2. Invention Invention Vacated and
Obvious Nonobvious Remanded
Precedential 6 2 1
Nonprecedential 2 0 1
Total 8 2 2
In the nine precedential post-KSR obviousness decisions, 3 six (6) held the
invention to be obvious, two (2) held the invention to be nonobvious, and one (1) vacated
and remanded for further consideration. In the twelve total post-KSR obviousness
decisions,4 eight (8) cases held the invention to be obvious, two (2) held the invention to
be nonobvious, and two (2) vacated and remanded for further consideration.
Judge Lourie has authored four of the nine precedential decisions. The other
authors of the precedential opinions are Judges Linn, Dyk, Prost, and Bryson. Judge
Newman dissented once and would have held the claimed invention to be nonobvious.
Judges Rader and Moore have yet to be on a post-KSR panel which issued an obviousness
opinion (excluding any cases summarily affirmed under Federal Circuit Rule 36).
Technologies include pharmaceuticals, an electronic learning toy, a financial
investment system, an exercise treadmill, an antibody-based antivenom, stem cells, and
transgenic corn.
While it is still difficult to discern any particular trends, we do note a few items of
interest. First, the Federal Circuit has on several occasions emphasized the deference
which should be accorded to the fact-finding by the district court or jury. KSR did not
explicitly address the standard of review for obviousness cases so there is nothing
doctrinally new here. But the implication of KSR was that courts had greater freedom to
decide the ultimate issue of obviousness because it is a question of law. The Federal
Circuit, in its post-KSR decisions, seems to have focused on distinctions between factual
and legal disputes. Whether this is hindsight analysis is uncertain at this point.
Nevertheless prudent litigants will craft their arguments to take advantage of the greater
deference the Federal Circuit gives to the lower tribunal’s findings of fact.
Second, a number of decisions appear to be analytically the same as pre-KSR
obviousness decisions. For instance, the Federal Circuit first determines whether there is
3
One decision was originally non-precedential, but later reissued as a precedential decision.
4
We note that we have not included any cases that were summarily affirmed under Federal Circuit
Rule 36. See, e.g., In re Benzer, No. 2007-1069 (Fed. Cir. Sept. 17, 2007), aff’g Ex parte Benzer, No.
2006-1881 (B.P.A.I. Aug. 11, 2006).
2
3. a prima facie case of obviousness. If so, the court then proceeds to the next step of
asking whether that prima facie case has been rebutted. This analysis is entirely
consistent with Federal Circuit precedent, but KSR may suggest that obviousness can be
analyzed more holistically. Indeed, KSR includes no discussion of the concept of prima
facie obviousness.
Additionally, the language used in the opinions is quite similar to pre-KSR cases.
Specifically, in a number of the opinions, the court inquires about “motivation.” At first
blush, the continued use of “motivation” might raise eyebrows, as one could get the
impression that the term “motivation” is now verboten. During oral argument,5 Justice
Scalia referred to the TSM test as “gobbledygook.” Justice Breyer commented, “I just
don't understand what is meant by the term ‘motivation.’” Chief Justice Roberts’ first
question to Deputy Solicitor Hungar was, “What do you understand motivation to refer to
in that test?” Mr. Hungar’s response was “Well, it’s not entirely clear, Your Honor.”
In the KSR opinion itself, the Supreme Court never used the term “motivation,”
other than in describing the TSM test or the ruling of the Federal Circuit.6 Instead, the
Court uses the term “reason.” For example, the Court wrote that:
it will be necessary for a court to look to interrelated
teachings of multiple patents; the effects of demands
known to the design community or present in the
marketplace; and the background knowledge possessed by
a person having ordinary skill in the art, all in order to
determine whether there was an apparent reason to
combine the known elements in the fashion claimed by the
patent at issue.7
In another section, the Court appreciated that inventions cannot be proven obvious
merely by demonstrating that each element was somewhere in the prior art.
Although common sense directs one to look with care at a
patent application that claims as innovation the
combination of two known devices according to their
established functions, it can be important to identify a
reason that would have prompted a person of ordinary skill
in the relevant field to combine the elements in the way the
claimed new invention does.8
5
KSR Oral Argument, available at
http://www.supremecourtus.gov/oral_arguments/argument_transcripts/04-1350.pdf.
6
127 S. Ct. at 1734, 1738, 1741, 1743.
7
Id. at 1740-41 (emphasis added).
8
Id. at 1741 (emphasis added).
3
4. Later, the Court stated that, “[u]nder the correct analysis, any need or problem
known in the field of endeavor at the time of invention and addressed by the patent can
provide a reason for combining the elements in the manner claimed.”9
Thus, it would appear that the Supreme Court was trying to distance itself from
the term “motivation.” In spite of that, the Federal Circuit has retained the “motivation”
language as part of its obviousness jurisprudence. In most of the post-KSR opinions, the
Federal Circuit analyzes whether there was a motivation in the prior art. Granted, sources
of that motivation acceptable to the court seem more inclusive, but the continued use of
the term “motivation” is noteworthy in comparison to its absence in the KSR opinion.
With these thoughts in mind, we provide below brief summaries of the post-KSR
obviousness cases decided by the Federal Circuit. 10 As most readers of this will be
familiar with the Federal Circuit opinions, we provide only a concise summary, reciting
only the minimum necessary to encourage discussion of the cases.
A. Aventis Pharma Deutschland GmbH v. Lupin, Ltd.11
This case was a patent infringement action involving ramipril, a compound
marketed as the successful blood pressure medicine Altace®. Lupin had filed an
abbreviated new drug application (“ANDA”) for a generic version of Altace®. The
district court held the patent to be nonobvious, but the Federal Circuit reversed on appeal.
The patent at issue claimed a formulation of 5(S)-ramipril “substantially free of
other isomers.” The Federal Circuit relied on several sources of prior art to conclude that
the claimed invention was obvious. For example, the court noted that related, known
compounds had the particular stereochemical configuration as ramipril. There was also a
Schering patent that disclosed a mixture of stereoisomers of ramipril, including the one
claimed by Aventis. Additionally, the court relied on work by a Schering scientist that
qualified as prior art under 35 U.S.C. § 102(g). That work taught the synthesis of a
mixture of the claimed ramipril compound and one of its stereoisomers (“SCH 31925
mixture”).
This case illustrates well the effect of KSR. The district court had made its ruling
prior to KSR. At that time, the district court thought it to be a close case, observing that
“[i]f the standard . . . had been by a preponderance of the evidence rather than by clear
and convincing evidence, the [c]ourt might have determined this case in Lupin’s favor.”
On appeal and in view of KSR, the Federal Circuit determined that the purified form of a
known mixture would be prima facie obvious if one of ordinary skill in the art would
have a reason to think that the beneficial properties of the mixture are derived from
particular components of that mixture.
9
Id. at 1742 (emphasis added).
10
We have not included any discussion of cases which were summarily affirmed by the Federal
Circuit. See Fed. Cir. R. 36.
11
Nos. 2006-1530, -1555, 2007 WL 2593791 (Fed. Cir. Sept. 11, 2007).
4
5. First, this was a case that turned on the question of reason, or motivation. As the
Federal Circuit noted, the district court’s decision hinged on the erroneous finding that
Lupin had failed to offer clear and convincing evidence that “a person of ordinary skill in
the art would have been motivated to purify 5(S) ramipril into a composition substantially
free of other isomers.”
The district court saw this as a close case based principally
on the absence of a clear and convincing showing of
motivation. Since the date of that decision, however, the
Supreme Court decided KSR International Co. v. Teleflex
Inc., which counsels against applying the “teaching,
suggestion, or motivation” (“TSM”) test as a “rigid and
mandatory formula[].” It remains necessary to show
“‘some articulated reasoning with some rational
underpinning to support the legal conclusion of
obviousness,’” but such reasoning “need not seek out
precise teachings directed to the specific subject matter of
the challenged claim.”12
Second, the court focused on the issue of structure obviousness in the chemical
arts. “We have long held that ‘structural similarity between claimed and prior art subject
matter, proved by combining references or otherwise, where the prior art gives reason or
motivation to make the claimed compositions, creates a prima facie case of
obviousness.’”13 That analysis applied here, where “a claimed composition is a purified
form of a mixture that existed in the prior art.”
The court hedged a bit, though.
Such a purified compound is not always prima facie
obvious over the mixture; for example, it may not be
known that the purified compound is present in or an active
ingredient of the mixture, or the state of the art may be such
that discovering how to perform the purification is an
invention of patentable weight in itself.
Nevertheless, in the very next sentence, the court seemed to lay down a per se
rule of prima facie obviousness for purified pharmaceutical compositions.
[I]f it is known that some desirable property of a mixture
derives in whole or in part from a particular one of its
components, or if the prior art would provide a person of
ordinary skill in the art with reason to believe that this is so,
the purified compound is prima facie obvious over the
12
Slip op. at 13 (citations omitted).
