “reasonable expectation of success” in reaching the resulting invention.  The rulings here included a conclusion that – even if the particular limitations were not obvious, it would have been obvious for a skilled artisan to try them out.
Vanda argues that the law of obviousness requires more than simply a reasonable expectation of success. Rather, in their petition to the Supreme Court, the patentee argues that the resulting invention must have been “predictable” or an “plainly indicated by the prior art.”
The question presented is: Whether obviousness requires a showing of “predictable” results, as this Court held in KSR, or a mere “reasonable expectation of success,” as the Federal Circuit has held both before and after KSR?
VandaCertPetition .
A new amicus brief strongly supports the petition with an interesting historical review of obviousness doctrine from the past 150 years.  The brief, filed by The National Association of Patent Practitioners and Professor Christopher Turoski (current NAPP president) brief argues that the Federal Circuit’s “reasonable expectation of success” standard for assessing obviousness departs from longstanding Supreme Court precedent on obviousness that was subsequently codified in 35 U.S.C. § 103.  NAPP Amicus Brief .
Under Pre-1952 “Invention” Standard
The brief traces the obviousness requirement back to Hotchkiss v. Greenwood , 52 U.S. (11 How.) 248 (1850), where the Court held that simply substituting one known material for another in an otherwise unchanged device was obvious and lacked “that degree of skill and ingenuity which constitute essential elements of every invention.” In the 100 years of “invention” cases following Hotchkiss, the Court consistently held that an invention “must be the result of invention, and not the mere exercise of the skill of the calling or an advance plainly indicated by the prior art.” Altoona Publix Theatres, Inc. v. Am. Tri-Ergon Corp. , 294 U.S. 477 (1935). The key question was whether the advance would “occur to any mechanic skilled in the art” or was “plainly foreshadowed by the prior art.” Loom Co. v. Higgins , 105 U.S. 580, 591 (1881); Textile Machine Works v. Louis Hirsch Textile Machines, Inc. , 302 U.S. 490, 498 (1938).  None of the Supreme Court cases, either pre- or post-1952, rely upon reasonable expectation of success as a determinative factor in assessing the obviousness of an invention.
In Altoona Publix Theatres , the patentee sought to enforce its patent covering covering the use of a flywheel to sound recording and reproduction equipment in order to make the film movement more uniform. The Supreme Court held the patent claims invalid for lack of invention. The Court explained that a flywheel was a very old and common mechanism for improving uniformity of motion in machinery. Its addition here merely involved “the skill of the calling” rather than the inventive faculty, as the flywheel’s use was plainly indicated by prior art showing flywheels applied in other sound recording devices. The Court relied on longstanding precedent that an improvement is not patentable unless it required invention, not just ordinary skill, and was not “plainly indicated” in the prior art.
A n improvement to an apparatus or method, to be patentable, must be the result of invention, and not the mere exercise of the skill of the calling or an advance plainly indicated by the prior art. . . . The inclusion of a flywheel in any form of mechanism to secure uniformity of its motion has so long been standard procedure in the field of mechanics and machine design that the use of it in the manner claimed by the present patent involved no more than the skill of the calling. . . . [The prior art] plainly  foreshadowed the use made of the flywheel in the present patent, if they did not anticipate it. The patentees brought together old elements, in a mechanism involving no new principle, to produce an old result, greater uniformity of motion. However skilfully this was done, and even though there was produced a machine of greater precision and a higher degree of motion-constancy, and hence one more useful in the art, it was still the product of skill, not of invention.
Altoona Publix Theatres, Inc. v. Am. Tri-Ergon Corp. , 294 U.S. 477 (1935).  In Altoona, the court thus concluded that the added flywheel failed this “invention” test, so the patent claims were held invalid.  The standard in Altoona of “plainly indicated” in the prior art is foreshadowed in the Supreme Court’s prior cases such as  Slawson v. Grand Street , P.P. & F.R. Co., 107 U.S. 649 (1883) (cannot patent “an idea which would naturally and spontaneously occur to any skilled mechanic or operator in the ordinary progress of manufactures”); see also Altantio Works v. Brady , 107 U.S. 192 (1883).


Similar “plainly indicated” language comes from the Supreme Court’s decision in Textile Machine Works v. Louis Hirsch Textile Machines, Inc. , 302 U.S. 490 (1938). The invention at issue in the case was an attachment for flat knitting machines to allow reinforcing and split-seam designs to be added to the knitted fabric. The Court held the patent claims invalid as obvious and embodying no more than “the skill of the calling.”
The Court explained that “[t]he addition of a new and useful element to an old combination may be patentable; but the addition must be the result of invention rather than the mere exercise of the skill of the calling, and not one plainly indicated by the prior art.” Id.
One confusing element of this history is that the Supreme Court also began to talk of invention in terms of the “flash of creative genius” or other similar language. See Cuno Engineering Corp. v. Automatic Devices Corp ., 314 U.S. 84 (1941). According to Cuno Engineering , to be patentable, a device “must reveal the flash of creative genius, not merely the skill of the calling.” Id .