13
Id. at 14 (citing Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., No. 06-1329, slip op. at 9
(Fed. Cir. June 28, 2007) (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc)).
5
6. mixture even without an explicit teaching that the
ingredient should be concentrated or purified.14
Having found prima facie obviousness, the court concluded that Aventis had
failed to prove unexpected results. Aventis had tried to use a comparison between
5(S)-ramipril and another isomer of ramipril. That was the incorrect comparison,
however. The court pointed out that the correct comparison should have been with the
SCH 31925 mixture, which included 5(S)-ramipril. When this comparison was made, no
unexpected increases in potency were observed, only increases in potency one would
expect from increasing the purity of 5(S)-ramipril.
The end result of this case is that it may become significantly more difficult to
patent pure isomers of pharmaceutical compounds if the mixtures are prior art.
B. Forest Laboratories, Inc. v. IVAX Pharmaceuticals, Inc.15
The invention is directed to a substantially pure isomer of citalopram (marketed
as the antidepressant drug Lexapro®). IVAX filed an ANDA for a generic version of
Lexapro®, asserting the patent to be invalid. The district court held the claims to be valid
as nonobvious, and the Federal Circuit affirmed.
Forest had a prior patent that covered racemic citalopram. Additional research by
Forest scientists identified (+)-citalopram as the active isomer. A prior art pharmacology
paper (“Smith”) discussed the different isomers of citalopram but did not teach a method
of isolating the claimed isomer.
IVAX asserted that the patent was invalid as anticipated and obvious. Regarding
anticipation, the court held that IVAX had failed to show error in the district court’s
finding that Smith did not enable one to make and isolate (+)-citalopram.
The obviousness analysis was not extensive and seemed to rely on the finding that
the prior art did not teach a person of ordinary skill in the art how to isolate the claimed
isomer.
We agree with Forest that the district court’s key factual
findings underlying its conclusions on obviousness are not
clearly erroneous, and, based upon those findings, we find
no error in the court’s conclusion that the asserted claims of
the ’712 patent are not invalid for obviousness. As with
their arguments on anticipation, Ivax and Cipla mainly
emphasize the evidence that is favorable to their desired
outcome without addressing the evidence favorable to
Forest. The latter includes the failure of the inventors and
others to resolve citalopram without undue experimentation
14
Id. at 15.
15
No. 2007-1059, 2007 WL 2482122 (Fed. Cir. Sept. 5, 2007).
6
7. and the testimony of Forest’s experts. The district court
applied the Graham factors to conduct a thorough analysis
of the evidence, and we find no clear error on facts and no
error of law. These findings fully support the conclusion
that the claimed subject matter would not have been
obvious to one of ordinary skill in the art.16
In this case, it was clear that the obviousness argument failed because the prior art
did not provide a reasonable expectation of success. The outcome seems consistent with
Supreme Court’s guidance in KSR that “[i]f a person of ordinary skill in the art can
implement a predictable variation, and would see the benefit of doing so, §103 likely bars
its patentability.” Here, the artisan could not implement the “predictable variation”
because one could not have made the pure isomer based on the prior art of record.
C. In re Sullivan17
The claimed invention was an antivenom composition comprising antibody
fragments that bind to particular species of rattlesnake (pit vipers) venom. The examiner
rejected the claim as obvious over combination of two prior art references, and the Board
agreed. The Federal Circuit agreed that claim was prima facie obvious but vacated the
Board’s decision because it did not consider evidence of nonobvious presented in three
declarations filed under 37 C.F.R. § 1.132.
During prosecution, the two inventors and an antivenom expert each submitted
declaration for purposes of rebutting the obviousness rejection. The Board gave no
consideration to the declarations because it thought that “the declarations of record relate
only to the use of the claimed composition as an antivenom, and thus the Board expressly
declined to give any meaningful consideration to them.” The Federal Circuit observed
that the “applicant does not concede that the only distinguishing factor of its composition
is the statement of intended use and, in fact, extensively argues that its claimed
composition exhibits the unexpected property of neutralizing the lethality of rattlesnake
venom while reducing the occurrence of adverse immune reactions in humans. Such a
use and unexpected property cannot be ignored.”
D. In re Trans Texas Holdings Corp.18
In Trans Texas, the Federal Circuit upheld the Board’s ruling that claims being
reexamined and directed to a system of inflation-adjusted deposit and loan accounts were
obvious. For example, claim 1 of one of the patents claimed “[a]n investment system for
providing an improved capital structure for an institution” composed of a deposit account
and an account management data processor, with other elements, such as “deposit accrual
component” is adjusted “in a manner responsive to the rate of inflation.” Other involved
16
Citations omitted.
17
No. 2006-1507, 2007 WL 2433841 (Fed. Cir. Aug. 29, 2007).
18
Nos. 2006-1599, -1600, 2007 WL 2377009 (Fed. Cir. Aug. 22, 2007).
7
8. claims were directed to similar subject matter with various additional elements. For
example, claim 9 of one of the patents claimed a method whereby the financial institution
“provides a deposit account to a depositor, uses a portion of the funds deposited to obtain
a financial instrument ‘whose rate of return adjusts with inflation,’ and pays the
‘depositor a rate of return on funds . . . based on a rate of inflation.’”
The Board and Federal Circuit held that all of the elements were disclosed in the
prior art, including the knowledge of those of skill in the art.
First, Trans Texas argued nonobviousness for some claims “because, even if
Mukherjee discloses deposit accounts responsive to the rate of inflation, Mukherjee does
not disclose loan accounts that were fully adjusted with the market indicator of inflation
(i.e., the inflation adjustment was equal to the increase in the market indicator of
inflation), but instead only discloses loan accounts that were adjusted on a proportional
basis with inflation (for example, a one percent increase in the market indicator would
only result in a one-half or one-fourth percent inflation adjustment).” The Federal Circuit
held that “[s]ubstantial evidence supports the Board’s conclusion that Mukherjee
discloses fully adjusting loan accounts based on increases in the rate of inflation.”
Second, Trans Texas argued that other claims were nonobvious because those
claims had an element that required annuities. The Board found that prior art (Bodie)
described a purchasing power annuity linked to consumer price levels. Trans Texas
argued the Bodie taught away (e.g., teaching that annuities were not commercially
available and a reluctance to price-indexed bonds), but the Board found that “Bodie never
indicated that such proposals would not work and in fact noted that proposals for price-
indexed bonds ‘have abounded.’” The Federal Circuit held that the Board’s finding was
supported by substantial evidence.
Third, Trans Texas argued that other claims were nonobvious because Mukherjee
(prior art) did not teach the limitation “obtaining an asset whose rate of return adjusts
with inflation.” The court held that the Board’s finding was supported by substantial
evidence. For example, Mukherjee disclosed “the desire of institutional buyers to
purchase ‘[inflation] index-linked securities’ and specifically note[d] that ‘[b]anks and
cooperative credit societies’ sought to buy inflation-adjusted bonds ‘to help pay
compensation on indexed deposit accounts.’”
Fourth, Trans Texas argued that Mukherjee did not teach the limitation “obtaining
. . . a mortgage secured by real estate” (responsive to the rate of inflation) of independent
claim 22 of the ’673 patent and its dependent claims (23 and 24). The court seemed to
agree, but the prior art supplied the missing element. “The Board did not err in
concluding that it would have been obvious to combine the indexed loan accounts
disclosed in Mukherjee with the well-known practice of offering loans secured by
mortgaged real estate.”
8
9. E. In re Icon Health & Fitness, Inc.19
The invention in this case was directed to a treadmill with a folding base,
allowing the base to swivel into an upright storage position. The issue was whether the
following element rendered the invention patentable: “a gas spring connected between
the tread base and the upright structure to assist in stably retaining said tread base in said
second position.”
Two prior art references disclosed all of the elements of the claim. First, Damark
was an advertisement for a folding treadmill that disclosed all elements of the claim
except for the gas spring. Teague disclosed a folding bed that had a novel dual-action
spring rather than the prior single-action spring. The spring in Teague partially supports
the weight of the bed in both open and closed positions.
Icon had two main non-obviousness arguments on appeal. First, Icon argued that
Teague was non-analogous art. Second, Icon argued that, even if Teague is proper prior
art, the claimed invention is nonobvious because Teague teaches away from Icon’s
invention.
In response to the first argument, the Federal Circuit relied upon the broad claim
construction that the law requires during reexamination. Icon argued that the gas spring
limitation “must provide a force continuing to urge the mechanism closed when in the
closed position.” But the court agreed with the Board that nothing in the claim or
specification limited the broadest reasonable construction of the “gas spring” element.
The court thus performed its obviousness analysis “while considering that Icon’s claims
encompass everything reasonably seen to assist in stably retaining the tread base.”
The Federal Circuit also held that Teague did not teach away from the claimed
invention. Icon asserted that (1) Teague teaches away from the use of single-action
springs; and (2) the use of dual-action springs described in Teague would render the
invention inoperable. The court rejected each of these arguments.
With respect to the first, the court found that Teague does not teach away from
single-action springs. Rather, “[a]t most, Teague only teaches away from single-action
springs in the context of decreasing the opening force.” Icon argued that “the gas spring
limitation in its application must increase the opening force provided by gravity,” but, as
the court noted, the single-action spring in Teague provided such a result.
With respect to the second assertion, the court observed that “Icon’s argument
may have carried some weight with more narrow claims, which it could have obtained by
amendment. But faced with broad claims encompassing anything that assists in stably
retaining the tread base, we reject Icon’s argument.”
19
No. 2006-1573, 2007 WL 2189161 (Fed. Cir. Aug. 1, 2007).
9
10. F. Pharmastem Therapeutics, Inc. v. Viacell, Inc.20
PharmaStem sued several defendants for infringement of its patents directed to
cryopreserved umbilical cord stem cells that can be used to reconstitute a person’s
immune system. The defendants offered cryopreservation services that allowed a person
to store his or her umbilical cord blood for possible use later in life. After trial to a jury,
the patents were found valid and infringed. The district court set aside the jury verdict
and held noninfringement. The district court also denied defendants’ JMOL that the
patents were anticipated and obvious. On appeal, the Federal Circuit affirmed the finding
of noninfringement but reversed on validity and held the patents to be obvious.
According to the Federal Circuit, the claims at issue were very broad. For
example, claim 1 of U.S. Patent No. 5,004,681 reads as follows:
A cryopreserved therapeutic composition comprising viable
human neonatal or fetal hematopoietic stem cells derived
from the umbilical cord blood or placental blood of a single
human collected at the birth of said human, in which said
cells are present in an amount sufficient to effect
hematopoietic reconstitution of a human adult; and an
amount of cryopreservative sufficient for cryopreservation
of said cells.
Other claims at issue were directed to similar subject matter, such as methods of using the
preserved stem cells.
With respect to invalidity, defendants argued that the claimed inventions were
obvious in light of a combination of prior art references. The Federal Circuit noted that
[t]he idea of using cryopreserved cord blood to effect
hematopoietic reconstitution was not new at the time the
inventors filed the applications that matured into the ‘681
and ‘553 patents. Two of the prior art references—articles
by Ende and Knudtzon—suggest using cord blood for that
purpose. Two others—an article by Koike and a doctoral
dissertation by Vidal—suggest cryopreservation and
storage of the cord blood until needed.
The more challenging question, according to the court, was whether a reasonable
expectation of success existed. Relying on prior art references and “admissions” of the
inventors found in the patent specifications—which contradicted expert testimony—the
Federal Circuit found a reasonable expectation of success.
That collection of prior art shows (1) that bone marrow
transplants can result in hematopoietic reconstitution; (2)
20
Nos. 05-1490, -1551, 2007 WL 1964863 (Fed. Cir. July 9, 2007).
10
11. that cord blood, like bone marrow but unlike adult blood,
contains large numbers of progenitor cells; and (3) that the
high concentration of primitive progenitor cells in cord
blood suggests that in humans, as in mice, the cells
responsible for hematopoiesis migrate at about the time of
birth from fetal organs to the bone marrow. Under those
circumstances, it was reasonable for the inventors of the
patent, like the authors of the prior art references, to infer
the presence of high concentrations of stem cells in cord
blood, even though the prior art studies did not offer
conclusive proof of their presence.
Based on the finding that the “jury was legally required to find that that those of
skill in the art would believe that cord blood contained hematopoietic stem cells,” the
Federal Circuit held that no reasonable jury could find the invention nonobvious. In
particular, the court suggested that merely proving a scientific idea was not patentable,
citing to KSR’s statement that “[g]ranting patent protection to advances that would occur
in the ordinary course without real innovation retards progress.”
We conclude a reasonable jury could not have done so.
While the inventors may have proved conclusively what
was strongly suspected before—that umbilical cord blood
is capable of hematopoietic reconstitution—and while their
work may have significantly advanced the state of the
science of hematopoietic transplantations by eliminating
any doubt as to the presence of stem cells in cord blood, the
mouse experiments and the conclusions drawn from them
were not inventive in nature. Instead, the inventors merely
used routine research methods to prove what was already
believed to be the case. Scientific confirmation of what
was already believed to be true may be a valuable
contribution, but it does not give rise to a patentable
invention.
The Federal Circuit further commented that its prior decision in In re O’Farrell21
gave useful guidance. In that case, the court stated that obviousness did not require
absolute predictability. At the same time, “an invention would not be invalid for
obviousness if the inventor would have been motivated ‘to vary all parameters or try each
of numerous possible choices until one possibly arrived at a successful result, where the
prior art gave either no indication of which parameters were critical or no direction as to
which of many possible choices is likely to be successful.’”22
21
853 F.2d 894, 903 (Fed. Cir. 1988).
22
Pharmastem (citing O’Farrell, 853 F.2d at 903).
11
12. The court then continued that the present cased differed from O’Farrell because
Pharmastem did not argue that there was an array of choices from which to choose how
to obtain the claimed invention. Rather, PharmaStem focused on the alleged “novelty of
its proof that stem cells are present in fetal blood, a demonstration that Dr. Bernstein
testified was necessary to give transplant physicians sufficient confidence in the use of
cord blood for hematopoietic reconstitution to try the procedure on humans.” The court
concluded that “proof sufficient to justify conducting in vivo procedures on humans,
while useful,” does not prove patentability.
Pharamstem presented evidence of secondary considerations, but the court found
such evidence insufficient to overcome the obviousness.
Pharmastem also argued that the jury’s verdict was supported by the successful
reexamination proceedings in which the PTO considered some of the same prior art
presented at trial. This argument failed.
Judge Newman filed a poignant dissent. Judge Newman focused on several
issues. First, she stressed that the panel “simply reweigh[ed] selectively extracted
evidence, ignore[d] the actual peer response and acclaim at the time these inventions
were made, and decide[d] that this long-sought advance would have been obvious to this
court.” Second, Judge Newman thought that more deference should have been given to
the PTO’s reexamination proceedings, which determined the reexamined claims to be
nonobvious.
G. Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd.23
Takeda’s patent was directed to a particular compounds useful for treating
diabetes. The patent at issue covered a compound called pioglitazone, which is the active
ingredient in ACTOS®.24 Alphapharm filed an ANDA to market a generic version of
ACTOS®. In the subsequent patent infringement suit, the district court held the claimed
invention to be nonobvious, and the Federal Circuit affirmed on appeal.
The invention in Takeda was directed to a group of compounds useful for treating
diabetes. The claimed compounds were structurally related to a prior art compound
(“compound b”) disclosed in two earlier patents issued to Takeda. Appellant
Alphapharm had argued that KSR required reversal, but the court disagreed. First, the
Federal Circuit affirmed the district court’s finding that one of ordinary skill in the art
would not have selected compound b as a starting point because, in part, the prior art as a
whole taught away from that compound. Second, the court found that the “obvious to
try” standard discussed in KSR was not applicable here partly because “the prior art
disclosed a broad selection of compounds any one of which could have been selected as a
lead compound for further investigation.” Third, the Federal Circuit agreed that, even if
one had selected compound b as the starting point, there was “nothing in the prior art to
23
No. 06-1329, 2007 WL 1839698 (Fed. Cir. June 28, 2007).
24
ACTOS® had sales about $1.7 billion in 2003.
12
13. suggest making the specific molecular modifications to compound b that are necessary to
achieve the claimed compounds.”
H. Leapfrog Enterprises, Inc. v. Fisher-Price, Inc.25
In Leapfrog, the Federal Circuit affirmed the district court’s finding of
obviousness.26 The claimed invention was an interactive learning device to help young
children to read phonetically. The accused infringing product was Fisher-Price’s
PowerTouch toy, which is an interactive electronic book designed to help children learn
how to read.
The district court concluded that the claimed invention was “obvious in view of
the combination of U.S. Patent 3,748,748 to Bevan, the Texas Instruments Super Speak
& Read (“SSR”) device, and the knowledge of one of ordinary skill in the art as
represented by the testimony of Fisher-Price’s technical expert.” Essentially, according
to the court, it seemed that what Leapfrog had done was put in electronic components
into a learning device that had been around in mechanical form before.
Bevan taught an older electro-mechanical learning toy (patent issued in 1973).
The Federal Circuit agreed that Bevan disclosed “an apparatus that achieves the goals
described above of associating letters with their sounds and encouraging children to
sound out words phonetically through a similar type of interaction.”
The SSR was a contemporary prior art learning toy made of electronic
components and having “a slightly different mode of operation than Bevan.” As the
court observed, “the SSR provides a roadmap for one of ordinary skill in the art desiring
to produce an electronics-based learning toy for children that allows the use of phonetic-
based learning methods, including the association of individual letters with their
phonemes.”