Section 103 Codifies Prior Precedent
Prior to 1952, the patent act did not include a statutory obviousness standard. Rather, both the statute and the US constitution simply required an “invention.”
Congress created Section 103 obviousness standard in the 1952 Patent Act that we all rely upon today.  But, in its key and still leading analysis of the statute, the Supreme Court explained that the new law was “intended merely as a codification of judicial precedents embracing the Hotchkiss condition.” Graham v. John Deere Co. , 383 U.S. 1, 17 (1966). Assessing obviousness under § 103 thus follows the Hotchkiss line of cases by determining whether the advance was “plainly evident from the prior art” such that one skilled in the art “would immediately see” that it was obvious based on the existing disclosures.
Of course, one change with the addition of Section 103 is the final sentence of the provision stating that the “manner in which the invention was made” will not negate patentability. The legislative history and Graham are both clear that this provision was intended “to abolish the test [Congress] believed [the Supreme Court] announced in the controversial phrase ‘flash of creative genius,’ used in Cuno.”  What is left then is a focus on whether the invention would be within the mere skill of the calling and plainly evident from the prior art. In its most recent analysis of KSR, the court did not use the plainly evident standard, but rather focused on situations where the elements of an invention were all known and the combination was nothing more than “predictable use of prior art elements.” KSR Int’l Co. v. Teleflex Inc. , 550 U.S. 398 (2007). Throughout this time the Supreme Court has never used a “reasonable expectation of success” test.
Departure from Binding Precedent
According to the petition and the amicus brief, the Federal Circuit’s “reasonable expectation of success” test sets a lower bar, finding obviousness wherever a skilled artisan might reasonably expect to achieve the result, even if it was not plainly foreshadowed in the prior art.  This includes situations where it might be obvious to pursue a research question — but where the answer to the question is unknown or unpredictable.
The first court reference that I have found for “reasonable expectation of success” standard appears to have originated in the case of Cmmw. Engr. Co. of Ohio v. Watson , 293 F.2d 157 (D.C. Cir. 1961).The Patent Office Board had originally stated that “Appellant has merely applied an old process to another analogous material with at least reasonable expectation of success. It is well settled that this does not constitute invention.”  The District Judge affirmed this holding in a Section 145 action, as did the D.C. Circuit Court on appeal. Cmmw. Engr. Co. of Ohio v. Watson , 188 F. Supp. 544 (D.D.C 1960), aff’d , 293 F.2d 157 (D.C. Cir. 1961).
I did also find a 1925 decision by the Commissioner of Patents office affirming a rejection. Ex parte McElroy , 337 Off. Gaz. Pat. Office 475 (1925).  In the case, the patent applicant argued that the cited reference was not sufficient to render the invention unpatentable — arguing “a reference must do more than suggest a possibility, that it must also postulate a reasonable expectation of success.”  The Assistant Commissioner rejected this argument, stating that Richter “carefully sets out the process of the present application and indicates its success.” The decision appears to agree with the  reasonable expectation of success standard, but concluded that the reference provided at least that level of teaching. But, it is not clear to me when this standard became sufficiently “settled” as recited in the 1960-61 Commonwealth Engineering decisions.  It was not until 1995 that reasonable-expectation-of-success was added to the MPEP, but by that time there had already been a number of Federal Circuit decisions on point.
In any event, I hope the Supreme Court will take up this case and push it forward — hopefully further developing obviousness doctrine.  Respondents in the case Teva and Apotex had waived their right to respond, but the Supreme Court expressed some interest in the case by requesting a response in a February 15 order (due March 18, 2024).
Parties:

Vanda Pharmaceuticals Inc., Petitioner, represented by Paul Hughes (McDermott Will & Emery)
Apotex Inc. and Apotex Corp., Respondent, represented by Aaron Lukas (Cozen O’Connor)
Teva Pharmaceuticals USA, Inc., Respondent,  represented by J.C. Rozendaal (Sterne Kessler)

Amici Curiae

American Council of the Blind, Blinded Veterans Association, and PRISMS, Amicus Curiae, represented by Mark Davies (Orrick)
Professor Christopher M. Turoski and The National Association of Patent Practitioners, Amicus Curiae, represented by Ryan Morris (Workman Nydegger)
Salix Pharmaceuticals, Inc. and Ocular Therapeutix, Inc., Amicus Curiae, represented by Justin Hasford (Finnegan)