The Federal Circuit agreed that it would be obvious to combine Bevan and SSR
“to update it using modern electronic components in order to gain the commonly
understood benefits of such adaptation, such as decreased size, increased reliability,
simplified operation, and reduced cost.” The combination of Bevan and SSR lacked only
one element—a reader—but the court found that readers were well-known in the art, and
that marketability and simplified use would have motivated the addition of the reader.
Leapfrog argued that the district court failed to consider adequately the secondary
considerations of nonobviousness, but the Federal Circuit disagreed, observing that the
district court “explicitly stated in its opinion that Leapfrog had provided substantial
evidence of commercial success, praise, and long-felt need, but that, given the strength of
the prima facie obviousness showing, the evidence on secondary considerations was
inadequate to overcome a final conclusion that claim 25 would have been obvious.”
25
485 F.3d 1157 (Fed. Cir. 2007).
26
The court made the obviousness determination after the jury deadlocked.
13
14. I. Daiichi Sankyo Co. v. Apotex, Inc.27
In Daiichi, the patented invention was directed to a method of treating an ear
infection comprising “the topical otic [i.e., ear] administration of an amount of ofloxacin
or a salt thereof effective to treat otopathy in a pharmaceutically acceptable carrier to the
area affected with otopathy.” Apotex filed an ANDA seeking approval to market a
generic ofloxacin ear drop.
One piece of prior art, Ganz, taught that a related antibiotic, ciprofloxacin, would
be suitable for eardrops. Apotex’s expert opined that Ganz suggested the claimed
invention. This testimony was not disputed by Daiichi, except on the basis that Ganz
“did not convey the same teaching to one of lower skill in the art such as a practicing
physician.” The district court erroneously found that a person of ordinary skill in the art
was a pediatrician or general practitioner, rather than “a person engaged in developing
pharmaceutical formulations and treatment methods for the ear or a specialist in ear
treatments such as an otologist, otolaryngologist, or otorhinolaryngologist who also has
training in pharmaceutical formulations.” According to the district court, Ganz would not
have suggested the invention to a pediatrician because “the article reported that use of
gyrase inhibitors ‘should be used only in difficult cases and exclusively by the
otologist.’”
This case seems to underscore the importance of the second factor of Graham—
the level of ordinary skill in the prior art. The district court was reversed because it ruled
incorrectly on the level of ordinary skill in the art, deciding that a person of ordinary skill
in the art would be a pediatrician or general practitioner, rather than the correct, and more
skilled, ear specialist, such as an otologist. Based on that incorrect factual finding, the
district court did not adequately consider the importance of a reference that rendered the
invention obvious.
Moreover, one might argue that the case does not implicate KSR, as it would
conceivably have been decided the same way prior April 30, 2007. The court simply
found that the district court erred in determining the level of skill in the art. “Factors that
may be considered in determining level of ordinary skill in the art include: (1) the
educational level of the inventor; (2) type of problems encountered in the art; (3) prior art
solutions to those problems; (4) rapidity with which innovations are made; (5)
sophistication of the technology; and (6) educational level of active workers in the
field.”28
Interestingly, the court could have invoked the Supreme Court’s discussion of the
ordinary artisan, but did not. Recall in KSR that the Supreme Court seemed to think that
the Federal Circuit set the bar too low for determining the skill of the ordinary artisan.
As stated in KSR, “[a] person of ordinary skill is also a person of ordinary creativity, not
an automaton.”
27
No. 2006-1564, 2007 WL 2032123 (Fed. Cir. July 11, 2007), , designated precedential on
Sept. 12, 2007.
28
Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
14
15. J. Frazier v. Layne Christensen Co.29
The invention in Frazier was directed to directed to a method of stimulating well
water production. After a jury trial, the district court granted defendant’s motion for
JMOL that the invention was obvious. On appeal, the plaintiff had four main arguments,
none of which was found persuasive, and the Federal Circuit affirmed the district court.
First, Frazier argued that the district court failed to identify with specificity the
relied-upon prior art for the obviousness holding. The Federal Circuit disagreed, noting
that “the district court’s opinion [made] clear that it relied on specific prior art references
in its analysis.”
Second, Frazier argued that the district court erroneously used the words “novel”
and “novelty” in its obviousness analysis. The Federal Circuit said no, saying it was just
the district court’s way of identifying differences between invention and prior art, and “a
way of expressing the idea that no new insight was required to make the needed
combination of prior art references.”
Third, Frazier argued that the district court erred when redirect testimony of its
expert was excluded. The Federal Circuit again disagreed. The district court stated that
it would have granted judgment as a matter of law even taking the testimony into
account.
Finally, Frazier argued that the district court erroneously assessed the level of
skill in the art. The Federal Circuit responded that “plaintiffs do not identify how that
purported error undermines the district court’s judgment, and we fail to perceive any such
effect.”
K. Omegaflex v. Parker-Hanafin Corp.30
In Omegaflex, the invention was directed to a pipe fitting used with corrugated
stainless steel tubing (CSST), often used for gas lines. The district court granted
summary judgment of infringement and nonobviousness, but the Federal Circuit vacated
and remanded for trial.
Omegaflex sued Parker-Hanafin Corp. (“Parker”) for patent infringement.
OmegaFlex sold its patented pipe fittings as the Autoline. OmegaFlex’s patented pipe
fitting incorporated a “locating sleeve” that helped connect the pipes in difficult
situations.
Parker was a competitor of OmegaFlex and sold a competing product as
FastMate. The FastMate fittings originally lacked the locating sleeve feature, but after a
recall, the FastMate was resold with the locating sleeve.
29
No. 06-1584, 2007 WL 1875909 (Fed. Cir. June 29, 2007) (non-precedential).
30
No. 2007-1044, 2007 WL 1733228 (Fed. Cir. June 18, 2007) (non-precedential).
15
16. One prior art patent (“Sweeney”) taught all elements of the claimed pipe fitting
except the locating sleeve. A prior art product sold by Parker, the Parker Compression
Fitting (“PCF”), did not have an integrated locating sleeve but was sold with an option to
insert such a sleeve when needed. Thus, all elements of the claim were in these two
pieces of prior art.
The Federal Circuit held that the district court erred in its analysis of (1)
motivation to combine, (2) reasonable expectation of success, and (3) secondary
considerations.
First, with respect to motivation, the Federal Circuit held that the district court
failed to give any weight to expert testimony that the ordinarily skilled person would
have been motivated to combine the prior art to obtain the claimed invention. Second,
the Federal Circuit also stated that it was erroneous for the district court to have
disregarded Parker’s (non-movant’s) expert testimony that there was a reasonable
expectation of success of combining the prior art. These rulings are consistent with other
cases, such as In re Sullivan, supra, in which all evidence of obviousness or
nonobviousness must be considered by the tribunal. Thus, contrary to the district court’s
conclusion, there existed genuine issues of material fact.
Finally, the court held that the “evidence also raises factual issues regarding
secondary indicators of non-obviousness that prevent summary judgment.” Interestingly,
the Federal Circuit stated that
Parker's later decision to add such a sleeve to the FastMate
fitting actually seems to support a finding of obviousness
rather than non-obviousness. When construed in Parker's
favor, the FastMate fitting's history is undisputed evidence
that the idea of incorporating a locating sleeve to improve
alignment capability was discussed and well within the
knowledge of skilled artisans at an early stage.
Although non-precedential, this case is a good example of a “combination”
invention of old elements. The panel quoted KSR several times.
L. Syngenta Seeds, Inc. v. Monsanto Co.31
The invention at issue was a transgenic corn plant modified to produce an
insecticidal protein (Bt protein). The jury found that the claims were obvious, and the
Federal Circuit affirmed.
The claimed invention was directed to a transgenic corn plant that produces the Bt
protein, “wherein the foreign DNA nucleic acid coding sequence has a G+C content of at
least about 60%.” The principal prior art reference was a published patent application
(“Barton”) which taught that “selecting codons rich in G+C would be likely to increase
31
Nos. 2006-1203, 2007 WL 1295028 (Fed. Cir. May 3, 2007) (non-precedential).
16
17. the expression of Bt in corn.” The court noted that this teaching was “consistent with the
testimony of two experts at trial, who testified that it would have been obvious to a
person of skill in the art to make a Bt gene more closely resemble a corn gene by
substituting codons that are rich in G+C for the codons of the native gene that code for
the same amino acids.”
Syngenta based its nonobviousness argument on three issues: (1) teaching away,
(2) no reasonable expectation of success, and (3) unexpected results. The Federal Circuit
found each of these unconvincing.
First, the court noted that, “[i]n the case of corn, as the defendants’ expert in
molecular biology testified, such a gene [as described in Barton] would necessarily have
a G+C content of more than 60 percent. The jury was free to credit that testimony and
thus to conclude that, in light of Barton, a person of skill in the art would have found it
obvious to produce a modified corn gene with a G+C content of more than 60 percent.”
Second, with respect to expectation of success, the court concluded that “[t]he
jury was entitled to rely on that portion of the Barton application in concluding that there
was a reasonable expectation of success from such an increase in the G+C content of the
codons in the genetic sequence.”
Third, regarding unexpected results, the Federal Circuit held that “the jury had
sufficient evidence, in the form of expert testimony, from which it could conclude that
the degree of success at the 60 percent level was not substantially different from what
could reasonably have been expected based on the prior art.”
M. Pfizer, Inc. v. Apotex, Inc.32
Pfizer, Inc. v. Apotex is a pre-KSR case, but was decided after oral argument at
the Supreme Court. The obviousness analysis appears consistent with KSR.
Furthermore, as summarized more fully below, three judges at the Federal Circuit
provided insightful comments in their dissents from the court’s decision to deny
rehearing en banc.
The invention was directed to a particular salt of amlodipine (i.e., amlodipine
besylate). The compound is sold by Pfizer as Norvasc® and is used to treat angina and
hypertension. The Federal Circuit held the claims to be obvious.
Pfizer had requested rehearing en banc. A number of prominent amici filed briefs
in support of Pfizer. Nevertheless, the court denied rehearing. Judges Newman, Lourie,
and Rader would have agreed to rehear the case. Their dissents focused on the lack of
deference to the district court’s fact-finding, the legal error of not adequately considering
the unexpected results of the improved physical characteristics of the salt, and the various
public policy ramifications of the panel’s obviousness analysis.
32
488 F.3d 1377, 1378 (Fed. Cir. 2007) (denying petition for rehearing en banc).
17
18. Judge Newman also stressed the purpose behind the Federal Circuit itself.
A primary purpose for which our court was formed was to
provide the judicial stability that supports commercial
investment -- this was a unique judicial role, and was
adopted in recognition of the dependence of technology-
based industry on an effective patent system. It was
recognized that a nationally uniform, consistent, and
correct patent law is an essential foundation of
technological innovation, which is today the dominant
contributor to the nation's economy.
Judge Lourie emphasized three points in his dissent. First, he thought the panel
did not adequately defer to the district court’s factual findings of nonobviousness.
Second, he thought it improper for the panel to disregard the unexpected physical
properties of the claimed salt. Third, he considered the panel’s decision to “conflict[]
with the statutory requirement that ‘[p]atentability shall not be negatived by the manner
in which the invention was made’” in that the panel considered the invention to be a
result of routine experimentation. Judge Lourie also recognized the importance of the
issues involved.
Chemical and pharmaceutical compounds often can be
found to be prima facie obvious, as they are based on prior
work that could reasonably suggest them, but
commercialization of such compounds may depend on their
possession of unexpected properties. Such properties may
be biological or physical. A failure to recognize all such
properties that may be relevant to the value of such a
compound may doom the compound to being poured down
the drain rather than becoming an important therapeutic.
The general public, innovative companies, and, ultimately,
generic companies, depend upon faithful adherence to this
principle.
Judge Rader likewise emphasized the importance of deference to the trial court’s
factual findings and the important policy considerations in providing patent protection for
new pharmaceutical inventions. First, Judge Rader noted that three different district
courts had ruled that the patent was nonobvious. Second, he asserted that “‘obvious to
try’ jurisprudence has a very limited application in cases of this nature. With
unpredictable pharmaceutical inventions, this court more wisely employs a reasonable
expectation of success analysis.” Third, he said “[t]he panel also mistakenly determined
that the superior properties of the besylate did not overcome a prima facie case of
obviousness because they showed no superior therapeutic value—the maleate salt form of
amlodipine worked just as well as the besylate form in clinical trials.” Finally, Judge
Rader thought the panel violated the second sentence of 103(a) by holding the invention
“not patentable since it was made by a routine testing or a ‘well known problem solving
strategy.’”
18
19. III. District Court Litigation
Arguably, KSR’s most significant effect in the short-term will be at the district
court level. District court judges will certainly be applying KSR more frequently than the
appellate judges at Madison Place. Moreover, decisions at the trial court level will have a
more immediate effect on on-going litigation.
KSR is certain to affect at least three aspects of patent litigation: (1) jury
instructions, (2) motions for summary judgment, and (3) motions for preliminary
injunctions.
A. Jury Instructions
KSR reaffirmed that obviousness is a question of law that can be decided on
summary judgment. With that reaffirmation comes the question of whether courts will
revise the role of juries in patent trials. Juries tend to play an important role in patent
trials.33 Under Federal Circuit law, the determination of obviousness can properly be
submitted to a jury even though it is a question of law.34 KSR does not change this, but
the Court’s reemphasis of the legal nature of the issue of obviousness may lead judges to
be more willing to limit jury determinations of obviousness or to require special verdict
forms for the factual issues. As a result, district courts may be more apt to enter
judgment as a matter of law after trial.
In those cases in which obviousness continues to be decided by the jury, the
particular wording of the jury instructions will be important. In part for this reason, the
Federal Circuit Bar Association recently promulgated Model Patent Jury Instructions.
The section of the Model Jury Instructions relating to motivation reads as follows:
In determining whether or not the invention(s)
would have been obvious to one of ordinary skill in the art
at the time the inventions were made, you must also
consider whether a person having ordinary skill in the field
at the time would have been motivated to select and
combine the prior art references in order to make the
claimed invention(s). In answering this question you must
consider the entire body of knowledge and technical
literature in the field, including that which might lead one
skilled in the art away from, or toward, the invention(s).
Thus, even though you may find that every feature of the
patented invention(s) can be found in the prior art, this, by
itself, does not prove that the patented invention(s) would
33
See generally Paul R. Michel & Michelle Rhyu, Improving Patent Jury Trials, 6 FED. CIR. B.J.
89 (1996) (providing an analysis of the role of juries in patent trials).
34
Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1547 (Fed. Cir. 1983).
19
20. have been obvious to one having ordinary skill in the field
at the time.
Features in the prior art may be combined to show
obviousness where one having ordinary skill in the field,
with no knowledge of the patented invention(s),
confronting the same problem(s) or issue(s) as the
inventor(s) at the time the invention was made, would have
been motivated to select and combine those features from
the prior art to make the patented invention(s) and have a
reasonable expectation of success at solving the problem(s)
or addressing the issue(s). The motivation to select and
combine features and a reasonable expectation of success
may be found in the teachings of the prior art references
themselves, in the nature of the problem to be solved, or in
the knowledge of persons having ordinary skill in the field
at the time. There need not be an express or explicit
suggestion to combine references.35
In contrast, we provide below a portion of jury instructions for obviousness in a
recently tried case. As can be seen, they are clearly influenced by KSR.
Granting patent protection to advances that would occur in
the ordinary course without real innovation retards progress
and may, in the case of patents combining previously
known elements, deprive prior inventions of their value or
utility. A patent for a combination which only unites old
elements with no change in their respective functions
withdraws what is already known into the field of its
monopoly and diminishes the resources available to skillful
individuals. This is a principal reason for declining to allow
patents for what is obvious.
* * *
In placing yourself in the shoes of a person having ordinary
skill in this field of technology in the mid 1990s at the time
the inventions were made, you may, but do not have to,
consider whether such a person would have been motivated
to combine these prior art references in order to arrive at
the claimed inventions. The analysis need not seek out
precise teachings directed to the specific subject matter of
the challenged claim; instead, you can take account of the
inferences and creative steps that a person of ordinary skill
in the art would employ. Common sense teaches that
35
The Federal Circuit Bar Association Model Patent Jury Instructions § 4.3bv (2007).
20
21. familiar items may have obvious uses beyond their primary
purposes, and in many cases a person of ordinary skill will
be able to fit the teachings of multiple patents together like
pieces of a puzzle.
The combination of familiar elements according to known
methods is likely to be obvious when it does no more than
yield predictable results. When a work is available in one
field of endeavor, design incentives and other market forces
can prompt variations of it, either in the same field or a
different one. If a person of ordinary skill can implement a
predictable variation, it is likely to be obvious. For the
same reason, if a technique has been used to improve one
device, and a person of ordinary skill in the art would
recognize that it would improve similar devices in the same
way, using the technique is obvious unless its actual
application is beyond his or her skill.
When there is a design need or market pressure to
solve a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good
reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is
likely the product not of innovation but of ordinary skill
and common sense. In that instance the fact that a
combination was obvious to try might show that it was
obvious36
B. Summary Judgment
With higher case loads than ever, district courts are more apt to utilize summary
judgment to dispose of cases. According to one report, federal district courts conducted
about 3,600 civil trials in 2006, compared to 5,800 in 1962.37 Courts increasingly rely on
summary judgment, which was granted in about 9 percent of all cases. 38 Summary
judgment is particularly important in patent litigation. With the fact-intensive analysis of
obviousness, however, summary judgment has been seen as less available when the issue
is whether an invention is obvious.
After KSR, courts may be more willing to grant summary judgment of
obviousness in patent litigation. When the parties do not dispute any material facts, the
36
AOL Instructions from Two-Way Media LLC v. America Online, Inc., CV-04-089 (S.D. Tex.
2007).
37
See Adam Liptak, Cases Keep Flowing In, But The Jury Pool Is Idle, N.Y. TIMES, Apr. 30,
2007, at 14, 2007 WLNR 8118157.
38
Id.
21
22. obviousness determination should be decided by the court, not the jury.39 Indeed, the
Court in KSR held that summary judgment was appropriate.
Consider the recent result in Süd-Chemie, Inc. v. Multisorb Technologies, Inc.40
In this case, Süd-Chemie filed for infringement of its patent directed to “a laminated,
water vapor permeable dessicant packaging material.” In granting summary judgment
that the patent was invalid as obvious, Judge Charles R. Simpson, III applied “the newly
articulated ‘expansive and flexible’ approach” promulgated by the Supreme Court.
Notably, the district court referred liberally to KSR without citing to a single precedent
from the Federal Circuit. Moreover, and perhaps to the horror of some, the district court
found that the claimed invention did not “create some new synergy,” quoting the
Supreme Court in Anderson’s-Black Rock, Inc. v. Pavement Salvage Co.41
One of the immediate effects of KSR was the renewal of summary judgment
motions by parties involved in pending litigation. In any case in which a court had
denied summary judgment prior to KSR, a moving party was well-advised to renewing its
motion for summary judgment under the new legal standard. In certain cases, where the
non-moving party argued that the prior art gave no motivation to make the claimed
invention, the moving party would have a strong basis for the court to at least reconsider
the motion.
We have only word of mouth data on the impact of KSR concerning summary
judgment motions in on-going district court litigations. Based on what we have been told
from about a dozen patent litigators, summary judgment motions of obviousness have
been renewed in many cases post KSR and the frequency of such motions has increased.
This may indicate a sustainable trend in district court litigation.
C. Preliminary Injunctions
Assuming KSR has raised the bar to patentability, it has concomitantly lowered
the likelihood of obtaining a preliminary injunction. This result will make it more
challenging for a patentee successfully request that a court enjoin the accused infringer
from continuing the infringing activity once litigation has started.
As an example, consider the result in a patent infringement action in the Northern
District of California. In MMJK, Inc. v. Ultimate Blackjack Tour LLC,42 plaintiff asserted
a patent “directed to computer networked multi-player games of both chance and skill
that allow subscription-based and non-subscription players (using an “alternative method
39
Structural Rubber Prods. Co. v. Park Rubber Co., 749 F.2d 707, 721 (Fed. Cir. 1984) (“[B]efore
submitting the issue of obviousness to the jury, the court must consider whether there is an underlying
factual dispute on that issue. If there is none, the issue should not be given to the jury since the application
of the law to undisputed facts is for the court.”).
40
No. 3:03CV-29-S, 2007 WL 2669366 (W.D. Ky. Sept. 7, 2007).
41
396 U.S. 57 (1969).
42
MMJK, Inc. v. Ultimate Blackjack Tour LLC, No. C07-3236 BZ, 2007 WL 2428047 (N.D. Cal.
Aug. 22, 2007).
22
23. of entry”) a chance to win prizes that have immediate value (i.e., cash, cash-equivalent
notes and objects).” In denying plaintiff’s request for a preliminary injunction,
Magistrate Judge Bernard Zimmerman squarely recognized the effect of KSR on the
preliminary injunction “likelihood of success on the merits” prong. Citing KSR, Judge
Zimmerman noted that “if design needs or market pressures urge solution to a problem,
‘and there are a finite number of identified, predictable solutions, a person of ordinary
skill has good reason to pursue the known options.’”
Plaintiff had argued that the inclusion of “subscription and non-subscription-
based paying and non-paying players in one site distinguishes it from the previous art.”
But Judge Zimmerman opined that “[a]ll this amounts to, however, is a combination of
technology previously employed.” Thus, “[i]n light of the KSR case, plaintiff has failed
to demonstrate that it is likely to overcome defendant’s assertion that the . . . patent is
invalid as obvious.” Motion for preliminary injunction was denied.
IV. PTO
At a July 2007 CLE presentation in Northern Virginia, Chief Judge Fleming of
the Board of Patent Appeals and Interferences (“Board”) stated that “KSR has been a
huge change for the Board. It has turned things upside down.”43 To the PTO, KSR
represents a sea change in how both patent examiners and the Board deal with
obviousness rejections over a combination of prior art references. To date, that change
has been publicly reflected in several recent precedential Board decisions. Further,
internal guidelines on how obviousness is to be treated by the patent examining corps
have apparently been completed, training on them has been conducted, and the guidelines
are now awaiting approval by the Office of Management and Budget (“OMB”) at the
White Hosue before being officially announced. As explained further below, the PTO,
including the Board and corps of patent examiners, views KSR as mandating a return to
the well-tested factors in the classic Supreme Court decision in Graham v. John Deere.44
A. Patent Prosecution
As noted above, the internal guidelines for examination post-KSR are complete
and in use by the corps of examiners. The new guidelines will be made public when
OMB has completed its review. Anecdotal evidence and off-the-record discussion with
those responsible for drafting the new guidelines suggest that the obviousness analysis
will be refocused on the Graham factors. Further, the new guidelines and training
sessions apparently urge examiners to develop clearly delineated factual findings
regarding the scope and content of the prior art before applying those findings to the law.
The new guidelines apparently have substantial “buy-in” across the PTO organization.
43
“Winning Your Appeal at the Board of Patent Appeals and Interferences,” presented by Hon.
Michael Fleming, Chief Administrative Patent Judge, USPTO, at Hot Topics in Patent Law CLE at George
Mason University (July 17, 2007).
44
383 U.S. 1 (1966).
23
24. The well-known Graham factors include determining the scope and content of the
prior art, analyzing the differences between prior art and the recited invention and
determining the level of ordinary skill in the art. With these factual findings complete,
the examiner then determines whether the person of ordinary skill can bridge the gap
between the prior art and the claimed invention. The obviousness calculus has thus
shifted from an evidentiary debate rooted in the old teaching-suggestion-motivation to
combine (“TSM”) test, to a much more subjective approach epitomized in KSR and
Graham.
For applicants faced with a well-supported obviousness rejection, the Federal
Circuit’s first post-KSR obviousness case in Leapfrog Enterprises, Inc. v. Fisher-Price,
Inc.45 supra is highly instructive. Therein, the Federal Circuit relied in part on the fact
that Leapfrog had presented no evidence that the inclusion of a reader in the combined
device was “uniquely challenging or difficult for one of ordinary skill in the art’ or
‘represented an unobvious step over the prior art.” Therefore, just as examiners need to
fully articulate and support obviousness rejections, so should Applicants present well-
articulated evidence to the contrary.
In many cases, presenting such evidence may require assistance from the inventor
and/or increased reliance on technical experts via declarations under 37 C.F.R. § 1.132.
Further, technically sound specifications that explain why the purported invention is not
obvious will also be useful. Pre-KSR, a minimal background section was often preferred
in patent specifications by applicants wary of creating harmful estoppels. Now, a more
compelling background setting up the merits of the inventions and the challenges faced
by the applicant is likely preferable.
B. Board of Patent Appeals and Interferences46
With a set of three non-precedential decisions, the Board of Patent Appeals and
Interferences (“Board”) recently signaled a fairly dramatic shift in how it will deal with
the obviousness question post-KSR. In those cases, the Board has clearly raised the
obviousness bar at the PTO. These precedential decisions apply KSR across three major
technology areas—mechanical, electrical, and biotechnology. Drawing from the
Supreme Court's cues in KSR, the Board put forth an obviousness analysis that
emphasizes a functional approach based on the Graham factors. Those factors include
consideration of the scope and content of prior art, the differences between the prior art
and claimed invention, level of skill in the art and any secondary indicia of non-
obviousness.
In each case, the Board affirmed obviousness rejections based on combinations of
prior art references and highlighted significant areas where such combinations are more
likely to render a claimed invention obvious under KSR. Areas where combinations of
45
485 F.3d 1157 (Fed. Cir. 2007).
46
Selected portions of this section are excerpted from Michael V. Messinger & Jon E. Wright,
“The BPAI Returns to Graham v. John Deere,” IP Law 360 (July 25, 2007); and from Eric K. Steffe &
Elizabeth J. Haanes, “Patent Board Challenges Federal Circuit to a Deuel,” IP Law 360 (July 27, 2007).
24
25. prior art references are more likely to show obviousness include combinations based on
known methods or predictable uses, or which achieve predictable results. Under this
analysis as applied by the Board, combinations may be made to obtain the benefit of
known advancements or improvements which are within the creativity of one of ordinary
skill in the art. An explicit teaching, suggestion, or motivation need not be present in the
references themselves but remains a plus for supporting a combination.
Whether one agrees with the outcome of KSR or not, it is at the Patent and
Trademark Office where the rubber hits the road, and the Board’s decisions offer
significant insight on the PTO’s direction. We provide a brief analysis of the three
precedential board decisions below.
1. Ex parte Smith47
Ex parte Smith dealt with a mechanical invention directed to a pocket insert
integrated into a bound book. A first claim rejection under 35 U.S.C. § 103(a) was made
based on a combination of two U.S. patents. The appeal of the rejection turned on
“whether it would have been obvious to glue two separate sheets to form a continuous
two-ply seam . . . rather than folding one sheet to create a seam along the folded edge.”
Additional claims were rejected for being obvious based on the same two U.S. patents
and further in view of a third U.S. patent. This second rejection turned on “whether it
would have been obvious to improve a pocket insert by creating two pockets from a
single pocket using an additional line of adhesive.”
In affirming both obviousness decisions, the Board stated that the two references
“together teach that a pocket can be made by either method and yield a predictable
result.” The Board noted the appellants’ lack of evidence supporting a position against a
combination, such as, a showing that the combination would been quot;uniquely challenging
or difficult for one of ordinary skill in the art.”
2. Ex parte Catan48
Ex parte Catan dealt with an electrical arts invention directed to a consumer
electronics device that used bioauthentication methods to control access to sensitive
information. A single rejection was made under § 103(a) based on a combination of three
prior U.S. patents. A first U.S. patent forming the basis of the rejection purportedly
taught a consumer electronics device with a password authentication, but no
authentication information provided by a bioauthentication device. A second U.S. patent
was relied upon for teaching a bioauthentication device. A third U.S. patent was used as
a link to further teach the substitution of password (e.g., a PIN) authentication with
bioauthentication to access credit information. The Board affirmed the rejection under
47
Ex parte Smith, No. 2007-1925, 2007 WL 1813761 (B.P.A.I. June 25, 2007), available at
http://www.uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf.
48
Ex parte Catan, No. 2007-0820, 2007 WL 1934867 (B.P.A.I. July 3, 2007), available at
http://www.uspto.gov/web/offices/dcom/bpai/prec/fd070820.pdf.
25
26. § 103(a) based on all three patents, and further held the claims obvious over the first two
patents alone—even without the linking patent.
In Catan, the Board found that because “[a]dding bio-authentication to the [base
reference] does no more to [that] device than it would do if it were added to any other
device, the function remains the same.” The Board also found that bioauthentication
“predictably” adds greater security and reliability to an authorization process.
With respect to the linking patent reference in Catan, the Board demonstrated that
elements of the teaching, suggestion, motivation test (“TSM”) are still valid tools in the
obviousness calculus. The Board used the linking reference to buttress it obviousness
rejection based on the first two references stating that “one of ordinary skill would have
been motivated to combine the bioauthentication device of the [second reference] with
the system in the [primary reference] because the [linking reference] teaches that one can
substitute bioauthentication information for PIN information.” TSM thus remains a valid
tool for determining obviousness, but it is no longer the sin qua non of patentability for
combination inventions.
3. Ex parte Kubin49
In Ex parte Kubin, the Board affirmed an examiner's rejection of DNA claims as
being obvious and failing to meet the written description requirement, but overturned a
rejection for lack of enablement. The exemplary claim in Kubin’s patent application
recites “[a]n isolated nucleic acid molecule comprising a polynucleotide encoding a
polypeptide at least 80% identical to amino acids 22-221 of SEQ ID NO:2, wherein the
polypeptide binds CD48.” SEQ ID NO:2 is the amino acid sequence of human NK Cell
Activation Inducing Ligand NAIL (also referred to as p38 below), with amino acids 22 to
221 corresponding to the extracellular (exposed) portion of the protein.
Here, the polynucleotide claims were rejected during examination as being
obvious over three prior art references. The first described human p38 [NAIL]
polypeptide via its binding to monoclonal antibody C1.7, and suggests that a cDNA
encoding p38 could be cloned and sequenced by standard methods, such as those
described in the second cited reference, a standard molecular biology textbook. The third
reference disclosed the gene encoding the mouse ortholog of NAIL by sequence.
According to the examiner, the claims were obvious given the availability of a
monoclonal antibody to NAIL and routine methods for cloning and sequencing the
human NAIL cDNA. The Board affirmed, relying in part on the Supreme Court decision
in KSR.
The Board’s obviousness determination is arguably contrary to longstanding
Federal Circuit precedent relating to structural non-obviousness, exemplified by In re
Deuel. 50 In Deuel, as in Kubin, the claims were to an isolated polynucleotide which
49
Ex parte Kubin, No. 2007-0819, 2007 WL 2070495 (B.P.A.I. May 31, 2007), available at
http://www.uspto.gov/web/offices/dcom/bpai/prec/fd070819.pdf.
50
51 F.3d 1552 (Fed. Cir. 1995).
26
27. encodes a polypeptide. The polypeptide was in the prior art, and had been isolated,
purified and partially sequenced. The examiner rejected the polynucleotide claim based
on the isolated polypeptide, in view of standard methods to isolate and sequence cDNAs,
citing an earlier edition of the same textbook cited by the examiner in Kubin. The Board
affirmed, but the Federal Circuit reversed, noting that “a conceived method of preparing
some undefined DNA does not define it with the precision necessary to render it obvious
over the protein it encodes.”
The Board in Kubin justified the departure from precedent in part by noting that
“Deuel is not controlling and thus does not stand in the way of our conclusion, given the
increased level of skill in the art and the factual differences.” However, virtually no
factual distinctions or analysis of the level of skill in the art is provided by the Board in
support of this conclusion.
Granted, certain factual distinctions can be made, and the level of skill in
molecular biology no doubt advanced between 1990, the filing date of Deuel, and Kubin's
filing in 2000. Nonetheless, the methodologies and level of skill pertinent to cDNA
cloning have remained relatively unchanged. For example, the prior art in Deuel
identified the isolated protein and a partial N-terminal sequence, which allowed
construction of a hybridization probe used to isolate the cDNA (quot;hybridization cloningquot;).
In contrast, the prior art in Kubin identified the isolated protein and a monoclonal
antibody which bound to the protein, allowing isolation of a cDNA clone from an
expression library via antibody screening (“expression cloning”).
Expression cloning and hybridization cloning, as well as polynucleotide
sequencing, were well established, routine procedures by the mid 1980s, well before
Deuel's filing in 1990. Thus, no apparent groundbreaking advances in the art occurred to
make the isolation of the cDNA by Kubin any more predictable than the isolation of the
cDNA by Deuel. Accordingly, it is unclear how factual differences or an increased level
of skill in the art justify the Board’s conclusion that Deuel is not controlling.
The Board attempted to further cast doubt on the viability of Deuel by arguing
that the Supreme Court in KSR left the door open to more liberal use of the “obvious to
try” standard. Indeed, according to the Supreme Court, where “there are a finite number
of identified, predictable solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp.” Based on this statement, the Board
concluded that the “obvious to try” standard was applicable because quot;[t]he 'problem'
facing those in the art was to isolate NAIL cDNA, and there were a limited number of
methodologies available to do so.”
However, the “problem to be solved” in Kubin was not a method of isolating
NAIL cDNA, rather the problem was the structure of the NAIL cDNA. The prior art
provided absolutely no structure, e.g., amino acid or polynucleotide sequence, by which a
human NAIL cDNA could be inferred. Thus, it did not provide any identified predictable
solutions, let alone a finite number of identified, predictable solutions to the problem.
Where KSR may have opened the door, nothing in the KSR opinion mandated dispensing
with the need for at least some structural similarity in the prior art.
27
28. 4. Ex parte Lyons51
Ex parte Lyons is a non-precedential decision we feel also deserves attention. The
disclosed invention related generally to an apparatus and method for detecting small
distances in the context of proximity sensing using gas flow. Four references were used
to make six separate obviousness rejections under 35 U.S.C. § 103(a). In each case,
Barada was the main reference, with Carraras and Zumbach the primary secondary
references.
The appellant argued, among other things, that there was no motivation to
combine certain references because (1) Carraras and Zumbach were non-analogous art to
the claimed invention, (2) the examiner relied on impermissible hindsight, and (3) the
applied references do not solve the same problem presented by the inventor. For each of
these three well-tested arguments for rebutting an obviousness rejection, the Board
pointed to KSR to illustrate how the Supreme Court had in some way cut back on their
efficacy.
With respect to the non-analogous art argument, the Board pointed to KSR, where
the Supreme Court stated that:
When a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of
it, either in the same field or a different one. If a person of
ordinary skill in the art can implement a predictable
variation, section 103 likely bars its patentability. For the
same reason, if a technique has been used to improve one
device, and a person of ordinary skill in the art would
recognize that it would improve similar devices in the same
way, using the technique is obvious unless its actual
application is beyond his or her skill.52
Without discussing in detail the merits of the non-analogous art argument, the Board
stated that “we agree with the Examiner that the expanded coverage area of the variant
elongated or rectangular nozzles of Carreras and Zumbach would have been recognized
by a person of ordinary skill in the art as an improvement over the conventional nozzle
orifices taught by Barada, given the limited surface area covered by Barada’s
conventional nozzle orifice.”
With respect to the hindsight argument, the Board again pointed to KSR and noted
that “the U.S. Supreme Court reaffirmed that ‘[a] factfinder should be aware, of course,
of the distortion caused by hindsight bias and must be cautious of arguments reliant upon
ex post reasoning.’ Nevertheless, in KSR the Supreme Court also qualified the issue of
hindsight by stating that ‘[r]igid preventative rules that deny factfinders recourse to
51
Appeal No. 2007-1570 (B.P.A.I. July 31, 2007).
52
KSR, 127 S. Ct. at 1740 (emphasis added).
28
29. common sense, however, are neither necessary under our case law nor consistent with
it’”53
With respect to the appellant’s third argument regarding the problem to be solved,
the Board again pointed to KSR stating that “any need or problem known in the field and
addressed by the patent can provide a reason for combining the elements in the manner
claimed.” Citing KSR, the Board noted that
[t]he flaws in the Federal Circuit’s analysis relate mostly to
its narrow conception of the obviousness inquiry
consequent in its application of the TSM test. The Circuit
first erred in holding that courts and patent examiners
should look only to the problem the patentee was trying to
solve. Under the correct analysis, any need or problem
known in the field and addressed by the patent can provide
a reason for combining the elements in the manner
claimed.54
In sum, the Board is using KSR not only to reject the prior TSM test but also to
weaken the efficacy of other well-tested arguments applicants have used to rebut
obviousness rejections.
5. Analysis of Board Decisions
When viewed generally, Catan, Smith, Kubin, and Lyons provide guidance to both
examiners and applicants in dealing with the obviousness question under the framework
of Graham. For examiners, obviousness rejections must be fully articulated and well-
supported. Citing KSR, the Board stated that to facilitate review, the obvious analysis
“should be made explicit.” Like the Supreme Court, the Board also pointed to the
Federal Circuit’s decision in In re Kahn,55 which stated that “[r]ejections on obviousness
grounds cannot be sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal conclusion of
obviousness.”
While the Board still requires examiners to articulate obviousness rejections, it
has made the analysis more subjective and less rooted in the literal language of the prior
art references themselves. In view of this more subjective approach, the Board takes care
to require fully developed obviousness determinations lest rejections become entirely
subjective and disputes devolve into unproductive, non-substantive, and essentially
unreviewable arguments. Applicants should hold examiners to this standard and demand
well-reasoned and fully articulated rejections.
53
Slip op. at 5-6.
54
KSR, 127 S.Ct. at 1732.
55
441 F.3d 977 (Fed. Cir. 2006).
29
30. C. Patent Reexaminations and the Central Reexamination Unit
Over the past several years, the role of patent reexaminations has increased as
parties have recognized the value of asking the PTO to reexamine a patent that is or will
be involved in litigation. KSR will probably increase the attractiveness of
reexaminations, especially where the prosecution history reveals that the applicant
overcame an obviousness rejection using the now discredited teaching-suggestion-
motivation analysis.
The Central Reexamination Unit (“CRU”) is a PTO entity created in 2005 which
is charged with conducting all reexaminations before the PTO. For the CRU to grant a
reexamination request, the applicant must convince the CRU that there is substantial new
question (“SNQ”) of patentability.56 From the above discussion, it should be clear that
the PTO views KSR as affecting a sea change to the obviousness calculus. Because the
obviousness standard is retroactive, the practical reality is that an SNQ of patentability
likely exists for nearly every issued patent that faced and overcame an obviousness
rejection based on a combination of prior art references. This is especially true where the
patent applicant relied on the old teaching-suggestion-motivation to combine test in
overcoming the obviousness rejection.
Facing a potential flood of challenges to issued patents in view of KSR, the CRU
will need to adopt standards by which the judge whether an SNQ exists vis-à-vis an
applicant relying solely on KSR and previously reviewed prior art combinations. Based
on our off-the-record conversations with PTO officials, the CRU has not yet developed
those standards. Realistically and practically speaking, however, a reexamination
applicant will likely have to do more than simply point to KSR and a previously
considered prior art combinations. The minimum threshold for raising a SNQ based
solely on previously considered prior art seems to be that this prior art most be viewed in
“a new light.” A full development of the obviousness arguments will likely be required
and reexamination applicants should expect the CRU to exercise its discretion in finding
a SNQ of patentability in these circumstances.
D. Report from the Trenches
Finally, in trying to determine KSR’s actual effect on patent prosecution, we
surveyed experienced patent attorneys and agents actively involved in the prosecution of
U.S. patent applications at the PTO to get their feedback. The practitioners who are
representing inventors before the PTO are likely to experience the most immediate
impact of KSR. While our survey is admittedly unscientific, and no judge should ever let
this into evidence, the responses have value at least because they provide some insight
into the practitioner’s perception of KSR. That perception may affect the advice provided
to the client, which in turn may affect whether a client files or continues prosecution of a
given patent application.
56
See 37 C.F.R. § 1.515.
30
31. Our survey received 32 responses from patent attorneys and agents who believed
they had had enough prosecution experiences involving obviousness since KSR to
comment meaningfully about what they saw as happening in prosecution. Obviously (no
pun intended) this is not a statistically significant sample based on the almost one million
pending patent applications at the PTO. But we believe it does provide some anecdotal
data on what is already happening with the examiners in patent applications covering a
myriad of technologies.
1. What is the primary technology in which you prosecute patents?
Our responses included practitioners who focus on a wide variety of technologies,
including biotechnology, electronics, nanotechnology, pharmaceuticals, software,
business methods, and others.
2. Since KSR, have you experienced any increase in the frequency
of obviousness rejections? If so, quantify the increase as best
you can.
Based on the responses, it is probably too early to quantify any increase in
obviousness rejections according to the bulk of respondents. However, several did
comment that they though there was a significant likelihood that an examiner would
impose an obviousness rejection in every case based on the post KSR standard where an
examiner could use more than two reference—conceivably three to six references—in
making a sustainable obviousness combination.
3. Have you noticed any change in the nature of obviousness
rejections since KSR? If so, describe the change.
Many respondents stated is was too early to tell. However, several did comment
that it appears that examiners have “been emboldened” in making obviousness rejections
and a less “likely to give in to non-obviousness” arguments, forcing cases to appeal.
4. What is the most common evidence of prior art now being cited
by examiners who raise obviousness objections? Patents,
publications, examiner statements of what was known to
artisans?
Most respondents stated that patents and printed publications were by far the most
common evidence of prior art. Whether they are patents or printed publications appears
to depend on the technical field of the claimed invention. We note that this could be
driven by how innovation is documented in a field or by the search resources at the PTO.
Some examiners seem to be taking “examiner notice” of what artisans of ordinary skill
know in the field of the claimed invention.
31
32. 5. Have you noticed any increase since KSR in examiners filing
declarations under 37 CFR 1.104(d)(2) (see MPEP 2144.03)? If
so, quantify the increase as best you can.
No respondent has had an examiner file a declaration as part of a rejection.
Rather, the examiners are just articulating what artisans of ordinary skill know in the field
of the claimed invention.
6. Has your success in rebutting obviousness rejections changed at
all since KSR? If so, how?
Most comment that it is too early to tell since they have not received Office
Actions responding to their Amendments or Responses conducted under the post-KSR
regime. However, many comment that they expect their success rates to drop because
they are uncertain what arguments or evidence will be persuasive. Moreover, many
comment that they expect the frequency of appeals to the Board to go up in routine
prosecution. One final point is the great concern about whether that the new PTO rules
on Claims and Continuations will further reduce the practical ability to overcome
obviousness rejections in many circumstances.
7. Has the nature of your responses to obviousness rejections
changed since KSR? If so, how?
Answers to this question indicated that KSR has an immediate and significant
impact on how patent applicants respond to rejections. First, the respondents suggest that
a response to an obviousness rejection is less likely to rely on, at least solely, an argument
based on an alleged lack of motivation in the prior art to achieve the claimed invention.
Likewise, the respondents suggest that responses to obviousness arguments now contain
more comprehensive replies and more often contain arguments based on a teaching away
or unexpected results.
Second, some respondents indicated that it is now advisable to strategize about
the reply to the rejections more quickly after receiving the rejection. In the past, perhaps
clients and attorneys alike felt that certain rejections could be prepared without much
strategizing because the response would largely comprise legal arguments as to why no
motivation existed. Now, however, the responses suggest that early strategizing is
important. With a diminished ability to argue no motivation to combine (or at least a
perception thereof), applicants and their attorneys will likely need more time to determine
whether factual evidence of nonobviousness, e.g., unexpected results, needs to be
developed or gathered.
8. Has there been any significant increase in the time needed to
obtain an allowance since KSR? If so, quantify the increase as
best you can.
Most respondents says it is too early to tell. But some speculated that they believe
the time needed will go up. One even predicted 50% on average.
32
